e8vk
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 26, 2006
Biogen Idec Inc.
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction
of incorporation)
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0-19311
(Commission
File Number)
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33-0112644
(I.R.S. Employer
Identification No.) |
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14 Cambridge Center, Cambridge, Massachusetts
(Address of principal executive offices)
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02142
(Zip Code) |
Registrants telephone number, including area code: (617) 679-2000
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c)) |
TABLE OF CONTENTS
Item 2.02 Results of Operations and Financial Condition.
On
April 26, 2006, the Registrant issued a press release announcing its
unaudited results of operations and financial condition for the three
months ended March 31, 2006. A copy of the press release is furnished
as Exhibit 99.1.
This press release is being furnished pursuant to Item 2.02 of this Current Report on Form 8-K
and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934
(the Exchange Act) or otherwise subject to the liabilities of that Section, nor shall such
documents be deemed incorporated by reference in any filing under the Securities Act of 1933 or the
Exchange Act.
Item 9.01 Financial Statements and Exhibits
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99.1 |
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The Registrants Press Release dated April 26, 2006. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Biogen Idec Inc.
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By: |
/s/ Susan H. Alexander
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Susan H. Alexander |
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Executive Vice President, General Counsel |
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Date: April 26, 2006
EXHIBIT INDEX
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Exhibit |
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Number |
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Description |
99.1
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The Registrants Press Release dated April 26, 2006. |
exv99w1
Exhibit 99.1
Page 1 Biogen Idec Reports First Quarter 2006 Results
Media Contact:
Jose Juves
Director, Public Affairs
Biogen Idec
Tel: (617) 914-6524
Investment Community Contact:
Elizabeth Woo
Vice President, Investor Relations
Biogen Idec
Tel: (617) 679-2812
FOR IMMEDIATE RELEASE
Biogen Idec Reports First Quarter 2006 Results
Cambridge, MA, April 26, 2006 Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader
with leading products and capabilities in oncology, neurology and immunology, today reported its
first quarter 2006 results.
First Quarter 2006 Highlights
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Total revenues for the first quarter were $611 million vs. prior
year $588 million, an increase of 4%, driven primarily by
RITUXANÒ (rituximab) revenues from the
unconsolidated joint business arrangement up 14% to $183 million
and AVONEXÒ (Interferon beta-1a) worldwide sales
up 5% to $393 million. |
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On a reported basis, calculated in accordance with U.S. generally
accepted accounting principles (GAAP), first quarter diluted
earnings per share (EPS) were $0.36, an increase of 200% over the
same period last year; excluding merger-related accounting impacts
and employee stock option expense, non-GAAP EPS were $0.55, an
increase of 83% over the same period last year. |
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With the adoption of Statement of Financial Accounting Standards
(FAS) 123R as of January 1, 2006, Biogen Idec is reporting
employee stock option expense in its GAAP results for the first
time. Total stock option expense on a pre-tax basis in R&D and
SG&A for the first quarter 2006 was $13 million, or $0.03 per
share. This impact has been excluded from non-GAAP performance
metrics. |
Page 2 Biogen Idec Reports First Quarter 2006 Results
James Mullen, Biogen Idecs Chief Executive Officer, commented, During the quarter we took several
key steps to secure the continued growth of our core business, specifically achieving major
milestones with two products, TYSABRI and RITUXAN. We are pleased with the unanimous vote by the
U.S. Food and Drug Administrations Advisory Committee supporting the reintroduction of TYSABRI and
expect to have this important therapeutic option available to multiple sclerosis patients later
this year. The approval and launch of RITUXAN in rheumatoid arthritis has allowed us to expand our
business focus and enter a therapeutic area with significant unmet medical need.
Financial Performance
On a reported basis, calculated in accordance with GAAP, Biogen Idec reported net income of $123
million (or EPS of $0.36) in the first quarter of 2006 (Q1 2005: net income of $43 million, or EPS
of $0.12).
The 2006 first quarter results include an after-tax credit of $4 million ($0.01 per share
after-tax) attributable to the cumulative effect of a change in accounting principle associated
with the adoption of FAS 123R on January 1, 2006. The cumulative effect adjustment reflects the
impact of estimating forfeitures of equity awards at the date of grant instead of the prior
accounting practice of recognizing forfeitures as incurred.
The difference between non-GAAP net income and EPS and GAAP net income and EPS in the first quarter
are itemized in Table 3 and are primarily due to:
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pre-tax charges of $75 million, consisting of amortization of
intangibles ($70.7 million), inventory step-up ($4.0 million), and
severance ($0.7 million). |
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pre-tax employee stock option expense of $13 million. |
On a non-GAAP basis, Biogen Idec reported net income of $189 million in the first quarter of 2006
(Q1 2005 non-GAAP: $106 million). Non-GAAP EPS were $0.55 for the first quarter of 2006 (Q1 2005
non-GAAP: $0.30).
Revenue Performance for the 3 Months ended March 31, 2006:
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Revenues from AVONEX increased 5% to $393 million (Q1 2005: $374 million). |
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U.S. sales were $232 million (Q1 2005: $233 million) |
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International sales increased 15% to $161 million. (Q1 2005: $141 million) |
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Revenues from Biogen Idecs joint business arrangement with Genentech, Inc. related to RITUXAN were up 14% to $183
million (Q1 2005: $160 million). 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. |
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U.S. net sales of RITUXAN increased 8% to $477 million in the first quarter of 2006
(Q1 2005: $440 million), as reported by Genentech. |
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Revenues from other products were $13 million (Q1 2005: $24
million). Details are provided in Table 4. |
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Royalties were $21 million (Q1 2005: $27 million). |
Page 3 Biogen Idec Reports First Quarter 2006 Results
Financial Guidance
Biogen Idec continues to expect that its 2006 non-GAAP earnings per share will be in the range of
$1.95 $2.10.
Guidance for full year 2006 reported earnings per share (GAAP-based financial measure) is not
currently known, as the Company cannot predict with any certainty the nature or the amount of
non-operating or unusual charges for subsequent quarters. The Company does anticipate that certain
charges related to purchase accounting will be included in the GAAP financials, such as
amortization of intangibles of approximately $250 330 million, primarily related to the AVONEX
intangibles. Separately, the impact of stock options being expensed due to FAS 123R in 2006 is now
estimated to be in the range of $0.08 $0.12. The Company additionally anticipates that it may
have to take other charges in subsequent quarters and that such charges, if material, would cause
reported earnings per share to further differ from non-GAAP earnings per share.
The Company anticipates that 2006 capital expenditures will be in the range of $190 $275
million.
Recent Highlights
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On February 28, 2006, Biogen Idec and Genentech announced that the
FDA had approved, following Priority Review, the therapeutic
antibody RITUXAN in combination with methotrexate (MTX) to reduce
signs and symptoms in adult patients with moderately-to-severely
active rheumatoid arthritis (RA) who have had an inadequate
response to one or more tumor necrosis factor (TNF) antagonist
therapies. |
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On March 8, 2006, Biogen Idec and Elan Corporation, plc announced
that the Peripheral and Central Nervous System Drugs Advisory
Committee of the FDA voted unanimously to recommend reintroduction
of TYSABRIÒ (natalizumab) as a treatment for
relapsing forms of MS. The Committees recommendation is advisory
to the FDA, and the agency is not bound by this recommendation.
The FDA has designated TYSABRI for Priority Review, a status for
products that are considered to be significant therapeutic
advancements over existing therapies that address an unmet medical
need. Biogen Idec and Elan will continue to work closely with the
FDA in the weeks ahead with the goal of making TYSABRI available.
Discussions with FDA will include, among other things, finalizing
the details of the TYSABRI risk management plan. The companies
anticipate action by the FDA by June 28, 2006. |
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On March 29, 2006, Biogen Idec and Elan announced that the first
patients in the TYSABRI monotherapy safety extension study program
in MS have been enrolled and dosed. Patients who previously
participated in the Phase III MS trials and subsequent safety
evaluation are eligible to be screened for entry in this open
label multi-center study. Sites throughout Europe, the United
States, Canada, Australia, New Zealand and Israel are expected to
enroll patients. This safety extension study is |
Page 4 Biogen Idec Reports First Quarter 2006 Results
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being conducted under an FDA Investigational New Drug (IND) application in the U.S. and similar
investigational approvals internationally. |
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On March 30, 2006, Biogen Idec and Genentech announced that the
companies submitted a supplemental Biologics License Application
(sBLA) to the FDA for the use of RITUXAN as first-line treatment
of previously-untreated patients with low-grade or follicular,
CD20-positive, B-cell non-Hodgkins lymphoma in combination with
CVP (cyclophosphamide, vincristine and prednisone) or CHOP
chemotherapy or following CVP chemotherapy in those patients who
achieved a response of stable disease or better. |
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As part of the restructuring plan announced in September 2005,
Biogen Idec completed the sale of the worldwide rights for
AMEVIVE® (alefacept) to Astellas Pharma US, Inc. in
April 2006. AMEVIVE is a biologic anti-inflammatory compound used
in the treatment of moderate-to-severe plaque psoriasis. |
Use of Non-GAAP Financial Measures
The non-GAAP financial measures presented in this press release are utilized by Biogen Idec
management to gain an understanding of the comparative financial performance of the Company.
Management believes that the non-GAAP financial measures are useful because they exclude those
non-operational activities or transactions that are not necessarily relevant to understanding the
trends of the Company or the prospects of future performance such as charges related to
amortization of intangibles, inventory step-up values, and employee stock option expense.
Management uses these measures to establish operational goals and believes that non-GAAP measures
may assist investors in analyzing the underlying trends in the Companys business over time. The
presentation of this information is not meant to be considered in isolation or as a substitute for
GAAP financial measures.
Conference Call and Webcast
The Companys earnings conference call for the first quarter will be broadcast via the Internet at
8:30 a.m. ET on April 26, 2006, and will be accessible through the investor relations section of
Biogen Idecs homepage, http://www.biogenidec.com.
About Biogen Idec
Biogen Idec (NASDAQ: BIIB) creates new standards of care in oncology, neurology 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.
Page 5 Biogen Idec Reports First Quarter 2006 Results
Safe Harbor
This press release contains forward-looking statements regarding expected future financial results,
including non-GAAP EPS and capital expenditures, the potential reintroduction of TYSABRI in MS, and
the potential for RITUXAN in RA.
These statements are based on the Companys current beliefs and expectations. A number of risks
and uncertainties could cause actual results to differ materially. For example, financial results
and external growth opportunities may be affected by a number of factors, including any unexpected
slowing of growth of the markets for AVONEX and RITUXAN, any change in market acceptance of AVONEX
and RITUXAN in key markets worldwide, the impact of reimbursement and pricing decisions related to
the Companys products, the impact of competitive products on the Companys products, any material
decreases in royalties which the Company receives, the impact of litigation, increases in costs
related to, or an inability for us to enter into in-licensing deals, collaborations or acquisitions
on acceptable terms, increases in costs related to research and development of new products as well
as increases in costs related to development of existing products in new indications, and any
material issues, delays or failures related to the manufacturing or supply of the Companys
products.
Our long-term growth will depend on the successful development and commercialization of new
products as well as the development and commercialization of existing products in new indications.
Drug development involves a high degree of risk. For example, the plans for our development
programs 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.
The potential for TYSABRI in MS is subject to a number of risks and uncertainties. There is no
assurance, for example, that we will be able to gain sufficient information to fully understand the
risks associated with the product. There is also no assurance that the Company and Elan will be
able to resume marketing and sales of TYSABRI.
For more detailed information on the risks and uncertainties associated with these forward looking
statements and the Companys 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.
TABLE 1
Biogen Idec Inc.
First Quarter 2006
Condensed Consolidated Statements Of Income
(in thousands, except per share amounts)
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Three Months Ended |
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March 31, |
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2006 |
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2005 |
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REVENUES |
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Product |
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$ |
406,519 |
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$ |
397,584 |
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Unconsolidated joint business |
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183,380 |
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160,453 |
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Royalties |
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20,561 |
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26,749 |
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Corporate partner |
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715 |
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3,016 |
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Total revenues |
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611,175 |
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|
587,802 |
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COST AND EXPENSES |
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Cost of goods sold and royalty revenues |
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67,494 |
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|
99,609 |
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Research and development |
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145,892 |
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172,477 |
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Selling, general and administrative |
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154,391 |
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158,472 |
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Amortization of acquired intangible assets |
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70,707 |
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75,677 |
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Impairment and loss on sale of long lived assets |
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(298 |
) |
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6,293 |
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Total cost and expenses |
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438,186 |
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512,528 |
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Income from operations |
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172,989 |
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|
75,274 |
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Other income, net |
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18,665 |
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(8,926 |
) |
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INCOME BEFORE TAXES AND CUMULATIVE EFFECT OF ACCOUNTING
CHANGE |
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191,654 |
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66,348 |
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Income taxes |
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72,464 |
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|
22,890 |
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INCOME BEFORE CUMULATIVE EFFECT OF ACCOUNTING CHANGE |
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119,190 |
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43,458 |
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Cumulative effect of accounting change, net of income tax |
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3,779 |
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NET INCOME |
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$ |
122,969 |
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$ |
43,458 |
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BASIC EARNINGS PER SHARE |
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Income before cumulative effect of accounting change |
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$ |
0.35 |
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$ |
0.13 |
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Cumulative effect of accounting change, net of income tax |
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0.01 |
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BASIC EARNINGS PER SHARE |
|
$ |
0.36 |
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$ |
0.13 |
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DILUTED EARNINGS PER SHARE |
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Income before cumulative effect of accounting change |
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$ |
0.34 |
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$ |
0.12 |
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Cumulative effect of accounting change, net of income tax |
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|
0.01 |
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|
|
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|
|
|
|
|
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DILUTED EARNINGS PER SHARE |
|
$ |
0.36 |
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|
$ |
0.12 |
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SHARES USED IN CALCULATING: |
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BASIC EARNINGS PER SHARE |
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339,653 |
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|
|
335,279 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
DILUTED EARNINGS PER SHARE |
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|
345,815 |
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|
|
352,173 |
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|
|
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|
Numbers may not foot due to rounding.
TABLE 2
Biogen Idec Inc.
First Quarter 2006
Condensed Consolidated Balance Sheets
(in thousands)
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Mar. 31, 2006 |
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Dec. 31, 2005 |
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Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Cash, cash equivalents and securities available-for-sale |
|
$ |
849,355 |
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$ |
850,753 |
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|
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|
|
|
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Accounts receivable, net |
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|
276,441 |
|
|
|
265,742 |
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|
|
|
|
|
|
|
|
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Inventory |
|
|
191,022 |
|
|
|
182,815 |
|
|
|
|
|
|
|
|
|
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Other current assets |
|
|
278,863 |
|
|
|
318,771 |
|
|
|
|
|
|
|
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Total current assets |
|
|
1,595,681 |
|
|
|
1,618,081 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term securities available-for-sale |
|
|
1,407,541 |
|
|
|
1,204,378 |
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|
|
|
|
|
|
|
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Property and equipment, net |
|
|
1,191,968 |
|
|
|
1,174,396 |
|
|
|
|
|
|
|
|
|
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Intangible assets, net |
|
|
2,904,838 |
|
|
|
2,975,601 |
|
|
Goodwill |
|
|
1,130,430 |
|
|
|
1,130,430 |
|
|
|
|
|
|
|
|
|
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Other |
|
|
293,768 |
|
|
|
264,061 |
|
|
|
|
|
|
|
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Total assets |
|
$ |
8,524,226 |
|
|
$ |
8,366,947 |
|
|
|
|
|
|
|
|
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|
|
|
|
|
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Liabilities and shareholders equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Current liabilities |
|
$ |
520,797 |
|
|
$ |
583,036 |
|
|
|
|
|
|
|
|
|
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Long-term deferred tax liability |
|
|
736,255 |
|
|
|
762,282 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities |
|
|
124,332 |
|
|
|
115,753 |
|
|
|
|
|
|
|
|
|
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Shareholders equity |
|
|
7,142,842 |
|
|
|
6,905,876 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
8,524,226 |
|
|
$ |
8,366,947 |
|
|
|
|
|
|
|
|
Numbers may not foot due to rounding.
TABLE 3
Biogen Idec Inc.
First Quarter 2006
Condensed Consolidated Statements Of Income Non-GAAP
(in millions, except per share amounts)
|
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Three Months Ended |
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|
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March 31, |
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|
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2006 |
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2005 |
|
Earnings per share |
|
|
|
|
|
|
|
|
GAAP Earnings per share Diluted |
|
$ |
0.36 |
|
|
$ |
0.12 |
|
Adjustment to Net Income (as detailed below) |
|
|
0.19 |
|
|
|
0.18 |
|
|
|
|
|
|
|
|
Non-GAAP Earnings per share Diluted |
|
$ |
0.55 |
|
|
$ |
0.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AN ITEMIZED RECONCILIATION BETWEEN NET INCOME ON A GAAP BASIS
AND NET INCOME ON A NON-GAAP BASIS IS AS FOLLOWS: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Net Income |
|
$ |
123.0 |
|
|
$ |
43.5 |
|
|
|
|
|
|
|
|
|
|
COGS: Fair value step up of inventory acquired from former Biogen, Inc |
|
|
4.0 |
|
|
|
9.3 |
|
|
|
|
|
|
|
|
|
|
R&D: Stock option expense |
|
|
4.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SG&A: Severance and restructuring |
|
|
0.7 |
|
|
|
0.5 |
|
|
|
|
|
|
|
|
|
|
SG&A: Stock option expense |
|
|
8.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase accounting: Amortization of acquired intangible assets related to the merger with former Biogen, Inc. |
|
|
70.7 |
|
|
|
75.7 |
|
|
|
|
|
|
|
|
|
|
Impairment and loss on sale of long lived assets |
|
|
(0.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes: Income tax effect of reconciling items |
|
|
(18.4 |
) |
|
|
(23.1 |
) |
|
|
|
|
|
|
|
|
|
Cumulative effect of accounting change from adoption of FAS123R, net of income tax |
|
|
(3.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net Income |
|
$ |
188.9 |
|
|
$ |
105.8 |
|
|
|
|
|
|
|
|
Numbers may not foot due to rounding.
The non-GAAP financial measures presented in this table are utilized by Biogen
Idec management to gain an understanding of the comparative financial
performance of the Company. Management believes that the non-GAAP financial
measures are useful because they exclude those non-operational activities or
transactions that are not necessarily relevant to understanding the trends of
the Company or the prospects of future performance. Management uses these
measures to establish operational goals and believes that non-GAAP measures may
assist investors in analyzing the underlying trends in the Companys business
over time. The presentation of this information is not meant to be considered
in isolation or as a substitute for GAAP financial measures.
TABLE 4
Biogen Idec Inc.
First Quarter 2006
Product Revenues
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2006 |
|
|
2005 |
|
PRODUCT REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Avonex® |
|
$ |
393,427 |
|
|
$ |
373,586 |
|
|
|
|
|
|
|
|
|
|
Amevive® |
|
|
8,278 |
|
|
|
12,016 |
|
|
|
|
|
|
|
|
|
|
Tysabri® |
|
|
(196 |
) |
|
|
5,946 |
|
|
|
|
|
|
|
|
|
|
Zevalin® |
|
|
5,010 |
|
|
|
6,036 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Product Revenues |
|
$ |
406,519 |
|
|
$ |
397,584 |
|
|
|
|
|
|
|
|
Numbers may not foot due to rounding.