That's how the U.S. Department of Health and Human Services (HHS) describes the opioid epidemic facing the country. The number of drug overdoses is soaring. Over 60% of those overdoses involved an opioid.
Two publicly traded companies are especially experiencing the impact of concerns about this epidemic. Insys Therapeutics (NASDAQ:INSY) is feeling the pain, while AstraZeneca (NASDAQ:AZN) has gained. Here's how high opioid usage is affecting these two drugmakers' fortunes.
Insys has one product currently on the market, Subsys. The drug, which helps manage breakthrough pain in cancer patients, gained FDA approval in 2012. Subsys roared out of the gate. In its first four weeks on the market, the drug grabbed more market share than the three previously approved transmucosal immediate-release fentanyl (TIRF) pain drugs combined.
In 2013, Insys reported sales for Subsys of $95.7 million. The next year, sales increased to $219.5 million. That tremendous growth continued into 2015, with Subsys generating net revenue of $329.5 million.
Subsys is now struggling, however. Sales in the first half of this year were $129.1 million, down 13% from the prior-year period. Insys recently announced preliminary third-quarter revenue estimates, and the situation isn't getting any better. Subsys sales are expected to be between $54 million and $55 million. That's roughly 40% below the drug's sales results from the third quarter of 2015.
Heightened awareness about the opioid overdose problems in the U.S. are taking a toll on Insys. Some doctors are now less likely to prescribe opioid painkillers. The bigger issue, though, is that some big payers refuse to cover Subsys and similar drugs.
Express Scripts (NASDAQ:ESRX) first included Subsys on its list of excluded drugs in 2015. Subsys remained on the exclusion list for 2016 and 2017. Because Express Scripts is the largest pharmacy benefits manager (PBM) in the U.S., its decision really hurt Insys. The giant PBM covers 85 million Americans. 25 million of those members must comply with Express Scripts' preferred formulary. Even if these patients and their physicians agreed that Subsys was the best medication to take, the patients' insurance wouldn't pay for the drug.
But Express Scripts hasn't rejected all opioids. Depomed's Lazanga, a nasal spray containing fentanyl, remains on the PBM's preferred formulary. Unlike Subsys, sales for Lazanga continue to soar.
While Insys stumbles in part because of concerns about opioids, AstraZeneca is benefiting from use of the painkillers. The drugmaker markets Movantik, one of the leading drugs for treating opioid-induced constipation in adults with chronic non-cancer pain.
AstraZeneca launched Movantik in March 2015. The drug generated sales of $29 million during the rest of the year. However, that was just the start. Movantik made $40 million in the first half of 2015.
Expectations for Movantik have been all over the map. Some analysts project that the drug could hit peak annual sales of $350 million. Others have been much more optimistic, estimating that Movantik could even reach annual sales around the $1 billion mark because of the high rates of opioid-induced constipation in patients taking opioids.
I suspect the lower peak sales projections are probably closer to what Movantik will actually achieve. The drug faces stiff competition from Valeant Pharmaceuticals' Relistor. Valeant and partner Progenics won FDA approval of an oral version of Relistor in July.
Still, though, AstraZeneca's fortunes should continue to be positively impacted by growing sales of Movantik. And that growth is at least in part a direct result of higher usage of opioids and the side effects of this use.
Despite the potential for Movantik, however, it's not enough to make AstraZeneca an attractive stock for investors. The big drugmaker's revenue and earnings are falling, primarily due to slowing sales of respiratory drug Symbicort and gastroesophageal reflux disease drug Nexium.
Will either of these two drugmakers' fortunes change anytime soon? I suspect Insys Therapeutics could continue to flail. Express Scripts doesn't appear likely to include Subsys on its formulary. There's also no indication that public concerns over taking opioid drugs will diminish in the near future.
AstraZeneca should still see solid results from Movantik even with competition from Relistor. However, the company has bigger problems to fix. AstraZeneca has a huge pipeline (146 clinical studies!) with 14 drugs in late-stage trials. Over the long run, I think AstraZeneca will be fine. I just wouldn't expect impressive earnings growth in the next few years.
And what about the raging opioid epidemic? Perhaps the most encouraging development comes from a small privately held company. Kaleo Pharma gained FDA approval for Evzio in 2014. Evzio is a hand-held injector that can reverse the effects of an opioid overdose. Widespread access to Evzio, combined with adherence to prescription guidelines for opioids and medication-assisted treatment for people with opioid addictions, might present the best opportunity to this unprecedented challenge.