-----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, BgHGrL7pKq9nZKyC4vzM81sReK/SULXaSDwwSHwjbzdtYzprB8lhkL3hfghp7wJR kkTu7/9/Noo/BPxcZ1pOXg== 0000936392-08-000692.txt : 20081031 0000936392-08-000692.hdr.sgml : 20081031 20081031163653 ACCESSION NUMBER: 0000936392-08-000692 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20081031 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20081031 DATE AS OF CHANGE: 20081031 FILER: COMPANY DATA: COMPANY CONFORMED NAME: LA JOLLA PHARMACEUTICAL CO CENTRAL INDEX KEY: 0000920465 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 330361285 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24274 FILM NUMBER: 081154991 BUSINESS ADDRESS: STREET 1: 6455 NANCY RIDGE DR CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 8584526600 MAIL ADDRESS: STREET 1: 6455 NANCY RIDGE DR CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 a50316e8vk.htm FORM 8-K e8vk
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): October 31, 2008
La Jolla Pharmaceutical Company
(Exact name of registrant as specified in its charter)
         
Delaware   0-24274   33-0361285
         
(State or other jurisdiction   (Commission   (IRS Employer
of incorporation)   File Number)   Identification No.)
     
6455 Nancy Ridge Drive, San Diego, California   92121
     
(Address of principal executive offices)   (Zip Code)
Registrant’s telephone number, including area code: (858) 452-6600
N/A
(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:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


 

2.02 Results of Operations and Financial Condition.
     On October 31, 2008, La Jolla Pharmaceutical Company announced and commented on its third quarter and year-to-date financial results for the periods ended September 30, 2008. A copy of the press release is attached hereto as Exhibit 99.1.
     In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.
9.01 Financial Statements and Exhibits.
(d) Exhibits.
     
Exhibit    
Number   Description of Exhibit
 
   
99.1
  Press Release, dated October 31, 2008.

 


 

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.
         
  La Jolla Pharmaceutical Company
 
 
Date: October 31, 2008  By:   /s/ Gail A. Sloan    
    Gail A. Sloan   
    Vice President of Finance and Secretary   
 

 


 

EXHIBIT INDEX
     
Exhibit    
Number   Description of Exhibit
 
   
99.1
  Press Release, dated October 31, 2008.

 

EX-99.1 2 a50316exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
LA JOLLA PHARMACEUTICAL COMPANY
REPORTS THIRD QUARTER AND YEAR-TO-DATE
FINANCIAL RESULTS
SAN DIEGO, October 31, 2008 — La Jolla Pharmaceutical Company (Nasdaq: LJPC) reported a net loss for the three months ended September 30, 2008 of $17.1 million, or $0.31 per share (on 55.3 million weighted-average shares), compared to a net loss of $13.3 million, or $0.34 per share (on 39.6 million weighted-average shares), for the same period in 2007. The Company reported a net loss for the nine months ended September 30, 2008 of $45.7 million, or $0.96 per share (on 47.8 million weighted-average shares), compared to a net loss of $38.7 million, or $1.04 per share (on 37.2 million weighted-average shares), for the same period in 2007.
Research and development expenses increased to $14.1 million and $38.2 million, respectively, for the three and nine months ended September 30, 2008 from $11.4 million and $34.0 million, respectively, for the same periods in 2007. These increases were primarily attributable to increased activity in the Phase 3 clinical trial of Riquent®.
General and administrative expenses increased slightly to $2.8 million and $6.8 million, respectively, for the three and nine months ended September 30, 2008 from $2.6 million and $6.7 million, respectively, for the same periods in 2007.
Cash, cash equivalents and short-term investments as of September 30, 2008 were $26.1 million compared to $39.4 million as of December 31, 2007. Short-term investments of $8.6 million consist of AAA rated student loan auction rate securities net of realized impairment losses of $1.4 million recorded in 2008.

 


 

About Riquent
Riquent is being developed to specifically treat lupus renal disease by preventing or delaying renal flares, a leading cause of sickness and death in lupus patients. It is also being studied to assess whether Riquent treatment improves proteinuria, as was observed in previous clinical trials. Proteinuria is an indicator of abnormal renal function. Riquent has been well tolerated in all 14 clinical trials, with no overall difference in the adverse event profiles for Riquent-treated patients compared with placebo-treated patients. Riquent specifically reduces circulating levels of anti-dsDNA antibodies and is also designed to specifically suppress the B cells that make these antibodies. Decreases in these antibodies are believed to be associated with a decreased risk of renal flare. Although clinical benefit has not yet been proven, Riquent treatment has significantly reduced these antibody levels in all clinical trials in which they were measured.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is dedicated to improving and preserving human life by developing innovative pharmaceutical products. The Company’s leading product in development is Riquent®, which is designed to treat lupus renal disease by preventing or delaying renal flares. Lupus renal disease is a leading cause of sickness and death in patients with lupus. The Company has also developed potential small molecule drug candidates to treat various other autoimmune and inflammatory conditions. The Company’s common stock is traded on The NASDAQ Global Market under the symbol LJPC. More information about the Company is available on its Web site: http://www.ljpc.com.
The forward-looking statements in this press release involve significant risks, assumptions and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from our current expectations. Forward-looking statements include those that express a plan, belief, expectation, estimation, anticipation, intent, contingency, future development or similar expression. The analyses of clinical results of Riquent® (abetimus sodium), previously known as LJP 394, our drug candidate for the treatment of systemic lupus erythematosus (lupus), and any other drug candidate that we may develop, including the results of any trials or models that are ongoing or that we may initiate in the future, could result in a finding that these drug candidates are not effective in large patient populations, do not provide a meaningful clinical benefit, or may reveal a potential safety issue requiring us to develop new candidates. The analysis of the data from our previous Phase 3 trial of Riquent showed that the trial did not reach statistical significance with respect to its primary endpoint, time to renal flare, or with respect to its secondary endpoint, time to treatment with high-dose corticosteroids or cyclophosphamide. The results from our clinical trials of Riquent, including the results of any trials that are ongoing or that we may initiate in the future, may not ultimately be sufficient to obtain regulatory clearance to market Riquent either in the United States or any other country, and we may be

 


 

required to conduct additional clinical studies to demonstrate the safety and efficacy of Riquent in order to obtain marketing approval. There can be no assurance, however, that we will have the necessary resources to complete any current or future trials or that any such trials will sufficiently demonstrate the safety and efficacy of Riquent. Our ability to develop and sell our products in the future may be adversely affected by the intellectual property rights of third parties or the validity or enforceability of our intellectual property rights. Additional risk factors include the uncertainty and timing of: our ability to raise additional capital; obtaining required regulatory approvals, including delays associated with any approvals that we may obtain; the timely supply of drug product for clinical trials; our ability to pass all necessary regulatory inspections; the increase in capacity of our manufacturing capabilities for possible commercialization; successfully marketing and selling our products; our lack of manufacturing, marketing and sales experience; our ability to make use of the orphan drug designation for Riquent; generating future revenue from product sales or other sources such as collaborative relationships; future profitability; and our dependence on patents and other proprietary rights. Accordingly, you should not rely upon forward-looking statements as predictions of future events. The outcome of the events described in these forward-looking statements are subject to the risks, uncertainties and other factors described in the “Risk Factors” contained in our Annual Report on Form 10-K for the year ended December 31, 2007, and in other reports and registration statements that we file with the Securities and Exchange Commission from time to time. We expressly disclaim any intent to update forward-looking statements.
###

 


 

La Jolla Pharmaceutical Company
Condensed Consolidated Financial Statements (in thousands except per share amounts)
Summary of Operations
                                 
    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
    2008     2007     2008     2007  
    (Unaudited)     (Unaudited)  
Research and development expenses
  $ 14,099     $ 11,448     $ 38,170     $ 34,009  
General and administrative expenses
    2,791       2,585       6,766       6,677  
 
                       
Total expenses
    16,890       14,033       44,936       40,686  
 
                       
 
                               
Loss from operations
    (16,890 )     (14,033 )     (44,936 )     (40,686 )
 
                               
Interest income
    163       752       653       2,084  
Interest expense
    (12 )     (8 )     (71 )     (74 )
Realized loss on investments, net
    (395 )           (1,352 )      
 
                               
 
                       
Net loss
  $ (17,134 )   $ (13,289 )   $ (45,706 )   $ (38,676 )
 
                       
 
                               
Basic and diluted net loss per share
  $ (0.31 )   $ (0.34 )   $ (0.96 )   $ (1.04 )
 
                               
Shares used in computing basic and diluted net loss per share
    55,327       39,577       47,764       37,215  
Balance Sheet Information
                 
    September 30,     December 31,  
    2008     2007  
    (Unaudited)          
Assets
               
Cash, cash equivalents, and short-term investments
  $ 26,069     $ 39,359  
 
               
Other assets
    4,682       5,046  
 
               
 
           
Total assets
  $ 30,751     $ 44,405  
 
           
 
               
Liabilities and Stockholders’ Equity
               
Liabilities
  $ 11,286     $ 10,884  
 
               
Stockholders’ equity
    19,465       33,521  
 
               
 
           
Total liabilities and stockholders’ equity
  $ 30,751     $ 44,405  
 
           

 

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