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 fourth quarter and
full year 2015 financial results and highlighted 2015 corporate
progress.
2015 Corporate Progress
- The ATHOS (Angiotensin II for the Treatment of High-Output Shock) 3 trial, La Jolla’s multicenter,
randomized, double-blind, placebo-controlled, Phase 3 clinical
trial of LJPC-501, La Jolla’s proprietary formulation of
angiotensin II, in catecholamine-resistant hypotension (CRH) was
initiated in March 2015. The initiation of the ATHOS 3 trial
followed the reaching of an agreement with the U.S. Food and Drug
Administration (FDA) on a Special Protocol Assessment (SPA), in
which the agreed-upon primary efficacy endpoint in ATHOS 3 is
increase in blood pressure. ATHOS 3 is enrolling as planned, and
results are expected by the end of 2016.
- A multicenter, open-label,
dose-escalation Phase 1 clinical trial of LJPC-401, the Company’s
novel formulation of hepcidin, in patients at risk for iron
overload due to conditions such as hereditary hemochromatosis, beta
thalassemia, sickle cell disease and myelodysplastic syndrome was
initiated in October 2015. Interim results, reported in January
2016, suggested a dose-dependent reduction in serum iron following
a single dose of LJPC-401. Additionally, the European Medicines
Agency (EMA) Committee for Orphan Medicinal Products (COMP)
designated LJPC-401 an orphan medicinal product for the treatment
of beta thalassemia intermedia and major.
- La Jolla entered into exclusive
worldwide license agreements with the Indiana University Research
and Technology Corporation and the University of Alabama at
Birmingham to acquire intellectual property rights covering
LJPC-30Sa and LJPC-30Sb in May 2015. LJPC-30Sa and LJPC-30Sb are La
Jolla’s next-generation gentamicin derivatives for the potential
treatment of serious bacterial infections and rare genetic
disorders, such as cystic fibrosis and Duchenne muscular
dystrophy.
- La Jolla completed a public offering of
common stock in September 2015, whereby La Jolla received
approximately $104.6 million, net of issuance costs. La Jolla
finished 2015 with $126.5 million in cash and cash equivalents and
believes this is sufficient to fund operations into 2018.
“2015 was a very exciting year for La Jolla, highlighted by the
initiation and continued progress of our Phase 3 clinical trial of
LJPC-501 and encouraging interim data from our recently initiated
Phase 1 clinical trial of LJPC-401,” said George Tidmarsh, M.D.,
Ph.D., La Jolla’s President and Chief Executive Officer. “We look
forward to a productive 2016, with the continued advancement of our
exciting product candidates and results from our LJPC-501 Phase 3
clinical trial expected by the end of the year.”
Results of Operations
As of December 31, 2015, La Jolla had $126.5 million in cash and
cash equivalents, compared to $48.6 million as of December 31,
2014. The increase in cash and cash equivalents was primarily due
to cash provided by our common stock offering that was completed in
September 2015, which was partially offset by net cash used for
operating activities. Based on current operating plans and
projections, La Jolla believes that its current cash and cash
equivalents are sufficient to fund operations into 2018.
La Jolla’s net cash used for operating activities for the three
and twelve months ended December 31, 2015 was $8.5 million and
$25.2 million, respectively, compared to net cash used for
operating activities of $5.4 million and $12.9 million,
respectively, for the same periods in 2014. La Jolla’s net loss for
the three and twelve months ended December 31, 2015 was $11.8
million and $41.9 million, or $0.69 per share and $2.68 per share,
respectively, compared to a net loss of $6.8 million and $21.3
million, or $0.45 per share and $2.00 per share, respectively, for
the same periods in 2014. During the three and twelve months ended
December 31, 2015, La Jolla recognized contract revenue of
approximately $0.4 million and $1.1 million, respectively, which
was pursuant to a services agreement initiated in 2015 under which
La Jolla provides research and development services to a related
party. The net loss includes non-cash, share-based compensation
expense of $2.8 million and $13.1 million for the three and twelve
months ended December 31, 2015, respectively, compared to $2.5
million and $9.1 million of noncash, share-based compensation
expense, respectively, for the same periods in 2014.
The increases in net cash used for operating activities and net
loss in 2015 as compared to 2014 were primarily due to increased
development costs associated with the Phase 3 clinical trial of
LJPC-501 in catecholamine-resistant hypotension and the costs
associated with the initiation of the Phase 1 clinical trial of
LJPC-401 in iron overload. In addition, there were increases in
personnel and related costs, which were mainly due to the hiring of
additional personnel and increased facility costs to support the
increased development activities.
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 angiotensin II for the potential
treatment of catecholamine-resistant hypotension. LJPC-401 is La
Jolla’s novel formulation of hepcidin for the potential treatment
of conditions characterized by iron overload, such as hereditary
hemochromatosis, beta thalassemia, sickle cell disease and
myelodysplastic syndrome. LJPC-30Sa and LJPC-30Sb are La Jolla’s
next-generation gentamicin derivatives for the potential treatment
of serious bacterial infections and 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 document 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 and
involve known and unknown risks, uncertainties and other factors,
which may cause actual results to be materially different from
these 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 for commencement
of clinical studies, the anticipated timing for completion of such
studies, and 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
Consolidated Statements of Operations
(in thousands, except per share
amounts)
Three Months Ended December 31,
(unaudited)
Year Ended December 31, 2015
2014 2015 2014 Revenue Contract
revenue - related party $ 410 $ — $ 1,057 $ —
Total revenue 410 — 1,057 —
Expenses Research and development 9,455 3,726 29,092 9,944
General and administrative 2,813 3,137 13,934
11,396 Total expenses 12,268 6,863 43,026
21,340 Loss from operations (11,858 ) (6,863 )
(41,969 ) (21,340 ) Other income, net 25 14 57
27
Net loss $ (11,833 ) $
(6,849 ) $ (41,912 ) $
(21,313 ) Basic and diluted net loss per share
$ (0.69 ) $ (0.45 )
$
(2.68
) $ (2.00 ) Shares used in computing
basic and diluted net loss per share 17,200 15,226
15,651 10,667
LA JOLLA
PHARMACEUTICAL COMPANY Consolidated Balance Sheets
(in thousands, except share and par value
amounts)
December 31,
2015
December 31,
2014
ASSETS Current assets: Cash and cash equivalents $
126,467 $ 48,555 Restricted cash 237 37 Prepaid clinical expenses
223 1,528 Prepaid expenses and other current assets 618 137
Total current assets 127,545 50,257 Property and equipment,
net 1,732 279 Other assets 70 —
Total assets
$ 129,347 $ 50,536
LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities:
Accounts payable $ 2,506 $ 730 Accrued expenses 1,224 926 Accrued
payroll and related expenses 1,090 424 Total current
liabilities 4,820 2,080 Shareholders’ equity: Common Stock, $0.0001
par value; 100,000,000 shares authorized, 18,244,009 and 15,225,980
shares issued and outstanding at December 31, 2015 and December 31,
2014, respectively 2 2 Series C-12 Convertible Preferred Stock,
$0.0001 par value; 11,000 shares authorized, 3,906 and 3,917 shares
issued and outstanding at December 31, 2015 and December 31, 2014,
respectively, and a liquidation preference of $3,906 and $3,917 at
December 31, 2015 and 2014, respectively 3,906 3,917 Series F
Convertible Preferred Stock, $0.0001 par value; 10,000 shares
authorized, 2,737 and 2,798 shares issued and outstanding at
December 31, 2015 and December 31, 2014, respectively, and
liquidation preference of $2,737 and $2,798 at December 31, 2015
and 2014, respectively 2,737 2,798 Additional paid-in capital
646,408 528,353 Accumulated deficit (528,526 ) (486,614 ) Total
shareholders’ equity
124,527 48,456
Total liabilities and shareholders’ equity $
129,347 $ 50,536
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La Jolla Pharmaceutical CompanyGeorge F. Tidmarsh, M.D.,
Ph.D.President & Chief Executive OfficerPhone: (858)
207-4264Email: gtidmarsh@ljpc.comorDennis M. MulroyChief Financial
OfficerPhone: (858) 433-6839Email: dmulroy@ljpc.com
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