Blueprint
FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending 03 December
2018
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
Issued: 3 December 2018, London UK - LSE Announcement
GSK reaches agreement to acquire TESARO, an oncology focused
biopharmaceutical company
GlaxoSmithKline plc (LSE/NYSE: GSK) and TESARO Inc (NASDAQ: TSRO)
today announced that the Companies have entered into a definitive
agreement pursuant to which GSK will acquire TESARO, an
oncology-focused company based in Waltham, Massachusetts, for an
aggregate cash consideration of approximately $5.1 billion
(£4.0 billion). The proposed transaction will significantly
strengthen GSK's pharmaceutical business, accelerating the build of
GSK's pipeline and commercial capability in oncology.
TESARO is a commercial-stage biopharmaceutical company, with a
major marketed product, Zejula (niraparib), an oral poly ADP ribose
polymerase (PARP) inhibitor currently approved for use in ovarian
cancer. PARP inhibitors are transforming the treatment of ovarian
cancer, notably demonstrating marked clinical benefit in patients
with and without germline mutations in a BRCA gene (gBRCA). Zejula is currently approved in the US and
Europe as a treatment for adult patients with recurrent ovarian
cancer who are in response to platinum-based chemotherapy,
regardless of BRCA mutation or biomarker
status.
Clinical trials to assess the use of Zejula in "all-comers" patient
populations, as a monotherapy and in combinations, for the
significantly larger opportunity of first line maintenance
treatment of ovarian cancer are also underway. These ongoing trials
are evaluating the potential benefit of Zejula in patients who
carry gBRCA mutations as well as the larger population
of patients without gBRCA mutations whose tumours are HRD-positive and
HRD-negative. Results from the first of these studies, PRIMA, are
expected to be available in the second half of
2019.
GSK also believes PARP inhibitors offer significant opportunities
for use in the treatment of multiple cancer types. In addition to
ovarian cancer, Zejula is currently being investigated for use as a
possible treatment in lung, breast and prostate cancer, both as a
monotherapy and in combination with other medicines, including with
TESARO's own anti-PD-1 antibody (dostarlimab, formerly known as
TSR-042).
In addition to Zejula, TESARO has several oncology assets in its
pipeline including antibodies directed against PD-1, TIM-3 and
LAG-3 targets.
Emma Walmsley, Chief Executive Officer, GSK,
said: "The acquisition of
TESARO will strengthen our pharmaceuticals business by accelerating
the build of our oncology pipeline and commercial footprint, along
with providing access to new scientific capabilities. This
combination will support our aim to deliver long-term sustainable
growth and is consistent with our capital allocation priorities. We
look forward to working with TESARO's talented team to bring
valuable new medicines to patients."
Hal Barron, Chief Scientific Officer and President, R&D, GSK,
said: "Our strong belief
is that PARP inhibitors are important medicines that have been
under appreciated in terms of the impact they can have on cancer
patients. We are optimistic that Zejula will demonstrate benefit in
patients with ovarian cancer beyond those who are BRCA-positive as
front-line treatment. We are also very excited that through this
transaction, we will have the opportunity to work with an
outstanding Boston-based oncology group with deep clinical
development expertise and together we will explore Zejula's
efficacy beyond ovarian cancer into multiple tumour types to help
many more patients."
Lonnie Moulder, Chief Executive Officer, TESARO,
said: "This transaction
marks the beginning of a new global partnership that will
accelerate our oncology business and allow our mission of
delivering transformative products to individuals living with
cancer to endure. Our Board and Management team are very pleased to
announce this transaction, and we are grateful to the management
team at GSK for their tremendous vision and the opportunity to
preserve and build upon the impact we have had in the cancer
community to date."
Mary Lynne Hedley, President and Chief Operating Officer, TESARO,
said: "This partnership
marks an evolution in the way we live out the TESARO mission and
will allow us to more rapidly deliver on our commitment to
patients. I am excited to be partnering with our new colleagues at
GSK as together we advance innovative scientific and drug
development strategies that ultimately enable us to provide more
time for more patients."
Financial highlights
The acquisition price of $75 per share in cash represents a 110%
premium to TESARO's 30 day Volume Weighted Average Price of $35.67
and an aggregate consideration of approximately $5.1 billion
(£4.0 billion) including the assumption of TESARO's net
debt.
Zejula's revenues in its current approved indication as second-line
maintenance treatment for ovarian cancer were $166 million for the
9 months ended 30 September 2018.
GSK expects the acquisition of TESARO and associated R&D and
commercial investments will impact Adjusted EPS for the first two
years by mid to high single digit percentages, reducing thereafter
with the acquisition expected to start to be accretive to Adjusted
EPS by 2022.
GSK's guidance for full-year 2018 Adjusted EPS growth remains
unchanged at 8 to 10% at CER. GSK continues to expect to deliver on
its previously published Group Outlooks to 2020, but following the
acquisition of TESARO now expects Adjusted EPS growth at CER for
the period 2016-2020 to be at the bottom end of the mid to high
single digit percentage CAGR range.
Guidance and Group Outlooks are given on the bases set out on pages
37 and 38 of GSK's Q3 2018 results, including definitions of CER
growth and Adjusted results.
GSK confirms no change to its current dividend policy and continues
to expect to pay 80p in dividends for 2018.
GSK expects to fund the acquisition from cash resources and drawing
under a new acquisition facility.
Structure and Terms of the Transaction
Under the terms of the merger agreement between GSK and TESARO,
unanimously approved by TESARO's Board of Directors, an indirect
subsidiary of GSK will commence a tender offer within the next 10
business days to acquire all of the issued and outstanding shares
of TESARO common stock for a price of $75 per share in cash upon
completion of the offer. The transaction is expected to complete in
the first quarter of 2019, subject to satisfaction of
customary closing conditions, including the tender by TESARO
stockholders of at least one share more than 50% of the issued and
outstanding shares of TESARO and required
regulatory approvals, including clearance by the US Federal
Trade Commission. Following closing of the tender offer, GSK will
acquire any shares of TESARO that are not tendered in the tender
offer through a second-step merger under Delaware law at the tender
offer price.
The value of the gross assets of TESARO to be acquired (as at 30
September 2018) is $711 million (£555 million at the rate of
£1 = $1.28, being the 30 November spot rate). The net
losses of the business were $466 million for the 9 months ended 30
September 2018 (£345 million, at the rate of £1 = $1.35,
being the average rate for the 9 months ended 30 September
2018).
GSK is in discussions with several key executives of TESARO to
ensure their continued employment with the company.
Additional information and where to find it
This press announcement is for informational purposes only and is
neither an offer to purchase nor a
solicitation of an offer or a recommendation to sell securities,
nor is it a substitute for the tender offer
materials that GSK and its indirect subsidiary, Adriatic
Acquisition Corporation, will file with the Securities and Exchange
Commission (the "SEC"). The tender offer for the outstanding shares
of TESARO's common stock described in this press announcement has
not commenced. At the time the tender offer is commenced, GSK and
Adriatic Acquisition Corporation will file, or will cause to be
filed, a Schedule TO Tender Offer Statement with the SEC, and,
thereafter, TESARO will file a Schedule 14D-9
Solicitation/Recommendation Statement with the SEC, in each case
with respect to the tender offer. The Schedule
TO Tender Offer Statement (including an offer to purchase, a
related letter of transmittal and other offer documents) and the
Schedule 14D-9 Solicitation/Recommendation Statement will contain
important information that should be read carefully before any
decision is made with respect to the tender
offer. Those materials (once they
become available) will be made available to TESARO's stockholders
at no expense to them by the information agent for the tender
offer, which will be announced. In addition, those materials and
all other documents filed by or caused to be filed by TESARO or GSK
with the SEC will be available at no charge on the SEC's website
at www.sec.gov . In
addition to the Schedule 14D-9 Solicitation/Recommendation
Statement and Schedule TO Offer Statement (once each becomes
available), TESARO and GSK file or furnish, as applicable, annual,
quarterly and current reports and other information with the SEC.
You may read and copy any reports or other information filed by
TESARO at the SEC public reference room at 100 F Street, N.E.,
Washington, D.C. 20549. Please call the SEC at 1-800-0330 for
further information on the public reference room. TESARO's and
GSK's filings with the SEC are also available to the public from
commercial document-retrieval services and at the SEC's website
at www.sec.gov.
This announcement contains inside information for the purposes of
Article 7 of EU Regulation 596/2014. The person responsible for
arranging the release of this announcement on behalf of GSK is V.A.
Whyte, Company Secretary.
Analyst conference call details
14:00 UK / 09:00 EST Monday 3 December
UK Direct: 01296 480 100
UK freephone: 0800 783 0906
US Direct: +1 718 354 1175
US freephone: + 1866 804 8688
Passcode: 177 245 38
Rest of world dial in numbers:
http://www.btconferencing.com/globalaccess/?bid=54_attended
TESARO portfolio and pipeline
Zejula is an orally active and potent poly ADP-ribose polymerase
(PARP) inhibitor. PARP is a family of proteins involved in many
functions in a cell, including DNA repair, gene expression, cell
cycle control, intracellular trafficking and energy metabolism.
PARP proteins play key roles in single strand break repair through
the base excision repair pathway. PARP inhibitors have shown
activity as a monotherapy against tumours with existing DNA repair
defects, such as BRCA1 and BRCA2, and as a combination therapy when administered
together with anti- cancer agents that induce DNA damage or
activate the immune system.
TESARO's development pipeline also has a number of novel oncology
candidates that modulate the function of the immune system via
different mechanisms. By blocking the interaction of PD-1, TIM-3
and LAG-3 with their respective ligands, antibodies to these
targets aim to restore immune anti-cancer function in patients
across a variety of tumour types.
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Compound
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Indication
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Phase
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Niraparib
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Ovarian cancer maintenance (PRIMA)
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Phase 3
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Niraparib + dostarlimab (anti-PD-1 mAb)
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First-line ovarian cancer treatment (FIRST)
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Phase 3
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Niraparib + anti-PD-1 mAb
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Advanced NSCLC, squamous cell carcinoma of the lung
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Phase 2
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Niraparib + bevacizumab
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First-line ovarian cancer maintenance (OVARIO)
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Phase 2
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Niraparib + bevacizumab
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Recurrent ovarian cancer (AVANOVA) (in collaboration with ENGOT,
the European Network for Gynaecological Oncological Trial
groups)
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Phase 2
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Niraparib + pembrolizumab
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Triple negative breast or ovarian cancer (TOPACIO)
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Phase 2
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Dostarlimab (anti-PD-1 mAb)
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MSI-H tumours including metastatic endometrial cancer
(GARNET)
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Phase 1
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Niraparib + chemotherapy
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Ewing's sarcoma (in collaboration with SARC, the Sarcoma Alliance
for Research through Collaboration)
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Phase 1
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Dostarlimab (anti-PD-1 mAb)
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Various tumour types
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Phase 1
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Dostarlimab +/- bevacizumab + niraparib or
carboplatin-paclitaxel
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Advanced or metastatic cancer
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Phase 1
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TSR-022 (anti-TIM-3 mAb)
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Various tumour types (AMBER)
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Phase 1
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TSR-033 (anti-LAG-3
mAb
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Various tumour types (CITRINO)
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Phase 1
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Anti-LAG-3/PD-1 bispecific antibody
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Various tumour types
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Discovery
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Undisclosed small molecule and antibody I-O candidates
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Various tumour types
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Discovery
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Advisors
GSK is being advised by PJT Partners and
additionally by Bank of America Merrill Lynch,
who is also acting as corporate broker. Legal advice is being
provided by Shearman & Sterling LLP, with Slaughter and
May advising on the acquisition facility.
Citi is serving as TESARO's lead financial advisor, with Centerview
Partners also providing financial advice. Legal advice is being
provided by Ropes & Gray LLP, and Hogan Lovells.
Notes to editors:
About TESARO
TESARO is an oncology-focused biopharmaceutical company
devoted to providing transformative therapies to people facing
cancer. The company is based in Boston and has 763 associates. For
more information, visit www.tesarobio.com,
and follow us on Twitter and LinkedIn.
About GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com.
About GSK Oncology
GSK is focused on delivering transformational therapies for cancer
patients. GSK's pipeline is focused on immuno-oncology, cell
therapy, and epigenetics. Our goal is to achieve a sustainable flow
of new treatments for cancer patients based on a diversified
portfolio of investigational medicines utilising modalities such as
small molecules, antibodies, multi-specific molecules, adjuvants
and cells, either alone or in combination.
About Zejula (niraparib)
Zejula (niraparib) is a poly (ADP-ribose) polymerase (PARP)
inhibitor indicated for the maintenance treatment of adult patients
with recurrent epithelial ovarian, fallopian tube, or primary
peritoneal cancer who are in a complete or partial response to
platinum-based chemotherapy. In preclinical studies, Zejula
concentrates in the tumour relative to plasma, delivering greater
than 90% durable inhibition of PARP 1/2 and a persistent antitumour
effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML),
including some fatal cases, was reported in patients treated with
Zejula. Discontinue Zejula if MDS/AML is confirmed.
Hematologic adverse reactions (thrombocytopenia, anemia and
neutropenia), as well as cardiovascular effects (hypertension and
hypertensive crisis) have been reported in patients treated with
Zejula. Monitor complete blood counts to detect hematologic adverse
reactions, as well as to detect cardiovascular disorders, during
treatment. Zejula can cause fetal harm and females of
reproductive potential should use effective contraception. Please
see full prescribing information, including additional important
safety information, available at www.zejula.com.
About Ovarian Cancer
Approximately 22,000 women are diagnosed with ovarian cancer each
year in the US, and more than 65,000 women are diagnosed annually
in Europe. Ovarian cancer is the fifth leading cause of cancer
death among women. Despite high-response rates to platinum-based
chemotherapy in the second-line advanced treatment setting,
approximately 85% of patients with advanced ovarian cancer will
experience recurrence. Once
ovarian cancer recurs, it's considered
incurable. From
there, with each recurrence, the time a woman may spend without her
cancer progressing until the next recurrence gets
shorter.
About PARP Inhibitor/PARP-1 and PARP-2 Inhibitors
PARP, or poly(ADP-ribose) polymerase, is a family of proteins that
helps repair damaged DNA in cells. A PARP inhibitor like
Zejula may prevent cancer cells from repairing their damaged
DNA, which can cause cancer cells to die. This may slow the return
or progress of cancer. Zejula can also impact other cells and
tissues in the body
About BRCA / HRD
BRCA is a gene that is linked to increased risk for cancer.
Mutations in this gene can prevent DNA repair. Mutations or
aberrations in BRCA or other genes that prevent DNA repair result
in a state of homologous recombination deficiency, or "HRD".
Cancer cells with HRD are especially sensitive to PARP inhibitors,
which have been shown to shrink tumours in patients with HRD and
increase the time in which patients are free from cancer
progression. The genomic tests used to define HRD are evolving. To
date, clinical studies of PARP inhibitors have primarily relied on
tests for BRCA gene mutations to select patients for treatment with
a PARP inhibitor. Other tests, such as MyChoice and FoundationOne
have been used in clinical trials of ovarian cancer to identify
patients whose tumors have HRD and are sensitive to PARP
inhibitors. However, more sensitive tests involving such things as
whole genome screening and functional genomic analyses are needed
to identify additional patients with cancer who might benefit from
treatment with PARP inhibitors.
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GSK enquiries:
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UK Media enquiries:
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Simon Steel
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+44 (0) 20 8047 5502
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(London)
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Tim Foley
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+44 (0) 20 8047 5502
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(London)
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US Media enquiries:
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Sarah Spencer
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+1 215 751 3335
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(Philadelphia)
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Mary Anne Rhyne
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+1 919 483 0492
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(North Carolina)
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Analyst/Investor enquiries:
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Sarah Elton-Farr
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+44 (0) 208 047 5194
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(London)
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Danielle Smith
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+44 (0) 20 8047 7562
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Mel Foster-Hawes
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+44 (0) 20 8047 0674
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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TESARO enquiries:
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Analyst/investor
enquiries:
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Kate Rausch
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+1
781 257 2505
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Media
enquiries
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Kristin Ainsworth
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+1
781 786 7007
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Cautionary
statements regarding forward-looking statements
GSK
cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
Principal risks and uncertainties in the company's Annual Report on
Form 20-F for 2017. Guidance and Group Outlooks are given on the
bases set out on pages 37 and 38 of GSK's Q3 2018 results,
including definitions of CER growth and Adjusted
results. This
communication also includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
related to TESARO and the acquisition of TESARO by GSK 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 TESARO and
members of its senior management team and can typically be
identified by words such as "believe," "expect," "estimate,"
"predict," "target," "potential," "likely," "continue," "ongoing,"
"could," "should," "intend," "may," "might," "plan," "seek,"
"anticipate," "project" and similar expressions, as well as
variations or negatives of these words. Forward-looking statements
include, without limitation, statements regarding the business
combination, similar transactions, prospective performance, future
plans, events, expectations, performance, objectives and
opportunities and the outlook for TESARO's business; the commercial
success of TESARO's products; 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 considering the various closing
conditions; 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 TESARO's stockholders will tender their stock in the
offer; 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 associates,
customers, other business partners or governmental entities;
transaction costs; the risk that the merger will divert
management's attention from TESARO's ongoing business operations;
changes in TESARO's businesses during the period between now and
the closing; risks associated with litigation; and other risks and
uncertainties detailed from time to time in documents filed with
the Securities and Exchange Commission by TESARO, 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
TESARO. All forward-looking statements are based on information
currently available to TESARO, and TESARO assumes no obligation to
update any forward-looking
statements.
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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: December
03, 2018
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By: VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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