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Actionable news in EGRX: EAGLE PHARMACEUTICALS Inc,

Eagle: January 2016 Corporate Overview

The following excerpt is from the company's SEC filing.

Forward Looking Statements This presentation contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities laws. Forward-looking statements are statements that are not historical facts. Words such as will, may, intends, anticipate(s), plan, enables, facilitates, potentially, look forward, on track, and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events including, but not limited to: the mar keting of Eagle products by the sales team at Spectrum Pharmaceuticals (Spectrum); Eagles plan to hire 20 direct sales representatives; the approval of, and marketing, sale, and distribution of, Docetaxel Injection Concentrate, Non-Alcohol Formula, under the licensing agreement with Teikoku Pharma USA (Teikoku); the results of data analysis of the RYANODEX® study; the achievement of milestones under the license agreement with Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd (Teva), for the U.S. and Canadian rights to BENDEKA® and their impact on Eagles profitability; the replication of the success of our sales of RYANODEX® for our other product candidates, including our RTU bivalirudin candidate and tentatively-approved liquid bendamustine product in the 500ml bag; and the impact of such anticipated events and outcomes on Eagles profitability. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond Eagles control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks include, but are not limited to: the success of our commercial relationship with the Spectrum sales team; our ability to hire, and the success of, the direct sales representatives we plan to hire; success in gaining timely FDA approval of the rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen, and for the RTU bivalirudin product for the treatment of patients (1) undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome, and/or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA), if at all; the timing and level of success of a future launch of BENDEKA by Teva and the RTU bivalirudin product by Eagle; the success of our commercial relationship with Teva and the parties ability to work effectively together; whether Eagle and Teva will successfully perform their respective obligations under the license agreement; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; general economic conditions; the strength and enforceability of our intellectual property rights; the timing of product launches; the successful marketing of our products; the risks inherent in the early stages of drug development and in conducting clinical trials; and other factors that are discussed in Eagles Annual Report on Form 10-K for the year ended September 30, 2014, and its other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Eagle is a fully commercial specialty company with a broad portfolio and deep near-term pipeline

Activity through May 2016 Bendeka launch with Teva: Expect complete / near-complete conversion from Treanda Anticipate FDA decision on 7 years of marketing exclusivity Anticipate J-code decision Bivalirudin RTU PDUFA March 2016; likely next entrant in limited market Right to launch tentatively approved Bendamustine RTD (500mL) May 1, 2016 Docetaxel launch first units shipping in January Ryanodex, Argatroban and Diclofenac currently in-market generating revenue FDA meeting to discuss potential Ryanodex label expansion to...


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