Form 8-K Neos Therapeutics, Inc. For: Nov 10

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

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)

Item 2.02. Results of Operations and Financial Condition.

On November 10, 2015, Neos Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended September 30, 2015. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.

On January 9, 2015, the Company submitted to the U.S. Food and Drug Administration (the “FDA”) a New Drug Application (the “NDA”) under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for Cotempla XR-ODT™ (Methylphenidate Extended Release Orally Disintegrating), 10 mg, 20 mg, and 30 mg tablets.  As previously disclosed, on October 16, 2015, the Company received a notification from the FDA stating that, as part of its ongoing review of the Company’s NDA, the FDA had identified deficiencies that precluded discussion of labeling and postmarketing requirements/commitments at that time.

On November 10, 2015, the Company issued a press release announcing that it received a complete response letter from the FDA for the Company’s NDA. A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated into this Item 8.01 by reference.

By filing this information, the Company makes no admission as to the materiality of any information in this report.  The information contained in this report is intended to be considered in the context of the Company’s filings with the U.S. Securities and Exchange Commission (the “Commission”) and other public announcements that the Company makes, by press release or otherwise, from time to time.  The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate.  Any such updating may be made through the filing of other reports or documents with the Commission, through press releases or through other public disclosure.

This report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements concerning our ability to commercialize Cotempla XR-ODT and the PDUFA date for our product candidates. Forward-looking statements generally relate to future events or our future financial or operating performance.  Any statements contained herein which do not describe historical facts, including but not limited to statements regarding the Company’s expectations with regard to discussions with the FDA, plans, and expectations as to the PDUFA date are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.

Such risks and uncertainties include, without limitation, any deficiencies the FDA may identify with respect to Cotempla XR-ODT and whether the Company will be able to address the issues that may relate to those deficiencies, the receipt of regulatory approval for Cotempla XR-ODT and the Company’s other product candidates

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for the treatment of attention deficit disorder (“ADHD”), the Company’s ability to market and sell its product candidates, the Company’s ability to successfully compete in the market for medications indicated for ADHD, the manufacture of Cotempla XR-ODT or its other product candidates, and other risks set forth under the caption “Risk Factors” in the Company’s final prospectus filed on July 24, 2015 pursuant to Rule 424(b) of the Securities Act of 1933, as amended, as updated by its subsequently filed Quarterly Reports on Form 10-Q and its other SEC filings. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits:

The following exhibit relating to Item 2.02 and 8.01 shall be deemed furnished, and not filed:

99.1 Press Release dated November 10, 2015.

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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.

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EXHIBIT INDEX

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Exhibit 99.1

Neos Therapeutics Receives Complete Response Letter from the FDA for Cotempla XR-ODT

Company Announces Financial Results for the Third Quarter Ended September 30, 2015

Conference call scheduled for November 11, 2015 at 8:30am ET

Dallas/Fort Worth, TX (November 10, 2015) — Neos Therapeutics, Inc. (Nasdaq: NEOS), a pharmaceutical company with a late-stage pipeline of innovative extended-release (XR) product candidates for the treatment of attention deficit hyperactivity disorder (ADHD), today announced that the Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for Cotempla XR-ODT™ (Methylphenidate Extended Release Orally Disintegrating) 10mg, 20mg, and 30mg tablets.  Neos Therapeutics also announced financial results for the third quarter ended September 30, 2015.

Complete Response Letter from the FDA for Cotempla XR-ODT

As the Company previously disclosed, the Company was informed on October 16, 2015 that the FDA had identified unspecified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments, and had set November 9, 2015 as the Prescription Drug User Fee Act (PDUFA) goal date for a decision on the NDA.

A CRL is issued by the FDA’s Center for Drug Evaluation and Research when it has completed its review of an NDA and questions remain that preclude the approval of the NDA in its current form. The CRL for Cotempla XR-ODT™ requires the Company to conduct a bridging study to demonstrate bioequivalence between the clinical trial material and to-be-marketed drug product, including an assessment of food effect, and to provide validation and three months of stability data.  The FDA did not raise any safety or efficacy issues with the clinical data previously provided beyond the need for an adequate bridge between the clinical trial material and the to-be-marketed drug product.

“We remain committed to commercializing Cotempla XR-ODT™ and will work closely with the FDA to address the deficiencies identified in the CRL,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. “We have a strong cash position and remain on track with the development of our other lead product candidate, NT-0202. Assuming a positive decision from the FDA surrounding our January 27, 2016 PDUFA date, we plan to accelerate commercialization of NT-0202 from the third quarter of 2016 to the second quarter of 2016.”

NT-0202, Neos’ amphetamine XR-ODT product candidate for the treatment of ADHD, currently has a PDUFA goal date of January 27, 2016 as set by the FDA. Neos also manufactures and markets a generic equivalent to the branded product Tussionex®(1).

Select Financial Results for the Third Quarter Ended September 30, 2015

Total revenues were $221,000 for the three months ended September 30, 2015, an increase of $246,000 compared to the three months ended September 30, 2014.  All $221,000 of revenue was generated from net sales of the Company’s generic Tussionex.  Commercialization and profit rights for this product were acquired in August 2014.

Cost of goods sold was $1.1 million for the three months ended September 30, 2015, an increase of $297,000 compared to the three months ended September 30, 2014.  This increase was primarily due to $200,000 amortization of intangible assets resulting from the acquisition of the rights to commercialize and derive future profits from the Company’s generic Tussionex and a $100,000 increase in other cost related to the Company’s generic Tussionex.

Research and development expenses were unchanged at $2.7 million for the three months ended September 30, 2015.

Selling and marketing expenses were $1.3 million for the three months ended September 30, 2015, compared to $100,000 for the three months ended September 30, 2014.  The increase was primarily due to pre-commercialization activities for the NT-0102 and NT-0202 product candidates and increased salary expense associated with building out the commercial team.

General and administrative expenses were $2.1 million for the three months ended September 30, 2015, an increase of $800,000 from $1.3 million for the three months ended September 30, 2014 due to an increase in share-based compensation and other professional fees.

The Company reported a net loss of $9.4 million in the three months ended September 30, 2015 compared with $5.2 million for the same period in 2014.

At September 30, 2015, the Company’s cash, cash equivalents and investments amounted to $102.9 million.

Conference Call Details

Neos Therapeutics will host a conference call at 8:30 a.m. ET tomorrow, November 11, 2015 to discuss the CRL regarding the Company’s NDA for Cotempla XR-ODT™ and the Company’s 2015 third quarter financial results. To access the call, dial 866-842-7969 (U.S.) or 704-908-0466 (outside of the U.S.). The Conference ID is 79118263. A live webcast will be available on the Investor Relations page of the company’s website at http://investors.neostx.com/. Please log in approximately 5-10 minutes prior to the scheduled start time.

The archived webcast will be available on the company’s Investor Relations page under Presentations.

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

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 platform.  The Company is initially focusing on the treatment of ADHD and has developed three branded product candidates that are XR medications in patient-friendly ODT or liquid suspension dosage forms.  In addition, Neos Therapeutics manufactures and markets its generic equivalent of the branded product Tussionex, an XR liquid suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.

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 our ability to commercialize Cotempla XR-ODT™ and the PDUFA date for NT-0202 and capabilities of our XR-ODT 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, prospects 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, including that we demonstrate bioequivalence between the clinical trial material and to-be-marketed drug product and that we assess the food effect on the to-be-marketed drug product, the receipt of regulatory approval for NT-0202, our ability to market and sell our product candidates, and other risks set forth under the caption “Risk Factors” in our final prospectus filed on July 24, 2015 pursuant to Rule 424(b) of the Securities Act of 1933, as amended, as updated by our subsequently filed Quarterly Reports on Form 10-Q and our other SEC filings. We assume no obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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Financial Tables Follow

Neos Therapeutics, Inc. and Subsidiaries

CONDENSED CONSOLIDATED BALANCE SHEETS

Neos Therapeutics, Inc. and Subsidiaries
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

CONTACTS:

Richard I. Eisenstadt, Chief Financial Officer

Neos Therapeutics

(972) 408-1389

[email protected]

David Carey, Investor Relations

Lazar Partners

(212) 867-1768

[email protected]