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 July 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: July 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 July 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 Second Quarter Revenues 17% to $4.9 Billion |
• | Posts Second Quarter GAAP and Non-GAAP EPS of $0.69 |
• | Achieves Important Regulatory Milestones in Immuno-Oncology |
◦ | Opdivo + Yervoy Regimen Approved in Europe for Metastatic Melanoma |
◦ | Opdivo Approved in the U.S. for the Treatment of Classical Hodgkin Lymphoma |
◦ | Opdivo Granted Breakthrough Therapy Designation for Advanced Form of Bladder Cancer |
◦ | Empliciti Approved in Europe for Combination Treatment for Multiple Myeloma |
◦ | Opdivo Application for Squamous Cell Carcinoma of the Head and Neck Accepted in the U.S., Europe and Japan |
• | Increases 2016 GAAP EPS Guidance Range to $2.43 - $2.53 and Non-GAAP EPS Guidance Range to $2.55 - $2.65 |
Second Quarter | ||||||||||
$ amounts in millions, except per share amounts | ||||||||||
2016 | 2015 | Change | ||||||||
Total Revenues | $ | 4,871 | $ | 4,163 | 17 | % | ||||
GAAP Diluted EPS | 0.69 | (0.08 | ) | ** | ||||||
Non-GAAP Diluted EPS | 0.69 | 0.53 | 30 | % |
• | Bristol-Myers Squibb posted second quarter 2016 revenues of $4.9 billion, an increase of 17% compared to the same period a year ago. Global revenues increased 18% adjusted for foreign exchange impact. Excluding Abilify and Erbitux, global revenues increased 24% or 26% adjusted for foreign exchange impact. |
• | U.S. revenues increased 46% to $2.7 billion in the quarter compared to the same period a year ago. International revenues decreased 6% primarily from lower Hepatitis C Franchise sales in Japan and France. When adjusted for foreign exchange impact, international revenues decreased 4%. |
• | Gross margin as a percentage of revenues was 75.2% in the quarter compared to 75.7% in the same period a year ago. |
• | Marketing, selling and administrative expenses increased 9% to $1.2 billion in the quarter. |
• | Research and development expenses decreased 32% to $1.3 billion in the quarter. Research and development expenses in the second quarter of 2015 include an $800 million charge resulting from the Flexus acquisition. |
• | The effective tax rate was 26.4% in the quarter, compared to 311.5% in the second quarter last year. The second quarter 2015 Flexus acquisition was non-deductible for tax purposes. |
• | The company reported net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.69 per share, in the quarter compared to a net loss of $130 million, or $0.08 per share, a year ago. The results in the second quarter of 2015 include a $0.48 per share charge from the Flexus acquisition. |
• | The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.69 per share, in the second quarter, compared to $890 million, or $0.53 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 $7.9 billion, with a net cash position of $1.2 billion, as of June 30, 2016. |
• | In July, the U.S. Food and Drug Administration (FDA) accepted for priority review and the European Medicines Agency (EMA) validated the applications we submitted for Opdivo for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Additionally, in Japan, Bristol-Myers Squibb’s partner Ono Pharmaceuticals submitted an application for Opdivo in SCCHN. The three submissions were based on CheckMate -141, a pivotal Phase 3 open-label, randomized study, that evaluated the overall survival (OS) of Opdivo in patients with SCCHN after platinum therapy compared to investigator’s choice of therapy (methotrexate, docetaxel, or cetuximab). This study was stopped early in January 2016 because an assessment conducted by the independent Data Monitoring Committee concluded the study met its primary endpoint of OS. The projected FDA action date is November 11, 2016. |
• | In June, the FDA granted Breakthrough Therapy Designation to Opdivo for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen. As part of the Breakthrough Therapy Designation submission, the company shared for the FDA’s review results from Phase 2 study CA209-275 and other supportive data investigating Opdivo in these previously treated bladder cancer patients. |
• | In May, the FDA approved Opdivo for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin. This accelerated approval was based on overall response rate. This first approval of a PD-1 inhibitor for cHL patients who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin is based on a combined analysis of data from the Phase 2 CheckMate -205 and the Phase 1 CheckMate -039 study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. |
• | In May, the European Commission (EC) approved Opdivo in combination with Yervoy for the treatment of advanced unresectable or metastatic melanoma in adults, representing the first and only approved combination of two Immuno-Oncology (I-O) agents in the European Union (EU). The approval is based on the results of the Phase 3 study CheckMate -067, the first Phase 3, double-blind, randomized study, in which the Opdivo + Yervoy regimen and Opdivo monotherapy demonstrated superior progression-free survival (PFS) and objective response rates (ORR) in patients with advanced melanoma, regardless of BRAF mutational status, versus Yervoy alone. This approval allows for the marketing of the Opdivo + Yervoy regimen in all 28 Member States of the EU. |
• | In June, during the Congress of the European Hematology Association (EHA) in Copenhagen, Denmark, the company announced results from CheckMate -205, a Phase 2 registrational study evaluating Opdivo in patients with cHL. The primary endpoint of ORR per an independent radiologic review committee (IRRC) was 66%. In an exploratory analysis, the authors observed 72% of patients who did not respond to the most recent prior brentuximab vedotin treatment did respond to Opdivo. The safety profile of Opdivo in CheckMate -205 was consistent with previously reported data in this tumor type. |
• | In June, during ASCO in Chicago, the company announced results from eight studies for Opdivo and the Opdivo + Yervoy regimen: |
◦ | CheckMate -067: In the pivotal Phase 3 study evaluating the Opdivo + Yervoy regimen or Opdivo monotherapy versus Yervoy monotherapy in patients with previously untreated advanced melanoma, including both BRAF V600 mutation positive or BRAF wild-type advanced melanoma, at a minimum follow-up of 18 months, the Opdivo + Yervoy regimen demonstrated continued clinical benefit with a 58% reduction in the risk of disease progression versus Yervoy monotherapy, while Opdivo monotherapy demonstrated a 45% risk reduction versus Yervoy alone. The safety profile of the Opdivo + Yervoy combination regimen in CheckMate -067 was consistent with previously reported studies of the combination. |
◦ | CheckMate -069: In a post-hoc analysis from the Phase 2 study evaluating patients with previously untreated unresectable or metastatic melanoma who received either the Opdivo + Yervoy regimen or Yervoy alone, durable responses were observed with the combination regimen in a subgroup of 35 patients who discontinued therapy due to treatment-related adverse events and appeared consistent with the overall randomized patient population. Among this subgroup of patients, the ORR was 66%, and 20% achieved a complete response, with a minimum follow-up of two years. At two years, the median duration of response was not reached and 74% remain in response. The safety profile of the Opdivo + Yervoy regimen in CheckMate -069 was consistent with previously reported studies of the combination. |
◦ | CA209-003: In this Phase 1 study evaluating Opdivo in patients with previously treated advanced renal cell carcinoma (RCC), in which OS is an exploratory endpoint, 38% of patients were alive at four years and 34% of patients were alive at five years. The long-term safety profile of Opdivo was consistent with previously reported studies. |
◦ | CA209-010: In this Phase 2 study evaluating Opdivo in patients with previously treated advanced RCC in which OS was a secondary endpoint, 29% of patients were alive at four years. The long-term safety profile of Opdivo was consistent with previously reported studies. |
◦ | CheckMate -025: In this pivotal Phase 3 study comparing Opdivo versus everolimus in patients with advanced RCC who received prior anti-angiogenic therapy, 55% of patients treated with Opdivo experienced a clinically meaningful improvement in disease-related symptoms, as defined in the study, versus 37% of patients treated with everolimus. This additional analysis of health-related quality of life data was a secondary endpoint in the study. |
◦ | CheckMate -142: In this Phase 2 study evaluating Opdivo alone or in combination with Yervoy in patients with previously treated metastatic colorectal cancer, including those with high microsatellite instability (MSI), the primary endpoint of investigator-assessed ORR for MSI-high metastatic colorectal cancer patients was 26% for Opdivo monotherapy and 33% for the Opdivo + Yervoy combination regimen. The six-month progression-free survival rates were 46% for Opdivo monotherapy and 67% for the Opdivo + Yervoy combination in patients with MSI-high metastatic colorectal cancer. The safety profile of Opdivo alone or in combination with Yervoy was consistent with other tumor types and prior combination studies. |
◦ | CheckMate -032: In this Phase 1/2 study evaluating Opdivo in patients with metastatic urothelial cancer, the most common type of bladder cancer, after platinum-based therapy, the primary endpoint of investigator-assessed confirmed ORR was 24% in patients treated with Opdivo, with a minimum follow-up of nine months. At one year, patients treated with Opdivo had an OS rate, a secondary endpoint, of 46%, with a median OS of 9.72 months. Response rates by tumor PD-L1 expression, evaluated as an exploratory endpoint, were similar regardless of PD-L1 expression levels. The safety profile of Opdivo in CheckMate -032 was consistent with the known safety profile of Opdivo in other tumor types. |
◦ | CheckMate -012: In this Phase 1b trial evaluating Opdivo and Yervoy in patients with chemotherapy-naïve advanced non-small cell lung cancer (NSCLC), findings from a pooled analysis of two Opdivo + Yervoy combination regimen cohorts [3 mg/kg of Opdivo every two weeks plus 1 mg/kg of Yervoy either every six (Q6W) or 12 weeks (Q12W)] in the study showed the magnitude of response rate from the combination regimen cohorts was enhanced with increased PD-L1 expression. In these combination regimen cohorts, the confirmed ORR in patients with ≥1% PD-L1 expression was 57% and the confirmed ORR was up to 92% (n=12/13) in patients with ≥50% PD-L1 expression. In patients with <1% PD-L1 expression, the confirmed ORR was 15%. Improved safety and tolerability was observed with current Opdivo + Yervoy combination cohorts compared to those previously studied in NSCLC. |
• | In May, in conjunction with ASCO, the company announced results from two studies for Opdivo: |
◦ | CheckMate -057: In this Phase 3 study evaluating Opdivo versus docetaxel in previously treated metastatic non-squamous NSCLC patients, Opdivo continued to demonstrate improved OS, the primary endpoint, at the landmark two-year time point, with 29% of patients treated with Opdivo alive at two years versus 16% of those treated with docetaxel. The safety profile of Opdivo at two years was consistent with previous reports of data from this study. |
◦ | CheckMate -017: In this Phase 3 study evaluating Opdivo versus docetaxel in previously treated metastatic squamous NSCLC patients, Opdivo continued to demonstrate improved OS, the primary endpoint, at the landmark two-year time point, with 23% of patients treated with Opdivo alive at two years versus 8% of those treated with docetaxel. The safety profile of Opdivo at two years was consistent with previous reports of data from this study. |
• | In May, the company and its partner, AbbVie Inc., announced the EC approval of Empliciti for the treatment of multiple myeloma as combination therapy with lenalidomide and dexamethasone in patients who have received at least one prior therapy. 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 that the combination of Empliciti with lenalidomide and dexamethasone delivered 53% relative improvement in progression-free survival vs. lenalidomide and dexamethasone alone at three years. |
• | In July, the company announced the commercial launch of the ORENCIA ClickJectTM Autoinjector, a new self-administered autoinjector for adults with moderate to severe rheumatoid arthritis (RA) which was approved by the FDA in June. |
• | In July, the company announced the EMA Committee for Medicinal Products for Human Use (CHMP) recommendation to approve the new indication for Orencia, in combination with methotrexate (MTX), for the treatment of highly active and progressive disease in adult patients with RA who have not received previous MTX treatment. The opinion is based on the AGREE and AVERT studies. Assuming EU approval, the new indication would make Orencia the first available biologic therapy specifically for this indication in the EU. |
• | In June, the company announced results from three studies at the Annual European Congress of Rheumatology (EULAR 2016): |
◦ | In a study exploring patients’ response to treatment for RA based on their baseline status for two biomarkers of poor prognosis, anti-cyclic citrullinated peptide (anti-CCP, also known as ACPA) and rheumatoid factor (RF), data from the Corrona, LLC RA registry showed that patients who tested positive for anti-CCP or RF were more likely to have a greater response with Orencia treatment than patients testing negative for the biomarkers. The study did not show significant differences in responses between anti-CCP/RF status in those administered TNF-inhibitors. |
◦ | In a Phase 3 study of juvenile idiopathic arthritis (pJIA), subcutaneous (SC) Orencia demonstrated equivalent efficacy and comparable safety to intravenous (IV) Orencia for pJIA patients. SC Orencia showed efficacy after four months with greater than 80% of patients achieving an ACR30 response with few clinically relevant adverse events. |
◦ | In a Phase 1 study, the company’s investigational Bruton’s Tyrosine Kinase (BTK) inhibitor, BMS-986142, targeted for RA and other inflammatory diseases, indicated it was well tolerated, warranting further development of the agent. |
• | In July, the company entered into a clinical trial collaboration to evaluate the safety, tolerability and efficacy of AbbVie’s investigational antibody drug conjugate Rova-T (rovalpituzumab tesirine) in combination with Opdivo and Opdivo + Yervoy regimen as a second-line treatment for extensive- stage small cell lung cancer (SCLC). The Phase 1/2 clinical program will explore whether combining these two agents will provide improved and sustained efficacy and tolerability above the current treatment protocol of chemotherapy and radiation to SCLC patients. |
• | In July, the company entered into a clinical collaboration to evaluate Opdivo in combination with Janssen Biotech, Inc.’s Live Attenuated Double-Deleted (LADD) Listerial monocytogenes cancer immunotherapy, expressing mesothelin and EGFRvIII (JNJ-64041757), in patients with NSCLC. The Phase 2 study will evaluate the tolerability and clinical activity of the combination of these agents. |
• | In July, the company acquired Cormorant Pharmaceuticals, a private, Stockholm, Sweden-based pharmaceutical company focused on the development of therapies for cancer and rare diseases. The acquisition gives Bristol-Myers Squibb full rights to Cormorant’s HuMax-IL8 antibody program and the lead candidate HuMax-IL8, a Phase 1/2 monoclonal antibody targeted against interleukin-8 (IL-8) that represents a potentially complementary Immuno-Oncology mechanism of action to T-cell directed antibodies and co-stimulatory molecules. |
• | In June, the company entered into an exclusive clinical collaboration agreement to evaluate the safety, tolerability, and preliminary efficacy of PsiOxus’ enadenotucirev, a systemically administered oncolytic adenovirus therapeutic, in combination with Opdivo to treat a range of tumor types in late-stage cancer patients. The clinical collaboration will support Phase 1 studies to determine whether combining these two agents can significantly improve the proportion of patients achieving objective tumor responses, the extent of tumor shrinkage, and/or the durability of responses. |
• | In June, the company and the University of Texas MD Anderson Cancer Center entered into a new clinical research collaboration to evaluate strategies for the potential use of Opdivo + Yervoy to treat early- and advanced-stage lung cancer patients. The collaboration will help support multiple Phase 1 and 2 clinical trials testing Opdivo as monotherapy, in combination with Yervoy, or in regimens with other agents, radiation or surgery in a range of clinical settings. These studies will also incorporate extensive translational work including exploration of novel biomarkers to better differentiate responders from non-responders in lung cancer as well as preclinical studies of next generation immunotherapeutic agents that may be used to expand the benefits to larger numbers of patients. |
Worldwide Revenues | U.S. Revenues | |||||||||||||||||||||
2016 | 2015 | % Change | 2016 | 2015 | % Change | |||||||||||||||||
Three Months Ended June 30, | ||||||||||||||||||||||
Key Products | ||||||||||||||||||||||
Oncology | ||||||||||||||||||||||
Empliciti | $ | 34 | $ | — | N/A | $ | 33 | $ | — | N/A | ||||||||||||
Erbitux(a) | — | 169 | (100 | )% | — | 165 | (100 | )% | ||||||||||||||
Opdivo | 840 | 122 | ** | 643 | 107 | ** | ||||||||||||||||
Sprycel | 451 | 405 | 11 | % | 233 | 205 | 14 | % | ||||||||||||||
Yervoy | 241 | 296 | (19 | )% | 179 | 136 | 32 | % | ||||||||||||||
Cardiovascular | ||||||||||||||||||||||
Eliquis | 777 | 437 | 78 | % | 444 | 243 | 83 | % | ||||||||||||||
Immunoscience | ||||||||||||||||||||||
Orencia | 593 | 461 | 29 | % | 401 | 310 | 29 | % | ||||||||||||||
Virology | ||||||||||||||||||||||
Baraclude | 299 | 343 | (13 | )% | 15 | 37 | (59 | )% | ||||||||||||||
Hepatitis C Franchise | 546 | 479 | 14 | % | 294 | — | N/A | |||||||||||||||
Reyataz Franchise | 247 | 303 | (18 | )% | 122 | 157 | (22 | )% | ||||||||||||||
Sustiva Franchise | 271 | 317 | (15 | )% | 227 | 258 | (12 | )% | ||||||||||||||
Neuroscience | ||||||||||||||||||||||
Abilify(b) | 35 | 107 | (67 | )% | — | 67 | (100 | )% | ||||||||||||||
Mature Products and All Other | 537 | 724 | (26 | )% | 97 | 152 | (36 | )% | ||||||||||||||
Total | $ | 4,871 | $ | 4,163 | 17 | % | $ | 2,688 | $ | 1,837 | 46 | % |
** | 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 | |||||||||||||||||||||
2016 | 2015 | % Change | 2016 | 2015 | % Change | |||||||||||||||||
Six Months Ended June 30, | ||||||||||||||||||||||
Key Products | ||||||||||||||||||||||
Oncology | ||||||||||||||||||||||
Empliciti | $ | 62 | $ | — | N/A | $ | 61 | $ | — | N/A | ||||||||||||
Erbitux | — | 334 | (100 | )% | — | 322 | (100 | )% | ||||||||||||||
Opdivo | 1,544 | 162 | ** | 1,237 | 145 | ** | ||||||||||||||||
Sprycel | 858 | 780 | 10 | % | 443 | 386 | 15 | % | ||||||||||||||
Yervoy | 504 | 621 | (19 | )% | 378 | 317 | 19 | % | ||||||||||||||
Cardiovascular | ||||||||||||||||||||||
Eliquis | 1,511 | 792 | 91 | % | 912 | 443 | ** | |||||||||||||||
Immunoscience | ||||||||||||||||||||||
Orencia | 1,068 | 861 | 24 | % | 722 | 569 | 27 | % | ||||||||||||||
Virology | ||||||||||||||||||||||
Baraclude | 590 | 683 | (14 | )% | 32 | 83 | (61 | )% | ||||||||||||||
Hepatitis C Franchise | 973 | 743 | 31 | % | 553 | — | N/A | |||||||||||||||
Reyataz Franchise | 468 | 597 | (22 | )% | 242 | 300 | (19 | )% | ||||||||||||||
Sustiva Franchise | 544 | 607 | (10 | )% | 455 | 492 | (8 | )% | ||||||||||||||
Neuroscience | ||||||||||||||||||||||
Abilify | 68 | 661 | (90 | )% | — | 575 | (100 | )% | ||||||||||||||
Mature Products and All Other | 1,072 | 1,363 | (21 | )% | 190 | 249 | (24 | )% | ||||||||||||||
Total | $ | 9,262 | $ | 8,204 | 13 | % | $ | 5,225 | $ | 3,881 | 35 | % |
** | In excess of +/- 100% |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
Net product sales | $ | 4,432 | $ | 3,572 | $ | 8,396 | $ | 6,631 | ||||||||
Alliance and other revenues | 439 | 591 | 866 | 1,573 | ||||||||||||
Total Revenues | 4,871 | 4,163 | 9,262 | 8,204 | ||||||||||||
Cost of products sold | 1,206 | 1,013 | 2,258 | 1,860 | ||||||||||||
Marketing, selling and administrative | 1,238 | 1,135 | 2,306 | 2,164 | ||||||||||||
Research and development | 1,266 | 1,856 | 2,402 | 2,872 | ||||||||||||
Other (income)/expense | (454 | ) | 107 | (974 | ) | (192 | ) | |||||||||
Total Expenses | 3,256 | 4,111 | 5,992 | 6,704 | ||||||||||||
Earnings Before Income Taxes | 1,615 | 52 | 3,270 | 1,500 | ||||||||||||
Provision for Income Taxes | 427 | 162 | 876 | 411 | ||||||||||||
Net Earnings/(Loss) | 1,188 | (110 | ) | 2,394 | 1,089 | |||||||||||
Net Earnings Attributable to Noncontrolling Interest | 22 | 20 | 33 | 33 | ||||||||||||
Net Earnings/(Loss) Attributable to BMS | $ | 1,166 | $ | (130 | ) | $ | 2,361 | $ | 1,056 | |||||||
Average Common Shares Outstanding: | ||||||||||||||||
Basic | 1,670 | 1,667 | 1,670 | 1,665 | ||||||||||||
Diluted | 1,679 | 1,667 | 1,679 | 1,677 | ||||||||||||
Earnings/(Loss) per Common Share | ||||||||||||||||
Basic | $ | 0.70 | $ | (0.08 | ) | $ | 1.41 | $ | 0.63 | |||||||
Diluted | $ | 0.69 | $ | (0.08 | ) | $ | 1.41 | $ | 0.63 | |||||||
Other (Income)/Expense | ||||||||||||||||
Interest expense | $ | 42 | $ | 49 | $ | 85 | $ | 100 | ||||||||
Investment income | (25 | ) | (26 | ) | (49 | ) | (56 | ) | ||||||||
Provision for restructuring | 18 | 28 | 22 | 40 | ||||||||||||
Litigation and other settlements | 6 | 4 | 49 | 16 | ||||||||||||
Equity in net income of affiliates | (20 | ) | (22 | ) | (46 | ) | (48 | ) | ||||||||
Divestiture gains | (283 | ) | (8 | ) | (553 | ) | (162 | ) | ||||||||
Royalties and licensing income | (167 | ) | (97 | ) | (421 | ) | (195 | ) | ||||||||
Transition and other service fees | (74 | ) | (27 | ) | (127 | ) | (54 | ) | ||||||||
Pension charges | 25 | 36 | 47 | 63 | ||||||||||||
Out-licensed intangible asset impairment | — | — | 15 | 13 | ||||||||||||
Equity investment impairment | 45 | — | 45 | — | ||||||||||||
Written option adjustment | — | — | — | (36 | ) | |||||||||||
Loss on debt redemption | — | 180 | — | 180 | ||||||||||||
Other | (21 | ) | (10 | ) | (41 | ) | (53 | ) | ||||||||
Other (income)/expense | $ | (454 | ) | $ | 107 | $ | (974 | ) | $ | (192 | ) |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
Cost of products sold(a) | $ | 4 | $ | 25 | $ | 8 | $ | 59 | ||||||||
Marketing, selling and administrative | — | 3 | — | 4 | ||||||||||||
License and asset acquisition charges | 139 | 869 | 264 | 1,031 | ||||||||||||
Other | 13 | 2 | 26 | 2 | ||||||||||||
Research and development | 152 | 871 | 290 | 1,033 | ||||||||||||
Provision for restructuring | 18 | 28 | 22 | 40 | ||||||||||||
Divestiture gains | (277 | ) | (8 | ) | (546 | ) | (160 | ) | ||||||||
Pension charges | 25 | 36 | 47 | 63 | ||||||||||||
Written option adjustment | — | — | — | (36 | ) | |||||||||||
Litigation and other settlements | — | 1 | 43 | 15 | ||||||||||||
Out-licensed intangible asset impairment | — | — | 15 | 13 | ||||||||||||
Loss on debt redemption | — | 180 | — | 180 | ||||||||||||
Other (income)/expense | (234 | ) | 237 | (419 | ) | 115 | ||||||||||
Increase/(decrease) to pretax income | (78 | ) | 1,136 | (121 | ) | 1,211 | ||||||||||
Income tax on items above | 76 | (116 | ) | 159 | (184 | ) | ||||||||||
Increase/(decrease) to net earnings | $ | (2 | ) | $ | 1,020 | $ | 38 | $ | 1,027 |
(a) | Specified items in cost of products sold are accelerated depreciation, asset impairment and other shutdown costs. |
Three Months Ended June 30, 2016 | GAAP | Specified Items(a) | Non- GAAP | |||||||||
Gross Profit | $ | 3,665 | $ | 4 | $ | 3,669 | ||||||
Marketing, selling and administrative | 1,238 | — | 1,238 | |||||||||
Research and development | 1,266 | (152 | ) | 1,114 | ||||||||
Other (income)/expense | (454 | ) | 234 | (220 | ) | |||||||
Effective Tax Rate | 26.4 | % | (3.6 | )% | 22.8 | % | ||||||
Three Months Ended June 30, 2015 | GAAP | Specified Items(a) | Non- GAAP | |||||||||
Gross Profit | $ | 3,150 | $ | 25 | $ | 3,175 | ||||||
Marketing, selling and administrative | 1,135 | (3 | ) | 1,132 | ||||||||
Research and development | 1,856 | (871 | ) | 985 | ||||||||
Other (income)/expense | 107 | (237 | ) | (130 | ) | |||||||
Effective Tax Rate | 311.5 | % | (288.1 | )% | 23.4 | % |
(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. |
Six Months Ended June 30, 2016 | GAAP | Specified Items(a) | Non- GAAP | |||||||||
Gross Profit | $ | 7,004 | $ | 8 | $ | 7,012 | ||||||
Marketing, selling and administrative | 2,306 | — | 2,306 | |||||||||
Research and development | 2,402 | (290 | ) | 2,112 | ||||||||
Other (income)/expense | (974 | ) | 419 | (555 | ) | |||||||
Effective Tax Rate | 26.8 | % | (4.0 | )% | 22.8 | % | ||||||
Six Months Ended June 30, 2015 | GAAP | Specified Items(a) | Non- GAAP | |||||||||
Gross Profit | $ | 6,344 | $ | 59 | $ | 6,403 | ||||||
Marketing, selling and administrative | 2,164 | (4 | ) | 2,160 | ||||||||
Research and development | 2,872 | (1,033 | ) | 1,839 | ||||||||
Other (income)/expense | (192 | ) | (115 | ) | (307 | ) | ||||||
Effective Tax Rate | 27.4 | % | (5.5 | )% | 21.9 | % |
(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. |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
Net Earnings/(Loss) Attributable to BMS used for Diluted EPS Calculation - GAAP | $ | 1,166 | $ | (130 | ) | $ | 2,361 | $ | 1,056 | |||||||
Less Specified Items* | (2 | ) | 1,020 | 38 | 1,027 | |||||||||||
Net Earnings used for Diluted EPS Calculation – Non-GAAP | $ | 1,164 | $ | 890 | $ | 2,399 | $ | 2,083 | ||||||||
Weighted-average Common Shares Outstanding - Diluted - GAAP | 1,679 | 1,667 | 1,679 | 1,677 | ||||||||||||
Incremental shares attributable to share-based compensation plans | — | 10 | — | — | ||||||||||||
Weighted-average Common Shares Outstanding- Diluted - Non-GAAP | 1,679 | 1,677 | 1,679 | 1,677 | ||||||||||||
Diluted Earnings/(Loss) Per Share — GAAP | $ | 0.69 | $ | (0.08 | ) | $ | 1.41 | $ | 0.63 | |||||||
Diluted EPS Attributable to Specified Items | — | 0.61 | 0.02 | 0.61 | ||||||||||||
Diluted Earnings Per Share — Non-GAAP | $ | 0.69 | $ | 0.53 | $ | 1.43 | $ | 1.24 |
* | Refer to the Specified Items schedule for further details. |
June 30, 2016 | March 31, 2016 | |||||||
Cash and cash equivalents | $ | 2,934 | $ | 2,644 | ||||
Marketable securities - current | 1,717 | 1,663 | ||||||
Marketable securities - non-current | 3,281 | 3,689 | ||||||
Cash, cash equivalents and marketable securities | 7,932 | 7,996 | ||||||
Short-term borrowings | (155 | ) | (106 | ) | ||||
Long-term debt | (6,581 | ) | (6,593 | ) | ||||
Net cash position | $ | 1,196 | $ | 1,297 |
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 | $ | 2,688 | $ | 5,225 | 46% | 35% | — | — | ||||||||||||||||||||||||||||||||
Europe | 782 | 974 | 1,756 | 813 | 2,569 | 922 | 3,491 | 870 | 1,039 | 1,909 | 7% | 9% | 1% | (1)% | ||||||||||||||||||||||||||||||||||||||||||
Rest of the World | 1,019 | 1,124 | 2,143 | 1,027 | 3,170 | 972 | 4,142 | 840 | 1,013 | 1,853 | (10)% | (14)% | (5)% | (6)% | ||||||||||||||||||||||||||||||||||||||||||
Other | 196 | 228 | 424 | 185 | 609 | 130 | 739 | 144 | 131 | 275 | (43)% | (35)% | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||
Total | $ | 4,041 | $ | 4,163 | $ | 8,204 | $ | 4,069 | $ | 12,273 | $ | 4,287 | $ | 16,560 | $ | 4,391 | $ | 4,871 | $ | 9,262 | 17% | 13% | (1)% | (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 | % | 55.2 | % | 56.4 | % | ||||||||||||||||||||||||||||||||||||
Europe | 19.4 | % | 23.4 | % | 21.4 | % | 20.0 | % | 20.9 | % | 21.5 | % | 21.1 | % | 19.8 | % | 21.3 | % | 20.6 | % | ||||||||||||||||||||||||||||||||||||
Rest of the World | 25.2 | % | 27.0 | % | 26.1 | % | 25.2 | % | 25.8 | % | 22.7 | % | 25.0 | % | 19.1 | % | 20.8 | % | 20.0 | % | ||||||||||||||||||||||||||||||||||||
Other | 4.8 | % | 5.5 | % | 5.2 | % | 4.6 | % | 5.0 | % | 3.0 | % | 4.5 | % | 3.3 | % | 2.7 | % | 3.0 | % | ||||||||||||||||||||||||||||||||||||
Total | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100 | % | 100 | % |
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 | $ | 4,432 | $ | 8,396 | 24% | 27% | ||||||||||||||||||||||||||||||||
Alliance and other revenues | 982 | 591 | 1,573 | 517 | 2,090 | 425 | 2,515 | 427 | 439 | 866 | (26)% | (45)% | ||||||||||||||||||||||||||||||||||||||||||
Total Revenues | $ | 4,041 | $ | 4,163 | $ | 8,204 | $ | 4,069 | $ | 12,273 | $ | 4,287 | $ | 16,560 | $ | 4,391 | $ | 4,871 | $ | 9,262 | 17% | 13% | ||||||||||||||||||||||||||||||||
Cost of products sold | 847 | 1,013 | 1,860 | 1,097 | 2,957 | 952 | 3,909 | 1,052 | 1,206 | 2,258 | 19% | 21% | ||||||||||||||||||||||||||||||||||||||||||
Marketing, selling and administrative | 1,029 | 1,135 | 2,164 | 1,176 | 3,340 | 1,501 | 4,841 | 1,068 | 1,238 | 2,306 | 9% | 7% | ||||||||||||||||||||||||||||||||||||||||||
Research and development | 1,016 | 1,856 | 2,872 | 1,132 | 4,004 | 1,916 | 5,920 | 1,136 | 1,266 | 2,402 | (32)% | (16)% | ||||||||||||||||||||||||||||||||||||||||||
Other (income)/expense | (299 | ) | 107 | (192 | ) | (323 | ) | (515 | ) | 328 | (187 | ) | (520 | ) | (454 | ) | (974 | ) | ** | ** | ||||||||||||||||||||||||||||||||||
Total Expenses | 2,593 | 4,111 | 6,704 | 3,082 | 9,786 | 4,697 | 14,483 | 2,736 | 3,256 | 5,992 | (21)% | (11)% | ||||||||||||||||||||||||||||||||||||||||||
Earnings/(Loss) Before Income Taxes | $ | 1,448 | $ | 52 | $ | 1,500 | $ | 987 | $ | 2,487 | $ | (410 | ) | $ | 2,077 | $ | 1,655 | $ | 1,615 | $ | 3,270 | ** | ** | |||||||||||||||||||||||||||||||
Provision for/(Benefit from) Income Taxes | 249 | 162 | 411 | 257 | 668 | (222 | ) | 446 | 449 | 427 | 876 | ** | ** | |||||||||||||||||||||||||||||||||||||||||
Net Earnings/(Loss) | $ | 1,199 | $ | (110 | ) | $ | 1,089 | $ | 730 | $ | 1,819 | $ | (188 | ) | $ | 1,631 | $ | 1,206 | $ | 1,188 | $ | 2,394 | ** | ** | ||||||||||||||||||||||||||||||
Net Earnings Attributable to Noncontrolling Interest | 13 | 20 | 33 | 24 | 57 | 9 | 66 | 11 | 22 | 33 | 10% | — | ||||||||||||||||||||||||||||||||||||||||||
Net Earnings/(Loss) Attributable to BMS | $ | 1,186 | $ | (130 | ) | $ | 1,056 | $ | 706 | $ | 1,762 | $ | (197 | ) | $ | 1,565 | $ | 1,195 | $ | 1,166 | $ | 2,361 | ** | ** | ||||||||||||||||||||||||||||||
Diluted Earnings/(Loss) per Common Share* | $ | 0.71 | $ | (0.08 | ) | $ | 0.63 | $ | 0.42 | $ | 1.05 | $ | (0.12 | ) | $ | 0.93 | $ | 0.71 | $ | 0.69 | $ | 1.41 | ** | ** | ||||||||||||||||||||||||||||||
Average Common Shares Outstanding - Diluted | 1,676 | 1,667 | 1,677 | 1,678 | 1,677 | 1,669 | 1,679 | 1,680 | 1,679 | 1,679 | 1% | — | ||||||||||||||||||||||||||||||||||||||||||
Dividends declared per common share | $ | 0.37 | $ | 0.37 | $ | 0.74 | $ | 0.37 | $ | 1.11 | $ | 0.38 | $ | 1.49 | $ | 0.38 | $ | 0.38 | $ | 0.76 | 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 | % | 75.2 | % | 75.6 | % | ||||||||||||||||||||||||||||||||||
Other Ratios | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Effective tax rate | 17.2 | % | 311.5 | % | 27.4 | % | 26.0 | % | 26.9 | % | 54.1 | % | 21.5 | % | 27.1 | % | 26.4 | % | 26.8 | % | ||||||||||||||||||||||||||||||||||
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 | $ | 42 | $ | 85 | (14 | )% | (15 | )% | ||||||||||||||||||||||||||||||
Investment income | (30 | ) | (26 | ) | (56 | ) | (18 | ) | (74 | ) | (27 | ) | (101 | ) | (24 | ) | (25 | ) | (49 | ) | (4 | )% | (13 | )% | ||||||||||||||||||||||||||||||
Provision for restructuring | 12 | 28 | 40 | 10 | 50 | 68 | 118 | 4 | 18 | 22 | (36 | )% | (45 | )% | ||||||||||||||||||||||||||||||||||||||||
Litigation and other settlements | 12 | 4 | 16 | (2 | ) | 14 | 145 | 159 | 43 | 6 | 49 | 50 | % | ** | ||||||||||||||||||||||||||||||||||||||||
Equity in net income of affiliates | (26 | ) | (22 | ) | (48 | ) | (19 | ) | (67 | ) | (16 | ) | (83 | ) | (26 | ) | (20 | ) | (46 | ) | (9 | )% | (4 | )% | ||||||||||||||||||||||||||||||
Divestiture (gains)/losses | (154 | ) | (8 | ) | (162 | ) | (208 | ) | (370 | ) | 174 | (196 | ) | (270 | ) | (283 | ) | (553 | ) | ** | ** | |||||||||||||||||||||||||||||||||
Royalties and licensing income | (98 | ) | (97 | ) | (195 | ) | (63 | ) | (258 | ) | (125 | ) | (383 | ) | (254 | ) | (167 | ) | (421 | ) | 72 | % | ** | |||||||||||||||||||||||||||||||
Transition and other service fees | (27 | ) | (27 | ) | (54 | ) | (37 | ) | (91 | ) | (31 | ) | (122 | ) | (53 | ) | (74 | ) | (127 | ) | ** | ** | ||||||||||||||||||||||||||||||||
Pension charges | 27 | 36 | 63 | 48 | 111 | 49 | 160 | 22 | 25 | 47 | (31 | )% | (25 | )% | ||||||||||||||||||||||||||||||||||||||||
Out-licensed intangible asset impairment | 13 | — | 13 | — | 13 | — | 13 | 15 | — | 15 | — | 15 | % | |||||||||||||||||||||||||||||||||||||||||
Equity investment impairment | — | — | — | — | — | — | — | — | 45 | 45 | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||
Written option adjustment | (36 | ) | — | (36 | ) | (87 | ) | (123 | ) | — | (123 | ) | — | — | — | — | (100 | )% | ||||||||||||||||||||||||||||||||||||
Loss on debt redemption | — | 180 | 180 | — | 180 | — | 180 | — | — | — | (100 | )% | (100 | )% | ||||||||||||||||||||||||||||||||||||||||
Other | (43 | ) | (10 | ) | (53 | ) | 12 | (41 | ) | 48 | 7 | (20 | ) | (21 | ) | (41 | ) | ** | (23 | )% | ||||||||||||||||||||||||||||||||||
$ | (299 | ) | $ | 107 | $ | (192 | ) | $ | (323 | ) | $ | (515 | ) | $ | 328 | $ | (187 | ) | $ | (520 | ) | $ | (454 | ) | $ | (974 | ) | ** | ** |
* | 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 | $ | 4,871 | $ | 4,163 | $ | 708 | 17% | $ | (47 | ) | $ | 4,918 | (1)% | 18% | ||||||||||||
Gross profit | 3,665 | 3,150 | 515 | 16% | N/A | N/A | N/A | N/A | ||||||||||||||||||
Gross profit excluding specified items(a) | 3,669 | 3,175 | 494 | 16% | N/A | N/A | N/A | N/A | ||||||||||||||||||
Gross profit excluding specified items as a % of revenues | 75.3 | % | 76.3 | % | ||||||||||||||||||||||
Marketing, selling and administrative | 1,238 | 1,135 | 103 | 9% | 11 | 1,249 | 1% | 10% | ||||||||||||||||||
Marketing, selling and administrative excluding specified items(a) | 1,238 | 1,132 | 106 | 9% | 11 | 1,249 | 1% | 10% | ||||||||||||||||||
MS&A excluding specified items as a % of revenues | 25.4 | % | 27.2 | % | ||||||||||||||||||||||
Research and development | 1,266 | 1,856 | (590 | ) | (32)% | 3 | 1,269 | — | (32)% | |||||||||||||||||
Research and development excluding specified items(a) | 1,114 | 985 | 129 | 13% | 3 | 1,117 | — | 13% | ||||||||||||||||||
Research and development excluding specified items as a % of revenues | 22.9 | % | 23.7 | % | ||||||||||||||||||||||
YEAR-TO-DATE | 2016 | 2015 | Growth $ | Growth % | Favorable / (Unfavorable) FX Impact $ * | 2016 Excluding FX | Favorable / (Unfavorable) FX Impact % * | Growth % Excluding FX | ||||||||||||||||||
Revenues | $ | 9,262 | $ | 8,204 | $ | 1,058 | 13% | $ | (141 | ) | $ | 9,403 | (2)% | 15% | ||||||||||||
Gross profit | 7,004 | 6,344 | 660 | 10% | N/A | N/A | N/A | N/A | ||||||||||||||||||
Gross profit excluding specified items(a) | 7,012 | 6,403 | 609 | 10% | N/A | N/A | N/A | N/A | ||||||||||||||||||
Gross profit excluding specified items as a % of revenues | 75.7 | % | 78.0 | % | ||||||||||||||||||||||
Marketing, selling and administrative | 2,306 | 2,164 | 142 | 7% | 37 | 2,343 | 1% | 8% | ||||||||||||||||||
Marketing, selling and administrative excluding specified items(a) | 2,306 | 2,160 | 146 | 7% | 37 | 2,343 | 1% | 8% | ||||||||||||||||||
MS&A excluding specified items as a % of revenues | 24.9 | % | 26.3 | % | ||||||||||||||||||||||
Research and development | 2,402 | 2,872 | (470 | ) | (16)% | 10 | 2,412 | — | (16)% | |||||||||||||||||
Research and development excluding specified items(a) | 2,112 | 1,839 | 273 | 15% | 10 | 2,122 | — | 15% | ||||||||||||||||||
Research and development excluding specified items as a % of revenues | 22.8 | % | 22.4 | % |
(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 | $ | 34 | $ | 62 | $ | 34 | $ | 62 | N/A | N/A | $ | 34 | $ | 62 | N/A | N/A | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||
Erbitux | 165 | 169 | 334 | 167 | 501 | — | 501 | — | — | — | (169 | ) | (334 | ) | (100 | )% | (100 | )% | — | — | (100 | )% | (100 | )% | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Opdivo | 40 | 122 | 162 | 305 | 467 | 475 | 942 | 704 | 840 | 1,544 | 718 | 1,382 | ** | ** | 840 | 1,548 | ** | ** | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sprycel | 375 | 405 | 780 | 411 | 1,191 | 429 | 1,620 | 407 | 451 | 858 | 46 | 78 | 11 | % | 10 | % | 453 | 873 | 12 | % | 12 | % | (1 | )% | (2 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Yervoy | 325 | 296 | 621 | 240 | 861 | 265 | 1,126 | 263 | 241 | 504 | (55 | ) | (117 | ) | (19 | )% | (19 | )% | 248 | 516 | (16 | )% | (17 | )% | (3 | )% | (2 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cardiovascular(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Eliquis | 355 | 437 | 792 | 466 | 1,258 | 602 | 1,860 | 734 | 777 | 1,511 | 340 | 719 | 78 | % | 91 | % | 766 | 1,507 | 75 | % | 90 | % | 3 | % | 1 | % | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Immunoscience(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Orencia(b) | 400 | 461 | 861 | 484 | 1,345 | 540 | 1,885 | 475 | 593 | 1,068 | 132 | 207 | 29 | % | 24 | % | 596 | 1,079 | 29 | % | 25 | % | — | (1 | )% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Virology(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baraclude | 340 | 343 | 683 | 320 | 1,003 | 309 | 1,312 | 291 | 299 | 590 | (44 | ) | (93 | ) | (13 | )% | (14 | )% | 300 | 601 | (13 | )% | (12 | )% | — | (2 | )% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Hepatitis C Franchise(c) | 264 | 479 | 743 | 402 | 1,145 | 458 | 1,603 | 427 | 546 | 973 | 67 | 230 | 14 | % | 31 | % | 553 | 989 | 15 | % | 33 | % | (1 | )% | (2 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reyataz Franchise | 294 | 303 | 597 | 270 | 867 | 272 | 1,139 | 221 | 247 | 468 | (56 | ) | (129 | ) | (18 | )% | (22 | )% | 258 | 491 | (15 | )% | (18 | )% | (3 | )% | (4 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sustiva Franchise(d) | 290 | 317 | 607 | 333 | 940 | 312 | 1,252 | 273 | 271 | 544 | (46 | ) | (63 | ) | (15 | )% | (10 | )% | 271 | 544 | (15 | )% | (10 | )% | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Neuroscience(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Abilify(e) | 554 | 107 | 661 | 46 | 707 | 39 | 746 | 33 | 35 | 68 | (72 | ) | (593 | ) | (67 | )% | (90 | )% | 37 | 72 | (65 | )% | (89 | )% | (2 | )% | (1 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Mature Products and All Other(f) | 639 | 724 | 1,363 | 625 | 1,988 | 583 | 2,571 | 535 | 537 | 1,072 | (187 | ) | (291 | ) | (26 | )% | (21 | )% | 562 | 1,121 | (22 | )% | (18 | )% | (4 | )% | (3 | )% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | $ | 4,041 | $ | 4,163 | $ | 8,204 | $ | 4,069 | $ | 12,273 | $ | 4,287 | $ | 16,560 | $ | 4,391 | $ | 4,871 | $ | 9,262 | $ | 708 | $ | 1,058 | 17 | % | 13 | % | $ | 4,918 | $ | 9,403 | 18 | % | 15 | % | (1 | )% | (2 | )% | ||||||||||||||||||||||||||||||||||||||||||
Total Excluding Abilify and Erbitux | $ | 3,322 | $ | 3,887 | $ | 7,209 | $ | 3,856 | $ | 11,065 | $ | 4,248 | $ | 15,313 | $ | 4,358 | $ | 4,836 | $ | 9,194 | $ | 949 | $ | 1,985 | 24 | % | 28 | % | $ | 4,881 | $ | 9,331 | 26 | % | 29 | % | (2 | )% | (1 | )% |
** | In excess of +/- 100% |
(a) | Key products listed do not represent all products in the respective therapeutic areas. |
(b) | Includes Orencia SubQ revenues of $292 million and $207 million for the three months ended June 30, 2016 and 2015, respectively, and $508 and $383 million for the six months ended June 30, 2016 and 2015, respectively. |
(c) | Includes Daklinza (daclatasvir) revenues of $537 million and $382 million for the three months ended June 30, 2016 and 2015, respectively, and $957 million and $562 million for the six months ended June 30, 2016 and 2015, respectively. Additionally, includes Sunvepra (asunaprevir) revenues of $9 million and $97 million for the three months ended June 30, 2016 and 2015, respectively, and $16 million and $181 million for the six months ended June 30, 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 $237 million and $276 million for the three months ended June 30, 2016 and 2015, respectively, and $478 million and $527 million for the six months ended June 30, 2016 and 2015, respectively. |
(e) | Includes alliance revenue of $70 million for the three months ended June 30, 2015 and $578 million for the six months ended June 30, 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 | $ | 33 | $ | 61 | N/A | N/A | ||||||||||||||||||||||||||||||
Erbitux | 157 | 165 | 322 | 165 | 487 | — | 487 | — | — | — | (100)% | (100)% | ||||||||||||||||||||||||||||||||||||||||
Opdivo | 38 | 107 | 145 | 268 | 413 | 410 | 823 | 594 | 643 | 1,237 | ** | ** | ||||||||||||||||||||||||||||||||||||||||
Sprycel | 181 | 205 | 386 | 215 | 601 | 228 | 829 | 210 | 233 | 443 | 14% | 15% | ||||||||||||||||||||||||||||||||||||||||
Yervoy | 181 | 136 | 317 | 121 | 438 | 164 | 602 | 199 | 179 | 378 | 32% | 19% | ||||||||||||||||||||||||||||||||||||||||
Cardiovascular | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Eliquis | 200 | 243 | 443 | 245 | 688 | 335 | 1,023 | 468 | 444 | 912 | 83% | ** | ||||||||||||||||||||||||||||||||||||||||
Immunoscience | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Orencia(a) | 259 | 310 | 569 | 330 | 899 | 372 | 1,271 | 321 | 401 | 722 | 29% | 27% | ||||||||||||||||||||||||||||||||||||||||
Virology | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Baraclude | 46 | 37 | 83 | 25 | 108 | 27 | 135 | 17 | 15 | 32 | (59)% | (61)% | ||||||||||||||||||||||||||||||||||||||||
Hepatitis C Franchise(b) | — | — | — | 111 | 111 | 212 | 323 | 259 | 294 | 553 | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||
Reyataz Franchise | 143 | 157 | 300 | 149 | 449 | 142 | 591 | 120 | 122 | 242 | (22)% | (19)% | ||||||||||||||||||||||||||||||||||||||||
Sustiva Franchise(c) | 234 | 258 | 492 | 280 | 772 | 269 | 1,041 | 228 | 227 | 455 | (12)% | (8)% | ||||||||||||||||||||||||||||||||||||||||
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 | 97 | 190 | (36)% | (24)% | ||||||||||||||||||||||||||||||||||||||||
Total(e) | $ | 2,044 | $ | 1,837 | $ | 3,881 | $ | 2,044 | $ | 5,925 | $ | 2,263 | $ | 8,188 | $ | 2,537 | $ | 2,688 | $ | 5,225 | 46% | 35% | ||||||||||||||||||||||||||||||
** | In excess of +/- 100% |
(a) | Includes Orencia SubQ revenues of $184 million and $136 million for the three months ended June 30, 2016 and 2015, respectively, and $316 million and $247 million for the six months ended June 30, 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Empliciti | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 1 | $ | 1 | N/A | N/A | N/A | N/A | ||||||||||||||||||||||||||||||||
Erbitux | 8 | 4 | 12 | 2 | 14 | — | 14 | — | — | — | (100)% | (100)% | — | — | ||||||||||||||||||||||||||||||||||||||||||
Opdivo | 2 | 15 | 17 | 37 | 54 | 65 | 119 | 110 | 197 | 307 | ** | ** | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||
Sprycel | 194 | 200 | 394 | 196 | 590 | 201 | 791 | 197 | 218 | 415 | 9% | 5% | (1)% | (4)% | ||||||||||||||||||||||||||||||||||||||||||
Yervoy | 144 | 160 | 304 | 119 | 423 | 101 | 524 | 64 | 62 | 126 | (61)% | (59)% | (4)% | (4)% | ||||||||||||||||||||||||||||||||||||||||||
Cardiovascular | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Eliquis | 155 | 194 | 349 | 221 | 570 | 267 | 837 | 266 | 333 | 599 | 72% | 72% | 6% | 2% | ||||||||||||||||||||||||||||||||||||||||||
Immunoscience | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Orencia | 141 | 151 | 292 | 154 | 446 | 168 | 614 | 154 | 192 | 346 | 27% | 18% | (2)% | (4)% | ||||||||||||||||||||||||||||||||||||||||||
Virology | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baraclude | 294 | 306 | 600 | 295 | 895 | 282 | 1,177 | 274 | 284 | 558 | (7)% | (7)% | — | (2)% | ||||||||||||||||||||||||||||||||||||||||||
Hepatitis C Franchise(a) | 264 | 479 | 743 | 291 | 1,034 | 246 | 1,280 | 168 | 252 | 420 | (47)% | (43)% | (1)% | (2)% | ||||||||||||||||||||||||||||||||||||||||||
Reyataz Franchise | 151 | 146 | 297 | 121 | 418 | 130 | 548 | 101 | 125 | 226 | (14)% | (24)% | (7)% | (8)% | ||||||||||||||||||||||||||||||||||||||||||
Sustiva Franchise(b) | 56 | 59 | 115 | 53 | 168 | 43 | 211 | 45 | 44 | 89 | (25)% | (23)% | — | — | ||||||||||||||||||||||||||||||||||||||||||
Neuroscience | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Abilify(c) | 46 | 40 | 86 | 28 | 114 | 32 | 146 | 33 | 35 | 68 | (13)% | (21)% | (5)% | (5)% | ||||||||||||||||||||||||||||||||||||||||||
Mature Products and All Other(d) | 542 | 572 | 1,114 | 508 | 1,622 | 489 | 2,111 | 442 | 440 | 882 | (23)% | (21)% | (4)% | (5)% | ||||||||||||||||||||||||||||||||||||||||||
Total | $ | 1,997 | $ | 2,326 | $ | 4,323 | $ | 2,025 | $ | 6,348 | $ | 2,024 | $ | 8,372 | $ | 1,854 | $ | 2,183 | $ | 4,037 | (6)% | (7)% | (2)% | (4)% |
** | In excess of +/- 100% |
(a) | Includes Daklinza (daclatasvir) revenues of $243 million and $382 million for the three months ended June 30, 2016 and 2015, respectively, and $404 million and $562 million for the six months ended June 30, 2016 and 2015, respectively. Additionally, includes Sunvepra (asunaprevir) revenues of $9 million and $97 million for the three months ended June 30, 2016 and 2015, respectively, and $16 million and $181 million for the six months ended June 30, 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 | $ | 3,665 | $ | 7,004 | ||||||||||||||||||||||||||||
Specified items(a) | 34 | 25 | 59 | 15 | 74 | 10 | 84 | 4 | 4 | 8 | ||||||||||||||||||||||||||||||||||||||
Gross profit excluding specified items | 3,228 | 3,175 | 6,403 | 2,987 | 9,390 | 3,345 | 12,735 | 3,343 | 3,669 | 7,012 | ||||||||||||||||||||||||||||||||||||||
Marketing, selling and administrative | 1,029 | 1,135 | 2,164 | 1,176 | 3,340 | 1,501 | 4,841 | 1,068 | 1,238 | 2,306 | ||||||||||||||||||||||||||||||||||||||
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 | 1,238 | 2,306 | ||||||||||||||||||||||||||||||||||||||
Research and development | 1,016 | 1,856 | 2,872 | 1,132 | 4,004 | 1,916 | 5,920 | 1,136 | 1,266 | 2,402 | ||||||||||||||||||||||||||||||||||||||
Specified items(a) | (162 | ) | (871 | ) | (1,033 | ) | (109 | ) | (1,142 | ) | (741 | ) | (1,883 | ) | (138 | ) | (152 | ) | (290 | ) | ||||||||||||||||||||||||||||
Research and development excluding specified items | 854 | 985 | 1,839 | 1,023 | 2,862 | 1,175 | 4,037 | 998 | 1,114 | 2,112 | ||||||||||||||||||||||||||||||||||||||
Other (income)/expense | (299 | ) | 107 | (192 | ) | (323 | ) | (515 | ) | 328 | (187 | ) | (520 | ) | (454 | ) | (974 | ) | ||||||||||||||||||||||||||||||
Specified items(a) | 122 | (237 | ) | (115 | ) | 227 | 112 | (428 | ) | (316 | ) | 185 | 234 | 419 | ||||||||||||||||||||||||||||||||||
Other (income)/expense excluding specified items | (177 | ) | (130 | ) | (307 | ) | (96 | ) | (403 | ) | (100 | ) | (503 | ) | (335 | ) | (220 | ) | (555 | ) | ||||||||||||||||||||||||||||
Effective Tax Rate | 17.2 | % | 311.5 | % | 27.4 | % | 26.0 | % | 26.9 | % | 54.1 | % | 21.5 | % | 27.1 | % | 26.4 | % | 26.8 | % | ||||||||||||||||||||||||||||
Specified items(a) | 3.6 | % | (288.1 | )% | (5.5 | )% | (1.8 | )% | (4.4 | )% | (39.0 | )% | (0.3 | )% | (4.4 | )% | (3.6 | )% | (4.0 | )% | ||||||||||||||||||||||||||||
Effective Tax Rate excluding specified items | 20.8 | % | 23.4 | % | 21.9 | % | 24.2 | % | 22.5 | % | 15.1 | % | 21.2 | % | 22.7 | % | 22.8 | % | 22.8 | % |
(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. |
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 | $ | 4 | $ | 8 | ||||||||||||||||||||||||||||
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 | 139 | 264 | ||||||||||||||||||||||||||||||||||||||
IPRD impairments | — | — | — | — | — | 160 | 160 | — | — | — | ||||||||||||||||||||||||||||||||||||||
Other | — | 2 | 2 | 15 | 17 | 27 | 44 | 13 | 13 | 26 | ||||||||||||||||||||||||||||||||||||||
Research and development | 162 | 871 | 1,033 | 109 | 1,142 | 741 | 1,883 | 138 | 152 | 290 | ||||||||||||||||||||||||||||||||||||||
Provision for restructuring | 12 | 28 | 40 | 10 | 50 | 65 | 115 | 4 | 18 | 22 | ||||||||||||||||||||||||||||||||||||||
Divestiture (gains)/losses | (152 | ) | (8 | ) | (160 | ) | (198 | ) | (358 | ) | 171 | (187 | ) | (269 | ) | (277 | ) | (546 | ) | |||||||||||||||||||||||||||||
Pension charges | 27 | 36 | 63 | 48 | 111 | 49 | 160 | 22 | 25 | 47 | ||||||||||||||||||||||||||||||||||||||
Written option adjustment | (36 | ) | — | (36 | ) | (87 | ) | (123 | ) | — | (123 | ) | — | — | — | |||||||||||||||||||||||||||||||||
Litigation and other settlements | 14 | 1 | 15 | — | 15 | 143 | 158 | 43 | — | 43 | ||||||||||||||||||||||||||||||||||||||
Out-licensed intangible asset impairment | 13 | — | 13 | — | 13 | — | 13 | 15 | — | 15 | ||||||||||||||||||||||||||||||||||||||
Loss on debt redemption | — | 180 | 180 | — | 180 | — | 180 | — | — | — | ||||||||||||||||||||||||||||||||||||||
Other (income)/expense | (122 | ) | 237 | 115 | (227 | ) | (112 | ) | 428 | 316 | (185 | ) | (234 | ) | (419 | ) | ||||||||||||||||||||||||||||||||
Increase/(decrease) to pretax income | 75 | 1,136 | 1,211 | (101 | ) | 1,110 | 1,183 | 2,293 | (43 | ) | (78 | ) | (121 | ) | ||||||||||||||||||||||||||||||||||
Income tax on items above | (68 | ) | (116 | ) | (184 | ) | 43 | (141 | ) | (339 | ) | (480 | ) | 83 | 76 | 159 | ||||||||||||||||||||||||||||||||
Increase/(decrease) to net earnings | $ | 7 | $ | 1,020 | $ | 1,027 | $ | (58 | ) | $ | 969 | $ | 844 | $ | 1,813 | $ | 40 | $ | (2 | ) | $ | 38 |
(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 | $ | 2,934 | ||||||||||||||||
Marketable securities - current | 1,313 | 1,277 | 1,438 | 1,885 | 1,663 | 1,717 | ||||||||||||||||||||||
Marketable securities - non-current | 4,279 | 4,632 | 4,627 | 4,660 | 3,689 | 3,281 | ||||||||||||||||||||||
Cash, cash equivalents and marketable securities | 11,886 | 10,108 | 10,040 | 8,930 | 7,996 | 7,932 | ||||||||||||||||||||||
Short-term borrowings | (330 | ) | (755 | ) | (642 | ) | (139 | ) | (106 | ) | (155 | ) | ||||||||||||||||
Long-term debt | (7,127 | ) | (6,615 | ) | (6,632 | ) | (6,550 | ) | (6,593 | ) | (6,581 | ) | ||||||||||||||||
Net cash position | $ | 4,429 | $ | 2,738 | $ | 2,766 | $ | 2,241 | $ | 1,297 | $ | 1,196 |
Full Year 2016 | ||
Projected Diluted Earnings Attributable to Shareholders per Common Share - GAAP | $2.43 to $2.53 | |
Projected Specified Items: | ||
Downsizing and streamlining of worldwide operations | (0.21 | ) |
License and asset acquisition charges | 0.26 | |
Pension charges | 0.04 | |
Litigation and other settlements | 0.03 | |
Other | — | |
Total | 0.12 | |
Projected Diluted Earnings Attributable to Shareholders per Common Share - Non-GAAP | $2.55 to $2.65 |
Gross margin as a percentage of revenues on a GAAP and non-GAAP basis for the six months ended June 30, 2016 was 75.6% and 75.7%, 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 six months ended June 30, 2016 were $2.3 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 six months ended June 30, 2016 were $2.4 billion and $2.1 billion, respectively. On a non-GAAP basis, the Company projects research and development expense for the full year 2016 to increase in the mid-teen 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 six months ended June 30, 2016 was 26.8%. On a non-GAAP basis, for the six months ended June 30, 2016 the effective tax rate was 22.8%. On a non-GAAP basis, the Company projects an annual effective tax rate of 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, charges associated with downsizing and streamlining worldwide operations, in-process research and development (IPRD) , license and asset acquisition charges, charges related to significant legal proceedings, licensed asset impairments, 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 additional gains or losses from divestitures, license and asset acquisition charges, charges for IPRD and licensed asset impairments, recoveries relating to significant legal proceedings 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 Second Quarter 2016 Financial Results, July 28, 2016 including “2016 Financial Guidance” and “Use of non-GAAP Financial Information” therein. | |||||||||
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