|$ amounts in millions, except per share amounts|
|GAAP Diluted EPS||0.44||0.56||(21||)%|
|Non-GAAP Diluted EPS||0.51||0.47||9||%|
|$ amounts in millions, except per share amounts|
|GAAP Diluted EPS||1.54||1.16||33||%|
|Non-GAAP Diluted EPS||1.82||1.99||(9||)%|
- Bristol-Myers Squibb posted fourth quarter 2013 revenues of $4.4 billion, an increase of 6% compared to the same period a year ago.
- U.S. revenues increased 1% to $2.3 billion in the quarter compared to the same period a year ago. International revenues increased 11% to $2.2 billion.
- Gross margin as a percentage of revenues was 71.3% in the quarter compared to 74.3% in the same period a year ago.
- Marketing, selling and administrative expenses decreased 7% to $1.1 billion in the quarter.
- Advertising and product promotion spending increased 20% to $254 million in the quarter.
- Research and development expenses decreased 12% to $957 million in the quarter.
- The effective tax rate on earnings before income taxes was 15.4% in the quarter, compared to a tax benefit rate of 80.1% in the fourth quarter last year attributed to a capital loss deduction in the quarter.
- The company reported net earnings attributable to Bristol-Myers Squibb of $726 million, or $0.44 per share, in the quarter compared to $925 million, or $0.56 per share, a year ago.
- The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $842 million, or $0.51 per share, in the fourth quarter, compared to $777 million, or $0.47 per share, for the same period in 2012. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section.
- Cash, cash equivalents and marketable securities were $8.3 billion, with a net debt position of $68 million, as of December 31, 2013.
- In January, the company and its partner, AstraZeneca, announced that the U.S. Food and Drug Administration (FDA) approved Farxiga, a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Farxiga is marketed as Forxiga outside the United States.
- In January, the company and its partner, AstraZeneca, announced that Xigduo (dapagliflozin and metformin hydrochloride) was granted Marketing Authorization by the European Commission for the treatment of type 2 diabetes in the European Union (EU). Xigduo combines dapagliflozin (trade name Forxiga), a selective and reversible inhibitor of SGLT2 with metformin hydrochloride, two anti-hyperglycemic products with complementary mechanisms of action to improve glycemic control, in a twice daily tablet.
- In December, the company and its partner, Pfizer, announced that the FDA has accepted for review a Supplemental New Drug Application for Eliquis for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the reduction in the risk of recurrent DVT and PE. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is August 25, 2014.
- In December, the company and its partner Pfizer, also announced that in November 2013, the European Medicines Agency (EMA) accepted for review an application for Eliquis for the treatment of DVT and PE, and prevention of recurrent DVT and PE.
- In December, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended the investigational medicine metreleptin for the treatment of pediatric and adult patients with generalized lipodystrophy. The EMDAC did not recommend metreleptin in patients with partial lipodystrophy. The FDA is not bound by the EMDAC’s recommendation but will take it into consideration when reviewing the Biologics License Application for metreleptin. The PDUFA goal date for metreleptin is February 24, 2014.
- In November, the European Commission approved an expanded indication for Yervoy for the first-line treatment of adult patients with advanced (unresectable or metastatic) melanoma. The expanded indication applies to all 28 European Union member states as well as Iceland and Norway.
- In January, the company announced that the EMA validated the company’s marketing authorization application for daclatasvir, an investigational NS5A complex inhibitor, to treat adults with chronic hepatitis C with compensated liver disease, including genotypes 1, 2, 3, and 4. The application seeks approval to use daclatasvir in combination with other agents, including sofosbuvir, to treat chronic hepatitis C. The validation marks the start of an accelerated regulatory review process for daclatasvir, which has the potential, when used in combination with other agents, to address a high unmet need in the European Union where an estimated 9 million people are living with hepatitis C.
- In November, the company announced it had submitted a New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency seeking approval for the world’s first interferon-free and ribavirin-free treatment regimen for patients with chronic hepatitis C. The submission is based on results from a Phase III study demonstrating that the 24-week, all-oral, interferon-free and ribavirin-free regimen of daclatasvir and asunaprevir achieved an overall sustained virologic response 24 weeks after the end of treatment of 84.7% in Japanese patients with chronic hepatitis C genotype 1b who were either interferon-ineligible/intolerant or non-responders to interferon-based therapies. These Phase III data were presented in November at the American Association for the Study of Liver Diseases annual meeting in Washington D.C.
- In December, at the American Society of Hematology’s annual meeting in New Orleans, the company and its partner, Otsuka America Pharmaceutical Inc., presented four-year follow-up data from the Phase III DASISION study of Sprycel 100 mg once daily vs. imatinib 400 mg daily in the first-line treatment of adults with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia. At four years, 76% of Sprycel patients vs. 63% of imatinib patients achieved a major molecular response and 84% of Sprycel patients vs. 64% of imatinib patients achieved an optimal molecular response at three months, as defined by treatment guidelines. Patients who achieved this response had improved overall survival vs. those who did not.
- In October, at the World Conference on Lung Cancer in Sydney, Australia, the company presented long-term follow-up results from the lung cancer cohort of an expanded Phase I dose-ranging study of nivolumab, an investigational PD-1 immune checkpoint inhibitor. The results showed sustained activity in heavily pre-treated patients with non-small-cell lung cancer as defined by one- and two-year survival rates of 42% and 24%, respectively, across dose cohorts. The spectrum, frequency and severity of treatment-related adverse events were consistent with those initially reported for nivolumab.
- In October, at the American College of Rheumatology’s annual meeting in San Diego, the company and its partner, Alder Biopharmaceuticals, presented efficacy and safety data from a Phase IIb dose-ranging study of subcutaneous clazakizumab in adults with moderate-to-severe rheumatoid arthritis and an inadequate response to methotrexate. Clazakizumab is a humanized anti-IL-6 monoclonal antibody that is directed against the IL-6 cytokine rather than its receptor. Clazakizumab demonstrated promising rates of low disease activity and remission based on DAS28, CDAI and SDAI criteria in the study, which included MTX and anti-TNF comparator arms. The overall safety profile for clazakizumab was consistent with the known pharmacology of IL-6 blockade.