Kite Pharmaceuticals, Inc.
Feb 29, 2016

Kite Pharma Reports Fourth Quarter and Full-Year 2015 Financial Results

- Interim KTE-C19 Data, Expected in Second Half of 2016, to Support Planned BLA Filing in Late 2016 and Potential Product Launch in 2017 -

            - Balance Sheet Further Strengthened Through 2015 Public Offering, $614.7 Million in Cash and Investments -

SANTA MONICA, Calif., Feb. 29, 2016 (GLOBE NEWSWIRE) -- Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous cell therapy (eACT™) products for the treatment of cancer, today provided a corporate update and reported full-year and fourth quarter 2015 financial results for the period ended December 31, 2015.

"2015 was a year of solid execution and transformation for Kite," noted Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "The development of KTE-C19, our breakthrough immunotherapy candidate for patients with refractory hematological malignancies who have limited or no treatment options, is currently advancing in four Kite-sponsored multi-center clinical studies. We expect interim pivotal data from ZUMA-1, our lead study of KTE-C19, in the second half of this year, positioning us to submit our registrational filing with the FDA by year end. Construction of our commercial manufacturing facility is complete, and commercial planning is currently progressing under the leadership of our Chief Commercial Officer, Shawn Tomasello, and her capable team."

Dr. Belldegrun continued, "We are advancing what we believe is the most robust clinical pipeline of chimeric antigen receptors and T cell receptors for both solid and hematological oncology. This effort is supported by our ongoing collaborations with distinguished academic and industry leaders in immuno-oncology. We expect that our pipeline progress in 2016 will include additional human proof of concept data supporting the potential of our TCRs for the treatment of solid tumors."

Full Year 2015 and Recent Highlights

KTE-C19 Program

Acquisition and Strategic Collaborations

Corporate Milestones

2016 Goals

Fourth Quarter and Full Year 2015 Financial Results

About Kite Pharma

Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on engineered autologous cell therapy (eACT™) designed to restore the immune system's ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at http://www.twitter.com/kitepharma.

Kite Pharma, Inc. Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and timing of obtaining interim KTE-C19 data and filing a Biologics License Application with the FDA by the end of 2016, meeting Kite's other 2016 goals, and Kite's 2016 financial guidance. Various factors may cause differences between Kite's expectations and actual results as discussed in greater detail in Kite's filings with the Securities and Exchange Commission, including without limitation in its Form 10-K for the year ended December 31, 2015. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Kite assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Conference Call and Webcast Details

Kite will host a live conference call and webcast today at 4:30PM Eastern Time (1:30PM Pacific Time) to discuss financial results and provide a business update. To access the live conference call by telephone, please dial (877) 301-8565 (U.S.) or (678) 562-4240 (International). The conference ID number for the live call is 45173015. Interested parties may access a live audio webcast of the conference call on the Investors section of Kite's website, www.kitepharma.com.  A replay of the audio webcast will be available on Kite's website for approximately 30 days.


KITE PHARMA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
       
    DECEMBER 31, DECEMBER 31,
    2015 2014
         
ASSETS     
 Current assets     
  Cash, cash equivalents, and marketable securities$614,722 $367,040
  Prepaid expenses and other current assets 16,371  1,330
   Total current assets 631,093  368,370
 Property and equipment, net 30,116  2,275
 Intangible assets and goodwill, net 36,740  
 Other assets 10,014  108
   Total assets$707,963 $370,753
LIABILITIES AND STOCKHOLDERS' EQUITY     
 Current liabilities      
  Accounts payable$8,049 $2,320
  Deferred revenue 16,333  
  Accrued expenses and other current liabilities 11,787  4,405
   Total current liabilities 36,169  6,725
  Deferred revenue, less current portion 32,176  
  Contingent consideration 16,080  
  Other non-current liabilities 7,778  1,439
   Total liabilities 92,203  8,164
   Total stockholders' equity 615,760   362,589
     Total liabilities and stockholders' equity$707,963 $370,753


KITE PHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
               
     THREE MONTHS ENDED
DECEMBER 31,
(unaudited)
  YEAR ENDED
DECEMBER 31,
     2015  2014  2015  2014
                
Revenue:           
 Revenue$  4,887  $    $ 17,258  $  
Operating expenses:           
 Research and development  28,794    7,857    76,369    23,089 
 General and administrative  14,127    5,398    44,207    13,569 
Total operating expenses  42,921    13,255     120,576    36,658 
Loss from operations  (38,034)   (13,255)   (103,318)   (36,658)
Other income (expense):           
  Interest income  503    242    1,809    371 
 Interest expense  (202)    (3)   (658)   (6,269)
 Other income (expense)  (7)   (3)   514    (13)
Total other income (expense)  294    236    1,665    (5,911)
Loss before income taxes  (37,740)   (13,019)   (101,653)   (42,569)
Provision (benefit) from income taxes  491               
Net loss  (38,231)   (13,019)   (101,653)   (42,569)
Series A preferred stock dividend               (1,089)
Net loss attributable to common stockholders$ (38,231 ) $ (13,019) $ (101,653) $ (43,658)
Net loss per share, basic and diluted$ (0.85) $ (0.33) $ (2.33) $ (1.91)
Weighted-average shares outstanding, basic and diluted  44,967    38,960    43,637    22,822 
            

Note Regarding Use of Non-GAAP Financial Measures

Kite provides non-GAAP net loss and non-GAAP net loss per share that include adjustments to GAAP figures. These adjustments to GAAP net loss exclude non-cash stock-based compensation expense.  Kite believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Kite's financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Kite's operating results. In addition, these non-GAAP financial measures are among the indicators Kite's management uses for planning purposes and measuring Kite's performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Kite may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer below for a reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.

KITE PHARMA, INC.
RECONCILIATION OF GAAP TO NON-GAAP NET LOSS
(In thousands, except per share amounts)
(Unaudited)
       
    THREE MONTHS
ENDED
DECEMBER 31,
 YEAR
ENDED
DECEMBER 31,
    2015 2015
Net loss attributable to common stockholders - GAAP$ (38,231) $ (101,653)
      
Adjustments:     
Non-cash stock-based compensation expense  13,770    40,672 
Net loss attributable to common stockholders - Non-GAAP$ (24,461) $ (60,981)
       
Net loss per share attributable to common stockholders, basic and diluted - GAAP$ (0.85) $ (2.33)
      
Adjustments:     
Non-cash stock-based compensation per share  0.31    0.93 
Net loss per share attributable to common stockholders, basic and diluted - Non-GAAP$ (0.54) $ (1.40)
      
Weighted average common shares outstanding, basic and diluted  44,967     43,637 

 


CONTACT: Kite Pharma, Inc.

Cynthia M. Butitta

Chief Financial Officer & Chief Operating Officer

310-824-9999



Greg Mann

VP, Investor Relations

gmann@kitepharma.com



For Media: Justin Jackson

Burns McClellan

212-213-0006

jjackson@burnsmc.com

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Source: Kite Pharma, Inc.

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