UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of April 2023
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 18 April 2023, London UK
GSK reaches agreement to acquire late-stage biopharmaceutical
company BELLUS Health
●
Acquisition
further strengthens specialty medicines and respiratory pipeline
with camlipixant,
a highly selective P2X3 antagonist and potential best-in-class
treatment for refractory chronic cough
●
Currently
in phase III clinical development with anticipated regulatory
approval and launch in 2026
● Accretive to adjusted EPS from 2027 with
significant sales potential through 2031
GSK plc (LSE/NYSE: GSK) and BELLUS Health Inc. (TSX/NASDAQ: BLU)
today announced that they have entered into an agreement under
which GSK will acquire BELLUS, a Canada-based, late-stage
biopharmaceutical company working to better the lives of patients
suffering from refractory chronic cough (RCC) for US$14.75 per
share of common stock in cash representing an approximate total
equity value of US$2.0 billion (£1.6 billion). The acquisition
provides GSK access to camlipixant, a potential best-in-class and
highly selective P2X3 antagonist currently in phase III development
for the first-line treatment of adult patients with
RCC.
It is estimated that 28 million patients suffer from chronic cough,
with 10 million patients globally and 6 million in the United
States (US) and European Union (EU) suffering
from RCC
for over a year.[1] RCC
is defined as a
persistent cough for more than eight weeks that does not respond to
treatment for an underlying condition or is otherwise
unexplained.[2] RCC
significantly impacts quality of life, with patients suffering from
depression (53%), urinary incontinence (~50%), pain, rib fractures,
social withdrawal, and loss of sleep.[3],[4] There
are no approved medicines for RCC in the US and
EU.
P2X3 is a validated biological target implicated in cough reflex
hypersensitisation, and camlipixant is a highly selective P2X3
antagonist. Current clinical data show that by selectively
inhibiting P2X3 receptors, camlipixant may reduce cough frequency
for patients suffering from RCC with a relatively low incidence of
dysgeusia, the taste disturbance adverse event associated with
other medicines that broadly target the P2X2/3 receptor. These
taste disturbances frequently lead to patients discontinuing
treatment. Notably, low rates of taste-related adverse events were
reported at all doses in the phase IIb trial
(≤6.5%).[5]
Luke Miels, Chief Commercial Officer, GSK, said: "Patients
suffering from severe forms of refractory chronic cough can
experience over 900 coughs daily, resulting in quality-of-life
issues. Camlipixant,
a novel, highly selective P2X3 antagonist, has the potential to be
a best-in-class treatment with significant sales
potential. This
proposed acquisition complements our portfolio of specialty
medicines and builds on our expertise in respiratory
therapies."
The acquisition of BELLUS is highly synergistic with
GSK's expertise in respiratory medicines and is further supported
by GSK's leading R&D,
manufacturing, and commercialisation
capabilities.
Following the anticipated regulatory approval and launch of
camlipixant in 2026, the acquisition is expected to be accretive to
adjusted EPS from 2027 and has the potential to deliver significant
sales through 2031 and beyond.
In December 2021, BELLUS announced positive data from the SOOTHE
phase IIb trial, indicating that it met its primary endpoint for
the 50 mg and 200 mg twice-daily doses. Based on these data, BELLUS
initiated the CALM phase III development programme consisting of
the CALM-1 and CALM-2 trials, with data anticipated in H2 2024 and
2025, respectively. BELLUS is also evaluating a QD (once-daily)
formulation for camlipixant, which is currently in phase
I.
Roberto Bellini, Chief Executive Officer of BELLUS,
said: "This
acquisition recognises the value of our highly selective P2X3
antagonist camlipixant and
validates the hard work and dedication of all the BELLUS employees
in advancing camlipixant to
date. As a leader in respiratory research for over five decades,
GSK shares our commitment to bettering the lives of individuals
suffering from a persistent cough and is the ideal Company to
rapidly bring camlipixant to
the millions suffering from refractory chronic cough around the
world."
The transaction remains subject to regulatory
approvals.
Financial Considerations
Under the terms of the agreement, the acquisition will be effected
through a Plan of Arrangement pursuant to the Canada Business
Corporations Act in which the shares of BELLUS outstanding will be
acquired by the Company in consideration of US$14.75 per share in
cash. Subject to customary conditions, including court approval,
the approval of the acquisition by at least 66.67% of the votes
cast at a meeting of BELLUS' shareholders and a majority of the
votes cast by non-interested shareholders at such meeting, and
approval by the appropriate regulatory agencies, the transaction is
expected to close in the third quarter of 2023 or
earlier.
The per-share price represents a premium of approximately 103% to
BELLUS' closing stock price on 17 April 2023 and a premium of
approximately 101% to BELLUS' volume-weighted average price (VWAP)
over the last 30 trading days. BELLUS' Board of Directors has
unanimously recommended that BELLUS' shareholders vote in favour of
the approval of the acquisition.
GSK will account for the transaction as a business combination and
expects it to be accretive to adjusted EPS in 2027, the expected
first full year of camlipixant's sales.
There is no change to GSK's full-year 2023 guidance or the
medium-term outlook for 2021-2026 of more than 5% sales and 10%
adjusted operating profit CAGR* at CER**.
* CAGR: Compound Annual Growth Rate; **CER: Constant Exchange
Rate
Advisors
PJT Partners is acting as the exclusive financial advisor to GSK.
Paul, Weiss, Rifkind, Wharton & Garrison LLP, and Stikeman
Elliott LLP serve as legal counsel to GSK in connection with the
transaction. Centerview Partners is acting as the exclusive
financial advisor, and Skadden, Arps, Slate, Meagher & Flom
LLP, and Davies Ward Phillips & Vineberg LLP serve as legal
counsel to BELLUS.
About BELLUS
BELLUS is a late-stage biopharmaceutical company working to better
the lives of patients suffering from persistent cough.
About GSK in respiratory
For over 50 years, GSK has led the way in developing medicines that
advance the management of asthma and COPD, from introducing the
world's first selective short-acting beta agonist in 1969 to
launching six treatments in five years to create today's
industry-leading respiratory portfolio.
About RCC
RCC is a cough that persists for more than eight weeks despite
optimal treatment of any underlying conditions or where there is no
identifiable underlying cause.[6] Cough
hypersensitivity syndrome - excessive coughing, often in response
to relatively innocuous stimuli - is now identified as the primary
pathology in RCC. RCC is a frequent, yet often under-recognised,
medical condition with significant physical, social, and
psychological consequences on a patient's quality of
life. Two-thirds
of patients are women averaging between 50-60 years
old.[7] There
are currently no approved treatments for this condition in the US
or the EU.
About camlipixant
Camlipixant is an investigational, twice-daily oral P2X3 receptor
antagonist for the treatment of RCC, which is currently being
evaluated in the CALM phase III clinical development programme.
Given the need for novel and effective medicines for RCC,
camlipixant has the potential to be a breakthrough in the treatment
landscape.
Camlipixant is not currently approved anywhere in the
world.
About GSK
GSK is a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at gsk.com/company.
GSK enquiries
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Cautionary statement regarding forward-looking statements relating
to BELLUS Health
This press release may include "forward-looking statements" within
the meaning of the applicable securities laws, including with
respect to the timing and completion of the arrangement, the
proposed timing of filings, the impact of the proposed transaction
on BELLUS Heath, and the operations of BELLUS Heath
post-transaction. Each forward-looking statement contained in this
press release is based on the current expectations of management
and is subject to known and unknown risks and uncertainties and
other unknown factors that could cause actual results to differ
materially from historical results and those expressed or implied
by such statement. In addition to statements which explicitly
describe such risks and uncertainties, readers are urged to
consider statements labelled with the terms "believes," "belief,"
"expects," "intends," "anticipates," "will," or "plans" to be
uncertain and forward-looking. Such statements include, but are not
limited to, the potential of camlipixant to successfully treat RCC
and other hypersensitization-related disorders, the success of
BELLUS Health's preclinical studies and clinical trials, and the
timing and outcome of anticipated regulatory approvals. Additional
risk factors include, but are not limited to, the impact of general
economic conditions, general conditions in the pharmaceutical
industry, the impact of the COVID-19 pandemic, including impact to
the initiation and completion of clinical trials in a timely manner
or at all, changes in the regulatory environment, supply chain
impacts, fluctuations in costs, changes to the competitive
environment, reliance on third parties to conduct preclinical
studies and clinical trials for camlipixant. Furthermore, the risks
and uncertainties include, among others, the risk that a condition
to closing of the arrangement may not be satisfied, the risk that
any required shareholder, court or applicable regulatory approvals
for the arrangement may not be obtained or be obtained subject to
conditions that are not anticipated, the failure to realize the
anticipated benefits of the transaction, the occurrence of any
event that could give rise to termination of the transaction, and
potential litigation in connection with the transaction or other
settlements or investigations that may affect the timing or
occurrence of the transaction or result in significant costs of
defence, indemnification and liability.
BELLUS Heath cautions investors not to rely on the forward-looking
statements contained in this press release when making an
investment decision in their securities. Investors are encouraged
to read BELLUS Health's filings available on the SEC website at
www.sec.gov and on the SEDAR website at www.sedar.com, for a
discussion of these and other risks and uncertainties. The
forward-looking statements in this press release speak only as of
the date of this press release and BELLUS Heath undertakes no
obligation to update or revise any of these statements, whether as
a result of new information, future events or otherwise, except as
required by law.
Cautionary statement regarding forward-looking statements relating
to GSK
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
'Risk factors" in the company's Annual Report on Form 20-F for
2022, GSK's Q4 Results for 2022 and any impacts of the COVID-19
pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
[1] Song
et al. The global epidemiology of chronic cough in adults: a
systematic review and meta-analysis. Eur Respir
J. 2015;
45: 1479-1481.
[2] Meltzer
et al. Prevalence and Burden of Chronic Cough in the United
States. J of Allergy
Clin Immunol Pract. 2021;
9:4037-44.
[3] Dicpinigaitis
et al. Prevalence of Depressive Symptoms Among Patients With
Chronic Cough. CHEST.
2006; 130 (6): 1839 - 43.
[4] Chamberlain
et al. The impact of chronic cough: a cross-sectional European
survey. Lung.
2015 Jun;193(3):401-8.
[5] BELLUS
Health Inc. Investor Presentation, Dec 2021.
[6] Meltzer
et al. Prevalence and Burden of Chronic Cough in the United
States. J of Allergy
Clin Immunol Pract. 2021;
9:4037-44.
[7] Morice
et al. A worldwide survey of chronic cough: a manifestation of
enhanced somatosensory response. Eur Respir
J. 2014
Nov;44(5):1149-55.
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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GSK plc
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(Registrant)
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Date: April
18, 2023
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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