What: Shares in Insys Therapeutics (NASDAQ:INSY) jumped 23.7% higher in November after CNBC highlighted allegations of improper marketing and the company's CEO stepped down last month.
So what: Insys Therapeutics has been under scrutiny for off-label marketing of Subsys, an opioid pain-killer, since 2013, but allegations have accelerated this year -- especially in the wake of a $1.1 million settlement with Oregon's state Attorney General in August.
The scrutiny isn't unexpected given that regulators have been ratcheting down on opioid abuse for years by instituting a series of programs, checks, and balances that are designed to restrict access to this class of drugs and reduce their potential misuse.
Nevertheless, CNBC's high-profile expose seems to have put enough pressure on Insys Therapeutics' board and C-suite to warrant changes, including the departure of CEO Michael Babich, a former venture capitalist.
Replacing him in the top spot is John Kapoor, the Chairman of Insys Therapeutics board of directors and a controlling Insys Therapeutics shareholder. Kapoor owns 21 million shares in Insys Therapeutics, so he has a vested interest in getting the Subsys allegations behind the company so it can focus on its oral formulation of the cancer nausea drug marinol and a slate of marijuana-derived medicines.
An FDA decision on its oral marinol, which will be sold under the brand name Syndros, is expected in April, and results from studies evaluating marijuana cannabinoids for use in treating epilepsy should be coming soon, too.
If Insys Therapeutics marijuana studies are positive, then it could position the company to compete head to head with GW Pharmaceuticals (NASDAQ:GWPH), another drug developer working on marijuana therapies for epilepsy indications, including Dravet syndrome and Lennox-Gastaut syndrome.
GW Pharmaceuticals is expected to provide insight from ongoing trials in these indications early in 2016, so there's a bit of a foot race between the two in this market.
Now what: Off-label use of medicine isn't illegal, but the marketing of it is, and that means if Subsys representatives were pushing the envelope, then Insys Therapeutics could face additional settlements.
Assuming Insys Therapeutics' C-suite has gotten the message and reined in its sales and marketing efforts, the allegations dissipate, and Syndros makes it through regulators, then Insys Therapeutics may make for a profit-friendly investment.
Subsys is selling at an annualized $360 million clip, and the marinol market could be worth another $200 million annually to the company. Also, Insys Therapeutics' balance sheet is clean and includes $187 million in cash and no debt, and its shares are trading at an arguably reasonable valuation of 20 times forward EPS -- this is intriguing, too.
However, despite those positives, the company is admittedly a risky investment, so its best suited only for those who can handle the potential for downside tied to more million-dollar settlements.