La Jolla Pharmaceutical Company Announces Fourth Quarter and Full Year 2015 Financial Results and Highlights Corporate Progress
Thursday, February 25, 2016 4:41:00 PM ET La
Jolla Pharmaceutical Company (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 Year Ended
December 31, December 31,
(unaudited)
------------------------------------------------------------------------------------------- -------------------------------------------------------------------------------------------
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, December 31,
2015 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, 2 2
18,244,009 and 15,225,980 shares issued and outstanding at December
31, 2015 and December 31, 2014, respectively
Series C-1(2) Convertible Preferred Stock, $0.0001 par 3,906 3,917
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
Series F Convertible Preferred Stock, $0.0001 par value; 10,000 2,737 2,798
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
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
===== ======= ==================== ======= ======= ====================
http://cts.businesswire.com/ct/CT?id=bwnews&sty=20160225006710r1&sid=cmtx6&distro=nx&lang=en
View source version on businesswire.com: http://www.businesswire.com/news/home/20160225006710/en/
SOURCE: La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
Phone: (858) 207-4264
Email: gtidmarsh@ljpc.com
or
Dennis M. Mulroy
Chief Financial Officer
Phone: (858) 433-6839
Email: dmulroy@ljpc.com
