Neos Therapeutics: All Angles Covered For PDUFA

  • Neos is a small company developing generic drugs.
  • Its past experience with the FDA gave it hindsight to approach the next PDUFA properly.
  • We believe there is now considerable upside from current levels.

By S. Mitra, MBA (ISB)

Neos Therapeutics (NEOS) looks more and more like a very good mid-term investment before the September PDUFA. It is a small company with just a $176mn market cap and yet has an existing revenue stream in the form of two revenue-generating products in the market. A third product, Cotempla XR-ODT, just got approved by the FDA in June, and should be in the market later this year. All these recent products target the large ADHD or Attention Deficit Hyperactivity Disorder market, and uptake and even treatment switching has been good so far. The products have a long patent runway extending to 2032. Recently revised guidance from the FDA regarding more stringent generic bioequivalence standards have also considerably limited competition. Finally, NT-0201, the company’s amphetamine XR liquid suspension, will have a PDUFA in September, providing an important catalyst for the company.

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