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Eagle Pharmaceuticals, Inc. (EGRX) SEC Filing 10-K Annual Report for the fiscal year ending Friday, December 31, 2021

Eagle Pharmaceuticals, Inc.

CIK: 827871 Ticker: EGRX

 

Exhibit 99.1

 

 

 

For Immediate Release

 

Eagle Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Results

 

·   Q4 2021 net loss was $(0.48) per basic and diluted share and adjusted non-GAAP net income* was $0.87 per basic and $0.85 per diluted share

 

·   FY 2021 net loss was $(0.66) per basic and diluted share and adjusted non-GAAP net income* was $2.64 per basic and $2.59 per diluted share

 

·    Early trends1 indicate that Q1 2022 revenue is expected to be in the range of $120 million - $130 million and adjusted non-GAAP earnings per share* in the range of $3.80 - $4.10

 

·   Commenced shipment of vasopressin, a generic alternative to Vasostrict®, with 180 days of marketing exclusivity

 

·   Announced commercial availability of novel product, PEMFEXY™ (pemetrexed for injection), a branded alternative to ALIMTA®

 

·   On track to support submission of new drug application in second quarter of 2022 for Landiolol, a beta-1 adrenergic blocker

 

·   Expects to start clinical trial in CAL02 patients in Q3 2022 during pneumonia season

 

WOODCLIFF LAKE, NJ—March 7, 2022—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three and twelve months ended December 31, 2021.

 

Business and Recent Highlights:

 

·Announced the commercial availability of its novel product, PEMFEXY™ (pemetrexed for injection), a branded alternative to ALIMTA®. PEMFEXY is a ready-to-use liquid with a unique J-code and is approved in the United States to treat nonsquamous non-small cell lung cancer and mesothelioma. Eagle received approval from the U.S. Food and Drug Administration (“FDA”) in February 2020 of its new drug application (“NDA”) for PEMFEXY, following the settlement agreement of patent litigation with Eli Lilly and Company in December 2019. The agreement provided for a release of all claims by the parties and allows for an initial entry of PEMFEXY into the market (equivalent to approximately a three-week supply of ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022. The ALIMTA U.S. market totaled $1.2 billion for the 12 months ended December 31, 2021, as reported by Eli Lilly and Company.

 

 

1 The Company’s expectations with respect to the first quarter of 2022 are based on its estimates and assumptions as of March 7, 2022 and are subject to substantial uncertainty. The Company’s first quarter of 2022 is ongoing and not complete, and the Company’s expectations with respect to revenues, earnings per share and adjusted non-GAAP earnings per share for the first quarter of 2022 are estimates. Actual revenue, earnings per share and adjusted non-GAAP earnings per share for the Company’s first quarter of 2022 are subject to completion of the quarter as well as financial closing procedures for the period, and the actual and reported financial results for the Company’s first quarter of 2022 may materially differ. As such, the Company’s expectations with respect to the first quarter of 2022 are inherently unpredictable and actual results and outcomes could differ materially for a variety of reasons, including the factors discussed below under “Forward-Looking Statements.”

 

* Adjusted non-GAAP net income, adjusted non-GAAP earnings per share, adjusted non-GAAP R&D expense and adjusted non-GAAP SG&A expense are non-GAAP financial measures. For descriptions and reconciliations of these non-GAAP financial measures to their most comparable GAAP financial measures, please see below and the tables at the end of this press release.

 


The following information was filed by Eagle Pharmaceuticals, Inc. (EGRX) on Monday, March 7, 2022 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

Audit Information
Cover
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Changes In Stockholders' Equity
Consolidated Statements Of Comprehensive (Loss) Income
Consolidated Statements Of Income
Balance Sheet Accounts
Balance Sheet Accounts (Tables)
Balance Sheet Accounts - Accrued Expenses And Other Liabilities (Details)
Balance Sheet Accounts - Lease Related Disclosures (Details)
Balance Sheet Accounts - Narrative (Details)
Balance Sheet Accounts - Prepaid Expenses And Other Current Assets (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 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)
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 (Tables)
Income Taxes - Narrative (Details)
Income Taxes - Schedule Of Components Of Income Tax Expense (Benefit) (Details)
Income Taxes - Schedule Of Deferred Tax Assets And Liabilities (Details)
Income Taxes - Schedule Of Effective Income Tax Rate Reconciliation (Details)
Intangible Assets, Net
Intangible Assets, Net (Tables)
Intangible Assets, Net - Narrative (Details)
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 - Collaboration With Tyme (Details)
License And Collaboration Agreements - License Agreements (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)
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 Financial Assets And Liabilities Measured And Recognized At Fair Value (Details)
Summary Of Significant Accounting Policies - Schedule Of Product Sales (Details)
Summary Of Significant Accounting Policies - Summary Of Sales Allowances And Related Accruals (Details)
Ticker: EGRX
CIK: 827871
Form Type: 10-K Annual Report
Accession Number: 0000827871-22-000008
Submitted to the SEC: Mon Mar 07 2022 6:10:20 PM EST
Accepted by the SEC: Tue Mar 08 2022
Period: Friday, December 31, 2021
Industry: Pharmaceutical Preparations

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