2 Wins for Gilead: HIV Present, HCV Future

Gilead Sciences' (NASDAQ: GILD  ) shares surged over 5% in after-hours trading on Thursday after the company announced its second-quarter earnings before giving up some of the gains. Yes, the results were pretty good -- but they weren't the sole reason the stock jumped. Gilead also benefited from a big setback from a key rival in the battle to win in the hepatitis C, or HCV, market. Here are the highlights from the latest developments.

HIV juggernaut
Revenue in the second quarter totaled $2.77 billion, a 15% increase over the same period in 2012, and better than the $2.66 billion expected by Wall Street. Gilead reported earnings of $772.6 million, up 8.6% year over year. On a per-diluted-share basis, earnings for the quarter remained flat compared to last year, at $0.46 per diluted share.

Non-GAAP earnings showed higher gains. Net income, excluding acquisition-related, restructuring and stock-based compensation expenses, totaled $839.7 million, reflecting a 9.4% jump year over year. This translated to $0.50 per diluted share, a slight increase over the $0.49 per diluted share from second quarter of 2012, and met the average analyst estimate.

Gilead's HIV drug portfolio continued to power the biotech's sales and earnings in the last quarter. Atripla and Truvada generated the most revenue -- $938.1 million and $807.8 million, respectively. Both drugs experienced modest revenue growth, with Atripla's sales up 4% year over year, and Truvada's sales increasing 3% year over year.

The biotech's other two HIV drugs brought in lower amounts, but are showing strong growth. The Complera/Eviplera franchise garnered $188.7 million during the quarter, up a whopping 159% year over year. Newer drug combo Stribild made $99.4 million.

While HIV drugs accounted for most of Gilead's revenue, others made solid contributions. Hepatitis B drug Viread's sales in the second quarter were $250.2 million, an increase of 16% from the same period last year. Combined sales for cardiovascular drugs Letairus and Ranexa increased by 19%, to $234.8 million.

Gilead's future
HIV drugs helped Gilead's second quarter look good, but the after-hours stock gains stemmed more from HCV. The Food and Drug Administration placed a partial clinical hold on a mid-stage HCV study of rival Vertex Pharmaceuticals (NASDAQ: VRTX  ) . The hold came after three patients experienced elevated liver enzyme levels.

Vertex stands as the leader in the HCV market currently, with Incivek, but other companies could challenge that position in the near future.The FDA's move on Thursday will slow Vertex, while competitors keep advancing.

AbbVie (NYSE: ABBV  ) currently has phase 3 trials under way for an all-oral HCV regimen. Its direct-acting antiviral combo of four drugs received Breakthrough Therapy designation from the FDA in May. Previous clinical studies demonstrated a 99% cure rate after 12 weeks for patients taking the AbbVie HCV combo.

Breakthrough Therapy status has become fairly commonplace these days for HCV drugs. Bristol-Myers Squibb also snagged the designation for its three-drug HCV combo in April. The company lags behind the others, though, and will initiate phase 3 trials in late 2013.

Meanwhile, the FDA granted priority review to Johnson & Johnson's (NYSE: JNJ  )  New Drug Application, or NDA, for HCV drug simeprevir in May. That should mean an FDA decision will come by early 2014. However, simeprevir will be taken with injected drugs, so it's not an all-oral regimen like the others.

Gilead commands the frontrunner position in the all-oral combo race. The company submitted an NDA for its combo in April. A decision from the FDA is due by Dec. 8. Most analysts project peak annual sales of $5 billion to $7 billion for Gilead's HCV regimen, although Michael Yee with RBC Capital suspects those estimates could be low.

Expansion into the world of oncology is on its way, also. Gilead's chief scientific officer, Norbert Bischofberger, says that the company plans to submit for regulatory approval of non-Hodgkin's lymphoma drug idelalisib in late 2013.

Gilead looks to be a good pick in my view. Analysts expect annual earnings growth of 26% over the next few years. With strength in HIV now, and HCV in the not-too-distant future, I'd say Gilead will remain a winner.

Gilead Sciences' tremendous gains since the company first went public help confirm that the best investing approach is to choose great companies and stick with them for the long term. The Motley Fool's free report, "3 Stocks That Will Help You Retire Rich," names other stocks that could help you build long-term wealth and retire well, along with some winning wealth-building strategies that every investor should be aware of. Click here now to keep reading.


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