DALLAS and FORT WORTH, Texas, May 09, 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 first quarter ended March 31, 2019 and provided a business update.

“We continued to make solid progress as we execute our new commercial strategy for our ADHD product portfolio. Throughout the first quarter, we realized improvements in net revenue per pack, primarily driven by our focus on more profitable business channels and market segments,” said Jerry McLaughlin, President and Chief Executive Officer. “Additionally, we implemented a number of new initiatives designed to foster the long-term growth of our business. We expect to demonstrate the impact of these cumulative strategies with continued increases in net revenue per pack, growth in prescription volume and increased market share in our target prescriber base during the second half of 2019. Turning to our pipeline, we have advanced the IND-enabling studies for NT0502, our product candidate for the treatment of sialorrhea, and anticipate commencing a Phase 1 clinical trial for this molecule in the first half of 2020.”

Recent Corporate Highlights

 Prescriptions*Net Revenue per Pack
  Q1 2019 Q1 2018%
Change		 Q1 2019 Q1 2018%
Change
Adzenys XR-ODT®58,75754,4957.8%$109$8626.7%
Cotempla XR-ODT®41,19828,94742.3%$102$7045.7%

* As reported by IQVIA                

Select Financial Results for the First Quarter Ended March 31, 2019

 Q1 2019Q1 2018% Change
Adzenys XR-ODT$6.7MM$5.0MM34%
Cotempla XR-ODT$5.8MM$3.6MM61%
Generic Tussionex$2.0MM$1.9MM5%
Total$14.6MM$10.7MM36%

*Adzenys ER revenue was negligible in Q1 2019 and 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 (562) 912-2654 for international callers, and referencing conference ID number 5799342. 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/. Following the conclusion of the call, the webcast will be available for replay for 30 days.

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

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, commercial products, including the intended benefits of the Company’s new initiatives to foster the long-term growth of its business, clinical development of its therapeutic candidates, including its development plans for its product candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “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 net sales, profitability, and growth of the Company’s commercial products, including whether the Company will realize improvements in net revenue per pack, prescription volume and market share in the Company’s target prescribed base during the second half of 2019, whether other initiatives will foster the long-term growth of the business, or whether the RxConnect program will expand to additional pharmacies throughout 2019; the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials, including whether the Company will be able to commence a Phase 1 clinical trial of NT0502 in the first half of 2020; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals; availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company’s intellectual property; other matters that could affect the availability or commercial potential of the Company’s commercial products or therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

Neos Therapeutics, Inc. and Subsidiaries
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
(unaudited)

  March 31, December 31,
  2019
 2018
ASSETS    
Current Assets:    
Cash and cash equivalents $32,760  $46,478 
Short-term investments  7,205   — 
Accounts receivable, net of allowances for chargebacks and cash discounts of $2,164 and $1,865, respectively 23,222  27,801 
Inventories 11,276  10,367 
Other current assets 2,555  4,032 
Total current assets 77,018  88,678 
     
Property and equipment, net 7,532  7,914 
Operating lease right-of-use assets 3,381  — 
Intangible assets, net 14,016  14,616 
Other assets 149  149 
     
Total assets $102,096  $111,357 
     
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)    
     
Current Liabilities:    
Accounts payable $8,552  $12,730 
Accrued expenses 34,118  35,818 
Current portion of operating lease liabilities 571  — 
Current portion of long-term debt 8,615  8,557 
     
Total current liabilities 51,856  57,105 
     
Long-Term Liabilities:    
Long-term debt, net of current portion 43,266  43,217 
Operating lease liabilities 3,775  — 
Derivative liability 1,888  2,017 
Deferred rent —  989 
Other long-term liabilities 183  184 
     
Total long-term liabilities 49,112  46,407 
     
Stockholders’ Equity (Deficit):    
Preferred stock, $0.001 par value, 5,000,000 shares authorized, no shares issued or outstanding at March 31, 2019 and December 31, 2018 —  — 
Common stock, $0.001 par value, 100,000,000 authorized at March 31, 2019 and December 31, 2018; 49,756,317 and 49,722,516 issued and outstanding, respectively, at March 31, 2019; 49,710,104 and 49,676,303 issued and outstanding, respectively, at December 31, 2018 50  50 
Treasury stock, at cost, 33,801 shares at March 31, 2019 and December 31, 2018 (352) (352)
Additional paid-in capital 326,014  325,130 
Accumulated deficit (324,583) (316,983)
Accumulated other comprehensive loss (1) — 
     
Total stockholders’ equity 1,128  7,845 
     
Total liabilities and stockholders’ equity $102,096  $111,357 
         
         

Neos Therapeutics, Inc. and Subsidiaries
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(unaudited)

  Three Months Ended
 March 31,		 
  2019 2018 
Revenues:     
Net product sales $14,634 $10,729 
      
Cost of goods sold 6,396 5,221 
Gross profit 8,238 5,508 
      
Research and development expenses 3,197 1,691 
Selling and marketing expenses 7,069 12,990 
General and administrative expenses 3,793 3,345 
      
Loss from operations (5,821)(12,518)
      
Interest expense (2,115)(2,220)
Other income, net 336 302 
      
Net loss $(7,600)$(14,436)
      
Weighted average common shares outstanding used to compute net loss per share, basic and diluted 49,703,563 28,996,956 
      
Net loss per share of common stock, basic and diluted $(0.15)$(0.50)
        

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