Exhibit 99.1
SciClone Reports Results for Fourth Quarter and Full Year 2003
SAN MATEO, Calif.--(BUSINESS WIRE)--Feb. 24, 2004--SciClone
Pharmaceuticals, Inc. (Nasdaq:SCLN) today reported results for the
fourth quarter and full year ended December 31, 2003. Revenues from
sales of ZADAXIN(R), the company's lead immune system enhancer drug,
were $5,104,000 for the fourth quarter of 2003, a 6% increase over the
$4,807,000 reported for the fourth quarter 2002. Higher research and
development expenses to support the Company's phase 3 clinical trials
was the primary factor in the increased net loss of $4,687,000, or
$0.11 per share, for the fourth quarter 2003 compared to $2,617,000,
or $0.07 per share, for the fourth quarter of 2002. Cash, cash
equivalents and short-term investments totaled $62,975,000 at December
31, 2003, compared to $66,256,000 at September 30, 2003 and
$21,150,000 at December 31, 2002.
For the full year 2003, revenues from sales of ZADAXIN were
$31,732,000, an 86% increase over the $17,101,000 reported for 2002.
The increase was largely a result of an unanticipated temporary
increase in sales of ZADAXIN to hospitals in China at the time of the
SARS outbreak during the second quarter of 2003. For the full year
2003, net loss was $5,275,000, or $0.13 per share, compared to
$10,037,000, or $0.29 per share, in 2002.
"2003 was a year of solid progress at SciClone. We made
significant advancements in the clinical and regulatory development of
our products, while achieving record sales and strengthening our
financial position," remarked Donald R. Sellers, SciClone's President
and Chief Executive Officer. "In 2004, we will build on these
accomplishments as we pursue our intended strategic goal of gaining
regulatory approvals for ZADAXIN in the U.S., Europe and Japan. We
expect to complete enrollment of the second of our two 500 patient
U.S. phase 3 hepatitis C clinical trials by the end of the second
quarter of 2004 and remain on track for completing both trials by the
end of 2005. In Japan, we have completed validation of the phase 3
hepatitis B data from all 49 clinical sites and anticipate filing a
Japanese New Drug Application by the end of 2004. Recent interim data
from our HCV triple therapy trial along with our oncology programs in
Europe and the U.S. suggest the possibility of additional development
opportunities for ZADAXIN. In addition to examining these new
opportunities for ZADAXIN, we intend to explore new delivery
technologies to enhance its use. We are also developing an oral
formulation for SCV-07, our in-licensed immune system enhancer
candidate, and we are regularly screening additional candidates to
enhance our product pipeline."
Richard A. Waldron, SciClone's Chief Financial Officer, added,
"Our strong cash position of over $60 million should allow us to
execute our strategic plan and complete our current clinical
development programs. As we begin production of ZADAXIN with
additional new contract manufacturers, we are building inventory
levels through the first half of 2004 to ensure an uninterrupted
supply of ZADAXIN for our distributors in China and elsewhere. For
2004, we expect net sales of $21 to 22 million, research and
development expenses of $21 to $23 million, a net loss of $18 to $20
million, or $0.43 to $0.50 per share, and year-end cash, cash
equivalents and short term investments of $43 to $47 million."
Other recent developments at SciClone include:
-- SciClone expects to complete enrollment of the second of its
two 500 patient phase 3 hepatitis C clinical trials by the end
of the second quarter 2004. Although the first and second
trials are identical in design, the second trial is enrolling
only patients with mild cirrhosis, who are more difficult to
recruit and qualify than non-cirrhotic patients. In September
2003, SciClone completed enrollment of the first 500 patient
(non-cirrhotic) phase 3 hepatitis C clinical trial. The entire
program is over 90% enrolled and SciClone continues to expect
all 1,000 patients from both clinical trials to have completed
the 12 months of therapy and 6 months of follow up observation
by the end of 2005.
-- In February, SciClone reported interim 24-week data from its
ongoing pilot triple therapy clinical trial in Mexico for
hepatitis C patients who have not responded to previous
therapy. 41% of patients tested HCV RNA negative and 50%
showed a virologic response, defined as a 2 log or greater
reduction in the level of HCV RNA, after 24 weeks of a new
combination therapy of ZADAXIN, pegylated interferon alpha and
ribavirin. By comparison, separate recent studies show that
after 24 weeks of double therapy with pegylated interferon
alpha plus ribavirin, approximately 30% of hepatitis C
non-responder patients tested HCV RNA negative. SciClone had
previously reported 12 week data on this group of hepatitis C
non-responder patients showing 61% reported an early virologic
response, or EVR, which is measured after 12 weeks of therapy
and is defined as a 2 log or greater reduction in the level of
HCV RNA, and 48% tested negative for HCV RNA. SciClone's
ongoing open label clinical trial plans to enroll a total of
50 hepatitis C non-responder patients, each of whom had failed
to respond to prior therapy of at least six months of
interferon alpha in combination with ribavirin. During the
course of this study, patients will receive 12 months of
triple therapy and will be observed for six months after
completing therapy to measure sustained response, defined as
negative HCV RNA by PCR test measured at week 72.
SciClone management will host a live audio webcast and conference
call at 2:00 p.m. EST (11:00 a.m. PST) today, Tuesday, February 24,
2004. The conference call will include forward looking statements.
Financial 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. To participate in the conference call, please log-on at
http://www.sciclone.com or call 800-901-5231 (U.S./Canada) or
617-786-2961 (international) and enter passcode 63600379. A replay
will be available for two weeks. To access the replay, log on to
http://www.sciclone.com or dial 888-286-8010 (U.S./Canada) or
617-801-6888 (international) and enter passcode 54205751.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in
the development of therapeutics to treat life-threatening diseases.
SciClone is currently evaluating its lead product ZADAXIN 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,
two phase 2 liver cancer pilot studies in the U.S., and a hepatitis C
triple therapy pilot clinical trial in Mexico. The Company's other
principal drug development candidate is SCV-07, a potentially orally
available therapeutic to treat viral and infectious diseases. 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 and research and
development expense levels, timing and completion of enrollment for
our second phase 3 hepatitis C clinical trial; timing and completion
of therapy and follow up observation for both of our phase 3 hepatitis
C clinical trials; timing of filing of our Japanese New Drug
Application; the enrollment of patients in our triple therapy
hepatitis C pilot clinical trial; our ability to implement our
strategic goals and clinical development programs 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 changes in demand for ZADAXIN, the progress
or failure of clinical trials, the statistical significance of data
obtained from clinical trials, the speed with which patients are
enrolled in our trials and programs, competition for enrollment of
patients meeting a particular patient profile, our ability to enroll a
sufficient number of eligible patients to yield statistically
significant results, maintenance of the sufficiency and eligibility of
the enrolled patient population, unexpected delays in preparation of
the Japanese New Drug Application, 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 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) (Unaudited) (Unaudited)
Three Months Three Months Year Year
Ended Ended Ended Ended
Dec. 31, Dec. 31, Dec. 31, Dec. 31,
2003 2002 2003 2002
------------ ------------ ------------ -------------
Product sales $5,104,000 $4,807,000 $31,732,000 $17,101,000
Contract revenue 134,000 223,000 806,000 671,000
------------ ------------ ------------ -------------
Total revenue 5,238,000 5,030,000 32,538,000 17,772,000
Cost of product
sales 754,000 962,000 5,636,000 3,487,000
------------ ------------ ------------ -------------
Gross margin 4,484,000 4,068,000 26,902,000 14,285,000
Operating
expenses:
Research and
development 6,273,000 3,240,000 18,949,000 11,647,000
Sales and
marketing 1,872,000 2,433,000 9,018,000 8,724,000
General and
administ-
rative 1,089,000 995,000 4,134,000 3,902,000
------------ ------------ ------------ -------------
Total operating
expenses 9,234,000 6,668,000 32,101,000 24,273,000
------------ ------------ ------------ -------------
Loss from
operations (4,750,000) (2,600,000) (5,199,000) (9,988,000)
Interest and
investment
income 123,000 71,000 266,000 323,000
Interest and
investment
expense (90,000) (90,000) (361,000) (361,000)
Other income
(expense), net 30,000 2,000 19,000 (11,000)
------------ ------------ ------------ -------------
Net loss $(4,687,000) $(2,617,000) $(5,275,000) $(10,037,000)
============ ============ ============ =============
Basic and diluted
net loss per share ($0.11) $(0.07) ($0.13) $(0.29)
============ ============ ============ =============
Weighted average
shares used in
computing basic
and diluted net
loss per share 44,441,967 36,891,892 39,568,199 35,002,003
============ ============ ============ =============
SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
ASSETS
December 31, December 31,
2003 2002
------------- -------------
(unaudited)
Current assets:
Cash and cash equivalents $52,899,000 $10,233,000
Restricted short-term investments 695,000 685,000
Other short-term investments 9,381,000 10,232,000
Accounts receivable, net of allowance of
$638,000 in 2003 and 2002 10,142,000 9,276,000
Inventories 5,778,000 3,431,000
Prepaid expenses and other current assets 2,456,000 2,297,000
------------- -------------
Total current assets 81,351,000 36,154,000
Property and equipment, net 325,000 111,000
Intangible assets, net 612,000 682,000
Other assets 1,534,000 164,000
------------- -------------
Total assets $83,822,000 $37,111,000
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $3,423,000 $3,150,000
Accrued compensation and employee
benefits 1,440,000 1,089,000
Accrued clinical trials expense 1,889,000 966,000
Accrued professional fees 481,000 679,000
Deferred revenue 537,000 895,000
Other accrued expenses 631,000 259,000
------------- -------------
Total current liabilities 8,401,000 7,038,000
Deferred revenue 671,000 1,119,000
Other long term liabilities 900,000 0
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 2003 and 2002,
respectively - - - - - -
Common stock; $0.001 par value (no par
value in 2002); 75,000,000
shares authorized; 44,484,144 and
36,904,916 shares issued and
outstanding in 2003 and 2002,
respectively 44,000 156,290,000
Additional paid-in capital 206,320,000 - - -
Accumulated other comprehensive income 176,000 79,000
Accumulated deficit (138,290,000) (133,015,000)
------------- -------------
Total stockholders' equity 68,250,000 23,354,000
------------- -------------
Total liabilities and stockholders' equity $83,822,000 $37,111,000
============= =============
SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year ended
December 31,
2003 2002
------------ -------------
(unaudited)
Operating activities:
Net loss $(5,275,000) $(10,037,000)
Adjustments to reconcile net loss
to net cash used in operating activities:
Depreciation and amortization 185,000 556,000
Non cash interest income (12,000) (21,000)
Changes in operating assets and
liabilities:
Accounts receivable, net (866,000) (484,000)
Inventories (2,347,000) 628,000
Prepaid expenses and other assets (355,000) (967,000)
Accounts payable and other accrued
expenses 345,000 1,576,000
Accrued compensation and employee
benefits 352,000 129,000
Accrued clinical trials expense 923,000 670,000
Accrued professional fees (198,000) 46,000
Deferred revenue (806,000) 2,014,000
------------ -------------
Net cash used in operating activities (8,054,000) (5,890,000)
------------ -------------
Investing activities:
Purchase of property and equipment (303,000) (66,000)
Proceeds from sales of short-term
investments 1,500,000 2,694,000
Payment on purchases of short-term
investments (550,000) (6,600,000)
------------ -------------
Net cash provided by (used in) investing
activities 647,000 (3,972,000)
------------ -------------
Financing activities:
Proceeds from issuance of common stock
net of financing costs 50,073,000 10,577,000
------------ -------------
Net cash provided by financing activities 50,073,000 10,577,000
------------ -------------
Net increase (decrease) in cash and cash
equivalents 42,666,000 715,000
Cash and cash equivalents, beginning of year 10,233,000 9,518,000
------------ -------------
Cash and cash equivalents, end of year $52,899,000 $10,233,000
============ =============
CONTACT: SciClone Pharmaceuticals, Inc.
Richard A. Waldron, 650-358-3437