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 nine months ended September 30, 2020.
On July 28, 2020, La Jolla completed its acquisition of
Tetraphase Pharmaceuticals, Inc. (Tetraphase), a biopharmaceutical
company focused on commercializing its novel tetracycline, XERAVATM
(eravacycline), to treat serious and life-threatening infections,
for $43 million in upfront cash plus potential future cash payments
of up to $16 million. Financial results for periods ending
September 30, 2020 and beyond include Tetraphase’s financial
results subsequent to the acquisition closing date of July 28,
2020.
For the three months ended September 30, 2020, GIAPREZA U.S. net
sales were $7.2 million, up 24% from the three months ended June
30, 2020 and up 26% from the three months ended September 30, 2019.
For the nine months ended September 30, 2020, GIAPREZA U.S. net
sales were $20.6 million, up 30% from the same period in 2019.
Subsequent to July 28, 2020 and through September 30, 2020,
XERAVA U.S. net sales were $1.9 million. For the three months ended
September 30, 2020, XERAVA U.S. net sales were $2.7 million, up 80%
from the three months ended June 30, 2020 and up 170% from the
three months ended September 30, 2019. For the nine months ended
September 30, 2020, XERAVA U.S. net sales were $5.9 million, up
181% from the same period in 2019.
La Jolla’s net loss for the three and nine months ended
September 30, 2020 was $11.8 million and $35.9 million, or $0.43
and $1.32 per share, respectively, compared to $29.2 million and
$91.3 million, or $1.08 per share and $3.37 per share,
respectively, for the same periods in 2019.
As of September 30, 2020, La Jolla had $27.8 million of cash and
cash equivalents. Net cash used in operating activities for the
three and nine months ended September 30, 2020 was $9.8 million and
$30.4 million, respectively, down 48% and 55%, respectively, from
the same periods in 2019. Net cash used in operating activities for
the three and nine months ended September 30, 2020, excluding cash
expenditures related to reductions in headcount and transaction
costs associated with the Tetraphase acquisition, was $5.6 million
and $21.6 million, respectively, down 70% and 67%, respectively,
from the same periods in 2019. Cash expenditures related to
reductions in headcount were $3.3 million and $7.9 million for the
three and nine months ended September 30, 2020, respectively, and
zero and $2.3 million, respectively, for the same periods in 2019.
Cash expenditures related to transaction costs associated with the
Tetraphase acquisition were $0.9 million for the three and nine
months ended September 30, 2020.
“The third quarter was productive for La Jolla as we completed
the integration of Tetraphase, increased net sales of both products
compared to the prior quarter and increased our presence in the
hospital,” said Larry Edwards, President and Chief Executive
Officer of La Jolla. “By leveraging the stronger platform that the
combined company is providing, we are increasing patient and
physician access to our two innovative therapies for
life-threatening diseases.”
About GIAPREZA
GIAPREZATM (angiotensin II) for 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.
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
XERAVATM (eravacycline) for injection is a novel fluorocycline
of the tetracycline class of antibacterials that is approved by the
U.S. Food and Drug Administration (FDA) 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.
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 XERAVATM (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;
the expected future cash flows of La Jolla; whether La Jolla can
become cash flow positive and the timing for achieving this; 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,
2020
2019
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
27,760
$
87,820
Accounts receivable, net
3,929
2,960
Inventory, net
7,274
2,211
Prepaid expenses and other current
assets
3,240
4,467
Total current assets
42,203
97,458
Property and equipment, net
284
18,389
Right-of-use lease assets
2,150
15,491
Restricted cash
699
909
Intangible assets, net
15,261
-
Goodwill
20,123
-
Total assets
$
80,720
$
132,247
LIABILITIES AND SHAREHOLDERS’
DEFICIT
Current liabilities:
Accounts payable
$
3,928
$
4,177
Accrued expenses
7,683
9,312
Accrued payroll and related expenses
6,164
8,332
Lease liabilities, current portion
985
2,766
Total current liabilities
18,760
24,587
Lease liabilities, less current
portion
1,249
26,481
Deferred royalty obligation, net
124,421
124,379
Other noncurrent liabilities
21,805
12,790
Total liabilities
$
166,235
$
188,237
Commitments and contingencies (Note 6)
Shareholders’ deficit:
Common Stock, $0.0001 par value;
100,000,000 shares authorized, 27,378,048 and 27,195,469 shares
issued and outstanding at September 30, 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 September 30, 2020 and December 31, 2019; and
liquidation preference of $3,906 at September 30, 2020 and December
31, 2019
3,906
3,906
Additional paid-in capital
983,850
977,432
Accumulated deficit
(1,073,274
)
(1,037,331
)
Total shareholders’ deficit
(85,515
)
(55,990
)
Total liabilities and shareholders’
deficit
$
80,720
$
132,247
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,
2020
2019
2020
2019
Revenue
Net product sales
$
9,072
$
5,706
$
22,468
$
15,804
Total revenue
9,072
5,706
22,468
15,804
Operating expenses
Cost of product sales
2,489
554
4,013
1,605
Research and development
3,617
21,182
21,581
64,469
Selling, general and administrative
12,493
10,782
29,322
34,425
Total operating expenses
18,599
32,518
54,916
100,499
Loss from operations
(9,527
)
(26,812
)
(32,448
)
(84,695
)
Other income (expense)
Interest expense
(2,526
)
(2,863
)
(7,402
)
(8,398
)
Interest income
12
501
234
1,818
Other income—related party
-
-
4,085
-
Other expense (expense)
281
-
(412
)
-
Total other income (expense), net
(2,233
)
(2,362
)
(3,495
)
(6,580
)
Net loss
$
(11,760
)
$
(29,174
)
$
(35,943
)
$
(91,275
)
Net loss per share, basic and
diluted
$
(0.43
)
$
(1.08
)
$
(1.32
)
$
(3.37
)
Weighted-average common shares
outstanding, basic and diluted
27,368
27,135
27,311
27,093
LA JOLLA PHARMACEUTICAL COMPANY Condensed
Consolidated Statements of Cash Flows (Unaudited) (in
thousands)
Nine Months Ended
September 30,
2020
2019
Operating activities
Net loss
$
(35,943
)
$
(91,275
)
Adjustments to reconcile net loss to net
cash used for operating activities:
Share-based compensation expense
5,385
19,522
Depreciation expense
2,155
3,408
Inventory fair value step-up adjustment
included in cost of product sales
1,186
-
Amortization of intangible assets
259
-
Amortization of right-of-use lease
assets
1,091
969
Non-cash interest expense
5,339
6,971
Loss on short-term investments
502
-
Loss on disposal of property and
equipment, net of gain on lease termination
59
15
Changes in operating assets and
liabilities:
Accounts receivable, net
218
(36
)
Inventory, net
(1,482
)
110
Prepaid expenses and other current
assets
2,445
328
Accounts payable
(1,649
)
(3,234
)
Accrued expenses
(5,786
)
(332
)
Accrued payroll and related expenses
(2,168
)
(2,391
)
Lease liabilities
(1,969
)
(1,873
)
Net cash used for operating activities
(30,358
)
(67,818
)
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
-
(679
)
Proceeds from the sale of short-term
investments
2,497
-
Purchases of short-term investments
(2,999
)
-
Net cash used for investing activities
(30,945
)
(679
)
Financing activities
Net proceeds from issuance of common stock
under 2013 Equity Plan
605
-
Net proceeds from issuance of common stock
under ESPP
428
661
Net cash provided by financing
activities
1,033
661
Net decrease in cash, cash equivalents
and restricted cash
(60,270
)
(67,836
)
Cash, cash equivalents and restricted
cash, beginning of period
88,729
173,513
Cash, cash equivalents and restricted
cash, end of period
$
28,459
$
105,677
Supplemental disclosure of non-cash
investing and financing activities
Conversion of Series F Convertible
Preferred Stock into common stock
$
-
$
2,737
Cumulative-effect adjustment from adoption
of ASU 2018-07
$
-
$
(160
)
Initial recognition of right-of-use lease
asset
$
-
$
16,798
Reconciliation of cash, cash
equivalents and restricted cash to the condensed consolidated
balance sheets
Cash and cash equivalents
$
27,760
$
104,768
Restricted cash
699
909
Total cash, cash equivalents and
restricted cash
$
28,459
$
105,677
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201109006157/en/
Michael Hearne Chief Financial Officer La Jolla Pharmaceutical
Company (858) 333-5769 mhearne@ljpc.com
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