La Jolla Pharmaceutical Company (Nasdaq: LJPC), which is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases, today announced financial results for the three and twelve months ended December 31, 2019.

For the three months ended December 31, 2019, GIAPREZA U.S. net sales were $7.3 million, up 74% from the three months ended December 31, 2018 and up 28% from the three months ended September 30, 2019. Vials of GIAPREZA shipped from distributors to hospitals (hospital demand) grew 74% for the three months ended December 31, 2019 as compared to the three months ended December 31, 2018 and 18% as compared to the three months ended September 30, 2019. GIAPREZA U.S. net sales were $23.1 million in 2019 compared to $10.1 million in 2018, an increase of 129%. La Jolla announced the commercial availability of GIAPREZA in the U.S. in March 2018.

La Jolla’s net loss for the three and twelve months ended December 31, 2019 was $25.2 million and $116.5 million, or $0.93 per share and $4.30 per share, respectively, compared to $45.4 million and $199.5 million, or $1.73 per share and $7.85 per share, respectively, for the same periods in 2018.

As of December 31, 2019, La Jolla had $87.8 million in cash, compared to $172.6 million as of December 31, 2018. Net cash used in operating activities for the three and twelve months ended December 31, 2019 was $17.1 million and $85.0 million, respectively, compared to $32.0 million and $152.4 million, respectively, for the same periods in 2018. La Jolla has no debt.

About GIAPREZA

In December 2017, GIAPREZA™ (angiotensin II) was approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. In August 2019, GIAPREZA was approved by the European Commission (EC) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. GIAPREZA mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure. Prescribing information for GIAPREZA is available at www.giapreza.com. GIAPREZA is marketed by La Jolla Pharmaceutical Company on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary.

IMPORTANT SAFETY INFORMATION

Contraindications

None.

Warnings and Precautions

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

Adverse Reactions

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

Drug Interactions

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

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

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

About LJPC-0118

LJPC-0118 (I.V. artesunate) is La Jolla’s investigational product for the treatment of severe malaria. The active pharmaceutical ingredient in LJPC-0118, artesunate, was compared to quinine in patients with severe falciparum malaria infection in two randomized, active-controlled, clinical studies. In both studies, in-hospital mortality in the artesunate group was statistically significantly lower than in-hospital mortality in the quinine group. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation and Orphan Drug designation for LJPC-0118 for the treatment of malaria in April 2019 and July 2019, respectively. La Jolla filed a New Drug Application (NDA) with the FDA for LJPC-0118 for the treatment of severe malaria in the second half of 2019. Severe malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito. Symptoms include: fever, chills, sweating, hypoglycemia and shock. In 2013, an estimated 2 million cases of severe malaria occurred worldwide. In 2018, an estimated 405,000 people died from malaria worldwide.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. In December 2017, GIAPREZA™ (angiotensin II) was approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. In August 2019, GIAPREZA was approved by the European Commission (EC) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. LJPC-0118 (artesunate) is La Jolla’s investigational product for the treatment of severe malaria. For more information, please visit www.ljpc.com.

Forward-looking Statements

This press release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: GIAPREZA™ (angiotensin II) sales; regulatory actions relating to La Jolla’s products by the U.S. Food and Drug Administration (FDA), European Commission and/or other regulatory authorities; cash used in operating activities and our capital requirements; and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.

LA JOLLA PHARMACEUTICAL COMPANY

Consolidated Balance Sheets(in thousands, except par value and share amounts)

  December 31, 2019   December 31, 2018
       
ASSETS      
Current assets:      
Cash $ 87,820     $ 172,604  
Accounts receivable, net 2,960     1,381  
Inventory, net 2,211     2,020  
Prepaid expenses and other current assets 4,467     5,111  
Total current assets 97,458     181,116  
Property and equipment, net 18,389     22,267  
Right-of-use lease asset 15,491      
Restricted cash 909     909  
Total assets $ 132,247     $ 204,292  
       
LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY      
Current liabilities:      
Accounts payable $ 4,177     $ 8,572  
Accrued expenses 9,312     8,485  
Accrued payroll and related expenses 8,332     7,509  
Lease liability, current portion 2,766      
Deferred rent, current portion     1,370  
Total current liabilities 24,587     25,936  
Lease liability, less current portion 26,481      
Deferred rent, less current portion     13,609  
Deferred royalty obligation, net 124,379     124,323  
Other noncurrent liabilities 12,790     4,503  
Total liabilities 188,237     168,371  
Shareholders’ (deficit) equity:      
Common Stock, $0.0001 par value; 100,000,000 shares authorized,27,195,469 and 26,259,254 shares issued and outstanding at December 31, 2019 and December 31, 2018, 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, 2019 and December 31, 2018; and liquidation preference of $3,906 at December 31, 2019 and December 31, 2018 3,906     3,906  
Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized,0 and 2,737 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively; and liquidation preference of $0 and $2,737 at December 31, 2019 and December 31, 2018, respectively     2,737  
Additional paid-in capital 977,432     950,258  
Accumulated deficit (1,037,331 )   (920,983 )
Total shareholders’ (deficit) equity (55,990 )   35,921  
Total liabilities and shareholders’ (deficit) equity $ 132,247     $ 204,292  

LA JOLLA PHARMACEUTICAL COMPANY

Consolidated Statements of Operations(in thousands, except per share amounts)

  Three Months Ended December 31,   Twelve Months Ended December 31,
  2019   2018   2019   2018
Revenue              
Net product sales $ 7,250     $ 4,184     $ 23,054     $ 10,056  
Total revenue 7,250     4,184     23,054     10,056  
Operating expenses              
Cost of product sales 787     1,200     2,392     1,643  
Research and development 20,860     27,567     85,329     117,302  
Selling, general and administrative 10,709     18,843     45,134     85,162  
Total operating expenses 32,356     47,610     132,855     204,107  
Loss from operations (25,106 )   (43,426 )   (109,801 )   (194,051 )
Other (expense) income              
Interest expense (2,376 )   (2,722 )   (10,774 )   (7,303 )
Interest income 310     730     2,128     1,885  
Other income—related party 1,939         1,939      
Total other expense, net (127 )   (1,992 )   (6,707 )   (5,418 )
Net loss $ (25,233 )   $ (45,418 )   $ (116,508 )   $ (199,469 )
Net loss per share, basic and diluted $ (0.93 )   $ (1.73 )   $ (4.30 )   $ (7.85 )
Weighted-average common shares outstanding, basic and diluted 27,169     26,242     27,112     25,422  

LA JOLLA PHARMACEUTICAL COMPANY

Consolidated Statements of Cash Flows(in thousands)

  Year Ended December 31,
  2019   2018
Operating activities      
Net loss $ (116,508 )   $ (199,469 )
Adjustments to reconcile net loss to net cash used for operating activities:      
Share-based compensation expense 23,733     35,151  
Depreciation and amortization expense 4,552     4,405  
Loss on disposal of equipment 24     236  
Non-cash interest expense 8,775     6,797  
Non-cash rent expense 1,307      
Changes in operating assets and liabilities:      
Accounts receivable, net (1,579 )   (1,381 )
Inventory, net (191 )   (2,020 )
Prepaid expenses and other current assets 644     (1,964 )
Accounts payable (4,395 )   (2,912 )
Accrued expenses 395     5,451  
Accrued payroll and related expenses 823     2,514  
Lease liability (2,530 )    
Deferred rent     824  
Net cash used for operating activities (84,950 )   (152,368 )
Investing activities      
Purchase of property and equipment (698 )   (2,340 )
Net cash used for investing activities (698 )   (2,340 )
Financing activities      
Net proceeds from issuance of common stock under ESPP 833     391  
Net proceeds from issuance of common stock under 2013 Equity Plan 31     1,908  
Net proceeds from royalty financing     124,289  
Net proceeds from the issuance of common stock     109,809  
Net cash provided by financing activities 864     236,397  
Net (decrease) increase in cash and restricted cash (84,784 )   81,689  
Cash and restricted cash at beginning of period 173,513     91,824  
Cash and restricted cash at end of period $ 88,729     $ 173,513  
Supplemental disclosure of non-cash investing and financing activities      
Conversion of Series F Convertible Preferred Stock into common stock $ 2,737     $  
Cumulative-effect adjustment from adoption of ASU 2018-07 $ (160 )   $  
Initial recognition of right-of-use lease asset $ 16,798     $  
Interest paid $ 1,999     $ 506  
Reconciliation of cash and restricted cash to the consolidated balance sheets      
Cash $ 87,820     $ 172,604  
Restricted cash 909     909  
Total cash and restricted cash $ 88,729     $ 173,513  

Company Contacts

Sandra VedrickSenior Director, Investor RelationsLa Jolla Pharmaceutical CompanyPhone: (858) 207-4264 Ext: 1135Email: svedrick@ljpc.com

and

Dennis MulroyChief Financial OfficerLa Jolla Pharmaceutical CompanyPhone: (858) 207-4264 Ext: 1040Email: dmulroy@ljpc.com

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