8-K

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 Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): July 25, 2016

NEOS THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-37508	27-0395455
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

2940 N. Highway 360, Grand Prairie, TX	75050
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (972) 408-1300

Not Applicable

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:

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 240.13e-4(c))

Item 8.01. Other Events.

Cotempla XR-ODT™Bioequivalence Bridging Study

On July 28, 2016, Neos Therapeutics, Inc. (“Neos”) issued a press release (the “Press Release”) announcing the successful completion of a bioequivalence bridging study for its late stage product candidate, Cotempla XR-ODT™ (methylphenidate extended-release orally disintegrating tablet). A copy of the Press Release is filed herewith as Exhibit 99.1 and is incorporated herein by reference.

Adzenys XR-ODT™  Paragraph IV Certification

On July 25, 2016, Neos received a paragraph IV certification from Actavis Laboratories FL, Inc. (“Actavis”) advising Neos that Actavis has filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (the “FDA”) for a generic version of Adzenys XR-ODT™  (amphetamine extended-release orally disintegrating tablet for the treatment of ADHD).

The certification notice alleges that the four U.S. patents listed in the FDA’s Orange Book for Adzenys XR-ODT, one with an expiration date in April 2026 and three with expiration dates in June 2032, will not be infringed by Actavis’s proposed product, are invalid and/or are unenforceable. Neos is evaluating the paragraph IV certification and intends to vigorously enforce its intellectual property rights relating to Adzenys XR-ODT.

Neos has 45 days from the receipt of the paragraph IV certification to commence a patent infringement lawsuit against Actavis that would automatically stay, or bar, the FDA from approving Actavis’s ANDA for 30 months or until a district court decision that is adverse to the asserted patents, whichever is earlier.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits:

Exhibit No.	Description
99.1	Press release dated July 28, 2016

*   *   *

Neos cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern Neos’ expectations, strategy, plans, prospects or intentions. Such statements include, without limitation, statements regarding Neos’s intention to vigorously enforce its intellectual property rights. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Neos’s actual future results may differ materially from its current expectations due to the risks and uncertainties inherent in its business. These risks include, but are not limited to: Neos’s ability to successfully enforce its intellectual property rights, and to defend its patents; the possibility that Neos may be required to file lawsuits to defend the patent rights covering its product or technology, and the substantial costs associated with such lawsuits; the possible introduction of generic competition to Adzenys XR-ODT; the risk that Neos may not be able to raise sufficient capital when needed, or at all; and other risks set forth under the caption “Risk Factors” in Neos’ most recent Annual Report on Form 10-K, as updated by Neos’ other subsequently filed SEC filings. Neos assume no obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

2

SIGNATURE

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.

Date: July 28, 2016	NEOS THERAPEUTICS, INC.
	By:	/s/ Vipin Garg
		Vipin Garg
		President and Chief Executive Officer

3

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press release dated July 28, 2016

4

EX-99.1

Exhibit 99.1

News

For Immediate Release

July 28, 2016

Neos Therapeutics Announces Successful Completion of Bioequivalence Bridging Study for Cotempla XR-ODT™ (Methylphenidate Extended-Release Orally Disintegrating Tablet)

Dallas/Fort Worth, Texas, July 28, 2016 — Neos Therapeutics, Inc. (Nasdaq: NEOS), a pharmaceutical company focused on developing and commercializing innovative extended-release (XR) products for the treatment of attention-deficit/hyperactivity disorder (ADHD), today announced the successful completion of a bioequivalence bridging study for its late stage product candidate, Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablet).

Cotempla XR-ODT met all of the primary and secondary endpoints, including partial AUCs, for establishing bioequivalence under fasting conditions. A Complete Response Letter for Cotempla XR-ODT was issued by the U.S. Food and Drug Administration (FDA) on November 6, 2015, requiring the Company to conduct a bridging study to demonstrate bioequivalence between the clinical trial material and the to-be-marketed commercial scale drug product, including an assessment of food effect, and to provide validation and three months of stability data.

“We are delighted with the results of our bioequivalence study and look forward to re-submitting our New Drug Application to the FDA for Cotempla XR-ODT by the end of this year and the anticipated marketing approval in time for the 2017 back-to-school season,” said Vipin K. Garg, PhD, President and CEO of Neos Therapeutics.

About ADHD

According to the Centers for Disease Control and Prevention, ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood(1). In fact, ADHD is estimated to affect 5 percent of children and 2.5 percent of adults in the U.S(2). Symptoms include inattentiveness, hyperactivity and impulsiveness(2). These patterns of behavior are seen in many settings (school, home, work) and can impact performance and relationships.

Stimulant medications such as amphetamine and methylphenidate are the standard of care for treating ADHD, and extended-release (XR) formulations of these medications allow for once-daily dosing(3). Most of the existing treatment formulations are tablets or capsules, which need to be swallowed intact or in some cases sprinkled on certain foods or fluids and ingested immediately. Orally disintegrating tablets differ from traditional tablets and capsules in that they are designed to disintegrate in the mouth, rather than being swallowed whole.

About Neos Therapeutics

Neos Therapeutics, Inc. is a pharmaceutical company focused on developing, manufacturing and commercializing products utilizing its proprietary modified-release drug delivery technology platforms.

(1) Centers for Disease Control. Attention-Deficit/Hyperactivity Disorder (ADHD). http://www.cdc.gov/ncbddd/adhd/facts.html Accessed July 27, 2016.

(2) American Psychiatric Association. (2013) Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Arlington, VA.

(3) Chew RH, Hales RE, Yudofsky SC: What Your Patients Need to Know About Psychiatric Medications, Second Edition. Washington, DC, American Psychiatric Publishing, 2009

(4) Tussionex® is a registered trademark of the UCB Group of Companies

1

Adzenys XR-ODT™ is the first and only commercially available amphetamine extended-release orally disintegrating tablet for the treatment of ADHD. Neos has two other branded product candidates in development, an XR-ODT of methylphenidate and a liquid suspension of amphetamine for the treatment of ADHD. In addition, Neos manufactures and markets its generic equivalent of the branded product Tussionex®(4), an XR liquid suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.

Special Note Regarding Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning the clinical development, regulatory approval and the therapeutic potential of Cotempla XR-ODT and other products and product candidates. Forward-looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. These forward-looking statements reflect our current views about our expectations, strategy, plans, prospects or intentions, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, our ability to successfully address the deficiencies identified by the FDA or which may be identified by the FDA which preclude approval of the NDA for our Cotempla XR-ODT product candidate, the receipt of regulatory approval for our product candidates and other risks set forth under the caption “Risk Factors” in our most recently filed Annual Report on Form 10-K as updated by our subsequently filed other SEC filings, including our Quarterly Report(s) on Form 10-Q. We assume no obligation to update any forward-looking statements contained in this document 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

David Carey

Investor Relations

Lazar Partners

(212) 867-1768

dcarey@lazarpartners.com

2