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): February 2, 2017
NEOS THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
|
Delaware |
|
001-37508 |
|
27-0395455 |
|
(State or other jurisdiction of |
|
(Commission File Number) |
|
(I.R.S. Employer |
|
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 2.02. Results of Operations and Financial Condition.
The information contained in the section titled “Financial Update” under Item 8.01 of this Form 8-K is hereby incorporated into this Item 2.02 by reference.
Pursuant to General Instruction B.2. to Form 8-K, the information set forth in this Item 2.02 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 incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01. Other Events.
On February 2, 2017, the Company issued a press release announcing the commencement of an offering of its common stock (the “Offering”). A copy of this press release is filed as Exhibit 99.1 to this Form 8-K.
On February 2, 2017, in connection with the Offering, the Company filed a preliminary prospectus supplement to the base prospectus included in the Company’s shelf registration statement on Form S-3 (No. 333-212809), filed with the SEC on August 1, 2016 and declared effective by the SEC on August 12, 2016. The preliminary prospectus supplement describes certain elements of the Company’s business strategy and certain recent developments, including those set forth below.
Recent Developments
ADHD market and Adzenys XR-ODT update
In 2016, 70.4 million prescriptions for medications with ADHD labeling were written in the United States, representing a 5.6% annual increase in prescriptions from 2015, and generated $10.4 billion in sales. Approximately 92% of these prescriptions were for stimulant medications, such as methylphenidate and amphetamine, which have been the standard of care for several decades. Methylphenidate and amphetamine prescriptions generated $3.4 billion and $5.7 billion in sales, respectively, in 2016 in the United States. A few non-stimulant medications are also available, but evidence of their efficacy for treating ADHD symptoms is less compelling. The market for ADHD medications outside of the United States is less developed, but the Company believes will continue to grow as recognition and awareness of the disorder increase.
With respect to Adzenys XR-ODT, monthly prescriptions filled have continued to increase since its commercial launch on May 16, 2016. Based on data from QuintilesIMS, a total of 35,059 prescriptions for Adzenys XR-ODT were filled for the period from its commercial launch through January 20, 2017.
Financial Update
The Company’s cash, cash equivalents and short-term investments was approximately $39.8 million at December 31, 2016, as compared to $90.8 million at December 31, 2015. In addition, the Company estimates that, for the three months ended December 31, 2016, total net product revenues were between $3.3 million and $3.6 million, an increase of 94% to 112% compared to $1.7 million for the three months ended December 31, 2015 and an increase of 106% to 125% compared to $1.6 million for the three months ended September 30, 2016. This change was primarily driven by net sales of the Company’s Adzenys XR-ODT product during the three months ended December 31, 2016 of between $2.0 million and $2.2 million as compared to $0.7 million for the three months ended September 30, 2016 as well as an increase in net sales of the Company’s generic Tussionex product during the three months ended December 31, 2016 of between $1.3 million and $1.4 million as compared to $0.9 million for the three months ended September 30, 2016.
This financial data as of and for the three months ended December 31, 2016 is preliminary and may change, and is based on information available to the Company’s management as of the date hereof and is subject to
completion by management of the Company’s financial statements as of and for the quarter and year ended December 31, 2016. The Company has provided ranges for preliminary revenues described above primarily because its financial closing procedures for the quarter ended December 31, 2016 are not yet complete. There can be no assurance that the Company’s final revenues for this period or cash position as of December 31, 2016 will not differ from these estimates, including as a result of year-end closing and audit procedures or review adjustments and any such changes could be material. In addition, the Company is not able to provide a range of operating or net loss at this time. Accordingly, you should not draw any conclusions as to the Company’s profitability based on the foregoing estimates. The preliminary results of operations for the quarter ended December 31, 2016 are not necessarily indicative of the results to be achieved for any future period.
The Company’s independent registered public accountants have not audited, reviewed or performed any procedures with respect to such preliminary financial data and accordingly do not express an opinion or any other form of assurance with respect thereto. These results could change as a result of further review. Complete quarterly results will be announced during the Company’s fourth quarter and 2016 year end financial results conference call and included in its Annual Report on Form 10-K for the year ended December 31, 2016.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
|
Exhibit |
|
Description |
|
|
|
|
|
99.1 |
|
Press release dated February 2, 2017 |
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: February 2, 2017 |
NEOS THERAPEUTICS, INC. | ||
|
|
|
| |
|
|
By: |
/s/ Vipin Garg | |
|
|
|
Vipin Garg | |
|
|
|
President and Chief Executive Officer | |
Exhibit 99.1
Neos Therapeutics Announces Proposed Offering of Common Stock
Dallas/Fort Worth, TX (February 2, 2017) — 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 commenced an underwritten public offering of its common stock. In addition, Neos expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering. This offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Cowen and Company and BMO Capital Markets are acting as joint book-running managers for the offering.
The shares of common stock are offered pursuant to a shelf registration statement on Form S-3 (File No. 333-212809), including a base prospectus, filed by Neos on August 1, 2016 and declared effective by the Securities and Exchange Commission, or the SEC, on August 12, 2016. The offering will be made only by means of a prospectus. A preliminary prospectus supplement related to the offering and a final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or by calling 631-274-2806, or by faxing 631-254-7140; or BMO Capital Markets Corp., 3 Times Square, New York, NY 10036, Attention: Equity Syndicate Department, or by calling (800) 414-3627, Email: bmoprospectus@bmo.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.
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. Adzenys XR-ODTTM, indicated for the treatment of ADHD in patients 6 years of age and older, is the first approved product using the Company’s extended-release (XR)-orally disintegrating tablet (ODT) technology platform. Neos, which is initially focusing on the treatment of ADHD, has filed New Drug Applications with the U.S. Food and Drug Administration for two other branded product candidates that are XR medications in ODT or oral suspension dosage forms. In addition, Neos manufactures and markets its generic equivalent of the branded product Tussionex®, an XR oral suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Neos Therapeutics, Inc., including statements about Neos’ anticipated public offering, future expectations, plans and prospects for the Company and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “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 market conditions and the completion of the public offering on the anticipated terms or at all, uncertainties inherent in the initiation of future clinical trials, expectations of expanding ongoing clinical trials and other factors discussed in the “Risk Factors” section of Neos’ Annual Report on Form 10-K for the year ended December 31, 2015, which is on file with the SEC, as updated by any subsequently filed SEC filings, including Neos’ Quarterly Reports on Form 10-Q, and the “Risk Factors” section of Neos’ prospectus supplement and accompanying prospectus related to this public offering. Any forward-looking statements contained 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.
Contact:
Richard Eisenstadt
Chief Financial Officer
Neos Therapeutics
(972) 408-1389
reisenstadt@neostx.com
Sarah McCabe
Vice President
Stern Investor Relations, Inc.
(212) 362-1200
sarah@sternir.com