UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Act of 1934

 

Date of Report (Date of earliest event reported): December 21, 2018

 

NEOS THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-37508

 

27-0395455

(State or other jurisdiction of
incorporation or organization)

 

(Commission
File Number)

 

(I.R.S. Employer
Identification Number)

 

2940 N. Highway 360

Grand Prairie, TX 75050

(972) 408-1300

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 

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:

 

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

 

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

 

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

 

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

 

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. x

 

 

 


 

Item 1.01. Entry Into a Material Definitive Agreement

 

On December 21, 2018, Neos Therapeutics, Inc. (the “Company”) entered into a confidential Settlement Agreement and Licensing Agreement (collectively, the “Agreement”), in each case between the Company, Neos Therapeutics, LP, a wholly-owned subsidiary of the Company, and Teva Pharmaceuticals USA, Inc. (“Teva”). This Agreement resolves all ongoing litigation involving the Company’s patents protecting its Cotempla XR-ODT® methylphenidate extended-release orally disintegrating tablets and Teva’s Abbreviated New Drug Application (the “ANDA”) filed with the U.S. Food and Drug Administration. Under the Agreement, the Company has granted Teva the right to manufacture and market its generic version of Cotempla XR-ODT under the ANDA beginning on July 1, 2026, or earlier under certain circumstances. The Agreement provides for a full settlement of all claims that were asserted in the suit, subject to the acceptance of the U.S. District Court for the District of Delaware of a stipulation of dismissal.  As required by law, the Agreement will be submitted to the U.S. Federal Trade Commission and U.S. Department of Justice.

 

The foregoing summary of the Agreement is qualified in its entirety by reference to the full text of the Agreement, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2018.

 

Item 8.01. Other Events.

 

On December 26, 2018, the Company issued a press release announcing its entry into the Agreement. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits:

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Press release dated December 26, 2018

 

2


 

SIGNATURES

 

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 thereunto duly authorized.

 

 

NEOS THERAPEUTCS, INC.

 

 

 

Date:

December 26, 2018

 

By:

/s/ Gerald McLaughlin

 

Title:

President and Chief Executive Officer

 

3


Exhibit 99.1

 

 

Neos Therapeutics Announces Settlement with Teva on

Cotempla XR-ODT® Patent Litigation

 

DALLAS/FORT WORTH, Texas, December, 26, 2018 (GLOBE NEWSWIRE) — Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company focused on developing, manufacturing, and commercializing innovative extended-release (XR) products using its proprietary modified-release drug delivery and orally disintegrating tablet (ODT) technology platforms, today announced that it has entered into a confidential settlement and licensing agreement with Teva Pharmaceuticals USA, Inc. (“Teva”) to resolve all ongoing litigation involving Neos’ patents protecting its Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets and Teva’s Abbreviated New Drug Application (ANDA) filed with the U.S. Food and Drug Administration to market a generic version of that product.

 

Under the settlement and license agreement, Neos has granted Teva the right to manufacture and market its generic version of Cotempla XR-ODT® under the Teva ANDA beginning on July 1, 2026, or earlier under certain circumstances.

 

The settlement and licensing agreement is confidential and the agreement is subject to submission to the Federal Trade Commission and the U.S. Department of Justice.

 

“We are pleased to have reached this settlement and will continue to defend our innovative medicines against any challenge,” said Jerry McLaughlin, Chief Executive Officer of Neos Therapeutics.

 

About Neos Therapeutics

 

Neos Therapeutics, Inc. (NASDAQ: NEOS) is a pharmaceutical company focused on developing, manufacturing and commercializing products utilizing its proprietary modified-release drug delivery technology platforms. Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER™ (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING), all for the treatment of ADHD, are three approved products using the Company’s extended-release  technology platform. Additional information about Neos is available at www.neostx.com.

 

Forward-Looking Statements

 

Any statements in this press release about future expectations, plans and prospects for Neos Therapeutics, Inc., including statements about Neos’ future expectations and plans to defend and enforce its intellectual property rights and other statements containing the words “will,” “would,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to governmental approvals of the settlement and license agreement, Neos’ ability to protect its intellectual property rights, uncertainties related to litigation Neos is involved or may become involved, uncertainties inherent in the initiation of future clinical trials, expectations of expanding ongoing clinical trials and other factors discussed in the “Risk Factors” section in our most recently filed Annual Report on Form 10-K for the year ended December 31, 2017, which is on file with the SEC, as updated by any subsequently filed SEC filings, including Neos’ Quarterly Reports on Form 10-Q. Any forward-looking statements contained

 

Corporate Office | 2940 N. Hwy 360, Suite 400 | Grand Prairie, TX 75050 | telephone 972.408.1300

 


 

in this press release speak only as of the date hereof, and Neos expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

###

 

CONTACTS:

 

Richard I. Eisenstadt

Chief Financial Officer

Neos Therapeutics

(972) 408-1389

reisenstadt@neostx.com

 

Sarah McCabe and Carl Mauch

Investor Relations

Stern Investor Relations, Inc.

(212) 362-1200

sarah@sternir.com and carl@sternir.com