CAMBRIDGE, Mass., April 30 /PRNewswire-FirstCall/ -- Biogen Idec Inc.
(Nasdaq: BIIB), a global biotechnology leader with top products and
capabilities in oncology and immunology, announced today first quarter 2004
earnings per share of $0.40 and net income of $143 million, both on an
adjusted non-GAAP basis.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031112/LAW121LOGO )
Adjusted non-GAAP earnings per share and net income for the first quarter
of 2004 excludes merger-related accounting impacts, such as amortization of
intangibles, inventory step up, and other merger-related charges, and all
other non-operating charges. Adjusted pro forma non-GAAP earnings per share
and net income for the first quarter of 2003 include revenue and expenses from
the former Biogen, Inc. from January 1 to March 31, 2003 but excludes all
other non-operating charges of former Biogen, Inc. and IDEC Pharmaceuticals
Corporation. These adjustments, expenses, and non-operating charges are
itemized on the attached reconciliation tables.
On a reported basis, calculated in accordance with U.S. generally accepted
accounting principles (GAAP), Biogen Idec reported a loss of $41 million (or
loss per share of $0.12) in the first quarter of 2004. The first quarter loss
was primarily due to $275 million of certain non-cash merger-related
accounting impacts.
Biogen Idec's revenues for the first quarter of 2004 rose 24% to $542
million versus adjusted pro forma revenues of $437 million in the first
quarter of 2003.
"We've had an excellent start to the year -- both revenue and earnings
results are up strongly. The U.S. filing of ANTEGREN by mid-year is on track.
Our recent good news on ANTEGREN's accelerated timeline highlights one of the
strategic benefits of the merger. With access to two large scale
manufacturing facilities on both coasts, the Company is well-positioned to
fulfill ANTEGREN's blockbuster potential," said James Mullen, Biogen Idec's
Chief Executive Officer.
William Rastetter, Biogen Idec's Executive Chairman, said, " With three
products in Phase III development -- ANTEGREN in MS and Crohn's disease, BG-12
for psoriasis in Europe, and RITUXAN(R) (rituximab) in rheumatoid arthritis --
we have a robust pipeline that reaffirms our commitment to our corporate goal
of averaging 15% revenue growth and 20% EPS growth through 2007."
Product Sales Performance
Revenues from AVONEX(R) (Interferon beta-1a), Biogen Idec's therapy for
patients with relapsing forms of multiple sclerosis (MS), for the first
quarter of 2004 increased 29% to $355 million from the first quarter of 2003.
U.S. sales of AVONEX in the first quarter of 2004 were $240 million and
international sales for AVONEX were $115 million.
AMEVIVE(R) (alefacept), Biogen Idec's treatment for moderate to severe
psoriasis, was approved at the end of January 2003. AMEVIVE sales were $13
million in the first quarter of 2004.
Revenues from ZEVALIN(R) (ibritumomab tiuxetan), Biogen Idec's
radioimmunotherapeutic agent, were $4.8 million in the first quarter as
compared to $5.7 million for the same period last year.
Revenues for the first quarter of 2004 included $134 million from Biogen
Idec's joint business arrangement with Genentech, Inc. related to RITUXAN, a
treatment for certain B-cell non-Hodgkin's lymphomas that the company co-
promotes in the U.S. with Genentech, compared to $111 million for the first
quarter of 2003. All U.S. sales of RITUXAN are recognized by Genentech, and
Biogen Idec records its share of the pretax co-promotion profits on a
quarterly basis. U.S. net sales of RITUXAN in the first quarter of 2004, as
recorded by Genentech, were $362 million compared to $310 million in first
quarter of 2003.
Recent Highlights
-- At the recent European Academy of Dermatology and Venereology (EADV) in
Budapest, Hungary, Biogen Idec and Fumapharm AG announced results from
a Phase II study of BG-12, an oral fumarate, in patients with severe
psoriasis. Patients who received BG-12 in the trial showed greater
improvement in their psoriasis than patients receiving placebo.
-- In April 2004, Roche, Genentech, and Biogen Idec were informed that a
Phase III study, European Organization for Research and Treatment of
Cancer (EORTC) 20981, evaluating the use of rituximab in patients with
relapsed indolent non-Hodgkin's lymphoma has met its primary endpoints
two years earlier than expected.
-- On March 23, 2004, Biogen Idec and Elan announced that they intend to
submit to the European Agency for the Evaluation of Medicinal Products
(EMEA) an application for approval of ANTEGREN as a treatment for MS.
The companies expect to submit the filing in the summer of 2004. The
decision to file was made after discussion with European regulatory
officials, based on one-year data from the ongoing Phase III trials in
MS. The companies are committed to completing these two-year trials.
Conference Call and Webcast
The Company's earnings conference call for the first quarter will be
broadcast via the Internet at 8:30 a.m. ET on April 30, 2004, and will be
accessible through the investor relations section of Biogen Idec's homepage,
http://www.biogenidec.com.
About Biogen Idec
Biogen Idec creates new standards of care in oncology and immunology. As a
global leader in the development, manufacturing, and commercialization of
novel therapies, Biogen Idec transforms scientific discoveries into advances
in human healthcare. For product labeling, press releases and additional
information about the company, please visit http://www.biogenidec.com
Safe Harbor
This press release contains forward-looking statements regarding expected
future financial results and plans for our development programs, including
ANTEGREN.
These statements are based on the Company's current beliefs and
expectations. A number of risks and uncertainties could cause actual results
to differ materially. For example, financial results, including future growth
may be affected by a number of factors, including any slowing of growth of the
markets for AVONEX and RITUXAN, any change in market acceptance of these
products in key markets worldwide, the extent to which the Company achieves
market acceptance of its other products, the impact of reimbursement and
pricing decisions related to the Company's products, the impact of competitive
products on the Company's products, the magnitude of costs associated with
launch of new products, the impact of litigation, any unanticipated increase
in expenses, in-licensing and product opportunities, and any material issues,
delays or failures related to the manufacturing or supply of the Company's
products. For example, we have encountered certain problems in the manufacture
of AVONEX. As a result, we have had to recall several batches and write down
a number of batches. If these problems were to recur, we would likely have to
incur additional charges and could potentially experience an interruption in
the supply of AVONEX.
Our long-term growth will also depend on the successful development and
commercialization of new products such as ANTEGREN. Drug development involves
a high degree of risk. For example, our plans to file applications for
approval of ANTEGREN as a treatment for MS in the U.S. and EU and our
expectations as to the potential of ANTEGREN could be negatively affected if
unexpected concerns arise from additional data or analysis, if regulatory
authorities require additional information or further studies, or if we were
to encounter other unexpected hurdles.
For more detailed information on the risks and uncertainties associated
with these forward looking statements and the Company's other activities see
the periodic reports filed by the Company with the Securities and Exchange
Commission. The Company does not undertake any obligation to publicly update
any forward-looking statements, whether as a result of new information, future
events, or otherwise.
Media Contact:
Amy Ryan
Associate Director, Public Affairs
Biogen Idec
Tel: (617) 914-6524
Investment Community Contact:
Elizabeth Woo
Senior Director, Investor Relations
Biogen Idec
Tel: (617) 679-2812
TABLE 1
Financial Results For The First Quarter of 2004
Condensed Consolidated Statements Of Income - GAAP Basis
(in thousands, except per share amounts)
Three Months Ended
March 31,
2004 2003
REVENUES
Product $372,537 $5,663
Revenue from unconsolidated joint
business 133,955 110,911
Royalties 25,213 -
Corporate partner 10,037 672
Total Revenues 541,742 117,246
COST AND EXPENSES
Cost of product and royalty revenues 254,767 852
Research and development 159,150 31,910
Selling, general and administrative 130,830 21,342
Amortization of acquired intangible
assets 80,860 -
Total Cost and Expenses 625,607 54,104
Income (loss) from Operations (83,865) 63,142
Other income, net 11,726 3,310
INCOME (LOSS) BEFORE INCOME TAXES (72,139) 66,452
Income taxes (benefit) (30,941) 25,252
NET INCOME (LOSS) $(41,198) $41,200
BASIC EARNINGS (LOSS) PER SHARE $(0.12) $0.27
DILUTED EARNINGS (LOSS) PER SHARE $(0.12) $0.24
SHARES USED IN CALCULATING:
BASIC EARNINGS (LOSS) PER SHARE 333,699 154,673
DILUTED EARNINGS (LOSS) PER SHARE 333,699 177,821
Table 2
Condensed Consolidated Balance Sheets
(dollars in thousands)
Mar. 31, 2004 Dec. 31, 2003
Assets:
Current assets
Cash, cash equivalents and
securities available-for-sale $761,547 $835,959
Accounts receivable, net 201,368 198,524
Inventory 311,395 496,349
Other current assets 293,854 307,832
Total current assets 1,568,164 1,838,664
Long-term securities available-
for-sale 1,816,680 1,502,327
Property and equipment, net 1,297,862 1,252,783
Intangible assets, net 3,557,630 3,638,812
Goodwill 1,151,066 1,151,066
Other 120,201 120,293
Total assets $9,511,603 $9,503,945
Liabilities and shareholders'
equity
Current liabilities $362,834 $404,825
Long-term deferred tax liability 1,038,058 1,108,318
Non-current liabilities 913,230 937,474
Shareholders' equity 7,197,481 7,053,328
Total liabilities and
shareholders' equity $9,511,603 $9,503,945
Biogen Idec TABLE 3
Condensed Consolidated Statements of Operations
and Reconciliation of GAAP Earnings to Adjusted Non-GAAP Earnings
(In millions, except per share data)
The non-GAAP financial measures presented below are utilized by
Biogen Idec management to gain an understanding of the
comparative revenue performance of the Company. Management
believes that the non-GAAP financial measures are useful because
they exclude those non-operational or unusual activities or
transactions that are not necessarily relevant to obtaining an
understanding of the trends of the Company or the prospects of
future performance.
Three Months Ended Three Months Ended
March 31, 2004 March 31, 2003
Adjusted Adjusted
Adjustments Adjustments Pro Forma
GAAP Non-GAAP GAAP Non-GAAP
Revenues
Product $372.5 - $372.5 $5.7 278.2 (E) $283.9
Revenues from
unconsolidated
joint
business 134.0 - 134.0 110.9 - 110.9
Royalties 25.2 - 25.2 - 41.4 (E) 41.4
Corporate partner
revenues 10.0 - 10.0 0.7 - 0.7
Total Revenues 541.7 - 541.7 117.2 319.6 436.8
Cost and Expenses
Cost of product and
royalty revenues 254.8 (194.3)(A) 60.5 0.9 46.3 (E) 47.2
Research and
development 159.2 (2.2)(B) 157.0 31.9 78.1 (E) 110.0
Selling, general and
administrative 130.8 (4.4)(B) 126.4 21.3 101.3 (E) 122.6
Write-off of acquired
in-process research
and development - - - - - -
Amortization of
acquired
intangibles 80.9 (80.9)(C) - - - -
Total costs and
expenses 625.6 (281.8) 343.8 54.1 225.7 279.8
Income (loss) from
operations (83.9) 281.8 197.9 63.1 93.9 (E) 157.0
Other income
(expense), net 11.7 - 11.7 3.3 10.3 (E) 13.6
Income (loss) before
income taxes (72.1) 281.8 209.7 66.5 104.2 170.7
Provision (benefit)
for income taxes (30.9) 98.0 (D) 67.1 25.3 29.4 (E) 54.6
Net income (loss) ($41.2) $183.8 $142.6 $41.2 74.8 $116.1
Numerator:
Net income
(loss) ($41.2) $142.6 $41.2 $116.1
Net adjustment
for interest
expense 2.6 1.3 1.3
Net income
(loss) used in
calculating
diluted eps ($41.2) $145.2 $42.5 $117.4
Shares used in
calculation of
earnings (loss) per
share:
Denominator:
Weighted average
number of
common shares
outstanding 333.7 333.7 154.7 328.1
Effect of
dilutive
securities:
stock options,
convertible
preferred
stock,
convertible
promissory
notes 33.6 23.1 32.8
Dilutive
potential
common shares 333.7 367.3 177.8 360.9
Earnings (loss) per
share:
Basic ($0.12) $0.43 $0.27 $0.35
Diluted ($0.12) $0.40 $0.24 $0.33
column 1 column 2 column 3= column4 column 5 column6=
columns columns
1 + 2 4+5
(A) Represents the non-cash expense related to valuing the inventory
acquired from former Biogen, Inc. at fair value.
(B) Represents external, incremental consulting, integration costs,
severance and restructuring charges related to the merger.
(C) Represents the ongoing, non-cash amortization of acquired intangible
assets related to the merger with former Biogen, Inc.
(D) Represents the tax effect of the above adjustments.
(E) Represents former Biogen, Inc. operating revenue and expenses for the
period Jan-Mar of 2003 prior to the merger, net of intercompany
transactions.
Table 4
Biogen Idec Inc
Product Revenues for 1st Quarter 2004
(in thousands)
The non-GAAP financial measures presented below are utilized by Biogen
Idec management to gain an understanding of the comparative revenue
performance of the Company. Management believes that the non-GAAP
financial measures are useful because they exclude those non-operational
or unusual activities or transactions that are not necessarily relevant to
obtaining an understanding of the trends of the Company or the prospects
of future performance.
Three Months Ended
March 31,
2004 2003
Biogen
GAAP GAAP Revenue Pro Forma
Pre-merger Combined
Revenue Revenue (a) Revenue
PRODUCT REVENUES
Avonex(R) $354,718 $- $274,357 $274,357
Amevive(R) 12,987 - 3,820 3,820
Zevalin(R) 4,832 5,663 - 5,663
Total Product Revenues $372,537 $5,663 $278,177 $283,840
(a) Represents former Biogen, Inc. revenue that is not included in
GAAP revenues.
SOURCE Biogen Idec Inc.
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http://www.biogenidec.com
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CONTACT:
Media Contact: Amy Ryan, Associate Director,
Public Affairs, +1-617-914-6524, or Investment Community Contact:
Elizabeth Woo, Senior Director, Investor Relations,
+1-617-679-2812, both of Biogen Idec
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