OREANDA-NEWS. Neos Therapeutics, Inc., a pharmaceutical company focused on developing and commercializing innovative extended-release (XR) products for the treatment of attention-deficit/hyperactivity disorder (ADHD), today announced the closing of a $60 million term loan from Deerfield Management. The Company also provided a business update and announced financial results for the first quarter ended March 31, 2016.

The Company intends to use the net proceeds from the debt financing, after repaying existing venture debt, to execute the launch of Adzenys XR-ODT that was announced this morning, as well as the potential launches in 2017 of the Company’s additional two ADHD products, if approved. Payments on the loan are interest-only for the first 36 months, and the principal is to be repaid in four equal annual installments of $15 million to be paid annually commencing in May 2019 and continuing through May 2022. There are no warrants or any other equity to be issued as part of this financing.

“We are thrilled to announce the commercial launch of Adzenys XR-ODT and the closing of the debt financing this morning,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics.  “Deerfield is a distinguished investment partner in healthcare, and we are pleased to have their support. This debt financing further strengthens our cash position and we believe it provides us with the financial resources to bring our entire suite of ADHD product candidates to the market.”

Upcoming Milestones

  • 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 First Quarter Ended March 31, 2016

Total revenues were $2.6 million for the three months ended March 31, 2016, an increase of $2.2 million compared to the three months ended March 31, 2015.  All $2.6 million of revenue was generated from net sales of the Company’s generic Tussionex.  The $2.2 million increase primarily resulted from sales to a large pharmacy chain in 2016, which was initiated in the second fiscal quarter of 2015.

Cost of goods sold was $2.3 million for the three months ended March 31, 2016, an increase of $1.2 million compared to the three months ended March 31, 2015, due to the increase in Tussionex sales. 

Research and development expenses were $2.3 million for the three months ended March 31, 2016, a decrease of $2.0 million compared to the three months ended March 31, 2015. This decrease was primarily due to the FDA filing fee submitted in January 2015 for Cotempla XR-ODT.

Selling and marketing expenses were $6.3 million for the three months ended March 31, 2016, compared to $326,000 for the three months ended March 31, 2015.  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 $3.5 million for the three months ended March 31, 2016, an increase of $2.2 million for the three months ended March 31, 2015 due to an increase in share?based compensation and costs associated with being a public company.

The Company reported a net loss of $12.6 million in the three months ended March 31, 2016, compared with $6.6 million for the same period in 2015.

At March 31, 2016, the Company's cash, cash equivalents and investments amounted to $76.1 million.