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Eagle Pharmaceuticals, Inc. (EGRX) SEC Filing 10-Q Quarterly report for the period ending Monday, September 30, 2019

Eagle Pharmaceuticals, Inc.

CIK: 827871 Ticker: EGRX

Exhibit 99.1

 

 

For Immediate Release

 

Eagle Pharmaceuticals Reports Third Quarter 2019 Results

 

-- Net loss of $0.17 per basic and diluted share and adjusted non-GAAP net income of

$0.27 per basic and $0.26 per diluted share in Q3 2019 --

 

-- Plan to initiate a clinical trial in December for Eagle’s innovative fulvestrant program, which has the potential to result in greater inhibition of estrogen receptors and better outcomes for patients with estrogen receptor-positive breast cancer --

 

-- Company returned to 2019 Hajj and enrolled additional EHS patients in its controlled clinical study --

 

-- Eagle expects to file a supplement to the current NDA for the treatment of brain damage secondary to nerve agent exposure in the second half of 2020 --

 

WOODCLIFF LAKE, NJ—November 12, 2019—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three- and nine-month periods ended September 30, 2019. Third quarter and recent highlights include:

 

·Invested $12 million in research and development and external legal costs to advance Eagle’s pipeline.

 

·Eagle’s Japanese marketing partner, SymBio Pharmaceuticals Limited, submitted a New Drug Application (“NDA”) for TREAKISYM, bendamustine ready-to-dilute liquid formulation, in Japan in September. Approval is expected in Q4 2020, which would trigger a $5 million milestone payment to Eagle. Potential payments to Eagle could reach $10 to $25 million per year in royalties and milestones.

 

·Advanced clinical development plans for Eagle’s innovative fulvestrant program, which has the potential to change the treatment of estrogen receptor-positive breast cancer. The program aims to determine if the unique properties of Eagle’s product will result in greater inhibition of estrogen receptors and better patient outcomes compared to currently available treatment options. The Company expects to dose the first subject in December.

 

·Enrolled additional patients in its controlled clinical study of RYANODEX® (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke (“EHS”) patients during the 2019 Hajj pilgrimage held from August 9-14 in Saudi Arabia. The Company has recruited a total of 41 patients at the 2015, 2018 and 2019 Hajj pilgrimages. Eagle has submitted a plan to the U.S. Food and Drug Administration (“FDA”) that proposes reviewing the data collectively for all 41 patients.  If FDA agrees with this plan, Eagle plans to resubmit the NDA for EHS in response to the Complete Response Letter received in 2017.

 

·The Company, in dialogue with FDA, has received further clarity regarding RYANODEX for the treatment of brain damage secondary to nerve agent exposure. FDA has recommended that, under the animal rule, an additional study be conducted in a second species. Eagle expects to file a supplement to the current NDA in the second half of 2020.

 

·Total revenue for Q3 2019 was $41.1 million, compared to $51.3 million in Q3 2018, primarily reflecting lower BENDEKA® royalty revenue and lower product sales of BELRAPZO® and RYANODEX, partially offset by higher product sales of BENDEKA.

 


The following information was filed by Eagle Pharmaceuticals, Inc. (EGRX) on Tuesday, November 12, 2019 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-Q Quarterly 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-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Cover Page
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical)
Condensed Consolidated Statement Of Changes In Stockholders' Equity (Unaudited)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Operations (Unaudited)
Acquisitions
Acquisitions - Narrative, Biologics (Details)
Acquisitions (Tables)
Acquisitions - Schedule Of Consideration Transferred, Biologics (Details)
Balance Sheet Accounts
Balance Sheet Accounts - Accrued Expenses (Details)
Balance Sheet Accounts - Future Minimum Lease Payments (Details)
Balance Sheet Accounts - Lease Related Disclosures (Details)
Balance Sheet Accounts - Prepaid And Other Current Assets (Details)
Balance Sheet Accounts (Tables)
Commitments
Commitments - Future Minimum Lease Payments (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 Stock Options Granted (Details)
Common Stock And Stock-Based Compensation - Narrative (Details)
Common Stock And Stock-Based Compensation - Schedule Of Share-Based Compensation (Details)
Common Stock And Stock-Based Compensation - Summary Of Stock Options, Rsu And Psu Activity (Details)
Debt
Debt (Details)
Debt (Tables)
Debt - Schedule Of Debt Maturities (Details)
Income Taxes
Income Taxes (Details)
Income Taxes (Tables)
Intangible Assets, Net
Intangible Assets, Net (Tables)
Intangible Assets, Net - Schedule Of Future Amortization Expense (Details)
Intangible Assets, Net - Schedule Of Intangible Assets (Details)
Interim Condensed Consolidated Financial Statements
Inventories
Inventories (Details)
Inventories (Tables)
Legal Proceedings
Organization And Business Activities
Organization And Business Activities (Details)
Related Party Transaction
Related Party Transaction (Details)
Restructuring
Restructuring (Details)
Subsequent Event
Subsequent Event Subsequent Event (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies - Anti-Dilutive Common Shares Equivalents Outstanding (Details)
Summary Of Significant Accounting Policies - Narrative (Details)
Summary Of Significant Accounting Policies - Revenue And Accounts Receivable By Major Customer (Details)
Summary Of Significant Accounting Policies - Schedule Of Basic And Diluted Net Income (Details)
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)

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: 0000827871-19-000026
Submitted to the SEC: Tue Nov 12 2019 11:30:55 AM EST
Accepted by the SEC: Tue Nov 12 2019
Period: Monday, September 30, 2019
Industry: Pharmaceutical Preparations

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