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La Jolla to receive upfront cash payment of $22.5 million plus potential commercial milestone payments of up to $109.5 million and double-digit tiered royalty payments
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 that it and certain of its wholly owned subsidiaries (collectively, La Jolla) have entered into an exclusive licensing agreement with PAION AG and its wholly owned subsidiary (PAION) for GIAPREZA™ (angiotensin II) and XERAVA™ (eravacycline) in the European Economic Area, the United Kingdom and Switzerland (the Territories).
Under the terms of the exclusive licensing agreement, La Jolla will be 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. In exchange, La Jolla granted PAION an exclusive license to commercialize GIAPREZA and XERAVA in the Territories.
GIAPREZA is approved by the European Commission as a vasoconstrictor indicated 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. XERAVA is approved by the European Commission for the treatment of complicated intra-abdominal infections in adults.
"Our agreement with PAION marks an important step in our global strategic plans to bring innovative therapies that improve outcomes in patients suffering from life-threatening diseases to Europe," said Larry Edwards, President and Chief Executive Officer of La Jolla. "We are excited to have PAION as a partner and expect its commercialization expertise will be invaluable in maximizing the value of GIAPREZA and XERAVA in Europe."
"We are excited to add these attractive hospital products to our portfolio, giving us a strong basis to launch our European commercial organization and to build out our sales and marketing activities," said Dr. Jim Phillips, Chief Executive Officer of PAION AG. "We will be using single, hospital focused sales teams in each country to commercialize these products in Europe. The licensing agreement announced today puts us on strong footing to become a leading specialty pharmaceutical company in the fields of anaesthesia and critical care."
About GIAPREZA
GIAPREZA™ (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, 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 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, 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; 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, including any upfront, milestone and/or royalty payments, resulting from La Jolla's exclusive license agreement with PAION AG and its wholly owned subsidiary; 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210112005460/en/
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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
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SAN DIEGO, California, Aug. 06, 2020 (GLOBE NEWSWIRE) -- 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 six months ended June 30, 2020 and highlighted recent corporate progress.
Recent Corporate Progress
- Acquisition of Tetraphase Pharmaceuticals, Inc.: On July 28, 2020, La Jolla completed its acquisition of Tetraphase Pharmaceuticals, Inc., a biopharmaceutical company focused on commercializing its novel tetracycline, XERAVA™ (eravacycline), to treat serious and life-threatening infections, for $43 million in upfront cash plus potential future cash payments of up to $16 million. For the three and six months ended June 30, 2020, U.S. net sales of XERAVA, which was launched in October 2018, were $1.5 million and $3.2 million, up 88% and 191%, respectively, from the same periods in 2019. Complete financial results of Tetraphase for the six months ended June 30, 2020 will be included in an amended Form 8-K to be filed by La Jolla on or before October 13, 2020. Financial results for periods ending September 30, 2020 and beyond will include Tetraphase's financial results subsequent to the acquisition closing date of July 28, 2020.
- Appointment of Larry Edwards as President and Chief Executive Officer: Effective July 28, 2020, La Jolla's Board of Directors appointed Larry Edwards as President and Chief Executive Officer of La Jolla.
"With two, FDA-approved, innovative therapies for life-threatening diseases, La Jolla is well-positioned to help patients in need," said Larry Edwards, President and Chief Executive Officer of La Jolla. "By leveraging the stronger platform that the combined company will provide, we look forward to increasing patient access to these important medicines."
Financial Results
For the three and six months ended June 30, 2020, U.S. net sales of GIAPREZA were $5.8 million and $13.4 million, up 2% and 33%, respectively, from the same periods in 2019.
La Jolla's net loss for the three and six months ended June 30, 2020 was $15.6 million and $24.2 million, or $0.57 and $0.89 per share, respectively, compared to $30.4 million and $62.1 million, or $1.12 per share and $2.29 per share, respectively, for the same periods in 2019.
As of June 30, 2020, La Jolla had $71.4 million of cash and short-term investments, compared to $87.8 million as of December 31, 2019. Net cash used in operating activities for the three and six months ended June 30, 2020 was $8.4 million and $20.6 million, respectively, down 49% and 58%, respectively, from the same periods in 2019.
About GIAPREZA
GIAPREZA™ (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
XERAVA™ (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 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; cash used in operating activities and our capital requirements; 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,
2020December 31,
2019(Unaudited) ASSETS Current assets: Cash $ 68,353 $ 87,820 Short-term investments 3,062 — Accounts receivable, net 1,843 2,960 Inventory, net 3,120 2,211 Prepaid expenses and other current assets 2,792 4,467 Total current assets 79,170 97,458 Property and equipment, net 12,827 18,389 Right-of-use lease asset 14,792 15,491 Restricted cash 606 909 Total assets $ 107,395 $ 132,247 LIABILITIES AND SHAREHOLDERS' DEFICIT Current liabilities: Accounts payable $ 2,481 $ 4,177 Accrued expenses 6,772 9,312 Accrued payroll and related expenses 5,741 8,332 Lease liability, current portion 2,890 2,766 Total current liabilities 17,884 24,587 Lease liability, less current portion 25,000 26,481 Deferred royalty obligation, net 124,406 124,379 Other noncurrent liabilities 15,317 12,790 Total liabilities 182,607 188,237 Commitments and contingencies (Note 6) Shareholders' deficit: Common Stock, $0.0001 par value; 100,000,000 shares authorized,
27,358,611 and 27,195,469 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively3 3 Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at June 30, 2020 and December 31, 2019; and liquidation preference of $3,906 at June 30, 2020 and December 31, 2019 3,906 3,906 Additional paid-in capital 982,393 977,432 Accumulated deficit (1,061,514 ) (1,037,331 ) Total shareholders' deficit (75,212 ) (55,990 ) Total liabilities and shareholders' deficit $ 107,395 $ 132,247 LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share amounts)Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Revenue Net product sales $ 5,805 $ 5,703 $ 13,396 $ 10,098 Total revenue 5,805 5,703 13,396 10,098 Operating expenses Cost of product sales 808 551 1,524 1,051 Research and development 8,781 22,043 17,964 43,287 Selling, general and administrative 8,677 11,323 16,829 23,643 Total operating expenses 18,266 33,917 36,317 67,981 Loss from operations (12,461 ) (28,214 ) (22,921 ) (57,883 ) Other income (expense) Interest expense (2,470 ) (2,806 ) (4,876 ) (5,535 ) Interest income 32 604 222 1,317 Other income—related party — — 4,085 — Other expense (693 ) — (693 ) — Total other income (expense), net (3,131 ) (2,202 ) (1,262 ) (4,218 ) Net loss $ (15,592 ) $ (30,416 ) $ (24,183 ) $ (62,101 ) Net loss per share, basic and diluted $ (0.57 ) $ (1.12 ) $ (0.89 ) $ (2.29 ) Weighted-average common shares outstanding, basic and diluted 27,326 27,108 27,282 27,071 LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Cash Flows
(Unaudited)Six Months Ended June 30, 2020 2019 Operating activities Net loss $ (24,183 ) $ (62,101 ) Adjustments to reconcile net loss to net cash used for operating activities: Share-based compensation expense 3,997 13,103 Depreciation and amortization expense 1,798 2,263 Loss on disposal of equipment 904 15 Unrealized gains on short-term investments (63 ) — Non-cash interest expense 3,392 4,678 Non-cash rent expense 699 639 Changes in operating assets and liabilities: Accounts receivable, net 1,117 (512 ) Inventory, net (909 ) 52 Prepaid expenses and other current assets 1,675 22 Accounts payable (1,696 ) (3,664 ) Accrued expenses (3,378 ) 974 Accrued payroll and related expenses (2,591 ) (3,429 ) Lease liability (1,357 ) (1,241 ) Net cash used for operating activities (20,595 ) (49,201 ) Investing activities Proceeds from the sale of property and equipment 2,860 — Purchase of property and equipment — (441 ) Purchase of short-term investments (2,999 ) — Net cash used for investing activities (139 ) (441 ) Financing activities Net proceeds from issuance of common stock under 2013 Equity Plan 605 — Net proceeds from issuance of common stock under ESPP 359 484 Net cash provided by financing activities 964 484 Net decrease in cash and restricted cash (19,770 ) (49,158 ) Cash and restricted cash at beginning of period 88,729 173,513 Cash and restricted cash at end of period $ 68,959 $ 124,355 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 and restricted cash to the condensed consolidated balance sheets Cash $ 68,353 $ 123,446 Restricted cash 606 909 Total cash and restricted cash $ 68,959 $ 124,355 La Jolla Pharmaceutical Company Contact
Michael Hearne
Chief Financial Officer
La Jolla Pharmaceutical Company
(858) 333-5769
[email protected]
- Acquisition of Tetraphase Pharmaceuticals, Inc.: On July 28, 2020, La Jolla completed its acquisition of Tetraphase Pharmaceuticals, Inc., a biopharmaceutical company focused on commercializing its novel tetracycline, XERAVA™ (eravacycline), to treat serious and life-threatening infections, for $43 million in upfront cash plus potential future cash payments of up to $16 million. For the three and six months ended June 30, 2020, U.S. net sales of XERAVA, which was launched in October 2018, were $1.5 million and $3.2 million, up 88% and 191%, respectively, from the same periods in 2019. Complete financial results of Tetraphase for the six months ended June 30, 2020 will be included in an amended Form 8-K to be filed by La Jolla on or before October 13, 2020. Financial results for periods ending September 30, 2020 and beyond will include Tetraphase's financial results subsequent to the acquisition closing date of July 28, 2020.
-
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SAN DIEGO, July 28, 2020 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (NASDAQ:LJPC) announced today that its Board of Directors has appointed Larry Edwards as President and Chief Executive Officer.
"Larry has an impressive track record bringing innovative treatments that address unmet medical needs to patients in the acute-care setting," said Kevin Tang, Chairman of La Jolla. "We are delighted to have Larry join the Company."
"I look forward to working with the La Jolla team to continue to expand patient access to GIAPREZA and XERAVA," said Larry Edwards, President and Chief Executive Officer of La Jolla. "I am grateful to have the opportunity to join a company that focuses on improving outcomes in patients suffering from life-threatening diseases."
From 2015 to 2020, Mr. Edwards served in various positions at Tetraphase Pharmaceuticals, Inc., most recently serving as Chief Executive Officer. From 2014 to 2015, he served as Senior Director of Marketing of the Gram-negative Franchise of Cubist Pharmaceuticals, Inc. (acquired by Merck & Co., Inc.). From 1999 to 2014, Mr. Edwards served in various positions at Merck and Co., Inc., most recently serving as Global Marketing Director of Clostridium Difficile and New Infectious Disease Products. Mr. Edwards received a B.S. degree in business and healthcare administration from Ohio University.About GIAPREZA
GIAPREZA™ (angiotensin II) for injection was 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 was 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 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
XERAVA™ (eravacycline) for injection was approved by the U.S. Food and Drug Administration (FDA) as a novel fluorocycline of the tetracycline class antibacterials indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of Tetraphase's IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. 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; cash used in operating activities and our capital requirements; 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 Contact:
Michael Hearne
Chief Financial Officer
La Jolla Pharmaceutical Company
(858) 333-5769
[email protected] -
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SAN DIEGO, California and WATERTOWN, Massachusetts, July 28, 2020 (GLOBE NEWSWIRE) -- 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, and Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA™ (eravacycline) to treat serious and life-threatening infections, today announced the closing of La Jolla's acquisition of Tetraphase. La Jolla acquired Tetraphase for $43.0 million in upfront cash plus potential future cash payments of up to $16.0 million pursuant to contingent value rights (CVRs). The holders of the CVRs are entitled to receive payments of up to an additional $16.0 million in the aggregate upon the achievement of certain net sales of XERAVA in the United States.
"With two, FDA-approved, innovative therapies for life-threatening diseases, La Jolla is well-positioned to help patients in need," said Larry Edwards, President and Chief Executive Officer of La Jolla. "By leveraging the stronger platform that the combined company will provide, we look forward to increasing patient access to these important medicines."
About GIAPREZA
GIAPREZA™ (angiotensin II) for injection was 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 was 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 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
XERAVA™ (eravacycline) for injection was approved by the U.S. Food and Drug Administration (FDA) as a novel fluorocycline of the tetracycline class antibacterials indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of Tetraphase's IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. 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 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; cash used in operating activities and our capital requirements; 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 Contact:
Michael Hearne
Chief Financial Officer
La Jolla Pharmaceutical Company
(858) 333-5769
[email protected] -
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SAN DIEGO, May 04, 2020 (GLOBE NEWSWIRE) -- 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 months ended March 31, 2020.
For the three months ended March 31, 2020, GIAPREZA U.S. net sales were $7.6 million, up 73% from the three months ended March 31, 2019 and up 5% from the three months ended December 31, 2019. Vials of GIAPREZA shipped from distributors to hospitals (hospital demand) grew 58% for the three months ended March 31, 2020 as compared to the three months ended March 31, 2019 and decreased 1% as compared to the three months ended December 31, 2019.
La Jolla's net loss for the three months ended March 31, 2020 was $8.6 million, or $0.32 per share, compared to $31.7 million, or $1.17 per share, for the same period in 2019.
As of March 31, 2020, La Jolla had $77.2 million in cash, compared to $87.8 million as of December 31, 2019. Net cash used in operating activities for the three months ended March 31, 2020 was $12.2 million, compared to $32.7 million for the same period in 2019. La Jolla has no debt.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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 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.
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 LJPC-0118
LJPC-0118 (I.V. artesunate) is La Jolla's investigational product for the treatment of severe malaria. The active pharmaceutical ingredient in LJPC-0118, artesunate, was compared to quinine in patients with severe falciparum malaria infection in two randomized, active-controlled, clinical studies. In both studies, in-hospital mortality in the artesunate group was statistically significantly lower than in-hospital mortality in the quinine group. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation and Orphan Drug designation for LJPC-0118 for the treatment of malaria in April 2019 and July 2019, respectively. La Jolla filed a New Drug Application (NDA) with the FDA for LJPC-0118 for the treatment of severe malaria in the second half of 2019. Severe malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito. Symptoms include: fever, chills, sweating, hypoglycemia and shock. In 2013, an estimated 2 million cases of severe malaria occurred worldwide. In 2018, an estimated 405,000 people died from malaria worldwide.
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. In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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. LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. 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) sales; regulatory actions relating to La Jolla's products by the U.S. Food and Drug Administration (FDA), European Commission and/or other regulatory authorities; cash used in operating activities and our capital requirements; 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)March 31,
2020December 31,
2019(Unaudited) ASSETS Current assets: Cash $ 77,219 $ 87,820 Accounts receivable, net 3,552 2,960 Inventory, net 1,960 2,211 Prepaid expenses and other current assets 3,383 4,467 Total current assets 86,114 97,458 Property and equipment, net 16,038 18,389 Right-of-use lease asset 15,146 15,491 Restricted cash 909 909 Total assets $ 118,207 $ 132,247 LIABILITIES AND SHAREHOLDERS' DEFICIT Current liabilities: Accounts payable $ 1,895 $ 4,177 Accrued expenses 7,675 9,312 Accrued payroll and related expenses 3,649 8,332 Lease liability, current portion 2,828 2,766 Total current liabilities 16,047 24,587 Lease liability, less current portion 25,745 26,481 Deferred royalty obligation, net 124,392 124,379 Other noncurrent liabilities 13,692 12,790 Total liabilities 179,876 188,237 Shareholders' deficit: Common Stock, $0.0001 par value; 100,000,000 shares authorized,
27,276,734 and 27,195,469 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively3 3 Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at March 31, 2020 and December 31, 2019; and liquidation preference of $3,906 at March 31, 2020 and December 31, 2019 3,906 3,906 Additional paid-in capital 980,344 977,432 Accumulated deficit (1,045,922 ) (1,037,331 ) Total shareholders' deficit (61,669 ) (55,990 ) Total liabilities and shareholders' deficit $ 118,207 $ 132,247 LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share amounts)Three Months Ended March 31, 2020 2019 Revenue Net product sales $ 7,591 $ 4,395 Total revenue 7,591 4,395 Operating expenses Cost of product sales 716 500 Research and development 9,183 21,244 Selling, general and administrative 8,152 12,320 Total operating expenses 18,051 34,064 Loss from operations (10,460 ) (29,669 ) Other income (expense) Interest expense (2,406 ) (2,729 ) Interest income 190 713 Other income—related party 4,085 — Total other expense, net 1,869 (2,016 ) Net loss $ (8,591 ) $ (31,685 ) Net loss per share, basic and diluted $ (0.32 ) $ (1.17 ) Weighted-average common shares outstanding, basic and diluted 27,238 27,035 LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)Three Months Ended March 31, 2020 2019 Operating activities Net loss $ (8,591 ) $ (31,685 ) Adjustments to reconcile net loss to net cash used for operating activities: Share-based compensation expense 2,407 6,711 Depreciation and amortization expense 1,060 1,130 Loss on disposal of equipment 148 15 Non-cash interest expense 1,682 2,310 Non-cash rent expense 345 316 Changes in operating assets and liabilities: Accounts receivable, net (592 ) (618 ) Inventory, net 251 43 Prepaid expenses and other current assets 1,084 (28 ) Accounts payable (2,282 ) (5,531 ) Accrued expenses (2,404 ) 742 Accrued payroll and related expenses (4,683 ) (5,473 ) Lease liability (674 ) (618 ) Net cash used for operating activities (12,249 ) (32,686 ) Investing activities Proceeds from the sale of property and equipment 1,143 — Purchase of property and equipment — (184 ) Net cash provided by (used for) investing activities 1,143 (184 ) Financing activities Net proceeds from issuance of common stock under 2013 Equity Plan 305 — Net proceeds from issuance of common stock under ESPP 200 283 Net cash provided by financing activities 505 283 Net decrease in cash and restricted cash (10,601 ) (32,587 ) Cash and restricted cash at beginning of period 88,729 173,513 Cash and restricted cash at end of period $ 78,128 $ 140,926 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 and restricted cash to the condensed consolidated balance sheets Cash $ 77,219 $ 140,017 Restricted cash 909 909 Total cash and restricted cash $ 78,128 $ 140,926 Company Contacts
Sandra Vedrick
Senior Director, Investor Relations
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: [email protected]and
Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: [email protected]
-
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SAN DIEGO, April 07, 2020 (GLOBE NEWSWIRE) -- 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 that it is providing GIAPREZA™ (angiotensin II) for named patient emergency use in patients with septic shock due to COVID-19 at University Hospital Münster in Germany. GIAPREZA is being made available for named patient emergency use based on a request from Professor Alexander Zarbock, M.D., Chair, Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster. According to German law, authorized medicines can be made available prior to commercial availability in order to fulfill special patient needs. GIAPREZA has been recently approved by the European Commission but is not yet commercially available in Europe.
In a report on 44,672 confirmed cases of COVID-19 (Wu et al, JAMA 2020; doi:10.1001/jama.2020.2648), approximately 14% of patients required hospitalization, and, among those, one-third became critically ill. Patients who became critically ill developed respiratory failure, septic shock and/or multiple organ failure. Approximately one-half of the critically ill patients died.
"La Jolla is committed to helping patients suffering from life-threatening diseases, and we hope that GIAPREZA will positively impact these patients," said Lakhmir Chawla, M.D., Chief Medical Officer, La Jolla Pharmaceutical Company.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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 on the EMA website: https://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.
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 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. In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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. LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. 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) sales; regulatory actions relating to La Jolla's products by the U.S. Food and Drug Administration (FDA), European Commission and/or other regulatory authorities; cash used in operating activities and our capital requirements; 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.
Company Contacts
Sandra Vedrick
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: [email protected]and
Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: [email protected] -
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SAN DIEGO, April 06, 2020 (GLOBE NEWSWIRE) -- 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 that it is providing GIAPREZA™ (angiotensin II) for named patient emergency use in patients with septic shock due to COVID-19 at Royal Surrey County Hospital, Guildford, Surrey, United Kingdom. GIAPREZA is being made available for named patient emergency use based on a request from Professor Lui G. Forni, MBBS, Ph.D., at Royal Surrey County Hospital NHS Foundation Trust. According to English law, authorized medicines can be made available prior to commercial availability in order to fulfill special patient needs. GIAPREZA has been recently approved by the European Commission but is not yet commercially available in Europe.
In a report on 44,672 confirmed cases of COVID-19 (Wu et al, JAMA 2020; doi:10.1001/jama.2020.2648), approximately 14% of patients required hospitalization, and, among those, one-third became critically ill. Patients who became critically ill developed respiratory failure, septic shock and/or multiple organ failure. Approximately one-half of the critically ill patients died.
"La Jolla is committed to helping patients suffering from life-threatening diseases, and we hope that GIAPREZA will positively impact these patients," said Lakhmir Chawla, M.D., Chief Medical Officer, La Jolla Pharmaceutical Company.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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 on the EMA website: https://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.
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 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. In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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. LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. 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) sales; regulatory actions relating to La Jolla's products by the U.S. Food and Drug Administration (FDA), European Commission and/or other regulatory authorities; cash used in operating activities and our capital requirements; 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.
Company Contacts
Sandra Vedrick
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: [email protected]and
Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: [email protected] -
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SAN DIEGO, April 03, 2020 (GLOBE NEWSWIRE) -- 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 that it is providing GIAPREZA™ (angiotensin II) for named patient emergency use in patients with septic shock due to COVID-19 at University Hospital Frankfurt in Germany. GIAPREZA is being made available for compassionate use based on a request from Professor Kai Zacharowski, M.D., Ph.D., ML, FRCA, Director of the Department of Anesthesia, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt. According to German law, authorized medicines can be made available prior to commercial availability in order to fulfill special patient needs. GIAPREZA has been recently approved by the European Commission but is not yet commercially available in Europe.
In a report on 44,672 confirmed cases of COVID-19 (Wu et al, JAMA 2020; doi:10.1001/jama.2020.2648), approximately 14% of patients required hospitalization, and, among those, one-third became critically ill. Patients who became critically ill developed respiratory failure, septic shock and/or multiple organ failure. Approximately one-half of the critically ill patients died.
"La Jolla is committed to helping patients suffering from life-threatening diseases, and we hope that GIAPREZA will positively impact these patients," said Lakhmir Chawla, M.D., Chief Medical Officer, La Jolla Pharmaceutical Company.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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 on the EMA website: https://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.
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 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. In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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. LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. 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) sales; regulatory actions relating to La Jolla's products by the U.S. Food and Drug Administration (FDA), European Commission and/or other regulatory authorities; cash used in operating activities and our capital requirements; 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.
Company Contacts
Sandra Vedrick
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: [email protected]and
Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: [email protected] -
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SAN DIEGO, April 02, 2020 (GLOBE NEWSWIRE) -- 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 that it is providing GIAPREZA™ (angiotensin II) for named patient emergency use in patients with septic shock due to COVID-19 at Guy's and St Thomas' NHS Foundation Trust in London, United Kingdom. GIAPREZA is being made available for named patient emergency use based on a request from Marlies Ostermann, M.D., Consultant in Nephrology and Critical Care at Guy's and St. Thomas' NHS Foundation Trust, London, England. According to English law, authorized medicines can be made available prior to commercial availability in order to fulfill special patient needs. GIAPREZA has been recently approved by the European Commission but is not yet commercially available in Europe.
In a report on 44,672 confirmed cases of COVID-19 (Wu et al, JAMA 2020; doi:10.1001/jama.2020.2648), approximately 14% of patients required hospitalization, and, among those, one-third became critically ill. Patients who became critically ill developed respiratory failure, septic shock and/or multiple organ failure. Approximately one-half of the critically ill patients died.
"La Jolla is committed to helping patients suffering from life-threatening diseases, and we hope that GIAPREZA will positively impact these patients," said Lakhmir Chawla, M.D., Chief Medical Officer, La Jolla Pharmaceutical Company.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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 on the EMA website: https://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.
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 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. In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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. LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. 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) sales; regulatory actions relating to La Jolla's products by the U.S. Food and Drug Administration (FDA), European Commission and/or other regulatory authorities; cash used in operating activities and our capital requirements; 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.
Company Contacts
Sandra Vedrick
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: [email protected]and
Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: [email protected] -
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SAN DIEGO, March 13, 2020 (GLOBE NEWSWIRE) -- 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 that it is providing GIAPREZA™ (angiotensin II) in Italy for compassionate use in patients with septic shock associated with COVID-19. GIAPREZA is being made available for compassionate use based on a request from Alberto Zangrillo, M.D., Full Professor of Anesthesia and Intensive Care and Giovanni Landoni, M.D., Associate Professor of Anesthesia and Intensive Care at San Raffaele Hospital in Milan, Italy. According to Italian law, authorized medicines for life-threatening and rare illnesses can be made available prior to commercial availability under a compassionate use program. GIAPREZA has been recently approved by the European Commission but is not yet commercially available in Europe.
In a report on 44,672 confirmed cases of COVID-19 (Wu et al, JAMA 2020; doi:10.1001/jama.2020.2648), approximately 14% of patients required hospitalization, and, among those, one-third became critically ill. Patients who became critically ill developed respiratory failure, septic shock and/or multiple organ failure. Approximately one-half of the critically ill patients died.
"La Jolla is committed to helping patients suffering from life-threatening diseases, and we hope that GIAPREZA will positively impact these patients," said Lakhmir Chawla, M.D., Chief Medical Officer, La Jolla Pharmaceutical Company.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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 on the EMA website: https://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.
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 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. In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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. LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. 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) sales; regulatory actions relating to La Jolla's products by the U.S. Food and Drug Administration (FDA), European Commission and/or other regulatory authorities; cash used in operating activities and our capital requirements; 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.
Company Contacts
Sandra Vedrick
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: [email protected]and
Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: [email protected] -
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SAN DIEGO, March 02, 2020 (GLOBE NEWSWIRE) -- 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, 2019.
For the three months ended December 31, 2019, GIAPREZA U.S. net sales were $7.3 million, up 74% from the three months ended December 31, 2018 and up 28% from the three months ended September 30, 2019. Vials of GIAPREZA shipped from distributors to hospitals (hospital demand) grew 74% for the three months ended December 31, 2019 as compared to the three months ended December 31, 2018 and 18% as compared to the three months ended September 30, 2019. GIAPREZA U.S. net sales were $23.1 million in 2019 compared to $10.1 million in 2018, an increase of 129%. La Jolla announced the commercial availability of GIAPREZA in the U.S. in March 2018.
La Jolla's net loss for the three and twelve months ended December 31, 2019 was $25.2 million and $116.5 million, or $0.93 per share and $4.30 per share, respectively, compared to $45.4 million and $199.5 million, or $1.73 per share and $7.85 per share, respectively, for the same periods in 2018.
As of December 31, 2019, La Jolla had $87.8 million in cash, compared to $172.6 million as of December 31, 2018. Net cash used in operating activities for the three and twelve months ended December 31, 2019 was $17.1 million and $85.0 million, respectively, compared to $32.0 million and $152.4 million, respectively, for the same periods in 2018. La Jolla has no debt.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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. GIAPREZA is marketed by La Jolla Pharmaceutical Company on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary.
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.
About LJPC-0118
LJPC-0118 (I.V. artesunate) is La Jolla's investigational product for the treatment of severe malaria. The active pharmaceutical ingredient in LJPC-0118, artesunate, was compared to quinine in patients with severe falciparum malaria infection in two randomized, active-controlled, clinical studies. In both studies, in-hospital mortality in the artesunate group was statistically significantly lower than in-hospital mortality in the quinine group. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation and Orphan Drug designation for LJPC-0118 for the treatment of malaria in April 2019 and July 2019, respectively. La Jolla filed a New Drug Application (NDA) with the FDA for LJPC-0118 for the treatment of severe malaria in the second half of 2019. Severe malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito. Symptoms include: fever, chills, sweating, hypoglycemia and shock. In 2013, an estimated 2 million cases of severe malaria occurred worldwide. In 2018, an estimated 405,000 people died from malaria worldwide.
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. In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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. LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. 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) sales; regulatory actions relating to La Jolla's products by the U.S. Food and Drug Administration (FDA), European Commission and/or other regulatory authorities; cash used in operating activities and our capital requirements; 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
Consolidated Balance Sheets
(in thousands, except par value and share amounts)December 31,
2019December 31,
2018ASSETS Current assets: Cash $ 87,820 $ 172,604 Accounts receivable, net 2,960 1,381 Inventory, net 2,211 2,020 Prepaid expenses and other current assets 4,467 5,111 Total current assets 97,458 181,116 Property and equipment, net 18,389 22,267 Right-of-use lease asset 15,491 — Restricted cash 909 909 Total assets $ 132,247 $ 204,292 LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY Current liabilities: Accounts payable $ 4,177 $ 8,572 Accrued expenses 9,312 8,485 Accrued payroll and related expenses 8,332 7,509 Lease liability, current portion 2,766 — Deferred rent, current portion — 1,370 Total current liabilities 24,587 25,936 Lease liability, less current portion 26,481 — Deferred rent, less current portion — 13,609 Deferred royalty obligation, net 124,379 124,323 Other noncurrent liabilities 12,790 4,503 Total liabilities 188,237 168,371 Shareholders' (deficit) equity: Common Stock, $0.0001 par value; 100,000,000 shares authorized,
27,195,469 and 26,259,254 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively3 3 Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized,
3,906 shares issued and outstanding at December 31, 2019 and December 31, 2018; and liquidation preference of $3,906 at December 31, 2019 and December 31, 20183,906 3,906 Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized,
0 and 2,737 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively; and liquidation preference of $0 and $2,737 at December 31, 2019 and December 31, 2018, respectively— 2,737 Additional paid-in capital 977,432 950,258 Accumulated deficit (1,037,331 ) (920,983 ) Total shareholders' (deficit) equity (55,990 ) 35,921 Total liabilities and shareholders' (deficit) equity $ 132,247 $ 204,292
LA JOLLA PHARMACEUTICAL COMPANY
Consolidated Statements of Operations
(in thousands, except per share amounts)Three Months Ended
December 31,Twelve Months Ended
December 31,2019 2018 2019 2018 Revenue Net product sales $ 7,250 $ 4,184 $ 23,054 $ 10,056 Total revenue 7,250 4,184 23,054 10,056 Operating expenses Cost of product sales 787 1,200 2,392 1,643 Research and development 20,860 27,567 85,329 117,302 Selling, general and administrative 10,709 18,843 45,134 85,162 Total operating expenses 32,356 47,610 132,855 204,107 Loss from operations (25,106 ) (43,426 ) (109,801 ) (194,051 ) Other (expense) income Interest expense (2,376 ) (2,722 ) (10,774 ) (7,303 ) Interest income 310 730 2,128 1,885 Other income—related party 1,939 — 1,939 — Total other expense, net (127 ) (1,992 ) (6,707 ) (5,418 ) Net loss $ (25,233 ) $ (45,418 ) $ (116,508 ) $ (199,469 ) Net loss per share, basic and diluted $ (0.93 ) $ (1.73 ) $ (4.30 ) $ (7.85 ) Weighted-average common shares outstanding, basic and diluted 27,169 26,242 27,112 25,422 LA JOLLA PHARMACEUTICAL COMPANY
Consolidated Statements of Cash Flows
(in thousands)Year Ended December 31, 2019 2018 Operating activities Net loss $ (116,508 ) $ (199,469 ) Adjustments to reconcile net loss to net cash used for operating activities: Share-based compensation expense 23,733 35,151 Depreciation and amortization expense 4,552 4,405 Loss on disposal of equipment 24 236 Non-cash interest expense 8,775 6,797 Non-cash rent expense 1,307 — Changes in operating assets and liabilities: Accounts receivable, net (1,579 ) (1,381 ) Inventory, net (191 ) (2,020 ) Prepaid expenses and other current assets 644 (1,964 ) Accounts payable (4,395 ) (2,912 ) Accrued expenses 395 5,451 Accrued payroll and related expenses 823 2,514 Lease liability (2,530 ) — Deferred rent — 824 Net cash used for operating activities (84,950 ) (152,368 ) Investing activities Purchase of property and equipment (698 ) (2,340 ) Net cash used for investing activities (698 ) (2,340 ) Financing activities Net proceeds from issuance of common stock under ESPP 833 391 Net proceeds from issuance of common stock under 2013 Equity Plan 31 1,908 Net proceeds from royalty financing — 124,289 Net proceeds from the issuance of common stock — 109,809 Net cash provided by financing activities 864 236,397 Net (decrease) increase in cash and restricted cash (84,784 ) 81,689 Cash and restricted cash at beginning of period 173,513 91,824 Cash and restricted cash at end of period $ 88,729 $ 173,513 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 $ — Interest paid $ 1,999 $ 506 Reconciliation of cash and restricted cash to the consolidated balance sheets Cash $ 87,820 $ 172,604 Restricted cash 909 909 Total cash and restricted cash $ 88,729 $ 173,513
Company ContactsSandra Vedrick
Senior Director, Investor Relations
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: [email protected]and
Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: [email protected] -
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SAN DIEGO, Jan. 09, 2020 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (NASDAQ:LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced preliminary GIAPREZA™ (angiotensin II) net sales for the three and twelve months ended December 31, 2019. For the three months ended December 31, 2019, preliminary GIAPREZA net sales were $7.2 million, up 71% from the three months ended December 31, 2018 and up 26% from the three months ended September 30, 2019. Vials of GIAPREZA shipped from distributors to hospitals (hospital demand) grew 74% for the three months ended December 31, 2019 as compared to the three months ended December 31, 2018 and 18% as compared to the three months ended September 30, 2019. For the twelve months ended December 31, 2019, preliminary GIAPREZA net sales were $23.1 million, up 129% from the twelve months ended December 31, 2018. La Jolla announced the commercial availability of GIAPREZA in the U.S. in March 2018.
As of December 31, 2019, La Jolla had approximately $87.8 million in cash and cash equivalents, compared to $104.8 million as of September 30, 2019. Net cash used in operating activities for the three months ended December 31, 2019 was approximately $17.0 million. La Jolla has no debt.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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 regulatory peptide that is central to the renin-angiotensin-aldosterone system to increase blood pressure. Prescribing information for GIAPREZA is available at www.giapreza.com. GIAPREZA is marketed by La Jolla Pharmaceutical Company on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary.
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 (ARB) 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.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life- threatening diseases. In December 2017, GIAPREZATM (angiotensin II) was 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. In August 2019, GIAPREZA was 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. LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. 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: GIAPREZATM (angiotensin II) sales; cash used in operating activities; regulatory actions relating to La Jolla's products by the U.S. Food and Drug Administration, European Medicines Agency and/or other regulatory authorities; the outcomes of clinical studies of La Jolla's products; 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.
Company Contacts
Sandra Vedrick
Senior Director, Investor Relations
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: [email protected]and
Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: [email protected] -
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SAN DIEGO, Nov. 25, 2019 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (NASDAQ:LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that it will reassess continued development of LJPC-401 (synthetic human hepcidin) based on recent mixed clinical results.
The Company plans to discontinue Study LJ401-BT01 due to lack of efficacy. Study LJ401-BT01 is a pivotal, multinational, multicenter, randomized, controlled study with a target enrollment of approximately 100 patients that is designed to evaluate the safety and efficacy of LJPC-401 as a treatment for iron overload in beta thalassemia (BT) patients who, despite chelation therapy, have cardiac iron levels above normal. The primary endpoint of this study is the change in cardiac iron levels, as measured by cardiac T2* magnetic resonance imaging (MRI), from baseline to 6 months following treatment. The Company recently conducted an interim analysis that included approximately one-half of the target-enrolled patients. There were no significant differences in the primary endpoint or key secondary endpoints between patients on the treatment arm and patients on the control arm.
Topline results of Study LJ401-HH01 are also now available. Study LJ401-HH01 is a multinational, multicenter, randomized, placebo-controlled, double-blind, Phase 2 study with a target enrollment of approximately 60 patients that is designed to evaluate the safety and efficacy of LJPC-401 as a treatment for patients with hereditary hemochromatosis (HH). Topline results from this study are consistent with the interim results reported in June 2019. The change in TSAT from baseline to the end of treatment (16 weeks), the primary efficacy endpoint of the study, was statistically significant: LJPC-401-treated patients had a mean reduction in TSAT of 33% compared to placebo-treated patients who had a mean reduction of 3% (p<0.0001). The requirement for and frequency of phlebotomy procedures, a key secondary endpoint of the study, was statistically significant: LJPC-401-treated patients had 0.10 phlebotomies per month compared to placebo-treated patients who had 0.50 phlebotomies per month (p<0.0001). LJPC-401 was well tolerated. The most frequent treatment-emergent adverse events (TEAEs) were injection site reactions (ISRs), which occurred in 79% of LJPC-401-treated patients compared to 6% of placebo-treated patients. The ISRs were all mild or moderate in severity, and no ISRs resulted in treatment discontinuation.
The Company expects to re-evaluate its current operating plan in light of the mixed results of these studies and to make adjustments as appropriate to manage the Company's available cash resources. The Company's near-term focus is to: (1) maximize sales of GIAPREZATM (angiotensin II) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock in the U.S., where it was launched by La Jolla in the first quarter of 2018; (2) maximize the value of GIAPREZA 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 in Europe, where it was approved by the European Commission in August 2019; and (3) seek U.S. Food and Drug Administration (FDA) approval of LJPC-0118 (artesunate) for the treatment of severe malaria, for which the Company recently submitted a New Drug Application.
About LJPC-401
LJPC‑401 (synthetic human hepcidin) is La Jolla's investigational product for the potential treatment of conditions characterized by iron overload. Hepcidin, an endogenous peptide hormone, is the body's naturally occurring regulator of iron absorption and distribution. In healthy individuals, hepcidin prevents excessive iron accumulation in vital organs, such as the liver and heart, where it can cause significant damage and even result in death. La Jolla has been developing LJPC-401 for the potential treatment of iron overload, which occurs as a result of primary iron overload diseases such as hereditary hemochromatosis (HH), or secondary iron overload diseases such as beta thalassemia (BT), sickle cell disease (SCD), myelodysplastic syndrome (MDS) and polycythemia vera.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life- threatening diseases. In December 2017, GIAPREZATM (angiotensin II) was 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. In August 2019, GIAPREZA was 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. LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. LJPC-401 (synthetic human hepcidin) is La Jolla's investigational product for the potential treatment of conditions characterized by iron overload. 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: GIAPREZATM (angiotensin II) sales; cash used in operating activities; regulatory actions relating to La Jolla's products by the U.S. Food and Drug Administration, European Medicines Agency and/or other regulatory authorities; the outcomes of clinical studies of La Jolla's products; 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.
Company Contacts
Sandra Vedrick
Senior Director, Investor Relations & Human Resources
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: [email protected]and
Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: [email protected] -
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SAN DIEGO, Nov. 25, 2019 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (NASDAQ:LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer, has left the Company to pursue other interests. A search for a new Chief Executive Officer has been initiated. In the interim, a committee of the Board, comprised of Kevin Tang and Craig Johnson, will provide Board-level oversight of the Company's management team.
"We would like to thank George for his contributions to the Company," said Kevin Tang, Chairman of the Board. "We wish George success in his future endeavors."
The Company's near-term focus is to: (1) maximize sales of GIAPREZATM (angiotensin II) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock in the U.S., where it was launched by La Jolla in the first quarter of 2018; (2) maximize the value of GIAPREZA 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 in Europe, where it was approved by the European Commission in August 2019; and (3) seek U.S. Food and Drug Administration (FDA) approval of LJPC-0118 (artesunate) for the treatment of severe malaria, for which the Company recently submitted a New Drug Application.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life- threatening diseases. In December 2017, GIAPREZATM (angiotensin II) was 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. In August 2019, GIAPREZA was 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. LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. LJPC-401 (synthetic human hepcidin) is La Jolla's investigational product for the potential treatment of conditions characterized by iron overload. 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: GIAPREZATM (angiotensin II) sales; cash used in operating activities; regulatory actions relating to La Jolla's products by the U.S. Food and Drug Administration, European Medicines Agency and/or other regulatory authorities; the outcomes of clinical studies of La Jolla's products; 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.
Company Contacts
Sandra Vedrick
Senior Director, Investor Relations & Human Resources
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: [email protected]and
Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: [email protected] -
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SAN DIEGO, Nov. 12, 2019 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (NASDAQ:LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced financial results for the three and nine months ended September 30, 2019 and highlighted recent corporate progress.
Recent Corporate Progress
- GIAPREZA™ (Angiotensin II) U.S. Net Sales: For the three months ended September 30, 2019, GIAPREZA U.S. net sales were $5.7 million, up 64% from the same period in 2018. For the nine months ended September 30, 2019, GIAPREZA U.S. net sales were $15.8 million, up 169% from the same period in 2018. La Jolla expects that its full-year 2019 GIAPREZA U.S. net sales will be $22 million to $25 million.
- GIAPREZA European Commission Approval: In August 2019, the European Commission (EC) approved GIAPREZA 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.
- LJPC-0118 (Artesunate) Orphan Drug Designation: In July 2019, the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation for LJPC-0118 for the treatment of malaria.
- Positive Results from Pre-Specified Interim Analysis of Phase 2 Study of LJPC-401 in Patients with Hereditary Hemochromatosis: In June 2019, La Jolla announced positive results from the pre-specified interim analysis of its Phase 2 study of LJPC-401 (synthetic human hepcidin) in patients with hereditary hemochromatosis (HH). The pre-specified interim analysis of efficacy included 26 patients who had reached the end of the 16-week treatment period, and the interim analysis of safety included 60 randomized patients. Treatment with LJPC-401 resulted in a statistically significant reduction in transferrin saturation (TSAT) from baseline to the end of treatment (16 weeks), the primary efficacy endpoint of the study: LJPC‑401‑treated patients had a mean reduction in TSAT of 42% compared to placebo-treated patients who had a mean reduction of 6% (p<0.0001). The requirement for and frequency of phlebotomy procedures, a key secondary endpoint of the study, also was statistically significant: LJPC-401-treated patients had 0.06 phlebotomies per month compared to placebo-treated patients who had 0.41 phlebotomies per month (p=0.003). We expect to announce top-line results from this study in the fourth quarter of 2019.
"Our recent corporate progress has included the approval of GIAPREZA by the European Commission, the granting of Orphan Drug designation for LJPC-0118 for the treatment of malaria by the FDA and positive results from a pre-specified interim analysis of our Phase 2 study of LJPC-401 in patients with hereditary hemochromatosis," said George Tidmarsh, M.D., Ph.D., La Jolla's President and Chief Executive Officer. "In the fourth quarter of 2019, we plan to report top-line results of our Phase 2 study of LJPC-401 in patients with hereditary hemochromatosis and report the filing of our New Drug Application for LJPC-0118 for the treatment of severe malaria."
Financial Results
For the three and nine months ended September 30, 2019, GIAPREZA U.S. net sales were $5.7 million and $15.8 million, respectively, compared to $3.5 million and $5.9 million, respectively, for the same periods in 2018. La Jolla's net loss for the three and nine months ended September 30, 2019 was $29.2 million and $91.3 million, or $1.08 per share and $3.37 per share, respectively, compared to $50.7 million and $154.1 million, or $1.93 per share and $6.15 per share, respectively, for the same periods in 2018.
As of September 30, 2019, La Jolla had $104.8 million in cash, compared to $172.6 million as of December 31, 2018. Net cash used in operating activities for the three and nine months ended September 30, 2019 was $18.6 million and $67.8 million, respectively, compared to $36.9 million and $120.3 million, respectively, for the same periods in 2018. La Jolla has no debt. La Jolla expects that its net cash used in operating activities in 2019 will be $88 million to $91 million.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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 regulatory peptide that is central to the renin-angiotensin-aldosterone system to increase blood pressure. Prescribing information for GIAPREZA is available at www.giapreza.com. GIAPREZA is marketed by La Jolla Pharmaceutical Company on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary.
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 (ARB) 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.
About LJPC-0118
LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. The active pharmaceutical ingredient in LJPC-0118, artesunate, was demonstrated to be superior to quinine in reducing mortality in patients with severe falciparum malaria infection in two randomized, controlled, clinical studies. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation and Orphan Drug designation for LJPC-0118 for the treatment of malaria in April 2019 and July 2019, respectively. La Jolla plans to file a New Drug Application (NDA) with the FDA for LJPC-0118 for the treatment of severe malaria in the fourth quarter of 2019. Severe malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito, which feeds on humans. Symptoms include but are not limited to: fever, chills, sweating, hypoglycemia and shock. Severe malaria is often complicated by central nervous system infections that may lead to delirium, which may progress to coma. Infections usually occur a few weeks after being bitten. In 2017, an estimated 219 million cases of malaria occurred worldwide, with an estimated 200 million of these cases occurring in the World Health Organization (WHO) African Region, and, in 2013, the global annual incidence of severe malaria was estimated to be 2 million cases. In 2017, an estimated 435,000 people died from malaria worldwide.
About LJPC-401
LJPC‑401 (synthetic human hepcidin) is La Jolla's investigational product for the potential treatment of conditions characterized by iron overload. Hepcidin, an endogenous peptide hormone, is the body's naturally occurring regulator of iron absorption and distribution. In healthy individuals, hepcidin prevents excessive iron accumulation in vital organs, such as the liver and heart, where it can cause significant damage and even result in death. La Jolla is developing LJPC-401 for the potential treatment of iron overload, which occurs as a result of primary iron overload diseases such as hereditary hemochromatosis (HH), or secondary iron overload diseases such as beta thalassemia (BT), sickle cell disease (SCD), myelodysplastic syndrome (MDS) and polycythemia vera. The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has designated LJPC‑401 as an orphan medicinal product for the treatment of beta thalassemia intermedia and major and SCD. LJPC-401 is being investigated in a pivotal study in BT patients with iron overload and in a Phase 2 study in patients with HH.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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. LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. LJPC‑401 (synthetic human hepcidin) is La Jolla's investigational product for the potential treatment of conditions characterized by iron overload. LJPC-401 is being investigated in a pivotal study in beta thalassemia patients with iron overload and in a Phase 2 study in patients with hereditary hemochromatosis. 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) sales; cash used in operating activities; regulatory actions relating to La Jolla's products by the U.S. Food and Drug Administration, European Medicines Agency and/or other regulatory authorities; the outcomes of clinical studies of La Jolla's products; 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 Statements of Operations
(Unaudited)
(in thousands, except per share amounts)Three Months Ended
September 30,Nine Months Ended
September 30,2019 2018 2019 2018 Revenue Net product sales $ 5,706 $ 3,470 $ 15,804 $ 5,872 Total revenue 5,706 3,470 15,804 5,872 Operating expenses Cost of product sales 554 256 1,605 443 Research and development 21,182 30,439 64,469 89,735 Selling, general and administrative 10,782 21,139 34,425 66,319 Total operating expenses 32,518 51,834 100,499 156,497 Loss from operations (26,812 ) (48,364 ) (84,695 ) (150,625 ) Other (expense) income Interest expense (2,863 ) (2,926 ) (8,398 ) (4,581 ) Interest income 501 545 1,818 1,155 Total other expense, net (2,362 ) (2,381 ) (6,580 ) (3,426 ) Net loss $ (29,174 ) $ (50,745 ) $ (91,275 ) $ (154,051 ) Net loss per share, basic and diluted $ (1.08 ) $ (1.93 ) $ (3.37 ) $ (6.15 ) Weighted-average common shares outstanding, basic and diluted 27,135 26,226 27,093 25,055 LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands, except par value and share amounts)September 30,
2019December 31,
2018(Unaudited) ASSETS Current assets: Cash $ 104,768 $ 172,604 Accounts receivable, net 1,417 1,381 Inventory, net 1,910 2,020 Prepaid expenses and other current assets 4,783 5,111 Total current assets 112,878 181,116 Property and equipment, net 19,523 22,267 Right-of-use lease asset 15,829 — Restricted cash 909 909 Total assets $ 149,139 $ 204,292 LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY Current liabilities: Accounts payable $ 5,338 $ 8,572 Accrued expenses 9,351 8,485 Accrued payroll and related expenses 5,118 7,509 Lease liability, current portion 2,705 — Deferred rent, current portion — 1,370 Total current liabilities 22,512 25,936 Lease liability, less current portion 27,199 — Deferred rent, less current portion — 13,609 Deferred royalty obligation, net 124,366 124,323 Other noncurrent liabilities 10,233 4,503 Total liabilities 184,310 168,371 Shareholders' (deficit) equity: Common Stock, $0.0001 par value; 100,000,000 shares authorized, 27,147,387 and 26,259,254 shares issued and outstanding at September 30, 2019 and December 31, 2018, 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, 2019 and December 31, 2018; and liquidation preference of $3,906 at September 30, 2019 and December 31, 2018 3,906 3,906 Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized, 0 and 2,737 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively; and liquidation preference of $0 and $2,737 at September 30, 2019 and December 31, 2018, respectively — 2,737 Additional paid-in capital 973,018 950,258 Accumulated deficit (1,012,098 ) (920,983 ) Total shareholders' (deficit) equity (35,171 ) 35,921 Total liabilities and shareholders' (deficit) equity $ 149,139 $ 204,292 Company Contacts
Sandra Vedrick
Senior Director, Investor Relations & Human Resources
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: [email protected]and
Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: [email protected] - GIAPREZA™ (Angiotensin II) U.S. Net Sales: For the three months ended September 30, 2019, GIAPREZA U.S. net sales were $5.7 million, up 64% from the same period in 2018. For the nine months ended September 30, 2019, GIAPREZA U.S. net sales were $15.8 million, up 169% from the same period in 2018. La Jolla expects that its full-year 2019 GIAPREZA U.S. net sales will be $22 million to $25 million.
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SAN DIEGO, Sept. 05, 2019 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (NASDAQ:LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla, will present at the 21st Annual H.C. Wainwright Global Investment Conference on Tuesday, September 10, 2019, at 8:20 a.m. Eastern Time at the Lotte New York Palace.
A live webcast of this presentation will be available on the Company's website at www.ljpc.com in the Investor Relations section. A replay of the presentation will be archived on the website for 60 days.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. GIAPREZA™ (angiotensin II), formerly known as LJPC-501, was approved by the U.S. Food and Drug Administration (FDA) in December 2017 as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. GIAPREZA was approved by the European Commission (EC) in August 2019 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. LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. LJPC‑401 (synthetic human hepcidin), a clinical-stage investigational product, is being developed for the potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis, beta thalassemia, sickle cell disease, myelodysplastic syndrome and polycythemia vera. For more information, please visit www.ljpc.com.
Company Contacts
Sandra Vedrick
Senior Director, Investor Relations & Human Resources
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: [email protected]and
Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: [email protected] -
La Jolla Pharmaceutical Company Receives European Commission Approval for GIAPREZA™ (angiotensin II)View Full Article Hide Full Article
SAN DIEGO, Aug. 29, 2019 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (NASDAQ:LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that the European Commission (EC) has approved GIAPREZA™ (angiotensin II) 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.
"We are pleased with the European Commission's approval of GIAPREZA and look forward to bringing this new treatment option to the many critically ill European patients suffering from septic or other distributive shock," said George F. Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. "We are appreciative of the patients, families and dedicated critical care teams who made the development of GIAPREZA possible."
The EC's approval is based on data from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study, which established the safety and efficacy of GIAPREZA in adults with septic or other distributive shock. The EC's decision is applicable to the 28 European Union member countries. Approval will also be recognized in Iceland, Norway and Liechtenstein.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was 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. In August 2019, GIAPREZA was 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 regulatory peptide that is central to the renin-angiotensin-aldosterone system to increase blood pressure. U.S. prescribing information for GIAPREZA is available at www.giapreza.com. GIAPREZA is marketed by La Jolla Pharmaceutical Company on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary.
U.S. 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 (ARB) 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.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. GIAPREZA™ (angiotensin II), formerly known as LJPC-501, was approved by the U.S. Food and Drug Administration (FDA) in December 2017 as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. GIAPREZA was approved by the European Commission (EC) in August 2019 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. LJPC-0118 (artesunate) is La Jolla's investigational product for the treatment of severe malaria. LJPC‑401 (synthetic human hepcidin), a clinical-stage investigational product, is being developed for the potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis, beta thalassemia, sickle cell disease, myelodysplastic syndrome and polycythemia vera. 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, including, but not limited to, statements related to the regulatory approval of GIAPREZA™ (angiotensin II) in Europe and to the anticipated timing for commercial availability of the product in Europe. These statements are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. La Jolla cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties and other factors are described in greater detail in La Jolla's filings with the U.S. Securities and Exchange Commission (SEC), all of which are available free of charge on the SEC's website at www.sec.gov. These risks include, but are not limited to, risks relating to: commercialization plans for GIAPREZA, including the timing for commercial launch of GIAPREZA in Europe; the scope of the GIAPREZA product label(s) and potential market sizes, as well as the broader commercial opportunity for GIAPREZA and our product candidates; risks relating to the scope of the GIAPREZA product label(s); the anticipated treatment of future clinical data by the U.S. Food and Drug Administration (FDA), European Commission (EC) and other regulatory authorities; the expected duration over which La Jolla's cash balances will fund its operations; and other risks and uncertainties identified in our filings with the SEC. Forward-looking statements are presented as of the date of this press release, and La Jolla expressly disclaims any intent to update any forward‑looking statements to reflect the outcome of subsequent events.
Company Contacts
Sandra Vedrick
Senior Director, Investor Relations & Human Resources
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: [email protected]and
Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: [email protected]