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Bristol-Myers Squibb Delivers Solid Fourth Quarter Results in a Year Highlighted by Robust Clinical Data, Continued Execution of Strategic Transactions and Good Operating Performance

  • Receives U.S. Regulatory Approval for KOMBIGLYZE™ XR, and First-Line Indication for SPRYCEL® in Fourth Quarter
  • Submits Dapagliflozin for Regulatory Review in U.S. and Europe in Fourth Quarter
  • Increases Sales 2% to $5.1 Billion in Fourth Quarter
  • Provides 2011 GAAP EPS From Continuing Operations Guidance Range of $2.00 to $2.10; 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)--Jan 27, 2011 - Bristol-Myers Squibb Company (NYSE: BMY) today announced solid results for the fourth quarter of 2010. This concludes a year in which the Company presented key data on marketed and investigational products across its pipeline, completed important regulatory milestones, continued its focus on strategic transactions and delivered on its commitment to drive shareholder value. In addition, the company provided guidance for 2011, and confirmed guidance for 2013.

“In the fourth quarter, we delivered solid financial results, concluding a very good year for the company,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “The performance in the quarter is reflective of a year in which robust clinical data, targeted execution of our String of Pearls strategy, and key regulatory submissions provided further proof of our ability to build one of the most innovative pipelines in the industry.”

“In 2011 we will build on the momentum created in 2010. We anticipate several key pipeline events that will help shape our future as we continue to position our company for long-term success as a focused, differentiated BioPharma company,” Andreotti said.

     
    Fourth Quarter

 

$ amounts in millions, except per share amounts            
    2010

 

  2009

 

  Change

 

Net Sales   $ 5,111   $ 5,033   2%
Net Earnings Per Common Share – Diluted     0.28   4.06*

 

  (93)%
GAAP Diluted EPS From Continuing Operations     0.28     0.41   (32)%
Non-GAAP Diluted EPS From Continuing Operations     0.47     0.47   -  

 

    Full Year

 

$ amounts in millions, except per share amounts            
    2010

 

  2009

 

  Change

 

Net Sales   $ 19,484   $ 18,808   4%
Net Earnings Per Common Share – Diluted     1.79     5.34   (66)%
GAAP Diluted EPS From Continuing Operations     1.79     1.63   10%
Non-GAAP Diluted EPS From Continuing Operations     2.16     1.85   17%
* Includes a $7.2 billion after tax gain, or $3.62 per share, attributed to the split-off of Mead Johnson Nutrition Company, which is recorded as discontinued operations.

FOURTH QUARTER FINANCIAL RESULTS

 

  • Bristol-Myers Squibb posted fourth quarter 2010 net sales of $5.1 billion. U.S. health care reform had a 1.5% negative effect on net sales in the fourth quarter.
  • U.S. net sales increased 5% to $3.3 billion in the fourth quarter of 2010 compared to the same period in 2009. International net sales decreased 5%, or 3% excluding foreign exchange impact, to $1.8 billion.
  • Gross margin as a percentage of net sales was 72.3% in the fourth quarter of 2010 compared to 71.5% in the same period in 2009.
  • Marketing, selling and administrative expenses decreased 15% to $1.0 billion in the fourth quarter of 2010.
  • Advertising and product promotion spending decreased 19% to $271 million in the fourth quarter of 2010.
  • Research and development expenses decreased 9% to $1.0 billion in the fourth quarter of 2010.
  • The effective tax rate on earnings from continuing operations before income taxes was 40.4% on a GAAP basis in the fourth quarter of 2010. The higher effective tax rate for the current quarter is primarily due to a $207 million specified tax charge mostly related to an internal restructuring of certain foreign legal entities and a change in earnings mix to high-tax jurisdictions.
  • The Company reported fourth quarter GAAP net earnings from continuing operations attributable to Bristol-Myers Squibb Company of $483 million, or $0.28 compared to $818 million or $ 0.41 per share for the same period in 2009.
  • The Company reported fourth quarter non-GAAP net earnings from continuing operations of $807 million or, $0.47 per share, compared to $928 million, or $0.47 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 fourth quarter EPS from continuing operations by approximately $0.02 on both a GAAP and non-GAAP basis.
  • Cash, cash equivalents and marketable securities as of the end of the fourth quarter were $10.0 billion, resulting in a net cash position of $4.5 billion as of December 31, 2010. During the fourth quarter, the Company acquired ZymoGenetics for $885 million and repurchased $750 million aggregate principal amount of its outstanding debt.

FOURTH QUARTER PRODUCT AND PIPELINE UPDATE

 

  • Bristol-Myers Squibb's global net sales growth in the fourth quarter was led by PLAVIX® (6%), the ONGLYZA®Franchise, BARACLUDE® (25%), SPRYCEL (42%), and ORENCIA® (20%). The growth in global net sales was mostly offset by declining sales from mature brands and AVAPRO®/AVALIDE ®.
  • In January, the U.S. Food and Drug Administration (FDA) granted the Company and its partner, sanofi-aventis, an additional six-month period of exclusivity to market PLAVIX. Exclusivity for PLAVIX in the U.S. is now expected to expire on May 17, 2012.
  • In October, the FDA approved SPRYCEL 100 mg once daily for newly diagnosed adults with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia. In December, the European Commission also approved SPRYCEL for use in a first-line setting. The Company commercializes SPRYCEL with its partner, Otsuka.
  • In November, the FDA approved KOMBIGLYZE XR for the treatment of adult patients with type 2 diabetes in the U.S. KOMBIGLYZE XR is a once-daily combination tablet of metformin extended release plus saxagliptin. The Company developed and commercializes KOMBIGLYZE XR with its partner, AstraZeneca.
  • In October, the FDA approved the supplemental New Drug Application (sNDA) of BARACLUDE for the treatment of chronic hepatitis B in adult patients with decompensated liver disease. In January, the Company received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for BARACLUDE for this indication.
  • In November, the FDA extended the review timeline for the Biologics License Application (BLA) for ipilimumab in advanced melanoma, and has moved the Prescription Drug Fee User Act (PDUFA) date—the date by which action from the FDA is expected—to March 26, 2011.
  • In December, the FDA accepted for review the supplemental Biologics License Application (sBLA) for the subcutaneous formulation for ORENCIA. The PDUFA date is August 4, 2011.
  • In December, the Company and its partner, AstraZeneca, completed the submission of a New Drug Application (NDA) with the FDA and a Marketing Authorization Application (MAA) with the EMA for dapagliflozin as a once-daily oral therapy for the treatment of adult patients with type 2 diabetes. The MAA was validated by the European Medicines Agency in January. The companies are awaiting acceptance of the submission in the U.S.
  • In December, the FDA informed the Company that the information submitted by the Company regarding belatacept is a Complete Response to the request for additional information outlined in the FDA letter dated May 1, 2010. A new PDUFA date of June 15, 2011, was set.
  • In January, the Company and its partner, sanofi-aventis, voluntarily withdrew certain lots of AVALIDE® from the U.S., Puerto Rican, Canadian, Mexican and Argentinean markets. The date of resupply of AVALIDE to these markets has not yet been determined.
  • In November, the Company and its partner, Pfizer, discontinued the Phase III APPRAISE-2 clinical trial in patients with recent Acute Coronary Syndrome treated with apixaban or placebo in addition to mono or dual antiplatelet therapy. The study was stopped early based on the recommendation of an Independent Data Monitoring Committee due to clear evidence of an increase in bleeding among patients taking apixaban.
  • In December, the Company and Pfizer published results from the Phase III ADVANCE-3 study of apixaban in The New England Journal of Medicine. The results showed that apixaban was statistically superior to 40 mg once-daily enoxaparin with comparable rates of bleeding in the prevention of venous thromboembolism following total hip replacement surgery.
  • In December at the American Society of Hematology meeting in Orlando, the Company and Otsuka presented follow-up results from the Phase III DASISION study comparing SPRYCEL to imatinib in first-line treatment of adults with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia. The 18-month results showed higher and faster response rates for SPRCYEL compared to imatinib that were consistent with the 12-month data presented at the American Society of Clinical Oncology meeting in June and published in the New England Journal of Medicine.

BUSINESS DEVELOPMENT UPDATE

 

  • In October, the Company completed its acquisition of ZymoGenetics, Inc.
  • In December, the Company entered into a licensing agreement with Oncolys BioPharma, a privately held biotech company based in Japan, to acquire exclusive worldwide rights to manufacture, develop and commercialize festinavir, a once-a-day, orally available nucleoside reverse transcriptase inhibitor (NRTI) in Phase II development for HIV.
  • In January, the Company entered into a clinical collaboration agreement with Pharmasset to conduct a proof of concept study to evaluate the potential to achieve sustained viral response 24 weeks post treatment in patients with chronic hepatitis C virus using an oral, once-daily treatment regimen of BMS-790052, Bristol-Myers Squibb's NS5A replication complex inhibitor, and PSI-7977, Pharmasset's nucleotide polymerase inhibitor, with and without ribavirin.

FINANCIAL GUIDANCE

2011

Bristol-Myers Squibb is setting its 2011 GAAP EPS guidance range from $2.00 to $2.10 and its non-GAAP EPS range from $2.10 to $2.20. Key 2011 non-GAAP guidance assumptions include:

 

  • Low- to mid-single-digit revenue growth.
  • Full-year gross margin as a percentage of sales being consistent with last year.
  • Advertising and promotion expense decrease in the mid- to high-single-digit range.
  • Marketing, sales and administrative expenses increasing in the mid-single-digit range, including the impact of the U.S. health care reform pharmaceutical company fee.
  • Research and development expense growth in the mid-single-digit range.
  • An effective tax rate between 25% and 26%.

On an incremental year-over-year basis, U.S. health care reform is expected to have a negative impact on 2011 EPS of approximately $0.15. This estimate includes:

 

  • The reduction in net sales of approximately $250 million due to new discounts associated with the Medicare Part D coverage gap.
  • The annual non-tax-deductable pharmaceutical company fee of approximately $250 million, to be recorded in marketing, sales and administrative expenses.

The guidance for 2011 also includes the effect of the AVALIDE recall and extended supply interruption. Net sales of AVALIDE in the affected markets were $355 million in 2010.

It is estimated that 30% to 40% of the research and development expenses in 2011 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.

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 foreign currency exchange rates and the negative impact of U.S. health care reform and European government-mandated cost containment measures are not substantially different from current expectations.

The financial guidance for 2011 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 2011 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, significant 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 and IPRD 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; 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. 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 of the new discounts and new pharmaceutical company fee under the 2010 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, the inability to improve or remediate FDA concerns raised in the warning letter regarding certain GMP processes at our Manati facility, 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 including the Avalide recall and extended supply shortage and any potential future recalls, 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 January 27, 2011, at 10:30 a.m. EST 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: 913-312-0732, confirmation code: 7584294. 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®, and PLAVIX® are trademarks of sanofi-aventis.
ERBITUX® is a trademark of ImClone LLC. ImClone Systems is a wholly-owned subsidiary of Eli Lilly and Company.
All other brand names of products appearing in all capital letters are registered trademarks of the Company or one of its subsidiaries.
 
 
BRISTOL-MYERS SQUIBB COMPANY
SELECTED PRODUCTS
FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2010 AND 2009
(Unaudited, dollars in millions)
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.
        Worldwide Net Sales

 

  U.S. Net Sales

 

     
        2010

 

  2009

 

  %
Change

 

  2010

 

  2009

 

  %
Change

 

  % Change in U.S. Total
Prescriptions vs. 2009

 

Three Months Ended December 31,

 

                             
                                   
Key Products

 

                             
    Plavix   $ 1,715   $ 1,618   6%   $ 1,593   $ 1,461   9%   (4)%  
    Avapro/Avalide     252     339   (26)%     118     184   (36)%   (20)%  
    Abilify     707     707   --

 

    535     563   (5)%   2%  
    Reyataz     374     388   (4)%     194     196   (1)%   (1)%  
    Sustiva Franchise (total revenue)     360     358   1%     227     224   1%   4%  
    Baraclude     264     212   25%     49     44   11%   8%  
    Erbitux     165     167   (1)%     160     163   (2)%   N/A  
    Sprycel     169     119   42%     61     32   91%   4%  
    Ixempra     30     28   7%     23     25   (8)%   N/A  
    Orencia     202     168   20%     146     126   16%   N/A  
    Onglyza/Kombiglyze     73     4   *     53     2   *   *  
                                   
Mature Products and All Other**     800     925   (14)%     125     95   32%   N/A  
                                   
        Worldwide Net Sales

 

  U.S. Net Sales

 

     
        2010

 

  2009

 

  %
Change

 

  2010

 

  2009

 

  %
Change

 

  % Change in U.S. Total
Prescriptions vs. 2009

 

Twelve Months Ended December 31,

 

                             
                                   
Key Products

 

                             
                                   
    Plavix   $ 6,666   $ 6,146   8%   $ 6,154   $ 5,556   11%   (1)%  
    Avapro/Avalide     1,176     1,283   (8)%     642     722   (11)%   (17)%  
    Abilify     2,565     2,592   (1)%     1,958     2,082   (6)%   5%  
    Reyataz     1,479     1,401   6%     754     727   4%   4%  
    Sustiva Franchise (total revenue)     1,368     1,277   7%     881     803   10%   7%  
    Baraclude     931     734   27%     179     160   12%   12%  
    Erbitux                                    

Posted: January 2011


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