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 nine months ended September 30, 2017 and
highlighted recent corporate progress.
Recent Corporate Progress
- In August 2017, La Jolla announced that
the U.S. Food and Drug Administration (FDA) accepted for
review the Company’s New Drug Application (NDA) for the
investigational drug LJPC-501, La Jolla’s propriety formulation of
synthetic human angiotensin II, for the treatment of hypotension in
adult patients with distributive or vasodilatory shock (dangerously
low blood pressure with adequate cardiac function) who remain
hypotensive despite fluid and vasopressor therapy (catecholamines
and/or vasopressin). The review classification for the application
is Priority, and the user fee goal date under the Prescription Drug
User Fee Act (PDUFA) is February 28, 2018. In its letter to the
Company, the FDA stated that it does not currently plan to hold an
advisory committee meeting to discuss this application. The NDA for
LJPC-501 is based on data from the ATHOS-3 (Angiotensin II for the
Treatment of High Output Shock) multicenter, randomized,
double-blind, placebo-controlled, Phase 3 clinical study of
LJPC-501 in patients with distributive or vasodilatory shock who
remain hypotensive despite fluid and vasopressor therapy, which
were published by The New England Journal of Medicine in May
2017.
- In September 2017, an analysis from
ATHOS-3 entitled, “Baseline angiotensin levels and ACE effects in
patients with vasodilatory shock treated with angiotensin II,” was
presented during the 30th European Society of Intensive Care
Medicine Annual Congress. The pre-specified analysis showed that a
relatively low angiotensin II state (as measured by the ratio of
angiotensin I to angiotensin II) predicted increased mortality in
patients with vasodilatory shock, suggesting that a low angiotensin
II state is a negative prognostic indicator of outcomes.
Furthermore, the analysis showed a statistically significant
treatment effect of LJPC-501 compared to placebo on mortality in
these patients with a relatively low angiotensin II state (relative
risk reduction of 36%; HR=0.64; 95% CI: 0.41-1.00; p=0.047).
- In September 2017, La Jolla announced
that the European Medicines Agency’s (EMA) Committee for Medicinal
Products for Human Use (CHMP) issued favorable Scientific Advice
regarding the EU regulatory pathway for LJPC-501 for the treatment
of hypotension in adult patients with distributive or vasodilatory
shock who remain hypotensive despite fluid and vasopressor therapy.
Based on this Advice, La Jolla intends to submit a Marketing
Authorization Application (MAA) for LJPC-501 in the third quarter
of 2018.
“The first nine months of 2017 have been exciting for La Jolla,
highlighted by the positive results from ATHOS-3, the publication
of these results in The New England Journal of Medicine and the FDA
acceptance of our NDA for LJPC-501,” said George Tidmarsh, M.D.,
Ph.D., President and Chief Executive Officer of La Jolla. “We look
forward to building on this momentum with the preparation for the
potential commercial launch of LJPC-501, if approved by the FDA,
and the initiation of our pivotal study of LJPC-401 in beta
thalassemia patients suffering from iron overload.”
Results of Operations
As of September 30, 2017, the Company had $120.8 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 nine months ended September 30, 2017 was $60.4
million, compared to $40.1 million for the same period in 2016. Net
loss for the three and nine months ended September 30, 2017 was
$26.3 million and $76.3 million, or $1.19 per share and $3.65 per
share, respectively, compared to a net loss of $21.3 million and
$53.3 million, or $1.23 per share and $3.10 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 hypotension in adult patients with
distributive or vasodilatory shock who remain hypotensive despite
fluid and vasopressor therapy. 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. 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 and prospects for
approval of LJPC-501 by the FDA, EMA and other regulatory
authorities; risks relating to the scope of product labels (if
approved); potential market sizes; the anticipated timing for
regulatory actions; the impact of pharmaceutical industry
regulation and health care legislation in the Europe and the
United States; 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 September 30,
Nine Months Ended
September 30,
2017 2016 2017 2016
Revenue Contract revenue - related party $ — $ 44
$ — $ 531 Total revenue — 44 —
531
Expenses Research and development 19,093
16,992 57,666 42,111 General and administrative 7,390 4,349
18,915 11,868 Total expenses 26,483
21,341 76,581 53,979 Loss from operations
(26,483 ) (21,297 ) (76,581 ) (53,448 ) Other income, net 195
46 324 150
Net loss $
(26,288 ) $ (21,251 ) $
(76,257 ) $ (53,298 ) Basic
and diluted net loss per share $ (1.19 )
$ (1.23 ) $ (3.65 )
$ (3.10 ) Weighted-average common shares
outstanding - basic and diluted 22,125 17,211 20,900
17,211
LA JOLLA PHARMACEUTICAL
COMPANY Condensed Consolidated Balance Sheets
(in thousands, except share and par value
amounts)
September 30, 2017
December 31, 2016
(Unaudited) ASSETS Current assets: Cash and cash
equivalents $ 120,840 $ 65,726 Restricted cash 911 200 Prepaid
expenses and other current assets 1,772 1,505 Total
current assets 123,523 67,431 Property and equipment, net 6,534
3,145 Other assets — 219
Total assets $
130,057 $ 70,795
LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities:
Accounts payable $ 6,239 $ 6,652 Accrued clinical and other
expenses 795 1,029 Accrued payroll and related expenses 3,228
2,077 Total current liabilities 10,262 9,758
Shareholders’ equity: Common Stock, $0.0001 par value;
100,000,000 shares authorized, 22,145,243 and 18,261,557 shares
issued and outstanding at September 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 September 30, 2017 and December 31, 2016, and
liquidation preference of $3,906 at September 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 September 30, 2017 and December 31, 2016, and
liquidation preference of $2,737 at September 30, 2017 and December
31, 2016 2,737 2,737 Additional paid-in capital 796,118 661,103
Accumulated deficit (682,968 ) (606,711 ) Total shareholders’
equity 119,795 61,037
Total liabilities and
shareholders’ equity $ 130,057 $
70,795
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version on businesswire.com: http://www.businesswire.com/news/home/20171026006645/en/
La Jolla Pharmaceutical CompanySandra VedrickAssociate Director,
Investor Relations & Human Resources(858)
256-7910svedrick@ljpc.comorLa Jolla Pharmaceutical CompanyDennis M.
MulroyChief Financial Officer(858) 433-6839dmulroy@ljpc.com
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