2nd Q:
>>SAN MATEO, Calif., Aug. 2 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: SCLN - news), today reported that total revenues for the quarter ended June 30, 2001 from sales of ZADAXIN®, the Company's immune system enhancer, were $3,250,000 compared to $4,206,000 for the same quarter last year. Net loss for the quarter was $2,219,000, or $0.07 per share, compared to a net loss of $589,000, or $0.02 per share, for the same quarter of 2000.
``We are taking advantage of the opportunities presented by the U.S. phase 3 hepatitis C program, our ZADAXIN cancer programs, the European and Japanese ZADAXIN programs as well as the CPX clinical program,'' said Richard A. Waldron, SciClone's Chief Financial Officer. ``We expect patient enrollment and research and development expenses for our U.S. and international clinical programs to accelerate over the next several quarters, while anticipating quarter-to-quarter sales growth for the remainder of 2001. We are managing the cash flow derived from our international sales to help fund these clinical programs.
SciClone's cash and short-term investments totaled $20,202,000 at June 30, 2001. Net cash used in operating activities for the quarter was $1,152,000.
The decrease in total revenue for the second quarter of 2001 compared to the same quarter last year was primarily due to greater sales last year to certain countries using ZADAXIN on a pre-approval named patient basis and to increased competition from other hepatitis B therapies.
We have initiated a phase 3 clinical program in the U.S. for the treatment of hepatitis C using ZADAXIN as part of a combination therapy with Pegasys®, pegylated interferon alfa-2a, a proprietary product of F. Hoffmann-La Roche Ltd. In addition, ZADAXIN is in two phase 2 clinical trials in the U.S. for the treatment of liver cancer and in a phase 2 clinical program in combination with lamivudine for the treatment of hepatitis B. A ZADAXIN phase 3 clinical program for European marketing registration currently is being planned for one or more indications that complement the Company's U.S. clinical program. ZADAXIN is also in clinical trials in Japan and in Australia.
ZADAXIN is a synthetic preparation of thymosin alpha 1, a peptide that occurs naturally in humans and is an immune system enhancer (``ISE'') that helps stimulate, maintain and direct the body's antiviral or anticancer responses. ZADAXIN has been administered to over 3,000 subjects in over 70 clinical trials covering a broad range of diseases and to many thousands of patients commercially around the world with virtually no serious drug related adverse events or toxicities. ZADAXIN is approved for sale in 24 countries, principally for the treatment of hepatitis B and hepatitis C, and also in certain countries as a vaccine adjuvant for patients with weakened immune systems and as an adjuvant to chemotherapy for the treatment of various cancers.
SECOND QUARTER 2001 HIGHLIGHTS
-- ZADAXIN's critical biological role in treating chronic hepatitis C as
part of a combination therapy with alpha interferon was supported in a
study published in the Journal of Viral Hepatitis. The study results
demonstrate that ZADAXIN increases the production of specific cytokines
that fight viral infection while at the same time decreasing the
production of other cytokines that make hepatitis C viral infection
more impervious to the body's immune response.
-- ZADAXIN used in combination therapy with alpha interferon showed
significantly greater sustained response rates in difficult-to-treat
chronic hepatitis B patients compared to treatment with alpha
interferon alone. This study was presented in a poster session at the
American Association for the Study of Liver Disease (AASLD) session at
the Digestive Disease Week (DDW) meeting.
-- We initiated our U.S. phase 2 liver cancer trial using ZADAXIN plus
transarterial chemoembolization (TACE). This complements our U.S. phase
2 liver cancer trial using ZADAXIN plus radio frequency ablation (RFA)
initiated earlier this year.
-- U.S. Patent and Trademark Office allowed SciClone a U.S. patent for
analogs of ZADAXIN. The new patent will give SciClone exclusive
"composition of matter" rights to several families of ZADAXIN analogs
the Company has determined could have proprietary therapeutic or
biologic distinctions from its current "natural synthetic" formulation,
such as length of circulation in the blood or alternative delivery
techniques.
-- ZADAXIN was approved in Mexico for treatment of hepatitis C and
hepatitis B. ZADAXIN had previously been approved in Mexico as
influenza vaccine adjuvant.
-- CPX was granted Orphan Drug Status throughout the European Union for
cystic fibrosis.
-- We presented at four investment conferences: the UBS Warburg Global
Specialty Pharmaceuticals Conference (New York); the Fourth Annual H.C.
Wainwright & Co. Select Stock Conference (New York); the 6th Biotech
& Partnering Conference (Milan, Italy); and the RedChip.com Investor
Conference (Portland).
SciClone Pharmaceuticals is a global specialty pharmaceutical company that develops and commercializes novel medicines for treating a broad range of the world's most serious diseases. The Company has focused its current product development and commercialization activities on hepatitis C, cancer, hepatitis B, drug-resistant tuberculosis and cystic fibrosis. Press releases and corporate information from SciClone Pharmaceuticals are available on the Internet at www.sciclone.com or by calling the Company's Investor Relations Department at 800-724-2566. SciClone's Common Stock is listed on The Nasdaq National Market® under the symbol SCLN.
The information in this press release includes certain forward-looking statements concerning the Company's current expectations regarding the planning for clinical trials in Europe and future events including the Company's expectations regarding trends in cash flow and expenses and plans and expectations regarding clinical trials and statements using the words ``expects,'' ``believes,'' ``anticipates'' or similar words. These statements include statements regarding the ongoing and prospective development, clinical trials and commercialization of ZADAXIN immunotherapy for hepatitis C, cancer, and hepatitis B. Actual events could differ materially from those projected herein, due to risks and uncertainties including market factors, competitive product introductions, the nature of product development, the progress or failure of clinical trials and the regulatory approval process. Additional risks and uncertainties include those reflected in the Company's filings with the Securities and Exchange Commission, particularly the Company's Annual Report on Form 10-K for the year ended December 31, 2000.
SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Three Months Three Months Six Months Six Months
Ended Ended Ended Ended
June 30, June 30, June 30, June 30,
2001 2000 2001 2000
Product revenue $3,250,000 $4,206,000 $6,363,000 $7,705,000
Cost of product 636,000 849,000 1,234,000 1,584,000
Gross margin 2,614,000 3,357,000 5,129,000 6,121,000
Operating expenses:
Research and
development 1,586,000 1,297,000 3,327,000 2,556,000
Marketing 2,651,000 2,036,000 4,928,000 3,952,000
General and
administrative 961,000 897,000 1,791,000 1,540,000
Total operating
expenses 5,198,000 4,230,000 10,046,000 8,048,000
Loss from
operations (2,584,000) (873,000) (4,917,000) (1,927,000)
Interest and
investment income,
net 365,000 284,000 573,000 463,000
Net loss ($2,219,000) ($589,000) ($4,344,000) ($1,464,000)
Basic and diluted
net loss per share ($0.07) ($0.02) ($0.13) ($0.05)
Weighted average
shares used in
computing basic and
diluted net loss
per share amounts 32,289,857 31,442,890 32,266,474 29,599,825
SCICLONE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
ASSETS
June 30, December 31,
2001 2000
(unaudited)
Cash and cash equivalents and short-term
investments $20,202,000 $22,497,000
Accounts receivable, net 7,934,000 8,621,000
Inventory 2,296,000 2,020,000
Other assets 3,672,000 3,029,000
Total assets $34,104,000 $36,167,000
LIABILITIES AND SHAREHOLDERS' EQUITY
Total liabilities $9,588,000 $8,090,000
Total shareholders' equity 24,516,000 28,077,000
Total liabilities and shareholders' equity $34,104,000 $36,167,000<<
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Cheers, Tuck |
