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 2016 financial results and highlighted 2016 corporate
progress.
2016 Corporate Progress
- In the fourth quarter of 2016, La
Jolla’s ATHOS (Angiotensin II
for the Treatment of
High-Output Shock) 3 Phase 3 trial completed patient
enrollment. ATHOS 3 is La Jolla’s 344-patient, multicenter,
randomized, double-blind, placebo-controlled, Phase 3 clinical
trial of LJPC-501, the Company’s proprietary formulation of
angiotensin II, in catecholamine-resistant hypotension (CRH).
Top-line results are expected in the first quarter of 2017.
- In the fourth quarter of 2016, the
European Medicines Agency (EMA) Committee for Orphan Medicinal
Products (COMP) designated LJPC-401, the Company’s novel
formulation of synthetic human hepcidin, as an orphan medicinal
product for the treatment of sickle cell disease (SCD).
- In the third quarter of 2016, La Jolla
reported positive results from a multicenter, open-label,
dose-escalation Phase 1 trial of LJPC-401 in patients at risk for
iron overload due to conditions such as hereditary hemochromatosis
(HH), thalassemia, and SCD. LJPC-401 was well tolerated, and there
were no dose-limiting toxicities observed. Furthermore, a
dose-dependent, statistically significant reduction in serum iron
was observed.
- In the third quarter of 2016, La Jolla
reached agreement with the EMA on the design of a pivotal trial of
LJPC-401. The pivotal trial will be a randomized, controlled,
multicenter trial in beta thalassemia patients suffering from iron
overload, a major unmet need in an orphan patient population. The
primary endpoint will be a clinically relevant measurement directly
related to iron overload. La Jolla plans to initiate this pivotal
trial in mid-2017.
“2016 was a productive year for La Jolla, highlighted by the
completion of enrollment of our ATHOS 3 Phase 3 trial of LJPC-501
and encouraging results from our Phase 1 trial of LJPC-401,” said
George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief
Executive Officer. “We look forward to an exciting 2017, with the
expected reporting of top-line results from our ATHOS 3 Phase 3
trial of LJPC-501 in the first quarter of 2017 and the initiation
of our pivotal trial for LJPC-401 in mid-2017.”
Results of Operations
As of December 31, 2016, La Jolla had $65.7 million in cash and
cash equivalents, compared to $126.5 million as of December 31,
2015. 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, 2016 was $18.6 million and
$58.7 million, respectively, compared to net cash used for
operating activities of $8.5 million and $25.2 million,
respectively, for the same periods in 2015. La Jolla’s net loss for
the three and twelve months ended December 31, 2016 was $24.9
million and $78.2 million, or $1.44 per share and $4.54 per share,
respectively, compared to a net loss of $11.8 million and $41.9
million, or $0.69 per share and $2.68 per share, respectively, for
the same periods in 2015. During the three and twelve months ended
December 31, 2016, La Jolla recognized contract revenue of
approximately $0.1 million and $0.6 million, respectively, compared
to contract revenue of $0.4 million and $1.1 million, respectively,
for the same periods in 2015. The net loss for the three and twelve
months ended December 31, 2016 includes non-cash, share-based
compensation expense of $3.6 million and $14.5 million,
respectively, compared to non-cash, share-based compensation
expense of $2.7 million and $13.1 million, respectively, for the
same periods in 2015. The increases in net cash used for operating
activities and net loss in 2016 as compared to 2015 were primarily
due to increased development costs associated with LJPC-501 and
LJPC-401.
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 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
therapeutics for 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 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 website 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, the anticipated timing for the Company’s filing of new
drug applications or similar filings for regulatory approval, and
the anticipated timing for regulatory actions; the success of
current and 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,
2016 2015 2016
2015 Revenue Contract revenue - related
party $ 85 $ 410 $ 616 $ 1,057 Total
revenue 85 410 616
1,057
Expenses Research and development 20,177 9,455
62,288 29,092 General and administrative 4,832
2,813 16,700 13,934 Total
expenses 25,009 12,268 78,988
43,026 Loss from operations (24,924 ) (11,858
) (78,372 )
(41,969
)
Other income, net 37 25 187
57
Net loss $ (24,887
) $ (11,833 )
$
(78,185
)
$
(41,912
)
Basic and diluted net loss per share $ (1.44
) $ (0.69 ) $ (4.54
)
$
(2.68
)
Shares used in computing basic and diluted net loss per share
17,280 17,200 17,228
15,651
LA JOLLA PHARMACEUTICAL
COMPANY Consolidated Balance Sheets
(in thousands, except share and par value
amounts)
December 31,
December 31, 2016 2015 ASSETS
Current assets: Cash and cash equivalents $ 65,726 $ 126,467
Restricted cash 200 237 Prepaid clinical expenses 67 223 Prepaid
expenses and other current assets 1,438 618
Total current assets 67,431 127,545 Property and equipment,
net 3,145 1,732 Other assets 219 70
Total assets $ 70,795 $
129,347 LIABILITIES AND SHAREHOLDERS’
EQUITY Current liabilities: Accounts payable $ 6,652 $ 3,052
Accrued clinical and other expenses 1,029 678 Accrued payroll and
related expenses 2,077 1,090 Total
current liabilities 9,758 4,820
Commitments and contingencies Shareholders’ equity: Common Stock,
$0.0001 par value; 100,000,000 shares authorized, 18,261,557 and
18,244,009 shares issued and outstanding at December 31, 2016 and
December 31, 2015, respectively 2 2 Series C-12 Convertible
Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906
shares issued and outstanding at December 31, 2016 and December 31,
2015, and a liquidation preference of $3,906 at December 31, 2016
and 2015 3,906 3,906 Series F Convertible Preferred Stock, $0.0001
par value; 10,000 shares authorized, 2,737 shares issued and
outstanding at December 31, 2016 and December 31, 2015, and
liquidation preference of $2,737 at December 31, 2016 and 2015
2,737 2,737 Additional paid-in capital 661,103 646,408 Accumulated
deficit (606,711 ) (528,526 ) Total shareholders’
equity
61,037 124,527
Total liabilities and shareholders’ equity $
70,795 $ 129,347
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version on businesswire.com: http://www.businesswire.com/news/home/20170223006732/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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