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Eagle Pharmaceuticals, Inc. (EGRX) SEC Filing 10-K Annual report for the fiscal year ending Tuesday, September 30, 2014

Eagle Pharmaceuticals, Inc.

CIK: 827871 Ticker: EGRX

Exhibit 99.1

 

 

For Immediate Release

 

Eagle Pharmaceuticals, Inc. Reports Fourth Quarter and Year End 2014 Financial Results

 

WOODCLIFF LAKE, N.J. — December 17, 2014 —Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq: EGRX) today announced its financial results for the three- and twelve- month periods ended September 30, 2014. Highlights of and subsequent to the fourth quarter include:

 

·                  The U.S. Food and Drug Administration (“FDA”) tentatively approved Eagle’s bendamustine hydrochloride (“HCl”) ready-to-dilute (“RTD”) product;

 

·                  Our clinical trial demonstrated that Eagle’s bendamustine HCl product administered in a 50mL admixture in 10 minutes (“rapid infusion”) is bioequivalent to Treanda® and has a comparable safety profile;

 

·                  Eagle’s bendamustine HCl rapid infusion product was granted orphan drug designation for the treatment of chronic lymphocytic leukemia (“CLL”) and indolent B-cell non-Hodgkin’s lymphoma (“NHL”), and a new patent covering the product was issued by the U.S. Patent and Trademark Office;

 

·                  FDA approved Ryanodex® (dantrolene sodium) injectable suspension for the treatment of malignant hyperthermia; Eagle has recorded approximately $0.8 million in Ryanodex sales since its launch in late August 2014;

 

·                  FDA approved Eagle’s Abbreviated New Drug Application for diclofenac/misoprostol tablets;

 

·                  Total revenue increased to $19.1 million in fiscal 2014, compared to $13.7 million in fiscal 2013;

 

·                  Research and development expenses increased to $16.8 million in fiscal 2014, compared to $9.8 million in fiscal 2013, reflecting Eagle’s investment in its pipeline;

 

·                  Net loss attributable to common stockholders was ($19.6) million in fiscal 2014, compared to ($9.9) million in fiscal 2013; and,

 

·                  Cash, cash equivalents and short-term investments of $42.7 million and a working capital surplus of $32.7 million as of September 30, 2014.

 

“I am proud of the many important milestones we achieved in fiscal 2014 that position Eagle for future growth,” said Scott Tarriff, President and Chief Executive Officer.  “We successfully completed our IPO in February, providing us with the financial flexibility to execute our strategy.  Our clinical and regulatory efforts resulted in two approvals and one tentative approval from the FDA for our products, several key patent issuances, and the granting of orphan designation for our rapidly administered bendamustine in the U.S. and Ryanodex in the EU.

 

“Perhaps our most significant achievement in 2014 was the successful completion of a clinical trial that established the bioequivalence and comparable safety profile of our tentatively approved bendamustine formulation, administered in a 50mL admixture in 10 minutes, to the in-market branded product, Treanda.  We believe this product offers significant advantages to the currently available formulations.

 

“Looking ahead, we anticipate Ryanodex may become the new standard of care for malignant hyperthermia, with many top-tier hospitals among our early conversions.  We plan to submit our NDA for RTU bivalirudin, we are preparing for a potential launch of bendamustine, and we aim to conduct a pivotal trial of Ryanodex for exertional heat stroke by the end of fiscal 2015.  We believe we are in a strong position to continue delivering results for

 


The following information was filed by Eagle Pharmaceuticals, Inc. (EGRX) on Wednesday, December 17, 2014 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside this 10-K Annual Report

Document And Entity Information Document
Condensed Balance Sheets
Condensed Balance Sheets (parentheticals)
Condensed Statements Of Cash Flows
Condensed Statements Of Cash Flows Parenthetical
Condensed Statements Of Changes In Stockholders' Equity (deficit) Statement
Condensed Statements Of Operations
Arbitration
Arbitration (details)
Asset Sales
Asset Sales (details)
Balance Sheet Accounts
Balance Sheet Accounts (tables)
Balance Sheet Accounts - Accrued Expenses (details)
Balance Sheet Accounts - Deferred Revenue (details)
Balance Sheet Accounts - Prepaid And Other Current Assets (details)
Commitments
Commitments (details)
Common Stock And Stock-based Compensation
Common Stock And Stock-based Compensation (tables)
Common Stock And Stock-based Compensation - Narrative (details)
Common Stock And Stock-based Compensation - Recognized Share-based Compensation (details)
Common Stock And Stock-based Compensation - Share-based Compensation, Options (details)
Income Taxes
Income Taxes (details)
Income Taxes (tables)
Income Taxes Deferred Income Taxes (details)
Income Taxes Income Tax Reconciliation (details)
Inventories
Inventories (details)
Inventories (tables)
Legal Proceedings
Legal Proceedings (details)
License Agreements Of Development And Commercialization Rights
License Agreements Of Development And Commercialization Rights (details)
Notes Payable
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Organization And Business Activities
Organization And Business Activities (details)
Property And Equipment
Property And Equipment (details)
Property And Equipment (tables)
Shares Subject To Redemption €” Convertible Preferred Stock
Shares Subject To Redemption €” Convertible Preferred Stock (details)
Shares Subject To Redemption €” Convertible Preferred Stock Tables (tables)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (policies)
Summary Of Significant Accounting Policies (tables)
Summary Of Significant Accounting Policies - Assumption Of Stock Options Granted (details)
Summary Of Significant Accounting Policies - Common Shares Equivalents Outstanding (details)
Summary Of Significant Accounting Policies - Major Customers As A Percentage (details)
Summary Of Significant Accounting Policies - Narrative (details)

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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: 0000827871-14-000015
Submitted to the SEC: Mon Dec 22 2014 3:29:21 PM EST
Accepted by the SEC: Mon Dec 22 2014
Period: Tuesday, September 30, 2014
Industry: Pharmaceutical Preparations

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