Growth Driven by 26 Percent Increase in AVONEX® (Interferon beta-1a) Sales More Than 100,000 Patients Worldwide Now on Therapy
Biogen, Inc. (NASDAQ/BGEN) today reported financial results for the first quarter of 2001. For the three months ended March 31, 2001, the Company reported a record $220 million in product revenues, representing a 26 percent increase in AVONEX® (Interferon beta-1a) sales versus the same period last year. Earnings per share were $0.47 on a reported basis and $0.46 per share before a gain on equity sales, representing a 12 percent increase over last year.
James C. Mullen, Biogen’s President and Chief Executive Officer, said, “Our strong performance this quarter reflects regained momentum in AVONEX sales. U.S. sales of AVONEX were outstanding, up 28 percent over the same period last year. We have achieved a major milestone, with more than 100,000 patients now on AVONEX therapy. AVONEX continues to be the leading treatment worldwide for MS.”
Mr. Mullen also said, “In addition to our success in the marketplace, we have made considerable progress at every point in our pipeline, ranging from compounds in research to late-stage clinical trials.” During the quarter:
? Biogen completed its Phase III clinical trials of AMEVIVE™ (alefacept) for the treatment of moderate-to-severe chronic plaque psoriasis. Phase II data presented at the American Academy of Dermatology (AAD) meeting in March continue to support an emerging profile that suggests a sustained duration of response with no reports of disease rebound.
? In January, Biogen and its partner, Elan Corporation, reported positive results in two large Phase II clinical trials of ANTEGREN® (natalizumab) in multiple sclerosis and Crohn’s disease. The companies are moving forward aggressively to initiate Phase III clinical trials in both indications in the second half of this year.
? Two new drug candidates representing very promising commercial opportunities entered the clinic. Phase I trials began in March for ADENTRI™, a highly selective small molecule A1 Adenosine receptor antagonist for congestive heart failure. ADENTRI promises to address a critical unmet medical need, reversing compromised kidney function in patients with decreased cardiac output.
? Also moving into the clinic this quarter in a Phase I trial was soluble lymphotoxin beta receptor (LT beta receptor). Biogen is the first company to develop a protein in this exciting new class of therapeutic agents that act on dendritic cells. (Dendritic cells play an important role early in the autoimmune cascade). LT beta receptor has disease-modifying potential in many autoimmune diseases, including rheumatoid arthritis.
? Two programs advanced from research into preclinical development. VLA-1 inhibitor represents a novel therapeutic approach to clinical indications of chronic inflammation and fibrosis. Biogen scientists have developed VLA-1 inhibitors as a means of blocking the inflammation and fibrotic process in a highly specific manner. In oncology, Biogen is developing an antibody directed against the lymphotoxin beta receptor. This member of the TNF-signaling family is believed to have important effects on tumor cell growth and differentiation.
In addition to historical information, this press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Reference is made in particular to statements regarding plans for commencement of various clinical trials and pre-clinical development programs. These statements are based on the Company’s current beliefs and expectations with respect to these programs. Drug development involves a high degree of risk. Success in early stage clinical trials and results in research and preclinical development do not ensure that later stage or larger scale clinical trials or in preclinical development will be successful. Factors which could cause actual results to differ from the Company’s current expectations include the risk that the Company will encounter one or more technical hurdles associated with new drug development or that problems or delays may arise during preparations for or the conduct of any phase of clinical trials, as well as the other risks and uncertainties associated with drug development described in the Company’s periodic reports filed with the Securities and Exchange Commission. Success in early stage clinical trials or preclinical work does not ensure that later stage or larger scale clinical trials will be successful.
Biogen, Inc., winner of the U.S. National Medal of Technology, is a biopharmaceutical company principally engaged in discovering and developing drugs for human healthcare through genetic engineering. Headquartered in Cambridge, MA, the Company’s revenues are generated from international sales of AVONEX® (Interferon beta-1a) for treatment of relapsing forms of multiple sclerosis, and from the worldwide sales by licensees of a number of products, including alpha interferon and hepatitis B vaccines and diagnostic products ( Prescribing Information ). Biogen’s research and development activities are focused on novel products to treat inflammatory and autoimmune diseases, neurological diseases, cancer, fibrosis and congestive heart failure. The Company maintains active clinical research programs in protein therapeutics, small molecules, genomics and gene therapy. For copies of press releases and additional information about the Company, please consult Biogen’s Homepage on the World Wide Web at http://www.biogen.com
AVONEX® (Interferon beta-1a) is a registered trademark of Biogen, Inc. AMEVIVE™ (alefacept) and ADENTRI™ (A1 Adenosine receptor antagonist) are trademarks of Biogen, Inc. ANTEGREN® (natalizumab) is a registered trademark of Elan Corporation. AVONEX is approved in the U.S. and in most other countries around the world for the treatment of relapsing forms of multiple sclerosis.
NOTE: The Company’s earnings conference call for the first quarter will be broadcast via the Internet at 8:00 a.m. EST on Thursday, April 12, 2001, and will be accessible through the investor relations section of Biogen’s homepage, http://www.biogen.com. The call will be available for replay on the Biogen website until April 19, 2001.
Condensed Consolidated Statements Of Income (in thousands, except per share amounts)
Three Months Ended March 31, 2001 2000 REVENUES Product $219,997 $174,596 Royalties 17,050 42,252 Total Revenues 237,047 216,848 COST AND EXPENSES Cost of revenues 29,146 28,623 Research and development 72,770 63,006 Selling, general and administrative 48,560 41,183 Total Cost and Expenses 150,476 132,812 Income from Operations 86,571 84,036 Other income, net 16,463 99,024 INCOME BEFORE INCOME TAXES 103,034 183,060 Income Taxes 30,911 61,694 NET INCOME $72,123 $121,366 BASIC EARNINGS PER SHARE $0.49 $0.81 DILUTED EARNINGS PER SHARE $0.47 $0.77 SHARES USED IN CALCULATING: BASIC EARNINGS PER SHARE 148,188 150,360 DILUTED EARNINGS PER SHARE 153,491 157,712
Condensed Consolidated Balance Sheets (in thousands)
Mar. 31, 2001 Dec. 31, 2000 ASSETS Current Assets Cash and marketable securities $748,027 $682,412 Accounts receivable, net 146,804 143,178 Other current assets 110,041 102,681 Total current assets 1,004,872 928,271 Property and equipment, net 428,625 400,429 Other assets 72,086 103,156 $1,505,583 $1,431,856 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities $226,187 $221,021 Long term debt & liabilities 99,039 104,433 Shareholders' equity 1,180,357 1,106,402 $1,505,583 $1,431,856