EX-99.1 2 exhibit2q17.htm EXHIBIT 99.1 Exhibit


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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, CA - July 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






Contacts

La Jolla Pharmaceutical Company
Sandra Vedrick
Associate Director, Investor Relations & Human Resources
(858) 256-7910
svedrick@ljpc.com

or

La Jolla Pharmaceutical Company
Dennis M. Mulroy
Chief Financial Officer
(858) 433-6839
dmulroy@ljpc.com