Steps to regain stakeholders’ confidence
Insys (INSY) is taking strategic steps to restore stakeholder confidence. The company aims to achieve one NDA (or new drug application) per year over the next five years. Insys is targeting treatments for orphan diseases, neurological diseases like pediatric epilepsy, genetic conditions like Prader-Willi syndrome, and treatments for secondary allergic reactions, anorexia, and products for opioid overdose. The company also plans to invest $14 million in its manufacturing facility at Round Rock, Texas.
Insys has brought new leadership on board with the appointment of Saeed Mohatari as the company’s new CEO and Andrew Long as the new CFO.
The management highlighted its priorities in the 3Q17 earnings presentation. The company’s top priority is resolving outstanding government investigations. The other priorities are stabilizing performance, advancing drug candidates in the pipeline, and enhancing the capability of the company.
Focus on drug pipeline
The company’s drug pipeline is divided into pharmaceutical cannabinoids and spray technology. In October 2017, Insys completed its PK study of intranasal naloxone spray for treating opioid overdose. The company aims to file an NDA and achieve FDA approval in 2018.
On December 26, 2017, the FDA granted fast track designation to Insys’s cannabidiol oral solution for the treatment of Prader-Willi syndrome. This is a rare genetic disorder that leads to insatiable appetite in children and often results in obesity and type 2 diabetes. Insys also plans to initiate a phase three program for infantile spasm utilizing cannabinoid in 4Q17.
Stock price fluctuations
The company’s stock price took a beating in 2017 with a loss of ~60% of its value as of the third week of December 2017. In the last one month, Insys stock has seen a stellar recovery, rising by ~105% from $5.5 on December 7, 2017, to $10.4 on January 5, 2018.
Insys makes up about 0.01% of the PowerShares FTSE RAFI US 1500 Small-Mid Portfolio ETF’s (PRFZ) total portfolio holdings.