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 nine
months ended September 30, 2021 and highlighted corporate
progress.
Corporate Progress
- Increased Net Product Sales: For the three and nine
months ended September 30, 2021, La Jolla’s net product sales were
$11.8 million and $31.5 million, respectively, compared to $9.1
million and $22.5 million, respectively, for the same periods in
2020. La Jolla acquired Tetraphase, which commercialized XERAVA, on
July 28, 2020. Net product sales for the three and nine months
ended September 30, 2020 excludes XERAVA for the period prior to
July 28, 2020.
- GIAPREZA U.S. Net Product Sales: For the three months
ended September 30, 2021, GIAPREZA U.S. net product sales were $8.9
million, up 3% from the three months ended June 30, 2021 and up 24%
from the three months ended September 30, 2020. For the nine months
ended September 30, 2021, GIAPREZA U.S. net product sales were
$24.3 million, up 18% from the same period in 2020.
- XERAVA U.S. Net Product Sales: For the three months
ended September 30, 2021, XERAVA U.S. net product sales were $2.9
million, up 16% from the three months ended June 30, 2021 and up 7%
from the three months ended September 30, 2020, including the
period prior to the acquisition of Tetraphase. For the nine months
ended September 30, 2021, XERAVA U.S. net product sales were $7.2
million, up 22% from the same period in 2020, including the period
prior to the acquisition of Tetraphase.
- Positive Net Cash Provided by Operating Activities: La
Jolla’s net cash provided by (used for) operating activities for
the three and nine months ended September 30, 2021 was $0.8 million
and $25.1 million, respectively, compared to $(9.8) million and
$(30.4) million, respectively, for the same periods in 2020. La
Jolla’s net cash provided by (used for) operating activities for
the three and nine months ended September 30, 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 $1.1 million and $1.5 million, respectively,
compared to $(5.6) million and $(21.6) million, respectively, for
the same periods in 2020.
“We are pleased to report that La Jolla had a record quarter for
net product sales of both GIAPREZA and XERAVA for the three months
ended September 30, 2021, and La Jolla had positive operating cash
flow for the third consecutive quarter. These are significant
achievements for La Jolla,” said Larry Edwards, President and Chief
Executive Officer of La Jolla. “La Jolla continues to focus on
growing net product sales of both GIAPREZA and XERAVA and
generating positive operating cash flow.”
Financial Results
For the three and nine months ended September 30, 2021, La
Jolla’s total revenue was $13.3 million and $63.5 million,
respectively, compared to $9.1 million and $22.5 million,
respectively, for the same periods in 2020. La Jolla’s total
revenue was comprised of the following:
- For the three and nine months ended September 30, 2021, La
Jolla’s net product sales were $11.8 million and $31.5 million,
respectively, compared to $9.1 million and $22.5 million,
respectively, for the same periods in 2020. GIAPREZA U.S. net
product sales were $8.9 million and $24.3 million for the three and
nine months ended September 30, 2021, compared to $7.2 million and
$20.6 million, respectively, for the same periods in 2020. XERAVA
U.S. net product sales were $2.9 million and $7.2 million for the
three and nine months ended September 30, 2021, compared to $1.9
million for the three and nine months ended September 30,
2020.
- For the three and nine months ended September 30, 2021, La
Jolla’s license and other revenue was $1.5 million and $32.0
million, respectively, compared to zero for the same periods in
2020.
La Jolla’s net income (loss) for the three and nine months ended
September 30, 2021 was $(2.3) million and $15.9 million, or $(0.08)
and $0.46 per diluted share, respectively, compared to $(11.8)
million and $(35.9) million, or $(0.43) and $(1.32) per diluted
share, respectively, for the same periods in 2020.
As of September 30, 2021 and December 31, 2020, La Jolla had
cash and cash equivalents of $46.8 million and $21.2 million,
respectively. La Jolla’s net cash provided by (used for) operating
activities for the three and nine months ended September 30, 2021
was $0.8 million and $25.1 million, respectively, compared to
$(9.8) million and $(30.4) million, respectively, for the same
periods in 2020.
La Jolla’s net cash provided by (used for) operating activities
for the three and nine months ended September 30, 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 $1.1 million and $1.5 million, respectively,
compared to $(5.6) million and $(21.6) 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 nine months ended
September 30, 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 nine months
ended September 30, 2021, and zero for the same periods in
2020.
- Payments related to reductions in headcount were $0.3 million
and $1.6 million for the three and nine months ended September 30,
2021, respectively, and $3.3 million and $7.9 million,
respectively, for the same periods in 2020.
- Payments related to transaction costs associated with the
Tetraphase acquisition were zero for the three and nine months
ended September 30, 2021, and $0.9 million for the three and nine
months ended September 30, 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)
September 30,
December 31,
2021
2020
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
46,765
$
21,221
Accounts receivable, net
8,793
5,834
Inventory, net
6,094
6,013
Prepaid expenses and other current
assets
4,263
3,388
Total current assets
65,915
36,456
Goodwill
20,123
20,123
Intangible assets, net
13,709
14,873
Right-of-use lease assets
367
536
Property and equipment, net
140
215
Restricted cash
40
40
Total assets
$
100,294
$
72,243
LIABILITIES AND SHAREHOLDERS’
DEFICIT
Current liabilities:
Accounts payable
$
2,314
$
2,762
Accrued expenses
11,720
6,494
Accrued payroll and related expenses
1,801
2,878
Lease liabilities, current portion
160
204
Total current liabilities
15,995
12,338
Deferred royalty obligation, net
124,487
124,437
Accrued interest expense on deferred
royalty obligation, less current portion
23,489
19,111
Lease liabilities, less current
portion
208
332
Other noncurrent liabilities
4,523
4,112
Total liabilities
168,702
160,330
Commitments and contingencies
Shareholders’ deficit:
Common Stock, $0.0001 par value;
100,000,000 shares authorized, 27,518,191 and 27,402,648 shares
issued and outstanding at September 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 September 30, 2021 and December 31, 2020; and
liquidation preference of $3,906 at September 30, 2021 and December
31, 2020
3,906
3,906
Additional paid-in capital
988,544
984,756
Accumulated deficit
(1,060,861
)
(1,076,752
)
Total shareholders’ deficit
(68,408
)
(88,087
)
Total liabilities and shareholders’
deficit
$
100,294
$
72,243
LA JOLLA PHARMACEUTICAL
COMPANY
Condensed Consolidated
Statements of Operations
(Unaudited)
(in thousands, except per share
amounts)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2021
2020
2021
2020
Revenue
Net product sales
$
11,781
$
9,072
$
31,477
$
22,468
License and other revenue
1,533
-
32,033
-
Total revenue
13,314
9,072
63,510
22,468
Operating expenses
Cost of product sales
2,031
2,489
6,918
4,013
Cost of license and other revenue
841
-
4,441
-
Selling, general and administrative
8,632
12,493
26,383
29,322
Research and development
1,285
3,617
3,957
21,581
Total operating expenses
12,789
18,599
41,699
54,916
Income (loss) from operations
525
(9,527
)
21,811
(32,448
)
Other (expense) income
Interest expense
(2,729
)
(2,526
)
(8,010
)
(7,402
)
Interest income
-
12
2
234
Other income—related party
-
-
2,532
4,085
Other (expense) income
(25
)
281
(395
)
(412
)
Total other (expense) income, net
(2,754
)
(2,233
)
(5,871
)
(3,495
)
Income (loss) before income taxes
(2,229
)
(11,760
)
15,940
(35,943
)
Provision for income taxes
31
-
49
-
Net income (loss)
$
(2,260
)
$
(11,760
)
$
15,891
$
(35,943
)
Earnings (loss) per share
Basic
$
(0.08
)
$
(0.43
)
$
0.58
$
(1.32
)
Diluted
$
(0.08
)
$
(0.43
)
$
0.46
$
(1.32
)
Shares used in computing earnings
(loss) per share
Basic
27,497
27,368
27,462
27,311
Diluted
27,497
27,368
34,206
27,311
LA JOLLA PHARMACEUTICAL
COMPANY
Condensed Consolidated
Statements of Cash Flows
(Unaudited)
(in thousands)
Nine Months Ended
September 30,
2021
2020
Operating activities
Net income (loss)
$
15,891
$
(35,943
)
Adjustments to reconcile net income (loss)
to net cash provided by (used for) operating activities:
Share-based compensation expense
3,315
5,385
Depreciation expense
84
2,155
Non-cash interest expense
5,587
5,339
Inventory fair value step-up adjustment
included in cost of product sales
850
1,186
Amortization of intangible assets
1,164
259
Loss on change in fair value of contingent
value rights
395
-
Amortization of right-of-use lease
assets
169
1,091
Loss on short-term investments
-
502
Loss on disposal of property and
equipment, net of gain on lease termination
-
59
Changes in operating assets and
liabilities:
Accounts receivable, net
(2,959
)
218
Inventory, net
(931
)
(1,482
)
Prepaid expenses and other current
assets
(875
)
2,445
Accounts payable
(448
)
(1,649
)
Accrued expenses
4,083
(5,786
)
Accrued payroll and related expenses
(1,077
)
(2,168
)
Lease liabilities
(168
)
(1,969
)
Net cash provided by (used for) operating
activities
25,080
(30,358
)
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
Net proceeds from issuance of common stock
under ESPP
317
428
Net proceeds from issuance of common stock
under 2013 Equity Plan
156
605
Net cash provided by financing
activities
473
1,033
Net increase (decrease) in cash, cash
equivalents and restricted cash
25,544
(60,270
)
Cash, cash equivalents and restricted
cash, beginning of period
21,261
88,729
Cash, cash equivalents and restricted
cash, end of period
$
46,805
$
28,459
Reconciliation of cash, cash
equivalents and restricted cash to the condensed consolidated
balance sheets
Cash and cash equivalents
$
46,765
$
27,760
Restricted cash
40
699
Total cash, cash equivalents and
restricted cash
$
46,805
$
28,459
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211104005327/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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