La Jolla Pharmaceutical Company

-----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, B17ZK8v+CVvpYjvQ2Lwk/hQ8nluP0miwHQzIlONZtXDPSMuEqmekZKcotrrloDzN J/sgezZNnkpaIQfLSWWbBA== 0000936392-04-000473.txt : 20040507 0000936392-04-000473.hdr.sgml : 20040507 20040506183012 ACCESSION NUMBER: 0000936392-04-000473 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040506 ITEM INFORMATION: FILED AS OF DATE: 20040507 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: 04786413 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 a98742e8vk.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): May 6, 2004

LA JOLLA PHARMACEUTICAL COMPANY

(Exact Name of Registrant as Specified in Charter)


Delaware (State or Other Jurisdiction of Incorporation)		0-24274 (Commission File Number)		33-0361285 (IRS Employer Identification No.)

6455 Nancy Ridge Drive
San Diego, California 92121
(Address of Principal Executive Offices, including Zip Code)

(858) 452-6600
(Registrant’s telephone number, including area code)

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	Item 12. Results of Operations and Financial Condition.
SIGNATURES
EXHIBIT INDEX
EXHIBIT 99.1

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Item 12. Results of Operations and Financial Condition.

In a press release on May 6, 2004, La Jolla Pharmaceutical Company announced and commented on its financial results for its first quarter ended March 31, 2004. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein. The press release is being furnished to the Securities and Exchange Commission under Item 12 Results of Operations and Financial Condition.

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.

Date: May 6, 2004

LA JOLLA PHARMACEUTICAL COMPANY

By: /s/ Gail A. Sloan
Gail A. Sloan
Vice President Finance, Controller and Secretary

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EXHIBIT INDEX


Exhibit
Number		Description of Exhibit
99.1		Press Release (furnished pursuant to Item 12 of Form 8-K)

EX-99.1 2 a98742exv99w1.txt EXHIBIT 99.1 EXHIBIT 99.1 LA JOLLA PHARMACEUTICAL COMPANY REPORTS FIRST QUARTER 2004 FINANCIAL RESULTS SAN DIEGO, MAY 6, 2004 -- La Jolla Pharmaceutical Company (Nasdaq: LJPC) reported a net loss for the first quarter ended March 31, 2004 of $8.4 million, or $0.15 per share (on 54.7 million weighted average shares), compared to a net loss of $13.5 million, or $0.32 per share (on 42.5 million weighted average shares), for the first quarter of 2003. Research and development expenses decreased to $6.8 million for the three months ended March 31, 2004 from $11.9 million for the same period in 2003 primarily due to a decrease in expenses related to the Company's open-label follow-on clinical trial of Riquent(R) which was closed in April 2003, a decrease in expenses related to the unblinding and analysis of the data from the Company's Phase 3 trial of Riquent in the first quarter of 2003 and a decrease in personnel costs related to the organizational restructuring that occurred in May 2003. Cash, cash equivalents and short-term investments as of March 31, 2004 were $53.7 million compared to $32.1 million as of December 31, 2003. In February and March 2004, the Company sold an aggregate of 10.0 million shares of its common stock in a public offering for net proceeds, after expenses, of approximately $29.4 million. The Company anticipates that its existing cash, cash investments and interest earned thereon will be sufficient to fund the Company's operations as currently planned into the second quarter of 2005, assuming that the Company does not engage in any significant clinical trial or commercialization activities and further assuming that the Company does not enter into an agreement with a collaborative partner or engage in any other fundraising activities. 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 developing LJP 1082 for the treatment of antibody-mediated thrombosis, a condition in which patients suffer from recurrent stroke, deep-vein thrombosis and other thrombotic events, and is 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 website at 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. Although our New Drug Application ("NDA") for Riquent(R) has been accepted by the United States Food and Drug Administration (the "FDA") for review, there is no guarantee that the FDA will approve Riquent in a timely manner, or at all. Our analyses of clinical results of Riquent, previously known as LJP 394, our drug candidate for the treatment of systemic lupus erythematosus ("lupus"), and LJP 1082, our drug candidate for the treatment of antibody-mediated thrombosis ("thrombosis"), are ongoing and 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 to the secondary endpoint, time to treatment with high-dose corticosteroids or cyclophosphamide. Although our NDA for Riquent has been accepted for review by the FDA, the results from our clinical trials of Riquent 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 is no guarantee, however, that we will have the necessary resources to complete any additional trial, that we will elect to conduct an 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 additional clinical trials, 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: obtaining required regulatory approvals, including delays associated with any approvals that we may obtain; the clear need for additional financing; our ability to pass FDA pre-approval inspections of our manufacturing facilities and processes; 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

BALANCE SHEET INFORMATION

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