Please wait while we load the requested 10-Q report or click the link below:
https://last10k.com/sec-filings/report/827871/000082787121000016/egrx-20210331.htm
August 2022
August 2022
July 2022
July 2022
June 2022
June 2022
June 2022
May 2022
May 2022
April 2022
Exhibit 99.1
For Immediate Release
Eagle Pharmaceuticals Reports First Quarter 2021 Results
Q1 2021 net loss was $0.03 per basic and diluted share and adjusted non-GAAP net income was $0.24 per basic and diluted share
Anticipate vasopressin approval and launch this year; completed last required study; expect to respond to vasopressin Complete Response Letter (CRL) in full by mid-year
Expects approximately $20-$25 million from combined royalty and milestone revenue in 2022 for TREAKISYM (bendamustine) Ready-to-Dilute (RTD) and Rapid Infusion (RI) formulations
WOODCLIFF LAKE, NJMay 10, 2021Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (Eagle or the Company) today announced financial results for the three months ended March 31, 2021.
Business and Recent Highlights:
· | Completed the last study required by FDA for the Companys vasopressin product and expect to have the results shortly. Eagle plans to respond to the CRL issued for its first-to-file Abbreviated New Drug Applicable (ANDA) for vasopressin in full by mid-year. The Companys 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 first-to-file 180 day exclusivity for vasopressin; |
· | Approval of TREAKISYM (bendamustine) RTD formulation, in combination with rituximab for treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) received from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. This represents a meaningful extension of Eagles bendamustine franchise and is expected to significantly increase the market opportunity; |
· | Filing of TREAKISYM RI (50ml) liquid formulation with the PMDA in Japan. Eagle expects approximately $20-$25 million from combined royalty and milestone revenue in 2022 for TREAKISYM (bendamustine) RTD and RI formulations; |
· | Appointed former FDA Official and Public Health Expert Dr. Luciana Borio to its Board of Directors; and |
· | In active discussions for several promising in-licensing and acquisition candidates that the Company believes will strengthen its portfolio and pipeline going forward. |
Financial Highlights
First Quarter 2021
Total revenue for Q1 2021 was $41.2 million, compared to $46.0 million in Q1 2020, primarily reflecting decreased product sales of RYANODEX® and royalty revenue of BENDEKA®.
Please wait while we load the requested 10-Q report or click the link below:
https://last10k.com/sec-filings/report/827871/000082787121000016/egrx-20210331.htm
Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were removed , added and changed by Eagle Pharmaceuticals, Inc..
Eagle Pharmaceuticals, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:
Rating
Learn More![]()
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.
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.
In addition, our sales and marketing teams have been working remotely and our virtual initiatives with respect to marketing and supporting the sale and administration of our products have not been as effective as our in-person sales and marketing activities.
This decrease is primarily related to the non-recurrence of the Tyme transaction associated costs of $2.5 million that was executed in 2020, $1.2 million decrease in marketing, travel, entertainment, and trade show expenses as a result of minimizing travel due to the impact of the COVID-19 pandemic, $0.4 million decrease in external legal costs and $0.3 million decrease in stock compensation expense.
This standard is effective for fiscal years beginning after December 15, 2019 and the Company adopted the standard effective January 1, 2020.
This was attributable to declining...Read more
Royalty revenue is recognized as...Read more
Our royalty revenue decreased $4.2...Read more
Net changes in working capital...Read more
Regulatory Activities: We may experience...Read more
If the COVID-19 pandemic continues...Read more
Our interest expense decreased $0.5...Read more
Costs for certain development activities,...Read more
Recoveries of previously recognized research...Read more
Selling, General and Administrative Our...Read more
This was attributable to an...Read more
The effective tax rate for...Read more
Impact of Inflation While it...Read more
35 Financing Activities: Net cash...Read more
The amendments are effective for...Read more
By focusing on patients' unmet...Read more
The decrease was attributable to...Read more
We recognize any interest and...Read more
The increase primarily resulted from...Read more
This increase is related to...Read more
Our actual results, performance or...Read more
Our research and development expenses...Read more
In the case of discounted...Read more
The new guidance provides optional...Read more
In particular, we are applying...Read more
Financial Statements, Disclosures and Schedules
Inside this 10-Q Quarterly Report
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: 0000827871-21-000016
Submitted to the SEC: Mon May 10 2021 5:15:40 PM EST
Accepted by the SEC: Mon May 10 2021
Period: Wednesday, March 31, 2021
Industry: Pharmaceutical Preparations