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, 2021 and highlighted
corporate progress.
Corporate Progress
- Exclusive Licensing Agreement for GIAPREZA™ (Angiotensin II)
and XERAVA™ (Eravacycline) in Europe: In January 2021, La Jolla
Pharmaceutical Company announced that it and certain of its wholly
owned subsidiaries (collectively, La Jolla) entered into an
exclusive licensing agreement with PAION AG and its wholly owned
subsidiary (collectively, PAION) to commercialize GIAPREZA and
XERAVA in the European Economic Area, the United Kingdom and
Switzerland (the Territories). Under the terms of the exclusive
licensing agreement, La Jolla is entitled to receive: (i) an
upfront cash payment of $22.5 million; (ii) potential commercial
milestone payments of up to $109.5 million; and (iii) double-digit
tiered royalty payments based on net sales of GIAPREZA and
XERAVA.
- Acquisition of Tetraphase Pharmaceuticals, Inc.
(Tetraphase): In July 2020, La Jolla completed its acquisition
of Tetraphase, a biopharmaceutical company focused on
commercializing its novel tetracycline, XERAVA, to treat serious
and life-threatening infections. Financial results for periods
ending December 31, 2020 and beyond include Tetraphase’s financial
results subsequent to the acquisition closing date of July 28,
2020.
- Net Sales: For the three and twelve months ended
December 31, 2020, net sales were $11.0 million and $33.4 million,
respectively, compared to $7.3 million and $23.1 million,
respectively, for the same periods in 2019.
- GIAPREZA Net Sales: For the three and twelve months
ended December 31, 2020, GIAPREZA U.S. net sales were $8.7 million
and $29.3 million, respectively, up 19% and 27%, respectively, from
the same periods in 2019.
- XERAVA Net Sales: Subsequent to July 28, 2020 and
through December 31, 2020, XERAVA U.S. net sales were $4.2 million.
For the three and twelve months ended December 31, 2020, including
the period prior to the acquisition of Tetraphase, XERAVA U.S. net
sales were $2.3 million and $8.2 million, respectively, up 53% and
128%, respectively, from the same periods in 2019.
“2020 was a productive year for La Jolla as we completed the
integration of Tetraphase, increased net sales of both products
compared to the prior year and reduced our operating costs,” said
Larry Edwards, President and Chief Executive Officer of La Jolla.
“Our agreement with PAION positions us well to serve the needs of
patients suffering from life-threatening diseases in both the U.S.
and Europe. As we enter 2021, our focus will be on continuing to
grow net sales of both GIAPREZA and XERAVA while continuing to
manage operating costs.”
Financial Results
For the three and twelve months ended December 31, 2020, net
sales were $11.0 million and $33.4 million, respectively, compared
to $7.3 million and $23.1 million, respectively, for the same
periods in 2019.
La Jolla’s net loss for the three and twelve months ended
December 31, 2020 was $3.5 million and $39.4 million, or $0.13 and
$1.44 per share, respectively, compared to $25.2 million and $116.5
million, or $0.93 per share and $4.30 per share, respectively, for
the same periods in 2019.
As of December 31, 2020, La Jolla had $21.2 million of cash and
cash equivalents. On a pro forma basis, adjusting for $18.9 million
of upfront net proceeds from its licensing agreement with PAION,
net of the amounts due under the George Washington University and
Harvard University license agreements, La Jolla had cash and cash
equivalents of $40.1 million.
Net cash used for operating activities for the three and twelve
months ended December 31, 2020 was $7.3 million and $37.6 million,
respectively, down 57% and 56%, respectively, from the same periods
in 2019. Net cash used for operating activities for the three and
twelve months ended December 31, 2020, excluding cash expenditures
related to reductions in headcount and transaction costs associated
with the Tetraphase acquisition, was $5.7 million and $27.2
million, respectively, down 65% and 67%, respectively, from the
same periods in 2019. Cash expenditures related to reductions in
headcount were $1.6 million and $9.5 million for the three and
twelve months ended December 31, 2020, respectively, and $0.9
million and $3.2 million, respectively, for the same periods in
2019. Cash expenditures related to transaction costs associated
with the Tetraphase acquisition were zero and $0.9 million for the
three and twelve months ended December 31, 2020, respectively.
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 on the EMA website:
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. 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.
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; whether La Jolla will realize the
benefits from the acquisition of Tetraphase Pharmaceuticals, Inc.;
regulatory actions relating to La Jolla’s products by the U.S. FDA,
European Commission and/or other regulatory authorities; expected
future cash flows of La Jolla, including milestone and/or royalty
payments resulting from La Jolla’s exclusive license agreement with
PAION AG; 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)
December 31,
December 31,
2020
2019
ASSETS
Current assets:
Cash and cash equivalents
$
21,221
$
87,820
Accounts receivable, net
5,834
2,960
Inventory, net
6,013
2,211
Prepaid expenses and other current
assets
3,388
4,467
Total current assets
36,456
97,458
Goodwill
20,123
-
Intangible assets, net
14,873
-
Right-of-use lease assets
536
15,491
Property and equipment, net
215
18,389
Restricted cash
40
909
Total assets
$
72,243
$
132,247
LIABILITIES AND SHAREHOLDERS’
DEFICIT
Current liabilities:
Accounts payable
$
2,762
$
4,177
Accrued expenses
6,494
9,312
Accrued payroll and related expenses
2,878
8,332
Lease liabilities, current portion
204
2,766
Total current liabilities
12,338
24,587
Deferred royalty obligation, net
124,437
124,379
Accrued interest expense on deferred
royalty obligation, less current portion
19,111
12,790
Lease liabilities, less current
portion
332
26,481
Other noncurrent liabilities
4,112
-
Total liabilities
$
160,330
$
188,237
Commitments and contingencies (Note 6)
Shareholders’ deficit:
Common Stock, $0.0001 par value;
100,000,000 shares authorized, 27,402,648 and 27,195,469 shares
issued and outstanding at December 31, 2020 and December 31, 2019,
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, 2020 and December 31, 2019; and
liquidation preference of $3,906 at December 31, 2020 and December
31, 2019
3,906
3,906
Additional paid-in capital
984,756
977,432
Accumulated deficit
(1,076,752
)
(1,037,331
)
Total shareholders’ deficit
(88,087
)
(55,990
)
Total liabilities and shareholders’
deficit
$
72,243
$
132,247
LA JOLLA PHARMACEUTICAL
COMPANY
Condensed Consolidated
Statements of Operations
(in thousands, except per share
amounts)
Year Ended
December 31,
2020
2019
Revenue
Net product sales
$
33,419
$
23,054
Total revenue
33,419
23,054
Operating expenses
Cost of product sales
7,819
2,392
Selling, general and administrative
38,428
45,134
Research and development
23,010
85,329
Total operating expenses
69,257
132,855
Loss from operations
(35,838
)
(109,801
)
Other income (expense)
Interest expense
(10,051
)
(10,774
)
Interest income
235
2,128
Other income—related party
6,279
1,939
Other income (expense)
(46
)
-
Total other income (expense), net
(3,583
)
(6,707
)
Net loss
$
(39,421
)
$
(116,508
)
Net loss per share, basic and
diluted
$
(1.44
)
$
(4.30
)
Weighted-average common shares
outstanding, basic and diluted
27,329
27,112
LA JOLLA PHARMACEUTICAL
COMPANY
Condensed Consolidated
Statements of Cash Flows
(Unaudited)
(in thousands)
Year Ended
December 31,
2020
2019
Operating activities
Net loss
$
(39,421
)
$
(116,508
)
Adjustments to reconcile net loss to net
cash used for operating activities:
Share-based compensation expense
6,207
23,733
Depreciation expense
2,188
4,552
Non-cash interest expense
6,379
8,775
Inventory fair value step-up adjustment
included in cost of product sales
2,458
-
Amortization of intangible assets
647
-
Change in fair value of contingent value
rights
(800
)
-
Amortization of right-of-use lease
assets
1,249
1,307
Loss on short-term investments
502
-
Loss on disposal of property and
equipment, net of gain on lease termination
10
24
Changes in operating assets and
liabilities:
Accounts receivable, net
(1,687
)
(1,579
)
Inventory, net
(1,493
)
(191
)
Prepaid expenses and other current
assets
2,297
644
Accounts payable
(2,815
)
(4,395
)
Accrued expenses
(5,781
)
395
Accrued payroll and related expenses
(5,454
)
823
Lease liabilities
(2,126
)
(2,530
)
Net cash used for operating activities
(37,640
)
(84,950
)
Investing activities
Acquisition of Tetraphase, net of cash,
cash equivalents and restricted cash acquired
(33,513
)
-
Purchases of short-term investments
(2,999
)
-
Purchases of property and equipment
-
(698
)
Proceeds from the sale of property and
equipment
3,070
-
Proceeds from the sale of short-term
investments
2,497
-
Net cash used for investing activities
(30,945
)
(698
)
Financing activities
Net proceeds from issuance of common stock
under 2013 Equity Plan
605
31
Net proceeds from issuance of common stock
under ESPP
512
833
Net cash provided by financing
activities
1,117
864
Net decrease in cash, cash equivalents
and restricted cash
(67,468
)
(84,784
)
Cash, cash equivalents and restricted
cash, beginning of period
88,729
173,513
Cash, cash equivalents and restricted
cash, end of period
$
21,261
$
88,729
Supplemental disclosure of non-cash
investing and financing activities
Initial recognition of right-of-use lease
asset
$
536
$
16,798
Conversion of Series F Convertible
Preferred Stock into common stock
$
-
$
2,737
Cumulative-effect adjustment from adoption
of ASU 2018-07
$
-
$
(160
)
Reconciliation of cash, cash
equivalents and restricted cash to the consolidated balance
sheets
Cash and cash equivalents
$
21,221
$
87,820
Restricted cash
40
909
Total cash, cash equivalents and
restricted cash
$
21,261
$
88,729
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210308005193/en/
Michael Hearne Chief Financial Officer La Jolla Pharmaceutical
Company (858) 333-5769 mhearne@ljpc.com
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