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 financial results for the three and nine months
ended September 30, 2020 and provides a corporate update.
"We continue to make outstanding progress and
are delighted to have started four clinical trials in the third
quarter including our pivotal ENHANCE-1 and 2 (Ensifentrine as a
Novel inHAled Nebulized COPD thErapy) Phase 3 studies," said David
Zaccardelli, Pharm. D., President and Chief Executive Officer.
"This important milestone brings us closer to potentially
submitting a New Drug Application in the U.S. for ensifentrine and
addressing the urgent need for a novel therapy for the treatment of
chronic obstructive pulmonary disease ("COPD").
"In addition to the two ENHANCE clinical trials
which have both enrolled patients, we started a pilot clinical
study to investigate ensifentrine delivered via pressurized
metered-dose inhaler ("pMDI") formulation in U.S. patients
hospitalized with COVID-19. Clinical data from prior studies of
ensifentrine have demonstrated that it improves lung function and
reduces cellular markers of inflammation in the lungs. We believe
ensifentrine, with its novel mechanism of action, has the potential
to benefit patients suffering from COVID-19. Results are
anticipated in the first half of 2021.
"Also during the third quarter, we initiated the
second, multiple dose part of a Phase 2 study with the pMDI
formulation of ensifentrine in COPD, which was postponed due to the
pandemic. Results are expected in the first half of 2021.
"This clinical progress is supported by the $200
million raise we completed in July and we appreciate the highly
experienced life science investors that participated in the
offering. The funds are expected to support our operations and
Phase 3 clinical programs into 2023."
OUTLOOK AND STRATEGY
Verona Pharma aims to improve health and quality
of life for the millions of people affected by respiratory
diseases. The Company's first-in-class development candidate,
ensifentrine, has the potential to provide benefit to patients
suffering from respiratory conditions such as COPD, COVID-19,
cystic fibrosis ("CF") and asthma.
Ensifentrine is a novel, investigational inhaled
therapy that has been shown to act as both a bronchodilator and an
anti-inflammatory agent in one compound. Initially, the Company is
advancing the development of nebulized ensifentrine for the
maintenance treatment of COPD.
We are pleased to announce that Verona Pharma
has met the following 2020 objectives that were established at the
time of the management change:
- Completing an End-of-Phase 2
meeting with the FDA in May to receive guidance on the design of
the Phase 3 program with nebulized ensifentrine.
- Securing $200 million in gross
proceeds ($185.5 million net of commissions and expenses) through a
private placement in July which we expect to be sufficient capital
to fund the Phase 3 program for nebulized ensifentrine.
- Initiating the ENHANCE Phase 3
program with nebulized ensifentrine in moderate to severe COPD
patients in September.
OPERATIONAL AND DEVELOPMENT HIGHLIGHTS FOR THE THREE
MONTH PERIOD ENDED SEPTEMBER 30, 2020
Financial
- In July, the Company completed a
$200 million private placement of American Depositary Shares
("ADSs") and ordinary shares that resulted in net proceeds of
approximately $185.5 million after giving effect to transaction
related fees and expenses (the "Private Placement"). The Company
expects the proceeds of the Private Placement to be sufficient to
support its operations and clinical programs into 2023.
- In September, Verona Pharma
announced plans to delist from the AIM stock market effective from
7:00 am GMT on October 30, 2020. The Company will retain its
listing on the Nasdaq Global Market ("Nasdaq"). The move is
expected to further enhance liquidity of trading by combining all
trading transactions on Nasdaq and to reduce costs through removing
duplicative listing and compliance fees.
- Also in September, Verona Pharma
rang the Nasdaq closing bell in celebration of the Company's $200
million financing.
- In the third quarter the Company
changed its accounting policy with regards to its presentational
currency and is now presenting financial results in US dollars.
Historical results, including the six months ended June 30, 2020,
have been retrospectively presented in US dollars.
Clinical
- In July, the Company received a
notice to proceed from the FDA for our Investigational New Drug
Application to evaluate pMDI ensifentrine in a randomized,
double-blind, placebo-controlled pilot clinical study for the
treatment of patients hospitalized with COVID-19 and, in September,
the Company initiated the study. The study will evaluate the effect
of ensifentrine on key outcomes in patients hospitalized with
COVID-19 including facilitation of recovery from the viral
infection, clinical status improvement and reduction in
supplemental oxygen use and progression to mechanical
ventilation.
- In August, the Company initiated
the second, multiple dose, part of a Phase 2 study to evaluate pMDI
ensifentrine in patients with moderate to severe COPD. Results are
expected in the first half of 2021.
- In September, the Company initiated
its ENHANCE Phase 3 trials to evaluate the efficacy and safety of
nebulized ensifentrine in patients with moderate to severe COPD.
The two randomized, double-blind, placebo-controlled studies
(ENHANCE-1 and ENHANCE-2) will evaluate ensifentrine as monotherapy
and added onto a single bronchodilator. Each study will enroll
approximately 800 moderate to severe, symptomatic COPD patients at
sites primarily in the U.S. and Europe. The two study designs will
replicate measurements of efficacy and safety data over 24 weeks,
but ENHANCE-1 will also evaluate longer-term safety in 400 patients
over 48 weeks.
- Additionally in September, a
detailed analysis of symptom data from a previously reported Phase
2b clinical trial with nebulized ensifentrine as a maintenance
treatment for COPD was published in the leading peer reviewed
journal for specialists and healthcare professionals, International
Journal of Chronic Obstructive Pulmonary Disease. The analyses
demonstrate that ensifentrine meaningfully improved symptoms and
quality of life after 4 weeks in patients with moderate to severe
COPD.
- Also in September, Dr. Tara
Rheault, Vice President, R&D and Global Project Management,
presented new subgroup analysis from Phase 2b trials with nebulized
ensifentrine in COPD at the European Respiratory Society
International Congress. The data demonstrated that ensifentrine as
monotherapy or added onto tiotropium (Spiriva® Respimat®) improved
lung function in moderate or severe COPD patients regardless of
smoking status or history of chronic bronchitis over 4 weeks.
FINANCIAL HIGHLIGHTS
- Net cash, cash equivalents and
short term investments at September 30, 2020, amounted to
$202.0 million (December 31, 2019: $40.8 million). The
increase is due to the completion of the Private Placement with
gross proceeds of approximately $200 million. The net proceeds of
the Private Placement were approximately $185.5 million after
deducting placement agent fees and other expenses. We continue to
evaluate and consider other financing vehicles, including venture
debt and other facilities, to potentially provide us with further
financial flexibility.
- For the nine months ended September
30, 2020, the Company reported operating loss of $46.2 million
(nine months ended September 30, 2019: $42.7 million) and reported
loss after tax of $41.4 million (nine months ended September 30,
2019: $31.0 million). Research and development costs fell by $7.1
million in the nine months ended September 30, 2020, compared to
the prior period, primarily due to significantly higher costs of an
ongoing Phase 2b study in 2019 compared to the start up costs
incurred in 2020 for the ENHANCE program. General and
administrative costs increased by $10.6 million as the 2020 period
had higher costs related to share based payment charges, executive
changes and certain costs related to the Private Placement recorded
as expenses in the Statement of Comprehensive Income.
- The Company reported loss per share
of 21.0 cents for the nine months ended September 30, 2020 (nine
months ended September 30, 2019: 29.4 cents).
- Net cash used in operating
activities for the nine months ended September 30, 2020 was $25.7
million (nine months ended September 30, 2019: $31.3 million). Cash
used was lower predominantly due to lower cash based operating
costs and a higher cash tax credit received.
- Cash generated from financing
activities of $188 million was primarily related to net cash
proceeds from the Private Placement.
- In the nine months ended September
30, 2020 the Company re-evaluated its assumed contingent liability
and In-Process Research and Development asset in light of its
determination that ensifentrine had moved from Phase 2 to Phase 3
stage of clinical development. Future cashflows relating to a
potential milestone payment and potential royalties payable were
remeasured applying updated estimates of probabilities of success
based on the assumed reduced clinical risk of moving into Phase 3.
Accordingly the Company recorded an increase of $27.7 million to
the assumed contingent liability and a corresponding increase to
the related In-Process Research and Development intangible asset.
There is no material effect on current period comprehensive loss,
net assets or cashflows.
CONFERENCE CALL AND WEBCAST INFORMATION
Verona Pharma will host an investment community
conference call at 9:00 a.m. EDT / 1:00 p.m. GMT on Thursday,
October 29, 2020 to discuss the Q3 2020 financial results and the
corporate update.
Analysts and investors may participate by dialing one of the
following numbers and reference conference number: 2469127:
- +1-888-317-6003 for callers in the United States
- +1-412-317-6061 for international callers
A live webcast will be available on the Events
and Presentations link on the Investors page of the Company's
website, www.veronapharma.com, and an audio replay will be
available there for 90 days. An electronic copy of the Q3 2020
results release will also 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.
For further information please contact:
Verona Pharma
plc |
Tel: +44 (0)20 3283 4200 |
Victoria Stewart, Director of
Communications |
info@veronapharma.com |
|
|
N+1
Singer |
Tel: +44 (0)20 3283 4200 |
(Nominated Adviser and UK
Broker) |
|
Aubrey Powell / George Tzimas
/ Iqra Amin (Corporate Finance) |
|
Tom Salvesen (Corporate
Broking) |
|
|
|
Optimum Strategic
Communications |
Tel: +44 (0)20 3950 9144 |
(European Media and Investor
Enquiries) |
verona@optimumcomms.com |
Mary Clark / Eva Haas /
Shabnam Bashir |
|
|
|
Argot
Partners |
Tel: +1 212-600-1902 |
(U.S. Investor Enquiries) |
verona@argotpartners.com |
Kimberly Minarovich / Michael
Barron |
|
|
|
COVID-19 IMPACT AND BUSINESS CONTINUITY
To help protect the health and safety of the
patients, caregivers and healthcare professionals involved in its
ongoing clinical trials of ensifentrine, as well as its employees
and independent contractors, the Company continues to follow
guidance from the FDA and other health regulatory authorities
regarding the conduct of clinical trials during the COVID-19
pandemic to ensure the safety of study participants, minimize risks
to study integrity, and maintain compliance with good clinical
practice (GCP). The Company continues to review this guidance and
the effect of the COVID-19 pandemic on its operations and clinical
trials and will provide an update if it becomes aware of any
meaningful disruption caused by the pandemic to its clinical
trials.
Verona Pharma is closely monitoring activities
at the Company’s contract manufacturers associated with clinical
supply for the ongoing clinical trials, and is satisfied that
appropriate plans and procedures are in place to ensure
uninterrupted future supply of ensifentrine to the clinical trial
sites, subject to potential limitations on their operations and on
the supply chain due to the COVID-19 pandemic. The Company is
continuing to monitor this situation and will provide an update if
it becomes aware of any meaningful disruption caused by the
pandemic to the clinical supply of ensifentrine for its clinical
trials.
Corporate Operations and Financial Impact
Verona Pharma has also implemented measures to
help keep the Company’s employees, families, and local communities
healthy and safe. All employees are working remotely and all
business travel has been restricted.
The COVID-19 pandemic has caused significant
disruption to the financial markets but Verona Pharma has
successfully raised sufficient capital to fund the Phase 3 program
for nebulized ensifentrine.
COVID-19 Risk Factor
Verona Pharma has assessed the potential impact
on its business of the COVID-19 pandemic and updated its risk
factor disclosures on a Report on Form 6-K filed with the SEC on
April 30, 2020.
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. If successfully developed and
approved, Verona Pharma’s product candidate, ensifentrine, has the
potential to be the first therapy for the treatment of respiratory
diseases that combines bronchodilator and anti-inflammatory
activities in one compound. The Company is evaluating nebulized
ensifentrine in its Phase 3 clinical program ENHANCE ("Ensifentrine
as a Novel inHAled Nebulized COPD thErapy") for COPD maintenance
treatment. The Company raised gross proceeds of $200 million
through a private placement in July 2020 and expects the funds to
support its operations and Phase 3 clinical program into 2023. Two
additional formulations of ensifentrine are currently in Phase 2
development for the treatment of COPD: dry powder inhaler ("DPI")
and pressurized metered-dose inhaler ("pMDI"). Ensifentrine is
being evaluated in a pilot clinical study in patients hospitalized
with COVID-19 and 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, with respect to our
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
development and potential of ensifentrine, including its potential
to help patients recover from COVID-19, the initiation, progress
and timing of clinical trials and related data readouts, our
expectations surrounding clinical trial results and responses from
the FDA, the market opportunity for various formulations of
ensifentrine, including estimates of the market size for COPD, the
impact of the COVID-19 pandemic on our business and operations and
the Company’s future financial results, the sufficiency of our cash
and cash equivalents, and our expectations surrounding additional
funding.
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, as
well as the impact of our management team transition; 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; lawsuits related to patents covering ensifentrine and
the potential for our patents to be found invalid or unenforceable;
the impact of the COVID-19 pandemic on our operations, the
continuity of our business and general economic conditions; and our
vulnerability to natural disasters, global economic factors and
other unexpected events, including health epidemics or pandemics
like COVID-19.
These and other important factors under the
caption “Risk Factors” in our Registration Statement on Form F-1
filed with the SEC on August 17, 2020, 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 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, operational review, outlook and financial
review.
THIS ANNOUNCEMENT CONTAINS INSIDE
INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO
596/2014
OPERATIONAL REVIEW
Company Overview
Verona Pharma is focused on developing and
commercializing our first-in-class Phase 3 candidate, ensifentrine,
for the treatment of significant unmet respiratory needs such as
chronic obstructive pulmonary disease (“COPD”). Ensifentrine has a
novel mechanism of action and has the potential to be the first
therapy for the treatment of respiratory diseases that combines
bronchodilator and anti-inflammatory activities in one compound. As
well as COPD, ensifentrine has potential applications in COVID-19,
cystic fibrosis, asthma and other respiratory diseases.
Verona Pharma is evaluating nebulized
ensifentrine in the Phase 3 clinical program ENHANCE (Ensifentrine
as a Novel inHAled Nebulized COPD thErapy) for the maintenance
treatment of COPD. The Company raised gross proceeds of $200
million through a private placement in July 2020 and expects the
funds to support its operations and Phase 3 clinical program into
2023. Two additional formulations of ensifentrine are currently in
Phase 2 development for the treatment of COPD: dry powder inhaler
("DPI") and pressurized metered-dose inhaler ("pMDI"). Ensifentrine
is being evaluated in a pilot clinical study in U.S. patients
hospitalized with COVID-19.
Ensifentrine has demonstrated significant and
clinically meaningful improvements in both lung function and COPD
symptoms, including breathlessness, in patients with moderate to
severe COPD. In addition, ensifentrine showed further improved lung
function and reduced lung volumes in patients taking standard
short- and long-acting bronchodilator therapy, including maximum
bronchodilator treatment with dual/triple therapy. Ensifentrine has
been well tolerated in clinical trials involving more than 1,300
people to date.
Ensifentrine highlights:
- First-in-class dual bronchodilator
and anti-inflammatory agent in a single molecule
- Potentially the first novel class
of bronchodilator in COPD in over 40 years
- Potentially the only bronchodilator
option as an add-on to existing dual / triple therapy
COPD is a common, progressive, and
life-threatening respiratory disease without a cure. It damages the
airways and lungs, leading to debilitating breathlessness,
hospitalizations and death. COPD has a major impact on everyday
life. Patients struggle with basic activities such as getting out
of bed, showering and walking. COPD affects approximately 384
million people worldwide. It is the third leading cause of death
globally, according to the World Health Organization.
COPD patients are frequently treated with
bronchodilators, to relieve airway constriction and make it easier
to breathe, and with corticosteroids, to reduce lung inflammation.
Despite receiving maximum therapy, many patients, more than 1.2
million in the U.S. alone, remain symptomatic and urgently need
additional treatment. We believe that ensifentrine can provide
significant benefits for these patients.
The pharmacological profile of ensifentrine
including its novel mechanism of action, which is complementary to
existing classes, strong improvement in COPD symptoms and
meaningful improvement in quality of life, addresses the large
unmet need experienced by COPD patients today.
Ensifentrine is a dual phosphodiesterase (“PDE”)
3 and PDE4 inhibitor. It is delivered via inhalation, locally to
the lung to maximize pulmonary exposure to ensifentrine while
minimizing systemic exposure. This minimizes side-effects such as
the gastrointestinal disturbance associated with oral PDE4
inhibitors and the cardiovascular side-effects seen with oral PDE3
inhibitors.
The nebulized formulation of ensifentrine can be
used by adults of any age and dexterity and regardless of peak
inspiratory flow, offering advantages to patients who may struggle
to operate handheld inhaler devices or have low peak inspiratory
flow. Nevertheless, handheld inhaler formats are also important
delivery mechanisms in the approximately $9.6 billion U.S. market
for maintenance COPD therapies. Verona Pharma has developed
formulations of ensifentrine in DPI and pMDI formats and
successfully demonstrated proof of concept in COPD patients with
these formulations. The development of pMDI and DPI formulations of
ensifentrine provides expanded opportunities in life cycle
management including new indications, formulation combinations and
collaborations.
Verona Pharma sees its initial market
opportunity as the U.S. and the Company intends to commercialize
nebulized ensifentrine itself in this market. Outside of the U.S.,
Verona Pharma intends to identify collaborators that can maximize
ensifentrine's potential in those regions.
FINANCIAL REVIEW
Financial review of the nine and three
month periods ended September 30, 2020
Nine months ended September 30,
2020
Research and Development Costs
Research and development costs were $28.1
million for the nine months ended September 30, 2020, compared
to $35.2 million for the nine months ended September 30, 2019, a
decrease of $7.1 million, predominantly attributable to a $9.9
million decrease in clinical trial expenses, partially offset by a
$2.5 million increase in non-cash share based payment charges.
While there were six clinical trials (ongoing, in preparation or
closing down) in the nine months ended September 30, 2020 compared
to four in the same period in 2019, the costs related to the Phase
2b four-week clinical study with ensifentrine added on to
tiotropium in the 2019 period were significantly higher than the
start-up costs of the ENHANCE program that were incurred in the
2020 period.
General and Administrative Costs
General and administrative costs were $18.1
million for the nine months ended September 30, 2020, compared
to $7.5 million for the nine months ended September 30, 2019,
an increase of $10.6 million. The increase included $2.7 million of
costs relating to executive changes and relocation of our U.S.
office to North Carolina, $1.7 million in higher Director's and
Officers liability insurance costs, $1.6 million in costs relating
to the Private Placement and a $4.4 million increase in non-cash
share based payment charges. Other costs increased by $0.2
million.
Finance Income and Expense
Finance income and expense are driven by the
changes in the fair value of the warrant liability, changes in the
present value of the assumed contingent liability, foreign exchange
movements on cash and cash equivalents and interest income and
expense.
Finance income was $1.3 million for the nine
months ended September 30, 2020, and $4.2 million for the nine
months ended September 30, 2019. Finance income was lower in
the nine months ended September 30, 2020 as the fair value of the
warrant liability decreased by $2.7 million in the 2019 period,
compared to an increase in the nine months ended September 30,
2020. The increase in the 2020 period was recorded in finance
expense.
Gains on cash and short term investments due to
foreign exchange movements were $1.2 million in the nine months
ended September 30, 2020, compared to $0.7 million in the same
period in the prior year.
Interest received on cash and short term
investments reduced by $0.7 million due to lower overall interest
rates and a change in our investment policy to use government debt
money market funds compared to term deposits previously
utilized.
Finance expense was $2.2 million for the
nine months ended September 30, 2020, compared to $0.1 million
for the nine months ended September 30, 2019. The increase in
the nine months ended September 30, 2020 was primarily related to a
$1.4 million accounting charge relating to the unwind of the
discount on the assumed contingent liability as the present value
of the contingent liability increases as the estimated time to
potential payment is becoming closer. Additionally, there was a
$0.7 million charge relating to an increase in the fair value of
the warrant liability in the nine months ended September 30, 2020.
In the prior period the present value of the warrant liability
decreased resulting in finance income.
Taxation
The tax credit in the Statement of Comprehensive
Income is predominantly made up of the UK tax credit and a small
tax charge relating to our US operations. The UK tax credits are
calculated as a percentage of qualifying research and development
expenditure and are payable in cash by the UK government to the
Company. Credits recorded in the 2020 financial year are expected
to be received in the 2021 financial year. We expect the magnitude
of these credits to increase as expenditures on our Phase 3 program
accelerate and they continue to be a significant element in our
financing strategy.
The tax credit for the nine month period ended
September 30, 2020 was $5.7 million compared to a credit of $7.6
million for the nine months ended September 30, 2019, a
decrease of $1.9 million. The decrease in the credit amount was
attributable to our decreased expenditures on research and
development in 2020, compared to the same period in 2019.
Assumed contingent liability and In-Process
Research and Development Asset
In the second quarter of 2020, the Company
re-evaluated its contingent liability and In-Process Research and
Development asset in light of its determination that ensifentrine
has moved from Phase 2 to Phase 3 stage of clinical development.
Future cashflows relating to a milestone payment and potential
royalties payable were remeasured. After applying estimated
probabilities of success, the assumed contingent liability that
relates to these potential future cashflows was adjusted.
Accordingly the Company recorded an increase of $27.7 million to
the contingent liability and a corresponding increase to the
related In-Process Research and Development asset. There is no
material effect on current period comprehensive loss, net assets or
cashflows.
The discount that is used to calculate the
present value of the assumed contingent liability unwinds each
quarter as the time to potential payment becomes closer and is
recorded as a finance expense.
Private Placement
On July 17, 2020, Verona Pharma announced that
it had raised approximately $200 million in a private placement
with new and existing institutional and accredited investors. The
Private Placement comprised a placement of 39,090,009 ADSs, each
representing eight Ordinary Shares or non-voting Ordinary Shares of
the Company, at a price of $4.50 per ADS, and 43,111,112 of the
Company’s Ordinary Shares at the equivalent price per Ordinary
Share of $0.5625.
The net proceeds of the Private Placement were
approximately $185.5 million after deducting placement agent fees
and associated expenses (including costs recorded to both equity
and the Statement of Comprehensive Income). $1 million of such
costs were paid in October 2020. Should the Company need to raise
additional capital in the future, there can be no assurance that we
will be able to do so on acceptable terms or at all.
Cash Flows
Net cash used in operating activities decreased
to $25.7 million for the nine months ended September 30, 2020,
from $31.3 million for the nine months ended September 30,
2019, a fall of $5.6 million. Operating loss in the nine months
ended September 30, 2020 was $3.5 million higher which included
$6.9 million higher non-cash share based payment charges, so cash
related charges were approximately $3.4 million lower. In addition,
the cash tax credit of $9.0 million received was $3.8 million
higher than in the nine months ended September 30, 2019. Offsetting
this, the timing of supplier payments led to $1.6 million higher
cash outflow in the current period.
The decrease in net cash generated in investing
activities to $9.7 million for the nine months ended
September 30, 2020, from $49.0 million for the nine months
ended September 30, 2019 was due to the net movement of funds
from short term investments to cash being less in the 2020
period.
The $187.5 million increase in cash generated
from financing activities was primarily due to net cash received
from the Private Placement.
Cash, cash equivalents and short-term
investments
Net cash, cash equivalents and short-term
investments at September 30, 2020, increased to $202.0 million
from $40.8 million at December 31, 2019 due to net receipts
from the Private Placement, partially offset by utilization of cash
in ordinary operating activities.
Net assets
Net assets increased to $197.7 million at
September 30, 2020, from $44.9 million at December 31,
2019. This was predominantly due to the increase in equity from the
Private Placement, partially offset by Company's operating
activities.
Three months ended September 30,
2020
The operating loss for the three months ended
September 30, 2020, was $21.2 million (September 30,
2019: $17.2 million) and the loss after tax for the three months
ended September 30, 2020, was $19.9 million
(September 30, 2019: $12.5 million).
Research and Development Costs
Research and development costs were $12.7
million for the three months ended September 30, 2020,
compared to $14.7 million for the three months ended
September 30, 2019, a decrease of $2.0 million.
This decrease was primarily attributable to a
$4.2 million decrease in clinical trial expenses partially offset
by a $2.4 million increase in the share based payment charge
recorded in the three months ended September 30, 2020. There were
costs relating to four clinical trials (ongoing, in preparation or
closing down) in the three months ended September 30, 2020,
compared to two in the comparative period, however, the costs
related to the Phase 2b four-week clinical study with ensifentrine
added on to tiotropium in the 2019 period, were significantly
higher than the start-up costs of the ENHANCE program that were
incurred in the 2020 period.
General and Administrative Costs
General and administrative costs were $8.5
million for the three months ended September 30, 2020,
compared to $2.4 million for the three months ended
September 30, 2019, an increase of $6.1 million. The increase
was attributable to $1.6 million of costs related to the Private
Placement which were recorded as expenses, a $1.0 million increase
in Directors and Officers liability insurance costs and a $3.4
million increase in non-cash share based payment charges.
Finance Income and Expense
Finance income was $0.9 million for the three
months ended September 30, 2020, and $1.5 million for the
three months ended September 30, 2019. Finance income in the
three months ended September 30, 2020, predominantly comprised a
$0.8 million foreign exchange gain on cash and cash equivalents,
which was broadly similar to the gain in the prior period. Also,
the prior period included $0.4 million relating to movements in the
fair value of the warrants (recorded in finance expense in the 2020
period) and $0.2 million of interest on cash balances.
Finance expense was $1.9 million for the
three months ended September 30, 2020, compared to $54
thousand for the three months ended September 30, 2019. The
increase was primarily due to a $1.0 million charge relating to the
revaluation of the warrants and a $0.9 million charge relating to
the unwind of the discount on the assumed contingent liability in
the 2020 period.
Taxation
Taxation for the three months ended
September 30, 2020, amounted to a credit of $2.3 million
compared to a credit of $3.2 million for the three months ended
September 30, 2019.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL
POSITION (UNAUDITED)
AS OF SEPTEMBER 30, 2020, DECEMBER 31, 2019
AND JANUARY 1, 2019
|
|
|
|
|
Restated* |
|
Restated* |
|
|
|
|
|
|
|
|
|
Notes |
|
As ofSeptember 30,2020 |
|
As ofDecember 31,2019 |
|
As ofJanuary 1,2019 |
|
|
|
$'000s |
|
$'000s |
|
$'000s |
ASSETS |
|
|
|
|
|
|
|
Non-current
assets: |
|
|
|
|
|
|
|
Goodwill |
|
|
545 |
|
|
|
585 |
|
|
|
563 |
|
|
Intangible assets |
10 |
|
31,507 |
|
|
|
3,659 |
|
|
|
3,340 |
|
|
Property, plant and
equipment |
|
|
107 |
|
|
|
57 |
|
|
|
27 |
|
|
Right-of-use asset |
11 |
|
1,194 |
|
|
|
1,288 |
|
|
|
415 |
|
|
Total non-current
assets |
|
|
33,353 |
|
|
|
5,589 |
|
|
|
4,345 |
|
|
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
Prepayments and other
receivables |
|
|
4,668 |
|
|
|
3,676 |
|
|
|
3,144 |
|
|
Current tax receivable |
|
|
5,838 |
|
|
|
9,814 |
|
|
|
5,741 |
|
|
Short term investments |
12 |
|
— |
|
|
|
10,380 |
|
|
|
57,320 |
|
|
Cash and cash equivalents |
13 |
|
201,968 |
|
|
|
30,428 |
|
|
|
25,243 |
|
|
Total current
assets |
|
|
212,474 |
|
|
|
54,298 |
|
|
|
91,448 |
|
|
Total
assets |
|
|
245,827 |
|
|
|
59,887 |
|
|
|
95,793 |
|
|
|
|
|
|
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
|
|
|
|
Capital and reserves
attributable to equity holders: |
|
|
|
|
|
|
|
Share capital |
|
|
30,054 |
|
|
|
7,265 |
|
|
|
7,265 |
|
|
Share premium |
|
|
330,068 |
|
|
|
165,408 |
|
|
|
165,408 |
|
|
Share-based payment
reserve |
|
|
23,430 |
|
|
|
14,127 |
|
|
|
11,008 |
|
|
Cumulative Translation
Adjustment |
|
|
(5,796 |
) |
|
|
(3,327 |
) |
|
|
(4,751 |
) |
|
Accumulated loss |
|
|
(180,041 |
) |
|
|
(138,542 |
) |
|
|
(98,031 |
) |
|
Total
equity |
|
|
197,715 |
|
|
|
44,931 |
|
|
|
80,899 |
|
|
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Derivative financial
instrument |
14 |
|
1,857 |
|
|
|
1,188 |
|
|
|
3,180 |
|
|
Lease liabilities |
|
|
808 |
|
|
|
611 |
|
|
|
441 |
|
|
Trade and other payables |
|
|
14,194 |
|
|
|
10,962 |
|
|
|
9,866 |
|
|
Total current
liabilities |
|
|
16,859 |
|
|
|
12,761 |
|
|
|
13,487 |
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities: |
|
|
|
|
|
|
|
Assumed contingent
liability |
15 |
|
30,552 |
|
|
|
1,463 |
|
|
|
1,271 |
|
|
Non-current lease
liability |
|
|
667 |
|
|
|
652 |
|
|
|
— |
|
|
Deferred income |
|
|
34 |
|
|
|
80 |
|
|
|
136 |
|
|
Total non-current
liabilities |
|
|
31,253 |
|
|
|
2,195 |
|
|
|
1,407 |
|
|
Total equity and
liabilities |
|
|
245,827 |
|
|
|
59,887 |
|
|
|
95,793 |
|
|
The accompanying notes form an integral part of these condensed
consolidated financial statements.
* Comparative results were restated to reflect the change in
presentational currency (see note 3).
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF
COMPREHENSIVE INCOME
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30,
2020, AND SEPTEMBER 30, 2019
(UNAUDITED)
|
|
|
|
|
Restated* |
|
Restated* |
|
Restated* |
|
|
|
|
|
|
|
|
|
|
|
Notes |
|
Three Months EndedSeptember 30,2020 |
|
Three Months EndedSeptember 30,2019 |
|
Nine Months EndedSeptember 30,2020 |
|
Nine Months EndedSeptember 30,2019 |
|
|
|
$'000s |
|
$'000s |
|
$'000s |
|
$'000s |
Research and development costs |
|
|
(12,704 |
) |
|
|
(14,741 |
) |
|
|
(28,149 |
) |
|
|
(35,200 |
) |
|
General and administrative
costs |
|
|
(8,456 |
) |
|
|
(2,424 |
) |
|
|
(18,083 |
) |
|
|
(7,549 |
) |
|
Operating
loss |
|
|
(21,160 |
) |
|
|
(17,165 |
) |
|
|
(46,232 |
) |
|
|
(42,749 |
) |
|
Finance income |
7 |
|
857 |
|
|
|
1,515 |
|
|
|
1,304 |
|
|
|
4,248 |
|
|
Finance expense |
7 |
|
(1,858 |
) |
|
|
(54 |
) |
|
|
(2,182 |
) |
|
|
(149 |
) |
|
Loss before
taxation |
|
|
(22,161 |
) |
|
|
(15,704 |
) |
|
|
(47,110 |
) |
|
|
(38,650 |
) |
|
Taxation — credit |
8 |
|
2,294 |
|
|
|
3,224 |
|
|
|
5,699 |
|
|
|
7,632 |
|
|
Loss for the
period |
|
|
(19,867 |
) |
|
|
(12,480 |
) |
|
|
(41,411 |
) |
|
|
(31,018 |
) |
|
Other comprehensive
loss: |
|
|
|
|
|
|
|
|
|
Items that might be
subsequently reclassified to profit or loss |
|
|
|
|
|
|
|
|
|
Exchange differences on
translation to presentational currency |
|
|
— |
|
|
|
(1,974 |
) |
|
|
(2,469 |
) |
|
|
(2,113 |
) |
|
Total comprehensive
loss attributable to owners of the Company |
|
|
(19,867 |
) |
|
|
(14,454 |
) |
|
|
(43,880 |
) |
|
|
(33,131 |
) |
|
Loss per ordinary share —
basic and diluted (cents) |
9 |
|
(5.8 |
) |
|
|
(11.8 |
) |
|
|
(21.0 |
) |
|
|
(29.4 |
) |
|
The accompanying notes form an integral part of these condensed
consolidated financial statements.
* Comparative results were restated to reflect the change in
presentational currency (see note 3).
VERONA PHARMA PLCCONDENSED CONSOLIDATED
INTERIM STATEMENTS OF CHANGES IN EQUITY
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2020, AND
SEPTEMBER 30, 2019 (UNAUDITED)
|
Restated* |
|
Restated* |
|
Restated* |
|
Restated* |
|
Restated* |
|
Restated* |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share Capital |
|
Share Premium |
|
Share-based Expenses |
|
Cumulative Translation Adjustment ("CTA") |
|
Accumulated Loss |
|
Total Equity |
|
$'000s |
|
$'000s |
|
$'000s |
|
$'000s |
|
$'000s |
|
$'000s |
Retranslated balances at July 1, 2019 |
7,265 |
|
|
165,408 |
|
|
|
12,676 |
|
|
77 |
|
|
|
(116,569 |
) |
|
|
68,857 |
|
|
Impact on CTA reserve of
change in presentation currency to US dollars (1) |
— |
|
|
— |
|
|
|
— |
|
|
(4,967 |
) |
|
|
— |
|
|
|
(4,967 |
) |
|
Adjusted balance at
July 1, 2019 |
7,265 |
|
|
165,408 |
|
|
|
12,676 |
|
|
(4,890 |
) |
|
|
(116,569 |
) |
|
|
63,890 |
|
|
Loss for the period |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
(12,480 |
) |
|
|
(12,480 |
) |
|
Other comprehensive income for
the year: |
|
|
|
|
|
|
|
|
|
|
|
Exchange differences on
translation to presentational currency |
— |
|
|
— |
|
|
|
— |
|
|
(1,974 |
) |
|
|
— |
|
|
|
(1,974 |
) |
|
Total comprehensive loss for
the period |
— |
|
|
— |
|
|
|
— |
|
|
(1,974 |
) |
|
|
(12,480 |
) |
|
|
(14,454 |
) |
|
Share-based payments |
— |
|
|
— |
|
|
|
711 |
|
|
— |
|
|
|
— |
|
|
|
711 |
|
|
Balance at September
30, 2019 |
7,265 |
|
|
165,408 |
|
|
|
13,387 |
|
|
(6,864 |
) |
|
|
(129,049 |
) |
|
|
50,147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at July 1,
2020 |
7,333 |
|
|
165,408 |
|
|
|
16,944 |
|
|
(5,796 |
) |
|
|
(160,154 |
) |
|
|
23,735 |
|
|
Loss for the period |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
(19,867 |
) |
|
|
(19,867 |
) |
|
Total comprehensive loss for
the period |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
(19,867 |
) |
|
|
(19,867 |
) |
|
New share capital issued on
Private Placement |
22,700 |
|
|
177,456 |
|
|
|
— |
|
|
— |
|
|
|
(20 |
) |
|
|
200,136 |
|
|
Transaction costs on share
capital issued |
— |
|
|
(12,796 |
) |
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
(12,796 |
) |
|
Share options exercised during
the period |
21 |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
21 |
|
|
Share-based payments |
— |
|
|
— |
|
|
|
6,486 |
|
|
— |
|
|
|
— |
|
|
|
6,486 |
|
|
Balance at September
30, 2020 |
30,054 |
|
|
330,068 |
|
|
|
23,430 |
|
|
(5,796 |
) |
|
|
(180,041 |
) |
|
|
197,715 |
|
|
(1) $4,967 thousand relates to the reversal of
previous cumulative translation adjustments (which were previously
recorded in Accumulated Loss and are now shown separately) relating
to the translation of Verona Pharma, Inc.'s results from US dollars
to pounds sterling and recording the cumulative translation
adjustments relating to the translation of Verona Pharma plc's
results from pounds sterling to US dollars as a result of the
change of the presentational currency. See note 3 for more
information.
* Comparative results were restated to reflect the change in
presentational currency (see note 3).
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN
EQUITY
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2020, AND
SEPTEMBER 30, 2019 (UNAUDITED)
|
Restated* |
|
Restated* |
|
Restated* |
|
Restated* |
|
Restated* |
|
Restated* |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share Capital |
|
Share Premium |
|
Share-based Expenses |
|
Cumulative Translation Adjustment ("CTA") |
|
Accumulated Loss |
|
Total Equity |
|
$'000s |
|
$'000s |
|
$'000s |
|
$'000s |
|
$'000s |
|
$'000s |
Retranslated balances at January 1, 2019 |
7,265 |
|
|
165,408 |
|
|
|
11,008 |
|
|
33 |
|
|
|
(98,005 |
) |
|
|
85,709 |
|
|
Impact of adoption of IFRS 16
(1) |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
(26 |
) |
|
|
(26 |
) |
|
Impact on CTA reserve of
change in presentation currency to US dollars (2) |
— |
|
|
— |
|
|
|
|
|
(4,784 |
) |
|
|
— |
|
|
|
(4,784 |
) |
|
Adjusted Balance at
January 1, 2019 |
7,265 |
|
|
165,408 |
|
|
|
11,008 |
|
|
(4,751 |
) |
|
|
(98,031 |
) |
|
|
80,899 |
|
|
Loss for the period |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
(31,018 |
) |
|
|
(31,018 |
) |
|
Other comprehensive income for
the year: |
|
|
|
|
|
|
|
|
|
|
|
Exchange differences on
translation to presentational currency |
— |
|
|
— |
|
|
|
— |
|
|
(2,113 |
) |
|
|
— |
|
|
|
(2,113 |
) |
|
Total comprehensive loss for
the period |
— |
|
|
— |
|
|
|
— |
|
|
(2,113 |
) |
|
|
(31,018 |
) |
|
|
(33,131 |
) |
|
Share-based payments |
— |
|
|
— |
|
|
|
2,379 |
|
|
— |
|
|
|
— |
|
|
|
2,379 |
|
|
Balance at September
30, 2019 |
7,265 |
|
|
165,408 |
|
|
|
13,387 |
|
|
(6,864 |
) |
|
|
(129,049 |
) |
|
|
50,147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1,
2020 |
7,265 |
|
|
165,408 |
|
|
|
14,127 |
|
|
(3,327 |
) |
|
|
(138,542 |
) |
|
|
44,931 |
|
|
Loss for the period |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
(41,411 |
) |
|
|
(41,411 |
) |
|
Other comprehensive loss for
the year: |
|
|
|
|
|
|
|
|
|
|
|
Exchange differences on
translation to presentational currency |
— |
|
|
— |
|
|
|
— |
|
|
(2,469 |
) |
|
|
— |
|
|
|
(2,469 |
) |
|
Total comprehensive loss for
the period |
— |
|
|
— |
|
|
|
— |
|
|
(2,469 |
) |
|
|
(41,411 |
) |
|
|
(43,880 |
) |
|
New share capital issued on
Private Placement |
22,700 |
|
|
177,456 |
|
|
|
— |
|
|
— |
|
|
|
(20 |
) |
|
|
200,136 |
|
|
Transaction costs on share
capital issued |
— |
|
|
(12,796 |
) |
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
(12,796 |
) |
|
Share options exercised during
the period |
89 |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
(68 |
) |
|
|
21 |
|
|
Share-based payments |
— |
|
|
— |
|
|
|
9,303 |
|
|
— |
|
|
|
— |
|
|
|
9,303 |
|
|
Balance at September
30, 2020 |
30,054 |
|
|
330,068 |
|
|
|
23,430 |
|
|
(5,796 |
) |
|
|
(180,041 |
) |
|
|
197,715 |
|
|
(1) $26 thousand relates to the adoption of IFRS 16. See note
2.17 of the 2019 20-F.
(2) $4,784 thousand relates to the reversal of
previous cumulative translation adjustments (which were previously
recorded in Accumulated Loss and are now shown separately) relating
to the translation of Verona Pharma, Inc.'s results from US dollars
to pounds sterling and recording the cumulative translation
adjustments relating to the translation of Verona Pharma plc's
results from pounds sterling to US dollars as a result of the
change of the presentational currency. See note 3 for more
information.
* Comparative results were restated to reflect the change in
presentational currency (see note 3).
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 2020, AND
SEPTEMBER 30, 2019 (UNAUDITED)
|
|
|
Restated* |
|
|
|
|
|
Nine MonthsEndedSeptember 30,2020 |
|
Nine MonthsEndedSeptember 30,2019 |
|
$'000s |
|
$'000s |
Cash used in operating
activities: |
|
|
|
Loss before taxation |
(47,110 |
) |
|
|
(38,650 |
) |
|
Finance income |
(1,304 |
) |
|
|
(4,248 |
) |
|
Finance expense |
2,182 |
|
|
|
149 |
|
|
Share-based payment
charge |
9,303 |
|
|
|
2,379 |
|
|
Increase in prepayments and
other receivables |
(1,368 |
) |
|
|
(1,970 |
) |
|
Increase in trade and other
payables |
2,931 |
|
|
|
5,280 |
|
|
Depreciation of property,
plant and equipment and right of use asset |
468 |
|
|
|
348 |
|
|
Impairment of right of use
asset |
289 |
|
|
|
— |
|
|
Unrealized foreign exchange
(gains) / losses |
(251 |
) |
|
|
15 |
|
|
Amortization of intangible
assets |
120 |
|
|
|
97 |
|
|
Cash used in operating
activities |
(34,740 |
) |
|
|
(36,600 |
) |
|
Cash inflow from taxation |
9,035 |
|
|
|
5,283 |
|
|
Net cash used in
operating activities |
(25,705 |
) |
|
|
(31,317 |
) |
|
Cash flow from
investing activities: |
|
|
|
Interest received |
191 |
|
|
|
1,046 |
|
|
Purchase of plant and
equipment |
(73 |
) |
|
|
(25 |
) |
|
Payment for patents and
computer software |
(228 |
) |
|
|
(233 |
) |
|
Transfer to short term
investments |
— |
|
|
|
(8,915 |
) |
|
Maturity of short term
investments |
9,792 |
|
|
|
57,144 |
|
|
Net cash generated in
investing activities |
9,682 |
|
|
|
49,017 |
|
|
Cash flow from
financing activities: |
|
|
|
Proceeds of Private
Placement |
200,156 |
|
|
|
— |
|
|
Transaction costs of Private
Placement |
(11,763 |
) |
|
|
— |
|
|
Payment of lease
liabilities |
(539 |
) |
|
|
(372 |
) |
|
Net cash generated
from / (used) in financing activities |
187,854 |
|
|
|
(372 |
) |
|
Net increase in cash
and cash equivalents |
171,831 |
|
|
|
17,328 |
|
|
Cash and cash equivalents at
the beginning of the period |
30,428 |
|
|
|
25,243 |
|
|
Effect of exchange rates on
cash and cash equivalents |
(291 |
) |
|
|
(966 |
) |
|
Cash and cash
equivalents at the end of the period |
201,968 |
|
|
|
41,605 |
|
|
* Comparative results were restated to reflect the change in
presentational currency (see note 3).
VERONA PHARMA PLC
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL
STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30,
2020
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 currently dual listed, with its ordinary shares listed on the
AIM market operated by the London Stock Exchange and its American
Depositary Shares ("ADSs") on the Nasdaq Global Market ("Nasdaq").
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.
In September, 2020, Verona Pharma announced
plans to delist from the AIM stock market effective as of October
30, 2020. The Company will retain its listing on the Nasdaq.
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, 2020, 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, 2019.
The 2019 Accounts, on which the Company’s
auditors delivered an unqualified audit report, have been delivered
to the Registrar of Companies.
In the period the Company's functional currency
changed from pounds sterling to US dollars and as a consequence the
Group changed its accounting policy to present its financial
statements in US dollars (see note 3). There have been no other
changes to the accounting policies as contained in the annual
consolidated financial statements as of and for the year ended
December 31, 2019, which have been prepared in accordance with
international financial reporting standards (“IFRS”) as issued by
the International Accounting Standards Board and as adopted in the
EU.
These unaudited condensed interim financial
statements were authorized for issue by the Company’s board of
directors on October 29, 2020.
The Group’s activities and results are not
exposed to any seasonality. The Group operates as a single
operating and reportable segment.
Going concern
The Group has incurred recurring losses since
inception, including net losses of $40.5 million, $27.2 million and
$26.8 million for the years ended December 31, 2019, 2018 and
2017, respectively. In addition, as of September 30, 2020, the
Group had an accumulated loss of $180.0 million. The Group expects
to continue to generate operating losses for the foreseeable
future. On July 17, 2020, the Group announced it raised $200
million in a private placement (the "Private Placement"), with net
proceeds after transaction related fees and expenses of
approximately $185.5 million (see note 18).
As of the issuance date of these condensed
consolidated interim financial statements, the Group therefore
expects that its cash and cash equivalents will be sufficient to
fund its operating expenses and capital expenditure requirements
for at least twelve months from the issuance date of these
condensed consolidated interim financial statements. Accordingly,
the consolidated financial statements have been prepared on a basis
that assumes the Group will continue as a going concern and which
contemplates the realization of assets and satisfaction of
liabilities and commitments in the ordinary course of business.
Impairment of intangible assets,
goodwill and non-financial assets
The Group continues to review the effect of the
COVID-19 pandemic on its operations, ongoing and planned clinical
trials and the potential disruption to financial markets.
Management has determined that the current effect on the Group does
not require an impairment of intangible assets or goodwill as the
Company's market value still supports the value of the assets.
However, management will continue to monitor the situation for any
triggering events that relate to the pandemic or other issues.
Dividend
The Directors do not recommend the payment of a
dividend for the nine months ended September 30, 2020, (nine months
ended September 30, 2019: $nil and the year ended
December 31, 2019: $nil).
3. Change in presentational and
functional currency
Accounting policy change - change in presentational
currency
On July 1, 2020, the Group changed its
presentational currency from pounds sterling to US dollars. This
change has been made retrospectively and comparative financial
statements, including the six months to June 30, 2020, have been
restated using the following procedures:
- assets and liabilities were
translated into US dollars at the closing rate of exchange;
- income and expenses were translated
into US dollars at the average rate for the month in which they
were recorded, which approximates to the rate at the date of the
transactions;
- equity balances were translated at
historical rates at the date of transactions;
- translation differences were taken
to the cumulative translation adjustment reserve; and
- statements of cash flows were
prepared in the functional currency of the entities and translated
into the presentational currency at rates approximating the dates
of transactions.
In accordance with IAS 1, Presentation of Financial Statements,
a transition balance sheet has been included in the primary
financial statements.
Change in functional currency
The functional currency of an entity is defined
by IAS 21, The Effects of Changes in Foreign Exchange Rates, as the
currency of the primary economic environment in which an entity
operates. Determining the point at which the functional currency
changes is a matter of judgment as economic activity changes over
time.
In the six months to June 30, 2020, management
changes resulted in lower people costs being paid in pounds
sterling. Following the Private Placement the Company entered into
contracts to commence Phase 3 trials for ensifentrine and the
majority of the costs are incurred in US dollars. Management has
reviewed budgeted activities over the next five years and
identified that the majority of costs from the second half of 2020
onwards will be incurred in US dollars. Furthermore, the Private
Placement in July, 2020, raised funds in US dollars and after
delisting from AIM any future fund raises will be in US dollars.
Also, the commercial focus of Company is the US market.
As a consequence, management determined that the
Company's functional currency has changed from sterling to US
dollars and this has been accounted for prospectively from July 1,
2020. To convert the Company's books and records into US dollars
assets and liabilities were translated at the closing rate of
exchange as of June 30, 2020.
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 apart from a right-of-use asset relating to a property
lease, and associated fixtures and fittings, in the United
States.
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, 2019. In
addition, due to the change of the Company's functional currency to
US dollars and Private Placement, the foreign exchange risk profile
of the Group has changed, discussed below.
Currency risk
Foreign currency risk reflects the risk that the
Company's net assets will be negatively impacted due to
fluctuations in exchange rates. The Company has not entered into
foreign exchange contracts to hedge against gains or losses from
foreign exchange fluctuations. Up to June 30, 2020, movements in
the value of its US dollar balances impacted its net assets. From
July 1, 2020, movements in the value of its pounds sterling
balances impact its net assets.
The summary data about the Company's exposure to currency risk
is as follows. Figures are the US dollar values of balances in each
currency:
|
|
September 30, 2020 |
|
|
USD |
|
GBP |
|
EUR |
|
|
$'000s |
|
$'000s |
|
$'000s |
Cash and cash equivalents |
|
185,608 |
|
|
|
16,078 |
|
|
|
282 |
|
Trade, other payables and
sterling element of assumed contingent liability |
|
10,714 |
|
|
|
8,716 |
|
|
|
742 |
|
Sensitivity Analysis
A reasonably possible strengthening or weakening of the Euro or
pounds sterling against US dollars as of September 30, 2020 would
have affected the measurement of the financial instruments
denominated in a foreign currency.
The following table shows how a movement in a currency would
give rise to a profit or (loss) and a corresponding entry in
equity.
|
|
Profit or Loss and equity |
|
|
Strengthening |
|
Weakening |
|
|
$'000s |
|
$'000s |
September 30,
2020 |
|
|
|
|
GBP (5% movement) |
|
368 |
|
|
|
(368 |
) |
|
EUR (5% movement) |
|
(23 |
) |
|
|
23 |
|
|
Foreign currency denominated trade payables are short term in
nature (generally 30 to 45 days) except for the sterling element of
the assumed contingent liability which is likely to become due
between two and five years from the balance sheet date.
6. Critical estimates and
judgements
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, 2019, with the exception of development of the COVID-19
pandemic and the judgment required in determining the date that the
Company's functional currency changed (see note 3).
We have assessed whether the COVID-19 pandemic
has any impact on the key estimates and judgments previously
reported in respect of the derivative financial instrument, the
assumed contingent liability or other balances and concluded that
there is no significant impact.
7. Finance income and expense
|
|
|
Restated |
|
|
|
Restated |
|
|
|
|
|
|
|
|
|
Three Months EndedSeptember 30, 2020 |
|
Three Months EndedSeptember 30, 2019 |
|
Nine Months EndedSeptember 30, 2020 |
|
Nine Months EndedSeptember 30, 2019 |
|
$'000s |
|
$'000s |
|
$'000s |
|
$'000s |
Finance
income: |
|
|
|
|
|
|
|
Interest received on cash and short term investments |
13 |
|
|
222 |
|
|
116 |
|
|
844 |
|
Foreign exchange gain on
translating foreign currency denominated cash balances |
844 |
|
|
860 |
|
|
1,188 |
|
|
709 |
|
Fair value adjustment on
derivative financial instruments (note 14) |
— |
|
|
433 |
|
|
— |
|
|
2,695 |
|
Total finance income |
857 |
|
|
1,515 |
|
|
1,304 |
|
|
4,248 |
|
|
|
|
Restated |
|
|
|
Restated |
|
|
|
|
|
|
|
|
|
Three Months EndedSeptember 30,2020 |
|
Three Months EndedSeptember 30,2019 |
|
Nine Months EndedSeptember 30,2020 |
|
Nine Months EndedSeptember 30,2019 |
|
$'000s |
|
$'000s |
|
$'000s |
|
$'000s |
Finance
expense: |
|
|
|
|
|
|
|
Fair value adjustment on derivative financial instruments
(note 14) |
978 |
|
|
— |
|
|
747 |
|
|
— |
|
Interest on discounted lease
liability |
25 |
|
|
17 |
|
|
78 |
|
|
37 |
|
Unwinding of discount factor
movements related to the assumed contingent liability
(note 15) |
855 |
|
|
37 |
|
|
1,357 |
|
|
112 |
|
Total finance expense |
1,858 |
|
|
54 |
|
|
2,182 |
|
|
149 |
|
8. Taxation
The tax credit for the nine month period ended
September 30, 2020, amounts to $5.7 million and primarily consists
of the estimated research and development tax credit receivable on
qualifying expenditure incurred during the nine month period ended
September 30, 2020 for an amount of $5.8 million less a tax expense
of $0.1 million related to the U.S. operations (nine month period
ended September 30, 2019: $7.6 million tax credit, comprising $7.7
million for research and development tax credit, less $45 thousand
expense for tax on U.S. operations).
The tax credit for the three month period ended
September 30, 2020, amounts to $2.3 million, and consists of the
estimated research and development tax credit receivable on
qualifying expenditure incurred during the three month period ended
September 30, 2020 for an amount of $2.3 million less a tax expense
of $44 thousand related to the U.S. operations (three month period
ended September 30, 2019: $3.2 million tax credit, comprising $3.2
million for research and development tax credit, less $20 thousand
expense for tax on U.S. operations).
9. Loss per share calculation
For the nine months ended September 30, 2020,
the basic loss per share of 21.0 cents (September 30, 2019:
29.4 cents) is calculated by dividing the loss for the nine months
ended September 30, 2020 by the weighted average number of ordinary
shares in issue of 197,049,240 during the nine months ended
September 30, 2020 (September 30, 2019: 105,326,638).
Potential ordinary shares are not treated as dilutive as the entity
is incurring losses and such shares would be anti-dilutive.
For the three months ended September 30, 2020,
the basic loss per share of 5.8 cents (September 30, 2019:
11.8 cents) is calculated by dividing the loss for the three months
ended September 30, 2020 by the weighted average number of ordinary
shares in issue of 344,809,792 during the three months ended
September 30, 2020 (September 30, 2019: 105,326,638).
Potential ordinary shares are not treated as dilutive as the entity
is incurring losses and such shares would be anti-dilutive.
Each ADS represents 8 ordinary shares of the
Company, so the profit or loss per ADS in any period is equal to
eight times the profit or loss per share.
10. Intangible assets
|
Restated |
|
Restated |
|
Restated |
|
Restated |
|
|
|
|
|
|
|
|
|
IP R&D |
|
Computersoftware |
|
Patents |
|
Total |
|
$'000s |
|
$'000s |
|
$'000s |
|
$'000s |
Cost |
|
|
|
|
|
|
|
At January 1, 2020 |
2,591 |
|
|
25 |
|
|
|
1,611 |
|
|
|
4,227 |
|
|
Additions |
27,666 |
|
|
— |
|
|
|
227 |
|
|
|
28,161 |
|
|
Translation differences
recognized in other comprehensive loss |
148 |
|
|
(2 |
) |
|
|
(112 |
) |
|
|
(234 |
) |
|
At September 30, 2020 |
30,405 |
|
|
23 |
|
|
|
1,726 |
|
|
|
32,154 |
|
|
Accumulated
amortization |
|
|
|
|
|
|
|
At January 1, 2020 |
— |
|
|
19 |
|
|
|
549 |
|
|
|
568 |
|
|
Charge for period |
— |
|
|
3 |
|
|
|
117 |
|
|
|
120 |
|
|
Translation differences
recognized in other comprehensive loss |
— |
|
|
(1 |
) |
|
|
(40 |
) |
|
|
(41 |
) |
|
At September 30, 2020 |
— |
|
|
21 |
|
|
|
626 |
|
|
|
647 |
|
|
Net book
value |
|
|
|
|
|
|
|
At September 30, 2020 |
30,405 |
|
|
2 |
|
|
|
1,100 |
|
|
|
31,507 |
|
|
Movements in the assumed contingent liability
(see note 15) that relate to changes in estimated cashflows or
probabilities of success are recognized as additions to the
In-Process Research and Development ("IP R&D") asset that it
relates to.
In the nine months ended September 30, 2020, the
Group determined that it had moved from Phase 2 of ensifentrine's
clinical development plan to Phase 3. The probability of success
and estimated cashflows have changed and the $27.7 million movement
in the liability relating to this was recorded as an addition to
the IP R&D asset that it relates to.
There were no changes in estimated cashflows or
probabilities of success in 2019.
11. Right-of-use assets
In the nine months ended September 30, 2020, an
office lease was signed in North Carolina and a liability and
corresponding right-of-use ("ROU") asset of $703 thousand were
recorded. The lease terminates on April 30, 2024.
As at December 31, 2019, the Group had an ROU
asset relating to office space in New York. In the nine months
ended September 30, 2020, the New York office was closed and the
ROU asset was subject to an impairment review and its net book
value of $290 thousand was subsequently expensed to the income
statement. The Group retains a liability of $195 thousand relating
to this asset.
12. Short term investments
Short term investments as at September 30,
2020, amounted to a total of $nil (December 31, 2019: $10.4
million) and in 2019 consisted of fixed term deposits.
13. Cash and cash equivalents
Included in cash and cash equivalents are cash
balances held at bank, term deposits with maturities of less than
three months at inception and investments in money market funds.
Money market funds have been classified as cash and cash
equivalents as they are low risk instruments, readily convertible
to a known amount of cash and are subject to an insignificant risk
of change in value. Management's intention is to manage these funds
as cash and to use them to meet short term cash requirements.
14. Derivative financial instrument
On July 29, 2016, the Company issued 31,115,926
warrants, allowing the holders to subscribe for 0.4 of an ordinary
share at a per share exercise price of £1.7238. The warrants can be
exercised until May 2, 2022.
The warrant holders can opt for a cashless
exercise of their warrants, whereby they can choose 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 warrants. The warrants are therefore classified as a derivative
financial liability, since their exercise could result in a
variable number of shares to be issued.
At September 30, 2020, and
December 31, 2019, warrants over 12,401,262 shares were in
effect.
|
As of September 30,2020 |
|
As of December 31,2019 |
Shares available to be issued
under warrants |
12,401,262 |
|
|
12,401,262 |
|
Exercise price |
£ |
1.7238 |
|
|
£ |
1.7238 |
|
Risk-free interest rate |
0.00 |
% |
|
0.54 |
% |
Remaining term to
exercise |
1.59 years |
|
2.34 years |
Annualized volatility |
90.07 |
% |
|
65.56 |
% |
Dividend rate |
0.00 |
% |
|
0.00 |
% |
As of September 30, 2020, the Group updated the
underlying assumptions and calculated a fair value of these
warrants of $1.9 million.
The variance for the nine month period ended
September 30, 2020, was $0.7 million (nine month period ended
September 30, 2019: $2.7 million) and is recorded as finance income
and expense in the Consolidated Statement of Comprehensive
Income.
|
|
|
Restated |
|
|
|
|
|
Derivative financial
instrument |
|
Derivative financial
instrument |
|
2020 |
|
2019 |
|
$'000s |
|
$'000s |
As of January 1 |
1,188 |
|
|
|
3,180 |
|
|
Fair value adjustments
recognized in profit or loss |
725 |
|
|
|
(2,695 |
) |
|
Foreign exchange differences
recognized in loss for the period |
22 |
|
|
|
— |
|
|
Translation differences
recognized in other comprehensive loss |
(78 |
) |
|
|
26 |
|
|
As of September
30 |
1,857 |
|
|
|
511 |
|
|
For the amount recognized as at
September 30, 2020, the effect if volatility were to deviate
up or down is presented in the following table:
|
Volatility (up / down 10
% pts) |
|
$'000s |
Variable up |
2,359 |
|
Base case, reported fair value |
1,857 |
|
Variable
down |
1,378 |
|
15. Assumed contingent liability related to the business
combination
The value of the assumed contingent liability as
of September 30, 2020, amounted to $30.6 million
(December 31, 2019: $1.5 million). The increase in value of
the assumed contingent liability during the nine months ended
September 30, 2020, amounted to $29.1 million (nine months ended
September 30, 2019: $78 thousand).
The assumed contingent liability relates to the
acquisition, in 2006, of rights to certain patents and patent
applications relating to ensifentrine and related compounds under
which the Company is obliged to pay royalties to Ligand.
The assumed contingent liability is accounted
for as a liability and its value is measured at amortized cost
using the effective interest rate method, and is re-measured for
changes in estimated cash flows or when the probability of success
changes.
The expected cash flows are based on estimated
future royalties payable, derived from sales forecasts, and an
assessment of the probability of success using standard market
probabilities for respiratory drug development. The risk-weighted
value of the assumed contingent arrangement is discounted back to
its net present value applying an effective interest rate of
12%.
Re-measurements relating to changes in estimated
cash flows and probabilities of success are recognized in the IP
R&D asset it relates to. The unwinding of the liability is
recorded in finance expense.
As at May 13, 2020, the Group determined that it
had moved from Phase 2 of ensifentrine's clinical development plan
to Phase 3. As a consequence, the probability of success has
changed, reducing the risk-weighting adjustment applied to
estimated cashflows. Furthermore, the Group had carried out market
research and updated its forecasts for ensifentrine's revenue for
the maintenance treatment of chronic obstructive pulmonary disorder
using a nebulized formulation in the U.S. The Group therefore
updated estimated cashflows in the second quarter of 2020. In the
third quarter of 2020 and in 2019 there were no events that
triggered remeasurement.
|
|
|
Restated |
|
|
|
|
|
2020 |
|
2019 |
|
$'000s |
|
$'000s |
January 1 |
1,463 |
|
|
|
1,271 |
|
|
Re-measurement of contingent liability |
27,666 |
|
|
|
— |
|
|
Foreign
exchange differences recognized in loss for the period |
223 |
|
|
|
14 |
|
|
Translation differences recognized in other comprehensive loss |
(157 |
) |
|
|
(48 |
) |
|
Unwinding of discount factor |
1,357 |
|
|
|
112 |
|
|
September 30 |
30,552 |
|
|
|
1,349 |
|
|
There is no material difference between the fair
value and carrying value of the financial liability.
For the amount recognized as at
September 30, 2020, of $30.6 million, the effect if underlying
assumptions were to deviate up or down is presented in the
following table (assuming other variables do not change):
|
Probability of success up / down 5 % pt |
|
Revenue(up / down
10%) |
|
$'000s |
|
|
$'000s |
|
Variable
up |
32,822 |
|
|
33,307 |
|
Base case, reported fair value |
30,552 |
|
|
30,552 |
|
Variable
down |
28,282 |
|
|
27,798 |
|
16. Share option plans
During the nine months ended September 30, 2020
the Company granted a total of 2,096,200 share options and
62,566,216 Restricted Stock Units (“RSUs”) (nine months ended
September 30, 2019, the Company granted 4,349,050 share options,
and 740,496 RSUs).
The movement in the number of the Company’s
share options is set out below and relate to options over ordinary
shares:
|
|
|
|
|
Restated |
|
|
|
|
|
|
|
|
|
|
|
Weighted average
exercise price |
|
2020 |
|
Weighted average
exercise price |
|
2019 |
|
$ |
|
|
|
$ |
|
|
Outstanding at January 1 |
1.55 |
|
|
14,179,196 |
|
|
|
2.09 |
|
|
8,752,114 |
|
|
Granted
during the period |
0.73 |
|
|
2,096,200 |
|
|
|
0.75 |
|
|
4,349,050 |
|
|
Expired
during the period |
1.93 |
|
|
(589,129 |
) |
|
|
3.06 |
|
|
(19,998 |
) |
|
Forfeited during the period |
1.51 |
|
|
(2,292,747 |
) |
|
|
1.07 |
|
|
(43,723 |
) |
|
Outstanding options at September 30 |
1.41 |
|
|
13,393,520 |
|
|
|
1.64 |
|
|
13,037,443 |
|
|
The movement in the number of the Company’s RSUs is set out
below and relate to RSUs over ordinary shares:
|
|
2020 |
|
2019 |
|
|
|
|
|
Outstanding at January 1 |
|
1,602,969 |
|
|
|
862,473 |
|
Granted during the period |
|
62,566,216 |
|
|
|
740,496 |
|
Exercised during the period |
|
(1,476,664 |
) |
|
|
— |
|
Forfeited during the period |
|
(84,889 |
) |
|
|
— |
|
Outstanding RSUs at September 30 |
|
62,607,632 |
|
|
|
1,602,969 |
|
1,069,184 of the RSUs issued related to an
element of annual base salary and 36,989,376 related to additional
equity grants for Dr. Zaccardelli and Mr. Hahn (see note 17). Using
the Black-Scholes valuation model the fair value of each RSUs
relating to annual base salary was $0.71 and the fair value of each
RSU relating to the additional grants was at $0.94.
The share-based payment expense for the nine
months ended September 30, 2020, was $9.3 million (nine months
ended September 30, 2019: $2.4 million).
17. Related party transactions
The Directors and Officers have authority and
responsibility for planning, directing and controlling the
activities of the Company and they therefore comprise key
management personnel as defined by IAS 24 ("Related Party
Disclosures").
During the nine months ended September 30, 2020,
Dr. Jan-Anders Karlsson, the Company’s former CEO, and Piers
Morgan, the Company’s former CFO, resigned and were replaced by Dr.
David Zaccardelli as CEO and President, and Mark Hahn as CFO.
Dr. Jan-Anders Karlsson's severance agreement
included severance pay equal to £479,160, a cash bonus of £40,000,
a payment as compensation of termination of employment of £100,000
and base salary in lieu of notice of £363,000. Other benefits
included continued medical and life insurance and continued pension
contributions until February 28, 2021.
Piers Morgan's severance agreement included
severance pay equal to £123,930 as payment in lieu of notice, a
cash bonus of £82,620, ex gratia compensation of £30,000 and
£40,000 additional compensation for termination of employment.
Pursuant to the terms of his employment
agreement Dr. Zaccardelli is entitled to receive an annual base
salary of $750,000, payable $250,000 in cash and $500,000 in
restricted stock units, and a target annual bonus opportunity of
50% of his annual base salary. Dr. Zaccardelli is also entitled to
receive an award of restricted stock units, equal to 4% of the
Company's outstanding ordinary shares, and an additional award of
restricted stock units if the Company raises additional equity
capital during fiscal year 2020, which is intended to result in
Dr. Zaccardelli’s equity awards (other than the portion of his
base salary payable in restricted stock units) being equal to 4% of
the Company's outstanding ordinary shares on the applicable date of
issuance. Following the Private Placement in July, 2020, Dr.
Zaccardelli received this additional award (see note 18).
Pursuant to the terms of his employment
agreement Mr. Hahn is entitled to receive an annual base salary of
$500,000, payable $250,000 in cash and $250,000 in restricted stock
units, and a target annual bonus opportunity of 50% of his annual
base salary. Mr. Hahn is also entitled to receive an initial award
of restricted stock units, equal to 3% of the Company's outstanding
ordinary shares and an award of restricted stock units equal to 1%
of the Company's outstanding ordinary shares after six months of
employment. He will also be entitled to an additional award of
restricted stock units if the Company raises additional equity
capital during fiscal year 2020, which is intended to result in Mr.
Hahn’s equity awards (other than the portion of his base salary
payable in restricted stock units) being equal to 4% of the
Company's outstanding ordinary shares on the applicable date of
issuance. Following the Private Placement in July 2020 Mr. Hahn
received this additional award (see note 18).
During the nine months ended September 30, 2020,
356,392 and 178,192 RSUs that were issued to Dr. Zaccardelli and
Mr. Hahn, respectively, vested. The shares were issued on May 12,
2020, and August 5, 2020.
Pursuant to their employment agreements, during
the nine months ended September 30, 2020, Dr. Zaccardelli and Mr.
Hahn were each awarded an aggregate of 18,494,688 RSUs equal to 4%
of the Company's outstanding ordinary shares as of July 23,
2020.
During the nine months ended September 30, 2020,
the board of directors were awarded RSUs or share options. Dr.
Ebsworth, Dr. Cunningham, Dr. Edwards, Dr. Shah, Mr. Sinha and Dr.
Ullman were awarded 116,000 RSUs each. Mr. Gupta and Dr. Sinclair
were awarded 185,600 share options each.
In connection with the Private Placement,
certain Directors and an Officer of the Company (the “Participating
Directors and Officer”) subscribed for new ordinary shares at a
price of $0.5625, or £0.45, or ADSs at a price of $4.50.
A summary of the Participating Directors and
Officers is shown below:
Name |
Title |
Amount |
Number of shares |
Dr. Ebsworth |
Chairman |
£ |
100,000 |
|
222,216 |
Dr.
Zaccardelli |
President & CEO |
$ |
249,998 |
|
444,440 |
Mr.
Sinha (through connected persons) |
Director |
$ |
299,997 |
|
533,328 |
Dr.
Ullman |
Director |
$ |
149,983 |
|
266,664 |
Dr.
Edwards |
Director |
$ |
29,997 |
|
53,328 |
Mr.
Hahn |
CFO |
$ |
100,004 |
|
177,784 |
As of July 15, 2020, Novo Holdings A/S and Vivo
Capital held approximately 11.63 per cent and 11.21 per cent,
respectively, of Verona Pharma’s issued ordinary share capital and
as such each is considered to be a related party of the Company as
defined in the AIM Rules for Companies. The participation by Novo
Holdings A/S and Vivo Capital in the Financing are deemed to each
constitute a related party transaction pursuant to AIM Rule 13.
Post the closing of the financing July 22, 2020, Novo Holdings A/S
and Vivo Capital were no longer related parties.
18. July 2020 Private Placement
On July 17, 2020, Verona Pharma announced that
it raised approximately $200 million in a private placement with
new and existing institutional and accredited investors (the
"Private Placement"). The Private Placement comprised a private
placement of 39,090,009 ADSs, each representing eight ordinary
shares or non-voting ordinary shares, at a price of $4.50 per ADS,
and 43,111,112 ordinary shares at the equivalent price of $0.5625
per ordinary share.
The net proceeds of the Financing were
approximately $185.5 million after deducting placement agent fees
and estimated expenses.
19. Post balance sheet events
There were no post balance sheet events to report.
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