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La Jolla Pharmaceutical Co (LJPC) SEC Filing 10-K Annual report for the fiscal year ending Monday, December 31, 2018

La Jolla Pharmaceutical Co

CIK: 920465 Ticker: LJPC
Exhibit 99.1



ljpcpressrelease_image1a23.jpg
La Jolla Pharmaceutical Company Announces Financial Results for the
Three and Twelve Months Ended December 31, 2018 and Highlights Recent Corporate Progress and Key Objectives

SAN DIEGO, CA - March 4, 2019 - 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 twelve months ended December 31, 2018 and highlighted recent corporate progress and key objectives.

Recent Corporate Progress and Key Objectives

GIAPREZATM (angiotensin II)

2018 Net Sales: Fourth-quarter 2018 net sales were $4.2 million, up 20% from the third quarter of 2018. 2018 net sales were $10.1 million. GIAPREZA was launched in March 2018.

2019 Net Sales Guidance: La Jolla expects 2019 net sales of $24 million to $28 million.

Decision on GIAPREZA MAA by EMA Expected in June of 2019: La Jolla expects a decision on the GIAPREZA Marketing Authorisation Application (MAA) by the European Medicines Agency (EMA) in June of 2019.

Investigational Products Update

NDA Planned for New Investigational Product, LJPC-0118, for the Treatment of Severe Malaria, in Fourth Quarter of 2019: La Jolla plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2019 for LJPC-0118. LJPC-0118 is La Jolla’s new investigational product for the treatment of severe malaria. The active pharmaceutical ingredient in LJPC-0118 was demonstrated to be superior to quinine in reducing mortality in patients with severe falciparum malaria infection in two randomized, controlled, clinical studies.

Topline Results of Phase 2 Study of LJPC-401 in Patients with Hereditary Hemochromatosis Expected in Second Half of 2019: La Jolla expects topline results in the second half of 2019 for LJ401-HH01, a multinational, multicenter, randomized, Phase 2 study that is designed to evaluate the safety and efficacy of LJPC-401, La Jolla’s proprietary formulation of synthetic human hepcidin, as a treatment for hereditary hemochromatosis (HH). The primary efficacy endpoint of the study is the change in transferrin saturation, a standard measurement of iron levels in the body and one of the two key measurements used to detect iron overload, from baseline to end of treatment.     

Topline Results of Pivotal Study of LJPC-401 in Patients with Beta Thalassemia Expected in Mid-2020: La Jolla expects topline results in mid-2020 for LJ401-BT01, a pivotal, multinational, multicenter, randomized, controlled study that is designed to evaluate the safety and efficacy of LJPC-401 as a treatment for beta thalassemia (BT) patients who, despite chelation therapy, have cardiac iron levels above normal. The primary efficacy endpoint of this study is the change in iron content in the heart after 6 months, as measured by cardiac magnetic resonance imaging (MRI). If this study is successful, La Jolla anticipates filing an MAA for LJPC-401 in the European Union (EU).


“We are excited to have launched GIAPREZA, our first commercial product, in 2018, and we look forward to executing on a number of initiatives that we believe will support its continued, increased adoption in 2019,” said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. “Our two randomized studies of LJPC-401 in BT and HH have the potential to demonstrate improved patient outcomes in these important diseases. Furthermore, we are excited to have recently announced a planned NDA submission for LJPC-0118, our new investigational product for the treatment of severe malaria, in the fourth quarter of 2019.”



The following information was filed by La Jolla Pharmaceutical Co (LJPC) on Monday, March 4, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside La Jolla Pharmaceutical Co's 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Operations
Consolidated Statements Of Shareholders' Equity
Balance Sheet Account Details
Balance Sheet Account Details (Accrued Expenses) (Details)
Balance Sheet Account Details (Narrative) (Details)
Balance Sheet Account Details (Property And Equipment) (Details)
Balance Sheet Account Details (Schedule Of Inventory) (Details)
Balance Sheet Account Details (Tables)
Business
Business (Details)
Commitments And Contingencies
Commitments And Contingencies (Annual Future Minimum Licensing Payments) (Details)
Commitments And Contingencies (Annual Future Minimum Payments For Manufacturing And Supply Agreements) (Details)
Commitments And Contingencies (Annual Future Minimum Payments Under Operating Leases) (Details)
Commitments And Contingencies (Narrative) (Details)
Commitments And Contingencies (Tables)
Contract Revenue - Related Party (Narrative) (Details)
Contract Revenue - Related Party (Notes)
Deferred Royalty Obligation
Deferred Royalty Obligation (Details)
Defined Contribution Plan
Defined Contribution Plan (Narrative) (Details)
Income Taxes
Income Taxes (Narrative) (Details)
Income Taxes (Provision For Income Taxes) (Details)
Income Taxes (Significant Components Of Deferred Tax Assets) (Details)
Income Taxes (Tables)
Licensed Technology
Licensed Technology (Narrative) (Details)
Restructuring (Details)
Restructuring (Notes)
Shareholders??? Equity
Shareholders??? Equity (Narrative) (Details)
Shareholders??? Equity (Share-Based Compensation Expense) (Details)
Shareholders??? Equity (Stock Option And Restricted Stock Award Activity) (Details)
Shareholders??? Equity (Stock Options, Valuation Assumptions) (Details)
Shareholders??? Equity (Summary Of Restricted Stock Awards) (Details)
Shareholders??? Equity (Tables)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Narrative) (Details)
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Schedule Of Concentration Risk) (Details)
Summary Of Significant Accounting Policies (Tables)
Ticker: LJPC
CIK: 920465
Form Type: 10-K Annual Report
Accession Number: 0000920465-19-000044
Submitted to the SEC: Mon Mar 04 2019 11:11:05 AM EST
Accepted by the SEC: Mon Mar 04 2019
Period: Monday, December 31, 2018
Industry: Biological Products No Disgnostic Substances

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