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 financial results for the second quarter ended June 30, 2016 and provided a business update.

“We are pleased with the steady increase in demand for Adzenys XR-ODT™ since the launch on May 16, 2016. We are receiving positive feedback from both physicians and patients, and adoption across multiple age groups has been encouraging. We anticipate increased demand for this product with the start of the new school year in August and September, as physicians often adjust or initiate ADHD medications when students return to school,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. “With the recent successful completion of our Cotempla XR-ODT™ bioequivalence bridging study, we look forward to pursuing FDA approval of our two additional late-stage product candidates for ADHD to ultimately provide patients and caregivers with a range of user friendly alternatives for the treatment of ADHD.”

Adzenys XR-ODT™ Launch Update

  • Prescriptions as reported by IMS for Adzenys XR-ODT from our May 16 product introduction through the end of June totaled 1,050.
  • Total prescriptions from launch through the week ended July 29, 2016 as reported by IMS are 2,548.
  • Prescriptions have continued to grow on a week over week basis. Prescriptions for Adzenys XR-ODT have grown by an average of 15.4% per week since the end of June, whereas over that same period, consistent with historical summer seasonality, IMS reported a decline of 0.5% in overall ADHD prescriptions.
  • The cumulative total number of prescribers of Adzenys XR-ODT as reported by IMS as of the week ended July 22, 2016 is 824. Of this total, 329 prescribers have written Adzenys XR-ODT prescriptions in multiple weeks.
  • To date, Adzenys XR-ODT has achieved managed care coverage with approximately 129 million lives covered by commercial providers.

Other Recent Highlights

  • In late July, the company announced the successful completion of bioequivalence bridging study for Cotempla XR-ODT™.
  • In May, Neos appointed Juergen Martens as Chief Technology and Operations Officer.

Upcoming 2016 Milestones

  • Resubmit the NDA for Cotempla XR?ODT™, the Company’s methylphenidate extended-release ODT product, by the end 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 Second Quarter Ended June 30, 2016
Total revenues were $1.5 million for the three months ended June 30, 2016, unchanged compared to the three months ended June 30, 2015. Principally all of second quarter 2016 revenue was generated from net sales of the Company’s generic Tussionex.

Gross loss for the three months ended June 30, 2016 was $0.2 million, unchanged from the three months ended June 30, 2015. 

Research and development expenses were $4.3 million for the three months ended June 30, 2016, an increase of $2.2 million compared to the three months ended June 30, 2015. This increase was primarily due to costs associated with the bioequivalence studies for Cotempla XR-ODT and NT-0201.

Selling and marketing expenses were $16.0 million for the three months ended June 30, 2016, an increase of $15.4 million from the three months ended June 30, 2015.  The increase was primarily due to the pre?commercialization, launch and sales activities for Adzenys XR-ODT which launched on May 16, 2016.

General and administrative expenses were $3.5 million for the three months ended June 30, 2016, an increase of $1.8 million compared to the three months ended June 30, 2015. The increase was primarily due to increases in salary and compensation expense associated with becoming a public reporting and commercial company, and share?based compensation.

The Company reported a net loss of $26.5 million in the three months ended June 30, 2016, compared with $5.8 million for the same period in 2015.

At June 30, 2016, the Company's cash, cash equivalents and investments amounted to $80.1 million.

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-ODT is the first approved product using the Company’s XR-ODT technology platform. Neos, which is initially focusing on the treatment of ADHD, has two other branded product candidates that are XR medications in ODT or liquid suspension dosage forms. In addition, Neos manufactures and markets its generic equivalent of the branded product Tussionex®, an XR liquid suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.