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Washington, D.C. 20549






Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934


Date of Report (Date of earliest event reported): March 13, 2020


Eagle Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)


Delaware 001-36306 20-8179278
(State or other jurisdiction (Commission File Number)   (IRS Employer Identification No.)  
of incorporation)    


50 Tice Boulevard, Suite 315
Woodcliff Lake, NJ
(Address of principal executive offices)     (Zip Code)  


Registrant’s telephone number, including area code: (201) 326-5300


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:


¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Securities registered pursuant to Section 12(b) of the Act:


Title of each class   Trading Symbol   Name of each exchange on which registered
Common Stock (par value $0.001 per share)   EGRX   The Nasdaq Global Market


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ¨


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨






Item 8.01Other Events.


On March 13, 2020, the U.S. Court of Appeals for the District of Columbia Circuit affirmed the decision originally issued by the U.S. District Court for the District of Columbia on June 8, 2018 requiring the U.S. Food and Drug Administration to grant Eagle Pharmaceuticals, Inc., or the Company, seven years of orphan drug exclusivity in the U.S. for BENDEKA (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride.


Cautionary Statement Regarding Forward-Looking Statements


This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are “forward-looking statements” for purposes of this Current Report on Form 8-K, including implied or explicit statements concerning the outcome of any additional litigation involving BENDEKA, the performance of the Company’s marketed products, including BENDEKA, the Company’s collaboration with Teva Pharmaceutical Industries Ltd. with respect to BENDEKA, whether the Company and Teva will successfully perform their respective obligations under the licensing arrangements for BENDEKA, and any statements or assumptions underlying any of the foregoing. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “expects,” “plans,” “anticipates,” “estimates,” or the negative thereof or other comparable terminology. Although the Company believes that the expectations reflected in the forward-looking statements contained herein are reasonable, such expectations or any of the forward-looking statements may prove to be incorrect and actual results could differ materially from those projected or assumed in the forward-looking statements. Any forward-looking statements are subject to inherent risks and uncertainties, including, but not limited to, the risks described in the Company’s filings with the Securities and Exchange Commission. All forward-looking statements and reasons why results may differ included in this report are made as of the date hereof and the Company does not intend to update any forward-looking statements except as required by law or applicable regulations.







Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.



    Eagle Pharmaceuticals, Inc.  
Dated: March 16, 2020        
    By: /s/ Scott Tarriff
        Scott Tarriff
        Chief Executive Officer