Wednesday July 26, 4:17 pm Eastern Time
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Company Press Release
Amgen Announces 12 Percent Increase in Second-Quarter Earnings Per Share, Approval of NEUPOGEN --R-- Syringe and European Il-1ra Regulatory Filing
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--July 26, 2000--Amgen (NASDAQ:AMGN - news) today announced that earnings per share for the second quarter ended June 30, 2000 increased 12 percent, to $0.28 from $0.25 for the second quarter of 1999. Net income increased 13 percent, to $303 million from $268 million for the second quarter of 1999. During the quarter, the Food and Drug Administration approved a more concentrated formulation of NEUPOGEN® (Filgrastim) in a prefilled syringe.
During the second quarter, total revenues increased 11 percent, to $914 million from $821 million, and total product sales increased 9 percent, to $807 million from $738 million for the second quarter of 1999.
``We remain focused on preparing to launch our four late-stage product candidates, NESP, IL-1ra, abarelix-depot-M and SD/01, over the next few years, and our organization continues to grow and change to meet this challenge,'' said Kevin Sharer, Amgen's Chief Executive Officer and President. ``We are balancing the need for continued investment to ensure the success of these new products while at the same time delivering continued earnings growth.''
Sales of EPOGEN® (Epoetin alfa) increased 15 percent, to $493 million from $428 million for the second quarter of 1999. The Company continues to estimate that full-year EPOGEN sales growth will be in the low teens.
Second-quarter sales of NEUPOGEN increased 2 percent, to $310 million from $304 million for the second quarter of 1999. NEUPOGEN sales were negatively impacted by several factors including foreign exchange effects and continued low inventory levels at major wholesalers. In addition, there was some softness in demand in the quarter due in part to the realignment of the oncology sales force.
Amgen expects NEUPOGEN demand growth to improve through the remainder of the year due to the Company's expanded and fully deployed sales force and new marketing initiatives. Assuming that the dollar remains at current foreign exchange levels, the Company now expects NEUPOGEN sales for the year to be approximately the same as last year.
During the second quarter, the FDA approved NEUPOGEN® SingleJect(TM) prefilled syringe containing a more concentrated formulation of NEUPOGEN. NEUPOGEN SingleJect allows reduced injection volumes through its higher concentration and may improve patient comfort. Because the prefilled syringe eliminates the need for handling of separate vials and syringes, NEUPOGEN SingleJect is more convenient and easier for caregivers to use. Amgen believes that a significant percentage of patients are not receiving the appropriate dose of NEUPOGEN and that reduced injection volume delivered through a prefilled syringe will be attractive to these patients and their caregivers.
In July, Johnson & Johnson agreed to pay Amgen approximately $78 million for certain costs and expenses, including attorneys' fees, associated with Amgen's spillover arbitration against Johnson & Johnson. This will be recorded in the third quarter. Excluding this item, Amgen continues to expect its earnings per share for the year to be in a range of $1.06 to $1.08.
During the quarter, Amgen submitted a regulatory application with the European Medicines Evaluation Agency (EMEA) for the use of IL-1ra in treating patients with rheumatoid arthritis (RA). IL-1ra selectively blocks the harmful effects of IL-1, one of the key cytokines involved in the pathology of RA.
Preclinical studies of IL-1ra in combination with Amgen's second RA product candidate, sTNF-R1, suggest that together they may have synergistic effects in slowing markers of disease progression. Based on these and other data, Amgen recently began phase 1 trials of combination therapy with IL-1ra and sTNF-R1 in patients with RA.
Regulatory reviews of Amgen's nephrology licensing applications for NESP in the United States, Europe, Australia, New Zealand and Canada are on track. In addition, the NESP oncology program continues in phase 2 clinical trials.
Amgen's other late-stage development programs continue on track. Assuming a successful outcome in the large abarelix-depot-M safety study, the Company anticipates that its partner, PRAECIS PHARMACEUTICALS, will be able to submit a regulatory application to the FDA by the end of the year.
Also, the SD/01 program continues to advance in phase 3 studies in the United States, Europe, Canada and Australia. Amgen anticipates filing regulatory submissions for SD/01 by mid-2001.
Amgen and its partner Guilford Pharmaceuticals have also advanced the neuroimmunophilin clinical program into phase 2 clinical testing in patients with Parkinson's disease. Parkinson's disease afflicts approximately one million patients in the U.S. and is a condition for which there is a significant unmet medical need.
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent Form 10-Q. Amgen conducts research in the biotechnology/pharmaceutical field where movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product.
Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. In addition, sales of our products are affected by reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers. These government regulations and reimbursement policies may affect the development, usage and pricing of our products.
In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors.
Amgen is a global biotechnology company that discovers, develops, manufactures and markets cost-effective human therapeutics based on advances in cellular and molecular biology.
EDITOR'S NOTE: An electronic version of this news release may be accessed via our web site at www.Amgen.com. Visit the Corporate Center and click on Amgen News. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Amgen News section of the web site.
Amgen Inc.
Condensed Consolidated Statements of Operations
(In millions, except per share data)
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