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| Total revenues in 2007 were $3.17 billion, an increase of 18% from $2.68 billion in 2006. The increase was driven primarily by the continued growth of TYSABRIÒ (natalizumab) revenue to $230 million for the year, RITUXANÒ (rituximab) revenues from the unconsolidated joint business arrangement, which were up 14% to $926 million, and AVONEXÒ (interferon beta-1a) sales, which increased 9% to $1.87 billion. |
| Global in-market net sales in 2007 of TYSABRI were $343 million, comprised of $218 million in the U.S. and $125 million in Europe. |
| On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), full year 2007 diluted earnings per share (EPS) were $1.99, an increase of 216% over $0.63 in 2006. GAAP net income for 2007 was $638 million, an increase of 193% over 2006 GAAP net income of $218 million. |
| Non-GAAP diluted EPS for 2007 were $2.74, an increase of 22% over 2006. Non-GAAP net income for 2007 was $879 million, an increase of 13% over 2006 non-GAAP net income of $777 million. These non-GAAP results exclude purchase accounting and merger-related accounting impacts, stock option expense and the |
cumulative effect of an accounting change relating to the adoption of the stock option expensing rules, and other items. |
| Fourth quarter revenues were $893 million, an increase of 26% from $708 million in the prior year, driven primarily by the continued growth of TYSABRI revenue to $90 million in the quarter, AVONEX sales up 15% to $503 million, and RITUXAN revenues from our unconsolidated joint business arrangement up 17% to $254 million. |
| Global in-market net sales of TYSABRI in the fourth quarter of 2007 were $129 million, comprised of $76 million in the U.S. and $53 million in Europe. |
| Fourth quarter 2007 GAAP diluted EPS were $0.67, an increase of 109% from $0.32 in the fourth quarter of 2006. GAAP net income for the quarter was $201 million, an increase of 84% from $109 million for the fourth quarter of 2006. |
| Fourth quarter 2007 non-GAAP diluted EPS were $0.89, an increase of 68% over non-GAAP diluted EPS of $0.53 in the fourth quarter 2006. Non-GAAP net income for the fourth quarter was $266 million, an increase of 45% over non-GAAP net income of $184 million in the fourth quarter of 2006. These non-GAAP results exclude purchase accounting and merger-related accounting impacts, stock option expense, and other items. |
| Pre-tax charges of $107 million for in-process R&D related to the consolidation of Neurimmune and Escoublac and the amortization of intangibles related to the 2003 |
Biogen and Idec merger, the 2006 acquisitions of Conforma and Fumapharm, and the 2007 acquisition of Syntonix; |
| Pre-tax other income of $34 million due to the consolidation of Neurimmune; |
| Pre-tax share-based payment expense under SFAS 123R of $9 million, primarily employee stock option expense; and |
| Tax effect of $16 million relating to the items listed above. |
| $37 million related to product sold through Elan in the U.S.; and |
| $53 million related to product sold in Europe. |
| In the US, approximately 12,900 patients were on TYSABRI therapy commercially and approximately 2,500 physicians have prescribed the therapy; | ||
| Internationally, approximately 7,500 patients were on TYSABRI therapy commercially; | ||
| In global clinical trials, approximately 700 patients were on TYSABRI therapy; and | ||
| There have been no cases of progressive multifocal leukoencephalopathy (PML) since re-launch in the US and launch internationally in July 2006. |
| Total revenue growth of 15%-20% over 2007 as TYSABRI market penetration continues; | ||
| Increasing operating margin leverage, including: |
| Non-GAAP R&D at 26-28% of total revenue | ||
| Non-GAAP SG&A at 21-23% of total revenue |
| Non-GAAP tax rate expected to be 28%-30% | ||
| Non-GAAP diluted EPS in the range of $3.20-$3.35, representing growth consistent with our long-term objectives. This non-GAAP diluted EPS estimate excludes the impact of purchase accounting, merger-related adjustments, stock option expense and their related tax effects; | ||
| GAAP diluted EPS in the range of $2.23-$2.38. | ||
| In order to reconcile the 2008 GAAP and non-GAAP guidance, we have excluded the following items from non-GAAP diluted EPS guidance provided above: |
| Purchase accounting charges, including amortization of acquired intangible assets and IPR&D, is estimated to be $340 million pre-tax, or approximately $0.92 per share after-tax, for already completed transactions; | ||
| 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 share after-tax. | ||
| The difference between the GAAP and non-GAAP tax rate is a result of the cumulative effects of the reconciliations listed above. |
| Capital expenditures of $210 to $260 million. |
| On November 9th, Biogen Idec presented positive results from its Phase IIa trial of baminercept (LTbR-Ig or BG9924), the first dual-mechanism, lymphotoxin-β and LIGHT pathway inhibitor in development for the treatment of autoimmune diseases, including RA. The data suggest clinically meaningful improvements in American College of Rheumatology (ACR) scores and individual core set measurements in patients with RA who received baminercept compared with placebo. Results from the Phase IIa trial were presented at ACRs 73rd Annual Meeting in Boston. |
| On November 20th, Biogen Idec and Neurimmune Therapeutics AG announced they entered into an agreement for the worldwide development and commercialization of novel, fully human antibodies for the treatment of Alzheimers disease (AD). The alliance will focus on the development of antibodies that bind to amyloid beta, a pathogenic molecule thought to cause neurodegeneration and loss of cognitive function in AD patients. | ||
| On December 12th, the Board of Directors of Biogen Idec announced that, after completing a review of strategic alternatives to maximize shareholder value, Biogen Idec will continue on its present course as an independent company. The Board emphasized that Biogen Idecs business strategy is working and generating strong operating and financial performance. The Board also noted that it is confident that continued execution of the Companys business plan will result in attractive value for stockholders. | ||
| On December 19th, Biogen Idec announced the first occupant in its Biogen Idec Innovation Incubator (bi3). Bi3 is a corporate initiative designed to contribute to the companys drug development pipeline by offering entrepreneurial scientists the opportunity to rapidly convert novel biological insights into life-saving and life-changing therapies. The incubator company, Escoublac, is based on the discovery of a new link between bone biology and metabolism by Gerard Karsenty, MD, PhD, professor and chair of Genetics & Development at Columbia University Medical Center. | ||
| On January 7th, Biogen Idec and Elan Corporation announced new data on the global utilization, safety and overall patient exposure of TYSABRI. As of late December 2007, more than 21,000 patients were on commercial and clinical therapy worldwide. To date, the safety data continue to support a favorable benefit-risk profile for TYSABRI. There have been no cases of PML since re-launch in the US and launch internationally in July 2006. | ||
| On January 7th, in a presentation to investors at the 26th Annual JPMorgan Healthcare Conference, CEO James C. Mullen outlined the companys key growth opportunities, long-range strategy and financial goals. In addition to reiterating Biogen Idecs 2010 business goals, Mullen announced new data on the global utilization, safety and overall patient exposure of TYSABRI. In addition, Mullen provided an update on Biogen Idecs 15 product candidates in Phase 2 clinical trials or beyond, as well as the 10 or more data readouts expected between September 2007 and year-end 2008. Biogen Idec also revised upward full-year 2007 financial guidance and issued full-year 2008 guidance. | ||
| On January 8th, Ophthotech Corp, Biogen Idec and PDL BioPharma announced that they have entered into an exclusive worldwide licensing agreement for an anti-angiogenesis antibody to treat Age-Related Macular Degeneration. Under the terms of the agreement, Biogen Idec and PDL have granted Ophthotech worldwide development and commercial rights to all ophthalmic uses of volociximab (M200). |
| On January 10th, Biogen Idec announced the appointment of Nancy L. Leaming to its Board of Directors. For twenty years, Leaming, 60, served in several executive positions at Tufts Health Plan, including President and CEO (2003-2005), President and Chief Operating Officer (1997-2003) and Chief Operating Officer (1986-1997). She is currently a member of the boards of directors at Hologic Inc., where she chairs the Audit Committee, Edgewater Technology Inc., the Massachusetts Taxpayers Foundation and the American Red Cross of Massachusetts. | ||
| On January 14th, Elan and Biogen Idec announced the approval of a supplemental Biologics License Application (sBLA) by the U.S. Food and Drug Administration (FDA) for TYSABRI. TYSABRI is now approved for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohns Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. The FDA granted approval based on its review of TYSABRI CD clinical trial data and overall safety data. The approval is accompanied by robust labeling with safety warnings; and a CD-specific risk management plan (including the mandatory TOUCH Prescribing Program) designed to inform prescribers, patients and infusion centers about the use of TYSABRI and to minimize potential risk of progressive multifocal leukoencephalopathy (PML) and other opportunistic infections. | ||
| On January 24th, Genentech and Biogen Idec announced that a Phase III clinical study of RITUXAN in biologic-naïve patients met its primary endpoint of a significantly greater proportion of RITUXAN-treated patients achieving an ACR20 response at week 24, compared to placebo. The study, known as SERENE, enrolled patients with moderately-to-severely active RA who had an inadequate response to prior treatment with methotrexate, a disease modifying antirheumatic drug (DMARD-IR). | ||
| On January 28th, Biogen Idec announced that it had received notice from Icahn Partners LP and certain of its affiliates for the nomination of three individuals, Alexander J. Denner, Richard C. Mulligan and Anne B. Young, to Biogen Idecs Board of Directors at the Companys 2008 Annual Meeting. The notice also includes a proposal to amend the Companys bylaws to set the size of the Board at 12. Biogen Idecs Board said it will review the notice and consider it in light of the best interests of all shareholders of the Company. |
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
REVENUES |
||||||||||||||||
Product |
$ | 604,227 | $ | 463,617 | $ | 2,136,821 | $ | 1,781,313 | ||||||||
Unconsolidated joint business |
253,707 | 217,568 | 926,098 | 810,864 | ||||||||||||
Royalties |
32,969 | 25,517 | 102,141 | 86,231 | ||||||||||||
Corporate partner |
2,397 | 1,639 | 6,557 | 4,641 | ||||||||||||
Total revenues |
893,300 | 708,341 | 3,171,617 | 2,683,049 | ||||||||||||
COST AND EXPENSES |
||||||||||||||||
Cost of sales |
87,566 | 62,103 | 335,192 | 274,383 | ||||||||||||
Research and development |
229,292 | 199,480 | 925,164 | 718,390 | ||||||||||||
Selling, general and administrative |
193,730 | 186,945 | 776,103 | 685,067 | ||||||||||||
Amortization of acquired intangible assets |
70,925 | 60,020 | 257,495 | 266,998 | ||||||||||||
Collaboration profit (loss) sharing |
13,909 | (4,393 | ) | 14,079 | (9,682 | ) | ||||||||||
Acquired in-process research and development |
35,808 | | 84,172 | 330,520 | ||||||||||||
Gain on sale of long lived assets and impairments, net |
(360 | ) | (15,584 | ) | (360 | ) | (16,507 | ) | ||||||||
Loss/(gain) on settlement of license agreements, net |
| 28,052 | | (6,140 | ) | |||||||||||
Total cost and expenses |
630,870 | 516,623 | 2,391,845 | 2,243,029 | ||||||||||||
Income from operations |
262,430 | 191,718 | 779,772 | 440,020 | ||||||||||||
Other income/(expense), net |
32,631 | (10,647 | ) | 130,823 | 52,143 | |||||||||||
INCOME BEFORE INCOME TAXES AND CUMULATIVE
EFFECT OF ACCOUNTING CHANGE |
295,061 | 181,071 | 910,595 | 492,163 | ||||||||||||
Income taxes |
93,911 | 72,515 | 272,423 | 278,431 | ||||||||||||
INCOME BEFORE CUMULATIVE EFFECT OF
ACCOUNTING CHANGE |
201,150 | 108,556 | 638,172 | 213,732 | ||||||||||||
Cumulative effect of accounting change, net of income tax |
| | | 3,779 | ||||||||||||
NET INCOME |
$ | 201,150 | $ | 108,556 | $ | 638,172 | $ | 217,511 | ||||||||
BASIC EARNINGS PER SHARE |
||||||||||||||||
Income before cumulative effect of accounting change |
$ | 0.68 | $ | 0.32 | $ | 2.02 | $ | 0.63 | ||||||||
Cumulative effect of accounting change, net of
income tax |
| | | 0.01 | ||||||||||||
BASIC EARNINGS PER SHARE |
$ | 0.68 | $ | 0.32 | $ | 2.02 | $ | 0.64 | ||||||||
DILUTED EARNINGS PER SHARE |
||||||||||||||||
Income before cumulative effect of accounting change |
$ | 0.67 | $ | 0.32 | $ | 1.99 | $ | 0.62 | ||||||||
Cumulative effect of accounting change, net of
income tax |
| | | 0.01 | ||||||||||||
DILUTED EARNINGS PER SHARE |
$ | 0.67 | $ | 0.32 | $ | 1.99 | $ | 0.63 | ||||||||
SHARES USED IN CALCULATING: |
||||||||||||||||
BASIC EARNINGS PER SHARE |
294,561 | 335,645 | 315,836 | 338,585 | ||||||||||||
DILUTED EARNINGS PER SHARE |
299,665 | 343,070 | 320,171 | 345,281 | ||||||||||||
December 31, | December 31, | |||||||
2007 | 2006 | |||||||
ASSETS |
||||||||
Cash, cash equivalents and marketable securities |
$ | 979,070 | $ | 902,691 | ||||
Cash collateral received for loaned securities |
208,209 | | ||||||
Accounts receivable, net |
392,646 | 317,353 | ||||||
Loaned securities |
204,433 | | ||||||
Inventory |
233,987 | 169,102 | ||||||
Other current assets |
350,062 | 323,421 | ||||||
Total current assets |
2,368,407 | 1,712,567 | ||||||
Marketable securities |
932,271 | 1,412,238 | ||||||
Property and equipment, net |
1,497,383 | 1,280,385 | ||||||
Intangible assets, net |
2,492,354 | 2,747,241 | ||||||
Goodwill |
1,137,372 | 1,154,757 | ||||||
Investments and other assets |
201,028 | 245,620 | ||||||
TOTAL ASSETS |
$ | 8,628,815 | $ | 8,552,808 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Collateral received on loaned securities |
$ | 208,209 | $ | | ||||
Short-term debt |
1,511,135 | | ||||||
Other current liabilities |
469,831 | 582,855 | ||||||
Long-term deferred tax liability |
521,525 | 643,645 | ||||||
Other long-term liabilities |
383,820 | 176,530 | ||||||
Shareholders equity |
5,534,295 | 7,149,778 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 8,628,815 | $ | 8,552,808 | ||||
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
EARNINGS PER SHARE | 2007 | 2006 | 2007 | 2006 | ||||||||||||
GAAP earnings per share Diluted |
$ | 0.67 | $ | 0.32 | $ | 1.99 | $ | 0.63 | ||||||||
Adjustment to net income (as detailed below) |
0.22 | 0.21 | 0.75 | 1.62 | ||||||||||||
Non-GAAP earnings per share Diluted |
$ | 0.89 | $ | 0.53 | $ | 2.74 | $ | 2.25 | ||||||||
An itemized reconciliation between net income on a GAAP basis and net income on a non-GAAP basis is as follows: |
||||||||||||||||
GAAP net income |
$ | 201.2 | $ | 108.6 | $ | 638.2 | $ | 217.5 | ||||||||
Adjustments: |
||||||||||||||||
COGS: Fair value step up of inventory acquired from former Biogen, Inc. and Fumapharm |
| | | 7.8 | ||||||||||||
COGS: Stock option expense |
| | 0.1 | 0.1 | ||||||||||||
R&D: Restructuring |
| | 1.2 | 0.3 | ||||||||||||
R&D: Stock option expense |
3.5 | 2.9 | 12.9 | 19.3 | ||||||||||||
SG&A: Merger related and purchase accounting costs |
| | | 0.1 | ||||||||||||
SG&A: Restructuring |
| 0.4 | 0.6 | 2.0 | ||||||||||||
SG&A: Stock option expense |
5.3 | 4.6 | 22.6 | 28.9 | ||||||||||||
Amortization of acquired intangible assets |
70.9 | 60.0 | 257.5 | 267.0 | ||||||||||||
In-process research and development related to the consolidation of Cardiokine, Neurimmune
and Escoublac, and acquisitions of Syntonix, Conforma, and Fumapharm |
35.8 | | 84.2 | 330.5 | ||||||||||||
Loss/(gain) on settlements of license agreements with Fumedica and with Fumapharm AG, net |
| 28.1 | | (6.1 | ) | |||||||||||
Gain on sale of long lived assets and impairments, net |
(0.4 | ) | (15.6 | ) | (0.4 | ) | (16.5 | ) | ||||||||
Other income, net: Consolidation of Cardiokine and Neurimmune and gain on sale of long
lived
assets |
(34.3 | ) | | (72.3 | ) | | ||||||||||
Income taxes: Income tax effect of reconciling items |
(16.0 | ) | (5.5 | ) | (65.5 | ) | (70.3 | ) | ||||||||
Cumulative effect of accounting change from adoption of SFAS 123R, net of income tax |
| | | (3.8 | ) | |||||||||||
Non-GAAP net income |
$ | 266.0 | $ | 183.5 | $ | 879.1 | $ | 776.8 | ||||||||
Three Months Ended | ||||||||
December 31, | ||||||||
2007 | 2006 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 502,525 | $ | 438,758 | ||||
Tysabri® |
89,642 | 17,569 | ||||||
Amevive® |
419 | 376 | ||||||
Zevalin® |
2,622 | 3,879 | ||||||
Fumaderm® |
9,019 | 3,035 | ||||||
Total product revenues |
$ | 604,227 | $ | 463,617 | ||||
Twelve Months Ended | ||||||||
December 31, | ||||||||
2007 | 2006 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 1,867,842 | $ | 1,706,719 | ||||
Tysabri® |
229,844 | 35,831 | ** | |||||
Amevive® |
724 | 11,524 | ||||||
Zevalin® |
16,864 | 17,767 | ||||||
Fumaderm® |
21,547 | 9,472 | ||||||
Total product revenues |
$ | 2,136,821 | $ | 1,781,313 | ||||
** | Biogen Idecs TYSABRI revenues for the twelve months ended December 31, 2006 includes $14 million of revenue that was deferred at the time of the initial TYSABRI launch in accordance with the Companys revenue recognition policy. The revenue was recognized in Q3 2006, as the ultimate disposition of the product was determined in that period. |