Delaware | 0-19311 | 33-0112644 | ||
(State or other jurisdiction of incorporation) |
(Commission file number) |
(IRS Employer Identification No.) |
133 Boston Post Road, Weston, Massachusetts | 02493 | |
(Address of principal executive offices) | (Zip Code) |
Biogen Idec Inc. |
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By: | /s/ Robert A. Licht | |||
Robert A. Licht | ||||
Senior Vice President | ||||
Exhibit | ||
Number | Description | |
99
|
Biogen Idecs press release dated February 1, 2011. |
| Total revenues in 2010 were $4.7 billion, an increase of 8% versus 2009. The increase was driven primarily by the continued growth of TYSABRIÒ (natalizumab) revenues, which increased 16% to $900 million, and AVONEXÒ (interferon beta-1a) revenues, which increased 8% to $2.5 billion. RITUXANÒ (rituximab) revenues from our unconsolidated joint business arrangement decreased 2% to $1.1 billion for the year due to the expiration of royalties on sales outside the United States. |
| Global in-market 2010 TYSABRI net sales were $1.2 billion, an increase of 16% over 2009. The total was comprised of $593 million in U.S. sales and $637 million in sales to rest of world markets. |
| On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), full-year 2010 diluted earnings per share (EPS) were $3.94, an increase of 18% over 2009. GAAP net income attributable to Biogen Idec for 2010 was $1.0 billion, an increase of 4% over 2009. |
| Non-GAAP diluted EPS for 2010 were $5.15, an increase of 25% over 2009. Non-GAAP net income attributable to Biogen Idec for 2010 was $1.3 billion, an increase of 10% over 2009. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release. |
| Fourth quarter revenues were $1.2 billion, an increase of 8% over the fourth quarter of 2009, driven primarily by the continued growth of TYSABRI revenues, which increased 12% to $242 million in the quarter, and AVONEX revenues, which increased 10% to $654 million. RITUXAN revenues were $258 million, an increase of 1%. |
| Global in-market net sales of TYSABRI in the fourth quarter of 2010 were $333 million, an increase of 12% over the fourth quarter of 2009, of which $162 million were in the U.S. and $171 million were in rest of world markets. |
| Fourth quarter 2010 GAAP diluted EPS were $0.99, a decrease of 7% over the fourth quarter of 2009. GAAP net income attributable to Biogen Idec for the quarter was $240 million, a decrease of 21% from the fourth quarter of 2009. |
| Fourth quarter 2010 non-GAAP diluted EPS were $1.42, an increase of 18% over the fourth quarter of 2009. Non-GAAP net income attributable to Biogen Idec for the quarter was flat, totaling $347 million. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release. |
| In October 2009 the Board authorized a $1.0 billion share repurchase program. During 2010 Biogen Idec purchased and retired 10.5 million shares for a total of $578 million under this authorization, completing the program. |
| In April 2010 the Board authorized a $1.5 billion share repurchase program. Biogen Idec purchased and retired 29.8 million shares for a total of $1.5 billion under this authorization. |
| Revenue growth is expected to be between flat and low single digit versus 2010. | ||
| R&D is expected to be approximately 22% to 24% of total revenue. | ||
| SG&A is expected to be approximately 20% to 21% of total revenue. | ||
| Tax rate is expected to be approximately 26% to 28% of total revenue. | ||
| GAAP diluted EPS is expected to be above $4.82. | ||
| Non-GAAP diluted EPS is expected to be above $5.70. | ||
| We expect capital expenditures in the range of $200 to $220 million. |
| On January 28, 2011, Genentech, a member of the Roche Group, and Biogen Idec announced the U.S. Food and Drug Administration (FDA) approved RITUXAN as a maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with RITUXAN plus chemotherapy (induction treatment). | ||
| On January 21, 2011, Biogen Idec announced that the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a negative opinion recommending against approval of FAMPYRA® (prolonged-release fampridine 10 mg tablets) to improve walking ability in adult patients with multiple sclerosis in the European Union. Biogen Idec intends to appeal this opinion and request a re-examination of the decision by the CHMP. | ||
| On January 5, 2011, Biogen Idec announced that Douglas E. Williams, Ph.D., had been named Executive Vice President, Research and Development (R&D), and Steven H. Holtzman had been named Executive Vice President, Corporate Development. | ||
| On December 22, 2010, Biogen Idec and Elan Corporation, plc announced that the companies had submitted a supplemental Biologics License Application to the FDA and a Type II Variation to the EMA to request review and approval to update the respective TYSABRI Prescribing Information and Summary of Product Characteristics. The companies are proposing updated product labeling to include anti-JC virus antibody status as one potential factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML), a serious brain infection, in the TYSABRI-treated population. | ||
| On December 20, 2010, Biogen Idec and Neurimmune Holding AG announced that Biogen Idec acquired the world-wide rights to three pre-clinical immunotherapy programs. The three programs are focused on the discovery and development of novel human antibodies that address three central nervous system targets: alpha-synuclein, tau and TDP-43. These targets are believed to be relevant for the treatment and prevention of a wide variety of neurodegenerative diseases, including Parkinsons disease, Alzheimers disease and amyotrophic lateral sclerosis. | ||
| On December 10, 2010, Biogen Idec and Swedish Orphan Biovitrum announced that the first patient had been dosed with the companies long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc) in a global registrational clinical trial. The study, called A-LONG, is an open-label, multicenter, Phase 2/3 study designed to evaluate the safety, pharmacokinetics and efficacy of rFVIIIFc in previously-treated hemophilia A patients. | ||
| On November 3, 2010, Biogen Idec announced a number of strategic, operational and organizational changes. The goals of these actions are to increase focus and efficiency and leverage the companys strengths to provide a solid framework for growth. |
| Strategically, Biogen Idec will focus on neurology and leverage its strengths in biologics R&D and manufacturing to pursue select, high- |
impact biological therapies. The company is terminating its efforts in cardiovascular medicine and seeking to spin out or outlicense its oncology assets. |
| Operationally, the company is consolidating its sites. The companys site in San Diego is being closed, and the companys sites in eastern Massachusetts are being consolidated. | ||
| Organizationally, Biogen Idec is in the process of reducing its headcount by approximately 13%. In addition, the company implemented a strong program management system to improve decision making and execution, and it reorganized business development, venture development and corporate strategy into a new Corporate Development Group. | ||
| Financially, as a result of these actions, the company expects to realize annual savings of approximately $300 million. |
| On November 3, 2010, Biogen Idec and Cardiokine, Inc. announced that they had agreed to dissolve their collaboration on lixivaptan. |
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
REVENUES |
||||||||||||||||
Product |
$ | 909,752 | $ | 826,874 | $ | 3,470,056 | $ | 3,152,941 | ||||||||
Unconsolidated joint business |
257,963 | 256,556 | 1,077,244 | 1,094,863 | ||||||||||||
Royalties |
45,328 | 40,807 | 137,401 | 124,438 | ||||||||||||
Corporate partner |
6,029 | 2,819 | 31,722 | 5,106 | ||||||||||||
Total revenues |
1,219,072 | 1,127,056 | 4,716,423 | 4,377,348 | ||||||||||||
COSTS AND EXPENSES |
||||||||||||||||
Cost of sales, excluding amortization of acquired
intangible assets |
100,304 | 99,700 | 400,262 | 382,104 | ||||||||||||
Research and development |
290,846 | 283,083 | 1,248,604 | 1,283,068 | ||||||||||||
Selling, general and administrative |
276,393 | 241,620 | 1,031,540 | 911,034 | ||||||||||||
Collaboration profit sharing |
67,831 | 63,296 | 258,071 | 215,904 | ||||||||||||
Amortization of acquired intangible assets |
53,360 | 55,981 | 208,928 | 289,811 | ||||||||||||
Restructuring charges |
75,153 | | 75,153 | | ||||||||||||
Acquired in-process research and development |
| | 244,976 | | ||||||||||||
Total costs and expenses |
863,887 | 743,680 | 3,467,534 | 3,081,921 | ||||||||||||
Income from operations |
355,185 | 383,376 | 1,248,889 | 1,295,427 | ||||||||||||
Other income (expense), net |
(4,664 | ) | 6,367 | (18,983 | ) | 37,252 | ||||||||||
INCOME BEFORE INCOME TAX EXPENSE |
350,521 | 389,743 | 1,229,906 | 1,332,679 | ||||||||||||
Income tax expense |
78,768 | 83,747 | 331,333 | 355,617 | ||||||||||||
NET INCOME |
$ | 271,753 | $ | 305,996 | $ | 898,573 | $ | 977,062 | ||||||||
Net income (loss) attributable to noncontrolling
interest, net of tax |
31,475 | 359 | (106,700 | ) | 6,930 | |||||||||||
NET INCOME ATTRIBUTABLE TO BIOGEN IDEC INC. |
$ | 240,278 | $ | 305,637 | $ | 1,005,273 | $ | 970,132 | ||||||||
BASIC EARNINGS PER SHARE |
$ | 1.00 | $ | 1.07 | $ | 3.98 | $ | 3.37 | ||||||||
DILUTED EARNINGS PER SHARE |
$ | 0.99 | $ | 1.06 | $ | 3.94 | $ | 3.35 | ||||||||
WEIGHTED-AVERAGE SHARES USED IN CALCULATING: |
||||||||||||||||
BASIC EARNINGS PER SHARE |
239,682 | 284,028 | 252,307 | 287,356 | ||||||||||||
DILUTED EARNINGS PER SHARE |
242,937 | 286,680 | 254,867 | 289,476 | ||||||||||||
December 31, | December 31, | |||||||
2010 | 2009 | |||||||
ASSETS |
||||||||
Cash, cash equivalents and marketable securities |
$ | 1,207,744 | $ | 1,263,724 | ||||
Accounts receivable, net |
605,329 | 551,208 | ||||||
Inventory |
289,066 | 293,950 | ||||||
Other current assets |
438,281 | 371,713 | ||||||
Total current assets |
2,540,420 | 2,480,595 | ||||||
Marketable securities |
743,101 | 1,194,080 | ||||||
Property, plant and equipment, net |
1,641,634 | 1,637,083 | ||||||
Intangible assets, net |
1,772,826 | 1,871,078 | ||||||
Goodwill |
1,146,314 | 1,138,621 | ||||||
Investments and other assets |
248,198 | 230,397 | ||||||
TOTAL ASSETS |
$ | 8,092,493 | $ | 8,551,854 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Current portion of notes payable and other
financing arrangements |
$ | 137,153 | $ | 19,762 | ||||
Other current liabilities |
912,969 | 695,180 | ||||||
Long-term deferred tax liability |
200,950 | 240,618 | ||||||
Notes payable and line of credit |
1,066,379 | 1,080,207 | ||||||
Other long-term liabilities |
325,599 | 254,205 | ||||||
Shareholders equity |
5,449,443 | 6,261,882 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 8,092,493 | $ | 8,551,854 | ||||
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
EARNINGS PER SHARE | 2010 | 2009 | 2010 | 2009 | ||||||||||||
GAAP earnings per share Diluted |
$ | 0.99 | $ | 1.06 | $ | 3.94 | $ | 3.35 | ||||||||
Adjustments to net income attributable to Biogen Idec Inc. (as detailed below) |
0.43 | 0.14 | 1.21 | 0.77 | ||||||||||||
Non-GAAP earnings per share Diluted |
$ | 1.42 | $ | 1.20 | $ | 5.15 | $ | 4.12 | ||||||||
GAAP net income attributable to Biogen Idec Inc. |
$ | 240.3 | $ | 305.6 | $ | 1,005.3 | $ | 970.1 | ||||||||
Adjustments: |
||||||||||||||||
R&D: Restructuring and severance |
| 0.5 | 1.2 | 3.0 | ||||||||||||
R&D: Stock option expense |
1.6 | 2.0 | 6.5 | 8.3 | ||||||||||||
R&D: Expenses paid by Cardiokine |
0.3 | 1.9 | 5.2 | 7.9 | ||||||||||||
SG&A: Restructuring and severance |
| | 5.7 | 0.4 | ||||||||||||
SG&A: Stock option expense |
3.7 | 5.2 | 26.8 | 20.4 | ||||||||||||
Amortization of acquired intangible assets |
53.4 | 56.0 | 208.9 | 289.8 | ||||||||||||
Restructuring charges |
75.2 | | 75.2 | | ||||||||||||
Acquired in-process research and development related to the consolidation of
Knopp and the contingent consideration payment made associated with the
2007 Syntonix acquisition |
| | 245.0 | | ||||||||||||
Income tax expense: Income tax effect
related to reconciling items |
(28.3 | ) | (24.1 | ) | (116.1 | ) | (96.9 | ) | ||||||||
Noncontrolling interest: Consolidation of Knopp and Neurimune and expenses paid by
Cardiokine |
0.7 | (1.9 | ) | (149.1 | ) | (7.9 | ) | |||||||||
Non-GAAP net income attributable to Biogen Idec Inc. |
$ | 346.9 | $ | 345.2 | $ | 1,314.6 | $ | 1,195.1 | ||||||||
$ Millions | Shares | Diluted EPS | ||||||||||
Projected GAAP net income attributable to Biogen Idec Inc. |
$ | 1,171.3 | 243 | $ | 4.82 | |||||||
Adjustments: |
||||||||||||
Stock option expense |
12.8 | |||||||||||
Amortization of acquired intangible assets |
207.7 | |||||||||||
Restructuring charges |
31.7 | |||||||||||
Contingent consideration |
11.7 | |||||||||||
Income taxes |
(50.1 | ) | ||||||||||
Projected Non-GAAP net income attributable to Biogen Idec Inc. |
$ | 1,385.1 | 243 | $ | 5.70 | |||||||
Three Months Ended | ||||||||
December 31, | ||||||||
2010 | 2009 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 654,072 | $ | 596,466 | ||||
Tysabri® |
241,629 | 216,188 | ||||||
Fumaderm® |
13,939 | 14,220 | ||||||
Other |
112 | | ||||||
Total product revenues |
$ | 909,752 | $ | 826,874 | ||||
Twelve Months Ended | ||||||||
December 31, | ||||||||
2010 | 2009 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 2,518,356 | $ | 2,322,894 | ||||
Tysabri® |
900,250 | 776,030 | ||||||
Fumaderm® |
51,194 | 49,624 | ||||||
Other |
256 | 4,393 | ||||||
Total product revenues |
$ | 3,470,056 | $ | 3,152,941 | ||||