La Jolla Pharmaceutical Co (LJPC) 10-Q Quarterly Report Mon May 06 2019

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

GIAPREZA^TM(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-Q Quarterly 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-Q Quarterly Report:

Financial - Expense Highlight
The decrease was primarily due to reduced clinical development costs, personnel and related costs and share-based compensation expense as a result of our Company-wide realignment in October 2018.

Financial - Expense Highlight
The following table summarizes our research and development expense for each of the periods below (in thousands): During the three months ended March 31, 2019, research and development expense decreased to $21.2 million from $28.4 million for the same period in 2018.
Financial - Expense Highlight
The following table summarizes our selling, general and administrative expense for each of the periods below (in thousands): During the three months ended March 31, 2019, selling, general and administrative expense decreased to $12.3 million from $23.0 million for the same period in 2018.
Other - Other Highlight
In addition, there was a consistent trend toward longer survival over the 28-day study period: 22% reduction in mortality risk through day 28 [hazard ratio=0.78 (0.57-1.07), p=0.12] for GIAPREZA-treated patients.
Financial - Expense Highlight
The decrease was due to reduced personnel and related costs and share-based compensation as a result of our Company-wide realignment in October 2018.
Other - Other
The outcomes of the events...Read more
Other - Other
The inability to achieve or...Read more
Financial - Expense
As of March 31, 2019,...Read more
Other - Other
The forward-looking statements in this...Read more
Other - Other
The active pharmaceutical ingredient in...Read more
Financial - Expense
The increase in expense was...Read more
Other - Other
Breakthrough Therapy designation is designed...Read more
Financial - Expense
We do not expect selling,...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

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

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

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: LJPC
CIK: 920465
Form Type: 10-Q Quarterly Report
Accession Number: 0000920465-19-000077
Submitted to the SEC: Mon May 06 2019 12:03:35 PM EST
Accepted by the SEC: Mon May 06 2019
Period: Sunday, March 31, 2019
Industry: Biological Products No Disgnostic Substances

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La Jolla Pharmaceutical Co (LJPC) SEC Filing 10-Q Quarterly report for the period ending Sunday, March 31, 2019

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