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, we’re
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 company’s
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
company’s 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 KAI’s 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
company’s 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 company’s 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 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 (including whether uncertainties in the credit
and capital markets or a further deterioration of these markets will
lead to future impairments to the company’s
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 court’s
decision in the PLAVIX®
patent litigation. These factors also include the company’s
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 |
|
Six Months |
|||||||||
|
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) |
|||||||||||||||||||
|
|
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|
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. |
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|
|
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|
Worldwide Net Sales |
U.S. Net Sales |
||||||||||||||||||
|
|
|
|
|
% Change |
|||||||||||||||
|
in U.S. Total |
|||||||||||||||||||
|
% |
% |
Prescriptions |
|||||||||||||||||
|
2008 |
2007 |
Change |
2008 |
2007 |
Change |
vs. 2007 |
|||||||||||||
|
|
|||||||||||||||||||
|
Three Months |
|||||||||||||||||||
|
|
|||||||||||||||||||
|
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 |
% |
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