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Gilead Sciences Inc. Message Board

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  • pkornie Apr 15, 2010 9:54 AM Flag

    Dead cat bounce...suckers. Now I'm pissed

    << GILEAD SCIENCES (TICKER: GILD) initiated two Phase III studies of the Quad regimen, timing and design as expected.

    We anticipate top-line data release on the primary endpoint around year-end 2011 or early 2012, for potential launch around year-end 2012 or early 2013. We note that this is an important step for Gilead in executing its HIV franchise life-cycle management strategy (Atripla->Btripla->Quad).

    Study 102 evaluates Quad versus Atripla in 700 naïve HIV patients (randomized 1:1) over 96 weeks at 130 sites in the U.S. and Puerto Rico. Study 103 evaluates Quad versus Truvada+Reyataz+ritonavir (a popular regimen outside of the U.S.) in 700 naïve HIV patients (randomized 1:1) also over 96 weeks at more than 200 sites in North and South America, Europe and Asia Pacific.

    The primary endpoint of both studies is the proportion of patients achieving a HIV Ribonucleic acid level less than 50 copies/milliliter at 48 weeks. Secondary endpoints include efficacy, safety and tolerability though 96 weeks. After week 96, patients will be given the option to participate in the open-label extension phase for Quad.

    Gilead is expected to report first-quarter results after market close on April 20. We are raising our first-quarter revenue estimate from $1.938 billion to $2.063 billion versus consensus of $2.049 billion, and GAAP earnings per share from 82 cents to 90 cents versus consensus of 87 cents, mostly due to adjustments on the contracts and royalties line. We have raised our first-quarter contracts and royalties estimate from $83 million to $208 million, after adjusting the Tamiflu royalties for the quarter based on Roche's reported fourth-quarter Tamiflu sales. >>

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