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Biotech: Sciclone (SCLN)

4.12.03

Sciclone (SCLN) is a biotech company that has a promising Hepatitis B and C treatment, Zadaxin, that is in Phase II and III trials around the world. In the United States, the drug is in a phase 3 Hepatitis C clinical trials and two phase 2 liver cancer clinical trials. In Japan, the company just completed a phase 3 Hepatitis B clinical trial using Zadaxin as a monotherapy and expects to report data during the second quarter of 2003. The same drug is undergoing a phase 2 malignant melanoma trial in Europe.

The company was profitable at one point nearly two years ago, thanks to growing sales of Zadaxin around the world (especially China). However, continued research costs mean that the company now operates at a loss that is offset from profits generated by Zadaxin sales. Zadaxin has already been approved for sale in over 30 countries and is being marketed in some of those countries.

Zadaxin is a pure synthetic preparation of thymosin alpha 1

Financials (as of 12.31.02)

Revenues 4Q2002:
Sales of Zadaxin: record $4,807,000 vs $3,888,000 during FY2001
Gross profit margin was 80% in 2002, 2001 and 2000.
For FY2002, importing agents in China accounted for 88% of sales

Revenues for FY2002:
Sales of ZADAXIN: record $17,101,000, a 24% increase over the $13,831,000 reported for FY 2001.
Total revenue for FY2002:$17,772,000 (up 28.5% compared to FY2001)

Net loss 4Q2002: $2,617,000, or $0.07 per share
Net loss 4Q2001: $1,715,000, or $0.05 per share.
Most of the difference was attributable to an increase in research and development expenses to support ZADAXIN's U.S. phase 3 hepatitis C clinical trials.

net loss FY2002: $10,037,000, or $0.29 per share
net loss FY 2001: $6,232,000, or $0.19 per share

Cash and short-term investments $21,151,000 . The company has total contractual cash obligations of $12,252,000 of which $1,367,000 is due within the next year.

Recent developments

April 9, 2003 - Sciclone release results of a study showing a 71% long-term sustained response rate for difficult to treat hepatitis B patients. These results Zadaxin and interferon alpha. This sustained response rate compares extremely favorably to 20% of patients using interferon alpha in combination with lamivudine and 10% of patients using interferon alpha alone. In the study, 74% (20/27) of patients receiving 26 weeks of ZADAXIN in combination with interferon followed by 26 weeks of interferon monotherapy (a total of 52 weeks of therapy) showed a sustained response at 6 months post-treatment. 71% (19/27) of these patients showed a sustained response at 18 months post-treatment.

By comparison, 53% (8/15) of patients receiving 52 weeks of interferon in combination therapy with lamivudine followed by continuous lamivudine monotherapy showed a sustained response at 6 months post-treatment but only 20% (3/15) at 18 months post-treatment. 40% (4/10) of patients receiving 52 weeks of interferon monotherapy showed a sustained response at 6 months post-treatment but only 10% (1/10) at 18 months post-treatment.

January 23, 2003 - Sigma Tau and its affiliates purchased nearly 10% of SciClone's common stock outstanding. 505,000 shares were purchased at $3.5648 for a price of $1.8 million. The stock price has nearly doubled since that purchase. The company and its affiliates now own 3.7 million shares. Sigma-Tau is SciClone's marketing and development partner for Zadaxin in the European Union and will have access to the data from SciClone's U.S. phase 3 hepatitis C clinical trials for European regulatory filing purposes. Sigma-Tau also is funding and conducting in Europe a large phase 2 ZADAXIN clinical trial for the treatment of malignant melanoma.

We continue to be bullish on Sciclone (SCLN), but the recent runup may temper near term gains. Outlook for the company long term continues to be good. We have been bullish on the company since June 2002, when the stock dropped below $2.50.

 

 


 

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