9. Letairis

Gilead will face several new losses of exclusivity in 2019, including pulmonary arterial hypertension med Letairis. (Gilead China)

Gilead Sciences
2018 U.S. sales: $943 million
Disease: Pulmonary arterial hypertension
Generics launched: Second quarter of 2019

Gilead’s recent troubles in hepatitis C aside, the company isn't challenge-free. It has a big patent loss coming this year for Letairis, approved in 2007 and used to treat pulmonary arterial hypertension.  

In fact, Gilead has been bracing for competition since a patent expiration last year, but so far, generics makers haven’t made it past FDA gatekeepers. Now, the company expects Letairis copies to roll out in the second quarter, CFO Robin Washington said during the company’s fourth-quarter conference call. No generics makers have yet won approval for their copycats, though, according to [email protected]

Letairis has been an important source of sales for Gilead as it nears the end of its exclusive life; last year, the drug pulled in $943 million in the U.S.  

Even as it braces for competition to Letairis, Gilead’s situation in hep C is even more dire. Because of competition from rival drugmakers, the company has been paying out high rebates to secure formulary coverage. Against that backdrop, the company last year unveiled a plan to roll out its own knockoffs to big-selling Epclusa and Harvoni as a way to pay lower rebates and boost patient access.  

And Letairis, Epclusa and Harvoni aren't the only Gilead brands set to face generics this year. Its angina drug Ranexa also loses its exclusive hold on the market, and last year, that drug pulled in $758 million in the U.S. Altogether, Gilead will likely face new competition to drugs that last year brought in billions of dollars—and that's on top of a severe fall in hep C over recent years.

To add to all of those issues, Gilead in February said its closely watched nonalcoholic steatohepatitis (NASH) drug had failed a phase 3 trial.

RELATED: Gilead executives predict patience—and some deal scouting—from new CEO Daniel O'Day 

So, it's clear the company needs growth, and it recently poached a Roche executive to chart the next leg of its journey. Roche's former pharma head Dan O'Day takes the Gilead helm March 1, and already Gilead executives have predicted the new chief will bring patience to the job and scout for deals.

When Gilead announced O’Day as its next CEO, market watchers predicted the company would intensify its push into cancer. The company inked its Kite Pharma buyout in 2017 to gain access to CAR-T technology, but in 2018, Yescarta sales hadn’t yet taken off. The drug turned in $264 million in 2018, far from enough to replace sales lost from discounting in hep C and new generics. 

9. Letairis