Kite Pharma (KITE) reported earnings on Tue 28 Feb 17 (b/o)

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Kite Pharma beats by $0.01, misses on revs; reaffirms completion of BLA for first CAR-T therapy to market in Q1 with potential US approval, launch this year; :

• Reports Q4 (Dec) loss of $1.31 per share, excluding non-recurring items, $0.01 better than the Capital IQ Consensus of ($1.32); revenues were unchanged from the year-ago period at $4.9 mln.
• Co issues guidance for FY17, sees FY17 revs of $40-50 mln, assuming no product rev, may not be comparable to $64.57 mln Capital IQ Consensus Estimate; op-ex $490-515 mln.
• Kite issued positive topline results from the primary analysis of the ZUMA-1 study of axicabtagene ciloleucel in patients with aggressive non-Hodgkin lymphoma (:NHL).
• Kite continues to expect completion of its rolling submission of a Biologics License Application (:BLA) to the U.S. Food and Drug Administration (:FDA) for axicabtagene ciloleucel (KTE-C19) for the treatment of aggressive NHL by the end of the first quarter 2017, with potential approval and commercial launch in 2017.
• Axicabtagene Ciloleucel Commercial & Manufacturing Readiness
  • Achieved 99 percent success rate in the manufacturing of clinical product patient dose from a single apheresis for the multi-center ZUMA-1 clinical trial.
  • Marked the official opening of Kite's commercial manufacturing plant, a state-of-the-art facility in El Segundo, California estimated to have the capacity to produce more than 4,000 patient therapies per year.
  • Initiated development of Kite Konnect, a cloud-based solution for commercial-scale ordering, logistics, monitoring and delivery of T-cell therapies, designed to enable a positive prescriber and patient experience.
• 2017 Financial Guidance
  • Kite expects full year 2017 net cash burn to be between $325 million and $340 million, which includes ~$30 million in capital expenditures but excludes cash inflows or cash outflows from business development activities, if any, and excludes planned upfront payments totaling $90 million from recently announced strategic collaborations in Asia.
  • Estimated full year 2017 cash burn is driven primarily by a projected GAAP net loss of between $450 million and $465 million. The 2017 projected net loss includes non-cash stock-based compensation expenses of ~$135 million. Kite expects full year 2017 revenue to be between $40 million and $50 million, which assumes no product revenue, and full year 2017 GAAP operating expenses to be between $490 million and $515 million.
  • As previously announced, Kite expects to have sufficient cash resources to fund its current operations, including planned clinical development programs, through the first half of 2018. This projection excludes cash inflows or cash outflows from future business development activity, if any.