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 an operational update and financial results for
the three months and nine months ended September 30, 2019.
The Company's first-in-class development
candidate, ensifentrine, is an inhaled, dual inhibitor of the
enzymes phosphodiesterase 3 and 4 that acts both as a
bronchodilator and an anti-inflammatory agent in a single compound.
Ensifentrine is currently in Phase 2b clinical development for the
maintenance treatment of chronic obstructive pulmonary disease
("COPD") and is planned to enter Phase 3 trials for this indication
in 2020. Verona Pharma may also develop ensifentrine for the
treatment of cystic fibrosis and asthma.
OPERATIONAL AND DEVELOPMENT HIGHLIGHTS FOR THE THREE AND
NINE MONTH PERIODS ENDED SEPTEMBER 30, 2019
Three months ended September 30,
2019
- Reported positive results from the second part of the Phase 2
study of the Dry Powder Inhaler ("DPI")
formulation of ensifentrine in COPD, delivered by handheld
inhaler over one week of twice-daily treatment. ° The
trial met all of its primary and secondary lung function
endpoints. ° The magnitude of improvement in lung
function and duration of action were highly statistically
significant and support twice daily dosing of ensifentrine
delivered in a DPI format for the treatment of COPD. •
Primary endpoint met: peak FEV1 corrected for placebo showed
dose-dependent improvements over baseline of 102 mL for the 150 µg
dose, 175 mL for the 500 µg dose, 180 mL for the 1500 µg dose and
260 mL for the 3000 µg dose, (p<0.0001 for all doses), all
highly statistically significant. • Secondary endpoints
met: ° Statistically significant improvements in
average FEV1 over 12 hours were observed over 7 days with all
doses (average FEV1 AUC(0-12hr) corrected for placebo: 36 mL
for the 150 µg dose, 90 mL for the 500 µg dose, 80 mL for the 1500
µg dose and 147 mL for the 3000 µg dose; p<0.05 for all
doses). ° Ensifentrine in a handheld dry
powder format was well tolerated at all doses with an adverse event
profile similar to placebo. The safety profile was comparable to
that observed in prior studies with nebulized ensifentrine.
- Presented at the European Respiratory Society (“ERS”)
International Congress in Madrid, Spain on the positive data from
the Phase 2 study of the DPI formulation of
ensifentrine in COPD. ° These single dose data
were first announced in March 2019 and followed by positive
multiple dose data in August 2019 where all the primary and
secondary lung function endpoints were met in the Phase 2
trial. ° The magnitude of improvement in lung
function and duration of action were highly statistically
significant and support twice daily dosing of ensifentrine for the
treatment of COPD.
Post-period end, the
Company:
- Announced that it had completed enrollment in its Phase 2b
four-week dose-ranging study evaluating the effect of
nebulized ensifentrine as an add-on to inhaled
tiotropium, a long acting bronchodilator, in patients with
moderate-to-severe COPD. ° Enrollment of 416
patients at 46 sites was completed on schedule with data expected
around year end 2019. ° Preparations underway for
End of Phase 2 meeting with the U.S. Food and Drug Administration
("FDA") expected in the first half of 2020.
° Commencement of Phase 3 trials expected in 2020.
FINANCIAL HIGHLIGHTS
- Net cash, cash equivalents and short term investments at
September 30, 2019, amounted to £41.1 million
(December 31, 2018: £64.7 million).
- For the nine months ended September 30, 2019, reported
operating loss of £33.7 million (nine months ended September 30,
2018: £18.3 million) and reported loss after tax of £24.5 million
(nine months ended September 30, 2018: £17.0 million). Operating
expenses increased from £18.2 million to £33.7 million due
primarily to development activities for ensifentrine.
- Reported loss per share of 23.3 pence for the nine months ended
September 30, 2019 (nine months ended September 30, 2018: 16.1
pence).
- Net cash used in operating activities for the nine months ended
September 30, 2019 was £24.5 million (nine months ended September
30, 2018: £13.1 million). The increase in cash used was due to
pre-clinical and clinical studies with ensifentrine and the timing
of supplier payments.
"We are very pleased that our four-week Phase 2b
dose-ranging clinical trial with nebulized ensifentrine is
progressing according to plan and that we have completed enrollment
of over 400 symptomatic patients with moderate to severe COPD. We
anticipate completing this study around the end of 2019. Informed
by this and prior studies in around 850 subjects, we plan to
advance into our Phase 3 clinical trial program which we expect to
commence in 2020 following an end of Phase 2 meeting with the FDA,"
commented Jan-Anders Karlsson, PhD, CEO of Verona Pharma.
"Millions of COPD patients in the US remain
symptomatic and breathless despite being treated with currently
available medicines. We believe ensifentrine, with its unique dual
mode of action and bronchodilator and anti-inflammatory properties,
has the potential to become an important additional treatment
option for many of these patients. In particular, the strong
reduction in COPD symptoms will be an attractive feature for many
of these patients. Initially we will focus on nebulized treatment
for more severe patients but we are very excited by the positive
DPI formulation results that support our view that ensifentrine is
an effective bronchodilator in COPD patients, whether administered
as a dry powder via a handheld inhaler or as a suspension via a
nebulizer."
GENERAL INFORMATION
Conference Call and Webcast
Information
Verona Pharma will host an investment community
conference call at 8:00 a.m. Eastern Standard Time (1:00 pm
Greenwich Mean Time) on Tuesday, November 5, 2019. Analysts and
investors may participate in the conference call by utilizing the
conference ID: 6498479 and dialing the following numbers:
- 866-940-4574 for callers in the United States
- 0800 028 8438 for callers in the United Kingdom
- 0800 181 5287 for callers in Germany
A live webcast will be available on the Events
and presentations link on the Investors page of the Company's
website at www.veronapharma.com and an audio replay will be
available there for 30 days.
An electronic copy of the interim results will
be made available today on the Company's website. 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 in
relation to revised timelines for the ongoing Phase 2 study of the
pMDI formulation. The person responsible for its release is Mr
Piers Morgan.
About Chronic Obstructive Pulmonary Disease
(COPD)
COPD is a progressive and life-threatening
respiratory disease without a cure. The World Health Organization
estimates that it will become the third leading cause of death
worldwide by 2030. The condition damages the airways and the lungs,
leading to debilitating breathlessness that has a devastating
impact on performing basic daily activities such as getting out of
bed, showering, eating and walking. In the United States alone, the
total annual medical costs related to COPD are projected to rise to
$49 billion in 2020. About 1.2 million U.S. COPD patients on
dual/triple inhaled therapy (long-acting beta-agonist
(LABA)/long-acting muscarinic antagonist (LAMA) +/- inhaled
corticosteroid (ICS)) remain uncontrolled, experiencing symptoms
that impair quality of life. These patients urgently need better
treatments.
About Ensifentrine
Ensifentrine (RPL554) is a first-in-class,
inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4
for the treatment of respiratory diseases. Verona is currently
developing three formulations of ensifentrine for the treatment of
COPD: nebulized, dry powder inhaler (DPI), and pressurized
metered-dose inhaler (pMDI). Phase 2 studies of nebulized
ensifentrine in patients with moderate-to-severe COPD have
demonstrated significant and clinically meaningful improvements in
both lung function and COPD symptoms, including breathlessness.
Nebulized ensifentrine also has shown further improved lung
function and reduced lung volumes in patients taking standard of
care, short- and long-acting bronchodilator therapy, including
maximum bronchodilator treatment with dual/triple therapy
(LABA/LAMA +/- ICS). Nebulized ensifentrine is currently in a Phase
2b clinical study evaluating its effect as an add-on to treatment
with a long-acting bronchodilator in patients with
moderate-to-severe COPD, which is expected to be completed around
year-end 2019. Verona Pharma reported positive results from its
Phase 2 study of the DPI formulation of ensifentrine in August
2019. Its pMDI formulation is currently being evaluated in a Phase
2 study, with single dose data expected in the first quarter of
2020 and final data around the middle of 2020. Ensifentrine has
potential applications in cystic fibrosis, asthma and other
respiratory diseases. It has been well tolerated in clinical trials
involving a total of around 850 people to date.
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,
ensifentrine, 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 combines bronchodilator and
anti-inflammatory activities in one compound. Verona Pharma is
currently in Phase 2 development of three formulations of
ensifentrine for the treatment of COPD: nebulized, dry powder
inhaler, and pressurized metered-dose inhaler. Ensifentrine also
has potential applications in cystic fibrosis, asthma and other
respiratory diseases. For more information, please visit
www.veronapharma.com.
Forward Looking Statements
This press release, operational review, outlook
and financial review contain forward-looking statements. All
statements contained in this press release, operational review,
outlook 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 design of
clinical trials and the timing of clinical trials, trial results
and an End of Phase 2 meeting with the FDA, ensifentrine as the
first novel class of bronchodilator in over 40 years and the first
therapy for the treatment of respiratory diseases that combines
bronchodilator and anti-inflammatory activities in one compound,
the efficacy of ensifentrine as a bronchodilator, ensifentrine’s
symptom benefit to all COPD patients, the progressive improvement
in the post-hoc analysis of the data from the four-week Phase 2b
study suggesting an anti-inflammatory benefit, the value of
ensifentrine for COPD patients on dual or triple therapy or on
maximum standard-of-care therapy, the number of COPD patients in
the United States and China, the market opportunity for
ensifentrine, the number of COPD patients who use inhalers for
maintenance therapy, the expansion of the market for ensifentrine
in a DPI or pMDI formulation and the size of such market, estimates
of medical costs for COPD and it becoming the third leading cause
of death worldwide by 2030, our goal to become a leading fully
integrated biopharmaceutical company, the treatment potential for
ensifentrine in asthma, cystic fibrosis and other respiratory
disease, and strategic collaborations and their value.
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 ensifentrine, 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 ensifentrine, 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 ensifentrine, which could
adversely affect our ability to develop or commercialize
ensifentrine; potential delays in enrolling patients, which could
adversely affect our research and development efforts; we may not
be successful in developing ensifentrine for multiple indications;
our ability to obtain approval for and commercialize ensifentrine
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
ensifentrine; and lawsuits related to patents covering ensifentrine
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 March 19, 2019, 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, operational review, outlook and financial review.
Any such forward-looking statements represent management's
estimates as of the date of this press release, operational review,
outlook 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, operational review, outlook and
financial review.
For further information please contact:
Verona Pharma plc |
Tel: +44 (0)20 3283 4200 |
Jan-Anders Karlsson, Chief
Executive Officer |
info@veronapharma.com |
Victoria Stewart, Director of
Communications |
|
|
|
N+1
Singer |
Tel: +44 (0)20 7496 3000 |
(Nominated Adviser and UK
Broker) |
|
Aubrey Powell / George Tzimas
/ Iqra Amin (Corporate Finance) |
|
Mia Gardner (Corporate
Broking) |
|
|
|
Optimum Strategic
Communications |
Tel: +44 (0)20 3950 9144 |
(European Media and Investor
Enquiries) |
verona@optimumcomms.com |
Mary Clark / Eva Haas / Hollie
Vile |
|
|
|
Argot
Partners |
|
(US Investor enquiries) |
|
Stephanie Marks / Kimberly
Minarovich / Michael Barron |
Tel: +1 212 600 1902 |
|
verona@argotpartners.com |
|
|
OPERATIONAL REVIEW
Overview
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,
ensifentrine, 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 combines bronchodilator and
anti-inflammatory activities in one compound.
We intend to address the significant unmet
medical need in moderate to severe COPD patients who remain
symptomatic despite treatment with dual bronchodilators (LAMA and
LABA) or triple therapy (with the addition of ICS). Our market
research shows that nebulized delivery is the preferred route of
administration for more severe COPD patients, especially in the
U.S., where out of approximately three million COPD patients
treated with dual/ triple inhaled therapy (LAMA/ LABA +/- ICS),
about 1.2 million remain uncontrolled, experiencing symptoms that
impair quality of life. These patients urgently need better
treatments.
COPD is a progressive respiratory disease with
no cure. Few therapeutic alternatives are available for these
patients. The bronchodilator and anti-inflammatory properties of
ensifentrine may be particularly helpful for these symptomatic
patients suffering from chronic cough, excessive sputum production
and breathlessness despite being treated with currently available
medicines.
China is estimated to have at least 70 million
COPD patients, with many still undiagnosed. Importantly, over 90%
of medications are prescribed in hospitals (in contrast to the
U.S.) and at least a third of patients use nebulized drugs. We
believe that by 2020 the Chinese COPD and asthma treated market
will exceed 40 million patients. There is an urgent need for new
effective and well-tolerated treatments to address this growing
population.
Verona Pharma is developing ensifentrine for the
treatment of COPD, cystic fibrosis (CF), and asthma and potentially
other respiratory diseases. Ensifentrine has been observed to be
well tolerated in clinical studies to date, having been studied in
around 850 subjects in 14 completed clinical trials.
Clinical update
Lead product - nebulized
ensifentrine
We are initially developing nebulized
ensifentrine for the maintenance treatment of COPD. In our clinical
trials we have observed that ensifentrine improves lung function in
COPD patients when used either as a stand-alone treatment or as an
add-on to treatment with single and dual bronchodilators. We
believe that the addition of nebulized ensifentrine to symptomatic
COPD patients already treated with standard-of-care medicines
represents a very significant market opportunity.
In May 2019 we initiated a Phase 2b dose-ranging
study evaluating nebulized ensifentrine as an add-on to treatment
with a long-acting bronchodilator in patients with
moderate-to-severe COPD. The four-week, randomized, double-blind,
placebo-controlled dose-ranging trial is designed to evaluate the
safety and efficacy of nebulized ensifentrine as an add-on to
inhaled tiotropium, a LAMA commonly used to treat COPD, and to
establish the dosing regimen for a potential Phase 3 program in
COPD.
The primary endpoint of this study is
improvement in lung function with ensifentrine, as measured by the
change in peak forced expiratory volume in one second ("FEV1") from
0 to 3 hours, a standard measure of exhaled breath volume. Key
additional endpoints include measurements of respiratory symptoms
and quality of life via different patient-reported outcome
tools.
On October 17, 2019, we announced that we have completed
enrollment for the Phase 2b study, with 416 COPD patients across 46
sites in the US, and that data are expected around year end 2019.
Preparations are underway for an End-of-Phase 2 meeting with the
U.S. Food and Drug Administration ("FDA"), which we expect to take
place in the first half of 2020. Subject to the FDA agreeing with
our proposed plan, we expect to commence Phase 3 trials in
2020.
The post-hoc analysis of data from the 4-week
Phase 2b (2018) study of ensifentrine as a maintenance treatment
for COPD, published in May 2019 at the ATS 2019 International
Conference, showed a significant and clinically meaningful
improvement in symptom scores, measured using the E-RS scale. This
was also observed among patients who did not show a large
improvement in lung function to standard beta2-agonist
bronchodilator treatment ('non-reversible' patients, who comprise
the majority of COPD patients). Therefore we believe ensifentrine
may offer a significant symptom benefit to all COPD patients, given
that the symptom improvement we have observed is not necessarily
linked to improvement in lung function. We also believe that the
progressive improvement in symptoms over the four-week period
observed in the post-hoc analysis suggests an anti-inflammatory
benefit that would be additional to that of standard treatment with
LAMA or LABA bronchodilator therapy.
In January 2019, we reported top-line data from
a 3-day Phase 2 cross-over trial that enrolled 79 patients to
investigate the efficacy and safety of two different doses (1.5 mg
and 6.0 mg, twice daily) of nebulized ensifentrine on top of an
inhaled LAMA/LABA therapy, tiotropium/olodaterol (Stiolto®
Respimat®), for COPD maintenance treatment. Each patient received
both doses and placebo during the three treatment periods and about
30% of patients also used stable inhaled corticosteroid (ICS)
therapy throughout the study.
The average improvement in peak FEV1 on the
morning of day 3 with the 1.5 mg dose was observed to be 46 mL,
which was not statistically significant, so the primary endpoint of
the study was not met. However, the average improvement in
FEV1 over the first 4 hours was 50 mL which was statistically
significant (p<0.05). Also, the average improvement in FEV1 over
24 hours was statistically significant (p<0.05). A post-hoc
analysis showed that more than 40% of patients reported an
improvement in peak FEV1 of more than 100 mL, which we believe
suggests that a significant number of COPD patients on dual or
triple therapy could derive a substantial benefit from adding
ensifentrine to their therapy. Importantly, in this and several
other clinical trials, ensifentrine produced clinically relevant
and statistically significant improvements in air trapping
(residual volume), both on its own as well as when administered on
top of single or dual bronchodilator treatment. We believe this may
translate into further symptom improvement in these patients
already on maximum standard-of-care therapy.
The learnings from our trials to date, including
patient responses, treatment regimes, as well as endpoints, are
being taken into account in the design of the Phase 3 trials.
We are also developing formulations of
ensifentrine in both dry powder inhaler ("DPI") and pressurized
metered-dose inhaler ("pMDI") formats, for the treatment of COPD
patients who prefer administration using a handheld inhaler
device.
Dry powder inhaler (“DPI”)
formulation
In August 2019, we reported top-line data from
our study to evaluate the ensifentrine DPI formulation in patients
with moderate-to-severe COPD over one week of twice-daily
treatment. The trial met all its primary and secondary lung
function endpoints. The magnitude of improvement in lung function
and duration of action were both clinically meaningful and highly
statistically significant and the data support twice daily dosing
of ensifentrine delivered in DPI format for the treatment of
COPD.
Peak FEV1, corrected for placebo, showed
improvements over baseline of 102 mL for the 150 µg dose, 175 mL
for the 500 µg dose, 180 mL for the 1500 µg dose and 260 mL for
3000 µg dose, (p<0.0001 for all doses), all highly statistically
significant.
Average FEV1 0-12h, corrected for placebo,
improved by 36 mL for the 150 µg dose, 90 mL for the 500 µg dose,
80 mL for the 1500 µg dose and 147 mL for the 3000 µg dose
(p<0.05 for all doses).
Ensifentrine was well tolerated at all doses
with an adverse event profile similar to placebo. The safety
profile was comparable to that observed in prior studies with
nebulized ensifentrine.
Metered-dose inhaler (“pMDI”)
formulation
In June 2019, we commenced a Phase 2
dose-ranging trial to evaluate the pharmacokinetic (“PK”) profile,
efficacy and safety of ensifentrine delivered by pMDI in patients
with moderate-to-severe COPD. The trial has a randomized,
double-blind, placebo-controlled, two-part design. We anticipate
reporting data from the first part of the trial in the first
quarter of 2020 and final data around the middle of 2020.
We believe the availability of ensifentrine in
handheld inhaler formats (DPI and pMDI) will greatly expand the
market potential for ensifentrine to the millions of COPD patients
who prefer to use handheld devices. In the U.S., DPI and pMDI
handheld inhalers are more commonly used than nebulizers for
medication in COPD.
Other
indications
Opportunities also exist to explore the
development of ensifentrine for the treatment of asthma, cystic
fibrosis and other respiratory diseases.
Enhancements to the senior
team
Verona Pharma deepened the expertise available
to the Company through a number of senior appointments. In April,
Dr Martin Edwards was appointed to the Board as a Non-Executive
Director. In June, we announced the expansion of our senior
clinical team to lead and manage the late stage development of
ensifentrine.
OUTLOOK
We intend to become a leading fully integrated
biopharmaceutical company, focused on the treatment of respiratory
diseases with significant unmet medical needs. Our initial focus,
the nebulized formulation of ensifentrine, addresses a clear unmet
medical need in moderate-to-severe COPD patients who remain
symptomatic despite treatment with dual bronchodilators (LAMA and
LABA) or triple therapy (with ICS added). We believe that this is a
very large market opportunity in the US and also in China. In the
US, we intend to pursue this market opportunity with a targeted
sales force.
Following completion of the Phase 2b
dose-ranging study evaluating nebulized ensifentrine as an add-on
to treatment with inhaled tiotropium a long acting bronchodilator
in patients with moderate-to-severe COPD, we expect to proceed to
an End of Phase 2 meeting with the FDA in the first half of 2020.
We expect to commence its Phase 3 clinical program with nebulized
ensifentrine for the maintenance treatment of COPD in 2020, subject
to the FDA’s authorization to proceed. We are also developing
ensifentrine for other respiratory diseases including CF and
asthma.
After the positive data from the Phase 2
DPI trial in patients with moderate-to-severe COPD, which was
reported in August, and the successful development of the pMDI
formulation of ensifentrine last year, which is currently being
studied in an ongoing Phase 2 pMDI trial, again in patients with
moderate-to-severe COPD, we believe these formulations could open
up a much larger patient population to ensifentrine treatment. In
the US, our market research suggests that about 5.5 million
moderate-to-severe COPD patients currently use either DPI or pMDI
devices for administering their COPD therapies. This market was
valued at approximately $9 billion in 2018.
We may seek strategic collaborations with market
leading biopharmaceutical companies to develop and commercialize
the DPI and pMDI formulations of ensifentrine. We believe that any
such collaborations (the signing and terms of which remain
uncertain) could provide significant funding to advance the
development of ensifentrine, while allowing us to benefit from the
development or commercialization expertise of our
collaborators.
Ensifentrine is protected by a broad patent
umbrella. We believe that future medicinal products containing
ensifentrine are protected by our IP beyond 2035. We have retained
the worldwide commercialization rights for ensifentrine.
We have strengthened and expanded our management
team and board of directors during the year, adding further
expertise. The Company has extensive experience in respiratory
product development and commercialization, including from members
of our management who were involved in the development and/or
marketing of commercial products such as Symbicort, Daliresp/Daxas,
Flutiform, Advair, Breo Ellipta and Anoro Ellipta, and thus is
favorably positioned for the late-stage development of
ensifentrine.
FINANCIAL REVIEW
Financial review of the nine and three
month period ended September 30, 2019
Nine months ended September 30,
2019
Research and Development Costs
Research and development costs were £27.8
million for the nine months ended September 30, 2019, compared
to £13.6 million for the nine months ended September 30, 2018, an
increase of £14.2 million. The increase was predominantly
attributable to a £13.4 million increase in clinical trial expenses
relating to four clinical trials (ongoing or in preparation) of
ensifentrine in the nine months ended September 30, 2019, including
a four-week 400 patient clinical trial, compared to three trials in
the nine months ended September 30, 2018. Salary costs increased by
£1.0 million reflecting the expansion of the clinical team.
General and Administrative Costs
General and administrative costs were £5.9
million for the nine months ended September 30, 2019, compared
to £4.6 million for the nine months ended September 30, 2018,
an increase of £1.3 million. The increase was primarily
attributable to a £0.7 million increase in professional and market
research fees and a £0.5 million increase in other overhead
expenses, predominantly salaries and insurance.
Finance Income and Expense
Finance income was £3.3 million for the nine
months ended September 30, 2019, and £1.8 million for the nine
months ended September 30, 2018. The increase in finance
income was primarily due to a decrease in the fair value of the
warrant liability of £2.1 million, because of a decline in the
Company's share price, compared to an increase in the liability in
the nine month period ended September 30, 2018 (which is recorded
as a finance expense). In the prior period, there was a foreign
exchange gain on cash and short term investments of £1.2 million,
compared to a gain of £0.6 million for the nine months ended
September 30, 2019.
Finance expense was £0.1 million for the
nine months ended September 30, 2019, compared to £3.5 million
for the nine months ended September 30, 2018. The decrease was
due to a £3.4 million rise in the value of the fair value of the
warrant liability in the 2018 period, recorded in finance expense,
compared to a decrease in value in the 2019 period recorded in
finance income.
Taxation
Taxation for the nine months ended
September 30, 2019, amounted to a credit of £6.0 million
compared to a credit of £3.0 million for the nine months ended
September 30, 2018, an increase of £3.0 million. The credits
are obtained at a rate of 14.5% of 230% of our qualifying research
and development expenditure. 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 £24.5 million for the nine months ended September 30, 2019,
from £13.1 million for the nine months ended September 30,
2018. This was principally due to an increase in operating costs
driven by higher research and development costs, as well as
differences in the timing of supplier payments. During the nine
months ended September 30, 2019, the Company received an R&D
tax credit of £4.4 million in respect of its 2018 tax credit on
qualifying research and development expenditure, compared to a
receipt of £5.0 million received during the nine months ended
September 30, 2018, in respect of the 2017 tax credit.
Net cash generated from investing activities
predominantly reflects the net movement of cash being placed on
deposit for more than three months and such deposits maturing.
Deposits of more than three months are disclosed as short term
investments, separately from cash. The increase in net cash
generated in investing activities to £38.5 million for the nine
months ended September 30, 2019, from £8.6 million for the
nine months ended September 30, 2018 was due to the net
movement of funds from short term investments to cash being greater
during the nine months ended September 30, 2019.
Cash, cash equivalents and short-term
investments
Net cash, cash equivalents and short-term
investments at September 30, 2019, decreased to £41.1 million
from £64.7 million at December 31, 2018 due to the utilization
of cash in ordinary operating activities.
Net assets
Net assets decreased to £40.3 million at
September 30, 2019, from £62.9 million at December 31,
2018. This was primarily due to losses generated by the operating
activities of the Company.
Three months ended September 30,
2019
The operating loss for the three months ended
September 30, 2019, was £13.9 million (September 30,
2018: £6.8 million) and the loss after tax for the three months
ended September 30, 2019, was £10.1 million
(September 30, 2018: loss of £2.3 million).
Research and Development Costs
Research and development costs were £12.0
million for the three months ended September 30, 2019,
compared to £5.3 million for the three months ended
September 30, 2018, an increase of £6.7 million. The increase
was predominantly attributable to a £6.4 million increase in
clinical trial expenses relating to three clinical trials of
ensifentrine in the three months ended September 30, 2019 compared
to two trials in the three months ended September 30, 2018. The
majority of the trial costs related to a Phase 2b four week study
in approximately 400 patients. Salary costs increased by £0.5
million reflecting the expansion of the clinical team.
General and Administrative Costs
General and administrative costs were £2.0
million for the three months ended September 30, 2019,
compared to £1.4 million for the three months ended
September 30, 2018, an increase of £0.6 million. The increase
was attributable to a £0.3 million increase in commercial market
research costs and £0.3 million in other overhead costs,
predominantly salaries and insurance.
Finance Income and Expense
Finance income was £1.2 million for the three
months ended September 30, 2019, and £3.3 million for the
three months ended September 30, 2018. Finance income in the
three months ended September 30, 2019 comprised £0.4 million in
relation to the decrease in the fair value of the warrant
liability, due to a fall in the Company's share price, compared to
a £2.6 million decrease in the prior period, together with a £0.7
million foreign exchange gain on cash and short term investments in
the three months ended September 30, 2019 compared to a £0.5
million gain in the prior period.
Finance expense was £46 thousand for the
three months ended September 30, 2019, as compared to £27
thousand for the three months ended September 30, 2018.
Taxation
Taxation for the three months ended
September 30, 2019, amounted to a credit of £2.6 million
compared to a credit of £1.1 million for the three months ended
September 30, 2018, a reflection of the higher research and
development costs in the current period.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL
POSITION (UNAUDITED)
AS OF SEPTEMBER 30, 2019, AND DECEMBER 31,
2018
|
Notes |
|
As of September 30, 2019 |
|
As of December 31, 2018 |
|
|
|
£'000s |
|
£'000s |
ASSETS |
|
|
|
|
|
Non-current
assets: |
|
|
|
|
|
Goodwill |
|
|
441 |
|
|
441 |
|
Intangible assets |
|
|
2,241 |
|
|
2,134 |
|
Property, plant and
equipment |
|
|
1,141 |
|
|
21 |
|
Total non-current
assets |
|
|
3,823 |
|
|
2,596 |
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Prepayments and other
receivables |
|
|
3,486 |
|
|
2,463 |
|
Current tax receivable |
|
|
6,177 |
|
|
4,499 |
|
Short term investments |
10 |
|
7,242 |
|
|
44,919 |
|
Cash and cash equivalents |
|
|
33,823 |
|
|
19,784 |
|
Total current
assets |
|
|
50,728 |
|
|
71,665 |
|
Total
assets |
|
|
54,551 |
|
|
74,261 |
|
|
|
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
|
|
Capital and reserves
attributable to equity holders: |
|
|
|
|
|
Share capital |
|
|
5,266 |
|
|
5,266 |
|
Share premium |
|
|
118,862 |
|
|
118,862 |
|
Share-based payment
reserve |
|
|
9,789 |
|
|
7,923 |
|
Accumulated loss |
|
|
(93,634 |
) |
|
(69,117 |
) |
Total
equity |
|
|
40,283 |
|
|
62,934 |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Derivative financial
instrument |
11 |
|
415 |
|
|
2,492 |
|
Lease liability |
|
|
440 |
|
|
— |
|
Trade and other payables |
|
|
11,605 |
|
|
7,733 |
|
Total current
liabilities |
|
|
12,460 |
|
|
10,225 |
|
|
|
|
|
|
|
Non-current
liabilities: |
|
|
|
|
|
Assumed contingent
obligation |
12 |
|
1,096 |
|
|
996 |
|
Non-current lease
liability |
|
|
640 |
|
|
— |
|
Deferred income |
|
|
72 |
|
|
106 |
|
Total non-current
liabilities |
|
|
1,808 |
|
|
1,102 |
|
Total equity and
liabilities |
|
|
54,551 |
|
|
74,261 |
|
The accompanying notes form an integral part of these condensed
consolidated financial statements.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF
COMPREHENSIVE INCOME
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30,
2019, AND SEPTEMBER 30, 2018
(UNAUDITED)
|
Notes |
|
ThreeMonthsEndedSeptember30, 2019 |
|
ThreeMonthsEndedSeptember30, 2018 |
|
NineMonthsEndedSeptember30, 2019 |
|
NineMonthsEndedSeptember30, 2018 |
|
|
|
£'000s |
|
£'000s |
|
£'000s |
|
£'000s |
Research and development
costs |
|
|
(11,971 |
) |
|
(5,346 |
) |
|
(27,815 |
) |
|
(13,649 |
) |
General and administrative
costs |
|
|
(1,972 |
) |
|
(1,417 |
) |
|
(5,933 |
) |
|
(4,647 |
) |
Operating
loss |
|
|
(13,943 |
) |
|
(6,763 |
) |
|
(33,748 |
) |
|
(18,296 |
) |
Finance income |
7 |
|
1,223 |
|
|
3,331 |
|
|
3,311 |
|
|
1,841 |
|
Finance expense |
7 |
|
(46 |
) |
|
(27 |
) |
|
(119 |
) |
|
(3,463 |
) |
Loss before
taxation |
|
|
(12,766 |
) |
|
(3,459 |
) |
|
(30,556 |
) |
|
(19,918 |
) |
Taxation — credit |
8 |
|
2,620 |
|
|
1,119 |
|
|
6,032 |
|
|
2,966 |
|
Loss for the
period |
|
|
(10,146 |
) |
|
(2,340 |
) |
|
(24,524 |
) |
|
(16,952 |
) |
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
Items that might be
subsequently reclassified to profit or loss |
|
|
|
|
|
|
|
|
|
Exchange differences on
translating foreign operations |
|
|
26 |
|
|
9 |
|
|
27 |
|
|
24 |
|
Total comprehensive
loss attributable to owners of the Company |
|
|
(10,120 |
) |
|
(2,331 |
) |
|
(24,497 |
) |
|
(16,928 |
) |
Loss per ordinary share —
basic and diluted (pence) |
9 |
|
(9.6 |
) |
|
(2.2 |
) |
|
(23.3 |
) |
|
(16.1 |
) |
The accompanying notes form an integral part of these condensed
consolidated financial statements.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN
EQUITY
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2019, AND
SEPTEMBER 30, 2018 (UNAUDITED)
|
Note |
Share Capital |
|
Share Premium |
|
Share-based Expenses |
|
Total Accumulated Losses |
|
Total Equity |
|
|
£'000s |
|
£'000s |
|
£'000s |
|
£'000s |
|
£'000s |
Balance at January 1, 2018 |
|
5,251 |
|
|
118,862 |
|
|
5,022 |
|
|
(49,254 |
) |
|
79,881 |
|
Loss for the period |
|
— |
|
|
— |
|
|
— |
|
|
(16,952 |
) |
|
(16,952 |
) |
Other comprehensive income for
the year: |
|
|
|
|
|
|
|
|
|
|
Exchange differences on
translating foreign operations |
|
— |
|
|
— |
|
|
— |
|
|
24 |
|
|
24 |
|
Total comprehensive loss for
the period |
|
— |
|
|
— |
|
|
— |
|
|
(16,928 |
) |
|
(16,928 |
) |
New share capital issued |
|
15 |
|
|
— |
|
|
— |
|
|
— |
|
|
15 |
|
Share-based payments |
|
— |
|
|
— |
|
|
2,231 |
|
|
— |
|
|
2,231 |
|
Balance at September
30, 2018 |
|
5,266 |
|
|
118,862 |
|
|
7,253 |
|
|
(66,182 |
) |
|
65,199 |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1,
2019, as previously reported |
|
5,266 |
|
|
118,862 |
|
|
7,923 |
|
|
(69,117 |
) |
|
62,934 |
|
Impact of change in accounting policy |
3 |
— |
|
|
— |
|
|
— |
|
|
(20 |
) |
|
(20 |
) |
Adjusted balance at
January 1, 2019 |
|
5,266 |
|
|
118,862 |
|
|
7,923 |
|
|
(69,137 |
) |
|
62,914 |
|
Loss for the period |
|
— |
|
|
— |
|
|
— |
|
|
(24,524 |
) |
|
(24,524 |
) |
Other comprehensive income for
the year: |
|
|
|
|
|
|
|
|
|
|
Exchange differences on
translating foreign operations |
|
— |
|
|
— |
|
|
— |
|
|
27 |
|
|
27 |
|
Total comprehensive loss for
the period |
|
— |
|
|
— |
|
|
— |
|
|
(24,497 |
) |
|
(24,497 |
) |
Share-based payments |
|
— |
|
|
— |
|
|
1,866 |
|
|
— |
|
|
1,866 |
|
Balance at September
30, 2019 |
|
5,266 |
|
|
118,862 |
|
|
9,789 |
|
|
(93,634 |
) |
|
40,283 |
|
The accompanying notes form an integral part of these condensed
consolidated financial statements.
The currency translation reserve for September 30, 2019,
and September 30, 2018, 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
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 2019, AND
SEPTEMBER 30, 2018 (UNAUDITED)
|
NineMonthsEndedSeptember30, 2019 |
|
NineMonthsEndedSeptember30, 2018 |
|
£'000s |
|
£'000s |
Cash used in operating
activities: |
|
|
|
Loss before taxation |
(30,556 |
) |
|
(19,918 |
) |
Finance income |
(3,311 |
) |
|
(1,841 |
) |
Finance expense |
119 |
|
|
3,463 |
|
Share-based payment
charge |
1,866 |
|
|
2,231 |
|
Increase in prepayments and
other receivables |
(1,236 |
) |
|
(223 |
) |
Increase / (decrease) in trade
and other payables |
3,852 |
|
|
(1,434 |
) |
Depreciation of property,
plant and equipment |
274 |
|
|
6 |
|
Unrealized foreign exchange
gains |
15 |
|
|
— |
|
Amortization of intangible
assets |
77 |
|
|
66 |
|
Cash used in operating
activities |
(28,900 |
) |
|
(17,650 |
) |
Cash inflow from taxation |
4,361 |
|
|
4,594 |
|
Net cash used in
operating activities |
(24,539 |
) |
|
(13,056 |
) |
Cash flow from
investing activities: |
|
|
|
Interest received |
827 |
|
|
681 |
|
Purchase of plant and
equipment |
(21 |
) |
|
(1 |
) |
Payment for patents and
computer software |
(184 |
) |
|
(235 |
) |
Transfer to short term
investments |
(7,240 |
) |
|
(44,716 |
) |
Maturity of short term
investments |
45,134 |
|
|
52,854 |
|
Net cash generated in
investing activities |
38,516 |
|
|
8,583 |
|
Cash flow from
financing activities: |
|
|
|
Payment of lease
liabilities |
(296 |
) |
|
— |
|
Net cash used in
financing activities |
(296 |
) |
|
— |
|
Net increase /
(decrease) in cash and cash equivalents |
13,681 |
|
|
(4,473 |
) |
Cash and cash equivalents at
the beginning of the period |
19,784 |
|
|
31,443 |
|
Effect of exchange rates on
cash and cash equivalents |
358 |
|
|
591 |
|
Cash and cash
equivalents at the end of the period |
33,823 |
|
|
27,561 |
|
VERONA PHARMA PLC
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL
STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30,
2019
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 dual listed, with its ordinary shares listed on the AIM market
operated by the London Stock Exchange and its American Depositary
Shares 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 and its
subsidiaries, Verona Pharma, Inc. and Rhinopharma Limited
(together the "Group”), for the nine months ended
September 30, 2019, 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, 2018.
The 2018 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 November 6, 2019. There have been no
changes, other than the adoption of IFRS 16, to the accounting
policies as contained in the annual consolidated financial
statements as of and for the year ended December 31, 2018,
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 cash and short term investments held as of
September 30, 2019, believes the Group has sufficient
resources to fund planned research and development activities,
including the initiation of Phase 3 trials, until September 30,
2020. The Group will need to raise additional funds in order to
continue its activities at this point.
The Group continues to seek additional funding
through public or private financing, license agreements, debt
finance, collaboration agreements and other arrangements. While
Management has reasonable expectations that the Group will obtain
the required finance, there is no guarantee that the Group will be
successful securing additional finance on acceptable terms, or at
all. Raising sufficient funds to fund planned research and
development activities, including Phase 3 trials, is likely to be
dependent on continuing to report positive data from clinical
trials in a timely manner.
Should the Group be unable to raise sufficient
additional funds it will be required to curtail planned research
and development activities, including initiating Phase 3 trials,
until such funding can be obtained.
The Group’s activities and results are not
exposed to seasonality. The Group operates as a single operating
and reportable segment.
Dividend
The Directors do not recommend the payment of a
dividend for the nine months ended September 30, 2019, (nine months
ended September 30, 2018: £nil and the year ended
December 31, 2018: £nil).
3. Change in accounting policy: adoption of IFRS
16
IFRS 16 ‘Leases’ is effective for accounting
periods beginning on or after January 1, 2019, and replaces IAS 17
‘Leases’. It eliminates the classification of leases as either
operating leases or finance leases and, instead, introduces a
single lessee accounting model. The adoption of IFRS 16 resulted in
the Group recognizing lease liabilities within current liabilities,
and corresponding ‘right-of-use’ assets for the arrangements within
property plant and equipment that were previously classified as
operating leases.
The Group’s principal lease arrangements are for
office buildings. The Group has adopted IFRS 16 retrospectively
with the cumulative effect of initially applying the standard as an
adjustment to the opening balance of retained earnings at January
1, 2019. The standard permits a choice on initial adoption, on a
lease-by-lease basis, to measure the right-of-use asset at either
its carrying amount as if IFRS 16 had been applied since the
commencement of the lease, or an amount equal to the lease
liability, adjusted for any accrued or prepaid lease payments. The
Group has elected to measure the right-of-use asset at its carrying
value as if IFRS 16 had been applied since the commencement of the
lease, with the result of a £20 thousand reduction in opening total
accumulated losses.
Initial adoption has resulted in the recognition
of right-of-use assets of £325 thousand and lease liabilities of
£316 thousand and the reclassification of prepaid lease rentals of
£29 thousand.
|
As of January 1, 2019 |
|
£'000s |
Operating lease commitments (including prepayments) disclosed as at
December 31, 2018 |
600 |
|
Less: adjustments relating to
prepaid lease payments |
(29 |
) |
Operating lease commitments as
at December 31, 2018 |
571 |
|
Discounted using the group’s
incremental borrowing rate |
526 |
|
Less: short-term leases
recognized on a straight-line basis as expense |
(210 |
) |
Lease liability
recognized as at January 1, 2019 |
316 |
|
In applying IFRS 16 for the first time, the
group has used the following practical expedients permitted by the
standard:
- the use of a single discount rate of 8% to a portfolio of
leases with reasonably similar characteristics;
- accounting for operating leases with a remaining lease term of
less than 12 months as at January 1, 2019, as short-term
leases;
- the use of hindsight in determining the lease term where the
contract contains options to extend or terminate the lease;
and
- excluding initial direct costs from the initial measurement of
the right-of-use asset.
The Group is applying IFRS 16’s low-value and
short-term exemptions. The adoption of IFRS 16 has had no impact on
the Group’s net cash flows, although a presentation change has been
reflected in 2019 whereby cash outflows of £296 thousand are now
presented as financing, instead of operating. There is a decrease
of £34 thousand in general and administrative costs as depreciation
of the right of use asset is less than the lease costs and a £30
thousand increase in finance expense from the presentation of a
portion of lease costs as interest costs. There is no significant
impact on overall loss before tax and loss per share.
In the period the Group agreed extensions to the
leases. As a result it recognized an additional liability and
right-of-use asset of £1,046 thousand.
4. 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.
5. 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, 2018.
6. 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, 2018. In addition the company carried out a value
in use impairment review.
Impairment of intangible assets,
goodwill and non-financial assets
The Company notes that after the reduction in
its share price since December 31, 2018, at various points in the
three months to March 31, 2019, the market value of the Company was
less than its net book value. The Company therefore carried out an
impairment review as at March 31, 2019. From market research
management assessed, among other inputs, potential patient numbers
from likely physician prescribing patterns, price points, the time
from possible launch to peak sales, script rejection, attrition
rates and probability of success. Management also carried out a
sensitivity analysis on key assumptions and assessed that a
reasonable change in these assumptions would not lead to the value
in use falling below net book value. Consequently, management
determined that the Company's value in use exceeded the carrying
value of the Company's assets and that no impairment was
required.
At various other points in the nine months to
September 30, 2019, the market value of the Company was less than
its net book value. Consequently, management re-performed the
impairment review as at September 30, 2019, and identified no
changes to market conditions, the competitive landscape, market
research insights or other factors that would change its
conclusions. Consequently, management determined that the Company's
value in use exceeded the carrying value of the Company's assets
and that no impairment was required.
7. Finance income and expense
|
Three MonthsEndedSeptember 30,2019 |
|
Three MonthsEndedSeptember 30,2018 |
|
Nine MonthsEndedSeptember 30,2019 |
|
Nine MonthsEndedSeptember 30,2018 |
|
£'000s |
|
£'000s |
|
£'000s |
|
£'000s |
Finance
income: |
|
|
|
|
|
|
|
Interest received on cash balances |
180 |
|
|
238 |
|
|
659 |
|
|
611 |
|
Foreign exchange gain on
translating foreign currency denominated bank balances |
689 |
|
|
502 |
|
|
575 |
|
|
1,230 |
|
Fair value adjustment on
derivative financial instruments (note 11) |
354 |
|
|
2,591 |
|
|
2,077 |
|
|
— |
|
Total finance income |
1,223 |
|
|
3,331 |
|
|
3,311 |
|
|
1,841 |
|
|
Three MonthsEndedSeptember 30,2019 |
|
Three MonthsEndedSeptember 30,2018 |
|
Nine MonthsEndedSeptember 30,2019 |
|
Nine MonthsEndedSeptember 30,2018 |
|
£'000s |
|
£'000s |
|
£'000s |
|
£'000s |
Finance
expense: |
|
|
|
|
|
|
|
Fair value adjustment on derivative financial instruments
(note 11) |
— |
|
|
— |
|
|
— |
|
|
3,385 |
|
Interest on discounted lease
liability |
15 |
|
|
— |
|
|
30 |
|
|
— |
|
Unwinding of discount factor
movements related to the assumed contingent arrangement
(note 12) |
31 |
|
|
27 |
|
|
89 |
|
|
78 |
|
Total finance expense |
46 |
|
|
27 |
|
|
119 |
|
|
3,463 |
|
8. Taxation
The tax credit for the nine month period ended
September 30, 2019, amounts to £6.0 million and consists of the
estimated research and development tax credit receivable on
qualifying expenditure incurred during the nine month period ended
September 30, 2019 for an amount of £6.1 million less a tax expense
of £35 thousand related to the US operations (nine month period
ended September 30, 2018: £3.0 million tax credit, comprising £3.0
million for research and development tax credit, less £35 thousand
expense for tax on US operations).
The tax credit for the three month period ended
September 30, 2019, amounts to £2.6 million, and consists of the
estimated research and development tax credit receivable on
qualifying expenditure incurred during the three month period ended
September 30, 2019 for an amount of £2.6 million less a tax expense
of £16 thousand related to the US operations (three month period
ended September 30, 2018: £1.1 million tax credit, comprising £1.1
million for research and development tax credit, plus tax credit
£28 thousand expense for tax on US operations).
9. Loss per share calculation
For the nine months ended September 30, 2019,
the basic loss per share of 23.3p (September 30, 2018: loss of
16.1p) is calculated by dividing the loss for the nine months ended
September 30, 2019 by the weighted average number of ordinary
shares in issue of 105,326,638 during the nine months ended
September 30, 2019 (September 30, 2018: 105,038,800). 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 September 30, 2019,
the basic loss per share of 9.6p (September 30, 2018: 2.2p) is
calculated by dividing the loss for the three months ended
September 30, 2019 (loss for September 30, 2018) by the weighted
average number of ordinary shares in issue of 105,326,638 during
the three months ended September 30, 2019 (September 30, 2018:
105,080,903).
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.
10. Short term investments
Short term investments as at September 30,
2019 amounted to a total of £7.2 million (December 31, 2018:
£44.9 million) and consisted of fixed term deposits in both US
Dollars and UK Pounds.
11. 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 £1.4365 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 (£1.7238). 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 September 30, 2019, and
December 31, 2018, warrants over 12,401,262 shares were in
effect.
|
As of September30, 2019 |
|
As of December31, 2018 |
Shares available to be issued
under warrants |
12,401,262 |
|
|
12,401,262 |
|
Exercise price |
£ |
1.7238 |
|
|
£ |
1.7238 |
|
Risk-free interest rate |
0.30 |
% |
|
0.76 |
% |
Remaining term to
exercise |
2.59 years |
|
3.34 years |
Annualized volatility |
60.98 |
% |
|
60.72 |
% |
Dividend rate |
0.00 |
% |
|
0.00 |
% |
Dilution discount |
8.55 |
% |
|
5.66 |
% |
As at September 30, 2019, 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 £0.4 million.
The variance for the nine month period ending
September 30, 2019, was £2.1 million (nine month period ending
September 30, 2018: £3.4 million) and is recorded as finance income
(September 30, 2018, recorded in finance expense) in the
Consolidated Statement of Comprehensive Income.
|
Derivativefinancialinstrument |
|
Derivativefinancialinstrument |
|
2019 |
|
2018 |
|
£'000s |
|
£'000s |
As of January, 1 |
2,492 |
|
|
1,273 |
|
Fair value adjustments
recognized in profit or loss |
(2,077 |
) |
|
3,385 |
|
As of September,
30 |
415 |
|
|
4,658 |
|
For the amount recognized as at
September 30, 2019, the effect if volatility were to deviate
up or down is presented in the following table.
|
Volatility(up / down10 %
pts) |
|
£'000s |
Variable up |
696 |
Base case, reported fair
value |
415 |
Variable down |
199 |
12. Assumed contingent obligation related to the
business combination
The value of the assumed contingent obligation
as of September 30, 2019, amounted to £1,096 thousand
(December 31, 2018: £996 thousand). The increase in value of
the assumed contingent obligation during the nine months ended
September 30, 2019, amounted to £100 thousand (nine months ended
September 30, 2018: £87 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 2018 and
the nine months ended September 30, 2019, there were no events that
triggered remeasurement.
|
2019 |
|
2018 |
|
£'000s |
|
£'000s |
January 1 |
996 |
|
|
875 |
|
Impact of changes in foreign
exchange rates |
11 |
|
|
9 |
|
Unwinding of discount factor |
89 |
|
|
78 |
|
September 30 |
1,096 |
|
|
962 |
|
There is no material difference between the fair
value and carrying value of the financial liability.
For the amount recognized as at
September 30, 2019, of £1,096 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(up / down1
% pt) |
Revenue(up / down10 %
pts) |
|
£'000s |
£'000s |
Variable up |
1,081 |
1,155 |
Base case, reported fair
value |
1,096 |
1,096 |
Variable down |
1,163 |
1,087 |
13. Share option scheme
During the nine months ended September 30, 2019
the Company granted a total of 4,349,050 share options and 740,496
Restricted Stock Units (“RSUs”) (nine months ended September 30,
2018, the Company granted 2,090,847 share options, and 273,390
RSUs).
The movement in the number of the Company’s
share options is set out below:
|
Weightedaverageexerciseprice |
|
2019 |
|
Weightedaverageexerciseprice |
|
2018 |
|
£ |
|
|
|
£ |
|
|
Outstanding at January 1 |
1.53 |
|
|
8,752,114 |
|
|
1.53 |
|
|
7,527,457 |
|
Granted during the period |
0.57 |
|
|
4,349,050 |
|
|
1.46 |
|
|
2,090,847 |
|
Expired during the period |
2.00 |
|
|
(19,998 |
) |
|
— |
|
|
— |
|
Forfeited during the period |
0.79 |
|
|
(43,723 |
) |
|
1.43 |
|
|
(799,524 |
) |
Outstanding options at September
30 |
1.21 |
|
|
13,037,443 |
|
|
1.53 |
|
|
8,818,780 |
|
The movement in the number of the Company’s RSUs is set out
below:
|
2019 |
|
2018 |
|
|
|
|
Outstanding at January 1 |
862,473 |
|
|
1,052,236 |
|
Granted during the period |
740,496 |
|
|
273,390 |
|
Exercised during the period |
— |
|
|
(309,237 |
) |
Forfeited during the
period |
— |
|
|
(153,916 |
) |
Outstanding RSUs at September
30 |
1,602,969 |
|
|
862,473 |
|
The share‑based payment expense for the nine
months ended September 30, 2019, was £1.9 million (nine months
ended September 30, 2018: £2.2 million). In the nine months ended
September 30, 2018, 799,524 unvested options and 153,916 RSUs were
forfeited. Previously £370 thousand had been recognized in
the statement of comprehensive income relating to their fair value;
in the nine months ended September 30, 2018, this charge was
reversed.
The options and RSUs granted during the nine
months ended September 30, 2019, were awarded under the Company’s
2017 Incentive Plan with total fair values estimated using the
Black Scholes option pricing model of £1.9 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
nine months ended September 30, 2019.
|
Share options |
|
RSUs |
|
Issued in the nine months endedSeptember 30,
2019 |
|
Issued in the nine months endedSeptember 30,
2019 |
Options / RSUs granted |
4,349,050 |
|
740,496 |
Risk‑free interest rate |
0.39% - 0.82% |
|
0.76% - 0.82% |
Expected life of options /
RSUs |
5.5 - 7 years |
|
1 - 5 years |
Annualized volatility |
64.85% - 69.71% |
|
67.98% - 69.71% |
Dividend rate |
0.00% |
|
0.00% |
Vesting period |
1 to 4 years |
|
1 to 5 years |
14. Related party transactions
Dr David Ebsworth, Chairman of the Company,
purchased 147,600 ordinary shares for £80 thousand from the market
in the period.
Piers Morgan, Chief Financial Officer of the
Company, and his spouse purchased 88,415 ordinary shares in total
for £53 thousand from the market in the period.
At December 31, 2018, there was a receivable
of £126 thousand due from one director and two key
management personnel relating to tax due on RSUs that vested in the
year ended December 31, 2018. Of this, £93 thousand was repaid with
interest in the quarter and £33 thousand relating to the Company’s
National Insurance obligation was settled by the Company.
In the period a director provided consultancy
services for £15 thousand (nine months to September 30, 2018: £22
thousand).
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 September 30,
2019, and for the three and nine month periods ended September 30,
2019 into US dollars at the noon buying rate of the Federal Reserve
Bank of New York on September 30, 2019, which was £1.00 to $1.2305.
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 STATEMENTS OF
COMPREHENSIVE INCOME FOR THE THREE AND NINE MONTHS ENDED
SEPTEMBER 30, 2019 (UNAUDITED)
|
Three Months Ended September 30, 2019 |
|
Three Months Ended September 30, 2019 |
|
Nine Months EndedSeptember 30, 2019 |
|
Nine Months EndedSeptember 30, 2019 |
|
£'000s |
|
$'000s |
|
£'000s |
|
$'000s |
Research and development costs |
(11,971 |
) |
|
(14,730 |
) |
|
(27,815 |
) |
|
(34,226 |
) |
General and administrative
costs |
(1,972 |
) |
|
(2,427 |
) |
|
(5,933 |
) |
|
(7,301 |
) |
Operating
loss |
(13,943 |
) |
|
(17,157 |
) |
|
(33,748 |
) |
|
(41,527 |
) |
Finance income |
1,223 |
|
|
1,505 |
|
|
3,311 |
|
|
4,074 |
|
Finance expense |
(46 |
) |
|
(57 |
) |
|
(119 |
) |
|
(146 |
) |
Loss before
taxation |
(12,766 |
) |
|
(15,709 |
) |
|
(30,556 |
) |
|
(37,599 |
) |
Taxation — credit |
2,620 |
|
|
3,224 |
|
|
6,032 |
|
|
7,422 |
|
Loss for the
period |
(10,146 |
) |
|
(12,485 |
) |
|
(24,524 |
) |
|
(30,177 |
) |
Other comprehensive
income: |
|
|
|
|
|
|
|
Items that might be
subsequently reclassified to profit or loss |
|
|
|
|
|
|
|
Exchange differences on
translating foreign operations |
26 |
|
|
32 |
|
|
27 |
|
|
33 |
|
Total comprehensive
loss attributable to owners of the Company |
(10,120 |
) |
|
(12,453 |
) |
|
(24,497 |
) |
|
(30,144 |
) |
Loss per ordinary share —
basic (pence / cents) |
(9.6 |
) |
|
(11.9 |
) |
|
(23.3 |
) |
|
(28.7 |
) |
CONDENSED CONSOLIDATED STATEMENTS OF
FINANCIAL POSITION AS AT SEPTEMBER 30, 2019, AND
DECEMBER 31, 2018 (UNAUDITED)
|
As of September 30, 2019 |
|
As of September 30, 2019 |
|
As of December 31, 2018 |
|
£'000s |
|
$'000s |
|
£'000s |
ASSETS |
|
|
|
|
|
Non-current
assets: |
|
|
|
|
|
Goodwill |
441 |
|
|
544 |
|
|
441 |
|
Intangible assets |
2,241 |
|
|
2,758 |
|
|
2,134 |
|
Property, plant and
equipment |
1,141 |
|
|
1,404 |
|
|
21 |
|
Total non-current
assets |
3,823 |
|
|
4,706 |
|
|
2,596 |
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Prepayments and other
receivables |
3,486 |
|
|
4,290 |
|
|
2,463 |
|
Current tax receivable |
6,177 |
|
|
7,601 |
|
|
4,499 |
|
Short term investments |
7,242 |
|
|
8,911 |
|
|
44,919 |
|
Cash and cash equivalents |
33,823 |
|
|
41,619 |
|
|
19,784 |
|
Total current
assets |
50,728 |
|
|
62,421 |
|
|
71,665 |
|
Total
assets |
54,551 |
|
|
67,127 |
|
|
74,261 |
|
|
|
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
|
|
Capital and reserves
attributable to equity holders: |
|
|
|
|
|
Share capital |
5,266 |
|
|
6,480 |
|
|
5,266 |
|
Share premium |
118,862 |
|
|
146,260 |
|
|
118,862 |
|
Share-based payment
reserve |
9,789 |
|
|
12,045 |
|
|
7,923 |
|
Accumulated loss |
(93,634 |
) |
|
(115,217 |
) |
|
(69,117 |
) |
Total
equity |
40,283 |
|
|
49,568 |
|
|
62,934 |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Derivative financial
instrument |
415 |
|
|
511 |
|
|
2,492 |
|
Finance lease liabilities |
440 |
|
|
541 |
|
|
— |
|
Trade and other payables |
11,605 |
|
|
14,281 |
|
|
7,733 |
|
Total current
liabilities |
12,460 |
|
|
15,333 |
|
|
10,225 |
|
|
|
|
|
|
|
Non-current
liabilities: |
|
|
|
|
|
Assumed contingent
obligation |
1,096 |
|
|
1,349 |
|
|
996 |
|
Non-current lease
liability |
640 |
|
|
788 |
|
|
— |
|
Deferred income |
72 |
|
|
89 |
|
|
106 |
|
Total non-current
liabilities |
1,808 |
|
|
2,226 |
|
|
1,102 |
|
Total equity and
liabilities |
54,551 |
|
|
67,127 |
|
|
74,261 |
|
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