EXHIBIT 99.1
SciClone Reports Third Quarter Results
SAN MATEO, Calif.--(BUSINESS WIRE)--Nov. 1, 2004--SciClone
Pharmaceuticals, Inc. (Nasdaq:SCLN) today reported results for the
third quarter and nine months ended September 30, 2004. Revenues from
sales of ZADAXIN(R), SciClone's lead product candidate, were
$5,753,000 for the third quarter and $16,780,000 for the nine months
ended September 30, 2004. Net loss for the third quarter 2004 was
$4,913,000, or $0.11 per share, and for the nine months ended
September 30, 2004 the net loss was $10,923,000, or $0.24 per share.
In addition, SciClone reported $134,000 in contract revenue for the
third quarter of 2004 and $1,497,000 for the nine months ended
September 30, 2004, which includes a $1,000,000 milestone payment
received from Sigma-Tau during the second quarter 2004. Contract
revenue was $224,000 for the third quarter of 2003 and $672,000 for
the nine months ended September 30, 2003.
In comparison, revenues for the third quarter of 2003 were
$5,421,000 and $26,628,000 for the nine months ended September 30,
2003. The revenues for the nine months ended September 30, 2003
included approximately $11,000,000 due to the unanticipated temporary
increase in sales of ZADAXIN in response to the now abated SARS
epidemic in China. Net loss for the third quarter 2003 was $2,850,000,
or $0.07 per share, and net loss for the nine months ended September
30, 2003 was $588,000, or $0.02 per share.
Research and development expenses were $4,858,000 for the third
quarter 2004, compared to $4,585,000 for the third quarter 2003.
Research and development expenses for the nine months ended September
30, 2004 totaled $13,552,000, compared to $12,676,000 incurred in the
nine months ended September 30, 2003. General and administrative
expenses for the third quarter 2004 were $2,573,000, compared to
$998,000 for the third quarter 2003. General and administrative
expenses for the nine months ended September 30, 2004 were $5,022,000,
compared to $3,045,000 incurred in the nine months ended September 30,
2003. The increase in general and administrative expenses is
attributable to a one-time expense incurred in connection with the
separation of the former Chief Executive Officer from the Company in
July 2004.
Cash, cash equivalents and short-term investments totaled
$52,986,000 at September 30, 2004, compared to $54,970,000 at June 30,
2004 and $66,256,000 at September 30, 2003.
"We remain focused on our primary objective of developing ZADAXIN
for the treatment of hepatitis C in the major pharmaceutical markets,"
commented Richard A. Waldron, SciClone's Chief Financial Officer. "In
addition, we are advancing the development of pegylated ZADAXIN and
our proprietary drug candidate SCV-07, a potential therapeutic to
treat viral and other infectious diseases."
Alfred Rudolph, M.D., SciClone's Chief Operating Officer, added,
"Our U.S. phase 3 hepatitis C clinical trials are ongoing and on
target to be completed by the end of next year. We continue to make
progress with our other clinical development programs with a ZADAXIN
triple therapy hepatitis C trial planned by our European partner
Sigma-Tau and preclinical studies to support an IND filing in the
United States during the first half of 2005 for SCV-07."
Financial outlook
For the fiscal year 2004, SciClone is refining its guidance for
certain financial items. SciClone's estimate for net sales of ZADAXIN
remains unchanged and is expected to be slightly greater than $22
million. Research and development expenses for the year are now
anticipated to be between $19 and $20 million, instead of the previous
estimate of between $19 and $21 million. Net loss for 2004 is now
expected to be between $15 and $16 million, lower than the previous
estimate of between $15 and $17 million. Accordingly, net loss per
share for 2004 is now expected to be between $0.35 and $0.37 per
share, lower than the previous estimate of between $0.35 and $0.39 per
share. SciClone's guidance for cash, cash equivalents and short-term
investments at December 31, 2004 remains unchanged at between $45 and
$47 million.
Recent Announcements
-- SciClone today reported that ZADAXIN in a triple therapy,
single-arm pilot trial in Mexico produced a sustained
virologic response at week 72 (SVR) in 19% of difficult to
treat hepatitis C patients, those who are non-responders
infected with the genotype 1 strain of the virus. These
results are more than twice the 9% SVR from a separate,
unrelated trial treating genotype 1 non-responder patients
with pegylated interferon and a similar dose and ribavirin but
without ZADAXIN. Although this was a small, uncontrolled pilot
trial and reliable conclusions cannot be drawn from
comparisons of results of different studies, SciClone is
encouraged by the results.
-- SciClone today announced the appointment of Richard J. Hawkins
to the company's Board of Directors as a non-executive member.
Mr. Hawkins is a highly experienced executive with over 30
years of experience in the pharmaceutical industry.
Conference Call
SciClone management will host a live audio webcast and conference
call at 11:30 a.m. EST (8:30 a.m. PST) today, Monday, November 1,
2004. The conference call will include forward-looking statements.
Financial information to be discussed in the conference call will be
posted on the investor relations section of SciClone's website at
http://www.sciclone.com prior to the commencement of the conference
call. To participate in the conference call, please log on at
http://www.sciclone.com or call 800-659-1942 (U.S. and Canada) or
617-614-2710 (International) and enter passcode 82758172. A replay of
the conference call will be available for two weeks beginning at 1:30
p.m. EST today, Monday, November 1, 2004. To access the replay, log on
to http://www.sciclone.com or call 888-286-8010 (U.S. and Canada) or
617-801-6888 (International) and enter passcode 76742003.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in
the development of therapeutics to treat life-threatening diseases.
SciClone's lead product ZADAXIN(R) is currently being evaluated in two
phase 3 hepatitis C clinical trials in the United States. ZADAXIN is
also being evaluated in other late-stage clinical trials for the
treatment of hepatitis B and certain cancers. The company's other
principal drug development candidate is SCV-07, which is currently
being evaluated in pre-clinical studies for the treatment of viral and
other infectious disease. For more information about SciClone, visit
www.sciclone.com.
The information in this press release contains forward-looking
statements including our expectations and beliefs regarding future
sales of our products, future financial results, research and
development expense levels, asset levels, timing of filing of our
Japanese New Drug Application, expectations regarding both of our
phase 3 hepatitis C clinical trials, and the fact that the
experimental or clinical data described may imply certain actual
results in human clinical trials or 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 changes in demand for ZADAXIN, the progress or failure of
clinical trials, the statistical significance of data obtained from
clinical trials, the fact that results from small studies may not be
predictive of results from larger studies, maintenance of the
sufficiency and eligibility of the enrolled patient population,
unanticipated delays or additional expenses incurred during our
clinical trials, our future cash requirements, unexpected delays in
preparation of the Japanese New Drug Application, delays in analyzing
and synthesizing data obtained from clinical trials, future actions of
our strategic partners, unexpected delays in preparation for
enrollment, future actions by the U.S. Food and Drug Administration or
equivalent regulatory authorities in Europe and Japan 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)
Three months ended Nine months ended
September 30, September 30,
2004 2003 2004 2003
------------ ------------ ------------- ------------
Product sales $5,753,000 $5,421,000 $16,780,000 $26,628,000
Contract revenue 134,000 224,000 1,497,000 672,000
------------ ------------ ------------- ------------
Total revenue 5,887,000 5,645,000 18,277,000 27,300,000
Cost of product
sales 1,109,000 935,000 3,429,000 4,882,000
------------ ------------ ------------- ------------
Gross margin 4,778,000 4,710,000 14,848,000 22,418,000
Operating
expenses:
Research and
development 4,858,000 4,585,000 13,552,000 12,676,000
Sales and
marketing 2,317,000 1,892,000 7,290,000 7,146,000
General and
administrative 2,573,000 998,000 5,022,000 3,045,000
------------ ------------ ------------- ------------
Total operating
expenses 9,748,000 7,475,000 25,864,000 22,867,000
------------ ------------ ------------- ------------
Loss from
operations (4,970,000) (2,765,000) (11,016,000) (449,000)
Interest and
investment
income 156,000 47,000 384,000 143,000
Interest and
investment
expense (90,000) (90,000) (271,000) (271,000)
Other income
(expense), net (9,000) (42,000) (20,000) (11,000)
------------ ------------ ------------- ------------
Net loss $(4,913,000) $(2,850,000) $(10,923,000) $(588,000)
============ ============ ============= ============
Basic and diluted
net loss per
share ($0.11) ($0.07) ($0.24) ($0.02)
============ ============ ============= ============
Weighted average
shares used in
computing basic
and diluted net
loss per share 44,651,084 38,768,350 44,610,958 37,925,757
============ ============ ============= ============
SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
ASSETS
Sept. 30, Dec. 31,
2004 2003
------------- -------------
(unaudited)
Current assets:
Cash and cash equivalents $42,791,000 $52,899,000
Restricted short-term investments 695,000 695,000
Other short-term investments 9,500,000 9,381,000
Accounts receivable, net of allowance
of $591,000 in 2004 and $638,000
in 2003 10,189,000 10,142,000
Inventories 4,336,000 5,778,000
Prepaid expenses and other current
assets 712,000 2,456,000
------------- -------------
Total current assets 68,223,000 81,351,000
Property and equipment, net 405,000 325,000
Intangible assets, net 560,000 612,000
Other assets 1,538,000 1,534,000
------------- -------------
Total assets $70,726,000 $83,822,000
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $1,469,000 $3,423,000
Accrued compensation and employee
benefits 1,716,000 1,440,000
Accrued clinical trials expense 1,000,000 1,889,000
Accrued professional fees 497,000 481,000
Deferred revenue 537,000 537,000
Other accrued expenses 968,000 631,000
------------- -------------
Total current liabilities 6,187,000 8,401,000
Deferred revenue 269,000 671,000
Other long-term liabilities 1,044,000 900,000
Convertible notes payable 5,600,000 5,600,000
Commitments and contingencies
Stockholders' equity:
Preferred stock; $0.001 par value;
10,000,000 shares authorized; no
shares outstanding in 2004 and 2003,
respectively - - - - - -
Common stock; $0.001 par value;
75,000,000 shares authorized;
44,662,744 and 44,484,144 shares
issued and outstanding 45,000 44,000
Additional paid-in capital 206,555,000 206,320,000
Accumulated other comprehensive income 239,000 176,000
Accumulated deficit (149,213,000) (138,290,000)
------------- -------------
Total stockholders' equity 57,626,000 68,250,000
------------- -------------
Total liabilities and stockholders'
equity $70,726,000 $83,822,000
============= =============
SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine months ended
September 30,
2004 2003
------------- ------------
Operating activities:
Net loss $(10,923,000) $(588,000)
Adjustments to reconcile net loss
to net cash used in operating
activities:
Depreciation and amortization 157,000 134,000
Changes in operating assets and
liabilities:
Accounts receivable, net (47,000) (2,500,000)
Inventories 1,442,000 (725,000)
Prepaid expenses and other assets 1,721,000 (468,000)
Accounts payable and other accrued
expenses (1,617,000) 544,000
Accrued compensation and employee
benefits 276,000 (81,000)
Accrued clinical trials expense (889,000) (286,000)
Accrued professional fees 16,000 (126,000)
Deferred revenue (402,000) (671,000)
Long-term liabilities 144,000 - - -
------------- ------------
Net cash used in operating activities (10,122,000) (4,767,000)
------------- ------------
Investing activities:
Purchase of property and equipment (166,000) (46,000)
Payment on purchase of marketable
securities (56,000) (11,000)
------------- ------------
Net cash used in investing activities (222,000) (57,000)
------------- ------------
Financing activities:
Proceeds from issuance of common stock,
net of financing costs 236,000 49,860,000
------------- ------------
Net cash provided by financing activities 236,000 49,860,000
------------- ------------
Net (decrease) increase in cash and cash
equivalents (10,108,000) 45,036,000
Cash and cash equivalents, beginning of
period 52,899,000 20,233,000
------------- ------------
Cash and cash equivalents, end of period $42,791,000 $65,269,000
============= ============
CONTACT: SciClone Pharmaceuticals, Inc.
Richard A. Waldron, 650-358-3437