Delaware | 0-19311 | 33-0112644 | ||
(State or other jurisdiction of incorporation) |
(Commission file number) |
(IRS Employer Identification No.) |
14 Cambridge Center, Cambridge, Massachusetts | 02142 | |
(Address of principal executive offices) | (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 Biogen Idec's press release dated July 16, 2009 |
Biogen Idec Inc. |
||||
By: | /s/ Robert A. Licht | |||
Robert A. Licht | ||||
Senior Vice President | ||||
| Total revenues were $1.1 billion, an increase of 10% from $1.0 billion in the second quarter of 2008. The increase was driven primarily by the continued growth of TYSABRI (natalizumab) revenues, which were up 27% over the prior year to $188 million for the quarter, and AVONEXÒ (interferon beta-1a) sales, which increased 12% over the prior year to $591 million for the quarter. | |
| TYSABRI global in-market net sales reached a $1 billion run rate. Global in-market net sales of TYSABRI in the second quarter of 2009 were $254 million, of which $125 million was in the U.S. and $129 million was in rest of world markets. | |
| The financial results for the second quarter included a payment of $110 million related to our recently announced collaboration and license agreement with Acorda Therapeutics, Inc. |
| On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), second quarter 2009 diluted earnings per share (EPS) was $0.49. GAAP net income attributable to Biogen Idec for the second quarter of 2009 was $143 million. | |
| Non-GAAP diluted EPS for the second quarter of 2009 was $0.75. Non-GAAP net income attributable to Biogen Idec for the second quarter was $219 million. These totals include the impact of the collaboration payment to Acorda. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release. |
| $57 million related to product sold through Elan in the U.S. (based on $125 million of in-market sales) and milestone amortization; and | |
| $130 million related to product sold in rest of world markets and milestone amortization. |
| In the U.S., approximately 22,000 patients were on TYSABRI therapy commercially; | |
| In the rest of world, approximately 20,700 patients were on TYSABRI therapy commercially; and, | |
| In global clinical trials, approximately 600 patients were on TYSABRI therapy. |
| Approximately 56,500 patients have been treated with TYSABRI; and |
| Of those patients, approximately 30,600 have received at least one year of TYSABRI therapy, approximately 18,400 patients have received at least 18 months of TYSABRI therapy, and approximately 10,000 patients have received at least 24 months of TYSABRI therapy. |
| Revenue growth is expected to be in the high single digits on a year over year basis. | ||
| Operating expenses, excluding collaboration profit share, are expected to be between $2.1 and $2.2 billion. This now includes the payment of $110 million to Acorda. | ||
| R&D is expected to be approximately 28% to 30% of total revenue. | ||
| SG&A is expected to be between 19% and 20% of total revenue. | ||
| Our Non-GAAP tax rate is expected to be between 29% and 31%. Our GAAP tax rate is expected to be between 30% and 32%. | ||
| Non-GAAP diluted EPS is expected to be above $3.85. GAAP diluted EPS is expected to be above $2.75. This includes the impact of the Acorda payment of approximately $0.38 per share. | ||
| The difference between the GAAP and non-GAAP EPS is the result of the full year effects of the reconciling items detailed in Table 3 within our press release. | ||
| Capital Expenditures are expected to be in the range of $180-$200 million. |
| On July 8, 2009, Biogen Idec announced the U.S. Food and Drug Administration (FDA) had granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS). The FDAs Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. | ||
| On July 1, 2009, Biogen Idec and Acorda Therapeutics, Inc. announced an exclusive collaboration and license agreement to develop and commercialize Fampridine-SR, an MS therapy, in markets outside the United States. Fampridine-SR is a novel, oral sustained-release compound being developed to improve walking ability in people with MS. | ||
Acorda previously announced that the European Medicines Agency notified Acorda that Fampridine-SR is eligible to be submitted for a Marketing Authorization Application via the agencys centralized procedure as a new active substance. | |||
| On June 22, 2009, Biogen Idec announced enrollment of the first patient in a global Phase III, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of PEGylated interferon beta-1a (BIIB017) in patients with RMS. The trial, called ADVANCE, will determine the efficacy of PEGylated interferon beta-1a in reducing relapse rates in patients with RMS. | ||
| On May 19, 2009, Biogen Idec and Genentech, Inc. announced that the companies submitted two supplemental Biologics License Applications to the FDA for RITUXAN plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia. | ||
| On April 30, 2009, Biogen Idec announced data results from the CHAMPIONS (Controlled High-Risk AVONEX Multiple Sclerosis Prevention Study In Ongoing Neurologic Surveillance) study, an open label follow-up to CHAMPS (Controlled High Risk Subjects AVONEX Multiple Sclerosis Prevention Study). Based on the CHAMPS study, AVONEX was granted approval for use in patients who experienced their first clinical MS episode with MRI findings. The CHAMPIONS ten-year follow up showed that patients treated immediately after their first episode had significantly less chance of experiencing a second attack versus those patients with delayed treatment. These results at ten years also indicate that 80 percent of patients taking AVONEX were below an expanded disability status scale score of three. These data were presented as a poster at the 61st Annual American Academy of Neurology (AAN) meeting. | ||
| On April 28, 2009, Biogen Idec and Elan Corporation, plc presented results of a study demonstrating that TYSABRI promoted regeneration and stabilization of damage done to the myelin sheath as measured by advanced MRI technology at the annual AAN meeting. Damage to the myelin sheath causes the symptoms of MS. Additional posters were also presented during the meeting highlighting the |
ability of TYSABRI, in some patients, to improve physical function and patient reported outcomes on cognition, quality of life, and fatigue. TYSABRI is the first approved MS therapy with reported data suggesting that some of the signs of disease progression can be stopped. The strong efficacy profile demonstrated in clinical trials is enhanced further from these data and may help redefine success in MS. |
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
REVENUES |
||||||||||||||||
Product |
$ | 790,970 | $ | 684,486 | $ | 1,524,378 | $ | 1,349,556 | ||||||||
Unconsolidated joint business |
275,570 | 278,822 | 554,388 | 526,045 | ||||||||||||
Royalties |
25,009 | 28,115 | 49,093 | 52,096 | ||||||||||||
Corporate partner |
1,740 | 2,021 | 1,915 | 7,933 | ||||||||||||
Total revenues |
1,093,289 | 993,444 | 2,129,774 | 1,935,630 | ||||||||||||
COST AND EXPENSES |
||||||||||||||||
Cost of sales |
90,721 | 92,401 | 188,918 | 193,335 | ||||||||||||
Research and development |
416,453 | 252,259 | 695,931 | 510,491 | ||||||||||||
Selling, general and administrative |
220,829 | 245,689 | 442,660 | 461,518 | ||||||||||||
Amortization of acquired intangible assets |
93,234 | 72,869 | 182,482 | 147,650 | ||||||||||||
Collaboration profit (loss) sharing |
49,138 | 33,429 | 91,911 | 54,835 | ||||||||||||
In-process research and development |
| | | 25,000 | ||||||||||||
Total cost and expenses |
870,375 | 696,647 | 1,601,902 | 1,392,829 | ||||||||||||
Income from operations |
222,914 | 296,797 | 527,872 | 542,801 | ||||||||||||
Other income (expense), net |
14,680 | (4,018 | ) | 21,526 | (938 | ) | ||||||||||
INCOME BEFORE INCOME TAXES |
237,594 | 292,779 | 549,398 | 541,863 | ||||||||||||
Income taxes |
92,709 | 84,706 | 157,934 | 167,983 | ||||||||||||
NET INCOME |
$ | 144,885 | $ | 208,073 | $ | 391,464 | $ | 373,880 | ||||||||
Less: Net income attributable to noncontrolling interests |
2,040 | 1,445 | 4,632 | 4,155 | ||||||||||||
NET INCOME ATTRIBUTABLE TO BIOGEN IDEC INC. |
$ | 142,845 | $ | 206,628 | $ | 386,832 | $ | 369,725 | ||||||||
BASIC EARNINGS PER SHARE |
$ | 0.49 | $ | 0.71 | $ | 1.34 | $ | 1.26 | ||||||||
DILUTED EARNINGS PER SHARE |
$ | 0.49 | $ | 0.70 | $ | 1.33 | $ | 1.24 | ||||||||
WEIGHTED-AVERAGE SHARES USED IN CALCULATING: |
||||||||||||||||
BASIC EARNINGS PER SHARE |
288,615 | 290,356 | 288,162 | 293,268 | ||||||||||||
DILUTED EARNINGS PER SHARE |
290,359 | 293,476 | 290,014 | 296,554 | ||||||||||||
June 30, 2009 | December 31, 2008 | |||||||
ASSETS |
||||||||
Cash, cash equivalents and marketable securities |
$ | 1,623,074 | $ | 1,341,971 | ||||
Collateral received for loaned securities |
| 29,991 | ||||||
Accounts receivable, net |
511,286 | 446,665 | ||||||
Loaned securities |
| 29,446 | ||||||
Inventory |
268,529 | 263,602 | ||||||
Other current assets |
341,389 | 346,325 | ||||||
Total current assets |
2,744,278 | 2,458,000 | ||||||
Marketable securities |
1,047,611 | 891,406 | ||||||
Property, plant and equipment, net |
1,608,660 | 1,594,754 | ||||||
Intangible assets, net |
1,978,519 | 2,161,058 | ||||||
Goodwill |
1,138,621 | 1,138,621 | ||||||
Investments and other assets |
259,507 | 235,152 | ||||||
TOTAL ASSETS |
$ | 8,777,196 | $ | 8,478,991 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Collateral payable on loaned securities |
$ | | $ | 29,991 | ||||
Current portion of notes payable |
14,697 | 27,667 | ||||||
Other current liabilities |
789,229 | 865,564 | ||||||
Long-term deferred tax liability |
310,962 | 356,017 | ||||||
Notes payable |
1,085,607 | 1,085,431 | ||||||
Other long-term liabilities |
330,996 | 280,369 | ||||||
Shareholders equity |
6,245,705 | 5,833,952 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 8,777,196 | $ | 8,478,991 | ||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
GAAP earnings per share Diluted |
$ | 0.49 | $ | 0.70 | $ | 1.33 | $ | 1.24 | ||||||||
Adjustments to net income
attributable to Biogen Idec, Inc. (as
detailed below) |
0.26 | 0.21 | 0.47 | 0.51 | ||||||||||||
Non-GAAP earnings per share Diluted |
$ | 0.75 | $ | 0.91 | $ | 1.80 | $ | 1.75 | ||||||||
GAAP net income attributable to Biogen Idec, Inc. |
$ | 142.8 | $ | 206.6 | $ | 386.8 | $ | 369.7 | ||||||||
Adjustments: |
||||||||||||||||
R&D: Restructuring |
0.7 | | 1.7 | | ||||||||||||
R&D: Stock option expense |
1.4 | 1.4 | 3.6 | 4.1 | ||||||||||||
R&D: Expenses paid by Cardiokine |
2.2 | 1.5 | 3.8 | 2.3 | ||||||||||||
SG&A: Restructuring |
0.2 | | 0.3 | | ||||||||||||
SG&A: Stock option expense |
5.0 | 3.8 | 9.5 | 6.9 | ||||||||||||
Amortization of acquired intangible assets |
93.2 | 72.8 | 182.5 | 147.6 | ||||||||||||
In-process research and development related to the
contingent consideration
payment in 2008 associated with the 2006 Conforma acquisition |
| | | 25.0 | ||||||||||||
Income taxes: Income tax effect primarily related to
reconciling items |
(24.8 | ) | (16.1 | ) | (60.3 | ) | (34.5 | ) | ||||||||
Noncontrolling interest: Expenses paid by Cardiokine |
(2.2 | ) | (1.5 | ) | (3.8 | ) | (2.3 | ) | ||||||||
Non-GAAP net income attributable to Biogen Idec, Inc. |
$ | 218.5 | $ | 268.5 | $ | 524.1 | $ | 518.8 | ||||||||
Shares | Diluted EPS | |||||||||||
Projected GAAP net income attributable to Biogen Idec, Inc. |
$ | 800.2 | 291.0 | $ | 2.75 | |||||||
Adjustments: |
||||||||||||
In-process research and development |
40.0 | |||||||||||
Stock option expense |
29.1 | |||||||||||
Amortization of acquired intangible assets |
365.2 | |||||||||||
Other items |
1.6 | |||||||||||
Income taxes |
(114.1 | ) | ||||||||||
Projected Non-GAAP net income attributable to Biogen Idec,
Inc. |
$ | 1,122.0 | 291.0 | $ | 3.85 | |||||||
Three Months Ended | ||||||||
June 30, | ||||||||
2009 | 2008 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 591,160 | $ | 527,152 | ||||
Tysabri® |
187,625 | 147,173 | ||||||
Fumaderm® |
12,185 | 9,989 | ||||||
Other |
| 172 | ||||||
Total product revenues |
$ | 790,970 | $ | 684,486 | ||||
Six Months Ended | ||||||||
June 30, | ||||||||
2009 | 2008 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 1,146,449 | $ | 1,063,261 | ||||
Tysabri® |
352,829 | 261,836 | ||||||
Fumaderm® |
22,769 | 21,703 | ||||||
Other |
2,331 | 2,756 | ||||||
Total product revenues |
$ | 1,524,378 | $ | 1,349,556 | ||||