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| Total revenues in 2009 were $4.4 billion, an increase of 7% versus 2008. The increase was driven primarily by the continued growth of TYSABRIÒ (natalizumab) revenues, which increased 32% to $776 million, and AVONEXÒ (interferon beta-1a) revenues, which increased 5% to $2.3 billion. RITUXANÒ (rituximab) revenues from our unconsolidated joint business arrangement decreased 3% to $1.1 billion for the year due to the expiration of royalties on sales outside the United States. | |
| Global in-market 2009 TYSABRI net sales were $1.1 billion, an increase of 30% over 2008. The total was comprised of $509 million in U.S. sales and $551 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 2009 diluted earnings per share (EPS) were $3.35, an increase of 26% over 2008. GAAP net income attributable to Biogen Idec for 2009 was $1.0 billion, an increase of 24% over 2008. |
| Non-GAAP diluted EPS for 2009 were $4.12, an increase of 13% over 2008. Non-GAAP net income attributable to Biogen Idec for 2009 was $1.2 billion, an increase of 11% over 2008. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release. |
| Fourth quarter revenues were $1.1 billion, an increase of 5% over the fourth quarter of 2008, driven primarily by the continued growth of TYSABRI revenues, which increased 39% to $216 million in the quarter, and AVONEX revenues, which increased 5% to $596 million. RITUXAN revenues decreased 15% to $257 million. | |
| Global in-market net sales of TYSABRI in the fourth quarter of 2009 were $296 million, an increase of 37% over the fourth quarter of 2008, of which $137 million were in the U.S. and $159 million were in rest of world markets. | |
| Fourth quarter 2009 GAAP diluted EPS were $1.06, an increase of 51% over the fourth quarter of 2008. GAAP net income attributable to Biogen Idec for the quarter was $306 million, an increase of 48% over the fourth quarter of 2008. | |
| Fourth quarter 2009 non-GAAP diluted EPS were $1.20, an increase of 29% over the fourth quarter of 2008. Non-GAAP net income attributable to Biogen Idec for the quarter was $345 million, an increase of 26% over the fourth quarter of 2008. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release. |
| Biogen Idec repurchased the 6.0 million shares remaining from its 2006 share repurchase authorization at a cost of $271 million. The 2006 share repurchase program was used principally for share stabilization. |
| In October 2009 the Board authorized a $1 billion share repurchase program; Biogen Idec purchased 8.8 million shares for a total of $422 million under this authorization. These shares have been retired. |
| Revenue growth in 2010 is expected to be in the mid single digits. | ||
| Core operating expense growth is expected to be in the low single digits. | ||
| R&D is expected to be approximately 24% to 27% of total revenue. | ||
| SG&A is expected to be approximately 20% to 22% of total revenue. | ||
| GAAP EPS is expected to be above $3.71. | ||
| Non-GAAP diluted EPS is expected to be above $4.55. | ||
| We expect capital expenditures in the range of $170 to $200 million. |
| On February 8, 2010, Biogen Idec announced that John R. Richert, M.D., and Nancy D. Richert, M.D., Ph.D., will be joining the company. Dr. John Richert joins Biogen Idec from the National Multiple Sclerosis Society, where he served as executive vice president for Research and Clinical Programs. Dr. Nancy Richert M.D., Ph.D., most recently served as a staff clinician at the National Institute of Neurological Disorders and Stroke and on the consulting staff at the Childrens National Medical Center. | ||
| On January 28, 2010, Biogen Idec reported that it had received a notice from Icahn Partners LP and certain of its affiliates for the nomination of three individuals, Thomas F. Deuel, Eric K. Rowinsky and Richard A. Young, to Biogen Idecs Board of Directors at the companys 2010 annual meeting of stockholders. The notice also includes a proposal to amend Biogen Idecs bylaws to set the size of the Board of Directors at 12. | ||
| On January 25, 2010, Biogen Idec and Swedish Orphan Biovitrum announced that the first patient was dosed in a registrational, open-label, multicenter trial designed to evaluate the safety, pharmacokinetics and efficacy of the companies long-acting, recombinant Factor IX Fc fusion protein in hemophilia B patients. | ||
| On January 12, 2010, Biogen Idec announced the submission of a marketing authorization application to the European Medicines Agency for Fampridine Prolonged Release tablets, a novel oral therapy for the improvement of walking ability in adult patients with multiple sclerosis (MS). The company announced it had also filed a New Drug Submission to Health Canada. | ||
| On January 11, 2010, Biogen Idec and its partner Elan Pharmaceuticals, Inc. announced that Baron Baptiste, bestselling author and founder of Baptiste Power Vinyasa Yoga, and Dr. Elliot Frohman, one of the worlds leading authorities on MS, had teamed up to develop My MS Yoga, a new program created especially for people with MS. | ||
| On January 7, 2010, Biogen Idec announced that Francesco Granata had been named Executive Vice President of Global Commercial Operations. In addition, Tony Kingsley was appointed Senior Vice President of U.S. Commercial Operations, and Dr. Frederick Munschauer was named Vice President of U.S. Medical Affairs. Dr. Granata most recently served as a Group Vice President at Schering-Plough Corp. Mr. Kingsley most recently served as Senior Vice President and General Manager, GYN Surgical Products at Hologic, Inc. Dr. |
Munschauer, a distinguished neurologist and professor, joins Biogen Idec from SUNY at Buffalo School of Medicine. | |||
| On January 4, 2010, Biogen Idec announced that James C. Mullen, President and CEO, will retire from his position effective June 8, 2010. Mr. Mullen will also retire from Biogen Idecs Board of Directors upon the completion of his current term as a Director at Biogen Idecs 2010 Annual Stockholders Meeting. Biogen Idec also announced it had initiated a search for Mr. Mullens successor. | ||
| On January 4, 2010, Biogen Idec announced the appointment of Caroline Dorsa, Executive Vice President and Chief Financial Officer of Public Service Enterprise Group (PSEG) and former Senior Vice President, Global Human Health, Strategy and Integration at Merck & Co., Inc., to its Board of Directors. | ||
| On December 10, 2009, Biogen Idec announced that William D. Young would become Chairman of Biogen Idecs Board of Directors, effective January 1, 2010. The appointment followed the decision by Bruce R. Ross, 68, Biogen Idecs Chairman since December 2005, to step down as Chairman, effective January 1, 2010. | ||
| On December 10, 2009, Genentech, Inc. a wholly owned member of the Roche Group, and Biogen Idec announced that a Phase 3 study (STAGE) of the investigational humanized anti-CD20 monoclonal antibody ocrelizumab given in combination with methotrexate (MTX) met its primary endpoint of improving signs and symptoms (as measured by criteria, known as the ACR 20 response, established by the American College of Rheumatology) in rheumatoid arthritis (RA) patients who had an inadequate response to MTX at both 24 and 48 weeks. | ||
| On December 7, 2009, Genentech and Biogen Idec announced that a three-year follow up of the pivotal Phase 3 CLL8 trial showed RITUXAN plus fludarabine and cyclophosphamide (FC) chemotherapy helped patients in the trial with previously untreated chronic lymphocytic leukemia (CLL) live longer than FC alone. | ||
| On November 18, 2009, Genentech and Biogen Idec announced that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies applications for RITUXAN plus FC for the treatment of CLL. The FDA did not request any new data to complete its review of these applications. Genentech and Biogen Idec have engaged in final label discussions with the FDA and expect to finalize these discussions during the first quarter of 2010. | ||
| On October 17, 2009, Genentech and Biogen Idec announced that the companies received a complete response letter from the FDA for a supplemental Biologics License Application (sBLA) for RITUXAN plus MTX in patients with |
moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX. The FDA approved an additional sBLA submission to include updated safety and efficacy data in the label that provides guidance on how later-stage patients, those who have inadequately responded to tumor necrosis factor (TNF)-antagonist therapies, can be retreated with RITUXAN. The prescribing information now includes language that subsequent courses of the standard RITUXAN regimen (two doses at 1,000 mg each) can be administered every 24 weeks or based on clinical evaluation. Subsequent courses should not be administered sooner than 16 weeks. RITUXANs ability to improve physical function and slow joint damage for up to two years as demonstrated in clinical studies was also added. |
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
REVENUES |
||||||||||||||||
Product |
$ | 826,874 | $ | 731,836 | $ | 3,152,941 | $ | 2,839,651 | ||||||||
Unconsolidated joint business |
256,556 | 303,213 | 1,094,863 | 1,128,238 | ||||||||||||
Royalties |
40,807 | 28,966 | 124,438 | 116,224 | ||||||||||||
Corporate partner |
2,819 | 4,898 | 5,106 | 13,394 | ||||||||||||
Total revenues |
1,127,056 | 1,068,913 | 4,377,348 | 4,097,507 | ||||||||||||
COST AND EXPENSES |
||||||||||||||||
Cost of sales |
99,700 | 101,161 | 382,104 | 401,989 | ||||||||||||
Research and development |
283,083 | 292,767 | 1,283,068 | 1,072,058 | ||||||||||||
Selling, general and administrative |
241,620 | 230,963 | 911,034 | 925,305 | ||||||||||||
Amortization of acquired intangible assets |
55,981 | 90,631 | 289,811 | 332,745 | ||||||||||||
Collaboration profit sharing |
63,296 | 37,673 | 215,904 | 136,041 | ||||||||||||
In-process research and development |
| | | 25,000 | ||||||||||||
Gain on sale of long lived assets |
| (9,242 | ) | | (9,242 | ) | ||||||||||
Total cost and expenses |
743,680 | 743,953 | 3,081,921 | 2,883,896 | ||||||||||||
Income from operations |
383,376 | 324,960 | 1,295,427 | 1,213,611 | ||||||||||||
Other income (expense), net |
6,367 | (33,078 | ) | 37,252 | (57,729 | ) | ||||||||||
INCOME BEFORE INCOME TAXES |
389,743 | 291,882 | 1,332,679 | 1,155,882 | ||||||||||||
Income taxes |
83,747 | 83,456 | 355,617 | 365,776 | ||||||||||||
NET INCOME |
$ | 305,996 | $ | 208,426 | $ | 977,062 | $ | 790,106 | ||||||||
Less: Net income attributable to noncontrolling interests, net of tax |
359 | 1,773 | 6,930 | 6,939 | ||||||||||||
NET INCOME ATTRIBUTABLE TO BIOGEN IDEC INC. |
$ | 305,637 | $ | 206,653 | $ | 970,132 | $ | 783,167 | ||||||||
BASIC EARNINGS PER SHARE |
$ | 1.07 | $ | 0.71 | $ | 3.37 | $ | 2.67 | ||||||||
DILUTED EARNINGS PER SHARE |
$ | 1.06 | $ | 0.70 | $ | 3.35 | $ | 2.65 | ||||||||
WEIGHTED-AVERAGE SHARES USED IN CALCULATING: |
||||||||||||||||
BASIC EARNINGS PER SHARE |
284,028 | 291,532 | 287,356 | 292,332 | ||||||||||||
DILUTED EARNINGS PER SHARE |
286,680 | 293,777 | 289,476 | 294,984 | ||||||||||||
December 31, | December 31, | |||||||
2009 | 2008 | |||||||
ASSETS |
||||||||
Cash, cash equivalents and marketable securities |
$ | 1,263,724 | $ | 1,341,971 | ||||
Collateral received for loaned securities |
| 29,991 | ||||||
Accounts receivable, net |
551,208 | 446,665 | ||||||
Loaned securities |
| 29,446 | ||||||
Inventory |
293,950 | 263,602 | ||||||
Other current assets |
371,713 | 346,325 | ||||||
Total current assets |
2,480,595 | 2,458,000 | ||||||
Marketable securities |
1,194,080 | 891,406 | ||||||
Property, plant and equipment, net |
1,637,083 | 1,594,754 | ||||||
Intangible assets, net |
1,871,078 | 2,161,058 | ||||||
Goodwill |
1,138,621 | 1,138,621 | ||||||
Investments and other assets |
230,397 | 235,152 | ||||||
TOTAL ASSETS |
$ | 8,551,854 | $ | 8,478,991 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Collateral payable on loaned securities |
$ | | $ | 29,991 | ||||
Current portion of notes payable |
19,762 | 27,667 | ||||||
Other current liabilities |
695,180 | 865,564 | ||||||
Long-term deferred tax liability |
240,618 | 356,017 | ||||||
Notes payable |
1,080,207 | 1,085,431 | ||||||
Other long-term liabilities |
254,205 | 280,369 | ||||||
Shareholders equity |
6,261,882 | 5,833,952 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 8,551,854 | $ | 8,478,991 | ||||
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
EARNINGS PER SHARE | 2009 | 2008 | 2009 | 2008 | ||||||||||||
GAAP earnings per share Diluted |
$ | 1.06 | $ | 0.70 | $ | 3.35 | $ | 2.65 | ||||||||
Adjustments to net income attributable to Biogen Idec, Inc. (as detailed below) |
0.14 | 0.23 | 0.77 | 1.01 | ||||||||||||
Non-GAAP earnings per share Diluted |
$ | 1.20 | $ | 0.93 | $ | 4.12 | $ | 3.66 | ||||||||
An itemized reconciliation between net income attributable to Biogen Idec, Inc. on a GAAP basis and net income attributable to Biogen Idec, Inc. on a non-GAAP basis is as follows: | ||||||||||||||||
GAAP net income attributable to Biogen Idec, Inc. |
$ | 305.6 | $ | 206.7 | $ | 970.1 | $ | 783.2 | ||||||||
Adjustments: |
||||||||||||||||
R&D: Restructuring |
0.5 | 1.1 | 3.0 | 1.2 | ||||||||||||
R&D: Stock option expense |
2.0 | 2.0 | 8.3 | 8.5 | ||||||||||||
R&D: Expenses paid by Cardiokine |
1.9 | 1.2 | 7.9 | 5.2 | ||||||||||||
SG&A: Restructuring |
| 0.9 | 0.4 | 3.8 | ||||||||||||
SG&A: Stock option expense |
5.2 | 5.5 | 20.4 | 17.7 | ||||||||||||
Amortization of acquired intangible assets |
56.0 | 90.6 | 289.8 | 332.7 | ||||||||||||
In-process research and development related to the contingent consideration
payment in 2008 associated with the 2006 Conforma acquisition |
| | | 25.0 | ||||||||||||
Gain on sale of long lived assets |
| (9.2 | ) | | (9.2 | ) | ||||||||||
Income taxes: Income tax effect primarily related to reconciling items |
(24.1 | ) | (23.3 | ) | (96.9 | ) | (81.9 | ) | ||||||||
Noncontrolling interest: Expenses paid by Cardiokine |
(1.9 | ) | (1.2 | ) | (7.9 | ) | (5.2 | ) | ||||||||
Non-GAAP net income attributable to Biogen Idec, Inc. |
$ | 345.2 | $ | 274.3 | $ | 1,195.1 | $ | 1,081.0 | ||||||||
Shares | Diluted EPS | |||||||||||
Projected GAAP net income attributable to Biogen Idec, Inc. |
$ | 1,001.0 | 269.7 | $ | 3.71 | |||||||
Adjustments: |
||||||||||||
In-process research and development |
40.0 | |||||||||||
Stock option expense |
37.7 | |||||||||||
Amortization of acquired intangible assets |
214.1 | |||||||||||
Income taxes |
(66.0 | ) | ||||||||||
Projected Non-GAAP net income attributable to Biogen Idec, Inc. |
$ | 1,226.8 | 269.7 | $ | 4.55 | |||||||
Three Months Ended | ||||||||
December 31, | ||||||||
2009 | 2008 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 596,466 | $ | 565,779 | ||||
Tysabri® |
216,188 | 155,593 | ||||||
Fumaderm® |
14,220 | 10,631 | ||||||
Other |
| (167 | ) | |||||
Total product revenues |
$ | 826,874 | $ | 731,836 | ||||
Twelve Months Ended | ||||||||
December 31, | ||||||||
2009 | 2008 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 2,322,894 | $ | 2,202,533 | ||||
Tysabri® |
776,030 | 588,598 | ||||||
Fumaderm® |
49,624 | 43,422 | ||||||
Other |
4,393 | 5,098 | ||||||
Total product revenues |
$ | 3,152,941 | $ | 2,839,651 | ||||