-
Completed Submission of Biologics License Application (BLA) to the
U.S. Food and Drug Administration (FDA) for Kite's CAR-T Therapy,
Axicabtagene Ciloleucel, in Patients with Aggressive Non-Hodgkin
Lymphoma (NHL)
-
Initiated Two New Clinical Studies as Part of an Expanded KTE-C19
Development Program
-
Advanced Additional New Cell Therapy Candidates Toward Clinical Study
in 2017
-
Expanded Cell Therapy Account Management Capabilities in Anticipation
of Potential Approval and Launch of Axicabtagene Ciloleucel
-
Completed $409.7 Million Follow-On Offering of Common Stock
-
Conference Call to Be Held Today at 5:30 AM PDT / 8:30 AM EDT
SANTA MONICA, Calif.--(BUSINESS WIRE)--
Kite Pharma, Inc. (NASDAQ:KITE), a cell therapy company, today reported
first quarter 2017 financial results and provided a corporate update for
the period ended March 31, 2017.
"Kite is intensely focused on bringing axicabtagene ciloleucel to market
in 2017. Our preparation for the potential commercialization of the
first CAR-T therapy in aggressive non-Hodgkin lymphoma began two years
ago. With the team and infrastructure we now have in place, we are
confident in our readiness to deliver upon potential approval in the
U.S. and expect to file for approval in Europe in the third quarter of
this year," said Arie Belldegrun, M.D., FACS, Chairman, President, and
Chief Executive Officer of Kite. "We are also keeping an eye toward
future growth with additional indications across the KTE-C19 program and
development of earlier stage product candidates, including KITE-585,
which we believe has the potential to become the next significant
opportunity for Kite."
First Quarter 2017 Financial Results
-
Revenues were $9.8 million for the first quarter of 2017.
-
Research and development expenses were $65.9 million for the first
quarter of 2017, which includes $12.7 million of non-cash stock-based
compensation expense.
-
General and administrative expenses were $35.8 million for the first
quarter of 2017, which includes $11.4 million of non-cash stock-based
compensation expense.
-
Net loss was $90.4 million, or $1.74 per share, for the first quarter
of 2017.
-
Non-GAAP net loss for the first quarter of 2017 was $66.3 million, or
$1.28 per share, excluding non-cash stock-based compensation expense
of $24.1 million.
-
As of March 31, 2017, Kite had $804.0 million in cash, cash
equivalents, and marketable securities. A public offering of common
stock generated approximately $409.7 million in gross proceeds to
Kite. In addition, Kite received a $50 million upfront payment related
to its strategic collaboration with Daiichi Sankyo.
2017 Financial Guidance
-
Kite continues to expect the full year 2017 net cash burn to be
between $325 million and $340 million. This guidance assumes GAAP
operating expenses to be between $490 million and $515 million, which
includes approximately $135 million in non-cash stock based
compensation expense. Kite expects 2017 total operating expenses to
consist of approximately 60 percent Research and Development and
approximately 40 percent General and Administrative.
First Quarter 2017 and Recent Highlights
Axicabtagene Ciloleucel/KTE-C19 Progress
-
Presented positive topline results from the primary analysis of the
ZUMA-1 study of axicabtagene ciloleucel in patients with aggressive
non-Hodgkin lymphoma (NHL) at the 2017 American Association of Cancer
Research annual meeting. Data included the 99 percent success rate in
the manufacturing of clinical product patient dose from a single
apheresis for the multi-center ZUMA-1 clinical trial.
-
Completed the submission of a Biologics License Application (BLA) to
the FDA for axicabtagene ciloleucel in patients with aggressive NHL.
-
Initiated ZUMA-5 study of axicabtagene ciloleucel in patients with
follicular NHL.
-
Initiated ZUMA-9 study to provide patients access to axicabtagene
ciloleucel during the regulatory review period.
Strategic Collaborations
-
Entered a strategic collaboration with Daiichi Sankyo to develop and
commercialize axicabtagene ciloleucel in Japan.
-
Established a joint venture with Fosun Pharma to develop and
commercialize T-cell therapies, including axicabtagene ciloleucel, in
China.
Pipeline Expansion
-
Cleared an investigational new drug (IND) application for KITE-718, a
T cell receptor (TCR) cell therapy candidate that targets MAGE-A3/A6
antigens expressed on solid tumors.
Commercial Preparation
-
Started recruitment and training of cell therapy account managers to
support customer service and logistical coordination.
Additional 2017 Clinical Milestones
KTE-C19 and axicabtagene ciloleucel
-
Submit marketing authorization application (MAA) to the European
Medicines Authority (EMA) for axicabtagene ciloleucel in aggressive
NHL in the third quarter of 2017.
-
Availability of preliminary 12-month follow-up data from ZUMA-1 study
of axicabtagene ciloleucel in patients with aggressive NHL.
-
Availability of preliminary follow-up Phase 1 data from ZUMA-3 and
ZUMA-4 studies of pediatric and adult acute lymphoblastic leukemia,
respectively.
-
Advance ZUMA-3 and ZUMA-4 studies into Phase 2.
-
Availability of preliminary data from ZUMA-6 combination study of
axicabtagene ciloleucel and atezolizumab PD-L1 checkpoint inhibitor in
aggressive NHL.
Cell Therapy Pipeline
-
Initiate Phase 1 study of KITE-718 in patients with solid tumors in
the second quarter of 2017.
-
File IND for KITE-585, a CAR T cell therapy candidate that targets
BCMA for the treatment of multiple myeloma, in the third quarter of
2017.
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 obtaining regulatory approval based on the studies of
axicabtagene ciloleucel, commercially launching axicabtagene ciloleucel,
submitting an MAA to the EMA for axicabtagene ciloleucel, and
researching and developing additional product candidates, including
KITE-718 and KITE-585, and meeting the additional 2017 clinical
milestones, and Kite's 2017 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 March 31, 2017. 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 5:30 AM
Pacific Time (8:30 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 44658201.
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MARCH 31, 2017 (unaudited)
|
|
|
DECEMBER 31, 2016
|
ASSETS
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
Cash, cash equivalents, and marketable securities
|
|
|
$
|
804,028
|
|
|
$
|
414,422
|
Prepaid expenses and other current assets
|
|
|
|
15,200
|
|
|
|
12,974
|
Total current assets
|
|
|
|
819,228
|
|
|
|
427,396
|
Restricted cash and investments
|
|
|
|
17,883
|
|
|
|
10,669
|
Property and equipment, net
|
|
|
|
46,241
|
|
|
|
44,409
|
Intangible assets and goodwill, net
|
|
|
|
30,873
|
|
|
|
31,398
|
Other assets
|
|
|
|
9,518
|
|
|
|
10,432
|
Total assets
|
|
|
$
|
923,743
|
|
|
$
|
524,304
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
Accounts payable
|
|
|
$
|
13,214
|
|
|
$
|
10,660
|
Accrued expenses and other current liabilities
|
|
|
|
26,492
|
|
|
|
29,482
|
Deferred revenue
|
|
|
|
39,886
|
|
|
|
15,000
|
Total current liabilities
|
|
|
|
79,592
|
|
|
|
55,142
|
Deferred revenue, less current portion
|
|
|
|
38,177
|
|
|
|
19,779
|
Contingent consideration
|
|
|
|
14,575
|
|
|
|
14,218
|
Other non-current liabilities
|
|
|
|
11,301
|
|
|
|
7,195
|
Total liabilities
|
|
|
|
143,645
|
|
|
|
96,334
|
Total stockholders' equity
|
|
|
|
780,098
|
|
|
|
427,970
|
Total liabilities and stockholders' equity
|
|
|
$
|
923,743
|
|
|
$
|
524,304
|
|
|
|
|
|
KITE PHARMA, INC.
|
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands, except per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
THREE MONTHS ENDED MARCH 31,
|
|
|
2017
|
|
2016
|
Revenues
|
|
$
|
9,836
|
|
|
$
|
5,127
|
|
Operating expenses:
|
|
|
|
|
Research and development
|
|
|
65,906
|
|
|
|
34,414
|
|
General and administrative
|
|
|
35,842
|
|
|
|
16,683
|
|
Total operating expenses
|
|
|
101,748
|
|
|
|
51,097
|
|
Loss from operations
|
|
|
(91,912
|
)
|
|
|
(45,970
|
)
|
Interest income
|
|
|
1,028
|
|
|
|
816
|
|
Interest expense
|
|
|
(4
|
)
|
|
|
-
|
|
Other income (expense)
|
|
|
428
|
|
|
|
29
|
|
Loss before income taxes
|
|
|
(90,460
|
)
|
|
|
(45,125
|
)
|
Benefit from income taxes
|
|
|
61
|
|
|
|
1,209
|
|
Net loss
|
|
$
|
(90,399
|
)
|
|
$
|
(43,916
|
)
|
Net loss per share, basic and diluted
|
|
$
|
(1.74
|
)
|
|
$
|
(0.90
|
)
|
Weighted-average shares outstanding, basic and diluted
|
|
|
51,840
|
|
|
|
48,832
|
|
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 MARCH 31,
|
|
|
2017
|
|
2016
|
Net loss - GAAP
|
|
$ (90,399)
|
|
$ (43,916)
|
Adjustments:
|
|
|
|
|
Non-cash stock-based compensation expense
|
|
24,076
|
|
14,864
|
Net loss - Non-GAAP
|
|
$ (66,323)
|
|
$ (29,052)
|
|
|
|
|
|
Net loss per share, basic and diluted - GAAP
|
|
$ (1.74)
|
|
$ (0.90)
|
Adjustments:
|
|
|
|
|
Non-cash stock-based compensation expense per share
|
|
0.46
|
|
0.30
|
Net loss per share, basic and diluted - Non-GAAP
|
|
$ (1.28)
|
|
$ (0.60)
|
Weighted average common shares outstanding, basic and diluted
|
|
51,840
|
|
48,832
|

View source version on businesswire.com: http://www.businesswire.com/news/home/20170508005428/en/
Kite Pharma, Inc.
Christine Cassiano
SVP, Corporate
Communications & Investor Relations
ccassiano@kitepharma.com
Greg
Mann
VP, Investor Relations
gmann@kitepharma.com
Source: Kite Pharma, Inc.
News Provided by Acquire Media