Delaware (State or other jurisdiction of incorporation) |
0-19311 (Commission file number) |
33-0112644 (IRS Employer Identification No.) |
133 Boston Post Road, Weston, Massachusetts (Address of principal executive offices) |
02493 (Zip Code) |
Item 2.02 Results of Operations and Financial Condition | ||||||||
Item 9.01 Financial Statements and Exhibits | ||||||||
SIGNATURES | ||||||||
EXHIBIT INDEX | ||||||||
EX-99.1 |
Biogen Idec Inc. |
||||
By: | /s/ Robert A. Licht | |||
Robert A. Licht | ||||
Senior Vice President | ||||
Date: July 26, 2011 |
| Second quarter revenues were $1.2 billion, flat compared to the second quarter of 2010. TYSABRI (natalizumab) revenues increased 28% year-over-year to $281 million while AVONEXÒ (interferon beta-1a) revenues increased 5% year-over-year to $659 million. RITUXANÒ (rituximab) revenues from our unconsolidated joint business arrangement were $216 million for the quarter, down 29% versus prior year. Our share of RITUXAN revenues from our unconsolidated joint business was reduced by approximately $50 million during the second quarter of 2011 as a result of an accrual relating to an intermediate decision in Genentech, Inc.s ongoing arbitration with Hoechst GmbH. | |
| Global in-market sales of TYSABRI in the second quarter of 2011 were $389 million, an increase of 31% over the second quarter of 2010. The total was comprised of $183 million in U.S. sales and $206 million in sales to markets outside the U.S. |
| On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), second quarter 2011 GAAP diluted EPS were $1.18, an increase of 5% over the second quarter of 2010. GAAP net income attributable to Biogen Idec for the quarter was $288 million, a decrease of 2% from the second quarter of 2010. | |
| Non-GAAP diluted EPS for the second quarter of 2011 were $1.36, an increase of 4% over the second quarter of 2010. Non-GAAP net income attributable to Biogen Idec for the second quarter of 2011 was $332 million, a decrease of approximately 3% from the second quarter of 2010. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release. |
| Revenue growth is expected to be in the low to mid-single digits versus 2010. | ||
| Cost of Sales is expected to be approximately 9% to 10% of total revenue. | ||
| R&D is expected to be approximately 22% to 24% of total revenue. | ||
| SG&A is expected to be approximately 20% to 21% of total revenue. | ||
| Tax rate is expected to be approximately 26% to 28% of pretax income. | ||
| GAAP diluted EPS is expected to be above $4.91. | ||
| Non-GAAP diluted EPS is expected to be above $5.70. | ||
| Capital expenditures are expected to be in the range of $200 to $220 million. |
| On July 26, 2011, Biogen Idec and Swedish Orphan Biovitrum presented data on the long-lasting recombinant factor VIII therapy at the International Society on Thrombosis and Haemostasis meeting. Results showed the potential to significantly reduce the burden of treatment for people with Hemophilia A. | ||
| On July 20, 2011, Biogen Idec received conditional approval in the European Union for FAMPYRA® (prolonged-release fampridine tablets) to improve walking in adults with multiple sclerosis. The novel oral therapy provides clinically meaningful improvement in daily function. | ||
| On July 3, 2011, Biogen Idec researchers identified a novel approach for promoting remyelination and inhibiting autoimmune activation as a potential therapeutic option for the treatment of multiple sclerosis. | ||
| On June 23, 2011, Biogen Idec announced that its share of RITUXAN revenues from the unconsolidated joint business will be reduced by approximately $50 million during the second quarter of 2011 as a result of an accrual relating to an intermediate decision in Genentechs ongoing arbitration with Hoechst. | ||
| On June 22, 2011, the European Commission approved the inclusion of Anti-JC Virus Antibody Status as a PML risk factor in TYSABRI labeling. A five year marketing authorization for TYSABRI was also renewed in the EU. |
| On June 7, 2011, Biogen Idec received approval in the European Union for AVONEX(R) PEN, the first single-use intramuscular autoinjector designed to improve convenience of once-weekly AVONEX administration. | ||
| On June 6, 2011, Biogen Idec announced positive data from the AVONEX Dose Titration Study at the 2011 Annual Meeting of the Consortium of Multiple Sclerosis Centers. The data showed that titrating AVONEX at the initiation of treatment reduced the severity of flu-like symptoms. | ||
| On May 20, 2011, the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use issued a positive opinion on the Marketing Authorisation Application for FAMPYRA. | ||
| On May 16, 2011, Biogen Idec received approval for FAMPYRA from The Australian Therapeutic Goods Administration to improve walking ability in adult patients with multiple sclerosis. | ||
| On May 9, 2011, Biogen Idec and Swedish Orphan Biovitrum received an opinion from the EMA agreeing to a pediatric investigational plan for the companies long-lasting Hemophilia B therapy. |
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
REVENUES | 2011 | 2010 | 2011 | 2010 | ||||||||||||
Product |
$ | 956,703 | $ | 859,235 | $ | 1,863,805 | $ | 1,683,455 | ||||||||
Unconsolidated joint business |
216,458 | 306,371 | 472,583 | 561,300 | ||||||||||||
Royalties |
28,649 | 30,098 | 54,227 | 56,120 | ||||||||||||
Corporate partner |
6,837 | 16,998 | 21,375 | 20,687 | ||||||||||||
Total revenues |
1,208,647 | 1,212,702 | 2,411,990 | 2,321,562 | ||||||||||||
COST AND EXPENSES |
||||||||||||||||
Cost of sales, excluding amortization of acquired intangible assets |
100,503 | 106,985 | 203,616 | 204,040 | ||||||||||||
Research and development |
285,644 | 331,675 | 579,277 | 638,705 | ||||||||||||
Selling, general and administrative |
266,301 | 262,322 | 510,819 | 510,987 | ||||||||||||
Collaboration profit sharing |
88,050 | 62,692 | 162,844 | 126,249 | ||||||||||||
Amortization of acquired intangible assets |
55,136 | 53,148 | 108,352 | 102,037 | ||||||||||||
Restructuring charges |
| | 16,587 | | ||||||||||||
Fair value adjustment of contingent consideration |
2,200 | | 3,400 | | ||||||||||||
Acquired in-process research and development |
| | | 39,976 | ||||||||||||
Total cost and expenses |
797,834 | 816,822 | 1,584,895 | 1,621,994 | ||||||||||||
Income from operations |
410,813 | 395,880 | 827,095 | 699,568 | ||||||||||||
Other income (expense), net |
(11,728 | ) | 1,012 | (1,777 | ) | (7,373 | ) | |||||||||
INCOME BEFORE INCOME TAX EXPENSE |
399,085 | 396,892 | 825,318 | 692,195 | ||||||||||||
Income tax expense |
95,036 | 102,243 | 212,504 | 177,553 | ||||||||||||
NET INCOME |
$ | 304,049 | $ | 294,649 | $ | 612,814 | $ | 514,642 | ||||||||
Net income attributable to noncontrolling interest, net of tax |
16,015 | 1,211 | 30,450 | 3,762 | ||||||||||||
NET INCOME ATTRIBUTABLE TO BIOGEN IDEC INC. |
$ | 288,034 | $ | 293,438 | $ | 582,364 | $ | 510,880 | ||||||||
BASIC EARNINGS PER SHARE |
$ | 1.19 | $ | 1.13 | $ | 2.40 | $ | 1.92 | ||||||||
DILUTED EARNINGS PER SHARE |
$ | 1.18 | $ | 1.12 | $ | 2.38 | $ | 1.91 | ||||||||
WEIGHTED-AVERAGE SHARES USED IN CALCULATING: |
||||||||||||||||
BASIC EARNINGS PER SHARE |
242,375 | 259,938 | 241,932 | 265,018 | ||||||||||||
DILUTED EARNINGS PER SHARE |
244,966 | 261,658 | 244,899 | 267,272 | ||||||||||||
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
ASSETS | ||||||||
Cash, cash equivalents and marketable securities |
$ | 1,326,744 | $ | 1,207,744 | ||||
Accounts receivable, net |
666,960 | 605,329 | ||||||
Inventory |
308,254 | 289,066 | ||||||
Other current assets |
386,665 | 438,281 | ||||||
Total current assets |
2,688,623 | 2,540,420 | ||||||
Marketable securities |
1,183,559 | 743,101 | ||||||
Property, plant and equipment, net |
1,712,869 | 1,641,634 | ||||||
Intangible assets, net |
1,678,867 | 1,772,826 | ||||||
Goodwill |
1,146,314 | 1,146,314 | ||||||
Investments and other assets |
211,747 | 248,198 | ||||||
TOTAL ASSETS |
$ | 8,621,979 | $ | 8,092,493 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Current portion of notes payable and other
financing arrangements |
$ | 131,981 | $ | 137,153 | ||||
Other current liabilities |
822,349 | 912,969 | ||||||
Long-term deferred tax liability |
196,784 | 200,950 | ||||||
Notes payable and line of credit |
1,062,986 | 1,066,379 | ||||||
Other long-term liabilities |
351,685 | 325,599 | ||||||
Shareholders equity |
6,056,194 | 5,449,443 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 8,621,979 | $ | 8,092,493 | ||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
EARNINGS PER SHARE | 2011 | 2010 | 2011 | 2010 | ||||||||||||
GAAP earnings per share Diluted |
$ | 1.18 | $ | 1.12 | $ | 2.38 | $ | 1.91 | ||||||||
Adjustments to net income attributable to Biogen Idec Inc. (as detailed below) |
0.18 | 0.19 | 0.40 | 0.48 | ||||||||||||
Non-GAAP earnings per share Diluted |
$ | 1.36 | $ | 1.31 | $ | 2.78 | $ | 2.39 | ||||||||
An itemized reconciliation between net income attributable to Biogen Idec Inc. on a GAAP basis and net income attributable to Biogen Idec Inc. on a non-GAAP basis is as follows: | ||||||||||||||||
GAAP net income attributable to Biogen Idec Inc. |
$ | 288.0 | $ | 293.4 | $ | 582.4 | $ | 510.9 | ||||||||
Adjustments: |
||||||||||||||||
R&D: Restructuring and severance |
| 0.6 | | 1.3 | ||||||||||||
R&D: Stock option expense |
0.5 | 0.8 | 1.7 | 2.4 | ||||||||||||
R&D: Expenses paid by Cardiokine |
| 1.9 | | 3.8 | ||||||||||||
SG&A: Restructuring and severance |
| 1.5 | | 5.8 | ||||||||||||
SG&A: Stock option expense |
1.2 | 8.8 | 2.5 | 19.5 | ||||||||||||
Amortization of acquired intangible assets |
55.1 | 53.2 | 108.4 | 102.0 | ||||||||||||
Restructuring charges |
| | 16.6 | | ||||||||||||
Fair value adjustment of contingent consideration associated with the 2010 Panima
acquisition |
2.2 | | 3.4 | | ||||||||||||
Acquired in-process research and development related to the contingent consideration
payment associated with the 2007 Syntonix acquisition |
| | | 40.0 | ||||||||||||
Income tax expense: Income tax effect
related to reconciling items |
(14.8 | ) | (15.1 | ) | (33.5 | ) | (42.3 | ) | ||||||||
Noncontrolling interest: Expenses paid by Cardiokine |
| (1.9 | ) | | (3.8 | ) | ||||||||||
Non-GAAP net income attributable to Biogen Idec Inc. |
$ | 332.2 | $ | 343.2 | $ | 681.5 | $ | 639.6 | ||||||||
$ Millions | Shares | Diluted EPS | ||||||||||
Projected GAAP net income attributable to Biogen Idec Inc. |
$ | 1,203.0 | 245 | $ | 4.91 | |||||||
Adjustments: |
||||||||||||
Stock option expense |
12.4 | |||||||||||
Amortization of acquired intangible assets |
220.7 | |||||||||||
Restructuring charges |
23.1 | |||||||||||
Contingent consideration |
5.5 | |||||||||||
Income taxes |
(68.2 | ) | ||||||||||
Projected Non-GAAP net income attributable to Biogen Idec Inc. |
$ | 1,396.5 | 245 | $ | 5.70 | |||||||
Three Months Ended | ||||||||
June 30, | ||||||||
2011 | 2010 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 659,233 | $ | 628,134 | ||||
Tysabri® |
281,383 | 219,238 | ||||||
Fumaderm® |
15,064 | 11,841 | ||||||
Other |
1,023 | 22 | ||||||
Total product revenues |
$ | 956,703 | $ | 859,235 | ||||
Six Months Ended | ||||||||
June 30, | ||||||||
2011 | 2010 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 1,301,711 | $ | 1,220,661 | ||||
Tysabri® |
532,776 | 437,882 | ||||||
Fumaderm® |
27,570 | 24,890 | ||||||
Other |
1,748 | 22 | ||||||
Total product revenues |
$ | 1,863,805 | $ | 1,683,455 | ||||