Bristol-Myers Squibb Company (NYSE: BMY) today announced results for the fourth quarter of 2012 highlighted by regulatory approvals for Eliquis® and Forxiga ®. This concluded a year in which the Company delivered growth of its key products as it transitioned to its promising future portfolio. In addition, the company provided financial guidance for 2013.
“With regulatory approvals for Eliquis and Forxiga, and good operating performance in the fourth quarter, Bristol-Myers Squibb had a strong finish to an important year of transition,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “In 2012 we continued to effectively execute our strategy, and continued to build the post- Plavix portfolio and operating structure that provide a solid foundation for our future growth. As we begin 2013, I am looking forward to our many opportunities, including the growth of the existing key brands, the execution of the new launches, and the continued delivery of a diverse and sustainable R&D pipeline.”
|$ amounts in millions, except per share amounts|
|GAAP Diluted EPS||0.56||0.50||12%|
|Non-GAAP Diluted EPS||0.47||0.53||(11)%|
|$ amounts in millions, except per share amounts|
|GAAP Diluted EPS||1.16||2.16||(46)%|
|Non-GAAP Diluted EPS||1.99||2.28||(13)%|
FOURTH QUARTER FINANCIAL RESULTS
- Bristol-Myers Squibb posted fourth quarter 2012 net sales of $4.2 billion, a decrease of 23% compared to the same period a year ago, following the U.S. patent expiration of Avapro ® /Avalide ® in March 2012 and Plavix ® in May 2012. Excluding Plavix and Avapro/Avalide, net sales grew by 13% compared to the fourth quarter of 2011.
- U.S. net sales decreased 38% to $2.2 billion in the quarter, compared to the same period a year ago. International net sales increased 6% to $2.0 billion.
- Gross margin as a percentage of net sales was 74.3% in the quarter, compared to 74.9% in the same period a year ago.
- Marketing, selling and administrative expenses decreased 6% to $1.1 billion in the quarter.
- Advertising and product promotion spending decreased 26% to $212 million in the quarter.
- Research and development expenses increased 7% to $1.1 billion in the quarter.
- The Company reported an overall tax benefit rate of 80.1% attributed to a capital loss deduction in the quarter. The effective tax rate on earnings before income taxes was 22.8% in the fourth quarter last year.
- The Company reported net earnings attributable to Bristol-Myers Squibb of $925 million, or $0.56 per share, in the quarter compared to $852 million, or $0.50 per share, a year ago.
- The Company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $777 million, or $0.47 per share, in the fourth quarter, compared to $906 million, or $0.53 per share, for the same period in 2011. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section.
- Cash, cash equivalents and marketable securities were $6.4 billion, with a net debt position of $1.0 billion, as of December 31, 2012.
FOURTH QUARTER PRODUCT AND PIPELINE UPDATEBristol-Myers Squibb’s global sales in the fourth quarter included Orencia®, which grew 26%, Yervoy®, which grew 47%, Sprycel®, which grew 24%, Onglyza® /Kombiglyze ™ , which grew 29%, and Baraclude ® , which grew 13%. Eliquis
- In December, the U.S. Food and Drug Administration (FDA) approved Eliquis to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis also received regulatory approval for this indication in Japan and Canada in December, in Europe in November, and in South Korea in January. The Company co-develops and co-commercializes Eliquis with its partner, Pfizer.
- In December, at the 54 th Annual Meeting of the American Society of Hematology in Atlanta, results of the Phase III AMPLIFY-EXT trial were announced in which Eliquis demonstrated superiority versus placebo in reducing symptomatic, recurrent venous thromboembolism and all-cause death versus placebo without increasing the rate of major bleeding during one year of extended treatment. The data were also published in The New England Journal of Medicine.
- In November, the European Commission approved Forxiga for the treatment of type 2 diabetes in the European Union. The Company co-develops and co-commercializes Forxiga with its partner, AstraZeneca.
- In November, at the 2012 American College of Rheumatology Annual Scientific Meeting in Washington, D.C., results were presented showing the subcutaneous formulation of Orencia, on a background of methotrexate (MTX), was similar to Humira ® (adalimumab) plus MTX in demonstrating clinical improvements in patient-reported outcomes that were sustained for one year among adults with moderate to severe rheumatoid arthritis.
- In December, at the 54 th Annual Meeting of the American Society of Hematology in Atlanta, the Company and its partner, Abbott, presented encouraging results from a small, randomized, Phase II open-label study of patients with previously treated multiple myeloma which showed that in patients treated with elotuzumab 10mg/kg plus lenalidomide and low-dose dexamethasone progression-free survival was not reached after 20.8 months of follow up and the objective response rate was 92%.
- In November, at the American Association for the Study of Liver Diseases congress in Boston, data from several Phase II clinical trials involving various investigational compounds for the treatment of hepatitis C virus (HCV) within the Company’s pipeline were presented, including:
- An investigational treatment regimen of three direct-acting antivirals—daclatasvir, an NS5A replication complex inhibitor, asunaprevir, an NS3 protease inhibitor, and BMS-791325, an NS5B non-nucleoside polymerase inhibitor—achieved sustained virologic response 12 weeks post-treatment in 94 percent of treatment-naïve, genotype 1 chronic HCV patients.
- The investigational dual regimen of daclatasvir and asunaprevir, without interferon or ribavirin, achieved high rates of sustained virologic response 12 weeks post-treatment in patients with genotype 1b hepatitis C virus who were prior null responders to alfa interferon and ribavirin.
|Phase II data on an investigational quadruple therapy regimen combining daclatasvir, asunaprevir, alfa interferon and ribarvirin, and first-time interim Phase IIb results on peginterferon lambda-1a in combination with daclatasvir and ribavirin were also presented.|