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Eagle Pharmaceuticals, Inc. (EGRX) SEC Filing 10-K Annual report for the fiscal year ending Tuesday, December 31, 2019

Eagle Pharmaceuticals, Inc.

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CIK: 827871 Ticker: EGRX

Exhibit 99.1

 

 

For Immediate Release

 

Eagle Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Results

 

-- Q4 2019 net income was $0.07 per basic and diluted share and adjusted non-GAAP net income was $0.49 per basic and $0.48 per diluted share –

 

-- FY 2019 net income was $1.04 per basic and $1.01 per diluted share and adjusted non-GAAP net income was $2.68 per basic and $2.61 per diluted share --

 

-- Significant pipeline advancements position Eagle for five potential commercial launches over next three years --

 

-- Company anticipates strong 2020 growth for total revenue and gross profit based on strength of marketed products, and assuming an on-time approval for RYANODEX® for exertional heat stroke and affirmation of orphan drug decision by the Appellate Court for BENDEKA® --

 

-- Received final approval from the U.S. Food and Drug Administration (“FDA”) for PEMFEXY™ (pemetrexed for injection), for an initial entry of PEMFEXY on February 1, 2022, and a subsequent uncapped entry on April 1, 2022 --

 

-- Resubmitted NDA for RYANODEX (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke with a PDUFA date of July 8, 2020 --

 

-- Entered into collaborations with NorthShore University HealthSystem and the University of Pennsylvania to investigate the potential use of RYANODEX for the treatment of traumatic brain injury, including concussion, and Alzheimer’s disease, respectively --

 

WOODCLIFF LAKE, NJ—March 2, 2020—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three and twelve months ended December 31, 2019.

 

Business and Recent Highlights:

 

·On a non-GAAP basis, invested $14 million, or $0.63 per diluted share in Q4 2019, to advance the Company’s pipeline, bringing total R&D, plus legal expenses related to Vasopressin and PEMFEXY, for the full year to $43 million, or $2.30 per diluted share.

 

·Received final approval from FDA for its novel product, PEMFEXY™ (ready-to-dilute pemetrexed for injection), a branded alternative to ALIMTA®. This approval follows the Company’s settlement agreement with Eli Lilly and Company in December 2019 and allows for an initial entry of PEMFEXY (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022.

 

·Entitled to a milestone payment from Japanese licensing partner SymBio, upon approval of its ready-to-dilute bendamustine product, TREAKISYM, expected in September; future royalties and milestones could range from $10 million to $25 million per year for launches of the 500 ml bag and then the 50 ml bag.

 

·Announced collaboration and agreement on terms for an exclusive worldwide license with the University of Pennsylvania (“UPenn”) for the development of dantrolene sodium for the potential treatment of people living with Alzheimer’s disease. At the 2019 Alzheimer's Association International Conference in July, Eagle and UPenn shared results from a proof-of-concept preclinical study documenting that intranasal administration of dantrolene sodium provided therapeutic effects on memory and cognition in an animal model.

 

The following information was filed by Eagle Pharmaceuticals, Inc. (EGRX) on Monday, March 2, 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-K Annual 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-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Changes In Stockholders' Equity
Consolidated Statements Of Operations
Acquisitions
Acquisitions - Narrative (Details)
Acquisitions (Tables)
Acquisitions - Schedule Of Consideration Transferred, Biologics (Details)
Acquisitions - Schedule Of Contingent Consideration Fair Value, Docetaxel (Details)
Acquisitions - Schedule Of Contingent Consideration, Biologic (Details)
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)
Commitments
Commitments (Tables)
Commitments - Future Minimum Lease Payments (Details)
Common Stock And Stock-Based Compensation
Common Stock And Stock-Based Compensation (Tables)
Common Stock And Stock-Based Compensation - Fair Value Of Share Options Granted (Details)
Common Stock And Stock-Based Compensation - Narrative (Details)
Common Stock And Stock-Based Compensation - Schedule Of Common Stock Repurchase (Details)
Common Stock And Stock-Based Compensation - Schedule Of Restricted And Phantom Stock Unit Activity (Details)
Common Stock And Stock-Based Compensation - Schedule Of Share-Based Compensation Cost (Details)
Common Stock And Stock-Based Compensation - Share-Based Compensation, Options (Details)
Debt
Debt (Details)
Debt (Tables)
Debt - Schedule Of Debt Maturities (Details)
Income Taxes
Income Taxes - Narrative (Details)
Income Taxes (Tables)
Income Taxes - Deferred Income Taxes (Details)
Income Taxes - Reconciliation (Details)
Income Taxes - Schedule Of Income Tax (Benefit) Expense (Details)
Intangible Assets, Net
Intangible Assets, Net - Schedule Of Intangible Assets (Details)
Intangible Assets, Net (Tables)
Intangible Assets, Net - Narrative (Details)
Intangible Assets, Net - Schedule Of Future Amortization Expense (Details)
Inventories
Inventories (Details)
Inventories (Tables)
Legal Proceedings
License Agreements Of Development And Commercialization Rights
License Agreements Of Development And Commercialization Rights (Details)
Organization And Business
Organization And Business (Details)
Property And Equipment, Net
Property And Equipment, Net (Details)
Property And Equipment, Net (Tables)
Related Party Transaction
Related Party Transaction (Details)
Restructuring
Restructuring - Narrative (Details)
Selected Quarterly Financial Data - Unaudited
Selected Quarterly Financial Data - Unaudited (Details)
Selected Quarterly Financial Data - Unaudited (Tables)
Subsequent Event
Subsequent Event (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Common Shares Equivalents Outstanding (Details)
Summary Of Significant Accounting Policies - Earnings Per Share (Details)
Summary Of Significant Accounting Policies - Major Customers As A Percentage (Details)
Summary Of Significant Accounting Policies - Narrative (Details)
Summary Of Significant Accounting Policies - Schedule Of Product Sales (Details)
Ticker: EGRX
CIK: 827871
Form Type: 10-K Annual Report
Accession Number: 0000827871-20-000007
Submitted to the SEC: Mon Mar 02 2020 5:26:23 PM EST
Accepted by the SEC: Mon Mar 02 2020
Period: Tuesday, December 31, 2019
Industry: Pharmaceutical Preparations

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