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La Jolla Pharmaceutical Company Announces Financial Results for the Three and Six Months Ended June 30, 2017 and Recent Corporate Progress

SAN DIEGO--(BUSINESS WIRE)--Jul. 27, 2017-- La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today reported financial results for the three and six months ended June 30, 2017 and recent corporate progress.

Recent Corporate Progress

  • In February 2017, La Jolla reported positive top-line results from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study of LJPC-501 in patients with catecholamine resistant hypotension (CRH). The analysis of the primary efficacy endpoint, defined as the percentage of patients achieving a pre-specified target blood pressure response, was highly statistically significant: 23% of the 158 placebo-treated patients had a blood pressure response compared to 70% of the 163 LJPC-501-treated patients (p<0.00001). In addition, a trend toward longer survival was observed: 22% reduction in mortality risk through day 28 [hazard ratio=0.78 (0.57-1.07), p=0.12] for LJPC-501-treated patients. In this critically ill patient population: 92% of placebo-treated patients compared to 87% of LJPC-501-treated patients experienced at least one adverse event, and 22% of placebo-treated patients compared to 14% of LJPC-501-treated patients discontinued treatment due to an adverse event.
  • In May 2017, the results of ATHOS-3 were published by The New England Journal of Medicine in an article entitled “Angiotensin II for the Treatment of Vasodilatory Shock.”

“The first half of 2017 was an exciting time for La Jolla, highlighted by the positive results from ATHOS-3, which were recently published in The New England Journal of Medicine,” said George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. “We now look forward to working towards an FDA-accepted New Drug Application filing for LJPC-501 in the second half of 2017.”

Results of Operations

As of June 30, 2017, the Company had $141.3 million in cash and cash equivalents, compared to $65.7 million of cash and cash equivalents at December 31, 2016. Cash used in operating activities for the six months ended June 30, 2017 was $41.9 million, compared to $25.1 million for the same period in 2016. Net loss for the three and six months ended June 30, 2017 was $26.7 million and $50.0 million, or $1.21 per share and $2.46 per share, respectively, compared to a net loss of $15.6 million and $32.0 million, or $0.90 per share and $1.86 per share, respectively, for the same periods in 2016.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. The Company has several product candidates in development. LJPC-501 is La Jolla’s proprietary formulation of synthetic human angiotensin II for the potential treatment of catecholamine resistant hypotension. LJPC-401 is La Jolla’s proprietary formulation of synthetic human hepcidin for the potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis, beta thalassemia, sickle cell disease and myelodysplastic syndrome. LJPC-30S is La Jolla’s next-generation gentamicin derivative program that is focused on the potential treatment of serious bacterial infections as well as rare genetic disorders, such as cystic fibrosis and Duchenne muscular dystrophy. For more information on La Jolla, please visit www.ljpc.com.

Forward Looking Statement Safe Harbor

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or the Company’s future results of operations. These statements are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties and other factors are described in greater detail in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), all of which are available free of charge on the SEC’s web site www.sec.gov. These risks include, but are not limited to, risks relating to: the timing of announcements regarding the New Drug Application (NDA) submission for LJPC-501 and prospects for approval of the LJPC-501 NDA; risks relating to the scope of product labels (if approved) and potential market sizes, as well as the broader commercial opportunity; the anticipated timing for regulatory actions; the success of future development activities; potential indications for which the Company’s product candidates may be developed; and the expected duration over which the Company’s cash balances will fund its operations. Subsequent written and oral forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in the Company’s reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.

 

LA JOLLA PHARMACEUTICAL COMPANY

Unaudited Condensed Consolidated Statements of Operations

(in thousands, except per share amounts)

 
    Three Months Ended
June 30,
  Six Months Ended

June 30

2017   2016 2017   2016
Revenue
Contract revenue - related party $   $ 253   $   $ 487  
Total revenue   253     487  
Expenses
Research and development 20,808 12,404 38,573 25,119
General and administrative 6,022   3,466   11,525   7,519  
Total expenses 26,830   15,870   50,098   32,638  
Loss from operations (26,830 ) (15,617 ) (50,098 ) (32,151 )
Other income, net 101   51   129   104  
Net loss $ (26,729 ) $ (15,566 ) $ (49,969 ) $ (32,047 )
Basic and diluted net loss per share $ (1.21 ) $ (0.90 ) $ (2.46 ) $ (1.86 )
Weighted average common shares outstanding - basic and diluted 22,123   17,211   20,277   17,211  
 
 

LA JOLLA PHARMACEUTICAL COMPANY

Condensed Consolidated Balance Sheets

(in thousands, except share and par value amounts)

 
    June 30,
2017
  December 31,
2016
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 141,317 $ 65,726
Restricted cash 910 200
Prepaid expenses and other current assets 1,775   1,505  
Total current assets 144,002 67,431
Property and equipment, net 4,585 3,145
Other assets   219  
Total assets $ 148,587   $ 70,795  
 
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 5,920 $ 6,652
Accrued clinical and other expenses 488 1,029
Accrued payroll and related expenses 1,863   2,077  
Total current liabilities 8,271   9,758  
Shareholders’ equity:
Common Stock, $0.0001 par value; 100,000,000 shares authorized, 22,123,456 and 18,261,557 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively 2 2
Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at June 30, 2017 and December 31, 2016, and liquidation preference of $3,906 at June 30, 2017 and December 31, 2016 3,906 3,906
Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized, 2,737 shares issued and outstanding at June 30, 2017 and December 31, 2016, and liquidation preference of $2,737 at June 30, 2017 and December 31, 2016 2,737 2,737
Additional paid-in capital 790,351 661,103
Accumulated deficit (656,680 ) (606,711 )
Total shareholders’ equity 140,316   61,037  
Total liabilities and shareholders’ equity $ 148,587   $ 70,795  
 

Source: La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company
Sandra Vedrick, 858-256-7910
Associate Director, Investor Relations & Human Resources
svedrick@ljpc.com
or
La Jolla Pharmaceutical Company
Dennis M. Mulroy, 858-433-6839
Chief Financial Officer
dmulroy@ljpc.com



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