• Key Data from Oncology, Diabetes and Cardiovascular Franchises Demonstrate Execution of BioPharma Strategy
• Sales Increase 2% to $4.8 billion in Second Quarter
• GAAP EPS Increases 20% to $0.53 in Second Quarter; Non-GAAP EPS Increases 13% to $0.54
• Confirms 2010 GAAP EPS Guidance Range of $1.84 to $1.94; Non-GAAP EPS Guidance Range of $2.10 to $2.20
• Confirms 2013 Minimum Non-GAAP EPS Guidance of $1.95

NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today reported results for the second quarter of 2010 which featured data on key marketed and investigational compounds in its oncology, diabetes and cardiovascular franchises, and growth in sales and EPS. The company also confirmed guidance for 2010 and minimum guidance for non-GAAP EPS in 2013.

“Our second quarter performance continues to strengthen our confidence in our ability to execute the key elements of our differentiated and focused BioPharma strategy. I am pleased with the progress we are making with our pipeline as it is one of the most important drivers of the long term success of our strategy," said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb.

“We delivered both sales and EPS growth in the quarter, and presented encouraging clinical data from across our portfolio of products. We completed filings in Europe and the U.S. for SPRYCEL^® for first-line treatment of chronic myeloid leukemia, and in Europe for ipilimumab. We announced the commencement of a $3 billion share repurchase program, reflecting our strong cash position and demonstrating our commitment to increasing shareholder value,” Andreotti said.

SECOND QUARTER FINANCIAL RESULTS

• Bristol-Myers Squibb posted second quarter 2010 net sales of $4.8 billion, an increase of 2% compared to the same period in 2009. U.S. Health care reform had a 1.5% negative effect on net sales in the second quarter.
• U.S. net sales increased 4% to $3.1 billion in the second quarter of 2010 compared to the same period in 2009. International net sales decreased 2%, or 3% excluding foreign exchange impact, to $1.7 billion.
• Gross margin as a percentage of net sales was 73.2% in the second quarter 2010 compared to 73.7% in the same period in 2009.
• Marketing, selling and administrative expenses decreased 3% to $894 million in the second quarter of 2010.
• Advertising and product promotion spending decreased by 12% to $263 million in the second quarter of 2010.
• Research and development expenses increased 1% to $822 million in the second quarter of 2010.
• The effective tax rate on earnings from continuing operations before income taxes was 20.4% in the second quarter of 2010, compared to 23.2% in the same period in 2009. The current quarter included a $59 million tax benefit related to an out-of-period adjustment for previously unrecognized deferred tax assets as of December 31, 2009.
• The Company reported second quarter GAAP net earnings from continuing operations of $927 million, or $0.53 per share, compared to $880 million, or $0.44 per share, for the same period in 2009.
• The Company reported second quarter non-GAAP net earnings from continuing operations of $944 million or, $0.54 per share, compared to $966 million, or $0.48 per share, for the same period in 2009. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section.
• The impact of U.S. health care reform decreased second quarter EPS from continuing operations by approximately $0.02 on both a GAAP and non-GAAP basis.
• Cash, cash equivalents and marketable securities were $10.2 billion, resulting in a net cash position of $3.7 billion as of June 30, 2010.

SECOND QUARTER PRODUCT AND PIPELINE UPDATE

• Bristol-Myers Squibb’s global sales growth in the second quarter was led by the Company’s virology franchise and by PLAVIX^®. Sales of BARACLUDE^® rose 25%, REYATAZ^® rose 8%, SUSTIVA^® rose 6% and PLAVIX rose 6%. Second quarter sales of ORENCIA^® and SPRYCEL grew 20% and 23% respectively compared to the same period in 2009.
• At the American Society of Clinical Oncology meeting in June, data were presented on 13 of the Company’s oncology compounds, including:
  • Positive results from a Phase III randomized double blind study of ipilimumab which demonstrated that overall survival was significantly extended in patients with previously-treated metastatic melanoma who received ipilimumab. The results were statistically significant for patients receiving ipilimumab alone or ipilimumab in combination with a gp100 peptide vaccine when compared to those patients who received the control therapy of gp100 alone. The results were published in the New England Journal of Medicine.
  • Positive results from a randomized Phase II study evaluating ipilimumab in combination with standard chemotherapy in previously untreated patients with advanced non-small cell lung cancer.
  • Phase III study results that demonstrated SPRYCEL 100 mg once daily achieved a superior rate of confirmed complete cytogenetic response compared to GLEEVEC^®* as a first-line treatment for patients with chronic phase chronic myeloid leukemia (CML). These results were published in the New England Journal of Medicine. SPRYCEL is being developed in collaboration with Otsuka Pharmaceutical Co.

• In May, the Marketing Authorization Application (MAA) for ipilimumab for metastatic melanoma in pre-treated patients was validated by the European Medicines Agency.
• In April, the Type II Variation submission for SPRYCEL for the treatment of adult patients with newly diagnosed CML in chronic phase was validated by the European Medicines Agency. In July, U.S. Food and Drug Administration (FDA) accepted for priority review the sNDA for SPRYCEL for the treatment of adult patients with newly diagnosed CML in chronic phase. The Prescription Drug User Fee Act (PDUFA) date—the date by which action from the FDA is expected—is October 28, 2010.
• At the American Diabetes Association Annual Scientific Sessions in June:
  • Results from a 76-week Phase III study of ONGLYZA™ as initial combination therapy with metformin were presented. Also presented were results from a 52-week Phase IIIb study in adults with type 2 diabetes who had inadequate glycemic control on metformin therapy plus diet and exercise. This study found that the addition of ONGLYZA 5 mg to existing metformin therapy achieved the primary objective of demonstrating non-inferiority compared to the addition of titrated glipizide, a sulphonylurea, to existing metformin therapy in reducing HbA1c levels. Additionally, the study found that treatment with ONGLYZA 5 mg plus metformin resulted in both statistically significant fewer patients reporting hypoglycemic events and statistically significant weight loss. ONGLYZA is being developed in collaboration with AstraZeneca.
  • Dapagliflozin is progressing in Phase III development with a novel mechanism for the treatment of type 2 diabetes that potentially offers a triad of benefits: glucose control, weight loss and improvements in blood pressure. Positive results were presented from a 24-week Phase III clinical study in inadequately controlled type 2 diabetes patients who were treated with insulin plus dapagliflozin. Dapagliflozin is being developed in collaboration with AstraZeneca.
• In June, Bristol-Myers Squibb and Pfizer, Inc. announced that the Phase III AVERROES clinical trial of apixaban in patients with atrial fibrillation is closing early due to clear evidence of efficacy. An interim analysis by the Independent Data Monitoring Committee showed a clinically important reduction in stroke and systematic embolism in patients with atrial fibrillation considered intolerant of or unsuitable for warfarin therapy who received apixaban as compared to aspirin. This interim analysis also demonstrated an acceptable safety profile for apixaban compared to aspirin.
• In July, Bristol-Myers Squibb announced that the European Commission approved a new indication for ORENCIA in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs including methotrexate or a TNF-alpha inhibitor.
• In May, the FDA issued a complete response letter regarding the Biologics License Application for belatacept in kidney transplant. We are working with the FDA to provide the requested data as soon as they are available and we expect to be able to provide a submission to the FDA by the fourth quarter.
• In June, Bristol-Myers Squibb terminated its development collaboration with Exelixis Inc. on the experimental cancer drug XL184. All rights to XL184 were returned to Exelixis.

FINANCIAL GUIDANCE

2010

• The Company reaffirms its 2010 GAAP EPS guidance range of $1.84 to $1.94 per share and its non-GAAP guidance range of $2.10 to $2.20 per share. Key 2010 guidance assumptions include: mid-single digit revenue growth; full-year gross margin being consistent with last year; advertising and promotion expense decrease in the high-single digit range; marketing, sales and administrative expenses remaining flat; research and development expense growth in the mid- to high-single-digit range; and an effective tax rate of between 23% and 24%.

2013

• The Company reaffirms its minimum non-GAAP EPS guidance of $1.95 for 2013. This 2013 guidance assumes strong underlying revenue trends for certain key products, timely regulatory approval of and significant contributions from pipeline products, continued and additional productivity savings, exclusivity for ABILIFY^® for the term of the current agreement with Otsuka Pharmaceutical Co., Ltd., and that the negative impact of U.S. health care reform and European government-mandated cost containment measures is not substantially different from current expectations.

The financial guidance for 2010 and the 2013 minimum non-GAAP EPS guidance exclude the impact of any potential future strategic transactions and specified items that have not yet been identified and quantified. The non-GAAP 2010 guidance and the 2013 minimum guidance also exclude other specified items such as gains or losses from sale of businesses and product lines; from sale of equity investments and from discontinued operations; restructuring and other exit costs; accelerated depreciation charges; asset impairments; charges and recoveries relating to significant legal proceedings; upfront and milestone payments for licensing arrangements; and debt retirement costs.

Use of Non-GAAP Financial Information

This press release contains non-GAAP financial measures, including non-GAAP earnings from continuing operations and related earnings per share information, adjusted to exclude certain costs, expenses, gains and losses and other specified items. Among the items in GAAP measures but excluded for purposes of determining adjusted earnings and other adjusted measures are: charges related to implementation of the Productivity Transformation Initiative; gains or losses from the purchase or sale of businesses and product lines; discontinued operations; restructuring and other exit costs; accelerated depreciation charges; asset impairments; charges and recoveries relating to significant legal proceedings; upfront and milestone payments for in-licensing of products that have not achieved regulatory approval, which are immediately expensed; in-process research and development charges prior to 2009; special initiative funding to the Bristol-Myers Squibb Foundation; and significant tax events. This information is intended to enhance an investor’s overall understanding of the company’s past financial performance and prospects for the future. For example, non-GAAP earnings and earnings per share information is an indication of the company’s baseline performance before items that are considered by the company not to be reflective of the company’s ongoing results. These items are also not included in the company’s operating segment results. In addition, this information is among the primary indicators the company uses as a basis for evaluating company performance, allocating resources, setting incentive compensation targets, and planning and forecasting of future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted earnings per share prepared in accordance with GAAP.

Statement on Cautionary Factors

This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans and projections regarding the company’s financial position, results of operations, market position, product development and business strategy. These statements may be identified by the fact that they use words such as "anticipate", "estimates", "should", "expect", "guidance", "project", "intend", "plan", "believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. These factors include, among other things, implementation guidance related to the new U.S. health care reform law, governmental laws and regulations related to Medicare, Medicaid, Medicaid managed care organizations and entities under the Public Health Service 340B program, pharmaceutical rebates and reimbursement, market factors, competitive product development and approvals, pricing controls and pressures (including changes in rules and practices of managed care groups and institutional and governmental purchasers), economic conditions such as interest rate and currency exchange rate fluctuations, judicial decisions, claims and concerns that may arise regarding the safety and efficacy of in-line products and product candidates, changes to wholesaler inventory levels, variability in data provided by third parties, changes in, and interpretation of, governmental regulations and legislation affecting domestic or foreign operations, including tax obligations, changes to business or tax planning strategies, difficulties and delays in product development, manufacturing or sales, patent positions and the ultimate outcome of any litigation matter. These factors also include the company’s ability to execute successfully its strategic plans, including its String of Pearls strategy and Productivity Transformation Initiative, the expiration of patents or data protection on certain products, and the impact and result of governmental investigations. There can be no guarantees with respect to pipeline products that future clinical studies will support the data described in this release, that the products will receive necessary regulatory approvals, or that they will prove to be commercially successful; nor are there guarantees that regulatory approvals will be sought, or sought within currently expected timeframes, or that contractual milestones will be achieved. For further details and a discussion of these and other risks and uncertainties, see the company's periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Company and Conference Call Information

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

There will be a conference call on July 22, 2010, at 10:30 a.m. EDT during which company executives will address inquiries from investors and analysts. Investors and the general public are invited to listen to a live web cast of the call at http://investor.bms.com or by dialing 913-981-5597, confirmation code 3687148. Materials related to the call will be available at the same website prior to the call.

ABILIFY^® is the trademark of Otsuka Pharmaceutical Co., Ltd.

ATRIPLA^® is a trademark of both Bristol-Myers Squibb Co. and Gilead Sciences, Inc.

AVAPRO^®, AVALIDE^®, PLAVIX^®, DUOPLAVIN^® and DUOCOVER^® are trademarks of sanofi-aventis.

ERBITUX^® is a trademark of ImClone LLC. ImClone Systems is a wholly-owned subsidiary of Eli Lilly and Company.

GLEEVEC^® is a trademark of Novartis AG.

The following table sets forth worldwide and U.S. reported net sales for selected products. In addition, the table includes, where applicable, the estimated total U.S. prescription change for the retail and mail-order channels for the comparative periods presented for certain of the company's U.S. pharmaceutical products based on third-party data. A significant portion of the company's U.S. pharmaceutical sales is made to wholesalers. Where changes in reported net sales differ from prescription growth, this change in net sales may not reflect underlying prescriber demand.