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

Eagle Pharmaceuticals, Inc.

CIK: 827871 Ticker: EGRX

 

Exhibit 99.1

 

 

For Immediate Release

 

Eagle Pharmaceuticals Reports Second Quarter 2021 Results

 

Q2 2021 net income was $0.28 per basic and $0.27 per diluted share and adjusted non-GAAP net income was $0.95 per basic and $0.93 per diluted share

 

Announced licensing agreement for U.S. commercial rights to Landiolol, a beta-1 adrenergic blocker and a leading hospital emergency use product in Europe and Japan

 

Responded to CRL for vasopressin and anticipates commercial launch by year-end; vasopressin patent trial decision expected around mid-September

 

FDA maintained Priority Review for the Company’s Abbreviated New Drug Application (“ANDA”) for vasopressin and assigned a GDUFA date of December 15, 2021

 

Expects approximately $20-$25 million from combined royalty and milestone revenue next year for TREAKISYM (bendamustine), if TREAKISYM RI formulation is approved

 

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

 

Business and Recent Highlights:

 

·Entered into a licensing agreement for the U.S. commercial rights to Landiolol, a leading hospital emergency use product in Europe and Japan. Landiolol is currently approved in Europe for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. Eagle will support the submission of a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) seeking approval for Landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia (“SVT”), including atrial fibrillation and atrial flutter.

 

·Advanced vasopressin program and continue to expect a commercial launch prior to year-end:

oResponded to the Complete Response Letter (“CRL”) for its Abbreviated New Drug Application (“ANDA”) for vasopressin received from FDA in February 2021;
oFDA maintained Priority Review for the Company’s ANDA for vasopressin and assigned a GDUFA date of December 15, 2021;
oPatent trial against Endo Par Innovation Company, LLC took place on July 7, 2021; Court ruling expected around mid-September.

 

·Approval of TREAKISYM (bendamustine) ready-to-dilute (“RTD”) formulation, in combination with rituximab for treatment of relapsed or refractory diffuse large B-cell lymphoma (“r/r DLBCL”) received from the Pharmaceuticals and Medical Devices Agency (“PMDA”) in Japan. This represents a meaningful extension of Eagle’s bendamustine franchise and is expected to significantly increase the market opportunity for bendamustine;

 

·Filing of TREAKISYM rapid infusion (“RI”) (50ml) liquid formulation with the PMDA in Japan. Eagle expects RTD, and RI, if approved, formulations to generate approximately $20-$25 million of combined royalty and milestone revenue;

 

·Appointed former FDA Official and Public Health Expert Dr. Luciana Borio to its Board of Directors; and

 

·Continue to pursue additional in-licensing and acquisition opportunities to broaden Eagle’s pipeline and revenue streams.

  


The following information was filed by Eagle Pharmaceuticals, Inc. (EGRX) on Monday, August 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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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 Operations (Unaudited)
Statement Of Comprehensive Income (Statement)
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)
Collaboration With Tyme
Collaboration With Tyme (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)
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)
Property And Equipment, Net
Property And Equipment, Net (Details)
Property And Equipment, Net (Tables)
Subsequent Event (Details)
Subsequent Events
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)

Material Contracts, Statements, Certifications & more

Eagle Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits

Ticker: EGRX
CIK: 827871
Form Type: 10-Q Quarterly Report
Accession Number: 0000827871-21-000022
Submitted to the SEC: Mon Aug 09 2021 5:19:55 PM EST
Accepted by the SEC: Mon Aug 09 2021
Period: Wednesday, June 30, 2021
Industry: Pharmaceutical Preparations

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