Delaware | 1-1136 | 22-0790350 | ||
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification Number) |
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition. |
Item 9.01. Financial Statements and Exhibits. |
99.1 | Press release of Bristol-Myers Squibb Company dated January 28, 2016. |
99.2 | Certain supplemental information posted on Bristol-Myers Squibb Company’s website at www.bms.com not included in the press release. |
BRISTOL-MYERS SQUIBB COMPANY | |||||
Dated: January 28, 2016 | By: | /s/ Katherine R. Kelly | |||
Name: | Katherine R. Kelly | ||||
Title: | Corporate Secretary |
Exhibit No. | Description |
99.1 | Press release of Bristol-Myers Squibb Company dated January 28, 2016. |
99.2 | Certain supplemental information posted on Bristol-Myers Squibb Company’s website at www.bms.com not included in the press release. |
• | Increases Fourth Quarter Revenues 1% to $4.3 Billion, 4% for Full Year to $16.6 Billion |
• | Posts Fourth Quarter GAAP Loss Per Share of $0.08 and Non-GAAP EPS of $0.38 |
• | Achieves Significant Regulatory Milestones in Immuno-Oncology |
◦ | Opdivo Approved in the U.S. for Advanced Renal Cell Carcinoma and for First-Line Treatment of BRAF v600 Wild-Type Metastatic Melanoma |
◦ | Opdivo + Yervoy Regimen Approved for Metastatic Melanoma Across BRAF Status |
◦ | Empliciti Approved in the U.S. for Combination Treatment for Multiple Myeloma |
◦ | Validation in Europe of Application for Opdivo in Renal Cell Carcinoma |
◦ | Early Stop of CheckMate -141, a Phase 3 Study Evaluating Opdivo in Patients with Head and Neck Cancer, After Data Demonstrates Superior Overall Survival |
• | Provides 2016 GAAP and Non-GAAP EPS Guidance Range of $2.30 to $2.40 |
Fourth Quarter | ||||||||||
$ amounts in millions, except per share amounts | ||||||||||
2015 | 2014 | Change | ||||||||
Total Revenues | $ | 4,287 | $ | 4,258 | 1 | % | ||||
GAAP Diluted EPS | (0.08 | ) | 0.01 | ** | ||||||
Non-GAAP Diluted EPS | 0.38 | 0.46 | (17 | )% |
Full Year | ||||||||||
$ amounts in millions, except per share amounts | ||||||||||
2015 | 2014 | Change | ||||||||
Total Revenues | $ | 16,560 | $ | 15,879 | 4 | % | ||||
GAAP Diluted EPS | 0.97 | 1.20 | (19 | )% | ||||||
Non-GAAP Diluted EPS | 2.01 | 1.85 | 9 | % |
• | Bristol-Myers Squibb posted fourth quarter 2015 revenues of $4.3 billion, an increase of 1% compared to the same period a year ago. Global revenues increased 6% adjusted for foreign exchange impact. |
• | U.S. revenues increased 9% to $2.3 billion in the quarter compared to the same period a year ago. International revenues decreased 7%. When adjusted for foreign exchange impact, international revenues increased 3%. |
• | Gross margin as a percentage of revenues was 77.8% in the quarter compared to 77.3% in the same period a year ago. |
• | Marketing, selling and administrative expenses, which includes advertising and product promotion expenses, increased 10% to $1.5 billion in the quarter. |
• | Research and development expenses increased 61% to $1.9 billion in the quarter due to higher charges resulting from business development transactions and an in-process research and development (IPRD) impairment. |
• | The effective tax benefit rate was 59.7% in the quarter, compared to 145.0% in the fourth quarter last year. Income taxes in both periods include net tax benefits attributed to specified items and the R&D credit for the full year. |
• | The company reported a net loss attributable to Bristol-Myers Squibb of $138 million, or $0.08 per share, in the quarter compared to net earnings of $13 million, or $0.01 per share, a year ago. Results in the current quarter include charges resulting from the Five Prime Therapeutics, Inc. and Cardioxyl Pharmaceuticals, Inc. business development transactions ($0.24 per share after tax) and non-cash charges resulting from an IPRD impairment for BMS-986020, an investigational oral lysophosphatidic acid 1 receptor antagonist, in fibrosis and the transfer of the Erbitux business in North America to Eli Lilly and Company ($0.14 per share after tax). |
• | The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $647 million, or $0.38 per share, in the fourth quarter, compared to $771 million, or $0.46 per share, for the same period in 2014. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section. |
• | Cash, cash equivalents and marketable securities were $8.9 billion, with a net cash position of $2.2 billion, as of December 31, 2015. |
• | In January, the company announced that a randomized Phase 3 study evaluating Opdivo versus investigator’s choice in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck (CheckMate -141) was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint, demonstrating superior overall survival (OS) in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon. |
• | In January, the company announced the U.S. Food and Drug Administration (FDA) has approved Opdivo in combination with Yervoy for the treatment of patients with BRAF v600 wild-type (WT) and BRAF v600 mutation-positive unresectable or metastatic melanoma. This approval expands the original indication for the Opdivo + Yervoy Regimen for the treatment of patients with BRAF v600 WT unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 trial which evaluated progression-free survival (PFS) and OS as co-primary endpoints. This indication is approved under accelerated approval based on PFS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. |
• | In December, the company and its partner Ono Pharmaceutical Co. Ltd., announced that Ono received manufacturing and marketing approval for Opdivo in Japan for the treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer. |
• | In December, the company, and its partner Seattle Genetics, Inc. announced the companies have initiated a Phase 1/2 clinical trial of ADCETRIS® (brentuximab vedotin) in combination with Opdivo for patients with CD30-expressing relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma, peripheral T-cell lymphoma and cutaneous T-cell lymphoma. This is the second of two trials being conducted under a previously announced clinical trial collaboration agreement between the company and Seattle Genetics, Inc. |
• | In November, the company announced the FDA approved Opdivo injection, for intravenous use, for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. Opdivo is the first and only PD-1 inhibitor to deliver significant OS in patients with advanced RCC who have received prior anti-angiogenic therapy. The approval, which was granted Breakthrough Therapy Designation by the FDA, was based on data from CheckMate -025, an open-label, randomized Phase 3 study evaluating Opdivo versus everolimus in patients with advanced RCC who have received prior anti-angiogenic therapy. |
• | In November, the company announced the FDA approved Opdivo injection, for intravenous use, as a single-agent for the treatment of patients with BRAF v600 WT unresectable or metastatic melanoma. The approval is based on data from the Phase 3 trial, CheckMate -066, which evaluated OS as the primary endpoint in treatment-naïve patients with BRAF WT unresectable or metastatic melanoma compared to chemotherapy (dacarbazine). Separately, the company announced the FDA issued a Complete Response Letter for its supplemental Biologics License Application (sBLA) for Opdivo as a single agent for the treatment of previously untreated patients, specifically those with BRAF v600 mutation positive unresectable or metastatic melanoma. The company submitted data for Opdivo in BRAF v600 mutation-positive metastatic melanoma, which was the subject of the FDA’s Complete Response Letter. |
• | In November, the company announced that the European Medicines Agency (EMA) validated a type II variation application which seeks to extend the current indication for Opdivo to include the treatment of adult patients with advanced RCC after prior therapy. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process. The type II variation submitted is based on data from CheckMate -025, a Phase 3 study that evaluated, as the primary endpoint, the OS of Opdivo versus everolimus, a current standard of care, in advanced or metastatic clear-cell RCC after prior anti-angiogenic treatment. |
• | In November, the company announced results from multiple clinical trials at the Society for Melanoma Research 2015 International Congress in San Francisco, California. |
◦ | CheckMate -066 - In the study evaluating Opdivo as a single agent versus dacarbazine in patients with previously untreated, BRAF WT unresectable or metastatic melanoma, Opdivo continued to demonstrate superior OS versus dacarbazine with 57.7% of patients alive at two years compared to 26.7% of patients treated with dacarbazine. The safety profile of Opdivo was consistent with prior studies. |
◦ | Study 004 - In the study evaluating Opdivo in combination with Yervoy in patients with unresectable or metastatic melanoma on which the proof of concept for Opdivo + Yervoy regimen approval was based, data from the longest follow-up of the regimen from various Phase 1 cohorts showed a three-year OS rate of 68% across Phase 1 dosing cohorts. The frequency of treatment-related adverse events (AE) in the study were similar between cohorts and was consistent with the Phase 2 and 3 trials for the combination therapy. |
• | In October, the company announced the FDA approved Yervoy 10 mg/kg for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection including total lymphadenectomy. The approval is based on clinical data from a pivotal Phase 3 trial, CA184-029 (EORTC 18071), initiated in 2008 by the European Organization for Research and Treatment of Cancer evaluating the 10 mg/kg dose in the adjuvant setting. |
• | In November, the company and its partner AbbVie, Inc. announced the FDA approved Empliciti for the treatment of multiple myeloma as combination therapy with Revlimid® and dexamethasone in patients who have received one to three prior therapies. The approval of this first and only immunostimulatory antibody for multiple myeloma is based on data from the randomized, open-label, Phase 3, ELOQUENT-2 study, which demonstrated the combination of Empliciti with Revlimid and dexamethasone delivered a 30% reduction in the risk of disease progression or death compared to dexamethasone alone. |
• | In December, the company announced extended follow-up data and a pre-specified interim OS analysis of Empliciti in combination with Revlimid® and dexamethasone in patients with relapsed or refractory multiple myeloma from ELOQUENT-2. The follow-up data demonstrated a 44% relative improvement in PFS at three years, which was consistent with the pivotal two-year analysis. The Empliciti combination delayed the need for subsequent myeloma therapy by a median of one year compared to dexamethasone alone. Data were presented at the 57th American Society of Hematology Annual Meeting and Exposition in Orlando, Florida. |
• | In November, the company announced results from the Phase 3 ALLY-3+ trial investigating a regimen of Daklinza in combination with sofosbuvir and ribavirin in genotype 3 hepatitis C patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. The results show that 100% of patients in the advanced fibrosis cohort achieved sustained virologic response (SVR12) in both the 12- and 16-week arms of the study. SVR12 rates were 83% and 89% in patients with cirrhosis in the 12- and 16-week arms, respectively. The combination regimen had no discontinuations due to adverse events and relapse occurred in four patients (two in the 16-week and two in the 12-week arm). There was one death (12-week arm; not treatment-related) and no virologic breakthroughs. Results were presented at The Liver Meeting 2015, the annual meeting of The American Association for the Study of Liver Diseases in San Francisco, California. |
• | In December, the company and its partner Pfizer, Inc. announced results from a post-hoc subanalysis of the Phase 3 AMPLIFY trial. Results demonstrated that Eliquis was comparable to conventional therapy (subcutaneous enoxaparin overlapped and followed by oral warfarin dose-adjusted to an international normalized ratio of 2.0 to 3.0) in recurrent venous thromboembolism (VTE) and VTE-related death. There was significantly less major bleeding during the first 7, 21 and 90 days after starting treatment. The data were published in Thrombosis and Haemostasis. |
• | In December, the company announced it has entered into agreements with ViiV Healthcare, a global HIV company, to divest its pipeline of investigational HIV medicines including an attachment inhibitor (BMS-663068), currently being investigated in Phase 3 as a therapeutic option for heavily treatment-experienced patients, and a maturation inhibitor (BMS-955176) currently being investigated in Phase 2b development for treatment-naïve and treatment-experienced patients. These transactions are consistent with the evolution of the company’s strategic focus, including the decision announced in June to discontinue its discovery efforts in virology. |
• | In December, the company announced a new research collaboration with the Department of Chemistry at Princeton University that includes the establishment of the Center for Molecular Synthesis (BMS-CMS). The agreement creates opportunities for scientists at Princeton University and the company to collaborate on top-flight synthetic chemistry research, leveraging the two sites’ close proximity to foster a robust exchange of scientific ideas. Research projects will investigate areas of mutual interest and benefit, using the expertise developed in the laboratories of the Princeton faculty to conduct frontier science within the pharmaceutical industry. Over the next five years, the Center will also fund a select group of research fellows each year. |
• | In November, the company announced a definitive agreement to acquire all of the issued and outstanding capital stock of Cardioxyl Pharmaceuticals, Inc., a private biotechnology company focused on the discovery and development of novel therapeutic agents for the treatment of cardiovascular disease. The company completed the acquisition in December. The acquisition gives the company full rights to Cardioxyl’s lead asset CXL-1427, a novel nitroxyl (HNO) donor (prodrug) in Phase 2 clinical development as an intravenous treatment for acute decompensated heart failure. |
• | In November, the company completed a previously announced agreement with Five Prime Therapeutics, Inc. for an exclusive worldwide license and collaboration agreement for the development and commercialization of Five Prime’s colony stimulating factor 1 receptor (CSF1R) antibody program, including FPA008, which is in Phase 1 development for immunology and oncology indications. |
• | The company announced several collaborations as part of the Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the U.S.: |
◦ | In December, the company announced an agreement with the David Geffen School of Medicine at UCLA to conduct a range of early phase clinical studies. The company will fund positions within UCLA’s fellowship program in the UCLA Division of Hematology/Oncology. |
◦ | In December, the company announced an agreement with The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute to conduct a range of early phase clinical studies. The company will fund training positions within the Hematology and Medical Oncology fellowship programs of the Ohio State University College of Medicine, Department of Internal Medicine. |
◦ | In November, the company announced an agreement with The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins to conduct a range of early phase clinical studies. The company will also fund positions within The Johns Hopkins University School of Medicine fellowship program. |
• | Worldwide revenues increasing in the mid-single digit range. |
• | Full-year gross margin as a percentage of revenues to be approximately 75% - 76%. |
• | Marketing, sales and administrative expenses decreasing in the mid-single digit range. |
• | Research and development expenses increasing in the high-single digit range. |
• | An effective tax rate between 21% and 22%. |
Worldwide Revenues | U.S. Revenues | |||||||||||||||||||||
2015 | 2014 | % Change | 2015 | 2014 | % Change | |||||||||||||||||
Three Months Ended December 31, | ||||||||||||||||||||||
Key Products | ||||||||||||||||||||||
Virology | ||||||||||||||||||||||
Baraclude | $ | 309 | $ | 341 | (9 | )% | $ | 27 | $ | 21 | 29 | % | ||||||||||
Hepatitis C Franchise | 458 | 207 | ** | 212 | — | N/A | ||||||||||||||||
Reyataz Franchise | 272 | 318 | (14 | )% | 142 | 176 | (19 | )% | ||||||||||||||
Sustiva Franchise | 312 | 407 | (23 | )% | 269 | 340 | (21 | )% | ||||||||||||||
Oncology | ||||||||||||||||||||||
Empliciti | 3 | — | N/A | 3 | — | N/A | ||||||||||||||||
Erbitux(a) | — | 181 | (100 | )% | — | 171 | (100 | )% | ||||||||||||||
Opdivo | 475 | 5 | ** | 410 | 1 | ** | ||||||||||||||||
Sprycel | 429 | 398 | 8 | % | 228 | 184 | 24 | % | ||||||||||||||
Yervoy | 265 | 366 | (28 | )% | 164 | 199 | (18 | )% | ||||||||||||||
Neuroscience | ||||||||||||||||||||||
Abilify(b) | 39 | 476 | (92 | )% | 7 | 423 | (98 | )% | ||||||||||||||
Immunoscience | ||||||||||||||||||||||
Orencia | 540 | 443 | 22 | % | 372 | 289 | 29 | % | ||||||||||||||
Cardiovascular | ||||||||||||||||||||||
Eliquis | 602 | 281 | ** | 335 | 136 | ** | ||||||||||||||||
Mature Products and All Other | 583 | 835 | (30 | )% | 94 | 142 | (34 | )% | ||||||||||||||
Total | 4,287 | 4,258 | 1 | % | 2,263 | 2,082 | 9 | % | ||||||||||||||
Total Excluding Diabetes Alliance | 4,262 | 4,211 | 1 | % | 2,263 | 2,086 | 8 | % |
** | In excess of +/- 100% |
(a) | Erbitux is a trademark of ImClone LLC. ImClone LLC is a wholly-owned subsidiary of Eli Lilly and Company. |
(b) | Abilify is a trademark of Otsuka Pharmaceutical Co., Ltd. |
Worldwide Revenues | U.S. Revenues | |||||||||||||||||||||
2015 | 2014 | % Change | 2015 | 2014 | % Change | |||||||||||||||||
Twelve Months Ended December 31, | ||||||||||||||||||||||
Key Products | ||||||||||||||||||||||
Virology | ||||||||||||||||||||||
Baraclude | $ | 1,312 | $ | 1,441 | (9 | )% | $ | 135 | $ | 215 | (37 | )% | ||||||||||
Hepatitis C Franchise | 1,603 | 256 | ** | 323 | — | N/A | ||||||||||||||||
Reyataz Franchise | 1,139 | 1,362 | (16 | )% | 591 | 689 | (14 | )% | ||||||||||||||
Sustiva Franchise | 1,252 | 1,444 | (13 | )% | 1,041 | 1,118 | (7 | )% | ||||||||||||||
Oncology | ||||||||||||||||||||||
Empliciti | 3 | — | N/A | 3 | — | N/A | ||||||||||||||||
Erbitux | 501 | 723 | (31 | )% | 487 | 682 | (29 | )% | ||||||||||||||
Opdivo | 942 | 6 | ** | 823 | 1 | ** | ||||||||||||||||
Sprycel | 1,620 | 1,493 | 9 | % | 829 | 671 | 24 | % | ||||||||||||||
Yervoy | 1,126 | 1,308 | (14 | )% | 602 | 709 | (15 | )% | ||||||||||||||
Neuroscience | ||||||||||||||||||||||
Abilify | 746 | 2,020 | (63 | )% | 600 | 1,572 | (62 | )% | ||||||||||||||
Immunoscience | ||||||||||||||||||||||
Orencia | 1,885 | 1,652 | 14 | % | 1,271 | 1,064 | 19 | % | ||||||||||||||
Cardiovascular | ||||||||||||||||||||||
Eliquis | 1,860 | 774 | ** | 1,023 | 404 | ** | ||||||||||||||||
Mature Products and All Other | 2,571 | 3,400 | (24 | )% | 460 | 591 | (22 | )% | ||||||||||||||
Total | 16,560 | 15,879 | 4 | % | 8,188 | 7,716 | 6 | % | ||||||||||||||
Total Excluding Diabetes Alliance | 16,364 | 15,584 | 5 | % | 8,185 | 7,606 | 8 | % |
** | In excess of +/- 100% |
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Net product sales | $ | 3,862 | $ | 3,240 | $ | 14,045 | $ | 11,660 | ||||||||
Alliance and other revenues | 425 | 1,018 | 2,515 | 4,219 | ||||||||||||
Total Revenues | 4,287 | 4,258 | 16,560 | 15,879 | ||||||||||||
Cost of products sold | 952 | 966 | 3,909 | 3,932 | ||||||||||||
Marketing, selling and administrative(a) | 1,501 | 1,364 | 4,841 | 4,822 | ||||||||||||
Research and development | 1,916 | 1,189 | 5,920 | 4,534 | ||||||||||||
Other (income)/expense | 238 | 799 | (277 | ) | 210 | |||||||||||
Total Expenses | 4,607 | 4,318 | 14,393 | 13,498 | ||||||||||||
Earnings/(Loss) Before Income Taxes | (320 | ) | (60 | ) | 2,167 | 2,381 | ||||||||||
Provision for/(Benefit from) Income Taxes | (191 | ) | (87 | ) | 477 | 352 | ||||||||||
Net Earnings/(Loss) | (129 | ) | 27 | 1,690 | 2,029 | |||||||||||
Net Earnings Attributable to Noncontrolling Interest | 9 | 14 | 66 | 25 | ||||||||||||
Net Earnings/(Loss) Attributable to BMS | $ | (138 | ) | $ | 13 | $ | 1,624 | $ | 2,004 | |||||||
Average Common Shares Outstanding: | ||||||||||||||||
Basic | 1,669 | 1,660 | 1,667 | 1,657 | ||||||||||||
Diluted | 1,669 | 1,673 | 1,679 | 1,670 | ||||||||||||
Earnings/(Loss) per Common Share | ||||||||||||||||
Basic | $ | (0.08 | ) | $ | 0.01 | $ | 0.97 | $ | 1.21 | |||||||
Diluted | $ | (0.08 | ) | $ | 0.01 | $ | 0.97 | $ | 1.20 | |||||||
Other (Income)/Expense | ||||||||||||||||
Interest expense | $ | 43 | $ | 53 | $ | 184 | $ | 203 | ||||||||
Investment income | (27 | ) | (30 | ) | (101 | ) | (101 | ) | ||||||||
Provision for restructuring | 68 | 91 | 118 | 163 | ||||||||||||
Litigation charges | 55 | 4 | 69 | 23 | ||||||||||||
Equity in net income of affiliates | (16 | ) | (26 | ) | (83 | ) | (107 | ) | ||||||||
Out-licensed intangible asset impairment | — | 11 | 13 | 29 | ||||||||||||
(Gain)/Loss on sale of businesses, product lines and assets | 174 | 3 | (196 | ) | (564 | ) | ||||||||||
Other alliance and licensing income | (156 | ) | (50 | ) | (628 | ) | (404 | ) | ||||||||
Pension charges | 49 | 740 | 160 | 877 | ||||||||||||
Loss on debt redemption | — | — | 180 | 45 | ||||||||||||
Other | 48 | 3 | 7 | 46 | ||||||||||||
Other (income)/expense | $ | 238 | $ | 799 | $ | (277 | ) | $ | 210 |
(a) | Includes advertising and product promotion expenses of $330 million and $213 million for the three months ended December 31, 2015 and 2014, respectively, and $825 million and $734 million for the twelve months ended December 31, 2015 and 2014, respectively. |
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Cost of products sold(a) | $ | 10 | $ | 31 | $ | 84 | $ | 151 | ||||||||
Additional year of Branded Prescription Drug Fee | — | — | — | 96 | ||||||||||||
Process standardization implementation costs | 4 | 1 | 10 | 9 | ||||||||||||
Marketing, selling and administrative | 4 | 1 | 10 | 105 | ||||||||||||
License and asset acquisition charges | 554 | 50 | 1,679 | 278 | ||||||||||||
IPRD impairments | 160 | — | 160 | 343 | ||||||||||||
Other | 27 | — | 44 | — | ||||||||||||
Research and development | 741 | 50 | 1,883 | 621 | ||||||||||||
Provision for restructuring | 65 | 91 | 115 | 163 | ||||||||||||
(Gain)/Loss on sale of businesses, product lines and assets | 171 | 3 | (187 | ) | (559 | ) | ||||||||||
Pension charges | 49 | 740 | 160 | 877 | ||||||||||||
Acquisition and alliance related items(b) | — | — | (123 | ) | 72 | |||||||||||
Litigation charges | 53 | 15 | 68 | 27 | ||||||||||||
Out-licensed intangible asset impairment | — | 11 | 13 | 11 | ||||||||||||
Loss on debt redemption | — | — | 180 | 45 | ||||||||||||
Upfront, milestone and other licensing receipts | — | (10 | ) | — | (10 | ) | ||||||||||
Other (income)/expense | 338 | 850 | 226 | 626 | ||||||||||||
Increase to pretax income | 1,093 | 932 | 2,203 | 1,503 | ||||||||||||
Income tax on items above | (308 | ) | (297 | ) | (449 | ) | (545 | ) | ||||||||
Specified tax charge(c) | — | 123 | — | 123 | ||||||||||||
Income taxes | (308 | ) | (174 | ) | (449 | ) | (422 | ) | ||||||||
Increase to net earnings | $ | 785 | $ | 758 | $ | 1,754 | $ | 1,081 |
(a) | Specified items in cost of products sold are accelerated depreciation, asset impairment and other shutdown costs. | |||
(b) | Includes $16 million of additional year of Branded Prescription Drug fee in the third quarter of 2014. | |||
(c) | The 2014 specified tax charge relates to transfer pricing matters. |
Three Months Ended December 31, 2015 | GAAP | Specified Items(a) | Non GAAP | |||||||||
Gross Profit | $ | 3,335 | $ | 10 | $ | 3,345 | ||||||
Marketing, selling and administrative(b) | 1,501 | (4 | ) | 1,497 | ||||||||
Research and development | 1,916 | (741 | ) | 1,175 | ||||||||
Other (income)/expense | 238 | (338 | ) | (100 | ) | |||||||
Effective Tax Rate | 59.7 | % | (44.6 | )% | 15.1 | % | ||||||
Three Months Ended December 31, 2014 | GAAP | Specified Items(a) | Non GAAP | |||||||||
Gross Profit | $ | 3,292 | $ | 31 | $ | 3,323 | ||||||
Marketing, selling and administrative(b) | 1,364 | (1 | ) | 1,363 | ||||||||
Research and development | 1,189 | (50 | ) | 1,139 | ||||||||
Other (income)/expense | 799 | (850 | ) | (51 | ) | |||||||
Effective Tax Rate | 145.0 | % | (135.0 | )% | 10.0 | % |
(a) | Refer to the Specified Items schedule for further details. Effective tax rate on the Specified Items represents the difference between the GAAP and Non-GAAP effective tax rate. | |||
(b) | Includes advertising and product promotion expenses of $330 million and $213 million for the three months ended December 31, 2015 and 2014, respectively. |
Twelve Months Ended December 31, 2015 | GAAP | Specified Items(a) | Non GAAP | |||||||||
Gross Profit | $ | 12,651 | $ | 84 | $ | 12,735 | ||||||
Marketing, selling and administrative(b) | 4,841 | (10 | ) | 4,831 | ||||||||
Research and development | 5,920 | (1,883 | ) | 4,037 | ||||||||
Other (income)/expense | (277 | ) | (226 | ) | (503 | ) | ||||||
Effective Tax Rate | 22.0 | % | (0.8 | )% | 21.2 | % | ||||||
Twelve Months Ended December 31, 2014 | GAAP | Specified Items(a) | Non GAAP | |||||||||
Gross Profit | $ | 11,947 | $ | 151 | $ | 12,098 | ||||||
Marketing, selling and administrative(b) | 4,822 | (105 | ) | 4,717 | ||||||||
Research and development | 4,534 | (621 | ) | 3,913 | ||||||||
Other (income)/expense | 210 | (626 | ) | (416 | ) | |||||||
Effective Tax Rate | 14.8 | % | 5.1 | % | 19.9 | % |
(a) | Refer to the Specified Items schedule for further details. Effective tax rate on the Specified Items represents the difference between the GAAP and Non-GAAP effective tax rate. | |||
(b) | Includes advertising and product promotion expenses of $825 million and $734 million for the twelve months ended December 31, 2015 and 2014, respectively. |
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Net Earnings/(Loss) Attributable to BMS used for Diluted EPS Calculation - GAAP | $ | (138 | ) | $ | 13 | $ | 1,624 | $ | 2,004 | |||||||
Less Specified Items* | 785 | 758 | 1,754 | 1,081 | ||||||||||||
Net Earnings used for Diluted EPS Calculation – Non-GAAP | $ | 647 | $ | 771 | $ | 3,378 | $ | 3,085 | ||||||||
Weighted-average Common Shares Outstanding - Diluted - GAAP | 1,669 | 1,673 | 1,679 | 1,670 | ||||||||||||
Contingently convertible debt common stock equivalents | — | — | — | — | ||||||||||||
Incremental shares attributable to share-based compensation plans | 12 | — | — | — | ||||||||||||
Weighted-average Common Shares Outstanding - Diluted - Non-GAAP | 1,681 | 1,673 | 1,679 | 1,670 | ||||||||||||
Diluted Earnings/(Loss) Per Share — GAAP | $ | (0.08 | ) | $ | 0.01 | $ | 0.97 | $ | 1.20 | |||||||
Diluted EPS Attributable to Specified Items | 0.46 | 0.45 | 1.04 | 0.65 | ||||||||||||
Diluted Earnings Per Share — Non-GAAP | $ | 0.38 | $ | 0.46 | $ | 2.01 | $ | 1.85 |
* | Refer to the Specified Items schedule for further details. |
December 31, 2015 | September 30, 2015 | |||||||
Cash and cash equivalents | $ | 2,385 | $ | 3,975 | ||||
Marketable securities - current | 1,885 | 1,438 | ||||||
Marketable securities - long term | 4,660 | 4,627 | ||||||
Cash, cash equivalents and marketable securities | 8,930 | 10,040 | ||||||
Short-term borrowings | (139 | ) | (642 | ) | ||||
Long-term debt | (6,550 | ) | (6,632 | ) | ||||
Net cash position | $ | 2,241 | $ | 2,766 |
Revenues | 2014 | 2015 | % Change | FX Impact | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | 1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | Qtr vs. Qtr | YTD vs. YTD | Qtr vs. Qtr | YTD vs. YTD | |||||||||||||||||||||||||||||||||||||||||||||||
US and Puerto Rico | $ | 1,765 | $ | 1,901 | $ | 3,666 | $ | 1,968 | $ | 5,634 | $ | 2,082 | $ | 7,716 | $ | 2,044 | $ | 1,837 | $ | 3,881 | $ | 2,044 | $ | 5,925 | $ | 2,263 | $ | 8,188 | 9% | 6% | — | — | ||||||||||||||||||||||||||||||||
Europe | 948 | 908 | 1,856 | 814 | 2,670 | 922 | 3,592 | 782 | 974 | 1,756 | 813 | 2,569 | 922 | 3,491 | — | (3)% | (13)% | (17)% | ||||||||||||||||||||||||||||||||||||||||||||||
Rest of the World | 830 | 811 | 1,641 | 838 | 2,479 | 980 | 3,459 | 1,019 | 1,124 | 2,143 | 1,027 | 3,170 | 972 | 4,142 | (1)% | 20% | (9)% | (13)% | ||||||||||||||||||||||||||||||||||||||||||||||
Other | 268 | 269 | 537 | 301 | 838 | 274 | 1,112 | 196 | 228 | 424 | 185 | 609 | 130 | 739 | (53)% | (34)% | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||||
Total | $ | 3,811 | $ | 3,889 | $ | 7,700 | $ | 3,921 | $ | 11,621 | $ | 4,258 | $ | 15,879 | $ | 4,041 | $ | 4,163 | $ | 8,204 | $ | 4,069 | $ | 12,273 | $ | 4,287 | $ | 16,560 | 1% | 4% | (5)% | (7)% | ||||||||||||||||||||||||||||||||
% of Revenues | 2014 | 2015 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | 1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | |||||||||||||||||||||||||||||||||||||||||||||||||||
US and Puerto Rico | 46.3 | % | 48.9 | % | 47.6 | % | 50.2 | % | 48.5 | % | 48.9 | % | 48.6 | % | 50.6 | % | 44.1 | % | 47.3 | % | 50.2 | % | 48.3 | % | 52.8 | % | 49.4 | % | ||||||||||||||||||||||||||||||||||||
Europe | 24.9 | % | 23.3 | % | 24.1 | % | 20.8 | % | 23.0 | % | 21.7 | % | 22.6 | % | 19.4 | % | 23.4 | % | 21.4 | % | 20.0 | % | 20.9 | % | 21.5 | % | 21.1 | % | ||||||||||||||||||||||||||||||||||||
Rest of the World | 21.8 | % | 20.9 | % | 21.3 | % | 21.4 | % | 21.3 | % | 23.0 | % | 21.8 | % | 25.2 | % | 27.0 | % | 26.1 | % | 25.2 | % | 25.8 | % | 22.7 | % | 25.0 | % | ||||||||||||||||||||||||||||||||||||
Other | 7.0 | % | 6.9 | % | 7.0 | % | 7.6 | % | 7.2 | % | 6.4 | % | 7.0 | % | 4.8 | % | 5.5 | % | 5.2 | % | 4.6 | % | 5.0 | % | 3.0 | % | 4.5 | % | ||||||||||||||||||||||||||||||||||||
Total | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % |
2014 | 2015 | % Change | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | 1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | Qtr vs. Qtr | YTD vs. YTD | |||||||||||||||||||||||||||||||||||||||||||||||
Net product sales | $ | 2,807 | $ | 2,770 | $ | 5,577 | $ | 2,843 | $ | 8,420 | $ | 3,240 | $ | 11,660 | $ | 3,059 | $ | 3,572 | $ | 6,631 | $ | 3,552 | $ | 10,183 | $ | 3,862 | $ | 14,045 | 19% | 20% | ||||||||||||||||||||||||||||||||
Alliance and other revenues | 1,004 | 1,119 | 2,123 | 1,078 | 3,201 | 1,018 | 4,219 | 982 | 591 | 1,573 | 517 | 2,090 | 425 | 2,515 | (58)% | (40)% | ||||||||||||||||||||||||||||||||||||||||||||||
Total Revenues | $ | 3,811 | $ | 3,889 | $ | 7,700 | $ | 3,921 | $ | 11,621 | $ | 4,258 | $ | 15,879 | $ | 4,041 | $ | 4,163 | $ | 8,204 | $ | 4,069 | $ | 12,273 | $ | 4,287 | $ | 16,560 | 1% | 4% | ||||||||||||||||||||||||||||||||
Cost of products sold | 968 | 991 | 1,959 | 1,007 | 2,966 | 966 | 3,932 | 847 | 1,013 | 1,860 | 1,097 | 2,957 | 952 | 3,909 | (1)% | (1)% | ||||||||||||||||||||||||||||||||||||||||||||||
Marketing, selling and administrative(a) | 1,120 | 1,138 | 2,258 | 1,200 | 3,458 | 1,364 | 4,822 | 1,029 | 1,135 | 2,164 | 1,176 | 3,340 | 1,501 | 4,841 | 10% | — | ||||||||||||||||||||||||||||||||||||||||||||||
Research and development | 946 | 1,416 | 2,362 | 983 | 3,345 | 1,189 | 4,534 | 1,016 | 1,856 | 2,872 | 1,132 | 4,004 | 1,916 | 5,920 | 61% | 31% | ||||||||||||||||||||||||||||||||||||||||||||||
Other (income)/expense | (208 | ) | (104 | ) | (312 | ) | (277 | ) | (589 | ) | 799 | 210 | (299 | ) | 107 | (192 | ) | (323 | ) | (515 | ) | 238 | (277 | ) | (70)% | ** | ||||||||||||||||||||||||||||||||||||
Total Expenses | 2,826 | 3,441 | 6,267 | 2,913 | 9,180 | 4,318 | 13,498 | 2,593 | 4,111 | 6,704 | 3,082 | 9,786 | 4,607 | 14,393 | 7% | 7% | ||||||||||||||||||||||||||||||||||||||||||||||
Earnings/(Loss) Before Income Taxes | $ | 985 | $ | 448 | $ | 1,433 | $ | 1,008 | $ | 2,441 | $ | (60 | ) | $ | 2,381 | $ | 1,448 | $ | 52 | $ | 1,500 | $ | 987 | $ | 2,487 | $ | (320 | ) | $ | 2,167 | ** | (9)% | ||||||||||||||||||||||||||||||
Provision for/(Benefit from) Income Taxes | 49 | 114 | 163 | 276 | 439 | (87 | ) | 352 | 249 | 162 | 411 | 257 | 668 | (191 | ) | 477 | ** | 36% | ||||||||||||||||||||||||||||||||||||||||||||
Net Earnings/(Loss) | $ | 936 | $ | 334 | $ | 1,270 | $ | 732 | $ | 2,002 | $ | 27 | $ | 2,029 | $ | 1,199 | $ | (110 | ) | $ | 1,089 | $ | 730 | $ | 1,819 | $ | (129 | ) | $ | 1,690 | ** | (17)% | ||||||||||||||||||||||||||||||
Net Earnings/(Loss) Attributable to Noncontrolling Interest | (1 | ) | 1 | — | 11 | 11 | 14 | 25 | 13 | 20 | 33 | 24 | 57 | 9 | 66 | (36)% | ** | |||||||||||||||||||||||||||||||||||||||||||||
Net Earnings/(Loss) Attributable to BMS | $ | 937 | $ | 333 | $ | 1,270 | $ | 721 | $ | 1,991 | $ | 13 | $ | 2,004 | $ | 1,186 | $ | (130 | ) | $ | 1,056 | $ | 706 | $ | 1,762 | $ | (138 | ) | $ | 1,624 | ** | (19)% | ||||||||||||||||||||||||||||||
Diluted Earnings/(Loss) per Common Share* | $ | 0.56 | $ | 0.20 | $ | 0.76 | $ | 0.43 | $ | 1.19 | $ | 0.01 | $ | 1.20 | $ | 0.71 | $ | (0.08 | ) | $ | 0.63 | $ | 0.42 | $ | 1.05 | $ | (0.08 | ) | $ | 0.97 | ** | (19)% | ||||||||||||||||||||||||||||||
Average Common Shares Outstanding - Diluted | 1,666 | 1,669 | 1,668 | 1,670 | 1,668 | 1,673 | 1,670 | 1,676 | 1,667 | 1,677 | 1,678 | 1,677 | 1,669 | 1,679 | — | 1% | ||||||||||||||||||||||||||||||||||||||||||||||
Dividends declared per common share | $ | 0.36 | $ | 0.36 | $ | 0.72 | $ | 0.36 | $ | 1.08 | $ | 0.37 | $ | 1.45 | $ | 0.37 | $ | 0.37 | $ | 0.74 | $ | 0.37 | $ | 1.11 | $ | 0.38 | $ | 1.49 | 3% | 3% | ||||||||||||||||||||||||||||||||
2014 | 2015 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
% of Total Revenues | 1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | 1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | ||||||||||||||||||||||||||||||||||||||||||||||||
Gross Margin | 74.6 | % | 74.5 | % | 74.6 | % | 74.3 | % | 74.5 | % | 77.3 | % | 75.2 | % | 79.0 | % | 75.7 | % | 77.3 | % | 73.0 | % | 75.9 | % | 77.8 | % | 76.4 | % | ||||||||||||||||||||||||||||||||||
Other Ratios | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Effective tax rate | 5.0 | % | 25.4 | % | 11.4 | % | 27.4 | % | 18.0 | % | 145.0 | % | 14.8 | % | 17.2 | % | 311.5 | % | 27.4 | % | 26.0 | % | 26.9 | % | 59.7 | % | 22.0 | % | ||||||||||||||||||||||||||||||||||
Other (Income)/Expense | 2014 | 2015 | % Change | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | 1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | Qtr vs. Qtr | YTD vs. YTD | |||||||||||||||||||||||||||||||||||||||||||||||
Interest expense | $ | 54 | $ | 46 | $ | 100 | $ | 50 | $ | 150 | $ | 53 | $ | 203 | $ | 51 | $ | 49 | $ | 100 | $ | 41 | $ | 141 | $ | 43 | $ | 184 | (19 | )% | (9 | )% | ||||||||||||||||||||||||||||||
Investment income | (23 | ) | (28 | ) | (51 | ) | (20 | ) | (71 | ) | (30 | ) | (101 | ) | (30 | ) | (26 | ) | (56 | ) | (18 | ) | (74 | ) | (27 | ) | (101 | ) | (10 | )% | — | |||||||||||||||||||||||||||||||
Provision for restructuring | 21 | 16 | 37 | 35 | 72 | 91 | 163 | 12 | 28 | 40 | 10 | 50 | 68 | 118 | (25 | )% | (28 | )% | ||||||||||||||||||||||||||||||||||||||||||||
Litigation charges/(recoveries) | 29 | (20 | ) | 9 | 10 | 19 | 4 | 23 | 12 | 4 | 16 | (2 | ) | 14 | 55 | 69 | ** | ** | ||||||||||||||||||||||||||||||||||||||||||||
Equity in net income of affiliates | (36 | ) | (33 | ) | (69 | ) | (12 | ) | (81 | ) | (26 | ) | (107 | ) | (26 | ) | (22 | ) | (48 | ) | (19 | ) | (67 | ) | (16 | ) | (83 | ) | (38 | )% | (22 | )% | ||||||||||||||||||||||||||||||
Out-licensed intangible asset impairment | — | — | — | 18 | 18 | 11 | 29 | 13 | — | 13 | — | 13 | — | 13 | (100 | )% | (55 | )% | ||||||||||||||||||||||||||||||||||||||||||||
(Gain)/Loss on sale of businesses, product lines and assets | (259 | ) | 7 | (252 | ) | (315 | ) | (567 | ) | 3 | (564 | ) | (154 | ) | (8 | ) | (162 | ) | (208 | ) | (370 | ) | 174 | (196 | ) | ** | (65 | )% | ||||||||||||||||||||||||||||||||||
Other alliance and licensing income | (108 | ) | (144 | ) | (252 | ) | (102 | ) | (354 | ) | (50 | ) | (404 | ) | (161 | ) | (124 | ) | (285 | ) | (187 | ) | (472 | ) | (156 | ) | (628 | ) | ** | 55 | % | |||||||||||||||||||||||||||||||
Pension charges | 64 | 45 | 109 | 28 | 137 | 740 | 877 | 27 | 36 | 63 | 48 | 111 | 49 | 160 | (93 | )% | (82 | )% | ||||||||||||||||||||||||||||||||||||||||||||
Loss on debt redemption | 45 | — | 45 | — | 45 | — | 45 | — | 180 | 180 | — | 180 | — | 180 | — | ** | ||||||||||||||||||||||||||||||||||||||||||||||
Other | 5 | 7 | 12 | 31 | 43 | 3 | 46 | (43 | ) | (10 | ) | (53 | ) | 12 | (41 | ) | 48 | 7 | ** | (85 | )% | |||||||||||||||||||||||||||||||||||||||||
$ | (208 | ) | $ | (104 | ) | $ | (312 | ) | $ | (277 | ) | $ | (589 | ) | $ | 799 | $ | 210 | $ | (299 | ) | $ | 107 | $ | (192 | ) | $ | (323 | ) | $ | (515 | ) | $ | 238 | $ | (277 | ) | (70 | )% | ** |
(a) | Includes advertising and product promotion expenses of $330 million and $213 million for the three months ended December 31, 2015 and 2014, respectively, and $825 million and $734 million for the twelve months ended December 31, 2015 and 2014, respectively. | |||||||||||
* | Quarterly amounts may not add to the year-to-date totals due to rounding of individual calculations. | |||||||||||
** | In excess of +/- 100% |
QUARTER-TO-DATE | 2015 | 2014 | Growth $ | Growth % | Favorable / (Unfavorable) FX Impact $ * | 2015 Excluding FX | Favorable / (Unfavorable) FX Impact % * | Growth % Excluding FX | ||||||||||||||||||
Revenues | $ | 4,287 | $ | 4,258 | $ | 29 | 1% | $ | (212 | ) | $ | 4,499 | (5)% | 6% | ||||||||||||
Gross profit | 3,335 | 3,292 | 43 | 1% | N/A | N/A | N/A | N/A | ||||||||||||||||||
Gross profit excluding specified items(a) | 3,345 | 3,323 | 22 | 1% | N/A | N/A | N/A | N/A | ||||||||||||||||||
Gross profit excluding specified items as a % of revenues | 78.0 | % | 78.0 | % | ||||||||||||||||||||||
Marketing, selling and administrative(b) | 1,501 | 1,364 | 137 | 10% | 66 | 1,567 | 5% | 15% | ||||||||||||||||||
Marketing, selling and administrative excluding specified items(a) | 1,497 | 1,363 | 134 | 10% | 66 | 1,563 | 5% | 15% | ||||||||||||||||||
MS&A excluding specified items as a % of revenues | 34.9 | % | 32.0 | % | ||||||||||||||||||||||
Research and development | 1,916 | 1,189 | 727 | 61% | 20 | 1,936 | 2% | 63% | ||||||||||||||||||
Research and development excluding specified items(a) | 1,175 | 1,139 | 36 | 3% | 20 | 1,195 | 2% | 5% | ||||||||||||||||||
Research and development excluding specified items as a % of revenues | 27.4 | % | 26.7 | % | ||||||||||||||||||||||
YEAR-TO-DATE | 2015 | 2014 | Growth $ | Growth % | Favorable / (Unfavorable) FX Impact $ * | 2015 Excluding FX | Favorable / (Unfavorable) FX Impact % * | Growth % Excluding FX | ||||||||||||||||||
Revenues | $ | 16,560 | $ | 15,879 | $ | 681 | 4% | $ | (1,100 | ) | $ | 17,660 | (7)% | 11% | ||||||||||||
Gross profit | 12,651 | 11,947 | 704 | 6% | N/A | N/A | N/A | N/A | ||||||||||||||||||
Gross profit excluding specified items(a) | 12,735 | 12,098 | 637 | 5% | N/A | N/A | N/A | N/A | ||||||||||||||||||
Gross profit excluding specified items as a % of revenues | 76.9 | % | 76.2 | % | ||||||||||||||||||||||
Marketing, selling and administrative(b) | 4,841 | 4,822 | 19 | — | 292 | 5,133 | 6% | 6% | ||||||||||||||||||
Marketing, selling and administrative excluding specified items(a) | 4,831 | 4,717 | 114 | 2% | 292 | 5,123 | 7% | 9% | ||||||||||||||||||
MS&A excluding specified items as a % of revenues | 29.2 | % | 29.7 | % | ||||||||||||||||||||||
Research and development | 5,920 | 4,534 | 1,386 | 31% | 87 | 6,007 | 1% | 32% | ||||||||||||||||||
Research and development excluding specified items(a) | 4,037 | 3,913 | 124 | 3% | 87 | 4,124 | 2% | 5% | ||||||||||||||||||
Research and development excluding specified items as a % of revenues | 24.4 | % | 24.6 | % |
(a) | Refer to the Specified Items schedule for further details. | |||||||||||
(b) | Includes advertising and product promotion expenses of $330 million and $213 million for the three months ended December 31, 2015 and 2014, respectively, and $825 million and $734 million for the twelve months ended December 31, 2015 and 2014, respectively. | |||||||||||
* | Foreign exchange (FX) impact determined by the change in a line item's current and prior period results at a common exchange rate and comparing this change to the actual reported change from the same period. This difference is determined to be the FX impact. |
2014 | 2015 | Growth $ | % Change | EX-FX | FX Impact | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | 1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | Qtr vs. Qtr | YTD vs. YTD | Qtr vs. Qtr | YTD vs. YTD | QTD $ | YTD $ | Qtr vs. Qtr % | YTD vs. YTD % | Qtr vs. Qtr | YTD vs. YTD | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Virology(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baraclude | $ | 406 | $ | 369 | $ | 775 | $ | 325 | $ | 1,100 | $ | 341 | $ | 1,441 | $ | 340 | $ | 343 | $ | 683 | $ | 320 | $ | 1,003 | $ | 309 | $ | 1,312 | $ | (32 | ) | $ | (129 | ) | (9 | )% | (9 | )% | $ | 330 | $ | 1,418 | (3 | )% | (2 | )% | (6 | )% | (7 | )% | ||||||||||||||||||||||||||||||||||||||||
Hepatitis C Franchise(b) | — | — | — | 49 | 49 | 207 | 256 | 264 | 479 | 743 | 402 | 1,145 | 458 | 1,603 | 251 | 1,347 | ** | ** | 484 | 1,822 | ** | ** | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reyataz Franchise | 344 | 362 | 706 | 338 | 1,044 | 318 | 1,362 | 294 | 303 | 597 | 270 | 867 | 272 | 1,139 | (46 | ) | (223 | ) | (14 | )% | (16 | )% | 287 | 1,211 | (10 | )% | (11 | )% | (4 | )% | (5 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sustiva Franchise(c) | 319 | 361 | 680 | 357 | 1,037 | 407 | 1,444 | 290 | 317 | 607 | 333 | 940 | 312 | 1,252 | (95 | ) | (192 | ) | (23 | )% | (13 | )% | 312 | 1,257 | (23 | )% | (13 | )% | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oncology(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Empliciti | — | — | — | — | — | — | — | — | — | — | — | — | 3 | 3 | 3 | 3 | N/A | N/A | 3 | 3 | N/A | N/A | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Erbitux | 169 | 186 | 355 | 187 | 542 | 181 | 723 | 165 | 169 | 334 | 167 | 501 | — | 501 | (181 | ) | (222 | ) | (100 | )% | (31 | )% | — | 502 | (100 | )% | (31 | )% | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Opdivo | — | — | — | 1 | 1 | 5 | 6 | 40 | 122 | 162 | 305 | 467 | 475 | 942 | 470 | 936 | ** | ** | 482 | 954 | ** | ** | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sprycel | 342 | 368 | 710 | 385 | 1,095 | 398 | 1,493 | 375 | 405 | 780 | 411 | 1,191 | 429 | 1,620 | 31 | 127 | 8 | % | 9 | % | 452 | 1,747 | 14 | % | 17 | % | (6 | )% | (8 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Yervoy | 271 | 321 | 592 | 350 | 942 | 366 | 1,308 | 325 | 296 | 621 | 240 | 861 | 265 | 1,126 | (101 | ) | (182 | ) | (28 | )% | (14 | )% | 280 | 1,218 | (23 | )% | (7 | )% | (5 | )% | (7 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Neuroscience(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Abilify(d) | 540 | 555 | 1,095 | 449 | 1,544 | 476 | 2,020 | 554 | 107 | 661 | 46 | 707 | 39 | 746 | (437 | ) | (1,274 | ) | (92 | )% | (63 | )% | 44 | 764 | (91 | )% | (62 | )% | (1 | )% | (1 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Immunoscience(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Orencia(e) | 363 | 402 | 765 | 444 | 1,209 | 443 | 1,652 | 400 | 461 | 861 | 484 | 1,345 | 540 | 1,885 | 97 | 233 | 22 | % | 14 | % | 562 | 1,990 | 27 | % | 20 | % | (5 | )% | (6 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cardiovascular(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Eliquis | 106 | 171 | 277 | 216 | 493 | 281 | 774 | 355 | 437 | 792 | 466 | 1,258 | 602 | 1,860 | 321 | 1,086 | ** | ** | 634 | 2,002 | ** | ** | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Mature Products and All Other(f) | 951 | 794 | 1,745 | 820 | 2,565 | 835 | 3,400 | 639 | 724 | 1,363 | 625 | 1,988 | 583 | 2,571 | (252 | ) | (829 | ) | (30 | )% | (24 | )% | 629 | 2,772 | (25 | )% | (18 | )% | (5 | )% | (6 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | $ | 3,811 | $ | 3,889 | $ | 7,700 | $ | 3,921 | $ | 11,621 | $ | 4,258 | $ | 15,879 | $ | 4,041 | $ | 4,163 | $ | 8,204 | $ | 4,069 | $ | 12,273 | $ | 4,287 | $ | 16,560 | $ | 29 | $ | 681 | 1 | % | 4 | % | $ | 4,499 | $ | 17,660 | 6 | % | 11 | % | (5 | )% | (7 | )% | ||||||||||||||||||||||||||||||||||||||||||
Total Excluding Diabetes Alliance | $ | 3,632 | $ | 3,862 | $ | 7,494 | $ | 3,879 | $ | 11,373 | $ | 4,211 | $ | 15,584 | $ | 3,987 | $ | 4,099 | $ | 8,086 | $ | 4,016 | $ | 12,102 | $ | 4,262 | $ | 16,364 | $ | 51 | $ | 780 | 1 | % | 5 | % | $ | 4,473 | $ | 17,462 | 6 | % | 12 | % | (5 | )% | (7 | )% |
** | In excess of +/- 100% |
(a) | Key products listed do not represent all products in the respective therapeutic areas. |
(b) | Includes Daklinza (daclatasvir) revenues of $423 million and $163 million for the three months ended December 31, 2015 and 2014, respectively, and $1,315 million and $201 million for the twelve months ended December 31, 2015 and 2014, respectively. Additionally, includes Sunvepra (asunaprevir) revenues of $35 million and $44 million for the three months ended December 31, 2015 and 2014, respectively, and $288 million and $55 million for the twelve months ended December 31, 2015 and 2014, respectively. |
(c) | The Sustiva Franchise includes sales of Sustiva and revenue from sales of bulk efavirenz included in the combination therapy, Atripla. Includes alliance and other revenue of $273 million and $361 million for the three months ended December 31, 2015 and 2014, respectively, and $1,096 million and $1,255 million for the twelve months ended December 31, 2015 and 2014, respectively. |
(d) | Includes alliance and other revenue of $7 million and $428 million for the three months ended December 31, 2015 and 2014, respectively, and $604 million and $1,778 million for the twelve months ended December 31, 2015 and 2014, respectively. BMS's U.S. rights to Abilify expired on April 20, 2015. |
(e) | Includes Orencia SubQ revenues of $262 million and $200 million for the three months ended December 31, 2015 and 2014, respectively, and $872 million and $688 million for the twelve months ended December 31, 2015 and 2014, respectively. |
(f) | Represents all other products, including those which have lost exclusivity in major markets, over the counter brands and royalty-related revenue. Includes Diabetes Alliance revenues of $25 million and $47 million for the three months ended December 31, 2015 and 2014, respectively, and $196 million and $295 million for the twelve months ended December 31, 2015 and 2014, respectively. |
2014 | 2015 | % Change | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | 1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | Qtr vs. Qtr | YTD vs. YTD | |||||||||||||||||||||||||||||||||||||||||||||
Virology | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baraclude | $ | 70 | $ | 84 | $ | 154 | $ | 40 | $ | 194 | $ | 21 | $ | 215 | $ | 46 | $ | 37 | $ | 83 | $ | 25 | $ | 108 | $ | 27 | $ | 135 | 29% | (37)% | ||||||||||||||||||||||||||||||
Hepatitis C Franchise(a) | — | — | — | — | — | — | — | — | — | — | 111 | 111 | 212 | 323 | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||
Reyataz Franchise | 176 | 168 | 344 | 169 | 513 | 176 | 689 | 143 | 157 | 300 | 149 | 449 | 142 | 591 | (19)% | (14)% | ||||||||||||||||||||||||||||||||||||||||||||
Sustiva Franchise(b) | 228 | 266 | 494 | 284 | 778 | 340 | 1,118 | 234 | 258 | 492 | 280 | 772 | 269 | 1,041 | (21)% | (7)% | ||||||||||||||||||||||||||||||||||||||||||||
Oncology | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Empliciti | — | — | — | — | — | — | — | — | — | — | — | — | 3 | 3 | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||
Erbitux | 158 | 178 | 336 | 175 | 511 | 171 | 682 | 157 | 165 | 322 | 165 | 487 | — | 487 | (100)% | (29)% | ||||||||||||||||||||||||||||||||||||||||||||
Opdivo | — | — | — | — | — | 1 | 1 | 38 | 107 | 145 | 268 | 413 | 410 | 823 | ** | ** | ||||||||||||||||||||||||||||||||||||||||||||
Sprycel | 145 | 163 | 308 | 179 | 487 | 184 | 671 | 181 | 205 | 386 | 215 | 601 | 228 | 829 | 24% | 24% | ||||||||||||||||||||||||||||||||||||||||||||
Yervoy | 146 | 173 | 319 | 191 | 510 | 199 | 709 | 181 | 136 | 317 | 121 | 438 | 164 | 602 | (18)% | (15)% | ||||||||||||||||||||||||||||||||||||||||||||
Neuroscience | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Abilify | 325 | 417 | 742 | 407 | 1,149 | 423 | 1,572 | 508 | 67 | 575 | 18 | 593 | 7 | 600 | (98)% | (62)% | ||||||||||||||||||||||||||||||||||||||||||||
Immunoscience | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Orencia(c) | 229 | 254 | 483 | 292 | 775 | 289 | 1,064 | 259 | 310 | 569 | 330 | 899 | 372 | 1,271 | 29% | 19% | ||||||||||||||||||||||||||||||||||||||||||||
Cardiovascular | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Eliquis | 61 | 94 | 155 | 113 | 268 | 136 | 404 | 200 | 243 | 443 | 245 | 688 | 335 | 1,023 | ** | ** | ||||||||||||||||||||||||||||||||||||||||||||
Mature Products and All Other(d) | 227 | 104 | 331 | 118 | 449 | 142 | 591 | 97 | 152 | 249 | 117 | 366 | 94 | 460 | (34)% | (22)% | ||||||||||||||||||||||||||||||||||||||||||||
Total(e) | $ | 1,765 | $ | 1,901 | $ | 3,666 | $ | 1,968 | $ | 5,634 | $ | 2,082 | $ | 7,716 | $ | 2,044 | $ | 1,837 | $ | 3,881 | $ | 2,044 | $ | 5,925 | $ | 2,263 | $ | 8,188 | 9% | 6% | ||||||||||||||||||||||||||||||
Total Excluding Diabetes Alliance | $ | 1,651 | $ | 1,901 | $ | 3,552 | $ | 1,968 | $ | 5,520 | $ | 2,086 | $ | 7,606 | $ | 2,044 | $ | 1,834 | $ | 3,878 | $ | 2,044 | $ | 5,922 | $ | 2,263 | $ | 8,185 | 8% | 8% |
** | In excess of +/- 100% |
(a) | Includes revenues of Daklinza (daclastasvir) only, which was launched in the U.S. in the third quarter of 2015. |
(b) | The Sustiva Franchise includes sales of Sustiva, as well as revenue from sales of bulk efavirenz included in the combination therapy, Atripla. |
(c) | Includes Orencia SubQ revenues of $174 million and $131 million for the three months ended December 31, 2015 and 2014, respectively, and $567 million and $458 million for the twelve months ended December 31, 2015 and 2014, respectively. |
(d) | Represents all other products sold in the U.S., including those which have lost exclusivity. |
(e) | Domestic revenues include United States and Puerto Rico. |
2014 | 2015 | % Change | FX Impact | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | 1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | Qtr vs. Qtr | YTD vs. YTD | Qtr vs. Qtr | YTD vs. YTD | |||||||||||||||||||||||||||||||||||||||||||||||
Virology | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baraclude | $ | 336 | $ | 285 | $ | 621 | $ | 285 | $ | 906 | $ | 320 | $ | 1,226 | $ | 294 | $ | 306 | $ | 600 | $ | 295 | $ | 895 | $ | 282 | $ | 1,177 | (12)% | (4)% | (7)% | (9)% | ||||||||||||||||||||||||||||||||
Hepatitis C Franchise(a) | — | — | — | 49 | 49 | 207 | 256 | 264 | 479 | 743 | 291 | 1,034 | 246 | 1,280 | 19% | ** | (12)% | N/A | ||||||||||||||||||||||||||||||||||||||||||||||
Reyataz Franchise | 168 | 194 | 362 | 169 | 531 | 142 | 673 | 151 | 146 | 297 | 121 | 418 | 130 | 548 | (8)% | (19)% | (10)% | (11)% | ||||||||||||||||||||||||||||||||||||||||||||||
Sustiva Franchise(b) | 91 | 95 | 186 | 73 | 259 | 67 | 326 | 56 | 59 | 115 | 53 | 168 | 43 | 211 | (36)% | (35)% | — | (1)% | ||||||||||||||||||||||||||||||||||||||||||||||
Oncology | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Erbitux | 11 | 8 | 19 | 12 | 31 | 10 | 41 | 8 | 4 | 12 | 2 | 14 | — | 14 | (100)% | (66)% | — | (3)% | ||||||||||||||||||||||||||||||||||||||||||||||
Opdivo | — | — | — | 1 | 1 | 4 | 5 | 2 | 15 | 17 | 37 | 54 | 65 | 119 | ** | ** | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||||
Sprycel | 197 | 205 | 402 | 206 | 608 | 214 | 822 | 194 | 200 | 394 | 196 | 590 | 201 | 791 | (6)% | (4)% | (11)% | (16)% | ||||||||||||||||||||||||||||||||||||||||||||||
Yervoy | 125 | 148 | 273 | 159 | 432 | 167 | 599 | 144 | 160 | 304 | 119 | 423 | 101 | 524 | (40)% | (13)% | (10)% | (16)% | ||||||||||||||||||||||||||||||||||||||||||||||
Neuroscience | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Abilify(c) | 215 | 138 | 353 | 42 | 395 | 53 | 448 | 46 | 40 | 86 | 28 | 114 | 32 | 146 | (40)% | (67)% | (10)% | (4)% | ||||||||||||||||||||||||||||||||||||||||||||||
Immunoscience | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Orencia | 134 | 148 | 282 | 152 | 434 | 154 | 588 | 141 | 151 | 292 | 154 | 446 | 168 | 614 | 9% | 4% | (14)% | (18)% | ||||||||||||||||||||||||||||||||||||||||||||||
Cardiovascular | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Eliquis | 45 | 77 | 122 | 103 | 225 | 145 | 370 | 155 | 194 | 349 | 221 | 570 | 267 | 837 | 84% | ** | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||||
Mature Products and All Other(d) | 724 | 690 | 1,414 | 702 | 2,116 | 693 | 2,809 | 542 | 572 | 1,114 | 508 | 1,622 | 489 | 2,111 | (29)% | (25)% | (6)% | (7)% | ||||||||||||||||||||||||||||||||||||||||||||||
Total | $ | 2,046 | $ | 1,988 | $ | 4,034 | $ | 1,953 | $ | 5,987 | $ | 2,176 | $ | 8,163 | $ | 1,997 | $ | 2,326 | $ | 4,323 | $ | 2,025 | $ | 6,348 | $ | 2,024 | $ | 8,372 | (7)% | 3% | (10)% | (13)% | ||||||||||||||||||||||||||||||||
Total Excluding Diabetes Alliance | $ | 1,981 | $ | 1,961 | $ | 3,942 | $ | 1,911 | $ | 5,853 | $ | 2,125 | $ | 7,978 | $ | 1,943 | $ | 2,265 | $ | 4,208 | $ | 1,972 | $ | 6,180 | $ | 1,999 | $ | 8,179 | (6)% | 3% | (10)% | (13)% |
** | In excess of +/- 100% |
(a) | Includes Daklinza (daclatasvir) revenues of $211 million and $163 million for the three months ended December 31, 2015 and 2014, respectively, and $992 million and $201 million for the twelve months ended December 31, 2015 and 2014, respectively. Additionally, includes Sunvepra (asunaprevir) revenues of $35 million and $44 million for the three months ended December 31, 2015 and 2014, respectively, and $288 million and $55 million for the twelve months ended December 31, 2015 and 2014, respectively. |
(b) | The Sustiva Franchise includes sales of Sustiva and revenue from sales of bulk efavirenz included in the combination therapy, Atripla. |
(c) | Includes revenue from the co-promotional agreement with Otsuka Pharmaceutical Co., Ltd. |
(d) | Represents all other products, including those which have lost exclusivity in major markets, over the counter brands and royalty-related revenue. |
2014 | 2015 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | 1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | |||||||||||||||||||||||||||||||||||||||||||
Gross Profit | $ | 2,843 | $ | 2,898 | $ | 5,741 | $ | 2,914 | $ | 8,655 | $ | 3,292 | $ | 11,947 | $ | 3,194 | $ | 3,150 | $ | 6,344 | $ | 2,972 | $ | 9,316 | $ | 3,335 | $ | 12,651 | ||||||||||||||||||||||||||||
Specified items(a) | 45 | 39 | 84 | 36 | 120 | 31 | 151 | 34 | 25 | 59 | 15 | 74 | 10 | 84 | ||||||||||||||||||||||||||||||||||||||||||
Gross profit excluding specified items | 2,888 | 2,937 | 5,825 | 2,950 | 8,775 | 3,323 | 12,098 | 3,228 | 3,175 | 6,403 | 2,987 | 9,390 | 3,345 | 12,735 | ||||||||||||||||||||||||||||||||||||||||||
Marketing, selling and administrative(b) | 1,120 | 1,138 | 2,258 | 1,200 | 3,458 | 1,364 | 4,822 | 1,029 | 1,135 | 2,164 | 1,176 | 3,340 | 1,501 | 4,841 | ||||||||||||||||||||||||||||||||||||||||||
Specified items(a) | (3 | ) | (3 | ) | (6 | ) | (98 | ) | (104 | ) | (1 | ) | (105 | ) | (1 | ) | (3 | ) | (4 | ) | (2 | ) | (6 | ) | (4 | ) | (10 | ) | ||||||||||||||||||||||||||||
Marketing, selling and administrative excluding specified items | 1,117 | 1,135 | 2,252 | 1,102 | 3,354 | 1,363 | 4,717 | 1,028 | 1,132 | 2,160 | 1,174 | 3,334 | 1,497 | 4,831 | ||||||||||||||||||||||||||||||||||||||||||
Research and development | 946 | 1,416 | 2,362 | 983 | 3,345 | 1,189 | 4,534 | 1,016 | 1,856 | 2,872 | 1,132 | 4,004 | 1,916 | 5,920 | ||||||||||||||||||||||||||||||||||||||||||
Specified items(a) | (48 | ) | (458 | ) | (506 | ) | (65 | ) | (571 | ) | (50 | ) | (621 | ) | (162 | ) | (871 | ) | (1,033 | ) | (109 | ) | (1,142 | ) | (741 | ) | (1,883 | ) | ||||||||||||||||||||||||||||
Research and development excluding specified items | 898 | 958 | 1,856 | 918 | 2,774 | 1,139 | 3,913 | 854 | 985 | 1,839 | 1,023 | 2,862 | 1,175 | 4,037 | ||||||||||||||||||||||||||||||||||||||||||
Other (income)/expense | (208 | ) | (104 | ) | (312 | ) | (277 | ) | (589 | ) | 799 | 210 | (299 | ) | 107 | (192 | ) | (323 | ) | (515 | ) | 238 | (277 | ) | ||||||||||||||||||||||||||||||||
Specified items(a) | 88 | (67 | ) | 21 | 203 | 224 | (850 | ) | (626 | ) | 122 | (237 | ) | (115 | ) | 227 | 112 | (338 | ) | (226 | ) | |||||||||||||||||||||||||||||||||||
Other (income)/expense excluding specified items | (120 | ) | (171 | ) | (291 | ) | (74 | ) | (365 | ) | (51 | ) | (416 | ) | (177 | ) | (130 | ) | (307 | ) | (96 | ) | (403 | ) | (100 | ) | (503 | ) | ||||||||||||||||||||||||||||
Effective Tax Rate | 5.0 | % | 25.4 | % | 11.4 | % | 27.4 | % | 18.0 | % | 145.0 | % | 14.8 | % | 17.2 | % | 311.5 | % | 27.4 | % | 26.0 | % | 26.9 | % | 59.7 | % | 22.0 | % | ||||||||||||||||||||||||||||
Specified items(a) | 18.0 | % | (4.1 | )% | 10.7 | % | (3.2 | )% | 4.8 | % | (135.0 | )% | 5.1 | % | 3.6 | % | (288.1 | )% | (5.5 | )% | (1.8 | )% | (4.4 | )% | (44.6 | )% | (0.8 | )% | ||||||||||||||||||||||||||||
Effective Tax Rate excluding specified items | 23.0 | % | 21.3 | % | 22.1 | % | 24.2 | % | 22.8 | % | 10.0 | % | 19.9 | % | 20.8 | % | 23.4 | % | 21.9 | % | 24.2 | % | 22.5 | % | 15.1 | % | 21.2 | % |
(a) | Refer to the Specified Items schedule for further details. Effective tax rate on the Specified Items represents the difference between the GAAP and Non-GAAP effective tax rate. | |||
(b) | Includes advertising and product promotion expenses of $330 million and $213 million for the three months ended December 31, 2015 and 2014, respectively, and $825 million and $734 million for the twelve months ended December 31, 2015 and 2014, respectively. |
2014 | 2015 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | 1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | |||||||||||||||||||||||||||||||||||||||||||
Cost of products sold(a) | $ | 45 | $ | 39 | $ | 84 | $ | 36 | $ | 120 | $ | 31 | $ | 151 | $ | 34 | $ | 25 | $ | 59 | $ | 15 | $ | 74 | $ | 10 | $ | 84 | ||||||||||||||||||||||||||||
Additional year of Branded Prescription Drug Fee | — | — | — | 96 | 96 | — | 96 | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Process standardization implementation costs | 3 | 3 | 6 | 2 | 8 | 1 | 9 | 1 | 3 | 4 | 2 | 6 | 4 | 10 | ||||||||||||||||||||||||||||||||||||||||||
Marketing, selling and administrative | 3 | 3 | 6 | 98 | 104 | 1 | 105 | 1 | 3 | 4 | 2 | 6 | 4 | 10 | ||||||||||||||||||||||||||||||||||||||||||
License and asset acquisition charges | 15 | 148 | 163 | 65 | 228 | 50 | 278 | 162 | 869 | 1,031 | 94 | 1,125 | 554 | 1,679 | ||||||||||||||||||||||||||||||||||||||||||
IPRD impairments | 33 | 310 | 343 | — | 343 | — | 343 | — | — | — | — | — | 160 | 160 | ||||||||||||||||||||||||||||||||||||||||||
Other | — | — | — | — | — | — | — | — | 2 | 2 | 15 | 17 | 27 | 44 | ||||||||||||||||||||||||||||||||||||||||||
Research and development | 48 | 458 | 506 | 65 | 571 | 50 | 621 | 162 | 871 | 1,033 | 109 | 1,142 | 741 | 1,883 | ||||||||||||||||||||||||||||||||||||||||||
Provision for restructuring | 21 | 16 | 37 | 35 | 72 | 91 | 163 | 12 | 28 | 40 | 10 | 50 | 65 | 115 | ||||||||||||||||||||||||||||||||||||||||||
(Gain)/Loss on sale of businesses, product lines and assets | (259 | ) | 12 | (247 | ) | (315 | ) | (562 | ) | 3 | (559 | ) | (152 | ) | (8 | ) | (160 | ) | (198 | ) | (358 | ) | 171 | (187 | ) | |||||||||||||||||||||||||||||||
Pension charges | 64 | 45 | 109 | 28 | 137 | 740 | 877 | 27 | 36 | 63 | 48 | 111 | 49 | 160 | ||||||||||||||||||||||||||||||||||||||||||
Acquisition and alliance related items(b) | 16 | 17 | 33 | 39 | 72 | — | 72 | (36 | ) | — | (36 | ) | (87 | ) | (123 | ) | — | (123 | ) | |||||||||||||||||||||||||||||||||||||
Litigation charges/(recoveries) | 25 | (23 | ) | 2 | 10 | 12 | 15 | 27 | 14 | 1 | 15 | — | 15 | 53 | 68 | |||||||||||||||||||||||||||||||||||||||||
Out-licensed intangible asset impairment | — | — | — | — | — | 11 | 11 | 13 | — | 13 | — | 13 | — | 13 | ||||||||||||||||||||||||||||||||||||||||||
Loss on debt redemption | 45 | — | 45 | — | 45 | — | 45 | — | 180 | 180 | — | 180 | — | 180 | ||||||||||||||||||||||||||||||||||||||||||
Upfront, milestone and other licensing receipts | — | — | — | — | — | (10 | ) | (10 | ) | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
Other (income)/expense | (88 | ) | 67 | (21 | ) | (203 | ) | (224 | ) | 850 | 626 | (122 | ) | 237 | 115 | (227 | ) | (112 | ) | 338 | 226 | |||||||||||||||||||||||||||||||||||
Increase/(decrease) to pretax income | 8 | 567 | 575 | (4 | ) | 571 | 932 | 1,503 | 75 | 1,136 | 1,211 | (101 | ) | 1,110 | 1,093 | 2,203 | ||||||||||||||||||||||||||||||||||||||||
Income tax on items above | (179 | ) | (102 | ) | (281 | ) | 33 | (248 | ) | (297 | ) | (545 | ) | (68 | ) | (116 | ) | (184 | ) | 43 | (141 | ) | (308 | ) | (449 | ) | ||||||||||||||||||||||||||||||
Specified tax charge(c) | — | — | — | — | — | 123 | 123 | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Income taxes | (179 | ) | (102 | ) | (281 | ) | 33 | (248 | ) | (174 | ) | (422 | ) | (68 | ) | (116 | ) | (184 | ) | 43 | (141 | ) | (308 | ) | (449 | ) | ||||||||||||||||||||||||||||||
Increase/(decrease) to net earnings | $ | (171 | ) | $ | 465 | $ | 294 | $ | 29 | $ | 323 | $ | 758 | $ | 1,081 | $ | 7 | $ | 1,020 | $ | 1,027 | $ | (58 | ) | $ | 969 | $ | 785 | $ | 1,754 |
(a) | Specified items in cost of products sold are accelerated depreciation, asset impairment and other shutdown costs. |
(b) | Includes $16 million of additional year of Branded Prescription Drug Fee in the third quarter of 2014. |
(c) | The 2014 specified tax charge relates to transfer pricing matters. |
March 31, 2014 | June 30, 2014 | September 30, 2014 | December 31, 2014 | March 31, 2015 | June 30, 2015 | September 30, 2015 | December 31, 2015 | |||||||||||||||||||||||||
Cash and cash equivalents | $ | 5,225 | $ | 4,282 | $ | 4,851 | $ | 5,571 | $ | 6,294 | $ | 4,199 | $ | 3,975 | $ | 2,385 | ||||||||||||||||
Marketable securities - current | 1,834 | 2,893 | 2,370 | 1,864 | 1,313 | 1,277 | 1,438 | 1,885 | ||||||||||||||||||||||||
Marketable securities - long term | 3,558 | 3,876 | 4,328 | 4,408 | 4,279 | 4,632 | 4,627 | 4,660 | ||||||||||||||||||||||||
Cash, cash equivalents and marketable securities | 10,617 | 11,051 | 11,549 | 11,843 | 11,886 | 10,108 | 10,040 | 8,930 | ||||||||||||||||||||||||
Short-term borrowings and current portion of long-term debt | (281 | ) | (365 | ) | (401 | ) | (590 | ) | (330 | ) | (755 | ) | (642 | ) | (139 | ) | ||||||||||||||||
Long-term debt | (7,367 | ) | (7,372 | ) | (7,267 | ) | (7,242 | ) | (7,127 | ) | (6,615 | ) | (6,632 | ) | (6,550 | ) | ||||||||||||||||
Net cash position | $ | 2,969 | $ | 3,314 | $ | 3,881 | $ | 4,011 | $ | 4,429 | $ | 2,738 | $ | 2,766 | $ | 2,241 |
Full Year 2016 | ||
Projected Diluted Earnings Attributable to Shareholders per Common Share - GAAP | $2.30 to $2.40 | |
Projected Specified Items: | ||
Downsizing and streamlining of worldwide operations | (0.17 | ) |
Upfront and milestone payments, net | 0.14 | |
Pension Related items | 0.03 | |
Total | — | |
Projected Diluted Earnings Attributable to Shareholders per Common Share - Non-GAAP | $2.30 to $2.40 |
Gross margin as a percentage of revenues on a GAAP and non-GAAP basis for the twelve months ended December 31, 2015 was 76.4% and 76.9%, respectively. On a non-GAAP basis, the Company projects gross margin as a percentage of revenues for the full year 2016 to be approximately 75% - 76%. There is no reliable comparable GAAP measure for this forward-looking information on gross margin. See "—Reconciliation of GAAP and non-GAAP Growth Dollars and Percentages Excluding Foreign Exchange Impact". | |||||||||
Research and development expenses on a GAAP and non-GAAP basis for the twelve months ended December 31, 2015 were $5.9 billion and $4.0 billion, respectively. On a non-GAAP basis, the Company projects research and development expense for the full year 2016 to increase in the high-single-digit range compared to 2015. It is estimated that 30% to 45% of the research and development expenses in 2016 will be incurred on late-stage development programs. There is no reliable comparable GAAP measure for this forward-looking information on research and development. See "—Reconciliation of Certain non-GAAP Line Items to Certain GAAP Line Items". | |||||||||
Marketing, selling and administrative expenses on a GAAP and non-GAAP basis for the twelve months ended December 31, 2015 were $4.8 billion. On a non-GAAP basis, the Company projects marketing, selling and administrative expenses for the full year 2016 to decrease in the mid-single-digit range compared to 2015. There is no reliable comparable GAAP measure for this forward-looking information on marketing, selling and administrative expense. See "—Reconciliation of Certain non-GAAP Line Items to Certain GAAP Line Items". | |||||||||
The effective tax rate on a GAAP basis for the twelve months ended December 31, 2015 was 22.0%. On a non-GAAP basis, for the twelve months ended December 31, 2015 the effective tax rate was 21.2%. On a non-GAAP basis, the Company projects an annual effective tax rate between 21% and 22%. There is no reliable comparable GAAP measure for this forward-looking information on the tax rate. See "—Reconciliation of Certain non-GAAP Line Items to Certain GAAP Line Items". | |||||||||
The GAAP financial results for the full year 2016 will include specified items, including gains on divestitures, expected charges associated with downsizing and streamlining worldwide operations, in-process research and development (IPRD) , upfront and milestone payments, restructuring and pension related items. The GAAP financial results for the full year 2016 could also include other specified items that have not yet been identified and quantified, including any gains or losses from acquisitions or divestitures, additional upfront, milestone and other licensing payments, charges for IPRD and licensed asset impairments, charges and recoveries relating to significant legal proceedings, restructuring activities and significant tax events. For a fuller discussion of certain litigation and other matters that could impact full year GAAP results, as well as the use of non-GAAP financial information, see Bristol-Myers Squibb Reports Fourth Quarter 2015 Financial Results, January 28, 2016 including “2016 Financial Guidance” and “Use of non-GAAP Financial Information” therein. | |||||||||
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