TIDMVRP
Significant progress with RPL554 as potential treatment for COPD and CF
Recently initiated important Phase 2 trial as add-on to dual
bronchodilator therapy for COPD maintenance treatment
LONDON, Aug. 07, 2018 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP)
(Nasdaq: VRNA) ("Verona Pharma" or the "Company"), a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for respiratory diseases, announces today an
operational update and financial results for the three months and six
months ended June 30, 2018.
The Company's product candidate, RPL554, is a first-in-class, inhaled,
dual inhibitor of the enzymes phosphodiesterase 3 and 4, or PDE3 and
PDE4, that acts as both a bronchodilator and an anti-inflammatory agent
in a single compound. Verona Pharma is developing RPL554 for the
treatment of chronic obstructive pulmonary disease ("COPD") and cystic
fibrosis ("CF"), and potentially asthma.
OPERATIONAL HIGHLIGHTS
During the three months ended June 30, 2018, the Company:
-- Presented two posters at the American Thoracic Society 2018 International
Conference:
-- demonstrated improvement in lung function produced by adding
RPL554 to tiotropium; and
-- showed that nebulized inhaled RPL554 is an appropriate form of
delivery.
During the three months ended March 31, 2018, the Company:
-- Reported positive top-line data from a Phase 2b four week, 400 patient
clinical trial for maintenance treatment of COPD:
-- RPL554 met the primary endpoint at all doses, showing a
statistically significant difference vs. placebo (p<0.001) with
absolute changes from baseline >200mL in peak FEV1 after 4 weeks
of dosing.
-- This peak bronchodilator effect was observed at the first dose and
was sustained over four weeks (p<0.001).
-- Recording of daily COPD symptoms, using E-RS (EXACT-PRO)
demonstrated a significant, clinically relevant, progressive
improvement in total COPD symptoms (p<0.002), including
improvements in breathlessness (p<0.02), chest symptoms (p<0.02),
and cough and sputum (p<0.02).
-- Strong trend of improvement in quality of life score, the St.
George's Respiratory Questionnaire (SGRQ-C) of >2.5 units was
observed in all dose groups after four weeks.
-- Patients' Global Impression of Change indicates that patients felt
better on RPL554 compared to placebo (p<0.01).
-- RPL554 was well tolerated at all doses with an adverse event
profile similar to placebo.
-- Reported positive top-line data from a Phase 2a clinical trial to study
pharmacokinetic and pharmacodynamic profile in CF:
-- PK profile was consistent with that observed in patients with COPD,
although with lower peak serum levels of RPL554 in CF patients.
-- Serum half-life was dose-dependent; 7.5 to 10.1 hours for 1.5 mg
and 6 mg, respectively.
Post-period end the Company:
-- Initiated a Phase 2 trial expected to enroll approximately 75 patients,
evaluating RPL554 as an add-on to dual bronchodilator therapy for COPD
maintenance treatment:
-- Randomized, double-blind three-way cross-over study at sites in
the US and the UK;
-- Add-on to an inhaled LAMA/LABA, tiotropium/olodaterol (Stiolto(R)
Respimat(R));
-- Expected that some patients will continue a stable dose of inhaled
corticosteroids (ICS) throughout the study, providing a "triple
therapy" background;
-- Top-line data expected first quarter 2019.
FINANCIAL HIGHLIGHTS
-- Net cash, cash equivalents and short term investments at June 30, 2018,
amounted to GBP68.9 million (December 31, 2017: GBP80.3 million).
-- For the six months ended June 30, 2018, reported operating loss of
GBP11.5 million (six months ended June 30, 2017: GBP10.9 million) and
reported loss after tax of GBP14.6 million (six months ended June 30,
2017: GBP5.1 million). Operating expenses increased from GBP10.9 million
to GBP11.5 million due primarily to development activities with RPL554.
The increase in loss after tax reflects GBP6.0 million of finance expense
relating to the increase in the fair value of the liability representing
the warrants over Verona Pharma shares, a non-cash item. This is as
opposed to GBP5.1 million of finance income in the six months ended June
30, 2017, due to a decrease in the fair value liability of these
warrants.
-- Reported loss per share of 13.9 pence for the six months ended June 30,
2018 (six months ended June 30, 2017: 7.3 pence).
-- Net cash used in operating activities for the six months ended June 30,
2018, of GBP12.3 million (six months ended June 30, 2017: GBP8.2
million). The increase in cash used was due to pre-clinical and clinical
studies with RPL554 and other working capital movements.
Jan-Anders Karlsson, PhD, CEO of Verona Pharma, commented: "We continue
to advance the clinical development of nebulized RPL554 for COPD as
exemplified by the data readout from the Phase 2b four week, 400 patient
trial in the first quarter and the recent commencement of dosing in our
next Phase 2 trial in the US and UK. This new trial will examine the
effect of inhaled RPL554 as an add-on to LAMA/LABA therapy, and in some
patients as an addition to triple therapy. Many of these COPD patients
continue to experience breathing difficulties and daily symptoms that
impair their quality of life despite treatment with double and triple
therapy. We believe the bronchodilator and anti-inflammatory properties
of RPL554 will be particularly useful in this large group of patients
with a high unmet medical need, and very limited treatment options. This
Phase 2 trial is intended to provide important data to inform the design
of pivotal Phase 3 trials with RPL554, expected to commence later next
year."
Conference Call and Webcast Information
Verona Pharma will host an investment community conference call at 8:00
a.m. Eastern Daylight Time (1:00 pm British Summer Time) on Tuesday,
August 7, 2018. Analysts and investors may participate in the conference
call by utilizing the conference ID: 7830929 and dialing the following
numbers:
-- 800-458-4121 or 929-477-0324 for callers in the United States
-- 0800 279 7204 or 44 (0)330 336 9411 for callers in the United Kingdom
-- 0800 101 1732 or 49 (0)69 2222 2018 for calls in Germany
Those interested in listening to the conference call live via the
internet may do so by visiting the "Investors" page of Verona Pharma's
website at www.veronapharma.com and clicking on the webcast link. A
webcast replay of the conference call [audio] will be available for 30
days by visiting the "Investors" page of Verona Pharma's website at
www.veronapharma.com and clicking on the "Events and presentations"
link.
An electronic copy of the interim results will be made available today
on the Company's website (www.veronapharma.com). This press release does
not constitute an offer to sell or the solicitation of an offer to buy
any of the Company's securities, and shall not constitute an offer,
solicitation or sale in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of that jurisdiction.
This press release contains inside information for the purposes of
Article 7 Regulation (EU) No. 596/2014.
About Verona Pharma plc
Verona Pharma is a clinical-stage biopharmaceutical company focused on
developing and commercializing innovative therapies for the treatment of
respiratory diseases with significant unmet medical needs. Verona
Pharma's product candidate, RPL554, is a first-in-class, inhaled, dual
inhibitor of the enzymes phosphodiesterase 3 and 4 that acts as both a
bronchodilator and an anti-inflammatory agent in a single compound. In
clinical trials, treatment with RPL554 has been observed to result in
statistically significant improvements in lung function and clinical
symptoms as compared to placebo, and has shown clinically meaningful and
statistically significant improvements in lung function when
administered in addition to frequently used short- and long-acting
bronchodilators as compared to such bronchodilators administered as a
single agent. Verona Pharma is developing RPL554 for the treatment of
chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), and
potentially asthma.
Forward Looking Statements
This press release and operational and financial review contain
forward-looking statements. All statements contained in this press
release and operational and financial review that do not relate to
matters of historical fact should be considered forward-looking
statements, including, but not limited to, statements regarding the
treatment potential for RPL554, the intent of the Phase 2 trial to
examine RPL554 as an add-on therapy or as a triple therapy, the
enrollment in the Phase 2 trial, the value of RPL554 for patients on
double or triple therapy and its attractiveness to such patients, the
expectation of continuing ICS dosing in the Phase 2 study of RPL554, the
utility of the data from the Phase 2 trial to inform the design of
pivotal Phase 3 trials and the timing of commencing such trials, the
timing of clinical data, the potential for RPL554 to be the first novel
class of bronchodilator in over 40 years and first therapy that acts as
a bronchodilator and anti-inflammatory agent, the size and number of
COPD patients with uncontrolled COPD, the placement and potential of
RPL554 as a safe and effective add-on therapy, the potential for a DPI
or pMDI formulation of RPL554 to treat COPD patients who prefer a
handheld inhaler device and the number of patients and market
opportunity for such formulations, our plans to out-license these
formulations to a third party and the development and commercialization
resources of such a party, the timing of clinical trials for DPI and
pMDI formulations, our plans to develop a DPI or pMDI formulation for
the treatment of asthma or other respiratory diseases, and the
sufficiency of our funds to progress development of a nebulized RPL554.
All statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements. These forward-looking statements are based on management's
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and other
important factors that may cause our actual results, performance or
achievements to be materially different from our expectations expressed
or implied by the forward-looking statements, including, but not limited
to, the following: our limited operating history; our need for
additional funding to complete development and commercialization of
RPL554, which may not be available and which may force us to delay,
reduce or eliminate our development or commercialization efforts; the
reliance of our business on the success of RPL554, our only product
candidate under development; economic, political, regulatory and other
risks involved with international operations; the lengthy and expensive
process of clinical drug development, which has an uncertain outcome;
serious adverse, undesirable or unacceptable side effects associated
with RPL554, which could adversely affect our ability to develop or
commercialize RPL554; potential delays in enrolling patients, which
could adversely affect our research and development efforts; we may not
be successful in developing RPL554 for multiple indications; our ability
to obtain approval for and commercialize RPL554 in multiple major
pharmaceutical markets; misconduct or other improper activities by our
employees, consultants, principal investigators, and third-party service
providers; the loss of any key personnel and our ability to recruit
replacement personnel, material differences between our "top-line" data
and final data; our reliance on third parties, including clinical
investigators, manufacturers and suppliers, and the risks related to
these parties' ability to successfully develop and commercialize RPL554;
and lawsuits related to patents covering RPL554 and the potential for
our patents to be found invalid or unenforceable.
These and other important factors under the caption "Risk Factors" in
our Annual Report on Form 20-F filed with the Securities and Exchange
Commission ("SEC") on February 27, 2018, and our other reports filed
with the SEC, could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press release
and operational and financial review. Any such forward-looking
statements represent management's estimates as of the date of this press
release and operational and financial review. While we may elect to
update such forward-looking statements at some point in the future, we
disclaim any obligation to do so, even if subsequent events cause our
views to change. These forward-looking statements should not be relied
upon as representing our views as of any date subsequent to the date of
this press release.
For further information please contact:
Verona Pharma plc Tel: +44 (0)20 3283 4200
Jan-Anders Karlsson, Chief Executive Officer info@veronapharma.com
Stifel Nicolaus Europe Limited (Nominated Adviser Tel: +44 (0)20 7710 7600
and UK Broker)
Stewart Wallace / Jonathan Senior / Ben Maddison
ICR, Inc. (US Media and Investor Enquiries)
James Heins Tel: +1 203 682 8251
James.Heins@icrinc.com
Stephanie Carrington Tel: +1 646 277 1282
Stephanie.Carrington@icrinc
.com
FTI Consulting (UK Media and Investor Enquiries) Tel: +44 (0)20 3727 1000
Simon Conway / Natalie Garland-Collins veronapharma@fticonsulting.
com
OPERATIONAL REVIEW
Company overview
We are a clinical-stage biopharmaceutical company focused on developing
and commercializing innovative therapies for the treatment of
respiratory diseases with significant unmet medical needs. Our product
candidate, RPL554, is a first-in-class, inhaled, dual inhibitor of the
enzymes phosphodiesterase 3 and 4, or PDE3 and PDE4, that acts as both a
bronchodilator and an anti-inflammatory agent in a single compound. We
believe RPL554 has the potential to be the first novel class of
bronchodilator in over 40 years, and the first therapy for the treatment
of respiratory diseases that acts as both a bronchodilator and
anti-inflammatory agent in a single compound.
We have completed 12 Phase 1 and Phase 2 clinical trials with RPL554
with over 730 subjects enrolled. In our clinical trials, treatment with
RPL554 has been observed to result in statistically significant
improvements in lung function as compared to placebo. Statistically
significant means that there is a low statistical probability, typically
less than 5 per cent, that the observed results occurred by chance
alone. Our most recent Phase 2b clinical trial in patients with
moderate-to-severe COPD has also shown clinically meaningful and
statistically significant improvements in daily reported COPD symptom
scores. Our trials have also shown clinically meaningful and
statistically significant improvements in lung function when RPL554 is
added to commonly used short- and long-acting bronchodilators as
compared to such bronchodilators administered as a single agent. RPL554
has also shown anti-inflammatory effects and been well tolerated in our
clinical trials to date and has not been observed to result in the
gastrointestinal or other side effects commonly associated with
roflumilast, the only PDE4 inhibitor currently on the market for the
treatment of COPD. We are developing RPL554 for the treatment of
patients with COPD and for the treatment of patients with CF.
Despite treatment with currently approved therapies, many patients with
COPD experience daily symptoms impairing their quality of life. Airway
obstruction and air trapping due to narrow air passages are major causes
of debilitating breathlessness (dyspnoea) reducing physical ability, and
causing anxiety and depression. Of the patients treated with dual
bronchodilator (LAMA/LABA) and triple therapy (LAMA/LABA/ICS), research
suggests that up to 40% (approximately 800,000 patients in the US alone)
are uncontrolled, remaining symptomatic and at an increased risk of
exacerbations.
We believe RPL554, having demonstrated improvement in FEV(1) and
symptoms (which commonly are a precursor to exacerbations) in clinical
trials, may be an attractive additional treatment in these patients.
Furthermore, in COPD patients novel anti-inflammatory therapies are
required, as current treatments such as ICS and PDE4 inhibitors are
either effective only in specific subsets of exacerbating COPD patients
or are associated with distressing side effects which can reduce
treatment compliance. In the US approximately 2.2 million COPD patients
are treated with LABA/ICS therapy. We have already demonstrated that
RPL554 is a very effective addition to single bronchodilators and we
believe it is well placed to potentially meet the need for a safe and
effective dual bronchodilator/anti-inflammatory treatment regimen as an
add-on to, for example, a LAMA.
Operational performance in the six months ended June 30, 2018
The recently completed 4 week Phase 2b study with nebulized RPL554 in
403 patients demonstrated a rapid onset and sustained bronchodilator
effect from the first to the last dose, that was both clinically and
statistically meaningful. In addition, the study demonstrated a marked
and significant improvement in daily reported COPD symptoms in the E-RS
(EXACT-PRO), and in each of the three sub-scores. The improvement in
symptoms was already statistically significant after the first week but
continued to progress and further improve during the 4 week treatment
period. Similar effects were seen with other symptom scores used, for
example the SGRQ. All RPL554 doses tested produced comparable
improvements in lung function and symptoms, and RPL554 was well
tolerated at all doses with an adverse event profile similar to placebo.
The Company continues to review its development strategy for RPL554 in
the context of additional data to be generated, including from clinical
trials and market research, to identify opportunities to enhance the
planned development and commercialization of RPL554, which may lead to
changes in the planned future clinical development of RPL554. The
recently obtained Phase 2b data in the maintenance treatment of COPD
with nebulized RPL554 provides a further impetus to accelerate the
progression towards Phase 3 studies in this indication.
The Company presented at the American Thoracic Society's International
Conference (San Diego, May 2018). The posters disclosed further analysis
of the benefit of treating with RPL554 on top of tiotropium and also the
suitability of RPL554 for inhaled delivery.
As announced July 30, 2018 we have also initiated a Phase 2 trial
evaluating nebulized RPL554 as an add-on to dual bronchodilator therapy
for COPD maintenance treatment. Initial data from this trial is expected
during the first quarter of 2019. The randomized, double-blind,
three-way crossover trial will enroll approximately 75 patients with
COPD to investigate the efficacy and safety of nebulized RPL554 as an
add-on to an inhaled LAMA/LABA, tiotropium/olodaterol (Stiolto(R)
Respimat(R)), compared to placebo. Those patients already receiving ICS
anti-inflammatory therapy will continue a stable dose of ICS throughout
the study, thus providing a "triple therapy" background. Following a 7-
to 14-day washout period in advance of dosing and between study arms,
patients will receive three days of treatment with each of two dose
strengths (1.5 mg or 6.0 mg) of nebulized RPL554 or placebo twice daily.
The primary endpoint of this trial is improvement in lung function with
RPL554 vs placebo (as add-on to tiotropium/olodaterol), as measured by
peak forced expired volume in one second (FEV(1) ), a standard measure
of exhaled breath volume to evaluate respiratory function.
This Phase 2 trial is intended to provide important data to inform the
design of pivotal Phase 3 trials with RPL554, and also to better
understand the strategic commercial potential of nebulized RPL554 used
in COPD patients with airway obstruction and COPD symptoms already using
standard-of-care bronchodilator treatments.
In addition to our nebulized formulation of RPL554, we are also
developing RPL554 in both dry powder inhaler, (DPI), and pressurized
metered dose inhaler, (pMDI), formulations for the maintenance treatment
of COPD. We are in the process of selecting a DPI and a pMDI formulation
to provide an opportunity to also treat patients with moderate-to-severe
COPD that use a handheld inhaler device. Verona estimates that, in the
United States, approximately 90% of the 3.7 million mild/moderate COPD
patients and 80% of 2.7 million severe/very severe COPD patients use
inhalers for maintenance therapy. Successful development of a DPI or
pMDI formulation of RPL554 for moderate disease would greatly expand the
addressable market for the drug and represents a multi-billion dollar
potential opportunity. Development of these new formulations is
progressing according to plan. We are completing pre-clinical
development and we expect a clinical trial with the DPI formulation to
commence in the fourth quarter of 2018, and a clinical trial with the
pMDI formulation to follow in the first half of 2019. These inhalation
formulations will be available for out-licensing once we establish their
clinical profile.
We may also explore the development of RPL554 in DPI and/or pMDI
formulations for the treatment of asthma and other respiratory diseases.
OUTLOOK
We intend to become a leading biopharmaceutical company focused on the
treatment of respiratory diseases with significant unmet medical needs.
We recognize that our proposed strategy for achieving this goal depends
on the totality of the data from all clinical trials conducted with
RPL554 to date, future interactions with regulatory authorities and our
commercial assessment of different development options for RPL554. Key
elements of this strategy include:
-- Proceeding rapidly towards Phase 3 clinical trials with nebulized RPL554
for the maintenance treatment of COPD which requires us to focus our
financial and other resources on maintenance treatment of COPD with
nebulized and inhaled formulations of RPL554 in the short term, which may
alter our timing to commence further trials using RPL554 in other
indications.
-- Identifying compelling market opportunities such as patients with COPD
that continue to experience daily symptoms impairing their quality of
life, despite treatment with currently available medicines. RPL554 is an
effective add-on to treatment with single bronchodilators, and we are now
examining RPL554 as an add-on also to patients treated with dual
bronchodilators. Add-on to first-line and second-line treatments both
represent very significant market opportunities.
-- A further Phase 2 clinical trial to evaluate nebulized RPL554 for the
maintenance treatment of severe COPD patients when dosed in addition to
LAMA/LABA or triple (LABA/LAMA/ICS) therapy, compared to placebo, which
has been initiated. We expect to announce top-line data in the first
quarter of 2019.
-- For the treatment of COPD patients who may prefer the more convenient
administration of an inhaler device, we are developing RPL554 in inhaler
formulations. We expect a clinical trial with the DPI formulation to
commence in the fourth quarter of 2018, and a clinical trial with the
pMDI formulation to follow in the first half of 2019.
-- Develop RPL554 for the treatment of CF. The timing for future studies in
this indication is dependent on our decision to move more rapidly towards
Phase 3 clinical trials with nebulized RPL554 for the maintenance
treatment of COPD.
-- Pursue development of RPL554 in other forms of respiratory disease. We
believe that RPL554's properties as an inhaled, dual inhibitor of PDE3
and PDE4 give it broad potential applicability in the treatment of other
respiratory diseases. We may explore development of RPL554 to treat other
forms of respiratory disease following development of RPL554 for the
treatment of COPD and CF.
-- Seek strategic collaborative relationships. We may seek strategic
collaborations with market leading biopharmaceutical companies to develop
and commercialize RPL554. We believe these collaborations could provide
significant funding to advance the development of RPL554 while allowing
us to benefit from the development or commercialization expertise of our
collaborators.
-- Acquire or in-license product candidates for the treatment of respiratory
diseases. We plan to leverage our respiratory disease expertise to
identify and in-license or acquire additional clinical stage product
candidates that we believe have the potential to become novel treatments
for respiratory diseases with significant unmet medical needs.
FINANCIAL REVIEW
Financial review of the six and three month period ended June 30, 2018
Six months ended June 30, 2018
Research and Development Costs
Research and development costs were GBP8.3 million for the six months
ended June 30, 2018, compared to GBP7.9 million for the six months ended
June 30, 2017, an increase of GBP0.4 million. The share-based payment
charge increased by GBP0.6 million and expenditure on manufacturing and
related development expense increased by GBP1.4 million. This was offset
by a GBP0.7 million reduction in pre-clinical development. There was
also a GBP0.9 million reduction in clinical trial costs; there were
three ongoing clinical trials during the first half of 2017; in the
first half of 2018 the Company incurred patient and close down costs in
respect of its Phase 2b trial for COPD maintenance treatment and
start-up costs in respect of a trial evaluating RPL554 as an add on to
LAMA/LABA maintenance treatment.
General and Administrative Costs
General and administrative costs were GBP3.2 million for the six months
ended June 30, 2018, compared to GBP3.0 million for the six months ended
June 30, 2017, an increase of GBP0.2 million. The increase was primarily
attributable to a GBP0.5 million increase in our share-based payment
charge offset by a decrease in professional fees, relating to the 2017
Global Offering, by GBP0.3 million.
Finance Income and Expense
Finance income was GBP1.1 million for the six months ended June 30,
2018, and GBP5.2 million for the six months ended June 30, 2017. The
decrease in finance income was primarily due to an increase in the fair
value of the warrant liability during the first half of 2018 (which is
recorded as a finance expense) compared to a decrease in the liability
in the six month period ended June 30, 2017, which resulted in a gain
(recorded as finance income) of GBP5.1 million in the comparative
period. Furthermore, foreign exchange gains on cash and short term
investments in the period resulted in a GBP0.7 million gain in 2018,
recorded in finance income, and a loss in 2017, recorded in finance
expense.
Finance expense was GBP6.0 million for the six months ended June 30,
2018, compared to GBP1.0 million for the six months ended June 30, 2017.
The movement was due to an increase in the fair value of the warrant
liability of GBP6.0 million, recorded in finance expense, compared to
reduction in the value of the liability in the comparable 2017 period
(recorded in finance income). In addition, foreign exchange losses on
cash and short term investments in the period resulted in a gain
recorded in finance income in 2018 and a GBP0.9 million loss recorded in
finance expense in 2017.
Taxation
Taxation for the six months ended June 30, 2018, amounted to a credit of
GBP1.8 million compared to a credit of GBP1.6 million for the six months
ended June 30, 2017, a movement of GBP0.2 million. The credits are
obtained at a rate of 14.5% of 230% of our qualifying research and
development expenditure and the increase in the credit amount was
attributable to our increased expenditure on research and development,
compared to the prior period, and a change in the mix of recoverable
spend.
Cash Flows
Net cash used in operating activities increased to GBP12.3 million for
the six months ended June 30, 2018, from GBP8.2 million for the six
months ended June 30, 2017. This increase was caused predominantly by
working capital movements driven by the timing of supplier payments.
Net cash generated in investing activities was GBP17.2 million for the
six months ended June 30, 2018, and net cash used was GBP32.1 million
for the six months ended June 30, 2017. These movements reflect deposits
with maturities of up to three months being classified as cash and
deposits with maturities of greater than three months being classified
as short term investments. During the first six months of 2017 the
Company placed a significant proportion of the proceeds from the Global
Offering on deposits that were classified as short term investments.
During the first half of 2018, as the Company has continued to incur
expenditure on its operations, some of these investments have matured
and been placed on shorter term deposits to maintain the Company's
liquidity profile.
There was no cash received or paid from financing activities for the six
months ended June 30, 2018. The GBP63.5 million received for the six
months ended June 30, 2017, represents the cash raised in the Global
Offering.
Cash, cash equivalents and short-term investments
Net cash, cash equivalents and short-term investments at June 30, 2018,
decreased to GBP68.9 million from GBP80.3 million at December 31, 2017
due to the utilization of cash in ordinary operating activities.
Net assets
Net assets decreased to GBP66.8 million at June 30, 2018, from GBP79.9
million at December 31, 2017. This decrease was primarily due to the
operating activities of the Company and the fair value remeasurement of
the warrant liability.
Three months ended June 30, 2018
The operating loss for the three months ended June 30, 2018, was GBP5.7
million (June 30, 2017: GBP6.8 million) and the profit after tax for the
three months ended June 30, 2018, was GBP0.6 million (June 30, 2017:
GBP3.2 million loss).
Research and Development Costs
Research and development costs were GBP3.9 million for the three months
ended June 30, 2018, compared to GBP4.8 million for the three months
ended June 30, 2017, a decrease of GBP0.9 million. The movement was
predominantly attributable to a GBP1.4 million decrease in clinical
trial expenses; there were three ongoing clinical trials during the
first quarter of 2017; in the first quarter of 2018 the Company incurred
patient and close down costs in respect of its Phase 2b trial for COPD
maintenance treatment and start-up costs in respect of a trial
evaluating RPL554 as an add on to LAMA/LABA maintenance treatment.
Pre-clinical development costs decreased by GBP0.4 million which was
offset by increased spending on contract manufacturing and other
formulation development by GBP0.9 million.
General and Administrative Costs
General and administrative costs were GBP1.8 million for the three
months ended June 30, 2018, as compared to GBP2.0 million for the three
months ended June 30, 2017, a decrease of GBP0.2 million. The decrease
was primarily attributable to a GBP0.2 million decrease in professional
fees relating to the Global Offering in 2017.
Finance Income and Expense
Finance income was GBP5.3 million for the three months ended June 30,
2018, and GBP3.4 million for the three months ended June 30, 2017. The
increase in finance income was predominantly due to foreign exchange
movements on cash and cash equivalents and short term investments that
led to a GBP2.1 million gain in 2018 and a loss, recorded in finance
expense, in 2017.
Finance expense was GBP35 thousand for the three months ended June 30,
2018, as compared to GBP0.8 million for the three months ended June 30,
2017. The decrease was due to changes in foreign exchange rates
resulting in a gain in the current period and a GBP0.8 million loss in
2017.
Taxation
Taxation for the three months ended June 30, 2018, amounted to a credit
of GBP1.0 million compared to a credit of GBP1.0 million for the three
months ended June 30, 2017.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENT OF FINANCIAL POSITION
(UNAUDITED)
AS OF JUNE 30, 2018, AND DECEMBER 31, 2017
As of As of
Notes June 30, 2018 December 31, 2017
-------------- --------------------
GBP'000s GBP'000s
ASSETS
Non-current assets:
Goodwill 441 441
Intangible assets 2,100 1,969
Property, plant and
equipment 13 16
Total non-current assets 2,554 2,426
------------- ----------------
Current assets:
Prepayments and other
receivables 2,227 1,810
Current tax receivable 7,013 5,006
Short term investments 9 32,282 48,819
Cash and cash equivalents 36,574 31,443
Total current assets 78,096 87,078
------------- ----------------
Total assets 80,650 89,504
============= ================
EQUITY AND LIABILITIES
Capital and reserves
attributable to equity
holders:
Share capital 5,251 5,251
Share premium 118,862 118,862
Share-based payment reserve 6,549 5,022
Accumulated loss (63,851) (49,254)
------------- ----------------
Total equity 66,811 79,881
------------- ----------------
Current liabilities:
Derivative financial
instrument 10 7,249 1,273
Trade and other payables 5,529 7,154
Tax payable -- U.S.
Operations -- 169
------------- ----------------
Total current liabilities 12,778 8,596
------------- ----------------
Non-current liabilities:
Assumed contingent
obligation 11 932 875
Deferred income 129 152
Total non-current
liabilities 1,061 1,027
------------- ----------------
Total equity and
liabilities 80,650 89,504
============= ================
The accompanying notes form an integral part of these consolidated
financial statements.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENT OF COMPREHENSIVE INCOME
FOR THE THREE AND SIX MONTHSED JUNE 30, 2018, AND JUNE 30, 2017
(UNAUDITED)
Three Months Three Months Six Months Six Months
Ended June Ended June Ended June Ended June
Notes 30, 2018 30, 2017 30, 2018 30, 2017
------------ ------------ ------------ ------------
GBP'000s GBP'000s GBP'000s GBP'000s
Research and development costs (3,882) (4,838) (8,303) (7,943)
General and administrative costs (1,772) (1,969) (3,230) (3,001)
------ --- ------ --- ------- -------
Operating loss (5,654) (6,807) (11,533) (10,944)
Finance income 7 5,273 3,440 1,101 5,205
Finance expense 7 (35) (797) (6,027) (978)
------ --- ------ --- ------- -------
Loss before taxation (416) (4,164) (16,459) (6,717)
Taxation -- credit 8 1,027 964 1,847 1,603
------ ---- ------ ---- ------- --- ------- ---
Profit / (loss) for the period 611 (3,200) (14,612) (5,114)
Other comprehensive profit / (loss) :
Items that might be subsequently reclassified to profit
or loss
Exchange differences on translating foreign operations 42 (10) 15 (14)
------ ---- ------ --- ------- --- -------
Total comprehensive income / (loss) attributable to
owners of the Company 653 (3,210) (14,597) (5,128)
====== ==== ====== === ======= =======
Basic earnings / (loss) per ordinary share -- (pence) 6 0.58 (3.60) (13.91) (7.30)
Diluted earnings / (loss) per ordinary share --(pence) 6 0.58 (3.60) (13.91) (7.30)
The accompanying notes form an integral part of these consolidated
financial statements.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENT OF CASH FLOWS FOR
THE SIX MONTHSED JUNE 30, 2018, AND JUNE 30, 2017 (UNAUDITED)
Six Months Six Months
Ended June Ended June
30, 2018 30, 2017
------------ ------------
GBP'000s GBP'000s
Cash used in operating activities:
Loss before taxation (16,459) (6,717)
Finance income (1,101) (5,205)
Finance expense 6,027 978
Share-based payment charge 1,527 968
Increase in prepayments and other receivables (424) (979)
(Decrease) / increase in trade and other payables (1,647) 2,930
Depreciation of property, plant and equipment 4 3
Amortization of intangible assets 43 32
------- --- ------- ---
Cash used in operating activities (12,030) (7,990)
Cash outflow from taxation (315) (166)
------- -------
Net cash used in operating activities (12,345) (8,156)
------- -------
Cash flow from investing activities:
Interest received 380 67
Purchase of plant and equipment (1) (2)
Payment for patents and computer software (174) (117)
Transfer to short term investments (14,923) (32,035)
Maturity of short term investments 31,948 --
------- --- ------- ---
Net cash generated / (used) in investing
activities 17,230 (32,087)
------- --- -------
Cash flow from financing activities:
Gross proceeds from the April 2017 Global Offering -- 69,885
Transaction costs on April 2017 Global Offering -- (6,357)
------- --- -------
Net cash generated in financing activities -- 63,528
------- --- ------- ---
Net increase in cash and cash equivalents 4,885 23,285
Cash and cash equivalents at the beginning of the
period 31,443 39,785
Effect of exchange rates on cash and cash
equivalents 246 (458)
------- --- -------
Cash and cash equivalents at the end of the period 36,574 62,612
======= === ======= ===
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHSED JUNE 30, 2018, AND JUNE 30, 2017 (UNAUDITED)
Total
Share Share Share-based Accumulated Total
Capital Premium Expenses Losses Equity
-------- -------- ----------- -------------- ----------
GBP'000s GBP'000s GBP'000s GBP'000s GBP'000s
Balance at
January 1,
2017 2,568 58,527 2,102 (28,728) 34,469
-------- ------- ----------- --------- -------
Loss for the
period -- -- -- (5,114) (5,114)
Other
comprehensive
loss for the
year:
Exchange
differences
on
translating
foreign
operations -- -- -- (14) (14)
-------- ------- ----------- --------- -------
Total
comprehensive
loss for the
period -- -- -- (5,128) (5,128)
New share
capital
issued 2,676 67,648 -- -- 70,324
Transaction
costs on
share capital
issued -- (7,453) -- -- (7,453)
Share-based
payments -- -- 968 -- 968
-------- ------- ----------- --------- --- -------
Balance at
June 30,
2017 5,244 118,722 3,070 (33,856) 93,180
======== ======= =========== ========= =======
Balance at
January 1,
2018 5,251 118,862 5,022 (49,254) 79,881
-------- ------- ----------- --------- -------
Loss for the
period -- -- -- (14,612) (14,612)
Other
comprehensive
income for the
year:
Exchange
differences
on
translating
foreign
operations -- -- -- 15 15
-------- ------- ----------- --------- --- -------
Total
comprehensive
loss for the
period -- -- -- (14,597) (14,597)
Share-based
payments -- -- 1,527 -- 1,527
-------- ------- ----------- --------- --- -------
Balance at
June 30,
2018 5,251 118,862 6,549 (63,851) 66,811
======== ======= =========== ========= =======
The currency translation reserve for June 30, 2018, and June 30, 2017,
is not considered material and as such is not presented in a separate
reserve but is included in the total accumulated losses reserve.
VERONA PHARMA PLC
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE SIX MONTHSED JUNE 30, 2018
1. General information
Verona Pharma plc (the "Company") and its subsidiaries are a
clinical-stage biopharmaceutical company focused on developing and
commercializing innovative therapeutics for the treatment of respiratory
diseases with significant unmet medical needs.
The Company is a public limited company which is listed on the
Alternative Investment Market of the London Stock Exchange and on April
27, 2017, the Company's American Depositary Shares began trading on the
Nasdaq Global Market. The Company is incorporated and domiciled in the
United Kingdom. The address of the registered office is 1 Central Square,
Cardiff, CF10 1FS, United Kingdom.
The Company has two subsidiaries, Verona Pharma Inc. and Rhinopharma
Limited ("Rhinopharma"), both of which are wholly owned.
2. Basis of accounting
The unaudited condensed consolidated interim financial statements of
Verona Pharma plc (the "Company") and its subsidiaries, Verona Pharma,
Inc., and Rhinopharma Limited (together the "Group"), for the six months
ended June 30, 2018, do not include all the statements required for full
annual financial statements and should be read in conjunction with the
consolidated financial statements of the Group as of December 31, 2017.
The 2017 Accounts, on which the Company's auditors delivered an
unqualified audit report, have been delivered to the Registrar of
Companies.
These unaudited condensed interim financial statements were authorized
for issue by the Company's board of directors (the "Directors") on
August 7, 2018. There have been no changes, except as otherwise stated,
to the accounting policies contained in the annual consolidated
financial statements as of and for the year ended December 31, 2017,
which have been prepared in accordance with international financial
reporting standards ("IFRS") as issued by the International Accounting
Standards Board ("IASB").
The interim condensed consolidated financial statements have been
prepared on a going-concern basis. Management, having reviewed the
future operating costs of the business in conjunction with the cash held
as of June 30, 2018, believes the Group has sufficient funds to continue
as a going concern for at least 12 months from August 7, 2018.
The Group's activities and results are not exposed to seasonality. The
Group operates as a single operating and reportable segment.
During the period the Group adopted IFRS 9. This has not had a material
impact on the accounting for financial instruments held by the Group,
including the assumed contingent obligation, the derivative financial
instrument or short term deposits. There has been no change in the
classification and measurement of these financial instruments.
IFRS 15 has also been adopted by the Group; this has had no impact as
the Group is not revenue generating.
Dividend
The Directors do not recommend the payment of a dividend for the six
months ended June 30, 2018, (six months ended June 30, 2017: GBPnil and
the year ended December 31, 2017: GBPnil).
3. Segmental reporting
The Group's activities are covered by one operating and reporting
segment: Drug Development. There have been no changes to management's
assessment of the operating and reporting segment of the Group during
the period.
All non-current assets are based in the United Kingdom.
4. Financial instruments
The Group's activities expose it to a variety of financial risks: market
risk (including foreign currency risk), cash flow and fair value
interest rate risk, credit risk and liquidity risk. The condensed
consolidated interim financial statements do not include all financial
risk management information and disclosures required in the annual
financial statements, and they should be read in conjunction with the
Group's annual financial statements for the year ended December 31,
2017.
5. Estimates
The preparation of condensed consolidated interim financial statements
require management to make judgments, estimates and assumptions that
affect the application of accounting policies and the reported amounts
of assets and liabilities, income and expenses. Actual results may
differ from those estimates.
In preparing these condensed consolidated interim financial statements,
the significant judgments made by management in applying the Group's
accounting policies and the key sources of estimation uncertainty were
the same as those applied to the consolidated financial statements for
the year ended December 31, 2017.
6. Earnings / loss per share calculation
For the six months ended June 30, 2018, the basic loss per share of
13.91p (June 30, 2017: loss of 7.30p) is calculated by dividing the loss
for the six months ended June 30, 2018 by the weighted average number of
ordinary shares in issue of 105,017,400 during the six months ended June
30, 2018 (June 30, 2017: 70,143,171). Since the Group has reported a net
loss, diluted loss per ordinary share is equal to basic loss per
ordinary share.
For the three months ended June 30, 2018, the basic earnings per share
of 0.58p (June 30, 2017: loss of 3.60p) is calculated by dividing the
profit for the three months ended June 30, 2018 (loss for June 30, 2017)
by the weighted average number of ordinary shares in issue of
105,017,400 during the three months ended June 30, 2018 (June 30, 2017:
88,516,972).
The diluted earnings per share of 0.58p for the three months ended June
30, 2018 is calculated by dividing the profit for the three months ended
June 30, 2018 by the weighted average number of ordinary shares in issue
of 105,017,400 plus the dilution of share options and awards of 813,046.
Where the Group has reported a net profit, diluted earnings per share
has been calculated after adjusting the weighted average number of
shares used in the basic calculation to assume the conversion of all
potentially dilutive shares. A potentially dilutive share arises from
employee share schemes where the exercise price is below the average
market price of the Company's shares during the period.
Each ADS represents 8 ordinary shares of the Company, so the profit or
loss per ADS in any period is equal to 8 times the profit or loss per
share.
7. Finance income and expense
Three Three Six
Months Months Months
Ended Ended Ended Six Months
June 30, June 30, June 30, Ended June
2018 2017 2018 30, 2017
-------- -------- -------- ----------
GBP'000s GBP'000s GBP'000s GBP'000s
Finance income:
Interest received on cash balances 213 58 373 92
Foreign exchange gain on translating foreign currency
denominated bank balances 2,060 -- 728 --
Fair value adjustment on derivative financial instruments
(note 10) 3,000 3,382 -- 5,113
--------
Total finance income 5,273 3,440 1,101 5,205
======== ======== ======== ========
Three Six
Months Three Months
Ended Months Ended Six Months
June 30, Ended June June 30, Ended June
2018 30, 2017 2018 30, 2017
-------- ----------- -------- -----------
GBP'000s GBP'000s GBP'000s GBP'000s
Finance expense:
Fair value adjustment on derivative financial instruments
(note 10) -- -- 5,976 --
Foreign exchange loss on translating foreign currency
denominated balances -- 782 -- 945
Impact of changes in foreign exchange rates on the
contingent arrangement 8 (8) -- (13)
Unwinding of discount factor movements related to
the assumed contingent arrangement (note 11) 27 23 51 46
-------- --- ------ -------- --- ------
Total finance expense 35 797 6,027 978
======== === ====== ======== === ======
8. Taxation
The tax credit for the six month period ended June 30, 2018, amounts to
GBP1.8 million and consists of the estimated research and development
tax credit receivable on qualifying expenditure incurred during the six
month period ended June 30, 2018 for an amount of GBP1.9 million less a
tax expense of GBP7 thousand related to the US operations (six month
period ended June 30, 2017: GBP1.6 million tax credit, comprising GBP1.7
million for research and development tax credit, less GBP0.1 million
expense for tax on US operations).
The tax credit for the three month period ended June 30, 2018, amounts
to GBP1.0 million, and consists of the estimated research and
development tax credit receivable on qualifying expenditure incurred
during the three month period ended June 30, 2018 for an amount of
GBP0.9 million plus a tax credit of GBP0.1 million related to the US
operations (three month period ended June 30, 2017: GBP1.0 million tax
credit, comprising GBP1.1 million for research and development tax
credit, less GBP0.1 million expense for tax on US operations).
9. Short term investments
Short term investments as at June 30, 2018 amounted to a total of
GBP32.3 million (December 31, 2017: GBP48.8 million) and consisted of
fixed term deposits in both US Dollars and UK Pounds.
10. Derivative financial instrument
Pursuant to the July 2016 placement the Company issued 31,115,926 units
to new and existing investors at the placing price of GBP1.4365 per unit,
each of which was comprised of one ordinary share and one warrant. The
warrant holders can subscribe for 0.4 of an ordinary share at a per
share exercise price of 120% of the placing price (GBP1.7238). The
warrant holders can opt for a cashless exercise of their warrants by
choosing to exchange the warrants held for a reduced number of warrants
exercisable at nil consideration. The reduced number of warrants is
calculated based on a formula considering the share price and the
exercise price of the shares. The warrants were therefore classified as
a derivative financial liability, since their exercise might result in a
variable number of shares to be issued. The warrants expire on May 2,
2022.
At June 30, 2018, and December 31, 2017, warrants over 12,401,262 shares
were in effect.
As of June 30, 2018 As of December 31, 2017
----------------------- ---------------------------
Shares available to be
issued under
warrants 12,401,262 12,401,262
Exercise price GBP 1.7238 GBP 1.7238
Risk-free interest
rate 0.84% 0.42%
Expected term to
exercise 3.84 years 1.79 years
Annualized volatility 64.30% 47.35%
Dividend rate 0.00% 0.00%
Dilution discount 3.44% 0.00%
As at June 30, 2018, the Group updated the underlying assumptions and
calculated a fair value of these warrants, using the Black-Scholes
pricing model (including level 3 assumptions), amounting to GBP7.2
million.
The variance for the six month period ending June 30, 2018, was GBP6.0
million (six month period ending June 30, 2017: GBP5.1 million) and is
recorded as finance expense (June 30, 2017, recorded in finance income)
in the Consolidated Statement of Comprehensive Income.
Derivative Derivative
financial financial
instrument instrument
----------- -------------
2018 2017
----------- -------------
GBP'000s GBP'000s
As of January, 1 1,273 7,923
Fair value adjustments recognized in profit or
loss 5,976 (5,113)
----------- ----------
As of June, 30 7,249 2,810
=========== ==========
For the amount recognized as at June 30, 2018, the effect if volatility
were to deviate up or down is presented in the following table.
Volatility
(up / down
10 % pts)
-----------
GBP'000s
Variable up 8,420
Base case, reported fair value 7,249
Variable down 6,016
11. Assumed contingent obligation related to the business combination
The value of the assumed contingent obligation as of June 30, 2018,
amounted to GBP932 thousand (December 31, 2017: GBP875 thousand). The
increase in value of the assumed contingent obligation during the six
months ended June 30, 2018, amounted to GBP57 thousand (six months ended
June 30, 2017: GBP33 thousand) and the unwinding of the discount on the
liability was recorded in finance expense. Periodic re-measurement is
triggered by changes in the probability of success. The discount
percentage applied is 12%. In 2017 and the six months ended June 30,
2018, there were no events that triggered remeasurement.
2018 2017
-------- ----------
GBP'000s GBP'000s
January 1, 875 803
Impact of changes in foreign exchange rates 6 (13)
Unwinding of discount factor 51 46
-------- ------
June 30, 932 836
======== ======
There is no material difference between the fair value and carrying
value of the financial liability.
For the amount recognized as at June 30, 2018, of GBP932 thousand, the
effect if underlying assumptions were to deviate up or down is presented
in the following table (assuming the probability of success does not
change):
Discount rate Revenue
(up / down (up / down
1 % pt) 10 % pts)
------------- -----------
GBP'000s GBP'000s
Variable up 889 959
Base case, reported fair value 932 932
Variable down 977 904
12. Share option scheme
During the six months ended June 30, 2018 the Company granted a total of
2,090,847 share options and 273,390 Restricted Stock Units ("RSUs") (six
months ended June 30, 2017, the Company granted 4,656,828 share options,
and 1,052,236 RSUs).
The movement in the number of the Company's share options is set out
below:
Weighted Weighted
average average
exercise exercise
price 2018 price 2017
--------- ---------- --------- ------------
GBP GBP
Outstanding at
January 1 1.53 7,527,457 1.87 3,037,333
Granted during the
period 1.46 2,090,847 1.32 4,656,828
Expired during the
period -- -- 1.90 (33,333)
Forfeited during
the period 1.43 (799,524) -- --
--------- ---------
Outstanding
options at June
30 1.53 8,818,780 1.53 7,660,828
========= =========
The movement in the number of the Company's RSUs is set out below:
2018 2017
---------- -----------
Outstanding at January 1 1,052,236 --
Granted during the period 273,390 1,052,236
Forfeited during the period (153,916) --
Outstanding RSUs at June 30 1,171,710 1,052,236
========= =========
The share--based payment expense for the six months ended June 30, 2018,
was GBP1,527 thousand (six months ended June 30, 2017: GBP968 thousand).
In the three months ended June 30, 2018, 153,916 unvested options and
RSUs were forfeited. Previously GBP370 thousand had been recognized in
the statement of comprehensive income relating to their fair value; in
the three months ended June 30, 2018, this charge was reversed.
The options and RSUs granted during the six months ended June 30, 2018,
were awarded under the Company's 2017 Incentive Plan with total fair
values estimated using the Black Scholes option pricing model of GBP2.3
million. The cost is amortized over the vesting period of the options
and the RSUs on a straight-line basis. The following assumptions were
used for the Black--Scholes valuation of share options and RSUs granted
in the six months ended June 30, 2018.
Share options RSUs
----------------------- -----------------------
Issued in the six Issued in the six
months ended June 30, months ended June 30,
2018 2018
----------------------- -----------------------
Options / RSUs granted 2,090,847 273,390
Risk--free interest rate 1.08% - 1.22% 1.08% - 1.22%
Expected life of options
/ RSUs 5.5 - 7 years 5.5 - 7 years
Annualized volatility 69.88% -71.35% 69.88% -71.35%
Dividend rate 0.00% 0.00%
Vesting period 1 to 4 years 1 to 4 years
13. Related party transactions
In the six months ended June 30, 2018, and 2017, the executive director
received regular salary, post-employment benefits and share-based
payments. Additionally, non-executive directors received compensation
for their services in the form of cash compensation and equity grants.
The compensation costs for the directors and senior staff for the three
and six months ended June 30, 2018, and 2017 were as follows:
Short term Post
employee Share-based employment
benefits payments benefits Total
---------- ----------- ----------- ----------
GBP'000s GBP'000s GBP'000s GBP'000s
Three
months
ended
June 30,
2018 Directors 239 370 2 611
Other key management
personnel 509 63 7 579
---------- ----------- ----------- --------
748 433 9 1,190
========== =========== =========== ========
Three
months
ended
June 30,
2017 Directors 295 242 4 541
Other key management
personnel 451 422 6 879
---------- ----------- ----------- --------
746 664 10 1,420
========== =========== =========== ========
Short term Post
employee Share-based employment
benefits payments benefits Total
---------- ----------- ----------- ----------
GBP'000s GBP'000s GBP'000s GBP'000s
Six
months
ended
June 30,
2018 Directors 445 741 7 1,193
Other key management
personnel 921 661 14 1,596
---------- ----------- ----------- --------
1,366 1,402 21 2,789
========== =========== =========== ========
Six
months
ended
June 30,
2017 Directors 494 342 8 844
Other key management
personnel 731 575 11 1,317
---------- ----------- ----------- --------
1,225 917 19 2,161
========== =========== =========== ========
Dr. Jan-Anders Karlsson, Chief Executive Officer of the Company,
purchased 3,250 ordinary shares for GBP5 thousand from the market in the
period.
14. Convenience translation
We maintain our books and records in pounds sterling and we prepare our
financial statements in accordance with IFRS, as issued by the IASB. We
report our results in pounds sterling. For the convenience of the reader
we have translated pound sterling amounts in the tables below as of June
30, 2018, and for the three and six month periods ended June 30, 2018
into US dollars at the noon buying rate of the Federal Reserve Bank of
New York on June 29, 2018, which was GBP1.00 to $1.3197. These
translations should not be considered representations that any such
amounts have been, could have been or could be converted into US dollars
at that or any other exchange rate as of that or any other date.
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME FOR THE THREE
AND SIX MONTHSED JUNE 30, 2018 (UNAUDITED)
Six Months Six Months
Three Months Ended Three Months Ended Ended June Ended June
June 30, 2018 June 30, 2018 30, 2018 30, 2018
-------------------- -------------------- ------------ ------------
GBP'000s $'000s GBP'000s $'000s
Research and development costs (3,882) (5,123) (8,303) (10,957)
General and administrative costs (1,772) (2,339) (3,230) (4,263)
----------- ------ ----------- ------ ------- -------
Operating loss (5,654) (7,462) (11,533) (15,220)
Finance income 5,273 6,959 1,101 1,453
Finance expense (35) (46) (6,027) (7,954)
----------- ------ ----------- ------ ------- -------
Loss before taxation (416) (549) (16,459) (21,721)
Taxation -- credit 1,027 1,355 1,847 2,437
----------- ------- ----------- ------- ------- --- ------- ---
Profit / (loss) for the year 611 806 (14,612) (19,284)
Other comprehensive income:
Items that might be subsequently reclassified to profit
or loss
Exchange differences on translating foreign operations 42 55 15 20
----------- ------- ----------- ------- ------- --- ------- ---
Total comprehensive income / (loss) attributable to
owners of the Company 653 861 (14,597) (19,264)
=========== ======= =========== ======= ======= =======
Earnings / (loss) per ordinary share -- basic (pence
/ cents) 0.58 0.77 (13.91) (18.36)
Earnings / (loss) per ordinary share -- diluted (pence
/ cents) 0.58 0.76 (13.91) (18.36)
CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS AT JUNE 30,
2018, AND DECEMBER 31, 2017 (UNAUDITED)
As of As of As of
June 30, 2018 June 30, 2018 December 31, 2017
-------------- -------------- --------------------
GBP'000s $'000s GBP'000s
ASSETS
Non-current
assets:
Goodwill 441 583 441
Intangible
assets 2,100 2,771 1,969
Property, plant
and equipment 13 17 16
Total
non-current
assets 2,554 3,371 2,426
------------- ------------- ----------------
Current assets:
Prepayments and
other
receivables 2,227 2,939 1,810
Current tax
receivable 7,013 9,255 5,006
Short term
investments 32,282 42,603 48,819
Cash and cash
equivalents 36,574 48,267 31,443
Total current
assets 78,096 103,064 87,078
------------- ------------- ----------------
Total assets 80,650 106,435 89,504
============= ============= ================
EQUITY AND
LIABILITIES
Capital and
reserves
attributable to
equity holders:
Share capital 5,251 6,930 5,251
Share premium 118,862 156,862 118,862
Share-based
payment
reserve 6,549 8,643 5,022
Accumulated loss (63,851) (84,264) (49,254)
------------- ------------- ----------------
Total equity 66,811 88,171 79,881
------------- ------------- ----------------
Current
liabilities:
Derivative
financial
instrument 7,249 9,567 1,273
Trade and other
payables 5,529 7,297 7,154
Tax payable --
U.S.
Operations -- -- 169
------------- ------------- ----------------
Total current
liabilities 12,778 16,864 8,596
------------- ------------- ----------------
Non-current
liabilities:
Assumed
contingent
obligation 932 1,230 875
Deferred income 129 170 152
Total
non-current
liabilities 1,061 1,400 1,027
------------- ------------- ----------------
Total equity and
liabilities 80,650 106,435 89,504
============= ============= ================
(END) Dow Jones Newswires
August 07, 2018 02:00 ET (06:00 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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