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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.
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Eagle Pharmaceuticals, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:
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The decrease primarily resulted from a decrease in clinical study project spending for vasopressin and Ryanodex for EHS indication, and employee-related costs, primarily stock compensation expense.
Research and Development Costs for research and development are charged to expenses as incurred and include: employee-related expenses including salaries, benefits, travel and stock-based compensation expense for research and development personnel; expenses incurred under agreements with contract research organizations, contract manufacturing organizations and service providers that assist in conducting clinical and preclinical studies; costs associated with preclinical activities and development activities; costs associated with regulatory operations; and depreciation expense for assets used in research and development activities.
This increase is related to fair value adjustments on equity investment in Tyme in the amount of $5.3 million and the related fair value adjustments related to the final settlement of the $25.0 million ASR transaction with JPMorgan as part of the Company's Share Repurchase Program.
Selling, General and Administrative Selling, general and administrative costs consist of employee-related costs including salaries, benefits and other related costs, stock-based compensation for executive, finance, sales and operations personnel.
At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct.
In addition, our sales and...Read more
Interest expense decreased primarily due...Read more
Interest expense decreased primarily due...Read more
Net income for the same...Read more
Results of Operations Comparison of...Read more
Net loss for the same...Read more
Comparison of Years Ended December...Read more
Royalty revenue is recognized as...Read more
In 2019, we received an...Read more
Cost of Revenue Cost of...Read more
Net changes in working capital...Read more
The effective tax rate for...Read more
Regulatory Activities: We may experience...Read more
We determined the ASR contained...Read more
If the COVID-19 pandemic continues...Read more
The Company determined the ASR...Read more
Financing Activities: Net cash used...Read more
Revenue Recognition Revenue is recognized...Read more
The effective tax rate for...Read more
Costs for certain development activities,...Read more
To determine revenue recognition for...Read more
Royalty revenue decreased $2.4 million...Read more
Cost of Revenue Cost of...Read more
Recoveries of previously recognized research...Read more
The effective tax rate for...Read more
Cost of royalty revenue decreased...Read more
In each instance, revenue is...Read more
The amendments are effective for...Read more
By focusing on patients' unmet...Read more
These increases were partially offset...Read more
Royalty revenue decreased $4.0 million...Read more
We recognize any interest and...Read more
Net cash used in financing...Read more
In the case of discounted...Read more
The new guidance provides optional...Read more
In particular, we are applying...Read more
Our license and other revenue...Read more
Vasopressin On January 18, 2022,...Read more
The amount of assets and...Read more
Liquidity and Capital Resources: We...Read more
Landiolol On January 31, 2022,...Read more
Financial Statements, Disclosures and Schedules
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Material Contracts, Statements, Certifications & more
Eagle Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits
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