La Jolla Pharmaceutical Company Announces Financial Results for the Three Months Ended March 31, 2018 and Recent Corporate Pr...
May 10 2018 - 4:45PM
La Jolla Pharmaceutical Company (Nasdaq:LJPC), a leader in the
discovery, development and commercialization of innovative
therapies intended to significantly improve outcomes in patients
suffering from life-threatening diseases, today announced financial
results for the three months ended March 31, 2018 and highlighted
recent corporate progress.
Recent Corporate Progress
- In May 2018, La Jolla closed a $125 million royalty financing
agreement with HealthCare Royalty Partners (HCR). Under the terms
of the agreement, La Jolla will receive $125 million in exchange
for tiered royalty payments on worldwide net sales of GIAPREZA.
Payments under the agreement start annually at a maximum royalty
rate, with step-downs based on the achievement of annual net sales
thresholds. Through December 31, 2021, the royalty rate will be a
maximum of 10%. Starting January 1, 2022, the maximum royalty rate
may increase by 4% if an agreed-upon, cumulative sales threshold
has not been met, and, starting January 1, 2024, the maximum
royalty rate may increase by an additional 4% if a different
agreed-upon, cumulative sales threshold has not been met. The
agreement is subject to maximum aggregate royalty payments to HCR
of 180% of the $125 million to be received by La Jolla, at which
time the payment obligations under the agreement would expire. The
agreement was entered into by La Jolla’s wholly owned subsidiary,
La Jolla Pharma, LLC, and HCR has no recourse under the agreement
against La Jolla or any assets other than
GIAPREZA.
- In March 2018, La Jolla announced the commercial availability
of GIAPREZA™ (angiotensin II) injection for intravenous
infusion (formerly known as LJPC-501). In December 2017,
GIAPREZA 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.
Prescribing information for GIAPREZA is available
at www.giapreza.com.
- In March 2018, an analysis, entitled “Outcomes in Patients with
Acute Kidney Injury Receiving Angiotensin II for Vasodilatory
Shock,” was presented at the 23rd International Conference on
Advances in Critical Care Nephrology AKI & CRRT 2018. The
manuscript of this analysis, entitled “Outcomes in patients with
vasodilatory shock and renal replacement therapy treated with
intravenous angiotensin II,” was published online in Critical Care
Medicine. The presentation and manuscript detail the outcomes of
patients with acute kidney injury (AKI) and vasodilatory shock
enrolled in the ATHOS-3 (Angiotensin II for the Treatment
of High-Output Shock) Phase 3 study of GIAPREZA. In this
post-hoc analysis, the data from 105 AKI patients (GIAPREZA n=45;
placebo n=60) requiring renal replacement therapy (RRT) at study
drug initiation were analyzed. Survival through day 28 was 53% (95%
CI: 38%-67%) for the GIAPREZA group compared to 30% (95% CI:
19%-41%) for the placebo group (p = 0.012). By day 7, 38% (95% CI:
25%-54%) of patients treated with GIAPREZA discontinued RRT
compared to 15% (95% CI: 8%-27%) of patients treated with placebo
(p = 0.007). Mean arterial pressure (MAP) response at hour 3 was
achieved in 53% (95% CI: 38%-68%) of patients treated with GIAPREZA
compared to 22% (95% CI: 12%-34%) of patients treated with placebo
(p = 0.001).
- In February 2018, an abstract, entitled “Effect of Disease
Severity on Survival in Patients Receiving Angiotensin II for
Vasodilatory Shock,” was presented at the Society of Critical Care
Medicine’s (SCCM) 47th Critical Care Congress. The abstract, which
was published in the January Supplement of Critical Care Medicine,
includes results from a pre-specified analysis from the ATHOS-3
Phase 3 study of GIAPREZA in patients with high severity of
illness, defined as an APACHE II (Acute Physiology and Chronic
Health Evaluation II) score > 30 or baseline MAP < 65 mmHg,
despite treatment with high-dose vasopressors. The authors
presented data showing a lower 28-day mortality rate in patients
with baseline APACHE II scores > 30 in the GIAPREZA group versus
the placebo group: 28-day mortality was 51.8% (n = 58) for the
GIAPREZA group compared to 70.8% (n = 65) for the placebo group
(hazard ratio=0.62 [95% CI: 0.39, 0.98; p=0.037]). In patients with
a baseline MAP < 65 mmHg, a trend towards improved 28-day
mortality was seen in the GIAPREZA group compared to the placebo
group: 28-day mortality was 54.2% (n = 52) for the GIAPREZA group
compared to 70.4% (n = 50) for the placebo group (hazard ratio=0.66
[95% CI: 0.40, 1.09; p=0.10]).
“This first quarter was the start of an exciting and
transformational year for La Jolla, highlighted by the commercial
launch 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 March 31, 2018, La Jolla had $154.4 million in cash and
cash equivalents, compared to $90.9 million as of December 31,
2017. On a pro-forma basis, adjusting for the net proceeds from the
May 2018 royalty financing, La Jolla’s cash and cash equivalents as
of March 31, 2018 were $279 million. Cash used for operating
activities for the three months ended March 31, 2018 was $45.9
million, compared to $22.0 million for the same period in 2017. La
Jolla recognized GIAPREZA net product sales of $0.8 million for the
three months ended March 31, 2018. La Jolla launched GIAPREZA in
March 2018. La Jolla’s net loss for the three months ended March
31, 2018 was $50.5 million, or $2.22 per share, compared to $23.2
million, or $1.26 per share, for the same period in 2017.
About Septic or Other Distributive Shock
Over one million Americans are affected by shock on an annual
basis, with one in three patients being treated for shock in the
intensive care unit. Distributive shock is the most common type of
shock in the inpatient setting with approximately 800,000
distributive shock cases in the U.S. per year. Of these cases, an
estimated 90% are septic shock patients. Approximately 300,000 do
not achieve adequate blood pressure response with standard of care
vasopressor therapy (catecholamines and vasopressin). The inability
to achieve or maintain adequate blood pressure results in
inadequate blood flow to the body’s organs and tissue and is
associated with a mortality rate exceeding most acute conditions
requiring hospitalization.
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. Prescribing information for GIAPREZA is
available at www.giapreza.com.
IMPORTANT SAFETY INFORMATION
Contraindications
None
Warnings and Precautions
There is a potential for venous and arterial thrombotic and
thromboembolic events in patients who receive GIAPREZA. Use
concurrent venous thromboembolism (VTE) prophylaxis.
Adverse Reactions
The most common adverse reactions that were reported in greater
than 10% of GIAPREZA-treated patients were thromboembolic
events.
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,
including post-approval studies for GIAPREZA; the successful and
timely completion of clinical trials; unforeseen safety issues from
the administration of product and product candidates in patients;
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
Unaudited Condensed Consolidated
Statements of Operations(in thousands, except per share
amounts)
|
Three Months Ended March
31, |
|
2018 |
|
2017 |
Revenue |
|
|
|
Net
product sales |
$ |
809 |
|
|
$ |
— |
|
Total revenue |
809 |
|
|
— |
|
Operating
expenses |
|
|
|
Cost of
product sales |
58 |
|
|
— |
|
Research
and development |
28,429 |
|
|
17,765 |
|
Selling,
general and administrative |
23,016 |
|
|
5,503 |
|
Total operating
expenses |
51,503 |
|
|
23,268 |
|
Loss from
operations |
(50,694 |
) |
|
(23,268 |
) |
Other income, net |
166 |
|
|
28 |
|
Net
loss |
$ |
(50,528 |
) |
|
$ |
(23,240 |
) |
Net loss per
share, basic and diluted |
$ |
(2.22 |
) |
|
$ |
(1.26 |
) |
Weighted-average common
shares outstanding, basic and diluted |
22,742 |
|
|
18,410 |
|
LA JOLLA PHARMACEUTICAL
COMPANY
Condensed Consolidated Balance
Sheets(in thousands, except share and par value
amounts)
|
March 31, 2018 |
|
December 31, 2017 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and
cash equivalents |
$ |
154,408 |
|
|
$ |
90,915 |
|
Inventory |
820 |
|
|
— |
|
Prepaid
expenses and other current assets |
6,326 |
|
|
3,147 |
|
Total
current assets |
161,554 |
|
|
94,062 |
|
Property and equipment,
net |
24,438 |
|
|
24,568 |
|
Restricted cash |
909 |
|
|
909 |
|
Total
assets |
$ |
186,901 |
|
|
$ |
119,539 |
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
7,321 |
|
|
$ |
11,484 |
|
Accrued
clinical and other expenses |
4,280 |
|
|
703 |
|
Accrued
payroll and related expenses |
3,044 |
|
|
4,995 |
|
Deferred
rent, current portion |
1,370 |
|
|
1,370 |
|
Total
current liabilities |
16,015 |
|
|
18,552 |
|
Deferred rent, less
current portion |
13,473 |
|
|
12,785 |
|
Total
liabilities |
29,488 |
|
|
31,337 |
|
Shareholders’
equity: |
|
|
|
Common
Stock, $0.0001 par value; 100,000,000 shares authorized, 26,154,439
and 22,167,529 shares issued and outstanding at March 31, 2018 and
December 31, 2017, respectively |
3 |
|
|
2 |
|
Series
C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares
authorized, 3,906 shares issued and outstanding at March 31, 2018
and December 31, 2017, and liquidation preference of $3,906 at
March 31, 2018 and December 31, 2017 |
3,906 |
|
|
3,906 |
|
Series F
Convertible Preferred Stock, $0.0001 par value; 10,000 shares
authorized, 2,737 shares issued and outstanding at March 31, 2018
and December 31, 2017, and liquidation preference of $2,737 at
March 31, 2018 and December 31, 2017 |
2,737 |
|
|
2,737 |
|
Additional paid-in capital |
922,809 |
|
|
803,071 |
|
Accumulated deficit |
(772,042 |
) |
|
(721,514 |
) |
Total shareholders’ equity |
157,413 |
|
|
88,202 |
|
Total
liabilities and shareholders’ equity |
$ |
186,901 |
|
|
$ |
119,539 |
|
|
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
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