Insys Therapeutics' (NASDAQ:INSY) investors have suffered a seemingly endless barrage of bad news since 2015. The company's one and only commercial drug -- Subsys -- has been marred by allegations of improper marketing, and delays in launching a new liquid formulation of the long-standing marijuana drug Marinol haven't helped boost investor morale, either.
However, perhaps things are about to brighten up a bit for this company's shareholders. New management appears committed to resolving investigations into Subsys marketing, and last month, it moved closer to a commercial launch of Syndros. Additionally, management affirmed its intention to file for FDA approval a third product candidate as well as continue development of future products, including a marijuana-based medicine for epilepsy.
Once upon a time, Subsys was a fast-growing source of sales and profit for the company. Today, it's a major drag on Insys' financials. Subsys is approved for use in treating breakthrough cancer pain, which typically affects cancer patients at the tail end of their fight with the disease, but investigations suggest the vast majority of its prescriptions have been for off-label use in other pain indications, and that those prescriptions were supported by improper marketing programs by Insys Therapeutics executives, including former CEO Michael Babich, who has since been arrested.
Insys Therapeutics' founder, John Kapoor, filled in for Babich when he stepped down as CEO in 2015; however, Kapoor walked away from the top spot at the company earlier this year, leaving chief medical officer Dr. Santosh Vetticaden in charge. In April, the revolving door continued with the appointment of former Purdue Pharma executive Saeed Motahari as CEO.
Motahari took over in April, and since then, Vetticaden has departed, and Chief Financial Officer Darryl Bake has said he'll be leaving once a successor is found. The house-cleaning creates uncertainty, but it may be necessary to repair confidence with investors, government agencies, and insurers.
Getting Insys Therapeutics' proverbial house in order is critical now because the company is prepping to launch Syndros, and its success could offset declining demand for Subsys. Subsys' sales totaled only $36 million last quarter, down from over $60 million in the same quarter of 2016.
The company's also got an application for FDA approval of a spray formulation of buprenorphine pending completion, and it desperately needs to kick-start its other research programs, including its work on new epilepsy treatments using cannabidiol, a marijuana chemical cannabinoid.
Can this marijuana stock turn the corner?
A lot of investors are betting against this company's success. Short-sellers hold an eye-popping 44% of the company's shares float short. This bearish bet is understandable given all that has gone wrong at the company over the past couple of years, but it's possible short-sellers have become too complacent, and they're now underestimating Matahari's chances for success.
During the company's first-quarter earnings conference call in May, Motahari assured investors he's on track to fix Insys Therapeutics' problems. He indicated management is working with investigators to resolve investigations, and he said Syndros will be on the market soon, and that research will continue on new products, including the use of marijuana-derived medicines in epilepsy, PTSD, and addiction.
Undeniably, accomplishing all of his goals quickly won't be easy. No one knows where Subsys sales will find their footing, and Syndros has dosing advantages over Marinol, but it has less favorable DEA scheduling, and that could hurt its chances at winning away Marinol market share. A settlement would be good news, but there's no telling what it might cost the company to get this debacle behind it.
The good news, though, is that Insys Therapeutics remains debt-free, and it's got $218 million in cash in the bank that's helping it survive. This financial flexibility -- if used appropriately -- makes its downfall a bit less likely, and perhaps, it suggests that the odds stacked against the company might not be as bad as they appear.