LJPC La Jolla Pharmaceutical Company

4.7
-0.01  -0%
Previous Close 4.71
Open 4.75
52 Week Low 2.3
52 Week High 10.53
Market Cap $128,601,870
Shares 27,362,100
Float 18,688,024
Enterprise Value $88,982,870
Volume 938,029
Av. Daily Volume 518,739
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Drug Pipeline

Drug Stage Notes
LJPC-0118
Severe Malaria
Approved
Approved
On May 29, 2020, La Jolla received tentative approved. La Jolla will not receive final approval until Amivas’ 7-year market exclusivity has expired.
Eravacycline (TP-434) - IGNITE4
cIAI (complicated intra-abdominal infections)
Approved
Approved
FDA approval announced August 27, 2018.
LJPC‑401
Hereditary Hemochromatosis
Phase 2
Phase 2
Phase 2 data met primary endpoint - June 6, 2019.
LJPC-401
Beta thalassemia patients suffering from iron overload
Phase 2
Phase 2
Development to be discontinued due to lack of efficacy - November 25, 2019.
GiaprezaTM (angiotensin II)
Increase blood pressure in adults with septic or other distributive shock
Approved
Approved
PDUFA date under priority review scheduled for February 28, 2018. Approval announced December 21, 2017.

Latest News

  1. 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…

    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,

    2020
     December 31,

    2019
     (Unaudited)  
    ASSETS   
    Current assets:   
    Cash$68,353  $87,820 
    Short-term investments3,062   
    Accounts receivable, net1,843  2,960 
    Inventory, net3,120  2,211 
    Prepaid expenses and other current assets2,792  4,467 
    Total current assets79,170  97,458 
    Property and equipment, net12,827  18,389 
    Right-of-use lease asset14,792  15,491 
    Restricted cash606  909 
    Total assets$107,395  $132,247 
        
    LIABILITIES AND SHAREHOLDERS' DEFICIT   
    Current liabilities:   
    Accounts payable$2,481  $4,177 
    Accrued expenses6,772  9,312 
    Accrued payroll and related expenses5,741  8,332 
    Lease liability, current portion2,890  2,766 
    Total current liabilities17,884  24,587 
    Lease liability, less current portion25,000  26,481 
    Deferred royalty obligation, net124,406  124,379 
    Other noncurrent liabilities15,317  12,790 
    Total liabilities182,607  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, respectively
    3  3 
    Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at June 30, 2020 and December 31, 2019; and liquidation preference of $3,906 at June 30, 2020 and December 31, 20193,906  3,906 
    Additional paid-in capital982,393  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  $10,098 
    Total revenue5,805  5,703  13,396  10,098 
    Operating expenses       
    Cost of product sales808  551  1,524  1,051 
    Research and development8,781  22,043  17,964  43,287 
    Selling, general and administrative8,677  11,323  16,829  23,643 
    Total operating expenses18,266  33,917  36,317  67,981 
    Loss from operations(12,461) (28,214) (22,921) (57,883)
    Other income (expense)       
    Interest expense(2,470) (2,806) (4,876) (5,535)
    Interest income32  604  222  1,317 
    Other income—related party    4,085   
    Other expense(693)   (693)  
    Total other income (expense), net(3,131) (2,202) (1,262) (4,218)
    Net loss$(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 diluted27,326  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 expense3,997  13,103 
    Depreciation and amortization expense1,798  2,263 
    Loss on disposal of equipment904  15 
    Unrealized gains on short-term investments(63)  
    Non-cash interest expense3,392  4,678 
    Non-cash rent expense699  639 
    Changes in operating assets and liabilities:   
    Accounts receivable, net1,117  (512)
    Inventory, net(909) 52 
    Prepaid expenses and other current assets1,675  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 equipment2,860   
    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 Plan605   
    Net proceeds from issuance of common stock under ESPP359  484 
    Net cash provided by financing activities964  484 
    Net decrease in cash and restricted cash(19,770) (49,158)
    Cash and restricted cash at beginning of period88,729  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 cash606  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

     

    Primary Logo

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  2. 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…

    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

    Primary Logo

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  3. 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…

    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

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  4. 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…

    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,
    2020
      December 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, respectively
    3     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:

    and

    Dennis Mulroy
    Chief Financial Officer
    La Jolla Pharmaceutical Company
    Phone: (858) 207-4264 Ext: 1040
    Email:

     

    Primary Logo

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  5. 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…

    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:

    and

    Dennis Mulroy

    Chief Financial Officer

    La Jolla Pharmaceutical Company

    Phone: (858) 207-4264 Ext: 1040

    Email:

     

    Primary Logo

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