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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 Eagles bendamustine hydrochloride (HCl) ready-to-dilute (RTD) product;
· Our clinical trial demonstrated that Eagles bendamustine HCl product administered in a 50mL admixture in 10 minutes (rapid infusion) is bioequivalent to Treanda® and has a comparable safety profile;
· Eagles bendamustine HCl rapid infusion product was granted orphan drug designation for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkins 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 Eagles 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 Eagles 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
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Eagle Pharmaceuticals, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2014 10-K Annual Report includes:
Financial Statements, Disclosures and Schedules
Inside this 10-K Annual Report
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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