Delaware (State or other jurisdiction of incorporation) |
0-19311 (Commission file number) |
33-0112644 (IRS Employer Identification No.) |
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14 Cambridge Center, Cambridge, Massachusetts |
02142 | |||
(Address of principal executive offices) |
(Zip Code) |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 | Results of Operations and Financial Condition. |
Item 9.01 | Financial Statements and Exhibits. |
Biogen Idec Inc. |
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By: | /s/ Robert A. Licht | |||
Robert A. Licht | ||||
Vice President and Assistant Secretary | ||||
Exhibit | ||||
Number | Description | |||
99.1 | The Companys press release dated October 21, 2008. |
| Third quarter 2008 revenues were $1,093 million, an increase of 38% from $789 million in the third quarter of 2007, driven primarily by AVONEXÒ (interferon beta-1a) sales up 26% to $573 million, TYSABRIÒ (natalizumab) sales up 172% to $171 million, and RITUXANÒ (rituximab) revenues from the unconsolidated joint business arrangement up 27% to $299 million. |
| On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), third quarter 2008 diluted earnings per share (EPS) were $0.70, an increase of 71% from $0.41 in the third quarter of 2007. GAAP net income for the third quarter 2008 was $207 million, an increase of 73% from $119 million in the third quarter of 2007. |
| Third quarter 2008 non-GAAP diluted EPS were $0.98, an increase of 69% from $0.58 in the third quarter of 2007. Non-GAAP net income for the third quarter 2008 was $288 million, an increase of 69% from $170 million in the third quarter of 2007. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release. |
| Global in-market net sales of TYSABRIÒ in the third quarter of 2008 were $236 million. Based on our collaboration structure with Elan Corporation, plc., Biogen Idec recognized revenue of $171 million related to TYSABRI in the third quarter of 2008. |
| $56 million related to product sold through Elan in the U.S. (based on $122 million of in-market sales); and |
| $115 million related to product sold by Biogen Idec, internationally. |
| In the U.S., more than 19,500 patients were on TYSABRI therapy commercially; | |
| Outside of the U.S., nearly 15,300 patients were on TYSABRI therapy commercially; | |
| In global clinical trials, more than 700 patients were on TYSABRI therapy; and | |
| There have been two confirmed cases of progressive multifocal leukoencephalopathy (PML) since re-launch in the US and the first international approval in July 2006. |
| More than 48,000 patients have been treated with TYSABRI; and |
| Of those patients, nearly 18,000 have received at least one year of TYSABRI therapy and approximately 9,500 patients have been on therapy for 18 months or longer. |
| Total revenue growth above the mid 20% range over 2007. | ||
| Operating margins similar to previous guidance, and total GAAP and 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%. GAAP Tax rate expected to be 31%-33%. The difference between the GAAP and non-GAAP tax rate is a result of the full year effects of the reconciling items detailed in Table 3 within this press release. | ||
| Non-GAAP diluted EPS above $3.50, representing growth consistent with the Companys stated goal of achieving 20% non-GAAP EPS compounded annual growth through 2010. GAAP diluted EPS above $2.51. Both Non-GAAP and GAAP diluted EPS include the potential for upfront and milestone payments of approximately $40 million which are under consideration for the fourth quarter. | ||
| Capital expenditures of $270 to $290 million. |
| On October 6, 2008, Biogen Idec and Genentech announced that a global Phase III study of RITUXAN in combination with fludarabine and cyclophosphamide chemotherapy met its primary endpoint of improving progression-free survival (PFS), as assessed by investigators, in patients with previously treated CD20-positive chronic lymphocytic leukemia (CLL) compared to chemotherapy alone. There were no new or unexpected safety signals reported in the study. An independent review of the primary endpoint is being conducted for U.S. regulatory purposes. | ||
| On September 18, 2008, Biogen Idec announced that data was presented from the ASSURANCE (ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs) study, showing the long-term benefits of AVONEX® therapy in patients with relapsing multiple sclerosis (MS) for up to 15 years. The ASSURANCE study represents the long-term follow-up of patients who participated in the Multiple Sclerosis Collaborative Research Group (MSCRG), the original Phase III pivotal trial from which AVONEX was approved. | ||
| On September 5, 2008, Biogen Idec and Elan Corporation, plc announced the initiation of the first clinical trial of TYSABRI in oncology. The objectives of this Phase I/II study are to evaluate the safety and potential anti-tumor activity of TYSABRI in patients with relapsed or refractory multiple myeloma. TYSABRI is a recombinant, humanized monoclonal antibody that targets the adhesion molecule VLA4 (also known as alpha-4 integrin) that is expressed on the surface of many types of immune cells. VLA4 is also found on the surface of multiple myeloma cells and may be involved in their survival. | ||
| On August 21, 2008, Biogen Idec announced the initiation of a Phase III clinical trial of intravenous (IV) ADENTRI® (BG9928), an adenosine A1 receptor antagonist, for acute decompensated heart failure (ADHF) patients with renal insufficiency. The trial will evaluate ADENTRI, which is being developed under a licensing agreement with CV Therapeutics (Nasdaq: CVTX), or placebo in addition to standard of care in approximately 900 patients in 21 countries globally, including the United States. |
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
REVENUES |
||||||||||||||||
Product |
$ | 758,260 | $ | 529,581 | $ | 2,107,816 | $ | 1,532,594 | ||||||||
Unconsolidated joint business |
298,979 | 234,637 | 825,024 | 672,391 | ||||||||||||
Royalties |
35,162 | 23,537 | 87,258 | 69,172 | ||||||||||||
Corporate partner |
563 | 1,476 | 8,496 | 4,160 | ||||||||||||
Total revenues |
1,092,964 | 789,231 | 3,028,594 | 2,278,317 | ||||||||||||
COST AND EXPENSES |
||||||||||||||||
Cost of sales |
107,493 | 81,613 | 300,828 | 247,626 | ||||||||||||
Research and development |
268,800 | 286,274 | 779,291 | 695,872 | ||||||||||||
Selling, general and administrative |
232,824 | 190,644 | 694,342 | 582,373 | ||||||||||||
Amortization of acquired intangible assets |
94,464 | 65,689 | 242,114 | 186,570 | ||||||||||||
Collaboration profit (loss) sharing |
43,533 | 5,842 | 98,368 | 170 | ||||||||||||
In-process research and development |
| 29,959 | 25,000 | 48,364 | ||||||||||||
Total cost and expenses |
747,114 | 660,021 | 2,139,943 | 1,760,975 | ||||||||||||
Income from operations |
345,850 | 129,210 | 888,651 | 517,342 | ||||||||||||
Other income (expense), net |
(24,725 | ) | 44,904 | (29,818 | ) | 98,192 | ||||||||||
INCOME BEFORE INCOME TAXES |
321,125 | 174,114 | 858,833 | 615,534 | ||||||||||||
Income taxes |
114,337 | 54,733 | 282,320 | 178,512 | ||||||||||||
NET INCOME |
$ | 206,788 | $ | 119,381 | $ | 576,513 | $ | 437,022 | ||||||||
BASIC EARNINGS PER SHARE |
$ | 0.71 | $ | 0.41 | $ | 1.97 | $ | 1.35 | ||||||||
DILUTED EARNINGS PER SHARE |
$ | 0.70 | $ | 0.41 | $ | 1.95 | $ | 1.34 | ||||||||
WEIGHTED-AVERAGE SHARES USED IN CALCULATING: |
||||||||||||||||
BASIC EARNINGS PER SHARE |
291,408 | 288,958 | 292,613 | 323,006 | ||||||||||||
DILUTED EARNINGS PER SHARE |
293,921 | 293,396 | 295,515 | 326,743 | ||||||||||||
September 30, | December 31, | |||||||
2008 | 2007 | |||||||
ASSETS |
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Cash, cash equivalents and marketable securities |
$ | 1,227,828 | $ | 979,070 | ||||
Cash collateral received for loaned securities |
178,129 | 208,209 | ||||||
Accounts receivable, net |
484,636 | 392,646 | ||||||
Loaned securities |
158,971 | 204,433 | ||||||
Inventory |
249,858 | 233,987 | ||||||
Other current assets |
339,658 | 350,062 | ||||||
Total current assets |
2,639,080 | 2,368,407 | ||||||
Marketable securities |
717,182 | 932,271 | ||||||
Property, plant and equipment, net |
1,579,938 | 1,497,383 | ||||||
Intangible assets, net |
2,250,766 | 2,492,354 | ||||||
Goodwill |
1,137,547 | 1,137,372 | ||||||
Investments and other assets |
210,695 | 201,028 | ||||||
TOTAL ASSETS |
$ | 8,535,208 | $ | 8,628,815 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Collateral payable on loaned securities |
$ | 178,129 | $ | 208,209 | ||||
Current portion of notes payable |
10,215 | 1,511,135 | ||||||
Other current liabilities |
797,528 | 469,831 | ||||||
Long-term deferred tax liability |
440,164 | 521,525 | ||||||
Notes payable |
1,042,427 | 51,843 | ||||||
Other long-term liabilities |
298,267 | 331,977 | ||||||
Shareholders equity |
5,768,478 | 5,534,295 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 8,535,208 | $ | 8,628,815 | ||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
EARNINGS PER SHARE |
||||||||||||||||
GAAP earnings per share Diluted |
$ | 0.70 | $ | 0.41 | $ | 1.95 | $ | 1.34 | ||||||||
Adjustments to net income (as detailed below) |
0.28 | 0.17 | 0.78 | 0.54 | ||||||||||||
Non-GAAP earnings per share Diluted |
$ | 0.98 | $ | 0.58 | $ | 2.73 | $ | 1.88 | ||||||||
An itemized reconciliation between net income on a GAAP basis and net income on a non-GAAP basis is as follows: |
||||||||||||||||
GAAP net income |
$ | 206.8 | $ | 119.4 | $ | 576.5 | $ | 437.0 | ||||||||
Adjustments: |
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COGS: Stock Option Expense |
| | | 0.1 | ||||||||||||
R&D: Restructuring |
0.1 | 0.8 | 0.1 | 1.2 | ||||||||||||
R&D: Stock option expense |
2.4 | 3.5 | 6.5 | 9.4 | ||||||||||||
R&D: FIN 46 consolidation of Cardiokine |
1.7 | | 4.0 | | ||||||||||||
SG&A: Restructuring |
2.9 | | 2.9 | 0.6 | ||||||||||||
SG&A: Stock option expense |
5.3 | 5.9 | 12.2 | 17.3 | ||||||||||||
Amortization of acquired intangible assets |
94.5 | 65.7 | 242.1 | 186.6 | ||||||||||||
In-process research and development related to the contingent consideration payment in 2008 associated
with Conforma acquisition and the 2007 acquisition of Syntonix and consolidation of Cardiokine |
| 30.0 | 25.0 | 48.4 | ||||||||||||
Other income (expense), net: FIN 46 consolidation of Cardiokine and gain on sale of long-lived assets |
(1.7 | ) | (38.0 | ) | (4.0 | ) | (38.0 | ) | ||||||||
Income taxes: Income tax effect of reconciling items |
(24.1 | ) | (16.9 | ) | (58.6 | ) | (49.5 | ) | ||||||||
Non-GAAP net income |
$ | 287.9 | $ | 170.4 | $ | 806.7 | $ | 613.1 | ||||||||
Shares | Diluted EPS | |||||||||||
Projected GAAP net income |
$ | 740.0 | 295.0 | $ | 2.51 | |||||||
Adjustments: |
||||||||||||
Stock option expense |
25.5 | |||||||||||
In-process research and development |
25.0 | |||||||||||
Amortization of acquired intangible assets |
317.5 | |||||||||||
Income taxes: Income tax effect of reconciling items |
(76.5 | ) | ||||||||||
Projected Non-GAAP net income |
$ | 1,031.5 | 295.0 | $ | 3.50 | |||||||
Three Months Ended | ||||||||
September 30, | ||||||||
2008 | 2007 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 573,493 | $ | 454,890 | ||||
Tysabri® |
171,169 | 62,903 | ||||||
Amevive® |
27 | 87 | ||||||
Zevalin® |
2,483 | 4,349 | ||||||
Fumaderm® |
11,088 | 7,352 | ||||||
Total product revenues |
$ | 758,260 | $ | 529,581 | ||||
Nine Months Ended | ||||||||
September 30, | ||||||||
2008 | 2007 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 1,636,754 | $ | 1,365,317 | ||||
Tysabri® |
433,005 | 140,202 | ||||||
Amevive® |
279 | 305 | ||||||
Zevalin® |
4,987 | 14,242 | ||||||
Fumaderm® |
32,791 | 12,528 | ||||||
Total product revenues |
$ | 2,107,816 | $ | 1,532,594 | ||||