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Eagle Pharmaceuticals, Inc. (EGRX) SEC Filing 10-Q Quarterly report for the period ending Tuesday, March 31, 2020

SEC Filings

EGRX Quarterly Reports

Eagle Pharmaceuticals, Inc.

CIK: 827871 Ticker: EGRX

Exhibit 99.1

 


 

For Immediate Release

 

Eagle Pharmaceuticals Reports First Quarter 2020 Results

 

-- Q1 2020 net loss was ($0.21) per basic and diluted share and adjusted non-GAAP net income was $0.86 per basic and $0.84 per diluted share --

 

-- Advanced novel fulvestrant product candidate, EA-114, which has the potential to enhance estrogen receptor (“ER”) inhibition in advanced hormone-receptor (“HR”)-positive breast cancer --

 

-- Received favorable patent litigation decision for BENDEKA® (bendamustine hydrochloride injection); ANDA holders to be enjoined from launching prior to 2031 --

 

-- Preparing for multiple potential product launches in the next three years; 13 ongoing initiatives underway including six additional potential new indications for RYANODEX --

WOODCLIFF LAKE, NJ—May 11, 2020—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three months ended March 31, 2020.

 

Business and Recent Highlights:

 

·Despite the ongoing COVID-19 pandemic, the Company has not experienced any impact to its supply chain to date, and believes it has sufficient supply chain inventory to continue manufacturing and to provide product without interruption consistent with its current business plan;

 

·Advanced pilot work on proprietary formulation of fulvestrant product candidate, EA-114, for HR-positive advanced breast cancer, met internal objectives, and requested additional meeting with U.S. Food and Drug Administration (“FDA”) to discuss regulatory path forward;

 

·Submitted Investigational New Drug (“IND”) application to FDA for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of RYANODEX (dantrolene sodium) in patients infected with SARS-CoV-2, the virus causing the COVID-19 pandemic;

 

·Favorable patent litigation decision issued by the U.S. District Court for the District of Delaware for Eagle and Teva Pharmaceutical Industries Ltd. for BENDEKA upholding the asserted patent claims as valid and infringed by the defendants’ proposed ANDA products. Defendants will be enjoined from launching their ANDA products before 2031;

 

·Received United States Court of Appeals for the D.C. Circuit affirmation of district court decision requiring FDA to recognize seven years of orphan drug exclusivity for BENDEKA. Accordingly, the Company does not believe other bendamustine products to treat the same indication, unless clinically superior to BENDEKA, will enter the market before 2022;

 

·July 8, 2020 Prescription Drug User Fee Act (“PDUFA”) date for the Company’s resubmitted New Drug Application (“NDA”) for RYANODEX for the treatment of exertional heat stroke (“EHS”), in conjunction with body cooling;

 


The following information was filed by Eagle Pharmaceuticals, Inc. (EGRX) on Monday, May 11, 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-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 2020 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 Statement Of Changes In Stockholders' Equity (Unaudited)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Operations (Unaudited)
Balance Sheet Accounts
Balance Sheet Accounts - Accrued Expenses (Details)
Balance Sheet Accounts - Future Minimum Lease Payments (Details)
Balance Sheet Accounts - Lease Related Disclosures (Details)
Balance Sheet Accounts - Prepaid And Other Current Assets (Details)
Balance Sheet Accounts (Tables)
Collaboration With Tyme (Details)
Collaboration With Tyme (Notes)
Commitments
Commitments - Future Minimum Lease Payments (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)
Debt
Debt (Details)
Debt (Tables)
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)
Interim Condensed Consolidated Financial Statements
Inventories
Inventories (Details)
Inventories (Tables)
Legal Proceedings
Organization And Business Activities
Organization And Business Activities (Details)
Property And Equipment, Net (Details)
Property And Equipment, Net (Notes)
Property And Equipment, Net (Tables)
Summary Of Significant Accounting Policies
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 Income (Details)
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)

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: 0000827871-20-000014
Submitted to the SEC: Mon May 11 2020 5:09:05 PM EST
Accepted by the SEC: Mon May 11 2020
Period: Tuesday, March 31, 2020
Industry: Pharmaceutical Preparations

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