Bristol-Myers Squibb Delivers Solid Fourth Quarter Capping A Year Highlighted By New Product Approvals, Continued Execution Of Strategic Transactions And Good Operating Performance

Bristol-Myers Squibb Company (NYSE: BMY) today announced solid financial results for the fourth quarter of 2011. This concludes a year in which the Company received important new product approvals for YERVOY® and NULOJIX® in both the U.S. and Europe, and ELIQUIS ^® in Europe for the prevention of venous thromboembolic events. Business development remained a top priority as the Company executed twelve strategic transactions in 2011, and announced the planned acquisition of Inhibitex earlier this month. These accomplishments, along with the dividend increase and ongoing share repurchase program, demonstrated the Company’s commitment to driving shareholder value in 2011.

“In the fourth quarter, we delivered solid financial results, concluding a very good year that sets the foundation for the long-term growth of the company,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “Our delivery of several important new products to patients, the ability of our productive R&D organization to build an innovative and diverse pipeline, and our continued commitment to business development gives us confidence in our future. In 2012, we will build on the momentum of 2011 as we transition beyond the loss of exclusivity of PLAVIX® and AVAPRO®,” Andreotti said.

				Fourth Quarter
$ amounts in millions, except per share amounts
					2011			2010		Change
Net Sales				$	5,454		$	5,111		7	%
GAAP Diluted EPS					0.50			0.28		79	%
Non-GAAP Diluted EPS					0.53			0.47		13	%
				Full Year
$ amounts in millions, except per share amounts
					2011			2010		Change
Net Sales				$	21,244		$	19,484		9	%
GAAP Diluted EPS					2.16			1.79		21	%
Non-GAAP Diluted EPS					2.28			2.16		6	%

FOURTH QUARTER FINANCIAL RESULTS

• Bristol-Myers Squibb posted fourth quarter 2011 net sales of $5.5 billion, an increase of 7% compared to the same period a year ago.
• U.S. net sales increased 8% to $3.6 billion in the quarter compared to the same period a year ago. International net sales increased 4% to $1.9 billion.
• Gross margin as a percentage of net sales was 74.9% in the quarter compared to 72.3% in the same period a year ago.
• Marketing, selling and administrative expenses increased 22% to $1.2 billion in the quarter.
• Advertising and product promotion spending increased 5% to $285 million in the quarter.
• Research and development expenses remained flat at $1.0 billion in the quarter.
• The effective tax rate on earnings before income taxes was 22.8% in the quarter, compared to 40.4% in the fourth quarter last year.
• The Company reported net earnings attributable to Bristol-Myers Squibb of $852 million, or $0.50 per share, in the quarter compared to $483 million, or $0.28 per share, a year ago.
• The Company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $906 million, or $0.53 per share, in the fourth quarter, compared to $807 million, or $0.47 per share, for the same period in 2010. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section.
• The incremental impact in 2011 over 2010 of the two additional U.S. health care reform provisions for new discounts associated with the Medicare Part D coverage gap and the annual pharmaceutical company fee decreased fourth-quarter EPS by approximately $0.04.
• Cash, cash equivalents and marketable securities were $11.6 billion, with a net cash position of $6.2 billion, as of December 31, 2011.

FOURTH QUARTER PRODUCT AND PIPELINE UPDATE

• Bristol-Myers Squibb’s global sales growth in the fourth quarter was led by ONGLYZA®/ KOMBIGLYZE™, which had sales growth of 110%, SPRYCEL®, which grew 34%, ORENCIA ®, which grew 27%, BARACLUDE®, which grew 20% and YERVOY ^®, which had sales of $144 million in the quarter.

Dapagliflozin

• In November, at the American Heart Association (AHA) Scientific Session in Orlando, Florida, the Company and its partner, AstraZeneca, presented results from a meta-analysis of clinical data on the cardiovascular safety of dapagliflozin in adult patients with type 2 diabetes that showed dapagliflozin was not associated with an unacceptable increase in cardiovascular risk relative to all comparators pooled in the clinical program.
• In December, at the International Diabetes Federation 2011 World Diabetes Congress in Dubai, United Arab Emirates, the companies presented results from a Phase III trial evaluating dapagliflozin that showed reductions in blood sugar levels seen at 24 weeks with dapagliflozin added to existing glimepiride therapy were maintained at 48 weeks in adults with type 2 diabetes.
• In January 2012, the companies announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application for dapagliflozin for the treatment of adults with type 2 diabetes. The letter requested additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. The companies will work closely with the FDA to determine the appropriate next steps for the dapagliflozin application, and are in ongoing discussions with health authorities in Europe and other countries as part of the application procedures.

ELIQUIS ^®

• In November, the Company and its partner, Pfizer, announced that the FDA accepted for review the New Drug Application for ELIQUIS ^® for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The Prescription Drug User Fee Act (PDUFA)—the date by which action by the FDA is expected—is March 28, 2012.
• In November, at the AHA, the companies presented new data from a Phase III trial of ELIQUIS ^® for the prevention of venous thromboembolism (VTE) in patients with acute medical illness that showed ELIQUIS ^® did not meet the primary efficacy outcome of superiority to enoxaparin for the prevention of VTE and VTE-related death. The data was also published in the New England Journal of Medicine.

ONGLYZA ^® and KOMBOGLYZE™

• In November, the Company and its partner, AstraZeneca, announced that the European Commission approved ONGLYZA ^® for use as a combination therapy with insulin (with or without metformin) to improve blood sugar control in adult patients with type 2 diabetes. In December, the FDA also approved ONGLYZA ^® for the same indication.
• In November, the companies announced that the European Commission approved KOMBOGLYZE ^™, a fixed dose combination of ONGLYZA ^® and metformin, for the treatment of adults with type 2 diabetes.

ERBITUX ^®

• In November, the Company and its partner, Eli Lilly, announced that the FDA approved ERBITUX® in combination with platinum-based chemotherapy with 5-fluorouracil, for the first-line treatment of recurrent locoregional or metastatic squamous cell carcinoma of the head and neck.

ORENCIA ^®

• In November, at the American College of Rheumatology Annual Scientific Meeting in Chicago, the Company presented new data on ORENCIA ^® from clinical trials that support the recent FDA approval of the subcutaneous formulation of ORENCIA ^® for the reduction of signs and symptoms in adults with moderate to severe rheumatoid arthritis. Other data presented on ORENCIA ^® included long-term immunogenicity data on the intravenous formulation, long-term safety data in rheumatoid arthritis, and results from a Phase II/III study in lupus nephritis.

BARACLUDE ^®

• In November, at the American Association for the Study of Liver Diseases (AASLD) in San Francisco, the Company presented results from a Phase IIIb study comparing BARACLUDE ^® monotherapy versus BARACLUDE ^® plus tenofovir in combination that showed no statistical difference between the study arms.

Brivanib

• In December, the Company reported that the Phase III study of brivanib in patients with hepatocellular carcinoma (HCC) who failed or are intolerant to sorafenib did not meet the primary endpoint of improving overall survival versus placebo. Results will be presented at an upcoming scientific meeting. The study is one of four Phase III clinical trials evaluating brivanib in different HCC patient populations.

Investigational Hepatitis C (HCV) Portfolio

• In November, at AASLD, the Company presented results from a ten patient cohort of an ongoing Phase II study evaluating the combination of two of the Company’s direct-acting antivirals that suggested sustained virologic response (SVR) can be achieved with the combination of daclatasvir (BMS-790052) and asunaprevir (BMS-650032) in patients with HCV genotype 1b who were null responders.
• In January 2012, the New England Journal of Medicine published the full results from a Phase II clinical trial in patients with HCV genotype 1 who were null responders that showed the achievement of SVR 12-weeks post-treatment is possible with a direct-acting antiviral-only combination containing daclatasvir and asunaprevir.

FOURTH QUARTER BUSINESS DEVELOPMENT UPDATE

• In November, the Company and Pharmasset announced the addition of four treatment arms to the ongoing Phase IIa trial evaluating the combination of Pharmasset’s PSI-7977, a nucleotide polymerase inhibitor, and Bristol-Myers Squibb’s daclatasvir (BMS-790052), an investigational NS5A replication complex inhibitor, for the treatment of HCV. This trial is the result of a clinical collaboration agreement between Pharmasset and Bristol-Myers Squibb announced in January 2011. The acquisition of Pharmasset by Gilead Sciences was completed in January 2012.
• In November, the Company entered an agreement with ASLAN Pharmaceuticals, headquartered in Singapore, under its Project Oyster strategy to develop BMS-777607, Bristol-Myers Squibb’s investigational small molecule inhibitor of the MET receptor tyrosine kinase, for the treatment of solid tumors.
• In December, the Company entered into a clinical collaboration agreement with Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical Companies, to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals' investigational NS3 protease inhibitor, TMC435, for the treatment of HCV.
• In December, the Company entered an agreement with Simcere Pharmaceutical Group under its Project Oyster strategy to co-develop BMS-795311, Bristol-Myers Squibb’s preclinical small molecule inhibitor of the Cholesteryl Ester Transfer Protein (CETP). Inhibiting CETP could potentially raise HDL (good cholesterol) levels and help prevent cardiovascular disease.
• In December, the Company and the Gladstone Institutes announced the formation of a discovery-based research collaboration to identify and validate novel targets in Alzheimer’s disease.
• In January 2012, the Company announced its intention to acquire Inhibitex, Inc., a clinical-stage biopharmaceutical company whose primary focus is on the development of innovative products that can treat or prevent serious infections, most notably nucleotide/nucleoside analogs for the treatment of HCV, like its lead asset INX-189. A cash tender offer at $26.00 per share began January 13, 2012.

2012 FINANCIAL GUIDANCE

Bristol-Myers Squibb is setting its 2012 GAAP and non-GAAP EPS guidance range from $1.90 to $2.00. Both GAAP and non-GAAP guidance assume current exchange rates. Key 2012 non-GAAP guidance assumptions include:

• Worldwide sales between $17.2 billion and $18.2 billion. This assumes full-year 2012 worldwide sales of PLAVIX ^® will be approximately $2.7 billion.
• Full-year gross margin as a percentage of sales being consistent with last year.
• Advertising and promotion expense decreasing in the mid-teens range.
• Marketing, sales and administrative expenses decreasing in the mid-single-digit range.
• Research and development expenses growing in the low-single-digit range.
• An effective tax rate between 25% and 26%.

It is estimated that 30% to 40% of the research and development expenses in 2012 will be incurred on late-stage development programs. Total research and development expenses include the costs of discovery research, preclinical development, early- and late-clinical development and drug formulation, as well as clinical trials and medical support of marketed products, proportionate allocations of enterprise-wide costs, and other appropriate costs. Late-stage development expenses refer to our investigational compounds that are in Phase III clinical development and our marketed products that are in Phase III development for additional indications or formulations.