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 24, 2014. |
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 24, 2014 | By: | /s/ Sandra Leung | |||
Name: | Sandra Leung | ||||
Title: | General Counsel and Corporate Secretary |
Exhibit No. | Description |
99.1 | Press release of Bristol-Myers Squibb Company dated July 24, 2014. |
99.2 | Certain supplemental information posted on Bristol-Myers Squibb Company’s website at www.bms.com not included in the press release. |
• | Posts Second Quarter GAAP EPS of $0.20 and Non-GAAP EPS of $0.48 |
• | Achieves Important Regulatory Milestones across Portfolio |
◦ | Approval for Daklinza+Sunvepra Dual Regimen in Japan |
◦ | Positive Advisory Opinions for Daklinza and Eliquis in Europe |
◦ | Plans for Third Quarter Submission of a Biologics License Application in the U.S. for |
• | Announces Strategic Immuno-Oncology Collaboration with Ono Pharmaceutical Co., Ltd. |
• | Adjusts 2014 GAAP EPS Guidance Range to $1.50-$1.60 and Confirms Non-GAAP EPS Guidance Range of $1.70-$1.80 |
Second Quarter | ||||||||||
$ amounts in millions, except per share amounts | ||||||||||
2014 | 2013 | Change | ||||||||
Total Revenues | $ | 3,889 | $ | 4,048 | (4 | )% | ||||
GAAP Diluted EPS | 0.20 | 0.32 | (38 | )% | ||||||
Non-GAAP Diluted EPS | 0.48 | 0.44 | 9 | % |
• | Bristol-Myers Squibb posted second quarter 2014 revenues of $3.9 billion, a decrease of 4% compared to the same period a year ago. Excluding the divested Diabetes Alliance, global revenues increased 7%. |
• | U.S. revenues decreased 7% to $1.9 billion in the quarter compared to the same period a year ago. International revenues decreased 1% to $2.0 billion. |
• | Gross margin as a percentage of revenues was 74.5% in the quarter compared to 72.6% in the same period a year ago. |
• | Marketing, selling and administrative expenses decreased 9% to $951 million in the quarter. |
• | Advertising and product promotion spending decreased 14% to $187 million in the quarter. |
• | Research and development expenses increased 49% to $1.4 billion in the quarter and included impairment and acquisition-related charges of $458 million. |
• | The effective tax rate on earnings before income taxes was 25.4% in the quarter, compared to 0% in the second quarter last year. Income taxes in the second quarter last year reflect a more favorable earnings mix between high and low tax jurisdictions, primarily driven by specified items. |
• | The company reported net earnings attributable to Bristol-Myers Squibb of $333 million, or $0.20 per share, in the quarter compared to $536 million, or $0.32 per share, a year ago. |
• | The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $798 million, or $0.48 per share, in the second quarter, compared to $730 million, or $0.44 per share, for the same period in 2013. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section. |
• | Cash, cash equivalents and marketable securities were $11.1 billion, with a net cash position of $3.3 billion, as of June 30, 2014. |
• | In July, the company announced that the Japanese Ministry of Health, Labor and Welfare has approved Daklinza (daclatasvir), the company’s potent, pan-genotypic NS5A replication complex inhibitor (in vitro), and Sunvepra (asunaprevir), the company’s NS3/4A protease inhibitor. The approvals are Japan’s first for an all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic hepatitis C virus infection, particularly those with compensated cirrhosis. The Daklinza+Sunvepra Dual Regimen provides a new treatment alternative that can lead to cure for many patients in Japan who currently have no treatment options. Daklinza and Sunvepra are expected to be commercially available in Japan in early September. |
• | In June, the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending that Daklinza be granted approval for use in combination with other medicinal products for the treatment of chronic hepatitis C virus infection in adults. This is the first positive opinion given by the CHMP for an NS5A inhibitor. It will now be reviewed by the European Commission (EC), which has the authority to approve medicines for all European Union (EU) member states plus Iceland and Norway. |
• | In April, the company announced the submission of New Drug Applications (NDAs) for Daklinza and Sunvepra to the U.S. Food and Drug Administration (FDA). The data submitted in the NDAs support use of the Daklinza+Sunvepra Dual Regimen in patients with genotype 1b hepatitis C. The Daklinza NDA also seeks approval for use of this compound in combination with other agents for multiple genotypes. The FDA accepted the submissions for filing and assigned both submissions priority review with a user fee goal date of November 30, 2014. |
• | In July, the company announced that, following discussions with the FDA, the company is planning a third quarter submission of a Biologics License Application (BLA) for Opdivo (nivolumab) for previously treated advanced melanoma. This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission under way for Opdivo in the U.S. In April, the company initiated a rolling BLA submission for Opdivo in third-line squamous cell non-small cell lung cancer (NSCLC). The company expects to complete the first submission by the end of the year. |
• | In June, the company announced that a randomized, blinded comparative Phase III study evaluating Opdivo versus dacarbazine in patients with previously untreated BRAF wild-type advanced melanoma (CheckMate -066) was stopped early because an analysis conducted by the independent Data Monitoring Committee showed evidence of superior overall survival in patients receiving Opdivo compared to the control arm. |
• | Also in June, at the American Society of Clinical Oncology (ASCO) meeting in Chicago, the company announced results from several clinical trials for Opdivo, both as monotherapy and in combination with Yervoy, in advanced cancers of the lungs, skin and kidneys. Bristol-Myers Squibb is at the forefront of research and discovery in the field of immuno-oncology and these data add to the growing body of research from its leading immuno-oncology pipeline, further supporting the scientific rationale for the potential of these checkpoint inhibitors as single agents or as part of a combination regimen. |
• | In May, the FDA granted Opdivo Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab. The designation is based on data from a cohort of patients with Hodgkin lymphoma in the company’s ongoing Phase Ib study of relapsed and refractory hematological malignancies. |
• | In July, the company and its partner, Pfizer, announced that the first patient has enrolled in a Phase IV clinical trial assessing the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation undergoing cardioversion. |
• | In June, the company and its partner, Pfizer, announced that CHMP has adopted a positive opinion recommending that Eliquis be granted marketing authorization for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE, in adults. The CHMP’s positive opinion will now be reviewed by the EC, which has the authority to approve medicines for all EU member states plus Iceland and Norway. |
• | In May, the company and its partner, AbbVie, announced that the FDA has granted elotuzumab, an investigational humanized monoclonal antibody, Breakthrough Therapy Designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies. The designation is based on findings from a randomized Phase II, open-label study that evaluated two dose levels of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated patients, including the 10 mg/kg dose that is being studied in Phase III trials. |
• | In June, at the ASCO meeting in Chicago, the company announced results from a Phase III randomized, double-blind study demonstrating that Yervoy 10 mg/kg (n=475) significantly improved recurrence-free survival (RFS, the length of time before recurrence or death) vs. placebo (n=476) for patients with Stage 3 melanoma who are at high risk of recurrence following complete surgical resection, an adjuvant setting. A 25% reduction in the risk of recurrence or death was observed. At three years, an estimated 46.5% of patients treated with Yervoy were free of disease recurrence compared to an estimated 34.8% of patients on placebo. The median RFS was 26.1 months for Yervoy vs. 17.1 months for placebo, with a median follow-up of 2.7 years. |
• | In June, at the European League Against Rheumatism meeting in Paris, the company presented data from the Phase IIIb AVERT trial showing that treatment with Orencia, a T-cell co-stimulation modulator, in combination with methotrexate (MTX) achieved significantly higher rates of DAS-defined (DAS28 CRP <2.6) remission at 12 months than treatment with standard of care agent MTX (60.9% vs. 45.2%, respectively), in biologic and MTX-naïve patients with early active rheumatoid arthritis (RA). A small but statistically significantly higher number of patients treated with Orencia plus MTX, versus MTX alone, for 12 months maintained remission 6 months after all RA treatment, including Orencia, MTX or steroids, was withdrawn. |
• | In June, the U.S. Court of Appeals for the Federal Circuit denied the company’s appeal of a February 2013 ruling by the U.S. District Court for the District of Delaware that found invalid the patent covering Baraclude (U.S. patent 5,206,244). In July, the company filed a petition for an en banc rehearing of the case by the full U.S. Court of Appeals. |
• | In July, the company and Ono Pharmaceutical Co., Ltd., signed a collaboration agreement to jointly develop and commercialize Opdivo, Yervoy and three immunotherapy agents in early clinical development as single agents and combination regimens in Japan, South Korea and Taiwan. Also in July, Ono announced that Opdivo received manufacturing and marketing approval in Japan for the treatment of unresectable melanoma. Opdivo is the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. |
• | In June, the company and Syngene International announced a five-year extension of their drug discovery and development collaboration at the Biocon Bristol-Myers Squibb Research Center in Bangalore, India. |
• | In May, the company announced a clinical trial collaboration with Incyte Corporation to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Opdivo and INCB24360, Incyte’s oral indoleamine dioxygenase-1 inhibitor, in a Phase I/II study. |
• | In May, the company also announced a clinical trial collaboration with Celldex Therapeutics to evaluate the safety, tolerability and preliminary efficacy of Opdivo and varlilumab, Celldex’s CD27 targeting investigational antibody, in a Phase I/II study. Multiple tumor types will be explored in the study, which could potentially include NSCLC, metastatic melanoma, ovarian, colorectal and squamous cell head and neck cancers. |
• | In May, the company and CytomX Therapeutics announced a worldwide research collaboration and license agreement to discover, develop and commercialize novel therapies against multiple immuno-oncology targets using CytomX’s proprietary Probody™ Platform. |
• | In June, the company announced a collaboration with Duke University, through its Duke Clinical Research Institute (DCRI), that will focus on clinical trial transparency. The company will expand access to a broader set of clinical trial information from in-scope company-sponsored studies and enable an independent scientific review through DCRI of requests from researchers that meet pre-specified requirements. |
Worldwide Revenues | U.S. Revenues | |||||||||||||||||||||
2014 | 2013 | % Change | 2014 | 2013 | % Change | |||||||||||||||||
Three Months Ended June 30, | ||||||||||||||||||||||
Key Products | ||||||||||||||||||||||
Virology | ||||||||||||||||||||||
Baraclude | $ | 369 | $ | 371 | (1 | )% | $ | 84 | $ | 73 | 15 | % | ||||||||||
Reyataz | 362 | 431 | (16 | )% | 168 | 200 | (16 | )% | ||||||||||||||
Sustiva Franchise | 361 | 411 | (12 | )% | 266 | 275 | (3 | )% | ||||||||||||||
Oncology | ||||||||||||||||||||||
Erbitux(a) | 186 | 171 | 9 | % | 178 | 168 | 6 | % | ||||||||||||||
Sprycel | 368 | 312 | 18 | % | 163 | 135 | 21 | % | ||||||||||||||
Yervoy | 321 | 233 | 38 | % | 173 | 140 | 24 | % | ||||||||||||||
Neuroscience | ||||||||||||||||||||||
Abilify(b) | 555 | 563 | (1 | )% | 417 | 378 | 10 | % | ||||||||||||||
Immunoscience | ||||||||||||||||||||||
Orencia | 402 | 352 | 14 | % | 254 | 238 | 7 | % | ||||||||||||||
Cardiovascular | ||||||||||||||||||||||
Eliquis | 171 | 12 | ** | 94 | 5 | ** | ||||||||||||||||
Diabetes Alliance | 27 | 438 | (94 | )% | — | 320 | (100 | )% | ||||||||||||||
Mature Products and All Other | 767 | 754 | 2 | % | 104 | 113 | (8 | )% | ||||||||||||||
Total | 3,889 | 4,048 | (4 | )% | 1,901 | 2,045 | (7 | )% | ||||||||||||||
Total Excluding Diabetes Alliance | 3,862 | 3,610 | 7 | % | 1,901 | 1,725 | 10 | % |
** | 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 | |||||||||||||||||||||
2014 | 2013 | % Change | 2014 | 2013 | % Change | |||||||||||||||||
Six Months Ended June 30, | ||||||||||||||||||||||
Key Products | ||||||||||||||||||||||
Virology | ||||||||||||||||||||||
Baraclude | $ | 775 | $ | 737 | 5 | % | $ | 154 | $ | 141 | 9 | % | ||||||||||
Reyataz | 706 | 792 | (11 | )% | 344 | 393 | (12 | )% | ||||||||||||||
Sustiva Franchise | 680 | 798 | (15 | )% | 494 | 526 | (6 | )% | ||||||||||||||
Oncology | ||||||||||||||||||||||
Erbitux | 355 | 333 | 7 | % | 336 | 326 | 3 | % | ||||||||||||||
Sprycel | 710 | 599 | 19 | % | 308 | 250 | 23 | % | ||||||||||||||
Yervoy | 592 | 462 | 28 | % | 319 | 299 | 7 | % | ||||||||||||||
Neuroscience | ||||||||||||||||||||||
Abilify | 1,095 | 1,085 | 1 | % | 742 | 706 | 5 | % | ||||||||||||||
Immunoscience | ||||||||||||||||||||||
Orencia | 765 | 672 | 14 | % | 483 | 452 | 7 | % | ||||||||||||||
Cardiovascular | ||||||||||||||||||||||
Eliquis | 277 | 34 | ** | 155 | 22 | ** | ||||||||||||||||
Diabetes Alliance | 206 | 796 | (74 | )% | 114 | 612 | (81 | )% | ||||||||||||||
Mature Products and All Other | 1,539 | 1,571 | (2 | )% | 217 | 289 | (25 | )% | ||||||||||||||
Total | 7,700 | 7,879 | (2 | )% | 3,666 | 4,016 | (9 | )% | ||||||||||||||
Total Excluding Diabetes Alliance | 7,494 | 7,083 | 6 | % | 3,552 | 3,404 | 4 | % |
** | In excess of 100% |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Net product sales | $ | 2,770 | $ | 3,024 | $ | 5,577 | $ | 5,981 | ||||||||
Alliance and other revenues | 1,119 | 1,024 | 2,123 | 1,898 | ||||||||||||
Total Revenues | 3,889 | 4,048 | 7,700 | 7,879 | ||||||||||||
Cost of products sold | 991 | 1,108 | 1,959 | 2,171 | ||||||||||||
Marketing, selling and administrative | 951 | 1,042 | 1,908 | 2,036 | ||||||||||||
Advertising and product promotion | 187 | 218 | 350 | 407 | ||||||||||||
Research and development | 1,416 | 951 | 2,362 | 1,881 | ||||||||||||
Other (income)/expense | (104 | ) | 199 | (312 | ) | 180 | ||||||||||
Total Expenses | 3,441 | 3,518 | 6,267 | 6,675 | ||||||||||||
Earnings Before Income Taxes | 448 | 530 | 1,433 | 1,204 | ||||||||||||
Provision for Income Taxes | 114 | — | 163 | 51 | ||||||||||||
Net Earnings | 334 | 530 | 1,270 | 1,153 | ||||||||||||
Net Earnings/(Loss) Attributable to Noncontrolling Interest | 1 | (6 | ) | — | 8 | |||||||||||
Net Earnings Attributable to BMS | $ | 333 | $ | 536 | $ | 1,270 | $ | 1,145 | ||||||||
Earnings per Common Share | ||||||||||||||||
Basic | $ | 0.20 | $ | 0.33 | $ | 0.77 | $ | 0.70 | ||||||||
Diluted | $ | 0.20 | $ | 0.32 | $ | 0.76 | $ | 0.69 | ||||||||
Average Common Shares Outstanding: | ||||||||||||||||
Basic | 1,657 | 1,644 | 1,655 | 1,641 | ||||||||||||
Diluted | 1,669 | 1,660 | 1,668 | 1,658 | ||||||||||||
Other (Income)/Expense | ||||||||||||||||
Interest expense | $ | 46 | $ | 50 | $ | 100 | $ | 100 | ||||||||
Investment income | (28 | ) | (28 | ) | (51 | ) | (53 | ) | ||||||||
Provision for restructuring | 16 | 173 | 37 | 206 | ||||||||||||
Litigation charges/(recoveries) | (20 | ) | (22 | ) | 9 | (22 | ) | |||||||||
Equity in net income of affiliates | (33 | ) | (50 | ) | (69 | ) | (86 | ) | ||||||||
Gain on sale of product lines, businesses and assets | 7 | — | (252 | ) | (1 | ) | ||||||||||
Other alliance and licensing income | (144 | ) | (32 | ) | (252 | ) | (89 | ) | ||||||||
Pension curtailments, settlements and special termination benefits | 45 | 101 | 109 | 101 | ||||||||||||
Other | 7 | 7 | 57 | 24 | ||||||||||||
Other (income)/expense | $ | (104 | ) | $ | 199 | $ | (312 | ) | $ | 180 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Accelerated depreciation, asset impairment and other shutdown costs | $ | 39 | $ | — | $ | 84 | $ | — | ||||||||
Amortization of acquired Amylin intangible assets | — | 137 | — | 275 | ||||||||||||
Amortization of Amylin alliance proceeds | — | (67 | ) | — | (134 | ) | ||||||||||
Amortization of Amylin inventory adjustment | — | — | — | 14 | ||||||||||||
Cost of products sold | 39 | 70 | 84 | 155 | ||||||||||||
Marketing, selling and administrative* | 3 | 1 | 6 | 2 | ||||||||||||
Upfront, milestone and other payments | 148 | — | 163 | — | ||||||||||||
IPRD impairments | 310 | — | 343 | — | ||||||||||||
Research and development | 458 | — | 506 | — | ||||||||||||
Provision for restructuring | 16 | 173 | 37 | 206 | ||||||||||||
Gain on sale of product lines, businesses and assets | 12 | — | (247 | ) | — | |||||||||||
Pension curtailments, settlements and special termination benefits | 45 | 99 | 109 | 99 | ||||||||||||
Acquisition and alliance related items | 17 | (10 | ) | 33 | (10 | ) | ||||||||||
Litigation charges/(recoveries) | (23 | ) | (23 | ) | 2 | (23 | ) | |||||||||
Loss on debt redemption | — | — | 45 | — | ||||||||||||
Upfront, milestone and other licensing receipts | — | — | — | (14 | ) | |||||||||||
Other (income)/expense | 67 | 239 | (21 | ) | 258 | |||||||||||
Increase to pretax income | 567 | 310 | 575 | 415 | ||||||||||||
Income tax on items above | (102 | ) | (116 | ) | (281 | ) | (151 | ) | ||||||||
Increase to net earnings | $ | 465 | $ | 194 | $ | 294 | $ | 264 |
* Specified items in marketing, selling and administrative are process standardization implementation costs. |
Three months ended June 30, 2014 | GAAP | Specified Items* | Non GAAP | |||||||||
Gross Profit | $ | 2,898 | $ | 39 | $ | 2,937 | ||||||
Marketing, selling and administrative | 951 | (3 | ) | 948 | ||||||||
Research and development | 1,416 | (458 | ) | 958 | ||||||||
Other (income)/expense | (104 | ) | (67 | ) | (171 | ) | ||||||
Effective Tax Rate | 25.4 | % | (4.1 | )% | 21.3 | % | ||||||
Three months ended June 30, 2013 | GAAP | Specified Items* | Non GAAP | |||||||||
Gross Profit | $ | 2,940 | $ | 70 | $ | 3,010 | ||||||
Marketing, selling and administrative | 1,042 | (1 | ) | 1,041 | ||||||||
Research and development | 951 | — | 951 | |||||||||
Other (income)/expense | 199 | (239 | ) | (40 | ) | |||||||
Effective Tax Rate | — | 13.8 | % | 13.8 | % |
* | 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, 2014 | GAAP | Specified Items* | Non GAAP | |||||||||
Gross Profit | $ | 5,741 | $ | 84 | $ | 5,825 | ||||||
Marketing, selling and administrative | 1,908 | (6 | ) | 1,902 | ||||||||
Research and development | 2,362 | (506 | ) | 1,856 | ||||||||
Other (income)/expense | (312 | ) | 21 | (291 | ) | |||||||
Effective Tax Rate | 11.4 | % | 10.7 | % | 22.1 | % | ||||||
Six Months Ended June 30, 2013 | GAAP | Specified Items* | Non GAAP | |||||||||
Gross Profit | $ | 5,708 | $ | 155 | $ | 5,863 | ||||||
Marketing, selling and administrative | 2,036 | (2 | ) | 2,034 | ||||||||
Research and development | 1,881 | — | 1,881 | |||||||||
Other (income)/expense | 180 | (258 | ) | (78 | ) | |||||||
Effective Tax Rate | 4.2 | % | 8.3 | % | 12.5 | % |
* | 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, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Net Earnings Attributable to BMS used for Diluted EPS Calculation - GAAP | $ | 333 | $ | 536 | $ | 1,270 | $ | 1,145 | ||||||||
Less Specified Items* | 465 | 194 | 294 | 264 | ||||||||||||
Net Earnings used for Diluted EPS Calculation – Non-GAAP | $ | 798 | $ | 730 | $ | 1,564 | $ | 1,409 | ||||||||
Average Common Shares Outstanding – Diluted | 1,669 | 1,660 | 1,668 | 1,658 | ||||||||||||
Diluted Earnings Per Share — GAAP | $ | 0.20 | $ | 0.32 | $ | 0.76 | $ | 0.69 | ||||||||
Diluted EPS Attributable to Specified Items | 0.28 | 0.12 | 0.18 | 0.16 | ||||||||||||
Diluted Earnings Per Share — Non-GAAP | $ | 0.48 | $ | 0.44 | $ | 0.94 | $ | 0.85 |
* | Refer to the Specified Items schedule for further details. |
June 30, 2014 | March 31, 2014 | |||||||
Cash and cash equivalents | $ | 4,282 | $ | 5,225 | ||||
Marketable securities - current | 2,893 | 1,834 | ||||||
Marketable securities - long term | 3,876 | 3,558 | ||||||
Cash, cash equivalents and marketable securities | 11,051 | 10,617 | ||||||
Short-term borrowings and current portion of long-term debt | (365 | ) | (281 | ) | ||||
Long-term debt | (7,372 | ) | (7,367 | ) | ||||
Net cash position | $ | 3,314 | $ | 2,969 |
Revenues | 2013 | 2014 | % 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 | |||||||||||||||||||||||||||||||||||||||
Total | $ | 3,831 | $ | 4,048 | $ | 7,879 | $ | 4,065 | $ | 11,944 | $ | 4,441 | $ | 16,385 | $ | 3,811 | $ | 3,889 | $ | 7,700 | (4)% | (2)% | — | — | ||||||||||||||||||||||||||||||||
US and Puerto Rico | 1,971 | 2,045 | 4,016 | 2,037 | 6,053 | 2,265 | 8,318 | 1,765 | 1,901 | 3,666 | (7)% | (9)% | — | — | ||||||||||||||||||||||||||||||||||||||||||
Europe | 946 | 950 | 1,896 | 985 | 2,881 | 1,049 | 3,930 | 948 | 908 | 1,856 | (4)% | (2)% | 4% | 3% | ||||||||||||||||||||||||||||||||||||||||||
Rest of the World | 765 | 835 | 1,600 | 805 | 2,405 | 890 | 3,295 | 830 | 811 | 1,641 | (3)% | 3% | (4)% | (5)% | ||||||||||||||||||||||||||||||||||||||||||
Other | 149 | 218 | 367 | 238 | 605 | 237 | 842 | 268 | 269 | 537 | 23% | 46% | — | — | ||||||||||||||||||||||||||||||||||||||||||
% of Revenues | 2013 | 2014 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | |||||||||||||||||||||||||||||||||||||||||||
Total | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | 100.0 | % | ||||||||||||||||||||||||||||||||||||
US and Puerto Rico | 51.4 | % | 50.5 | % | 51.0 | % | 50.1 | % | 50.7 | % | 51.0 | % | 50.8 | % | 46.3 | % | 48.9 | % | 47.6 | % | ||||||||||||||||||||||||||||||||||||
Europe | 24.7 | % | 23.5 | % | 24.1 | % | 24.2 | % | 24.1 | % | 23.6 | % | 24.0 | % | 24.9 | % | 23.3 | % | 24.1 | % | ||||||||||||||||||||||||||||||||||||
Rest of the World | 20.0 | % | 20.6 | % | 20.3 | % | 19.8 | % | 20.1 | % | 20.0 | % | 20.1 | % | 21.8 | % | 20.9 | % | 21.3 | % | ||||||||||||||||||||||||||||||||||||
Other | 3.9 | % | 5.4 | % | 4.6 | % | 5.9 | % | 5.1 | % | 5.4 | % | 5.1 | % | 7.0 | % | 6.9 | % | 7.0 | % |
QUARTER-TO-DATE | Revenues | Analysis of % Change | ||||||||||||||
2014 | 2013 | Total Change | Volume | Price | Foreign Exchange | |||||||||||
US and Puerto Rico | $ | 1,901 | $ | 2,045 | (7)% | (12)% | 5% | — | ||||||||
Europe | 908 | 950 | (4)% | (1)% | (7)% | 4% | ||||||||||
Rest of the World | 811 | 835 | (3)% | 3% | (2)% | (4)% | ||||||||||
Other | 269 | 218 | 23% | N/A | N/A | — | ||||||||||
Total | $ | 3,889 | $ | 4,048 | (4)% | (5)% | 1% | — | ||||||||
YEAR-TO-DATE | Revenues | Analysis of % Change | ||||||||||||||
2014 | 2013 | Total Change | Volume | Price | Foreign Exchange | |||||||||||
US and Puerto Rico | $ | 3,666 | $ | 4,016 | (9)% | (12)% | 3% | — | ||||||||
Europe | 1,856 | 1,896 | (2)% | 2% | (7)% | 3% | ||||||||||
Rest of the World | 1,641 | 1,600 | 3% | 10% | (2)% | (5)% | ||||||||||
Other | 537 | 367 | 46% | N/A | N/A | — | ||||||||||
Total | $ | 7,700 | $ | 7,879 | (2)% | (2)% | — | — |
2013 | 2014 | % Change | ||||||||||||||||||||||||||||||||||||||||||||||||||
1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | 1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | Qtr vs. Qtr | YTD vs. YTD | |||||||||||||||||||||||||||||||||||||
Net product sales | $ | 2,957 | $ | 3,024 | $ | 5,981 | $ | 3,025 | $ | 9,006 | $ | 3,298 | $ | 12,304 | $ | 2,807 | $ | 2,770 | $ | 5,577 | (8)% | (7)% | ||||||||||||||||||||||||||||||
Alliance and other revenues | 874 | 1,024 | 1,898 | 1,040 | 2,938 | 1,143 | 4,081 | 1,004 | 1,119 | 2,123 | 9% | 12% | ||||||||||||||||||||||||||||||||||||||||
Total Revenues | $ | 3,831 | $ | 4,048 | $ | 7,879 | $ | 4,065 | $ | 11,944 | $ | 4,441 | $ | 16,385 | $ | 3,811 | $ | 3,889 | $ | 7,700 | (4)% | (2)% | ||||||||||||||||||||||||||||||
Cost of products sold | 1,063 | 1,108 | 2,171 | 1,175 | 3,346 | 1,273 | 4,619 | 968 | 991 | 1,959 | (11)% | (10)% | ||||||||||||||||||||||||||||||||||||||||
Marketing, selling and administrative | 994 | 1,042 | 2,036 | 980 | 3,016 | 1,068 | 4,084 | 957 | 951 | 1,908 | (9)% | (6)% | ||||||||||||||||||||||||||||||||||||||||
Advertising and product promotion | 189 | 218 | 407 | 194 | 601 | 254 | 855 | 163 | 187 | 350 | (14)% | (14)% | ||||||||||||||||||||||||||||||||||||||||
Research and development | 930 | 951 | 1,881 | 893 | 2,774 | 957 | 3,731 | 946 | 1,416 | 2,362 | 49% | 26% | ||||||||||||||||||||||||||||||||||||||||
Other (income)/expense | (19 | ) | 199 | 180 | 5 | 185 | 20 | 205 | (208 | ) | (104 | ) | (312 | ) | ** | ** | ||||||||||||||||||||||||||||||||||||
Total Expenses | 3,157 | 3,518 | 6,675 | 3,247 | 9,922 | 3,572 | 13,494 | 2,826 | 3,441 | 6,267 | (2)% | (6)% | ||||||||||||||||||||||||||||||||||||||||
Earnings Before Income Taxes | $ | 674 | $ | 530 | $ | 1,204 | $ | 818 | $ | 2,022 | $ | 869 | $ | 2,891 | $ | 985 | $ | 448 | $ | 1,433 | (15)% | 19% | ||||||||||||||||||||||||||||||
Provision for Income Taxes | 51 | — | 51 | 126 | 177 | 134 | 311 | 49 | 114 | 163 | — | ** | ||||||||||||||||||||||||||||||||||||||||
Net Earnings | $ | 623 | $ | 530 | $ | 1,153 | $ | 692 | $ | 1,845 | $ | 735 | $ | 2,580 | $ | 936 | $ | 334 | $ | 1,270 | (37)% | 10% | ||||||||||||||||||||||||||||||
Net Earnings/(Loss) Attributable to Noncontrolling Interest | 14 | (6 | ) | 8 | — | 8 | 9 | 17 | (1 | ) | 1 | — | ** | (100)% | ||||||||||||||||||||||||||||||||||||||
Net Earnings Attributable to BMS | $ | 609 | $ | 536 | $ | 1,145 | $ | 692 | $ | 1,837 | $ | 726 | $ | 2,563 | $ | 937 | $ | 333 | $ | 1,270 | (38)% | 11% | ||||||||||||||||||||||||||||||
Diluted Earnings per Common Share* | $ | 0.37 | $ | 0.32 | $ | 0.69 | $ | 0.42 | $ | 1.11 | $ | 0.44 | $ | 1.54 | $ | 0.56 | $ | 0.20 | $ | 0.76 | (38)% | 10% | ||||||||||||||||||||||||||||||
Average Common Shares Outstanding - Diluted | 1,655 | 1,660 | 1,658 | 1,662 | 1,659 | 1,666 | 1,662 | 1,666 | 1,669 | 1,668 | 1% | 1% | ||||||||||||||||||||||||||||||||||||||||
Dividends declared per common share | $ | 0.35 | $ | 0.35 | $ | 0.70 | $ | 0.35 | $ | 1.05 | $ | 0.36 | $ | 1.41 | $ | 0.36 | $ | 0.36 | $ | 0.72 | 3% | 3% | ||||||||||||||||||||||||||||||
2013 | 2014 | |||||||||||||||||||||||||||||||||||||||||||||||||||
% 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 | 72.3 | % | 72.6 | % | 72.4 | % | 71.1 | % | 72.0 | % | 71.3 | % | 71.8 | % | 74.6 | % | 74.5 | % | 74.6 | % | ||||||||||||||||||||||||||||||||
Other Ratios | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Effective tax rate | 7.6 | % | — | 4.2 | % | 15.4 | % | 8.8 | % | 15.4 | % | 10.8 | % | 5.0 | % | 25.4 | % | 11.4 | % | |||||||||||||||||||||||||||||||||
Other (Income)/Expense | 2013 | 2014 | % 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 | $ | 50 | $ | 50 | $ | 100 | $ | 46 | $ | 146 | $ | 53 | $ | 199 | $ | 54 | $ | 46 | $ | 100 | (8)% | — | ||||||||||||||||||||||||||||||
Investment income | (25 | ) | (28 | ) | (53 | ) | (23 | ) | (76 | ) | (28 | ) | (104 | ) | (23 | ) | (28 | ) | (51 | ) | — | 4% | ||||||||||||||||||||||||||||||
Provision for restructuring | 33 | 173 | 206 | 6 | 212 | 14 | 226 | 21 | 16 | 37 | (91)% | (82)% | ||||||||||||||||||||||||||||||||||||||||
Litigation charges/(recoveries) | — | (22 | ) | (22 | ) | 17 | (5 | ) | 25 | 20 | 29 | (20 | ) | 9 | 9% | ** | ||||||||||||||||||||||||||||||||||||
Equity in net income of affiliates | (36 | ) | (50 | ) | (86 | ) | (42 | ) | (128 | ) | (38 | ) | (166 | ) | (36 | ) | (33 | ) | (69 | ) | 34% | 20% | ||||||||||||||||||||||||||||||
Gain on sale of product lines, businesses and assets | (1 | ) | — | (1 | ) | — | (1 | ) | (1 | ) | (2 | ) | (259 | ) | 7 | (252 | ) | N/A | ** | |||||||||||||||||||||||||||||||||
Other alliance and licensing income | (57 | ) | (32 | ) | (89 | ) | (31 | ) | (120 | ) | (28 | ) | (148 | ) | (108 | ) | (144 | ) | (252 | ) | ** | ** | ||||||||||||||||||||||||||||||
Pension curtailments, settlements and special termination benefits | — | 101 | 101 | 37 | 138 | 27 | 165 | 64 | 45 | 109 | (55)% | 8% | ||||||||||||||||||||||||||||||||||||||||
Other | 17 | 7 | 24 | (5 | ) | 19 | (4 | ) | 15 | 50 | 7 | 57 | — | ** | ||||||||||||||||||||||||||||||||||||||
$ | (19 | ) | $ | 199 | $ | 180 | $ | 5 | $ | 185 | $ | 20 | $ | 205 | $ | (208 | ) | $ | (104 | ) | $ | (312 | ) | ** | ** |
* Quarterly amounts may not add to the year-to-date totals due to rounding of individual calculations. |
** In excess of 100% |
2014 | 2013 | Growth $ | Growth % | Favorable / (Unfavorable) FX Impact $ * | 2014 Excluding FX | Favorable / (Unfavorable) FX Impact % * | Growth % Excluding FX | ||||||||||||||||||
Revenues | $ | 3,889 | $ | 4,048 | (159 | ) | (4)% | $ | 10 | $ | 3,879 | — | (4)% | ||||||||||||
Gross profit | 2,898 | 2,940 | (42 | ) | (1)% | N/A | N/A | N/A | N/A | ||||||||||||||||
Gross profit excluding specified items(a) | 2,937 | 3,010 | (73 | ) | (2)% | N/A | N/A | N/A | N/A | ||||||||||||||||
Gross profit excluding specified items as a % of revenues | 75.5 | % | 74.4 | % | |||||||||||||||||||||
Marketing, selling and administrative | 951 | 1,042 | (91 | ) | (9)% | 2 | 953 | — | (9)% | ||||||||||||||||
Marketing, selling and administrative excluding specified items(a) | 948 | 1,041 | (93 | ) | (9)% | 2 | 950 | — | (9)% | ||||||||||||||||
Advertising and product promotion | 187 | 218 | (31 | ) | (14)% | — | 187 | — | (14)% | ||||||||||||||||
SG&A excluding specified items as a % of revenues | 29.2 | % | 31.1 | % | |||||||||||||||||||||
Research and development | 1,416 | 951 | 465 | 49% | (4 | ) | 1,412 | (1)% | 48% | ||||||||||||||||
Research and development excluding specified items(a) | 958 | 951 | 7 | 1% | (4 | ) | 954 | (1)% | — | ||||||||||||||||
Research and development excluding specified items as a % of revenues | 24.6 | % | 23.5 | % | |||||||||||||||||||||
YEAR-TO-DATE | |||||||||||||||||||||||||
2014 | 2013 | Growth $ | Growth % | Favorable / (Unfavorable) FX Impact $ * | 2014 Excluding FX | Favorable / (Unfavorable) FX Impact % * | Growth % Excluding FX | ||||||||||||||||||
Revenues | $ | 7,700 | $ | 7,879 | (179 | ) | (2)% | $ | (14 | ) | $ | 7,714 | — | (2)% | |||||||||||
Gross profit | 5,741 | 5,708 | 33 | 1% | N/A | N/A | N/A | N/A | |||||||||||||||||
Gross profit excluding specified items(a) | 5,825 | 5,863 | (38 | ) | (1)% | N/A | N/A | N/A | N/A | ||||||||||||||||
Gross profit excluding specified items as a % of revenues | 75.6 | % | 74.4 | % | |||||||||||||||||||||
Marketing, selling and administrative | 1,908 | 2,036 | (128 | ) | (6)% | 11 | 1,919 | — | (6)% | ||||||||||||||||
Marketing, selling and administrative excluding specified items(a) | 1,902 | 2,034 | (132 | ) | (6)% | 11 | 1,913 | — | (6)% | ||||||||||||||||
Advertising and product promotion | 350 | 407 | (57 | ) | (14)% | 2 | 352 | — | (14)% | ||||||||||||||||
SG&A excluding specified items as a % of revenues | 29.2 | % | 31.0 | % | |||||||||||||||||||||
Research and development | 2,362 | 1,881 | 481 | 26% | (2 | ) | 2,360 | (1)% | 25% | ||||||||||||||||
Research and development excluding specified items(a) | 1,856 | 1,881 | (25 | ) | (1)% | (2 | ) | 1,854 | — | (1)% | |||||||||||||||
Research and development excluding specified items as a % of revenues | 24.1 | % | 23.9 | % |
(a) Refer to the Specified Items schedule for further details. | |||
* Foreign exchange (FX) impact determined by the change in a line item's current and prior period results at a common exchange rate and comparing this change to the actual reported change from the same period. This difference is determined to be the FX impact. |
2013 | 2014 | 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 EX-FX $ | YTD EX-FX $ | Qtr vs. Qtr % | YTD vs. YTD % | Qtr vs. Qtr | YTD vs. YTD | |||||||||||||||||||||||||||||||||||||||||||||||||||||
TOTAL | $ | 3,831 | $ | 4,048 | $ | 7,879 | $ | 4,065 | $ | 11,944 | $ | 4,441 | $ | 16,385 | $ | 3,811 | $ | 3,889 | $ | 7,700 | $ | (159 | ) | $ | (179 | ) | (4)% | (2)% | $ | 3,879 | $ | 7,714 | (4)% | (2)% | — | — | ||||||||||||||||||||||||||||||||||||||||
Virology (a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baraclude | 366 | 371 | 737 | 378 | 1,115 | 412 | 1,527 | 406 | 369 | 775 | (2 | ) | 38 | (1)% | 5% | 367 | 779 | (1)% | 6% | 1% | (1)% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reyataz | 361 | 431 | 792 | 375 | 1,167 | 384 | 1,551 | 344 | 362 | 706 | (69 | ) | (86 | ) | (16)% | (11)% | 365 | 713 | (15)% | (10)% | (1)% | (1)% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sustiva Franchise (b) | 387 | 411 | 798 | 389 | 1,187 | 427 | 1,614 | 319 | 361 | 680 | (50 | ) | (118 | ) | (12)% | (15)% | 356 | 673 | (13)% | (16)% | 1% | 1% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oncology (a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Erbitux | 162 | 171 | 333 | 183 | 516 | 180 | 696 | 169 | 186 | 355 | 15 | 22 | 9% | 7% | 187 | 356 | 9% | 7% | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sprycel | 287 | 312 | 599 | 316 | 915 | 365 | 1,280 | 342 | 368 | 710 | 56 | 111 | 18% | 19% | 369 | 719 | 18% | 20% | — | (1)% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Yervoy | 229 | 233 | 462 | 238 | 700 | 260 | 960 | 271 | 321 | 592 | 88 | 130 | 38% | 28% | 318 | 588 | 36% | 27% | 1% | 1% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Neuroscience(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Abilify(c) | 522 | 563 | 1,085 | 569 | 1,654 | 635 | 2,289 | 540 | 555 | 1,095 | (8 | ) | 10 | (1)% | 1% | 551 | 1,089 | (2)% | — | 1% | 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Immunoscience(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Orencia(d) | 320 | 352 | 672 | 375 | 1,047 | 397 | 1,444 | 363 | 402 | 765 | 50 | 93 | 14% | 14% | 405 | 774 | 15% | 15% | (1)% | (1)% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cardiovascular(a) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Eliquis | 22 | 12 | 34 | 41 | 75 | 71 | 146 | 106 | 171 | 277 | 159 | 243 | ** | ** | 170 | 278 | ** | ** | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Diabetes Alliance (e) | 358 | 438 | 796 | 432 | 1,228 | 455 | 1,683 | 179 | 27 | 206 | (411 | ) | (590 | ) | (94)% | (74)% | 27 | 206 | (94)% | (74)% | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Mature Products and All Other (f) | 817 | 754 | 1,571 | 769 | 2,340 | 855 | 3,195 | 772 | 767 | 1,539 | 13 | (32 | ) | 2% | (2)% | 764 | 1,539 | 1% | (2)% | 1% | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total Excluding Diabetes Alliance | 3,473 | 3,610 | 7,083 | 3,633 | 10,716 | 3,986 | 14,702 | 3,632 | 3,862 | 7,494 | 252 | 411 | 7% | 6% | 3,852 | 7,508 | 7% | 6% | — | — |
** | In excess of 100% |
(a) | Key products listed do not represent all products in the respective therapeutic areas. |
(b) | The Sustiva Franchise includes sales of Sustiva and revenue from sales of bulk efavirenz included in the combination therapy, Atripla. Includes alliance and other revenue of $313M and $346M for the three months ended June 30, 2014 and 2013, respectively, and $585M and $670M for the six months ended June 30, 2014 and 2013, respectively. |
(c) | Includes revenue from the co-promotional agreement with Otsuka Pharmaceutical Co., Ltd. Includes alliance and other revenue of $499M and $454M for three months ended June 30, 2014 and 2013, respectively, and $940M and $849M for the six months ended June 30, 2014 and 2013, respectively. |
(d) | Includes Orencia SubQ revenues of $160M and $100M for three months ended June 30, 2014 and 2013, respectively, and $296M and $184M for the six months ended June 30, 2014 and 2013, respectively. |
(e) | The six months ended June 30, 2014 includes pre-divestiture revenues of Bydureon, Byetta, Farxiga/Forxiga/Xigduo, Onglyza/Kombiglyze, Symlin and Myalept of $153M and post-divestiture revenues of $53M. |
(f) | Represents all other products, including those which have lost exclusivity in major markets, over the counter brands and royalty-related revenue. Includes Plavix revenues of $45M and $44M for the three months ended June 30, 2014 and 2013, respectively, and $93M and $135M for the six months ended June 30, 2014 and 2013, respectively. Additionally, includes Avapro/Avalide revenues of $59M and $56M for the three months ended June 30, 2014 and 2013, respectively, and $115M and $102M for the six months ended June 30, 2014 and 2013, respectively. |
2013 | 2014 | % 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 | |||||||||||||||||||||||||||||||||||||
TOTAL (a) | $ | 1,971 | $ | 2,045 | $ | 4,016 | $ | 2,037 | $ | 6,053 | $ | 2,265 | $ | 8,318 | $ | 1,765 | $ | 1,901 | $ | 3,666 | (7)% | (9)% | ||||||||||||||||||||||||||||||
Virology | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Baraclude | 68 | 73 | 141 | 67 | 208 | 81 | 289 | 70 | 84 | 154 | 15% | 9% | ||||||||||||||||||||||||||||||||||||||||
Reyataz | 193 | 200 | 393 | 189 | 582 | 187 | 769 | 176 | 168 | 344 | (16)% | (12)% | ||||||||||||||||||||||||||||||||||||||||
Sustiva Franchise (b) | 251 | 275 | 526 | 259 | 785 | 307 | 1,092 | 228 | 266 | 494 | (3)% | (6)% | ||||||||||||||||||||||||||||||||||||||||
Oncology | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Erbitux | 158 | 168 | 326 | 180 | 506 | 176 | 682 | 158 | 178 | 336 | 6% | 3% | ||||||||||||||||||||||||||||||||||||||||
Sprycel | 115 | 135 | 250 | 134 | 384 | 157 | 541 | 145 | 163 | 308 | 21% | 23% | ||||||||||||||||||||||||||||||||||||||||
Yervoy (c) | 159 | 140 | 299 | 130 | 429 | 148 | 577 | 146 | 173 | 319 | 24% | 7% | ||||||||||||||||||||||||||||||||||||||||
Neuroscience | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Abilify | 328 | 378 | 706 | 378 | 1,084 | 435 | 1,519 | 325 | 417 | 742 | 10% | 5% | ||||||||||||||||||||||||||||||||||||||||
Immunoscience | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Orencia (d) | 214 | 238 | 452 | 246 | 698 | 256 | 954 | 229 | 254 | 483 | 7% | 7% | ||||||||||||||||||||||||||||||||||||||||
Cardiovascular | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Eliquis | 17 | 5 | 22 | 27 | 49 | 48 | 97 | 61 | 94 | 155 | ** | ** | ||||||||||||||||||||||||||||||||||||||||
Diabetes Alliance (e) | 292 | 320 | 612 | 308 | 920 | 322 | 1,242 | 114 | — | 114 | (100)% | (81)% | ||||||||||||||||||||||||||||||||||||||||
Mature Products and All Other (f) | 176 | 113 | 289 | 119 | 408 | 148 | 556 | 113 | 104 | 217 | (8)% | (25)% | ||||||||||||||||||||||||||||||||||||||||
Total Excluding Diabetes Alliance | 1,679 | 1,725 | 3,404 | 1,729 | 5,133 | 1,943 | 7,076 | 1,651 | 1,901 | 3,552 | 10% | 4% |
** | In excess of 100% |
(a) | Domestic revenues include United States and Puerto Rico. |
(b) | The Sustiva Franchise includes sales of Sustiva, as well as revenue from sales of bulk efavirenz included in the combination therapy, Atripla. |
(c) | Six months ended June 30, 2013 includes $25 million of net sales that were previously deferred until sufficient historical experience to estimate sales returns was developed. The following table provides a reconciliation of the net impact of reversal of previously deferred net sales. |
2014 | 2013 | % Change | |||||||
2nd Qtr | 6 Months | 2nd Qtr | 6 Months | Qtr vs. Qtr | YTD vs. YTD | ||||
Yervoy Revenues As Reported | 173 | 319 | 140 | 299 | 24% | 7% | |||
Reversal of deferred revenues, net | — | — | — | (25) | — | (100)% | |||
Yervoy Revenues - Adjusted | 173 | 319 | 140 | 274 | 24% | 16% | |||
(d) | Includes Orencia SubQ revenues of $105M and $82M for three months ended June 30, 2014 and 2013, respectively, and $198M and $153M for the six months ended June 30, 2014 and 2013, respectively. |
(e) | Includes Bydureon, Byetta, Farxiga, Onglyza/Kombiglyze and Symlin and Myalept. |
(f) | Represents all other products sold in the U.S., including those which have lost exclusivity in major markets. |
2013 | 2014 | % 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 | |||||||||||||||||||||||||||||||||||||||
TOTAL | $ | 1,860 | $ | 2,003 | $ | 3,863 | $ | 2,028 | $ | 5,891 | $ | 2,176 | $ | 8,067 | $ | 2,046 | $ | 1,988 | $ | 4,034 | (1)% | 4% | — | (1)% | ||||||||||||||||||||||||||||||||
Virology | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baraclude | 298 | 298 | 596 | 311 | 907 | 331 | 1,238 | 336 | 285 | 621 | (4)% | 4% | 1% | (1)% | ||||||||||||||||||||||||||||||||||||||||||
Reyataz | 168 | 231 | 399 | 186 | 585 | 197 | 782 | 168 | 194 | 362 | (16)% | (9)% | (1)% | (2)% | ||||||||||||||||||||||||||||||||||||||||||
Sustiva Franchise(a) | 136 | 136 | 272 | 130 | 402 | 120 | 522 | 91 | 95 | 186 | (30)% | (32)% | 3% | 2% | ||||||||||||||||||||||||||||||||||||||||||
Oncology | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Erbitux | 4 | 3 | 7 | 3 | 10 | 4 | 14 | 11 | 8 | 19 | ** | ** | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||
Sprycel | 172 | 177 | 349 | 182 | 531 | 208 | 739 | 197 | 205 | 402 | 16% | 15% | (1)% | (3)% | ||||||||||||||||||||||||||||||||||||||||||
Yervoy | 70 | 93 | 163 | 108 | 271 | 112 | 383 | 125 | 148 | 273 | 59% | 67% | 3% | 2% | ||||||||||||||||||||||||||||||||||||||||||
Neuroscience | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Abilify (b) | 194 | 185 | 379 | 191 | 570 | 200 | 770 | 215 | 138 | 353 | (25)% | (7)% | 2% | 2% | ||||||||||||||||||||||||||||||||||||||||||
Immunoscience | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Orencia | 106 | 114 | 220 | 129 | 349 | 141 | 490 | 134 | 148 | 282 | 30% | 28% | (3)% | (5)% | ||||||||||||||||||||||||||||||||||||||||||
Cardiovascular | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Eliquis | 5 | 7 | 12 | 14 | 26 | 23 | 49 | 45 | 77 | 122 | ** | ** | N/A | N/A | ||||||||||||||||||||||||||||||||||||||||||
Diabetes Alliance (c) | 66 | 118 | 184 | 124 | 308 | 133 | 441 | 65 | 27 | 92 | (77)% | (50)% | — | — | ||||||||||||||||||||||||||||||||||||||||||
Mature Products and All Other (d) | 641 | 641 | 1,282 | 650 | 1,932 | 707 | 2,639 | 659 | 663 | 1,322 | 3% | 3% | 1% | — | ||||||||||||||||||||||||||||||||||||||||||
Total Excluding Diabetes Alliance | 1,794 | 1,885 | 3,679 | 1,904 | 5,583 | 2,043 | 7,626 | 1,981 | 1,961 | 3,942 | 4% | 7% | 1% | — |
** | In excess of 100% |
(a) | The Sustiva Franchise includes sales of Sustiva and revenue from sales of bulk efavirenz included in the combination therapy, Atripla. |
(b) | Includes revenue from the co-promotional agreement with Otsuka Pharmaceutical Co., Ltd. |
(c) | Includes Bydureon, Byetta, Forxiga/Xigduo, Onglyza/Kombiglyze, Symlin and Myalept. |
(d) | Represents all other products, including those which have lost exclusivity in major markets, over the counter brands and royalty-related revenue. |
2013 | 2014 | |||||||||||||||||||||||||||||||||||||||||||||||
1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | 1st Qtr | 2nd Qtr | 6 Months | 3rd Qtr | 9 Months | 4th Qtr | Year | |||||||||||||||||||||||||||||||||||
Gross Profit | $ | 2,768 | $ | 2,940 | $ | 5,708 | $ | 2,890 | $ | 8,598 | $ | 3,168 | $ | 11,766 | $ | 2,843 | $ | 2,898 | $ | 5,741 | ||||||||||||||||||||||||||||
Specified items (a) | 85 | 70 | 155 | 69 | 224 | 102 | 326 | 45 | 39 | 84 | ||||||||||||||||||||||||||||||||||||||
Gross profit excluding specified items | 2,853 | 3,010 | 5,863 | 2,959 | 8,822 | 3,270 | 12,092 | 2,888 | 2,937 | 5,825 | ||||||||||||||||||||||||||||||||||||||
Marketing, selling and administrative | 994 | 1,042 | 2,036 | 980 | 3,016 | 1,068 | 4,084 | 957 | 951 | 1,908 | ||||||||||||||||||||||||||||||||||||||
Specified items (a) | (1 | ) | (1 | ) | (2 | ) | (4 | ) | (6 | ) | (10 | ) | (16 | ) | (3 | ) | (3 | ) | (6 | ) | ||||||||||||||||||||||||||||
Marketing, selling and administrative excluding specified items | 993 | 1,041 | 2,034 | 976 | 3,010 | 1,058 | 4,068 | 954 | 948 | 1,902 | ||||||||||||||||||||||||||||||||||||||
Research and development | 930 | 951 | 1,881 | 893 | 2,774 | 957 | 3,731 | 946 | 1,416 | 2,362 | ||||||||||||||||||||||||||||||||||||||
Specified items (a) | — | — | — | — | — | (16 | ) | (16 | ) | (48 | ) | (458 | ) | (506 | ) | |||||||||||||||||||||||||||||||||
Research and development excluding specified items | 930 | 951 | 1,881 | 893 | 2,774 | 941 | 3,715 | 898 | 958 | 1,856 | ||||||||||||||||||||||||||||||||||||||
Other (income)/expense | (19 | ) | 199 | 180 | 5 | 185 | 20 | 205 | (208 | ) | (104 | ) | (312 | ) | ||||||||||||||||||||||||||||||||||
Specified items (a) | (19 | ) | (239 | ) | (258 | ) | (43 | ) | (301 | ) | (39 | ) | (340 | ) | 88 | (67 | ) | 21 | ||||||||||||||||||||||||||||||
Other (income)/expense excluding specified items | (38 | ) | (40 | ) | (78 | ) | (38 | ) | (116 | ) | (19 | ) | (135 | ) | (120 | ) | (171 | ) | (291 | ) | ||||||||||||||||||||||||||||
Effective Tax Rate | 7.6 | % | — | 4.2 | % | 15.4 | % | 8.8 | % | 15.4 | % | 10.8 | % | 5.0 | % | 25.4 | % | 11.4 | % | |||||||||||||||||||||||||||||
Specified items (a) | 3.4 | % | 13.8 | % | 8.3 | % | 2.4 | % | 5.6 | % | 2.5 | % | 4.6 | % | 18.0 | % | (4.1 | )% | 10.7 | % | ||||||||||||||||||||||||||||
Effective Tax Rate excluding specified items | 11.0 | % | 13.8 | % | 12.5 | % | 17.8 | % | 14.4 | % | 17.9 | % | 15.4 | % | 23.0 | % | 21.3 | % | 22.1 | % |
(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. |
2013 | 2014 | |||||||||||||||||||||||||||||||||||||||||||||||
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 | |||||||||||||||||||||||||||||||||||
Accelerated depreciation, asset impairment and other shutdown costs | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 36 | $ | 36 | $ | 45 | $ | 39 | $ | 84 | ||||||||||||||||||||||||||||
Amortization of acquired Amylin intangible assets | 138 | 137 | 275 | 137 | 412 | 137 | 549 | — | — | — | ||||||||||||||||||||||||||||||||||||||
Amortization of Amylin alliance proceeds | (67 | ) | (67 | ) | (134 | ) | (68 | ) | (202 | ) | (71 | ) | (273 | ) | — | — | — | |||||||||||||||||||||||||||||||
Amortization of Amylin inventory adjustment | 14 | — | 14 | — | 14 | — | 14 | — | — | — | ||||||||||||||||||||||||||||||||||||||
Cost of products sold | 85 | 70 | 155 | 69 | 224 | 102 | 326 | 45 | 39 | 84 | ||||||||||||||||||||||||||||||||||||||
Marketing, selling and administrative* | 1 | 1 | 2 | 4 | 6 | 10 | 16 | 3 | 3 | 6 | ||||||||||||||||||||||||||||||||||||||
Upfront, milestone and other payments | — | — | — | — | — | 16 | 16 | 15 | 148 | 163 | ||||||||||||||||||||||||||||||||||||||
IPRD impairments | — | — | — | — | — | — | — | 33 | 310 | 343 | ||||||||||||||||||||||||||||||||||||||
Research and development | — | — | — | — | — | 16 | 16 | 48 | 458 | 506 | ||||||||||||||||||||||||||||||||||||||
Provision for restructuring | 33 | 173 | 206 | 6 | 212 | 14 | 226 | 21 | 16 | 37 | ||||||||||||||||||||||||||||||||||||||
Gain on sale of product lines, businesses and assets | — | — | — | — | — | — | — | (259 | ) | 12 | (247 | ) | ||||||||||||||||||||||||||||||||||||
Pension curtailments, settlements and special termination benefits | — | 99 | 99 | 37 | 136 | 25 | 161 | 64 | 45 | 109 | ||||||||||||||||||||||||||||||||||||||
Acquisition and alliance related items | — | (10 | ) | (10 | ) | — | (10 | ) | — | (10 | ) | 16 | 17 | 33 | ||||||||||||||||||||||||||||||||||
Litigation charges/(recoveries) | — | (23 | ) | (23 | ) | — | (23 | ) | — | (23 | ) | 25 | (23 | ) | 2 | |||||||||||||||||||||||||||||||||
Loss on debt redemption | — | — | — | — | — | — | — | 45 | — | 45 | ||||||||||||||||||||||||||||||||||||||
Upfront, milestone and other licensing receipts | (14 | ) | — | (14 | ) | — | (14 | ) | — | (14 | ) | — | — | — | ||||||||||||||||||||||||||||||||||
Other (income)/expense | 19 | 239 | 258 | 43 | 301 | 39 | 340 | (88 | ) | 67 | (21 | ) | ||||||||||||||||||||||||||||||||||||
Increase to pretax income | 105 | 310 | 415 | 116 | 531 | 167 | 698 | 8 | 567 | 575 | ||||||||||||||||||||||||||||||||||||||
Income tax on items above | (35 | ) | (116 | ) | (151 | ) | (40 | ) | (191 | ) | (51 | ) | (242 | ) | (179 | ) | (102 | ) | (281 | ) | ||||||||||||||||||||||||||||
Increase/(decrease) to net earnings | $ | 70 | $ | 194 | $ | 264 | $ | 76 | $ | 340 | $ | 116 | $ | 456 | $ | (171 | ) | $ | 465 | $ | 294 |
* Specified items in marketing, selling and administrative are process standardization implementation costs. |
March 31, 2013 | June 30, 2013 | September 30, 2013 | December 31, 2013 | March 31, 2014 | June 30, 2014 | September 30, 2014 | December 31, 2014 | |||||||||||||||||||||
Cash and cash equivalents | $ | 1,355 | $ | 1,821 | $ | 1,771 | $ | 3,586 | $ | 5,225 | $ | 4,282 | ||||||||||||||||
Marketable securities - current | 1,178 | 978 | 951 | 939 | 1,834 | 2,893 | ||||||||||||||||||||||
Marketable securities - long term | 3,242 | 3,223 | 3,623 | 3,747 | 3,558 | 3,876 | ||||||||||||||||||||||
Cash, cash equivalents and marketable securities | 5,775 | 6,022 | 6,345 | 8,272 | 10,617 | 11,051 | ||||||||||||||||||||||
Short-term borrowings and current portion of long-term debt | (1,372 | ) | (764 | ) | (680 | ) | (359 | ) | (281 | ) | (365 | ) | ||||||||||||||||
Long-term debt | (6,522 | ) | (6,442 | ) | (6,532 | ) | (7,981 | ) | (7,367 | ) | (7,372 | ) | ||||||||||||||||
Net cash/(debt) position | $ | (2,119 | ) | $ | (1,184 | ) | $ | (867 | ) | $ | (68 | ) | $ | 2,969 | $ | 3,314 |
Full Year 2014 | ||
Projected Diluted Earnings Attributable to Shareholders per Common Share - GAAP | $1.50 to $1.60 | |
Projected Specified Items: | ||
Downsizing and streamlining of worldwide operations | 0.18 | |
Upfront and milestone payments, net | 0.13 | |
Gain on diabetes business divestiture and other related impacts | (0.28 | ) |
Pension settlements | 0.06 | |
Impairment Charges | 0.13 | |
Other | (0.02 | ) |
Total | 0.20 | |
Projected Diluted Earnings Attributable to Shareholders per Common Share - Non-GAAP | $1.70 to $1.80 |
Gross margin as a percentage of revenues on a GAAP and non-GAAP basis for the six months ended June 30, 2014 was 74.6% and 75.6%, respectively. On a non-GAAP basis, the Company projects gross margin as a percentage of revenues for the full year 2014 between 75% and 76%. There is no reliable comparable GAAP measure for this forward-looking information on gross margin. See "—Reconciliation of GAAP and non-GAAP Growth Dollars and Percentages Excluding Foreign Exchange Impact". | |||||||||
Research and development expenses on a GAAP and non-GAAP basis for the six months ended June 30, 2014 were $2.4 billion and $1.9 billion, respectively. On a non-GAAP basis, the Company projects research and development expense for the full year 2014 to grow in the mid single digit range compared to 2013. It is estimated that 30% to 45% of the research and development expenses in 2014 will be incurred on late-stage development programs. There is no reliable comparable GAAP measure for this forward-looking information on research and development. See "—Reconciliation of Certain non-GAAP Line Items to Certain GAAP Line Items". | |||||||||
Marketing, selling and administrative expenses on a GAAP and non-GAAP basis for the six months ended June 30, 2014 were $1.9 billion. On a GAAP basis, expenses for the six months ended June 30, 2014 included specified items of $6 million. On a non-GAAP basis, the Company projects marketing, selling and administrative expenses for the full year 2014 to decrease in the mid single digit range compared to 2013. There is no reliable comparable GAAP measure for this forward-looking information on marketing, selling and administrative expense. See "—Reconciliation of Certain non-GAAP Line Items to Certain GAAP Line Items". | |||||||||
The effective tax rate on a GAAP basis for the six months ended June 30, 2014 was 11.4%. On a non-GAAP basis, for the six months ended June 30, 2014 the effective tax rate was 22.1%. On a non-GAAP basis, the Company projects an annual effective tax rate of approximately 18%. 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 2014 will include specified items, including gains on divestitures, expected charges associated with downsizing and streamlining worldwide operations, asset impairments, milestone payments, restructuring, charges and recoveries relating to significant legal proceedings, and pension settlements. The GAAP financial results for the full year 2014 could also include other specified items that have not yet been identified and quantified, including any gains or losses from acquisitions or divestitures, additional upfront, milestone and other licensing payments, charges for in-process research and development 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 Second Quarter 2014 Financial Results, July 24, 2014 including “2014 Financial Guidance” and “Use of non-GAAP Financial Information” therein. | |||||||||
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