TIDMCIR
RNS Number : 0800C
Circassia Pharmaceuticals Plc
27 September 2018
CIRCASSIA PHARMACEUTICALS PLC
INTERIM RESULTS FOR THE SIX MONTHSED 30 JUNE 2018
NIOX(R) sales growth continued
Tudorza(R) profit share revenues increased
Duaklir(R) NDA and Tudorza(R) sNDA accepted for review by
FDA
China commercial expansion on track
AstraZeneca equity stake increased
Oxford, UK - 27 September 2018: Circassia Pharmaceuticals plc
("Circassia" or "the Company") (LSE: CIR), a specialty
pharmaceutical company focused on respiratory disease, today
announces its interim results for the six months ended 30 June 2018
and a post-period update.
Financial progress
Key H1 2018 H1 2017 KPI: H1 2018: H1 2017:
performance KPI: underlying total total
indicators underlying continuing
(KPIs) continuing operations(1)
operations
Revenue GBP28.4m GBP18.3m GBP28.4m GBP18.3m
---------------------- ------------------------- ---------------------- ----------------------
R&D (GBP5.7m) (GBP7.1m) (GBP6.9m) (GBP27.2m)
---------------------- ------------------------- ---------------------- ----------------------
G&A (GBP5.2m) (GBP4.6m) (GBP5.5m) (GBP5.1m)
---------------------- ------------------------- ---------------------- ----------------------
S&M (GBP27.7m) (GBP21.1m) (GBP27.7m) (GBP21.6m)
---------------------- ------------------------- ---------------------- ----------------------
EBITDA (GBP12.1m) (GBP16.8m) (GBP13.6m) (GBP35.5m)
---------------------- ------------------------- ---------------------- ----------------------
Net cash (GBP8.7m) (GBP23.4m) H2 (GBP8.7m) (GBP34.5m)
flow(6) 2017
---------------------- ------------------------- ---------------------- ----------------------
Cash(2) at GBP50.8m GBP59.5m at GBP50.8m GBP82.9m
period end at 30 June 31 Dec 2017
2018
---------------------- ------------------------- ---------------------- ----------------------
NIOX(R) progress
-- Sales increased 12% at CER(3) to GBP14.0 million (H1 2017 CER: GBP12.5 million)
-- Clinical sales (non-research sales(4) ) increased 11% at CER vs H1 2017
-- US clinical revenues grew 13% at CER compared with H1 2017
-- Reimbursement increased to 80% of US covered lives
-- NIOX VERO(R) upgrade in market testing
US COPD portfolio progress
-- Tudorza(R) profit share revenues increased 4% at CER to GBP14.4 million vs H2 2017
-- Tudorza(R) prescriptions continued to stabilise during H1 2018
-- Duaklir(R)(5) NDA accepted for review; PDUFA action date 31 March 2019
-- Tudorza(R) sNDA under review for inclusion of unique clinical data in label
Commercial expansion progress
-- China expansion on track; sales force launch anticipated by year end
-- UK team expansion to exploit highly supportive NICE guidelines for FeNO testing in asthma
AstraZeneca agreement progress
-- New shares issued to AstraZeneca increasing holding to 19.9%
-- $26.7 million consideration for new shares paid to AstraZeneca as R&D contributions
-- Vendor loan backstop extended to cover remaining $18.3 million R&D payments due by end 2019
-- Commitment to FCA to seek shareholder approval to move to AIM if free float remains below 25%
Steve Harris, Circassia's Chief Executive, said: "During 2018 we
have accelerated our transition into a commercially-focused
organisation as part of our strategy to build a high growth,
profitable specialty pharmaceutical business. In the first six
months of the year we have made good financial progress, increasing
our revenues from both NIOX(R) and Tudorza(R), delivering R&D
cost savings and significantly reducing our net loss and cash
outflow."
"Building on this progress, we are further expanding our
commercial capabilities and continuing to pursue additional
products to commercialise through our platform. In the coming weeks
we plan to launch our new sales team in China, and in the next six
months we look forward to the FDA completing its review of the
Duaklir(R) NDA and Tudorza(R) sNDA. With the team making
encouraging progress right across Circassia, we are working hard to
make 2018 a transformational year for the Company, as we lay the
foundations to transition to profitability."
Analyst meeting and webcast
An analyst meeting will take place today at 9.30am at FTI
Consulting, 200 Aldersgate, Aldersgate Street, London, EC1A 4HD. A
webcast will be available on the Company's website at
www.circassia.com.
Enquiries
Circassia
Steve Harris, Chief Executive Tel: +44 (0) 1865 405 560
Officer
Julien Cotta, Chief Financial
Officer
Rob Budge, Corporate Communications
Peel Hunt
James Steel / Christopher Golden Tel: +44 (0) 20 7418 8900
Numis Securities
James Black / Freddie Barnfield Tel: +44 (0) 20 7260 1000
FTI Consulting
Simon Conway / Mo Noonan Tel: +44 (0) 20 3727 1000
About Circassia
Circassia is a world-class specialty pharmaceutical business
focused on respiratory disease. Circassia sells its novel,
market-leading NIOX(R) asthma management products directly to
specialists in the United States, United Kingdom and Germany, and
in a wide range of other countries through its network of partners.
In 2017, the Company established a commercial collaboration with
AstraZeneca in the United States in which it promotes the chronic
obstructive pulmonary disease (COPD) treatment Tudorza(R) and has
the commercial rights to NDA-stage COPD product Duaklir(R). For
more information please visit www.circassia.com.
(1) Restated to show results of respiratory R&D in
non-underlying operations
(2) Cash, cash equivalents and short-term deposits
(3) Constant exchange rates (CER) for H1 2017 represent reported
numbers re--stated using H1 2018 average exchange rates; management
believes CER better represents underlying Group performance due to
currency fluctuations against sterling
(4) Direct clinical sales to clinicians, hospitals and
distributors; research sales to pharmaceutical companies for use in
clinical studies (5) Duaklir(R) is a registered trademark in Europe
and other markets; use of the trademark in the US is subject to
approval by the FDA
(6) Net cashflow includes movements in cash, cash equivalents
and short-term deposits
Forward-looking statements
This press release contains certain projections and other
forward-looking statements with respect to the financial condition,
results of operations, businesses and prospects of Circassia. The
use of terms such as "may", "will", "should", "expect",
"anticipate", "project", "estimate", "intend", "continue", "target"
or "believe" and similar expressions (or the negatives thereof) are
generally intended to identify forward-looking statements. These
statements are based on current expectations and involve risk and
uncertainty because they relate to events and depend upon
circumstances that may or may not occur in the future. There are a
number of factors that could cause actual results or developments
to differ materially from those expressed or implied by these
forward-looking statements. Any of the assumptions underlying these
forward-looking statements could prove inaccurate or incorrect and
therefore any results contemplated in the forward-looking
statements may not actually be achieved. Nothing contained in this
press release should be construed as a profit forecast or profit
estimate. Investors or other recipients are cautioned not to place
undue reliance on any forward-looking statements contained herein.
Circassia undertakes no obligation to update or revise (publicly or
otherwise) any forward-looking statement, whether as a result of
new information, future events or other circumstances.
OPERATING REVIEW
During 2018, Circassia has made rapid progress in its strategic
transition into a commercially-focused specialty pharmaceutical
company, containing its R&D expenditure and reallocating
resources to focus on commercial growth. The Company has
significantly expanded its commercial infrastructure in China and
added a number of distributors to its international network of
partners promoting NIOX(R). It is increasing its UK sales force and
rolling out new promotional campaigns for both Tudorza(R) and
NIOX(R). The Company has also significantly reduced its R&D
headcount and halted internal investment in its respiratory
pipeline. Subsequently, it has started out-licensing / partnering
discussions to attract potential external funding to advance these
programmes, while retaining potential financial upside.
As a result, the Company is making good progress across its
business and during the first half of the year continued to grow
its revenues while significantly reducing underlying R&D
expenditure compared with the same period in 2017.
NIOX(R) asthma management products
NIOX(R) is used by physicians around the world to improve asthma
diagnosis and management. It is the leading point-of-care system
for measuring fractional exhaled nitric oxide (FeNO), an important
biomarker of the major underlying cause of asthma, type 2 airway
inflammation. Circassia sells NIOX(R) direct in the United States,
UK and Germany, and through a network of international partners in
a wide range of other countries. The Company plans to initiate
direct sales in China, alongside its existing distributor base, at
the end of the year.
Continuing sales growth
NIOX(R) revenues continued to grow during the first half of
2018. Global sales totalled GBP14.0 million, an increase of 12% at
constant exchange rates (CER) compared with the same period the
year before. Sales for clinical use grew at a similar rate (11% at
CER), while sales to pharmaceutical companies for use in clinical
trials increased at a faster rate, growing 20% at CER. Revenues
continued to increase in markets where the Company sold direct,
increasing 13% in the United States at CER, 45% in the UK and 11%
in Germany. Revenues in China, where the Company did not sell
direct during the first half of the year, have fluctuated
historically based on the local importer's order pattern. With
destocking in the first six months of 2018, sales decreased 13% at
CER compared with the same period the previous year, which followed
a 36% increase during 2017. Circassia anticipates revenues will
grow at a more predictable rate following the launch of its direct
sales team in China later in the year.
Expanding access
During 2018, Circassia has continued NIOX(R) market access
activities in a number of countries. In the United States, the team
increased the Company's key accounts with healthcare systems,
multi-site groups, group purchasing organisations and physician
purchasing groups to 80. In addition, payor coverage has increased
by an additional 37 million lives, including 22 million covered by
Aetna following the health insurer's recent policy update to
include FeNO testing as 'medically necessary' for asthma patients.
As a result, approximately 80% of all US covered lives now have
access to NIOX(R). In Europe, Circassia is focused on gaining wider
reimbursement in key markets, such as Germany where the team is
making progress with local payors. In the UK, the Company is
expanding its commercial team, leveraging new NICE guidelines to
target Clinical Commissioning Groups and Health Boards. In China,
the market access team is also making progress, with a number of
additional provinces now reimbursing FeNO testing.
Geographic expansion
In addition to Circassia's direct sales infrastructure, the
Company sells its NIOX(R) products through a global network of
distributors. Throughout 2018 the Company has focused on expanding
this distribution base and added new partners in Mexico and
Thailand. Discussions are also ongoing in several other countries,
including Canada. This expansion is closely co-ordinated with
Circassia's regulatory and supply chain functions to exploit new
NIOX VERO(R) approvals. During 2018, the distribution management
team also continued promotional support activities, including the
provision of new NIOX(R) marketing materials, brand building at
national conferences and face-to-face training in a number of key
markets.
NIOX(R) brand building
Throughout 2018 Circassia has continued NIOX(R) brand building
initiatives, including the ongoing roll-out of its digital
strategy. This includes online advertising and web-based promotion
focused on new NICE guidelines that recommend FeNO testing in
asthma diagnosis. In the UK, the team is leveraging these
guidelines to introduce NIOX(R) into primary care and Circassia is
sponsoring the Primary Care Respiratory Academy's educational
activities and learning resources that relate to FeNO testing.
Circassia has also undertaken a range of promotional activities
at major medical congresses, including the American Thoracic
Society. At the recent European Respiratory Society International
Congress, the world's largest meeting for respiratory specialists,
the Company launched its new NIOX(R) international marketing
campaign. It also used the event to bring together NIOX(R)
distributors from around the world to train on the new campaign
materials.
NIOX(R) product development
Circassia is developing a NIOX VERO(R) upgrade to build on the
system's existing strengths and offer customers an improved user
experience. This is designed to exploit features available in
consumer electronics while avoiding the cost and complexity
associated with modifying the core FeNO measurement technology.
This product update is making good progress, and during the first
half of 2018 the Company completed market research of potential
screen upgrades and concept testing of a number of additional
features is ongoing.
US COPD portfolio
In 2017, Circassia and AstraZeneca established a commercial
collaboration in the United States for the COPD products Tudorza(R)
and Duaklir(R). Under the initial Tudorza(R) profit share
arrangement, Circassia took responsibility for the product's
promotion while AstraZeneca continued its manufacture,
distribution, pharmacovigilance, development and regulatory
activities. Circassia also has the commercialisation rights to
NDA-stage combination treatment Duaklir(R).
AstraZeneca agreement amendment
Under the terms of the original agreement, AstraZeneca took a
14.2% stake in Circassia as upfront consideration. A further
deferred payment of $100 million is payable on the earlier of
Duaklir(R) approval or 30 June 2019. Circassia also has an option
to acquire the full Tudorza(R) commercial rights, which is
exercisable from H2 2018, with the amount payable dependent on the
product's sales and Duaklir(R) approval. Both the deferred and
option payments may be converted into a vendor loan in the event
that third-party financing is unavailable.
During the first half of 2018, AstraZeneca and Circassia agreed
to amend the original agreement. Under this amendment, AstraZeneca
increased its holding in Circassia to 19.9%. Circassia subsequently
paid the $26.7 million proceeds from this subscription towards the
$45 million of R&D contributions due to AstraZeneca by the end
of 2019. The amendment also extended the original vendor loan back
stop to cover the outstanding R&D contribution of $18.3
million. Based on these payments, Circassia anticipates a total of
approximately $9 million of R&D tax credits from HMRC, a
proportion of which has now been received.
As a related-party transaction under the Listing Rules, the
amendment required the publication of a Financial Conduct Authority
(FCA) approved circular and approval by independent shareholders,
which was granted on 16 July. The subsequent issue of equity to
AstraZeneca reduced the free float in Circassia's shares to
approximately 10%. Under the Listing Rules, companies are required
to maintain a minimum 25% free float, which excludes shareholdings
of more than 5% and those held by Directors. As a result, the
Company committed to the FCA that if its free float does not reach
the required level by 27 December 2018 it will seek shareholder
approval to move to AIM, which does not have the same requirement.
With a strong shareholder base and minimal movement in its free
float in recent months, the Company has determined to initiate the
activities required to admit its shares to trading on AIM and
anticipates convening a shareholder vote to approve such a move in
the coming weeks.
Tudorza(R) commercial progress
Tudorza(R) (aclidinium bromide) is a long-acting muscarinic
antagonist (LAMA) used in the long-term maintenance treatment of
COPD. It is administered via the simple-to-use, multi-dose
Pressair(R) dry powder inhaler and is approved in many countries
worldwide, including the United States. With the US COPD treatment
market estimated at over $5 billion in 2017, Tudorza(R) represents
an important commercial opportunity for Circassia, and third-party
estimates suggest the product has annual peak sales potential of
over $90 million(6) .
Circassia's US promotional strategy for Tudorza(R) targets
existing customers and COPD high prescribers. During 2018, the
Company has rolled out a new 'TUNIGHT + TUMORROW' marketing
campaign, which focuses on the benefits of twice-daily dosing, with
a morning and evening dose delivering significantly improved lung
function. The campaign features new sales materials, healthcare
professionals' website, paid digital search advertisements, banner
adverts, promotion at leading conferences and presentations to
nurse practitioners.
Since the Company started promoting the product in 2017,
Circassia's salesforce has continued to exceed Tudorza(R) call
targets and prescription levels have responded positively following
the previous sustained period of decline. As a result, by the
beginning of 2018 Circassia was halting this earlier decline and
during the first half of the year prescriptions have continued to
stabilise. With the rate of decline in 2017 prior to Circassia's
full promotion greatly reduced during the first six months of 2018,
prescriptions averaged approximately 4,700 per week during the
period, providing a foundation to return the product to growth.
Circassia's Tudorza(R) profit share revenues totalled GBP14.4
million during the first half of 2018, which based on channel mix
was 4% ahead at CER of the GBP13.8 million the Company received in
the second half of 2017.
Tudorza(R) regulatory progress
During 2018, Tudorza(R) has made good regulatory progress. In
June, the Company announced the filing of a supplemental New Drug
Application (sNDA) to include compelling new clinical data from the
ASCENT study in Tudorza(R)'s label. The FDA subsequently accepted
the filing for review and set a Prescription Drug User Fee Act
(PDUFA) target action date of 31 March 2019.
The phase IV ASCENT study was conducted in patients with
moderate-to-very severe COPD and cardiovascular disease and / or
risk factors. The results demonstrate that Tudorza(R) is effective
at reducing COPD exacerbations without increasing cardiovascular
events and at decreasing hospitalisations due to COPD exacerbations
in this at-risk population. Cardiovascular disease is the most
common and significant comorbidity of COPD, with approximately 30%
of COPD patients dying from cardiovascular conditions. If the sNDA
is approved, Tudorza(R) will be the only LAMA in the United States
with these data in its label. Headline results from this unique,
large-scale study were presented at the American Thoracic Society
2018 International Conference in May.
Duaklir(R) regulatory progress
Duaklir(R) is a fixed-dose combination COPD product containing
the LAMA aclidinium bromide and long-acting beta agonist (LABA)
formoterol fumarate. It is delivered via the Pressair(R) multi-dose
dry powder inhaler and is approved in approximately 50 countries
worldwide. Duaklir(R) represents a significant commercial
opportunity for Circassia, with third-party estimates suggesting
the product may have peak sales potential of over $180 million per
annum(6) .
Following Circassia's acquisition of the Duaklir(R) US
commercialisation rights in 2017, the product has made good
progress. During the second half of 2017, Duaklir(R) successfully
completed its phase III AMPLIFY study, meeting the co-primary
efficacy endpoints, and an NDA seeking marketing authorisation was
submitted in the first half of 2018. The FDA recently accepted the
filing for review and set a PDUFA target completion date of 31
March 2019.
Circassia is advancing its launch planning for Duaklir(R) and
has completed a number of market research projects to inform its
market access and promotional strategies. The Company has convened
an opinion leader advisory board, appointed an advertising agency
and plans to complete further market research to inform
Duaklir(R)'s product positioning, messaging and creative campaign
in the near future. As part of its launch planning, the Company is
also refining its broader commercialisation strategy, to focus
sales team resources and optimise customer targeting and territory
definition. This is designed to provide the potential for a focused
COPD sales force, achieving Tudorza(R) targets, while supporting
NIOX(R) with a mix of sales team, telesales and experience program
resources.
Commercial infrastructure expansion
As part of its strategic transition, the Company is continuing
to broaden its commercialisation capabilities. Following the
significant expansion of its US commercial team in 2017, Circassia
has focused on rapidly growing its China organisation during
2018.
Previously, the Company's Beijing-based team was focused on
supporting local distributors, undertaking promotion, opinion
leader development, speaker programmes and market access
activities. Circassia is now significantly expanding these
capabilities to enable the Company to promote NIOX(R) alongside its
existing distributor base. Circassia anticipates that this new
commercial infrastructure will increase NIOX(R) revenues, while
also providing a strategic platform to attract potential
third-party products for commercialisation in this major market.
The expansion includes the recruitment of a full support team with
marketing, sales training, commercial operations and compliance
expertise, and back office functions including finance, IT and HR.
This team is now in place and will soon be complemented by a sales
force of approximately 85. Recruitment is progressing well, with
regional managers already in the field, and Circassia plans to
launch the full sales team by the end of the year. Once
established, the sales force will target approximately 2,000
leading hospitals that are not currently NIOX(R) customers,
alongside the 400 that are served by the Company's existing
distributors.
Alongside this major expansion in China, Circassia is expanding
its UK commercial team to leverage the new NICE guidelines
published at the end of 2017. These are highly supportive of FeNO
testing in asthma diagnosis and the addition of new Key Account
Managers will allow the team to focus a proportion of its
promotional effort on the primary care sector, while continuing to
target specialist centres and payor organisations.
Cost containment
Circassia's investment strategy includes building on previous
cost savings and refocusing resources to support commercial
expansion. During 2016 and 2017, Circassia consolidated its
facilities in the US, UK and Sweden and substantially cut the size
of its R&D team. In 2018, it has continued its cost containment
initiatives, most notably halting internal investment in its
respiratory pipeline and seeking partners to develop the products.
As a result, Circassia has reduced its R&D team by
approximately a third since the beginning of the year, and during
the first half of 2018 decreased underlying R&D expenditure by
20% compared with the same period the year before. The Company's
R&D investment is now focused on development of the NIOX
VERO(R) upgrade as well as regulatory, medical affairs,
pharmacovigilance, quality and supply chain functions that support
its marketed products.
During the coming months, Circassia plans to continue its focus
on corporate expenditure, including reducing intellectual property
costs and further consolidating its Oxford facilities. Corporate
cost reductions typically lag cuts to R&D, and while the
Company's administrative expenditure did not fall during the first
six months of 2018 versus the same period the previous year, due to
restructuring, increased business development and legal costs,
underlying spending fell by 13% compared with the second half of
2017.
As a result, Circassia is making progress in its cost
containment strategy announced in April 2018. As previously
announced, the Company plans to refocus spending, in particular
into the expansion of its commercial team in China and US launch
preparations for Duaklir(R).
Summary and outlook
During the first half of 2018, Circassia has made rapid progress
implementing its strategy. The Company's revenues and commercial
capabilities continued to grow, its underlying cost base remained
carefully controlled and its loss for the period and cash outflow
were significantly reduced.
During the second half of the year, Circassia intends to build
on this progress. The expansion of its commercial team in China is
progressing well and the Company anticipates completing the
recruitment and launch of its sales team in the coming months. The
Company plans to complete the growth of its UK sales force, and in
the United States the commercial team is accelerating preparations
for the launch of Duaklir(R), and an expanded label for Tudorza(R),
following the FDA's recent acceptance of both applications for
review.
In the coming months, the Company plans to continue the
development of its NIOX VERO(R) upgrade. It also plans to exploit
its broader commercial platform, targeting a larger potential
customer base, and to continue the roll out of its new promotional
campaigns for NIOX(R) and Tudorza(R).
During the remainder of the year, Circassia anticipates ongoing
revenue growth and containment of non-commercial costs. Cash use
fell significantly to under GBP10 million in the first half of 2018
and the Company is well on track to substantially reduce its net
loss and cash outflow for the full year. Consequently, with over
GBP50 million of cash on the balance sheet at the end of the first
half of the year, Circassia remains well-resourced to pursue its
commercial strategy.
In the last two years Circassia has come a long way. It has
largely completed its transformation from an R&D-focused
organisation into a strong commercial business with a unique
commercialisation platform and compelling respiratory products. As
a result, Circassia is coming ever closer to achieving its ambition
of becoming a self-sustaining specialty pharmaceutical business, as
it continues its trajectory to profitability.
(6) Channel BioConsulting LLC analysis January 2017
FINANCIAL REVIEW
Loss for the period significantly reduced by 31% mainly due to
increased revenues and gross profit following the AstraZeneca
collaboration, combined with a decrease in operating costs from
both continuing non-underlying operations and discontinued
operations.
Continuing operations include revenue and costs derived from the
collaboration with AstraZeneca, in particular the sale of
Tudorza(R) and development of Duaklir(R), as well as sales of
NIOX(R) and costs for the existing underlying Circassia business.
Continuing operations are further divided into underlying and
non-underlying operations.
Non-underlying operations include irregular and non-recurring
expenditure, such as those relating to the internal respiratory
pipeline, and the AstraZeneca R&D contribution. Under its
refocused strategy announced in April 2018, Circassia has reduced
R&D expenditure and is seeking to out-license / partner its
internal respiratory pipeline of directly substitutable generic
products and novel formulations of currently approved drugs.
Discontinued operations include direct costs and overheads
associated with the previous allergy programmes for which the
Company decided to stop all further development in April 2017. The
loss relating to the allergy business reduced to GBP0.2 million (H1
2017: GBP4.7 million), with no further costs expected.
The table below sets out the Group's results for H1 2018
compared with H1 2017, separated into continuing underlying
operations, continuing non-underlying operations and discontinued
operations.
Underlying operations Non-underlying Total continuing
operations operations
H1 2018 H1 2017 H1 2018 H1 2017 H1 2018 H1 2017
Restated(2) Restated(2) Restated(4)
GBPm GBPm GBPm GBPm GBPm GBPm
========================== =========== =========== ======== ======== ======== ============
Revenue 28.4 18.3 - - 28.4 18.3
Cost of sales (4.2) (4.7) - - (4.2) (4.7)
Gross profit 24.2 13.6 - - 24.2 13.6
Gross margin 85% 74% - - 85% 74%
Research and development (5.7) (7.1) (1.0) (15.7) (6.7) (22.8)
Sales and marketing (27.7) (21.1) - - (27.7) (21.1)
Administrative expenses (5.2) (4.6) (0.3) (0.4) (5.5) (5.0)
Total expenditure (38.6) (32.8) (1.3) (16.1) (39.9) (48.9)
EBITDA (12.1) (16.8) (1.3) (13.7) (13.4) (30.5)
Operating loss (14.4) (19.2) (1.3) (16.1) (15.7) (35.3)
Other gains/losses 0.1 (0.1) (2.3) 2.7 (2.2) 2.6
Share of (loss)/profit
of joint venture - - - - - -
Finance income net 0.0 0.1 (6.0) (1.5) (6.0) (1.4)
Loss before tax (14.3) (19.2) (9.6) (14.9) (23.9) (34.1)
Taxation 0.3 1.1 0.3 3.4 0.6 4.5
Loss for the financial
period (14.0) (18.1) (9.3) (11.5) (23.3) (29.6)
Cash(3)
========================== =========== =========== ======== ======== ======== ============
Discontinued operations(1) Total
H1 2018 H1 2017 H1 2018 H1 2017
Restated(4)
GBPm GBPm GBPm GBPm
========================== ============== ============= ======== ============
Revenue - - 28.4 18.3
Cost of sales - - (4.2) (4.7)
Gross profit - - 24.2 13.6
Gross margin - - 85% 74%
Research and development (0.2) (4.4) (6.9) (27.2)
Sales and marketing - (0.5) (27.7) (21.6)
Administrative expenses - (0.1) (5.5) (5.1)
Total expenditure (0.2) (5.0) (40.1) (53.9)
EBITDA (0.2) (5.0) (13.6) (35.5)
Operating loss (0.2) (5.0) (15.9) (40.3)
Other gains/losses - - (2.2) 2.6
Share of (loss)/profit
of joint venture (0.1) (0.5) (0.1) (0.5)
Finance income net - - (6.0) (1.4)
Loss before tax (0.3) (5.5) (24.2) (39.6)
Taxation 0.1 0.8 0.7 5.3
Loss for the financial
period (0.2) (4.7) (23.5) (34.3)
Cash(3) 50.8 82.9
========================== ============== ============= ======== ============
(1) Disclosed as a single amount in the condensed interim
consolidated statement of comprehensive income
(2) Restated to show the results of the respiratory business in
non-underlying operations.
(3) Includes cash, cash equivalents and short-term deposits.
(4) Restated to show Foreign exchange differences within 'Other
gains and losses' (previously shown within 'Finance income and
costs').
Revenue
Circassia's revenues of GBP28.4 million (H1 2017: GBP18.3
million) include Tudorza(R) revenues of GBP14.4 million (H1 2017:
GBP5.2 million) and NIOX(R) revenues of GBP14.0 million (H1 2017:
GBP13.1m).
Tudorza(R) revenues derive from the joint profit arrangement
with AstraZeneca from sales of the product. AstraZeneca records
in-market sales, cost of sales and other operational costs,
Circassia records the costs of the field force and promotion and
the companies share the remaining profits equally. As a result,
Circassia's Tudorza(R) revenues reflect both its costs and share of
the profit. Revenue from the AstraZeneca collaboration of GBP14.4
million is higher compared to H1 2017, as sales were only
recognised from 12 April 2017, being the date the agreement became
unconditional, and is 4% ahead at CER of the GBP13.8 million the
Company received in the second half of 2017.
NIOX(R) revenues include clinical sales of GBP11.7 million (H1
2017: GBP11.0 million), research sales of GBP2.1 million (H1 2017:
GBP1.9 million) and other revenues of GBP0.2 million (H1 2017:
GBP0.2 million), which include freight. NIOX(R) clinical revenues
represent sales to physicians, hospitals and distributors for use
in clinical practice, while research sales are those to
pharmaceutical companies for use in clinical studies.
Gross profit
Gross margin increased from 74% to 85%. This was mainly due to
the contribution of revenues from the AstraZeneca collaboration,
which are earned at a 100% gross margin. The gross margin was
higher in H1 2018 than in H1 2017 based on receipt of these
revenues for the full six month period. Gross profit on NIOX(R)
sales was GBP9.8 million (H1 2017: GBP8.4 million), with a gross
margin of 70% (H1 2017: 64%). The increase was mainly due to the
weakening of sterling against the dollar.
Research and development activities
Research and development costs decreased to GBP6.9 million (H1
2017: GBP27.2 million). This was mainly due to a decrease in
non-underlying costs, notably the non-recurring AstraZeneca
research and development contribution of GBP14.6 million in H1
2017, and a decrease in discontinued operations following the
halting of expenditure on allergy programmes.
Sales and marketing
Sales and marketing costs increased during H1 2018 to GBP27.7
million (H1 2017: GBP21.6 million). This was mainly due to the
expanded US field force being in place for the full period as well
as building commercial operations in China.
Administrative expenditure
Administrative expenditure, which includes overheads specific to
corporate functions, centrally managed support functions and
corporate costs, increased to GBP5.5 million (H1 2017: GBP5.1
million). This was mainly due to restructuring, business
development and legal costs.
Other gains and losses
Other losses increased to GBP2.2 million (H1 2017: GBP2.6
million gain). This was mainly due to unrealised foreign exchange
losses on consideration payable to AstraZeneca due to the weakening
of sterling against the dollar.
Net finance income
Net finance costs were GBP6.0 million (H1 2017: GBP1.4 million).
This is a non-cash charge to the income statement for the period
that is the difference in the discounted consideration payable to
AstraZeneca recorded on the balance sheet and the consideration
payable. This discounted amount reflects the time value of
money.
Share of loss of joint venture
A joint venture between Circassia and McMaster University was
established previously to collaborate on the development of allergy
immunotherapies. Loss for the period in respect of the joint
venture was GBP0.1 million (H1 2017: GBP0.5 million), which has
been included in discontinued operations.
R&D tax credits
The tax credit on qualifying expenditure for the period was
GBP0.7 million (H1 2017: GBP5.3 million). The decrease since the
previous year reflects the reducing R&D expenditure on the
Group's internal respiratory programmes and the non-recurring
R&D contribution to AstraZeneca in 2017. The R&D tax credit
relating to the allergy portfolio is included in discontinued
operations.
Loss after tax and loss per share
Basic loss per share for the period was 7p (H1 2017: 11p)
reflecting a loss for the financial period of GBP23.5 million (H1
2017: GBP34.3 million), with the loss per share for continuing
operations of 7p (H1 2017: 10p) reflecting a loss for the financial
period of GBP23.3 million (H1 2017: GBP29.6 million). This decrease
in loss per share mainly arose due to the increase in Tudorza(R)
revenues and the reduction in R&D expenditure, in particular,
the AstraZeneca research and development contribution.
Statement of financial position
The Group's net assets at 30 June 2018 were GBP198.0 million (31
December 2017: GBP224.8 million). The decrease is mainly caused by
a lower trade receivables balance, combined with a decrease in the
Company's deposits balance.
Current liabilities at the end of the period were GBP27.7
million (31 December 2017: GBP30.8 million). The decrease is mainly
due to a reduction in R&D expenditure.
Current tax assets at 30 June 2018 were GBP10.5 million (31
December 2017: GBP6.5 million), representing the R&D tax credit
due from HM Revenue and Customs (HMRC). An R&D tax credit of
GBP10.9 million was received in July 2018.
Cash flow
The Group's cash position (including cash, cash equivalents and
short-term deposits) decreased from GBP59.5 million at 31 December
2017 to GBP50.8 million at 30 June 2018.
In terms of cash usage, GBP7.4 million was used in operations
(H1 2017: GBP34.2 million), with the decrease reflecting higher
revenues and a net decrease in the overall cost base of the
business, mainly due to the non-recurring AstraZeneca research and
development contribution in H1 2017.
Exchange differences on cash and cash equivalents arose as a
result of translation of foreign currency balances at the beginning
and end of the relevant period. The exchange loss for the period
was GBP1.5 million (H1 2017: GBP0.6 million gain). The increase
compared with H1 2017 was due to greater fluctuations in exchange
rates, in particular, the dollar.
Summary and outlook
The outlook for the second half of 2018 is positive, reflecting
the Company's increasing focus on commercial expansion and its
intention to build on the cost containment measures achieved in
2017. With further savings in the non-commercial organisation,
together with the benefit of a full year of Tudorza(R) sales and
growing NIOX(R) revenues, the overall net loss and cash outflow for
the full year is expected to decrease significantly.
PRINCIPAL RISKS AND UNCERTAINTIES
Circassia has considered the principal risks and uncertainties
facing the Group for the remaining six months of this year and does
not consider them to have changed from those set out on pages 33 to
38 of the 2017 Annual report and accounts except in respect of
risks relating to: (a) the Group's increased investment in China;
(b) the Company's free float (where much of the uncertainty has
been removed); and (c) research and development risks, which are
reduced in scope following the Group's decision to out-license its
pipeline of early stage respiratory products. A summary of these
risks is as follows:
Commercial success
The Group's competitors - many of whom have considerably greater
financial and human resources - may develop safer or more effective
products or be able to compete more effectively in the markets
targeted by the Group. New companies may enter these markets and
novel products and technologies may become available which are more
commercially successful than those being developed by the Group.
The Group is expanding its operations in China where it has seen
significant growth in previous years. However, there is no
guarantee that this investment will lead to increased commercial
success in the Chinese market.
Compliance with healthcare regulations
The Group must comply with complex regulations in relation to
the marketing of its device products (and in the future will need
to comply with such regulations in relation to its drug products).
These regulations are strictly enforced. Failure by the Group (or
its commercial partners) to comply with the US False Claims Act,
Anti- Kickback Statute and the US Foreign and Corrupt Practices Act
and regulations relating to data privacy (amongst others) and
similar legislation in countries outside the US, such as China
where the Group is expanding its operations significantly, may
result in criminal and civil proceedings against the Group.
Regulatory approvals
The Group may not receive regulatory approval for those of its
products which are in development or regulatory review. Even where
products are approved, subsequent regulatory difficulties may
arise, or the conditions relating to the approval may be more
onerous or restrictive than the Group expects, or existing
approvals might be withdrawn.
Unforeseen side effects
Unforeseen side effects may result from the use of the Group's
products or product candidates.
Supply Chain
The Group relies on third parties for the supply of key
materials and services, such as AstraZeneca for Tudorza(R).
Problems at these contractors, such as technical issues,
contamination, and regulatory actions may lead to delays or even
loss of supply or inadequate supply of these materials and services
either prior to launch or thereafter.
Research and development risks
The Group may not be successful in its efforts to develop the
next generation of its NIOX(R) device. This could have an impact on
the long-term success of the NIOX(R) business.
Intellectual property, know how, and trade secrets
The Group may be affected by challenges relating to the validity
of its or its licensed patents. If these challenges are successful,
then the Group may be exposed to generic competition.
The Group could also be sued for infringement of third party
patent rights or not be able to secure intellectual property
protection, or sufficient protection, in relation to products which
are acquired or in development.
The Group may rely upon know how and trade secrets to protect
its products and maintain a competitive advantage. This may be
especially important where patent protection is limited or
lacking.
The Group licenses certain intellectual property rights from
third parties. The rights that are licensed to the Group as part of
the collaboration with AstraZeneca relating to Tudorza(R) and
Duaklir(R) fall within this category. If the Group fails to comply
with its obligations under these licence agreements it may enable
the other party to terminate the agreement.
Organisational capabilities and capacity
The Group may be unable to successfully implement its plans for
growth if it does not attract and retain employees with the
requisite capabilities and experience, in appropriate numbers.
Free float
The FCA requires issuers with a premium listing to maintain at
least 25% free float in their listed shares. The Company continues
to have a free float significantly below this level. The Company
has committed to the FCA that if the level of free float cannot be
increased to 25% by 27 December 2018 then it will seek shareholder
approval to move to AIM (which does not have this requirement). In
order to expedite this process, the Company has determined to
initiate the activities required to admit its shares to trading on
AIM, and anticipates convening a shareholder vote to approve such a
move in the coming weeks. There is therefore some residual
uncertainty about the timing of this move.
Financial operations
The Group has incurred significant losses since the inception of
its various businesses and anticipates that it will continue to do
so for some time due to the high level of expenditure required to
develop its NIOX(R) business and to promote Tudorza(R) and launch
Duaklir(R).
Foreign exchange fluctuations may adversely affect the Group's
results and financial condition.
Adverse decisions of regulators, including tax authorities, or
changes in tax treaties, laws, or the interpretation of those laws,
could reduce or eliminate research and development tax credits
which the Group currently receives in the United Kingdom.
Brexit
At the referendum held on 23 June 2016, the UK voted to leave
the EU. The Group faces a range of risks associated with this
decision. For example, the vote to leave the EU may lead to changes
in the regulatory system by which medical devices and
pharmaceutical products are approved for use.
Brexit may also result in restrictions on the movement of people
which make it harder for the Group to attract the talent it needs
to support the business. The general economic uncertainty created
by the process may also make it harder to enter into strategic
partnerships with European companies.
CONDENSED INTERIM CONSOLIDATED STATEMENT OF COMPREHENSIVE
INCOME
FOR THE SIX MONTHSED 30 JUNE 2018
30 June 2018 30 June 2017
Underlying Non-underlying Total Underlying Non-underlying Total
operations items operations items
Unaudited Unaudited Unaudited Unaudited Unaudited Unaudited
Restated(1,2) Restated(1,2) Restated(2)
Notes GBPm GBPm GBPm GBPm GBPm GBPm
Continuing
operations
Revenue 28.4 - 28.4 18.3 - 18.3
Cost of sales (4.2) - (4.2) (4.7) - (4.7)
-------------------- ------ ------------ --------------- ---------- -------------- --------------- ------------
Gross profit 24.2 - 24.2 13.6 - 13.6
Research and
development
costs (5.7) (1.0) (6.7) (7.1) (15.7) (22.8)
Sales and marketing (27.7) - (27.7) (21.1) - (21.1)
Administrative
expenses (5.2) (0.3) (5.5) (4.6) (0.4) (5.0)
Operating loss 4 (14.4) (1.3) (15.7) (19.2) (16.1) (35.3)
Other gains and
(losses) 5 0.1 (2.3) (2.2) (0.1) 2.7 2.6
Finance costs 6 (0.1) (6.0) (6.1) (0.1) (1.5) (1.6)
Finance income 6 0.1 - 0.1 0.2 - 0.2
Loss before tax (14.3) (9.6) (23.9) (19.2) (14.9) (34.1)
Taxation 0.3 0.3 0.6 1.1 3.4 4.5
-------------------- ------ ------------ --------------- ---------- -------------- --------------- ------------
Loss for the
financial period
from continuing
operations (14.0) (9.3) (23.3) (18.1) (11.5) (29.6)
-------------------- ------ ------------ --------------- ---------- -------------- --------------- ------------
Discontinued
operations
Loss for the period
from
discontinued
operations
attributable
to owners of the
parent 7 - (0.2) (0.2) - (4.7) (4.7)
Loss for the period
attributable
to owners of the
parent (14.0) (9.5) (23.5) (18.1) (16.2) (34.3)
-------------------- ------ ------------ --------------- ---------- -------------- --------------- ------------
Other comprehensive
income
Items that may be
subsequently
reclassified to
profit or
loss
Currency
translation
differences (4.6) - (4.6) 1.8 - 1.8
Total other
comprehensive
income for the
period (4.6) - (4.6) 1.8 - 1.8
-------------------- ------ ------------ --------------- ---------- -------------- --------------- ------------
Total comprehensive
expense
for the period (18.6) (9.5) (28.1) (16.3) (16.2) (32.5)
-------------------- ------ ------------ --------------- ---------- -------------- --------------- ------------
Loss per share attributable to owners of the parent during the
period (expressed in GBP per share)
30 June 2018 30 June 2017
Basic and diluted loss GBP GBP
per share
------------------------------- ------- ------------- -------------
Loss per share from continuing 15 (GBP0.07) (GBP0.10)
operations
Total loss per share 15 (GBP0.07) (GBP0.11)
------------------------------- ------- ------------- -------------
(1) Restated to show the results of the respiratory business as
non-underlying. See note 8 for details.
(2) Restated to show Foreign exchange differences within 'Other
gains and losses' (previously shown within 'Finance income and
costs').
The notes on pages 16 to 24 are an integral part of these
condensed interim consolidated financial statements.
CONDENSED INTERIM CONSOLIDATED STATEMENT OF FINANCIAL
POSITION
AS AT 30 JUNE 2018
Notes 30 June 31 December
2018 2017
GBPm GBPm
Unaudited Audited
------------------------------------- ------ ---------- ------------
Assets
Non-current assets
Property, plant & equipment 1.0 1.4
Goodwill 10 9.7 10.0
Intangible assets 11 194.6 199.7
Deferred tax assets 9 15.7 15.7
Investment in joint venture 12 0.1 0.5
Prepayment for business combination 13 77.9 77.9
Non-current tax assets 9 4.0 7.3
303.0 312.5
------------------------------------- ------ ---------- ------------
Current assets
Inventories 4.7 5.0
Trade and other receivables 11.8 18.9
Current tax assets 9 10.5 6.5
Short-term bank deposits 10.0 15.0
Cash and cash equivalents 40.8 44.5
------------------------------------- ------ ---------- ------------
77.8 89.9
------------------------------------- ------ ---------- ------------
Total assets 380.8 402.4
------------------------------------- ------ ---------- ------------
Equity and liabilities
Ordinary shares 17 0.3 0.3
Share premium 17 602.2 602.2
Other reserves 18 14.0 17.2
Accumulated losses (418.5) (394.9)
------------------------------------- ------ ---------- ------------
Total equity 198.0 224.8
Liabilities
Non-current liabilities
Deferred tax liabilities 9 24.1 24.1
Non-contingent consideration 13 72.1 68.7
Contingent consideration 13 38.1 33.6
Non-current trade payables 14 20.8 20.4
------------------------------------- ------ ---------- ------------
155.1 146.8
------------------------------------- ------ ---------- ------------
Current liabilities
Trade and other payables 14 27.7 30.8
27.7 30.8
Total liabilities 182.8 177.6
------------------------------------- ------ ---------- ------------
Total equity and liabilities 380.8 402.4
------------------------------------- ------ ---------- ------------
The notes on pages 16 to 24 are an integral part of these
condensed interim consolidated financial statements.
CONDENSED INTERIM CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHSED 30 JUNE 2018
Notes 30 June 30 June
2018 2017
GBPm GBPm
Unaudited Unaudited
---------------------------------------------------- ------ ---------- ----------
Cash flows from operating activities
Cash used in operations 16 (7.4) (34.2)
Interest and bank charges paid (0.1) (0.1)
Net cash used in operating activities (7.5) (34.3)
---------------------------------------------------- ------ ---------- ----------
Cash flows from investing activities
Interest received 0.1 0.5
Joint venture distributions to owners 0.3 -
Purchase of intangible assets (0.1) -
Purchase of property, plant and equipment - (0.5)
Decrease in short term bank deposits 5.0 -
Net cash generated from investing activities 5.3 -
---------------------------------------------------- ------ ---------- ----------
Cash flows from financing activities
Costs offset against share premium - (0.8)
Net cash used in financing activities - (0.8)
---------------------------------------------------- ------ ---------- ----------
Net decrease in cash and cash equivalents (2.2) (35.1)
Cash and cash equivalents at 1 January 44.5 97.4
Exchange (loss)/ gain on cash and cash equivalents (1.5) 0.6
---------------------------------------------------- ------ ---------- ----------
Cash and cash equivalents at 30 June 40.8 62.9
---------------------------------------------------- ------ ---------- ----------
The notes on pages 16 to 24 are an integral part of these
condensed interim consolidated financial statements.
CONDENSED INTERIM CONSOLIDATED STATEMENT OF CHANGES IN
EQUITY
Notes Share Share Other(1) Accumulated Total
capital premium reserves losses equity
GBPm GBPm GBPm GBPm GBPm
----------------------------- ------ --------- --------- ---------- ------------ --------
At 1 January 2018 (audited) 0.3 602.2 17.2 (395.0) 224.8
Comprehensive expense:
Loss for the period - - - (23.5) (23.5)
Other comprehensive
expense:
Currency translation
differences 18 - - (4.6) - (4.6)
----------------------------- ------ --------- --------- ---------- ------------ --------
Total comprehensive
income /(expense) 0.3 602.2 12.6 (418.5) 196.6
Transactions with owners:
Employee share option
scheme 18 - - 1.4 - 1.4
At 30 June 2018 (unaudited) 0.3 602.2 14.0 (418.5) 198.0
----------------------------- ------ --------- --------- ---------- ------------ --------
At 1 January 2017 (audited) 0.2 563.8 12.5 (295.8) 280.7
Comprehensive expense:
Loss for the period - - - (34.3) (34.3)
Other comprehensive
income:
Currency translation
differences - - 1.8 - 1.8
----------------------------- ------ --------- --------- ---------- ------------ --------
Total comprehensive
income /(expense) - - 1.8 (34.3) (32.5)
Transactions with owners:
Issue of ordinary shares 0.1 38.4 - - 38.5
----------------------------- ------ --------- --------- ---------- ------------ --------
At 30 June 2017 (unaudited) 0.3 602.2 14.3 (330.1) 286.7
----------------------------- ------ --------- --------- ---------- ------------ --------
(1) Other reserves include the share option reserve, translation
reserve, treasury shares reserve and transactions with NCI
reserve
The notes on pages 16 to 24 are an integral part of these
condensed interim consolidated financial statements.
NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL
STATEMENTS
1. General information
Circassia Pharmaceuticals plc is a public limited company which
is listed on the London Stock Exchange and incorporated and
domiciled in England and Wales. The address of its registered
office is The Magdalen Centre, Robert Robinson Avenue, Oxford
Science Park, Oxford, Oxfordshire, England, OX4 4GA.
The condensed consolidated interim financial statements were
approved for issue on 27 September 2018.
The condensed consolidated interim financial statements do not
comprise statutory accounts within the meaning of section 434 of
the Companies Act 2006. Statutory accounts for the year ended 31
December 2017 were approved by the Board of Directors on 24 April
2018 and delivered to the Registrar of Companies. The report of the
auditors on those accounts was unqualified, did not contain an
emphasis of matter paragraph and did not contain any statement
under section 498 of the Companies Act 2006.
The condensed consolidated interim financial statements have not
been audited or reviewed.
Basis of preparation
The condensed consolidated interim financial statements for the
six months ended 30 June 2018 have been prepared in accordance with
the Disclosure and Transparency Rules of the Financial Conduct
Authority (previously the Financial Services Authority) and IAS 34
'Interim financial reporting', as adopted by the European
Union.
The condensed consolidated interim financial statements should
be read in conjunction with the annual financial statements for the
year ended 31 December 2017, which have been prepared in accordance
with IFRSs as adopted by the European Union.
Going concern
The Group has sufficient cash and cash equivalents to meet its
day-to-day working capital requirements. Though the Group continues
to make losses, the Directors have reviewed the current and
projected financial position of the Group, taking into account
existing cash balances. On the basis of this review, the Directors
have not identified any material uncertainties to the Group's
ability to meet its liabilities as they fall due for the
foreseeable future.
Accounting policies
The accounting policies adopted are consistent with those of the
previous financial year except as described below.
Foreign currency translation
Monetary assets and liabilities in foreign currencies are
translated into sterling at the rates of exchange ruling at the end
of the financial period. Transactions in foreign currencies are
translated into sterling at the rates of exchange ruling at the
date of the transaction. Foreign exchange differences are taken to
the income statement in the year in which they arise and are
presented within 'Other gains and losses'. In the condensed interim
financial statements for the period ended 30 June 2017 foreign
exchange differences were presented within 'Finance costs or
income'. The change in the presentation reflects the fact that
historically the foreign exchange differences were to a large
extent driven by movements on foreign cash balances whereas
following the AstraZeneca collaboration agreement the foreign
exchange differences also arise from translation of monetary
liabilities and as such the change in presentation to 'Other gains
and losses' was deemed appropriate. This constitutes a voluntary
change in accounting policy and has been applied retrospectively in
these condensed interim financial statements resulting in 'Finance
income' reducing by GBP2.6 million for the period to 30 June 2017
and 'Other gains' increasing by GBP2.6 million. There has been no
impact to total loss for the current or previous financial period
as a result of the policy change.
There are not considered to be any new standards, amendments to
IFRS's and interpretations effective for the financial year ending
31 December 2018 that would have a material impact on the
Group.
Use of estimates and assumptions
The preparation of interim financial statements requires
management to make judgements, estimates and assumptions that
affect the application of accounting policies and the reported
amounts of assets and liabilities, income and expense. Actual
results may differ from these estimates.
In preparing these condensed interim financial statements, the
significant judgements made by management in applying the Group's
accounting policies and the key sources of estimation uncertainty
were the same as those that applied to the annual financial
statements for the year ended 31 December 2017 except as disclosed
below.
Financial instruments
The Group's financial instruments comprise cash and cash
equivalents, short-term bank deposits, receivables and payables
arising directly from operations. The Directors consider that the
fair values of the Group's financial instruments do not differ
significantly from their carrying values.
2. Financial and capital risk management
The condensed interim financial statements do not include all
financial and capital risk management information and disclosures
required in the annual financial statements; they should be read in
conjunction with the Group's annual financial statements for the
year ended 31 December 2017. The viability consideration has been
disclosed in the last annual report and the Directors believe that
the year-end position remains unchanged.
The majority of operating costs are denominated in sterling,
United States dollars, euro or Swedish krona. Foreign exchange risk
arises from future commercial transactions and recognised assets
and liabilities. The Directors expect foreign exchange volatility
to continue to affect the Group's results and the resulting impact
will be assessed in the annual report.
3. Operating segments
The chief operating decision-maker (the Executive Directors) is
responsible for making key operating decisions in the Group.
Assessment of performance and decisions regarding the allocation of
resources are made by operating segment. Performance of each
segment is assessed on revenue and operating profit/ (loss) . The
operating segments are identified within the Group by product
portfolios:
- NIOX(R) relates to the portfolio of products used to improve
asthma diagnosis and management by measuring fractional exhaled
nitric oxide (FeNO);
- Respiratory relates to the portfolio of asthma and chronic
obstructive pulmonary disease product candidates; and
- US AZ collaboration relates to the US collaboration agreement with AstraZeneca regarding the commercialisation of Tudorza(R) and Duaklir(R) once approved.
The allergy operating segment is classified as a discontinued
operation. Information about this discontinued segment is provided
in note 7.
The table below presents revenue from external customers and
operating profit/ (loss) information regarding the Group's
operating segments for the six months ended 30 June 2018 and 2017.
Costs shared between the segments are not allocated to individual
segments for decision making purposes. These are disclosed under
the column headed 'Unallocated'.
Non-underlying operations
Underlying operations
-------------------------------------------- --------------------------
NIOX(R) US AZ collaboration Unallocated Respiratory Total
GBPm GBPm GBPm GBPm GBPm
---------------------------- -------- -------------------- ------------ -------------------------- -------
Six months to 30 June 2018
Revenue 14.0 14.4 - - 28.4
Operating (loss)/ profit (6.9) 1.5 (9.0) (1.3) (15.7)
Six months to 30 June 2017
Revenue 13.1 5.2 - - 18.3
Operating loss (12.0) (13.4) (8.7) (1.2) (35.3)
---------------------------- -------- -------------------- ------------ -------------------------- -------
There were no sales between the segments in either reporting
period.
There have been no material changes in total assets or total
liabilities from the amounts disclosed in the last annual financial
statements.
4. Operating loss
Included within the operating loss for the six months ended 30
June 2017 is a GBP14.6 million R&D contribution to AstraZeneca
relating to research and development costs of Tudorza(R) and
Duaklir(R).
Transaction costs totalling GBP1.9 million were incurred on the
collaboration arrangement with AstraZeneca, of which GBP0.3 million
is included within the operating loss to 30 June 2017 and GBP1.6
million was offset against the share premium reserve.
5. Other gains and losses
Six months ended 30 June
---------------------------
2018 2017
Restated(1)
GBPm GBPm
------------------------------------------------- ---------- ---------------
Net foreign exchange loss 0.1 (0.1)
Foreign exchange (loss)/ gain on non-underlying
items (2.3) 2.7
Total other gains and losses (2.2) 2.6
------------------------------------------------- ---------- ---------------
(1) Restated to show Foreign exchange differences within 'Other
gains and losses' (previously shown within 'Finance income and
costs').
Foreign exchange loss on non-underlying items of GBP2.3 million
(30 June 2017: GBP2.7 million gain) is made up foreign exchange
loss of GBP1.6 million (30 June 2017: GBP2.7 million gain) on the
non-contingent consideration and foreign exchange loss of GBP0.7
million (30 June 2017: GBPnil) on the contingent royalty
consideration. See note 13 for further details.
6. Finance income and costs
Six months ended 30 June
2018 2017
---------- ---------------
Restated(1)
GBPm GBPm
--------------------------------------------- ---------- ---------------
Finance costs:
Interest and bank charges payable (0.1) (0.1)
Non-contingent consideration: unwinding
of discount (1.8) (1.5)
Contingent royalty consideration: unwinding (3.8) -
of discount
Non-current trade payables: unwinding (0.4) -
of discount
Total finance costs (6.1) (1.6)
--------------------------------------------- ---------- ---------------
Finance income:
Bank interest receivable 0.1 0.2
Total finance income 0.1 0.2
--------------------------------------------- ---------- ---------------
(1) Restated to show Foreign exchange differences within 'Other
gains and losses'.
7. Discontinued operations
During 2017 it was announced that Circassia would no longer
continue development of the allergy programmes. Therefore, the
allergy programme costs and the associated research and development
tax credit are reclassified as discontinued operations in the
condensed interim consolidated statement of comprehensive income to
comply with IFRS 5 requirements.
Loss for the period For the six months ended 30 June
-----------------------------------
Notes 2018 2017
GBPm GBPm
----------------------------------- ------ ----------------- ----------------
Expenditure (0.2) (5.0)
Share of loss of joint venture 12 (0.1) (0.5)
Loss before tax (0.3) (5.5)
Taxation 0.1 0.8
----------------------------------- ------ ----------------- ----------------
Loss from discontinued operations (0.2) (4.7)
----------------------------------- ------ ----------------- ----------------
Cash flow For the six months ended 30 June
-----------------------------------
2018 2017
GBPm GBPm
--------------------------------------------------- ----------------- ----------------
Net cash outflow from operating activities (0.2) (8.8)
Net decrease in cash from discontinued operations (0.2) (8.8)
--------------------------------------------------- ----------------- ----------------
8. Non-underlying items
Management primarily manage the business and measure performance
based on the results of "underlying operations". Significant
irregularly occurring and exceptional items and items relating to
programmes the Company now intends to out license/ partner are
classified as "non-underlying" items and are excluded from the
underlying measures. The following non-underlying items have been
recognised in the income statement for the period:
For the six months ended 30 June
-----------------------------------
Notes 2018 2017
GBPm GBPm
-------------------------------------------------------------------- ------ ---------------- -----------------
Charged to research and development costs
In-house respiratory programme costs (0.7) (1.1)
Restructuring costs (0.3) -
AstraZeneca R&D contribution - (14.6)
(1.0) (15.7)
Charged to administrative expenses
Transaction costs in relation to AstraZeneca collaboration - (0.3)
Legal and patent costs relating to in-house respiratory programmes (0.3) (0.1)
(0.3) (0.4)
Credited to other gains and losses
Foreign exchange movement on non-contingent consideration 5 (1.6) 2.7
Foreign exchange movement on contingent royalty consideration 5 (0.7) -
(2.3) 2.7
Charged to finance costs
Non-contingent consideration: unwinding of discount 6 (1.8) (1.5)
Contingent royalty consideration: unwinding of discount 6 (3.8) -
Non-current trade payables: unwinding of discount 6 (0.4) -
-------------------------------------------------------------------- ------ ---------------- -----------------
(6.0) (1.5)
-------------------------------------------------------------------- ------ ---------------- -----------------
Loss before tax (9.6) (14.9)
Credited to taxation 0.3 3.4
Loss from continuing operations (9.3) (11.5)
Loss from discontinued operations (0.2) (4.7)
Total loss (9.5) (16.2)
-------------------------------------------------------------------- ------ ---------------- -----------------
In-house respiratory programme costs
Under its refocused strategy announced in April 2018, Circassia
ceased investment in the Respiratory CGU and is seeking to
out-license/ partner its respiratory pipeline of directly
substitutable generic products and novel formulations of currently
approved drugs. As a result, respiratory programmes are not
considered to be part of the underlying operations for the period
ended 30 June 2018. The respiratory programme costs are classified
as non-underlying items. To enable comparison respiratory programme
results for the period ended 30 June 2017 are also presented in
non-underlying items.
Restructuring costs
Restructuring costs comprise cost optimisation initiatives
including severance payments, compensation for loss of office,
property and other contract termination costs.
AstraZeneca R&D contribution
The cost in the period to 30 June 2017 includes a R&D
contribution accrual of GBP14.6 million for Tudorza(R) and
Duaklir(R) product development. An R&D tax credit of GBP3.2
million related to this expenditure is included in the taxation
line for non-underlying items.
Non-contingent consideration
The GBP2.3 million loss (30 June 2017: gain of GBP2.7 million)
relating to foreign exchange movement on non-contingent
consideration relates to the impact of the strengthening (2017:
weakening) dollar on translation of the $100 million deferred
non-contingent consideration payable to AstraZeneca. The
consideration was measured by discounting the liability with GBP1.8
million (30 June 2017: GBP1.5 million) increasing in the liability
due to the passage of time (unwinding of discount) recognised as a
finance cost for the period.
Contingent royalty consideration
Contingent royalty consideration relates to the amount of
royalties payable to AstraZeneca on the future Duaklir(R) sales.
The liability was remeasured to fair value at the period end with
no change in fair value (30 June 2017: GBPnil). The GBP0.7 million
(30 June 2017: GBPnil) foreign exchange movement relates to the
impact of the strengthening dollar on translation of the contingent
royalty consideration.
Loss from discontinued operations
The costs relating to the discontinued allergy operation are
deemed to be an exceptional item to be excluded from the underlying
operations, see note 7 for further details.
9. Taxation
R&D tax credit
Included within the GBP14.5 million tax debtor is an R&D tax
credit of GBP0.6 million (H1 2017: GBP4.5 million) relating to the
six months ended 30 June 2018. This represents the credit
receivable by the Group for the period as well as adjustments to
prior years. These have been estimated at a rate of 14.5% for
qualifying expenditure, being the prevailing R&D tax credit
rate at the time. An uplift of 130% has been applied to all
qualifying expenditure in line with R&D tax rules.
Deferred taxation
Intangibles Tax losses Net deferred tax liability
GBPm GBPm GBPm
At 1 January 2018 24.1 (15.7) 8.4
At 30 June 2018 24.1 (15.7) 8.4
------------------- ------------ ----------- ---------------------------
30 June 2018 31 December 2017
GBPm GBPm
Deferred tax liabilities 24.1 24.1
Deferred tax assets (15.7) (15.7)
Total deferred tax position 8.4 8.4
----------------------------- ------------- -----------------
The Group has the following unrecognised potential deferred tax
assets as at
30 June 2018 31 December 2017
GBPm GBPm
Losses 64.8 60.3
Total unrecognised deferred tax asset 64.8 60.3
--------------------------------------- ------------- -----------------
10. Goodwill
GBPm
At 31 December 2017
Cost 84.5
Accumulated impairment (74.5)
------------------------------- -------
Net book amount 10.0
------------------------------- -------
Six months ended 30 June 2018
Opening net book amount 10.0
Exchange differences (0.3)
Closing net book amount 9.7
------------------------------- -------
At 30 June 2018
Cost 84.2
Accumulated impairment (74.5)
------------------------------- -------
Net book amount 9.7
------------------------------- -------
Under its refocused strategy, Circassia ceased investment in the
Respiratory CGU and is seeking to out-license/ partner its
respiratory pipeline of directly substitutable generic products and
novel formulations of currently approved drugs.
Management has revised its forecast of the future performance of
the Respiratory CGU based on the current strategic plans. The
recoverable amount of the CGU was determined based on value in use
calculations using a consistent methodology to that disclosed in
the 2017 annual report.
No impairment loss has been recognised in the six-month period
ended 30 June 2018 as the carrying value of the Respiratory CGU can
be supported by the fair value generated by the future
out-licensing/ partnering activity.
As there were no indicators for impairment of any of the other
CGUs, management has not updated any of the other impairment
calculations.
The carrying value of goodwill is allocated to the following
CGUs:
30 June 2018 31 December
2017
Cash GBPm GBPm
generating
unit
NIOX(R) 5.1 5.4
Respiratory 4.4 4.4
AstraZeneca
collaboration 0.2 0.2
---------------- ------------- ------------
9.7 10.0
---------------- ------------- ------------
11. Intangible assets
IPR&D Customer relationships Technology Other Total intangible assets
GBPm GBPm GBPm GBPm GBPm
------------------------------------- ------- ----------------------- ----------- ------ ------------------------
At 31 December 2017
Cost 161.9 34.6 50.3 1.6 248.4
Accumulated amortisation and
impairment (37.1) (4.8) (5.2) (1.6) (48.7)
------------------------------------- ------- ----------------------- ----------- ------ ------------------------
Net book amount 124.8 29.8 45.1 - 199.7
------------------------------------- ------- ----------------------- ----------- ------ ------------------------
Six months ended 30 June 2018
Opening net book amount 124.8 29.8 45.1 - 199.7
Additions - - - 0.1 0.1
Amortisation charge - (0.9) (1.0) - (1.9)
Impairment - - - - -
Exchange differences - (1.8) (1.5) - (3.3)
------------------------------------- ------- ----------------------- ----------- ------ ------------------------
Closing net book amount 124.8 27.1 42.6 0.1 194.6
------------------------------------- ------- ----------------------- ----------- ------ ------------------------
At 30 June 2018
Cost 161.9 34.6 50.3 1.7 248.5
Accumulated amortisation and
impairment (37.1) (7.5) (7.7) (1.6) (53.9)
------------------------------------- ------- ----------------------- ----------- ------ ------------------------
Net book amount 124.8 27.1 42.6 0.1 194.6
------------------------------------- ------- ----------------------- ----------- ------ ------------------------
Due to change in strategy, Circassia ceased investment in the
Respiratory CGU. This is considered to be an indicator of
impairment in the Respiratory CGU intangible assets as at 30 June
2018. Impairment review was performed as outlined in note 10 with
no impairment charges recognised in the period.
12. Investment in joint venture
Six months ended 30 June 2018 Year ended
GBPm 31 Dec 2017
GBPm
At 1 January 0.5 0.9
Share of (loss)/profit (0.1) (0.2)
Distributions to owners (0.3) (0.2)
At period end 0.1 0.5
------------------------- ------------------------------ -------------
The Adiga Life Sciences joint venture managed clinical research
organisations (CRO's) in Canada in respect of allergy programmes on
behalf of Circassia. As the allergy programmes are no longer being
continued, the results of the joint venture for the six months
ended 30 June 2018 and 2017 have been included within discontinued
operations in the condensed interim consolidated statement of
comprehensive income, see note 7.
13. Business combinations
Prepayment for business combination
On 12 April 2017, Circassia's collaboration and profit share
arrangement with AstraZeneca became unconditional. Under the
agreement, Circassia secured certain US commercial rights to
Tudorza(R) and Duaklir(R). On that day Circassia issued 47,355,417
ordinary shares with a value of $50 million to AstraZeneca. In
addition, Circassia will pay AstraZeneca deferred non-contingent
consideration of $100 million on the earlier of: (i) 30 June 2019;
and (ii) the approval of Duaklir(R) by the FDA; and royalties on
sales of Duaklir(R) in the United States.
Under the terms of the agreement, Circassia will have the option
to secure the remaining commercial rights and economic benefits of
Tudorza(R). This will become exercisable from H2 2018 based on the
sales performance of Tudorza(R) in the preceding 12 month period,
or if Duaklir(R) gains FDA approval before 31 December 2019. Until
the option becomes exercisable Circassia does not have control over
the Tudorza(R) business hence the consideration paid and payable
represents a prepayment for the business combination.
Following positive results from the AMPLIFY Phase III study, the
filing of a New Drug Application (NDA) for Duaklir(R) with the
United States Food and Drug Administration (FDA) took place in the
first half of 2018. Circassia has exclusive commercialisation
rights to Duaklir(R) in the United States and as such it is
considered that the Group assumed control over the Duaklir(R)
business when the collaboration agreement
became unconditional.
Consideration GBPm
------------------------------------------------------- ------
Ordinary share capital 47,355,417 shares at GBP0.0008 -
Share premium 40.0
Deferred non-contingent consideration 71.4
Contingent Duaklir(R) royalty consideration 39.7
151.1
------------------------------------------------------- ------
Recognised amounts of identifiable assets acquired GBPm
---------------------------------------------------- ------
Duaklir(R) IPR&D 33.3
Duaklir(R) royalty IPR&D 39.7
----------------------------------------------------- ------
Total identifiable net assets 73.0
AstraZeneca collaboration goodwill 0.2
Prepayment for Tudorza(R) business combination 77.9
151.1
---------------------------------------------------- ------
Tudorza(R) option
If the option to secure the remaining commercial rights and
economic benefits of Tudorza(R) is taken, Circassia will make
further payments to AstraZeneca of up to $80 million dependent on
the level of Tudorza(R) sales in the United States and if
Duaklir(R) gains FDA approval. Such payments are not considered to
be a present obligation until the option becomes exercisable
therefore this has not been recognised as a liability in the
interim financial statements for the six months ended 30 June
2018.
Until the Tudorza(R) option is exercised, the Group promotes the
chronic obstructive pulmonary disease (COPD) treatment Tudorza(R)
in the US in accordance with the collaboration and profit share
arrangement. The commission fees receivable are based on Tudorza(R)
product in-market sales and promotion activities performed by
Circassia.
Deferred non-contingent consideration
30 June 2018 31 December 2017
GBPm GBPm
--------------------------- ------------- -----------------
Opening 68.7 71.4
Unwinding of discount 1.8 2.7
Foreign exchange movement 1.6 (5.4)
At period end 72.1 68.7
---------------------------- ------------- -----------------
Contingent Duaklir(R) royalty consideration
30 June 2018 31 December 2017
GBPm GBPm
--------------------------- ------------- -----------------
Opening 33.6 39.7
Change in fair value - (3.2)
Unwinding of discount 3.8 -
Foreign exchange movement 0.7 (2.9)
At period end 38.1 33.6
---------------------------- ------------- -----------------
14. Trade and other payables
30 June 2018 31 December 2017
GBPm GBPm
------------------------- ------------- -----------------
Payable within one
year
Trade payables 21.4 22.7
Social security and
other taxes 0.3 0.3
Accruals 5.2 6.7
Other payables 0.8 1.1
------------------------- ------------- -----------------
Total trade and other
payables 27.7 30.8
------------------------- ------------- -----------------
Payable after one year
Trade payables 20.8 20.4
------------------------- ------------- -----------------
Total non-current other
payables 20.8 20.4
------------------------- ------------- -----------------
15. Net loss per ordinary share
Basic loss per share is calculated by dividing the loss
attributable to ordinary equity holders of the parent company by
the weighted average number of ordinary shares in issue during the
period.
For the period ending
30 June 2018
Continuing Discontinued Total
operations operations
------------------------- ---------- -------------- -------------- --------------
Loss attributable to
ordinary equity owners
of the parent company GBPm (23.3) (0.2) (23.5)
Weighted average number
of ordinary shares in
issue Number 333,466,262 333,466,262 333,466,262
------------------------- ---------- -------------- -------------- --------------
Loss per share (GBP0.07) (GBP0.00) (GBP0.07)
------------------------- ---------- -------------- -------------- --------------
For the period ending
30 June 2017
Continuing Discontinued Total
operations operations
------------------------- ---------- -------------- -------------- --------------
Loss attributable to
ordinary equity owners
of the parent company GBPm (29.6) (4.7) (34.3)
Weighted average number
of ordinary shares in
issue Number 305,720,065 305,720,065 305,720,065
------------------------- ---------- -------------- -------------- --------------
Loss per share (GBP0.10) (GBP0.01) (GBP0.11)
------------------------------------- -------------- -------------- --------------
As net losses were recorded in the six months ended 30 June 2018
and 2017, the dilutive potential shares are anti-dilutive and
therefore were excluded from the earnings per share
calculation.
16. Cash used in operations
Reconciliation of loss before tax to net cash used in
operations
For the six months ended 30 June
-----------------------------------
2018 2017
GBPm GBPm
----------------------------------------------------- ----------------- ----------------
Loss from continuing operations before tax (23.9) (34.1)
Loss from discontinued operation before tax (0.3) (5.5)
----------------------------------------------------- ----------------- ----------------
Loss before tax (24.2) (39.6)
Adjustment for:
Finance income (0.1) (0.2)
Finance costs 6.1 1.6
Depreciation 0.4 0.3
Amortisation (note 11) 1.9 2.1
Share of joint venture loss (note 12) 0.1 0.5
Share based payment charge 1.4 -
Foreign exchange on non-operating items 2.3 (3.0)
Changes in working capital:
Decrease/ (increase) in trade and other receivables 7.1 (3.1)
(Increase)/ decrease in inventories 0.3 (1.4)
(Decrease)/ increase in trade and other payables (2.7) 8.6
Net cash used in operations (7.4) (34.2)
----------------------------------------------------- ----------------- ----------------
17. Share capital and share premium
Number of shares Share capital Share premium
(millions) GBPm GBPm
------------------------------ ------------------ -------------- --------------
Balance as at 1 January 2018 332.6 0.3 602.2
At 31 December 2018 332.6 0.3 602.2
------------------------------- ----------------- -------------- --------------
Number of shares Share capital Share premium
(millions) GBPm GBPm
--------------------------------------- ----------------- -------------- --------------
Balance as at 1 January 2017 284.9 0.2 563.8
Issue of new shares 47.7 0.1 40.0
Expenses offset against share premium - - (1.6)
At 31 December 2017 332.6 0.3 602.2
--------------------------------------- ----------------- -------------- --------------
18. Other reserves
Share option Translation Treasury Transactions Total other
reserve reserve reserve with non-controlling reserves
interests
GBPm GBPm GBPm GBPm GBPm
----------------------- ------------- ------------ --------- ---------------------- ------------
At 1 January 2018 8.9 15.1 (0.7) (6.1) 17.2
Employee share option
scheme 1.4 - - - 1.4
Currency translation
differences - (4.6) - - (4.6)
At 30 June 2018 10.3 10.5 (0.7) (6.1) 14.0
----------------------- ------------- ------------ --------- ---------------------- ------------
At 1 January 2017 6.4 12.9 (0.7) (6.1) 12.5
Employee share option
scheme 2.5 - - - 2.5
Currency translation
differences - 2.2 - - 2.2
At 31 December 2017 8.9 15.1 (0.7) (6.1) 17.2
----------------------- ------------- ------------ --------- ---------------------- ------------
19. Related party transactions
There have been no new IAS 24 related-party transactions in the
first six months of the current financial year. The post-period
AstraZeneca transaction described in note 20 was a related-party
transaction under the Listing Rules.
20. Events occurring after the reporting date
AstraZeneca share issue
On 18 July 2018, Circassia issued 23,725,800 ordinary shares
with a value of GBP20.4 million to AstraZeneca such that
AstraZeneca's holding increased from 14.2% to 19.9%. Circassia used
the proceeds to fund a deferred R&D contribution of $20 million
payable by the end of 2018 and part fund a final R&D
contribution of $25 million payable by the end of 2019.
The financial effects of the above transaction have not been
brought to account at 30 June 2018.
STATEMENT OF DIRECTORS' RESPONSIBILITIES
The Directors confirm that these condensed interim financial
statements have been prepared in accordance with International
Accounting Standard 34, 'Interim Financial Reporting', as adopted
by the European Union and that the interim management report
includes a fair review of the information required by DTR 4.2.7 and
DTR 4.2.8, namely:
- an indication of important events that have occurred during
the first six months and their impact on the ondensed set of
financial statements, and a description of the principal risks and
uncertainties for the remaining six months of the financial year;
and
- material related-party transactions in the first six months
and any material changes in the related-party transactions
described in the last annual report. The Directors of Circassia
Pharmaceuticals plc are listed on page 26.
The Directors are responsible for the maintenance and integrity
of the Group's website www.circassia.com. Legislation in the UK
governing the preparation and dissemination of interim financial
statements may differ from legislation in other jurisdictions.
On behalf of the Board
Steven Harris Julien Cotta
Chief Executive Officer Chief Financial Officer
27 September 2018
SHAREHOLDER INFORMATION
Indicative financial calendar
Preliminary results for the 12 months ending 31 December 2018:
H1 2019
Annual General Meeting: H1 2019
Registrars
All administrative enquiries relating to shareholdings and
requests to receive corporate documents by email should, in the
first instance, be directed to Equiniti. Shareview is Equiniti's
shareholder portal offering access to services and information to
help manage your shareholdings and inform your important investment
decisions.
Shareview portfolio
Shareview Portfolio is an online portfolio management tool which
enables you to view and manage all the shareholdings you have,
where Equiniti is the Registrar, in one place. It is free to use
and provides access to a wide range of market information and
investment services. Please visit www.shareview.co.uk.
This is not a recommendation to buy or sell shares. The price of
shares can go down as well as up, and you are not guaranteed to get
back the amount that you originally invested.
Addresses for correspondence
Head office Registrars
Circassia Pharmaceuticals plc Equiniti Limited
Northbrook House Aspect House
Robert Robinson Avenue Spencer Road
The Oxford Science Park Lancing
Oxford OX4 4GA West Sussex BN99 6DA
United Kingdom United Kingdom
Tel: +44 (0)1865 405560 Shareholder support: 0871 384
Fax: +44 (0)7092 987560 2030
General enquiries: info@circassia.com Calls to this number are charged
Investors: IR@circassia.com at 10p per minute plus network
Website: www.circassia.com extras. Lines are open 8:30am
to 5:30pm Monday to Friday.
Directors
Dr Francesco Granata (Chairman)
Steven Harris (Chief Executive Officer and co-founder)
Julien Cotta (Chief Financial Officer)
Dr Rod Hafner (Senior Vice President Research and
Development)
Russell Cummings (Non-Executive Director)
Lota Zoth (Independent Non-Executive Director)
Jo Le Couilliard (Independent Non-Executive Director)
Sharon Curran (Independent Non-Executive Director)
Dr Heribert Staudinger (Independent Non-Executive Director)
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
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