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For Immediate Release
Eagle Pharmaceuticals, Inc. Reports First Quarter 2019 Results
Q1 2019 net income of $0.64 per basic and $0.62 per diluted share and adjusted non-GAAP net income of $1.05 per basic and $1.01 per diluted share
Revised licensing agreement for BENDEKA® extends term of contract and increases royalty rate to 32% in 2021
CMS issues unique J-code for BELRAPZO (500mL infusion bendamustine solution)
Announced statistically significant neuroprotective effects of RYANODEX® in a well-established nerve agent model
WOODCLIFF LAKE, NJMay 7, 2019Eagle Pharmaceuticals, Inc. (Eagle or the Company) (Nasdaq: EGRX) today announced its financial results for the three months ended March 31, 2019. Highlights of, and subsequent to, the first quarter of 2019 include:
Business and Recent Highlights:
· Completed a successful study to evaluate the neuroprotective effects of RYANODEX® (dantrolene sodium) for the treatment of nerve agent exposure:
· Conducted in collaboration with the United States Army Medical Research Institute of Chemical Defense (USAMRICD), the nations leading science and technology laboratory in the area of medical chemical countermeasures research and development;
· The Company plans to meet with the U.S. Food and Drug Administration (FDA) as soon as possible;
· Announced a revised licensing agreement for BENDEKA that extends the term of the agreement until the product is no longer sold and increases Eagles royalty rate from 25% to 30% in October 2019 and by 1% annually until it reaches 32%;
· The FDA issued a decision in favor of Eagle regarding the scope of BENDEKAs Orphan Drug Exclusivity (ODE), further protecting the longevity of the BENDEKA franchise; and
· The Centers for Medicare and Medicaid Services (CMS) established a unique, product specific, billing code (J-code: J9036) effective July 1, 2019, for BELRAPZO, the brand name under which Eagles currently marketed 500mL infusion bendamustine solution will be sold beginning June 3, 2019.
Financial Highlights:
· Total revenue for the first quarter of 2019 was $49.8 million, compared to $46.6 million in the first quarter of 2018;
· Q1 2019 bendamustine hydrochloride 500ml solution (Big Bag or BELRAPZO) product sales were $3.2 million;
· Q1 2019 RYANODEX product sales were $4.0 million, compared to $4.4 million in Q1 2018;
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Eagle Pharmaceuticals, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2019 10-K Annual Report includes:
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Costs for research and development are charged to expense 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.
On October 30, 2018, the Company announced that its Board of Directors has approved a new share repurchase program providing for the repurchase of up to $150 million of the Company's outstanding common stock, consisting of (i) up to $50 million in repurchases pursuant to an accelerated share repurchase agreement (the "ASR") with JPMorgan Chase Bank, N.A. ("JPMorgan"), and (ii) up to $100 million in additional repurchases (the "2018 Share Repurchase Program").
Selling, general and administrative costs consist primarily of salaries, benefits and other related costs, including stock-based compensation for executive, finance, sales and operations personnel.
License and other revenue in the three months ended March 31, 2019 represents an upfront cash payment of $9.0 million upon execution of an amendment to the BENDEKA License Agreement to terminate Tevas obligation to pay future milestones and royalties on BENDEKA sales outside of the U.S. Cost of revenue increased by $1.3 million to $13.1 million in the three months ended March 31, 2019 as compared to $11.8 million in the three months ended March 31, 2018.
Royalty revenue is recognized as earned in accordance with contract terms when it can be reasonably estimated and collectability is reasonably assured.
Net changes in working capital...Read more
The guidance is effective for...Read more
Product sales increased $3.6 million...Read more
Research and development expenses decreased...Read more
Costs for certain development activities,...Read more
In addition, we plan to...Read more
Total revenue increased $3.2 million...Read more
Under the terms of the...Read more
Royalty revenue decreased $9.5 million...Read more
The Company may enter into...Read more
Selling, general and administrative expenses...Read more
We recognize any interest and...Read more
Net income for the period...Read more
The preliminary assessment of patients...Read more
The effective tax rate for...Read more
In the case of discounted...Read more
The royalty rate will increase...Read more
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Eagle Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits
Ticker: EGRX
CIK: 827871
Form Type: 10-Q Quarterly Report
Accession Number: 0000827871-19-000013
Submitted to the SEC: Tue May 07 2019 1:06:39 PM EST
Accepted by the SEC: Tue May 07 2019
Period: Sunday, March 31, 2019
Industry: Pharmaceutical Preparations