sein, sieht sehr gut aus.
SciClone Reports Record ZADAXIN Sales for Fourth Quarter and Full Year 2002; Phase 3 Hepatitis B Clinical Trial in Japan Completed on Schedule
SAN MATEO, Calif., Feb 4, 2003 (BUSINESS WIRE) -- SciClone Pharmaceuticals,
Inc. (Nasdaq: SCLN) today reported results for the fourth quarter ended December
31, 2002. Revenues from sales of ZADAXIN(R), the company's lead immune system
enhancer drug, reached a record $4,807,000, a 24% increase over the $3,888,000
reported for the fourth quarter of 2001. In addition, the company recognized
$223,000 as contract revenue from our European marketing partner, Sigma-Tau. For
the full year 2002, revenues from sales of ZADAXIN reached a record $17,101,000,
a 24% increase over the $13,831,000 reported for the full year 2001. Including
$671,000 of contract revenue in 2002, total revenue for the full year 2002
increased by 28.5% to $17,772,000 compared to the $13,831,000 reported for the
full year 2001.
Net loss for the fourth quarter 2002 was $2,617,000, or $0.07 per share,
compared to a net loss of $1,715,000, or $0.05 per share, for the fourth quarter
of 2001. Most of the difference was attributable to an increase in research and
development expenses to support ZADAXIN's U.S. phase 3 hepatitis C clinical
trials. Research and development expenses were $3,240,000 during the fourth
quarter of 2002 compared to $1,844,000 during the fourth quarter of 2001. For
the full year 2002, net loss was $10,037,000, or $0.29 per share, compared to
$6,232,000, or $0.19 per share, in 2001.
Cash and short-term investments totaled $21,151,000 at December 31, 2002,
compared to $24,506,000 at September 30, 2002 and $16,468,000 at December 31,
"ZADAXIN sales in international markets, primarily in China, are an important
source of funding for our U.S. clinical trials. In 2002, we significantly
increased cash flow from international sales of ZADAXIN by growing sales 24%,
holding marketing expenses flat, and improving accounts receivable and inventory
levels," said Richard A. Waldron, SciClone's Chief Financial Officer. "We expect
research and development expenses and cash disbursements to continue to increase
over the coming quarters as we progress with our phase 3 hepatitis C clinical
trials in the U.S."
Donald R. Sellers, SciClone's President and Chief Executive Officer, added,
"During 2002, we continued to make significant clinical progress towards
reaching our primary goal of ZADAXIN approvals in the U.S., Europe, and Japan.
We completed our phase 3 hepatitis B clinical trial in Japan on target at the
end of 2002 and expect to report data during the second quarter of 2003.
Particularly exciting was the hepatitis C clinical data presented at the annual
meeting of the American Association for the Study of Liver Disease (AALSD) that
showed ZADAXIN in combination with pegylated interferon alpha increased the
early virologic response rates up to 36% in patients who had failed prior
therapy. Moving forward into 2003, we continue to enroll and treat patients in
our phase 3 hepatitis C clinical trials in the U.S. and are looking forward to
another year of progress in the clinic, in research, and in our business model."
Recent developments at SciClone include: -- Sigma-Tau and its affiliates
increased their aggregate ownership to just under 10% of SciClone's common stock
outstanding through a $1.8 million investment in January 2003. Two Sigma-Tau
affiliates purchased a total of approximately 505,000 unregistered shares of
common stock at $3.5648 per share directly from SciClone. Sigma-Tau is
SciClone's marketing and development partner for ZADAXIN in the European Union
and will have access to the data from SciClone's phase 3 hepatitis C clinical
trials in the U.S. for European regulatory filing purposes. Sigma-Tau also is
funding and conducting in Europe a 300 patient phase 2 clinical trial using
ZADAXIN in combination with the standard chemotherapy for the treatment of
malignant melanoma. -- Positive data from a ZADAXIN melanoma animal study were
presented at the American Society of Clinical Oncologists (ASCO) meeting in
November 2002. This new study demonstrated that ZADAXIN treatment following
standard chemotherapy for melanoma significantly increases survival. In the
study, 60% of the group treated with ZADAXIN via continuous infusion for four
days after receiving chemotherapy survived to the 60 day endpoint. By
comparison, none of the mice receiving only chemotherapy survived after 42 days.
SciClone management will host a live audio webcast and conference call at 1:00
pm EST (10:00 am PST) today, Tuesday, February 4, 2003. The conference call will
include forward looking statements. Please log-on at www.sciclone.com
or call 800-374-0561 (U.S./Canada) or 706-634-6375 (international)
and refer to SciClone when your call is answered by the operator.
SciClone Pharmaceuticals is a biopharmaceutical company primarily focused on the
development of Immune System Enhancers (ISEs). Its lead product ZADAXIN is in
two phase 3 hepatitis C clinical trials in the U.S., a phase 3 hepatitis B
clinical trial in Japan, a phase 2 malignant melanoma clinical trial in Europe,
and two phase 2 liver cancer clinical trials in the U.S.
ZADAXIN has been approved for sale by the ministries of health in over 30
countries and is marketed in China and selected other countries outside the U.S.
ZADAXIN has been administered to more than 10,000 patients in both clinical and
commercial use, alone and in combination with anti-viral and anti-cancer drugs,
without producing any reported ZADAXIN related significant side effects or
SciClone's strategic goal is to become a principal worldwide provider of Immune
System Enhancers both as monotherapies and as critical components of combination
drug therapies for infectious diseases and cancer. In addition to ZADAXIN,
SciClone's drug development opportunities include SCV-07, a potentially orally
available ISE, and products to address the protein-based disorder that causes
The information in this press release contains forward-looking statements
including expectations and beliefs regarding demand for ZADAXIN, expense levels,
ZADAXIN research and clinical trials, the timing and reporting of clinical trial
results and enrollment, potential regulatory approvals and the data necessary to
support such approvals. Words such as "expects," "plans," "believe," "may,"
"will," "anticipated," "intended" and variations of these words or similar
expressions are intended to identify forward-looking statements. In addition,
any statements that refer to expectations, goals, projections or other
characterizations of future events or circumstances, including any underlying
assumptions, are forward-looking statements. These statements are not guarantees
of future performance and are subject to risks, uncertainties and assumptions
that are difficult to predict. Therefore, our actual results could differ
materially and adversely from those expressed in any forward-looking statements
as a result of various factors, including the progress or failure of clinical
trials, changes in demand for ZADAXIN, results obtained from future studies of
ZADAXIN, delays in analyzing and synthesizing data obtained from clinical
trials, future actions by the U.S. Food and Drug Administration or equivalent
regulatory authorities in Europe and in Japan, the regulatory approval process,
the statistical significance of data obtained from the clinical trials, the
speed at which patients are enrolled in trials and programs and maintenance of
the sufficiency and eligibility of the enrolled patient population, unexpected
adverse results to patients and other events that could prolong the studies or
result in unanticipated expense, as well as other risks and uncertainties
described in SciClone's filings with the Securities and Exchange Commission.