-----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, RFFwuRh2lf5268qMANkvKOAzHRy44U2/RhtZeHwxbDChVhouF+3DNG8Imgebyasw X91zpSJ/nweDCnmrm4k2Nw== 0001193125-09-043631.txt : 20090303 0001193125-09-043631.hdr.sgml : 20090303 20090303160621 ACCESSION NUMBER: 0001193125-09-043631 CONFORMED SUBMISSION TYPE: DEFA14A PUBLIC DOCUMENT COUNT: 3 FILED AS OF DATE: 20090303 DATE AS OF CHANGE: 20090303 EFFECTIVENESS DATE: 20090303 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: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: DEFA14A SEC ACT: 1934 Act SEC FILE NUMBER: 000-19825 FILM NUMBER: 09651723 BUSINESS ADDRESS: STREET 1: 950 TOWER LANE STREET 2: SUITE 900 CITY: FOSTER CITY STATE: CA ZIP: 94404-2125 BUSINESS PHONE: 650-358-3456 MAIL ADDRESS: STREET 1: 950 TOWER LANE STREET 2: SUITE 900 CITY: FOSTER CITY STATE: CA ZIP: 94404-2125 DEFA14A 1 d8k.htm FORM 8-K Form 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: March 3, 2009

(Date of earliest event reported)

SciClone Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   0-19825   94-3116852

(State or other jurisdiction

of incorporation)

 

(Commission File

Number)

 

(IRS Employer

Identification Number)

950 Tower Lane, Suite 900, Foster

City, CA

    94404
(Address of principal executive offices)     (Zip Code)

(650) 358-3456

(Registrant’s telephone number, including area code)

Not Applicable

(Former Name or Former Address, if changed since last report)

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:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

x 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 March 3, 2009, SciClone Pharmaceuticals, Inc. (“SciClone”) issued a press release announcing, among other things, audited financial results for the fourth quarter and year ended December 31, 2008. The press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein in its entirety.

 

Item 8.01. Other Events.

The press release attached hereto as Exhibit 99.1 to this Current Report is incorporated by reference into Item 8.01 of this Current Report as it may be deemed to include solicitation materials under Rule 14A of the Securities Exchange Act of 1934, as amended.

The information in Item 2.02 and Item 8.01 of this Current Report, including Exhibit 99.1 to this Current Report, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in Item 2.02 and Item 8.01 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document filed by SciClone with the Securities and Exchange Commission, whether made before or after the date of this Current Report, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference to Item 2.02 and Item 8.01 and the accompanying Exhibit 99.1 in such filing.

Forward-Looking Statements.

The exhibits to this Current Report contain forward-looking statements regarding the business, products and financial results of SciClone Pharmaceuticals, Inc., including statements regarding our guidance for 2009 and other expectations for 2009. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These risks and uncertainties include changes to SciClone’s final fiscal year 2008 results that may result in the course of completion of SciClone’s audit, developments with respect to SciClone’s products as well as the outcome of the director nomination notice received by SciClone in December 2008 from a company controlled by Sigma-Tau Finanziaria S.p.A. Please also refer to other risks and uncertainties described in SciClone’s filings with the Securities and Exchange Commission. All forward-looking statements are based on information currently available to SciClone and SciClone assumes no obligation to update any such forward-looking statements.

Important Information/ Solicitation Participants Legend.

SciClone Pharmaceuticals, Inc. will file a proxy statement in connection with its 2009 annual meeting of stockholders and advises its stockholders to read that proxy statement when it becomes available because it will contain important information. Stockholders will be able to obtain a free copy of that proxy statement and other documents (when available) that SciClone files with the Securities and Exchange Commission at the Commission’s website at www.sec.gov. That proxy statement and these other documents will also be available free of charge by directing a request to SciClone Pharmaceuticals, Inc., Attn: Investor Relations, 950 Tower Lane, Suite 900, Foster City, CA 94404, or from SciClone at www.sciclone.com.

SciClone, its directors and named executive officers may be deemed to be participants in the solicitation of proxies from the SciClone stockholders in connection with the 2009 annual meeting. Stockholders may obtain information regarding the names, affiliations and interests of such individuals in SciClone’s proxy statement filed on May 5, 2008 for the 2008 annual meeting of stockholders. To the extent that holdings of SciClone securities on the part of those individuals have changed since the date of that proxy statement, those changes have been reflected on Statements of Changes in Ownership on Forms 3 or 4 filed with the Securities and Exchange Commission. More current information regarding the interests of the directors and named executive officers of SciClone will be contained in the proxy statement referred to in the preceding paragraph.


Item 9.01. Financial Statements and Exhibits

(d) Exhibits

 

Exhibit 99.1    Press release dated March 3, 2009.


SIGNATURE

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.

 

Dated: March 3, 2009     SCICLONE PHARMACEUTICALS, INC.
    By:   /S/ FRIEDHELM BLOBEL
      Friedhelm Blobel
      President and Chief Executive Officer


Exhibit Index

 

Exhibit No.

  

Description

99.1    Press release dated March 3, 2009.
EX-99.1 2 dex991.htm PRESS RELEASE DATED MARCH 3, 2009 Press release dated March 3, 2009

Exhibit 99.1

LOGO

 

SciClone Pharmaceuticals Contacts:    
Gary Titus     Ana Kapor
650.358.3456     650.358.3437
gtitus@sciclone.com     investorrelations@sciclone.com

SCICLONE REPORTS FINANCIAL RESULTS FOR THE

FOURTH QUARTER AND YEAR-END 2008

FOSTER CITY, CA – March 3, 2009 – SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today reported results for the fourth quarter and year ended December 31, 2008. The fourth quarter 2008 revenues grew 53% to $15,317,000 over the same period last year, and net loss declined to $3,143,000 or $0.07 per share on a basic and diluted basis, compared with a net loss of $3,612,000 or $0.08 per share in the fourth quarter of 2007.

“SciClone today is a profit-driven company, committed to maximizing the international sales of our lead commercial product, ZADAXIN®, expanding our commercial operations with a planned new product introduction and advancing our oncology and infectious disease product portfolio,” said Friedhelm Blobel, Ph.D., SciClone’s President and Chief Executive Officer. “We believe our strategy of expanding existing sales and building brand identity in key emerging markets, introducing revenue-generating products such as DC Bead TM in China while evaluating additional pipeline expansion possibilities and practicing fiscal discipline, will enable us to realize our goal of continuing revenue growth and achieving sustainable profitability. We believe that 2008 was a transformative year in our Company’s history and we look forward to 2009 as another year of strong value creation.”

Financial Results

For the fourth quarter 2008, product revenues from the sale of ZADAXIN increased by 53% resulting in total revenue of $15,317,000, compared with revenues of $10,018,000 for the fourth quarter 2007. For the year ended December 31, 2008, product revenues increased by 46% to $54,108,000, compared with product revenues of $37,038,000 for the same period of 2007. The increase in product revenues for the fourth quarter and year ended December 31, 2008 was primarily attributable to an increase in the quantity of ZADAXIN sold, mainly to China and now also in Russia.

Research and development expenses for the fourth quarter 2008 totaled $6,747,000, compared with $5,518,000 for the fourth quarter 2007. For the year ended December 31, 2008, research and development expenses were $23,537,000, compared with $17,446,000 for the same period of 2007. The increase in R&D expenses relates to our ongoing phase 2 clinical trial of RP101 for metastatic pancreatic cancer, the accrual of clinical trial expenses for a payment to be made to our development partner Sigma-Tau, and the initiation of phase 2 clinical trials of SCV-07 for two indications, severe oral mucositis and chronic Hepatitis C.

Sales and marketing expenses for the fourth quarter of 2008 were $4,997,000, compared with $3,960,000 for the fourth quarter of 2007. For the year ended December 31, 2008, sales and marketing expenses were $17,325,000, compared with $13,928,000 for the same period of 2007. The increase in sales and marketing expenses in 2008 was primarily due to increases in personnel and promotional activities related to our expanding sales and marketing efforts for our lead product, ZADAXIN, including those activities in both China and Russia.


General and administrative expenses for the fourth quarter of 2008 were $3,572,000, compared with $2,597,000 for the fourth quarter of 2007. For the year ended December 31, 2008, general and administrative expenses were $11,858,000, compared with $10,245,000 for the same period of 2007. The increase is primarily due to increased professional fees and compensation related expenses.

Net loss for the fourth quarter 2008 totaled $3,143,000, or $0.07 per share, compared with $3,612,000, or $0.08 per share, for the fourth quarter 2007. For the year ended December 31, 2008, net loss was $8,348,000, or $0.18 per share, compared with net loss of $9,948,000, or $0.22 per share, for the same period of 2007. The fourth quarter and the full year 2008 expenses include $429,000 and $1,843,000 of non-cash stock-based compensation charges.

Cash and cash equivalents totaled $27,673,000 at December 31, 2008, compared with $31,817,000 at December 31, 2007 and $24,162,000 at September 30, 2008. In addition, the Company had long-term investments of $1,485,000 at December 31, 2008. SciClone’s operating subsidiaries also have a $6 million bank line provided by Silicon Valley Bank, which may be used to provide additional working capital to support the company’s growth.

Financial Outlook for 2009

As announced in the SciClone press release dated February 9, 2009, the Company anticipates 2009 revenues of between $60 and $62 million, an increase of approximately 15% over 2008. SciClone expects its revenue growth to be driven by the sales of ZADAXIN and the introduction in 2009 of DC Bead in China for the treatment of patients with liver cancer. The Company anticipates earnings per share for the full year to be between $0.00 and $0.02. SciClone cash, cash equivalents and investments at December 31, 2009 are projected to be greater than $20 million.

2009 Corporate Milestones

SciClone Pharmaceuticals expects to achieve the following significant milestones in 2009:

 

   

Complete enrollment in the phase 2 clinical trial of RP101 in patients with pancreatic cancer in the first half of 2009;

 

   

Achieve continued strong revenue growth and full year profitability in 2009;

 

   

Launch DC Bead in China in 2009;

 

   

Complete enrollment in the Phase 2 trial of SCV-07 in severe oral mucositis in the latter part of 2009.

During 2009, SciClone is focused on discussions with prospective partners for a phase 3 thymalfasin stage IV melanoma trial. SciClone reached an agreement with the FDA in late 2008 on a Special Protocol Assessment (SPA) regarding the design of a phase 3 registration trial for thymalfasin as a potential treatment for stage IV melanoma.

Fourth Quarter and Year 2008 Results Conference Call

SciClone will hold a conference call later today, Tuesday, March 3, 2009 at 8:00 am PT to discuss fourth quarter and full year 2008 financial results and give a business and product update and guidance for 2009.


The call will be hosted by Friedhelm Blobel, Gary Titus, Chief Financial Officer and Senior Vice President, and Israel Rios, MD, Chief Medical Officer and Senior Vice President.

 

LIVE CALL:

   877-741-4248 (U.S./Canada)
   719-325-4813 (International)

REPLAY:

   888-203-1112 (U.S./Canada)
   719-457-0820 (International)
   Passcode: 9394431
   (Replay available from Tuesday, March 3, 2009 at 2:00 p.m. ET until 11:59 p.m. ET on Friday, April 3, 2009)
  

The conference call will contain forward-looking statements. Interested parties who wish to listen to the webcast should visit the Investor Relations section of SciClone’s website at www.sciclone.com. The information provided on the teleconference is only accurate at the time of the conference call, and SciClone will take no responsibility for providing updated information except as required by law.

About SciClone

SciClone Pharmaceuticals (NASDAQ: SCLN) is a profit-driven international biopharmaceutical company with a successful international business and a product portfolio of novel therapies for cancer and infectious diseases. The Company is focused on achieving worldwide sales growth, a cost-containing clinical development strategy, and tight expense management. ZADAXIN is sold in over 30 countries for the treatment of hepatitis B and hepatitis C, certain cancers and as a vaccine adjuvant. SciClone’s pipeline of phase 2 and 3 drug candidates, includes: thymalfasin for stage IV melanoma for which the Company has reached agreement with the FDA on the design of a phase 3 trial; RP101 in phase 2 for the treatment of pancreatic cancer; SCV-07 in phase 2 trials for the treatment of HCV and oral mucositis; and, awaiting approval in China, DC Bead for the treatment of liver cancer. For additional information, please visit www.sciclone.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding the business, products and financial results of SciClone Pharmaceuticals, Inc., including statements regarding our guidance for 2009 and other expectations for 2009. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These risks and uncertainties include changes to our final fiscal year 2008 results that may result in the course of completion of our audit, developments with respect to our clinical programs and our products, including in particular our ability to achieve our product revenue goals which may be affected by economic conditions, competition, regulatory restrictions and other matters, as well as the outcome of the director nomination notice received by SciClone in December 2008 from a company controlled by Sigma-Tau Finanziaria S.p.A. Please also refer to other risks and uncertainties described in SciClone’s filings with the Securities and Exchange Commission. All forward-looking statements are based on information currently available to SciClone and SciClone assumes no obligation to update any such forward-looking statements.


Important Information/ Solicitation Participants Legend

SciClone Pharmaceuticals, Inc. will file a proxy statement in connection with its 2009 annual meeting of stockholders and advises its stockholders to read that proxy statement when it becomes available because it will contain important information. Stockholders will be able to obtain a free copy of that proxy statement and other documents (when available) that SciClone files with the Securities and Exchange Commission at the Commission’s website at www.sec.gov. That proxy statement and these other documents will also be available free of charge by directing a request to SciClone Pharmaceuticals, Inc., Attn: Investor Relations, 950 Tower Lane, Suite 900, Foster City, CA 94404, or from SciClone at www.sciclone.com.

SciClone, its directors and named executive officers may be deemed to be participants in the solicitation of proxies from the SciClone stockholders in connection with the 2009 annual meeting. Stockholders may obtain information regarding the names, affiliations and interests of such individuals in SciClone’s proxy statement filed on May 5, 2008 for the 2008 annual meeting of stockholders. To the extent that holdings of SciClone securities on the part of those individuals have changed since the date of that proxy statement, those changes have been reflected on Statements of Changes in Ownership on Forms 3 or 4 filed with the Securities and Exchange Commission. More current information regarding the interests of the directors and named executive officers of SciClone will be contained in the proxy statement referred to in the preceding paragraph.


SCICLONE PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

 

     Three months ended
December 31,
    Twelve months ended
December 31,
 
     2008     2007     2008     2007  
     (Unaudited)     (Unaudited)     (Unaudited)        

Product sales

   $ 15,312,000     $ 10,018,000     $ 54,108,000     $ 37,038,000  

Contract revenue

     5,000       —         5,000       20,000  
                                

Total revenues

     15,317,000       10,018,000       54,113,000       37,058,000  

Cost of product sales

     3,063,000       1,757,000       9,827,000       6,735,000  
                                

Gross margin

     12,254,000       8,261,000       44,286,000       30,323,000  

Operating expenses:

        

Research and development

     6,690,000       5,391,000       23,215,000       16,939,000  

Related party research and development

     57,000       127,000       322,000       507,000  

Sales and marketing

     4,997,000       3,960,000       17,325,000       13,928,000  

General and administrative

     3,572,000       2,597,000       11,858,000       10,245,000  
                                

Total operating expenses

     15,316,000       12,075,000       52,720,000       41,619,000  
                                

Loss from operations

     (3,062,000 )     (3,814,000 )     (8,434,000 )     (11,296,000 )

Interest and investment income

     107,000       349,000       608,000       1,629,000  

Interest and investment expense

     (31,000 )     —         (31,000 )     (20,000 )

Other (expense) income, net

     (23,000 )     64,000       (16,000 )     40,000  
                                

Loss before provision for income tax

     (3,009,000 )     (3,401,000 )     (7,873,000 )     (9,647,000 )

Provision for income tax

     134,000       211,000       475,000       301,000  
                                

Net loss

   $ (3,143,000 )   $ (3,612,000 )   $ (8,348,000 )   $ (9,948,000 )
                                

Basic and diluted net loss per share

   $ (0.07 )   $ (0.08 )   $ (0.18 )   $ (0.22 )

Weighted average shares used in computing basic and diluted net loss per share

     46,219,562       46,115,932       46,212,223       46,099,641  

 

     December 31,
     2008    2007
     (Unaudited)     

Balance Sheet Data:

     

Cash and cash equivalents

   $ 27,673,000    $ 31,817,000

Short-term investments

     100,000      3,392,000

Accounts receviable

     11,927,000      12,650,000

Inventories

     6,056,000      5,579,000

Long-term investments

     1,485,000      —  

Total assets

     51,905,000      58,659,000

Total currents liabilities

     10,223,000      11,059,000

Total Shareholders’ equity

     40,903,000      47,259,000
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