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Kite Pharma (KITE) Q2 Loss Wider but Focus is on KTE-C19
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Kite Pharma, Inc. reported a loss of $1.31 per share in the second quarter of 2016, wider than the Zacks Consensus Estimate of a loss of $1.28 per share and the year-ago loss of 48 cents.
Second-quarter revenues came in at $4.8 million, slightly above the Zacks Consensus Estimate of $4.7 million and up 8.9% from the year-ago period.
Revenues consisted entirely of the amortization of deferred collaboration revenues related to the $60 million upfront payment received under the collaboration agreement with Amgen Inc. (AMGN - Free Report) in the first quarter of 2015.
While Kite’s research and development expenses shot up 185.5% from the year-ago period to $47.4 million in the reported quarter, general and administrative expenses were $23.5 million, up 140.6% from the year-ago period.
Kite continues to expect cash burn of $235–$250 million in 2016 including both operating expenses and about $20 million of capital expenditures but excluding the impact of business development activities.
With no approved product in its portfolio at the moment, focus remains on KTE-C19, Kite’s lead pipeline candidate, which is currently in the pivotal phase of a phase I-II study (ZUMA-1) in patients with refractory diffuse large B cell lymphoma (DLBCL) including primary mediastinal B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL). All these are types of aggressive non-Hodgkin’s lymphoma (NHL). Interim results from the phase II part of this study are expected late in the third quarter of 2016. Depending on these results, the company expects to file for approval in late 2016 and potentially launch KTE-C19 next year.
Kite is also evaluating KTE-C19 in a phase II study (ZUMA-2) in patients with relapsed/refractory mantle cell lymphoma (MCL) and in two additional pivotal studies (phase I/II) for acute lymphoblastic leukemia (ALL) - ZUMA-3 for adult ALL and ZUMA-4 for pediatric ALL, with results from all these studies due in 2017.
Kite plans to move KTE-C19 into a second series of studies for additional indications and earlier lines of therapy in DLBCL patients in 2017. KTE-C19 studies will be initiated in Europe later this year.
A phase Ib/II combination study evaluating KTE-C19 plus Genentech’s Tecentriq (atezolizumab) in patients with chemorefractory DLBCL is scheduled to commence later in the third quarter.
Investor focus will remain on KTE-C19 interim results and the company’s Investor Day on Oct 18, 2016 where an update will be provided on the ZUMA studies, other pipeline programs as well as an overview of commercial and manufacturing preparations.
Kite is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the healthcare sector include Cambrex Corporation and Heska Corporation . Both are Zacks Rank #1 (Strong Buy) stocks.
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Kite Pharma (KITE) Q2 Loss Wider but Focus is on KTE-C19
Kite Pharma, Inc. reported a loss of $1.31 per share in the second quarter of 2016, wider than the Zacks Consensus Estimate of a loss of $1.28 per share and the year-ago loss of 48 cents.
Second-quarter revenues came in at $4.8 million, slightly above the Zacks Consensus Estimate of $4.7 million and up 8.9% from the year-ago period.
Revenues consisted entirely of the amortization of deferred collaboration revenues related to the $60 million upfront payment received under the collaboration agreement with Amgen Inc. (AMGN - Free Report) in the first quarter of 2015.
KITE PHARMA INC Price, Consensus and EPS Surprise
KITE PHARMA INC Price, Consensus and EPS Surprise | KITE PHARMA INC Quote
KTE-C19 Year End Filing Plan Remains on Track
While Kite’s research and development expenses shot up 185.5% from the year-ago period to $47.4 million in the reported quarter, general and administrative expenses were $23.5 million, up 140.6% from the year-ago period.
Kite continues to expect cash burn of $235–$250 million in 2016 including both operating expenses and about $20 million of capital expenditures but excluding the impact of business development activities.
With no approved product in its portfolio at the moment, focus remains on KTE-C19, Kite’s lead pipeline candidate, which is currently in the pivotal phase of a phase I-II study (ZUMA-1) in patients with refractory diffuse large B cell lymphoma (DLBCL) including primary mediastinal B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL). All these are types of aggressive non-Hodgkin’s lymphoma (NHL). Interim results from the phase II part of this study are expected late in the third quarter of 2016. Depending on these results, the company expects to file for approval in late 2016 and potentially launch KTE-C19 next year.
Kite is also evaluating KTE-C19 in a phase II study (ZUMA-2) in patients with relapsed/refractory mantle cell lymphoma (MCL) and in two additional pivotal studies (phase I/II) for acute lymphoblastic leukemia (ALL) - ZUMA-3 for adult ALL and ZUMA-4 for pediatric ALL, with results from all these studies due in 2017.
Kite plans to move KTE-C19 into a second series of studies for additional indications and earlier lines of therapy in DLBCL patients in 2017. KTE-C19 studies will be initiated in Europe later this year.
A phase Ib/II combination study evaluating KTE-C19 plus Genentech’s Tecentriq (atezolizumab) in patients with chemorefractory DLBCL is scheduled to commence later in the third quarter.
Investor focus will remain on KTE-C19 interim results and the company’s Investor Day on Oct 18, 2016 where an update will be provided on the ZUMA studies, other pipeline programs as well as an overview of commercial and manufacturing preparations.
Kite is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the healthcare sector include Cambrex Corporation and Heska Corporation . Both are Zacks Rank #1 (Strong Buy) stocks.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>