Kite Pharma, Inc.
Feb 28, 2017

Kite Reports Fourth Quarter and Full Year 2016 Financial Results

SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite Pharma, Inc. (Nasdaq:KITE) today provided a corporate update and reported fourth quarter and full-year 2016 financial results for the period ended December 31, 2016.

In a separate announcement today, 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.

"The accomplishments, leadership additions to the company, and performance of Kite during 2016 put us in a position of strength as we prepare to potentially deliver the first CAR-T therapy for aggressive NHL to patients later this year," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "Beyond axicabtagene ciloleucel, we have taken important steps to expand Kite's global footprint and pipeline of cell therapy candidates. Through our recently announced strategic collaborations with Fosun Pharma and Daiichi Sankyo, our plans for submission and potential launch in Europe, and ongoing clinical studies of axicabtagene ciloleucel, we look ahead to an increasingly strong future for Kite."

Fourth Quarter and Full Year 2016 Financial Results

2017 Financial Guidance

2016 Highlights

Axicabtagene Ciloleucel/KTE-C19 Progress

Regulatory Milestones

Axicabtagene Ciloleucel Commercial & Manufacturing Readiness

Pipeline Expansion and Developments

Strategic Collaborations

About Kite

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

Cautionary Note on 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," "expected," "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 initiating and completing a submission of the BLA for axicabtagene ciloleucel with the FDA, obtaining regulatory approval based on the studies of axicabtagene ciloleucel, commercially launching axicabtagene ciloleucel, and researching and developing additional product candidates, expectations regarding the clinical effectiveness and safety of axicabtagene ciloleucel, and Kite's 2017 financial guidance including the sufficiency of Kite's cash, cash equivalents and marketable securities. 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, 2016. 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 6:00 AM Pacific Time (9:00 AM Eastern Time) to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 888-771-4371 (U.S.) or 847-585-4405 (International). The conference ID number for the live call is 44040763. The webcast will be made available on the Company's website at www.kitepharma.com under the Investors tab in the Events and Presentations section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days.

       
KITE PHARMA, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands)
(unaudited)
 

DECEMBER 31,
2016

DECEMBER 31,
2015

ASSETS
Current assets
Cash, cash equivalents, and marketable securities $ 414,422 $ 614,722
Prepaid expenses and other current assets   12,974   16,371

Total current assets

427,396 631,093
Restricted cash and investments 10,669 1,540
Property and equipment, net 44,409 30,116
Intangible assets and goodwill, net 31,398 36,740
Other assets   10,432   8,474
Total assets $ 524,304 $ 707,963
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable $ 10,660 $ 8,049
Accrued expenses and other current liabilities 29,482 11,787
Deferred revenue   15,000   16,333
Total current liabilities 55,142 36,169
Deferred revenue, less current portion 19,779 32,176
Contingent consideration 14,218 16,080
Other non-current liabilities   7,195   7,778
Total liabilities 96,334 92,203
Total stockholders' equity   427,970   615,760
Total liabilities and stockholders' equity $ 524,304 $ 707,963
 
 
KITE PHARMA, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(unaudited)
               

THREE MONTHS ENDED
DECEMBER 31,

YEAR ENDED
DECEMBER 31,

2016 2015 2016 2015
Revenues $ 4,907 $ 4,887 $ 22,170 $ 17,258
Operating expenses:
Research and development 58,902 28,794 197,934 76,369
General and administrative   31,802     14,316     97,423     44,839  
Total operating expenses   90,704     43,110     295,357     121,208  
Loss from operations (85,797 ) (38,223 ) (273,187 ) (103,950 )
Interest income 912 503 3,624 1,809
Interest expense (68 ) (13 ) (13 ) (26 )
Other income (expense)   (293 )   (7 )   (388 )   514  
Loss before income taxes (85,246 ) (37,740 ) (269,964 ) (101,653 )
Benefit (provision) from income taxes   312     (491 )   2,894     -  
Net loss $ (84,934 ) $ (38,231 ) $ (267,070 ) $ (101,653 )
Net loss per share, basic and diluted $ (1.70 ) $ (0.85 ) $ (5.46 ) $ (2.33 )
Weighted-average shares outstanding, basic and diluted   49,903     44,967     48,940     43,637  
 

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 U.S. Generally Accepted Accounting Principles (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,

2016     2015 2016     2015
Net loss - GAAP $ (84,934 ) $ (38,231 ) $ (267,070 ) $ (101,653 )
Adjustments:
Non-cash stock-based compensation expense   19,696     13,770     73,579     40,672  
Net loss - Non-GAAP $ (65,238 ) $ (24,461 ) $ (193,491 ) $ (60,981 )
 
Net loss per share, basic and diluted - GAAP $ (1.70 ) $ (0.85 ) $ (5.46 ) $ (2.33 )
Adjustments:
Non-cash stock-based compensation expense per share   0.39     0.31     1.51     0.93  
Net loss per share, basic and diluted - Non-GAAP $ (1.31 ) $ (0.54 ) $ (3.95 ) $ (1.40 )
Weighted average common shares outstanding, basic and diluted   49,903     44,967     48,940     43,637  

Kite Pharma, Inc.
Christine Cassiano
SVP, Corporate Communications & Investor Relations
ccassiano@kitepharma.com
or
Greg Mann
VP, Investor Relations
gmann@kitepharma.com

Source: Kite Pharma, Inc.

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