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 six months
ended June 30, 2020 and provides a corporate update.
"We have made significant progress in the second
quarter and are extremely pleased to have raised $200 million from
a group of highly experienced life science investors in July,” said
David Zaccardelli, Pharm. D., President and Chief Executive
Officer. “Following the financing and the positive response from
the U.S. Food and Drug Administration (“FDA”) to our End-of-Phase 2
briefing package in May, we are on schedule to initiate our ENHANCE
(Ensifentrine as a Novel inHAled Nebulized COPD thErapy) Phase 3
clinical trials with nebulized ensifentrine for the treatment of
chronic obstructive pulmonary disease ("COPD") later this year.
I am also pleased to announce that we have
received a notice to proceed for our Investigational New Drug
(“IND”) from the FDA to study ensifentrine in patients with
COVID-19. We plan to initiate a randomized, double-blind,
placebo-controlled pilot clinical study to evaluate ensifentrine
delivered via pressurized metered-dose inhaler ("pMDI") formulation
as a treatment for patients hospitalized with COVID-19 at the
University of Alabama at Birmingham. Clinical data from prior
studies of ensifentrine in other respiratory diseases have
demonstrated ensifentrine 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 improve oxygenation and lung function assisting recovery from
COVID-19.
To date, the impact of COVID-19 on clinical
development programs has been limited, but we continue to monitor
the situation and have put in place mitigation strategies to reduce
the risk of COVID-19 related delays. In March, due to the pandemic,
we postponed the start of the second, multiple dose, part of the
Phase 2 study with the pMDI formulation of ensifentrine in patients
with moderate to severe COPD. I am pleased to report that we now
plan to initiate the second part of this study in the third quarter
of 2020 with results anticipated in the first half of 2021.”
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 relief for patients
suffering from respiratory conditions such as COPD, cystic fibrosis
("CF"), asthma, as well as patients suffering from COVID-19.
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.
In the first quarter results, Verona Pharma
outlined the Company’s key objectives for 2020:
- Completing an End-of-Phase 2
meeting with the FDA in the second quarter of 2020 to receive
guidance on the design of the Phase 3 program with nebulized
ensifentrine
- Securing sufficient capital to fund
the Phase 3 program for nebulized ensifentrine
- Initiating the Phase 3 program with
nebulized ensifentrine in moderate to severe COPD patients
Verona Pharma is pleased to have met the first
two objectives, obtaining clarity from the FDA on important
features of the pivotal Phase 3 clinical program and securing $200
million ($183 million net of commissions and expenses) through a
private placement. The Company is on track to meet the third
objective as it plans to start the Phase 3 program with nebulized
ensifentrine in COPD later this year.
OPERATIONAL AND DEVELOPMENT HIGHLIGHTS
FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30,
2020
Financial
- In July, the Company completed a
$200 million (£159 million) private placement of American
Depository Shares ("ADSs") and ordinary shares that resulted in net
proceeds of approximately $183 million (£145 million) after giving
effect to transaction related fees and expenses ("Private
Placement"). The Company expect the proceeds of the Private
Placement to be sufficient to support its operations and clinical
programs into 2023 including the Phase 3 ENHANCE program with
nebulized ensifentrine for the treatment of COPD, which is expected
to start later this year.
Clinical
- In May, the FDA provided written
comments in response to the Company’s End-of-Phase 2 briefing
package for nebulized ensifentrine as a maintenance treatment for
COPD. The response supports progressing the Phase 3 program,
ENHANCE, to support a New Drug Application and the Company is
preparing to initiate the clinical studies later in 2020. The two
randomized, double-blind, placebo-controlled studies (ENHANCE-1 and
ENHANCE-2) will evaluate the efficacy and safety of nebulized
ensifentrine as monotherapy and as an add-on to standard of care
treatment with 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 are
essentially identical over 24 weeks, but ENHANCE-1 will also
evaluate longer-term safety in 400 patients over 48 weeks.
- Additionally in May 2020, six
abstracts presenting findings from clinical trials with
ensifentrine for the treatment of COPD were accepted by the
American Thoracic Society International Conference (“ATS”) 2020.
The abstracts were published on the ATS website and in the peer
reviewed publication, American Journal of Respiratory and Critical
Care Medicine. The presentations included a late-breaking abstract
that expanded on the Phase 2b efficacy and symptom data first
announced by the Company in January 2020 where nebulized
ensifentrine added on to tiotropium demonstrated clinically and
statistically significant dose-dependent improvements in lung
function as well as COPD symptoms.
- In June 2020, the Company hosted an
“Investor and Analyst KOL Webcast” to provide insights into the
unmet medical need and challenges of treating COPD, as well as
details of the planned Phase 3 ENHANCE program. The forum featured
a panel of leading U.S. respiratory clinicians who spoke about the
urgent need for a new COPD treatment with a different mechanism of
action that better addresses symptoms and offers greater benefits
to patients.
- In July 2020, the Company received
a notice to proceed from the FDA to evaluate pMDI ensifentrine in a
randomized, double-blind, placebo-controlled pilot clinical study
for the treatment of patients hospitalized with COVID-19. The
Company plans to start the study in the third quarter.
Management
- In June 2020, the Company appointed
a U.S. commercial expert, Christopher Martin, as Vice President of
Commercial. He will lead the Company’s commercialization efforts
for ensifentrine. Mr. Martin brings more than 15 years of
commercial experience spanning sales, marketing and business
development. Previously, he served as Executive Director of
Marketing at SK Life Science, a subsidiary of SK Biopharmaceutical,
where he was instrumental in launching the company’s first
commercial product, an anti-epileptic medication. Mr. Martin
previously worked with Verona Pharma’s Chief Executive Officer and
Chief Financial Officer, David Zaccardelli and Mark W. Hahn
respectively, at Cempra. Mr. Martin is based in the Company's U.S.
office in Raleigh, North Carolina.
THREE MONTHS ENDED MARCH 31,
2020
- In January 2020, the Company
reported positive top-line data from a Phase 2b clinical study with
nebulized ensifentrine added on to tiotropium (Spiriva®), a long
acting anti-muscarinic (“LAMA”) bronchodilator in symptomatic
patients with moderate to severe COPD. The study met the primary
endpoint at all doses and also met clinically relevant secondary
endpoints.
- In February 2020, the Company
published its Phase 2b clinical results with nebulized ensifentrine
as a monotherapy for maintenance treatment of COPD in the peer
reviewed journal, Respiratory Research. The 403-patient trial,
reported in March 2018, was the first of two large Phase 2b trials
with nebulized ensifentrine for this indication. The study met its
primary endpoint demonstrating that ensifentrine produced
clinically and statistically significant improvements in lung
function at all doses. In addition, clinically relevant secondary
endpoints were met including significant progressive improvements
in COPD symptoms.
- In March 2020, the Company reported
positive efficacy and safety data with a single dose of the pMDI
formulation of ensifentrine in a Phase 2 clinical trial in patients
with moderate to severe COPD. With these results and those observed
in previous Phase 2 clinical trials, ensifentrine has demonstrated
statistically significant and clinically meaningful improvements in
lung function in COPD patients when delivered via any of the three
widely used inhaled modes: nebulizer, DPI and pMDI. Results from
the single dose part of the study (Part A) demonstrated a
statistically significant and clinically meaningful increase in
lung function as measured by FEV11 compared to placebo. The
positive data supported initiation of the second, multiple dose,
part of the study (Part B), which will evaluate the pMDI
formulation in this patient population over 7 days of twice-daily
treatment. Verona Pharma postponed the initiation of Part B due to
concerns regarding the safety of trial subjects, caregivers and
medical staff during the coronavirus (COVID-19) pandemic, but
following an assessment of the safety plans and procedures put in
place by the UK clinical trial site, the Company is planning to
initiate Part B of this study in the third quarter of 2020.
- Also, during the first quarter of
2020, the Company requested an End-of-Phase 2 meeting with the FDA
for nebulized ensifentrine as a maintenance treatment for
COPD.
FINANCIAL HIGHLIGHTS
- Net cash, cash equivalents and
short term investments at June 30, 2020, amounted to £18.1
million ($22.4 million) (December 31, 2019: £30.8 million). In
July 2020 the Company completed the Private Placement with gross
proceeds of approximately £159 million ($200 million). The net
proceeds of the Private Placement will be approximately £145
million ($183 million) after deducting placement agent fees and
estimated expenses.
- For the six months ended June 30,
2020, the Company reported operating loss of £19.7 million ($24.4
million) (six months ended June 30, 2019: £19.8 million) and
reported loss after tax of £16.9 million (six months ended June 30,
2019: £14.4 million). Research and development costs fell in the
six months ended June 30, 2020, compared to the prior period as the
six months ended June 30, 2019, included significant costs relating
to a Phase 2b study. This fall was outweighed by higher general and
administrative costs in the 2020 period as it included costs
relating to executive changes and associated reorganization.
- The Company reported loss per share
of 16.0 pence for the six months ended June 30, 2020 (six months
ended June 30, 2019: 13.7 pence).
- Net cash used in operating
activities for the six months ended June 30, 2020 was £12.7 million
($15.7 million) (six months ended June 30, 2019: £18.1 million).
Cash used was lower as the £7.3 million tax credit for the 2019
fiscal year was received in April 2020, and the £4.4 million tax
credit for the 2018 fiscal year was received in August 2019.
- The Company has 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, in the second quarter
of 2020 the Company recorded an increase of £22.6 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.
COVID-19 IMPACT AND BUSINESS CONTINUITY
To help protect the health and safety of the
patients, caregivers and healthcare professionals involved in its
planned clinical trials of ensifentrine, as well as its employees
and independent contractors, the Company plans 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 is continuing 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
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 planned 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 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.
____________1 FEV1 Forced Expiratory Volume
in one second
Conference Call and Webcast
Information
Verona Pharma will host an investment community
conference call at 9:00 a.m. EDT / 2:00 p.m. BST on Friday, August
14, 2020 to discuss the Q2 2020 financial results and the corporate
update.
Analysts and investors may participate by dialing one of the
following numbers and reference conference ID: 4180419:
- 877-870-9135 for callers in the United States
- +44 800 279 6619 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 30 days. An electronic copy of the Q2 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.
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. Following a response from the U.S. FDA
to Verona Pharma’s End-of-Phase 2 briefing package, the Company
plans to initiate its Phase 3 clinical program ENHANCE
(Ensifentrine as a Novel inHAled Nebulized COPD thErapy) later in
2020 for nebulized ensifentrine 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. Verona Pharma is
currently in Phase 2 development with two additional formulations
of ensifentrine for the treatment of COPD: dry powder inhaler
("DPI") and pressurized metered-dose inhaler ("pMDI"). Ensifentrine
also has potential applications in cystic fibrosis, asthma,
COVID-19 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, 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 Annual Report on Form 20-F filed with
the Securities and Exchange Commission (“SEC”) on February 27,
2020, under the caption “Supplemental Risk Factor Disclosures” in
our Report on Form 6-K filed with the SEC on April 30, 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
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 |
|
|
|
|
|
OPERATIONAL REVIEW
Company Overview
Verona Pharma is focused on developing and
commercializing our first-in-class, late-stage 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 also has potential
applications in cystic fibrosis, asthma, COVID-19 and other
respiratory diseases.
Nebulized ensifentrine is expected to start a
Phase 3 clinical program ENHANCE (Ensifentrine as a Novel inHAled
Nebulized COPD thErapy) later in 2020 for the maintenance treatment
of COPD. 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 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 complementary to existing
classes, strong improvement in COPD symptoms and unprecedented
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, thereby minimizing 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 offers advantages to patients who may
struggle to operate handheld inhaler devices. Handheld inhaler
formats may also be desirable, and Verona Pharma has developed
formulations of ensifentrine in dry powder inhaler and pressurized
metered dose inhaler formats, successfully demonstrating proof of
concept in COPD patients with these formulations. An estimated 5.5
million people in the U.S. use pMDI or DPI formulations delivered
via handheld inhalers for COPD maintenance treatment. The
availability of these formulations of ensifentrine, if successfully
developed and approved, creates new opportunities for using
ensifentrine with existing inhaled medications. U.S. sales of pMDI
and DPI COPD maintenance medication were approximately $9 billion
in 2019.
Management Update
Verona Pharma sees its initial market
opportunity as the U.S. and in June 2020, the Company appointed a
U.S. commercial expert, Christopher Martin, as Vice President of
Commercial. He will help assess the market, develop KOL
relationships, and begin initial pre-commercialization activities
to support a potential U.S. launch of ensifentrine.
FINANCIAL REVIEW
Financial review of the six and three
month periods ended June 30, 2020
Six months ended June 30,
2020
Research and Development Costs
Research and development costs were £12.1
million for the six months ended June 30, 2020, compared to
£15.8 million for the six months ended June 30, 2019, a decrease of
£3.7 million, predominantly attributable to a £4.2 million decrease
in clinical trial expenses. In both periods there were costs
relating to four clinical trials (ongoing, in preparation or
closing down) though in the six months ended 30 June 2019, there
were significant costs relating to the Phase 2 four-week trial
studying ensifentrine as an add-on therapy to a long acting
bronchodilator. This outweighed the start-up costs for the ENHANCE
program that were incurred in the current period. Salary costs
increased by £0.4 million reflecting the expansion of the clinical
team.
General and Administrative Costs
General and administrative costs were £7.6
million for the six months ended June 30, 2020, compared to
£4.0 million for the six months ended June 30, 2019, an
increase of £3.6 million. The increase was primarily attributable
to a £2.9 million increase in costs relating to executive changes
and costs associated with the closure of our New York office and
relocation of our U.S. base of operations to North Carolina. We
booked costs of £1.9 million relating to payments with respect to
contractual notice periods and other severance costs. There was a
£0.2 million impairment relating to the closure of the New York
office and an increase in the share based payment charge of £0.8
million for Restricted Stock Units issued to new executive officers
and accelerated charges relating to severance agreements.
In addition there was a £0.5 million increase
relating to Directors' and Officers' insurance, and recruitment
costs, professional fees and other costs increased by £0.2
million.
Finance Income and Expense
Finance income was £0.5 million for the six
months ended June 30, 2020, and £2.2 million for the six
months ended June 30, 2019. The decrease in finance income was
primarily due to a smaller decrease in the fair value of the
warrant liability of £0.2 million compared to a decrease of £1.7
million in the warrant liability during the six month period ended
June 30, 2019. Interest received on cash and short term investments
reduced by £0.4 million due to a lower cash balances held and there
was a £0.3 million increase in income booked in relation to foreign
exchange rate movements.
Finance expense was £0.4 million for the
six months ended June 30, 2020, compared to £0.2 million for
the six months ended June 30, 2019. The increase was primarily
due to a £0.4 million cost relating to the unwind of the discount
on the assumed contingent liability in the six months ended June
30, 2020 compared to £0.1 million in the prior period. There was
also a £0.1m foreign exchange loss in the period compared to a gain
in the current period noted above.
Taxation
Taxation for the six months ended June 30,
2020, amounted to a credit of £2.7 million compared to a credit of
£3.4 million for the six months ended June 30, 2019, a
decrease of £0.7 million. The credits are obtained at a rate of
14.5% of 230% of our qualifying research and development
expenditure. The decrease in the credit amount was attributable to
our decreased expenditure on research and development in 2020,
compared to the prior period, and a change in the mix of
recoverable spend.
Assumed contingent liability and In-Process
Research and Development Asset
The Company has 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. In the second quarter of 2020, the Company
recorded an increase of £22.6 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.
Cash Flows
Net cash used in operating activities decreased
to £12.7 million for the six months ended June 30, 2020, from
£18.1 million for the six months ended June 30, 2019. While
the operating loss in both periods was similar and non-cash costs
in the six months ended June 30, 2020, were slightly higher, the
cash used in operating activities in this period was greater due to
timing of supplier payments.
This increase in cash used in operating
activities in the six months ended June 30, 2020, was more than
offset as the Company received £7.3 million in respect of its 2019
tax credit on qualifying research and development in the period,
whereas the 2018 tax credit of £4.4 million was received in the
quarter ended September 30, 2019. As a result, net cash used in
operating activities was lower in the current period compared to
the six months ended June 30, 2019.
The decrease in net cash generated in investing
activities to £7.9 million for the six months ended June 30,
2020, from £20.9 million for the six months ended June 30,
2019 was due to the net movement of funds from short term
investments to cash being less during the six months ended June 30,
2020.
Cash, cash equivalents and short-term
investments
Net cash, cash equivalents and short-term
investments at June 30, 2020, decreased to £18.1 million from
£30.8 million at December 31, 2019 due to the utilization of
cash in ordinary operating activities.
Net assets
Net assets decreased to £19.2 million at
June 30, 2020, from £33.9 million at December 31, 2019.
This was primarily due to losses generated by the operating
activities of the Company.
Post-period end
On July 16, 2020, Verona Pharma announced that
it raised approximately £159 million in a private placement with
new and existing institutional and accredited investors. The
Private Placement comprised a placement of 39,090,009 of the
Company’s American Depository Shares (“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, being
£0.45 or $0.5625.
The net proceeds of the Financing will be
approximately £145 million (USD 183 million) after deducting
placement agent fees and estimated expenses. The offering closed on
July 22, 2020.
Three months ended June 30,
2020
The operating loss for the three months ended
June 30, 2020, was £8.5 million (June 30, 2019: £12.0
million) and the loss after tax for the three months ended
June 30, 2020, was £7.4 million (June 30, 2019: loss of
£9.0 million).
Research and Development Costs
Research and development costs were £6.2 million
for the three months ended June 30, 2020, compared to £9.9
million for the three months ended June 30, 2019, a decrease
of £3.7 million. This decrease was predominantly attributable to a
£3.8 million decrease in clinical trial expenses. In both periods
there were costs relating to four clinical trials (ongoing, in
preparation or closing down) though in the three months ended 30
June 2019, there were significant costs relating to the Phase 2
four-week trial studying ensifentrine as an add-on therapy to a
long acting bronchodilator. This outweighs the start-up costs for
the ENHANCE program that have been incurred in the current
period.
General and Administrative Costs
General and administrative costs were £2.3
million for the three months ended June 30, 2020, compared to
£2.1 million for the three months ended June 30, 2019, an
increase of £0.2 million. The increase was attributable to a £0.4
million increase in directors and officers insurance and £0.3
million in salary and related costs due to organizational changes.
This was offset by a £0.4 million gain on foreign exchange, driven
by the assumed contingent liability, and a £0.1 million fall in
other expenses .
Finance Income and Expense
Finance income was £0.1 million for the three
months ended June 30, 2020, and £1.0 million for the three
months ended June 30, 2019. Finance income in the three months
ended June 30, 2020 comprised £28 thousand in relation to interest
received on cash and short term investments, compared to a £0.2
million in the prior period, together with a £41 thousand foreign
exchange gain on cash and short term investments in the three
months ended June 30, 2020 compared to a £0.7 million gain in
the prior period.
Finance expense was £395 thousand for the
three months ended June 30, 2020, compared to £36 thousand for
the three months ended June 30, 2019. The increase was
primarily due to a £0.4 million cost relating to the unwind of the
discount on the assumed contingent liability in the three months
ended June 30, 2020.
Taxation
Taxation for the three months ended
June 30, 2020, amounted to a credit of £1.4 million compared
to a credit of £2.1 million for the three months ended
June 30, 2019.
VERONA PHARMA PLCCONDENSED
CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)AS OF JUNE 30, 2020, AND
DECEMBER 31, 2019
|
Notes |
|
As ofJune 30,2020 |
|
As ofDecember 31,2019 |
|
|
|
£'000s |
|
£'000s |
ASSETS |
|
|
|
|
|
Non-current
assets: |
|
|
|
|
|
Goodwill |
|
|
441 |
|
|
441 |
|
Intangible assets |
9 |
|
25,430 |
|
|
2,757 |
|
Property, plant and
equipment |
|
|
37 |
|
|
43 |
|
Right-of-use asset |
10 |
|
1,096 |
|
|
971 |
|
Total non-current
assets |
|
|
27,004 |
|
|
4,212 |
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Prepayments and other
receivables |
|
|
4,420 |
|
|
2,770 |
|
Current tax receivable |
|
|
2,770 |
|
|
7,396 |
|
Short term investments |
11 |
|
— |
|
|
7,823 |
|
Cash and cash equivalents |
12 |
|
18,081 |
|
|
22,934 |
|
Total current
assets |
|
|
25,271 |
|
|
40,923 |
|
Total
assets |
|
|
52,275 |
|
|
45,135 |
|
|
|
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
|
|
Capital and reserves
attributable to equity holders: |
|
|
|
|
|
Share capital |
|
|
5,324 |
|
|
5,266 |
|
Share premium |
|
|
118,862 |
|
|
118,862 |
|
Share-based payment
reserve |
|
|
12,572 |
|
|
10,364 |
|
Accumulated loss |
|
|
(117,565 |
) |
|
(100,627 |
) |
Total
equity |
|
|
19,193 |
|
|
33,865 |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Derivative financial
instrument |
13 |
|
711 |
|
|
895 |
|
Lease liabilities |
|
|
638 |
|
|
460 |
|
Trade and other payables |
|
|
7,111 |
|
|
8,261 |
|
Total current
liabilities |
|
|
8,460 |
|
|
9,616 |
|
|
|
|
|
|
|
Non-current
liabilities: |
|
|
|
|
|
Assumed contingent
obligation |
14 |
|
23,907 |
|
|
1,103 |
|
Non-current lease
liability |
|
|
677 |
|
|
491 |
|
Deferred income |
|
|
38 |
|
|
60 |
|
Total non-current
liabilities |
|
|
24,622 |
|
|
1,654 |
|
Total equity and
liabilities |
|
|
52,275 |
|
|
45,135 |
|
The accompanying notes form an integral part of these condensed
consolidated financial statements.
VERONA PHARMA PLCCONDENSED CONSOLIDATED
INTERIM STATEMENTS OF COMPREHENSIVE INCOMEFOR THE
THREE AND SIX MONTHS ENDED JUNE 30, 2020,
AND JUNE 30, 2019
(UNAUDITED)
|
Notes |
|
Three MonthsEndedJune 30,2020 |
|
Three MonthsEndedJune 30,2019 |
|
Six MonthsEndedJune 30,2020 |
|
Six MonthsEndedJune 30,2019 |
|
|
|
£'000s |
|
£'000s |
|
£'000s |
|
£'000s |
Research and development costs |
|
|
(6,203 |
) |
|
(9,916 |
) |
|
(12,075 |
) |
|
(15,844 |
) |
General and administrative
costs |
|
|
(2,315 |
) |
|
(2,130 |
) |
|
(7,616 |
) |
|
(3,961 |
) |
Operating
loss |
|
|
(8,518 |
) |
|
(12,046 |
) |
|
(19,691 |
) |
|
(19,805 |
) |
Finance income |
6 |
|
141 |
|
|
1,011 |
|
|
532 |
|
|
2,202 |
|
Finance expense |
6 |
|
(395 |
) |
|
(36 |
) |
|
(447 |
) |
|
(187 |
) |
Loss before
taxation |
|
|
(8,772 |
) |
|
(11,071 |
) |
|
(19,606 |
) |
|
(17,790 |
) |
Taxation — credit |
7 |
|
1,422 |
|
|
2,099 |
|
|
2,683 |
|
|
3,412 |
|
Loss for the
period |
|
|
(7,350 |
) |
|
(8,972 |
) |
|
(16,923 |
) |
|
(14,378 |
) |
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
Items that might be
subsequently reclassified to profit or loss |
|
|
|
|
|
|
|
|
|
Exchange differences on
translating foreign operations |
|
|
3 |
|
|
14 |
|
|
43 |
|
|
1 |
|
Total comprehensive
loss attributable to owners of the Company |
|
|
(7,347 |
) |
|
(8,958 |
) |
|
(16,880 |
) |
|
(14,377 |
) |
Loss per ordinary share —
basic and diluted (pence) |
8 |
|
(6.9 |
) |
|
(8.5 |
) |
|
(16.0 |
) |
|
(13.7 |
) |
The accompanying notes form an integral part of these condensed
consolidated financial statements.
VERONA PHARMA PLCCONDENSED CONSOLIDATED
INTERIM STATEMENTS OF CHANGES IN EQUITYFOR THE
THREE MONTHS ENDED JUNE 30, 2020, AND JUNE 30, 2019
(UNAUDITED)
|
Share Capital |
|
Share Premium |
|
Share-based Expenses |
|
Total Accumulated
Losses |
|
Total Equity |
|
£'000s |
|
£'000s |
|
£'000s |
|
£'000s |
|
£'000s |
Balance at April 1, 2019 |
5,266 |
|
|
118,862 |
|
|
8,543 |
|
|
(74,072 |
) |
|
58,599 |
|
Loss for the period |
— |
|
|
— |
|
|
— |
|
|
(8,972 |
) |
|
(8,972 |
) |
Other comprehensive income for
the year: |
|
|
|
|
|
|
|
|
|
Exchange differences on
translating foreign operations |
— |
|
|
— |
|
|
— |
|
|
14 |
|
|
14 |
|
Total comprehensive loss for
the period |
— |
|
|
— |
|
|
— |
|
|
(8,958 |
) |
|
(8,958 |
) |
Share-based payments |
— |
|
|
— |
|
|
666 |
|
|
— |
|
|
666 |
|
Balance at June 30,
2019 |
5,266 |
|
|
118,862 |
|
|
9,209 |
|
|
(83,030 |
) |
|
50,307 |
|
|
|
|
|
|
|
|
|
|
|
Balance at April 1,
2020 |
5,311 |
|
|
118,862 |
|
|
11,811 |
|
|
(110,160 |
) |
|
25,824 |
|
Loss for the period |
— |
|
|
— |
|
|
— |
|
|
(7,350 |
) |
|
(7,350 |
) |
Other comprehensive income for
the year: |
|
|
|
|
|
|
|
|
|
Exchange differences on
translating foreign operations |
— |
|
|
— |
|
|
— |
|
|
3 |
|
|
3 |
|
Total comprehensive loss for
the period |
— |
|
|
— |
|
|
— |
|
|
(7,347 |
) |
|
(7,347 |
) |
New share capital issued |
13 |
|
|
— |
|
|
— |
|
|
(58 |
) |
|
(45 |
) |
Share-based payments |
— |
|
|
— |
|
|
761 |
|
|
— |
|
|
761 |
|
Balance at June 30,
2020 |
5,324 |
|
|
118,862 |
|
|
12,572 |
|
|
(117,565 |
) |
|
19,193 |
|
The currency translation reserve for June 30, 2020, and
June 30, 2019, 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 PLCCONDENSED CONSOLIDATED
INTERIM STATEMENTS OF CHANGES IN EQUITYFOR THE SIX
MONTHS ENDED JUNE 30, 2020, AND JUNE 30, 2019
(UNAUDITED)
|
Share Capital |
|
Share Premium |
|
Share-based Expenses |
|
Total Accumulated
Losses |
|
Total Equity |
|
£'000s |
|
£'000s |
|
£'000s |
|
£'000s |
|
£'000s |
Balance at January 1, 2019 |
5,266 |
|
|
118,862 |
|
|
7,923 |
|
|
(68,633 |
) |
|
63,418 |
|
Impact of change in accounting
policy(1) |
— |
|
|
— |
|
|
— |
|
|
(20 |
) |
|
(20 |
) |
Adjusted Balance at
January 1, 2019 |
5,266 |
|
|
118,862 |
|
|
7,923 |
|
|
(68,653 |
) |
|
63,398 |
|
Loss for the period |
— |
|
|
— |
|
|
— |
|
|
(14,378 |
) |
|
(14,378 |
) |
Other comprehensive income for
the year: |
|
|
|
|
|
|
|
|
|
Exchange differences on
translating foreign operations |
— |
|
|
— |
|
|
— |
|
|
1 |
|
|
1 |
|
Total comprehensive loss for
the period |
— |
|
|
— |
|
|
— |
|
|
(14,377 |
) |
|
(14,377 |
) |
Share-based payments |
— |
|
|
— |
|
|
1,286 |
|
|
— |
|
|
1,286 |
|
Balance at June 30,
2019 |
5,266 |
|
|
118,862 |
|
|
9,209 |
|
|
(83,030 |
) |
|
50,307 |
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1,
2020 |
5,266 |
|
|
118,862 |
|
|
10,364 |
|
|
(100,627 |
) |
|
33,865 |
|
Loss for the period |
— |
|
|
— |
|
|
— |
|
|
(16,923 |
) |
|
(16,923 |
) |
Other comprehensive income for
the year: |
|
|
|
|
|
|
|
|
|
Exchange differences on
translating foreign operations |
— |
|
|
— |
|
|
— |
|
|
43 |
|
|
43 |
|
Total comprehensive loss for
the period |
— |
|
|
— |
|
|
— |
|
|
(16,880 |
) |
|
(16,880 |
) |
New share capital issued |
58 |
|
|
— |
|
|
— |
|
|
(58 |
) |
|
— |
|
Share-based payments |
— |
|
|
— |
|
|
2,208 |
|
|
— |
|
|
2,208 |
|
Balance at June 30,
2020 |
5,324 |
|
|
118,862 |
|
|
12,572 |
|
|
(117,565 |
) |
|
19,193 |
|
The currency translation reserve for June 30, 2020, and
June 30, 2019, is not considered material and as such is not
presented in a separate reserve but is included in the total
accumulated losses reserve.
(1) This relates to the adoption of IFRS 16. See note 2.17 of
the 2019 20-F.
VERONA PHARMA PLCCONDENSED
CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
FORTHE SIX MONTHS ENDED JUNE 30, 2020, AND
JUNE 30, 2019 (UNAUDITED)
|
Six MonthsEndedJune 30, 2020 |
|
Six MonthsEndedJune 30, 2019 |
|
£'000s |
|
£'000s |
Cash used in operating
activities: |
|
|
|
Loss before taxation |
(19,606 |
) |
|
(17,790 |
) |
Finance income |
(532 |
) |
|
(2,202 |
) |
Finance expense |
447 |
|
|
187 |
|
Share-based payment
charge |
2,208 |
|
|
1,286 |
|
(Increase) / decrease in
prepayments and other receivables |
(1,710 |
) |
|
65 |
|
(Decrease) / increase in trade
and other payables |
(1,146 |
) |
|
163 |
|
Depreciation of property,
plant and equipment and right of use asset |
247 |
|
|
157 |
|
Impairment of right of use
asset |
232 |
|
|
— |
|
Unrealized foreign exchange
(gains) / losses |
(232 |
) |
|
3 |
|
Amortization of intangible
assets |
61 |
|
|
50 |
|
Cash used in operating
activities |
(20,031 |
) |
|
(18,081 |
) |
Cash inflow from taxation |
7,319 |
|
|
— |
|
Net cash used in
operating activities |
(12,712 |
) |
|
(18,081 |
) |
Cash flow from
investing activities: |
|
|
|
Interest received |
141 |
|
|
296 |
|
Purchase of plant and
equipment |
(4 |
) |
|
(21 |
) |
Payment for patents and
computer software |
(105 |
) |
|
(90 |
) |
Maturity of short term
investments |
7,848 |
|
|
20,686 |
|
Net cash generated in
investing activities |
7,880 |
|
|
20,871 |
|
Cash flow from
financing activities: |
|
|
|
Repayment of lease
liabilities |
(263 |
) |
|
(168 |
) |
Net cash used in
financing activities |
(263 |
) |
|
(168 |
) |
Net (decrease) /
increase in cash and cash equivalents |
(5,095 |
) |
|
2,622 |
|
Cash and cash equivalents at
the beginning of the period |
22,934 |
|
|
19,784 |
|
Effect of exchange rates on
cash and cash equivalents |
242 |
|
|
28 |
|
Cash and cash
equivalents at the end of the period |
18,081 |
|
|
22,434 |
|
VERONA PHARMA PLCNOTES TO THE CONDENSED
CONSOLIDATED INTERIM FINANCIAL STATEMENTSFOR THE
SIX MONTHS ENDED JUNE 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 dual listed, with its ordinary shares listed on the AIM market
operated by the London Stock Exchange and its American Depository
Shares ("ADSs") 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 six months ended June 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.
These unaudited condensed interim financial
statements were authorized for issue by the Company’s board of
directors (the “Directors”) on August 14, 2020. There have been no
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 (“IASB”).
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 £31.9 million, £19.9 million and
£20.5 million for the years ended December 31, 2019, 2018 and
2017, respectively. In addition, as of June 30, 2020, the Group had
an accumulated loss of £117.6 million. The Group expects to
continue to generate operating losses for the foreseeable future.
On July 17, 2020, the Group announced it raised £159 million in a
private placement, with net proceeds after transaction related fees
and expenses of approximately £145 million (see note 17).
As of the issuance date of these condensed
consolidated interim financial statements, the Group therefore
expects that its cash and cash equivalents would 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.
Dividend
The Directors do not recommend the payment of a
dividend for the six months ended June 30, 2020, (six months ended
June 30, 2019: £nil and the year ended December 31, 2019:
£nil).
3. Segmental reporting
The Group’s activities are covered by one
operating and reporting segment: Drug Development. There have been
no changes to management’s assessment of the operating and
reporting segment of the Group during the period.
All non-current assets are based in the United
Kingdom apart from a right-of-use asset relating to a property
lease in the United States.
4. Financial instruments
The Group’s activities expose it to a variety of
financial risks: market risk (including foreign currency risk),
cash flow and fair value interest rate risk, credit risk and
liquidity risk. The condensed consolidated interim financial
statements do not include all financial risk management information
and disclosures required in the annual financial statements, and
they should be read in conjunction with the Group’s annual
financial statements for the year ended December 31, 2019.
5. 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.
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 obligation or other balances and concluded that
there is no significant impact.
6. Finance income and expense
|
Three MonthsEndedJune 30, 2020 |
|
Three MonthsEndedJune 30, 2019 |
|
Six MonthsEndedJune 30, 2020 |
|
Six MonthsEndedJune 30, 2019 |
|
£'000s |
|
£'000s |
|
£'000s |
|
£'000s |
Finance
income: |
|
|
|
|
|
|
|
Interest received on cash and short term investments |
28 |
|
|
229 |
|
|
81 |
|
|
479 |
|
Foreign exchange gain on
translating foreign currency denominated cash balances |
41 |
|
|
669 |
|
|
267 |
|
|
— |
|
Fair value adjustment on
derivative financial instruments (note 13) |
72 |
|
|
113 |
|
|
184 |
|
|
1,723 |
|
Total finance income |
141 |
|
|
1,011 |
|
|
532 |
|
|
2,202 |
|
|
Three MonthsEndedJune 30, 2020 |
|
Three MonthsEndedJune 30, 2019 |
|
Six MonthsEndedJune 30, 2020 |
|
Six MonthsEndedJune 30, 2019 |
|
£'000s |
|
£'000s |
|
£'000s |
|
£'000s |
Finance
expense: |
|
|
|
|
|
|
|
|
|
|
|
Interest on discounted lease
liability |
22 |
|
|
6 |
|
|
42 |
|
|
15 |
|
Foreign exchange loss on
translating foreign currency denominated balances |
— |
|
|
— |
|
|
— |
|
|
114 |
|
Unwinding of discount factor
movements related to the assumed contingent arrangement
(note 14) |
373 |
|
|
30 |
|
|
405 |
|
|
58 |
|
Total finance expense |
395 |
|
|
36 |
|
|
447 |
|
|
187 |
|
7. Taxation
The tax credit for the six month period ended
June 30, 2020, amounts to £2.7 million and consists of the
estimated research and development tax credit receivable on
qualifying expenditure incurred during the six month period ended
June 30, 2020 for an amount of £2.7 million less a tax expense of
£52 thousand related to the U.S. operations (six month period ended
June 30, 2019: £3.4 million tax credit, comprising £3.4 million for
research and development tax credit, less £19 thousand expense for
tax on U.S. operations).
The tax credit for the three month period ended
June 30, 2020, amounts to £1.4 million, and consists of the
estimated research and development tax credit receivable on
qualifying expenditure incurred during the three month period ended
June 30, 2020 for an amount of £1.4 million less a tax expense of
£12 thousand related to the U.S. operations (three month period
ended June 30, 2019: £2.1 million tax credit, comprising £2.1
million for research and development tax credit, plus tax credit
£20 thousand expense for tax on U.S. operations).
8. Loss per share calculation
For the six months ended June 30, 2020, the
basic loss per share of 16.0p (June 30, 2019: 13.7p) is
calculated by dividing the loss for the six months ended June 30,
2020 by the weighted average number of ordinary shares in issue of
105,908,648 during the six months ended June 30, 2020
(June 30, 2019: 105,326,638). Potential ordinary shares are
not treated as dilutive as the entity is loss making and such
shares would be anti-dilutive.
For the three months ended June 30, 2020, the
basic loss per share of 6.9p (June 30, 2019: 8.5p) is
calculated by dividing the loss for the three months ended June 30,
2020 by the weighted average number of ordinary shares in issue of
106,360,580 during the three months ended June 30, 2020
(June 30, 2019: 105,326,638). Potential ordinary shares are
not treated as dilutive as the entity is loss making 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.
9. Intangible assets
|
IP R&D |
|
Computersoftware |
|
Patents |
|
Total |
|
£'000s |
|
£'000s |
|
£'000s |
|
£'000s |
Cost |
|
|
|
|
|
|
|
At January 1, 2020 |
1,953 |
|
|
18 |
|
|
1,214 |
|
|
3,185 |
|
Additions |
22,629 |
|
|
— |
|
|
105 |
|
|
22,734 |
|
At June 30, 2020 |
24,582 |
|
|
18 |
|
|
1,319 |
|
|
25,919 |
|
Accumulated
amortization |
|
|
|
|
|
|
|
At January 1, 2020 |
— |
|
|
15 |
|
|
413 |
|
|
428 |
|
Charge for year |
— |
|
|
1 |
|
|
60 |
|
|
61 |
|
At June 30, 2020 |
— |
|
|
16 |
|
|
473 |
|
|
489 |
|
Net book
value |
|
|
|
|
|
|
|
At June 30, 2020 |
24,582 |
|
|
2 |
|
|
846 |
|
|
25,430 |
|
Movements in the assumed contingent liability
(see note 14) 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 six months ended June 30, 2020, the Group
determined that it moved from Phase 2 of ensifentrine's clinical
development plan to Phase 3. The probability of success and
estimated cashflows have changed and the £22.6 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.
10. Right-of-use assets
In the six months to June 30, 2020, a new lease
was signed in North Carolina and a liability and corresponding
right-of-use ("ROU") asset of £575 thousand was recognized. 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 six months to
June 30, 2020, the New York office was closed and the ROU asset was
subject to an impairment review and its net book value of £232
thousand was subsequently expensed to the income statement. The
Group retains a liability of £192 thousand relating to this
asset.
11. Short term investments
Short term investments as at June 30, 2020,
amounted to a total of £0.0 million (December 31, 2019: £7.8
million) and consisted of fixed term deposits.
12. 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.
13. Derivative financial instrument
On July 29, 2016 the Company issued 31,115,926
units to new and existing investors at the placing price of £1.4365
per unit. Each unit comprises one ordinary share and one warrant
and the warrant holders may subscribe for 0.4 of an ordinary share
at a per share exercise price of £1.7238.
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.
The warrants entitled the investors to subscribe
for, in aggregate, a maximum of 12,401,262 shares. The
warrants can be exercised until May 2, 2022.
At June 30, 2020, and December 31,
2019, warrants over 12,401,262 shares were in effect.
|
As of June 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 |
1.84 years |
|
2.34 years |
Annualized volatility |
81.86 |
% |
|
65.56 |
% |
Dividend rate |
0.00 |
% |
|
0.00 |
% |
As of June 30, 2020, the Group updated the
underlying assumptions and calculated a fair value of these
warrants of £0.7 million.
The variance for the six month period ending
June 30, 2020, was £0.2 million (six month period ending June 30,
2019: £1.7 million) and is recorded as finance income in the
Consolidated Statement of Comprehensive Income.
|
Derivative financial
instrument |
|
Derivative financial
instrument |
|
2020 |
|
2019 |
|
£'000s |
|
£'000s |
As of January, 1 |
895 |
|
|
2,492 |
|
Fair value adjustments
recognized in profit or loss |
(184 |
) |
|
(1,723 |
) |
As of June,
30 |
711 |
|
|
769 |
|
For the amount recognized as at June 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 |
989 |
|
Base case, reported
fair value |
711 |
|
Variable down |
463 |
|
14. Assumed contingent obligation related to the
business combination
The value of the assumed contingent obligation
as of June 30, 2020, amounted to £23.9 million
(December 31, 2019: £1.1 million). The increase in value of
the assumed contingent obligation during the six months ended June
30, 2020, amounted to £22.8 million (six months ended June 30,
2019: £60 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 has 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 2019 there were no events that
triggered remeasurement.
|
2020 |
|
2019 |
|
£'000s |
|
£'000s |
January 1 |
1,103 |
|
|
996 |
|
Re-measurement of contingent
liability |
22,629 |
|
|
— |
|
Impact of changes in foreign
exchange rates |
(230 |
) |
|
2 |
|
Unwinding of discount
factor |
405 |
|
|
58 |
|
June 30 |
23,907 |
|
|
1,056 |
|
There is no material difference between the fair
value and carrying value of the financial liability.
For the amount recognized as at June 30,
2020, of £23.9 million, 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):
|
USD/GBPexchange rateup/down 1 % pt |
Probabilityof successup/down 5 % pt |
Revenue(up / down
10%) |
|
£'000s |
£'000s |
£'000s |
Variable up |
23,693 |
|
25,683 |
|
26,071 |
|
Base case, reported fair
value |
23,907 |
|
23,907 |
|
23,907 |
|
Variable down |
24,125 |
|
22,131 |
|
21,742 |
|
15. Share option plans
During the six months ended June 30, 2020 the
Company granted a total of 1,605,000 share options and 8,442,048
Restricted Stock Units (“RSUs”) (six months ended June 30, 2019,
the Company granted 4,249,050 share options, and 740,496 RSUs).
The movement in the number of the Company’s
share options is set out below:
|
Weighted average
exercise price |
|
2020 |
|
Weighted average
exercise price |
|
2019 |
|
£ |
|
|
|
£ |
|
|
Outstanding at January 1 |
1.15 |
|
|
14,179,196 |
|
|
1.53 |
|
|
8,752,114 |
|
Granted during the period |
0.55 |
|
|
1,605,000 |
|
|
0.57 |
|
|
4,249,050 |
|
Expired during the period |
1.39 |
|
|
(589,129 |
) |
|
2.00 |
|
|
(19,998 |
) |
Forfeited during the
period |
1.04 |
|
|
(1,899,284 |
) |
|
— |
|
|
— |
|
Outstanding options at June
30 |
1.08 |
|
|
13,295,783 |
|
|
1.22 |
|
|
12,981,166 |
|
The movement in the number of the Company’s RSUs is set out
below:
|
|
2020 |
|
2019 |
|
|
|
|
|
|
Outstanding at January 1 |
|
1,602,969 |
|
|
862,473 |
|
Granted during the period |
|
8,442,048 |
|
|
740,496 |
|
Exercised during the
period |
|
(1,154,368 |
) |
|
— |
|
Forfeited during the
period |
|
(84,889 |
) |
|
— |
|
Outstanding RSUs at June
30 |
|
8,805,760 |
|
|
1,602,969 |
|
1,069,184 of the RSUs issued related to an
element of annual base salary and 7,372,865 related to additional
equity grants for Dr. Zaccardelli and Mr. Hahn (see note 16). Using
the Black-Scholes valuation model the fair value of each RSUs
relating to annual base salary was £0.55 and the fair value of each
RSU relating to the additional grants was at £0.43.
The share-based payment expense for the six
months ended June 30, 2020, was £2.2 million (six months ended June
30, 2019: £1.3 million).
16. 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 six months ended June 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.
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 an equity capital raise in July, 2020, Dr.
Zaccardelli is now entitled to this additional award (see note
17).
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 share 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 an equity capital raise in July 2020 Mr. Hahn
is now entitled to this additional award (see note 17).
During the six months ended June 30, 2020,
178,192 and 89,096 RSUs that were issued to Dr. Zaccardelli and Mr.
Hahn respectively vested. The shares were issued on May 12,
2020.
17. Post balance sheet events
On July 17, 2020, Verona Pharma announced that
it raised approximately £159 million in a private placement with
new and existing institutional and accredited investors (the
"Financing"). The Financing comprised a private placement of
39,090,009 of the Company’s American Depository Shares (“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, being £0.45 or $0.5625.
The net proceeds of the Financing will be
approximately £145 million after deducting placement agent fees and
estimated expenses.
Convenience translation
We maintain our books and records in pounds
sterling and we prepare our financial statements in accordance with
IFRS, as issued by the IASB. We report our results in pounds
sterling. For the convenience of the reader we have translated
pound sterling amounts in the tables below as of June 30,
2020, and for the three and six month periods ended June 30, 2020
into U.S. dollars at the noon buying rate of the Federal Reserve
Bank of New York on June 30, 2020, which was £1.00 to $1.2369.
These translations should not be considered representations that
any such amounts have been, could have been or could be converted
into U.S. 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 SIX MONTHS ENDED
JUNE 30, 2020 (UNAUDITED)
|
Three MonthsEndedJune 30,
2020 |
|
Three MonthsEndedJune 30,
2020 |
|
Six MonthsEndedJune 30, 2020 |
|
Six MonthsEndedJune 30, 2020 |
|
£'000s |
|
$'000s |
|
£'000s |
|
$'000s |
Research and development costs |
(6,203 |
) |
|
(7,672 |
) |
|
(12,075 |
) |
|
(14,936 |
) |
General and administrative
costs |
(2,315 |
) |
|
(2,863 |
) |
|
(7,616 |
) |
|
(9,420 |
) |
Operating
loss |
(8,518 |
) |
|
(10,535 |
) |
|
(19,691 |
) |
|
(24,356 |
) |
Finance income |
141 |
|
|
174 |
|
|
532 |
|
|
658 |
|
Finance expense |
(395 |
) |
|
(489 |
) |
|
(447 |
) |
|
(553 |
) |
Loss before
taxation |
(8,772 |
) |
|
(10,850 |
) |
|
(19,606 |
) |
|
(24,251 |
) |
Taxation — credit |
1,422 |
|
|
1,759 |
|
|
2,683 |
|
|
3,319 |
|
Loss for the
period |
(7,350 |
) |
|
(9,091 |
) |
|
(16,923 |
) |
|
(20,932 |
) |
Other comprehensive
income: |
|
|
|
|
|
|
|
Items that might be
subsequently reclassified to profit or loss |
|
|
|
|
|
|
|
Exchange differences on
translating foreign operations |
3 |
|
|
4 |
|
|
43 |
|
|
53 |
|
Total comprehensive
loss attributable to owners of the Company |
(7,347 |
) |
|
(9,087 |
) |
|
(16,880 |
) |
|
(20,879 |
) |
Loss per ordinary share —
basic (pence / cents) |
(6.9 |
) |
|
(8.5 |
) |
|
(16.0 |
) |
|
(19.8 |
) |
CONDENSED CONSOLIDATED STATEMENTS OF
FINANCIAL POSITION AS AT JUNE 30, 2020, AND DECEMBER 31,
2019 (UNAUDITED)
|
As ofJune 30,2020 |
|
As ofJune 30,2020 |
|
As ofDecember 31,2019 |
|
£'000s |
|
$'000s |
|
£'000s |
ASSETS |
|
|
|
|
|
Non-current
assets: |
|
|
|
|
|
Goodwill |
441 |
|
|
546 |
|
|
441 |
|
Intangible assets |
25,430 |
|
|
31,454 |
|
|
2,757 |
|
Property, plant and
equipment |
37 |
|
|
46 |
|
|
43 |
|
Right-of-use asset |
1,096 |
|
|
1,356 |
|
|
971 |
|
Total non-current
assets |
27,004 |
|
|
33,402 |
|
|
4,212 |
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Prepayments and other
receivables |
4,420 |
|
|
5,467 |
|
|
2,770 |
|
Current tax receivable |
2,770 |
|
|
3,426 |
|
|
7,396 |
|
Short term investments |
— |
|
|
— |
|
|
7,823 |
|
Cash and cash equivalents |
18,081 |
|
|
22,364 |
|
|
22,934 |
|
Total current
assets |
25,271 |
|
|
31,257 |
|
|
40,923 |
|
Total
assets |
52,275 |
|
|
64,659 |
|
|
45,135 |
|
|
|
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
|
|
Capital and reserves
attributable to equity holders: |
|
|
|
|
|
Share capital |
5,324 |
|
|
6,585 |
|
|
5,266 |
|
Share premium |
118,862 |
|
|
147,020 |
|
|
118,862 |
|
Share-based payment
reserve |
12,572 |
|
|
15,550 |
|
|
10,364 |
|
Accumulated loss |
(117,565 |
) |
|
(145,416 |
) |
|
(100,627 |
) |
Total
equity |
19,193 |
|
|
23,739 |
|
|
33,865 |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Derivative financial
instrument |
711 |
|
|
879 |
|
|
895 |
|
Finance lease liabilities |
638 |
|
|
789 |
|
|
460 |
|
Trade and other payables |
7,111 |
|
|
8,796 |
|
|
8,261 |
|
Total current
liabilities |
8,460 |
|
|
10,464 |
|
|
9,616 |
|
|
|
|
|
|
|
Non-current
liabilities: |
|
|
|
|
|
Assumed contingent
obligation |
23,907 |
|
|
29,571 |
|
|
1,103 |
|
Non-current lease
liability |
677 |
|
|
837 |
|
|
491 |
|
Deferred income |
38 |
|
|
47 |
|
|
60 |
|
Total non-current
liabilities |
24,622 |
|
|
30,455 |
|
|
1,654 |
|
Total equity and
liabilities |
52,275 |
|
|
64,658 |
|
|
45,135 |
|
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