La Jolla Pharmaceutical Company Announces Financial Results for the Three Months Ended March 31, 2017 and Recent Corporate Progress

SAN DIEGO--()--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 months ended March 31, 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. La Jolla plans to present and publish detailed results from ATHOS-3 later this year.
  • In March 2017, La Jolla completed a common stock offering and received proceeds of approximately $117.5 million, net of issuance costs.

“The first quarter of 2017 was an exciting time at La Jolla, highlighted by the positive top-line results from ATHOS-3,” said George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. “We look forward to continuing a productive 2017, with the expected LJPC-501 New Drug Application submission in the second half of 2017.”

Results of Operations

As of March 31, 2017, the Company had $162.4 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 three months ended March 31, 2017 was $22.1 million, compared to $13.0 million for the same period in 2016. Net loss for the three months ended March 31, 2017 was $23.2 million, or $1.26 per share, compared to $16.5 million, or $0.96 per share for the same period 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 the NDA submission for LJPC-501 and prospects for approval of the LJPC-501 NDA; risks that the full data set from ATHOS-3 will not be consistent with the top-line results of the study; 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
March 31,
2017       2016
Revenue
Contract revenue - related party $   $ 234  
Total revenue       234  
Expenses
Research and development 17,765 12,715
General and administrative   5,503     4,053  
Total expenses   23,268     16,768  
Loss from operations (23,268 ) (16,534 )
Other income, net   28     53  
Net loss $ (23,240 ) $ (16,481 )
Basic and diluted net loss per share $ (1.26 ) $ (0.96 )
Weighted average common shares outstanding - basic and diluted   18,410     17,210  
 
 
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets

(in thousands, except share and par value amounts)

 
      March 31,       December 31,
2017 2016
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 162,382 $ 65,726
Restricted cash 304 200
Prepaid expenses and other current assets   1,687     1,505  
Total current assets 164,373 67,431
Property and equipment, net 3,614 3,145
Other assets   20     219  
Total assets $ 168,007   $ 70,795  
 
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 4,173 $ 6,652
Accrued clinical and other expenses 590 1,029
Accrued payroll and related expenses   910     2,077  
Total current liabilities   5,673     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 March 31, 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 March 31, 2017 and December 31, 2016, and liquidation preference of $3,906 at March 31, 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 March 31, 2017 and December 31, 2016, and liquidation preference of $2,737 at March 31, 2017 and December 31, 2016 2,737 2,737
Additional paid-in capital 785,640 661,103
Accumulated deficit   (629,951 )   (606,711 )
Total shareholders’ equity   162,334     61,037  
Total liabilities and shareholders’ equity $ 168,007   $ 70,795  
 

Contacts

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

Contacts

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