La Jolla Pharmaceutical Company Announces Financial Results for the Three and Twelve Months Ended December 31, 2017 and Recen...
February 22 2018 - 5:17PM
La Jolla Pharmaceutical Company (Nasdaq:LJPC), a leader in the
development of innovative therapies intended to significantly
improve outcomes in patients suffering from life-threatening
diseases, today announced financial results for the three and
twelve months ended December 31, 2017 and highlighted recent
corporate progress.
Recent Corporate Progress
- In December 2017, GIAPREZA™ (angiotensin II), injection
for intravenous infusion, formerly known as LJPC-501, was approved
by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor
indicated to increase blood pressure in adults with septic or other
distributive shock.
- In December 2017, La Jolla announced the initiation of
LJ401-HH01, a multinational, multicenter, randomized,
placebo-controlled, double-blind, Phase 2 study that is designed to
evaluate the safety and efficacy of LJPC-401 (synthetic human
hepcidin) as a treatment for hereditary hemochromatosis (HH).
Approximately 60 patients in 5 countries will be randomized to
receive weekly subcutaneous injections of either LJPC-401 or
placebo for 12 weeks. The primary efficacy endpoint of the study is
the change in transferrin saturation, a standard measurement of
iron levels in the body and one of the two key measurements used to
detect iron overload, from baseline to end of treatment. Secondary
efficacy endpoints include: (i) the change in serum ferritin, the
other key measurement used to detect iron overload, from baseline
to end of treatment; and (ii) the requirement for and frequency of
phlebotomy procedures used during the study.
- In December 2017, La Jolla announced the initiation of
LJ401-BT01, a pivotal, multinational, multicenter, randomized,
controlled study of LJPC-401 in patients with transfusion-dependent
beta thalassemia who, despite chelation therapy, have cardiac iron
levels above normal. Approximately 100 patients in 9 countries,
including the U.S., will be randomized 1:1 to receive either: (i)
weekly subcutaneous injections of LJPC-401, while continuing
standard-of-care chelation therapy (LJPC-401 treatment arm); or
(ii) a continuation of standard-of-care chelation therapy only
(observation arm). After 6 months of treatment, patients randomized
to the observation arm will cross over to receive LJPC-401 (plus
standard-of-care chelation therapy) for 6 months, while patients
randomized to the LJPC-401 treatment arm will continue with
LJPC-401 (plus standard-of-care chelation therapy) for an
additional 6 months (for a total of one year). The primary efficacy
endpoint of this study is the change in iron content in the heart
after 6 months, as measured by cardiac magnetic resonance imaging
(MRI). If this study is successful, we would anticipate filing a
market authorization application (MAA) for LJPC-401 in Europe.
“2017 was an exciting year for La Jolla, highlighted by the
FDA’s approval of GIAPREZA,” said George Tidmarsh, M.D., Ph.D., La
Jolla’s President and Chief Executive Officer. “We are excited to
bring this new treatment option to the many critically ill patients
suffering from septic or other distributive shock.”
Results of Operations
As of December 31, 2017, La Jolla had $90.9 million in cash and
cash equivalents, compared to $65.7 as of December 31, 2016. La
Jolla’s net cash used for operating activities for the twelve
months ended December 31, 2017 was $84.9 million compared to net
cash used for operating activities of $58.7 million for the same
period in 2016. La Jolla’s net loss for the three and twelve months
ended December 31, 2017 was $38.5 million and $114.8 million, or
$1.74 per share and $5.41 per share, respectively, compared to a
net loss of $24.9 million and $78.2 million, or $1.44 per share and
$4.54 per share, respectively, for the same periods in 2016.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was approved
by the U.S. Food and Drug Administration (FDA) to increase blood
pressure in adults with septic or other distributive shock.
GIAPREZA mimics the body’s endogenous regulatory peptide that is
central to the renin-angiotensin-aldosterone system to increase
blood pressure. In the ATHOS-3 Phase 3 study, the primary endpoint
of: (i) a mean arterial pressure (MAP) increase of ≥ 10 mmHg; or
(ii) a MAP of ≥ 75 mmHg, was achieved by 70% of patients randomized
to GIAPREZA, compared to 23% of patients randomized to placebo (p
< 0.0001); both arms were treated with standard-of-care
vasopressors. The recommended starting dosage of GIAPREZA is 20
nanograms (ng)/kg/min via continuous intravenous infusion. Close
monitoring during the first 5 minutes of GIAPREZA initiation is
recommended. GIAPREZA is available in 1 mL single dose vials, each
containing 2.5 mg of angiotensin II (as a sterile liquid).
Prescribing information for GIAPREZA is available at
www.giapreza.com.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
The safety of GIAPREZA was evaluated in 321 adults with septic
or other distributive shock in the randomized, double-blind,
placebo-controlled Phase 3 study, ATHOS-3. There was a higher
incidence of venous and arterial thrombotic and thromboembolic
events in patients who received GIAPREZA compared to
placebo-treated patients in the ATHOS-3 study [13% (21/163
patients) vs. 5% (8/158 patients)]. The major imbalance was in deep
venous thromboses. Use concurrent venous thromboembolism
prophylaxis.
Adverse Reactions
Adverse reactions that occurred in ≥4% of patients treated with
GIAPREZA and ≥1.5% more often than placebo-treated patients in the
ATHOS-3 study were thromboembolic events (including deep vein
thrombosis), thrombocytopenia, tachycardia, fungal infection,
delirium, acidosis, hyperglycemia and peripheral ischemia.
Drug Interactions
Angiotensin converting enzyme (ACE) inhibitors may increase
response to GIAPREZA. Angiotensin II receptor blockers (ARB) may
reduce response to GIAPREZA.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
For additional information, please see Full
Prescribing Information.
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.
GIAPREZA™ (angiotensin II), formerly known as LJPC-501, was
approved by the U.S. Food and Drug Administration
(FDA) on December 21, 2017 as a vasoconstrictor to
increase blood pressure in adults with septic or other distributive
shock. LJPC‑401 (synthetic human hepcidin), a clinical-stage
investigational product, is being developed 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, please visit
www.ljpc.com.
Forward-looking Statements
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 expectations regarding future
events or La Jolla’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. La Jolla 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 La Jolla’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: our ability to
successfully commercialize, market and achieve market acceptance of
GIAPREZA and other product candidates; potential market sizes,
including for septic or other distributive shock; the success of
development activities for LJPC-401 and other product candidates;
and other risks and uncertainties identified in our filings with
the SEC. Forward-looking statements are presented as of the date of
this press release, and La Jolla expressly disclaims any intent to
update any forward‑looking statements to reflect the outcome of
subsequent events.
|
LA JOLLA PHARMACEUTICAL COMPANY |
|
Consolidated Statements of
Operations |
(in thousands, except per share amounts) |
|
|
Three Months
Ended December 31, |
|
Year Ended December 31, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
Revenue |
|
|
|
|
|
|
|
Contract
revenue - related party |
$ |
— |
|
|
$ |
85 |
|
|
$ |
— |
|
|
$ |
616 |
|
Total revenue |
— |
|
|
85 |
|
|
— |
|
|
616 |
|
Operating
expenses |
|
|
|
|
|
|
|
Research
and development |
26,909 |
|
|
20,177 |
|
|
84,575 |
|
|
62,288 |
|
General
and administrative |
11,937 |
|
|
4,832 |
|
|
30,852 |
|
|
16,700 |
|
Total operating
expenses |
38,846 |
|
|
25,009 |
|
|
115,427 |
|
|
78,988 |
|
Loss from
operations |
(38,846 |
) |
|
(24,924 |
) |
|
(115,427 |
) |
|
(78,372 |
) |
Other income, net |
300 |
|
|
37 |
|
|
624 |
|
|
187 |
|
Net
loss |
$ |
(38,546 |
) |
|
$ |
(24,887 |
) |
|
$ |
(114,803 |
) |
|
$ |
(78,185 |
) |
Basic and
diluted net loss per share |
$ |
(1.74 |
) |
|
$ |
(1.44 |
) |
|
$ |
(5.41 |
) |
|
$ |
(4.54 |
) |
Weighted-average common
shares outstanding – basic and diluted |
22,151 |
|
|
17,280 |
|
|
21,215 |
|
|
17,228 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LA JOLLA PHARMACEUTICAL COMPANY |
|
Consolidated Balance Sheets |
(in thousands, except share and par value amounts) |
|
|
December 31,2017 |
|
December 31,2016 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and
cash equivalents |
$ |
90,915 |
|
|
$ |
65,726 |
|
Restricted cash, current portion |
— |
|
|
200 |
|
Prepaid
expenses and other current assets |
3,147 |
|
|
1,505 |
|
Total
current assets |
94,062 |
|
|
67,431 |
|
Property
and equipment, net |
24,568 |
|
|
3,145 |
|
Restricted cash, less current portion |
909 |
|
|
— |
|
Other
assets |
— |
|
|
219 |
|
Total
assets |
$ |
119,539 |
|
|
$ |
70,795 |
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
11,484 |
|
|
$ |
6,652 |
|
Accrued
clinical and other expenses |
703 |
|
|
905 |
|
Accrued
payroll and related expenses |
4,995 |
|
|
2,077 |
|
Deferred
rent, current portion |
1,370 |
|
|
124 |
|
Total
current liabilities |
18,552 |
|
|
9,758 |
|
Deferred rent, less
current portion |
12,785 |
|
|
— |
|
Total
liabilities |
31,337 |
|
|
9,758 |
|
Commitments and
contingencies |
|
|
|
Shareholders’
equity: |
|
|
|
Common
Stock, $0.0001 par value; 100,000,000 shares authorized, 22,167,529
and18,261,557 shares issued and outstanding at December 31, 2017
and December 31, 2016,respectively |
2 |
|
|
2 |
|
Series
C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares
authorized, 3,906shares issued and outstanding at December 31, 2017
and December 31, 2016, and aliquidation preference of $3,906
at December 31, 2017 and 2016 |
3,906 |
|
|
3,906 |
|
Series F
Convertible Preferred Stock, $0.0001 par value; 10,000 shares
authorized, 2,737shares issued and outstanding at December 31, 2017
and December 31, 2016, and aliquidation preference of $2,737
at December 31, 2017 and 2016 |
2,737 |
|
|
2,737 |
|
Additional paid-in capital |
803,071 |
|
|
661,103 |
|
Accumulated deficit |
(721,514 |
) |
|
(606,711 |
) |
Total
shareholders’ equity |
88,202 |
|
|
61,037 |
|
Total
liabilities and shareholders’ equity |
$ |
119,539 |
|
|
$ |
70,795 |
|
|
|
|
|
|
|
|
|
Company Contacts
Sandra VedrickDirector, Investor Relations & Human
ResourcesLa Jolla Pharmaceutical CompanyPhone: (858) 207-4264 Ext:
1135Email: svedrick@ljpc.com
and
Dennis M. MulroyChief Financial OfficerLa Jolla Pharmaceutical
CompanyPhone: (858) 207-4264 Ext: 1040Email:
dmulroy@ljpc.com
La Jolla Pharmaceutical (NASDAQ:LJPC)
Historical Stock Chart
From Aug 2024 to Sep 2024
La Jolla Pharmaceutical (NASDAQ:LJPC)
Historical Stock Chart
From Sep 2023 to Sep 2024