-----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, Rke8ZUdnJVBsv6QvE/hVbWdP2hhX9TpeErQX8BMzuJBAbZ2UySSHGHyp2HP0sQ+d ekp6vxdwUKxs2WJJJLrg3w== 0000950137-05-002606.txt : 20050303 0000950137-05-002606.hdr.sgml : 20050303 20050303143506 ACCESSION NUMBER: 0000950137-05-002606 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050303 ITEM INFORMATION: Results of Operations and Financial Condition FILED AS OF DATE: 20050303 DATE AS OF CHANGE: 20050303 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: 05657428 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 a06395e8vk.htm FORM 8-K La Jolla Pharmaceutical Company
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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): March 3, 2005

La Jolla Pharmaceutical Company

(Exact name of registrant as specified in its charter)
         
Delaware   0-24274   33-0361285
         
(State or other jurisdiction
of incorporation) 		  (Commission
File Number) 		  (IRS Employer
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))

 
 

 

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2.02 Results of Operations and Financial Condition.
SIGNATURES
EXHIBIT INDEX
EXHIBIT 99.1

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2.02 Results of Operations and Financial Condition.

     On March 3, 2005, La Jolla Pharmaceutical Company announced and commented on its financial results for its fourth quarter and year ended December 31, 2004. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.

     The information in this Form 8-K and the exhibit attached hereto and incorporated herein shall not be deemed “filed” for purposes of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

 

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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: March 3, 2005  By:   /s/ Steven B. Engle    
    Steven B. Engle   
    Chairman and Chief Executive Officer   
 

 

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EXHIBIT INDEX

     
Exhibit    
Number   Description of Exhibit

 
 
99.1  
Press Release (furnished pursuant to Item 2.02 of Form 8-K)

 

EX-99.1 2 a06395exv99w1.txt EXHIBIT 99.1 Exhibit 99.1 LA JOLLA PHARMACEUTICAL COMPANY REPORTS FOURTH QUARTER AND YEAR END 2004 FINANCIAL RESULTS SAN DIEGO, MARCH 3, 2005 -- La Jolla Pharmaceutical Company (Nasdaq: LJPC) reported a net loss for the fourth quarter ended December 31, 2004 of $11.0 million, or $0.18 per share (on 61.4 million weighted average shares), compared to a net loss of $8.4 million, or $0.17 per share (on 51.0 million weighted average shares), for the fourth quarter of 2003. The net loss for the twelve months ended December 31, 2004 was $40.5 million, or $0.68 per share (on 59.7 million weighted average shares), compared to a net loss of $38.8 million, or $0.85 per share (on 45.8 million weighted average shares), for the same period in 2003. Research and development expenses increased to $8.9 million for the three months ended December 31, 2004 from $6.4 million for the same period in 2003 primarily due to the purchase of raw materials, which the Company expects to use in the production of validation lots of Riquent(R) (abetimus sodium) in 2005. The Company expects to use the validation lots in connection with its ongoing clinical trial and for other purposes. Research and development expenses slightly increased to $33.2 million for the twelve months ended December 31, 2004 from $32.4 million for the same period in 2003. This increase was primarily due to the increase in expenses noted above, offset by the decreases in costs incurred for clinical studies of Riquent, including the open-label follow-on clinical trial which was closed in April 2003 and the unblinding and analysis of the data from the Phase 3 trial of Riquent in the first quarter of 2003. Cash, cash equivalents and short-term investments as of December 31, 2004 were $23.1 million compared to $32.1 million as of December 31, 2003. On February 2, 2005, the Company sold 12,250,000 shares of its common stock in a public offering for net proceeds, after expenses, of approximately $15.8 million. La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people in the United States and Europe. The Company is developing Riquent(R) for the treatment of lupus kidney disease, a leading cause of sickness and death in patients with lupus. The Company is also in the early stage of developing small molecules to treat various other autoimmune and inflammatory conditions. The Company's common stock is traded on The Nasdaq Stock Market under the symbol LJPC. For more information about the Company, visit its Web site: http://www.ljpc.com The forward-looking statements in this press release involve significant risks 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, previously known as LJP 394, our drug candidate for the treatment of systemic lupus erythematosus ("lupus"), including the results of any trials 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 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 the 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 Europe, 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 additional trial or that any additional trial will sufficiently demonstrate the safety and efficacy of Riquent. Our blood test to measure the binding affinity for Riquent is experimental, has not been validated by independent laboratories and will likely be reviewed as part of the Riquent approval process. Our other potential drug candidates are at earlier stages of development and involve comparable risks. Analysis of our clinical trials could have negative or inconclusive results. Any positive results observed to date may not be indicative of future results. In any event, regulatory authorities may require clinical trials in addition to our current clinical trial, or may not approve our drugs. Our ability to develop and sell our products in the future may be adversely affected by the intellectual property rights of third parties. Additional risk factors include the uncertainty and timing of: our clear need for additional financing; obtaining required regulatory approvals, including delays associated with any approvals that we may obtain; our ability to pass all necessary FDA 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. Readers are cautioned to not place undue reliance upon forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date hereof. Interested parties are urged to review the risks described in our Annual Report on Form 10-K for the year ended December 31, 2003, and in other reports and registration statements that we file with the Securities and Exchange Commission from time to time. ### LA JOLLA PHARMACEUTICAL COMPANY CONDENSED FINANCIAL STATEMENTS (IN THOUSANDS EXCEPT PER SHARE DATA) SUMMARY OF OPERATIONS
THREE MONTHS ENDED TWELVE MONTHS ENDED DECEMBER 31, DECEMBER 31, (UNAUDITED) 2004 2003 2004 2003 ---------------------- ----------------------- Research and development expense $ 8,901 $ 6,415 $ 33,169 $ 32,385 General and administrative expense 2,116 2,096 7,568 6,908 -------- ------- -------- -------- Total expenses 11,017 8,511 40,737 39,293 -------- ------- -------- -------- Loss from operations (11,017) (8,511) (40,737) (39,293) Interest income, net 48 71 193 455 -------- ------- -------- -------- Net loss $(10,969) $(8,440) $(40,544) $(38,838) ======== ======= ======== ======== Basic and diluted net loss per share $ (0.18) $ (0.17) $ (0.68) $ (0.85) Shares used in computing basic and diluted net loss per share 61,402 50,970 59,704 45,804
BALANCE SHEET INFORMATION
DECEMBER 31, DECEMBER 31, 2004 2003 ------------ ------------ ASSETS Cash, cash equivalents, and short-term investments $ 23,065 $ 32,133 Other assets 9,961 9,811 --------- --------- Total assets $ 33,026 $ 41,944 ========= ========= LIABILITIES AND STOCKHOLDERS' EQUITY Liabilities $ 7,025 $ 5,517 Stockholders' equity 26,001 36,427 --------- --------- Total liabilities and stockholders' equity $ 33,026 $ 41,944 ========= ========
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