La Jolla Pharmaceutical Company (Nasdaq: LJPC), which is
dedicated to the development and commercialization of innovative
therapies that improve outcomes in patients suffering from
life-threatening diseases, today announced financial results for
the three and twelve months ended December 31, 2019.
For the three months ended December 31, 2019, GIAPREZA U.S.
net sales were $7.3 million, up 74% from the three months ended
December 31, 2018 and up 28% from the three months
ended September 30, 2019. Vials of GIAPREZA shipped from
distributors to hospitals (hospital demand) grew 74% for the three
months ended December 31, 2019 as compared to the
three months ended December 31, 2018 and 18% as
compared to the three months ended September 30, 2019.
GIAPREZA U.S. net sales were $23.1 million in 2019 compared to
$10.1 million in 2018, an increase of 129%. La Jolla announced the
commercial availability of GIAPREZA in the U.S. in March
2018.
La Jolla’s net loss for the three and twelve months ended
December 31, 2019 was $25.2 million and $116.5 million, or $0.93
per share and $4.30 per share, respectively, compared to $45.4
million and $199.5 million, or $1.73 per share and $7.85 per share,
respectively, for the same periods in 2018.
As of December 31, 2019, La Jolla had $87.8 million in
cash, compared to $172.6 million as of December 31, 2018. Net
cash used in operating activities for the three and twelve months
ended December 31, 2019 was $17.1 million and $85.0 million,
respectively, compared to $32.0 million and $152.4 million,
respectively, for the same periods in 2018. La Jolla has no
debt.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) 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 August 2019, GIAPREZA was approved by the
European Commission (EC) for the treatment of refractory
hypotension in adults with septic or other distributive shock who
remain hypotensive despite adequate volume restitution and
application of catecholamines and other available vasopressor
therapies. GIAPREZA mimics the body’s endogenous angiotensin II
peptide, which is central to the renin-angiotensin-aldosterone
system, which in turn regulates blood pressure. Prescribing
information for GIAPREZA is available at www.giapreza.com. GIAPREZA
is marketed by La Jolla Pharmaceutical Company on behalf of La
Jolla Pharma, LLC, its wholly owned subsidiary.
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 (ARBs) 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 for the
United States.
About LJPC-0118
LJPC-0118 (I.V. artesunate) is La Jolla’s investigational
product for the treatment of severe malaria. The active
pharmaceutical ingredient in LJPC-0118, artesunate, was compared to
quinine in patients with severe falciparum malaria infection in two
randomized, active-controlled, clinical studies. In both studies,
in-hospital mortality in the artesunate group was statistically
significantly lower than in-hospital mortality in the quinine
group. The U.S. Food and Drug Administration (FDA) granted
Breakthrough Therapy designation and Orphan Drug designation for
LJPC-0118 for the treatment of malaria in April 2019 and July 2019,
respectively. La Jolla filed a New Drug Application (NDA) with the
FDA for LJPC-0118 for the treatment of severe malaria in the second
half of 2019. Severe malaria is a serious and sometimes fatal
disease caused by a parasite that commonly infects a certain type
of mosquito. Symptoms include: fever, chills, sweating,
hypoglycemia and shock. In 2013, an estimated 2 million cases of
severe malaria occurred worldwide. In 2018, an estimated 405,000
people died from malaria worldwide.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is dedicated to the development
and commercialization of innovative therapies that improve outcomes
in patients suffering from life-threatening diseases. In December
2017, GIAPREZA™ (angiotensin II) 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 August 2019, GIAPREZA was approved by the European
Commission (EC) for the treatment of refractory hypotension in
adults with septic or other distributive shock who remain
hypotensive despite adequate volume restitution and application of
catecholamines and other available vasopressor therapies. LJPC-0118
(artesunate) is La Jolla’s investigational product for the
treatment of severe malaria. For more information, please visit
www.ljpc.com.
Forward-looking Statements
This press release contains “forward-looking statements” as
defined by the Private Securities Litigation Reform Act of 1995. We
caution investors that forward-looking statements are based on
management’s expectations and assumptions as of the date of this
press release and involve substantial risks and uncertainties that
could cause the actual outcomes to differ materially from what we
currently expect. These risks and uncertainties include, but are
not limited to, those associated with: GIAPREZA™ (angiotensin II)
sales; regulatory actions relating to La Jolla’s products by the
U.S. Food and Drug Administration (FDA), European Commission and/or
other regulatory authorities; cash used in operating activities and
our capital requirements; and other risks and uncertainties
identified in our filings with the U.S. Securities and Exchange
Commission. Forward-looking statements in this press release apply
only as of the date made, and we undertake no obligation to update
or revise any forward-looking statements to reflect subsequent
events or circumstances.
LA JOLLA PHARMACEUTICAL
COMPANY
Consolidated Balance Sheets(in
thousands, except par value and share amounts)
|
December 31, 2019 |
|
December 31, 2018 |
|
|
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash |
$ |
87,820 |
|
|
$ |
172,604 |
|
Accounts receivable, net |
2,960 |
|
|
1,381 |
|
Inventory, net |
2,211 |
|
|
2,020 |
|
Prepaid expenses and other current assets |
4,467 |
|
|
5,111 |
|
Total current assets |
97,458 |
|
|
181,116 |
|
Property and equipment,
net |
18,389 |
|
|
22,267 |
|
Right-of-use lease asset |
15,491 |
|
|
— |
|
Restricted cash |
909 |
|
|
909 |
|
Total
assets |
$ |
132,247 |
|
|
$ |
204,292 |
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS’ (DEFICIT) EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
4,177 |
|
|
$ |
8,572 |
|
Accrued expenses |
9,312 |
|
|
8,485 |
|
Accrued payroll and related expenses |
8,332 |
|
|
7,509 |
|
Lease liability, current portion |
2,766 |
|
|
— |
|
Deferred rent, current portion |
— |
|
|
1,370 |
|
Total current liabilities |
24,587 |
|
|
25,936 |
|
Lease liability, less current
portion |
26,481 |
|
|
— |
|
Deferred rent, less current
portion |
— |
|
|
13,609 |
|
Deferred royalty obligation,
net |
124,379 |
|
|
124,323 |
|
Other noncurrent
liabilities |
12,790 |
|
|
4,503 |
|
Total
liabilities |
188,237 |
|
|
168,371 |
|
Shareholders’ (deficit)
equity: |
|
|
|
Common Stock, $0.0001 par value; 100,000,000 shares
authorized,27,195,469 and 26,259,254 shares issued and outstanding
at December 31, 2019 and December 31, 2018, respectively |
3 |
|
|
3 |
|
Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000
shares authorized,3,906 shares issued and outstanding at December
31, 2019 and December 31, 2018; and liquidation preference of
$3,906 at December 31, 2019 and December 31, 2018 |
3,906 |
|
|
3,906 |
|
Series F Convertible Preferred Stock, $0.0001 par value; 10,000
shares authorized,0 and 2,737 shares issued and outstanding at
December 31, 2019 and December 31, 2018, respectively; and
liquidation preference of $0 and $2,737 at December 31, 2019 and
December 31, 2018, respectively |
— |
|
|
2,737 |
|
Additional paid-in capital |
977,432 |
|
|
950,258 |
|
Accumulated deficit |
(1,037,331 |
) |
|
(920,983 |
) |
Total shareholders’ (deficit) equity |
(55,990 |
) |
|
35,921 |
|
Total liabilities and
shareholders’ (deficit) equity |
$ |
132,247 |
|
|
$ |
204,292 |
|
LA JOLLA PHARMACEUTICAL
COMPANY
Consolidated Statements of
Operations(in thousands, except per share amounts)
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Revenue |
|
|
|
|
|
|
|
Net product sales |
$ |
7,250 |
|
|
$ |
4,184 |
|
|
$ |
23,054 |
|
|
$ |
10,056 |
|
Total revenue |
7,250 |
|
|
4,184 |
|
|
23,054 |
|
|
10,056 |
|
Operating
expenses |
|
|
|
|
|
|
|
Cost of product sales |
787 |
|
|
1,200 |
|
|
2,392 |
|
|
1,643 |
|
Research and development |
20,860 |
|
|
27,567 |
|
|
85,329 |
|
|
117,302 |
|
Selling, general and administrative |
10,709 |
|
|
18,843 |
|
|
45,134 |
|
|
85,162 |
|
Total operating expenses |
32,356 |
|
|
47,610 |
|
|
132,855 |
|
|
204,107 |
|
Loss from operations |
(25,106 |
) |
|
(43,426 |
) |
|
(109,801 |
) |
|
(194,051 |
) |
Other (expense)
income |
|
|
|
|
|
|
|
Interest expense |
(2,376 |
) |
|
(2,722 |
) |
|
(10,774 |
) |
|
(7,303 |
) |
Interest income |
310 |
|
|
730 |
|
|
2,128 |
|
|
1,885 |
|
Other income—related party |
1,939 |
|
|
— |
|
|
1,939 |
|
|
— |
|
Total other expense, net |
(127 |
) |
|
(1,992 |
) |
|
(6,707 |
) |
|
(5,418 |
) |
Net loss |
$ |
(25,233 |
) |
|
$ |
(45,418 |
) |
|
$ |
(116,508 |
) |
|
$ |
(199,469 |
) |
Net loss per share,
basic and diluted |
$ |
(0.93 |
) |
|
$ |
(1.73 |
) |
|
$ |
(4.30 |
) |
|
$ |
(7.85 |
) |
Weighted-average common shares
outstanding, basic and diluted |
27,169 |
|
|
26,242 |
|
|
27,112 |
|
|
25,422 |
|
LA JOLLA PHARMACEUTICAL
COMPANY
Consolidated Statements of Cash
Flows(in thousands)
|
Year Ended December 31, |
|
2019 |
|
2018 |
Operating
activities |
|
|
|
Net loss |
$ |
(116,508 |
) |
|
$ |
(199,469 |
) |
Adjustments to reconcile net
loss to net cash used for operating activities: |
|
|
|
Share-based compensation expense |
23,733 |
|
|
35,151 |
|
Depreciation and amortization expense |
4,552 |
|
|
4,405 |
|
Loss on disposal of equipment |
24 |
|
|
236 |
|
Non-cash interest expense |
8,775 |
|
|
6,797 |
|
Non-cash rent expense |
1,307 |
|
|
— |
|
Changes in operating assets
and liabilities: |
|
|
|
Accounts receivable, net |
(1,579 |
) |
|
(1,381 |
) |
Inventory, net |
(191 |
) |
|
(2,020 |
) |
Prepaid expenses and other current assets |
644 |
|
|
(1,964 |
) |
Accounts payable |
(4,395 |
) |
|
(2,912 |
) |
Accrued expenses |
395 |
|
|
5,451 |
|
Accrued payroll and related expenses |
823 |
|
|
2,514 |
|
Lease liability |
(2,530 |
) |
|
— |
|
Deferred rent |
— |
|
|
824 |
|
Net cash used for operating
activities |
(84,950 |
) |
|
(152,368 |
) |
Investing
activities |
|
|
|
Purchase of property and equipment |
(698 |
) |
|
(2,340 |
) |
Net cash used for investing
activities |
(698 |
) |
|
(2,340 |
) |
Financing
activities |
|
|
|
Net proceeds from issuance of common stock under ESPP |
833 |
|
|
391 |
|
Net proceeds from issuance of common stock under 2013 Equity
Plan |
31 |
|
|
1,908 |
|
Net proceeds from royalty financing |
— |
|
|
124,289 |
|
Net proceeds from the issuance of common stock |
— |
|
|
109,809 |
|
Net cash provided by financing
activities |
864 |
|
|
236,397 |
|
Net (decrease)
increase in cash and restricted cash |
(84,784 |
) |
|
81,689 |
|
Cash and restricted cash at
beginning of period |
173,513 |
|
|
91,824 |
|
Cash and restricted
cash at end of period |
$ |
88,729 |
|
|
$ |
173,513 |
|
Supplemental
disclosure of non-cash investing and financing
activities |
|
|
|
Conversion of Series F
Convertible Preferred Stock into common stock |
$ |
2,737 |
|
|
$ |
— |
|
Cumulative-effect adjustment
from adoption of ASU 2018-07 |
$ |
(160 |
) |
|
$ |
— |
|
Initial recognition of
right-of-use lease asset |
$ |
16,798 |
|
|
$ |
— |
|
Interest paid |
$ |
1,999 |
|
|
$ |
506 |
|
Reconciliation of cash
and restricted cash to the consolidated balance
sheets |
|
|
|
Cash |
$ |
87,820 |
|
|
$ |
172,604 |
|
Restricted cash |
909 |
|
|
909 |
|
Total cash and
restricted cash |
$ |
88,729 |
|
|
$ |
173,513 |
|
Company Contacts
Sandra VedrickSenior Director, Investor RelationsLa Jolla
Pharmaceutical CompanyPhone: (858) 207-4264 Ext: 1135Email:
svedrick@ljpc.com
and
Dennis MulroyChief Financial OfficerLa Jolla Pharmaceutical
CompanyPhone: (858) 207-4264 Ext: 1040Email: dmulroy@ljpc.com
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