February 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,
"2015 was a year of solid execution and transformation for Kite," noted
Full Year 2015 and Recent Highlights
Kite's lead multi-center study (ZUMA-1) for KTE-C19 for the treatment
of aggressive, refractory diffuse large B cell lymphoma (DLBCL), primary
mediastinal B cell lymphoma (PMBCL), and transformed follicular
lymphoma (TFL). DLBCL is the most common form of non-Hodgkin Lymphoma
- Announced positive data from the Phase 1 portion
of ZUMA-1 and advanced the study to the pivotal phase. The overall
safety, efficacy, and biomarker data were generally consistent with
data from the National Cancer Institute (NCI).
three additional pivotal multi-center studies of KTE-C19 for the
treatment of relapsed/refractory mantle cell lymphoma (MCL), adult
relapsed/refractory acute lymphoblastic leukemia (ALL), and pediatric
- Received Breakthrough Therapy Designation for KTE-C19 for the treatment of patients with refractory DLBCL, PMBCL, and TFL.
- Secured Orphan Drug Designations in the EU for KTE-C19 for all of Kite's hematological indications.
Kite's clinical manufacturing facility that is manufacturing KTE-C19
and that will manufacture future product candidates.
construction of Kite's commercial manufacturing facility, which is on
track for qualification and validation later this year.
Acquisition and Strategic Collaborations
- Established European operations with the acquisition of
T-Cell Factory, now known as Kite Pharma EU. Through this acquisition, Kite also gained the proprietary TCR-GENErator discovery platform developed by Ton Schumacher, Ph.D., Chief Scientific Officer of Kite Pharma EU.
- Expanded clinical and research partnership with the NCI including:
- An enhanced
Cooperative Researchand Development Agreement (CRADA) with the NCI's Surgery Branch to advance multiple CAR and TCR programs led by Steven Rosenberg, M.D., Ph.D.
separate CRADA with the NCI's Experimental Transplantation and
Immunology Branch to advance the development of a fully human anti-CD19
CAR product candidate.
James Kochenderfer, M.D. is leading the Phase 1 study.
- An enhanced
- Expanded agreement with the
Netherlands Cancer Institutefor the exclusive option to license multiple TCR gene sequences for the development and commercialization of immunotherapy candidates targeting solid tumors.
- Entered into a research and license
agreement with Leiden University Medical Center in the Netherlands to
identify and develop TCR product candidates targeting solid tumors that
are associated with the human papillomavirus (HPV) type 16 infection.
- Partnered with Amgen to develop and commercialize the next generation of novel CAR T cell immunotherapies.
into a collaboration with bluebird bio to advance second-generation TCR
cell therapy products to treat HPV-associated cancers.
- Secured an
exclusive license to Alpine Immune Sciences' transmembrane immunomodulatory protein (TIPTM) technology for eACT-based products.
- Strengthened the organization with the addition of more than 100 new hires across all functions.
- Formed Kite's integrated commercial leadership team, led by
Shawn Tomasello, Kite's Chief Commercial Officer.
- Appointed Dr.
Franz B. Humer, former Chairman and Chief Executive of Roche Holding Ltd., to Kite's Board of Directors.
- Strengthened Kite's
Scientific Advisory Boardwith the addition of James Allison, Ph.D. and Padmanee Sharma, M.D., Ph.D., recognized immunotherapy leaders from MD Anderson Cancer Center.
$272.6 millionin net proceeds from a public offering in December 2015.
interim Phase 2 pivotal data from the ZUMA-1 study for the first 50
patients with 90-day follow-up in the second half of 2016.
- Submit the KTE-C19 registration filing to the
U.S. Food and Drug Administration(FDA) based on interim data from ZUMA-1 study by the end of 2016.
- Expand KTE-C19 clinical program to
Europein preparation for a European registration filing in 2017.
- Complete the qualification and validation testing of the commercial manufacturing facility in
anticipation of pre-approval inspection by the
- Initiate a second series of KTE-C19 studies for additional indications and earlier lines of therapy in DLBCL patients.
- Present longer term follow-up KTE-C19 data in patients with refractory aggressive DLBCL from the Phase 1 portion of ZUMA-1.
- File investigational new drug (IND) application with the
FDAfor a TCR product candidate that targets a MAGE antigen expressed on solid tumors.
- Advance the Kite-Amgen collaboration resulting in the filing of an IND application with the
FDAfor a next generation CAR T cell immunotherapy candidate, the first of multiple INDs expected to originate from the collaboration.
Fourth Quarter and Full Year 2015 Financial Results
- Revenue was
$4.9 millionfor the fourth quarter of 2015 compared to $0for the fourth quarter of 2014, and $17.3 millionfor the full year of 2015, compared to $0for the full year of 2014. The increase was primarily due to revenue recognized under the Kite-Amgen collaboration.
- Research and development expenses were
$28.8 millionfor the fourth quarter of 2015, compared to $7.9 millionfor the fourth quarter of 2014, and $76.4 millionfor the full year of 2015 compared to $23.1 millionin 2014. The full-year increase of $53.3 millionwas primarily attributable to a $31.5 millionincrease in research and development and manufacturing expenses supporting the advancement of KTE-C19 and other programs, $11.8 millionin expenses related to increased personnel and consulting costs, and $10.0 millionof non-cash stock-based compensation expense.
- General and administrative expenses were
$14.1 millionfor the fourth quarter of 2015, compared to $5.4 millionfor the fourth quarter of 2014, and $44.2 millionfor the full year of 2015, compared to $13.6 millionin 2014. The full-year increase of $30.6 millionwas primarily attributable to an $8.2 millionincrease in personnel related expenses, $7.8 millionfor public company expenses and license obligations, and $14.6 millionof non-cash stock-based compensation.
- Net loss attributable to common stockholders was
$38.2 million, or $0.85per share, for the fourth quarter of 2015, compared to $13.0 million, or $0.33per share, for the fourth quarter of 2014. For the full year of 2015, the net loss was $101.7 million, or $2.33per share, compared to $43.7 million, or $1.91per share, in 2014.
- Non-GAAP net loss attributable to common stockholders for the fourth quarter of 2015 was
$24.5 million, or $0.54per share, which excludes non-cash stock-based compensation expense of $13.8 millionfor the fourth quarter of 2015. Non-GAAP net loss attributable to common stockholders for the full year of 2015 was $61.0 million, or $1.40per share, which excludes non-cash stock-based compensation expense of $40.7 millionfor the full year of 2015.
- As of
December 31, 2015, Kite had $614.7 millionin cash, cash equivalents, and marketable securities, compared to $367.0 millionas of December 31, 2014.
- Kite expects the full year 2016 net cash burn to be
$235to $250 million dollars, which includes approximately $20 millionin capital expenditures, but excludes any inflows or outflows from business development activities. The estimated full year 2016 net cash burn is primarily driven by an estimated net loss of $295to $310 million, which includes an estimated $80 millionof non-cash stock-based compensation expense.
press release contains forward-looking statements for purposes of the
safe harbor provisions of the Private Securities Litigation Reform Act
of 1995. The press release may, in some cases, use terms such as
"predicts," "believes," "potential," "proposed," "continue,"
"estimates," "anticipates," "expects," "plans," "intends," "may,"
"could," "might," "will," "should" or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. Forward-looking statements
include statements regarding intentions, beliefs, projections, outlook,
analyses or current expectations concerning, among other things: the
ability and timing of obtaining interim KTE-C19 data and filing a
Biologics License Application with the
Conference Call and Webcast Details
Kite will host a live conference call and webcast today at 4:30PM Eastern Time (
|KITE PHARMA, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash, cash equivalents, and marketable securities||$||614,722||$||367,040|
|Prepaid expenses and other current assets||16,371||1,330|
|Total current assets||631,093||368,370|
|Property and equipment, net||30,116||2,275|
|Intangible assets and goodwill, net||36,740||—|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||11,787||4,405|
|Total current liabilities||36,169||6,725|
|Deferred revenue, less current portion||32,176||—|
|Other non-current liabilities||7,778||1,439|
|Total stockholders' equity||615,760||362,589|
|Total liabilities and stockholders' equity||$||707,963||$||370,753|
|KITE PHARMA, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|THREE MONTHS ENDED|
|YEAR ENDED |
|Research and development||28,794||7,857||76,369||23,089|
|General and administrative||14,127||5,398||44,207||13,569|
|Total operating expenses||42,921||13,255||120,576||36,658|
|Loss from operations||(38,034||)||(13,255||)||(103,318||)||(36,658||)|
|Other income (expense):|
|Other income (expense)||(7||)||(3||)||514||(13||)|
|Total other income (expense)||294||236||1,665||(5,911||)|
|Loss before income taxes||(37,740||)||(13,019||)||(101,653||)||(42,569||)|
|Provision (benefit) from income taxes||491||—||—||—|
|Series A preferred stock dividend||—||—||—||(1,089||)|
|Net loss attributable to common stockholders||$||(38,231||)||$||(13,019||)||$||(101,653||)||$||(43,658||)|
|Net loss per share, basic and diluted||$||(0.85||)||$||(0.33||)||$||(2.33||)||$||(1.91||)|
|Weighted-average shares outstanding, basic and diluted||44,967||38,960||43,637||22,822|
Note Regarding Use of Non-GAAP Financial Measures
Kite provides non-GAAP net loss and non-GAAP net loss per share that include adjustments to GAAP figures. These adjustments to GAAP net loss exclude non-cash stock-based compensation expense. Kite believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Kite's financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Kite's operating results. In addition, these non-GAAP financial measures are among the indicators Kite's management uses for planning purposes and measuring Kite's performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Kite may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer below for a reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.
|KITE PHARMA, INC.|
|RECONCILIATION OF GAAP TO NON-GAAP NET LOSS|
|(In thousands, except per share amounts)|
|THREE MONTHS |
|Net loss attributable to common stockholders - GAAP||$||(38,231||)||$||(101,653||)|
|Non-cash stock-based compensation expense||13,770||40,672|
|Net loss attributable to common stockholders - Non-GAAP||$||(24,461||)||$||(60,981||)|
|Net loss per share attributable to common stockholders, basic and diluted - GAAP||$||(0.85||)||$||(2.33||)|
|Non-cash stock-based compensation per share||0.31||0.93|
|Net loss per share attributable to common stockholders, basic and diluted - Non-GAAP||$||(0.54||)||$||(1.40||)|
|Weighted average common shares outstanding, basic and diluted||44,967||43,637|
Kite Pharma, Inc. Cynthia M. ButittaChief Financial Officer & Chief Operating Officer 310-824-9999 Greg MannVP, Investor Relations firstname.lastname@example.org For Media: Justin Jackson Burns McClellan212-213-0006 email@example.com
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