SciClone Pharmaceuticals, Inc. (SCLN) - 500 Beiträge pro Seite

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Profile:SciClone Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of therapeutics to treat life-threatening diseases. The company in-licenses products in the areas of cancer and viral infectious diseases, and develops them for commercialization in the various pharmaceutical markets with a particular focus on China. It sells ZADAXIN (thymalfasin) in China for liver disease, cancer, and the intensive care. ZADAXIN is in late-stage clinical development in Europe for the treatment of malignant melanoma and hepatitis C virus. The company's other product candidates include proprietary in-licensed compound SCV-07, an orally available immune system modulator known to act on the TLR pathway, which has completed phase 1 clinical trial for viral infectious disease; and RP101, a clinical-stage drug development candidate for the treatment of pancreatic cancer. SciClone Pharmaceuticals also holds Chinese marketing rights, from Biocompatibles International plc., for the DC Bead embolizing and chemotherapy releasing device. The company was founded in 1989 and is headquartered in San Mateo, California.

http://www.sciclone.com/

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SciClone Reports Second Quarter 2007 Results
Tuesday August 7, 6:30 am ET


SAN MATEO, CA--(MARKET WIRE)--Aug 7, 2007 -- SciClone Pharmaceuticals, Inc. (NasdaqGM:SCLN - News) today reported results for the second quarter ended June 30, 2007. For the second quarter 2007, product revenues from the sale of ZADAXIN® (thymalfasin), SciClone's lead product, increased by 13% to $8,955,000, compared with revenues of $7,910,000 for the second quarter 2006. For the six months ended June 30, 2007, product revenues increased by 12% to $17,599,000, compared with product revenues of $15,699,000 for the same period of 2006. The increase in product revenues for the second quarter and six months ended June 30, 2007 is primarily attributable to an increase in the quantity of ZADAXIN sold in China, which accounts for over 90% of total ZADAXIN sales.
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"During the second quarter, we continued to grow our sales of ZADAXIN to China, hired key regulatory and business development personnel and further expanded our well established sales organization in China," said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "Broadening our capabilities while adding sales representatives to our strong sales and marketing base are key parts of our strategy to build a leading pharmaceutical business in this rapidly growing market."

Dr. Blobel continued, "We are making significant progress in advancing our product development portfolio for the U.S. and European markets. Most notably we reported that the primary endpoint in a large phase 2 study of thymalfasin for malignant melanoma was achieved and we acquired the U.S. and Canadian rights to RP101, a clinical compound for the treatment of pancreatic cancer. Both of these cancer indications present markets with significant unmet medical needs. Moving forward, we expect to initiate a phase 2 pancreatic cancer clinical trial for RP101 by the fourth quarter of this year. We also will be meeting with the FDA early next quarter to discuss our multinational phase 3 melanoma clinical trial for thymalfasin, which we expect to commence in the first quarter of 2008. In addition, we look forward to analyzing and reporting final results from our European phase 3 hepatitis C clinical trial using thymalfasin in triple therapy in the second half of 2008."

Net loss for the second quarter 2007 totaled $2,657,000, or $0.06 per share, compared with net income of $5,960,000, or $0.13 per share, for the second quarter 2006. For the six months ended June 30, 2007, net loss was $3,281,000, or $0.07 per share, compared with net income of $3,536,000, or $0.08 per share, for the same period of 2006. Net income for the second quarter and six months ended June 30, 2006 included an $8,000,000 settlement received in April 2006; there was no similar income received during the corresponding periods of 2007.

Research and development expenses for the second quarter 2007 totaled $4,712,000, compared with $3,901,000 for the second quarter 2006. For the six months ended June 30, 2007, research and development expenses were $7,135,000, compared with $ 7,730,000 for the same period of 2006.

Cash, cash equivalents and short-term investments totaled $37,481,000 at June 30, 2007, compared with $38,986,000 at March 31, 2007, and $44,091,000 at June 30, 2006.

Financial Guidance for Full Year 2007

For the full year 2007, SciClone is maintaining its current guidance. SciClone maintains its revenue estimate of approximately $35,000,000 to $36,000,000, driven primarily by continued growth in sales of ZADAXIN to China. Also, SciClone is maintaining its estimates for research and development expenses of approximately $19,000,000 for the full year 2007, net loss of approximately $13,000,000, or $0.28 net loss per share, for the full year 2007, and cash, cash equivalents and short-term investments at December 31, 2007 of approximately $26,000,000. Second quarter 2007 highlights included:



-- To further expand SciClone's capabilities in China, SciClone hired
Annie Qi-man Yin as the Head of Regulatory Affairs and Clinical Operations
in China and Asia and Horace Hao Wu as the Head of Marketing and Business
Development in China. Mrs. Yin joined SciClone in July 2007 from Shanghai
Roche Pharmaceuticals Ltd. where she was Medical Manager of the
Medical/Pharma Development Department. Prior to Roche, Mrs. Yin was with
Eli Lilly Asia where she was the Regulatory Affairs Team Leader. Mrs. Yin
has been involved with 23 new product approvals in China over the span of
her career. Mr. Wu will join SciClone in August 2007 and has 13 years of
experience in marketing and sales with Schering-Plough (China), Shanghai
Roche Pharmaceuticals Ltd., and most recently with Eisai China. At Eisai
he was Head of Marketing Division, Shanghai and in charge of business
development to introduce new products and enhance the product portfolio of
Eisai China.

-- In June 2007, SciClone initiated a proof-of-concept phase 2 clinical
trial using its proprietary compound SCV-07 as a sole agent to treat
patients infected with the hepatitis C virus. SciClone expects to report
data in the first quarter of 2008.

-- In June 2007 at the Annual Meeting of the American Society of Clinical
Oncology, SciClone and its European partner Sigma-Tau S.p.A reported that
thymalfasin (ZADAXIN, thymosin alpha 1) achieved its primary endpoint in a
phase 2 clinical trial treating patients diagnosed with stage IV malignant
melanoma. Results showed that thymalfasin in combination with dacarbazine
(DTIC) chemotherapy tripled the overall response rate and extended overall
survival by nearly 3 months compared to patients treated with DTIC, the
current standard of care, and interferon alpha. SciClone plans to initiate
a phase 3 clinical trial in melanoma in the first quarter of 2008.

-- In April 2007, SciClone acquired the exclusive rights in the United
States and Canada to develop and commercialize RP101, a clinical-stage
compound for the treatment of cancer. In a previous phase 1 clinical trial
evaluating RP101 in combination with gemcitabine, the current standard of
care, to treat late-stage pancreatic cancer patients, the median survival
for the RP101 treated group was 9.3 months, compared to the historical
control of approximately 6 months for patients treated with gemcitabine
alone. SciClone expects to initiate a phase 2 pancreatic cancer trial for
RP101 by the fourth quarter of 2007.

Conference Call

SciClone will host a conference call at 10:30 a.m. ET (7:30 a.m. PT) today, Tuesday, August 7, 2007. The call will contain forward-looking statements. Financial and statistical information to be discussed in the conference call will be posted on the Investor Relations section of SciClone's web site at www.sciclone.com prior to the commencement of the conference call.



DATE: Tuesday, August 7, 2007
TIME: 10:30 a.m. ET (7:30 a.m. PT)
WEBCAST: Live call and replay accessible at http://www.sciclone.com
LIVE CALL: 800-289-0533 (U.S./Canada)
913-981-5525 (International)
REPLAY: 888-203-1112 (U.S./Canada)
719-457-0820 (International)
Passcode: 4316600
(Replay available from 1:30 p.m. ET on August 7, 2007
through 12:00 a.m. ET on September 7, 2007)

About SciClone

SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN® is currently being evaluated in late-stage clinical trials for the treatment of malignant melanoma and hepatitis C. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. A key part of SciClone's strategy is to leverage its advantage and broaden its portfolio in the rapidly growing Chinese market by in-licensing or acquiring the marketing rights to other products, such as DC Bead™. For the U.S. market, SciClone's clinical-stage drug development candidates are SCV-07 for the treatment of hepatitis C virus and RP101 for the treatment of pancreatic cancer. 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 and financial results for 2007, and progress and results of our clinical trials. 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, our actual experience in executing on our objectives, the performance of our partners, 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, delays in analyzing and synthesizing data obtained from clinical trials, the performance and future actions of our strategic partners, unexpected delays in clinical trial enrollment, future actions by the U.S. Food and Drug Administration or equivalent regulatory authorities in Europe 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. Further, although our financial guidance is based on our current estimates, factors such as the actual timeline and design of the phase 3 melanoma clinical trial and final decisions regarding expense sharing arrangements for the trial could alter the estimates of our research and development expenses, net loss and year end cash balance for 2007.







SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)


Three months ended Six months ended
June 30, June 30,
2007 2006 2007 2006
=========== =========== =========== ===========

Product sales $ 8,955,000 $ 7,910,000 $17,599,000 $15,699,000
Contract revenue - 54,000 - 144,000
----------- ----------- ----------- -----------

Total revenues 8,955,000 7,964,000 17,599,000 15,843,000
Cost of product sales 1,687,000 1,373,000 3,315,000 2,939,000
----------- ----------- ----------- -----------

Gross margin 7,268,000 6,591,000 14,284,000 12,904,000

Operating expenses:
Research and
development 4,712,000 3,901,000 7,135,000 7,730,000
Sales and marketing 3,139,000 2,843,000 6,163,000 5,675,000
General and
administrative 2,444,000 2,294,000 5,054,000 4,681,000
----------- ----------- ----------- -----------
Total operating
expenses 10,295,000 9,038,000 18,352,000 18,086,000
----------- ----------- ----------- -----------

Loss from operations (3,027,000) (2,447,000) (4,068,000) (5,182,000)

Interest and investment
income 419,000 446,000 873,000 798,000
Interest and investment
expense (10,000) (22,000) (20,000) (63,000)
Other (expense) income,
net (11,000) 7,983,000 (17,000) 7,983,000
----------- ----------- ----------- -----------
(Loss) income before
provision for income
tax (2,629,000) 5,960,000 (3,232,000) 3,536,000
Provision for income tax 28,000 - 49,000 -
----------- ----------- ----------- -----------

Net (loss) income $(2,657,000) $ 5,960,000 $(3,281,000) $ 3,536,000
=========== =========== =========== ===========

(Loss) earnings per share:
Basic net (loss)
income per share $ (0.06) $ 0.13 $ (0.07) $ 0.08
Diluted net (loss)
income per share $ (0.06) $ 0.13 $ (0.07) $ 0.08

Weighted average shares
used in computing:
Basic net (loss)
income per share 46,093,452 45,899,646 46,083,777 45,895,784
Diluted net (loss)
income per share 46,093,452 46,090,981 46,083,777 46,076,921






SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS

ASSETS


June 30, December 31,
2007 2006
============ ============
(unaudited)
Current assets:
Cash and cash equivalents $ 27,385,000 $ 25,615,000
Restricted short-term investments 700,000 698,000
Other short-term investments 9,396,000 16,279,000
Accounts receivable, net of allowance of
$15,000 at June 30, 2007 and $50,000 at
December 31, 2006 13,353,000 13,277,000
Inventories 4,504,000 3,232,000
Prepaid expenses and other current assets 2,332,000 1,640,000
------------ ------------
Total current assets 57,670,000 60,741,000
Property and equipment, net 239,000 297,000
Intangible assets, net 367,000 402,000
Other assets 1,088,000 1,144,000
------------ ------------
Total assets $ 59,364,000 $ 62,584,000
============ ============

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:
Accounts payable $ 1,000,000 $ 963,000
Accrued compensation and employee benefits 1,206,000 1,813,000
Accrued professional fees 995,000 754,000
Other accrued expenses 1,780,000 2,487,000
Accrued clinical trials expense 1,436,000 1,803,000
Deferred revenue 36,000 62,000
------------ ------------
Total current liabilities 6,453,000 7,882,000
Other Long-term liabilities 126,000 68,000
Commitments and contingencies
Stockholders' equity:
Preferred stock; $0.001 par value;
10,000,000 shares authorized; no shares
outstanding in 2007 and 2006 - -
Common stock; $0.001 par value; 75,000,000
shares authorized; 46,114,562 and
46,001,249 shares issued and outstanding at
June 30, 2007 and December 31, 2006,
respectively 46,000 46,000
Additional paid-in capital 214,497,000 213,064,000
Accumulated other comprehensive income 77,000 78,000
Accumulated deficit (161,835,000) (158,554,000)
------------ ------------
Total stockholders' equity 52,785,000 54,634,000
------------ ------------
Total liabilities and stockholders' equity $ 59,364,000 $ 62,584,000
============ ============





SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)


Six months ended
June 30,
2007 2006
============ ============

Operating activities:
Net (loss) income $ (3,281,000) 3,536,000
Adjustments to reconcile net (loss) income to
net cash (used in) provided by operating
activities:
Non cash expense related to employee stock
options 1,158,000 1,231,000
Depreciation and amortization 109,000 118,000
Loss from disposal of property and equipment - 1,000
Changes in operating assets and liabilities:
Accounts receivable, net (76,000) (779,000)
Inventories (1,222,000) 101,000
Prepaid expenses and other assets (636,000) 249,000
Accounts payable and other accrued expenses (670,000) (212,000)
Accrued compensation and employee benefits (607,000) (829,000)
Accrued clinical trials expenses (367,000) (111,000)
Accrued professional fees 241,000 301,000
Deferred revenue (26,000) (150,000)
Long-term liabilities 58,000 (58,000)
------------ ------------
Net cash provided by (used in) operating
activities (5,319,000) 3,398,000
------------ ------------

Investing activities:
Purchases of property and equipment (16,000) (26,000)
Sales (purchases) of short-term investments,
net 6,880,000 (161,000)
------------ ------------
Net cash (used in) provided by investing
activities 6,864,000 (187,000)
------------ ------------

Financing activities:
Proceeds from issuances of common stock 225,000 44,000
Repayment of notes payable - (1,600,000)
------------ ------------
Net cash (used in) provided by financing
activities 225,000 (1,556,000)
------------ ------------

Net increase in cash and cash equivalents 1,770,000 1,655,000
Cash and cash equivalents, beginning of period 25,615,000 25,845,000
------------ ------------
Cash and cash equivalents, end of period $ 27,385,000 $ 27,500,000
============ ============



Contact:
Corporate Contact
Richard Waldron
Executive Vice President and Chief Financial Officer
SciClone Pharmaceuticals, Inc.
650-358-3437



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Source: SciClone Pharmaceuticals, Inc.