LJPC La Jolla Pharmaceutical Company

3.54
-0.1  -3%
Previous Close 3.64
Open 3.7
52 Week Low 3.35
52 Week High 7.85
Market Cap $97,248,678
Shares 27,471,378
Float 17,772,639
Enterprise Value $67,241,674
Volume 239,962
Av. Daily Volume 276,029
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Drug Pipeline

Drug Stage Notes
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.
XERAVA (eravacycline)
cIAI (complicated intra-abdominal infections)
Approved
Approved
FDA approval announced August 27, 2018.
GIAPREZA (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.
Artesunate (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.
LJPC‑401
Hereditary Hemochromatosis
Phase 2
Phase 2
Phase 2 data met primary endpoint - June 6, 2019.

Latest News

  1. 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, 2021 and highlighted corporate progress.

    Corporate Progress

    • Operating Cash Flow Improved: La Jolla's net cash provided by (used for) operating activities for the three months ended March 31, 2021 was $17.2 million, compared to $(12.2) million for the same period in 2020. La Jolla's net cash provided by (used for) operating activities excluding net receipts in connection with license agreements and payments related to reductions in headcount for the three months ended…

    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, 2021 and highlighted corporate progress.

    Corporate Progress

    • Operating Cash Flow Improved: La Jolla's net cash provided by (used for) operating activities for the three months ended March 31, 2021 was $17.2 million, compared to $(12.2) million for the same period in 2020. La Jolla's net cash provided by (used for) operating activities excluding net receipts in connection with license agreements and payments related to reductions in headcount for the three months ended March 31, 2021 was $(1.8) million, compared to $(9.2) million for the same period in 2020.
    • $3.0 Million Milestone Payment Associated with NDA Submission for XERAVA™ (Eravacycline) in China by Licensee Everest Received: In March 2021, under its license agreement with Everest Medicines Limited, the Company received a $3.0 million milestone payment associated with the submission of a New Drug Application (NDA) with the China National Medical Products Administration (NMPA) for XERAVA for the treatment of cIAI in patients in China. The Company previously granted Everest an exclusive license to develop and commercialize XERAVA for the treatment of cIAI and other indications in mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, the Malaysian Federation, the Kingdom of Thailand, the Republic of Indonesia, the Socialist Republic of Vietnam and the Republic of the Philippines. The Company is eligible to receive an additional $8.0 million regulatory milestone payment and up to an aggregate of $20.0 million in sales milestone payments. The Company is also entitled to receive royalties from Everest on sales, if any, by Everest of products containing eravacycline.
    • License Agreement for GIAPREZA™ (Angiotensin II) and XERAVA in Europe, which Included a $22.5 Million Upfront Payment, Executed with PAION: In January 2021, the Company entered into a license agreement with PAION AG to commercialize GIAPREZA and XERAVA in the European Economic Area, the United Kingdom and Switzerland. Pursuant to the agreement: (i) the Company has received an upfront cash payment of $22.5 million, less a 15% refundable withholding tax; and (ii) the Company is entitled to receive potential commercial milestone payments of up to $109.5 million and royalties on net sales of GIAPREZA and XERAVA.

    "We are pleased to report continued progress toward our goal of becoming cash flow positive from operations," said Larry Edwards, President and Chief Executive Officer of La Jolla. "The filing of an NDA for XERAVA in China by our licensee Everest and the execution of our license agreement with PAION for GIAPREZA and XERAVA in Europe position us well to serve the needs of patients suffering from life-threatening diseases globally while significantly strengthening our balance sheet. We continue to focus on growing net sales of both GIAPREZA and XERAVA while managing operating costs."

    Financial Results

    For the three months ended March 31, 2021, La Jolla's total revenue was $34.1 million, compared to $7.6 million for the same period in 2020. For the three months ended March 31, 2021, La Jolla's net product sales were $8.7 million, compared to $7.6 million for the same period in 2020. GIAPREZA U.S. net sales were $6.9 million for the three months ended March 31, 2021, compared to $7.6 million for the same period in 2020. XERAVA U.S. net sales were $1.8 million for the three months ended March 31, 2021, compared to zero for the same period in 2020. La Jolla acquired Tetraphase, which commercialized XERAVA, on July 28, 2020.

    La Jolla's net income (loss) for the three months ended March 31, 2021 was $14.4 million, or $0.42 per diluted share, compared to $(8.6) million, or $(0.32) per diluted share, for the same period in 2020.

    As of March 31, 2021 and December 31, 2020, La Jolla had cash and cash equivalents of $38.6 million and $21.2 million, respectively.

    La Jolla's net cash provided by (used for) operating activities for the three months ended March 31, 2021 was $17.2 million, compared to $(12.2) million for the same period in 2020. La Jolla's net cash provided by (used for) operating activities excluding net receipts in connection with license agreements and payments related to reductions in headcount for the three months ended March 31, 2021 was $(1.8) million, compared to $(9.2) million for the same period in 2020. Net receipts in connection with license agreements were $19.8 million for the three months ended March 31, 2021, compared to zero for the same period in 2020. Payments related to reductions in headcount were $0.8 million for the three months ended March 31, 2021, compared to $3.0 million for the same period in 2020.

    About GIAPREZA

    GIAPREZA™ (angiotensin II) injection is approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. GIAPREZA is approved by the European Commission (EC) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. GIAPREZA mimics the body's endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure. Prescribing information for GIAPREZA is available at http://www.giapreza.com. The European Summary of Product Characteristics is available at www.ema.europa.eu/en/medicines/human/EPAR/giapreza. GIAPREZA is marketed in the U.S. by La Jolla Pharmaceutical Company on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary, and will be marketed in Europe by PAION AG on behalf of La Jolla Pharma, LLC.

    GIAPREZA Important Safety Information

    Contraindications

    None.

    Warnings and Precautions

    There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis.

    Adverse Reactions

    The most common adverse reactions that were reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events.

    Drug Interactions

    Angiotensin converting enzyme (ACE) inhibitors may increase response to GIAPREZA. Angiotensin II receptor blockers (ARBs) may reduce response to GIAPREZA.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    For additional information, please see Full Prescribing Information for the United States and the Summary of Product Characteristics for the European Union.

    About XERAVA

    XERAVA™ (eravacycline) for injection is approved by the U.S. Food and Drug Administration (FDA) as a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA is approved by the European Commission (EC) for the treatment of cIAI in adults. Prescribing information for XERAVA is available at www.xerava.com. The European Summary of Product Characteristics is available at www.ema.europa.eu/en/medicines/human/EPAR/xerava. XERAVA is marketed in the U.S. by Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of La Jolla, and will be marketed in Europe by PAION AG on behalf of Tetraphase Pharmaceuticals, Inc. Everest, the Company's licensee for mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, the Malaysian Federation, the Kingdom of Thailand, the Republic of Indonesia, the Socialist Republic of Vietnam and the Republic of the Philippines, recently submitted an NDA in China.

    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, China National Medical Products Administration and/or other regulatory authorities; expected future cash flows of La Jolla, including upfront, milestone, royalty and other payments resulting from La Jolla's out-license agreements and commercial supply agreements; and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.

    LA JOLLA PHARMACEUTICAL COMPANY

    Condensed Consolidated Balance Sheets

    (in thousands, except par value and share amounts)

     

     

     

    March 31,

     

     

    December 31,

     

     

     

    2021

     

     

    2020

     

     

     

    (Unaudited)

     

     

     

     

     

    ASSETS

     

     

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    38,634

     

     

    $

    21,221

     

    Accounts receivable, net

     

     

    4,153

     

     

     

    5,834

     

    Inventory, net

     

     

    5,374

     

     

     

    6,013

     

    Prepaid expenses and other current assets

     

     

    6,104

     

     

     

    3,388

     

    Total current assets

     

     

    54,265

     

     

     

    36,456

     

    Goodwill

     

     

    20,123

     

     

     

    20,123

     

    Intangible assets, net

     

     

    14,485

     

     

     

    14,873

     

    Right-of-use lease assets

     

     

    490

     

     

     

    536

     

    Property and equipment, net

     

     

    186

     

     

     

    215

     

    Restricted cash

     

     

    40

     

     

     

    40

     

    Total assets

     

    $

    89,589

     

     

    $

    72,243

     

     

     

     

     

     

     

     

     

     

    LIABILITIES AND SHAREHOLDERS' DEFICIT

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    1,098

     

     

    $

    2,762

     

    Accrued expenses

     

     

    8,721

     

     

     

    6,494

     

    Accrued payroll and related expenses

     

     

    1,693

     

     

     

    2,878

     

    Lease liabilities, current portion

     

     

    196

     

     

     

    204

     

    Total current liabilities

     

     

    11,708

     

     

     

    12,338

     

    Deferred royalty obligation, net

     

     

    124,453

     

     

     

    124,437

     

    Accrued interest expense on deferred royalty obligation, less current portion

     

     

    20,884

     

     

     

    19,111

     

    Lease liabilities, less current portion

     

     

    294

     

     

     

    332

     

    Other noncurrent liabilities

     

     

    4,568

     

     

     

    4,112

     

    Total liabilities

     

     

    161,907

     

     

     

    160,330

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

    Shareholders' deficit:

     

     

     

     

     

     

     

     

    Common Stock, $0.0001 par value; 100,000,000 shares authorized, 27,448,571 and 27,402,648 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively

     

     

    3

     

     

     

    3

     

    Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at March 31, 2021 and December 31, 2020; and liquidation preference of $3,906 at March 31, 2021 and December 31, 2020

     

     

    3,906

     

     

     

    3,906

     

    Additional paid-in capital

     

     

    986,107

     

     

     

    984,756

     

    Accumulated deficit

     

     

    (1,062,334

    )

     

     

    (1,076,752

    )

    Total shareholders' deficit

     

     

    (72,318

    )

     

     

    (88,087

    )

    Total liabilities and shareholders' deficit

     

    $

    89,589

     

     

    $

    72,243

     

    LA JOLLA PHARMACEUTICAL COMPANY

    Condensed Consolidated Statements of Operations

    (in thousands, except per share amounts)

     

     

     

    Three Months Ended

     

     

     

    March 31,

     

     

     

    2021

     

     

    2020

     

    Revenue

     

     

     

     

     

     

     

     

    Net product sales

     

    $

    8,637

     

     

    $

    7,591

     

    License revenue

     

     

    25,500

     

     

     

    -

     

    Total revenue

     

     

    34,137

     

     

     

    7,591

     

    Operating expenses

     

     

     

     

     

     

     

     

    Cost of product sales

     

     

    2,731

     

     

     

    716

     

    Cost of license revenue

     

     

    3,600

     

     

     

    -

     

    Selling, general and administrative

     

     

    8,755

     

     

     

    8,152

     

    Research and development

     

     

    1,558

     

     

     

    9,183

     

    Total operating expenses

     

     

    16,644

     

     

     

    18,051

     

    Income (loss) from operations

     

     

    17,493

     

     

     

    (10,460

    )

    Other (expense) income

     

     

     

     

     

     

     

     

    Interest expense

     

     

    (2,609

    )

     

     

    (2,406

    )

    Interest income

     

     

    2

     

     

     

    190

     

    Other income—related party

     

     

    -

     

     

     

    4,085

     

    Other expense

     

     

    (450

    )

     

     

    -

     

    Total other (expense) income, net

     

     

    (3,057

    )

     

     

    1,869

     

    Income (loss) before income taxes

     

     

    14,436

     

     

     

    (8,591

    )

    Provision for income taxes

     

     

    18

     

     

     

    -

     

    Net income (loss)

     

    $

    14,418

     

     

    $

    (8,591

    )

    Earnings (loss) per share

     

     

     

     

     

     

     

     

    Basic

     

    $

    0.53

     

     

    $

    (0.32

    )

    Diluted

     

    $

    0.42

     

     

    $

    (0.32

    )

    Shares used in computing earnings (loss) per share

     

     

     

     

     

     

     

     

    Basic

     

     

    27,427

     

     

     

    27,238

     

    Diluted

    34,183

    27,238

     

    LA JOLLA PHARMACEUTICAL COMPANY

    Condensed Consolidated Statements of Cash Flows

    (Unaudited)

    (in thousands)

     

     

     

    Three Months Ended

     

     

     

    March 31,

     

     

     

    2021

     

     

    2020

     

    Operating activities

     

     

     

     

     

     

     

     

    Net income (loss)

     

    $

    14,418

     

     

    $

    (8,591

    )

    Adjustments to reconcile net income (loss) to net cash provided by (used for) operating activities:

     

     

     

     

     

     

     

     

    Share-based compensation expense

     

     

    1,116

     

     

     

    2,407

     

    Depreciation expense

     

     

    29

     

     

     

    1,060

     

    Non-cash interest expense

     

     

    1,736

     

     

     

    1,682

     

    Inventory fair value step-up adjustment included in cost of product sales

     

     

    850

     

     

     

    -

     

    Amortization of intangible assets

     

     

    388

     

     

     

    -

     

    Loss on change in fair value of contingent value rights

     

     

    450

     

     

     

    -

     

    Amortization of right-of-use lease assets

     

     

    46

     

     

     

    345

     

    Loss on disposal of property and equipment

     

     

    -

     

     

     

    148

     

    Changes in operating assets and liabilities:

     

     

     

     

     

     

     

     

    Accounts receivable, net

     

     

    1,681

     

     

     

    (592

    )

    Inventory, net

     

     

    (211

    )

     

     

    251

     

    Prepaid expenses and other current assets

     

     

    (2,716

    )

     

     

    1,084

     

    Accounts payable

     

     

    (1,664

    )

     

     

    (2,282

    )

    Accrued expenses

     

     

    2,286

     

     

     

    (2,404

    )

    Accrued payroll and related expenses

     

     

    (1,185

    )

     

     

    (4,683

    )

    Lease liabilities

     

     

    (46

    )

     

     

    (674

    )

    Net cash provided by (used for) operating activities

     

     

    17,178

     

     

     

    (12,249

    )

    Investing activities

     

     

     

     

     

     

     

     

    Proceeds from the sale of property and equipment

     

     

    -

     

     

     

    1,143

     

    Net cash provided by investing activities

     

     

    -

     

     

     

    1,143

     

    Financing activities

     

     

     

     

     

     

     

     

    Net proceeds from issuance of common stock under 2013 Equity Plan

     

     

    154

     

     

     

    305

     

    Net proceeds from issuance of common stock under ESPP

     

     

    81

     

     

     

    200

     

    Net cash provided by financing activities

     

     

    235

     

     

     

    505

     

    Net increase (decrease) in cash, cash equivalents and restricted cash

     

     

    17,413

     

     

     

    (10,601

    )

    Cash, cash equivalents and restricted cash, beginning of period

     

     

    21,261

     

     

     

    88,729

     

    Cash, cash equivalents and restricted cash, end of period

     

    $

    38,674

     

     

    $

    78,128

     

    Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    38,634

     

     

    $

    77,219

     

    Restricted cash

     

     

    40

     

     

     

    909

     

    Total cash, cash equivalents and restricted cash

     

    $

    38,674

    $

    78,128

     

     

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  2. La Jolla Pharmaceutical Company (NASDAQ:LJPC), which is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases, today announced financial results for the three and twelve months ended December 31, 2021 and highlighted corporate progress.

    Corporate Progress

    • Exclusive Licensing Agreement for GIAPREZA™ (Angiotensin II) and XERAVA™ (Eravacycline) in Europe: In January 2021, La Jolla Pharmaceutical Company announced that it and certain of its wholly owned subsidiaries (collectively, La Jolla) entered into an exclusive licensing agreement with PAION AG and its wholly owned subsidiary (collectively, PAION) to commercialize GIAPREZA and XERAVA in the European…

    La Jolla Pharmaceutical Company (NASDAQ:LJPC), which is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases, today announced financial results for the three and twelve months ended December 31, 2021 and highlighted corporate progress.

    Corporate Progress

    • Exclusive Licensing Agreement for GIAPREZA™ (Angiotensin II) and XERAVA™ (Eravacycline) in Europe: In January 2021, La Jolla Pharmaceutical Company announced that it and certain of its wholly owned subsidiaries (collectively, La Jolla) entered into an exclusive licensing agreement with PAION AG and its wholly owned subsidiary (collectively, PAION) to commercialize GIAPREZA and XERAVA in the European Economic Area, the United Kingdom and Switzerland (the Territories). Under the terms of the exclusive licensing agreement, La Jolla is 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.
    • Acquisition of Tetraphase Pharmaceuticals, Inc. (Tetraphase): In July 2020, La Jolla completed its acquisition of Tetraphase, a biopharmaceutical company focused on commercializing its novel tetracycline, XERAVA, to treat serious and life-threatening infections. Financial results for periods ending December 31, 2020 and beyond include Tetraphase's financial results subsequent to the acquisition closing date of July 28, 2020.
    • Net Sales: For the three and twelve months ended December 31, 2020, net sales were $11.0 million and $33.4 million, respectively, compared to $7.3 million and $23.1 million, respectively, for the same periods in 2019.



      • GIAPREZA Net Sales: For the three and twelve months ended December 31, 2020, GIAPREZA U.S. net sales were $8.7 million and $29.3 million, respectively, up 19% and 27%, respectively, from the same periods in 2019.



      • XERAVA Net Sales: Subsequent to July 28, 2020 and through December 31, 2020, XERAVA U.S. net sales were $4.2 million. For the three and twelve months ended December 31, 2020, including the period prior to the acquisition of Tetraphase, XERAVA U.S. net sales were $2.3 million and $8.2 million, respectively, up 53% and 128%, respectively, from the same periods in 2019.

    "2020 was a productive year for La Jolla as we completed the integration of Tetraphase, increased net sales of both products compared to the prior year and reduced our operating costs," said Larry Edwards, President and Chief Executive Officer of La Jolla. "Our agreement with PAION positions us well to serve the needs of patients suffering from life-threatening diseases in both the U.S. and Europe. As we enter 2021, our focus will be on continuing to grow net sales of both GIAPREZA and XERAVA while continuing to manage operating costs."

    Financial Results

    For the three and twelve months ended December 31, 2020, net sales were $11.0 million and $33.4 million, respectively, compared to $7.3 million and $23.1 million, respectively, for the same periods in 2019.

    La Jolla's net loss for the three and twelve months ended December 31, 2020 was $3.5 million and $39.4 million, or $0.13 and $1.44 per share, respectively, compared to $25.2 million and $116.5 million, or $0.93 per share and $4.30 per share, respectively, for the same periods in 2019.

    As of December 31, 2020, La Jolla had $21.2 million of cash and cash equivalents. On a pro forma basis, adjusting for $18.9 million of upfront net proceeds from its licensing agreement with PAION, net of the amounts due under the George Washington University and Harvard University license agreements, La Jolla had cash and cash equivalents of $40.1 million.

    Net cash used for operating activities for the three and twelve months ended December 31, 2020 was $7.3 million and $37.6 million, respectively, down 57% and 56%, respectively, from the same periods in 2019. Net cash used for operating activities for the three and twelve months ended December 31, 2020, excluding cash expenditures related to reductions in headcount and transaction costs associated with the Tetraphase acquisition, was $5.7 million and $27.2 million, respectively, down 65% and 67%, respectively, from the same periods in 2019. Cash expenditures related to reductions in headcount were $1.6 million and $9.5 million for the three and twelve months ended December 31, 2020, respectively, and $0.9 million and $3.2 million, respectively, for the same periods in 2019. Cash expenditures related to transaction costs associated with the Tetraphase acquisition were zero and $0.9 million for the three and twelve months ended December 31, 2020, respectively.

    About GIAPREZA

    GIAPREZA™ (angiotensin II) injection is approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. GIAPREZA is approved by the European Commission (EC) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. GIAPREZA mimics the body's endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure. Prescribing information for GIAPREZA is available at http://www.giapreza.com. The European Summary of Product Characteristics is available on the EMA website: www.ema.europa.eu/en/medicines/human/EPAR/giapreza. GIAPREZA is marketed in the U.S. by La Jolla Pharmaceutical Company on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary, and will be marketed in Europe by PAION AG on behalf of La Jolla Pharma, LLC.

    GIAPREZA Important Safety Information

    Contraindications

    None.

    Warnings and Precautions

    There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis.

    Adverse Reactions

    The most common adverse reactions that were reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events.

    Drug Interactions

    Angiotensin converting enzyme (ACE) inhibitors may increase response to GIAPREZA. Angiotensin II receptor blockers (ARBs) may reduce response to GIAPREZA.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    For additional information, please see Full Prescribing Information for the United States and the Summary of Product Characteristics for the European Union.

    About XERAVA

    XERAVA™ (eravacycline) for injection is approved by the U.S. Food and Drug Administration (FDA) as a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA is approved by the European Commission (EC) for the treatment of cIAI in adults. Prescribing information for XERAVA is available at www.xerava.com. XERAVA is marketed in the U.S. by Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of La Jolla, and will be marketed in Europe by PAION AG on behalf of Tetraphase Pharmaceuticals, Inc.

    XERAVA Important Safety Information

    XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older.

    XERAVA is not indicated for the treatment of complicated urinary tract infections.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

    The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

    The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

    The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea and vomiting.

    XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri and anti-anabolic action, which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    For additional information, please see Full Prescribing Information for the United States.

    About La Jolla Pharmaceutical Company

    La Jolla Pharmaceutical Company is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. GIAPREZA™ (angiotensin II) is approved by the U.S. FDA as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. XERAVA™ (eravacycline) is approved by the U.S. FDA for the treatment of complicated intra-abdominal infections. For more information, please visit www.ljpc.com.

    Forward-looking Statements

    This press release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that forward-looking statements are based on management's expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: GIAPREZA™ (angiotensin II) and XERAVA™ (eravacycline) sales; whether La Jolla will realize the benefits from the acquisition of Tetraphase Pharmaceuticals, Inc.; regulatory actions relating to La Jolla's products by the U.S. FDA, European Commission and/or other regulatory authorities; expected future cash flows of La Jolla, including milestone and/or royalty payments resulting from La Jolla's exclusive license agreement with PAION AG; and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.

    LA JOLLA PHARMACEUTICAL COMPANY

    Condensed Consolidated Balance Sheets

    (in thousands, except par value and share amounts)

     

     

     

    December 31,

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

    ASSETS

     

     

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    21,221

     

     

    $

    87,820

     

    Accounts receivable, net

     

     

    5,834

     

     

     

    2,960

     

    Inventory, net

     

     

    6,013

     

     

     

    2,211

     

    Prepaid expenses and other current assets

     

     

    3,388

     

     

     

    4,467

     

    Total current assets

     

     

    36,456

     

     

     

    97,458

     

    Goodwill

     

     

    20,123

     

     

     

    -

     

    Intangible assets, net

     

     

    14,873

     

     

     

    -

     

    Right-of-use lease assets

     

     

    536

     

     

     

    15,491

     

    Property and equipment, net

     

     

    215

     

     

     

    18,389

     

    Restricted cash

     

     

    40

     

     

     

    909

     

    Total assets

     

    $

    72,243

     

     

    $

    132,247

     

     

     

     

     

     

     

     

     

     

    LIABILITIES AND SHAREHOLDERS' DEFICIT

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    2,762

     

     

    $

    4,177

     

    Accrued expenses

     

     

    6,494

     

     

     

    9,312

     

    Accrued payroll and related expenses

     

     

    2,878

     

     

     

    8,332

     

    Lease liabilities, current portion

     

     

    204

     

     

     

    2,766

     

    Total current liabilities

     

     

    12,338

     

     

     

    24,587

     

    Deferred royalty obligation, net

     

     

    124,437

     

     

     

    124,379

     

    Accrued interest expense on deferred royalty obligation, less current portion

     

     

    19,111

     

     

     

    12,790

     

    Lease liabilities, less current portion

     

     

    332

     

     

     

    26,481

     

    Other noncurrent liabilities

     

     

    4,112

     

     

     

    -

     

    Total liabilities

     

    $

    160,330

     

     

    $

    188,237

     

    Commitments and contingencies (Note 6)

     

     

     

     

     

     

     

     

    Shareholders' deficit:

     

     

     

     

     

     

     

     

    Common Stock, $0.0001 par value; 100,000,000 shares authorized, 27,402,648 and 27,195,469 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively

     

     

    3

     

     

     

    3

     

    Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at December 31, 2020 and December 31, 2019; and liquidation preference of $3,906 at December 31, 2020 and December 31, 2019

     

     

    3,906

     

     

     

    3,906

     

    Additional paid-in capital

     

     

    984,756

     

     

     

    977,432

     

    Accumulated deficit

     

     

    (1,076,752

    )

     

     

    (1,037,331

    )

    Total shareholders' deficit

     

     

    (88,087

    )

     

     

    (55,990

    )

    Total liabilities and shareholders' deficit

     

    $

    72,243

     

     

    $

    132,247

     

    LA JOLLA PHARMACEUTICAL COMPANY

    Condensed Consolidated Statements of Operations

    (in thousands, except per share amounts)

     

     

     

    Year Ended

     

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

    Revenue

     

     

     

     

     

     

     

     

    Net product sales

     

    $

    33,419

     

     

    $

    23,054

     

    Total revenue

     

     

    33,419

     

     

     

    23,054

     

    Operating expenses

     

     

     

     

     

     

     

     

    Cost of product sales

     

     

    7,819

     

     

     

    2,392

     

    Selling, general and administrative

     

     

    38,428

     

     

     

    45,134

     

    Research and development

     

     

    23,010

     

     

     

    85,329

     

    Total operating expenses

     

     

    69,257

     

     

     

    132,855

     

    Loss from operations

     

     

    (35,838

    )

     

     

    (109,801

    )

    Other income (expense)

     

     

     

     

     

     

     

     

    Interest expense

     

     

    (10,051

    )

     

     

    (10,774

    )

    Interest income

     

     

    235

     

     

     

    2,128

     

    Other income—related party

     

     

    6,279

     

     

     

    1,939

     

    Other income (expense)

     

     

    (46

    )

     

     

    -

     

    Total other income (expense), net

     

     

    (3,583

    )

     

     

    (6,707

    )

    Net loss

     

    $

    (39,421

    )

     

    $

    (116,508

    )

    Net loss per share, basic and diluted

     

    $

    (1.44

    )

     

    $

    (4.30

    )

    Weighted-average common shares outstanding, basic and diluted

     

     

    27,329

     

     

     

    27,112

     

    LA JOLLA PHARMACEUTICAL COMPANY

    Condensed Consolidated Statements of Cash Flows

    (Unaudited)

    (in thousands)

     

     

     

    Year Ended

     

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

    Operating activities

     

     

     

     

     

     

     

     

    Net loss

     

    $

    (39,421

    )

     

    $

    (116,508

    )

    Adjustments to reconcile net loss to net cash used for operating activities:

     

     

     

     

     

     

     

     

    Share-based compensation expense

     

     

    6,207

     

     

     

    23,733

     

    Depreciation expense

     

     

    2,188

     

     

     

    4,552

     

    Non-cash interest expense

     

     

    6,379

     

     

     

    8,775

     

    Inventory fair value step-up adjustment included in cost of product sales

     

     

    2,458

     

     

     

    -

     

    Amortization of intangible assets

     

     

    647

     

     

     

    -

     

    Change in fair value of contingent value rights

     

     

    (800

    )

     

     

    -

     

    Amortization of right-of-use lease assets

     

     

    1,249

     

     

     

    1,307

     

    Loss on short-term investments

     

     

    502

     

     

     

    -

     

    Loss on disposal of property and equipment, net of gain on lease termination

     

     

    10

     

     

     

    24

     

    Changes in operating assets and liabilities:

     

     

     

     

     

     

     

     

    Accounts receivable, net

     

     

    (1,687

    )

     

     

    (1,579

    )

    Inventory, net

     

     

    (1,493

    )

     

     

    (191

    )

    Prepaid expenses and other current assets

     

     

    2,297

     

     

     

    644

     

    Accounts payable

     

     

    (2,815

    )

     

     

    (4,395

    )

    Accrued expenses

     

     

    (5,781

    )

     

     

    395

     

    Accrued payroll and related expenses

     

     

    (5,454

    )

     

     

    823

     

    Lease liabilities

     

     

    (2,126

    )

     

     

    (2,530

    )

    Net cash used for operating activities

     

     

    (37,640

    )

     

     

    (84,950

    )

    Investing activities

     

     

     

     

     

     

     

     

    Acquisition of Tetraphase, net of cash, cash equivalents and restricted cash acquired

     

     

    (33,513

    )

     

     

    -

     

    Purchases of short-term investments

     

     

    (2,999

    )

     

     

    -

     

    Purchases of property and equipment

     

     

    -

     

     

     

    (698

    )

    Proceeds from the sale of property and equipment

     

     

    3,070

     

     

     

    -

     

    Proceeds from the sale of short-term investments

     

     

    2,497

     

     

     

    -

     

    Net cash used for investing activities

     

     

    (30,945

    )

     

     

    (698

    )

    Financing activities

     

     

     

     

     

     

     

     

    Net proceeds from issuance of common stock under 2013 Equity Plan

     

     

    605

     

     

     

    31

     

    Net proceeds from issuance of common stock under ESPP

     

     

    512

     

     

     

    833

     

    Net cash provided by financing activities

     

     

    1,117

     

     

     

    864

     

    Net decrease in cash, cash equivalents and restricted cash

     

     

    (67,468

    )

     

     

    (84,784

    )

    Cash, cash equivalents and restricted cash, beginning of period

     

     

    88,729

     

     

     

    173,513

     

    Cash, cash equivalents and restricted cash, end of period

     

    $

    21,261

     

     

    $

    88,729

     

    Supplemental disclosure of non-cash investing and financing activities

     

     

     

     

     

     

     

     

    Initial recognition of right-of-use lease asset

     

    $

    536

     

     

    $

    16,798

     

    Conversion of Series F Convertible Preferred Stock into common stock

     

    $

    -

     

     

    $

    2,737

     

    Cumulative-effect adjustment from adoption of ASU 2018-07

     

    $

    -

     

     

    $

    (160

    )

    Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    21,221

     

     

    $

    87,820

     

    Restricted cash

     

     

    40

     

     

     

    909

     

    Total cash, cash equivalents and restricted cash

     

    $

    21,261

     

     

    $

    88,729

     

     

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  3. 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…

    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.

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  4. 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…

    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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  5. 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,