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 April 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: April 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 April 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 First Quarter Revenues 9% to $4.4 Billion |
• | Posts First Quarter GAAP EPS of $0.71 and Non-GAAP EPS of $0.74 |
• | Achieves Significant European Regulatory Milestones in Immuno-Oncology |
◦ | Opdivo Approved for Previously Treated Advanced Renal Cell Carcinoma |
◦ | Expanded Use of Opdivo to Include Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer |
◦ | Positive Advisory Opinions for Opdivo + Yervoy Regimen and Empliciti |
◦ | Validation of Application for Opdivo in Classical Hodgkin Lymphoma |
• | Announces Opdivo Granted Breakthrough Therapy Designation for Previously Treated Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck, and Priority Review in Classical Hodgkin Lymphoma from the FDA |
• | Presents Significant New Data on Immuno-Oncology Portfolio at AACR |
• | Increases 2016 GAAP EPS Guidance Range to $2.37 - $2.47 and Non-GAAP EPS Guidance Range to $2.50 - $2.60 |
First Quarter | ||||||||||
$ amounts in millions, except per share amounts | ||||||||||
2016 | 2015 | Change | ||||||||
Total Revenues | $ | 4,391 | $ | 4,041 | 9 | % | ||||
GAAP Diluted EPS | 0.71 | 0.71 | — | |||||||
Non-GAAP Diluted EPS | 0.74 | 0.71 | 4 | % |
• | Bristol-Myers Squibb posted first quarter 2016 revenues of $4.4 billion, an increase of 9% compared to the same period a year ago. Global revenues increased 11% adjusted for foreign exchange impact. Excluding Abilify and Erbitux, global revenues increased 31% or 34% adjusted for foreign exchange impact. |
• | U.S. revenues increased 24% to $2.5 billion in the quarter compared to the same period a year ago. International revenues decreased 7%. When adjusted for foreign exchange impact, international revenues decreased 2%. |
• | Gross margin as a percentage of revenues was 76.0% in the quarter compared to 79.0% in the same period a year ago. |
• | Marketing, selling and administrative expenses increased 4% to $1.1 billion in the quarter. |
• | Research and development expenses increased 12% to $1.1 billion in the quarter. |
• | The effective tax rate was 27.1% in the quarter, compared to 17.2% in the first quarter last year. |
• | The company reported net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.71 per share, in the quarter compared to net earnings of $1.2 billion, or $0.71 per share, a year ago. |
• | The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.74 per share, in the first quarter, compared to $1.2 billion, or $0.71 per share, for the same period in 2015. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section. |
• | Cash, cash equivalents and marketable securities were $8.0 billion, with a net cash position of $1.3 billion, as of March 31, 2016. |
• | In April, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Opdivo for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy. The designation is based on results of CheckMate -141, a Phase 3, open-label, randomized trial evaluating Opdivo versus investigator’s choice of therapy in patients with recurrent or metastatic SCCHN with tumor progression within six months of platinum therapies in the adjuvant, primary, recurrent or metastatic setting. This trial was stopped early in January 2016 because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint of overall survival (OS). |
• | In April, the FDA accepted for filing and review a Supplemental Biologics License Application (sBLA) for Opdivo which seeks to expand use to patients with classical Hodgkin lymphoma (cHL) after prior therapies. The application included CheckMate -205 data, which evaluated Opdivo in cHL patients who have received autologous stem cell transplant and brentuximab vedotin. |
• | In April, the European Commission (EC) approved Opdivo monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. The approval expands Opdivo’s existing lung cancer indication in previously treated metastatic squamous NSCLC to include the non-squamous patient population. Opdivo is the only approved PD-1 immune checkpoint inhibitor to demonstrate superior OS in two separate Phase 3 trials in previously treated metastatic NSCLC, regardless of PD-L1 expression; one trial in squamous NSCLC (CheckMate -017) and the other in non-squamous NSCLC (CheckMate -057), which were the basis of this approval. The approval allows for the expanded marketing of Opdivo in previously treated metastatic NSCLC in all 28 Member States of the European Union. |
• | In April, the EC approved Opdivo monotherapy for advanced renal cell carcinoma (RCC) after prior therapy in adults. Opdivo is the first and only PD-1 immune checkpoint inhibitor approved in Europe to demonstrate an OS benefit versus a standard of care in this patient population. The approval is based on the results of the Phase 3 study CheckMate -025, which evaluated Opdivo in patients with advanced clear-cell RCC who received prior anti-angiogenic therapy compared to everolimus. This approval allows for the expanded marketing of Opdivo in previously treated advanced RCC in all 28 Member States of the European Union. |
• | In April, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of Opdivo in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults. This CHMP recommendation will now be reviewed by the EC, which has the authority to approve medicines for the European Union. |
• | In April, the company announced results from three studies for Opdivo and the Opdivo + Yervoy Regimen: |
◦ | CheckMate -141: In this Phase 3 open-label, randomized trial, evaluating Opdivo in patients with recurrent or metastatic SCCHN after platinum therapy compared to investigator’s choice of therapy, Opdivo met the primary endpoints and demonstrated statistically significant OS versus three standards of care (cetuximab, docetaxel, or methotrexate). In the trial, patients treated with Opdivo had a one-year survival rate of 36% compared to 16.6% for investigator’s choice, and experienced a 30% reduction in the risk of death. Median OS was 7.5 months for Opdivo compared to 5.1 months for investigator’s choice. The safety profile of Opdivo in CheckMate -141 was consistent with prior studies, with no new safety signals identified. |
◦ | CheckMate -069: In this Phase 2 trial, which is the first randomized study to evaluate the Opdivo + Yervoy combination regimen in patients with previously untreated advanced melanoma, the combination regimen demonstrated a two-year OS rate of 69% compared to 53% for Yervoy alone in patients with BRAF wild-type advanced melanoma. Similar results were observed in the overall study population, with an OS rate of 64% at two years for the combination regimen compared to 54% for Yervoy alone. A change in tumor burden was also seen with the combination regimen, with a median change of 70% compared to 5% for Yervoy alone. Overall survival was an exploratory endpoint in this trial. The safety profile of the Opdivo + Yervoy combination regimen in this study was consistent with previously reported studies. |
◦ | CA209-003: In this Phase 1 study, evaluating Opdivo monotherapy in heavily pretreated advanced melanoma, the company reported extended follow-up, including five-year OS rates. This data represents the longest survival follow-up of patients who received an anti-PD-1 therapy in a clinical trial. At five years, Opdivo demonstrated a durable and consistent survival benefit with an OS rate of 34%, with an evident plateau in survival at approximately 4 years. The safety profile of Opdivo in Study 003 was similar to previously reported studies, with no new safety signals identified. |
• | In March, the EMA validated a type II variation application, which seeks to extend the current indications for Opdivo to include the treatment of patients with cHL after prior therapies. The application included data from CheckMate -205, a Phase 2 study which evaluated Opdivo in cHL patients who have received autologous stem cell transplant and brentuximab vedotin. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process. |
• | In January, the company and its partner, AbbVie, Inc., announced the CHMP adopted a positive opinion recommending Empliciti, an investigational immunostimulatory antibody, be granted approval for the treatment of multiple myeloma as combination therapy with Revlimid® and dexamethasone in patients who have received at least one prior therapy. The application will now be reviewed by the EC, which has the authority to approve medicines for the European Union. The CHMP positive opinion is based on data from the Phase 3, open-label ELOQUENT-2 study, which evaluated Empliciti in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone. |
• | In February, the FDA approved Daklinza, an NS5A replication complex inhibitor, in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 (human immunodeficiency virus) coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is also available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. The approval is based on data evaluating the Daklinza regimens from the Phase 3 ALLY-1 and ALLY-2 clinical trials. |
• | In February, the company announced results from the first completed all-oral chronic HCV regimen Phase 3 trial that includes a Chinese patient population. In the study, which evaluated Daklinza in combination with asunaprevir for 24 weeks in Asian (non-Japanese) patients with genotype 1b HCV, 91% of patients from China achieved sustained virologic response at post-treatment week 24 (SVR24), which rose to 98% of patients without NS5A resistance-associated variants (RAVs) at baseline. SVR24 results were similarly high across all subgroups with genotype 1b HCV, including those with cirrhosis, and patients from Korea and Taiwan. SVR24 rates were also higher in all patients without baseline NS5A RAVs, regardless of the presence or absence of cirrhosis, and lower in patients with baseline NS5A RAVs. Results were presented at the Asian Pacific Association for the Study of the Liver Conference in Tokyo. |
• | In January, the EC approved Daklinza for the treatment of chronic HCV in three new patient populations which provides additional treatment options for multiple HCV patient populations, including difficult-to-treat patients with decompensated cirrhosis. The expanded label allows for the use of Daklinza in combination with sofosbuvir (with or without ribavirin, depending on the indication and HCV genotype) in HCV patients with decompensated cirrhosis, HIV-1 coinfection, and post-liver transplant recurrence of HCV. The approval is based on data from the Phase 3 ALLY-2 and ALLY-2 clinical trials. |
• | In April, the company acquired Padlock Therapeutics, Inc. (Padlock), a private, Cambridge, Massachusetts-based biotechnology company dedicated to creating new medicines to treat destructive autoimmune diseases. The acquisition gives the company full rights to Padlock’s Protein/Peptidyl Arginine Deiminase (PAD) inhibitor discovery program focused on the development of potentially transformational treatment approaches for patients with rheumatoid arthritis. Padlock’s PAD discovery program may have additional utility in treating systemic lupus erythematosus and other autoimmune diseases. |
• | In March, the company announced an agreement with LabCentral, an innovative, shared laboratory space designed as a launch pad for life-sciences and biotech startup companies, to become a LabCentral platinum sponsor. The company can nominate up to two innovative life-sciences and biotech startup companies per year to take up residence in LabCentral’s Kendall Square facilities. |
• | In February, the company and its partner, Pfizer Inc., announced a collaboration agreement with Portola Pharmaceuticals Inc. to develop and commercialize the investigational agent andexanet alfa in Japan. Andexanet alfa, which is in Phase 3 clinical development in the U.S. and Europe, is designed to reverse the anticoagulant activity of Factor Xa inhibitors, including Eliquis. This agreement builds on the companies’ existing clinical collaboration to develop andexanet alfa in the U.S. and Europe. |
• | In February, the company entered into a research collaboration agreement with the Dana-Farber Cancer Institute as part of the Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the U.S. As part of the I-O RPM program, the company and the Dana-Farber Cancer Institute will conduct a range of early phase clinical studies and Bristol-Myers Squibb will support the training of young investigators who contribute to the I-O RPM program at Dana-Farber. |
• | In February, the company completed the previously announced sale of its HIV R&D portfolio to ViiV Healthcare. The sale included a number of programs at different stages of discovery, preclinical and clinical development. The agreements with ViiV Healthcare do not impact the company’s marketed HIV medicines, including Reyataz, Evotaz, Sustiva and Atripla. |
• | Worldwide revenues increasing in the low-double digit range. |
• | Marketing, sales and administrative expenses decreasing in the low-single digit range. |
• | Research and development expenses increasing in the low-double digit range. |
Worldwide Revenues | U.S. Revenues | |||||||||||||||||||||
2016 | 2015 | % Change | 2016 | 2015 | % Change | |||||||||||||||||
Three Months Ended March 31, | ||||||||||||||||||||||
Key Products | ||||||||||||||||||||||
Oncology | ||||||||||||||||||||||
Empliciti | $ | 28 | $ | — | N/A | $ | 28 | $ | — | N/A | ||||||||||||
Erbitux(a) | — | 165 | (100 | )% | — | 157 | (100 | )% | ||||||||||||||
Opdivo | 704 | 40 | ** | 594 | 38 | ** | ||||||||||||||||
Sprycel | 407 | 375 | 9 | % | 210 | 181 | 16 | % | ||||||||||||||
Yervoy | 263 | 325 | (19 | )% | 199 | 181 | 10 | % | ||||||||||||||
Cardiovascular | ||||||||||||||||||||||
Eliquis | 734 | 355 | ** | 468 | 200 | ** | ||||||||||||||||
Immunoscience | ||||||||||||||||||||||
Orencia | 475 | 400 | 19 | % | 321 | 259 | 24 | % | ||||||||||||||
Virology | ||||||||||||||||||||||
Baraclude | 291 | 340 | (14 | )% | 17 | 46 | (63 | )% | ||||||||||||||
Hepatitis C Franchise | 427 | 264 | 62 | % | 259 | — | N/A | |||||||||||||||
Reyataz Franchise | 221 | 294 | (25 | )% | 120 | 143 | (16 | )% | ||||||||||||||
Sustiva Franchise | 273 | 290 | (6 | )% | 228 | 234 | (3 | )% | ||||||||||||||
Neuroscience | ||||||||||||||||||||||
Abilify(b) | 33 | 554 | (94 | )% | — | 508 | (100 | )% | ||||||||||||||
Mature Products and All Other | 535 | 639 | (16 | )% | 93 | 97 | (4 | )% | ||||||||||||||
Total | $ | 4,391 | $ | 4,041 | 9 | % | $ | 2,537 | $ | 2,044 | 24 | % |
** | 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. |
Three Months Ended March 31, | ||||||||
2016 | 2015 | |||||||
Net product sales | $ | 3,964 | $ | 3,059 | ||||
Alliance and other revenues | 427 | 982 | ||||||
Total Revenues | 4,391 | 4,041 | ||||||
Cost of products sold | 1,052 | 847 | ||||||
Marketing, selling and administrative | 1,068 | 1,029 | ||||||
Research and development | 1,136 | 1,016 | ||||||
Other (income)/expense | (520 | ) | (299 | ) | ||||
Total Expenses | 2,736 | 2,593 | ||||||
Earnings Before Income Taxes | 1,655 | 1,448 | ||||||
Provision for Income Taxes | 449 | 249 | ||||||
Net Earnings | 1,206 | 1,199 | ||||||
Net Earnings Attributable to Noncontrolling Interest | 11 | 13 | ||||||
Net Earnings Attributable to BMS | $ | 1,195 | $ | 1,186 | ||||
Average Common Shares Outstanding: | ||||||||
Basic | 1,669 | 1,663 | ||||||
Diluted | 1,680 | 1,676 | ||||||
Earnings per Common Share | ||||||||
Basic | $ | 0.72 | $ | 0.71 | ||||
Diluted | $ | 0.71 | $ | 0.71 | ||||
Other (Income)/Expense | ||||||||
Interest expense | $ | 43 | $ | 51 | ||||
Investment income | (24 | ) | (30 | ) | ||||
Provision for restructuring | 4 | 12 | ||||||
Litigation and other settlements | 43 | 12 | ||||||
Equity in net income of affiliates | (26 | ) | (26 | ) | ||||
Out-licensed intangible asset impairment | 15 | 13 | ||||||
Divestiture gains | (270 | ) | (154 | ) | ||||
Royalties and licensing income | (254 | ) | (98 | ) | ||||
Transition and other service fees | (53 | ) | (27 | ) | ||||
Pension charges | 22 | 27 | ||||||
Written option adjustment | — | (36 | ) | |||||
Other | (20 | ) | (43 | ) | ||||
Other (income)/expense | $ | (520 | ) | $ | (299 | ) |
Three Months Ended March 31, | ||||||||
2016 | 2015 | |||||||
Cost of products sold(a) | $ | 4 | $ | 34 | ||||
Marketing, selling and administrative | — | 1 | ||||||
License and asset acquisition charges | 125 | 162 | ||||||
Other | 13 | — | ||||||
Research and development | 138 | 162 | ||||||
Provision for restructuring | 4 | 12 | ||||||
Divestiture gains | (269 | ) | (152 | ) | ||||
Pension charges | 22 | 27 | ||||||
Written option adjustment | — | (36 | ) | |||||
Litigation and other settlements | 43 | 14 | ||||||
Out-licensed intangible asset impairment | 15 | 13 | ||||||
Other (income)/expense | (185 | ) | (122 | ) | ||||
Increase/(decrease) to pretax income | (43 | ) | 75 | |||||
Income tax on items above | 83 | (68 | ) | |||||
Increase to net earnings | $ | 40 | $ | 7 |
(a) | Specified items in cost of products sold are accelerated depreciation, asset impairment and other shutdown costs. |
Three Months Ended March 31, 2016 | GAAP | Specified Items(a) | Non- GAAP | |||||||||
Gross Profit | $ | 3,339 | $ | 4 | $ | 3,343 | ||||||
Marketing, selling and administrative | 1,068 | — | 1,068 | |||||||||
Research and development | 1,136 | (138 | ) | 998 | ||||||||
Other (income)/expense | (520 | ) | 185 | (335 | ) | |||||||
Effective Tax Rate | 27.1 | % | (4.4 | )% | 22.7 | % | ||||||
Three Months Ended March 31, 2015 | GAAP | Specified Items(a) | Non- GAAP | |||||||||
Gross Profit | $ | 3,194 | $ | 34 | $ | 3,228 | ||||||
Marketing, selling and administrative | 1,029 | (1 | ) | 1,028 | ||||||||
Research and development | 1,016 | (162 | ) | 854 | ||||||||
Other (income)/expense | (299 | ) | 122 | (177 | ) | |||||||
Effective Tax Rate | 17.2 | % | 3.6 | % | 20.8 | % |
(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. |
Three Months Ended March 31, | ||||||||
2016 | 2015 | |||||||
Net Earnings Attributable to BMS used for Diluted EPS Calculation - GAAP | $ | 1,195 | $ | 1,186 | ||||
Less Specified Items* | 40 | 7 | ||||||
Net Earnings used for Diluted EPS Calculation – Non-GAAP | $ | 1,235 | $ | 1,193 | ||||
Average Common Shares Outstanding- Diluted | 1,680 | 1,676 | ||||||
Diluted Earnings Per Share — GAAP | $ | 0.71 | $ | 0.71 | ||||
Diluted EPS Attributable to Specified Items | 0.03 | — | ||||||
Diluted Earnings Per Share — Non-GAAP | $ | 0.74 | $ | 0.71 |
* | Refer to the Specified Items schedule for further details. |
March 31, 2016 | December 31, 2015 | |||||||
Cash and cash equivalents | $ | 2,644 | $ | 2,385 | ||||
Marketable securities - current | 1,663 | 1,885 | ||||||
Marketable securities - non-current | 3,689 | 4,660 | ||||||
Cash, cash equivalents and marketable securities | 7,996 | 8,930 | ||||||
Short-term borrowings | (106 | ) | (139 | ) | ||||
Long-term debt | (6,593 | ) | (6,550 | ) | ||||
Net cash position | $ | 1,297 | $ | 2,241 |
Revenues | 2015 | 2016 | % 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 | $ | 2,044 | $ | 1,837 | $ | 3,881 | $ | 2,044 | $ | 5,925 | $ | 2,263 | $ | 8,188 | $ | 2,537 | 24% | 24% | — | — | ||||||||||||||||||||||||||||||||
Europe | 782 | 974 | 1,756 | 813 | 2,569 | 922 | 3,491 | 870 | 11% | 11% | (4)% | (4)% | ||||||||||||||||||||||||||||||||||||||||
Rest of the World | 1,019 | 1,124 | 2,143 | 1,027 | 3,170 | 972 | 4,142 | 840 | (18)% | (18)% | (7)% | (7)% | ||||||||||||||||||||||||||||||||||||||||
Other | 196 | 228 | 424 | 185 | 609 | 130 | 739 | 144 | (27)% | (27)% | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||
Total | $ | 4,041 | $ | 4,163 | $ | 8,204 | $ | 4,069 | $ | 12,273 | $ | 4,287 | $ | 16,560 | $ | 4,391 | 9% | 9% | (2)% | (2)% | ||||||||||||||||||||||||||||||||
% of Revenues | 2015 | 2016 | ||||||||||||||||||||||||||||||||||||||||||||||||||
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 | 50.6 | % | 44.1 | % | 47.3 | % | 50.2 | % | 48.3 | % | 52.8 | % | 49.4 | % | 57.8 | % | ||||||||||||||||||||||||||||||||||||
Europe | 19.4 | % | 23.4 | % | 21.4 | % | 20.0 | % | 20.9 | % | 21.5 | % | 21.1 | % | 19.8 | % | ||||||||||||||||||||||||||||||||||||
Rest of the World | 25.2 | % | 27.0 | % | 26.1 | % | 25.2 | % | 25.8 | % | 22.7 | % | 25.0 | % | 19.1 | % | ||||||||||||||||||||||||||||||||||||
Other | 4.8 | % | 5.5 | % | 5.2 | % | 4.6 | % | 5.0 | % | 3.0 | % | 4.5 | % | 3.3 | % | ||||||||||||||||||||||||||||||||||||
Total | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % |
2015 | 2016 | % 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 | $ | 3,059 | $ | 3,572 | $ | 6,631 | $ | 3,552 | $ | 10,183 | $ | 3,862 | $ | 14,045 | $ | 3,964 | 30% | 30% | ||||||||||||||||||||||||||||||||
Alliance and other revenues | 982 | 591 | 1,573 | 517 | 2,090 | 425 | 2,515 | 427 | (57)% | (57)% | ||||||||||||||||||||||||||||||||||||||||
Total Revenues | $ | 4,041 | $ | 4,163 | $ | 8,204 | $ | 4,069 | $ | 12,273 | $ | 4,287 | $ | 16,560 | $ | 4,391 | 9% | 9% | ||||||||||||||||||||||||||||||||
Cost of products sold | 847 | 1,013 | 1,860 | 1,097 | 2,957 | 952 | 3,909 | 1,052 | 24% | 24% | ||||||||||||||||||||||||||||||||||||||||
Marketing, selling and administrative | 1,029 | 1,135 | 2,164 | 1,176 | 3,340 | 1,501 | 4,841 | 1,068 | 4% | 4% | ||||||||||||||||||||||||||||||||||||||||
Research and development | 1,016 | 1,856 | 2,872 | 1,132 | 4,004 | 1,916 | 5,920 | 1,136 | 12% | 12% | ||||||||||||||||||||||||||||||||||||||||
Other (income)/expense | (299 | ) | 107 | (192 | ) | (323 | ) | (515 | ) | 328 | (187 | ) | (520 | ) | 74% | 74% | ||||||||||||||||||||||||||||||||||
Total Expenses | 2,593 | 4,111 | 6,704 | 3,082 | 9,786 | 4,697 | 14,483 | 2,736 | 6% | 6% | ||||||||||||||||||||||||||||||||||||||||
Earnings/(Loss) Before Income Taxes | $ | 1,448 | $ | 52 | $ | 1,500 | $ | 987 | $ | 2,487 | $ | (410 | ) | $ | 2,077 | $ | 1,655 | 14% | 14% | |||||||||||||||||||||||||||||||
Provision for/(Benefit from) Income Taxes | 249 | 162 | 411 | 257 | 668 | (222 | ) | 446 | 449 | 80% | 80% | |||||||||||||||||||||||||||||||||||||||
Net Earnings/(Loss) | $ | 1,199 | $ | (110 | ) | $ | 1,089 | $ | 730 | $ | 1,819 | $ | (188 | ) | $ | 1,631 | $ | 1,206 | 1% | 1% | ||||||||||||||||||||||||||||||
Net Earnings Attributable to Noncontrolling Interest | 13 | 20 | 33 | 24 | 57 | 9 | 66 | 11 | (15)% | (15)% | ||||||||||||||||||||||||||||||||||||||||
Net Earnings/(Loss) Attributable to BMS | $ | 1,186 | $ | (130 | ) | $ | 1,056 | $ | 706 | $ | 1,762 | $ | (197 | ) | $ | 1,565 | $ | 1,195 | 1% | 1% | ||||||||||||||||||||||||||||||
Diluted Earnings/(Loss) per Common Share* | $ | 0.71 | $ | (0.08 | ) | $ | 0.63 | $ | 0.42 | $ | 1.05 | $ | (0.12 | ) | $ | 0.93 | $ | 0.71 | — | — | ||||||||||||||||||||||||||||||
Average Common Shares Outstanding - Diluted | 1,676 | 1,667 | 1,677 | 1,678 | 1,677 | 1,669 | 1,679 | 1,680 | — | — | ||||||||||||||||||||||||||||||||||||||||
Dividends declared per common share | $ | 0.37 | $ | 0.37 | $ | 0.74 | $ | 0.37 | $ | 1.11 | $ | 0.38 | $ | 1.49 | $ | 0.38 | 3% | 3% | ||||||||||||||||||||||||||||||||
2015 | 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||
% 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 | 79.0 | % | 75.7 | % | 77.3 | % | 73.0 | % | 75.9 | % | 77.8 | % | 76.4 | % | 76.0 | % | ||||||||||||||||||||||||||||||||||
Other Ratios | ||||||||||||||||||||||||||||||||||||||||||||||||||
Effective tax rate | 17.2 | % | 311.5 | % | 27.4 | % | 26.0 | % | 26.9 | % | 54.1 | % | 21.5 | % | 27.1 | % | ||||||||||||||||||||||||||||||||||
Other (Income)/Expense | 2015 | 2016 | % 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 | $ | 51 | $ | 49 | $ | 100 | $ | 41 | $ | 141 | $ | 43 | $ | 184 | $ | 43 | (16 | )% | (16 | )% | ||||||||||||||||||||||||||||||
Investment income | (30 | ) | (26 | ) | (56 | ) | (18 | ) | (74 | ) | (27 | ) | (101 | ) | (24 | ) | (20 | )% | (20 | )% | ||||||||||||||||||||||||||||||
Provision for restructuring | 12 | 28 | 40 | 10 | 50 | 68 | 118 | 4 | (67 | )% | (67 | )% | ||||||||||||||||||||||||||||||||||||||
Litigation and other settlements | 12 | 4 | 16 | (2 | ) | 14 | 145 | 159 | 43 | ** | ** | |||||||||||||||||||||||||||||||||||||||
Equity in net income of affiliates | (26 | ) | (22 | ) | (48 | ) | (19 | ) | (67 | ) | (16 | ) | (83 | ) | (26 | ) | — | — | ||||||||||||||||||||||||||||||||
Out-licensed intangible asset impairment | 13 | — | 13 | — | 13 | — | 13 | 15 | 15 | % | 15 | % | ||||||||||||||||||||||||||||||||||||||
Divestiture (gains)/losses | (154 | ) | (8 | ) | (162 | ) | (208 | ) | (370 | ) | 174 | (196 | ) | (270 | ) | 75 | % | 75 | % | |||||||||||||||||||||||||||||||
Royalties and licensing income | (98 | ) | (97 | ) | (195 | ) | (63 | ) | (258 | ) | (125 | ) | (383 | ) | (254 | ) | ** | ** | ||||||||||||||||||||||||||||||||
Transition and other service fees | (27 | ) | (27 | ) | (54 | ) | (37 | ) | (91 | ) | (31 | ) | (122 | ) | (53 | ) | 96 | % | 96 | % | ||||||||||||||||||||||||||||||
Pension charges | 27 | 36 | 63 | 48 | 111 | 49 | 160 | 22 | (19 | )% | (19 | )% | ||||||||||||||||||||||||||||||||||||||
Written option adjustment | (36 | ) | — | (36 | ) | (87 | ) | (123 | ) | — | (123 | ) | — | (100 | )% | (100 | )% | |||||||||||||||||||||||||||||||||
Loss on debt redemption | — | 180 | 180 | — | 180 | — | 180 | — | — | — | ||||||||||||||||||||||||||||||||||||||||
Other | (43 | ) | (10 | ) | (53 | ) | 12 | (41 | ) | 48 | 7 | (20 | ) | (53 | )% | (53 | )% | |||||||||||||||||||||||||||||||||
$ | (299 | ) | $ | 107 | $ | (192 | ) | $ | (323 | ) | $ | (515 | ) | $ | 328 | $ | (187 | ) | $ | (520 | ) | 74 | % | 74 | % |
* | Quarterly amounts may not add to the year-to-date totals due to rounding of individual calculations. | |||||||||||
** | In excess of +/- 100% |
QUARTER-TO-DATE | 2016 | 2015 | Growth $ | Growth % | Favorable / (Unfavorable) FX Impact $ * | 2016 Excluding FX | Favorable / (Unfavorable) FX Impact % * | Growth % Excluding FX | ||||||||||||||||||
Revenues | $ | 4,391 | $ | 4,041 | $ | 350 | 9% | $ | (95 | ) | $ | 4,486 | (2)% | 11% | ||||||||||||
Gross profit | 3,339 | 3,194 | 145 | 5% | N/A | N/A | N/A | N/A | ||||||||||||||||||
Gross profit excluding specified items(a) | 3,343 | 3,228 | 115 | 4% | N/A | N/A | N/A | N/A | ||||||||||||||||||
Gross profit excluding specified items as a % of revenues | 76.1 | % | 79.9 | % | ||||||||||||||||||||||
Marketing, selling and administrative | 1,068 | 1,029 | 39 | 4% | 26 | 1,094 | 2% | 6% | ||||||||||||||||||
Marketing, selling and administrative excluding specified items(a) | 1,068 | 1,028 | 40 | 4% | 26 | 1,094 | 2% | 6% | ||||||||||||||||||
MS&A excluding specified items as a % of revenues | 24.3 | % | 25.4 | % | ||||||||||||||||||||||
Research and development | 1,136 | 1,016 | 120 | 12% | 8 | 1,144 | 1% | 13% | ||||||||||||||||||
Research and development excluding specified items(a) | 998 | 854 | 144 | 17% | 8 | 1,006 | 1% | 18% | ||||||||||||||||||
Research and development excluding specified items as a % of revenues | 22.7 | % | 21.1 | % | ||||||||||||||||||||||
(a) | Refer to the Specified Items schedule for further details. | |||||||||||
* | Foreign exchange impacts were derived by applying the prior period average currency rates to the current period sales and expenses. |
2015 | 2016 | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oncology(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Empliciti | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 3 | $ | 3 | $ | 28 | $ | 28 | $ | 28 | N/A | N/A | $ | 28 | $ | 28 | N/A | N/A | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||
Erbitux | 165 | 169 | 334 | 167 | 501 | — | 501 | — | (165 | ) | (165 | ) | (100 | )% | (100 | )% | — | — | (100 | )% | (100 | )% | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Opdivo | 40 | 122 | 162 | 305 | 467 | 475 | 942 | 704 | 664 | 664 | ** | ** | 707 | 707 | ** | ** | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sprycel | 375 | 405 | 780 | 411 | 1,191 | 429 | 1,620 | 407 | 32 | 32 | 9 | % | 9 | % | 420 | 420 | 12 | % | 12 | % | (3 | )% | (3 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Yervoy | 325 | 296 | 621 | 240 | 861 | 265 | 1,126 | 263 | (62 | ) | (62 | ) | (19 | )% | (19 | )% | 268 | 268 | (18 | )% | (18 | )% | (1 | )% | (1 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Cardiovascular(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Eliquis | 355 | 437 | 792 | 466 | 1,258 | 602 | 1,860 | 734 | 379 | 379 | ** | ** | 741 | 741 | ** | ** | (2 | )% | (2 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Immunoscience(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Orencia(b) | 400 | 461 | 861 | 484 | 1,345 | 540 | 1,885 | 475 | 75 | 75 | 19 | % | 19 | % | 484 | 484 | 21 | % | 21 | % | (2 | )% | (2 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Virology(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baraclude | 340 | 343 | 683 | 320 | 1,003 | 309 | 1,312 | 291 | (49 | ) | (49 | ) | (14 | )% | (14 | )% | 301 | 301 | (11 | )% | (11 | )% | (3 | )% | (3 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Hepatitis C Franchise(c) | 264 | 479 | 743 | 402 | 1,145 | 458 | 1,603 | 427 | 163 | 163 | 62 | % | 62 | % | 436 | 436 | 65 | % | 65 | % | (3 | )% | (3 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reyataz Franchise | 294 | 303 | 597 | 270 | 867 | 272 | 1,139 | 221 | (73 | ) | (73 | ) | (25 | )% | (25 | )% | 233 | 233 | (21 | )% | (21 | )% | (4 | )% | (4 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Sustiva Franchise(d) | 290 | 317 | 607 | 333 | 940 | 312 | 1,252 | 273 | (17 | ) | (17 | ) | (6 | )% | (6 | )% | 273 | 273 | (6 | )% | (6 | )% | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Neuroscience(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Abilify(e) | 554 | 107 | 661 | 46 | 707 | 39 | 746 | 33 | (521 | ) | (521 | ) | (94 | )% | (94 | )% | 36 | 36 | (94 | )% | (94 | )% | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Mature Products and All Other(f) | 639 | 724 | 1,363 | 625 | 1,988 | 583 | 2,571 | 535 | (104 | ) | (104 | ) | (16 | )% | (16 | )% | 559 | 559 | (13 | )% | (13 | )% | (3 | )% | (3 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | $ | 4,041 | $ | 4,163 | $ | 8,204 | $ | 4,069 | $ | 12,273 | $ | 4,287 | $ | 16,560 | $ | 4,391 | $ | 350 | $ | 350 | 9 | % | 9 | % | $ | 4,486 | $ | 4,486 | 11 | % | 11 | % | (2 | )% | (2 | )% | ||||||||||||||||||||||||||||||||||||||||||
Total Excluding Abilify and Erbitux | $ | 3,322 | $ | 3,887 | $ | 7,209 | $ | 3,856 | $ | 11,065 | $ | 4,248 | $ | 15,313 | $ | 4,358 | $ | 1,036 | $ | 1,036 | 31 | % | 31 | % | $ | 4,450 | $ | 4,450 | 34 | % | 34 | % | (3 | )% | (3 | )% |
** | In excess of +/- 100% |
(a) | Key products listed do not represent all products in the respective therapeutic areas. |
(b) | Includes Orencia SubQ revenues of $216 million and $176 million for the three months ended March 31, 2016 and 2015, respectively. |
(c) | Includes Daklinza (daclatasvir) revenues of $420 million and $180 million for the three months ended March 31, 2016 and 2015, respectively. Additionally, includes Sunvepra (asunaprevir) revenues of $7 million and $84 million for the three months ended March 31, 2016 and 2015, respectively. |
(d) | The Sustiva Franchise includes sales of Sustiva and revenue from sales of bulk efavirenz included in the combination therapy, Atripla. Includes alliance revenue of $241 million and $251 million for the three months ended March 31, 2016 and 2015, respectively. |
(e) | Includes alliance revenue of $508 million for the three months ended March 31, 2015. BMS's U.S. commercialization rights to Abilify expired in April 2015. |
(f) | Represents all other products, including those which have lost exclusivity in major markets, over the counter brands and royalty-related revenue. |
Note: 2015 year-to-date revenues of new and inline brands grew 41% excluding Abilify, Baraclude and the Sustiva Franchise. |
2015 | 2016 | % 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 | |||||||||||||||||||||||||||||||||
Oncology | ||||||||||||||||||||||||||||||||||||||||||||||||
Empliciti | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 3 | $ | 3 | $ | 28 | N/A | N/A | ||||||||||||||||||||||||||||||
Erbitux | 157 | 165 | 322 | 165 | 487 | — | 487 | — | (100)% | (100)% | ||||||||||||||||||||||||||||||||||||||
Opdivo | 38 | 107 | 145 | 268 | 413 | 410 | 823 | 594 | ** | ** | ||||||||||||||||||||||||||||||||||||||
Sprycel | 181 | 205 | 386 | 215 | 601 | 228 | 829 | 210 | 16% | 16% | ||||||||||||||||||||||||||||||||||||||
Yervoy | 181 | 136 | 317 | 121 | 438 | 164 | 602 | 199 | 10% | 10% | ||||||||||||||||||||||||||||||||||||||
Cardiovascular | ||||||||||||||||||||||||||||||||||||||||||||||||
Eliquis | 200 | 243 | 443 | 245 | 688 | 335 | 1,023 | 468 | ** | ** | ||||||||||||||||||||||||||||||||||||||
Immunoscience | ||||||||||||||||||||||||||||||||||||||||||||||||
Orencia(a) | 259 | 310 | 569 | 330 | 899 | 372 | 1,271 | 321 | 24% | 24% | ||||||||||||||||||||||||||||||||||||||
Virology | ||||||||||||||||||||||||||||||||||||||||||||||||
Baraclude | 46 | 37 | 83 | 25 | 108 | 27 | 135 | 17 | (63)% | (63)% | ||||||||||||||||||||||||||||||||||||||
Hepatitis C Franchise(b) | — | — | — | 111 | 111 | 212 | 323 | 259 | N/A | N/A | ||||||||||||||||||||||||||||||||||||||
Reyataz Franchise | 143 | 157 | 300 | 149 | 449 | 142 | 591 | 120 | (16)% | (16)% | ||||||||||||||||||||||||||||||||||||||
Sustiva Franchise(c) | 234 | 258 | 492 | 280 | 772 | 269 | 1,041 | 228 | (3)% | (3)% | ||||||||||||||||||||||||||||||||||||||
Neuroscience | ||||||||||||||||||||||||||||||||||||||||||||||||
Abilify | 508 | 67 | 575 | 18 | 593 | 7 | 600 | — | (100)% | (100)% | ||||||||||||||||||||||||||||||||||||||
Mature Products and All Other(d) | 97 | 152 | 249 | 117 | 366 | 94 | 460 | 93 | (4)% | (4)% | ||||||||||||||||||||||||||||||||||||||
Total(e) | $ | 2,044 | $ | 1,837 | $ | 3,881 | $ | 2,044 | $ | 5,925 | $ | 2,263 | $ | 8,188 | $ | 2,537 | 24% | 24% | ||||||||||||||||||||||||||||||
** | In excess of +/- 100% |
(a) | Includes Orencia SubQ revenues of $132 million and $111 million for the three months ended March 31, 2016 and 2015, respectively. |
(b) | Includes revenues of Daklinza (daclastasvir) only, which was launched in the U.S. in the third quarter of 2015. |
(c) | The Sustiva Franchise includes sales of Sustiva, as well as revenue from sales of bulk efavirenz included in the combination therapy, Atripla. |
(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. |
2015 | 2016 | % 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 | |||||||||||||||||||||||||||||||||||
Oncology | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Erbitux | $ | 8 | $ | 4 | $ | 12 | $ | 2 | $ | 14 | $ | — | $ | 14 | $ | — | (100)% | (100)% | — | — | ||||||||||||||||||||||||||||||||
Opdivo | 2 | 15 | 17 | 37 | 54 | 65 | 119 | 110 | ** | ** | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||
Sprycel | 194 | 200 | 394 | 196 | 590 | 201 | 791 | 197 | 2% | 2% | (6)% | (6)% | ||||||||||||||||||||||||||||||||||||||||
Yervoy | 144 | 160 | 304 | 119 | 423 | 101 | 524 | 64 | (56)% | (56)% | (5)% | (5)% | ||||||||||||||||||||||||||||||||||||||||
Cardiovascular | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Eliquis | 155 | 194 | 349 | 221 | 570 | 267 | 837 | 266 | 72% | 72% | (4)% | (4)% | ||||||||||||||||||||||||||||||||||||||||
Immunoscience | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Orencia | 141 | 151 | 292 | 154 | 446 | 168 | 614 | 154 | 9% | 9% | (6)% | (6)% | ||||||||||||||||||||||||||||||||||||||||
Virology | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Baraclude | 294 | 306 | 600 | 295 | 895 | 282 | 1,177 | 274 | (7)% | (7)% | (4)% | (4)% | ||||||||||||||||||||||||||||||||||||||||
Hepatitis C Franchise(a) | 264 | 479 | 743 | 291 | 1,034 | 246 | 1,280 | 168 | (36)% | (36)% | (3)% | (3)% | ||||||||||||||||||||||||||||||||||||||||
Reyataz Franchise | 151 | 146 | 297 | 121 | 418 | 130 | 548 | 101 | (33)% | (33)% | (8)% | (8)% | ||||||||||||||||||||||||||||||||||||||||
Sustiva Franchise(b) | 56 | 59 | 115 | 53 | 168 | 43 | 211 | 45 | (20)% | (20)% | — | — | ||||||||||||||||||||||||||||||||||||||||
Neuroscience | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Abilify(c) | 46 | 40 | 86 | 28 | 114 | 32 | 146 | 33 | (28)% | (28)% | (6)% | (6)% | ||||||||||||||||||||||||||||||||||||||||
Mature Products and All Other(d) | 542 | 572 | 1,114 | 508 | 1,622 | 489 | 2,111 | 442 | (18)% | (18)% | (4)% | (4)% | ||||||||||||||||||||||||||||||||||||||||
Total | $ | 1,997 | $ | 2,326 | $ | 4,323 | $ | 2,025 | $ | 6,348 | $ | 2,024 | $ | 8,372 | $ | 1,854 | (7)% | (7)% | (5)% | (5)% |
** | In excess of +/- 100% |
(a) | Includes Daklinza (daclatasvir) revenues of $161 million and $180 million for the three months ended March 31, 2016 and 2015, respectively. Additionally, includes Sunvepra (asunaprevir) revenues of $7 million and $84 million for the three months ended March 31, 2016 and 2015, 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. |
2015 | 2016 | |||||||||||||||||||||||||||||||||||||||||||
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 | $ | 3,194 | $ | 3,150 | $ | 6,344 | $ | 2,972 | $ | 9,316 | $ | 3,335 | $ | 12,651 | $ | 3,339 | ||||||||||||||||||||||||||||
Specified items(a) | 34 | 25 | 59 | 15 | 74 | 10 | 84 | 4 | ||||||||||||||||||||||||||||||||||||
Gross profit excluding specified items | 3,228 | 3,175 | 6,403 | 2,987 | 9,390 | 3,345 | 12,735 | 3,343 | ||||||||||||||||||||||||||||||||||||
Marketing, selling and administrative | 1,029 | 1,135 | 2,164 | 1,176 | 3,340 | 1,501 | 4,841 | 1,068 | ||||||||||||||||||||||||||||||||||||
Specified items(a) | (1 | ) | (3 | ) | (4 | ) | (2 | ) | (6 | ) | (4 | ) | (10 | ) | — | |||||||||||||||||||||||||||||
Marketing, selling and administrative excluding specified items | 1,028 | 1,132 | 2,160 | 1,174 | 3,334 | 1,497 | 4,831 | 1,068 | ||||||||||||||||||||||||||||||||||||
Research and development | 1,016 | 1,856 | 2,872 | 1,132 | 4,004 | 1,916 | 5,920 | 1,136 | ||||||||||||||||||||||||||||||||||||
Specified items(a) | (162 | ) | (871 | ) | (1,033 | ) | (109 | ) | (1,142 | ) | (741 | ) | (1,883 | ) | (138 | ) | ||||||||||||||||||||||||||||
Research and development excluding specified items | 854 | 985 | 1,839 | 1,023 | 2,862 | 1,175 | 4,037 | 998 | ||||||||||||||||||||||||||||||||||||
Other (income)/expense | (299 | ) | 107 | (192 | ) | (323 | ) | (515 | ) | 328 | (187 | ) | (520 | ) | ||||||||||||||||||||||||||||||
Specified items(a) | 122 | (237 | ) | (115 | ) | 227 | 112 | (428 | ) | (316 | ) | 185 | ||||||||||||||||||||||||||||||||
Other (income)/expense excluding specified items | (177 | ) | (130 | ) | (307 | ) | (96 | ) | (403 | ) | (100 | ) | (503 | ) | (335 | ) | ||||||||||||||||||||||||||||
Effective Tax Rate | 17.2 | % | 311.5 | % | 27.4 | % | 26.0 | % | 26.9 | % | 54.1 | % | 21.5 | % | 27.1 | % | ||||||||||||||||||||||||||||
Specified items(a) | 3.6 | % | (288.1 | )% | (5.5 | )% | (1.8 | )% | (4.4 | )% | (39.0 | )% | (0.3 | )% | (4.4 | )% | ||||||||||||||||||||||||||||
Effective Tax Rate excluding specified items | 20.8 | % | 23.4 | % | 21.9 | % | 24.2 | % | 22.5 | % | 15.1 | % | 21.2 | % | 22.7 | % |
(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. |
2015 | 2016 | |||||||||||||||||||||||||||||||||||||||||||
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) | $ | 34 | $ | 25 | $ | 59 | $ | 15 | $ | 74 | $ | 10 | $ | 84 | $ | 4 | ||||||||||||||||||||||||||||
Marketing, selling and administrative | 1 | 3 | 4 | 2 | 6 | 4 | 10 | — | ||||||||||||||||||||||||||||||||||||
License and asset acquisition charges | 162 | 869 | 1,031 | 94 | 1,125 | 554 | 1,679 | 125 | ||||||||||||||||||||||||||||||||||||
IPRD impairments | — | — | — | — | — | 160 | 160 | — | ||||||||||||||||||||||||||||||||||||
Other | — | 2 | 2 | 15 | 17 | 27 | 44 | 13 | ||||||||||||||||||||||||||||||||||||
Research and development | 162 | 871 | 1,033 | 109 | 1,142 | 741 | 1,883 | 138 | ||||||||||||||||||||||||||||||||||||
Provision for restructuring | 12 | 28 | 40 | 10 | 50 | 65 | 115 | 4 | ||||||||||||||||||||||||||||||||||||
Divestiture (gains)/losses | (152 | ) | (8 | ) | (160 | ) | (198 | ) | (358 | ) | 171 | (187 | ) | (269 | ) | |||||||||||||||||||||||||||||
Pension charges | 27 | 36 | 63 | 48 | 111 | 49 | 160 | 22 | ||||||||||||||||||||||||||||||||||||
Written option adjustment | (36 | ) | — | (36 | ) | (87 | ) | (123 | ) | — | (123 | ) | — | |||||||||||||||||||||||||||||||
Litigation and other settlements | 14 | 1 | 15 | — | 15 | 143 | 158 | 43 | ||||||||||||||||||||||||||||||||||||
Out-licensed intangible asset impairment | 13 | — | 13 | — | 13 | — | 13 | 15 | ||||||||||||||||||||||||||||||||||||
Loss on debt redemption | — | 180 | 180 | — | 180 | — | 180 | — | ||||||||||||||||||||||||||||||||||||
Other (income)/expense | (122 | ) | 237 | 115 | (227 | ) | (112 | ) | 428 | 316 | (185 | ) | ||||||||||||||||||||||||||||||||
Increase/(decrease) to pretax income | 75 | 1,136 | 1,211 | (101 | ) | 1,110 | 1,183 | 2,293 | (43 | ) | ||||||||||||||||||||||||||||||||||
Income tax on items above | (68 | ) | (116 | ) | (184 | ) | 43 | (141 | ) | (339 | ) | (480 | ) | 83 | ||||||||||||||||||||||||||||||
Increase/(decrease) to net earnings | $ | 7 | $ | 1,020 | $ | 1,027 | $ | (58 | ) | $ | 969 | $ | 844 | $ | 1,813 | $ | 40 |
(a) | Specified items in cost of products sold are accelerated depreciation, asset impairment and other shutdown costs. |
March 31, 2015 | June 30, 2015 | September 30, 2015 | December 31, 2015 | March 31, 2016 | June 30, 2016 | September 30, 2016 | December 31, 2016 | |||||||||||||||||||
Cash and cash equivalents | $ | 6,294 | $ | 4,199 | $ | 3,975 | $ | 2,385 | $ | 2,644 | ||||||||||||||||
Marketable securities - current | 1,313 | 1,277 | 1,438 | 1,885 | 1,663 | |||||||||||||||||||||
Marketable securities - non-current | 4,279 | 4,632 | 4,627 | 4,660 | 3,689 | |||||||||||||||||||||
Cash, cash equivalents and marketable securities | 11,886 | 10,108 | 10,040 | 8,930 | 7,996 | |||||||||||||||||||||
Short-term borrowings | (330 | ) | (755 | ) | (642 | ) | (139 | ) | (106 | ) | ||||||||||||||||
Long-term debt | (7,127 | ) | (6,615 | ) | (6,632 | ) | (6,550 | ) | (6,593 | ) | ||||||||||||||||
Net cash position | $ | 4,429 | $ | 2,738 | $ | 2,766 | $ | 2,241 | $ | 1,297 |
Full Year 2016 | ||
Projected Diluted Earnings Attributable to Shareholders per Common Share - GAAP | $2.37 to $2.47 | |
Projected Specified Items: | ||
Downsizing and streamlining of worldwide operations | (0.19 | ) |
License and asset acquisition charges | 0.24 | |
Pension charges | 0.04 | |
Litigation and other settlements | 0.03 | |
Other | 0.01 | |
Total | 0.13 | |
Projected Diluted Earnings Attributable to Shareholders per Common Share - Non-GAAP | $2.50 to $2.60 |
Gross margin as a percentage of revenues on a GAAP and non-GAAP basis for the three months ended March 31, 2016 was 76.0% and 76.1%, 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". | |||||||||
Marketing, selling and administrative expenses on a GAAP and non-GAAP basis for the three months ended March 31, 2016 were $1.1 billion. On a non-GAAP basis, the Company projects marketing, selling and administrative expenses for the full year 2016 to decrease in the low-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". | |||||||||
Research and development expenses on a GAAP and non-GAAP basis for the three months ended March 31, 2016 were $1.1 billion and $1.0 billion, respectively. On a non-GAAP basis, the Company projects research and development expense for the full year 2016 to increase in the low-double-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". | |||||||||
The effective tax rate on a GAAP basis for the three months ended March 31, 2016 was 27.1%. On a non-GAAP basis, for the three months ended March 31, 2016 the effective tax rate was 22.7%. 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) , license and asset acquisition charges, restructuring and pension charges. 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 divestitures, additional license and asset acquisition charges, 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 First Quarter 2016 Financial Results, April 28, 2016 including “2016 Financial Guidance” and “Use of non-GAAP Financial Information” therein. | |||||||||
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