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Eagle Pharmaceuticals, Inc. (EGRX) SEC Filing 10-Q Quarterly Report for the period ending Thursday, September 30, 2021

Eagle Pharmaceuticals, Inc.

CIK: 827871 Ticker: EGRX

Exhibit 99.1

 

 

For Immediate Release

 

Eagle Pharmaceuticals Reports Third Quarter 2021 Results

 

·       Q3 2021 net loss was $0.43 per basic and diluted share and adjusted non-GAAP net income was $0.57 per basic and $0.56 per diluted share

 

·       Expect to receive approval for Abbreviated New Drug Application (“ANDA”) for vasopressin; December 15, 2021 GDUFA date

 

·       Received favorable district court decision that Eagle’s proposed vasopressin product does not infringe any of the patents Par asserted against Eagle

 

·       Entered into worldwide licensing agreement for CAL02, a novel first-in-class antitoxin agent ready for Phase 2b/3 development for the treatment of severe bacterial pneumonia

 

·       Licensed U.S. commercial rights to landiolol, a beta-1 adrenergic blocker, a leading hospital emergency use product in Europe and Japan

 

WOODCLIFF LAKE, NJ—November 9, 2021—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three and nine months ended September 30, 2021.

 

Business and Recent Highlights:

 

·Entered into a worldwide licensing agreement for the commercial rights to CAL02, a novel first-in-class antitoxin agent ready for Phase 2b/3 development for the treatment of severe bacterial pneumonia in combination with traditional antibacterial drugs.

 

·Vasopressin updates:

 

oIn August 2021, received favorable decision from the U.S. District Court for the District of Delaware that Eagle’s proposed vasopressin product does not infringe any of the patents Par Pharmaceutical, Inc. asserted against Eagle.

oU.S. Food and Drug Administration (“FDA”) maintained Priority Review for the Company’s ANDA with December 15, 2021 GDUFA date.

oReceived a 30-day information request from the FDA; Eagle fully responded to the request on September 20, 2021, and there are no other review requests outstanding.

 

·Granted U.S. Patent No. 11,103,483, “Formulations of Bendamustine,” which has been listed in the FDA Orange Book for BENDEKA® and BELRAPZO®.

 


The following information was filed by Eagle Pharmaceuticals, Inc. (EGRX) on Tuesday, November 9, 2021 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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Eagle Pharmaceuticals, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:

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Inside Eagle Pharmaceuticals, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Cover Page
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Changes In Stockholders' Equity (Unaudited)
Condensed Consolidated Statements Of Comprehensive Income (Loss) (Unaudited)
Condensed Consolidated Statements Of Operations (Unaudited)
Balance Sheet Accounts
Balance Sheet Accounts (Tables)
Balance Sheet Accounts - Accrued Expenses (Details)
Balance Sheet Accounts - Future Minimum Lease Payments (Details)
Balance Sheet Accounts - Lease Related Disclosures (Details)
Balance Sheet Accounts - Narrative (Details)
Balance Sheet Accounts - Prepaid And Other Current Assets (Details)
Basis Of Presentation And Other Company Information
Basis Of Presentation And Other Company Information (Details)
Commitments
Commitments (Details)
Commitments (Tables)
Common Stock And Stock-Based Compensation
Common Stock And Stock-Based Compensation (Tables)
Common Stock And Stock-Based Compensation - Fair Value Of Stock Options Granted (Details)
Common Stock And Stock-Based Compensation - Narrative (Details)
Common Stock And Stock-Based Compensation - Schedule Of Share-Based Compensation (Details)
Common Stock And Stock-Based Compensation - Summary Of Stock Options, Rsu And Psu Activity (Details)
Convertible Promissory Note
Convertible Promissory Note (Details)
Convertible Promissory Note (Tables)
Debt
Debt (Tables)
Debt - Narrative (Details)
Debt - Schedule Of Debt Maturities (Details)
Income Taxes
Income Taxes (Details)
Income Taxes (Tables)
Intangible Assets, Net
Intangible Assets, Net (Tables)
Intangible Assets, Net - Schedule Of Future Amortization Expense (Details)
Intangible Assets, Net - Schedule Of Intangible Assets (Details)
Inventories
Inventories (Details)
Inventories (Tables)
Legal Proceedings
Legal Proceedings (Details)
License And Collaboration Agreements
License And Collaboration Agreements (Details)
Property And Equipment, Net
Property And Equipment, Net (Details)
Property And Equipment, Net (Tables)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Anti-Dilutive Common Shares Equivalents Outstanding (Details)
Summary Of Significant Accounting Policies - Narrative (Details)
Summary Of Significant Accounting Policies - Revenue And Accounts Receivable By Major Customer (Details)
Summary Of Significant Accounting Policies - Schedule Of Basic And Diluted Net (Loss) Earnings (Details)
Summary Of Significant Accounting Policies - Schedule Of Financial Assets And Liabilities Measured And Recognized At Fair Value (Details)
Ticker: EGRX
CIK: 827871
Form Type: 10-Q Quarterly Report
Accession Number: 0000827871-21-000029
Submitted to the SEC: Tue Nov 09 2021 4:22:13 PM EST
Accepted by the SEC: Tue Nov 09 2021
Period: Thursday, September 30, 2021
Industry: Pharmaceutical Preparations

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