Quite a ride today, but the report looks great and after hours seems to confirm. We sure need a new drug. What's the anticipated market for it? Any doctors out there with an opinion?
Here's most of the release:
Amgen Announces 22% Increase in Second- Quarter Earnings per Share, Plans FDA Filing of Potential Rheumatoid Arthritis Treatment in 1999 and Raises 1999 Earnings Guidance
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--July 12, 1999--Amgen
(Nasdaq:AMGN) today announced that earnings per share for the second
quarter ended June 30, 1999 increased 22 percent, to $0.50 from $0.41
for the second quarter a year ago. Net income increased 24 percent, to
$268 million from $216 million. Total product sales for the quarter
increased 21 percent, to $738 million from $611 million.
Additionally, based on the strength of the results of two large
phase 2 randomized and controlled studies in rheumatoid arthritis and
discussions with the Food and Drug Administration, the Company plans
to file a BLA with the agency by the end of the year for approval of
IL-1ra. An additional phase 3 efficacy trial will not be needed for
filing.
The second of these two studies, in which IL-1ra was combined
with methotrexate, produced a statistically significant dose response
relationship and demonstrated an added benefit over the use of
methotrexate alone. The potential of IL-1ra to reduce both
inflammation and bone and cartilage destruction suggests that this
molecule may provide a meaningful benefit to patients suffering from
rheumatoid arthritis. Additional studies are planned to supplement the
safety database, support the regulatory submission and explore in more
detail the effect of IL-1ra on disease progression.
Sales of EPOGEN(R) (Epoetin alfa) increased 27 percent, to $428
million from $337 million, and sales of NEUPOGEN(R) (Filgrastim)
increased 12 percent, to $304 million from $271 million a year ago.
Sales of INFERGEN(R) (Interferon alfacon-1) increased to $6 million
from $4 million for the second quarter a year ago.
Amgen said it now expects earnings per share for the full year to
be at the high end of a range of $1.90 to $1.95, assuming that the
government will extend the R&E tax credit for the second half of 1999.
The Company also expects full-year growth of total product sales to be
in the high teens. For the full year, Amgen expects the EPOGEN sales
growth rate to be in the mid-20s and the NEUPOGEN sales growth rate to
be in the high single- to low double-digit range.
"We are extremely pleased with our continuing strong financial
performance, as well as the compelling new IL-1ra clinical results and
progress in the rest of our advancing product pipeline. We now have
four late stage product candidates, and we are hopeful that they will
gain regulatory approval over the next several years, providing
important benefits to patients and fueling our Company's continued
growth," said Gordon Binder, chairman and chief executive officer.
During the second quarter, in discussions with the FDA, Amgen
agreed to increase the number of patients in the abarelix clinical
program. To achieve this, the Company plans to begin a new study to
enroll additional patients in order to enlarge the abarelix safety
package for prostate cancer. Assuming successful outcomes, the Company
expects to have sufficient data from these and other ongoing studies
to support a potential regulatory submission in late 2000.
In addition, based on the favorable safety and efficacy of the
phase 2 studies, Amgen has decided to advance its sustained duration
G-CSF molecule, SD-01, into phase 3 testing. This trial is expected to
commence during the third quarter of this year.
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 it is difficult to move from concept to product;
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.
Note to Editors: 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. |
