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 months ended March 31, 2021 and highlighted corporate
progress.
Corporate Progress
- Operating Cash Flow Improved: La Jolla’s net cash
provided by (used for) operating activities for the three months
ended March 31, 2021 was $17.2 million, compared to $(12.2) million
for the same period in 2020. La Jolla’s net cash provided by (used
for) operating activities excluding net receipts in connection with
license agreements and payments related to reductions in headcount
for the three months ended March 31, 2021 was $(1.8) million,
compared to $(9.2) million for the same period in 2020.
- $3.0 Million Milestone Payment Associated with NDA
Submission for XERAVA™ (Eravacycline) in China by Licensee Everest
Received: In March 2021, under its license agreement with
Everest Medicines Limited, the Company received a $3.0 million
milestone payment associated with the submission of a New Drug
Application (NDA) with the China National Medical Products
Administration (NMPA) for XERAVA for the treatment of cIAI in
patients in China. The Company previously granted Everest an
exclusive license to develop and commercialize XERAVA for the
treatment of cIAI and other indications in mainland China, Taiwan,
Hong Kong, Macau, South Korea, Singapore, the Malaysian Federation,
the Kingdom of Thailand, the Republic of Indonesia, the Socialist
Republic of Vietnam and the Republic of the Philippines. The
Company is eligible to receive an additional $8.0 million
regulatory milestone payment and up to an aggregate of $20.0
million in sales milestone payments. The Company is also entitled
to receive royalties from Everest on sales, if any, by Everest of
products containing eravacycline.
- License Agreement for GIAPREZA™ (Angiotensin II) and XERAVA
in Europe, which Included a $22.5 Million Upfront Payment, Executed
with PAION: In January 2021, the Company entered into a license
agreement with PAION AG to commercialize GIAPREZA and XERAVA in the
European Economic Area, the United Kingdom and Switzerland.
Pursuant to the agreement: (i) the Company has received an upfront
cash payment of $22.5 million, less a 15% refundable withholding
tax; and (ii) the Company is entitled to receive potential
commercial milestone payments of up to $109.5 million and royalties
on net sales of GIAPREZA and XERAVA.
“We are pleased to report continued progress toward our goal of
becoming cash flow positive from operations,” said Larry Edwards,
President and Chief Executive Officer of La Jolla. “The filing of
an NDA for XERAVA in China by our licensee Everest and the
execution of our license agreement with PAION for GIAPREZA and
XERAVA in Europe position us well to serve the needs of patients
suffering from life-threatening diseases globally while
significantly strengthening our balance sheet. We continue to focus
on growing net sales of both GIAPREZA and XERAVA while managing
operating costs.”
Financial Results
For the three months ended March 31, 2021, La Jolla’s total
revenue was $34.1 million, compared to $7.6 million for the same
period in 2020. For the three months ended March 31, 2021, La
Jolla’s net product sales were $8.7 million, compared to $7.6
million for the same period in 2020. GIAPREZA U.S. net sales were
$6.9 million for the three months ended March 31, 2021, compared to
$7.6 million for the same period in 2020. XERAVA U.S. net sales
were $1.8 million for the three months ended March 31, 2021,
compared to zero for the same period in 2020. La Jolla acquired
Tetraphase, which commercialized XERAVA, on July 28, 2020.
La Jolla’s net income (loss) for the three months ended March
31, 2021 was $14.4 million, or $0.42 per diluted share, compared to
$(8.6) million, or $(0.32) per diluted share, for the same period
in 2020.
As of March 31, 2021 and December 31, 2020, La Jolla had cash
and cash equivalents of $38.6 million and $21.2 million,
respectively.
La Jolla’s net cash provided by (used for) operating activities
for the three months ended March 31, 2021 was $17.2 million,
compared to $(12.2) million for the same period in 2020. La Jolla’s
net cash provided by (used for) operating activities excluding net
receipts in connection with license agreements and payments related
to reductions in headcount for the three months ended March 31,
2021 was $(1.8) million, compared to $(9.2) million for the same
period in 2020. Net receipts in connection with license agreements
were $19.8 million for the three months ended March 31, 2021,
compared to zero for the same period in 2020. Payments related to
reductions in headcount were $0.8 million for the three months
ended March 31, 2021, compared to $3.0 million for the same period
in 2020.
About GIAPREZA
GIAPREZA™ (angiotensin II) injection is 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. GIAPREZA is 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
http://www.giapreza.com. The European Summary of Product
Characteristics is available at
www.ema.europa.eu/en/medicines/human/EPAR/giapreza. GIAPREZA is
marketed in the U.S. by La Jolla Pharmaceutical Company on behalf
of La Jolla Pharma, LLC, its wholly owned subsidiary, and will be
marketed in Europe by PAION AG on behalf of La Jolla Pharma,
LLC.
GIAPREZA 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 and the Summary of Product
Characteristics for the European Union.
About XERAVA
XERAVA™ (eravacycline) for injection is approved by the U.S.
Food and Drug Administration (FDA) as a tetracycline class
antibacterial indicated for the treatment of complicated
intra-abdominal infections (cIAI) in patients 18 years of age and
older. XERAVA is approved by the European Commission (EC) for the
treatment of cIAI in adults. Prescribing information for XERAVA is
available at www.xerava.com. The European Summary of Product
Characteristics is available at
www.ema.europa.eu/en/medicines/human/EPAR/xerava. XERAVA is
marketed in the U.S. by Tetraphase Pharmaceuticals, Inc., a wholly
owned subsidiary of La Jolla, and will be marketed in Europe by
PAION AG on behalf of Tetraphase Pharmaceuticals, Inc. Everest, the
Company’s licensee for mainland China, Taiwan, Hong Kong, Macau,
South Korea, Singapore, the Malaysian Federation, the Kingdom of
Thailand, the Republic of Indonesia, the Socialist Republic of
Vietnam and the Republic of the Philippines, recently submitted an
NDA in China.
XERAVA Important Safety Information
XERAVA is a tetracycline class antibacterial indicated for the
treatment of complicated intra-abdominal infections in patients 18
years of age and older.
XERAVA is not indicated for the treatment of complicated urinary
tract infections.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of XERAVA and other antibacterial drugs,
XERAVA should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by susceptible
bacteria.
XERAVA is contraindicated for use in patients with known
hypersensitivity to eravacycline, tetracycline-class antibacterial
drugs or to any of the excipients. Life-threatening
hypersensitivity (anaphylactic) reactions have been reported with
XERAVA.
The use of XERAVA during tooth development (last half of
pregnancy, infancy and childhood to the age of eight years) may
cause permanent discoloration of the teeth (yellow-gray-brown) and
enamel hypoplasia.
The use of XERAVA during the second and third trimester of
pregnancy, infancy and childhood up to the age of eight years may
cause reversible inhibition of bone growth.
Clostridium difficile associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range
in severity from mild diarrhea to fatal colitis.
The most common adverse reactions observed in clinical trials
(incidence ≥ 3%) were infusion site reactions, nausea and
vomiting.
XERAVA is structurally similar to tetracycline-class
antibacterial drugs and may have similar adverse reactions. Adverse
reactions including photosensitivity, pseudotumor cerebri and
anti-anabolic action, which has led to increased blood urea
nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis and
abnormal liver function tests, have been reported for other
tetracycline-class antibacterial drugs, and may occur with XERAVA.
Discontinue XERAVA if any of these adverse reactions are
suspected.
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 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. GIAPREZA™
(angiotensin II) is approved by the U.S. FDA as a vasoconstrictor
indicated to increase blood pressure in adults with septic or other
distributive shock. XERAVA™ (eravacycline) is approved by the U.S.
FDA for the treatment of complicated intra-abdominal infections.
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)
and XERAVA™ (eravacycline) sales; regulatory actions relating to La
Jolla’s products by the U.S. FDA, European Commission, China
National Medical Products Administration and/or other regulatory
authorities; expected future cash flows of La Jolla, including
upfront, milestone, royalty and other payments resulting from La
Jolla’s out-license agreements and commercial supply agreements;
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
Condensed Consolidated Balance
Sheets
(in thousands, except par value
and share amounts)
March 31,
December 31,
2021
2020
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
38,634
$
21,221
Accounts receivable, net
4,153
5,834
Inventory, net
5,374
6,013
Prepaid expenses and other current
assets
6,104
3,388
Total current assets
54,265
36,456
Goodwill
20,123
20,123
Intangible assets, net
14,485
14,873
Right-of-use lease assets
490
536
Property and equipment, net
186
215
Restricted cash
40
40
Total assets
$
89,589
$
72,243
LIABILITIES AND SHAREHOLDERS’
DEFICIT
Current liabilities:
Accounts payable
$
1,098
$
2,762
Accrued expenses
8,721
6,494
Accrued payroll and related expenses
1,693
2,878
Lease liabilities, current portion
196
204
Total current liabilities
11,708
12,338
Deferred royalty obligation, net
124,453
124,437
Accrued interest expense on deferred
royalty obligation, less current portion
20,884
19,111
Lease liabilities, less current
portion
294
332
Other noncurrent liabilities
4,568
4,112
Total liabilities
161,907
160,330
Commitments and contingencies
Shareholders’ deficit:
Common Stock, $0.0001 par value;
100,000,000 shares authorized, 27,448,571 and 27,402,648 shares
issued and outstanding at March 31, 2021 and December 31, 2020,
respectively
3
3
Series C-12 Convertible Preferred Stock,
$0.0001 par value; 11,000 shares authorized, 3,906 shares issued
and outstanding at March 31, 2021 and December 31, 2020; and
liquidation preference of $3,906 at March 31, 2021 and December 31,
2020
3,906
3,906
Additional paid-in capital
986,107
984,756
Accumulated deficit
(1,062,334
)
(1,076,752
)
Total shareholders’ deficit
(72,318
)
(88,087
)
Total liabilities and shareholders’
deficit
$
89,589
$
72,243
LA JOLLA PHARMACEUTICAL
COMPANY
Condensed Consolidated Statements
of Operations
(in thousands, except per share
amounts)
Three Months Ended
March 31,
2021
2020
Revenue
Net product sales
$
8,637
$
7,591
License revenue
25,500
-
Total revenue
34,137
7,591
Operating expenses
Cost of product sales
2,731
716
Cost of license revenue
3,600
-
Selling, general and administrative
8,755
8,152
Research and development
1,558
9,183
Total operating expenses
16,644
18,051
Income (loss) from operations
17,493
(10,460
)
Other (expense) income
Interest expense
(2,609
)
(2,406
)
Interest income
2
190
Other income—related party
-
4,085
Other expense
(450
)
-
Total other (expense) income, net
(3,057
)
1,869
Income (loss) before income taxes
14,436
(8,591
)
Provision for income taxes
18
-
Net income (loss)
$
14,418
$
(8,591
)
Earnings (loss) per share
Basic
$
0.53
$
(0.32
)
Diluted
$
0.42
$
(0.32
)
Shares used in computing earnings
(loss) per share
Basic
27,427
27,238
Diluted
34,183
27,238
LA JOLLA PHARMACEUTICAL
COMPANY
Condensed Consolidated Statements
of Cash Flows
(Unaudited)
(in thousands)
Three Months Ended
March 31,
2021
2020
Operating activities
Net income (loss)
$
14,418
$
(8,591
)
Adjustments to reconcile net income (loss)
to net cash provided by (used for) operating activities:
Share-based compensation expense
1,116
2,407
Depreciation expense
29
1,060
Non-cash interest expense
1,736
1,682
Inventory fair value step-up adjustment
included in cost of product sales
850
-
Amortization of intangible assets
388
-
Loss on change in fair value of contingent
value rights
450
-
Amortization of right-of-use lease
assets
46
345
Loss on disposal of property and
equipment
-
148
Changes in operating assets and
liabilities:
Accounts receivable, net
1,681
(592
)
Inventory, net
(211
)
251
Prepaid expenses and other current
assets
(2,716
)
1,084
Accounts payable
(1,664
)
(2,282
)
Accrued expenses
2,286
(2,404
)
Accrued payroll and related expenses
(1,185
)
(4,683
)
Lease liabilities
(46
)
(674
)
Net cash provided by (used for) operating
activities
17,178
(12,249
)
Investing activities
Proceeds from the sale of property and
equipment
-
1,143
Net cash provided by investing
activities
-
1,143
Financing activities
Net proceeds from issuance of common stock
under 2013 Equity Plan
154
305
Net proceeds from issuance of common stock
under ESPP
81
200
Net cash provided by financing
activities
235
505
Net increase (decrease) in cash, cash
equivalents and restricted cash
17,413
(10,601
)
Cash, cash equivalents and restricted
cash, beginning of period
21,261
88,729
Cash, cash equivalents and restricted
cash, end of period
$
38,674
$
78,128
Reconciliation of cash, cash
equivalents and restricted cash to the condensed consolidated
balance sheets
Cash and cash equivalents
$
38,634
$
77,219
Restricted cash
40
909
Total cash, cash equivalents and
restricted cash
$
38,674
$
78,128
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version on businesswire.com: https://www.businesswire.com/news/home/20210507005115/en/
La Jolla Pharmaceutical Company Contact Michael Hearne Chief
Financial Officer La Jolla Pharmaceutical Company (617) 715-3598
mhearne@ljpc.com
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