As if anyone actually needs to stoke the hype surrounding Gilead Sciences (GILD -2.70%) following its bonkers first quarter this year by releasing Sovaldi, aka the fastest selling drug in history, the CDC just came out with a set of guidelines for doctors to prescribe their anti-HIV medication Truvada to any and all at risk individuals.
The CDC endorses Truvada for HIV prevention
The so called pre-exposure prophylaxis, or PrEP, regimen can substantially reduce the chance of getting the HIV virus, and already a number of HIV-free consumers reportedly take the drug. What the new CDC report does is outline a set of protocols for health care providers in order to increase the adoption of the PrEP treatment across the country. One survey of infectious disease specialists showed that while 74% of those interviewed supported the treatment, only 9% had written a prescription. The report puts the significant policy weight of the CDC behind the treatment, which may help improve prescribing by doctors. They estimate that there are potentially 500,000 at-risk individuals in the US that could benefit from PrEP. With a price tag of $15,000 per year of treatment, widespread adoption could result in a significant revenue boost for Gilead. That said, adoption of the protocol has been slow to date, and by the CDC's own admission, many patients might not take the drug continuously. But even a modest 10% adoption rate would create a small but stable additional revenue stream for Gilead.
Expect the pricing debate to get worse
The major caveat here is that this announcement is coming in the midst of widespread criticism of Gilead's pricing policy, ultimately resulting in a congressional hearing over the $84,000 price tag for Sovaldi. It's arguable that that price point may be justifiable considering it's a one time cost against a lifetime of treating hepatitis C. Politically, it may be difficult to justify insurers and taxpayers footing a $15,000 a year bill for healthy individuals as a preventative measure. The blessing of the CDC and increased adoption of the PrEP guidelines is a good thing for Gilead, but don't expect an end to the controversy in the near term.
Can its HIV portfolio strengthen Gilead's growth?
Although Gilead has been one of the most talked about biotech stocks in recent memory, its stock price has fallen short of analyst's targets, in part due to uncertainty surrounding the sustained profitability of Sovaldi. Its high price tag and capacity to cure hep-C in one shot mean there's a serious possibility that the drug will sell well for a short period of time and then see usage drop off as hepatitis C declines. Sovaldi likely won't have the same sort of sustained income stream that Truvada and Gilead's HIV drug cocktails Stribild and Complera have.
The CDC's goal appears to be to change how people think about certain HIV medications as potential preventative measures, and as this idea gains traction, we could see sustained growth from an ever-increasing population of preventative-minded consumers. Even before the CDC report, things started to change as the declining sales of Truvada turned around, up 8% last recent quarter to $760 million. The skepticism in the company is based around it being a one trick pony, but with a little help, it might have a few more tricks up its sleeve, not to mention the latitude to invest in a more diversified research portfolio with its anti-cancer drug Idelalisib facing its PDUFA in September of this year.
And that's the real bottom line here. There are a variety of ways this could shape up, but two seem most likely to me: the hype around Sovaldi could be right and it could pull in a lot of money and send Gilead through the stratosphere, or you could just get stuck with a solid, diversified growth investment. That's a risk I'm willing to take.
