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Bristol-Myers Squibb Continues Strong Financial Performance Led by Double-Digit Global Sales Growth

2008-07-24 06:29:00

Bristol-Myers Squibb Continues Strong Financial Performance Led by Double-Digit Global Sales Growth

Reports Broad-Based Net Sales Growth of 16% from Continuing

Operations

Records Pre-Tax Earnings from Continuing Operations of $1,221

Million representing an Increase of 24% from Second Quarter 2007

Posts Second Quarter 2008 GAAP EPS from Continuing Operations of

$0.36 Compared to $0.30 in 2007, an Increase of 20%, and Non-GAAP EPS

Growth from Continuing Operations of $0.43 Compared to $0.31 in 2007,

an Increase of 39%

Reaffirms 2008 EPS Guidance and 2007-2010 Expected 15% Non-GAAP EPS

CAGR

Plans Additional $1 Billion in Productivity Savings by 2012

Submits Regulatory Filings for ONGLYZA (saxagliptin) in U.S.

NEW YORK–(EMWNews)–Bristol-Myers Squibb Company

(NYSE:BMY) today reported very strong sales and earnings growth for the

second quarter 2008 and announced additional plans to proactively manage

costs.

We are making measurable strides against the

strategy we outlined for investors last year. In addition to strong

sales growth, we are making acquisitions, entering licensing agreements

and investing in our pipeline, as we deliver on our commitments to

patients and investors, said James M.

Cornelius, chairman and chief executive officer, Bristol-Myers Squibb. We

are also taking steps now to manage through future exclusivity losses.

Our improvement initiatives are enabling us to better manage our costs

and work more efficiently.

We are selecting the best of biotech and the

best of the pharmaceutical industry and combining these traits into a

model which will position us as a next-generation BioPharma leader. As

our second quarter 2008 results indicate, were

on the right path to help patients prevail over serious disease both

today, and in the future.

Second Quarter 2008

2008

 

2007

 

Change

Net Sales

$

5,203

$

4,471

16

%

Net Earnings From Continuing Operations

$

722

$

588

23

%

GAAP Diluted EPS From Continuing Operations

0.36

0.30

20

%

Non-GAAP Diluted EPS From Continuing Operations

0.43

0.31

39

%

($ amounts in millions, except per share amounts)

EXPANSION OF PRODUCTIVITY

ADDITIONAL $1 BILLION BY 2012

In December 2007, the company announced a $1.5 billion productivity

transformation initiative (PTI) to be completed by 2010. The company is

well on track to achieve this goal as underlined by its current margin

performance. At the time this initiative was announced, the company

indicated this was the first step to achieve a culture focused on

continuous improvement.

As part of the plan to maximize our growth

opportunities through 2011 and improve our earnings base in 2012-2013,

we have initiated an expansion of our productivity initiatives which

will result in an additional $1 billion of cost savings by 2012,

said Jean-Marc Huet, senior vice president and chief financial officer. We

have commissioned several internal teams to execute against some already

identified projects. We will provide additional information on this

second wave of productivity initiatives and its costs by year-end.

While managing our cost base is critical, it

is only one part of our strategy as we transition to a next-generation

BioPharma company. We continue to invest to improve the growth of our

marketed products and strengthen our pipeline. We are confident that we

can deliver on our commitments and improve our base business in

2012-2013.

SECOND QUARTER RESULTS

  • Bristol-Myers Squibb posted second quarter 2008 net sales from

    continuing operations of $5.2 billion, an increase of 16%, including a

    5% favorable foreign exchange impact, compared to the same period in

    2007. Pharmaceutical net sales totaled $4.5 billion and sales of

    Nutritionals totaled $728 million in the second quarter of 2008,

    representing increases of 16% and 17%, respectively, compared to 2007.

  • U.S. pharmaceutical net sales increased 17% to $2.6 billion in the

    second quarter of 2008 compared to the same period in 2007, primarily

    due to increased sales of PLAVIX®,

    the continued growth of ABILIFY®

    , strong results from the HIV and hepatitis portfolio and

    increasing contribution of recent launches of products such as ORENCIA®and

    IXEMPRA.

  • International pharmaceutical net sales increased 15%, including a 12%

    favorable foreign exchange impact, to $1.9 billion in the second

    quarter of 2008 compared to the same period in 2007. The increase was

    primarily due to higher sales of BARACLUDE®

    and increased contributions from ABILIFY®,

    SPRYCEL and the HIV portfolio. The companys

    reported international net sales do not include copromotion sales

    reported by its alliance partner, sanofi-aventis, for PLAVIX®

    and AVAPRO®/AVALIDE®,

    which continue to show growth in the second quarter of 2008.

  • Cost of products sold, as a percentage of net sales, increased to

    32.1% in the second quarter of 2008 compared to 31.5% in the same

    period in 2007. This increase of 0.6% was driven by higher

    manufacturing rationalization charges in 2008 related to the

    implementation of the PTI which accounted for a 0.8% increase,

    partially offset by manufacturing cost improvements from previously

    implemented initiatives.

  • Marketing, selling and administrative expenses increased by 6%,

    including an unfavorable 5% foreign exchange impact, to $1,165 million

    in the second quarter of 2008 compared to the same period in 2007,

    primarily due to implementation costs associated with the PTI.

  • Advertising and product promotion spending increased by 19%, including

    an unfavorable 5% foreign exchange impact, to $420 million in the

    second quarter of 2008 compared to the same period in 2007, primarily

    due to increased investment in ABILIFY®

    and ORENCIA®.

  • Research and development expenses increased 9%, including an

    unfavorable 2% foreign exchange impact, to $826 million in the second

    quarter of 2008 from $755 million in the same period in 2007. The

    increase primarily reflects higher development spending for pipeline

    compounds as well as higher upfront and milestone payments in 2008.

  • Acquired in-process research and development charge of $32 million in

    the second quarter of 2008 relates to the acquisition of Kosan

    Biosciences, Inc.

  • The company recorded earnings from continuing operations before

    minority interest and income taxes of $1,221 million in the second

    quarter of 2008, an increase of 24% compared to $985 million in the

    same period in 2007. The increase was driven by strong product

    performance in the pharmaceutical business as well as cost containment

    and productivity initiatives.

  • The effective tax rate on earnings from continuing operations before

    minority interest and income taxes was 21.1% for the second quarter of

    2008, compared with 20.6% in the second quarter of 2007. The second

    quarter 2008 effective tax rate includes the favorable impact related

    to the resolution of a tax audit from prior years. The Company expects

    the full year 2008 non-GAAP effective tax rate from continuing

    operations to be in line with the previously issued guidance of

    approximately 24%.

  • On a GAAP basis, the company reported second quarter 2008 net earnings

    from continuing operations of $722 million or $0.36 per diluted share,

    compared to net earnings from continuing operations of $588 million or

    $0.30 per diluted share for the same period in 2007. This represents

    growth of 23% for net earnings and 20% for EPS from continuing

    operations. The 2008 operating results include charges of $109 million

    associated with the implementation of the previously announced PTI as

    well as a favorable resolution of a tax audit from prior years. On a

    non-GAAP basis excluding specified items, second quarter 2008 net

    earnings from continuing operations were $861 million, or $0.43 per

    diluted share, compared to $608 million, or $0.31 per diluted share

    for the same period in 2007. This represents non-GAAP growth of 42%

    for net earnings and 39% for EPS from continuing operations.

  • The company continues to focus on being efficient with its use of

    cash. Cash flow from operations totaled $1.1 billion in the second

    quarter of 2008. Also, net debt decreased by $386 million between the

    end of the first quarter and end of the second quarter of 2008.

PIPELINE AND BUSINESS DEVELOPMENTS

Bristol-Myers Squibb and its partner AstraZeneca announced on July 23

that the regulatory submissions for ONGLYZA (saxagliptin) were made in

both the United States and in Europe on June 30 and July 1,

respectively. The concurrent European filing further demonstrates the

companys commitment to rapidly bring forward

new medicines for serious unmet medical needs like type II diabetes.

Bristol-Myers Squibb is focusing on supplementing its internal research

and development portfolio with strategic partnerships and acquisitions.

In May, the company entered into an agreement with KAI Pharmaceuticals

to develop and commercialize KAIs novel

acute heart attack medicine, KAI-9803. In June, Bristol-Myers Squibb

completed the acquisition of Kosan Biosciences, Inc., a cancer

therapeutics company with a library of novel compounds including Hsp90

inhibitors for cancer and microtubule stabilizers, which may have

additional potential in neurodegenerative diseases.

The following regulatory and data milestones occurred in the second

quarter:

  • In July, approval of ERBITUX®

    in Japan for treatment of metastatic colorectal cancer.

  • At the annual meeting of the American Society of Clinical Oncology

    (ASCO), a landmark phase III study (FLEX) showed that the addition of

    ERBITUX®to

    platinum-based chemotherapy significantly increased overall survival

    in the first-line treatment of patients with advanced non-small cell

    lung cancer, when compared to platinum-based chemotherapy alone.

  • In the United States, approval for new ABILIFY®indications

    for pediatric bipolar maintenance therapy, pediatric schizophrenia

    maintenance therapy, and as add-on treatment to lithium or valproate

    for acute treatment of bipolar disorder.

  • In Europe, approval for a 300 mg tablet of PLAVIX®.

  • Also in Europe, approval of an expanded indication for REYATAZ®

    300 mg once-daily boosted with ritonavir 100 mg as part of combination

    therapy in treatment-naïve HIV-1 infected

    patients.

  • New Phase II data presented at the European League Against Rheumatism

    (EULAR) demonstrated that ORENCIA®may

    delay the development of rheumatoid arthritis in people with

    undifferentiated inflammatory arthritis.

  • In April, ORENCIA®

    was approved by the FDA for treatment of juvenile rheumatoid

    arthritis. Additionally, the U.S. label for ORENCIA®

    was revised with an indication that means ORENCIA®

    is an appropriate option for patients with moderate-to-severe

    rheumatoid arthritis, regardless of prior treatment received.

  • At the annual scientific sessions of the American Diabetes

    Association, a phase III study demonstrated that saxagliptin produced

    significant reductions in key measures of glucose control in

    treatment-naïve people with type 2 diabetes

    compared to placebo.

DISCONTINUED OPERATIONS

The company agreed to sell the ConvaTec business for approximately $4.1

billion, subject to customary post closing adjustments, to Avista

Capital Partners L.P. and Nordic Capital Fund VII in April 2008. The

company expects to close the divestiture agreement by August 2008. The

results of the ConvaTec business are included in income from

discontinued operations, net of tax, for all periods presented.

2008 GUIDANCE

Bristol-Myers Squibb reaffirms its 2008 earnings guidance for fully

diluted earnings per share from continuing operations on a GAAP basis to

be between $1.36 and $1.46. The company also reaffirms its 2008 fully

diluted earnings per share from continuing operations guidance on a

non-GAAP basis to be between $1.60 and $1.70. The non-GAAP guidance

excludes specified items as discussed under Use

of Non-GAAP Financial Information. Details

reconciling adjusted non-GAAP amounts with the amounts reflecting

specified items are provided in supplemental materials available on the

companys website.

The company reaffirms guidance that it expects non-GAAP earnings per

share from continuing operations to grow at a minimum of 15 percent

compounded annual growth rate, from the 2007 base through 2010 without

rebasing for the agreement to sell the ConvaTec business, excluding

costs associated with the Productivity Transformation Initiative and

other specified items that have not yet been identified and quantified.

The 2008 guidance and the three-year compound annual growth rate exclude

other specified items such as gains or losses from sale of businesses

and product lines; from sale of equity investments and from

discontinuations of 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; payments for in-process

research and development; debt retirement costs; impairments to

investments; and significant tax events.

The financial guidance for 2008 and the three-year compound annual

growth rate exclude the impact of any potential strategic acquisitions

and divestitures and further assume that the company and its product

partner, sanofi-aventis, maintain U.S. exclusivity for the PLAVIX®

patent through at least 2010.

Use of Non-GAAP Financial Information

This press release contains non-GAAP financial measures, including

non-GAAP earnings and 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

and the companys strategy for Mead Johnson

Nutritionals; gains or losses from sale and leaseback of properties and

from discontinuations of operations; restructuring and other exit costs;

accelerated depreciation charges; asset impairments; charges relating to

significant legal proceedings; upfront and milestone payments for

in-licensing of products that have not achieved regulatory approval that

are immediately expensed; payments for in-process research and

development; impairments to investments; and significant tax events.

This information is intended to enhance an investors

overall understanding of the companys past

financial performance and prospects for the future. For example,

non-GAAP earnings and earnings per share information is an indication of

the companys baseline performance before

items that are considered by the company to be not reflective of the

companys 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 companys 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, market factors (including whether uncertainties in the credit

and capital markets or a further deterioration of these markets will

lead to future impairments to the companys

investment portfolio), 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 and governmental laws and regulations

related to Medicare, Medicaid and healthcare reform, 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, including whether Apotex will prevail

in its appeal of the District courts

decision in the PLAVIX®

patent litigation. These factors also include the companys

ability to execute successfully its strategic plans, including its

productivity transformation initiatives, the expiration of patents or

data protection on certain products (including the recent expiration of

data protection for PLAVIX®

in the European Union), 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 pharmaceutical and related health care

products company whose mission is to extend and enhance human life.

There will be a conference call on July 24, 2008 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 www.bms.com/ir

or by dialing 913-312-0976, confirmation code 2526349. 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 Systems Incorporated

BRISTOL-MYERS SQUIBB COMPANY

NET SALES BY OPERATING SEGMENTS

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2008 AND 2007

(Unaudited, dollars in millions)

 

Three Months
Ended June 30,

 

Six Months
Ended June 30,

2008

 

2007

2008

 

2007

 

Pharmaceuticals

$

4,475

$

3,851

$

8,663

$

7,308

 

Nutritionals

 

728

 

 

620

 

 

1,431

 

 

1,226

 

Net Sales

$

5,203

 

$

4,471

 

$

10,094

 

$

8,534

BRISTOL-MYERS SQUIBB COMPANY

SELECTED PRODUCTS

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2008 AND 2007

(Unaudited, dollars in millions)

 

The following table sets forth worldwide and U.S. reported net

sales for selected products for the three and six months ended

June 30, 2008 compared to the three and six months ended June 30,

2007.  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

%

%

Prescriptions

2008

2007

Change

2008

2007

Change

vs. 2007

 

Three Months
Ended June 30,

 

Pharmaceuticals

Cardiovascular

Plavix

$

1,387

$

1,189

17

%

$1,207

$ 1,015

19

%

11%

Avapro/Avalide

335

297

13

%

184

170

8

%

(8)%

Pravachol

69

132

(48

)%

10

47

(79

)%

(83)%

Virology

Reyataz

324

254

28

%

159

138

15

%

13%

Sustiva Franchise (total revenue)

282

233

21

%

171

147

16

%

13%

Baraclude

136

59

131

%

35

20

75

%

60%

Oncology

Erbitux

196

162

21

%

Bristol-Myers Squibb Company
Communications:
Brian Henry,

609-252-3337
Tracy Furey, 609-252-3208
or
Investor

Relations:
John Elicker, 212-546-3775
Suketu Desai,

609-252-5796

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