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Eagle Pharmaceuticals, Inc. (EGRX) SEC Filing 10-Q Quarterly report for the period ending Tuesday, June 30, 2020

Eagle Pharmaceuticals, Inc.

CIK: 827871 Ticker: EGRX

 

Exhibit 99.1

 

 

 

For Immediate Release

 

Eagle Pharmaceuticals Reports Second Quarter 2020 Results

 

-- Q2 2020 net loss was ($0.02) per basic and diluted share and adjusted non-GAAP net income was $0.59 per basic and $0.57 per diluted share --

 

-- Anticipate launch of vasopressin, maintaining our 180-day market exclusivity --

 

-- CMS establishes unique J-code for PEMFEXY™ (pemetrexed for injection); FDA granted supplement approval for 500mg multiple-dose vial --

 

-- Received positive additional data for the Company’s fulvestrant product candidate, EA-114, for HR-positive advanced breast cancer --

 

-- Received a Complete Response Letter for NDA for RYANODEX for EHS --

 

WOODCLIFF LAKE, NJ—August 10, 2020—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three and six months ended June 30, 2020.

 

Business and Recent Highlights:

 

·Centers for Medicare & Medicaid Services (“CMS”) established unique Healthcare Common Procedure Coding System (“HCPCS”) code, or J-code, for PEMFEXY™ (Pemetrexed for Injection, 10 mg), a branded alternative to ALIMTA® effective October 1, 2020;

 

·Granted a supplement approval by U.S. Food and Drug Administration (“FDA”) for 500mg multiple-dose vial of PEMFEXY. The Company has initial market entry (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022;

 

·The Company’s strategic collaboration partner, Tyme Technologies, Inc. (“Tyme”), announced that FDA granted Orphan Drug Designation for its lead product candidate, SM-88, a treatment for patients with pancreatic cancer;

 

·On August 7, 2020, the Company received a Complete Response Letter for its New Drug Application (“NDA”) for RYANODEX® for the treatment of exertional heat stroke (“EHS”); Eagle has decided that it will no longer pursue this indication;

 

·Received encouraging recent additional data for the Company’s fulvestrant product candidate, EA-114, for HR-positive advanced breast cancer; next steps are to meet with FDA to finalize clinical trial plans; product could potentially represent cornerstone of Eagle’s oncology franchise treating HR positive breast cancer patients;

 

·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 Abbreviated New Drug Application (“ANDA”) products. Under this decision, defendants are enjoined from launching their ANDA products before 2031;

 


The following information was filed by Eagle Pharmaceuticals, Inc. (EGRX) on Monday, August 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-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 (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 - Prepaid And Other Current Assets (Details)
Collaboration With Tyme (Details)
Collaboration With Tyme (Notes)
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)
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)
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 (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)

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: 0000827871-20-000024
Submitted to the SEC: Mon Aug 10 2020 4:51:01 PM EST
Accepted by the SEC: Mon Aug 10 2020
Period: Tuesday, June 30, 2020
Industry: Pharmaceutical Preparations

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