Bristol-Myers Squibb Reports Strong Sales, Earnings Performance in First Quarter

  • Double-digit Sales Growth Led by the Performance of PLAVIX® and the Virology Franchise
  • Operating Margin Improvement Driven by Sales and Productivity
  • GAAP EPS From Continuing Operations Increases 30% Compared to First Quarter 2009; Non-GAAP EPS From Continuing Operations Increases 33%
  • Company Updates 2010 GAAP EPS Guidance Range to $1.84 to $1.94; Non-GAAP EPS Guidance Range to $2.10 to $2.20

NEW YORK--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE: BMY) today reported strong sales and earnings growth for the first quarter of 2010.

“Double-digit growth for both sales and earnings per share marks a very positive start to the year for our company,” said Lamberto Andreotti, CEO-designate, Bristol-Myers Squibb. “While we remain clearly committed to productivity, we are also focused on giving maximum priority to driving sales growth.”

“The challenges of an increasingly complex business environment, now including U.S. health care reform, can be addressed successfully through a sustainable pipeline. I am excited about the portfolio of products we have in development and look forward to key clinical data for many of them being presented in the next few months,” Andreotti added.

Phase III results for ipilimumab in metastatic melanoma and SPRYCEL® for the first-line treatment of chronic myeloid leukemia have been accepted for presentation by the American Society of Clinical Oncology. Results of a Phase III study of dapagliflozin for the treatment of Type 2 diabetes are planned for presentation at the American Diabetes Association scientific sessions. New data for belatacept will be presented at the American Transplant Congress.

   

First Quarter

$ amounts in millions, except per share amounts        

2010

2009

Change

Net Sales $ 4,807 $ 4,322 11 %
Net Earnings Per Common Share -- Diluted 0.43 0.32 34 %
GAAP Diluted EPS From Continuing Operations 0.43 0.33 30 %
Non-GAAP Diluted EPS From Continuing Operations 0.56 0.42 33 %
                     

FIRST QUARTER FINANCIAL RESULTS

  • Bristol-Myers Squibb posted first quarter 2010 net sales of $4.8 billion, an increase of 11%, or 8% excluding foreign exchange impact, compared to the same period in 2009. Health care reform had a 1% negative effect on net sales in the first quarter.
  • U.S. net sales increased 11% to $3.1 billion in the first quarter of 2010 compared to the same period in 2009. International net sales increased 11%, or 3% excluding foreign exchange impact, to $1.7 billion.
  • Gross margin as a percentage of net sales was 72.8% in the first quarter 2010 compared to 73.0% in 2009.
  • Marketing, selling and administrative expenses remained flat, or decreased 3% excluding foreign exchange impact, to $900 million in the first quarter of 2010 compared to the same period in 2009.
  • Advertising and product promotion spending decreased by 15%, or 17% excluding foreign exchange impact, to $212 million in the first quarter of 2010, compared to the same period in 2009.
  • Research and development expenses remained flat, or decreased by 1% excluding foreign exchange impact, to $910 million in the first quarter of 2010 compared to the same period in 2009.
  • The effective tax rate on earnings from continuing operations before income taxes was 24.2% in the first quarter of 2010, compared to 23.0% in the same period in 2009.
  • The Company reported first quarter GAAP net earnings from continuing operations of $743 million or $0.43 per share, compared to $649 million or $0.33 per share for the same period in 2009.
  • The Company reported first quarter non-GAAP net earnings from continuing operations of $967 million or $0.56 per share, compared to $829 million or $0.42 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 first quarter EPS from continuing operations by approximately $0.03 on both a GAAP and non-GAAP basis. Further details are discussed under the “Health Care Reform Impact” section.

FIRST QUARTER PRODUCT AND PIPELINE UPDATE

  • Bristol-Myers Squibb’s global sales growth in the first quarter was led by an increase of 16% for PLAVIX. The Company’s virology franchise, including BARACLUDE® (42%) for hepatitis B, and REYATAZ® (16%) and SUSTIVA® (15%) for HIV demonstrated consistent growth. First quarter sales of ORENCIA® and SPRYCEL grew 36% and 49% respectively compared to the same period in 2009.
  • In March, the Company and sanofi-aventis announced revisions to the U.S. prescribing information for PLAVIX, which include a boxed warning. The boxed warning concerns the diminished effectiveness of PLAVIX in patients who have a genetic variation leading to reduced formation of the active metabolite. The percentage of poor metabolizers is estimated to be approximately 3% of the population, based on published studies.
  • In March, the Company and sanofi-aventis announced that the European Commission approved the dual antiplatelet combination tablet DUOPLAVIN®/DUOCOVER® (clopidogrel 75 mg and acetylsalicylic acid 100 mg or 75 mg) for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid.
  • In February, the belatacept Marketing Authorization Application (MAA) for the treatment of prophylaxis of organ rejection in kidney transplant patients was validated by the European Medicines Agency.
  • In March, the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee voted 13 to 5 to recommend approval of belatacept, a selective co-stimulation blocker, for the prophylaxis of acute rejection in de novo kidney transplant patients. The Prescription Drug User Fee Act (PDUFA) date—the date by which a decision from the U.S. Food and Drug Administration (FDA) is expected—for belatacept is May 1, 2010.
  • In March, the Company and AstraZeneca announced that the FDA has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ and metformin HCL extended-release tablets as a once-daily treatment for Type 2 diabetes mellitus in adults. The PDUFA date for the combination therapy is October 29, 2010.
  • In March, the Company and AstraZeneca announced the commencement of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus” trial (SAVOR-TIMI 53), a multicenter, randomized, double-blind, placebo-controlled Phase IV study to evaluate treatment with ONGLYZA in adult Type 2 diabetes patients with cardiovascular risk factors. The five-year study will follow approximately 12,000 patients with Type 2 diabetes who have either a history of previous cardiovascular events or multiple risk factors for vascular disease, and includes patients with renal impairment.
  • In March, the apixaban MAA for the prevention of venous thromboembolic (VTE) events in adult patients who have undergone elective hip or knee replacement was validated by the European Medicines Agency.
  • In January, the European Commission approved ORENCIA in combination with methotrexate for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in pediatric patients six years of age and older who have had an insufficient response to other disease-modifying anti-rheumatic drugs, including at least one TNF inhibitor.
  • In April, week 12 data from a Phase IIa study of BMS-790052, an NS5A inhibitor under investigation for the treatment of Hepatitis C virus (HCV), were presented at the European Association for the Study of the Liver (EASL). The data showed that once-daily dosing of the NS5A inhibitor plus peginterferon-alpha-2a and ribavirin produces high rates of extended rapid virologic response in treatment-naive HCV-genotype 1 subjects, compared to peginterferon-alpha-2a and ribavirin alone. The rate of adverse events was comparable across BMS-790052 dosing arms and placebo.

BUSINESS DEVELOPMENT UPDATE

On March 3, Bristol-Myers Squibb and Allergan, Inc. announced a global agreement for the development and commercialization of AGN-209323, a Phase II-ready, orally administered small molecule in clinical development for neuropathic pain.

HEALTH CARE REFORM IMPACT

The impact of U.S. health care reform decreased first quarter EPS from continuing operations by $0.03 on both a GAAP and non-GAAP basis. Higher rebates to Medicaid and Medicaid managed care organizations had a negative impact of $0.02 per share. There was also a one-time $0.01 per share charge due to the elimination of the tax deductibility of a portion of Company’s retiree health care costs.

The Company expects additional negative financial impact in 2010 as other parts of the new health care law are implemented, including discounts to certain critical access hospitals, cancer hospitals and other covered entities as required by the expansion of the 340B Drug Pricing Program. In addition, beginning in 2011, the Company will provide a 50% discount on its brand-name drugs to patients who fall within the Medicare Part D coverage gap, also referred to as the “Donut Hole,” and the Company will pay a non-deductible annual fee to the federal government based on an allocation of its market share of branded prior year sales to certain government programs including Medicare, Medicaid, Department of Veterans Affairs, Department of Defense and TriCare.

A positive impact on net sales from the expected increase in the number of people with health care coverage could potentially occur in the future, but not until 2014 at the earliest.

2010 FINANCIAL GUIDANCE

In January, the Company announced 2010 GAAP EPS guidance range of $1.94 to $2.04 and 2010 non-GAAP EPS guidance range of $2.15 to $2.25 that explicitly excluded the impact of U.S. health care reform. The Company now estimates the negative impact of health care reform on both a GAAP EPS and non-GAAP EPS basis to be approximately $0.12 and is updating its 2010 non-GAAP EPS guidance range by $0.05 to $2.10 to $2.20 as the impact of health care reform is expected to be partially offset by the strength of the underlying business and mitigating actions taken by the Company. The Company is also updating its 2010 GAAP EPS guidance range to $1.84 to $1.94 to reflect higher manufacturing rationalization costs and a licensing transaction, in addition to health care reform impact.

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%. The financial guidance for 2010 excludes the impact of any potential future strategic transactions and specified items that have not yet been identified and quantified.

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; impairments to investments; 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, pharmaceutical rebates and reimbursement, 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, 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 committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com.

There will be a conference call on April 29, 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 913-312-1425, confirmation code 2479915. 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.

BRISTOL-MYERS SQUIBB COMPANY
SELECTED PRODUCTS
FOR THE THREE MONTHS ENDED MARCH 31, 2010 AND 2009
(Unaudited, dollars in millions)

The following table sets forth worldwide and U.S. reported net sales for selected products for the three months ended March 31, 2010 compared to the three months ended March 31, 2009. 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

       

%

       

%

% Change in U.S. Total

2010

2009

Change

2010

2009

Change

Prescriptions vs. 2009

 

Three Months Ended March 31,

 

BioPharmaceuticals

Cardiovascular
Plavix $ 1,666 $ 1,435 16 % $ 1,531 $ 1,296 18 % 2 %
Avapro/Avalide 314 302 4 % 186 173 8 % (14 )%
Virology
Reyataz 373 322 16 % 186 176 6 % 7 %
Sustiva Franchise (total revenue) 335 292 15 % 214 190 13 % 10 %
Baraclude 216 152 42 % 42 36 17 % 12 %
Oncology
Erbitux 166 164 1 % 163 162 1 % N/A
Sprycel 131 88 49 % 38 30 27 % 7 %
Ixempra 29 24 21 % 25 22 14 % N/A
Affective (Psychiatric) Disorders
Abilify 617 589 5 % 470 481 (2 )% 9 %
Immunoscience
Orencia 169 124 36 % 126 99 27 % N/A
Metabolics
Onglyza 10 N/A 6 N/A N/A
 

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF EARNINGS

FOR THE THREE MONTHS ENDED MARCH 31, 2010 AND 2009

(Unaudited, amounts in millions except per share data)

 

Three Months Ended March 31,

   
EARNINGS

2010

2009

 
Net Sales $ 4,807   $ 4,322  
Cost of products sold 1,306 1,165
Marketing, selling and administrative 900 901
Advertising and product promotion 212 248
Research and development 910 908
Provision for restructuring, net 11 19
Litigation expense, net 104
Equity in net income of affiliates (97 ) (146 )
Other (income)/expense, net   113     (72 )
Total Expenses, net   3,355     3,127  
Earnings Before Income Taxes 1,452 1,195
Provision for income taxes   351     275  
 
 
Net Earnings from Continuing Operations   1,101     920  
 
 
Net Earnings from Discontinued Operations       1  
Net Earnings 1,101 921
Net Earnings Attributable to Noncontrolling Interest   358     283  
Net Earnings Attributable to BMS $ 743   $ 638  
 
 
Amounts Attributable to BMS
Income from Continuing Operations $ 743 $ 649
Income from Discontinued Operations

 

      (11 )
Net Income $ 743   $ 638  
 
 
Earnings per Common Share from Continuing Operations
Attributable to BMS:
Basic $ 0.43 $ 0.33
Diluted $ 0.43 $ 0.33
 
 
Earnings per Common Share Attributable to BMS:
Basic $ 0.43 $ 0.32
Diluted $ 0.43 $ 0.32
 
 
Average Common Shares Outstanding:
Basic 1,715 1,978
Diluted 1,725 1,981
 
 
Interest expense $ 33 $ 52
Interest income (15 ) (13 )
Impairment of manufacturing operations 200
Foreign exchange transaction gains (16 ) (13 )
Gain on sale of product lines, businesses and assets (10 ) (44 )
Net royalty and other alliance income (50 ) (35 )
Other, net   (29 )   (19 )
Other (income)/ expense, net $ 113   $ (72 )
                     

BRISTOL-MYERS SQUIBB

COMPANYSPECIFIED ITEMS

FOR THE THREE MONTHS ENDED MARCH 31, 2010 AND 2009

(Unaudited, dollars in millions)

Three months ended March 31, 2010

 
Cost of Marketing, Research Other
products selling and and Provision for (income)/
Dollars in Millions

sold

administrative

development

restructuring

expense

Total

Restructuring Activity:

Downsizing and streamlining of

worldwide operations

$ $ $ $ 11 $ $ 11
Impairment of manufacturing operations 200 200
Accelerated depreciation, asset impairment and other shutdown costs 31 31
Process standardization implementation costs     13         13  
Total Restructuring 31 13 11 200 255
 
Other:
Upfront licensing and milestone payments       55       55  
Total $ 31 $ 13 $ 55 $ 11 $ 200 310
Income taxes on items above   (86 )
Decrease to Net Earnings from Continuing Operations $ 224  

Three months ended March 31, 2009

                         
Cost of Marketing, Research Other
products selling and and Provision for Litigation (income)/
Dollars in Millions

sold

administrative

development

restructuring

expense

expense

Total

Restructuring Activity:
Downsizing and streamlining of worldwide operations $ — $ — $ — $ 15 $ — $ — $ 15

Accelerated depreciation, asset impairment and other shutdown costs

26 4 30
Process standardization implementation costs 20 20
Gain on sale of product lines, businesses and assets (44) (44)
Total Restructuring 26 20 19 (44) 21
Other:
Litigation charges 104 104
Upfront licensing and milestone payments 145 145
Product liability 8 (5) 3
Total $ 34 $ 20 $ 145 $ 19 $ 104 $ (49) 273
Income taxes on items above (93)
Decrease to Net Earnings from Continuing Operations $ 180
                       

BRISTOL-MYERS SQUIBB COMPANY

RECONCILIATION OF GAAP RESULTS OF CONTINUING OPERATIONS

TO NON-GAAP RESULTS OF CONTINUING OPERATIONS

FOR THE THREE MONTHS ENDED MARCH 31, 2010 AND 2009

(Unaudited, amounts in millions except per share data)

 
GAAP     Q1 2010
Specified
Items*
    Non
GAAP
    GAAP     Q1 2009
Specified
Items*
    Non
GAAP
 
Net Sales $ 4,807 - $ 4,807 $ 4,322 - $ 4,322
Cost of Products Sold   1,306   (31 )   1,275     1,165   (34 )   1,131  
Gross Profit 3, 501 31 3,532 3,157 34 3,191
Gross Profit as a % of Sales 72.8 % 0.7 % 73.5 % 73.0 % 0.8 % 73.8 %
 
Marketing Selling and Administration 900 (13 ) 887 901 (20 ) 881
Advertising and Product Promotion   212   -   212     248   -   248  
Total SGA 1,112 (13 ) 1,099 1,149 (20 ) 1,129
SG&A as a % of Sales 23.1 % (0.2 )% 22.9 % 26.6 % (0.5 )% 26.1 %
 
R&D 910 (55 ) 855 908 (145 ) 763
R&D as a % of Sales 18.9 % (1.1 )% 17.8 % 21.0 % (3.3 )% 17.7 %
 
Operating Margin 1,479 99 1,578 1,100 199 1,299
Operating Margin as % of Sales 30.8 % 2.0 % 32.8 % 25.5 % 4.6 % 30.1 %
 
Provision for restructuring, net 11 (11 ) - 19 (19 ) -
Litigation expense, net - - - 104 (104 ) -
Equity in net income of affiliates (97 ) - (97 ) (146 ) - (146 )
Other (income)/expense, net   113   (200 )   (87 )   (72 ) 49   (23 )
 
Earnings from Continuing Operations Before Income Taxes $ 1,452 310 $ 1,762 $ 1,195 273 $ 1,468
 
Provision for income taxes   351   86   437     275   93   368  
 
Net Earnings – Continuing Operations $ 1,101 224 $ 1,325 $ 920 180 $ 1,100
Net Earnings – Continuing Operations Attributable to Noncontrolling Interest   358     358     271     271  
Net Earnings - Continuing Operations Attributable to BMS $ 743 224 $ 967 $ 649 180 $ 829
Contingently convertible debt interest expense and dividends attributable to unvested shares   (3 )   (3 )   (4 )   (4 )
Net Earnings used for Diluted EPS Calc - Continuing Operations-Attributable BMS $ 740 224 $ 964 $ 645 180 $ 825
 
Avg Shares (Diluted) 1,725 1,725 1,981 1,981
 
Diluted EPS – Continuing Operations Attributable to BMS $ 0.43 0.13 $ 0.56 $ 0.33 0.09 $ 0.42
 
Net Earnings from Continuing Operations Attributable to BMS as a % of sales 15.5 % 4.6 % 20.1. % 15.0 % 4.2 % 19.2 %
 
Effective Tax Rate 24.2 % 0.6 % 24.8 % 23.0 % 2.1 % 25.1 %
 

* Please refer to the Specified Items schedules for further details.

   

BRISTOL-MYERS SQUIBB COMPANY

NET DEBT CALCULATION

AS OF MARCH 31, 2010 AND DECEMBER 31, 2009

(Unaudited, dollars in millions)

 

March 31, 2010

December 31, 2009

Cash and cash equivalents $ 5,135 $ 7,683
Marketable securities-current 1,641 831
Marketable securities-long term 2,997 1,369
Short-term borrowings (208 ) (231 )
Long-term debt   (6,081 )       (6,130 )
Net cash $ 3,484       $ 3,522  



CONTACT:

Bristol-Myers Squibb Company
Communications:
Tracy Furey, 609-252-3208
Jennifer Fron Mauer, 609-252-6579
or
Investor Relations:
Teri Loxam, 609-252-3368
Suketu Desai, 609-252-5796

KEYWORDS:   United States  North America  New York

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Infectious Diseases  Pharmaceutical  General Health

MEDIA:

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