TIDMDNL
RNS Number : 3289B
Diurnal Group PLC
20 September 2018
20 September 2018
Diurnal Group plc
("Diurnal" or the "Group" or "Company")
Results for the year ended 30 June 2018
A transformational year as the Group reports first commercial
revenues
Further key clinical and regulatory milestones expected in the
next 12 months
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces its audited results for the year ended 30 June
2018.
Operational highlights
-- Grant of a paediatric use marketing authorisation (PUMA) by
the European Commission for Alkindi(R) (hydrocortisone granules in
capsules for opening) as replacement therapy of adrenal
insufficiency (AI) in infants, children and adolescents (from birth
to < 18 years old)
-- First launch of Alkindi(R) in Germany as replacement therapy of paediatric AI
-- Completion of patient recruitment for the European Phase III
trial of Chronocort(R) (modified-release hydrocortisone) in
congenital adrenal hyperplasia (CAH)
o Headline data expected during early Q4 2018
-- Grant of first US patent for Chronocort(R) and grant of first
Japanese patents for Alkindi(R) and Chronocort(R)
-- Marketing and distribution agreement with Emerge Health for
Alkindi(R) and Chronocort(R) in Australia and New Zealand
executed
Financial overview
-- Successful completion of GBP10.5m placing with institutional
and private investors to fund further development of Diurnal's
late-stage pipeline
-- First commercial revenues recorded for the period from launch in May 2018
-- Operating loss of GBP16.8m (2016/17: GBP12.1m) reflecting
increased investment in clinical and development activities and
build-out of commercial organisation
-- Held to maturity financial assets, cash and cash equivalents
at 30 June 2018 of GBP17.3m (30 June 2017: GBP19.9m)
-- Net cash used in operating activities was GBP12.8m (2016/17:
GBP10.5m), in line with the Board's expectations
Post-period highlights
-- Treatment phase of European Phase III trial of Chronocort(R) in CAH completed
Martin Whitaker, PhD, Chief Executive Officer of Diurnal,
commented:
"Diurnal has had a transformational year, with the approval of
our first product, Alkindi(R) , and delivery of our first
commercial revenues following its launch in Germany in May 2018. We
have also made excellent progress with our late-stage pipeline, in
particular the completion of recruitment and treatment in our
Chronocort(R) European Phase III study, which is expected to report
headline data in Q4 2018, and with the establishment of a clear
regulatory path in the US. With a number of key clinical and
regulatory milestones due in the next 12 months, we believe that
Diurnal is entering a very exciting period as it executes its
strategy to become a world-leading, endocrinology focused
speciality pharmaceutical company."
This announcement contains insider information for the purposes
of Article 7 of Regulatory (EU) No596/2014.
For further information, please visit www.diurnal.co.uk or contact:
+44 (0)20 3727
Diurnal Group plc 1000
Martin Whitaker, Chief Executive Officer
Richard Bungay, Chief Financial Officer
Panmure Gordon (UK) Limited (Nominated Adviser +44 (0) 20 7886
and Joint Broker) 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: James Stearns
+44 (0)20 7894
Cantor Fitzgerald Europe (Joint Broker) 7000
Corporate Finance: Phil Davies, Will Goode,
Michael Boot
Healthcare Equity Sales: Andrew Keith
+44 (0)20 3727
FTI Consulting (Media and Investor Relations) 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
About Diurnal
Founded in 2004, Diurnal is a UK-based specialty pharma company
developing high quality products for the global market for the
life-long treatment of chronic endocrine conditions, including
Congenital Adrenal Hyperplasia and Adrenal Insufficiency. Its
expertise and innovative research activities focus on
circadian-based endocrinology to yield novel product candidates in
the rare and chronic endocrine disease arena.
For further information about Diurnal, please visit
www.diurnal.co.uk
Forward looking statements
Certain information contained in this announcement, including
any information as to the Group's strategy, plans or future
financial or operating performance, constitutes "forward-looking
statements". These forward-looking statements may be identified by
the use of forward-looking terminology, including the terms
"believes", "estimates", "anticipates", "projects", "expects",
"intends", "aims", "plans", "predicts", "may", "will", "seeks"
"could" "targets" "assumes" "positioned" or "should" or, in each
case, their negative or other variations or comparable terminology,
or by discussions of strategy, plans, objectives, goals, future
events or intentions. These forward-looking statements include all
matters that are not historical facts. They appear in a number of
places throughout this announcement and include statements
regarding the intentions, beliefs or current expectations of the
Directors concerning, among other things, the Group's results of
operations, financial condition, prospects, growth, strategies and
the industries in which the Group operates. The directors of the
Company believe that the expectations reflected in these statements
are reasonable, but may be affected by a number of variables which
could cause actual results or trends to differ materially. Each
forward-looking statement speaks only as of the date of the
particular statement.
By their nature, forward-looking statements involve risks and
uncertainties because they relate to events and depend on
circumstances that may or may not occur in the future or are beyond
the Group's control. Forward-looking statements are not guarantees
of future performance. Even if the Group's actual results of
operations, financial condition and the development of the
industries in which the Group operates are consistent with the
forward-looking statements contained in this document, those
results or developments may not be indicative of results or
developments in subsequent periods.
Chairman's Statement
During the last financial year, Diurnal continued to deliver
against key milestones, culminating in the Group's first commercial
product launch in May 2018 and generation of our first product
revenues. This puts Diurnal amongst a small group of UK companies
that have successfully taken a product from initial concept all the
way to commercialisation. It has been possible due to a clear
strategy, highly skilled staff, the support of physicians and
patient groups, the backing of our investors and not least the
patients who take part in our clinical trials.
Delivering on strategy
With the recent launch of Alkindi(R) , Diurnal has become a
fully integrated organisation with the capabilities to successfully
design, develop and commercialise innovative products that address
key unmet patient needs in chronic endocrine diseases. In the
short-term, Diurnal has in place plans to roll out Alkindi(R)
across key European markets, whilst maximising the potential for
this product elsewhere through entry via local distribution or
licensing arrangements. In the medium term, Diurnal plans to use
the same infrastructure to commercialise Chronocort(R) in Europe,
following the anticipated successful completion of the European
Phase III study in congenital adrenal hyperplasia (CAH) and
subsequent regulatory approval. Diurnal is also exploring the
potential for Chronocort(R) in adrenal insufficiency (AI), a much
larger market opportunity, as well as other potential indications.
By leveraging its late-stage portfolio in this way, Diurnal
believes that it can build a cash-generative business, providing
the capability to invest both in its own innovative product
portfolio as well as seeking new opportunities from external
sources, to drive long-term growth for shareholders.
Diurnal's product development pipeline primarily comprises novel
formulations of existing pharmaceutical agents, which the Board
believes provides a lower development risk profile for investors,
while providing substantial upside through successful registration
and commercialisation of these products. Development of
pharmaceutical products remains challenging across the industry,
particularly in relation to evolving regulatory requirements and
the pricing of pharmaceutical products. Pricing of novel,
innovative products that are based upon existing active ingredients
presents a particular pricing challenge. Diurnal believes that by
focusing on rare and orphan diseases in the endocrine space, it can
gain great insights into the burden of living with these diseases
through our interactions with physicians and patient groups, and
consequently is able to develop high-quality products that
demonstrate clear clinical benefits, both to physicians and
payers.
Significant operational progress
During the year, Diurnal has continued to make significant
progress with its innovative late-stage pipeline, focused on
diseases of cortisol deficiency, meeting key milestones that
underpin its future growth plans. In Europe, where Diurnal plans to
build an in-house commercialisation capability, Alkindi(R) was
approved in February 2018 and patient recruitment was completed in
the Chronocort(R) European Phase III trial in the same month.
Alkindi(R) was launched in Germany, utilising the highly
experienced commercial team that Diurnal has built with Ashfield
Healthcare (Ashfield), with further product launches planned over
the coming months. In the US, where Diurnal's current plans are to
seek a commercialisation partner, significant progress has been
made in defining the regulatory path for these products, with
Alkindi(R) approaching the end of its Phase III development
programme and the Chronocort(R) registration studies scheduled to
commence in early Q4 2018. This progress was underpinned by the
grant of key Alkindi(R) and Chronocort(R) patents during the year.
In these key markets, Diurnal's late-stage pipeline is protected
not only by an extensive patent portfolio, but also by strong
regulatory designations providing data and market exclusivity on
approval.
Outside of these territories, the Group continued to maximise
the value of its late-stage development pipeline with the entry
into a distribution arrangement for Australia and New Zealand, and
the grant of key Alkindi(R) and Chronocort(R) patients in
Japan.
Strong financial position
Diurnal's IPO in December 2015, raising GBP30m before expenses,
put it in a strong position to build a platform for growth. The
Group further strengthened its financial position through the
successful completion of a GBP10.5m fundraising in April 2018,
which has enabled it to pursue the US development of Chronocort(R)
, with the Phase III registration study in CAH due to commence
shortly. Diurnal also believes that it is well placed to raise the
further funds required to reach sustainable profitability. I would
like to thank our existing and new shareholders for their support
as Diurnal aims to make a real difference to patients without
effective treatment options for chronic endocrine diseases.
Governance and risk management
As the Group continues its rapid growth, the Board and senior
management remain focused on maintaining a strong system of
internal controls and appropriate risk management systems, to
ensure that this growth is well-controlled and does not compromise
the integrity of the organisation. During the year, the Group
formally adopted the QCA Corporate Governance code, although in
large part this represents a formalisation of existing governance
practices of the Group.
The Board continues to monitor the potential effects of Brexit
on the Group's business and, in particular, any impact on the
regulatory framework for pharmaceutical product development,
approval and commercialisation, as well as potential disruption in
movement of goods between the UK and Europe. Diurnal made the
decision some time ago to place its commercial supply chain
entirely within Europe, in order to minimise any cross-border
trading impacts on the commercialisation Alkindi(R) across Europe
and continues to assess developments closely in the run up to
Brexit in March 2019.
People and culture
Throughout the period of rapid growth over the last few years,
Diurnal has managed to retain an entrepreneurial culture, both in
its direct employees and also in the commercial team built with
Ashfield and the highly skilled contractors and consultants who
support the business. The Board closely monitors the corporate
culture through discussions with the executive management to ensure
that it remains consistent with its strategy of being a small,
focused specialty pharmaceutical player focused in the endocrine
area. I would like to thank our employees for their continued
support and hard work in driving the Group's successful
commercialisation of its first product, whilst continuing to
develop our innovative pipeline products to provide a solid
platform for our future growth.
Key milestones expected in the next 12 months
The next 12 months are expected to see further significant
progress in Diurnal, with two major regulatory filings anticipated
within the next year and continued launches of Alkindi(R) in key
European markets. The next key milestone following the completion
of recruitment and treatment in the Chronocort(R) European Phase
III study for CAH is the report of headline data, expected in Q4
2018. Diurnal also plans to investigate the potential of
Chronocort(R) in the larger AI market alongside the US registration
study for Chronocort(R) in CAH. The Group continues discussions
with interested parties to access key markets outside of Europe,
and also remains mindful of external growth opportunities and
continues to assess endocrinology assets that fit within its
disease focus. Diurnal also expects to complete a further
fundraising during the next year in order to support its growth
plans.
I look forward with optimism and believe the Group is
increasingly well positioned to achieve its ambition of becoming a
world-leading, endocrinology-focused specialty pharma company,
delivering significant value for our shareholders.
Peter Allen
Chairman
19 September 2018
Operational Review
This has been a transformational year for the Group, receiving
approval for its first product Alkindi(R) , in Europe, successfully
launching Alkindi(R) in Germany in May 2018 and securing its first
commercial sales.
With progress made over the past year, Diurnal believes that it
can become one of the few UK biotechnology companies to
successfully take multiple products from concept to
commercialisation.
In keeping with the Group's strategy set out at IPO, Diurnal
believes that developing novel products containing
well-characterised active ingredients targeting endocrine
conditions with high unmet needs offers a lower risk approach than
developing new chemical entities, whilst retaining exclusivity
through orphan drug and regulatory routes. Following our
achievements in Europe, this approach can now be expanded to other
territories worldwide and specifically the initiation of clinical
studies in the US following the success fundraising of GBP10.5
million during the year.
Late-stage pipeline: challenging diseases of cortisol
deficiency
Diurnal's late-stage development pipeline is targeting disorders
of the adrenal axis with two novel formulations of
hydrocortisone.
Congenital adrenal hyperplasia (CAH) is an orphan condition
caused by deficiency of adrenal enzymes, most commonly
21-hydroxylase, which is required to produce cortisol. The block in
the cortisol production pathway causes the over-production of male
steroid hormones (androgens), which are precursors to cortisol. The
condition is congenital and affects both sexes. The cortisol
deficiency and over-production of male sex hormones can lead to
increased mortality, infertility and severe development defects
including ambiguous genitalia, premature (precocious) sexual
development and short stature. Sufferers, even if treated, remain
at risk of death through an adrenal crisis. The condition is
estimated to affect approximately 47,000 patients in Europe and
17,000 patients in the US, with approximately 400,000 patients in
the rest of the world.
Adrenal insufficiency (AI) is a condition characterised by
deficiency in cortisol, an essential hormone in regulating
metabolism and the response to stress. The primary symptoms of AI
are chronic fatigue and patients are at risk of adrenal crisis and
death if they do not have adequate cortisol replacement. AI is
either primary or secondary, with primary AI resulting from
diseases intrinsic to the adrenal gland and secondary AI resulting
from pituitary diseases where there is a failure of stimulation of
the adrenal gland by the pituitary gland. The condition is
estimated to affect approximately 296,000 patients in Europe and
138,000 patients in the US, with approximately 4 million patients
in the rest of the world.
Paediatric AI (including CAH) has been identified as an orphan
disease in the US where there are estimated to be approximately
4,500 sufferers under the age of 16. In Europe there are estimated
to be around 10,000 suffers under the age 18. Untreated, the
disease is associated with significant morbidity and increased
mortality.
Alkindi(R) : first approval and commercial revenues in
Europe
In December 2017, the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) recommended
granting a paediatric use marketing authorisation (PUMA) for
Alkindi(R) (hydrocortisone granules in capsules for opening) for
the treatment of primary AI. The positive opinion from the CHMP was
based on review of data from the Group's pivotal open-label Phase
III clinical trial conducted in 24 subjects before their sixth
birthday, requiring replacement therapy for AI due to CAH, primary
adrenal failure or hypopituitarism. The study successfully met its
primary endpoint and no serious adverse events were reported. Based
on these data, and a comprehensive market authorisation application
dossier from Diurnal, the CHMP recommended the product's use to
include paediatric patients up to 18 years of age. This expansion
of Alkindi(R) 's label, beyond the anticipated label of use in
children aged up to six years old, provides Diurnal with a much
broader commercial opportunity for Alkindi(R) in Europe.
Subsequently, in February 2018 the CHMP opinion was adopted by the
European Commission enabling EU-wide marketing authorisation for
Alkindi(R) .
Following the grant of marketing authorisation, decisions about
price and reimbursement will take place at the level of each
European Member State. As part of the pan-European
commercialisation programme for Alkindi(R) , Diurnal is currently
in discussion with various health authorities to ensure timely
launches in all major European countries.
The first of these launches occurred during May 2018 in Germany,
with the Alkindi(R) price being in line with the Group's
expectations and published in the LAUER-TAXE(R) (the reference for
all German pharmacies, insurers and wholesalers). Given the
concentrated endocrinologist prescribing base, and to retain the
full value of the product, Diurnal is commercialising Alkindi(R)
itself in major European markets, focusing its marketing efforts
initially on patients aged 0-6 years where the unmet need is
highest. Diurnal has established the commercial infrastructure
required to support a successful launch of Alkindi(R) working
closely with Ashfield to supplement Diurnal's small, but very
experienced in-house commercial team. The Diurnal European-wide
team consists of 14 individuals in place in key European
territories and fully integrated with Diurnal's in-house team.
Diurnal has now completed implementation of the commercial
supply chain with leading global service providers for
manufacturing, packaging and distribution that are completely
located within the EU.
Chronocort(R) : targeting effective disease control in
adults
Chronocort(R) is a modified-release preparation of
hydrocortisone that has been designed to mimic the circadian rhythm
of cortisol when given in a twice-a-day "toothbrush" regimen (last
thing at night before sleep and first thing in the morning on
waking). The first planned indication for Chronocort(R) is CAH in
adults and the clinical data in patients from a successfully
completed Phase II trial demonstrated that Chronocort(R) was able
to control CAH (as determined by control of androgens) in 94% of
patients after receiving Chronocort(R) for six months.
Chronocort(R) is currently in a Phase III trial in Europe, which
during the year successfully completed enrolment of 122 patients
with CAH across seven countries and eleven clinical trial sites.
Patients being treated for CAH with combinations of generic
steroids (standard of care) were enrolled on the trial and
randomised to either Chronocort(R) on a twice-daily regime or
continued their standard-of-care regimen. The primary endpoint of
the trial is the control of androgens on the same or lower total
daily dose of steroid when treated with Chronocort(R) when compared
to standard-of-care treatment. This primary endpoint is identical
to the previously successful Phase II clinical trial for
Chronocort(R) . Secondary and exploratory endpoints include an
assessment of body mass index, bone turnover and levels of fatigue.
The last patient was dosed after the year end and the initial
read-out on the primary endpoint is expected during Q4 2018.
An open label safety extension trial of long-term safety,
efficacy and tolerability of Chronocort(R) in patients with CAH,
previously enrolled in the Phase III registration trial, is
continuing with over 80% of patients rolling over into this trial
and, of those patients enrolling, the proportion of patients
remaining within the trial has been very high (>90%). This trial
is intended to provide further valuable safety data to support the
registration and commercialisation of Chronocort(R) .
Significant progress in defining the regulatory path in the
US
The US remains the second most important market for Diurnal's
late-stage pipeline, with an estimated 17,000 patients suffering
from CAH and an estimated 138,000 sufferers with AI.
During the period, the Group announced that it had entered into
an agreement with Worldwide Clinical Trials (Worldwide) to support
the US clinical development of Chronocort(R) in both CAH and
AI.
Working with Worldwide, Diurnal will conduct the US Phase III
registration trial and follow-on study for Chronocort(R) for the
treatment of CAH. Following recent progress in the Group's
discussions with the US Food and Drug Administration (FDA), Diurnal
expects to initiate the Phase III study in early Q4 2018. The Phase
III study will recruit around 150 patients with CAH, who will be
randomised to either receive Chronocort(R) twice-daily or
standard-of-care. Patients in the study will be treated for 12
months, with the primary endpoint of the study being the proportion
of patients achieving biochemical control with Chronocort(R) or
standard of care. A number of secondary endpoints including weight,
body composition, hirsutism, fatigue and quality of life will be
used to determine clinical benefit of Chronocort(R) over standard
of care.
In advance of the start of the US Phase III pivotal trial,
Diurnal completed a bioavailability study post period, which
demonstrated that subjects dosed with Chronocort(R) had comparable
exposure to hydrocortisone when compared to subjects dosed with
immediate-release hydrocortisone. This bioavailability study will
form part of the regulatory package to support the registration of
Chronocort(R) for CAH in the US.
In addition, Diurnal is seeking to pave the way for future
indication expansion opportunities with Chronocort(R) through the
initiation of a Phase II proof-of-concept study in AI patients.
Worldwide will also conduct this Phase II study, which is expected
to commence around the end of 2018.
For Alkindi(R) , during the year, Diurnal successfully completed
a food matrix compatibility study, which is supportive of the
package of data that the Group believes is required by the FDA for
successful registration of the product in the US. This study was a
single centre, open label, randomised, single dose crossover study
in 18 healthy adult subjects. The primary objective of the study
was to evaluate the bioavailability of Alkindi(R) multi-particulate
granules administered as sprinkles onto soft food or yoghurt
compared with direct administration to the back of the mouth. The
results of the study confirm that the pharmacokinetics of
Alkindi(R) when sprinkled onto soft food or yoghurt are equivalent
to Alkindi(R) administered directly. There were no adverse events
and Alkindi(R) was well tolerated.
In addition, a second Alkindi(R) study assessing bioequivalence
to adult doses of hydrocortisone was started and fully enrolled
during the period. This bioequivalence study is anticipated to read
out during Q4 2018 and, together with the food matrix compatibility
study, and Alkindi(R) European data, will be submitted for review
to the FDA around the end of 2018 with a view to submitting an NDA
in 2019 with approval anticipated during 2020.
Endocrine focused early-stage pipeline
Diurnal aspires to be a significant participant in the
endocrinology field with a pipeline of therapies targeting multiple
endocrine disorders.
The Group continues the proof-of-concept Phase I/II study with
its native oral testosterone product, DITEST(TM), for the treatment
of male hypogonadism. This study is designed to evaluate the
pharmacokinetics, safety, tolerability and food effect of
DITEST(TM) in male patients with hypogonadism. The study is
expected to complete around the end of 2018.
The Group continues to assess the potency of different
formulations of its oligonucleotide (siRNA) therapy, targeted to
the pituitary gland, for the potential treatment of Cushing's
Disease (cortisol excess).
The Group continues with plans to finalise development of a
modified-release T3 (triiodothyronine) for the treatment of
hypothyroidism where the needs of up to 25% of patients on existing
replacement therapy, T4 (thyroxine), are not being adequately
met.
The Group continues to explore other indications that may
benefit from Chronocort(R) , such as inflammatory diseases.
Delivering on the Group's marketing and distribution
strategy
Geographic expansion of Alkindi(R) and Chronocort(R) outside the
Group's stated core markets is an important element of Diurnal's
broader commercialisation strategy and further progress was made in
this respect during the year.
In February 2018, a marketing and distribution agreement with
Emerge Health, a leading, specialised Australian pharmaceutical
company focused on the marketing and sales of niche, high quality
medicines to the hospital sector, was executed for Alkindi(R) and
Chronocort(R) in Australia and New Zealand. Under the terms of the
agreement, Emerge Health will receive the exclusive rights to
market and sell Alkindi(R) and Chronocort(R) in Australia and New
Zealand. Diurnal will provide Emerge Health with product from its
established European supply chain. Diurnal anticipates the market
authorisation of Alkindi(R) in Australia during 2020.
The Group continues to work closely with Medison Pharma Limited,
Israel's leading group for the marketing of innovative niche
healthcare solutions, with whom Diurnal executed a marketing and
distribution agreement in 2017, with anticipated market
authorisation of Alkindi(R) in Israel during 2020.
Diurnal continues to assess opportunities for similar agreements
in selected high-value markets which can utilise existing
regulatory data sets.
Further strengthening of the in-market exclusivity position
Diurnal continues to protect its product candidates through a
robust and extensive patent portfolio.
During the year, the Group received notification of grant of the
first of its US Chronocort(R) patents: a composition of matter
patent for the product formulation for use as a treatment for
conditions such as AI. The Group also received grant of its first
Japanese patents for Alkindi(R) and Chronocort(R) and, post-period
end, a notice of grant in Japan for a second Alkindi(R) patent.
These granted patents provide in-market protection for Alkindi(R)
to 2034 and for Chronocort(R) until 2033. The Group expects to
continue to expand patent coverage for its products in the
future.
Diurnal's late-stage products are targeting rare and orphan
diseases and, therefore, in addition to the strong and expanding
patent portfolio, have the benefit of additional regulatory
protection in key markets. In Europe, the EMA offers 10 years of
exclusivity (eight years' data plus two years' market exclusivity)
through a PUMA, which serves as an inducement for pharmaceutical
manufacturers to specifically develop therapies for use in the
paediatric population. During the year, the grant of the marketing
authorisation by the European Commission confirmed that Alkindi(R)
has PUMA status and therefore exclusivity until 2028. Chronocort(R)
already benefits from granted orphan drug designations in Europe
for both CAH and AI, meaning that it has the potential to have 10
years' market exclusivity post-approval. In the US, the FDA has
granted Chronocort(R) orphan drug designation in the treatment of
both CAH and AI and granted Alkindi(R) orphan drug designation in
the treatment of paediatric AI, which affords seven years market
exclusivity post-approval.
Outlook
The Group is well positioned to build on the approval of its
first product Alkindi(R) , and to become a fast growing,
independent, international specialty pharmaceutical company
focusing on creating products that address unmet patient needs in
endocrinology. Together with its other late-stage product,
Chronocort(R) , Diurnal has the opportunity to build a valuable
life-long adrenal franchise, providing critical medicines in
underserved disease of cortisol deficiency, and believes that it is
well-positioned to raise the funding required to support these
growth plans. With the European Chronocort(R) trial now completed
and on track to read out during Q4 2018, the Group believes that a
recommendation for approval could be forthcoming in 2020.
Reflecting a combined cortisol deficiency market size of over
400,000 patients in Europe and US alone, in addition to further
opportunities beyond these two territories, the Board believes that
the potential for Diurnal is very positive.
Martin Whitaker
Chief Executive Officer
19 September 2018
Financial Review
Revenues
The Group achieved a significant milestone during the year, with
the recording of its first commercial revenues, following the
launch of Alkindi(R) in Germany in May 2018. Total revenues
recorded for the year were GBP73k (2017: nil), which is net of
provisions for stock placed into the wholesale distribution chain
on a sale-or-return basis.
Operating income and expenses
Operating expenses are in a growth phase, reflecting the
investment in headcount and business infrastructure to support the
transition of the business to a fully integrated speciality pharma
organisation with commercialisation capabilities in Europe,
alongside increased investment in developing the late-stage
clinical pipeline. This continued investment in the business will
support its anticipated growth and development in the coming
years.
Research and development expenditure for the year was GBP10.0m
(2017: GBP8.3m). Expenditure on product development and clinical
costs increased during the year as the Group progressed towards
completion of recruitment for the Chronocort(R) Phase III
registration trial in Europe and transitioned patients completing
this study into the long-term follow-on study, as well as
commencing studies to support both the Alkindi(R) and Chronocort(R)
US Phase III programmes and planning activities for the
commencement of a Phase II trial for Chronocort(R) in AI, to be
conducted in the US, around the end of 2018.
As previously highlighted in the interim report for the six
months ended 31 December 2017, the approval of the Alkindi(R)
paediatric use marketing authorisation (PUMA) in February 2018 was
the trigger for the Group to commence capitalisation of development
costs for Alkindi(R) in Europe under IAS38. Costs capitalised
during the year amounted to GBP15k, which are recorded as an
intangible asset on the balance sheet and will be amortised over
the duration of the regulatory protection afforded by the PUMA
until February 2028. The Group will continue to expense development
costs relating to the separate development programme for Alkindi(R)
in the US.
Administrative expenses for the year were GBP6.8m (2017:
GBP3.7m), reflecting a substantial increase in infrastructure and
pre-commercialisation expenses in preparation for the first
commercial launch of Alkindi(R) , which was achieved as expected in
May 2018. The Alkindi(R) launch is underpinned by the Group's
arrangements with Ashfield, who provide contract staff on a
fee-for-service basis. The increased costs reflect the team of
medical scientific liaisons (MSLs), key account managers (KAMs) and
support staff engaged by Ashfield, with 14 individuals in place at
the end of the financial year, along with health economic and
market access activities to support pricing discussions with
healthcare payers.
Operating loss
Operating loss for the year increased to GBP16.8m (2017:
GBP12.1m), reflecting the increased operating expenses outlined
above.
Financial income and expense
Financial income in the year was GBP95k (2017: GBP182k), due to
lower average cash balances compared to the previous year. The
Group successfully completed a follow-on offering in April 2018,
raising GBP10.5m before expenses; however, these funds only had an
impact for the last three months of the year.
Financial expense for the year was GBP221k (2017: GBP272k),
being the non-cash financial expense of the convertible loan. As
part of the recent fundraising, IP Group exercised its option to
convert the loan into equity at the IPO price of 144 pence per
share. The financial expense for the year represents the accrual of
the effective interest required under accounting standards to
charge the transaction costs and equity element of the loan to the
income statement over the term of the loan up to the date of
conversion of the loan.
Loss on ordinary activities before tax
Loss before tax for the period was GBP16.9m (2017:
GBP12.2m).
Tax
The current year includes the estimated research and development
tax credit claim in respect of the year ended 30 June 2018 of
GBP2,275k, which has not yet been submitted to HMRC, along with an
additional GBP7k in respect of the year ended 30 June 2017,
following finalisation and agreement of the claim. The prior year
includes the cash received in respect of the R&D tax credit
claim for the year ended 30 June 2016 of GBP911k, which was
received in August 2017, along with the R&D tax credit claim
for the year ended 30 June 2017 of GBP1,819k, which was received in
May 2018. The Group has not recognised any deferred tax assets in
respect of trading losses arising in either the current financial
year or accumulated losses in previous financial years.
Earnings per share
Loss per share was 26.8 pence (2017: 18.0 pence).
Cash flow
Net cash used in operating activities was GBP12.8m (2017:
GBP10.5m), driven by the planned increase in commercial
infrastructure, pre-commercialisation activities and development of
the late-stage clinical pipeline during the year. Net cash flows
from operating activities include an exchange gain of GBP228k
arising from holding a proportion of its cash balances in US
dollars in order to provide budgeting certainty for the future
costs of its Chronocort(R) US development activities.
Net cash from investing activities was GBP11.1m (2017: net cash
used in investing activities GBP3.2m), reflecting the movement of
all longer-dated held to maturity financial assets to short-dated
cash and cash equivalents. This reflects the change in the Group's
treasury arrangements during the year: all its cash deposits are
now immediately accessible and, consequently, are classified as
cash and cash equivalents.
Net cash generated by financing during the prior period of
GBP9.9m reflects the net proceeds of the placing completed in April
2018.
Balance sheet
Total assets decreased to GBP22.5m (2017: GBP23.9m), largely
reflecting the utilisation of cash in operating activities
highlighted above, partly offset by the follow-on financing
completed in April 2018.
Following the approval of the Alkindi(R) PUMA in February 2018,
the Group is now recognising stocks of raw materials, components,
work in progress and finished goods relating to its commercial
supplies of Alkindi(R) on the balance sheet, including certain
costs which had previously been expensed. Total stock at the year
end was GBP123k (2017: GBPnil).
Cash and cash equivalents were GBP17.3m (2017: GBP8.9m) and held
to maturity financial assets were GBPnil (2017: GBP11.0m),
reflecting the change in treasury arrangements noted above. Total
liabilities decreased to GBP5.7m (2017: GBP6.9m), reflecting an
increase in trade payables and accruals at the year end associated
with the increased level of operating activities, offset by the
early retirement of the convertible loan noted above. Net assets
were GBP16.9m (2017: GBP17.1m).
Richard Bungay
Chief Financial Officer
19 September 2018
Consolidated income statement
for the year ended 30 June 2018
Year ended Year ended
30 June 30 June
2018 2017
Note GBP000 GBP000
Sales 73 -
Cost of sales (15) -
----------- -----------
Gross profit 58 -
Research and development
expenditure (10,024) (8,340)
Administrative expenses (6,813) (3,734)
Other operating income - 9
----------- -----------
Operating loss (16,779) (12,065)
Financial income 5 95 182
Financial expense 6 (221) (272)
Loss before tax (16,905) (12,155)
Taxation 7 2,282 2,730
Loss for the year (14,623) (9,425)
----------- -----------
Basic and diluted loss per
share (pence per share) 8 (26.8) (18.0)
----------- -----------
All activities relate to continuing operations.
Consolidated statement of comprehensive income
for the year ended 30 June 2018
Year ended Year ended
30 June 30 June
2018 2017
GBP000 GBP000
Loss for the year (14,623) (9,425)
----------- -----------
Consolidated balance sheet
as at 30 June 2018
2018 2017
Note GBP000 GBP000
Non-current assets
Intangible assets 16 4
Property, plant and equipment 26 18
--------- --------
42 22
Current assets
Inventories 9 123 -
Trade and other receivables 10 5,093 4,025
Held to maturity financial
assets 11 - 11,000
Cash and cash equivalents 12 17,284 8,881
--------- --------
22,500 23,906
Total assets 22,542 23,928
Current liabilities
Trade and other payables 13 (5,661) (3,341)
--------- --------
(5,661) (3,341)
Non-current liabilities
Loans and borrowings 14 - (3,511)
--------- --------
- (3,511)
Total liabilities (5,661) (6,852)
Net assets 16,881 17,076
--------- --------
Equity
Share capital 15 3,067 2,616
Share premium 37,769 23,675
Group reconstruction reserve (2,943) (2,943)
Other reserve - 1,458
Accumulated losses (21,012) (7,730)
--------- --------
Total equity 16,881 17,076
--------- --------
Consolidated statement of changes in equity
for the year ended 30 June 2018
Retained
earnings
Share Share Group reconstruction Other / (Accumulated
capital premium reserve reserve losses) Total
GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
Balance
at 30 June
2016 2,610 23,632 (2,943) 1,458 1,177 25,934
Loss for
the year
and total
comprehensive
loss for
the year - - - - (9,425) (9,425)
Equity
settled
share-based
payment
transactions - - - - 518 518
Issue of
shares
for cash 6 43 - - - 49
--------- --------- --------------------- --------- ---------------- ---------
Total transactions
with owners
recorded
directly
in equity 6 43 - - 518 567
--------- --------- --------------------- --------- ---------------- ---------
Balance
at 30 June
2017 2,616 23,675 (2,943) 1,458 (7,730) 17,076
Loss for
the year
and total
comprehensive
loss for
the year - - - - (14,623) (14,623)
Equity
settled
share-based
payment
transactions - - - - 808 808
Issue of
shares
for cash 289 10,235 - - (4) 10,520
Costs charged
against
share premium - (630) - - - (630)
Issue of
share capital
on conversion
of loan 162 4,489 - (921) - 3,730
Equity
component
of convertible
loan - - - (537) 537 -
--------- --------- --------------------- --------- ---------------- ---------
Total transactions
with owners
recorded
directly
in equity 451 14,094 - (1,458) 1,341 14,428
--------- --------- --------------------- --------- ---------------- ---------
Balance
at 30 June
2018 3,067 37,769 (2,943) - (21,012) 16,881
--------- --------- --------------------- --------- ---------------- ---------
Consolidated cash flow statement
for the year ended 30 June 2018
Year ended Year ended
30 June 2018 30 June 2017
Note GBP000 GBP000
Cash flows from operating activities
Loss for the year (14,623) (9,425)
Adjustments for:
Depreciation, amortisation and
impairment 14 7
Share-based payment 808 518
Net foreign exchange gain (203) (16)
Financial income 5 (95) (182)
Finance expenses 6 221 272
Taxation 7 (2,282) (2,730)
Increase in inventories (123) -
Increase in trade and other
receivables (1,535) (771)
Increase in trade and other
payables 2,320 1,861
------------- -------------
Cash used in operations (15,498) (10,466)
Interest paid (2) -
Tax received 8 2,737 -
------------- -------------
Net cash used in operating activities (12,763) (10,466)
------------- -------------
Cash flows from investing activities
Additions of property, plant
and equipment (19) (20)
Capitalisation of research and (15) -
development
Purchases of held to maturity
financial assets (5,500) (11,000)
Disposal of held to maturity
financial assets 16,500 14,000
Interest received 107 189
------------- -------------
Net cash from investing activities 11,073 3,169
------------- -------------
Cash flows from financing activities
Net proceeds from issue of share
capital 9,890 48
Net cash from financing activities 9,890 48
------------- -------------
Net increase / (decrease) in
cash and cash equivalents 8,200 (7,249)
Cash and cash equivalents at
the start of the year 8,881 16,114
Effect of exchange rate changes
on cash and cash equivalents 203 16
------------- -------------
Cash and cash equivalents at
the end of the year 17,284 8,881
------------- -------------
Notes to the consolidated financial statements
1 Corporate information
Diurnal Group plc (the "Company" or the "parent") is a public
limited company incorporated and domiciled in the United Kingdom,
and registered in England (registered number: 09846650), whose
shares are publicly traded. The registered office is located at
Cardiff Medicentre, Heath Park, Cardiff CF14 4UJ.
The Group is a clinical stage specialty pharmaceutical business
targeting patient needs in chronic endocrine (hormonal)
diseases.
2. Basis of preparation
The financial information set out above does not constitute the
Group's statutory accounts for the years ended 30 June 2018 or 2017
but is derived from those accounts. Statutory accounts for 2017
have been delivered to the registrar of companies, and those for
2018 will be delivered in due course. The auditor has reported on
those accounts; their report for 2018 was unqualified and included
a material uncertainty relating to the going concern paragraph
which drew attention to a note in those financial statements
covering the same matter as disclosed in Note 3 of this
announcement. Their report for 2017 was (i) unqualified, (ii) did
not include a reference to any matters to which the auditor drew
attention by way of emphasis without qualifying their report, and
(iii) did not contain a statement under section 498 (2) or (3) of
the Companies Act 2006.
The consolidated financial information has been prepared in
accordance with International Financial Reporting Standards (IFRS)
as adopted by the European Union, IFRIC interpretations and the
Companies Act 2006. The financial information contained in these
financial statements have been prepared under the historical cost
convention, and on a going concern basis.
The accounting policies used in the financial information are
consistent with those used in the prior year. The following adopted
IFRSs have been issued but have not been applied by the Group in
these financial statements. Their adoption is not expected to have
a material effect on the financial statements unless otherwise
indicated:
-- IFRS 17 'Insurance Contracts' effective 1 January 2021
-- IFRS 9 'Financial Instruments' effective 1 January 2018
-- IFRS 15 'Revenue from Contracts with Customers' effective 1 January 2018
-- IFRS 16 'Leases' effective 1 January 2019
-- IFRIC 22 'Foreign Currency Transactions and Advance Consideration' effective 1 January 2018
-- IFRIC 23 'Uncertainty over Income Tax Treatments' effective 1 January 2019
-- IAS 19 'Employee Benefits' Amendments regarding plan
amendments, curtailments or settlements effective 1 January
2019
-- IAS 28 'Investments in Associates and Joint Ventures'
Amendments regarding long-term interests in associates and joint
ventures effective 1 January 2019
-- IAS 40 'Investment Property' Amendments to clarify transfers
or property to, or from, investment property effective 1 January
2018
-- Amendments resulting from Annual Improvements 2015-2017 Cycle effective 1 January 2019.
The preparation of financial information in conformity with IFRS
requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities at the date of the
financial statements and the reported amounts of revenues and
expenses during the reporting period. Although these estimates are
based on management's best knowledge of the amount, event or
actions, actual events ultimately may differ from those
estimates.
3. Going concern
For the year ended 30 June 2018, the Group made an operating
loss of GBP16.8m on revenue of GBP0.07m, with the gross profit
being GBP0.05m, and used net cash in operating activities of
GBP12.8m. Cash and cash equivalents at 30 June 2018 were
GBP17.3m.
The Board has considered the applicability of the going concern
basis in the preparation of the financial statements. This included
the review of internal budgets and financial results and a review
of cash flow forecasts for the 12 month period following the date
of signing the financial statements. Under current business plans
the Group's cash resources will extend to Q2 2019. Based on this,
additional equity funding is expected to be required by the end of
Q1 2019. In addition, further funding may be required in the medium
term to support the Group in reaching sustainable profitability.
The level of additional funds required (if any) will be dependent
upon the amount funds raised in Q1 2019, the Group's performance
against forecasts, and the level of income generated from licensing
activities, which itself is dependent upon the forthcoming result
from the Phase III trial of Chronocort(R) in Europe.
The Group completed a GBP10.5m fundraising with existing and new
investors in April 2018. The Directors have a reasonable
expectation that the Group will be able to raise further equity
financing to support its ongoing development and commercialisation
activities. The funding environment is expected to be more
challenging in the event that the result of the Phase III trial of
Chronocort(R) in Europe is not positive. However, the Directors
also have a reasonable expectation that the Group will be able to
generate significant funding through entering into strategic
collaborations for the development and commercialisation of
Alkindi(R) in the event that the result of the Phase III trial of
Chronocort(R) in Europe is not positive.
However, there can be no guarantee that the result of the Phase
III trial of Chronocort(R) in Europe will be positive, that the
Group will be able to raise sufficient funding from existing and
new investors, nor that the Group will be able to secure strategic
collaborations for its late-stage pipeline. In the event that the
additional funding required in Q1 2019 is delayed, the Directors
consider that the Group would be able to reduce expenditure on its
development programmes, and also accelerate licensing arrangements
for Alkindi(R) and, subject to its Phase III results, Chronocort(R)
, in order to continue funding its operations until additional
financing is secured.
Based on the above factors the Directors believe that it remains
appropriate to prepare the financial statements on a going concern
basis. However, the above factors give rise to a material
uncertainty which may cast significant doubt on the Group's and the
Company's ability to continue as a going concern and, therefore, to
continue realising its assets and discharging its liabilities in
the normal course of business. The financial statements do not
include any adjustments that would result from the basis of
preparation being inappropriate.
4. Segmental information
Previously, the Group reported one segment, which is Clinical
Development. Reflecting the approval of the Alkindi(R) paediatric
use marketing authorisation (PUMA) during the year, the Board
considers it appropriate to report as follows:
-- Alkindi(R) - development and supply of the Group's Alkindi(R) product
-- Chronocort(R) - development of the Group's Chronocort(R) product
-- Central and early-stage - all other activities, including
development of the Group's early-stage pipeline products
Segmental results are calculated on an IFRS basis.
Alkindi(R) Chronocort(R) Central and Total
early-stage
2018 2018 2018 2018
GBP000 GBP000 GBP000 GBP000
Revenue 73 - - 73
----------- -------------- ------------- ---------
Operating loss (2,685) (6,210) (7,884) (16,779)
Financial income - - 95 95
Financial expense - - (221) (221)
Taxation - - 2,282 2,282
----------- -------------- ------------- ---------
Loss for the year (2,685) (6,210) (5,728) (14,623)
----------- -------------- ------------- ---------
Alkindi(R) Chronocort(R) Central and Total
early-stage
2017 2017 2017 2017
GBP000 GBP000 GBP000 GBP000
Revenue - - - -
----------- -------------- ------------- ---------
Operating loss (2,188) (4,896) (4,981) (12,065)
Financial income - - 182 182
Financial expense - - (272) (272)
Taxation - - 2,730 2,730
----------- -------------- ------------- ---------
Loss for the year (2,188) (4,896) (2,341) (9,425)
----------- -------------- ------------- ---------
The revenue analysis below is based on the country of
registration of the fee-paying party:
Year ended Year ended
30 June 2018 30 June 2017
GBP000 GBP000
Europe 73 -
An analysis of revenue by customer is set out in the table
below:
Year ended Year ended
30 June 2018 30 June 2017
GBP000 GBP000
Customer A 55 -
Customer B 17 -
Other customers 1 -
------------- -------------
73 -
------------- -------------
5. Finance income
Year ended Year ended
30 June 2018 30 June 2017
GBP000 GBP000
Interest receivable on cash and cash equivalents
and term deposits 95 182
Total finance income 95 182
------------- -------------
6. Finance expenses
Year ended Year ended
30 June 2018 30 June 2017
GBP000 GBP000
Total interest payable on loans 221 272
Total finance expense 221 272
------------- -------------
The financial expense for the year ended 30 June 2018 represents
the accrual of the effective interest required to charge the
transaction costs and equity element of the loan to the income
statement over the term of the loan for the period up to the date
of conversion of the loan (see Note 14).
7. Taxation
The Group is entitled to claim tax credits in the United Kingdom
under the UK research and development (R&D) small or
medium-sized enterprise (SME) scheme, which provides additional
taxation relief for qualifying expenditure on R&D activities
and includes an option to surrender a portion of tax losses arising
from qualifying activities in return for a cash payment from HM
Revenue & Customs (HMRC). The tax credit included in the income
statement for the year ended 30 June 2016 reflected the approval by
HMRC of the R&D tax credit claim in respect of the 13 month
period ended 30 June 2015. With effect from the year ended 30 June
2017, the Group reflects R&D tax credits on an accruals basis
since it has established a track record of agreeing claims with
HMRC. Consequently, the income statement for the year ended 30 June
2017 reflects the R&D tax credit claim for the year ended 30
June 2016, which was approved by HMRC in July 2017, along with the
estimated claim for the year ended 30 June 2017, which was received
in May 2018. The amount in respect of the year ended 30 June 2018
has not yet been agreed with HMRC, although there is no reason to
believe that this claim will be rejected.
Year ended Year ended
30 June 2018 30 June 2017
GBP000 GBP000
Current tax:
- UK corporation tax on losses of year - -
- Research and development tax credit receivable
for the current year (2,275) (1,819)
- Prior year adjustment in respect of research
and development tax credit (7) (911)
Deferred tax:
- Origination and reversal of temporary
differences - -
------------- -------------
Tax on loss on ordinary activities (2,282) (2,730)
------------- -------------
Reconciliation of total tax expense
The tax assessed for the year varies from the small company rate
of corporation tax as explained below:
Year ended Year ended
30 June 2018 30 June 2017
GBP000 GBP000
Loss on ordinary activities before tax (16,905) (12,155)
------------- -------------
Tax at the standard rate of UK corporation
tax rate of 19% (2016/17: 19.75%) (3,212) (2,401)
Effects of:
Expenses not deductible for tax purposes 154 1
Depreciation in excess of capital allowances (2) (3)
Enhanced research and development relief (978) (741)
Share-based payments (62) 102
Prior year adjustments (7) (911)
Tax losses carried forward 1,825 1,223
------------- -------------
Current tax credits for the year (2,282) (2,730)
------------- -------------
The standard rate of UK corporation tax was reduced from 20% to
19% with effect from 1 April 2017, giving rise to an effective rate
of tax for the year ended 30 June 2018 of 19% (year ended 30 June
2017: 19.75%).
8. Loss per share
Year ended Year ended
30 June 2018 30 June 2017
Loss for the year (GBP000) (14,623) (9,425)
Weighted average number of shares (000) 54,596 52,235
Basic and diluted loss per share (pence
per share) (26.8) (18.0)
------------- -------------
The diluted loss per share is identical to the basic loss per
share in all years, as potentially dilutive shares are not treated
as such since they would reduce the loss per share.
9. Inventories
2018 2017
GBP000 GBP000
Work in progress 14 -
Finished goods 109 -
------- -------
123 -
------- -------
10. Trade and other receivables
2018 2017
GBP000 GBP000
Trade receivables 77 -
VAT recoverable 732 300
Prepayments 1,904 705
Other debtors 105 290
R&D tax credit claims receivable 2,275 2,730
------- -------
5,093 4,025
------- -------
11. Held to maturity financial assets
2018 2017
GBP000 GBP000
Bank term deposits - 11,000
--------- -------
During the year, the Group changed its treasury arrangements to
a segregated cash facility with instant access to deposits;
consequently, there were no held to maturity financial assets as at
30 June 2018.
12. Cash and cash equivalents
2018 2017
GBP000 GBP000
Cash at bank and on hand 17,284 8,881
------- -------
The Group holds its cash and cash equivalents with its clearing
bank and in a segregated cash facility providing same day access to
its cash. The Group's treasury policy requires that deposits are
held with financial institutions having a minimum credit rating of
A- (from Moody's S&P or Fitch), that individual counterparty
exposure is no more than GBP5m and that the maximum term is 12
months. The Group's deposits are in line with this policy.
13. Trade and other payables
2018 2017
GBP000 GBP000
Trade payables 3,159 1,724
Other payables 9 -
Other tax and social security 72 65
Accrued expenses 2,421 1,552
------- -------
5,661 3,341
------- -------
14. Loans and borrowings
2018 2017
GBP000 GBP000
Non-current loans and borrowings
Convertible Loans - 3,511
--------- -------
IP Group convertible loan
On 24 December 2015 the Company received GBP4.7m from IP2IPO
Limited, a wholly owned subsidiary of IP Group plc, under a
convertible loan agreement. The convertible loan facility is
interest free and unsecured with a maturity date of 24 December
2020 (or such other date as the parties may agree) at which point
the Company may either repay the principal amount outstanding in
full or convert such amount into non-voting shares at a lower
nominal value to that of the ordinary shares to ensure that IP2IPO
Limited did not have control of the Company. The convertible loan
note is a compound financial instrument containing a host financial
liability and an equity component as there is a contractual
obligation to deliver a fixed number of shares at the IPO price if
the loan note is converted.
At the time of the fundraising in April 2018, IP2IPO Limited
exercised its option to convert the loan into equity at the IPO
price of 144 pence per share. The effective interest required under
accounting standards to charge the transaction costs and equity
element of the loan to the income statement over the term of the
loan was accrued for the period up to the date of conversion of the
loan (see Note 6). Upon conversion of the loan, 3,229,575 new
ordinary shares were issued, with the difference between the value
of shares issued and accrued loan amount of GBP921k being debited
from other reserves. The shortfall of GBP537k between the
redemption value of the loan at maturity and the accrued value at
the date of conversion was transferred from other reserves to
accumulated losses.
15. Share capital
2018 2018 2017 2017
Number GBP000 Number GBP000
Ordinary shares of GBP0.05 each 61,336,523 3,067 52,320,759 2,616
----------- ------- ----------- -------
Date of Preparation: September 2018 Code: CORP-GB-0020
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
FR BCGDCXGBBGIC
(END) Dow Jones Newswires
September 20, 2018 02:01 ET (06:01 GMT)
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