La Jolla Pharmaceutical Co (LJPC) 10-K Annual Report Mon Mar 02 2020

SAN DIEGO, CA - January 9, 2020 - 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 preliminary GIAPREZA™ (angiotensin II) net sales for the three and twelve months ended December 31, 2019. For the three months ended December 31, 2019, preliminary GIAPREZA net sales were $7.2 million, up 71% from the three months ended December 31, 2018 and up 26% 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. For the twelve months ended December 31, 2019, preliminary GIAPREZA net sales were $23.1 million, up 129% from the twelve months ended December 31, 2018. La Jolla announced the commercial availability of GIAPREZA in the U.S. in March 2018.

As of December 31, 2019, La Jolla had approximately $87.8 million in cash and cash equivalents, compared to $104.8 million as of September 30, 2019. Net cash used in operating activities for the three months ended December 31, 2019 was approximately $17.0 million. 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 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.

The following information was filed by La Jolla Pharmaceutical Co (LJPC) on Friday, January 10, 2020 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 - Earnings Highlight
This increase was primarily due to a $3.5 million increase in interest accrued for our deferred royalty obligation, partially offset by the receipt of distributions of $1.9 million in connection with the Company's non-voting profits interest in a related party and a $0.2 million increase in interest income generated from cash held in savings accounts.

Financial - Expense Highlight
During the year ended December 31, 2019, total research and development personnel expense, including share-based compensation expense, decreased as a result of reduced headcount in 2019 from a Company-wide realignment in October 2018, partially offset by $4.4 million of one-time charges in 2019 resulting from another Company-wide realignment in November 2019.
Financial - Expense Highlight
We anticipate research and development expense will decrease significantly in 2020 as a result of the de-prioritization of LJPC-401 and the Company-wide realignment in November 2019.
Financial - Expense Highlight
During the year ended December 31, 2019, total selling, general and administrative expense, including share-based compensation expense, decreased as a result of reduced headcount in 2019 from a Company-wide realignment in October 2018.
Financial - Expense Highlight
Interest expense and the amortization of issuance costs related to the deferred royalty obligation are recognized over the expected repayment term using the effective interest method.
Revenue - Product
The decrease in cash provided...Read more
Revenue - Product
GIAPREZA U.S. net sales were...Read more
Other - Other
The decrease in cash used...Read more
Financial - Expense
Changes in interest expense resulting...Read more
Financial - Expense
GIAPREZA-related expenses decreased as a...Read more
Financial - Expense
LJPC-0118-related expenses decreased as a...Read more
Other - Other
The financial terms of our...Read more
Financial - Expense
During the year ended December...Read more
Revenue - Product
GIAPREZA U.S. net sales were...Read more
Financial - Expense
We anticipate selling, general and...Read more
Financial - Expense
During the year ended December...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

La Jolla Pharmaceutical Co provided additional information to their SEC Filing as exhibits

Exhibit 4.2: Instruments Defining The Rights Of Security Holders, Including Indentures

Exhibit 10.1: Material Contract

Exhibit 10.5: Material Contract

Exhibit 21.1: Subsidaries Of The Registrant

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: LJPC
CIK: 920465
Form Type: 10-K Annual Report
Accession Number: 0000920465-20-000036
Submitted to the SEC: Mon Mar 02 2020 8:15:23 AM EST
Accepted by the SEC: Mon Mar 02 2020
Period: Tuesday, December 31, 2019
Industry: Biological Products No Disgnostic Substances

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La Jolla Pharmaceutical Co (LJPC) SEC Filing 10-K Annual report for the fiscal year ending Tuesday, December 31, 2019

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