[February 28, 2017] |
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Kite Reports Fourth Quarter and Full Year 2016 Financial Results
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
-
Revenues were $4.9 million for the fourth quarter of 2016 and $22.2
million for the full year of 2016.
-
Research and development expenses were $58.9 million for the fourth
quarter of 2016, which includes $8.9 million of non-cash stock-based
compensation expense. For the full year of 2016, research and
development expenses were $197.9 million, which includes $34.7 million
of non-cash stock-based compensation expense.
-
General and administrative expenses were $31.8 million for the fourth
quarter of 2016, which includes $10.8 million of non-cash stock-based
compensation expense. For the full year of 2016, general and
administrative expenses were $97.4 million, which includes $38.8
million of non-cash stock-based compensation expense.
-
Net loss was $84.9 million, or $1.70 per share, for the fourth quarter
of 2016. For the full year of 2016, net loss was $267.1 million, or
$5.46 per share.
-
Non-GAAP net loss for the fourth quarter of 2016 was $65.2 million, or
$1.31 per share, excluding non-cash stock-based compensation expense
of $19.7 million. For the full year of 2016, non-GAAP net loss was
$193.5 million, or $3.95 per share, excluding non-cash stock-based
compensation expense of $73.6 million.
-
As of December 31, 2016, Kite had $414.4 million in cash, cash
equivalents, and marketable securities. In January 2017, Kite received
a $50 million upfront payment from Daiichi Sankyo related to the
recently announced strategic collaboration in Japan.
2017 Financial Guidance
-
Kite expects full year 2017 net cash burn to be between $325 million
and $340 million, which includes approximately $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 approximately $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.
2016 Highlights
Axicabtagene Ciloleucel/KTE-C19 Progress
-
Presented positive interim results from the ZUMA-1 Phase 2 study of
axicabtagene ciloleucel in aggressive NHL in a late-breaker oral
presentation at the 2016 American Society of Hematology (ASH) annual
meeting.
-
Reported a Phase 1 update from the ZUMA-3 and ZUMA-4 trials of KTE-C19
in adult and pediatric relapsed/refractory acute lymphoblastic
leukemia at the 2016 ASH annual meeting.
-
Initiated ZUMA-6, a Phase 1b/2 study of axicabtagene ciloleucel in
combination with the checkpoint inhibitor atezolizumab in patients
with chemorefractory diffuse large B-cell lymphoma (DLBCL) in
collaboration with Genentech.
-
Presented results from SCHOLAR-1, the first patient-level pooled
analysis of outcomes in chemorefractory DLBCL, providing an important
historical benchmark for studies of the disease.
Regulatory Milestones
-
Initiated BLA rolling submission to the FDA for axicabtagene
ciloleucel in December 2016.
-
Received Orphan Drug Designation from the FDA for KTE-C19 in the
treatment of five additional B-cell malignancies, granting Kite the
designation for the major indications in hematologic malignancies in
the US. KTE-C19 also has Orphan Drug Designation in the EU for these
indications.
-
Received Priority Medicines (PRIME) status from the European Medicines
Agency for KTE-C19 in the treatment of chemorefractory DLBCL.
Axicabtagene Ciloleucel Commercial & Manufacturing Readiness
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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.
Pipeline Expansion and Developments
-
Submitted an investigational new drug (IND) application for KITE-718,
a TCR product candidate that targets MAGE-A3/A6 antigens expressed on
solid tumors.
-
Initiated plans to file an IND application in 2017 for KITE-585, a CAR
product candidate targeting B cell maturation antigen (BCMA) for
multiple myeloma.
-
Initiated plans to file IND applications in 2018 for KITE-796, a CAR
product candidate targeting CLL-1 in acute myeloid leukemia (AML), and
for KITE-439, a TCR product candidate targeting human papillomavirus
(HPV)-16 E7 for cervical cancer, head and neck cancer, and other solid
tumors.
Strategic Collaborations
-
Entered into a new Cooperative Research and Development Agreement
(CRADA) for the development of a fully human anti-CD19 CAR product
candidate to treat B-cell malignancies with the National Cancer
Institute (NCI).
-
Licensed intellectual property related to a fully human anti-CD19 CAR
to treat B-cell malignancies from the National Institutes of Health
(NIH).
-
Expanded the TCR portfolio by licensing intellectual property from the
NIH related to multiple TCR product candidates for the treatment of
solid tumors expressing mutated KRAS antigens.
-
Entered into a new CRADA for the development of TCR product candidates
directed against HPV-16 E6 and E7 for the treatment of HPV-associated
cancers with the NCI.
-
Licensed a technology platform from The Regents of the University of
California, on behalf of the University of California, Los Angeles,
for the scalable production of T cells using pluripotent stem cell
lines capable of indefinite self-renewal and designed to overcome
limitations of current allogeneic approaches.
-
Partnered with Leiden University Medical Center to develop TCR product
candidates targeting solid tumors associated with HPV-16 infection.
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 (News - Alert). For more information on Kite, please visit www.kitepharma.com.
Sign up to follow @KitePharma on Twitter (News - Alert) 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.
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KITE PHARMA, INC.
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CONSOLIDATED BALANCE SHEETS
|
(In thousands)
|
(unaudited)
|
|
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DECEMBER 31, 2016
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DECEMBER 31, 2015
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ASSETS
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Current assets
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Cash, cash equivalents, and marketable securities
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|
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$
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414,422
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|
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$
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614,722
|
Prepaid expenses and other current assets
|
|
|
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12,974
|
|
|
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16,371
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Total current assets
|
|
|
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427,396
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|
|
|
631,093
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Restricted cash and investments
|
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|
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10,669
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|
|
|
1,540
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Property and equipment, net
|
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44,409
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30,116
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Intangible assets and goodwill, net
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31,398
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|
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36,740
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Other assets
|
|
|
|
10,432
|
|
|
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8,474
|
Total assets
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|
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$
|
524,304
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|
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$
|
707,963
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LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
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Current liabilities
|
|
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Accounts payable
|
|
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$
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10,660
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|
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$
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8,049
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Accrued expenses and other current liabilities
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29,482
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11,787
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Deferred revenue
|
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15,000
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|
|
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16,333
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Total current liabilities
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|
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55,142
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36,169
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Deferred revenue, less current portion
|
|
|
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19,779
|
|
|
|
32,176
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Contingent consideration
|
|
|
|
14,218
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|
|
|
16,080
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Other non-current liabilities
|
|
|
|
7,195
|
|
|
|
7,778
|
Total liabilities
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|
|
|
96,334
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|
|
|
92,203
|
Total stockholders' equity
|
|
|
|
427,970
|
|
|
|
615,760
|
Total liabilities and stockholders' equity
|
|
|
$
|
524,304
|
|
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$
|
707,963
|
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KITE PHARMA, INC.
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CONSOLIDATED STATEMENTS OF OPERATIONS
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(In thousands, except per share amounts)
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(unaudited)
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THREE MONTHS ENDED DECEMBER 31,
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YEAR ENDED DECEMBER 31,
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2016
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|
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2015
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|
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2016
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2015
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Revenues
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|
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$
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4,907
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|
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$
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4,887
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|
|
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$
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22,170
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|
|
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$
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17,258
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Operating expenses:
|
|
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|
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Research and development
|
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58,902
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|
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28,794
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|
|
|
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197,934
|
|
|
|
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76,369
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General and administrative
|
|
|
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31,802
|
|
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|
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14,316
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|
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|
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97,423
|
|
|
|
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44,839
|
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Total operating expenses
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|
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90,704
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|
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|
|
43,110
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|
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|
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295,357
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|
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|
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121,208
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Loss from operations
|
|
|
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(85,797
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)
|
|
|
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(38,223
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)
|
|
|
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(273,187
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)
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|
|
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(103,950
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)
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Interest income
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|
|
912
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|
|
|
|
503
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|
|
|
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3,624
|
|
|
|
|
1,809
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Interest expense
|
|
|
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(68
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)
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|
|
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(13
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)
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|
|
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(13
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)
|
|
|
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(26
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)
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Other income (expense)
|
|
|
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(293
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)
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|
|
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(7
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)
|
|
|
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(388
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)
|
|
|
|
514
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Loss before income taxes
|
|
|
|
(85,246
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)
|
|
|
|
(37,740
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)
|
|
|
|
(269,964
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)
|
|
|
|
(101,653
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)
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Benefit (provision) from income taxes
|
|
|
|
312
|
|
|
|
|
(491
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)
|
|
|
|
2,894
|
|
|
|
|
-
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Net loss
|
|
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$
|
(84,934
|
)
|
|
|
$
|
(38,231
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)
|
|
|
$
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(267,070
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)
|
|
|
$
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(101,653
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)
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Net loss per share, basic and diluted
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|
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$
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(1.70
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)
|
|
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$
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(0.85
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)
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|
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$
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(5.46
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)
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$
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(2.33
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)
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Weighted-average shares outstanding, basic and diluted
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49,903
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|
|
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44,967
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|
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48,940
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|
|
|
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43,637
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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.
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KITE PHARMA, INC.
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Reconciliation of GAAP to Non-GAAP Net Loss
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(In thousands, except per share amounts)
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(unaudited)
|
|
|
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THREE MONTHS ENDED DECEMBER 31,
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YEAR ENDED DECEMBER 31,
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2016
|
|
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2015
|
|
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2016
|
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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
|
)
|
|
|
|
|
|
|
|
|
|
|
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|
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Net loss per share, basic and diluted - GAAP
|
|
|
$
|
(1.70
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)
|
|
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$
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(0.85
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)
|
|
|
$
|
(5.46
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)
|
|
|
$
|
(2.33
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)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
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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
|
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