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| First quarter revenues were $942 million, an increase of 32% from $716 million in the first quarter of 2007, driven primarily by AVONEXÒ (interferon beta-1a) sales up 19% to $536 million, TYSABRIÒ (natalizumab) sales up 283% to $115 million, and RITUXANÒ (rituximab) revenues from the unconsolidated joint business arrangement up 19% to $247 million. |
| On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), first quarter 2008 diluted earnings per share (EPS) were $0.54, an increase of 42% from $0.38 in the first quarter of 2007. GAAP net income for the quarter was $163 million, an increase of 23% from $132 million in the prior year. |
| First quarter 2008 non-GAAP diluted EPS were $0.83, an increase of 41% from $0.59 in the first quarter of 2007. Non-GAAP net income for the first quarter was $250 million, an increase of 24% from $202 million in the first quarter of 2007. These non-GAAP results exclude purchase accounting and merger-related accounting impacts, stock option expense, and other items. |
| Global in-market net sales of TYSABRIÒ (natalizumab) in the first quarter of 2008 were $160 million. Based on our collaboration structure with Elan, Biogen Idec recognized revenue of $115 million related to TYSABRI in the first quarter of 2008. |
| Pre-tax charges of $75 million for the amortization of intangibles relating to the 2003 Biogen and Idec merger and the acquisitions of Conforma, Fumapharm, and Syntonix; |
| Pre-tax in-process research & development charge of $25 million related to the contingent consideration payment associated with the Conforma acquisition; |
| Pre-tax share-based compensation expense under SFAS No. 123R of $6 million; and |
| Tax effect of $18 million relating to the pre-tax items listed above. |
| $41 million related to product sold through Elan in the U.S. (based on $86 million of in-market sales); and |
| $73 million related to product sold by Biogen Idec in Europe. |
| In the U.S., approximately 15,300 patients were on TYSABRI therapy commercially and approximately 2,750 physicians have prescribed the therapy; |
| Outside of the U.S., more than 10,200 patients were on TYSABRI therapy commercially; |
| In global clinical trials, more than 600 patients were on TYSABRI therapy; and |
| There have been no cases of PML since re-launch in the US and launch internationally in July 2006. |
| More than 36,700 patients have been treated with TYSABRI; and |
| Of those patients, over 9,900 have received at least one year of TYSABRI therapy and more than 3,600 patients have been on therapy for 18 months or longer. |
| Total revenue growth of approximately 20% over 2007 as TYSABRI market penetration continues; | ||
| Operating margins similar to previous guidance, and total 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%. The difference between the GAAP and non-GAAP tax rate is a result of the cumulative effects of the reconciliations discussed below. |
| Non-GAAP diluted EPS in the range of $3.25-$3.45 representing growth consistent with the Companys stated goal of achieving 20% non-GAAP EPS compound annual growth through 2010. | ||
| GAAP diluted EPS in the range of $2.28-$2.48. | ||
| In order to reconcile the 2008 GAAP and non-GAAP EPS guidance, we have excluded the following items from non-GAAP diluted EPS guidance provided above: |
o | Purchase accounting charges, including amortization of acquired intangible assets and IPR&D, are estimated to be $340 million pre-tax, or approximately $0.92 per diluted share after-tax, for already completed transactions; | ||
o | Stock option expense due to SFAS 123R in 2008 is estimated to be approximately $20 million pre-tax (including approximately $4 million in R&D and approximately $16 million in SG&A), or approximately $0.05 per diluted share after-tax. |
| On February 14, 2008, Biogen Idec and Cardiokine, Inc. announced the initiation of a Phase III multi-center, randomized, placebo controlled, double-blind study of lixivaptan for congestive heart failure patients who suffer from hyponatremia, which is an electrolyte disturbance marked by low sodium levels in the blood. The trial will compare treatment with lixivaptan to placebo in approximately 650 patients in the U.S. and Europe. The primary endpoint of the study is to evaluate the safety and effectiveness of lixivaptan, when compared to placebo, in increasing serum sodium from baseline in heart failure patients with hyponatremia. | ||
| On February 29, 2008, Biogen Idec Inc priced a public offering of $1.0 billion principal amount of senior unsecured notes. The offering of senior unsecured notes included $450 million in aggregate principal amount of 6.0% notes due 2013 and $550 million in aggregate principal amount of 6.875% notes due 2018. The sale of the notes closed on March 4, 2008. | ||
| On March 24, 2008, Biogen Idec, in collaboration with scientists at the University of Arizona and Tufts University, reported in the April issue of the journal Nature Neuroscience that in preclinical studies, injections of the protein neublastin promoted the regeneration of damaged sensory nerve cells and produced virtually complete, long-term restoration of sensory and motor function. These studies suggest neublastin has potential for further development as a treatment for traumatic nerve injury. |
| On April 15, 2008, Biogen Idec announced that 17 company-sponsored plenary sessions, platform presentations, and poster presentations were presented at the 60th Annual Meeting of the American Academy of Neurology. These presentations covered four compounds that are marketed or currently in development by Biogen Idec and its partners for the treatment of multiple sclerosis (MS). They included two approved therapies for MS; TYSABRI® (natalizumab) and AVONEX® (Interferon beta-1a); and two additional agents in development; BG-12 (dimethyl fumarate) and daclizumab. | ||
| On April 15, 2008, Biogen Idec and Elan announced new data on the global utilization, safety and overall patient exposure of TYSABRI® (natalizumab). As of the end of March 2008, approximately 26,000 patients were on commercial and clinical therapy worldwide with no cases of progressive multifocal leukoencephalopathy (PML) reported since re-launch in the U.S. and launch internationally in July 2006. Growth in global utilization plus increasing confidence in the favorable benefit-risk profile of TYSABRI indicate the companies are making great progress toward the goal of 100,000 patients on therapy by year-end 2010 | ||
| On April 16, 2008, Biogen Idec and Elan announced additional findings from the PLEX study which showed that plasma exchange accelerates the removal of TYSABRI® (natalizumab) from blood serum in patients and may help improve central nervous system immune response based on an in vitro model. Plasma exchange is one of several research efforts the companies have underway to learn more about potential interventions or treatments for progressive multifocal leukoencephalopathy (PML). | ||
| On April 17, 2008, the Board of Directors announced its nominees for election at the 2008 Annual Meeting of shareholders. The Board of Directors has nominated Cecil B. Pickett, Ph.D., Lynn Schenk and Phillip A. Sharp, Ph.D., for re-election as directors of Biogen Idec. These three individuals have a proven track record of creating value for all Biogen Idec shareholders. In addition, the Board has nominated Stelios Papadopoulos, Ph.D., for election as a director of the Company. The Board noted that all four of these highly regarded and accomplished individuals are committed to building on the Companys strong record of growth and delivering significant value to shareholders. |
Three Months Ended | ||||||||
March 31, | ||||||||
2008 | 2007 | |||||||
REVENUES |
||||||||
Product |
$ | 665,070 | $ | 484,388 | ||||
Unconsolidated joint business |
247,223 | 207,164 | ||||||
Royalties |
23,981 | 22,987 | ||||||
Corporate partner |
5,912 | 1,371 | ||||||
Total revenues |
942,186 | 715,910 | ||||||
COST AND EXPENSES |
||||||||
Cost of sales |
100,934 | 81,950 | ||||||
Research and development |
258,232 | 191,449 | ||||||
Selling, general and administrative |
215,829 | 188,061 | ||||||
Amortization of acquired intangible assets |
74,781 | 59,920 | ||||||
Collaboration profit (loss) sharing |
21,406 | (5,567 | ) | |||||
Acquired in-process research and development |
25,000 | 18,405 | ||||||
Total cost and expenses |
696,182 | 534,218 | ||||||
Income from operations |
246,004 | 181,692 | ||||||
Other income, net |
370 | 21,702 | ||||||
INCOME BEFORE INCOME TAXES |
246,374 | 203,394 | ||||||
Income taxes |
83,277 | 71,893 | ||||||
NET INCOME |
$ | 163,097 | $ | 131,501 | ||||
BASIC EARNINGS PER SHARE |
$ | 0.55 | $ | 0.39 | ||||
DILUTED EARNINGS PER SHARE |
$ | 0.54 | $ | 0.38 | ||||
SHARES USED IN CALCULATING: |
||||||||
BASIC
EARNINGS PER SHARE |
296,171 | 340,310 | ||||||
DILUTED
EARNINGS PER SHARE |
299,500 | 344,058 | ||||||
March 31, | December 31, | |||||||
2008 | 2007 | |||||||
ASSETS |
||||||||
Cash, cash equivalents and marketable securities |
$ | 845,418 | $ | 979,070 | ||||
Cash collateral received for loaned securities |
124,693 | 208,209 | ||||||
Accounts receivable, net |
451,480 | 392,646 | ||||||
Loaned securities |
140,981 | 204,433 | ||||||
Inventory |
237,172 | 233,987 | ||||||
Other current assets |
340,731 | 350,062 | ||||||
Total current assets |
2,140,475 | 2,368,407 | ||||||
Marketable securities |
674,529 | 932,271 | ||||||
Property and equipment, net |
1,581,664 | 1,497,383 | ||||||
Intangible assets, net |
2,421,255 | 2,492,354 | ||||||
Goodwill |
1,140,190 | 1,137,372 | ||||||
Investments and other assets |
212,540 | 201,028 | ||||||
TOTAL ASSETS |
$ | 8,170,653 | $ | 8,628,815 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Collateral payable on loaned securities |
$ | 124,693 | $ | 208,209 | ||||
Short-term debt |
12,841 | 1,511,135 | ||||||
Other current liabilities |
569,638 | 469,831 | ||||||
Long-term deferred tax liability |
523,392 | 521,525 | ||||||
Long-term debt |
1,060,448 | 51,843 | ||||||
Other long-term liabilities |
346,933 | 331,977 | ||||||
Shareholders equity |
5,532,708 | 5,534,295 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 8,170,653 | $ | 8,628,815 | ||||
Three Months Ended | ||||||||
March 31, | ||||||||
EARNINGS PER SHARE | 2008 | 2007 | ||||||
GAAP earnings per share Diluted |
$ | 0.54 | $ | 0.38 | ||||
Adjustment to net income (as detailed below) |
0.29 | 0.21 | ||||||
Non-GAAP earnings per share Diluted |
$ | 0.83 | $ | 0.59 | ||||
GAAP net income |
$ | 163.1 | $ | 131.5 | ||||
Adjustments: |
||||||||
R&D: Stock option expense |
2.7 | 3.0 | ||||||
R&D: FIN 46 consolidations of Cardiokine and Neurimmune |
0.8 | | ||||||
SG&A: Restructuring |
| 0.1 | ||||||
SG&A: Stock option expense |
3.1 | 6.1 | ||||||
Amortization of acquired intangible assets |
74.8 | 59.9 | ||||||
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, net: FIN 46 consolidations of Cardiokine and Neurimmune |
(0.8 | ) | | |||||
Income taxes: Income tax effect of reconciling items |
(18.4 | ) | (16.6 | ) | ||||
Non-GAAP net income |
$ | 250.3 | $ | 202.4 | ||||
Three Months Ended | ||||||||
March 31, | ||||||||
2008 | 2007 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 536,109 | $ | 448,809 | ||||
Tysabri® |
114,663 | 29,760 | ||||||
Amevive® |
139 | 216 | ||||||
Zevalin® |
2,445 | 5,603 | ||||||
Fumaderm® |
11,714 | | ||||||
Total product revenues |
$ | 665,070 | $ | 484,388 | ||||