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
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version on businesswire.com: http://www.businesswire.com/news/home/20170727006478/en/
La Jolla Pharmaceutical CompanySandra Vedrick,
858-256-7910Associate Director, Investor Relations & Human
Resourcessvedrick@ljpc.comorLa Jolla Pharmaceutical CompanyDennis
M. Mulroy, 858-433-6839Chief Financial Officerdmulroy@ljpc.com
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