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) |
Biogen Idec Inc. |
||||
By: | /s/ Robert A. Licht | |||
Robert A. Licht | ||||
Senior Vice President | ||||
Exhibit | ||
Number | Description | |
99
|
Biogen Idecs press release dated July 20, 2010. |
| Second quarter revenues were $1.2 billion, an increase of 11% over the second quarter of 2009, driven primarily by the continued growth of TYSABRI® (natalizumab) revenues, which increased 17% to $219 million in the quarter, AVONEX® (interferon beta-1a) revenues, which increased 6% to $628 million and RITUXAN® (rituximab) revenues, which increased 11% to $306 million. |
| Global in-market net sales of TYSABRI in the second quarter of 2010 were $298 million, an increase of 17% over the second quarter of 2009, of which $145 million were in the U.S. and $153 million were in rest of world markets. |
| Second quarter 2010 GAAP diluted EPS were $1.12, an increase of 129% over the second quarter of 2009. GAAP net income attributable to Biogen Idec for the quarter was $293 million, an increase of 105% over the second quarter of 2009. |
| Second quarter 2010 non-GAAP diluted EPS were $1.31, an increase of 75% over the second quarter of 2009. Non-GAAP net income attributable to Biogen Idec for the quarter was $343 million, an increase of 57% over the second quarter of 2009. A reconciliation of Biogen Idecs GAAP to non-GAAP results is included on Table 3 within this press release. |
| Year over year comparisons are impacted by the $110 million upfront payment that was due Acorda Therapeutics during the second quarter of 2009, which reduced Biogen Idecs GAAP and non-GAAP EPS in that period by 32 cents. |
| Revenue growth in 2010 is expected to be in the mid single digits, unchanged from previous guidance. | ||
| Core operating expense growth is expected to be in the low single digits, unchanged from previous guidance. | ||
| R&D expense is expected to be approximately 24% to 27% of total revenue, unchanged from previous guidance. | ||
| SG&A expense is expected to be at the upper end of Biogen Idecs previous guidance of 20% to 22% of total revenue. | ||
| GAAP diluted EPS is expected to be above $3.82, an increase over prior guidance. | ||
| Non-GAAP diluted EPS is expected to be above $4.70, an increase over prior guidance. |
| On July 15, 2010, George A. Scangos, Ph.D. began his service as Biogen Idecs Chief Executive Officer and member of its Board of Directors. | ||
| On July 12, 2010, Biogen Idec and Swedish Orphan Biovitrum AB announced results from a Phase 1/2a open-label, dose-escalation, safety and pharmacokinetic study of the companies long-lasting, fully-recombinant factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The data, which were presented at the World Federation of Hemophilia Congress in Buenos Aires, Argentina on July 11, 2010, showed that rFIXFc was well tolerated and demonstrated an approximately three-fold increase in half-life compared to historical data for BeneFIX®. | ||
| On July 9, 2010, Biogen Idec and Swedish Orphan Biovitrum AB announced that they plan to advance the companies long-lasting, fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial in people with hemophilia A. | ||
| In July 2010, Biogen Idec updated the TYSABRI label in the U.S. to reflect that the risk of progressive multifocal leukoencephalopathy (PML) increases in patients with prior |
immunosuppressant use and that such increased risk appears to be independent of TYSABRI treatment duration. | |||
| On June 15, 2010, Biogen Idec announced enrollment of the first patient in a multicenter Phase 2 clinical trial designed to evaluate its investigational oral therapy BG-12 (dimethyl fumarate) in combination with commonly used first-line treatments in patients with relapsing-remitting multiple sclerosis (RRMS). | ||
| On June 9, 2010, Biogen Idec held its annual meeting of stockholders. Biogen Idecs stockholders elected Nancy L. Leaming, Brian S. Posner, Eric K. Rowinsky and Stephen A. Sherwin as directors to serve a three-year term extending until the 2013 annual meeting of stockholders and until their successors are duly elected and qualified. | ||
| On May 24, 2010, Biogen Idec and Abbott Laboratories announced enrollment of the first patient in a global Phase 3 study evaluating the efficacy and safety of daclizumab compared to interferon beta-1a (AVONEX) in patients with RRMS. | ||
| On May 20, 2010, Biogen Idec and Genentech, Inc., a wholly owned member of the Roche Group, announced data from the Phase 3 PRIMA study showed that continuing RITUXAN for two years in patients who responded to initial treatment with RITUXAN plus chemotherapy doubled the likelihood of them living without their disease worsening (progression-free survival) compared to those who stopped treatment. No new safety signals were observed in this study and the safety profile was consistent with previous experience with RITUXAN. | ||
| On May 19, 2010, the Roche Group and Biogen Idec announced their decision to discontinue the ocrelizumab clinical development program in patients with rheumatoid arthritis (RA). Following a detailed analysis of the efficacy and safety results from the RA program, the companies concluded that the overall benefit to risk profile of ocrelizumab was not favorable in RA taking into account the currently available treatment options. | ||
| In May 2010, Biogen Idec updated the TYSABRI label in the E.U. consistent with the recommendations of the European Medicines Agency. The label now states that the risk of PML increases after two years of therapy, with limited experience beyond three years. The label also states there is a risk for the occurrence of immune reconstitution inflammatory syndrome in patients with PML following discontinuation or removal of TYSABRI by plasma exchange. |
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
REVENUES |
||||||||||||||||
Product |
$ | 859,235 | $ | 790,970 | $ | 1,683,455 | $ | 1,524,378 | ||||||||
Unconsolidated joint business |
306,371 | 275,570 | 561,300 | 554,388 | ||||||||||||
Royalties |
30,098 | 25,009 | 56,120 | 49,093 | ||||||||||||
Corporate partner |
16,998 | 1,740 | 20,687 | 1,915 | ||||||||||||
Total revenues |
1,212,702 | 1,093,289 | 2,321,562 | 2,129,774 | ||||||||||||
COST AND EXPENSES |
||||||||||||||||
Cost of sales, excluding amortization of acquired intangibles |
106,985 | 90,721 | 204,040 | 188,918 | ||||||||||||
Research and development |
331,675 | 416,453 | 638,705 | 695,931 | ||||||||||||
Selling, general and administrative |
262,322 | 220,829 | 510,987 | 442,660 | ||||||||||||
Collaboration profit sharing |
62,692 | 49,138 | 126,249 | 91,911 | ||||||||||||
Amortization of acquired intangible assets |
53,148 | 93,234 | 102,037 | 182,482 | ||||||||||||
Acquired in-process research and development |
| | 39,976 | | ||||||||||||
Total cost and expenses |
816,822 | 870,375 | 1,621,994 | 1,601,902 | ||||||||||||
Income from operations |
395,880 | 222,914 | 699,568 | 527,872 | ||||||||||||
Other income (expense), net |
1,012 | 14,680 | (7,373 | ) | 21,526 | |||||||||||
INCOME BEFORE INCOME TAX EXPENSE |
396,892 | 237,594 | 692,195 | 549,398 | ||||||||||||
Income tax expense |
102,243 | 92,709 | 177,553 | 157,934 | ||||||||||||
NET INCOME |
$ | 294,649 | $ | 144,885 | $ | 514,642 | $ | 391,464 | ||||||||
Net income attributable to noncontrolling interest, net of tax |
1,211 | 2,040 | 3,762 | 4,632 | ||||||||||||
NET INCOME ATTRIBUTABLE TO BIOGEN IDEC INC. |
$ | 293,438 | $ | 142,845 | $ | 510,880 | $ | 386,832 | ||||||||
BASIC EARNINGS PER SHARE |
$ | 1.13 | $ | 0.49 | $ | 1.92 | $ | 1.34 | ||||||||
DILUTED EARNINGS PER SHARE |
$ | 1.12 | $ | 0.49 | $ | 1.91 | $ | 1.33 | ||||||||
WEIGHTED-AVERAGE SHARES USED IN CALCULATING: |
||||||||||||||||
BASIC EARNINGS PER SHARE |
259,938 | 288,615 | 265,018 | 288,162 | ||||||||||||
DILUTED EARNINGS PER SHARE |
261,658 | 290,359 | 267,272 | 290,014 | ||||||||||||
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
ASSETS |
||||||||
Cash, cash equivalents and marketable securities |
$ | 969,672 | $ | 1,263,724 | ||||
Accounts receivable, net |
548,893 | 551,208 | ||||||
Inventory |
267,878 | 293,950 | ||||||
Other current assets |
468,788 | 371,713 | ||||||
Total current assets |
2,255,231 | 2,480,595 | ||||||
Marketable securities |
566,118 | 1,194,080 | ||||||
Property, plant and equipment, net |
1,571,521 | 1,637,083 | ||||||
Intangible assets, net |
1,768,929 | 1,871,078 | ||||||
Goodwill |
1,138,621 | 1,138,621 | ||||||
Investments and other assets |
201,730 | 230,397 | ||||||
TOTAL ASSETS |
$ | 7,502,150 | $ | 8,551,854 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Current portion of notes payable and line of credit |
$ | 10,096 | $ | 19,762 | ||||
Other current liabilities |
745,562 | 695,180 | ||||||
Long-term deferred tax liability |
207,492 | 240,618 | ||||||
Notes payable and line of credit |
1,069,725 | 1,080,207 | ||||||
Other long-term liabilities |
257,985 | 254,205 | ||||||
Shareholders equity |
5,211,290 | 6,261,882 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 7,502,150 | $ | 8,551,854 | ||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
EARNINGS PER SHARE |
||||||||||||||||
GAAP earnings per share Diluted |
$ | 1.12 | $ | 0.49 | $ | 1.91 | $ | 1.33 | ||||||||
Adjustments to net income attributable to Biogen Idec Inc. (as detailed below) |
0.19 | 0.26 | 0.48 | 0.47 | ||||||||||||
Non-GAAP earnings per share Diluted |
$ | 1.31 | $ | 0.75 | $ | 2.39 | $ | 1.80 | ||||||||
GAAP net income attributable to Biogen Idec Inc. |
$ | 293.4 | $ | 142.8 | $ | 510.9 | $ | 386.8 | ||||||||
Adjustments: |
||||||||||||||||
R&D: Restructuring and severance |
0.6 | 0.7 | 1.3 | 1.7 | ||||||||||||
R&D: Stock option expense |
0.8 | 1.4 | 2.4 | 3.6 | ||||||||||||
R&D: Expenses paid by Cardiokine |
1.9 | 2.2 | 3.8 | 3.8 | ||||||||||||
SG&A: Restructuring and severance |
1.5 | 0.2 | 5.8 | 0.3 | ||||||||||||
SG&A: Stock option expense |
8.8 | 5.0 | 19.5 | 9.5 | ||||||||||||
Amortization of acquired intangible assets |
53.2 | 93.2 | 102.0 | 182.5 | ||||||||||||
Acquired in-process research and development related to the contingent
consideration payment made associated with the 2007 Syntonix acquisition |
| | 40.0 | | ||||||||||||
Income tax expense: Income tax effect primarily related to reconciling items |
(15.1 | ) | (24.8 | ) | (42.3 | ) | (60.3 | ) | ||||||||
Noncontrolling interest: Expenses paid by Cardiokine |
(1.9 | ) | (2.2 | ) | (3.8 | ) | (3.8 | ) | ||||||||
Non-GAAP net income attributable to Biogen Idec Inc. |
$ | 343.2 | $ | 218.5 | $ | 639.6 | $ | 524.1 | ||||||||
Diluted | ||||||||||||
Shares* | EPS | |||||||||||
Projected GAAP net income attributable to Biogen Idec, Inc. |
$ | 971.1 | 254.2 | $ | 3.82 | |||||||
Adjustments: |
||||||||||||
Restructuring and severance expense |
9.7 | |||||||||||
Stock option expense |
33.2 | |||||||||||
Amortization of acquired intangible assets |
211.9 | |||||||||||
Acquired in-process research and development |
40.0 | |||||||||||
Income taxes |
(71.2 | ) | ||||||||||
Projected Non-GAAP net income attributable to Biogen Idec,
Inc. |
$ | 1,194.7 | 254.2 | $ | 4.70 | |||||||
* | The forecasted fully diluted share count assumes the completion of the $1.5 billion share repurchase program in Q3 2010. |
Three Months Ended | ||||||||
June 30, | ||||||||
2010 | 2009 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 628,134 | $ | 591,160 | ||||
Tysabri® |
219,238 | 187,625 | ||||||
Fumaderm® |
11,841 | 12,185 | ||||||
Other |
22 | | ||||||
Total product revenues |
$ | 859,235 | $ | 790,970 | ||||
Six Months Ended | ||||||||
June 30, | ||||||||
2010 | 2009 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 1,220,661 | $ | 1,146,449 | ||||
Tysabri® |
437,882 | 352,829 | ||||||
Fumaderm® |
24,890 | 22,769 | ||||||
Other |
22 | 2,331 | ||||||
Total product revenues |
$ | 1,683,455 | $ | 1,524,378 | ||||