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
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version on businesswire.com: http://www.businesswire.com/news/home/20170427006700/en/
La Jolla Pharmaceutical CompanySandra Vedrick, (858)
256-7910Associate Director, Investor Relations & Human
Resourcessvedrick@ljpc.comorDennis M. Mulroy, (858) 433-6839Chief
Financial Officerdmulroy@ljpc.com
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