Biogen Idec Reports Second Quarter 2008 Results
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28% Revenue Growth and 30% Earnings Growth
CAMBRIDGE, Mass.--(Business Wire)--
Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in
the discovery, development, manufacturing, and commercialization of
innovative therapies, today reported its second quarter 2008 results.
Second Quarter 2008 Highlights:
-- Second quarter revenues were $993 million, an increase of 28%
from $773 million in the second quarter of 2007, driven
primarily by AVONEX(R) (interferon beta-1a) sales up 14% to
$527 million, TYSABRI(R) (natalizumab) sales up 210% to $147
million, and RITUXAN(R) (rituximab) revenues from the
unconsolidated joint business arrangement up 21% to $279
million.
-- On a reported basis, calculated in accordance with accounting
principles generally accepted in the U.S. (GAAP), second
quarter 2008 diluted earnings per share (EPS) were $0.70, an
increase of 30% from $0.54 in the second quarter of 2007. GAAP
net income for the second quarter was $207 million, an
increase of 11% from $186 million in the second quarter of
2007.
-- Second quarter 2008 non-GAAP diluted EPS were $0.91, an
increase of 30% from $0.70 in the second quarter of 2007.
Non-GAAP net income for the second quarter was $269 million,
an increase of 12% from $240 million in the second quarter of
2007. A reconciliation of our GAAP to non-GAAP results is
included on Table 3 within this press release.
-- Global in-market net sales of TYSABRI(R) (natalizumab) in the
second quarter of 2008 were $200 million. Based on our
collaboration structure with Elan, Biogen Idec recognized
revenue of $147 million related to TYSABRI in the second
quarter of 2008.
"Our prospects for growth remain strong," said James Mullen,
Biogen Idec's Chief Executive Officer. "TYSABRI sales nearly tripled
compared to the same period last year, our core products continue to
grow, our pipeline is overflowing, and our revenues have grown more
than 25 percent year-over-year for three consecutive quarters. Given
the strong momentum underway, we are raising our full-year guidance
and setting an aspirational goal of generating a record $4 billion in
revenues this year."
Financial Performance
On a reported basis, calculated in accordance with GAAP, Biogen
Idec reported net income of $207 million and diluted EPS of $0.70 in
the second quarter of 2008. On a non-GAAP basis, Biogen Idec reported
net income of $269 million in the second quarter of 2008. Non-GAAP
diluted EPS were $0.91 for the second quarter of 2008.
As of June 30, 2008 Biogen Idec had cash, cash equivalents, loaned
securities and marketable securities of $1.583 billion.
A reconciliation of our GAAP to non-GAAP results is included on
Table 3 within this press release.
Revenue Performance
Revenues from AVONEX, one of Biogen Idec's therapies for patients
with relapsing forms of multiple sclerosis (MS), increased 14% in the
second quarter to $527 million. U.S. sales increased 13% to $306
million and international sales increased 15% to $221 million.
Revenues for the second quarter of 2008 included $279 million from
Biogen Idec's joint business arrangement related to RITUXAN, a
treatment for certain B-cell non-Hodgkin's lymphomas (NHL) and
rheumatoid arthritis (RA) that Biogen Idec co-promotes in the U.S.
with Genentech, Inc. All U.S. sales of RITUXAN are recognized by
Genentech, and Biogen Idec records its share of the pretax
co-promotion profits. As reported by Genentech, U.S. net sales of
RITUXAN were $651 million in the second quarter, as compared to $582
million in the second quarter of 2007.
During the second quarter of 2008, Biogen Idec recognized revenue
of $147 million related to TYSABRI comprising:
-- $46 million related to product sold through Elan in the U.S.
(based on $99 million of in-market sales); and
-- $101 million related to product sold by Biogen Idec
Internationally.
As of the end of June 2008, more than 31,800 patients were on
commercial and clinical TYSABRI therapy worldwide. According to data
available as of the end of June 2008:
-- In the U.S., more than 17,800 patients were on TYSABRI therapy
commercially and more than 3,100 physicians have prescribed
the therapy;
-- Outside of the U.S., nearly 13,400 patients were on TYSABRI
therapy commercially;
-- In global clinical trials, more than 600 patients were on
TYSABRI therapy; and
-- There have been no confirmed cases of progressive multifocal
leukoencephalopathy (PML) since re-launch in the US and the
first international approval in July 2006.
Cumulatively, in the combined clinical trial and post-marketing
settings:
-- More than 43,300 patients have been treated with TYSABRI; and
-- Of those patients, nearly 13,900 have received at least one
year of TYSABRI therapy and approximately 6,600 patients have
been on therapy for 18 months or longer.
Revenues from other products were $10 million and $9 million in
the second quarter of 2008 and 2007, respectively. Current quarter
revenues consist primarily of FUMADERM(R) (fumaric acid esters).
Table 4 provides individual product revenues.
Royalties were $28 million and $23 million in the second quarter
of 2008 and 2007, respectively.
Share Repurchase Program
Biogen Idec repurchased 4,971,804 shares in the second quarter of
2008 under the 20 million share repurchase program authorized by
Biogen Idec's Board of Directors in October 2006.
Financial Guidance
Following its strong performance, Biogen Idec raised its 2008
financial guidance:
-- Total revenue growth in the mid 20% range over 2007 as TYSABRI
market penetration and favorable foreign exchange continue.
-- Operating margins similar to previous guidance, and total GAAP
and non-GAAP R&D and SG&A expenses to be in the range of $2
billion.
-- Non-GAAP tax rate expected to be 28%-30%. GAAP Tax rate
expected to be 31%-33%. The difference between the GAAP and
non-GAAP tax rate is a result of the full year effects of the
reconciling items detailed in Table 3 within this press
release.
-- Non-GAAP diluted EPS at or above $3.50, representing growth
consistent with the Company's stated goal of achieving 20%
non-GAAP EPS compounded annual growth through 2010. GAAP
diluted EPS at or above $2.51. Both Non-GAAP and GAAP diluted
EPS estimates exclude the impact of any future acquisitions or
transactions.
-- Capital expenditures of $270 to $290 million.
The reconciling items between the GAAP diluted EPS and non-GAAP
diluted EPS for full year 2008 are itemized in Table 3 within this
press release.
Recent Highlights
-- On May 29, 2008, Biogen Idec named Hans Peter Hasler Chief
Operating Officer (COO) of the company. Mr. Hasler, age 52,
has served as Executive Vice President, Global Neurology and
Head of International. In his new role, Mr. Hasler will
oversee all commercial operations as well as the company's
business development function.
-- On June 19, 2008, the Board of Directors announced that Biogen
Idec stockholders elected all of its four nominees - Cecil B.
Pickett, Ph.D., the Honorable Lynn Schenk, Phillip A. Sharp,
Ph.D., and Stelios Papadopoulos, Ph.D. - to the Biogen Idec
Board of Directors. Based on the final tabulation, announced
on July 9, 2008, Dr. Sharp received 98 percent of the votes
cast and each of the Board's three other nominees received
nearly 75 percent of the votes cast.
Conference Call and Webcast
The Company's earnings conference call for the second quarter will
be broadcast via the internet at 8:30 a.m. ET on July 22, 2008, and
will be accessible through the investor relations section of Biogen
Idec's homepage, http://www.biogenidec.com. Supplemental information
in the form of a slide presentation will also be accessible at the
same location on the internet at the time of the earnings conference
call and will be available on our web site subsequently through August
22, 2008.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas
with high unmet medical needs. Founded in 1978, Biogen Idec is a
global leader in the discovery, development, manufacturing, and
commercialization of innovative therapies. Patients in more than 90
countries benefit from Biogen Idec's significant products that address
diseases such as lymphoma, multiple sclerosis, and rheumatoid
arthritis. For product labeling, press releases and additional
information about the company, please visit www.biogenidec.com.
Safe Harbor
This press release contains forward-looking statements, which
appear under the heading "Financial Guidance" above and in the
comments from James Mullen, our CEO. Forward-looking statements are
subject to risks and uncertainties that could cause actual results to
differ materially from that which we expect, including our continued
dependence on our two principal products, AVONEX and RITUXAN, the
uncertainty of success in commercializing other products including
TYSABRI, the occurrence of adverse safety events with our products,
the failure to execute our growth strategy successfully or to compete
effectively in our markets, our dependence on collaborations over
which we may not always have full control, possible adverse impact of
government regulation and changes in the availability of reimbursement
for our products, problems with our manufacturing processes and our
reliance on third parties, our ability to attract and retain qualified
personnel, the risks of doing business internationally, fluctuations
in our operating results, our ability to protect our intellectual
property rights and the cost of doing so, product liability claims,
our significant investments in marketable securities, fluctuations in
our effective tax rate, our substantial indebtedness, environmental
risks, the actions of activist shareholders and the other risks and
uncertainties that are described in Item 1.A. Risk Factors in our
annual report on Form 10-K and our quarterly reports on Form 10-Q and
in other reports we file with the SEC. These forward-looking
statements speak only as of the date of this press release, and we do
not undertake any obligation to publicly update any forward-looking
statements, whether as a result of new information, future events, or
otherwise.
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TABLE 1
Biogen Idec Inc.
June 30, 2008
Consolidated Statements of Income
(in thousands, except per share amounts)
(unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2008 2007 2008 2007
----------- ----------- ----------- -----------
REVENUES
Product $ 684,486 $ 518,625 $1,349,556 $1,003,013
Unconsolidated joint
business 278,822 230,590 526,045 437,754
Royalties 28,115 22,648 52,096 45,635
Corporate partner 2,021 1,313 7,933 2,684
----------- ----------- ----------- -----------
Total revenues 993,444 773,176 1,935,630 1,489,086
----------- ----------- ----------- -----------
COST AND EXPENSES
Cost of sales 92,401 84,063 193,335 166,013
Research and
development 252,259 218,149 510,491 409,598
Selling, general and
administrative 245,689 203,668 461,518 391,729
Amortization of
acquired intangible
assets 72,869 60,961 147,650 120,881
Collaboration profit
(loss) sharing 33,429 (105) 54,835 (5,672)
In-process research
and development - - 25,000 18,405
----------- ----------- ----------- -----------
Total cost and
expenses 696,647 566,736 1,392,829 1,100,954
----------- ----------- ----------- -----------
Income from operations 296,797 206,440 542,801 388,132
Other income
(expense), net (5,463) 31,586 (5,093) 53,288
----------- ----------- ----------- -----------
INCOME BEFORE INCOME
TAXES 291,334 238,026 537,708 441,420
Income taxes 84,706 51,886 167,983 123,779
----------- ----------- ----------- -----------
NET INCOME $ 206,628 $ 186,140 $ 369,725 $ 317,641
=========== =========== =========== ===========
BASIC EARNINGS PER
SHARE $ 0.71 $ 0.55 $ 1.26 $ 0.93
=========== =========== =========== ===========
DILUTED EARNINGS PER
SHARE $ 0.70 $ 0.54 $ 1.24 $ 0.92
=========== =========== =========== ===========
WEIGHTED-AVERAGE
SHARES USED IN
CALCULATING:
BASIC EARNINGS PER
SHARE 290,356 340,315 293,268 340,312
=========== =========== =========== ===========
DILUTED EARNINGS PER
SHARE 293,476 343,389 296,554 343,713
=========== =========== =========== ===========
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TABLE 2
Biogen Idec Inc.
June 30, 2008
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
June 30, December 31,
2008 2007
------------ ------------
ASSETS
Cash, cash equivalents and marketable
securities $ 701,008 $ 979,070
Cash collateral received for loaned
securities 146,956 208,209
Accounts receivable, net 482,797 392,646
Loaned securities 191,244 204,433
Inventory 255,028 233,987
Other current assets 383,995 350,062
------------ ------------
Total current assets 2,161,028 2,368,407
------------ ------------
Marketable securities 691,044 932,271
Property, plant and equipment, net 1,629,398 1,497,383
Intangible assets, net 2,347,561 2,492,354
Goodwill 1,139,597 1,137,372
Investments and other assets 204,198 201,028
------------ ------------
TOTAL ASSETS $ 8,172,826 $ 8,628,815
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
Collateral payable on loaned securities $ 146,956 $ 208,209
Current portion of notes payable 11,544 1,511,135
Other current liabilities 726,941 469,831
Long-term deferred tax liability 501,452 521,525
Notes payable 1,038,086 51,843
Other long-term liabilities 224,916 331,977
Shareholders' equity 5,522,931 5,534,295
------------ ------------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 8,172,826 $ 8,628,815
============ ============
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TABLE 3
Biogen Idec Inc.
June 30, 2008
Condensed Consolidated Statements of Income - Non-GAAP
(in millions, except per share amounts)
(unaudited)
Three Months Six Months
Ended Ended
June 30, June 30,
EARNINGS PER SHARE 2008 2007 2008 2007
------- ------- ------- -------
GAAP earnings per share -
Diluted $ 0.70 $ 0.54 $ 1.24 $ 0.92
Adjustment to net income (as
detailed below) 0.21 0.16 0.51 0.37
------- ------- ------- -------
Non-GAAP earnings per share
- Diluted $ 0.91 $ 0.70 $ 1.75 $ 1.29
======= ======= ======= =======
An itemized reconciliation between net
income on a GAAP basis and net income
on a non-GAAP basis is as follows:
GAAP net income $206.6 $186.1 $369.7 $317.6
Adjustments:
COGS: Stock Option Expense - 0.1 - 0.1
R&D: Restructuring - 0.4 - 0.4
R&D: Stock option expense 1.4 2.9 4.1 5.9
R&D: FIN 46 consolidation of
Cardiokine 1.5 - 2.3 -
SG&A: Restructuring - 0.5 - 0.6
SG&A: Stock option expense 3.8 5.3 6.9 11.4
Amortization of acquired
intangible assets 72.8 61.0 147.6 120.9
In-process research and development
related to the contingent
consideration payment in 2008
associated with Conforma acquisition
and the acquisition of Syntonix in
2007 - - 25.0 18.4
Other income (expense), net:
FIN 46 consolidation of
Cardiokine (1.5) - (2.3) -
Income taxes: Income tax
effect of reconciling items (16.1) (16.0) (34.5) (32.6)
------- ------- ------- -------
Non-GAAP net income $268.5 $240.3 $518.8 $442.7
======= ======= ======= =======
2008 Full Year Guidance GAAP to non-
GAAP adjustments
An itemized reconciliation between
projected EPS on a GAAP basis and on a
non-GAAP basis is as follows:
Diluted
Shares EPS
------------------------
Projected GAAP net income $ 740.0 295.0 $ 2.51
Adjustments:
R&D: Stock option expense 8.5
SG&A: Stock option expense 17.0
In process research and
development 25.0
Amortization of acquired
intangible assets 317.5
Income taxes: Income tax
effect of reconciling items (76.5)
------------------------
Projected Non-GAAP net
income $1,031.5 295.0 $ 3.50
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Use of Non-GAAP Financial Measures
Our "non-GAAP net income" and "non-GAAP diluted EPS" financial
measures exclude the following items from GAAP net income and diluted
EPS:
1. Purchase accounting and merger-related adjustments.
We exclude certain purchase accounting impacts, such as those
related to our 2003 merger with Biogen, Inc., the acquisitions of
Fumapharm AG, Conforma Therapeutics and Syntonix Pharmaceuticals, and
the consolidation of Cardiokine and Neurimmune. These include charges
for in-process research and development and the incremental charges
related to the amortization of the acquired intangible assets.
Excluding these charges provides management and investors with a
supplemental measure of performance in which the Company's acquired
intellectual property is treated in a comparable manner to its
internally developed intellectual property.
2. Stock option expense recorded in accordance with SFAS 123R.
We believe that excluding the impact of expensing stock options
better reflects the recurring economic characteristics of our
business. We also exclude stock option expense from our non-GAAP R&D
expenses and SG&A expenses, but include the P&L impact of restricted
stock awards and cash incentives in our non-GAAP results.
3. Unusual or non-recurring items.
We evaluate these on an individual basis, and consider both the
quantitative and qualitative aspects of the item, including (i) its
size and nature, (ii) whether or not it relates to our ongoing
business operations, and (iii) whether or not we expect it to occur as
part of our normal business on a regular basis.
We believe it is important to share these non-GAAP financial
measures with shareholders as they better represent the ongoing
economics of the business, reflect how we manage the business
internally and set operational goals, and form the basis of our
management incentive programs. Non-GAAP net income and diluted EPS
should not be viewed in isolation or as a substitute for reported, or
GAAP, net income and diluted EPS.
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TABLE 4
Biogen Idec Inc.
June 30, 2008
Product Revenues
(in thousands)
(unaudited)
Three Months Ended
June 30,
2008 2007
---------- ----------
PRODUCT REVENUES
Avonex(R) $ 527,152 $ 461,618
Tysabri(R) 147,173 47,539
Amevive(R) 113 2
Zevalin(R) 59 4,290
Fumaderm(R) 9,989 5,176
---------- ----------
Total product revenues $ 684,486 $ 518,625
========== ==========
Six Months Ended
June 30,
2008 2007
---------- ----------
PRODUCT REVENUES
Avonex(R) $1,063,261 $ 910,427
Tysabri(R) 261,836 77,299
Amevive(R) 252 218
Zevalin(R) 2,504 9,893
Fumaderm(R) 21,703 5,176
---------- ----------
Total product revenues $1,349,556 $1,003,013
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Biogen Idec
Media Contact:
Naomi Aoki, 617-914-6524
Director, Public Affairs
or
Investment Community Contact:
Eric Hoffman, 617-679-3916
Director, Investor Relations
Copyright Business Wire 2008
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