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 six
months ended June 30, 2021 and highlighted corporate progress.
Corporate Progress
- Positive Net Cash Provided by Operating Activities: La
Jolla’s net cash provided by (used for) operating activities for
the three and six months ended June 30, 2021 was $7.1 million and
$24.3 million, respectively, compared to $(8.4) million and $(20.6)
million, respectively, for the same periods in 2020. La Jolla’s net
cash provided by (used for) operating activities for the three and
six months ended June 30, 2021, excluding net receipts in
connection with out-license agreements, commercial supply
agreements and payments related to reductions in headcount, was
$2.2 million and $0.4 million, respectively, compared to $(6.7)
million and $(16.0) million, respectively, for the same periods in
2020.
- Increased Net Product Sales: For the three and six
months ended June 30, 2021, La Jolla’s net product sales were $11.1
million and $19.7 million, respectively, compared to $5.8 million
and $13.4 million, respectively, for the same periods in 2020. La
Jolla acquired Tetraphase, which commercialized XERAVA, on July 28,
2020. Net product sales excludes XERAVA for the three and six
months ended June 30, 2020.
- GIAPREZA U.S. Net Sales: For the three months ended June
30, 2021, GIAPREZA U.S. net sales were $8.6 million, up 25% from
the three months ended March 31, 2021 and up 48% from the three
months ended June 30, 2020. For the six months ended June 30, 2021,
GIAPREZA U.S. net sales were $15.4 million, up 15% from the same
period in 2020.
- XERAVA U.S. Net Sales: For the three months ended June
30, 2021, XERAVA U.S. net sales were $2.5 million, up 39% from the
three months ended March 31, 2021 and up 67% from the three months
ended June 30, 2020, including the period prior to the acquisition
of Tetraphase. For the six months ended June 30, 2021, XERAVA U.S.
net sales were $4.3 million, up 34% from the same period in 2020,
including the period prior to the acquisition of Tetraphase.
“We are pleased to report that La Jolla had positive net cash
provided by operating activities for the three and six months ended
June 30, 2021. We believe this is a significant achievement,” said
Larry Edwards, President and Chief Executive Officer of La Jolla.
“La Jolla continues to focus on growing net sales of both GIAPREZA
and XERAVA while managing operating costs. We believe we are
well-positioned to serve the needs of patients suffering from
life-threatening diseases.”
Financial Results
For the three and six months ended June 30, 2021, La Jolla’s
total revenue was $16.1 million and $50.2 million, respectively,
compared to $5.8 million and $13.4 million, respectively, for the
same periods in 2020. For the three and six months ended June 30,
2021, La Jolla’s net product sales were $11.1 million and $19.7
million, respectively, compared to $5.8 million and $13.4 million,
respectively, for the same periods in 2020. GIAPREZA U.S. net sales
were $8.6 million and $15.4 million for the three and six months
ended June 30, 2021, compared to $5.8 million and $13.4 million,
respectively, for the same periods in 2020. XERAVA U.S. net sales
were $2.5 million and $4.3 million for the three and six months
ended June 30, 2021, compared to zero for the same periods in 2020.
For the three and six months ended June 30, 2021, La Jolla’s
license revenue was $5.0 million and $30.5 million, respectively,
compared to zero for the same periods in 2020.
La Jolla’s net income (loss) for the three and six months ended
June 30, 2021 was $3.7 million and $18.2 million, or $0.11 and
$0.53 per diluted share, respectively, compared to $(15.6) million
and $(24.2) million, or $(0.57) and $(0.89) per diluted share,
respectively, for the same periods in 2020.
As of June 30, 2021 and December 31, 2020, La Jolla had cash and
cash equivalents of $45.9 million and $21.2 million, respectively.
La Jolla’s net cash provided by (used for) operating activities for
the three and six months ended June 30, 2021 was $7.1 million and
$24.3 million, respectively, compared to $(8.4) million and $(20.6)
million, respectively, for the same periods in 2020.
La Jolla’s net cash provided by (used for) operating activities
for the three and six months ended June 30, 2021, excluding net
receipts in connection with out-license agreements, commercial
supply agreements and payments related to reductions in headcount,
was $2.2 million and $0.4 million, respectively, compared to $(6.7)
million and $(16.0) million, respectively, for the same periods in
2020. Net receipts (payments) in connection with out-license
agreements were $(1.4) million and $18.4 million for the three and
six months ended June 30, 2021, respectively, and zero for the same
periods in 2020. Net receipts in connection with commercial supply
agreements were $6.8 million for the three and six months ended
June 30, 2021, and zero for the same periods in 2020. Payments
related to reductions in headcount were $0.5 million and $1.3
million for the three and six months ended June 30, 2021,
respectively, and $1.6 million and $4.6 million, respectively, for
the same periods in 2020.
La Jolla’s consolidated financial results for the three and six
months ended June 30, 2020 exclude the financial results of
Tetraphase. La Jolla acquired Tetraphase, which commercialized
XERAVA, on July 28, 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 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)
June 30,
December 31,
2021
2020
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
45,888
$
21,221
Accounts receivable, net
8,596
5,834
Inventory, net
5,481
6,013
Prepaid expenses and other current
assets
5,201
3,388
Total current assets
65,166
36,456
Goodwill
20,123
20,123
Intangible assets, net
14,097
14,873
Right-of-use lease assets
419
536
Property and equipment, net
163
215
Restricted cash
40
40
Total assets
$
100,008
$
72,243
LIABILITIES AND SHAREHOLDERS’
DEFICIT
Current liabilities:
Accounts payable
$
1,846
$
2,762
Accrued expenses
12,175
6,494
Accrued payroll and related expenses
1,912
2,878
Lease liabilities, current portion
168
204
Total current liabilities
16,101
12,338
Deferred royalty obligation, net
124,470
124,437
Accrued interest expense on deferred
royalty obligation, less current portion
22,136
19,111
Lease liabilities, less current
portion
251
332
Other noncurrent liabilities
4,493
4,112
Total liabilities
167,451
160,330
Commitments and contingencies
Shareholders’ deficit:
Common Stock, $0.0001 par value;
100,000,000 shares authorized, 27,482,231 and 27,402,648 shares
issued and outstanding at June 30, 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 June 30, 2021 and December 31, 2020; and
liquidation preference of $3,906 at June 30, 2021 and December 31,
2020
3,906
3,906
Additional paid-in capital
987,249
984,756
Accumulated deficit
(1,058,601
)
(1,076,752
)
Total shareholders’ deficit
(67,443
)
(88,087
)
Total liabilities and shareholders’
deficit
$
100,008
$
72,243
LA JOLLA PHARMACEUTICAL
COMPANY
Condensed Consolidated Statements
of Operations
(Unaudited)
(in thousands, except per share
amounts)
Three Months Ended
Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Revenue
Net product sales
$
11,059
$
5,805
$
19,696
$
13,396
License revenue
5,000
-
30,500
-
Total revenue
16,059
5,805
50,196
13,396
Operating expenses
Cost of product sales
2,156
808
4,887
1,524
Cost of license revenue
-
-
3,600
-
Selling, general and administrative
8,996
8,677
17,751
16,829
Research and development
1,114
8,781
2,672
17,964
Total operating expenses
12,266
18,266
28,910
36,317
Income (loss) from operations
3,793
(12,461
)
21,286
(22,921
)
Other (expense) income
Interest expense
(2,672
)
(2,470
)
(5,281
)
(4,876
)
Interest income
-
32
2
222
Other income—related party
2,532
-
2,532
4,085
Other income (expense)
80
(693
)
(370
)
(693
)
Total other (expense) income, net
(60
)
(3,131
)
(3,117
)
(1,262
)
Income (loss) before income taxes
3,733
(15,592
)
18,169
(24,183
)
Provision for income taxes
-
-
18
-
Net income (loss)
$
3,733
$
(15,592
)
$
18,151
$
(24,183
)
Earnings (loss) per share
Basic
$
0.14
$
(0.57
)
$
0.66
$
(0.89
)
Diluted
$
0.11
$
(0.57
)
$
0.53
$
(0.89
)
Shares used in computing earnings
(loss) per share
Basic
27,461
27,326
27,444
27,282
Diluted
34,201
27,326
34,192
27,282
LA JOLLA PHARMACEUTICAL
COMPANY
Condensed Consolidated Statements
of Cash Flows
(Unaudited)
(in thousands)
Six Months Ended
June 30,
2021
2020
Operating activities
Net income (loss)
$
18,151
$
(24,183
)
Adjustments to reconcile net income (loss)
to net cash provided by (used for) operating activities:
Share-based compensation expense
2,140
3,997
Depreciation expense
56
1,798
Non-cash interest expense
3,718
3,392
Inventory fair value step-up adjustment
included in cost of product sales
850
-
Amortization of intangible assets
776
-
Loss on change in fair value of contingent
value rights
370
-
Amortization of right-of-use lease
assets
117
699
Loss on disposal of property and
equipment
-
904
Unrealized gains on short-term
investments
-
(63
)
Changes in operating assets and
liabilities:
Accounts receivable, net
(2,762
)
1,117
Inventory, net
(318
)
(909
)
Prepaid expenses and other current
assets
(1,813
)
1,675
Accounts payable
(920
)
(1,696
)
Accrued expenses
5,032
(3,378
)
Accrued payroll and related expenses
(966
)
(2,591
)
Lease liabilities
(117
)
(1,357
)
Net cash provided by (used for) operating
activities
24,314
(20,595
)
Investing activities
Proceeds from the sale of property and
equipment
-
2,860
Purchases of short-term investments
-
(2,999
)
Net cash used for investing activities
-
(139
)
Financing activities
Net proceeds from issuance of common stock
under 2013 Equity Plan
155
605
Net proceeds from issuance of common stock
under ESPP
198
359
Net cash provided by financing
activities
353
964
Net increase (decrease) in cash, cash
equivalents and restricted cash
24,667
(19,770
)
Cash, cash equivalents and restricted
cash, beginning of period
21,261
88,729
Cash, cash equivalents and restricted
cash, end of period
$
45,928
$
68,959
Reconciliation of cash, cash
equivalents and restricted cash to the condensed consolidated
balance sheets
Cash and cash equivalents
$
45,888
$
68,353
Restricted cash
40
606
Total cash, cash equivalents and
restricted cash
$
45,928
$
68,959
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210805005263/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)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
La Jolla Pharmaceutical (NASDAQ:LJPC)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024