Biogen Idec Inc. | ||
(Exact name of registrant as specified in its charter) |
Delaware | 0-19311 | 33-0112644 | ||
(State or other jurisdiction | (Commission File Number) | (IRS Employer | ||
of incorporation) | Identification No.) |
14 Cambridge Center, Cambridge, Massachusetts | 02142 | |||
(Address of principal executive offices) | (Zip Code) |
Not Applicable | ||
(Former name or former address, if changed since last report) |
Item 2.02 | Results of Operations and Financial Condition. |
Item 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits |
99.1 | Registrants press release dated July 24, 2007. |
Biogen Idec Inc. | |||
By: | /s/ Robert A. Licht | ||
Robert A. Licht | |||
Vice President and Assistant Secretary |
| Second quarter revenues were $773 million, an increase of 17% from $660 million in the prior year. There were three main drivers of this growth. |
| AVONEXÒ (interferon beta-1a) sales increased 8% to $462 million | ||
| RITUXANÒ (rituximab) revenues from the unconsolidated joint business arrangement increased 12% to $231 million | ||
| Global in-market net sales of TYSABRIÒ (natalizumab) in the second quarter of 2007 totaled $72 million. Based on the collaboration structure with Elan, Biogen Idec recognized revenue of $48 million related to TYSABRI. |
| On July 2, 2007, Biogen Idec announced the final results of its Dutch Auction tender offer which expired at 12:00 midnight ET on Tuesday, June 26, 2007. Biogen Idec accepted for payment an aggregate of 56,424,155 shares of its common stock at a purchase price of $53.00 per share, for an aggregate share repurchase of approximately $3 billion. These shares represented approximately 16.4% of the shares outstanding as of June 26, 2007. The share repurchase was funded by approximately equal parts cash and debt. |
| On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), second quarter 2007 diluted earnings per share (EPS) were $0.54, an increase from a loss of $0.50 in the second quarter of 2006. GAAP net income |
for the quarter was $186 million, an increase from a $171 million loss in the second quarter of 2006. |
| Second quarter 2007 non-GAAP diluted EPS were $0.70, an increase of 23% over non-GAAP diluted EPS of $0.57 in the second quarter 2006. Non-GAAP net income for the second quarter was $240 million, an increase of 22% over non-GAAP net income of $197 million in the second 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 $61 million for 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 share-based compensation expense under SFAS No. 123R of $8 million; and | |
| Tax benefit of $16 million related to the pre-tax reconciling items. |
| $22.3 million related to product sold through Elan in the U.S. (based on $46.8 million of in-market sales); and | |
| $25.2 million related to product sold by Biogen Idec in Europe. |
| In the US, approximately 8,600 patients are on TYSABRI therapy commercially. | |
| In the EU, approximately 4,300 patients are on TYSABRI therapy commercially. | |
| In clinical trial settings, approximately 1,000 patients are on TYSABRI therapy. |
| Total revenue growth of 16%-18% over 2006; | |
| Similar financial margins for 2006 and 2007, except for R&D, which will be approximately 28%-30% of revenue. This includes a $50 million milestone payment in Q3 related to the anticipated Cardiokine deal; | |
| Non-GAAP diluted EPS, incorporating the impact of the recent tender offer, in the range of $2.60-$2.70 which represents 16%-20% annual growth. This non-GAAP diluted EPS estimate excludes the impact of purchase accounting, merger-related adjustments, stock option expense, and other items and their related tax effects; | |
| Fully diluted weighted average shares outstanding for the first half of the year totaled approximately 343 million. Due to the tender offer, the Company expects fully diluted share count to be approximately 290-296 million for the second half of the year and 316 - -322 million for the full year. | |
| The Company anticipates that 2007 capital expenditures will be in the range of $250 - $300 million. |
| Purchase accounting charges, including amortization of acquired intangible assets and IPR&D, is estimated to be $287 million, or approximately $0.90 per share, for already completed transactions; | |
| Stock option expense due to FAS 123R in 2007 is estimated to be in the range of $30-$40 million, or approximately $ 0.07-$ 0.09 per share. |
| On April 26th, Biogen Idec announced the national launch of the new AVONEX Nurse Services program which is designed to help people with multiple sclerosis as they begin and continue treatment with AVONEX, the most prescribed treatment for relapsing forms of MS worldwide. This new program underscores Biogen Idecs commitment to the MS community, which includes offering the best support services to patients and undertaking innovative research efforts to develop new therapeutic options. | |
| On May 1st, Genentech and Biogen Idec announced that positive data from a Phase II clinical study of RITUXAN in patients with relapsing-remitting multiple sclerosis (RRMS) were presented at the American Academy of Neurology annual meeting held in Boston. | |
| On May 3rd, Biogen Idec and Elan Corporation announced that new data from the TOUCH Prescribing Program and TYGRIS safety study confirm the safety profile from previous clinical studies of TYSABRI. Also presented at the 59th annual meeting of the American Academy of Neurology in Boston, MA were extension study data that showed that TYSABRI has a sustained treatment effect on clinical relapses and the risk of disability progression in multiple sclerosis patients treated for up to three years. | |
| On May 8th, Biogen Idec and Vernalis announced the initiation of the Phase II program of BIIB014 (also known as V2006), an oral compound for the treatment of Parkinsons disease. BIIB014 is an adenosine A2A receptor antagonist that may offer a non-dopaminergic therapy for patients with Parkinsons disease. | |
| On June 26th, Biogen Idec and UCB announced the initiation of a Phase II study of CDP323 (an oral VLA-4 antagonist) under development for relapsing-remitting multiple sclerosis . The double-blind, randomized Phase II study commenced with dosing of the first patient. The study is designed to enroll over 200 patients with relapsing-remitting MS who have failed earlier treatment with a beta-interferon. | |
| On July 2nd, Biogen Idec Inc announced the final results of its modified Dutch Auction tender offer, which expired at 12:00 midnight ET on Tuesday, June 26, 2007. Biogen Idec accepted for payment an aggregate of 56,424,155 shares of its common stock at a purchase price of $53.00 per share, for an aggregate share repurchase of approximately $3 |
billion. These shares represented approximately 16.4% of the shares outstanding as of June 26, 2007. | ||
| On July 2nd, Biogen Idec and Elan Corporation welcomed the announcement by the National Institute for Health and Clinical Excellence (NICE) in the final appraisal determination that recommended use of TYSABRI in people with highly active relapsing-remitting multiple sclerosis. TYSABRI is the first treatment for multiple sclerosis to be recommended for use by NICE. | |
| On July 2nd, Biogen Idec and Cardiokine announced they agreed to jointly develop lixivaptan, an oral compound being tested for treatment of hyponatremia in patients with congestive heart failure. Lixivaptan is expected to enter a late-stage clinical trial this year. Under terms of the agreement, which is expected to become effective in the third quarter of 2007, Cardiokine, will receive a $50 million upfront payment and up to $170 million in additional milestone payments for successful development and global commercialization of lixivaptan, as well as royalties on commercial sales. Biogen Idec will be responsible for the global commercialization of lixivaptan, and Cardiokine will have an option for limited co-promotion in the U.S. |
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
REVENUES |
||||||||||||||||
Product |
$ | 518,625 | $ | 436,081 | $ | 1,003,013 | $ | 842,600 | ||||||||
Unconsolidated joint business |
230,590 | 206,095 | 437,754 | 389,476 | ||||||||||||
Royalties |
22,648 | 18,286 | 45,635 | 38,847 | ||||||||||||
Corporate partner |
1,313 | (421 | ) | 2,684 | 293 | |||||||||||
Total revenues |
773,176 | 660,041 | 1,489,086 | 1,271,216 | ||||||||||||
COST AND EXPENSES |
||||||||||||||||
Cost of sales |
84,063 | 77,993 | 166,013 | 145,488 | ||||||||||||
Research and development |
218,149 | 161,985 | 409,598 | 307,877 | ||||||||||||
Selling, general and administrative |
203,668 | 170,289 | 391,729 | 324,680 | ||||||||||||
Amortization of acquired intangible assets |
60,961 | 76,260 | 120,881 | 146,967 | ||||||||||||
Collaboration profit (loss) sharing |
(105 | ) | | (5,672 | ) | | ||||||||||
Acquired in-process research and development |
| 330,520 | 18,405 | 330,520 | ||||||||||||
Gain on sale of long lived assets |
| (799 | ) | | (1,098 | ) | ||||||||||
Gain on settlement of license agreement |
| (34,192 | ) | | (34,192 | ) | ||||||||||
Total cost and expenses |
566,736 | 782,056 | 1,100,954 | 1,220,242 | ||||||||||||
Income (loss) from operations |
206,440 | (122,015 | ) | 388,132 | 50,974 | |||||||||||
Other income, net |
31,586 | 21,806 | 53,288 | 40,471 | ||||||||||||
INCOME (LOSS) BEFORE INCOME TAXES AND CUMULATIVE
EFFECT OF ACCOUNTING CHANGE |
238,026 | (100,209 | ) | 441,420 | 91,445 | |||||||||||
Income taxes |
51,886 | 70,404 | 123,779 | 142,868 | ||||||||||||
INCOME (LOSS) BEFORE CUMULATIVE EFFECT OF
ACCOUNTING CHANGE |
186,140 | (170,613 | ) | 317,641 | (51,423 | ) | ||||||||||
Cumulative effect of accounting change, net of income tax |
| | | 3,779 | ||||||||||||
NET INCOME (LOSS) |
$ | 186,140 | $ | (170,613 | ) | $ | 317,641 | $ | (47,644 | ) | ||||||
BASIC EARNINGS (LOSS) PER SHARE |
||||||||||||||||
Income (loss) before cumulative effect of accounting change |
$ | 0.55 | $ | (0.50 | ) | $ | 0.93 | $ | (0.15 | ) | ||||||
Cumulative effect of accounting change, net of income tax |
| | | 0.01 | ||||||||||||
BASIC EARNINGS (LOSS) PER SHARE |
$ | 0.55 | $ | (0.50 | ) | $ | 0.93 | $ | (0.14 | ) | ||||||
DILUTED EARNINGS (LOSS) PER SHARE |
||||||||||||||||
Income (loss) before cumulative effect of accounting change |
$ | 0.54 | $ | (0.50 | ) | $ | 0.92 | $ | (0.15 | ) | ||||||
Cumulative effect of accounting change, net of income tax |
| | | 0.01 | ||||||||||||
DILUTED EARNINGS (LOSS) PER SHARE |
$ | 0.54 | $ | (0.50 | ) | $ | 0.92 | $ | (0.14 | ) | ||||||
WEIGHTED AVERAGE SHARES USED IN CALCULATING: |
||||||||||||||||
BASIC EARNINGS (LOSS) PER SHARE |
340,315 | 342,375 | 340,312 | 341,742 | ||||||||||||
DILUTED EARNINGS (LOSS) PER SHARE |
343,389 | 342,375 | 343,713 | 341,742 | ||||||||||||
Numbers may not foot due to rounding. |
June 30, | December 31, | |||||||
2007 | 2006 | |||||||
ASSETS |
||||||||
Cash, cash equivalents and marketable securities |
$ | 1,802,717 | $ | 902,691 | ||||
Accounts receivable, net |
359,518 | 317,353 | ||||||
Inventory |
207,897 | 169,102 | ||||||
Other current assets |
323,874 | 323,421 | ||||||
Total current assets |
2,694,006 | 1,712,567 | ||||||
Marketable securities |
917,403 | 1,412,238 | ||||||
Property and equipment, net |
1,330,899 | 1,280,385 | ||||||
Intangible assets, net |
2,626,838 | 2,747,241 | ||||||
Goodwill |
1,135,939 | 1,154,757 | ||||||
Investments and other assets |
230,630 | 245,620 | ||||||
TOTAL ASSETS |
$ | 8,935,715 | $ | 8,552,808 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Tender offer obligation |
$ | 2,990,030 | $ | | ||||
Other current liabilities |
474,899 | 582,855 | ||||||
Long-term deferred tax liability |
588,784 | 643,645 | ||||||
Other long-term liabilities |
245,303 | 176,530 | ||||||
Shareholders equity |
4,636,699 | 7,149,778 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 8,935,715 | $ | 8,552,808 | ||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
EARNINGS (LOSS) PER SHARE | 2007 | 2006 | 2007 | 2006 | ||||||||||||
GAAP earnings (loss) per share Diluted |
$ | 0.54 | $ | (0.50 | ) | $ | 0.92 | $ | (0.14 | ) | ||||||
Adjustment to net income (loss) (as detailed below) |
0.16 | 1.06 | 0.37 | 1.26 | ||||||||||||
Non-GAAP earnings per share Diluted |
$ | 0.70 | $ | 0.57 | $ | 1.29 | $ | 1.11 | ||||||||
An itemized reconciliation between net income (loss) on a GAAP basis and net income on a non-GAAP basis is as follows: | ||||||||||||||||
GAAP net income (loss) |
$ | 186.1 | $ | (170.6 | ) | $ | 317.6 | $ | (47.6 | ) | ||||||
Adjustments: |
||||||||||||||||
COGS: Fair value step up of inventory acquired from former Biogen, Inc. |
| 0.9 | | 4.9 | ||||||||||||
COGS: Stock option expense |
0.1 | 0.1 | 0.1 | 0.1 | ||||||||||||
R&D: Restructuring |
0.4 | 0.3 | 0.4 | 0.3 | ||||||||||||
R&D: Stock option expense |
2.9 | 6.4 | 5.9 | 11.2 | ||||||||||||
SG&A: Merger related and purchase accounting costs |
| 0.1 | | 0.1 | ||||||||||||
SG&A: Restructuring |
0.5 | 0.9 | 0.6 | 1.6 | ||||||||||||
SG&A: Stock option expense |
5.3 | 8.3 | 11.4 | 16.6 | ||||||||||||
Amortization of acquired intangible assets |
61.0 | 76.3 | 120.9 | 147.0 | ||||||||||||
In-process research and development related to the acquisition of Syntonix
Pharmaceuticals Inc., Conforma Therapeutics Corporation and Fumapharm AG |
| 330.5 | 18.4 | 330.5 | ||||||||||||
Gain on settlement of license agreement with Fumapharm AG |
| (34.2 | ) | | (34.2 | ) | ||||||||||
Gain on sale of long lived assets |
| (0.8 | ) | | (1.1 | ) | ||||||||||
Income taxes: Income tax effect of reconciling items |
(16.0 | ) | (20.9 | ) | (32.6 | ) | (39.3 | ) | ||||||||
Cumulative
effect of accounting change from adoption of FAS 123R, net of
income tax |
| | | (3.8 | ) | |||||||||||
Non-GAAP net income |
$ | 240.3 | $ | 197.3 | $ | 442.7 | $ | 386.4 | ||||||||
Three Months Ended | ||||||||
June 30, | ||||||||
2007 | 2006 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 461,618 | $ | 429,377 | ||||
Amevive® |
2 | 2,460 | ||||||
Tysabri® |
47,539 | (196 | ) | |||||
Zevalin® |
4,290 | 4,440 | ||||||
Fumaderm® |
5,176 | | ||||||
Total product revenues |
$ | 518,625 | $ | 436,081 | ||||
Six Months Ended | ||||||||
June 30, | ||||||||
2007 | 2006 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 910,427 | $ | 822,805 | ||||
Amevive® |
218 | 10,737 | ||||||
Tysabri® |
77,299 | (393 | ) | |||||
Zevalin® |
9,893 | 9,450 | ||||||
Fumaderm® |
5,176 | | ||||||
Total product revenues |
$ | 1,003,013 | $ | 842,600 | ||||