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 Press release dated July 26, 2006 |
99.1 | Registrants press release dated July 26, 2006. |
Biogen Idec Inc. |
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By: | /s/ Daniel S. Char | |||
Daniel S. Char | ||||
Associate General Counsel and Assistant Secretary |
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| Total revenues for the second quarter were $660 million vs. prior year $606 million, an increase of 9%, driven primarily by AVONEXÒ (Interferon beta-1a) worldwide sales up 12% to $429 million and RITUXANÒ (rituximab) revenues from the unconsolidated joint business arrangement up 11% to $206 million. |
| On a reported basis, calculated in accordance with U.S. generally accepted accounting principles (GAAP), the loss per share was $0.50 for the second quarter. The GAAP earnings loss reflects a $331 million write-off of acquired in-process R&D, an accounting implication of the two successful acquisitions in the quarter (Conforma Therapeutics Corporation and Fumapharm AG), as well as other acquisition related adjustments, and the impact of share-based payment expense in accordance with FAS 123R, primarily employee stock options. |
| Biogen Idecs second quarter 2006 non-GAAP earnings per share (EPS) increased to $0.57, up 33% from the same period last year. |
| TYSABRIÒ (natalizumab) has been approved for reintroduction by the U.S. Food and Drug Administration (FDA), and for marketing by the European Commission, as a treatment for relapsing forms of multiple sclerosis (MS) to slow the progression of |
| pre-tax charges related to the acquisitions of Conforma and Fumapharm, including a $331 million write-off of acquired in-process R&D, offset by a $34 million gain on settlement of the license agreement with Fumapharm, |
| pre-tax charges related to the Biogen and Idec merger, consisting of $76 million amortization of intangibles and $1 million inventory step-up, |
| pre-tax share-based payment expense under FAS 123R of $15 million (or $0.03 per share), primarily employee stock option expense. |
| Revenues from AVONEX increased 12% to $429 million (Q2 2005: $382 million). |
- | U.S. sales increased 14% to $261 million (Q2 2005: $230 million) | ||
- | International sales increased 11% to $169 million. (Q2 2005: $152 million) |
| Revenues from Biogen Idecs joint business arrangement with Genentech, Inc. related to RITUXAN were up 11% to $206 million (Q2 2005: $185 million). All U.S. sales of RITUXAN are recognized by Genentech and Biogen Idec records its share of the pretax co-promotion profits on a quarterly basis. |
- | U.S. net sales of RITUXAN increased 17% to $526 million in the second quarter of 2006 (Q2 2005: $450 million), as reported by Genentech. |
| Revenues from other products were $7 million (Q2 2005: $17 million). Details are provided in Table 4. |
| Royalties were $18 million (Q2 2005: $22 million). |
| In May 2006, Biogen Idec acquired Conforma, a privately held biopharmaceutical company focused on the design and development of novel drugs for the treatment of cancer. Conforma focused on the discovery and development of drugs that inhibit heat shock protein 90 (HSP90) molecules, which are involved in protecting and supporting the growth of cancer cells across a range of tumor types, and play a role in tumor resistance to a number of leading cancer therapies. Biogen Idec acquired two compounds in Phase I clinical trials: CNF1010, a proprietary form of the geldanamycin derivative 17-AAG; and CNF2024, a totally synthetic, orally bioavailable HSP90 inhibitor. |
| On May 30, 2006, Biogen Idec and Fumapharm announced positive results from a Phase II study designed to evaluate the efficacy and safety of BG-12, an oral fumarate, in patients with relapsing-remitting MS. The study achieved its primary endpoint, demonstrating that treatment with BG-12 led to a statistically significant reduction in the total number of gadolinium-enhancing brain lesions as measured by MRI with six months of treatment versus placebo. These data were presented at the annual meeting of the European Neurological Society in Lausanne, Switzerland. In June 2006, Biogen Idec acquired privately held Fumapharm. Fumapharm developed therapeutics derived from fumaric acid esters for patients with high unmet medical need and had FUMADERM, a commercial product available in Germany for the |
| On June 5, 2006, Biogen Idec and Elan Corporation, plc announced the approval of a supplemental Biologics License Application (sBLA) by the FDA for the reintroduction of TYSABRI as a monotherapy treatment for relapsing forms of MS to slow the progression of disability and reduce the frequency of clinical relapses. On June 29, 2006, Biogen Idec and Elan announced that they had received approval from the European Commission to market TYSABRI as a treatment for relapsing remitting MS to delay the progression of disability and reduce the frequency of relapses. |
| On June 22, 2006, Genentech and Biogen Idec announced positive results from an analysis of REFLEX, a Phase III clinical study of RITUXAN in patients with rheumatoid arthritis (RA) who have had an inadequate response to previous treatment with one or more tumor necrosis factor (TNF) antagonist therapies. The findings showed that treatment with RITUXAN in combination with a stable dose of methotrexate (MTX) reduced joint erosion and joint space narrowing at 56 weeks, compared to placebo and MTX. These were the first data to measure the progression of joint damage in this difficult-to-treat patient population. Results were presented for the first time at the European League Against Rheumatism (EULAR) meeting in Amsterdam, Netherlands. |
| On July 12, 2006, Biogen Idec announced that Cecil B. Pickett, Ph.D., has been named President, Research & Development (R&D). In September, Dr. Pickett will join the Biogen Idec Board of Directors, and will report to James C. Mullen, Biogen Idecs President and Chief Executive Officer. Dr. Pickett joins Biogen Idec from Schering-Plough Corporation, where he held several senior R&D positions since 1993, most recently as Corporate Senior Vice President & President, Schering-Plough Research Institute. In this capacity, Dr. Pickett helped bring several large and small molecule candidates into the Schering-Plough clinical development pipeline. Prior to joining Schering-Plough, he held several senior R&D positions at Merck & Company. |
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
REVENUES |
||||||||||||||||
Product |
$ | 436,081 | $ | 398,822 | $ | 842,600 | $ | 796,406 | ||||||||
Unconsolidated joint business |
206,095 | 184,934 | 389,476 | 345,387 | ||||||||||||
Royalties |
18,286 | 21,734 | 38,847 | 48,483 | ||||||||||||
Corporate partner |
(421 | ) | 144 | 293 | 3,160 | |||||||||||
Total revenues |
660,041 | 605,634 | 1,271,216 | 1,193,436 | ||||||||||||
COST AND EXPENSES |
||||||||||||||||
Cost of goods sold and royalty revenues |
77,993 | 71,093 | 145,488 | 170,701 | ||||||||||||
Research and development |
161,985 | 179,843 | 307,877 | 358,611 | ||||||||||||
Selling, general and administrative |
170,289 | 155,754 | 324,680 | 314,227 | ||||||||||||
Amortization of acquired intangible assets |
76,260 | 77,078 | 146,967 | 152,756 | ||||||||||||
Acquired in-process R&D |
330,520 | | 330,520 | | ||||||||||||
Impairment and loss on sale of long lived assets |
(799 | ) | 75,565 | (1,098 | ) | 75,565 | ||||||||||
Gain on settlement of license agreement |
(34,192 | ) | | (34,192 | ) | | ||||||||||
Total cost and expenses |
782,056 | 559,333 | 1,220,242 | 1,071,860 | ||||||||||||
Income (loss) from operations |
(122,015 | ) | 46,301 | 50,974 | 121,576 | |||||||||||
Other income (expense), net |
21,806 | 6,051 | 40,471 | (2,874 | ) | |||||||||||
INCOME (LOSS) BEFORE TAXES AND CUMULATIVE EFFECT OF
ACCOUNTING CHANGE |
(100,209 | ) | 52,352 | 91,445 | 118,702 | |||||||||||
Income taxes |
70,404 | 17,848 | 142,868 | 40,738 | ||||||||||||
INCOME (LOSS) BEFORE CUMULATIVE EFFECT OF ACCOUNTING CHANGE |
(170,613 | ) | 34,504 | (51,423 | ) | 77,964 | ||||||||||
Cumulative effect of accounting change, net of income tax |
| | 3,779 | | ||||||||||||
NET INCOME (LOSS) |
$ | (170,613 | ) | $ | 34,504 | $ | (47,644 | ) | $ | 77,964 | ||||||
BASIC EARNINGS PER SHARE |
||||||||||||||||
Income (loss) before cumulative effect of accounting change |
$ | (0.50 | ) | $ | 0.10 | $ | (0.15 | ) | $ | 0.23 | ||||||
Cumulative effect of accounting change, net of income tax |
| | 0.01 | | ||||||||||||
BASIC EARNINGS (LOSS) PER SHARE |
$ | (0.50 | ) | $ | 0.10 | $ | (0.14 | ) | $ | 0.23 | ||||||
DILUTED EARNINGS PER SHARE |
||||||||||||||||
Income (loss) before cumulative effect of accounting change |
$ | (0.50 | ) | $ | 0.10 | $ | (0.15 | ) | $ | 0.23 | ||||||
Cumulative effect of accounting change, net of income tax |
| | 0.01 | | ||||||||||||
DILUTED EARNINGS (LOSS) PER SHARE |
$ | (0.50 | ) | $ | 0.10 | $ | (0.14 | ) | $ | 0.23 | ||||||
SHARES USED IN CALCULATING: |
||||||||||||||||
BASIC EARNINGS (LOSS) PER SHARE |
342,375 | 332,629 | 341,742 | 333,946 | ||||||||||||
DILUTED EARNINGS (LOSS) PER SHARE |
342,375 | 344,735 | 341,742 | 348,086 | ||||||||||||
ASSETS | June 30, 2006 | Dec. 31, 2005 | ||||||
Cash, cash equivalents and securities available-for-sale |
$ | 713,774 | $ | 850,753 | ||||
Accounts receivable, net |
290,325 | 265,742 | ||||||
Inventory |
147,024 | 182,815 | ||||||
Other current assets |
304,030 | 318,771 | ||||||
Total current assets |
1,455,153 | 1,618,081 | ||||||
Long-term securities available-for-sale |
1,417,482 | 1,204,378 | ||||||
Property and equipment, net |
1,227,296 | 1,174,396 | ||||||
Intangible assets, net |
2,856,292 | 2,975,601 | ||||||
Goodwill |
1,150,935 | 1,130,430 | ||||||
Other |
233,004 | 264,061 | ||||||
TOTAL ASSETS |
$ | 8,340,162 | $ | 8,366,947 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Current liabilities |
$ | 499,982 | $ | 583,036 | ||||
Long-term deferred tax liability |
691,395 | 762,282 | ||||||
Non-current liabilities |
140,194 | 115,753 | ||||||
Shareholders equity |
7,008,591 | 6,905,876 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 8,340,162 | $ | 8,366,947 | ||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
EARNINGS (LOSS) PER SHARE | 2006 | 2005 | 2006 | 2005 | ||||||||||||
GAAP Earnings (loss) per share Diluted |
$ | (0.50 | ) | $ | 0.10 | $ | (0.14 | ) | $ | 0.23 | ||||||
Adjustment to Net Income (loss) (as detailed below) |
1.06 | 0.33 | 1.26 | 0.50 | ||||||||||||
Non-GAAP Earnings per share Diluted |
$ | 0.57 | $ | 0.43 | $ | 1.11 | $ | 0.73 | ||||||||
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) |
$ | (170.6 | ) | $ | 34.5 | $ | (47.6 | ) | $ | 78.0 | ||||||
Adjustments: |
||||||||||||||||
COGS: Fair value step up of inventory acquired from former Biogen, Inc. |
0.9 | 9.0 | 4.9 | 18.3 | ||||||||||||
COGS: Stock option expense |
0.1 | | 0.1 | | ||||||||||||
R&D: Costs associated with sale of Oceanside Manufacturing Facility |
| 1.9 | | 1.9 | ||||||||||||
R&D: Severance and restructuring |
0.3 | | 0.3 | | ||||||||||||
R&D: Stock option expense |
6.4 | | 11.2 | | ||||||||||||
SG&A: Merger related and purchase accounting costs |
0.1 | | 0.1 | 0.4 | ||||||||||||
SG&A: Severance and restructuring |
0.9 | | 1.6 | | ||||||||||||
SG&A: Stock option expense |
8.3 | | 16.6 | | ||||||||||||
Purchase accounting: Amortization of acquired intangible assets related to the merger with former Biogen, Inc. |
76.3 | 77.1 | 147.0 | 152.8 | ||||||||||||
Purchase accounting: In-process research and development related to the acquisition of Conforma Therapeutics Corporation and Fumapharm AG |
330.5 | | 330.5 | | ||||||||||||
Purchase accounting: Gain on settlement of license agreement with Fumapharm AG |
(34.2 | ) | | (34.2 | ) | | ||||||||||
Impairment and loss on sale of long lived assets |
(0.8 | ) | 75.6 | (1.1 | ) | 75.6 | ||||||||||
Income taxes: Income tax effect of reconciling items |
(20.9 | ) | (49.0 | ) | (39.3 | ) | (72.1 | ) | ||||||||
Cumulative effect of accounting change from adoption of FAS123R, net of income tax |
| | (3.8 | ) | | |||||||||||
Non-GAAP Net Income |
$ | 197.3 | $ | 149.0 | $ | 386.4 | $ | 254.8 | ||||||||
Three Months Ended | ||||||||
June 30, | ||||||||
PRODUCT REVENUES | 2006 | 2005 | ||||||
Avonex® |
$ | 429,377 | $ | 381,789 | ||||
Amevive® |
$ | 2,460 | $ | 12,456 | ||||
Tysabri® |
$ | (196 | ) | $ | (897 | ) | ||
Zevalin® |
$ | 4,440 | $ | 5,474 | ||||
Total Product Revenues |
$ | 436,081 | $ | 398,822 | ||||
Six Months Ended | ||||||||
June 30, | ||||||||
PRODUCT REVENUES | 2006 | 2005 | ||||||
Avonex® |
$ | 822,805 | $ | 755,374 | ||||
Amevive® |
$ | 10,737 | $ | 24,473 | ||||
Tysabri® |
$ | (393 | ) | $ | 5,049 | |||
Zevalin® |
$ | 9,450 | $ | 11,510 | ||||
Total Product Revenues |
$ | 842,600 | $ | 796,406 | ||||