-- Immediately Positions Gilead as a Leader
in Cell Therapy --
-- Kite’s Lead CAR T Therapy Candidate,
Axicabtagene Ciloleucel, Under Priority Review in the U.S. and
Expedited Review in the EU --
-- Provides Broad Pipeline in Hematologic
Malignances and Solid Tumors and Robust Platform for Continued
Innovation --
-- Leverages Gilead’s Expertise in Rapidly
Advancing Therapies to Address Unmet Patient Needs --
Gilead Sciences, Inc. (Nasdaq: GILD) and Kite Pharma, Inc.
(Nasdaq: KITE) announced today that the companies have entered into
a definitive agreement pursuant to which Gilead will acquire Kite
for $180.00 per share in cash. The transaction, which values Kite
at approximately $11.9 billion, was unanimously approved by both
the Gilead and Kite Boards of Directors and is anticipated to close
in the fourth quarter of 2017. The transaction will provide
opportunities for diversification of revenues, and is expected to
be neutral to earnings by year three and accretive thereafter.
This Smart News Release features multimedia.
View the full release here:
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Kite is an industry leader in the emerging field of cell
therapy, which uses a patient’s own immune cells to fight cancer.
The company has developed engineered cell therapies that express
either a chimeric antigen receptor (CAR) or an engineered T cell
receptor (TCR), depending on the type of cancer. Kite’s most
advanced therapy candidate, axicabtagene ciloleucel (axi-cel), is a
CAR T therapy currently under priority review by the U.S. Food and
Drug Administration (FDA). It is expected to be the first to market
as a treatment for refractory aggressive non-Hodgkin lymphoma,
which includes diffuse large B-cell lymphoma (DLBCL), transformed
follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma
(PMBCL). The FDA has set a target action date of November 29, 2017
under the Prescription Drug User Fee Act (PDUFA). A marketing
authorization application (MAA) has also been filed for axi-cel for
the treatment of relapsed/refractory DLBCL, TFL and PMBCL with the
European Medicines Agency (EMA), representing the first submission
in Europe for a CAR T therapy. Approval in Europe is expected in
2018. Kite has additional candidates in clinical trials in both
hematologic cancers and solid tumors, including KITE-585, a CAR T
therapy candidate that targets BCMA expressed in multiple
myeloma.
“The acquisition of Kite establishes Gilead as a leader in
cellular therapy and provides a foundation from which to drive
continued innovation for people with advanced cancers,” said John
F. Milligan, PhD, Gilead’s President and Chief Executive Officer.
“The field of cell therapy has advanced very quickly, to the point
where the science and technology have opened a clear path toward a
potential cure for patients. We are greatly impressed with the Kite
team and what they have accomplished, and share their belief that
cell therapy will be the cornerstone of treating cancer. Our
similar cultures and histories of driving rapid innovation in order
to bring more effective and safer products to as many patients as
possible make this an excellent strategic fit.”
Research and development as well as the commercialization
operations for Kite will remain based in Santa Monica, California,
with product manufacturing remaining in El Segundo, California.
“From the release of our pivotal data for axi-cel, to our
potential approval by the FDA, this is a year of milestones. Each
and every accomplishment is a reflection of the talent that is
unique to Kite. We are excited that Gilead, one of the most
innovative companies in the industry, recognized this value and
shares our passion for developing cutting-edge and potentially
curative therapies for patients,” said Arie Belldegrun, MD, FACS,
Chairman, President and Chief Executive Officer of Kite. “CAR T has
the potential to become one of the most powerful anti-cancer agents
for hematologic cancers. With Gilead’s expertise and support, we
hope to fulfill that potential by rapidly accelerating our robust
pipeline and next-generation research and manufacturing
technologies for the benefit of patients around the world.”
Benefits of the
Transaction
Near-term Product Opportunity
- Axi-cel approval for refractory
aggressive non-Hodgkin lymphoma is expected in Q4 2017 in the
United States and in 2018 in Europe
- U.S. commercial launch and
manufacturing preparations complete
- Building infrastructure in Europe
Robust Pipeline and Technology Platform to Drive Future
Growth
- Multiple development programs ongoing
to broaden axi-cel utilization in earlier lines of therapy in
aggressive NHL and other B-cell malignancies
- Advancing additional CAR Ts to treat
multiple myeloma and acute myeloid leukemia
- Progressing TCRs for potential use in
solid tumors
Positions Gilead to be a Global Leader in Oncology and Cell
Therapy
- Cell therapy has generated compelling
clinical data in patients for whom all other treatments have
failed
- Axi-cel, coupled with Kite’s leading
manufacturing capabilities and its portfolio of next-generation
technologies and therapy candidates, will serve as a foundation for
Gilead’s efforts to build an industry-leading cell therapy
franchise
Leverages Gilead’s Core Capabilities to Maximize the Value of
Kite’s Portfolio
- Ability to drive continuous scientific
and medical innovation that improves or replaces existing
products
- Demonstrated ability to scale
complicated manufacturing processes to meet patient demand
- Rapid design and execution of clinical
development programs that shorten development timelines
- Successful track record of launching
innovative, specialty medicines
Transaction Terms
Under the terms of the merger agreement, a wholly-owned
subsidiary of Gilead will promptly commence a tender offer to
acquire all of the outstanding shares of Kite’s common stock at a
price of $180.00 per share in cash. Following successful completion
of the tender offer, Gilead will acquire all remaining shares not
tendered in the offer through a second step merger at the same
price as in the tender offer.
The consummation of the tender offer is subject to various
conditions, including a minimum tender of at least a majority of
outstanding Kite shares on a fully diluted basis, the expiration or
termination of the waiting period under the Hart Scott Rodino
Antitrust Improvements Act, and other customary conditions.
Gilead plans to finance the transaction with a combination of
cash on hand, bank debt and senior unsecured notes. The tender
offer is not subject to a financing condition.
The $180.00 per share acquisition price represents a 29 percent
premium to Kite’s closing on Friday, August 25, and a 50 percent
premium to the company’s 30-day volume weighted average stock
price.
BofA Merrill Lynch and Lazard are acting as financial advisors
to Gilead. Centerview Partners is acting as exclusive financial
advisor to Kite. Jefferies LLC and Cowen and Company, LLC also
provided advice to Kite. Skadden, Arps, Slate, Meagher & Flom
is serving as legal counsel to Gilead and Sullivan & Cromwell
LLP and Cooley LLP are serving as legal counsel to Kite.
Conference Call
At 8:00 a.m. Eastern Time today, Gilead’s management will host a
conference call and a simultaneous webcast to discuss the
transaction. To access the webcast live via the internet, please
connect to the company’s website at www.gilead.com/investors 15
minutes prior to the conference call to ensure adequate time for
any software download that may be needed to hear the webcast.
Alternatively, please call 1-877-359-9508 or 1-224-357-2393
(international) and dial the conference ID 77187238 to access the
call.
A replay of the webcast will be archived on the company’s
website for one year, and a phone replay will be available
approximately two hours following the call through August 30, 2017.
To access the phone replay, please call 1-855-859-2056 (U.S.) or
1-404-537-3406 (international) and dial the conference ID
77187238.
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. On March 31, 2017, Kite submitted a Biologics License
Application to the FDA for its lead product candidate, axi-cel, as
a treatment for patients with relapsed or refractory aggressive
non-Hodgkin lymphoma who are ineligible for autologous stem cell
transplant. Kite received priority review on May 29, 2017 with the
Prescription Drug User Fee Act action date set for November 29,
2017. This submission comes after positive results from Kite’s
ZUMA-1 pivotal trial with axi-cel in patients with chemorefractory
aggressive non-Hodgkin lymphoma. Kite is based in Santa Monica,
California. For more information on Kite, please visit
www.kitepharma.com.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that
discovers, develops and commercializes innovative therapeutics in
areas of unmet medical need. The company’s mission is to advance
the care of patients suffering from life-threatening diseases.
Gilead has operations in more than 30 countries worldwide, with
headquarters in Foster City, California.
Forward-Looking
Statement
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of
1995, related to Gilead, Kite and the acquisition of Kite by Gilead
that are subject to risks, uncertainties and other factors. All
statements other than statements of historical fact are statements
that could be deemed forward-looking statements, including all
statements regarding the intent, belief or current expectation of
the companies’ and members of their senior management team.
Forward-looking statements include, without limitation, statements
regarding the business combination; its effect on Gilead’s revenues
and earnings; the commercial success of Kite’s products; approval
of axi-cel by the FDA; approval of axi-cel by the EMA; the ability
of Gilead to advance Kite’s product pipeline, including axi-cel;
the anticipated timing of clinical data; the possibility of
unfavorable results from clinical trials; filings and approvals
relating to the transaction; the expected timing of the completion
of the transaction; the ability to complete the transaction in a
timely manner or at all; difficulties or unanticipated expenses in
connection with integrating the companies; and the accuracy of any
assumptions underlying any of the foregoing. Investors are
cautioned that any such forward-looking statements are not
guarantees of future performance and involve risks and
uncertainties and are cautioned not to place undue reliance on
these forward-looking statements. Actual results may differ
materially from those currently anticipated due to a number of
risks and uncertainties. Risks and uncertainties that could cause
the actual results to differ from expectations contemplated by
forward-looking statements include: uncertainties as to the timing
of the tender offer and merger; uncertainties as to how many of
Kite’s stockholders will tender their stock in the offer; the
possibility that competing offers will be made; the possibility
that various closing conditions for the transaction may not be
satisfied or waived, including that a governmental entity may
prohibit, delay or refuse to grant approval for the consummation of
the transaction; the occurrence of any event, change or other
circumstance that could give rise to the termination of the merger
agreement; the effects of the transaction (or the announcement
thereof) on relationships with employees, customers, other business
partners or governmental entities; transaction costs; the risk that
the merger will divert management’s attention from Gilead’s or
Kite’s ongoing business operations, as the case may be; and other
risks and uncertainties detailed from time to time in the
companies’ periodic reports filed with the Securities and Exchange
Commission, including current reports on Form 8-K, quarterly
reports on Form 10-Q and annual reports on Form 10-K, as well as
the Schedule 14D-9 to be filed by Kite and the Schedule TO and
related tender offer documents to be filed by Gilead and Dodgers
Merger Sub, Inc., a wholly owned subsidiary of Gilead. All
forward-looking statements are based on information currently
available to Gilead and Kite, and Gilead and Kite assume no
obligation and disclaim any intent to update any such
forward-looking statements.
Additional Information and Where to
Find It
The tender offer described in this document has not yet
commenced. This announcement is neither an offer to purchase nor a
solicitation of an offer to sell shares of Kite. A solicitation and
an offer to buy shares of Kite will be made only pursuant to an
offer to purchase and related materials that Gilead intends to file
with the U.S. Securities and Exchange Commission. At the time the
offer is commenced, Gilead will file a Tender Offer Statement on
Schedule TO with the U.S. Securities and Exchange Commission, and
Kite will file a Solicitation/Recommendation Statement on Schedule
14D-9 with respect to the offer.
Kite stockholders and other investors are urged to read the
tender offer materials (including an Offer to Purchase, a related
Letter of Transmittal and certain other offer documents) and the
Solicitation/Recommendation Statement, in each case as may be
amended from time to time, because they will contain important
information which should be read carefully before any decision is
made with respect to the tender offer. The Offer to Purchase, the
related Letter of Transmittal and certain other offer documents, as
well as the Solicitation/Recommendation Statement, will be sent to
all stockholders of Kite at no expense to them. The Tender Offer
Statement and the Solicitation/Recommendation Statement will be
made available for free at the Commission’s web site at
www.sec.gov. Free copies of these materials and certain other
offering documents will be made available by Gilead by mail to
Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404,
attention: Investor Relations, by phone at 1-800-GILEAD-5 or
1-650-574-3000, or by directing requests for such materials to the
information agent for the offer, which will be named in the Tender
Offer Statement.
In addition to the Offer to Purchase, the related Letter of
Transmittal and certain other offer documents, as well as the
Solicitation/Recommendation Statement, Gilead and Kite file annual,
quarterly and special reports, proxy statements and other
information with the Securities and Exchange Commission. You may
read and copy any reports, statements or other information filed by
Gilead or Kite at the SEC public reference room at 100 F Street,
N.E., Washington, D.C. 20549. Please call the Commission at
1-800-SEC-0330 for further information on the public reference
room. Gilead’s and Kite’s filings with the Commission are also
available to the public from commercial document-retrieval services
and at the website maintained by the Commission at www.sec.gov.
For more information on Gilead Sciences,
please visit the company’s website at www.gilead.com, follow
Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170828005415/en/
GileadSung Lee, 650-524-7792InvestorsorAmy Flood,
650-522-5643MediaorKiteChristine Cassiano,
424-532-5084Investors & Media
Grafico Azioni KITE PHARMA, INC. (NASDAQ:KITE)
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