Biogen Idec Reports Full Year and Fourth Quarter 2006 Results.CAMBRIDGE, Mass. -- Biogen Idec Biogen Idec, Inc. (NASDAQ: BIIB) is a biotechnology company specializing in drugs for neurological disorders, autoimmune disorders and cancer. The company was formed in 2003 by the merger of Cambridge, Massachusetts-based Biogen and San Diego, California-based Idec Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : BIIB BIIB Basic Imagery Interpretation Brief ), a global biotechnology leader with leading products and capabilities in oncology, neurology and immunology, today reported its full year and fourth quarter 2006 results. Full Year 2006 Highlights: * Total revenues in 2006 were $2.68 billion, an increase of 11% from $2.42 billion in 2005. The increase was driven primarily by RITUXAN([R]) (rituximab) revenues from the unconsolidated joint business arrangement, which were up 14% to $811 million and AVONEX([R]) (interferon beta-1a interferon beta-1a Avonex, Rebif Pharmacologic class: Biological response modifier Therapeutic class: Antiviral, immunoregulator Pregnancy risk category C Action) sales, which increased 11% to $1.71 billion. During 2006, Biogen Idec also successfully launched RITUXAN in rheumatoid arthritis rheumatoid arthritisChronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. (RA) and TYSABRI([R]) (natalizumab) in multiple sclerosis (MS). * On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). ), full year 2006 diluted earnings per share diluted earnings per share An earnings measure calculated by dividing net income less preferred stock dividends for a period by the average number of shares of common stock that would be outstanding if all convertible securities were converted into shares of (EPS (Encapsulated PostScript) A PostScript file format used to transfer a graphic image between applications and platforms. EPS files contain PostScript code as well as an optional preview image in TIFF, WMF, PICT or EPSI, the latter being an ASCII-only format. ) were $0.63, an increase of 34% over $0.47 in 2005. GAAP net income for 2006 was $218 million, an increase of 35% over 2005 GAAP net income of $161 million. * Non-GAAP diluted EPS for 2006 were $2.25, an increase of 43% over 2005. Non-GAAP net income for 2006 was $777 million, an increase of 43% over 2005 non-GAAP net income of $542 million. These non-GAAP results exclude purchase accounting and merger-related accounting impacts, stock option expense and the cumulative effect of an accounting change relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the adoption of the stock option expensing rules, and other items. James Mullen, Biogen Idec's Chief Executive Officer, commented, "In 2006, we built a strong foundation for future growth by executing against three key value drivers for the company. First, we significantly reinvested in the pipeline through partnerships, acquisitions, and strong internal development work, and today we have three compounds in registrational trials. Second, we successfully launched two products: RITUXAN in rheumatoid arthritis and TYSABRI for multiple sclerosis in the U.S. and Europe. With the introduction of a new therapeutic option for treating multiple sclerosis, we have found the MS community increasingly focused on TYSABRI's efficacy. Third, we made these investments while maintaining the core business, growing revenue by 11%, and we are on track to achieve 20% annualized annualized Of or relating to a variable that has been mathematically converted to a yearly rate. Inflation and interest rates are generally annualized since it is on this basis that these two variables are ordinarily stated and compared. non-GAAP diluted EPS growth for 2003 - 2007." Fourth Quarter 2006 Highlights: * Fourth quarter revenues were $708 million, an increase of 12% from $633 million in the prior year, driven primarily by AVONEX sales up 6% to $439 million and RITUXAN revenues from the unconsolidated joint business arrangement up 20% to $218 million. * Fourth quarter 2006 GAAP diluted EPS were $0.32, an increase of 100% from $0.16 in the fourth quarter of 2005. GAAP net income for the quarter was $109 million, an increase of 95% from $56 million in the prior year. * Fourth quarter 2006 non-GAAP diluted EPS were $0.53, an increase of 10% over non-GAAP diluted EPS of $0.48 in the fourth quarter 2005. Non-GAAP net income for the fourth quarter was $184 million, an increase of 11% over non-GAAP net income of $165 million in the fourth quarter of 2005. These non-GAAP results exclude purchase accounting and merger-related accounting impacts, stock option expense and the cumulative effect of an accounting change relating to the adoption of the stock option expensing rules, and other items. * Global in-market net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight of TYSABRI in the fourth quarter of 2006 were $30 million, comprised of $23 million in the U.S. and $7 million in Europe. Based on our collaboration structure with Elan, Biogen Idec recognized revenue of $18 million related to TYSABRI in the fourth quarter of 2006. Financial Performance On a non-GAAP basis, Biogen Idec reported net income of $184 million in the fourth quarter of 2006 and $777 million for the full year 2006. Non-GAAP diluted EPS were $0.53 for the fourth quarter of 2006 and $2.25 for the full year 2006. On a reported basis, calculated in accordance with GAAP, Biogen Idec reported net income of $109 million (or diluted EPS of $0.32) in the fourth quarter of 2006 and net income of $218 million (or diluted EPS of $0.63) for the full year 2006. The reconciling items between GAAP net income and diluted GAAP EPS and adjusted non-GAAP net income and diluted non-GAAP EPS in the fourth quarter, as itemized in Table 3 within this press release, were primarily as follows: * Pre-tax charges of $60 million for the amortization of intangibles relating to the 2003 Biogen and Idec merger and the acquisitions of Conforma and Fumapharm; * Pre-tax loss of $28 million on the settlement of a license agreement with Fumedica; * Pre-tax gain of $16 million on the sale of our Bio-1 research facility located in Cambridge, MA; * Pre-tax share-based payment expense under FAS 123R of $8 million (or $0.01 per share), primarily employee stock option expense; and * Tax benefit relating to the pre-tax items listed above. Revenue Performance Revenues from AVONEX, Biogen Idec's therapy for patients with relapsing forms of MS, increased 6% in the fourth quarter to $439 million. Full year AVONEX sales increased 11% to $1.71 billion. In 2006, U.S. sales increased 9% to $1.02 billion and international sales increased 13% to $685 million. Revenues for the fourth quarter and full year 2006 included $218 million and $811 million, respectively, from Biogen Idec's joint business arrangement related to RITUXAN, a treatment for certain B-cell non-Hodgkin's lymphomas (NHL NHL Non-Hodgkin's lymphoma, see there ) and RA that Biogen Idec co-promotes in the U.S. with Genentech, Inc. All U.S. sales of RITUXAN are recognized by Genentech, and Biogen Idec records its share of the pretax co-promotion profits. U.S. net sales of RITUXAN were $560 million in the fourth quarter (Q4 2005: $484 million) and $2.07 billion for the full year (2005: $1.83 billion), as reported by Genentech. During the fourth quarter of 2006, Biogen Idec recognized revenue of $18 million related to TYSABRI. This amount is comprised of: * $10.3 million related to product sold through Elan in the U.S.; and * $7.2 million related to product sold in Europe. To date, nearly 10,000 patients have been prescribed TYSABRI worldwide. Almost 8,000 patients in the U.S. have enrolled in the TOUCH Program and of these, approximately 5,000 are on therapy. Approximately 1,600 patients internationally have received TYSABRI infusions, primarily in Germany and Sweden. Revenues from other products in the fourth quarter of 2006 were $7 million (Q4 2005: $16 million). Current revenues now include FUMADERM([R]) (fumaric acid esters fumaric acid esters (fy n. ) obtained in connection with the Fumapharm acquisition. Related revenues in the prior year included AMEVIVE([R])(alefacept), which has since been divested. Table 4 provides individual product revenues. Royalties were $26 million in the fourth quarter and $86 million for the full year 2006. Financial Guidance Biogen Idec today provided guidance for the full year 2007. The Company anticipates for 2007: * Total revenue growth of mid-teens percentage over 2006; * We expect the non-GAAP P&L to have a margin structure (as a percentage of revenues) similar to 2006, with the exception of Research and Development expense; * Research and Development expense of 27 - 29% of total revenues, assuming a slightly higher level of new business development than in 2006. This excludes any potential charges for acquired in-process research and development (IPR&D). * Non-GAAP diluted EPS will be in the range of $2.50 - $2.65. This non-GAAP diluted EPS estimate excludes the impact of purchase accounting and merger-related adjustments, and stock option expense; * The Company anticipates that 2007 capital expenditures will be in the range of $250 - $300 million. Guidance for full year 2007 GAAP diluted EPS is estimated to be in the range of $1.69 - $1.84, excluding any future acquisitions or other transactions. In order to reconcile GAAP and non-GAAP EPS guidance, we have excluded the following items from our non-GAAP EPS guidance provided above: * Purchase accounting charges, including amortization of acquired intangible assets and IPR&D, is estimated to be in the range of $300 - $315 million for already completed transactions; and * Stock options expense due to FAS 123R in 2007 is estimated to be in the range of $40 - $55 million, or approximately $0.08 - $0.11 per share. Because the Company cannot predict with certainty the nature or the amount of non-operating or unusual charges for 2007, we have made no assumption regarding future purchase accounting charges in this GAAP guidance. The Company may incur charges or realize gains in 2007 which could cause actual results to vary from this guidance. Recent Highlights * On November 8th, AVONEX, the most prescribed MS therapy worldwide, launched in Japan. * On November 11th, Biogen Idec and Genentech announced positive results from interim analyses of ongoing open-label extension studies of RITUXAN therapy in patients with RA who have had an inadequate response to previous treatment with one or more tumor necrosis factor tumor necrosis factor n. Abbr. TNF A protein that is produced in the presence of an endotoxin, especially by monocytes and macrophages, is able to attack and destroy tumor cells, and exacerbates chronic inflammatory diseases. (TNF TNF abbr. tumor necrosis factor TNF, n an abbreviation for tumor necrosis f ) antagonist therapies. Interim findings showed that a greater proportion of patients achieved an American College American College is the name of:
rheu·ma·tol·o·gy n. (ACR See riser card. ) 20, 50 or 70 response following treatment with a subsequent course of RITUXAN, in combination with methotrexate methotrexate, drug used in halting the growth of actively proliferating tissues. Introduced in the 1950s, it is used in the treatment of leukemia, psoriasis, and non-Hodgkin's lymphoma. (MTX MTX abbr. methotrexate methotrexate (amethopterin, MTX) Warning - Hazardous drug! Maxtrex (UK), Metoject (UK) Pharmacologic class: ), compared to outcomes after their first course. These findings, along with data on physical function and mental and physical health measures and a preliminary safety analysis of TNF antagonist use following RITUXAN treatment, have been presented at the ACR Annual Scientific Meeting. * On December 10th, Biogen Idec announced data from a Phase I/II study of an investigational anti-CD23 monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing , lumiliximab, suggesting it may be synergistic with fludarabine, cyclophosphamide cyclophosphamide /cy·clo·phos·pha·mide/ (-fos´fah-mid) a cytotoxic alkylating agent of the nitrogen mustard group; used as an antineoplastic, as an immunosuppressant to prevent transplant rejection, and to treat some diseases and rituximab (FCR FCR feed conversion rate. ), an emerging standard of care for chronic lymphocytic leukemia chronic lymphocytic leukemia n. Abbr. CLL Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. (CLL CLL abbr. chronic lymphocytic leukemia CLL, n.pr See leukemia, chronic lymphocytic. CLL 1. Chronic lymphocytic leukemia 2. Cholesterol-lowering lipid ) patients. When added to the FCR regimen, lumiliximab demonstrated a 52 percent complete response (CR) rate in patients who have CLL that was progressing after prior therapy. The data were announced at the 48th Annual Meeting of the American Society of Hematology (ASH), held December 9-12 in Orlando. Based on the positive results of the trial, Biogen Idec is initiating a registrational global, multicenter clinical trial comparing lumiliximab plus FCR vs. FCR alone. * On December 15th, Biogen Idec and Elan announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) seeking approval to market TYSABRI in the U.S. as a treatment for patients with moderately to severely active Crohn's disease Crohn's disease: see colitis. (CD). * On January 9th, Biogen Idec announced the initiation of the Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA clinical program of BG-12, an oral fumarate fumarate /fu·ma·rate/ (fu´mah-rat) a salt of fumaric acid. fumarate a salt of fumaric acid. in development for relapsing-remitting MS. * On January 25th, Biogen Idec announced the initiation of a Phase III randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind study double-blind study, n experimental technique in clinical research in which neither the researcher nor the patient knows whether the treatment administered is considered inactive (placebo) or active (medicinal). of an investigational anti-CD80 monoclonal antibody, galiximab, for patients with lymphoma. The trial will compare treatment with galiximab in combination with RITUXAN to RITUXAN in combination with placebo in patients with follicular fol·lic·u·lar adj. 1. Relating to, having, or resembling a follicle or follicles. 2. Affecting or growing out of a follicle or follicles. 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 $40 million purchase price is subject to increase to as much as $120 million if certain development milestones with respect to Syntonix's lead product, FIX:Fc, are achieved, and we expect substantially all of the purchase price of Syntonix to be allocated to IPR&D. * 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 CLL. The trial will compare treatment with lumiliximab in combination FCR, an emerging standard of care, to FCR alone in patients with CLL that has relapsed or failed to respond to initial therapy. Lumiliximab has been granted Fast Track and Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designations by the FDA for the above indication. Biogen Idec owns the worldwide rights to lumiliximab. Use of Non-GAAP Financial Measures Our "non-GAAP net income" and "non-GAAP diluted EPS" financial measures are defined as reported, or GAAP, net income and diluted EPS excluding, for the reasons discussed below, (1) purchase accounting and merger-related adjustments, (2) stock option expense and the cumulative effect of an accounting change relating to the initial adoption of SFAS SFAS Statement of Financial Accounting Standards SFAS Special Forces Assessment and Selection SFAS Student Financial Aid Services SFAS Sport Fishing Association of Singapore SFAS Safety Features Actuation System SFAS Statewide Fixed Assets System No. 123R and (3) other items. Our management uses these non-GAAP financial measures to establish financial goals and to gain an understanding of the comparative financial performance of the Company from year to year and quarter to quarter. Accordingly, we believe investors' understanding of the Company's financial performance is enhanced as a result of our disclosing these non-GAAP financial measures. Non-GAAP net income and diluted EPS should not be viewed in isolation or as a substitute for reported, or GAAP, net income and diluted EPS. (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 and Conforma Therapeutics Corporation. These include charges for IPR&D and the incremental charge to cost of goods sold Cost of goods sold The total cost of buying raw materials, and paying for all the factors that go into producing finished goods. 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 Company's 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 and the adoption impact facilitates comparisons between 2006 and prior periods, which do not include a similar charge in reported, or GAAP, net income and diluted EPS. Additionally, in order to facilitate comparability between 2006 and prior periods, we do include the P&L impact of restricted stock awards and other cash incentives in our non-GAAP financials. (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 gains and losses on the settlement of license agreements in connection with our Fumapharm AG acquisition and Fumedica transaction, gains and losses on the sale and impairments of long-lived assets and product lines, including Amevive and our Bio 1 facility, and severance and restructuring charges related to the planned ZEVALIN[R] (ibritumomab tiuxetan ibritumomab tiuxetan Warning - Hazardous drug! Zevalin Pharmacologic class: Monoclonal antibody Therapeutic class: Antineoplastic Pregnancy risk category D ) disposition. The Company has reconciled the GAAP net income and diluted EPS for the three-month periods and full years ended December 31, 2006 and 2005 to the non-GAAP measures of net income and diluted EPS in Table 3 of this press release. Conference Call and Webcast The Company's earnings conference call for the fourth quarter will be broadcast via the internet at 8:30 a.m. ET on February 15, 2007, and will be accessible through the investor relations Investor relations The process by which the corporation communicates with its investors. section of Biogen Idec's homepage, http://www.biogenidec.com. About Biogen Idec Biogen Idec creates new standards of care Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. This press release contains forward-looking statements, which appear under the heading "Financial Guidance" above and in the comments from James Mullen, our CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from that which we expect. Important factors that could cause our actual results to differ include our continued dependence on our two principal products, the uncertainty of success in commercializing other products including the launch of TYSABRI, the occurrence of adverse safety events with our products, the failure to execute our growth strategy successfully or to compete effectively in our markets, our dependence on collaborations over which we may not always have full control, possible adverse impact of government regulation and changes in the availability of reimbursement for our products, problems with our manufacturing processes and our reliance on third parties, fluctuations in our operating results, our ability to protect our intellectual property rights and the cost of doing so, the risks of doing business internationally and the other risks and uncertainties that are described in our most recent Form 10-Q Form 10-Q See 10-Q. filing with the SEC. These forward-looking statements speak only as of the date of this press release, and we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise. [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] |
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