Kite Pharmaceuticals, Inc.
Aug 8, 2016

Kite Pharma Reports Second Quarter 2016 Financial Results

Interim Results from Pivotal Phase 2 Portion of ZUMA-1 Clinical Trial of KTE-C19 Expected in Late Third Quarter of 2016

KTE-C19 Biologics License Application Filing Planned in Late 2016; Commercial Launch of KTE-C19 Expected in 2017

Kite Investor Day Scheduled for October 18, 2016

Conference Call to Be Held Today at 4:30pm Eastern Time

SANTA MONICA, Calif.--(BUSINESS WIRE)-- 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 reported financial results for the second quarter 2016 and recent business highlights.

"During the second quarter we continued to expand our pipeline, broaden our engineered cell therapy capabilities through access to key enabling technologies, and advance the development of KTE-C19 as a potential first-to-market breakthrough immunotherapy for patients with advanced non-Hodgkin lymphoma (NHL)," noted Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "We have enrolled all 72 chemorefractory diffuse large B-cell lymphoma (DLBCL) patients in the pivotal portion of our ZUMA-1 study, and Kite remains on track to announce interim data from approximately 50 of these patients at 3-month follow-up later this quarter. Subject to these interim results and discussions with the U.S. Food and Drug Administration (FDA), we expect to submit a Biologics License Application (BLA) for KTE-C19 by the end of 2016. We look forward to sharing details about KTE-C19 commercial preparations, manufacturing readiness and new development programs at our Investor Day and webcast on October 18."

Second Quarter 2016 and Recent Highlights

Second Quarter 2016 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, filing a Biologics License Application with the FDA, obtaining regulatory approval based on the studies of KTE-C19, commercially launching KTE-C19, the ability to research and develop additional product candidates, expectations regarding the clinical effectiveness and safety of KTE-C19, the ability and willingness of the NCI to continue research and development activities pursuant to the CRADA, 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-Q for the quarter ended June 30, 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 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 40985316. 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.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
   
JUNE 30, 2016 DECEMBER 31,
(unaudited) 2015
ASSETS
Current assets
Cash, cash equivalents, and marketable securities $ 531,126 $ 614,722
Prepaid expenses and other current assets   10,472   16,371
Total current assets 541,598 631,093
Property and equipment, net 42,466 30,116
Intangible assets and goodwill, net 35,280 36,740
Other assets   16,331   10,014
Total assets $ 635,675 $ 707,963
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable $ 6,802 $ 8,049
Deferred revenue 16,167 16,333
Accrued expenses and other current liabilities   20,050   11,787
Total current liabilities 43,019 36,169
Deferred revenue, less current portion 25,139 32,176
Contingent consideration 16,685 16,080
Other non-current liabilities   5,376   7,778
Total liabilities   90,219   92,203
Total stockholders' equity   545,456   615,760
Total liabilities and stockholders' equity $ 635,675 $ 707,963
 
KITE PHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(unaudited)
       
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
  2016     2015     2016     2015  
Revenue:
Revenue $ 4,795 $ 4,403 $ 9,922 $ 7,284
Operating expenses:
Research and development 47,356 16,588 81,771 25,849
General and administrative   23,520     9,774     40,013     18,945  
Total operating expenses   70,876     26,362     121,784     44,794  
Loss from operations (66,081 ) (21,959 ) (111,862 ) (37,510 )
Other income (expense):
Interest income 953 498 1,769 965
Interest expense (196 ) (1 ) (322 ) (5 )
Other income (expense)   (30 )   570     (63 )   571  
Total other income   727     1,067     1,384     1,531  
Benefit from income taxes   1,080     -     2,289     -  
Net loss $ (64,274 ) $ (20,892 ) $ (108,189 ) $ (35,979 )
Net loss per share, basic and diluted $ (1.31 ) $ (0.48 ) $ (2.21 ) $ (0.84 )
Weighted-average shares outstanding, basic and diluted   49,157     43,249     48,877     42,860  

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
JUNE 30,
  2016       2015  
Net loss - GAAP $ (64,274 ) $ (20,892 )
Adjustments:
Non-cash stock-based compensation expense   19,758     9,381  
Net loss - Non-GAAP $ (44,516 ) $ (11,511 )
 
Net loss per share, basic and diluted - GAAP $ (1.31 ) $ (0.48 )
Adjustments:
Non-cash stock-based compensation expense per share   0.40     0.22  
Net loss per share, basic and diluted - Non-GAAP $ (0.91 ) $ (0.26 )
Weighted average common shares outstanding, basic and diluted   49,157     43,249  

Kite Pharma, Inc.
Greg Mann
VP, Investor Relations
gmann@kitepharma.com
or
For Media:
inVentiv Health
David Polk, 310-309-1029
david.polk@inventivhealth.com

Source: Kite Pharma, Inc.

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