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| Total revenues in 2008 were $4.1 billion, an increase of 29% from $3.2 billion in 2007. The increase was driven primarily by the continued growth of TYSABRIÒ (natalizumab) revenues, which were up 156% to $589 million for the year, RITUXANÒ (rituximab) revenues from our unconsolidated joint business arrangement, which were up 22% to $1.1 billion, and AVONEXÒ (interferon beta-1a) sales, which increased 18% to $2.2 billion. | |
| Global in-market net sales in 2008 of TYSABRI were $813 million, an increase of 137% over 2007, of which $422 million was in the U.S. and $391 million was in rest of world markets. | |
| On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), full-year 2008 diluted earnings per share (EPS) were $2.65, an increase of 33% over $1.99 in 2007. GAAP net income for 2008 was $783 million, an increase of 23% over 2007 GAAP net income of $638 million. |
| Non-GAAP diluted EPS for 2008 were $3.66, an increase of 34% over 2007. Non-GAAP net income for 2008 was $1.1 billion, an increase of 23% over 2007 non-GAAP net income of $879 million. 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 20% from $893 million in the prior year, driven primarily by the continued growth of TYSABRI revenue to $156 million in the quarter, AVONEX sales up 13% to $566 million, and RITUXAN revenues from our unconsolidated joint business arrangement up 20% to $303 million. | |
| Global in-market net sales of TYSABRI in the fourth quarter of 2008 were $218 million, of which $115 million was in the U.S. and $103 million was in rest of world markets. | |
| Fourth quarter 2008 GAAP diluted EPS were $0.70, an increase of 4% from $0.67 in the fourth quarter of 2007. GAAP net income for the quarter was $207 million, an increase of 3% from $201 million for the fourth quarter of 2007. | |
| Fourth quarter 2008 non-GAAP diluted EPS were $0.93, an increase of 4% over non-GAAP diluted EPS of $0.89 in the fourth quarter 2007. Non-GAAP net income for the fourth quarter was $274 million, an increase of 3% over non-GAAP net income of $266 million in the fourth quarter of 2007. A reconciliation of our GAAP to non- GAAP results is included on Table 3 within this press release. |
| $53 million related to product sold through Elan in the U.S.; and, | |
| $103 million related to product sold in rest of world markets. |
| In the U.S., approximately 20,200 patients were on TYSABRI therapy commercially; | |
| Outside the U.S., approximately 16,900 patients were on TYSABRI therapy commercially; and, | |
| In global clinical trials, approximately 600 patients were on TYSABRI therapy. |
| Approximately 48,300 patients have been treated with TYSABRI; and, | |
| Of those patients, approximately 20,000 have received at least one year of TYSABRI therapy, approximately 10,700 patients have received at least 18 months of TYSABRI therapy, and 4,300 patients have received at least 24 months of TYSABRI therapy. |
| Revenue growth is expected to be in the high single digits. |
o | This includes the expected decline in the RITUXAN rest of world revenues, and the recent strengthening of the U.S. dollar. |
| Operating Expenses, excluding collaboration profit share, is expected to be between $2.0 to $2.1 billion. | ||
| R&D is expected to be approximately 26-28% of total revenue. | ||
| SG&A is expected to be approximately 19-20% of total revenue. | ||
| Non-GAAP tax rate is expected to be between 28-30%. GAAP tax rate is expected to be between 32%-34%. The difference between the GAAP and non-GAAP tax rate is the result of the full year effects of the reconciling items detailed in Table 3 within this press release. | ||
| Non-GAAP diluted EPS is expected to be above $4.00. GAAP diluted EPS is expected to be above $2.80. | ||
| Capital Expenditures in the range of $210-$250 million. |
| On January 13, 2009, Biogen Idec presented at the JP Morgan Healthcare Conference and provided a number of pipeline updates. Namely, the company plans to begin a Phase 3 program of pegylated interferon beta 1a in 2009; plans to start multiple Phase 2 trials this year of the Hsp90 inhibitor in various tumor types based on positive interim data from the GIST trial; and discussed positive data from Phase 2a trials of BIIB14 in Parkinsons and the decision to advance to the next clinical step of development. | ||
| On December 18, 2008, Biogen Idec and Genentech announced that a Phase 3 clinical study of RITUXAN (rituximab) in patients with early rheumatoid arthritis (RA) who have not previously been treated with methotrexate (MTX) met its primary endpoint. In this study, known as IMAGE, patients received two infusions of either 500 mg or 1000 mg of RITUXAN or placebo for up to two treatment courses in combination with a stable dose of MTX. At week 52, only patients in the 1000 mg treatment group met the primary endpoint and showed |
significantly less progression of joint damage compared to patients who received placebo in combination with MTX. |
| On December 6, 2008, Biogen Idec and Genentech announced that two global Phase 3 studies in chronic lymphocytic leukemia (CLL), CLL8 and REACH, showed RITUXAN (rituximab) plus chemotherapy significantly increased the time patients lived without their disease advancing, as defined by the primary endpoint of progression-free survival (PFS), when compared to chemotherapy alone. Results from both studies were featured during a press briefing at the 50th Annual Meeting of the American Society of Hematology (ASH) in San Francisco. | ||
| On October 30, 2008, Biogen Idec announced that it elected to participate with Genentech in the development and commercialization of GA101 in the United States. Genentech recently acquired development and U.S. commercialization rights to GA101 from Glycart, a company owned by Roche, and Roche. GA101 is a novel humanized anti-CD20 monoclonal antibody engineered to increase both direct- and immune-mediated target cell death for the potential treatment of hematologic malignancies. | ||
| On October 23, 2008, Biogen Idec announced the publication of Phase 2b data showing that a 240 mg three-times-daily dose of the companys novel oral compound, BG-12 (BG00012, dimethyl fumarate), reduced the number of new gadolinium enhancing (Gd+) lesions by 69 percent in patients with relapsing-remitting multiple sclerosis (MS) when compared to treatment with placebo (p<0.0001). These results have been published in the October 25th issue of The Lancet. |
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
REVENUES |
||||||||||||||||
Product |
$ | 731,836 | $ | 604,227 | $ | 2,839,651 | $ | 2,136,821 | ||||||||
Unconsolidated joint business |
303,213 | 253,707 | 1,128,238 | 926,098 | ||||||||||||
Royalties |
28,966 | 32,969 | 116,224 | 102,141 | ||||||||||||
Corporate partner |
4,898 | 2,397 | 13,394 | 6,557 | ||||||||||||
Total revenues |
1,068,913 | 893,300 | 4,097,507 | 3,171,617 | ||||||||||||
COST AND EXPENSES |
||||||||||||||||
Cost of sales |
101,161 | 87,566 | 401,989 | 335,192 | ||||||||||||
Research and development |
292,767 | 229,292 | 1,072,058 | 925,164 | ||||||||||||
Selling, general and administrative |
230,963 | 193,730 | 925,305 | 776,103 | ||||||||||||
Amortization of acquired intangible assets |
90,631 | 70,925 | 332,745 | 257,495 | ||||||||||||
Collaboration profit sharing |
37,673 | 13,909 | 136,041 | 14,079 | ||||||||||||
In-process research and development |
| 35,808 | 25,000 | 84,172 | ||||||||||||
Gain on sale of long lived assets |
(9,242 | ) | (360 | ) | (9,242 | ) | (360 | ) | ||||||||
Total cost and expenses |
743,953 | 630,870 | 2,883,896 | 2,391,845 | ||||||||||||
Income from operations |
324,960 | 262,430 | 1,213,611 | 779,772 | ||||||||||||
Other income (expense), net |
(34,851 | ) | 32,631 | (64,668 | ) | 130,823 | ||||||||||
INCOME BEFORE INCOME TAXES |
290,109 | 295,061 | 1,148,943 | 910,595 | ||||||||||||
Income taxes |
83,456 | 93,911 | 365,776 | 272,423 | ||||||||||||
NET INCOME |
$ | 206,653 | $ | 201,150 | $ | 783,167 | $ | 638,172 | ||||||||
BASIC EARNINGS PER SHARE |
$ | 0.71 | $ | 0.68 | $ | 2.67 | $ | 2.02 | ||||||||
DILUTED EARNINGS PER SHARE |
$ | 0.70 | $ | 0.67 | $ | 2.65 | $ | 1.99 | ||||||||
WEIGHTED-AVERAGE SHARES USED IN CALCULATING: |
||||||||||||||||
BASIC EARNINGS PER SHARE |
291,532 | 294,561 | 292,332 | 315,836 | ||||||||||||
DILUTED EARNINGS PER SHARE |
293,777 | 299,665 | 294,984 | 320,171 | ||||||||||||
December 31, | December 31, | |||||||
2008 | 2007 | |||||||
ASSETS |
||||||||
Cash, cash equivalents and marketable securities |
$ | 1,341,971 | $ | 979,070 | ||||
Collateral received for loaned securities |
29,991 | 208,209 | ||||||
Accounts receivable, net |
446,665 | 392,646 | ||||||
Loaned securities |
29,446 | 204,433 | ||||||
Inventory |
263,602 | 233,987 | ||||||
Other current assets |
346,325 | 350,062 | ||||||
Total current assets |
2,458,000 | 2,368,407 | ||||||
Marketable securities |
891,406 | 932,271 | ||||||
Property, plant and equipment, net |
1,594,754 | 1,497,383 | ||||||
Intangible assets, net |
2,161,058 | 2,492,354 | ||||||
Goodwill |
1,138,621 | 1,137,372 | ||||||
Investments and other assets |
235,152 | 201,028 | ||||||
TOTAL ASSETS |
$ | 8,478,991 | $ | 8,628,815 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Collateral payable on loaned securities |
$ | 29,991 | $ | 208,209 | ||||
Current portion of notes payable |
27,667 | 1,511,135 | ||||||
Other current liabilities |
865,564 | 469,831 | ||||||
Long-term deferred tax liability |
356,017 | 521,525 | ||||||
Notes payable |
1,085,431 | 51,843 | ||||||
Other long-term liabilities |
308,238 | 331,977 | ||||||
Shareholders equity |
5,806,083 | 5,534,295 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 8,478,991 | $ | 8,628,815 | ||||
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
EARNINGS PER SHARE | 2008 | 2007 | 2008 | 2007 | ||||||||||||
GAAP earnings per share Diluted |
$ | 0.70 | $ | 0.67 | $ | 2.65 | $ | 1.99 | ||||||||
Adjustments to net income (as detailed below) |
0.23 | 0.22 | 1.01 | 0.75 | ||||||||||||
Non-GAAP earnings per share Diluted |
$ | 0.93 | $ | 0.89 | $ | 3.66 | $ | 2.74 | ||||||||
An itemized reconciliation between net income on a GAAP basis and net income on a non-GAAP basis is as follows: |
||||||||||||||||
GAAP net income |
$ | 206.7 | $ | 201.2 | $ | 783.2 | $ | 638.2 | ||||||||
Adjustments: |
||||||||||||||||
COGS: Stock Option Expense |
| | | 0.1 | ||||||||||||
R&D: Restructuring |
1.1 | | 1.2 | 1.2 | ||||||||||||
R&D: Stock option expense |
2.0 | 3.5 | 8.5 | 12.9 | ||||||||||||
R&D: Expenses paid by Cardiokine |
1.2 | | 5.2 | | ||||||||||||
SG&A: Restructuring |
0.9 | | 3.8 | 0.6 | ||||||||||||
SG&A: Stock option expense |
5.5 | 5.3 | 17.7 | 22.6 | ||||||||||||
Amortization of acquired intangible assets |
90.6 | 70.9 | 332.7 | 257.5 | ||||||||||||
In-process research and development related to the contingent consideration payment in 2008
associated with the 2006 Conforma acquisition, and the 2007 acquisition of Syntonix and
consolidation of Cardiokine and Neurimmune |
| 35.8 | 25.0 | 84.2 | ||||||||||||
Gain on sale of long lived assets |
(9.2 | ) | (0.4 | ) | (9.2 | ) | (0.4 | ) | ||||||||
Other income (expense), net: Expenses paid by Cardiokine in 2008, consolidation of Cardiokine and
Neurimmune in 2007 |
(1.2 | ) | (34.3 | ) | (5.2 | ) | (72.3 | ) | ||||||||
Income taxes: Income tax effect of above reconciling items |
(23.3 | ) | (16.0 | ) | (81.9 | ) | (65.5 | ) | ||||||||
Non-GAAP net income |
$ | 274.3 | $ | 266.0 | $ | 1,081.0 | $ | 879.1 | ||||||||
Diluted | ||||||||||||
Shares | EPS | |||||||||||
Projected GAAP net income |
$ | 820.6 | 292.6 | $ | 2.80 | |||||||
Adjustments: |
||||||||||||
In-process research and development |
40.0 | |||||||||||
Stock option expense |
29.3 | |||||||||||
Amortization of acquired intangible assets |
357.1 | |||||||||||
Other items |
4.0 | |||||||||||
Income taxes: Income tax effect of reconciling items |
(81.7 | ) | ||||||||||
Projected Non-GAAP net income |
$ | 1,169.3 | 292.6 | $ | 4.00 | |||||||
Three Months Ended | ||||||||
December 31, | ||||||||
2008 | 2007 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 565,779 | $ | 502,525 | ||||
Tysabri® |
155,593 | 89,642 | ||||||
Fumaderm® |
10,631 | 9,019 | ||||||
Other |
(167 | ) | 3,041 | |||||
Total product revenues |
$ | 731,836 | $ | 604,227 | ||||
Twelve Months Ended | ||||||||
December 31, | ||||||||
2008 | 2007 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 2,202,533 | $ | 1,867,842 | ||||
Tysabri® |
588,598 | 229,844 | ||||||
Fumaderm® |
43,422 | 21,547 | ||||||
Other |
5,098 | 17,588 | ||||||
Total product revenues |
$ | 2,839,651 | $ | 2,136,821 | ||||