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Neos Therapeutics Reports Second Quarter 2017 Financial Results

Company to Host Conference Call at 8:30am ET Today

DALLAS and FORT WORTH, Texas, Aug. 08, 2017 (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) technologies, today reported financial results for the second quarter ended June 30, 2017 and provided a business update.

"We are very excited about the recent FDA approval of Cotempla XR-ODT™. As we prepare for the launch this fall, we will be able to leverage our existing sales force and commercial infrastructure which was used for last year's successful launch and the continued commercialization of our first product, Adzenys XR-ODT®. When both products are on the market this fall, we will be able to offer patients and caregivers two treatment options to manage the symptoms commonly associated with ADHD. This milestone will make Neos the only company to have both a branded methylphenidate and a branded amphetamine product available in an extended-release orally disintegrating tablet dosage form," said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. "We recently raised approximately $34.5 million before offering expenses through a public offering, and we believe we have sufficient cash to get to cash-flow positive based on our current business plan."

Key Recent Accomplishments and Anticipated Milestones for 2017

  • On June 19, 2017, the Company announced that the U.S. Food and Drug Administration (FDA) approved Cotempla XR-ODT, the first and only methylphenidate extended-release orally disintegrating tablet for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients 6 to 17 years old. Cotempla XR-ODT will be commercially available in a portable, child-resistant blister pack in the fall of 2017.
  • On June 27, 2017, Neos announced the pricing of an underwritten public offering of 4.8 million shares of its common stock for total proceeds of $30.0 million before estimated offering costs of $0.2 million.
  • On July 26, 2017, the underwriter exercised in full its option to purchase an additional 720,000 shares of the Company's common stock for total proceeds of $4.5 million.
  • A New Drug Application (NDA) is currently under review for NT-0201, the Company's amphetamine XR liquid suspension product candidate, and its Prescription Drug User Fee Act (PDUFA) goal date is September 15, 2017. If approved, the Company anticipates a launch of this product in January 2018.

Commercial Highlights for Adzenys XR-ODT™

  • Prescription Growth Continues into Second Year on Market: Adzenys XR- ODT continued to perform well and the cumulative total number of prescriptions filled for Adzenys XR-ODT, as reported by IMS, were 41,954 for the three months ended June 30, 2017, an increase of 29.9% over the 32,296 for the three months ended March 31, 2017. As of July 21, 2017, the cumulative total number of prescriptions filled for Adzenys XR-ODT since its launch in May 2016, as reported by IMS, were 114,112.
  • New to Brand Market Share Continues to Grow Rapidly: As of June 2017, Adzenys XR-ODT has become the preferred alternative dosage treatment for ADHD, as more patients (35%) started on Adzenys XR-ODT than any other alternative dosage form product.
  • Number of Prescribers Continues to Grow Throughout the US: The number of prescribers of Adzenys XR-ODT continued to grow since launch, and as of June 30, 2017, 7,405 health care providers had written prescriptions for the product. As of July 14, 2017, that number had increased to 7,699.
  • Doctors are Switching Their Patients Over to Adzenys XR-ODT: Patients switching from another ADHD medication accounted for approximately 74% of all new Adzenys XR-ODT prescriptions, as reported by IMS, as of the week ended July 21, 2017.
  • Product Appeal for All Patient Types: As of the week ended July 21, 2017...