(Source: Business Wire)

Bristol-Myers
Squibb Company (NYSE:BMY) today reported strong sales and earnings
growth for the third quarter 2009.
"The performance in the third quarter of 2009 clearly shows the results
of our outstanding business performance, disciplined financial
management and overall strategic execution," said James
M. Cornelius, chairman and chief executive officer. "We are
transforming Bristol-Myers Squibb into a BioPharma leader and the recent
approval and launch of ONGLYZA
for the treatment of type 2 diabetes is a great example of what we do
best: discover, develop and deliver innovative medicines that help
patients prevail over serious diseases.
"As part of our transformation, we are continuing to advance our String
of Pearls strategy and I'm pleased to see that we've rapidly
integrated Medarex into our R&D organization. Since formally acquiring
Medarex in September, its scientific leadership, clinical assets and
platform technologies have been a welcome addition as we work toward
becoming a leader in immuno-oncology."
Third Quarter Performance
2009 2008 Change
Net Sales $ 5,487 $ 5,254 4%
Net Earnings from Continuing Operations $ 966 $ 588 64%
GAAP Diluted EPS from Continuing Operations 0.48 0.29 66%
Non-GAAP Diluted EPS from Continuing Operations 0.52 0.45 16%
($ amounts in millions, except per share amounts)
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THIRD QUARTER FINANCIAL RESULTS
Bristol-Myers Squibb posted third quarter 2009 net sales from
continuing operations of $5.5 billion, an increase of 4%, or 7%
excluding foreign exchange impact, compared to the same period in 2008.
Gross profit improved to 71.5% of net sales in the third quarter 2009
compared to 68.9% in 2008. The improvement was driven by higher
biopharmaceutical average prices, realized manufacturing efficiencies,
including savings from continuous improvement efforts, favorable
foreign exchange impact and favorable worldwide product mix.
Marketing, selling and administrative expenses decreased by 8%, or 5%
excluding foreign exchange impact, to $1.1 billion in the third
quarter of 2009 compared to the same period in 2008, primarily due to
a continued reduction in general and administrative expenses through
continuous improvement initiatives.
Advertising and product promotion spending was flat or increased 3%
excluding foreign exchange impact, to $361 million in the third
quarter of 2009 compared to 2008.
Research and development expenses were relatively flat or increased 2%
excluding foreign exchange impact, to $838 million in the third
quarter of 2009 compared to the same period in 2008.
The effective tax rate on earnings from continuing operations was
25.2% for the third quarter compared to 26.7% in 2008.
The company reported third quarter net earnings from continuing
operations attributable to Bristol-Myers Squibb Company of $966
million or $0.48 per diluted share, compared to $588 million or $0.29
per diluted share for the same period in 2008.
The company reported third quarter non-GAAP net earnings from
continuing operations attributable to Bristol-Myers Squibb Company of
$1,046 million or $0.52 per diluted share, compared to $910 million or
$0.45 per diluted share for the same period in 2008. An overview of
specified items is discussed under "Use of Non-GAAP Financial
Information."
Cash, cash equivalents and marketable securities were $7.9 billion as
of September 30, 2009. The company maintains a strong net cash
position of $1.3 billion. This takes into account the $2.1 billion net
impact of the Medarex acquisition. Cash flow from operating activities
amounted to $1.5 billion during the third quarter of 2009 and the
company remains focused on strengthening its balance sheet and
maintaining financial flexibility. Based on Mead Johnson Nutrition
Company's announcement today that it is considering options to
refinance its outstanding intercompany debt, Bristol-Myers Squibb
expects to receive approximately $1.75 billion in cash upon closing of
the refinancing.
SEGMENT RESULTS
BioPharmaceuticals
BioPharmaceuticals net sales totaled $4.8 billion in the third quarter
of 2009, representing an increase of 6%, or 9% excluding foreign
exchange impact, compared to the same period in 2008. U.S.
BioPharmaceuticals net sales increased 12% to $3.0 billion in the
third quarter of 2009 compared to 2008. International
BioPharmaceuticals net sales decreased 2%, or increased 5% excluding
foreign exchange impact, to $1.8 billion.
Sales growth in the third quarter was led by continued sales
increases for PLAVIX®
(+8%) and strong global sales growth for ABILIFY®
(+16%).
The virology portfolio continues to demonstrate worldwide sales
growth, led by BARACLUDE®
for hepatitis B (+33%), the Sustiva franchise (+7%) and REYATAZ®
for HIV (+5%).
ORENCIA®
and SPRYCEL®
grew worldwide 36% and 30%, respectively as compared to the same
period in 2008.
ERBITUX®
sales were down 3% compared to the third quarter 2008.
ONGLYZA®
has been launched in the U.S. and Europe and contributed
approximately $20 million in sales in the third quarter.
BioPharmaceuticals realized a 170 basis point increase in gross margin
compared to the third quarter of 2008. Key drivers of the improvement
were higher biopharmaceutical average price, cost savings, including
those related to continuous improvement initiatives, foreign exchange
favorability and product mix.
BioPharmaceuticals pre-tax earnings increased 19% to $1.2 billion in
the third quarter of 2009 compared to the same period in 2008. The
increase in earnings was driven by increased sales, improved gross
margins as well as reductions in marketing, selling and administrative
expenses from the company's continuous improvement initiatives.
Mead Johnson Nutrition Company
Mead Johnson's net sales totaled $699 million in the third quarter of
2009, representing a 6% decrease, or 2% excluding foreign exchange
impact, compared to the same period in 2008.
Bristol-Myers Squibb's share of Mead Johnson's earnings decreased by
20% to $127 million primarily due to the impact of items attributed to
the February 2009 initial public offering, including the 17% reduction
in ownership.
THIRD QUARTER PRODUCT AND PIPELINE
UPDATE
Metabolics/Cardiovascular
Bristol-Myers Squibb and AstraZeneca announced on July 31 that the
U.S. Food and Drug Administration (FDA) approved ONGLYZA®
(saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, for the
treatment of type 2 diabetes mellitus in adults. The companies also
announced on October 5 that the European Commission granted marketing
authorization for ONGLYZA.
In October, the company announced results of a 18-week Phase IIIb
study in adults with type 2 diabetes with inadequate glycemic control
on metformin therapy alone. The study showed that the addition of
treatment with ONGLYZA 5mg per day achieved the primary objective of
demonstrating non-inferiority compared to addition of treatment with
JANUVIA (sitagliptin) 100mg per day in reducing glycosylated
hemoglobin level (HbA1c) from baseline.
In October, the company also announced results from a 24-week Phase
III clinical study of the investigational drug dapagliflozin. The
study showed that dapagliflozin, added to metformin, demonstrated
significant mean reductions in the primary endpoint, HbA1c, and in the
secondary endpoint, fasting plasma glucose in patients with type 2
diabetes inadequately controlled with metformin alone, as compared to
placebo plus metformin. The study also showed that individuals
receiving dapagliflozin had statistically greater mean reductions in
body weight compared to individuals taking placebo.
Bristol-Myers Squibb and sanofi-aventis announced results of the
CURRENT OASIS-7 study at the European Society of Cardiology. The study
provided information about an intensified dose-regimen of PLAVIX® in
acute coronary syndrome (ACS) patients intended to undergo angioplasty.
While the study showed no added benefit on the composite primary
end-point (cardiovascular death, heart attack or stroke at 30
days) with the higher dose when the entire ACS study population
was considered, potentially medically relevant differences in
patient outcomes were observed in relevant subgroups pre-specified
for preliminary analysis, such as the percutaneous coronary
intervention group.
In July, the results of the apixaban ADVANCE-2 study were presented at
a late-breaking clinical trial session at the Congress of the
International Society of Thrombosis and Hemostasis. The study
demonstrated that apixaban was superior to the European regimen of
enoxaparin (standard of care) for reducing the risk of venous
thromboembolism in patients undergoing total knee replacement surgery
and showed lower observed bleeding rates compared to enoxaparin. The
study also showed that the overall safety profile for apixaban was
similar to enoxaparin.
Oncology
On September 23 at the European Cancer Organisation/European Society
of Medical Oncology Multidisciplinary Congress (ECCO/ESMO), data were
presented on two Phase III ERBITUX® studies in first-line metastatic
colorectal cancer patients.
A retrospective analysis of the Phase III CRYSTAL study
demonstrated that ERBITUX®, when added to a FOLFIRI chemotherapy
regimen, was shown to increase median overall survival in
first-line metastatic colorectal cancer (mCRC) patients compared
to those receiving FOLFIRI alone. In a subset of patients with
wild-type K-ras tumors, median overall survival was increased to
23.5 months in patients who received ERBITUX plus FOLFIRI compared
to 20 months for those taking FOLFIRI alone.
Another Phase III study of ERBITUX plus chemotherapy (primarily
capecitabine plus oxaliplatin) in first-line mCRC, known as COIN,
was conducted in the UK by the Medical Research Council. The COIN
study did not meet its primary endpoint of overall survival.
On July 20, the FDA approved revisions to the U.S. prescribing
information for ERBITUX® concerning treatment of patients with
epidermal growth factor receptor (EGFR)-expressing mCRC.
Immunology
The company announced on September 3 that the FDA had accepted, for
filing and review, the company's submission of a biologic license
application for belatacept, which is in ongoing Phase III development
for use in kidney transplantation. The Prescription Drug User Fee Act
(PDUFA) goal date for the FDA is May 1, 2010.
On August 26, the company announced that clinical data added to the
labeling for ORENCIA® support use of ORENCIA for patients with
moderate to severe rheumatoid arthritis of less than or equal to two
years duration. The efficacy and safety data further support use of
ORENCIA in new-to-biologic patients with moderate to severe rheumatoid
arthritis.
STRATEGIC UPDATE
Bristol-Myers Squibb completed its tender offer for the acquisition of
Medarex, Inc. on September 1. The acquisition positions Bristol-Myers
Squibb for long-term leadership in biologics; gives the company full
rights to a promising Phase III compound, ipilimumab; significantly
expands the company's oncology and immunology pipeline and provides
access to novel antibody discovery technology.
On September 15, Bristol-Myers Squibb announced the sale of its OTC
assets in Asia Pacific, excluding China and Japan, and shares in PT
Bristol-Myers Squibb Indonesia Tbk to Taisho Pharmaceutical Company Ltd.
for $310 million, due in the fourth quarter.
On October 1, the company sold its mature pharmaceutical brands and a
manufacturing facility in Australia to Sigma Pharmaceuticals Limited for
$62 million, also due in the fourth quarter.
2009 GUIDANCE
Bristol-Myers Squibb is raising its 2009 GAAP EPS from continuing
operations guidance to $1.72 to $1.77 and refining its non-GAAP EPS from
continuing operations guidance to $2.00 to $2.05. Key 2009 guidance
assumptions include mid single-digit revenue growth (high single digit
growth excluding foreign exchange); a full-year gross margin improvement
of approximately 200 basis points; advertising and promotion increase in
the low-to-mid single-digit range; marketing, sales and administrative
expense decrease in the low-to-mid single digits; research and
development expense growth in the mid single-digit range; and an
effective tax rate of approximately 25%.
The company reaffirms guidance that it expects non-GAAP earnings per
share from continuing operations attributable to the company to grow at
a minimum 15 percent compounded annual growth rate, from the 2007 base
through 2010 without rebasing for the sale of the ConvaTec business,
excluding the impact of any U.S. healthcare reforms, costs associated
with productivity transformation initiatives and other specified items
that have not yet been identified and quantified.
The financial guidance for 2009 and the three-year compound annual
growth rate include the impact of the company's acquisition of Medarex
and exclude any potential future strategic acquisitions and
divestitures. The acquisition of Medarex is expected to decrease the
company's earnings per share by $0.02 to $0.03 in 2009 and $0.07 to
$0.09 in 2010.
The non-GAAP 2009 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
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; debt retirement costs; impairments to
investments; and significant tax events.
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;
gains or losses from the purchase or sale of businesses and product
lines, including Medarex; 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 that are immediately expensed;
in-process research and development charges prior to 2009; impairments
to investments; 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 to be not 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, 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 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 appealing of the Circuit Court's decision in the PLAVIX® patent
litigation. 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 (including the 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 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 October 22, 2009 at 10:30 a.m. (ET)
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 913-312-1296, confirmation code 4883550. 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.