We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Register for streaming realtime charts, analysis tools, and prices.
| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| Verona Pharma Plc | LSE:VRP | London | Ordinary Share | GB00BYW2KH80 | ORD 5P |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 55.00 | 45.00 | 65.00 | 0.00 | 01:00:00 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| 0 | 0 | N/A | 0 |
Hot Features
Premium
TIDMVRP TIDMVRP
Announced positive top-line data from two Phase 2 clinical trials ahead
of schedule
Met primary and key secondary endpoints in 403 patient Phase 2b clinical
trial for maintenance treatment of COPD
Met primary and secondary endpoints in Cystic Fibrosis Phase 2a clinical
trial
LONDON, May 08, 2018 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM:VRP)
(Nasdaq:VRNA) ("Verona Pharma" or the "Company"), a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for respiratory diseases, announces today an
operational update and financial results for the three months ended
March 31, 2018.
The Company's product candidate, RPL554, is a first-in-class, inhaled,
dual inhibitor of the enzymes phosphodiesterase 3 and 4, or PDE3 and
PDE4, that acts as both a bronchodilator and an anti-inflammatory agent
in a single compound. Verona Pharma is developing RPL554 for the
treatment of chronic obstructive pulmonary disease ("COPD") and cystic
fibrosis ("CF"), and potentially asthma.
OPERATIONAL HIGHLIGHTS
During the three months ended March 31, 2018, the Company:
-- Successfully completed two further clinical trials with nebulized RPL554
ahead of schedule.
-- Reported positive top-line data from a Phase 2b clinical trial for
maintenance treatment of COPD: Primary endpoint: -- RPL554 met
the primary endpoint at all doses, showing a statistically significant
difference vs. placebo (p<0.001) with absolute changes from baseline
>200mL in peak FEV1 after 4 weeks of dosing. No minimum effective dose
could be determined. -- This peak bronchodilator effect was observed
at the first dose and was sustained over four weeks (p<0.001).
Secondary endpoints include: -- Statistically significant
improvements in average FEV1 over 12 hours were observed at all doses
after the first administration, and this effect was sustained over four
weeks. -- This study did not demonstrate consistent improvements in
trough FEV1. -- Recording of daily COPD symptoms, using E-RS
(EXACT-PRO) demonstrated a significant, clinically relevant, progressive
improvement in total COPD symptoms (p<0.002), including improvements in
breathlessness (p<0.02), chest symptoms (p<0.02), and cough and sputum
(p<0.02). -- Strong trend of improvement in quality of life score,
the St. George's Respiratory Questionnaire (SGRQ-C) of >2.5 units was
observed in all dose groups after four weeks. -- Patients' Global
Impression of Change indicates that patients felt better on RPL554
compared to placebo (p<0.01). -- RPL554 was well tolerated at all
doses with an adverse event profile similar to placebo.
-- Reported positive top-line data from a Phase 2a clinical trial to study
pharmacokinetic and pharmacodynamic profile in CF: Primary
endpoint: -- The PK profile was consistent with that observed in
patients with COPD, although with lower peak serum levels of RPL554 in CF
patients. -- Serum half-life was dose-dependent; 7.5 to 10.1 hours
for 1.5 mg and 6 mg, respectively. Secondary endpoint measures:
-- RPL554 also elicited a statistically significant increase in
average FEV1 in treated patients for 1.5 mg (all P<0.01) and 6 mg (all
P<0.05) at 4, 6 and 8 hour time points. -- The drug was
well-tolerated in this patient group with an adverse event profile
consistent with other studies with RPL554.
-- Preparations for Phase 2 nebulized RPL554 add-on study to LABA/LAMA or
triple therapy continue to progress according to plan and the clinical
trial is expected to start in 3Q 2018.
-- MDI and DPI formulation work progressing well with pre-clinical studies
with RPL554 in new formulations now expected to complete in 2H 2018.
FINANCIAL HIGHLIGHTS
-- Net cash, cash equivalents and short term investments at March 31, 2018
amounted to GBP72.6 million (December 31, 2017: GBP80.3 million).
-- For the three months ended March 31, 2018, reported operating loss of
GBP5.9 million (three months ended March 31, 2017: GBP4.1 million) and
reported loss after tax of GBP15.2 million (three months ended March 31,
2017: loss after tax of GBP1.9 million). Operating expenses increased due
to an expansion of research and development activity. The increase in net
loss reflects the finance expense for the increase in the fair value of
the liability representing the warrants over Verona shares, of GBP9.0
million, which is a non-cash item.
-- Reported loss per share of 14.5 pence for the three months ended March
31, 2018 (three months ended March 31, 2017: loss per share 3.7 pence).
-- Net cash used in operating activities for the three months ended March
31, 2018 of GBP6.2 million (three months ended March 31, 2017: GBP3.5
million) reflecting increased clinical activities.
Jan-Anders Karlsson, PhD, CEO of Verona Pharma, commented:
"We are pleased to have reported positive top-line data from two
clinical studies that we completed ahead of schedule during the first
quarter. In our largest and longest trial to date, a 403 patient
four-week Phase 2b trial, RPL554 demonstrated a significant and
clinically meaningful improvement in lung function in COPD patients, as
well as a clinically meaningful improvement in daily reported COPD
symptom scores in all sub-domains, that continued to improve over the
four-week treatment period. These data give us confidence in progressing
nebulized RPL554 towards Phase 3 studies in COPD patients. Likewise, the
positive data in our Phase 2a trial in CF patients now makes a
proof-of-concept study in patients with CF feasible. We are delighted
with the significant progress we made with RPL554 during the reporting
period, providing further support for RPL554 potentially becoming an
important novel and well-differentiated treatment for patients with COPD,
as well as CF."
Conference Call and Webcast Information
Verona Pharma will host an investment community conference call at 9:00
a.m. Eastern Standard Time (2:00 pm British Summer Time) on Tuesday, May
8, 2018. Analysts and investors may participate in the conference call
by utilizing the conference ID: 3853885 and dialing the following
numbers:
-- 888-394-8218 or (646) 646-828-8193 for callers in the United States
-- 0800 279 7204 or 44 (0)330 336 9411 for callers in the United Kingdom
-- 0800 101 1732 or 49 (0)69 2222 2018 for callers in Germany
Those interested in listening to the conference call live via the
internet may do so by visiting the "Investors" page of Verona Pharma's
website at www.veronapharma.com and clicking on the webcast link. A
webcast replay of the conference call [audio] will be available for 30
days by visiting the "Investors" page of Verona Pharma's website at
www.veronapharma.com and clicking on the "Events and presentations"
link.
An electronic copy of the interim results will be made available today
on the Company's website (http://www.veronapharma.com). This press
release does not constitute an offer to sell or the solicitation of an
offer to buy any of the Company's securities, and shall not constitute
an offer, solicitation or sale in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of that jurisdiction.
This press release contains inside information for the purposes of
Article 7 Regulation (EU) No. 596/2014.
About Verona Pharma plc
Verona Pharma is a clinical-stage biopharmaceutical company focused on
developing and commercializing innovative therapies for the treatment of
respiratory diseases with significant unmet medical needs. Verona
Pharma's product candidate, RPL554, is a first-in-class, inhaled, dual
inhibitor of the enzymes phosphodiesterase 3 and 4 that acts as both a
bronchodilator and an anti-inflammatory agent in a single compound. In
clinical trials, treatment with RPL554 has been observed to result in
statistically significant improvements in lung function and clinical
symptoms as compared to placebo, and has shown clinically meaningful and
statistically significant improvements in lung function when
administered in addition to frequently used short- and long-acting
bronchodilators as compared to such bronchodilators administered as a
single agent. Verona Pharma is developing RPL554 for the treatment of
chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), and
potentially asthma.
Forward Looking Statements
This press release contains forward-looking statements. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including, but not limited to, statements regarding the design of the
Phase 2b clinical trial of RPL554, the importance of the Phase 2b
clinical trial to our development plans for RPL554, the potential of
RPL554 as a promising first-in-class treatment option for COPD, and the
value of the data and insights that may be gathered from the Phase 2b
clinical trial.
All statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements. These forward-looking statements are based on management's
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and other
important factors that may cause our actual results, performance or
achievements to be materially different from our expectations expressed
or implied by the forward-looking statements, including, but not limited
to, the following: our limited operating history; our need for
additional funding to complete development and commercialization of
RPL554, which may not be available and which may force us to delay,
reduce or eliminate our development or commercialization efforts; the
reliance of our business on the success of RPL554, our only product
candidate under development; economic, political, regulatory and other
risks involved with international operations; the lengthy and expensive
process of clinical drug development, which has an uncertain outcome;
serious adverse, undesirable or unacceptable side effects associated
with RPL554, which could adversely affect our ability to develop or
commercialize RPL554; potential delays in enrolling patients, which
could adversely affect our research and development efforts; we may not
be successful in developing RPL554 for multiple indications; our ability
to obtain approval for and commercialize RPL554 in multiple major
pharmaceutical markets; misconduct or other improper activities by our
employees, consultants, principal investigators, and third-party service
providers; the loss of any key personnel and our ability to recruit
replacement personnel, material differences between our "top-line" data
and final data; our reliance on third parties, including clinical
investigators, manufacturers and suppliers, and the risks related to
these parties' ability to successfully develop and commercialize RPL554;
and lawsuits related to patents covering RPL554 and the potential for
our patents to be found invalid or unenforceable.
These and other important factors under the caption "Risk Factors" in
our Annual Report on Form 20-F filed with the Securities and Exchange
Commission ("SEC") on February 27, 2018 relating to our Registration
Statement on Form F-1, 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. Any such
forward-looking statements represent management's estimates as of the
date of this press release. While we may elect to update such
forward-looking statements at some point in the future, we disclaim any
obligation to do so, even if subsequent events cause our views to
change. These forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of this
press release.
For further information please contact:
Verona Pharma plc Tel: +44 (0)20 3283 4200
Jan-Anders Karlsson, Chief Executive Officer info@veronapharma.com
Stifel Nicolaus Europe Limited (Nominated Adviser Tel: +44 (0)20 7710 7600
and UK Broker)
Stewart Wallace / Jonathan Senior / Ben Maddison SNELVeronaPharma@stifel.com
ICR, Inc. (US Media and Investor Enquiries)
James Heins Tel: +1 203 682 8251
James.Heins@icrinc.com
Stephanie Carrington Tel: +1 646 277 1282
Stephanie.Carrington@icrinc
.com
FTI Consulting (UK Media and Investor Enquiries) Tel: +44 (0)20 3727 1000
Simon Conway / Natalie Garland-Collins veronapharma@fticonsulting.
com
OPERATIONAL REVIEW
Company overview
We are a clinical-stage biopharmaceutical company focused on developing
and commercializing innovative therapies for the treatment of
respiratory diseases with significant unmet medical needs. Our product
candidate, RPL554, is a first-in-class, inhaled, dual inhibitor of the
enzymes phosphodiesterase 3 and 4, or PDE3 and PDE4, that acts as both a
bronchodilator and an anti-inflammatory agent in a single compound. We
are not aware of any other therapy in a single compound in clinical
development or approved by the U.S. Food and Drug Administration, or FDA,
or the European Medicines Agency, or EMA, for the treatment of
respiratory diseases that acts as both a bronchodilator and
anti-inflammatory agent. We believe RPL554 has the potential to be the
first novel class of bronchodilator in over 40 years.
We have completed 12 Phase 1 and Phase 2 clinical trials with RPL554
with over 730 subjects enrolled. In our clinical trials, treatment with
RPL554 has been observed to result in statistically significant
improvements in lung function as compared to placebo. Statistically
significant means that there is a low statistical probability, typically
less than 5 per cent, that the observed results occurred by chance
alone. Our most recent clinical trial in patients with
moderate-to-severe COPD has also shown clinically meaningful and
statistically significant improvements in daily reported COPD symptom
scores. Our trials have also shown clinically meaningful and
statistically significant improvements in lung function when RPL554 is
added to commonly used short- and long-acting bronchodilators as
compared to such bronchodilators administered as a single agent. RPL554
has also shown anti-inflammatory effects and been well tolerated in our
clinical trials and has not been observed to result in the
gastrointestinal or other side effects commonly associated with
roflumilast, the only PDE4 inhibitor currently on the market for the
treatment of COPD. We are developing RPL554 for the treatment of
patients with COPD and for the treatment of patients with CF.
Operational performance in the first quarter
The recently completed 4 week Phase 2b study with nebulized RPL554 in
403 patients demonstrated a rapid onset and sustained bronchodilator
effect from the first to the last dose, that was both clinically and
statistically meaningful. In addition, the study demonstrated a marked
and significant improvement in daily reported COPD symptoms in the E-RS
(EXACT-PRO), and in each of the three sub-scores. The improvement in
symptoms was already statistically significant after the first week but
continued to progress and further improve during the 4 week treatment
period. Similar effects were seen with other symptom scores used, for
example the SGRQ. All RPL554 doses tested produced comparable
improvements in lung function and symptoms, and RPL554 was well
tolerated at all doses with an adverse event profile similar to placebo.
The Company continues to review its development strategy for RPL554 in
the context of additional data generated, including from clinical trials
and market research, to identify opportunities to enhance the planned
development and commercialization of RPL554, which may lead to changes
in the planned future clinical development of RPL554. The recently
obtained Phase 2b data in the maintenance treatment of COPD with
nebulized RPL554 provides a further impetus to accelerate the
progression towards Phase 3 studies in this indication.
In addition to our nebulized formulation of RPL554, we are also
developing RPL554 in both pressurized metered dose inhaler, or pMDI, and
dry powder inhaler, or DPI, formulations for the maintenance treatment
of COPD. We plan to select a pMDI and a DPI formulation as part of an
expansion to the RPL554 clinical development program for the treatment
of patients with moderate-to-severe COPD. It is estimated that in the US
approximately 4.5 million patients with moderate-to-severe COPD use
inhalers for maintenance therapy.
Delivery of orally inhaled drugs by pMDI or DPI is a mainstay of
maintenance treatment for patients with moderate-to-severe COPD.
Successful development of a pMDI or DPI formulation of RPL554 for
moderate disease would greatly expand the addressable market for the
drug and represents a multi-billion dollar potential opportunity. We
believe that about 90% of patients with diagnosed COPD use inhalers,
such as a pMDI or DPI, rather than a nebulizer, to administer treatment.
Development of these new formulations is progressing according to plan
and we now expect to complete pre-clinical studies for RPL554 in these
formulations in 2018, followed by the first clinical trials in healthy
subjects or patients with COPD.
We may also explore the development of RPL554 in pMDI and/or MDI
formulations for the treatment of asthma and other respiratory diseases.
OUTLOOK
Having successfully completed last year a global offering comprised of
an initial public offering of our American Depositary Shares ("ADSs") on
Nasdaq and an offering in Europe of our ordinary shares, we believe that
we now have the funding in place to progress the development of
nebulized RPL554 as maintenance therapy for both COPD and CF, as well as
for the treatment of acute exacerbations of COPD.
We intend to become a leading biopharmaceutical company focused on the
treatment of respiratory diseases with significant unmet medical needs.
We recognize that our proposed strategy for achieving this goal depends
on the data from all clinical trials conducted with RPL554 to date,
future interactions with regulatory authorities and our commercial
assessment of different development options for RPL554. That said, key
elements of this strategy include:
-- Consideration of any opportunity to focus and accelerate our development
plans for RPL554, including proceeding more rapidly towards Phase 3
clinical trials, particularly with nebulized RPL554 for the maintenance
treatment of COPD. Proceeding more rapidly towards Phase 3 clinical
trials with nebulized RPL554 for the maintenance treatment of COPD may
require us to focus our financial and other resources on maintenance
treatment of COPD with nebulized and inhaled formulations of RPL554 in
the short term, which may alter our timing to commence further trials
using RPL554 in other indications.
-- We plan to conduct a further Phase 2a clinical trial to evaluate
nebulized RPL554 as maintenance treatment of severe COPD patients when
dosed in addition to LAMA/LABA or triple (LABA/LAMA/ICS) therapy,
compared to placebo. We expect to commence this study in the third
quarter of 2018, with top-line data expected in 2019.
-- For the treatment of COPD patients who may prefer the more convenient
administration of an inhaler device, we are developing RPL554 in inhaler
formulations. We plan to complete pre-clinical studies for RPL554 in
these formulations in 2018, followed by the first clinical trials in
healthy subjects or patients with COPD.
-- Develop RPL554 for the treatment of CF. The timing for future studies in
this indication may be dependent on any decision to move more rapidly
towards Phase 3 clinical trials with nebulized RPL554 for the maintenance
treatment of COPD.
-- Pursue development of RPL554 in other forms of respiratory disease. We
believe that RPL554's properties as an inhaled, dual inhibitor of PDE3
and PDE4 give it broad potential applicability in the treatment of other
respiratory diseases. We may explore development of RPL554 to treat other
forms of respiratory disease following development of RPL554 for the
treatment of COPD and CF.
-- Seek strategic collaborative relationships. We may seek strategic
collaborations with market leading biopharmaceutical companies to develop
and commercialize RPL554. We believe these collaborations could provide
significant funding to advance the development of RPL554 while allowing
us to benefit from the development or commercialization expertise of our
collaborators.
-- Acquire or in-license product candidates for the treatment of respiratory
diseases. We plan to leverage our respiratory disease expertise to
identify and in-license or acquire additional clinical stage product
candidates that we believe have the potential to become novel treatments
for respiratory diseases with significant unmet medical needs.
FINANCIAL REVIEW
Financial review of the three month period ended March 31, 2018
The operating loss for the three months ended March 31, 2018, was GBP5.9
million (March 31, 2017: GBP4.1 million) and the loss after tax for the
three months ended March 31, 2018, was GBP15.2 million (March 31, 2017:
GBP1.9 million).
Research and Development Costs
Research and development costs were GBP4.4 million for the three months
ended March 31, 2018, as compared to GBP3.1 million for the three months
ended March 31, 2017, an increase of GBP1.3 million. The increase was
predominantly attributable to a GBP0.5 million increase in clinical
trial expenses related to the continuing activities of the Phase 2b
clinical trial of RPL554 in 2018. In addition, we increased spending on
contract manufacturing and other formulation work by GBP0.5 million but
this was offset by a decrease in pre-clinical development by GBP0.3
million. Our share-based payment charge increased by GBP0.4 million as
we issued long term incentives to our staff to drive development of
RPL554.
General and Administrative Costs
General and administrative costs were GBP1.5 million for the three
months ended March 31, 2018, as compared to GBP1.0 million for the three
months ended March 31, 2017, an increase of GBP0.5 million. The increase
was primarily attributable to a GBP0.3 million increase in our
share-based payment charge.
Finance Income and Expense
Finance income was GBP0.2 million for the three months ended March 31,
2018, and GBP1.8 million for the three months ended March 31, 2017. The
decrease in finance income was primarily due to an increase in the fair
value of the warrant liability during the first quarter of 2018 (which
is recorded as a finance expense) compared to a decrease in the
liability in the three month period ended March 31, 2017, which resulted
in a gain (recorded as finance income) of GBP1.8 million in the
comparative period.
Finance expense was GBP10.3 million for the three months ended March 31,
2018, as compared to GBP0.2 million for the three months ended March 31,
2017. The increase was due to an increase in the fair value of the
warrant liability of GBP9.0 million arising from changes in the inputs
and other underlying assumptions for measuring the liability of the
warrants, issued in the July 2016 Placement, including the price and
volatility of our ordinary shares; this charge is a non-cash expense.
As part of our approach to risk management we hold cash and short term
investments in a mix of currencies. There was a further expense of
GBP1.3 million due to the foreign exchange loss on translation of
foreign currency denominated cash and cash equivalents and short term
investments.
Taxation
Taxation for the three months ended March 31, 2018, amounted to a credit
of GBP0.8 million compared to a credit of GBP0.6 million for the three
months ended March 31, 2017, an increase of GBP0.2 million. The credits
are obtained at a rate of 14.5% of 230% of our qualifying research and
development expenditure and the increase in the credit amount was
attributable to our increased expenditure on research and development,
compared to the prior period.
Cash Flows
Net cash used in operating activities increased to GBP6.2 million for
the three months ended March 31, 2018, from GBP3.5 million for the three
months ended March 31, 2017. This was due to an increase in operating
costs driven by higher research and development costs, as well as
working capital movements driven by research and development costs
incurred in the three months ended December 31, 2017.
The increase in net cash generated in investing activities to GBP4.5
million for the three months ended March 31, 2018, from GBP0.0 million
for the three months ended March 31, 2017, was due to the maturity of
short term investments held as treasury deposits.
There was no cash received or paid from financing activities for the
three months ended March 31, 2018. The GBP1.1 million paid for the three
months ended March 31, 2017, was the cash paid in advance for financing
costs of the Global Offering on the 26 April 2018.
Cash, cash equivalents and short-term investments
Net cash, cash equivalents and short-term investments at March 31, 2018,
decreased to GBP72.6 million from GBP80.3 million at December 31, 2017
due to the utilization of cash in the ordinary operating activities and
the effect of the GBP exchange rate strengthening on our USD cash and
cash equivalents and short term investments.
Net assets
Net assets decreased to GBP65.7 million in the three month period ended
March 31, 2018, from GBP79.9 million at December 31, 2017. This decrease
was primarily due to the operating activities of the Company and the
fair value remeasurement of the warrant liability.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENT OF FINANCIAL
POSITION
AS OF DECEMBER 31, 2017, AND MARCH 31, 2018
As of As of
Notes December 31, 2017 March 31, 2018
(audited) (unaudited)
GBP'000s GBP'000s
ASSETS
Non-current assets:
Goodwill 441 441
Intangible assets 1,969 2,088
Property, plant and
equipment 16 15
Total non-current assets 2,426 2,544
Current assets:
Prepayments and other
receivables 1,810 1,870
Current tax receivable 5,006 5,929
Short term investments 9 48,819 43,605
Cash and cash
equivalents 31,443 29,013
Total current assets 87,078 80,417
Total assets 89,504 82,961
EQUITY AND LIABILITIES
Capital and reserves
attributable to equity
holders:
Share capital 5,251 5,251
Share premium 118,862 118,862
Share-based payment
reserve 5,022 6,041
Accumulated loss (49,254) (64,504)
Total equity 79,881 65,650
Current liabilities:
Derivative financial
instrument 10 1,273 10,250
Trade and other payables 7,154 5,766
Tax payable-U.S.
Operations 169 265
Total current
liabilities 8,596 16,281
Non-current liabilities:
Assumed contingent
obligation 11 875 890
Deferred income 152 140
Total non-current
liabilities 1,027 1,030
Total equity and
liabilities 89,504 82,961
The accompanying notes form an integral part of these consolidated
financial statements.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENT OF COMPREHENSIVE
INCOME FOR THE THREE MONTHSED MARCH 31, 2017,
AND MARCH 31, 2018
Three Months Three Months
Ended March Ended March
Notes 31, 2017 31, 2018
(unaudited) (unaudited)
GBP'000s GBP'000s
Research and development costs (3,105) (4,421)
General and administrative costs (1,032) (1,458)
Operating loss (4,137) (5,879)
Finance income 7 1,765 160
Finance expense 7 (181) (10,324)
Loss before taxation (2,553) (16,043)
Taxation - credit 8 639 820
Loss for the year (1,914) (15,223)
Other comprehensive loss :
Items that might be subsequently reclassified to profit
or loss
Exchange differences on translating foreign operations (4) (27)
Total comprehensive loss attributable to owners of
the Company (1,918) (15,250)
Loss per ordinary share - basic and diluted (pence) 6 (3.7) (14.5)
The accompanying notes form an integral part of these consolidated
financial statements.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENT OF CASH FLOWS
FOR
THE THREE MONTHSED MARCH 31, 2017, AND MARCH 31,
2018
Three Three
Months Months
Ended Ended
March 31, March 31,
2017 2018
(unaudited) (unaudited)
GBP'000s GBP'000s
Cash used in operating activities:
Loss before taxation (2,553) (16,043)
Finance income (1,765) (160)
Finance expense 181 10,324
Share-based payment charge 270 1,019
Decrease in prepayments and other receivables 499 35
Decrease in trade and other payables (50) (1,434)
Depreciation of property, plant and equipment 1 2
Amortization of intangible assets 15 21
Cash used in operating activities (3,402) (6,236)
Cash outflow from taxation (131) -
Net cash used in operating activities (3,533) (6,236)
Cash flow from investing activities:
Interest received 34 65
Purchase of plant and equipment - (1)
Payment for patents and computer software (69) (140)
Transfer to short term investments - (3,858)
Maturity of short term investments - 8,386
Net cash (used) / generated in investing
activities (35) 4,452
Cash flow from financing activities:
Transaction costs on April 2017 Global Offering (1,059) -
Net cash used in financing activities (1,059) -
Net decrease in cash and cash equivalents (4,627) (1,784)
Cash and cash equivalents at the beginning of the
period 39,785 31,443
Effect of exchange rates on cash and cash
equivalents (162) (646)
Cash and cash equivalents at the end of the period 34,996 29,013
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENT OF CHANGES
IN EQUITY
FOR THE THREE MONTHSED MARCH 31, 2017, AND MARCH
31, 2018
Total
Share Share Share-based Accumulated Total
Capital Premium Expenses Losses Equity
GBP'000s GBP'000s GBP'000s GBP'000s GBP'000s
Balance at
January 1,
2017 2,568 58,526 2,103 (28,728) 34,469
Loss for the
year - - - (1,914) (1,914)
Other
comprehensive
income for the
year:
Exchange
differences on
translating
foreign
operations - - - (4) (4)
Total
comprehensive
loss for the
period - - - (1,918) (1,918)
Share-based
payments - - 270 - 270
Balance at
March 31,
2017 2,568 58,526 2,373 (30,646) 32,821
Balance at
January 1,
2018 5,251 118,862 5,022 (49,254) 79,881
Loss for the
year - - - (15,223) (15,223)
Other
comprehensive
loss for the
year:
Exchange
differences on
translating
foreign
operations - - - (27) (27)
Total
comprehensive
loss for the
period - - - (15,250) (15,250)
Share-based
payments - - 1,019 - 1,019
Balance at
March 31,
2018 5,251 118,862 6,041 (64,504) 65,650
The currency translation reserve for March 31, 2017, and March 31, 2018,
is not considered material and as such is not presented in a separate
reserve but is included in the total accumulated losses reserve.
VERONA PHARMA PLC
NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHSED MARCH 31, 2018
1. General information
Verona Pharma plc (the "Company") and its subsidiaries are a
clinical-stage biopharmaceutical company focused on developing and
commercializing innovative therapeutics for the treatment of respiratory
diseases with significant unmet medical needs.
The Company is a public limited company, which is dual listed on the
Alternative Investment Market of the London Stock Exchange and on April
27, 2017, American Depositary Shares began trading on Nasdaq Global
Market. The Company is incorporated and domiciled in the United Kingdom.
The address of the registered office is 1 Central Square, Cardiff, CF10
1FS, United Kingdom.
The Company has two subsidiaries, Verona Pharma Inc. and Rhinopharma
Limited ("Rhinopharma"), both of which are wholly owned.
2. Basis of accounting
The unaudited condensed consolidated interim financial statements of
Verona Pharma Plc (the "Company") and its subsidiaries, Verona Pharma,
Inc., and Rhinopharma Limited (together "the Group"), for the three
months ended March 31, 2018 do not include all the statements required
for full annual financial statements and should be read in conjunction
with the consolidated financial statements of the Group as of December
31, 2018.
The 2017 Accounts, on which the Company's auditors delivered an
unqualified audit report, have been delivered to the Registrar of
Companies.
These unaudited condensed interim financial statements were authorized
for issue by the Company's board of directors (the "Directors") on May
8, 2018. There have been no changes, except as otherwise stated, to the
accounting policies as contained in the annual consolidated financial
statements as of and for the year ended December 31, 2017, which have
been prepared in accordance with international financial reporting
standards ("IFRS") as issued by the International Accounting Standards
Board ("IASB").
The interim condensed consolidated financial statements have been
prepared on a going-concern basis. Management, having reviewed the
future operating costs of the business in conjunction with the cash held
as of March 31, 2018, believes the Group has sufficient funds to
continue as a going concern for at least 12 months from the end of the
reporting period.
The Group's activities and results are not exposed to any seasonality.
The Group operates as a single operating and reportable segment.
During the period the Group adopted IFRS 9. This has not had a material
impact on the accounting for financial instruments held by the company,
including the assumed contingent obligation, the derivative financial
instrument or short term deposits. There has been no change in the
classification and measurement of these financial instruments.
IFRS 15 has also been adopted by the Group; this has had no impact as
the Group is not currently revenue generating.
Dividend
The Directors do not recommend the payment of a dividend for the three
months ended March 31, 2018, (three months ended March 31, 2017: GBPnil
and the year ended December 31, 2017: GBPnil).
3. Segmental reporting
The Group's activities are covered by one operating and reporting
segment: Drug Development. There have been no changes to management's
assessment of the operating and reporting segment of the Group during
the period.
All non-current assets are based in the United Kingdom.
4. Financial Instruments
The Group's activities expose it to a variety of financial risks: market
risk (including foreign currency risk); cash flow and fair value
interest rate risk; and credit risk and liquidity risk. The condensed
consolidated interim financial statements do not include all financial
risk management information and disclosures required in the annual
financial statements, and they should be read in conjunction with the
Group's annual financial statements for the year ended December 31,
2017.
5. Estimates
The preparation of condensed consolidated interim financial statements
require management to make judgments, estimates and assumptions that
affect the application of accounting policies and the reported amounts
of assets and liabilities, income and expenses. Actual results may
differ from those estimates.
In preparing these condensed consolidated interim financial statements,
the significant judgments made by management in applying the Group's
accounting policies and the key sources of estimation uncertainty were
the same as those applied to the consolidated financial statements for
the year ended December 31, 2017.
6. Loss per share calculation
The basic loss per share of 14.5p (March 31, 2017: loss of 3.7p) for the
three months ended March 31, 2018 is calculated by dividing the loss for
the three months ended March 31, 2018 by the weighted average number of
ordinary shares in issue of 105,017,400 during the three months ended
March 31, 2018 (March 31, 2017: 51,361,063). Since the Group has
reported a net loss, diluted loss per ordinary share is equal to basic
loss per ordinary share.
Each ADS represents 8 shares of the Company, so the loss per ADS is any
period is equal to 8 times the loss per share.
7. Finance income and expense
Three months Three months
ended March 31, ended March 31,
2017 2018
GBP'000s GBP'000s
Finance income:
Interest received on cash balances 34 160
Fair value adjustment on derivative financial instruments
(note 10) 1,731 -
Total finance income 1,765 160
Three months Three months
ended March 31, ended March 31,
2017 2018
GBP'000s GBP'000s
Finance expense:
Fair value adjustment on derivative financial instruments
(note 10) - 8,977
Foreign exchange loss on translating foreign currency
denominated balances 162 1,332
Unwinding of discount factor and foreign exchange
movements related to the assumed contingent arrangement
(note 11) 19 15
Total finance expense 181 10,324
8. Taxation
The tax credit for the three month period ended March 31, 2018, amounts
to GBP820 thousand, and consists of the estimated research and
development tax credit receivable on qualifying expenditure incurred
during the three month period ended March 31, 2018 for an amount of
GBP923 thousand less a tax expense of GBP103 thousand related to the US
operations (three month period ended March 31, 2017: GBP639 thousand tax
credit, comprising GBP669 thousand for research and development tax
credit, less GBP30 thousand expense for tax on US operations).
9. Short term investments
Short term investments as at March 31, 2018 amounted to a total of
GBP43.6 million (December 31, 2017: GBP48.8 million) and consisted of
fixed term deposits, in both US Dollars and UK Pounds.
10. Derivative financial instrument
Pursuant to the July 2016 placement the Company issued 31,115,926 units
to new and existing investors at the placing price of GBP1.4365 per unit,
each of which was comprised of one ordinary share and one warrant. The
warrant holders can subscribe for 0.4 of an ordinary share at a per
share exercise price of 120% of the placing price (GBP1.7238). The
warrant holders can opt for a cashless exercise of their warrants by
choosing to exchange the warrants held for a reduced number of warrants
exercisable at nil consideration. The reduced number of warrants is
calculated based on a formula considering the share price and the
exercise price of the shares. The warrants were therefore classified as
a derivative financial liability, since their exercise might result in a
variable number of shares to be issued.
At December 31, 2017, and March 31, 2018, warrants over 12,446,370
shares were in effect.
At December 31, At March 31,
2017 2018
Shares available to be issued under
warrants 12,401,262 12,401,262
Exercise price GBP 1.7238 GBP 1.7238
Risk-free interest rate 0.420% 0.90%
Expected term to exercise 1.79 years 3.33 years
Annualized volatility 47.35% 62.40%
Dividend rate 0.00% 0.00%
Dilution discount 0.00% 2.80%
As at March 31, 2018, the Group updated the underlying assumptions and
calculated a fair value of these warrants, using the Black-Scholes
pricing model (including level 3 assumptions), amounting to GBP10.3
million.
The variance for the three month period ending March 31, 2018, was
GBP9.0 million (three month period ending March 31, 2017: GBP1.7
million) and is recorded as finance expense (March 31, 2017, recorded in
finance income) in the Consolidated Statement of Comprehensive Income.
Derivative Derivative
financial financial
instrument instrument
2017 2018
GBP'000s GBP'000s
At January 1 7,923 1,273
Fair value adjustments recognized in profit or
loss (1,731) 8,977
At March 31 6,192 10,250
For the amount recognized as at March 31, 2018, the effect if volatility
were to deviate up or down is presented in the following table.
Volatility
(up / down
10 % pts)
GBP'000s
Variable up 11,523
Base case, reported fair value 10,250
Variable down 8,910
11. Assumed contingent obligation related to the business combination
The value of the assumed contingent obligation as of March 31, 2018,
amounted to GBP890 thousand (December 31, 2017: GBP875 thousand). The
increase in value of the assumed contingent obligation during the three
months ended March 31, 2018, amounted to GBP15 thousand (three months
ended March 31, 2017: GBP19 thousand) and was recorded in finance
expense as it related to the unwind of the discount on the liability and
retranslation for changes in US Dollar exchange rates. Periodic
re-measurement is triggered by changes in the probability of success.
The discount percentage applied is 12%. In 2017 and the three months
ended March 31, 2018, there were no events that triggered remeasurement.
2017 2018
GBP'000s GBP'000s
January 1, 802 875
Impact of changes in foreign exchange rates (4) (9)
Unwinding of discount factor 23 24
March 31, 821 890
There is no material difference between the fair value and carrying
value of the financial liability.
For the amount recognized as at March 31, 2018, of GBP890 thousand, the
effect if underlying assumptions were to deviate up or down is presented
in the following table (assuming the probability of success does not
change):
Discount rate Revenue
(up / down (up / down
1 % pt) 10 % pts)
GBP'000s GBP'000s
Variable up 848 915
Base case, reported fair value 890 890
Variable down 935 865
12. Share option scheme
During the three months ended March 31, 2018 the Company granted a total
of 2,090,847 share options and 273,390 Restricted Stock Units ("RSUs")
(three months ended March 31, 2017 the Company granted nil share options,
and nil RSUs).
The movement in the number of the Company's share options is set out
below:
Weighted Weighted
average average
exercise exercise
price 2017 price 2018
GBP GBP
Outstanding at
January 1 1.87 3,037,333 1.54 7,527,457
Granted during the
period - - 1.46 2,090,847
Outstanding options
at March 31 1.87 3,037,333 1.52 9,618,304
The movement in the number of the Company's RSUs is set out below:
Weighted Weighted
average average
exercise exercise
price 2017 price 2018
GBP GBP
Outstanding at
January 1 n/a - n/a 1,052,236
Granted during
the period - - - 273,390
Outstanding RSUs
at March 31 n/a - n/a 1,325,626
The share-based payment expense for the three months ended March 31,
2018, was GBP1,019 thousand (three months ended March 31, 2017: GBP270
thousand).
The options and RSUs granted during the three months ended March 31,
2018, were awarded under the Company's 2017 Incentive Plan with total
fair values estimated using the Black Scholes option pricing model of
GBP2.3 million. The cost is amortized over the vesting period of the
options and the RSUs on a straight-line basis. The following assumptions
were used for the Black-Scholes valuation of share options and RSUs
granted in the three months ended March 31, 2018.
Share options RSUs
Issued in the three months ended Issued in the three months ended
March 31, 2018 March 31, 2018
Options / RSUs
granted 2,090,847 273,390
Risk-free interest
rate 1.08% - 1.22% 1.08% - 1.22%
Expected life of
options / RSUs 5.5 - 7 years 5.5 - 7 years
Annualized volatility 69.88% -71.35% 69.88% -71.35%
Dividend rate 0.00% 0.00%
Vesting period 1 to 4 years 1 to 4 years
13. Related party transactions
In the three months ended March 31, 2018, and 2017, executive directors
received regular salaries, post-employment benefits and share-based
payments. Additionally, non-executive directors received compensation
for their services in the form of cash compensation and equity grants.
The compensation costs for the Directors and senior staff for the three
months ended March 31, 2018, and 2017 were as follows:
Short term Post
employee Share-based employment
benefits payments benefits Total
GBP'000s GBP'000s GBP'000s GBP'000s
Three months ended
March 31, 2017 Directors 199 100 4 303
Other key management personnel 280 153 5 438
479 253 9 741
Three months ended
March 31, 2018 Directors 206 371 5 582
Other key management personnel 412 598 7 1,017
618 969 12 1,599
Dr. Jan-Anders Karlsson, Chief Executive Officer of the Company,
purchased 3,250 thousand ordinary shares for GBP5 thousand from the
market in the period.
14. Convenience translation
We maintain our books and records in pounds sterling and we prepare our
financial statements in accordance with IFRS, as issued by the IASB. We
report our results in pounds sterling. For the convenience of the reader
we have translated pound sterling amounts in the tables below as of
March 31, 2018, and for the three month period ended March 31, 2018,
into US dollars at the noon buying rate of the Federal Reserve Bank of
New York on March 30, 2018, which was GBP1.00 to $1.4027. These
translations should not be considered representations that any such
amounts have been, could have been or could be converted into US dollars
at that or any other exchange rate as of that or any other date.
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE
INCOME FOR THE THREE MONTHS ENDED MARCH 31, 2017 AND
MARCH 31, 2018
Three month Three months Three months
ended March ended March ended March
31, 2017 31, 2018 31, 2018
(unaudited) (unaudited) (unaudited)
GBP'000s GBP'000s $'000s
Research and development costs (3,105) (4,421) (6,201)
General and administrative costs (1,032) (1,458) (2,045)
Operating loss (4,137) (5,879) (8,246)
Finance income 1,765 160 224
Finance expense (181) (10,324) (14,481)
Loss before taxation (2,553) (16,043) (22,503)
Taxation - credit 639 820 1,150
Loss for the year (1,914) (15,223) (21,353)
Other comprehensive loss :
Items that might be subsequently reclassified to profit
or loss
Exchange differences on translating foreign operations (4) (27) (38)
Total comprehensive loss attributable to owners of
the Company (1,918) (15,250) (21,391)
Loss per ordinary share - basic and diluted (pence) (3.7) (14.5) (20.3)
CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT DECEMBER 31, 2017 AND MARCH 31, 2018
As of As of As of
December 31, March 31, March 31,
2017 2018 2018
(audited) (unaudited) (unaudited)
GBP'000s GBP'000s $'000s
ASSETS
Non-current assets:
Goodwill 441 441 619
Intangible assets 1,969 2,088 2,929
Property, plant and
equipment 16 15 21
Total non-current assets 2,426 2,544 3,569
Current assets:
Prepayments and other
receivables 1,810 1,870 2,623
Current tax receivable 5,006 5,929 8,317
Short term investments 48,819 43,605 61,165
Cash and cash equivalents 31,443 29,013 40,697
Total current assets 87,078 80,417 112,802
Total assets 89,504 82,961 116,371
EQUITY AND LIABILITIES
Capital and reserves
attributable to equity
holders:
Share capital 5,251 5,251 7,366
Share premium 118,862 118,862 166,728
Share-based payment reserve 5,022 6,041 8,474
Accumulated loss (49,254) (64,504) (90,480)
Total equity 79,881 65,650 92,088
Current liabilities:
Derivative financial
instrument 1,273 10,250 14,378
Trade and other payables 7,154 5,766 8,088
Tax payable-U.S. Operations 169 265 373
Total current liabilities 8,596 16,281 22,839
Non-current liabilities:
Assumed contingent
obligation 875 890 1,248
Deferred income 152 140 196
Total non-current
liabilities 1,027 1,030 1,444
Total equity and
liabilities 89,504 82,961 116,371
This announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the information
contained therein.
Source: Verona Pharma plc via Globenewswire
http://www.veronapharma.com/
(END) Dow Jones Newswires
May 08, 2018 02:00 ET (06:00 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
1 Year Verona Pharma Chart |
1 Month Verona Pharma Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions
