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CST: 15/12/2019 18:11:54   

La Jolla Pharmaceutical Company Announces Financial Results for the Three and Nine Months Ended September 30, 2019 and Highlights Recent Corporate Progress

33 Days ago

SAN DIEGO, Nov. 12, 2019 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (Nasdaq: LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced financial results for the three and nine months ended September 30, 2019 and highlighted recent corporate progress.

Recent Corporate Progress

  • GIAPREZA™  (Angiotensin II) U.S. Net Sales: For the three months ended September 30, 2019, GIAPREZA U.S. net sales were $5.7 million, up 64% from the same period in 2018. For the nine months ended September 30, 2019, GIAPREZA U.S. net sales were $15.8 million, up 169% from the same period in 2018. La Jolla expects that its full-year 2019 GIAPREZA U.S. net sales will be $22 million to $25 million.

  • GIAPREZA European Commission Approval: In August 2019, the European Commission (EC) approved GIAPREZA for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies.

  • LJPC-0118 (Artesunate) Orphan Drug Designation: In July 2019, the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation for LJPC-0118 for the treatment of malaria.

  • Positive Results from Pre-Specified Interim Analysis of Phase 2 Study of LJPC-401 in Patients with Hereditary Hemochromatosis: In June 2019, La Jolla announced positive results from the pre-specified interim analysis of its Phase 2 study of LJPC-401 (synthetic human hepcidin) in patients with hereditary hemochromatosis (HH). The pre-specified interim analysis of efficacy included 26 patients who had reached the end of the 16-week treatment period, and the interim analysis of safety included 60 randomized patients. Treatment with LJPC-401 resulted in a statistically significant reduction in transferrin saturation (TSAT) from baseline to the end of treatment (16 weeks), the primary efficacy endpoint of the study: LJPC‑401‑treated patients had a mean reduction in TSAT of 42% compared to placebo-treated patients who had a mean reduction of 6% (p<0.0001). The requirement for and frequency of phlebotomy procedures, a key secondary endpoint of the study, also was statistically significant: LJPC-401-treated patients had 0.06 phlebotomies per month compared to placebo-treated patients who had 0.41 phlebotomies per month (p=0.003). We expect to announce top-line results from this study in the fourth quarter of 2019.

“Our recent corporate progress has included the approval of GIAPREZA by the European Commission, the granting of Orphan Drug designation for LJPC-0118 for the treatment of malaria by the FDA and positive results from a pre-specified interim analysis of our Phase 2 study of LJPC-401 in patients with hereditary hemochromatosis,” said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. “In the fourth quarter of 2019, we plan to report top-line results of our Phase 2 study of LJPC-401 in patients with hereditary hemochromatosis and report the filing of our New Drug Application for LJPC-0118 for the treatment of severe malaria.”

Financial Results

For the three and nine months ended September 30, 2019, GIAPREZA U.S. net sales were $5.7 million and $15.8 million, respectively, compared to $3.5 million and $5.9 million, respectively, for the same periods in 2018. La Jolla’s net loss for the three and nine months ended September 30, 2019 was $29.2 million and $91.3 million, or $1.08 per share and $3.37 per share, respectively, compared to $50.7 million and $154.1 million, or $1.93 per share and $6.15 per share, respectively, for the same periods in 2018.

As of September 30, 2019, La Jolla had $104.8 million in cash, compared to $172.6 million as of December 31, 2018. Net cash used in operating activities for the three and nine months ended September 30, 2019 was $18.6 million and $67.8 million, respectively, compared to $36.9 million and $120.3 million, respectively, for the same periods in 2018. La Jolla has no debt. La Jolla expects that its net cash used in operating activities in 2019 will be $88 million to $91 million.

About GIAPREZA

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

IMPORTANT SAFETY INFORMATION

Contraindications

None.

Warnings and Precautions

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

Adverse Reactions

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

Drug Interactions

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

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

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

About LJPC-0118

LJPC-0118 (artesunate) is La Jolla’s investigational product for the treatment of severe malaria. The active pharmaceutical ingredient in LJPC-0118, artesunate, was demonstrated to be superior to quinine in reducing mortality in patients with severe falciparum malaria infection in two randomized, controlled, clinical studies. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation and Orphan Drug designation for LJPC-0118 for the treatment of malaria in April 2019 and July 2019, respectively. La Jolla plans to file a New Drug Application (NDA) with the FDA for LJPC-0118 for the treatment of severe malaria in the fourth quarter of 2019. Severe malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito, which feeds on humans. Symptoms include but are not limited to: fever, chills, sweating, hypoglycemia and shock. Severe malaria is often complicated by central nervous system infections that may lead to delirium, which may progress to coma. Infections usually occur a few weeks after being bitten. In 2017, an estimated 219 million cases of malaria occurred worldwide, with an estimated 200 million of these cases occurring in the World Health Organization (WHO) African Region, and, in 2013, the global annual incidence of severe malaria was estimated to be 2 million cases. In 2017, an estimated 435,000 people died from malaria worldwide.

About LJPC-401

LJPC‑401 (synthetic human hepcidin) is La Jolla’s investigational product for the potential treatment of conditions characterized by iron overload. Hepcidin, an endogenous peptide hormone, is the body’s naturally occurring regulator of iron absorption and distribution. In healthy individuals, hepcidin prevents excessive iron accumulation in vital organs, such as the liver and heart, where it can cause significant damage and even result in death. La Jolla is developing LJPC-401 for the potential treatment of iron overload, which occurs as a result of primary iron overload diseases such as hereditary hemochromatosis (HH), or secondary iron overload diseases such as beta thalassemia (BT), sickle cell disease (SCD), myelodysplastic syndrome (MDS) and polycythemia vera. The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has designated LJPC‑401 as an orphan medicinal product for the treatment of beta thalassemia intermedia and major and SCD. LJPC-401 is being investigated in a pivotal study in BT patients with iron overload and in a Phase 2 study in patients with HH.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. In December 2017, GIAPREZA™ (angiotensin II) was approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. In August 2019, GIAPREZA was approved by the European Commission (EC) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. LJPC-0118 (artesunate) is La Jolla’s investigational product for the treatment of severe malaria. LJPC‑401 (synthetic human hepcidin) is La Jolla’s investigational product for the potential treatment of conditions characterized by iron overload. LJPC-401 is being investigated in a pivotal study in beta thalassemia patients with iron overload and in a Phase 2 study in patients with hereditary hemochromatosis. For more information, please visit www.ljpc.com.

Forward-looking Statements

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

LA JOLLA PHARMACEUTICAL COMPANY

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

  Three Months Ended 
September 30,
  Nine Months Ended 
September 30,
  2019   2018   2019   2018
Revenue              
Net product sales $ 5,706     $ 3,470     $ 15,804     $ 5,872  
Total revenue 5,706     3,470     15,804     5,872  
Operating expenses              
Cost of product sales 554     256     1,605     443  
Research and development 21,182     30,439     64,469     89,735  
Selling, general and administrative 10,782     21,139     34,425     66,319  
Total operating expenses 32,518     51,834     100,499     156,497  
Loss from operations (26,812 )   (48,364 )   (84,695 )   (150,625 )
Other (expense) income              
Interest expense (2,863 )   (2,926 )   (8,398 )   (4,581 )
Interest income 501     545     1,818     1,155  
Total other expense, net (2,362 )   (2,381 )   (6,580 )   (3,426 )
Net loss $ (29,174 )   $ (50,745 )   $ (91,275 )   $ (154,051 )
Net loss per share, basic and diluted $ (1.08 )   $ (1.93 )   $ (3.37 )   $ (6.15 )
Weighted-average common shares outstanding, basic and diluted 27,135     26,226     27,093     25,055  
                       

LA JOLLA PHARMACEUTICAL COMPANY

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

  September 30,
2019
  December 31,
2018
  (Unaudited)    
ASSETS      
Current assets:      
Cash $ 104,768     $ 172,604  
Accounts receivable, net 1,417     1,381  
Inventory, net 1,910     2,020  
Prepaid expenses and other current assets 4,783     5,111  
Total current assets 112,878     181,116  
Property and equipment, net 19,523     22,267  
Right-of-use lease asset 15,829      
Restricted cash 909     909  
Total assets $ 149,139     $ 204,292  
       
LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY      
Current liabilities:      
Accounts payable $ 5,338     $ 8,572  
Accrued expenses 9,351     8,485  
Accrued payroll and related expenses 5,118     7,509  
Lease liability, current portion 2,705      
Deferred rent, current portion     1,370  
Total current liabilities 22,512     25,936  
Lease liability, less current portion 27,199      
Deferred rent, less current portion     13,609  
Deferred royalty obligation, net 124,366     124,323  
Other noncurrent liabilities 10,233     4,503  
Total liabilities 184,310     168,371  
Shareholders’ (deficit) equity:      
Common Stock, $0.0001 par value; 100,000,000 shares authorized, 27,147,387 and 26,259,254 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively 3     3  
Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at September 30, 2019 and December 31, 2018; and liquidation preference of $3,906 at September 30, 2019 and December 31, 2018 3,906     3,906  
Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized, 0 and 2,737 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively; and liquidation preference of $0 and $2,737 at September 30, 2019 and December 31, 2018, respectively     2,737  
Additional paid-in capital 973,018     950,258  
Accumulated deficit (1,012,098 )   (920,983 )
Total shareholders’ (deficit) equity (35,171 )   35,921  
Total liabilities and shareholders’ (deficit) equity $ 149,139     $ 204,292  
               

Company Contacts

Sandra Vedrick
Senior Director, Investor Relations & Human Resources
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: svedrick@ljpc.com

and

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

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