BIOPHARMA

Gilead Shares Surged on Positive Results from Phase III Clinical Study 119 of Leukemia Drug Zydelig (idelalisib)

Witawat (Ed) Wijaranakula, Ph.D.
Mon Jun 1, 2015

Shares of Gilead Sciences, Inc. [NASDAQ: GILD] jumped 1.61% on Monday after the company said that their Phase III clinical study 119 in previously-treated patients with chronic lymphocytic leukemia (CLL) showed a 73% reduction in the risk of disease progression or death for patients that received Zydelig (idelalisib) in combination with Novartis’s [NYSE-ADR:NVS] Arzerra (ofatumumab), compared to patients that received Arzerra (ofatumumab) alone.

The company also said that it has filed a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) to include data from this study in the U.S. label. In July 2014, the U.S. FDA approved Zydelig (idelalisib), a PI3K delta inhibitor, to treat patients with relapsed chronic lymphocytic leukemia (CLL), patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL), another type of non-Hodgkin lymphoma. In the first-quarter ended March 2015, Zydelig (idelalisib) generated revenues of $26 million. Label expansion of the product should boost sales further.

Arzerra (ofatumumab) is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes. The U.S. FDA approved Arzerrs (ofatumumab), made by GlaxoSmithKline [NYSE-ADR:GSK], for patients with CLL in October 2009. Arzerra is marketed under a co-development and collaboration agreement between Genmab [OTC:GNMSF] and Novartis, as successor in interest to GSK. 

CLL, a slowly progressing cancer of the blood and bone marrow, is the most commonly diagnosed adult leukemia in the United States and Western countries, accounting for approximately 1 in 4 cases of all leukemia.

Gilead Sciences just announced its blowout first-quarter ended March 2015 revenues of $7.6 billion compared to $5.0 billion in 2014. Net income was $4.3 billion, or $2.76 per diluted share in 2015 compared to $2.2 billion or $1.33 per diluted share in 2014. Wall Street expected non-GAAP adjusted earnings of $2.32 a share and revenue of $6.92 billion for the quarter.

Gilead said that its combined revenues from their top selling hepatitis C drug Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) was $4.55 billion for the quarter, beating analysts' estimates of $3.61 billion.

The company raised its revenue guidance for the full year to between $28 billion to $29 billion, versus its prior forecast of between $26 billion to $29 billion. The consensus estimates are $29.64 billion for revenue and EPS of $10.38 per share.

GILD stock made a confirmed symmetrical triangle breakout in mid-April and a breakout of the long-term $110 head resistance level last month. The next head resistance is $117.

The 12-month target price for GILD on Yahoo Finance is $121.57 per share. Gilead will report its second-quarter 2015 earnings on July 21-27. Analysts are expecting earnings of $2.66 per share, up 12.7%, on revenue of $7.52 billion, up 15.1%.

Disclosure: No position in GILD with no recommendation.

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