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Exhibit 99.1
For Immediate Release
Eagle Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Results and Provides Pipeline Review
-- Q4 2020 net income was $0.62 per basic and $0.60 per diluted share and adjusted non-GAAP net income was $0.98 per basic and $0.96 per diluted share –
-- FY 2020 net income was $0.89 per basic and $0.87 per diluted share and adjusted non-GAAP net income was $3.62 per basic and $3.54 per diluted share --
-- Posted strong 36% adjusted non-GAAP earnings growth 2020 over 2019 --
WOODCLIFF LAKE, NJ—March 2, 2021—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three and twelve months ended December 31, 2020, and reviewed key pipeline programs.
Business and Recent Highlights:
· | Posted strong year-over-year adjusted non-GAAP earnings growth of 36%; |
· | Received a complete response letter (“CRL”) from U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application (“ANDA”) for vasopressin. Eagle had a post-CRL meeting with FDA late last week and believes it has clear agreement on how to proceed. As previously disclosed, FDA restated that it has prioritized Eagle’s ANDA, and it is also flagged as a COVID priority. Eagle plans to re-submit its ANDA by mid-year. The patent trial against Endo Par Innovation Company, LLC was postponed and is now scheduled to begin on July 7, 2021; the Company believes it will have 180 days of exclusivity. |
· | Added four experienced pharmaceutical industry executives to clinical, formulations and commercial leadership teams as follows: Judith (“Judi”) Ng-Cashin, M.D., is EVP and Chief Medical Officer; John Kimmet, is EVP, Oncology and Acute Care Marketing; Valentin R. Curt, M.D., is SVP, Clinical Drug Development; and Gaozhong Zhu, Ph.D., is SVP, Pharmaceutical Development, and |
· | Continued productive engagement with FDA for EA-114, the Company’s fulvestrant product candidate. The Company now has agreement for the clinical design and study endpoints, and following additional formulation work, intends to begin a clinical trial in patients. |
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Eagle Pharmaceuticals, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2021 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
We regard an accounting estimate...Read more
Selling, General and Administrative This...Read more
This standard is effective for...Read more
Results of Operations Comparison of...Read more
Royalty revenue is recognized as...Read more
In 2019, we received an...Read more
The effective tax rate for...Read more
Regulatory Activities: We may experience...Read more
If the COVID-19 pandemic continues...Read more
The Company determined the ASR...Read more
Revenue Recognition Revenue is recognized...Read more
The effective tax rate for...Read more
Net cash used in financing...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
Royalty revenue decreased $30.0 million...Read more
Recoveries of previously recognized research...Read more
In addition, our reported financial...Read more
Change in Independent Registered Public...Read more
Additionally, we consider other factors...Read more
Impact of Inflation While it...Read more
Executive Officer Transitions Chief Medical...Read more
In each instance, revenue is...Read more
The estimates that are most...Read more
The amendments are effective for...Read more
We do not provide incentives...Read more
By focusing on patients' unmet...Read more
These increases were partially offset...Read more
O n December 18, 2020,...Read more
Comparison of Years Ended December...Read more
Not all of these significant...Read more
In connection with his departure,...Read more
We recognize any interest and...Read more
Financing Activities: Net cash used...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
These reserves are recorded in...Read more
Other income (expense), net Interest...Read more
Financial Statements, Disclosures and Schedules
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Eagle Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits
Ticker: EGRX
CIK: 827871
Form Type: 10-K Annual Report
Accession Number: 0000827871-21-000011
Submitted to the SEC: Fri Mar 05 2021 9:07:31 AM EST
Accepted by the SEC: Fri Mar 05 2021
Period: Thursday, December 31, 2020
Industry: Pharmaceutical Preparations