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La Jolla Pharmaceutical Co (LJPC) SEC Filing 10-K Annual report for the fiscal year ending Saturday, December 31, 2016

La Jolla Pharmaceutical Co

CIK: 920465 Ticker: LJPC


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La Jolla Pharmaceutical Company Announces Fourth Quarter and Full Year 2016
Financial Results and Corporate Progress

SAN DIEGO, CA - February 23, 2017 - La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today reported fourth quarter and full year 2016 financial results and highlighted 2016 corporate progress.

2016 Corporate Progress
In the fourth quarter of 2016, La Jolla’s ATHOS (Angiotensin II for the Treatment of High-Output Shock) 3 Phase 3 trial completed patient enrollment. ATHOS 3 is La Jolla’s 344-patient, multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial of LJPC-501, the Company’s proprietary formulation of angiotensin II, in catecholamine-resistant hypotension (CRH). Top-line results are expected in the first quarter of 2017.

In the fourth quarter of 2016, the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) designated LJPC-401, the Company’s novel formulation of synthetic human hepcidin, as an orphan medicinal product for the treatment of sickle cell disease (SCD).

In the third quarter of 2016, La Jolla reported positive results from a multicenter, open-label, dose-escalation Phase 1 trial of LJPC-401 in patients at risk for iron overload due to conditions such as hereditary hemochromatosis (HH), thalassemia, and SCD. LJPC-401 was well tolerated, and there were no dose-limiting toxicities observed. Furthermore, a dose-dependent, statistically significant reduction in serum iron was observed.

In the third quarter of 2016, La Jolla reached agreement with the EMA on the design of a pivotal trial of LJPC-401. The pivotal trial will be a randomized, controlled, multicenter trial in beta thalassemia patients suffering from iron overload, a major unmet need in an orphan patient population. The primary endpoint will be a clinically relevant measurement directly related to iron overload. La Jolla plans to initiate this pivotal trial in mid-2017.

“2016 was a productive year for La Jolla, highlighted by the completion of enrollment of our ATHOS 3 Phase 3 trial of LJPC-501 and encouraging results from our Phase 1 trial of LJPC-401,” said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. “We look forward to an exciting 2017, with the expected reporting of top-line results from our ATHOS 3 Phase 3 trial of LJPC-501 in the first quarter of 2017 and the initiation of our pivotal trial for LJPC-401 in mid-2017.”

Results of Operations

As of December 31, 2016, La Jolla had $65.7 million in cash and cash equivalents, compared to $126.5 million as of December 31, 2015. Based on current operating plans and projections, La Jolla believes that its current cash and cash equivalents are sufficient to fund operations into 2018.

La Jolla’s net cash used for operating activities for the three and twelve months ended December 31, 2016 was $18.6 million and $58.7 million, respectively, compared to net cash used for operating activities of $8.5 million and $25.2 million, respectively, for the same periods in 2015. La Jolla’s net loss for the three and twelve months ended December 31, 2016 was $24.9 million and $78.2 million, or $1.44 per share and $4.54 per share, respectively, compared to a net loss of $11.8 million and $41.9 million, or $0.69 per share and $2.68 per share, respectively, for the same periods in 2015. During the three and twelve months ended December 31, 2016, La Jolla recognized contract revenue of approximately $0.1 million and $0.6 million, respectively, compared to contract revenue of $0.4 million and $1.1 million, respectively, for the same periods in 2015. The net loss for the three and twelve months ended December 31, 2016 includes non-cash, share-based compensation expense of $3.6 million and $14.5 million, respectively, compared to non-cash, share-based compensation expense of $2.7 million and $13.1



The following information was filed by La Jolla Pharmaceutical Co (LJPC) on Thursday, February 23, 2017 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 (property And Equipment) (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 Under Operating Leases) (details)
Commitments And Contingencies (narrative) (details)
Commitments And Contingencies (tables)
Contract Revenue - Related Party (narrative) (details)
Contract Revenue - Related Party (notes)
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)
Quarterly Financial Information (unaudited)
Quarterly Financial Information (unaudited) (details)
Quarterly Financial Information (unaudited) (tables)
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)
Ticker: LJPC
CIK: 920465
Form Type: 10-K Annual Report
Accession Number: 0000920465-17-000025
Submitted to the SEC: Thu Feb 23 2017 4:14:02 PM EST
Accepted by the SEC: Thu Feb 23 2017
Period: Saturday, December 31, 2016
Industry: Biological Products No Disgnostic Substances

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