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Share Name | Share Symbol | Market | Type |
---|---|---|---|
La Jolla Pharmaceutical Company | NASDAQ:LJPC | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 6.23 | 6.54 | 6.25 | 0 | 01:00:00 |
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
“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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