La Jolla Pharmaceutical Company (Nasdaq: LJPC), which is
dedicated to the 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, 2022 and highlighted corporate progress.
Corporate Progress
- Net Product Sales: For the three months ended March 31,
2022, La Jolla’s net product sales were $10.4 million, up 21% from
the same period in 2021.
- GIAPREZA U.S. Net Product Sales: For the three months
ended March 31, 2022, GIAPREZA U.S. net product sales were $7.7
million, up 13% from the same period in 2021.
- XERAVA U.S. Net Product Sales: For the three months
ended March 31, 2022, XERAVA U.S. net product sales were $2.7
million, up 50% from the same period in 2021.
- Positive Net Cash Provided by Operating Activities: For
the three months ended March 31, 2022, La Jolla’s net cash provided
by operating activities was $2.5 million compared to $17.2 million
for the same period in 2021. The 2021 period included a $16.8
million net upfront payment and a $3.0 million milestone payment
received in connection with the Company’s agreements with PAION AG
and Everest Medicines Limited covering ex-U.S. rights to GIAPREZA
and XERAVA.
“We are pleased to report that La Jolla continues to grow net
product sales and generate positive operating cash flow,” said
Larry Edwards, President and Chief Executive Officer of La Jolla.
“La Jolla’s focus remains on growing its GIAPREZA and XERAVA
franchises while increasing operating cash flow.”
Financial Results
For the three months ended March 31, 2022, La Jolla’s total
revenue was $10.4 million compared to $34.1 million for the same
period in 2021. The 2021 period included a $22.5 million upfront
payment and a $3.0 million milestone payment received in connection
with the Company’s agreements with PAION AG and Everest Medicines
Limited covering ex-U.S. rights to GIAPREZA and XERAVA. For the
three months ended March 31, 2022, La Jolla’s net product sales
were $10.4 million compared to $8.6 million for the same period in
2021, an increase of 21%. GIAPREZA U.S. net product sales were $7.7
million for the three months ended March 31, 2022 compared to $6.8
million for the same period in 2021, an increase of 13%. XERAVA
U.S. net product sales were $2.7 million for the three months ended
March 31, 2022 compared to $1.8 million for the same period in
2021, an increase of 50%.
For the three months ended March 31, 2022, La Jolla’s net income
was approximately $2,000, or $0.00 per diluted share, compared to
$14.4 million, or $0.42 per diluted share, for the same period in
2021.
As of March 31, 2022, La Jolla had $44.6 million of cash, cash
equivalents and short-term investments compared to $46.7 million as
of December 31, 2021. The $2.1 million decrease in cash, cash
equivalents and short-term investments is primarily due to $2.5
million of net cash provided by operating activities, offset by
$5.2 million in purchases of the Company’s common stock under its
stock repurchase plan. For the three months ended March 31, 2022,
La Jolla’s net cash provided by operating activities was $2.5
million compared to $17.2 million for the same period in 2021. The
2021 period included a $16.8 million net upfront payment and a $3.0
million milestone payment received in connection with the Company’s
agreements with PAION AG and Everest Medicines Limited covering
ex-U.S. rights to GIAPREZA and XERAVA.
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
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
is marketed in Europe by PAION Deutschland GmbH 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 is marketed in Europe by PAION
Deutschland GmbH 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, submitted
an NDA in China, which was accepted by the China National Medical
Products Administration (NMPA) in March 2021. XERAVA was approved
in Singapore by the Health Science Authority in April 2020.
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
commercialization of innovative therapies that improve outcomes in
patients suffering from life-threatening diseases. GIAPREZA®
(angiotensin II) injection is approved by the FDA as a
vasoconstrictor indicated to increase blood pressure in adults with
septic or other distributive shock. XERAVA® (eravacycline) for
injection is approved by the FDA as a tetracycline class
antibacterial indicated for the treatment of complicated
intra-abdominal infections (cIAI) in patients 18 years of age and
older. 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; operating costs; 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,
2022
2021
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
44,169
$
46,668
Short-term investments
390
-
Accounts receivable, net
5,729
8,610
Inventory, net
7,113
6,281
Prepaid expenses and other current
assets
5,518
5,756
Total current assets
62,919
67,315
Goodwill
20,123
20,123
Intangible assets, net
12,933
13,321
Right-of-use lease assets
275
318
Property and equipment, net
88
113
Restricted cash
40
40
Total assets
$
96,378
$
101,230
LIABILITIES AND STOCKHOLDERS’
DEFICIT
Current liabilities:
Accounts payable
$
2,789
$
2,278
Accrued expenses
4,297
4,866
Accrued interest expense on deferred
royalty obligation, current portion
5,957
5,163
Deferred revenue
2,849
2,849
Paycheck Protection Program loan
-
2,325
Lease liabilities, current portion
156
154
Total current liabilities
16,048
17,635
Deferred royalty obligation, net
124,519
124,503
Accrued interest expense on deferred
royalty obligation, less current portion
25,262
24,590
Lease liabilities, less current
portion
120
164
Fair value of contingent value rights
923
1,076
Total liabilities
166,872
167,968
Commitments and contingencies
Stockholders’ deficit:
Common Stock, $0.0001 par value;
100,000,000 shares authorized, 25,663,667 and 26,783,544 shares
issued and outstanding at March 31, 2022 and December 31, 2021,
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, 2022 and December 31, 2021; and
liquidation preference of $3,906 at March 31, 2022 and December 31,
2021
3,906
3,906
Additional paid-in capital
982,687
986,445
Accumulated deficit
(1,057,090
)
(1,057,092
)
Total stockholders’ deficit
(70,494
)
(66,738
)
Total liabilities and stockholders’
deficit
$
96,378
$
101,230
LA JOLLA PHARMACEUTICAL
COMPANY
Condensed Consolidated
Statements of Operations
(Unaudited)
(in thousands, except per share
amounts)
Three Months Ended
March 31,
2022
2021
Revenue
Net product sales
$
10,409
$
8,637
License and other revenue
16
25,500
Total revenue
10,425
34,137
Operating expenses
Cost of product sales
2,165
2,731
Cost of license and other revenue
5
3,600
Selling, general and administrative
10,274
8,755
Research and development
27
1,558
Total operating expenses
12,471
16,644
(Loss) income from operations
(2,046
)
17,493
Other income (expense)
Interest expense
(2,402
)
(2,609
)
Gain on forgiveness of Paycheck Protection
Program loan
2,325
-
Other income—related party
1,583
-
Other income (expense)
543
(448
)
Total other income (expense), net
2,049
(3,057
)
Income before income taxes
3
14,436
Provision for income taxes
1
18
Net income
$
2
$
14,418
Earnings per share
Basic
$
0.00
$
0.53
Diluted
$
0.00
$
0.42
Shares used in computing earnings per
share
Basic
26,163
27,427
Diluted
32,916
34,183
LA JOLLA PHARMACEUTICAL
COMPANY
Condensed Consolidated
Statements of Cash Flows
(Unaudited)
(in thousands)
Three Months Ended
March 31,
2022
2021
Operating activities
Net income
$
2
$
14,418
Adjustments to reconcile net income to net
cash provided by operating activities:
Non-cash interest expense
1,482
1,736
Share-based compensation expense
1,262
1,116
Amortization of intangible assets
388
388
Amortization of right-of-use lease
assets
43
46
Depreciation expense
25
29
Loss on short-term investments
309
-
Gain on forgiveness of Paycheck Protection
Program loan
(2,325
)
-
Gain on sale of non-controlling equity
interest
(699
)
-
(Gain) loss on change in fair value of
contingent value rights
(153
)
450
Inventory fair value step-up adjustment
included in cost of product sales
-
850
Changes in operating assets and
liabilities:
Accounts receivable, net
2,881
1,681
Inventory, net
(832
)
(211
)
Prepaid expenses and other current
assets
238
(2,716
)
Accounts payable
511
(1,664
)
Accrued expenses
(569
)
1,101
Lease liabilities
(42
)
(46
)
Net cash provided by operating
activities
2,521
17,178
Investing activities
Net cash provided by (used for) investing
activities
-
-
Financing activities
Purchases of common stock under Stock
Repurchase Plan
(5,179
)
-
Net proceeds from issuance of common stock
under ESPP
159
81
Net proceeds from issuance of common stock
under 2013 Equity Plan
-
154
Net cash (used for) provided by financing
activities
(5,020
)
235
Net (decrease) increase in cash, cash
equivalents and restricted cash
(2,499
)
17,413
Cash, cash equivalents and restricted
cash, beginning of period
46,708
21,261
Cash, cash equivalents and restricted
cash, end of period
$
44,209
$
38,674
Supplemental disclosure of non-cash
investing and financing activities
Sale of non-controlling equity
interest
$
699
$
-
Forgiveness of Paycheck Protection Program
loan
$
2,325
$
-
Reconciliation of cash, cash
equivalents and restricted cash to the condensed consolidated
balance sheets
Cash and cash equivalents
$
44,169
$
38,634
Restricted cash
40
40
Total cash, cash equivalents and
restricted cash
$
44,209
$
38,674
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220516005125/en/
La Jolla Pharmaceutical Company Contact Michael Hearne Chief
Financial Officer La Jolla Pharmaceutical Company (617) 715-3598
mhearne@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