Here's something else to complain about:
>>SAN MATEO, Calif., Nov. 8 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: SCLN - news), today reported that total revenues for the quarter ended September 30, 2001 from sales of ZADAXIN®, the Company's immune system enhancer, were $3,580,000 compared to $4,675,000 for the same quarter last year. Net loss for the quarter was $173,000, or $0.01 per share, compared to a net loss of $137,000, or $0.00 per share, for the same quarter of 2000. In the quarter ended September 30, 2001, SciClone received a lump sum net payment of $3,205,000 in full satisfaction of a promissory note that had been previously written off in a non-cash charge to earnings in the fourth quarter of 1998.
``In the third quarter of 2000, a new customer in China, an importing agent for our distributors, placed a large order for ZADAXIN which has been used to help supply the growing demand for ZADAXIN in China over the past several quarters,'' said Richard A. Waldron, SciClone's Chief Financial Officer. Total ZADAXIN sales from our importing agents in China to the ZADAXIN distributors in China increased over 45 percent in the third quarter of 2001 compared to the same quarter in 2000. Mr. Waldron added, ``Research and development expenses for the quarter ended September 30, 2001, were $3,390,000 compared to $1,340,000 for the previous year's third quarter. The increase in research and development expenses is primarily attributable to increases in clinical trial program expenses.''
``Our U.S. phase 3 clinical program for ZADAXIN as a treatment for hepatitis C is well underway,'' said Eduardo Martins, M.D., Ph. D., SciClone's Medical Director. ``Site selection and investigator organizational meetings for our two phase 3 trials have been completed with leading hepatitis clinical investigators on board. The clinical research organization (CRO) has been engaged, investigational review board (IRB) approvals are being completed and patients are being screened for eligibility. We expect to begin patient enrollment in early 2002 and treatment and follow-up to be nearly completed by the end of 2003.''
ZADAXIN, to SciClone's knowledge, is the only new therapy in development for hepatitis C that is entering a phase 3 program. SciClone planned and timed its phase 3 program so that ZADAXIN could be used in combination with the new pegylated form of alpha interferon, the most recent entry in the fight against the hepatitis C virus. Pegasys® brand of pegylated interferon for the entire phase 3 program is being provided at no cost to SciClone by F. Hoffmann La-Roche in exchange for access to clinical data. This significant savings and contributions from its European partner Sigma-Tau allowed SciClone to double the size of its U.S. phase 3 trials from one 500 patient study to two 500 patient studies, for a total of 1000 patients, creating a much stronger statistical and regulatory position at the conclusion of the trials. The ZADAXIN plus Pegasys trial program will treat the most difficult hepatitis C patients, those that have not responded to therapy with the combination of interferon plus ribavirin or to interferon alone. This non-responder patient population today is over 200,000 patients and SciClone estimates that this target population will comprise some 500,000 identifiable U.S. patients by 2005.
In the third quarter of 2001, SciClone announced two major developments in Japan related to ZADAXIN. Enrollment was completed with 319 patients entered into the ZADAXIN phase 3 monotherapy hepatitis B trial. Over two-thirds of the patients in this phase 3 trial have already completed the six month therapy and 12 month follow-up evaluation period. The final patients are now undergoing therapy to be followed by the evaluation period. Second, the Japanese patent office allowed patent protection covering the use of ZADAXIN for the treatment of hepatitis C. The new patent, which extends through 2012, also covers the use of ZADAXIN in combination with alpha interferons for the treatment of hepatitis C in Japan, the world's second largest pharmaceutical market. SciClone previously was granted a Japanese patent for the use of ZADAXIN in the treatment of hepatitis B. Additional progress is being made in other significant international markets. In Mexico, ZADAXIN is being considered for inclusion on the national formulary after which social security reimbursement can be requested. In India, where ZADAXIN was recently approved, SciClone expects the drug to be classified as a life saving medicine during 2002 which would eliminate significant import duty barriers and open the way to greater sales.
SciClone ended the third quarter of 2001 with approximately $19.1 million in cash, cash equivalents, and short-term investments. On November 6, 2001, we filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission. SciClone has no plans at this time to issue securities pursuant to such registration statement.
ZADAXIN is a pure 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 patients in clinical trials covering a broad range of diseases and to many thousands of patients commercially around the world. In all of this experience ZADAXIN, to the Company's knowledge, has not produced any serious, adverse side effects. ZADAXIN is approved for sale in 25 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.
SciClone is a specialty drug company founded to commercialize pharmaceutical or biological therapeutic compounds that are in-licensed at the stage of late pre-clinical or early clinical development. SciClone's primary current goal, based on the broad therapeutic promise of our lead drug ZADAXIN, is to become the preeminent provider of immune system enhancers, or ISEs, as critical components of combination drug therapies for infectious diseases and cancer. Other drugs in our pipeline are intended to protect and expand this franchise, and to address the protein-based disorder that causes 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.
SciClone management will host a conference call to discuss third quarter financial performance at 1:00 p.m. Pacific Standard Time (4:00 p.m. Eastern Standard Time) today, Thursday, November 8, 2001. Please call 1-800-450-0821 and refer to SciClone when your call is answered by the operator.
The information in this press release includes certain forward-looking statements including statements using the words ``expects,'' ``promise'' or similar words. These statements include statements regarding the timing of patient enrollment and completion of the ZADAXIN phase 3 trials, and other 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 Nine Months Nine Months
Ended Ended Ended Ended
Sept 30, Sept 30, Sept 30, Sept 30,
2001 2000 2001 2000
Product sales $3,580,000 $4,675,000 $9,943,000 $12,380,000
Cost of product sales 714,000 914,000 1,948,000 2,497,000
Gross margin 2,866,000 3,761,000 7,995,000 9,883,000
Operating expenses:
Research and
development 3,390,000 1,340,000 6,717,000 3,896,000
Marketing 2,256,000 2,204,000 7,184,000 6,156,000
General and
administrative 749,000 659,000 2,532,000 2,199,000
Total operating expenses 6,395,000 4,203,000 16,433,000 12,251,000
Loss from operations (3,529,000) (442,000) (8,438,000) (2,368,000)
Other income 3,205,000 0 3,497,000 0
Interest and investment
income, net 151,000 305,000 424,000 768,000
Net loss ($173,000) ($137,000) ($4,517,000) ($1,600,000)
Basic and diluted net
loss per share ($0.01) ($0.00) ($0.14) ($0.05)
Weighted average shares
used in computing
basic and diluted net
loss per share amounts 32,429,345 31,685,177 32,272,682 29,766,480
SCICLONE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, December 31,
2001 2000
(unaudited)
ASSETS
Cash and cash equivalents and
short-term investments $19,096,000 $22,497,000
Accounts receivable, net 9,227,000 8,621,000
Inventory 2,595,000 2,020,000
Other assets 3,033,000 3,029,000
Total assets $33,951,000 $36,167,000
LIABILITIES AND SHAREHOLDERS' EQUITY
Total liabilities $9,528,000 $8,090,000
Total shareholders' equity 24,423,000 28,077,000
Total liabilities and
shareholders' equity $33,951,000 $36,167,000<<
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Cheers, Tuck |
