SCLN reports, and I'm not impressed. I didn't manage to get filled on my last attempt to write calls on this one, darn it.
>>SAN MATEO, Calif., May 11 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: SCLN - news), today reported total revenues for the quarter ended March 31, 2001 from sales of ZADAXIN®, the Company's immune system enhancer, were $3,113,000 compared to $3,499,000 for the same quarter last year. Net loss for the quarter was $2,125,000, or $.07 per share compared to a net loss of $875,000, or $.03 per share for the same quarter of 2000. SciClone's cash and short-term investments totaled $21,057,000 at March 31, 2001.
The 11 percent decrease in total revenues for the first quarter of 2001 compared to the same quarter last year was primarily due to lower sales to importing agents in the People's Republic of China who supply the Company's distributors in China with ZADAXIN and to increased competition from other hepatitis B therapies. Research and development expenses in the first quarter of 2001 were $1,741,000, a 38% increase over this expense for the first quarter in 2000. As the Company continues to focus on expanding its clinical programs, research and development expenses are expected to rise to higher levels in the remaining quarters of 2001 and through 2002. In addition to the U.S. hepatitis C phase 3 clinical program for ZADAXIN, SciClone is conducting a U.S. phase 2 liver cancer clinical program for ZADAXIN and a U.S. cystic fibrosis clinical program for the Company's proprietary protein repair therapy, CPX.
``SciClone achieved two major clinical milestones in the first quarter. We initiated our phase 3 hepatitis C clinical program in the United States and we started the CPX program with its new liquid formulation a quarter ahead of plan. As the Company pursues U.S. Food and Drug Administration approval for ZADAXIN and a share of the multi-billion dollar market for hepatitis C in the United States, Europe and Japan, ZADAXIN sales in the developing world continue to be strong,'' said Donald Sellers, SciClone's President and Chief Executive Officer. ``ZADAXIN sales in emerging markets continue to provide incremental value to SciClone and, together with our strengthened financial resources, provide essentially all of the planned required funding for the ZADAXIN U.S. clinical programs.''
In 2000, the Company added a third importing agent located in the Shanghai area to facilitate the distribution of ZADAXIN in central China. No sales were made to this agent in the fourth quarter of 2000 or in the quarter ended March 31, 2001. The Company will recognize the revenue for any future sales to this importing agent at the time such importing agent sells the product to the distributors. This change will better reflect the timing and the volume of market consumption of ZADAXIN moving through this importing agent. We expect that sales in the current quarter ending June 30, 2001 to be lower than they otherwise would be as some or all of the shipments to this importing agent in the second quarter may not be recognized as revenue until subsequent quarters. This change will not affect the growth of the importing agents' in-market sales of ZADAXIN or cash flow from operations in the quarter and will tend to reduce the length of accounts receivables in future quarters. Management expects to focus the Company's financial resources on supporting clinical trials in the United States.
First Quarter 2001 Highlights
-- Started pivotal U.S. phase 3 hepatitis C program with ZADAXIN in
combination with Pegasys®, pegylated interferon alfa-2a (being
supplied for the clinical trials by F. Hoffman La-Roche, Ltd. at no
cost to SciClone), to target the largest group of hepatitis C patients
in the United States who are non-responders to the current standard
therapy (alpha interferon or alpha interferon plus ribavirin).
-- Initiated U.S. phase 2 liver cancer trial with ZADAXIN plus radio
frequency ablation (RFA) to evaluate whether a ZADAXIN-enhanced immune
response may contribute to the effectiveness of tumor therapy with RFA.
-- Publication in the International Journal of Immunopharmacology
discussed ZADAXIN's ability to increase anti-tumor effects, while
markedly reducing the toxicity of chemotherapy, in treating melanoma,
colorectal cancer, and non-small cell lung cancer.
-- Received ZADAXIN marketing approval in India for hepatitis B.
ZADAXIN, 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, has been administered to over 3,000 subjects in over 70 clinical trials covering a broad range of diseases and to several 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 as a vaccine adjuvant for patients with weakened immune systems. ZADAXIN is currently in a phase 3 program in the U.S. in combination with Pegasys®, pegylated interferon alfa-2a, for the treatment of hepatitis C, in a phase 2 program in combination with lamivudine for the treatment of hepatitis B and in a phase 2 trial for the treatment of liver cancer. In Europe, a phase 3 ZADAXIN program will be undertaken which would complement the Company's U.S. clinical program. ZADAXIN is also in clinical trials in Japan and Australia.
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.<<
statements and safe harbor boilerplate snipped
Cheers, Tuck |
