Launch of Adzenys XR-ODT in Second Quarter of 2016
Company to Host Conference Call at 8:30am ET Today
DALLAS/FORT WORTH, Texas, March 17, 2016 (GLOBE NEWSWIRE) -- 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 financial results for the fourth quarter and 2015 fiscal year ended December 31, 2015.
“The past fifteen months have been incredibly exciting for Neos Therapeutics as we have worked towards our goal of providing more patient- and caregiver-friendly dosing options for the treatment of ADHD. With the January 2016 FDA approval of our first branded product, Adzenys XR-ODT, patients with ADHD will soon have access to the first and only extended-release orally disintegrating tablet (ODT) for the treatment of their condition,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. “This year, in addition to our launch of Adzenys XR-ODT, we are actively working to advance our late-stage product pipeline. If approved, these products would provide clinicians with a portfolio of treatment options for patients suffering from ADHD.”
2016 Milestones
- Initiate full field force launch of Adzenys XR-ODT in the second quarter of 2016.
- Announce results of bioequivalence study for Cotempla XR-ODT, the Company’s methylphenidate extended-release orally disintegrating tablet, in the third quarter of 2016.
- Resubmit the New Drug Application (NDA) for Cotempla XR‑ODT in the fourth quarter of 2016.
- Submit the NDA for NT‑0201, the Company’s amphetamine XR liquid suspension in the fourth quarter of 2016.
Select Financial Results for the Fourth Quarter Ended December 31, 2015
Total revenues were $1.7 million for the three months ended December 31, 2015, an increase of $1.2 million compared to the three months ended December 31, 2014. All $1.7 million of revenue was generated from net sales of the Company’s generic Tussionex.
Cost of goods sold was $1.7 million for the three months ended December 31, 2015, an increase of $585,000 compared to the three months ended December 31, 2014 due to the increase in Tussionex sales.
Research and development expenses were $2.8 million for the three months ended December 31, 2015, an increase of $358,000 compared to the three months ended December 31, 2014.
Selling and marketing expenses were $3.2 million for the three months ended December 31, 2015, compared to $95,000 for the three months ended December 31, 2014. The increase was primarily due to pre‑commercialization activities for Adzenys XR-ODT and increased salary expense associated with building out the commercial team.
General and administrative expenses were $2.4 million for the three months ended December 31, 2015, an increase of $1.5 million for the three months ended December 31, 2014 due to an increase in share‑based compensation and other professional fees.
The Company reported a net loss of $9.1 million in the three months ended December 31, 2015, compared with $4.9 million for the same period in 2014.
Select Financial Results for the Fiscal Year Ended December 31, 2015
Total revenues were $3.8 million for the year ended December 31, 2015, an increase of $3.0 million compared to the year ended December 31, 2014. All $3.8 million of revenue was generated from net sales of the Company’s generic Tussionex.
Cost of goods sold was $5.5 million for the year ended December 31, 2015, an increase of $2.2 million compared to the year ended December 31, 2014. This increase was primarily due to increased sales of Tussionex.
Research and development expenses were $11.9 million for the year ended December 31, 2015, an increase of $1.3 million as compared to the year ended December 31, 2014. This increase was primarily due to the FDA filing fee for the NDA of Cotempla XR-ODT submitted in January 2015.
Selling and marketing expenses were $5.5 million for the year ended December 31, 2015, compared to $212,000 for the year ended December 31, 2014. The increase was primarily due to pre‑commercialization activities for Adzenys XR-ODT and the Cotempla XR-ODT product candidate and increased salary expense associated with building out the commercial team.
General and administrative expenses were $7.5 million for the year ended December 31, 2015, an increase of $2.4 million from $5.1 million for the year ended December 31, 2014 due to an increase in share‑based compensation and other professional fees.
The Company reported a net loss of $30.8 million in the year ended December 31, 2015 compared with $20.8 million for the same period in 2014.
At December 31, 2015, the Company's cash, cash equivalents and short term investments amounted to $90.8 million.
Conference Call Details
Neos Therapeutics will host a conference call at 8:30 a.m. ET today, March 17, 2016, to discuss the Company’s 2015 fourth quarter and full year 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 67016685. 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.
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. The Company recently received FDA approval of Adzenys XR-ODT™ - the first and only FDA-approved 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®1, an XR liquid suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.
1Tussionex® is a registered trademark of the UCB Group of Companies
Forward-Looking Statements
This press release contains forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 launch Adzenys XR-ODTTM, 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-ODTTM 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-0201, 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.
Financial Tables Follow
| Neos Therapeutics, Inc. and Subsidiaries | |||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||
| (UNAUDITED) | |||||||||||
| December 31, | |||||||||||
| In thousands, except share and per share data | 2015 | 2014 | |||||||||
| ASSETS | |||||||||||
| Current Assets: | |||||||||||
| Cash and cash equivalents | $ | 90,763 | $ | 13,343 | |||||||
| Short term investments | - | 3,000 | |||||||||
| Accounts receivable, net of allowances of $1,039 and $204, respectively | 3,903 | 367 | |||||||||
| Inventories | 2,520 | 2,031 | |||||||||
| Other current assets | 1,058 | 264 | |||||||||
| Total current assets | 98,244 | 19,005 | |||||||||
| Property and equipment, net | 5,124 | 5,831 | |||||||||
| Intangible assets, net | 16,672 | 18,167 | |||||||||
| Other assets | 2,470 | 2,227 | |||||||||
| Total assets | $ | 122,510 | $ | 45,230 | |||||||
| LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY/(DEFICIT) | |||||||||||
| Current Liabilities: | |||||||||||
| Accounts payable | $ | 4,824 | $ | 1,257 | |||||||
| Accrued expenses | 3,141 | 2,715 | |||||||||
| Current portion of long-term debt | 7,973 | 1,653 | |||||||||
| Total current liabilities | 15,938 | 5,625 | |||||||||
| Long-Term Liabilities: | |||||||||||
| Long-term debt, net of current portion | 26,271 | 23,121 | |||||||||
| Earnout liability | 214 | 756 | |||||||||
| Deferred gain on leaseback | 547 | 1,383 | |||||||||
| Deferred rent | 1,166 | 1,189 | |||||||||
| Warrant liabilities | - | 1,789 | |||||||||
| Total long-term liabilities | 28,198 | 28,238 | |||||||||
| Redeemable Preferred Stock | |||||||||||
| Redeemable Preferred Stock (Series A, B, B-1 and C), $0.001 par value; 27,500,000 authorized, 18,498,448 issued and 15,011,927 outstanding at December 31, 2014; aggregate liquidation preference of $126,830 at December 31, 2014 | - | 90,149 | |||||||||
| Stockholders' Equity (Deficit): | |||||||||||
| Preferred stock, $0.001 par value, 5,000,000 shares authorized, no shares issued or outstanding at December 31, 2015, no shares authorized, issued or outstanding at December 31, 2014 | - | - | |||||||||
| Common stock, $0.001 par value, 100,000,000 and 35,000,000, authorized at December 31, 2015 and 2014, respectively; 16,025,155 and 16,015,958 issued and outstanding, respectively, at December 31, 2015; 938,859 and 882,954 issued and outstanding at December 31, 2014, respectively | 16 | 1 | |||||||||
| Treasury stock, at cost, 9,197 and 55,905 shares at December 31, 2015 and 2014, respectively | (171 | ) | - | ||||||||
| Additional paid-in capital | 195,314 | 4,831 | |||||||||
| Accumulated deficit | (116,785 | ) | (83,614 | ) | |||||||
| Total stockholders' equity (deficit) | 78,374 | (78,782 | ) | ||||||||
| Total liabilities, redeemable preferred stock and stockholders’ equity (deficit) | $ | 122,510 | $ | 45,230 | |||||||
| Neos Therapeutics, Inc. and Subsidiaries | ||||||||||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | ||||||||||||||||||||||||
| For the Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||||||||||
| In thousands, except share and per share amounts | 2015 | 2014 | 2015 | 2014 | ||||||||||||||||||||
| Revenues: | ||||||||||||||||||||||||
| Product | $ | 1,659 | $ | 436 | $ | 3,792 | $ | 316 | ||||||||||||||||
| Manufacturing | - | - | - | 113 | ||||||||||||||||||||
| Profit Sharing | - | - | - | 169 | ||||||||||||||||||||
| Development | - | - | - | 160 | ||||||||||||||||||||
| 1,659 | 436 | 3,792 | 758 | |||||||||||||||||||||
| Cost of Goods Sold | 1,714 | 1,129 | 5,547 | 3,354 | ||||||||||||||||||||
| Gross loss | (55 | ) | (693 | ) | (1,755 | ) | (2,596 | ) | ||||||||||||||||
| Research and Development | 2,764 | 2,406 | 11,887 | 10,601 | ||||||||||||||||||||
| Selling and marketing expenses | 3,191 | 95 | 5,462 | 212 | ||||||||||||||||||||
| General and administrative expenses | 2,405 | 867 | 7,474 | 5,063 | ||||||||||||||||||||
| Loss from operations | (8,415 | ) | (4,061 | ) | (26,578 | ) | (18,472 | ) | ||||||||||||||||
| Interest Expense | (1,036 | ) | (755 | ) | (3,721 | ) | (2,954 | ) | ||||||||||||||||
| Other Income, net | 208 | 208 | 831 | 826 | ||||||||||||||||||||
| Change in fair value of earnout and warrant liabilities | 139 | (249 | ) | (1,313 | ) | (249 | ) | |||||||||||||||||
| Net loss | (9,104 | ) | (4,857 | ) | (30,781 | ) | (20,849 | ) | ||||||||||||||||
| Preferred Stock Accretion to Redemption Value | - | (268 | ) | (1,169 | ) | (1,118 | ) | |||||||||||||||||
| Preferred Stock Dividends | - | (551 | ) | (1,221 | ) | (2,185 | ) | |||||||||||||||||
| Net loss attributable to common stock | $ | (9,104 | ) | $ | (5,676 | ) | $ | (33,171 | ) | $ | (24,152 | ) | ||||||||||||
| Weighted average common shares outstanding used to compute net loss per share, basic and diluted | 15,933,315 | 881,309 | 7,581,881 | 876,318 | ||||||||||||||||||||
| Net loss per share attributable to common stock | $ | (0.57 | ) | $ | (6.44 | ) | $ | (4.38 | ) | $ | (27.56 | ) | ||||||||||||