Delaware (State or other jurisdiction of incorporation) |
0-19311 (Commission file number) |
33-0112644 (IRS Employer Identification No.) |
14 Cambridge Center, Cambridge, Massachusetts (Address of principal executive offices) |
02142 (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. | ||||||||
SIGNATURES | ||||||||
EXHIBIT INDEX | ||||||||
EX-99.1 REGISTRANTS PRESS RELEASE DATED MAY 2, 2007 |
Biogen Idec Inc. |
||||
By: | /s/ Robert A. Licht | |||
Robert A. Licht | ||||
Vice President and Assistant Secretary | ||||
| First quarter revenues were $716 million, an increase of 17% from $611 million in the prior year, driven primarily by AVONEXÒ (interferon beta-1a) sales up 14% to $449 million and RITUXANÒ (rituximab) revenues from the unconsolidated joint business arrangement up 13% to $207 million. |
| On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), first quarter 2007 diluted earnings per share (EPS) were $0.38, an increase of 6% from $0.36 in the first quarter of 2006. GAAP net income for the quarter was $132 million, an increase of 7% from $123 million in the prior year. |
| First quarter 2007 non-GAAP diluted EPS were $0.59, an increase of 7% over non-GAAP diluted EPS of $0.55 in the first quarter 2006. Non-GAAP net income for the first quarter was $202 million, an increase of 7% over non-GAAP net income of $189 million in the first quarter of 2006. These non-GAAP results exclude purchase accounting and merger-related accounting impacts, stock option expense, and other items. |
| Global in-market net sales of TYSABRIÒ (natalizumab) in the first quarter of 2007 were $48 million. Based on our collaboration structure with Elan, Biogen Idec recognized revenue of $30 million related to TYSABRI in the first quarter of 2007. |
| Pre-tax charges of $60 million for the amortization of intangibles relating to the 2003 Biogen and Idec merger, the 2006 acquisitions of Conforma and Fumapharm, and the 2007 acquisition of Syntonix; |
| Pre-tax in-process Research & Development charge of $18 million related to the acquisition of Syntonix; |
| Pre-tax share-based compensation expense under SFAS No. 123R of $9 million (or $0.02 per share); and |
| Tax benefit of $17 million relating to the pre-tax items listed above. |
| $17.0 million related to product sold through Elan in the U.S. (based on $35.7 million of in market sales); and |
| $12.7 million related to product sold by Biogen Idec in Europe. |
| In the US, approximately 6,600 patients are on TYSABRI therapy commercially. Approximately 10,000 patients have enrolled in the TOUCH program and 1,500 physicians have enrolled patients. |
| In the EU, approximately 2,500 patients have received TYSABRI infusions commercially, mostly in Germany and the Nordic countries. |
| In clinical trial settings, over 1,000 patients are on TYSABRI therapy. |
| Biogen Idec reiterated guidance for the full year 2007, including: |
| Total revenue growth of mid-teens percentage over 2006; |
| Non-GAAP diluted EPS in the range of $2.50 $2.65. 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; |
| GAAP diluted EPS in the range of $1.69 $1.84, excluding any future acquisitions or other transactions. |
| On January 9th, Biogen Idec announced the initiation of the Phase III clinical program for BG-12, an oral fumarate in development for relapsing-remitting MS. The DEFINE and CONFIRM trials are two-year, randomized, multi-center, double-blind, placebo-controlled, dose-comparison studies to determine the safety and efficacy of BG-12 in subjects with relapsing-remitting MS. |
| On January 25th, Biogen Idec announced the initiation of a Phase III randomized, double-blind study of an investigational anti-CD80 monoclonal antibody, galiximab, for patients with lymphoma. The TARGET trial will compare treatment with galiximab in combination with RITUXAN to RITUXAN in combination with placebo in patients with follicular NHL that has relapsed or failed to respond to initial therapy. |
| On January 31st, Biogen Idec completed its acquisition of Syntonix Pharmaceuticals. Syntonix will continue to focus on discovering and developing long-acting therapeutic products to improve treatment regimens for chronic diseases, and has multiple pre-clinical programs in hemophilia. The $44 million purchase price is subject to increase to as much as $124 million if certain development milestones with respect to Syntonixs lead product, long acting recombinant Factor IX, are achieved. |
| On February 7th, Biogen Idec announced the initiation of a randomized, controlled, registration trial of an investigational anti-CD23 monoclonal antibody, lumiliximab, for patients with chronic lymphocytic leukemia (CLL). The LUCID trial will compare treatment with lumiliximab in combination with fludarabine, cyclophosphamide, and RITUXAN (FCR), an emerging standard of care, to FCR alone. |
| On March 12th, Biogen Idec and partner PDL BioPharma, Inc. announced that the ongoing CHOICE trial, a Phase II, randomized, double-blind, placebo-controlled trial of daclizumab, met its primary endpoint in relapsing MS patients being treated with interferon beta. Patients receiving daclizumab 2 mg/kg subcutaneously every 2 weeks showed a significant reduction in the number of new or enlarged gadolinium-contrast-enhancing lesions at week 24. |
| On April 13th, Biogen Idec announced that one-year data presented at the Academy of Managed Care Pharmacys 2007 Annual Meeting show that AVONEX is a cost-effective therapy in MS when compared to other interferon beta treatments. Using a comprehensive analysis of medical and pharmacy costs, the results of the research concluded that patients treated with AVONEX, the most prescribed MS therapy worldwide, have the lowest total one-year cost to a health plan when compared to other interferon beta treatments. |
(1) | Purchase accounting and merger-related adjustments Non-GAAP net income and diluted EPS exclude certain purchase accounting impacts such as those related to the merger with Biogen, Inc. (the Merger) and the acquisitions of Fumapharm AG, Conforma Therapeutics Corporation and Syntonix Pharmaceuticals, Inc. These include charges for IPR&D and the incremental charge to cost of goods sold from our sale of acquired inventory that was written up to fair value at the acquisition date. Additionally, these excluded impacts include the incremental charges related to the amortization of the acquired intangible assets. Excluding these charges allows management and investors an alternative view of our financial results as if the acquired intangible asset had been developed internally rather than acquired and, therefore, provides a supplemental measure of performance in which the Companys acquired intellectual property is treated in a comparable manner to its internally developed intellectual property. |
(2) | Stock option expense and the cumulative effect of an accounting change relating to the initial adoption of SFAS No. 123R Non-GAAP net income and diluted EPS exclude the impact of our stock option expense recorded in accordance with SFAS No. 123R and the cumulative effect of an accounting change relating to its initial adoption. We believe that excluding the impact of expensing stock options better reflects the recurring economic characteristics of our integrated business. We do include the P&L impact of restricted stock awards and other cash incentives in our non-GAAP results. |
(3) | Other items Non-GAAP net income and diluted EPS exclude other unusual or non-recurring items that are evaluated on an individual basis. Our evaluation of whether to exclude an item for purposes of determining our non-GAAP financial measures considers both the quantitative and qualitative aspects of the item, including, among other things (i) its size and nature, (ii) whether or not it relates to our ongoing business operations, and (iii) whether or not we expect it to occur as part of our normal business on a regular basis. Items excluded for purposes of determining non-GAAP net income and diluted EPS are severance and restructuring charges and a gain on sale of long-lived assets. |
Three Months Ended | ||||||||
March 31, | ||||||||
2007 | 2006 | |||||||
REVENUES |
||||||||
Product |
$ | 484,388 | $ | 406,519 | ||||
Unconsolidated joint business |
207,164 | 183,380 | ||||||
Royalties |
22,987 | 20,561 | ||||||
Corporate partner |
1,371 | 715 | ||||||
Total revenues |
715,910 | 611,175 | ||||||
COST AND EXPENSES |
||||||||
Cost of sales |
81,950 | 67,494 | ||||||
Research and development |
191,449 | 145,892 | ||||||
Selling, general and administrative |
188,061 | 154,391 | ||||||
Amortization of acquired intangible assets |
59,920 | 70,707 | ||||||
Collaboration profit (loss) sharing |
(5,567 | ) | | |||||
Acquired in-process research and development |
18,405 | | ||||||
Gain on sale of long lived assets |
| (298 | ) | |||||
Total cost and expenses |
534,218 | 438,186 | ||||||
Income from operations |
181,692 | 172,989 | ||||||
Other income, net |
21,702 | 18,665 | ||||||
INCOME BEFORE INCOME TAXES AND CUMULATIVE EFFECT
OF ACCOUNTING CHANGE |
203,394 | 191,654 | ||||||
Income taxes |
71,893 | 72,464 | ||||||
INCOME BEFORE CUMULATIVE EFFECT OF ACCOUNTING
CHANGE |
131,501 | 119,190 | ||||||
Cumulative effect of accounting change, net of income tax |
| 3,779 | ||||||
NET INCOME |
$ | 131,501 | $ | 122,969 | ||||
BASIC EARNINGS PER SHARE |
||||||||
Income before cumulative effect of accounting change |
$ | 0.39 | $ | 0.35 | ||||
Cumulative effect of accounting change, net of income tax |
| 0.01 | ||||||
BASIC EARNINGS PER SHARE |
$ | 0.39 | $ | 0.36 | ||||
DILUTED EARNINGS PER SHARE |
||||||||
Income before cumulative effect of accounting change |
$ | 0.38 | $ | 0.35 | ||||
Cumulative effect of accounting change, net of income tax |
| 0.01 | ||||||
DILUTED EARNINGS PER SHARE |
$ | 0.38 | $ | 0.36 | ||||
SHARES USED IN CALCULATING: |
||||||||
BASIC EARNINGS PER SHARE |
340,310 | 339,653 | ||||||
DILUTED EARNINGS PER SHARE |
344,058 | 345,815 | ||||||
March 31, | December 31, | |||||||
2007 | 2006 | |||||||
ASSETS |
||||||||
Cash, cash equivalents and marketable securities |
$ | 1,127,579 | $ | 902,691 | ||||
Accounts receivable, net |
324,569 | 317,353 | ||||||
Inventory |
186,220 | 169,102 | ||||||
Other current assets |
302,973 | 323,421 | ||||||
Total current assets |
1,941,341 | 1,712,567 | ||||||
Marketable securities |
1,385,666 | 1,412,238 | ||||||
Property and equipment, net |
1,291,041 | 1,280,385 | ||||||
Intangible assets, net |
2,688,090 | 2,747,241 | ||||||
Goodwill |
1,135,745 | 1,154,757 | ||||||
Investments and other assets |
267,697 | 245,620 | ||||||
TOTAL ASSETS |
$ | 8,709,580 | $ | 8,552,808 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Current liabilities |
$ | 500,448 | $ | 582,855 | ||||
Long-term deferred tax liability |
614,586 | 643,645 | ||||||
Other long-term liabilities |
247,380 | 176,530 | ||||||
Shareholders equity |
7,347,166 | 7,149,778 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 8,709,580 | $ | 8,552,808 | ||||
Three Months Ended | ||||||||
March 31, | ||||||||
2007 | 2006 | |||||||
EARNINGS PER SHARE |
||||||||
GAAP earnings per share Diluted |
$ | 0.38 | $ | 0.36 | ||||
Adjustment to net income (as detailed below) |
0.21 | 0.19 | ||||||
Non-GAAP earnings per share Diluted |
$ | 0.59 | $ | 0.55 | ||||
An itemized reconciliation between net income on a GAAP basis and net income on a non-GAAP basis is as follows: |
||||||||
GAAP net income |
$ | 131.5 | $ | 123.0 | ||||
Adjustments: |
||||||||
COGS: Fair value step up of inventory acquired from former Biogen, Inc. |
| 4.0 | ||||||
R&D: Stock option expense |
3.0 | 4.8 | ||||||
SG&A: Severance and restructuring |
0.1 | 0.7 | ||||||
SG&A: Stock option expense |
6.1 | 8.3 | ||||||
Amortization of acquired intangible assets related to the merger with former Biogen, Inc., and the
acquisitions of Conforma Therapeutics Corporation, Fumapharm AG and Syntonix Pharmaceuticals Inc. |
59.9 | 70.7 | ||||||
In-process research and development related to the acquisition of Syntonix Pharmaceuticals Inc. |
18.4 | | ||||||
Gain on sale of long lived assets |
| (0.3 | ) | |||||
Income taxes: Income tax effect of reconciling items |
(16.6 | ) | (18.4 | ) | ||||
Cumulative effect of accounting change from adoption of FAS123R, net of income tax |
| (3.8 | ) | |||||
Non-GAAP net income |
$ | 202.4 | $ | 188.9 | ||||
Three Months Ended | ||||||||
March 31, | ||||||||
2007 | 2006 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 448,809 | $ | 393,427 | ||||
Amevive® |
216 | 8,278 | ||||||
Tysabri® |
29,760 | (196 | ) | |||||
Zevalin® |
5,603 | 5,010 | ||||||
Total product revenues |
$ | 484,388 | $ | 406,519 | ||||