Exhibit 99.1
SciClone Reports First Quarter Results;
Record ZADAXIN Sales for First Quarter 2003
SAN MATEO, Calif.--(BUSINESS WIRE)--xx--SciClone Pharmaceuticals,
Inc. (Nasdaq:SCLN) today reported results for the first quarter ended
March 31, 2003. Revenues from sales of ZADAXIN(R), the company's lead
immune system enhancer drug, reached a record $5,000,000, a 27%
increase over the $3,948,000 reported for the first quarter of 2002.
In addition, the company recognized $224,000 of contract revenue from
its European marketing partner, Sigma-Tau.
Net loss for the first quarter 2003 was $2,862,000, or $0.08 per
share, compared to a net loss of $2,403,000, or $0.07 per share, for
the first quarter of 2002. Research and development expenses were
$3,783,000 during the first quarter of 2003 compared to $2,526,000
during the first quarter of 2002. The increase in both net loss and
research and development expense was attributable primarily to
additional research and development expenses to support ZADAXIN's
phase 3 hepatitis C clinical trials in the U.S.
Cash, cash equivalents, and short-term investments totaled
$17,585,000 at March 31, 2003, compared to $21,150,000 at December 31,
2002 and $16,525,000 at March 31, 2002.
"The growing demand for ZADAXIN, especially in our largest market
China, has generated increasing revenues in each quarter for the past
nine quarters. The cash flow from our international operations has
become an important source of funding for our phase 3 hepatitis C
clinical trials in the U.S.," said Richard A. Waldron, SciClone's
Chief Financial Officer. "During the coming quarters, we expect our
research and development expenses and cash disbursements will increase
to support these trials."
Donald R. Sellers, SciClone's President and Chief Executive
Officer, commented, "We remain focused on our primary goal of ZADAXIN
approvals in the U.S., Europe, and Japan where we are conducting
late-stage clinical trials. We continue to enroll patients in our
phase 3 hepatitis C clinical trials in the U.S. and expect to report
milestones when achieved. For our recently completed phase 3 hepatitis
B clinical trial in Japan, we expect to report data in June."
Mr. Sellers added, "In the People's Republic of China, beginning
in this second quarter, there has been a significant and unanticipated
increase in local sales of ZADAXIN to hospitals. In China, immune
system enhancers are being used in connection with SARS and we believe
that an increase in the rate of our sales to China during our second
quarter relates to this. It is too early to predict the magnitude or
sustainability of this development and we do not know if the effect on
revenue will extend beyond the second quarter."
Other recent developments at SciClone include:
-- The People's Republic of China has recently renewed and
extended into 2008 the license to import ZADAXIN as a finished
product.
-- This month, SciClone announced the results of a 27 patient
pilot study showing a 71% long-term sustained response rate
for difficult to treat hepatitis B patients infected with the
HBeAg-negative (precore mutant) strain of the virus. These
results were obtained using a combination of ZADAXIN and
interferon. This sustained response rate compares extremely
favorably to 20% for patients using interferon in combination
with lamivudine and 10% for patients using interferon alone.
-- In January, Sigma-Tau, which is conducting a ZADAXIN
combination therapy phase 2 clinical trial for the treatment
of malignant melanoma, increased its ownership in SciClone to
9.9% by purchasing $1,800,000 of unregistered common stock
from the Company.
SciClone management will host a live audio webcast and conference
call at 2:00 pm EDT (11:00 am PDT) today, Thursday, April 24, 2003.
The conference call will include forward looking statements. Financial
and statistical information to be discussed in the conference call
will be posted on the newsroom section of SciClone's web site at
http://www.sciclone.com prior to the commencement of the conference
call. Please log-on at http://www.sciclone.com or call 800-374-0564
(U.S./Canada) or 706-634-6376 (international) and refer to SciClone
when your call is answered by the operator. A replay will be available
for two weeks. To access the replay, log on to http://www.sciclone.com
or dial 800-642-1687 (U.S./Canada) or 706-645-9291 (international) and
enter access code 9741331.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in
the development of therapeutics to treat life-threatening diseases.
Its lead product ZADAXIN is in several late-stage clinical trials,
including two phase 3 hepatitis C clinical trials in the U.S., a
recently completed phase 3 hepatitis B clinical trial in Japan, a
phase 2 malignant melanoma clinical trial in Europe, and two phase 2
liver cancer trials in the U.S. In addition to ZADAXIN, SciClone's
drug development opportunities include SCV-07, a potentially orally
available therapy to treat viral and infectious diseases, and products
to address the protein-based disorder that causes cystic fibrosis.
The information in this press release contains forward-looking
statements including our expectations and beliefs regarding sales and
demand for ZADAXIN, research and development expense levels, the
timing and reporting of clinical trial results and enrollment,
potential regulatory approvals and the data necessary to support such
approvals and the fact that the experimental or clinical data
described may imply certain actual results in larger patient
populations. 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, other events that could prolong the studies or
result in unanticipated expense and the fact that experimental data
and clinical results derived from studies with a limited group of
patients may not be predictive of the results of larger studies, as
well as other risks and uncertainties described in SciClone's filings
with the Securities and Exchange Commission.
SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited) (Unaudited) (Unaudited)
Three Months Three Months Three Months
Ended Ended Ended
March 31, December 31, March 31,
2003 2002 2002
------------ ------------ ------------
Product sales $5,000,000 $4,807,000 $3,948,000
Contract revenue 224,000 223,000 -
------------ ------------ ------------
Total revenues 5,224,000 5,030,000 3,948,000
Cost of product sales 1,016,000 962,000 792,000
------------ ------------ ------------
Gross margin 4,208,000 4,068,000 3,156,000
Operating expenses:
Research and development 3,783,000 3,240,000 2,526,000
Sales and marketing 2,229,000 2,433,000 2,008,000
General and administrative 1,012,000 995,000 992,000
------------ ------------ ------------
Total operating expenses 7,024,000 6,668,000 5,526,000
------------ ------------ ------------
Loss from operations (2,816,000) (2,600,000) (2,370,000)
Interest and investment income 53,000 71,000 76,000
Interest and investment expense (91,000) (90,000) (90,000)
Other income (expense), net (8,000) 2,000 (19,000)
------------ ------------ ------------
Net loss $(2,862,000) $(2,617,000) $(2,403,000)
============ ============ ============
Basic and diluted net loss per
share $(0.08) $(0.07) $(0.07)
============ ============ ============
Weighted average shares used in
computing basic and diluted net
loss per share 37,320,130 36,891,892 32,583,558
============ ============ ============
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited) (Unaudited)
March 31, December 31,
2003 2002
------------ ------------
ASSETS
Cash and cash equivalents and short-term
investments $17,585,000 $21,150,000
Accounts receivable, net 10,541,000 9,276,000
Inventory 3,385,000 3,431,000
Other assets 3,296,000 3,254,000
------------ ------------
Total assets $34,807,000 $37,111,000
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
Other liabilities $4,997,000 $6,143,000
Deferred revenue 1,790,000 2,014,000
Convertible notes payable 5,600,000 5,600,000
Total shareholders' equity 22,420,000 23,354,000
------------ ------------
Total liabilities and shareholders'
equity $34,807,000 $37,111,000
============ ============
CONTACT: SciClone Pharmaceuticals, Inc.
Richard A. Waldron, 650/358-3437