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| First quarter 2009 revenues were $1,036 million, an increase of 10% as compared to the first quarter of 2008, driven primarily by a 44% increase in TYSABRI® (natalizumab) revenue to $165 million in the quarter, a 13% increase in RITUXAN® (rituximab) revenues from our unconsolidated joint business arrangement to $279 million, and a 4% increase in AVONEX® (interferon beta-1a) sales to $555 million. | |
| Global in-market net sales of TYSABRI in the first quarter of 2009 were $227 million, of which $116 million was in the U.S. and $111 million was in rest of world markets. | |
| First quarter 2009 GAAP diluted earnings per share (EPS) were $0.84, an increase of 56% over $0.54 in the first quarter of 2008. GAAP net income attributable to Biogen Idec for the first quarter 2009 was $244 million, an increase of 50% over $163 million for the first quarter of 2008. | |
| First quarter 2009 non-GAAP diluted EPS were $1.05, an increase of 27% over non-GAAP diluted EPS of $0.83 in the first quarter of 2008. Non-GAAP net income attributable to Biogen Idec for the first quarter 2009 was $306 million, an increase of 22% over non-GAAP net income attributable to Biogen Idec of $250 million for the |
first quarter of 2008. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release. |
| $54 million related to product sold through Elan in the U.S. (based on $116 million of in-market sales); and, | |
| $111 million related to product sold in rest of world markets. |
| In the U.S., approximately 20,800 patients were on TYSABRI therapy commercially; | |
| In the rest of world, approximately 18,500 patients were on TYSABRI therapy commercially; and, | |
| In global clinical trials, approximately 600 patients were on TYSABRI therapy. |
| Approximately 52,000 patients have been treated with TYSABRI; and, | |
| Of those patients, approximately 24,900 have received at least one year of TYSABRI therapy, approximately 14,400 patients have received at least 18 months of |
TYSABRI therapy, and 6,800 patients have received at least 24 months of TYSABRI therapy. |
| Revenue growth is expected to be in the high single digits. | ||
| Operating Expenses, excluding collaboration profit share, are 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 April 16, 2009, Biogen Idec announced that the U.S. Food and Drug Administration (FDA) approved the companys high titer process for the production of its MS drug TYSABRI. Biogen Idec received similar approval from the European Medicines Agency (EMEA) for the high titer process in December 2008. The new, higher-yield process will be used to manufacture TYSABRI at the companys plant in Research Triangle Park (RTP). |
| On March 30, 2009, Biogen Idec named Robert Hamm Chief Operating Officer. Mr. Hamm has been Executive Vice President, Pharmaceutical Operations & Technology at the Company since 2007. As COO, he will add Global Business Operations to his responsibilities, effective immediately. Mr. Hamm joined |
Biogen Idec in 1994. He served as Senior Vice President, Neurology Strategic Business Unit beginning from 2004 to 2007. Previously he served in a variety of positions of increasing responsibility, including Senior Vice President, Europe, Africa, Canada and Middle East; Vice President, Sales and Marketing; Vice President, Manufacturing & Engineering; and Director, Northern Europe and Distributors Markets. | |||
| On March 25, 2009, Biogen Idec highlighted the progress and breadth of its pipeline programs as part of the Companys R&D Day. President of Research and Development Cecil Pickett, Ph.D., along with other members of the Companys R&D leadership team provided a detailed review of key late-stage clinical development programs in each of the Companys core therapeutic areas of neurology, oncology, immunology and cardiopulmonary, as well as the Companys Factor IX program in hemophilia. In addition, Biogen Idec scientists presented many of the Companys innovative pre-clinical and early-stage development programs. | ||
| On February 23, 2009, Biogen Idec named Michael Lytton Executive Vice President of Business and Corporate Development. In this position, Mr. Lytton will be responsible for leading the Companys business development activities. From 2001 to 2009, Mr. Lytton served as a General Partner at Oxford Bioscience Partners, a venture capital firm that provides equity financing and general management assistance to emerging life sciences companies. During his tenure, Mr. Lytton led or co-led a dozen investments in companies working in a range of therapeutic areas, including central nervous system disorders, inflammatory diseases and oncology. | ||
| On February 9, 2009, Biogen Idec and Elan Corporation, plc announced the publication of new efficacy data on TYSABRI in the March 2009 issue of The Lancet Neurology. Results of a retrospective analysis of data from the Phase 3 AFFIRM trial indicate that five-times as many multiple sclerosis (MS) patients taking TYSABRI were free from disease activity versus placebo in the overall patient population. Results showed that two years after beginning treatment with TYSABRI, 37 percent of patients remained free of disease activity, compared to seven percent of placebo-treated patients. Sixty-four percent of patients showed no sign of relapse or sustained disability progression and 58 percent were free of radiological disease activity. Both of these measures were used to define freedom from disease activity in this analysis of the AFFIRM clinical trial. |
Three Months Ended | ||||||||
March 31, | ||||||||
2009 | 2008 | |||||||
REVENUES |
||||||||
Product |
$ | 733,409 | $ | 665,070 | ||||
Unconsolidated joint business |
278,818 | 247,223 | ||||||
Royalties |
24,083 | 23,981 | ||||||
Corporate partner |
174 | 5,912 | ||||||
Total revenues |
1,036,484 | 942,186 | ||||||
COST AND EXPENSES |
||||||||
Cost of sales |
98,197 | 100,934 | ||||||
Research and development |
279,478 | 258,232 | ||||||
Selling, general and administrative |
221,830 | 215,829 | ||||||
Amortization of acquired intangible assets |
89,248 | 74,781 | ||||||
Collaboration profit (loss) sharing |
42,773 | 21,406 | ||||||
In-process research and development |
| 25,000 | ||||||
Total cost and expenses |
731,526 | 696,182 | ||||||
Income from operations |
304,958 | 246,004 | ||||||
Other income (expense), net |
6,846 | 3,080 | ||||||
INCOME BEFORE INCOME TAXES |
311,804 | 249,084 | ||||||
Income taxes |
65,225 | 83,277 | ||||||
NET INCOME |
246,579 | 165,807 | ||||||
Less: Net income attributable to noncontrolling interests |
2,592 | 2,710 | ||||||
NET INCOME ATTRIBUTABLE TO BIOGEN IDEC INC. |
$ | 243,987 | $ | 163,097 | ||||
BASIC EARNINGS PER SHARE |
$ | 0.85 | $ | 0.55 | ||||
DILUTED EARNINGS PER SHARE |
$ | 0.84 | $ | 0.54 | ||||
WEIGHTED-AVERAGE SHARES USED IN CALCULATING: |
||||||||
BASIC EARNINGS PER SHARE |
287,703 | 296,171 | ||||||
DILUTED EARNINGS PER SHARE |
289,744 | 299,500 | ||||||
March 31, | December 31, | |||||||
2009 | 2008 | |||||||
ASSETS |
||||||||
Cash, cash equivalents and marketable securities |
$ | 1,401,323 | $ | 1,341,971 | ||||
Collateral received for loaned securities |
| 29,991 | ||||||
Accounts receivable, net |
481,214 | 446,665 | ||||||
Loaned securities |
| 29,446 | ||||||
Inventory |
268,076 | 263,602 | ||||||
Other current assets |
330,040 | 346,325 | ||||||
Total current assets |
2,480,653 | 2,458,000 | ||||||
Marketable securities |
1,060,875 | 891,406 | ||||||
Property, plant and equipment, net |
1,562,174 | 1,594,754 | ||||||
Intangible assets, net |
2,071,809 | 2,161,058 | ||||||
Goodwill |
1,138,621 | 1,138,621 | ||||||
Investments and other assets |
261,074 | 235,152 | ||||||
TOTAL ASSETS |
$ | 8,575,206 | $ | 8,478,991 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Collateral payable on loaned securities |
$ | | $ | 29,991 | ||||
Current portion of notes payable |
26,488 | 27,667 | ||||||
Other current liabilities |
781,279 | 865,564 | ||||||
Long-term deferred tax liability |
345,784 | 356,017 | ||||||
Notes payable |
1,082,909 | 1,085,431 | ||||||
Other long-term liabilities |
318,492 | 280,369 | ||||||
Shareholders equity |
6,020,254 | 5,833,952 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 8,575,206 | $ | 8,478,991 | ||||
Three Months Ended | ||||||||
March 31, | ||||||||
2009 | 2008 | |||||||
EARNINGS PER SHARE |
||||||||
GAAP earnings per share Diluted |
$ | 0.84 | $ | 0.54 | ||||
Adjustments to net income attributable to Biogen Idec Inc. (as detailed below) |
0.21 | 0.29 | ||||||
Non-GAAP earnings per share Diluted |
$ | 1.05 | $ | 0.83 | ||||
GAAP net income attributable to Biogen Idec Inc. |
$ | 244.0 | $ | 163.1 | ||||
Adjustments: |
||||||||
R&D: Restructuring |
1.0 | | ||||||
R&D: Stock option expense |
2.2 | 2.7 | ||||||
R&D: Expenses paid by Cardiokine |
1.6 | 0.8 | ||||||
SG&A: Restructuring |
0.1 | | ||||||
SG&A: Stock option expense |
4.5 | 3.1 | ||||||
Amortization of acquired intangible assets |
89.2 | 74.8 | ||||||
In-process research and development related to the
contingent consideration payment in 2008
associated with the 2006 Conforma acquisition |
| 25.0 | ||||||
Income
taxes: Income tax effect primarily related to reconciling items |
(35.4 | ) | (18.4 | ) | ||||
Noncontrolling interest: Expenses paid by Cardiokine |
(1.6 | ) | (0.8 | ) | ||||
Non-GAAP net income attributable to Biogen Idec Inc. |
$ | 305.6 | $ | 250.3 | ||||
Diluted | ||||||||||||
Shares | EPS | |||||||||||
Projected GAAP net income attributable to Biogen Idec Inc. |
$ | 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 |
(81.7 | ) | ||||||||||
Projected Non-GAAP net income attributable to Biogen Idec Inc. |
$ | 1,169.3 | 292.6 | $ | 4.00 | |||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2009 | 2008 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 555,289 | $ | 536,109 | ||||
Tysabri® |
165,205 | 114,663 | ||||||
Fumaderm® |
10,585 | 11,714 | ||||||
Other |
2,330 | 2,584 | ||||||
Total product revenues |
$ | 733,409 | $ | 665,070 | ||||