- Posts First Quarter 2007 GAAP EPS of $0.35 compared to $0.36 in 2006
- Posts First Quarter 2007 Non-GAAP EPS of $0.38 compared to $0.32 in 2006
- Company Raises 2007 Full-Year GAAP EPS Guidance to $1.24 to $1.34 and
Non-GAAP Guidance to $1.30 to $1.40 reflecting strong first quarter
performance and a lower forecasted tax rate
NEW YORK, April 26 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb
Company (NYSE: BMY) today reported financial results for the first quarter
of 2007 and raised earnings guidance for the full year.
Bristol-Myers Squibb posted first quarter 2007 net sales of $4.5
billion, compared to $4.7 billion for the same period in 2006. The company
reported first quarter 2007 net earnings of $690 million, or $0.35 per
diluted share, under U.S. Generally Accepted Accounting Principles (GAAP),
compared to $714 million, or $0.36 per diluted share for the same period in
2006. The company's first quarter 2006 results included a $200 million
pre-tax gain on the sale of the DOVONEX(R) assets. On a non-GAAP basis
excluding specified items, first quarter 2007 net earnings were $744
million, or $0.38 per diluted share, compared to $637 million, or $0.32 per
diluted share for the same period in 2006. The first quarter 2007 results
were driven by growth in demand for several pharmaceutical products, lower
than expected operating expenses and a favorable tax rate, including a tax
benefit due to a favorable resolution of certain tax matters.
"Our strong first quarter resulted from a combination of factors,
including increased demand for several of our pharmaceutical products,"
said Jim Cornelius, chief executive officer, Bristol-Myers Squibb.
"PLAVIX(R) performed better than expected, due to accelerated U.S.
prescription growth for the molecule as we continue to recapture market
share while remaining generic inventory is depleted. Our first-quarter
performance enables us both to reinvest in our key products and raise our
full-year earnings guidance by $0.12 and $0.10 on a GAAP and non-GAAP
basis, respectively."
NEW PRODUCT AND PIPELINE DEVELOPMENTS
On April 26, the company and Pfizer Inc (Pfizer) announced a worldwide
collaboration to develop and commercialize apixaban, an anticoagulant
discovered by the company being studied for the prevention and treatment of
a broad range of venous and arterial thrombotic conditions. Terms of the
apixaban agreement include an upfront payment of $250 million by Pfizer to
the company. Pfizer will fund 60% of all development costs effective
January 1, 2007 going forward, and the company will fund 40%. The company
may also receive additional payments of up to $750 million based on
development and regulatory milestones. The companies will jointly develop
the clinical and marketing strategy of apixaban, and will share
commercialization expenses and profits/losses equally on a global basis. In
a separate agreement, the companies will also collaborate on the research,
development and commercialization of a Pfizer discovery program which
includes advanced pre- clinical compounds with potential applications for
the treatment of metabolic disorders, including obesity and diabetes.
Pfizer will be responsible for all research and early-stage development
activities for the metabolic disorders program, and the companies will
jointly conduct Phase III development and commercialization activities. The
company will make an upfront payment of $50 million to Pfizer as part of
this agreement. The companies will share all development and
commercialization expenses along with profits/losses on a 60%- 40% basis,
with Pfizer assuming the larger share of both expenses and profit/losses.
On March 22, the Committee for Medicinal Products for Human Use of the
European Medicines Agency granted a positive opinion on the company's
application for ORENCIA(R) in Europe for the treatment of rheumatoid
arthritis.
On April 25, the company announced that the U.S. Food and Drug
Administration (FDA) approved an update to the ORENCIA(R) product labeling
regarding the progression of structural joint damage -- an important
measure in the treatment of rheumatoid arthritis (RA). The indication was
strengthened from "slowing" to "inhibiting" the progression of structural
damage in adult patients with moderately to severely active RA who have had
an inadequate response to one or more disease-modifying anti-rheumatic
drugs, such as methotrexate or tumor necrosis factor antagonists.
On April 18, the FDA's Cardio-Renal Advisory Committee voted
unanimously to recommend approval of a new indication for AVALIDE(R), as
initial treatment of hypertension. AVALIDE(R), a fixed-dose combination of
irbesartan and hydrochlorothiazide, is currently approved for the treatment
of hypertension, for hypertensive patients with blood pressure uncontrolled
on monotherapy. If approved, the new indication for AVALIDE(R) would be for
the first-line treatment of hypertension in patients who are unlikely to
obtain their blood pressure goals on monotherapy.
On February 5, Bristol-Myers Squibb and ImClone announced that an
application was submitted to the Japanese Pharmaceuticals and Medical
Devices Agency for the use of ERBITUX(R) in treating patients with advanced
colorectal cancer. The Japanese submission was based on results from
studies conducted in Europe and Japan which confirm the activity of
ERBITUX(R) in patients with metastatic colorectal cancer. The filing in
Japan is a result of a development collaboration between Bristol-Myers
Squibb, ImClone and Merck KGaA of Darmstadt, Germany.
In February, BARACLUDE(R) was added to the American Association for the
Study of Liver Disease treatment guidelines for hepatitis B as a first-line
treatment option. BARACLUDE(R) also received approval and/or reimbursement
in additional key European markets throughout the first quarter, including
Italy.
SPRYCEL(TM) received approval and/or reimbursement in additional
European markets, including Ireland, Norway, Sweden and Greece during the
first quarter, and was also approved in Canada and New Zealand.
FIRST QUARTER RESULTS
-- First quarter 2007 net sales decreased 4% to $4.5 billion compared to
the same period in 2006. U.S. net sales decreased 5% to $2.5 billion
for the quarter compared to 2006, while international net sales
remained constant at $2.0 billion, including a 5% favorable foreign
exchange impact.
-- Cost of products sold, as a percentage of net sales, decreased to 31.1%
in the first quarter of 2007 compared to 31.6% in the same period in
2006. This decrease was due primarily to lower charges for asset
impairment and accelerated depreciation in the current year and sales
growth of higher margin products, partially offset by $24 million of
certain costs, which were reported in marketing, selling and
administrative expenses in the same period in 2006.
-- Marketing, selling and administrative expenses decreased by 6% to $1.2
billion in the first quarter of 2007 compared to the same period in
2006, including a 2% decrease resulting from the above-mentioned
classification in 2006, lower expenses for PRAVACHOL(R) and lower U.S.
selling expenses.
-- Advertising and product promotion spending decreased by 9% to $269
million in the first quarter of 2007 from $295 million in the same
period in 2006, driven primarily by lower spending within the
pharmaceutical business.
-- Research and development expenses increased by 8% to $807 million in
the first quarter of 2007 from $750 million in the same period in 2006.
This increase primarily reflects higher licensing up-front payments and
continued investments in late-stage compounds, partially offset by an
alliance partner's share of codevelopment costs related to saxagliptin
and dapagliflozin.
INCOME TAXES
The effective income tax rate on earnings before minority interest and
income taxes was 9.4% in the first quarter of 2007 compared to 27.5% in the
first quarter of 2006. The first quarter 2007 effective tax rate included
$105 million of benefit due to a favorable resolution of certain tax
matters, including a $39 million benefit related to a prior year specified
item.
SPECIFIED ITEMS
In the three months ended March 31, 2007 and 2006, the company recorded
specified income and expense items that affected the comparability of the
results.
The pre-tax specified items before minority interest in 2007 included:
-- $80 million in upfront payments
-- $53 million of charges primarily related to downsizing and streamlining
of worldwide operations and accelerated depreciation
In addition, a benefit of $39 million was recognized to reflect a
change in estimate for taxes on a prior year specified item.
The pre-tax specified items in 2006 included:
-- $51 million of charges primarily related to asset impairment,
accelerated depreciation, and downsizing and streamlining of worldwide
operations
-- $40 million charge related to commercial litigation matters
-- $18 million for an upfront payment
-- $200 million gain on the sale of assets related to DOVONEX(R), a
product for the treatment for psoriasis
-- $21 million income from an insurance recovery related to previously
settled litigation matters
For additional information on specified items, see Appendix 1. Details
reconciling these non-GAAP amounts with GAAP amounts including specified
items are provided in supplemental materials available on the company's
website.
PHARMACEUTICALS
Worldwide pharmaceutical sales decreased 7%, including a 2% favorable
foreign exchange impact, to $3.5 billion in the first quarter of 2007
compared to the same period in 2006.
U.S. pharmaceutical sales decreased 6% to $1.9 billion in the first
quarter of 2007 compared to the same period in 2006, largely due to the
loss of exclusivity of PRAVACHOL(R) and lower sales of PLAVIX(R), partially
offset by continued growth of other key products and sales of newer
products ORENCIA(R) and SPRYCEL(TM). In aggregate, estimated U.S.
wholesaler inventory levels of the company's key pharmaceutical products
sold by the U.S. Pharmaceutical business at the end of the first quarter
decreased to less than two and a half weeks.
International pharmaceutical sales decreased 7%, including a 4%
favorable foreign exchange impact, to $1.5 billion for the first quarter of
2007 compared to the same period in 2006. The decrease was due primarily to
a decline in PRAVACHOL(R) and TAXOL(R) sales resulting from increased
generic competition, partially offset by strong sales growth in REYATAZ(R),
BARACLUDE(R), ABILIFY(R) and SPRYCEL(TM). The company's reported
international sales do not include copromotion sales reported by its
alliance partner, sanofi-aventis, for PLAVIX(R) and AVAPRO(R)/AVALIDE(R),
which continue to show growth in the first quarter of 2007 compared to the
same period in 2006.
Product Sales
-- Sales of PLAVIX(R), a platelet aggregation inhibitor that is part of
the company's alliance with sanofi-aventis, decreased 5%, including a
1% favorable foreign exchange impact, to $938 million in the first
quarter of 2007 from $986 million in the same period in 2006. Sales of
PLAVIX(R) decreased 7% in the U.S. in the first quarter of 2007 to $787
million from $850 million in the same period in 2006. This was due to
the impact of residual sales of generic clopidogrel bisulfate,
partially offset by the replenishment of branded PLAVIX(R) inventory in
the distribution channels. U.S. PLAVIX(R) net sales in the first
quarter of 2007 have increased by 129% compared to $343 million in the
fourth quarter of 2006 as generic clopidogrel bisulfate inventory in
the distribution channels is depleted. The company estimates the
adverse effect of the at-risk launch of generic clopidogrel bisulfate
to be in the range of $300 million to $350 million for the first
quarter of 2007. Estimated total U.S. prescription demand for
clopidogrel bisulfate (branded and generic) increased by 18% in the
first quarter of 2007 compared to 2006, while estimated total U.S.
prescription demand for branded PLAVIX(R) decreased by 28% in the same
period.
-- Sales of AVAPRO(R)/AVALIDE(R), an angiotensin II receptor blocker for
the treatment of hypertension, also part of the sanofi-aventis
alliance, increased 16%, including a 2% favorable foreign exchange
impact, to $270 million in the first quarter of 2007 from $233 million
in the same period in 2006. U.S. sales increased 17% to $163 million
in the first quarter of 2007 from $139 million in the same period in
2006, primarily due to higher average net selling prices compared to
the first quarter of 2006. Estimated total U.S. prescription demand
decreased approximately 1% compared to 2006. International sales
increased 14%, including a 5% favorable foreign exchange impact, to
$107 million in the first quarter of 2007 from $94 million in the same
period in 2006.
-- Total revenue for ABILIFY(R), an antipsychotic agent for the treatment
of schizophrenia, acute bipolar mania and bipolar disorder, increased
29%, including a 2% favorable foreign exchange impact, to $366 million
in the first quarter of 2007 from $283 million in the same period in
2006. U.S. sales increased 27% to $293 million in the first quarter
2007 from $231 million in the same period in 2006, primarily due to
higher demand and higher average net selling prices. Estimated total
U.S. prescription demand increased approximately 14% compared to the
same period last year. International sales continued to gain momentum,
increasing 40%, including a 10% favorable foreign exchange impact, to
$73 million in the first quarter of 2007 from $52 million in the same
period in 2006. Total revenue for ABILIFY(R) primarily consists of
alliance revenue representing the company's 65% share of net sales in
countries where it copromotes with Otsuka Pharmaceutical Co., Ltd.
-- Sales of REYATAZ(R), a protease inhibitor for the treatment of human
immunodeficiency virus (HIV), increased 27%, including a 3% favorable
foreign exchange impact, to $263 million in the first quarter of 2007
from $207 million in the same period in 2006. U.S. sales increased 20%
to $143 million in the first quarter of 2007 from $119 million in the
same period in 2006, primarily due to higher demand. Estimated total
U.S. prescription demand increased approximately 17% compared to 2006.
International sales increased 36%, including a 7% favorable foreign
exchange impact, to $120 million in the first quarter of 2007 from $88
million in the same period in 2006, primarily due to increased demand
in Europe, Latin America and Canada.
-- Sales of ERBITUX(R), which is sold by the company almost exclusively in
the U.S., increased 16% to $160 million in the first quarter of 2007
from $138 million in the same period in 2006, due to increased demand
for usage in the treatment of head and neck cancer. ERBITUX(R) net
sales have decreased by 4% compared to the fourth quarter of 2006
reflecting increased competition in the colorectal cancer market.
ERBITUX(R) is marketed by the company under a distribution and
copromotion agreement with ImClone.
-- Total revenue for the SUSTIVA(R) Franchise, a non-nucleoside reverse
transcriptase inhibitor for the treatment of HIV, increased 29%,
including a 4% favorable foreign exchange impact, to $226 million in
the first quarter of 2007 from $175 million in the same period in 2006.
Estimated total U.S. prescription growth increased approximately 25%
compared to 2006. Total revenue for the SUSTIVA(R) Franchise includes
sales of SUSTIVA(R) as well as revenue from bulk efavirenz included in
the combination therapy ATRIPLA(TM), which is sold through a joint
venture with Gilead Sciences, Inc.
-- Sales of BARACLUDE(R), an oral antiviral agent for the treatment of
chronic hepatitis B, increased to $45 million in the first quarter of
2007 from $11 million in the same period in 2006, as the product
becomes commercialized in international markets and continues to grow
in the U.S.
-- Sales of ORENCIA(R), a fusion protein indicated for adult patients with
moderate to severe rheumatoid arthritis, increased to $41 million in
the first quarter of 2007 from $5 million in the same period in 2006.
ORENCIA(R) was launched in the U.S. in February 2006 and Canada in
August 2006.
-- Sales for SPRYCEL(TM), an oral inhibitor of multiple tyrosine kinases,
were $21 million in the first quarter of 2007, compared to $14 million
in fourth quarter of 2006. SPRYCEL(TM) was launched in the U.S. in
July 2006 and in certain European markets beginning in the fourth
quarter of 2006.
-- Sales of PRAVACHOL(R), an HMG Co-A reductase inhibitor, decreased 75%,
including a 1% favorable foreign exchange impact, to $135 million in
the first quarter of 2007 from $536 million in the same period in 2006,
due to loss of market exclusivity resulting in generic competition for
most strengths in the U.S. beginning in April 2006, and generic
competition in key European markets, including France beginning in July
2006.
-- Sales of TAXOL(R), an anti-cancer agent sold almost exclusively in non-
U.S. markets, decreased 24%, including a 1% favorable foreign exchange
impact to $111 million in the first quarter of 2007 from $147 million
in the same period in 2006, primarily due to increased generic
competition in Europe and generic entry in Japan during the third
quarter of 2006.
HEALTH CARE GROUP
The combined first quarter 2007 revenues from the Health Care Group
increased 4% to $1.0 billion compared to the same period in 2006.
Nutritionals
-- Worldwide Nutritional sales increased 7%, including a 2% favorable
foreign exchange impact, to $606 million in the first quarter of 2007
from $565 million in the same period in 2006. U.S. Nutritional sales
increased 11% to $274 million in the first quarter of 2007, primarily
due to increased sales of ENFAMIL(R), the company's best-selling infant
formula. International Nutritional sales increased 4% to $332 million
in the first quarter of 2007, including a 3% favorable foreign exchange
impact.
Other Health Care
-- Worldwide ConvaTec sales increased 10%, including a 5% favorable
foreign exchange impact, to $254 million in the first quarter of 2007
from $230 million in the same period in 2006. Sales of wound
therapeutic products increased 9%, including a 5% favorable foreign
exchange impact, to $107 million in the first quarter of 2007 from $98
million in the same period in 2006, primarily due to continued growth
of AQUACEL(R).
-- Worldwide Medical Imaging sales decreased 12% to $159 million in the
first quarter of 2007 from $181 million in the same period in 2006,
primarily due to higher sales in 2006 for Technetium Tc99m Generators
and a 4% decrease for CARDIOLITE(R) primarily due to lower U.S. average
selling prices.
2007 GUIDANCE
Bristol-Myers Squibb raises its 2007 earnings guidance for
fully-diluted earnings per share from continuing operations on a GAAP basis
to be between $1.24 and $1.34 from the previous guidance of $1.12 to $1.22.
The company also raises its 2007 fully-diluted earnings per share
guidance on a non-GAAP basis to be between $1.30 and $1.40 from the
previous guidance of $1.20 to $1.30, reflecting strong first quarter
performance and a lower forecasted tax rate. 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
company's website.
The company expects generic clopidogrel bisulfate that was sold into
distribution channels following the Apotex at-risk launch in August 2006
will continue to have a declining residual impact on PLAVIX(R) net sales
and the company's overall financial results at least through the second
quarter of 2007. While the company cannot estimate with certainty the full
amount and duration of the impact, the potential variability around the
estimate of the impact has been factored into the company's 2007 guidance
range, assuming the absence of renewed or additional generic competition.
For 2007, the company expects reductions of net sales for products that
have lost exclusivity in previous years to moderate to a range between $900
million and $1.0 billion, as compared to $1.4 billion in 2006, and $1.3
billion in 2005. While the company expects generic clopidogrel bisulfate
inventory in the market to have a continued residual impact on 2007
PLAVIX(R) net sales, the company does expect PLAVIX(R) net sales and
earnings growth in 2007, assuming the absence of renewed or additional
generic competition. The company expects increased prescription demand for
PLAVIX(R) as well as for other key brands and newly launched products.
Compared to 2006, the gross margin is expected to improve due to net sales
growth of higher margin products, lower margin erosion related to
exclusivity losses, and manufacturing efficiencies. Marketing, selling and
administrative expense is expected to remain relatively unchanged as the
company continues to focus on high value primary care and specialist
physicians and implements various productivity initiatives. The company
expects to continue to increase investments to develop additional new
compounds and support the introduction of new products.
The company and its subsidiaries are the subject of a number of
significant pending lawsuits, claims, proceedings and investigations in
addition to the pending PLAVIX(R) litigation, described below. It is not
possible at this time reasonably to assess the final outcome of these
investigations or litigations. Management continues to believe, as
previously disclosed, that the aggregate impact, beyond current reserves,
of the pending PLAVIX(R) patent litigation, these other litigations and
investigations and other legal matters affecting the company is reasonably
likely to be material to the company's results of operations and cash
flows, and may be material to its financial condition and liquidity. The
company's GAAP and non-GAAP guidance for 2007 described above does not
reflect the potential impact of either the pending PLAVIX(R) patent
litigation as described below or the impact of any other legal matters on
the company's results of operations for 2007, beyond current reserves for
ongoing matters.
As previously disclosed, the composition of matter patent for
PLAVIX(R), which expires in 2011, is subject to litigation in the U.S. with
Apotex. The trial testimony ended on February 15, 2007 and the parties are
awaiting the court's decision. If Apotex were to prevail in the trial in
the patent litigation, the company would expect to face renewed generic
competition for PLAVIX(R) promptly thereafter. There are other pending
PLAVIX(R) patent litigations in the United States and in other less
significant markets for the product. The company continues to believe that
the PLAVIX(R) patents are valid and infringed, and with its alliance
partner, sanofi-aventis, is vigorously pursuing these cases.
It is not possible at this time reasonably to assess the ultimate
outcome of the patent litigation with Apotex or of the other PLAVIX(R)
patent litigations, or the timing of any renewed generic competition for
PLAVIX(R) from Apotex or additional generic competition for PLAVIX(R) from
other generic pharmaceutical companies. Loss of market exclusivity of
PLAVIX(R) and/or the development of sustained generic competition would be
material to the company's sales of PLAVIX(R), results of operations and
cash flows, and could be material to the company's financial condition and
liquidity. PLAVIX(R) is the company's largest product by net sales, and
U.S. net sales for PLAVIX(R) were $2.7 billion and $3.2 billion in 2006 and
2005, respectively.
As previously disclosed, the Antitrust Division of the United States
Department of Justice (DOJ) is conducting a criminal investigation into the
proposed settlement and the company has received a Civil Investigative
Demand by the Federal Trade Commission (FTC) requesting documents related
to the proposed settlement. In addition, on April 13, 2007, the company
received a subpoena from the New York State Attorney General's Office --
Antitrust Bureau for documents relating to the proposed PLAVIX(R)
settlement. The company is cooperating fully with the investigations. It is
not possible at this time reasonably to assess the outcome of the
investigations or its impact on the company. It is also not possible at
this time reasonably to assess the impact of the investigations, if any, on
the company's compliance with the Deferred Prosecution Agreement (DPA) with
the United States Attorney's Office for the District of New Jersey.
As previously disclosed, in December 2006, the company, the DOJ and the
Office of the United States Attorney for the District of Massachusetts have
reached an agreement in principle, subject to approval by the DOJ, to
settle several investigations involving the company's drug pricing, and
sales and marketing activities. The agreement in principle provides for a
civil resolution and an expected payment of $499 million, which is fully
reserved. There would be no criminal charges against the company. The
agreement in principle also provides for the company to enter into a
corporate integrity agreement with the Office of Inspector General of the
U.S. Department of Health and Human Services. The settlement is contingent
upon the parties' agreement to the terms of a final settlement agreement,
including on the terms of the corporate integrity agreement, and approval
by the DOJ. There can be no assurance that the settlement will be
finalized.
For additional discussion of legal matters, including the PLAVIX(R)
patent litigation, the Antitrust Division investigation related to the
proposed settlement with Apotex and the terms of the DPA and SEC Consent,
see "Item 1. Financial Statements Note 21. Legal Proceedings and
Contingencies," and "Management's Discussion and Analysis -- SEC Consent
Order and Deferred Prosecution Agreement" in the company's Form 10-K Annual
Report for the fiscal year ended December 31, 2006.
Use of Non-GAAP Financial Information
This press release contains 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 earnings but excluded
for purposes of determining adjusted earnings are: gains or losses from
sale of businesses and product lines; from sale or write-down of equity
investments and from discontinuations of operations; restructuring items
that meet the requirements of SFAS 112 for severance and SFAS 146 for other
exit costs; accelerated depreciation charges under SFAS 144 related to
restructuring items described above; 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; copromotion or alliance charges and
payments for in-process research and development which under GAAP are
immediately expensed rather than amortized over the life of the agreement;
income from upfront and milestone payments that is immediately recognized
for out-licensing of products, including deferred income recognized upon
termination; costs of early debt retirement; 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, a non-GAAP 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 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, 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, changes in, and
interpretation of, governmental regulations and legislation affecting
domestic or foreign operations, including tax obligations, difficulties and
delays in product development, manufacturing and sales, patent positions
and the unpredictability of the ultimate outcome of any litigation matter,
including whether the company will prevail at trial in the patent
litigation with Apotex, as well as any risks associated with the criminal
investigation conducted by the Department of Justice, the civil
investigation conducted by the Federal Trade Commission, or the
investigation conducted by the New York State Attorney General's Office in
connection with the proposed settlement with Apotex, and the launch of a
generic clopidogrel bisulfate product by Apotex, including the amount of
generic product distributed and the rate at which it will be utilized by
prescription demand, and the time-period in which it will impact the
company's results. These factors also include the ability to realize
projected cost savings and the expiration of patents on certain other
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 current reports on Form 8-K, quarterly reports
on Form 10-Q and the annual report on Form 10-K, furnished to and filed
with 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 April 26, 2007 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
webcast of the call at http://www.bms.com/ir or by dialing 913-981-4911. Materials
related to the call will be available at the same website prior to the
call.
For more information, contact: Tony Plohoros, 212-546-4379,
Communications, Jeff Macdonald, 212-546-4824, Communications, or John
Elicker, 212-546-3775, or Blaine Davis, 212-546-4631, Investor Relations.
ABILIFY(R) is the trademark of Otsuka Pharmaceutical Co., Ltd.
AVAPRO(R), AVALIDE(R) and PLAVIX(R) are trademarks of sanofi-aventis
Erbitux(R) is a trademark of ImClone Systems Incorporated
ATRIPLA(TM) is a trademark of both Bristol-Myers Squibb Co. and Gilead
Sciences, Inc.
BRISTOL-MYERS SQUIBB COMPANY
NET SALES BY OPERATING SEGMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2007 AND 2006
(Unaudited, dollars in millions)
Three Months
Ended March 31,
2007 2006
Pharmaceuticals $3,457 $3,700
Nutritionals 606 565
Other Health Care 413 411
Health Care Group 1,019 976
Net Sales $4,476 $4,676
BRISTOL-MYERS SQUIBB COMPANY
SELECTED PRODUCTS
FOR THE THREE MONTHS ENDED MARCH 31, 2007 AND 2006
(Unaudited, dollars in millions except prescription data)
The following table set forth worldwide and U.S. reported net sales for
selected products for the three months ended March 31, 2007 compared to the
three months ended March 31, 2006. 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.
Three Months Ended March 31,
Worldwide Net Sales U.S. Net Sales
% Change in
U.S. Total
% % Prescriptions
2007 2006 Change 2007 2006 Change vs. 2006
Pharmaceuticals
Cardiovascular
Plavix $938 $986 (5)% $787 $850 (7)% (28)%
Pravachol 135 536 (75)% 57 302 (81)% (86)%
Avapro/Avalide 270 233 16% 163 139 17% (1)%
Coumadin 46 55 (16)% 38 47 (19)% (17)%
Virology
Reyataz 263 207 27% 143 119 20% 17%
Sustiva Franchise
(total revenue) 226 175 29% 144 108 33% 25%
Baraclude 45 11 ** 17 9 89% 127%
Oncology
Erbitux 160 138 16% 158 136 16% N/A
Taxol 111 147 (24)% 4 4 -- N/A
Sprycel 21 -- -- 10 -- -- N/A
Affective
(Psychiatric)
Disorders
Abilify
(total
revenue) 366 283 29% 293 231 27% 14%
Immunoscience
Orencia 41 5 ** 40 5 ** N/A
Other
Pharmaceuticals
Efferalgan 81 68 19% -- -- -- N/A
Nutritionals
Enfamil 254 237 7% 171 155 10% N/A
Enfagrow 72 67 7% -- -- -- N/A
Other Health
Care
Ostomy 130 123 6% 34 34 -- N/A
Wound
Therapeutics 107 98 9% 32 30 7% N/A
Cardiolite 99 103 (4)% 87 91 (4)% N/A
** Change is in excess of 200%
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENT OF EARNINGS
FOR THE THREE MONTHS ENDED MARCH 31, 2007 AND 2006
(Unaudited, dollars in millions except per share data)
Three Months Ended March 31,
2007 2006
Net Sales $4,476 $4,676
Cost of products sold 1,392 1,476
Marketing, selling and administrative 1,158 1,238
Advertising and product promotion 269 295
Research and development 807 750
Provision for restructuring, net 37 1
Litigation income, net -- (21)
Gain on sale of product asset -- (200)
Equity in net income of affiliates (126) (93)
Other expense, net (a) 22 37
3,559 3,483
Earnings Before Minority Interest and
Income Taxes 917 1,193
Provision for income taxes 86 328
Minority interest, net of taxes 141 151
Net Earnings $690 $ 714
Earnings per Common Share:
Basic $0.35 $0.36
Diluted $0.35 $0.36
Average Common Shares Outstanding:
Basic 1,962 1,957
Diluted 1,997 1,988
(a) Other expense, net
Interest expense $109 $116
Interest income (53) (62)
Foreign exchange transaction losses/(gains) 8 (12)
Other, net (42) (5)
$22 $37
APPENDIX 1
BRISTOL-MYERS SQUIBB COMPANY
SPECIFIED ITEMS
FOR THE THREE MONTHS ENDED MARCH 31, 2007 AND 2006
(Unaudited, dollars in millions)
Three months ended March 31, 2007
Provision for
Cost of Research and restructuring,
products sold development net Total
Upfront payments $-- $80 $-- $80
Downsizing and
streamlining of
worldwide operations -- -- 37 37
Accelerated depreciation 16 -- -- 16
$ 16 $80 $37 133
Income taxes on items
above (40)
Change in estimate for
taxes on a prior year
specified item (39)
Reduction to Net Earnings $54
Three months ended March 31, 2006
Cost Re- Marketing, Provision Litiga- Other Gain on
of search selling for tion expense, sale of
prod- and and restruct- settle- net prod-
ucts develop- admin uring, ment uct Total
sold ment net income asset
Litigation
Matters:
Insurance
recovery $-- $-- $-- $-- $(21) $-- $-- $ (21)
Commercial
litigations -- -- -- -- -- 40 -- 40
-- -- -- -- (21) 40 -- 19
Other:
Accelerated
depreciation
and asset
impairment 46 -- 4 -- -- -- -- 50
Upfront
payments -- 18 -- -- -- -- -- 18
Downsizing
and
stream-
lining of
worldwide
operations -- -- -- 1 -- -- -- 1
Gain on
sale of
product
asset -- -- -- -- -- -- (200) (200)
$46 $18 $4 $1 $(21) $40 $ (200) (112)
Income
taxes on
items
above 48
Minority
interest,
net of
taxes
(13)
Increase
to Net
Earnings $ (77)
SOURCE Bristol Myers Squibb Company
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Related links:
http://www.bms.com
http://www.bms.com/ir
CONTACT:
Media: Tony Plohoros, Communications,
+1-212-546-4379, tony.plohoros@bms.com, or Investors: John
Elicker, Investor Relations, +1-212-546-3775,
john.elicker@bms.com, or Blaine Davis, Investor Relations,
+1-212-546-4631, blaine.davis@bms.com, all of Bristol Myers
Squibb Company
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