SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of the earliest event reported): July 24, 2018
NEUROCRINE BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of
incorporation or organization)
|12780 El Camino Real, San Diego, California||92130|
|(Address of principal executive offices)||(Zip Code)|
Registrants telephone number, including area code: (858) 617-7600
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation 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))|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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 8.01||Other Events.|
In June 2010, Neurocrine Biosciences, Inc. (the Company) announced an exclusive worldwide collaboration with AbbVie Inc. (AbbVie) to develop and commercialize elagolix and all next-generation gonadotropin-releasing hormone (GnRH) antagonists.
On July 24, 2018, AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved ORILISSA (elagolix), the first and only oral GnRH antagonist specifically developed for women with moderate to severe pain associated with endometriosis. ORILISSA will be available in retail pharmacies in August 2018 with a list price of approximately $845 for a monthly script. With this FDA approval, a $40 million event-based payment will be made to the Company by AbbVie under the related collaboration agreement and recognized as revenue by the Company in the third quarter of 2018.
Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Companys filings with the Securities and Exchange Commission, including without limitation the Companys most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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.
|NEUROCRINE BIOSCIENCES, INC.|
|Dated: July 24, 2018|
|Darin M. Lippoldt|
|Chief Legal Officer|