- New commercial strategy including optimized salesforce structure, new distribution network and focus on improving net margins expected to accelerate path to profitability –
- Company to host conference call today at 8:30am ET -
DALLAS and FORT WORTH, Texas, March 14, 2019 (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 reported financial results for the fourth quarter and full year ended December 31, 2018 and provided a business update.
“In late November 2018, we unveiled a new commercial strategy for the company that includes an optimized salesforce structure, territory realignment and expanded distribution network with a goal of increasing net margins and increasing market share for our ADHD product portfolio. We believe that this new strategy will drive the continued growth of our ADHD business and accelerate our path to profitability. This, coupled with a focus on growing our development pipeline using our proprietary microparticle technology, will create value for our stakeholders,” said Jerry McLaughlin, Chief Executive Officer of Neos Therapeutics. “We look forward to continuing to execute on this new strategy as we help more patients living with ADHD and advance toward becoming cash self-sufficient while also exploring opportunities within and beyond our current core focus in ADHD.”
Commercial Product Highlights
Neos’ three commercial attention deficit hyperactivity disorder (ADHD) products are Adzenys XR-ODT®, Cotempla XR-ODT® and Adzenys ER®, which launched in May 2016, September 2017 and February 2018, respectively. Continued growth in prescription trends for Adzenys XR-ODT and Cotempla XR-ODT builds momentum for the Neos ADHD product franchise.
Cumulative TRx (4Q18) | Cumulative TRx (4Q17) | Year-over- year increase | Patients switching from another medication (4Q18) | |||||
Adzenys XR-ODT® | 64,939 | 54,802 | 18 | % | 64 | % | ||
Cotempla XR-ODT® | 45,080 | 8,797 | 412 | % | 64 | % |
* As reported by IQVIA
Additional Commercial Product Highlights
Corporate Updates
Select Financial Results for the Fourth Quarter Ended December 31, 2018
Q4 2018 | Q4 2017 | % Change | FY 2018 | FY 2017 | % Change | |||||||||
Adzenys XR-ODT | $8.1MM | $7.5MM | 8.0 | % | $26.6MM | $20.4MM | 30.4 | % | ||||||
Cotempla XR- ODT | $6.1MM | $1.1MM | 454.5 | % | $19.0MM | $1.6MM | 1,087.5 | % | ||||||
Generic Tussionex | $1.4MM | $0.6MM | 133.3 | % | $4.3MM | $5.2MM | (17.3) | % | ||||||
Total | $15.4MM | $9.2MM | 67.4 | % | $50.0MM | $27.1MM | 84.5 | % | ||||||
*Adzenys ER revenue was negligible in Q4 and FY 2018 | ||||||||||||||
Conference Call Details
Neos management will host a conference call and live audio webcast to discuss results and provide a company update at 8:30 a.m. ET today. The live call may be accessed by dialing (877) 388-8985 for domestic calls, or +1 (562) 912-2654 for international callers, and referencing conference ID number 3293884. A live audio webcast for the conference call will be available on the Investor Relations page of the Company’s website at http://investors.neostx.com/.
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
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning the commercialization of Adzenys XR-ODT, Cotempla XR-ODT™ and Adzenys ER, the prescription growth for our products, our marketing plans, the therapeutic potential of our products, the strategic expansion of our product pipeline and commercial product portfolio, the research and development plan for our potential product candidates, including licensed product candidates, the terms of our amended senior debt facility, our financial position and cash runway, and the growth and profitability of our business. 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 market and sell our products, the inherent uncertainty of drug research and development and commercialization, that we may use our cash resources more quickly than anticipated, 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.
Neos Therapeutics, Inc. and Subsidiaries CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data) | ||||||
December 31, | ||||||
2018 | 2017 (as adjusted) | |||||
ASSETS Current Assets: | ||||||
Cash and cash equivalents | $46,478 | $31,969 | ||||
Short‑term investments | — | 18,448 | ||||
Accounts receivable, net of allowances for charge backs and cash discounts of $1,865 and $1,154, respectively | 27,801 | 13,671 | ||||
Inventories | 10,367 | 11,732 | ||||
Other current assets | 4,032 | 3,575 | ||||
Total current assets | 88,678 | 79,395 | ||||
Property and equipment, net | 7,914 | 8,203 | ||||
Intangible assets, net | 14,616 | 16,348 | ||||
Other assets | 149 | 162 | ||||
Total assets | $111,357 | $104,108 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
Current Liabilities: | ||||||
Accounts payable | $12,730 | $11,460 | ||||
Accrued expenses | 35,818 | 20,944 | ||||
Current portion of long‑term debt | 8,557 | 896 | ||||
Total current liabilities | 57,105 | 33,300 | ||||
Long‑Term Liabilities: | ||||||
Long‑term debt, net of current portion | 43,217 | 58,938 | ||||
Derivative liability | 2,017 | 1,660 | ||||
Deferred rent | 989 | 1,083 | ||||
Other long-term liabilities | 184 | 180 | ||||
Total long‑term liabilities | 46,407 | 61,861 | ||||
Stockholders’ Equity (Deficit): | ||||||
Preferred stock, $0.001 par value, 5,000,000 shares authorized, no shares issued or outstanding at December 31, 2018 and December 31, 2017 | — | — | ||||
Common stock, $0.001 par value, 100,000,000 authorized at December 31, 2018 and December 31, 2017; 49,710,104 and 49,676,303 issued and outstanding, respectively, at December 31, 2018; 29,030,757 and 28,996,956 issued and outstanding, respectively, at December 31, 2017 | 50 | 29 | ||||
Treasury stock, at cost, 33,801 shares at December 31, 2018 and December 31, 2017 | (352) | (352) | ||||
Additional paid‑in capital | 325,130 | 274,584 | ||||
Accumulated deficit | (316,983) | (265,308) | ||||
Accumulated other comprehensive loss | — | (6) | ||||
Total stockholders’ equity | 7,845 | 8,947 | ||||
Total liabilities and stockholders’ equity | $111,357 | $104,108 | ||||
Neos Therapeutics, Inc. and Subsidiaries CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except share and per share data) | ||||||||||||
Three Months Ended December 31, | Year Ended December 31, | |||||||||||
2018 | 2017 (as adjusted) | 2018 | 2017 (as adjusted) | |||||||||
Revenues: | ||||||||||||
Net product sales | $ | 15,393 | $ | 9,222 | $ | 49,988 | $ | 27,132 | ||||
Cost of goods sold | 7,762 | 3,640 | 26,928 | 14,030 | ||||||||
Gross profit | 7,631 | 5,582 | 23,060 | 13,102 | ||||||||
Research and development | 2,399 | 1,784 | 8,508 | 8,957 | ||||||||
Selling and marketing expenses | 9,140 | 11,851 | 44,133 | 46,881 | ||||||||
General and administrative expenses | 3,328 | 3,039 | 13,915 | 13,805 | ||||||||
Loss from operations | (7,236 | ) | (11,092 | ) | (43,496 | ) | (56,541 | ) | ||||
Interest expense | (2,262 | ) | (2,836 | ) | (8,974 | ) | (10,085 | ) | ||||
Other income, net | 161 | 276 | 795 | 854 | ||||||||
Net loss | $ | (9,337 | ) | $ | (13,652 | ) | $ | (51,675 | ) | $ | (65,772 | ) |
Weighted average common shares outstanding used to compute net loss per share, basic and diluted | 41,415,358 | 28,746,608 | 32,288,555 | 24,751,091 | ||||||||
Net loss per share of common stock, basic and diluted | $ | (0.23 | ) | $ | (0.47 | ) | $ | (1.60 | ) | $ | (2.66 | ) |
Contacts:
Richard Eisenstadt
Chief Financial Officer
Neos Therapeutics
(972) 408-1389
reisenstadt@neostx.com
Sarah McCabe
Stern Investor Relations, Inc.
(212) 362-1200
sarah@sternir.com