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 and
twelve months ended December 31, 2021 and highlighted corporate
progress.
Corporate Progress
- Record Fourth Quarter and Full Year Net Product Sales:
La Jolla had record net product sales for the three and twelve
months ended December 31, 2021. For the three and twelve months
ended December 31, 2021, La Jolla’s net product sales were $12.1
million and $43.5 million, respectively, compared to $11.0 million
and $33.4 million, respectively, for the same periods in 2020. La
Jolla acquired Tetraphase, which commercialized XERAVA, on July 28,
2020. Net product sales for the twelve months ended December 31,
2020 exclude XERAVA for the period prior to July 28, 2020.
- GIAPREZA U.S. Net Product Sales: For the three months
ended December 31, 2021, GIAPREZA U.S. net product sales were $9.2
million, up 3% from the three months ended September 30, 2021 and
up 6% from the three months ended December 31, 2020. For the twelve
months ended December 31, 2021, GIAPREZA U.S. net product sales
were $33.4 million, up 14% from the same period in 2020.
- XERAVA U.S. Net Product Sales: For the three months
ended December 31, 2021, XERAVA U.S. net product sales were $2.9
million, consistent with the three months ended September 30, 2021
and up 26% from the three months ended December 31, 2020. For the
twelve months ended December 31, 2021, XERAVA U.S. net product
sales were $10.1 million, up 23% from the same period in 2020,
including the period prior to the acquisition of Tetraphase.
- Fourth Consecutive Quarter of Positive Net Cash Provided by
Operating Activities: La Jolla had positive net cash provided
by operating activities for the fourth consecutive quarter. La
Jolla’s net cash provided by (used for) operating activities for
the three and twelve months ended December 31, 2021 was $3.1
million and $28.2 million, respectively, compared to $(7.2) million
and $(37.6) million, respectively, for the same periods in
2020.
“We are pleased to report that La Jolla had record net product
sales for the three and twelve months ended December 31, 2021 and
positive operating cash flow for the fourth consecutive quarter.
These are significant achievements for La Jolla,” said Larry
Edwards, President and Chief Executive Officer of La Jolla. “As we
enter 2022, our focus will be on continuing to grow net product
sales and operating cash flow.”
Financial Results
For the three and twelve months ended December 31, 2021, La
Jolla’s total revenue was $12.2 million and $75.7 million,
respectively, compared to $11.0 million and $33.4 million,
respectively, for the same periods in 2020. For the three and
twelve months ended December 31, 2021, La Jolla’s net product sales
were $12.1 million and $43.5 million, respectively, compared to
$11.0 million and $33.4 million, respectively, for the same periods
in 2020. GIAPREZA U.S. net product sales were $9.2 million and
$33.4 million for the three and twelve months ended December 31,
2021, respectively, compared to $8.7 million and $29.3 million,
respectively, for the same periods in 2020. XERAVA U.S. net product
sales were $2.9 million and $10.1 million for the three and twelve
months ended December 31, 2021, respectively, compared to $2.3
million and $4.2 million, respectively, for the same periods in
2020. For the three and twelve months ended December 31, 2021, La
Jolla’s license and other revenue was $0.1 million and $32.2
million, respectively, compared to zero for the same periods in
2020.
La Jolla’s net income (loss) for the three and twelve months
ended December 31, 2021 was $3.8 million and $19.7 million, or
$0.11 and $0.58 per diluted share, respectively, compared to $(3.5)
million and $(39.4) million, or $(0.13) and $(1.44) per diluted
share, respectively, for the same periods in 2020.
As of December 31, 2021 and 2020, La Jolla had cash and cash
equivalents of $46.7 million and $21.2 million, respectively. La
Jolla’s net cash provided by (used for) operating activities for
the three and twelve months ended December 31, 2021 was $3.1
million and $28.2 million, respectively, compared to $(7.2) million
and $(37.6) million, respectively, for the same periods in 2020. La
Jolla’s net cash provided by (used for) operating activities for
the three and twelve months ended December 31, 2021, excluding
upfront net receipts in connection with out-license agreements and
commercial supply agreements, payments related to reductions in
headcount, and transaction costs associated with the Tetraphase
acquisition, was $3.1 million and $4.6 million, respectively,
compared to $(5.6) million and $(27.2) million, respectively, for
the same periods in 2020. The exclusions above are comprised of the
following:
- Upfront net receipts in connection with out-license agreements
were zero and $18.4 million for the three and twelve months ended
December 31, 2021, respectively, and zero for the same periods in
2020.
- Upfront net receipts in connection with commercial supply
agreements were zero and $6.8 million for the three and twelve
months ended December 31, 2021, respectively, and zero for the same
periods in 2020.
- Payments related to reductions in headcount were zero and $1.6
million for the three and twelve months ended December 31, 2021,
respectively, and $1.6 million and $9.5 million, respectively, for
the same periods in 2020.
- Payments related to transaction costs associated with the
Tetraphase acquisition were zero for the three and twelve months
ended December 31, 2021, and zero and $0.9 million, respectively,
for the same periods 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
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
Consolidated Balance
Sheets
(in thousands, except par value
and share amounts)
December 31,
December 31,
2021
2020
ASSETS
Current assets:
Cash and cash equivalents
$
46,668
$
21,221
Accounts receivable, net
8,610
5,834
Inventory, net
6,281
6,013
Prepaid expenses and other current
assets
5,756
3,388
Total current assets
67,315
36,456
Goodwill
20,123
20,123
Intangible assets, net
13,321
14,873
Right-of-use lease assets
318
536
Property and equipment, net
113
215
Restricted cash
40
40
Total assets
$
101,230
$
72,243
LIABILITIES AND STOCKHOLDERS’
DEFICIT
Current liabilities:
Accounts payable
$
2,278
$
2,762
Accrued expenses
4,866
5,617
Accrued interest expense on deferred
royalty obligation, current portion
5,163
3,567
Deferred revenue
2,849
188
Paycheck Protection Program loan, current
portion
2,325
-
Lease liabilities, current portion
154
204
Total current liabilities
17,635
12,338
Deferred royalty obligation, net
124,503
124,437
Accrued interest expense on deferred
royalty obligation, less current portion
24,590
19,111
Lease liabilities, less current
portion
164
332
Other noncurrent liabilities
1,076
4,112
Total liabilities
167,968
160,330
Commitments and contingencies
Stockholders’ deficit:
Common Stock, $0.0001 par value;
100,000,000 shares authorized, 26,783,544 and 27,402,648 shares
issued and outstanding at December 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 December 31, 2021 and December 31, 2020; and
liquidation preference of $3,906 at December 31, 2021 and December
31, 2020
3,906
3,906
Additional paid-in capital
986,445
984,756
Accumulated deficit
(1,057,092
)
(1,076,752
)
Total stockholders’ deficit
(66,738
)
(88,087
)
Total liabilities and stockholders’
deficit
$
101,230
$
72,243
LA JOLLA PHARMACEUTICAL
COMPANY
Consolidated Statements of
Operations
(in thousands, except per share
amounts)
Year Ended
December 31,
2021
2020
Revenue
Net product sales
$
43,532
$
33,419
License and other revenue
32,188
-
Total revenue
75,720
33,419
Operating expenses
Cost of product sales
8,976
7,819
Cost of license and other revenue
4,513
-
Selling, general and administrative
35,386
38,428
Research and development
5,014
23,010
Total operating expenses
53,889
69,257
Income (loss) from operations
21,831
(35,838
)
Other (expense) income
Interest expense
(10,458
)
(10,051
)
Interest income
7
235
Other income—related party
7,596
6,279
Other income (expense)
733
(46
)
Total other (expense) income, net
(2,122
)
(3,583
)
Income (loss) before income taxes
19,709
(39,421
)
Provision for income taxes
49
-
Net income (loss)
$
19,660
$
(39,421
)
Earnings (loss) per share
Basic
$
0.72
$
(1.44
)
Diluted
$
0.58
$
(1.44
)
Shares used in computing earnings
(loss) per share
Basic
27,436
27,329
Diluted
34,179
27,329
LA JOLLA PHARMACEUTICAL
COMPANY
Consolidated Statements of
Cash Flows
(in thousands)
Year Ended
December 31,
2021
2020
Operating activities
Net income (loss)
$
19,660
$
(39,421
)
Adjustments to reconcile net income (loss)
to net cash provided by (used for) operating activities:
Non-cash interest expense
7,141
6,379
Share-based compensation expense
4,477
6,207
Amortization of intangible assets
1,552
647
Amortization of right-of-use lease
assets
218
1,249
Depreciation expense
111
2,188
Inventory fair value step-up adjustment
included in cost of product sales
850
2,458
Gain on change in fair value of contingent
value rights
(734
)
(800
)
Loss on short-term investments
-
502
Loss on disposal of property and
equipment, net of gain on lease termination
-
10
Changes in operating assets and
liabilities:
Accounts receivable, net
(2,776
)
(1,687
)
Inventory, net
(1,118
)
(1,493
)
Prepaid expenses and other current
assets
(2,368
)
2,297
Accounts payable
(484
)
(2,815
)
Accrued expenses
(728
)
(11,423
)
Deferred revenue
2,661
188
Lease liabilities
(218
)
(2,126
)
Net cash provided by (used for) operating
activities
28,244
(37,640
)
Investing activities
Acquisition of Tetraphase, net of cash,
cash equivalents and restricted cash acquired
-
(33,513
)
Proceeds from the sale of property and
equipment
-
3,070
Purchases of property and equipment
(9
)
-
Proceeds from the sale of short-term
investments
-
2,497
Purchases of short-term investments
-
(2,999
)
Net cash used for investing activities
(9
)
(30,945
)
Financing activities
Purchases of common stock under Stock
Repurchase Plan
(3,380
)
-
Net proceeds from issuance of common stock
under ESPP
436
512
Net proceeds from issuance of common stock
under 2013 Equity Plan
156
605
Net cash (used for) provided by financing
activities
(2,788
)
1,117
Net increase (decrease) in cash, cash
equivalents and restricted cash
25,447
(67,468
)
Cash, cash equivalents and restricted
cash, beginning of period
21,261
88,729
Cash, cash equivalents and restricted
cash, end of period
$
46,708
$
21,261
Supplemental disclosure of non-cash
investing and financing activities
Initial recognition of right-of-use lease
asset
$
-
$
536
Reconciliation of cash, cash
equivalents and restricted cash to the consolidated balance
sheets
Cash and cash equivalents
$
46,668
$
21,221
Restricted cash
40
40
Total cash, cash equivalents and
restricted cash
$
46,708
$
21,261
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version on businesswire.com: https://www.businesswire.com/news/home/20220309005270/en/
Michael Hearne Chief Financial Officer La Jolla Pharmaceutical
Company (617) 715-3598 mhearne@ljpc.com
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