-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Gao8Ei+cGJ3lpcJ7mU5+iSV9agc2O08S+SPs3Ilw2IONsq3AjWxfrvQXocUkhU91 q194xgmPSlyFrYByRe53aw== 0001157523-04-010139.txt : 20041101 0001157523-04-010139.hdr.sgml : 20041101 20041101064118 ACCESSION NUMBER: 0001157523-04-010139 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20041101 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041101 DATE AS OF CHANGE: 20041101 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SCICLONE PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000880771 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943116852 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19825 FILM NUMBER: 041108125 BUSINESS ADDRESS: STREET 1: 901 MARINER'S ISLAND BLVD. STREET 2: SUITE 205 CITY: SAN MATEO STATE: CA ZIP: 94404 BUSINESS PHONE: 650-358-3456 MAIL ADDRESS: STREET 1: 901 MARINER'S ISLAND BLVD. STREET 2: SUITE 205 CITY: SAN MATEO STATE: CA ZIP: 94404 8-K 1 a4754116.txt SCICLONE PHARMACEUTICALS 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 1, 2004 SCICLONE PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 0-19825 94-3116852 (State or other jurisdiction of (Commission (I.R.S. Employer) incorporation) File Number) Identification No.) 901 Mariner's Island Blvd., Suite 205 San Mateo, California 94404 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (650) 358-3456 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): |_| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |_| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |_| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Item 2.02. Results of Operations and Financial Condition. On November 1, 2004, SciClone Pharmaceuticals, Inc. (the "Company") issued a press release announcing its financial results for the third quarter and nine months ended September 30, 2004. A copy of the Company's press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. Item 9.01. Financial Statements and Exhibits. (c) Exhibits. Exhibit Description ------------------- 99.1 Press Release issued by SciClone Pharmaceuticals, Inc., dated November 1, 2004, announcing financial results for the third quarter and nine months ended September 30, 2004. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. SCICLONE PHARMACEUTICALS, INC. Dated: November 1, 2004 By: /s/ Richard A. Waldron ---------------------- Richard A. Waldron Chief Financial Officer EX-99.1 2 a4754116ex991.txt PRESS RELEASE EXHIBIT 99.1 SciClone Reports Third Quarter Results SAN MATEO, Calif.--(BUSINESS WIRE)--Nov. 1, 2004--SciClone Pharmaceuticals, Inc. (Nasdaq:SCLN) today reported results for the third quarter and nine months ended September 30, 2004. Revenues from sales of ZADAXIN(R), SciClone's lead product candidate, were $5,753,000 for the third quarter and $16,780,000 for the nine months ended September 30, 2004. Net loss for the third quarter 2004 was $4,913,000, or $0.11 per share, and for the nine months ended September 30, 2004 the net loss was $10,923,000, or $0.24 per share. In addition, SciClone reported $134,000 in contract revenue for the third quarter of 2004 and $1,497,000 for the nine months ended September 30, 2004, which includes a $1,000,000 milestone payment received from Sigma-Tau during the second quarter 2004. Contract revenue was $224,000 for the third quarter of 2003 and $672,000 for the nine months ended September 30, 2003. In comparison, revenues for the third quarter of 2003 were $5,421,000 and $26,628,000 for the nine months ended September 30, 2003. The revenues for the nine months ended September 30, 2003 included approximately $11,000,000 due to the unanticipated temporary increase in sales of ZADAXIN in response to the now abated SARS epidemic in China. Net loss for the third quarter 2003 was $2,850,000, or $0.07 per share, and net loss for the nine months ended September 30, 2003 was $588,000, or $0.02 per share. Research and development expenses were $4,858,000 for the third quarter 2004, compared to $4,585,000 for the third quarter 2003. Research and development expenses for the nine months ended September 30, 2004 totaled $13,552,000, compared to $12,676,000 incurred in the nine months ended September 30, 2003. General and administrative expenses for the third quarter 2004 were $2,573,000, compared to $998,000 for the third quarter 2003. General and administrative expenses for the nine months ended September 30, 2004 were $5,022,000, compared to $3,045,000 incurred in the nine months ended September 30, 2003. The increase in general and administrative expenses is attributable to a one-time expense incurred in connection with the separation of the former Chief Executive Officer from the Company in July 2004. Cash, cash equivalents and short-term investments totaled $52,986,000 at September 30, 2004, compared to $54,970,000 at June 30, 2004 and $66,256,000 at September 30, 2003. "We remain focused on our primary objective of developing ZADAXIN for the treatment of hepatitis C in the major pharmaceutical markets," commented Richard A. Waldron, SciClone's Chief Financial Officer. "In addition, we are advancing the development of pegylated ZADAXIN and our proprietary drug candidate SCV-07, a potential therapeutic to treat viral and other infectious diseases." Alfred Rudolph, M.D., SciClone's Chief Operating Officer, added, "Our U.S. phase 3 hepatitis C clinical trials are ongoing and on target to be completed by the end of next year. We continue to make progress with our other clinical development programs with a ZADAXIN triple therapy hepatitis C trial planned by our European partner Sigma-Tau and preclinical studies to support an IND filing in the United States during the first half of 2005 for SCV-07." Financial outlook For the fiscal year 2004, SciClone is refining its guidance for certain financial items. SciClone's estimate for net sales of ZADAXIN remains unchanged and is expected to be slightly greater than $22 million. Research and development expenses for the year are now anticipated to be between $19 and $20 million, instead of the previous estimate of between $19 and $21 million. Net loss for 2004 is now expected to be between $15 and $16 million, lower than the previous estimate of between $15 and $17 million. Accordingly, net loss per share for 2004 is now expected to be between $0.35 and $0.37 per share, lower than the previous estimate of between $0.35 and $0.39 per share. SciClone's guidance for cash, cash equivalents and short-term investments at December 31, 2004 remains unchanged at between $45 and $47 million. Recent Announcements -- SciClone today reported that ZADAXIN in a triple therapy, single-arm pilot trial in Mexico produced a sustained virologic response at week 72 (SVR) in 19% of difficult to treat hepatitis C patients, those who are non-responders infected with the genotype 1 strain of the virus. These results are more than twice the 9% SVR from a separate, unrelated trial treating genotype 1 non-responder patients with pegylated interferon and a similar dose and ribavirin but without ZADAXIN. Although this was a small, uncontrolled pilot trial and reliable conclusions cannot be drawn from comparisons of results of different studies, SciClone is encouraged by the results. -- SciClone today announced the appointment of Richard J. Hawkins to the company's Board of Directors as a non-executive member. Mr. Hawkins is a highly experienced executive with over 30 years of experience in the pharmaceutical industry. Conference Call SciClone management will host a live audio webcast and conference call at 11:30 a.m. EST (8:30 a.m. PST) today, Monday, November 1, 2004. The conference call will include forward-looking statements. Financial information to be discussed in the conference call will be posted on the investor relations section of SciClone's website at http://www.sciclone.com prior to the commencement of the conference call. To participate in the conference call, please log on at http://www.sciclone.com or call 800-659-1942 (U.S. and Canada) or 617-614-2710 (International) and enter passcode 82758172. A replay of the conference call will be available for two weeks beginning at 1:30 p.m. EST today, Monday, November 1, 2004. To access the replay, log on to http://www.sciclone.com or call 888-286-8010 (U.S. and Canada) or 617-801-6888 (International) and enter passcode 76742003. About SciClone SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN(R) is currently being evaluated in two phase 3 hepatitis C clinical trials in the United States. ZADAXIN is also being evaluated in other late-stage clinical trials for the treatment of hepatitis B and certain cancers. The company's other principal drug development candidate is SCV-07, which is currently being evaluated in pre-clinical studies for the treatment of viral and other infectious disease. 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 of our products, future financial results, research and development expense levels, asset levels, timing of filing of our Japanese New Drug Application, expectations regarding both of our phase 3 hepatitis C clinical trials, and the fact that the experimental or clinical data described may imply certain actual results in human clinical trials or in larger patient populations. 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, the statistical significance of data obtained from clinical trials, the fact that results from small studies may not be predictive of results from larger studies, 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, unexpected delays in preparation of the Japanese New Drug Application, delays in analyzing and synthesizing data obtained from clinical trials, future actions of our strategic partners, unexpected delays in preparation for enrollment, future actions by the U.S. Food and Drug Administration or equivalent regulatory authorities in Europe and Japan 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. SCICLONE PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Three months ended Nine months ended September 30, September 30, 2004 2003 2004 2003 ------------ ------------ ------------- ------------ Product sales $5,753,000 $5,421,000 $16,780,000 $26,628,000 Contract revenue 134,000 224,000 1,497,000 672,000 ------------ ------------ ------------- ------------ Total revenue 5,887,000 5,645,000 18,277,000 27,300,000 Cost of product sales 1,109,000 935,000 3,429,000 4,882,000 ------------ ------------ ------------- ------------ Gross margin 4,778,000 4,710,000 14,848,000 22,418,000 Operating expenses: Research and development 4,858,000 4,585,000 13,552,000 12,676,000 Sales and marketing 2,317,000 1,892,000 7,290,000 7,146,000 General and administrative 2,573,000 998,000 5,022,000 3,045,000 ------------ ------------ ------------- ------------ Total operating expenses 9,748,000 7,475,000 25,864,000 22,867,000 ------------ ------------ ------------- ------------ Loss from operations (4,970,000) (2,765,000) (11,016,000) (449,000) Interest and investment income 156,000 47,000 384,000 143,000 Interest and investment expense (90,000) (90,000) (271,000) (271,000) Other income (expense), net (9,000) (42,000) (20,000) (11,000) ------------ ------------ ------------- ------------ Net loss $(4,913,000) $(2,850,000) $(10,923,000) $(588,000) ============ ============ ============= ============ Basic and diluted net loss per share ($0.11) ($0.07) ($0.24) ($0.02) ============ ============ ============= ============ Weighted average shares used in computing basic and diluted net loss per share 44,651,084 38,768,350 44,610,958 37,925,757 ============ ============ ============= ============ SCICLONE PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS ASSETS Sept. 30, Dec. 31, 2004 2003 ------------- ------------- (unaudited) Current assets: Cash and cash equivalents $42,791,000 $52,899,000 Restricted short-term investments 695,000 695,000 Other short-term investments 9,500,000 9,381,000 Accounts receivable, net of allowance of $591,000 in 2004 and $638,000 in 2003 10,189,000 10,142,000 Inventories 4,336,000 5,778,000 Prepaid expenses and other current assets 712,000 2,456,000 ------------- ------------- Total current assets 68,223,000 81,351,000 Property and equipment, net 405,000 325,000 Intangible assets, net 560,000 612,000 Other assets 1,538,000 1,534,000 ------------- ------------- Total assets $70,726,000 $83,822,000 ============= ============= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $1,469,000 $3,423,000 Accrued compensation and employee benefits 1,716,000 1,440,000 Accrued clinical trials expense 1,000,000 1,889,000 Accrued professional fees 497,000 481,000 Deferred revenue 537,000 537,000 Other accrued expenses 968,000 631,000 ------------- ------------- Total current liabilities 6,187,000 8,401,000 Deferred revenue 269,000 671,000 Other long-term liabilities 1,044,000 900,000 Convertible notes payable 5,600,000 5,600,000 Commitments and contingencies Stockholders' equity: Preferred stock; $0.001 par value; 10,000,000 shares authorized; no shares outstanding in 2004 and 2003, respectively - - - - - - Common stock; $0.001 par value; 75,000,000 shares authorized; 44,662,744 and 44,484,144 shares issued and outstanding 45,000 44,000 Additional paid-in capital 206,555,000 206,320,000 Accumulated other comprehensive income 239,000 176,000 Accumulated deficit (149,213,000) (138,290,000) ------------- ------------- Total stockholders' equity 57,626,000 68,250,000 ------------- ------------- Total liabilities and stockholders' equity $70,726,000 $83,822,000 ============= ============= SCICLONE PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) Nine months ended September 30, 2004 2003 ------------- ------------ Operating activities: Net loss $(10,923,000) $(588,000) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 157,000 134,000 Changes in operating assets and liabilities: Accounts receivable, net (47,000) (2,500,000) Inventories 1,442,000 (725,000) Prepaid expenses and other assets 1,721,000 (468,000) Accounts payable and other accrued expenses (1,617,000) 544,000 Accrued compensation and employee benefits 276,000 (81,000) Accrued clinical trials expense (889,000) (286,000) Accrued professional fees 16,000 (126,000) Deferred revenue (402,000) (671,000) Long-term liabilities 144,000 - - - ------------- ------------ Net cash used in operating activities (10,122,000) (4,767,000) ------------- ------------ Investing activities: Purchase of property and equipment (166,000) (46,000) Payment on purchase of marketable securities (56,000) (11,000) ------------- ------------ Net cash used in investing activities (222,000) (57,000) ------------- ------------ Financing activities: Proceeds from issuance of common stock, net of financing costs 236,000 49,860,000 ------------- ------------ Net cash provided by financing activities 236,000 49,860,000 ------------- ------------ Net (decrease) increase in cash and cash equivalents (10,108,000) 45,036,000 Cash and cash equivalents, beginning of period 52,899,000 20,233,000 ------------- ------------ Cash and cash equivalents, end of period $42,791,000 $65,269,000 ============= ============ CONTACT: SciClone Pharmaceuticals, Inc. Richard A. Waldron, 650-358-3437 -----END PRIVACY-ENHANCED MESSAGE-----