TIDMHVO
RNS Number : 5083K
hVIVO plc
22 September 2016
For immediate release 7.00am: 22 September 2016
HVIVO PLC
("hVIVO" or the "Company")
HALF-YEAR FINANCIAL REPORT
FOR THE SIX MONTHSED 30 JUNE 2016
hVIVO plc (AIM: HVO), a specialty biopharma company with
clinical testing capabilities, is pleased to announce its half-year
financial report for the six months ended 30 June 2016.
Financial Highlights
-- Revenue of GBP8.6 million (H1'15 - GBP2.9 million), with
PrEP-001 flu study completing in H1'16 and revenue recognition of
licence fee.
-- Gross profit was GBP0.8 million and gross margin 9.4% (H1'15
- GBP0.9 million and 29.9%) reflecting a greater mix of workload
from our equity investments and a postponed client engagement from
H1'16 into H2'16.
-- Research and development expense was GBP3.0 million (H1'15 -
GBP7.4 million) from hVIVO's continued investment in discovery
research and product validation capabilities, with spend lower in
H1'16 compared to 2015 due to timing of R&D programmes and cost
commitments.
-- Loss before tax of GBP11.8 million (H1'15: GBP12.0
million).
-- Loss for the period of GBP9.7 million (H1'15: GBP9.8
million).
-- Due to the linked nature of the Imutex Limited ("Imutex")
transaction, gains arising on the delivery of the SEEK Group
("SEEK") FLU-v study will be shown net as gain on provision of
services to joint venture in the income statement.
-- Strong financial position with short-term deposits, cash and
cash equivalents at 30 June 2016 of GBP34.1 million (30 June 2015:
GBP42.5 million) - 2015 R&D tax credit refund of GBP4.6 million
received from HM Revenue & Customs on 1 July 2016, the day
after the half-year end.
Operational Highlights
-- Phase IIa results in June 2016: Achieved Proof of Concept in
flu for PrEP-001, positioning the drug to potentially become the
first ever pan-viral product that prevents both colds and flu.
-- Progressed two additional PrEP-001 Phase IIa trials in asthma
and dose duration. On track for both to be completed by end of
2016.
-- Entered into the Company's second equity investment in
Imutex, a joint venture between hVIVO and SEEK to develop a Phase
IIa universal flu vaccine (FLU-v) and a first-in-man (FIM)
mosquito-borne illness vaccine platform (AGS-v), with utility
against Zika.
-- Developed a precedent setting Phase IIa two-part clinical
trial design for universal flu vaccines with the US National
Institute of Health (NIH), which will be used for FLU-v in H2
2016.
-- Via Imutex, negotiated truncated pre-clinical package with US
Food and Drug Administration (FDA) in order to get AGS-v into human
testing in H2'16.
-- Completed the qualification process for the Company's
pioneering insight into the biological pathways responsible for
severe flu, which culminated in the Company's first
pathomics-backed patent application for a severe flu drug treatment
in early July 2016.
Kym Denny, Chief Executive Officer, commented, "I am delighted
with the rapid progress we are making with PrEP-001, just a few
months after our equity investment. Securing the product's second
Proof of Concept, this time in flu, has propelled PrEP-001 into the
enviable position as potentially the first product to prevent both
colds and flu safely. From a patient and clinician's point of view,
this is a significant break-through, offering the possibility of
one day protecting those most vulnerable to disease exacerbation
caused by viral infections, without the worry of having to be so
specific regarding which virus they might be exposed to. I am
further delighted with the progress of our second equity
investment, Imutex. In less than six months from signature, we are
in the clinic with FLU-v and about to be with AGS-v in Zika. It is
noteworthy that in less than a year, the hVIVO platform has
transformed the Company's product pipeline with three clinical
stage assets, whilst simultaneously progressing strategically
important customer products, and yielding the biological insight
that has resulted in our first pathomics informed severe flu
therapy patent. Our platform is well-positioned to run at its full
potential, positioning hVIVO to advance game-changing therapies
with ever-growing speed and agility in 2017 and beyond."
For further information please contact:
hVIVO plc +44 207 756 1300
Kym Denny (Chief Executive Officer)
Graham Yeatman (Chief Financial & Business Officer)
Media Enquiries +44 203 021 3933 / +44 7854 979 420
Colin Paterson (Director of Marketing, Communication and Public
Relations)
Numis Securities Limited +44 207 260 1000
Michael Meade / Freddie Barnfield (Nominated Adviser)
James Black / Michael Burke (Corporate Broking)
Notes to Editors:
hVIVO plc ("hVIVO"), a specialty biopharma company with clinical
testing capabilities, is pioneering a human-based analytical
platform to accelerate drug discovery and development in
respiratory and infectious diseases. Leveraging human disease
models in flu, RSV, and asthma exacerbation, the hVIVO platform
captures disease in motion, illuminating the entire disease life
cycle from healthy to sick and back to health. Based in the UK,
market leader hVIVO has conducted more than 45 clinical studies,
inoculated over 2000 volunteers and has three first-in-class
therapies currently in development with a growing pre-clinical
pipeline.
hVIVO plc
Statement from Chief Executive Officer
Introduction
I am pleased to present the hVIVO half-year financial report for
the six months ended 30 June 2016. During this time, hVIVO
significantly advanced PrEP-001 in three key Phase IIa clinical
studies, entered into its second equity investment, Imutex, and
filed the Company's first Pathomics-backed patent application for
one of the first severe flu drug treatments.
Revenue for the six months ended 30 June 2016 was GBP8.6 million
and gross margin 9.4%, reflecting the lower margins we expect from
equity investment work and a client's temporary clinical hold that
pushed some workload from H1'16 to H2'16. R&D expense of GBP3.0
million was lower than in previous reporting periods but in line
with expectations, reflecting the analysis stage of our R&D
work compared to the more costly sample generation we did
previously. With our business model flexing the platform's usage
between our discovery work, our client's product testing and our
new equity investment engagements, we are focused on achieving the
optimum combination of work type to advance our products and
progress our models. In the first half of 2016 our priority was to
advance PrEP-001 and I am delighted to say that a significant step
forward was taken in the Proof of Concept (POC) Study that
demonstrated PrEP-001 reduced the number of clinically ill patients
with flu infections compared against placebo. PrEP-001 previously
demonstrated POC in the Common Cold, the combination of which
positions PrEP-001 to potentially become the first pan-viral
prophylactic drug that works against both colds and flu.
Background
hVIVO, a specialty biopharma company with clinical testing
capabilities, is pioneering a human-based analytical platform to
accelerate drug discovery and development in respiratory and
infectious diseases.
Leveraging human disease models in flu, RSV, and asthma
exacerbation, the hVIVO platform captures 'disease in motion',
illuminating the entire disease life cycle from healthy to sick and
back to health. Via this insight, the platform enables the rational
selection of drug targets and biomarkers while simultaneously
providing a revolutionary methodology for testing product safety
and efficacy. The Company has three clinical stage products
currently in development as well as a growing pre-clinical
pipeline.
Drug & Biomarker Discovery
By mapping the right biological targets and biomarkers, the
hVIVO platform accelerates and de-risks product discovery. In the
last two years alone, hVIVO's disruptive "pathomics" approach to
get at the root cause of disease has reduced the drug pre-discovery
timeline by 90% and produced the first-ever map of the human host
response to flu, allowing hVIVO to identify the pathophysiology
behind flu infections in order to produce targeted products and
therapies. Through pathomics, drug targets to prevent, treat, and
aide recovery are revealed, along with the biomarkers to simplify
drug development, as well as the causal biology that can be
developed into ground-breaking predictor and patient stratification
tools. hVIVO' s strategy is to exhaustively mine its flu data for
discoveries, the first of which is expected in 2016. Sample
collection has begun to next map asthma using this pioneering
pathomics approach.
Clinical Product Testing
By identifying the promising products, the hVIVO platform
accelerates drug development and reduces costs and risks. As market
leader, hVIVO has pioneered the use of human disease models for
early stage clinical testing with over 45 trials in over 2,200
subjects, for a wide range of industry, government, and academic
clients and collaborators. Market adoption of this disruptive
methodology by industry and regulators has progressed quickly with
nearly $2 billion in exit events underpinned by hVIVO data since
2010 alone. hVIVO' s 'human in a lab' approach generates a disease
state in which to test the safety and efficacy of products in a
controlled and tailored setting. Because the infections are
generated with wild-type viruses, hVIVO provides a way to test with
lab-like precision in humans before investing time and money in
less-controlled field based studies, thus minimising the risk of
later stage failures. In addition to providing services to
strategically important customers, hVIVO uses the platform to test
products born out of its equity investments, and will in due course
use the platform to test its proprietary inventions from
pathomics.
PrEP-001 - Two Proof of Concepts Highlight Pan-Viral
Potential
A key highlight of the first half of 2016 was the completion of
PrEP-001's Proof of Concept (POC) study in flu, the first of three
Phase IIa studies being run in the hVIVO platform in 2016 with the
novel antiviral prophylactic. The POC Phase IIa trial achieved
positive results in flu in June 2016. This, coupled with the
product's previous POC in the common cold, makes PrEP-001 the first
potential pan-viral drug with utility against both colds and flu,
two very different viruses that cause over 500 million infections
per annum.
PrEP--001 is a nasally administered, broad--spectrum agent that
leverages the innate immune system to prevent upper respiratory
tract viral infections. In a 2014 study conducted within the hVIVO
platform, PrEP-001 secured its first POC as a prophylaxis against
the common cold by showing a threefold reduction in clinical
illness and an eightfold reduction in common cold symptoms compared
to placebo. Most people are aware that there is currently no
treatment nor vaccine for the common cold, but less are aware of
the healthcare burden the virus causes: with more than 6 million
emergency room visits for the common cold and 110 million physician
visits annually and $40 billion in healthcare costs per year from
non-influenza viral infections in the US alone. The market
increases the more upper respiratory viruses one adds to the mix,
and so it became a potential key differentiator if PrEP-001
successfully demonstrated the potential to work in flu as well.
So in late 2015 we began the second POC PrEP-001 trial, this
time taking aim at flu. Within six months of the first subject
visit, hVIVO produced positive flu results from the 63 subject
Phase IIa study. This data was recently showcased on 14 September
2016 at the 9(th) Annual International Partnering Conference
Biopharm America 2016. In summary, patients who received PrEP-001
showed a two-fold reduction in the AUC of the Total Symptom Score
(TSS) (the primary endpoint), a two-fold reduction in the mean TSS,
and a two and a half-fold reduction in clinical illnesses for flu
when compared to placebo. In both the cold and flu POC studies,
PrEP-001 reduced the number of infections as well as symptom
severity and duration for those who become infected and the adverse
events were similar to placebo.
hVIVO has leveraged its clinical trial expertise and drug
development knowhow to accelerate the conduct of three Phase IIa
studies on behalf of PrEP Biopharm. Underpinning this speed to
market approach is our 'human lab' platform, which is addressing
the complicated questions of drug development before commencing
pivotal Phase III trials, de-risking late stage development and
reducing overall costs. To that end, we are currently conducting
two additional Phase II studies to answer key questions around
PrEP-001's performance in asthma patients and dose duration in
healthy subjects. These studies are on track to be completed by the
end of 2016 - completing all three Phase II studies in just over a
year, in comparison to more than three cold and flu seasons for the
traditional process. We are currently planning for our Phase II
field study, which we aim to commence in 2017. hVIVO holds a
non-controlling 63% stake in PrEP Biopharm.
Imutex Limited - hVIVO's Second Equity Investment
In addition to conducting the Phase IIa studies for PrEP-001
during the first half of 2016, hVIVO completed its second equity
investment, Imutex, with the SEEK Group, in April 2016. Via the
Imutex joint venture, hVIVO gained a share of two additional
clinical stage assets to advance our product pipeline: FLU-v, a
Phase IIa universal flu vaccine, and AGS-v, a mosquito-borne
illness vaccine platform slated to begin human testing in the
coming months for use against Zika. hVIVO holds a 49% stake in
Imutex.
The development of universal flu and Zika vaccines are key
public health priorities identified by the World Health
Organisation (WHO), US Centers for Disease Control and Prevention
(CDC) and the National Institutes of Health (NIH) in the United
States. hVIVO and Imutex are collaborating with the National
Institute of Allergy and Infectious Diseases (NIAID), a division of
the NIH, to accelerate development of both vaccines. Both products
have the potential to qualify for Fast Track designation, depending
on the outcome of the trials being conducted this year. hVIVO has
commenced the Phase IIa Flu-v trial in the second half of 2016 in
the hVIVO platform. The AGS-v First-In-Man (FIM) study in Zika will
be conducted in Q4 2016 at the National Institutes of Health
facility in Bethesda, Maryland.
FLU-v Universal Flu Vaccine
FLU-v belongs to a group of novel new 'universal flu' vaccines
that are designed to provide broad spectrum coverage against
multiple flu strains. The success of such an approach would
eliminate the sensitivity to strain variability seen with
traditional vaccines and promote single vaccine coverage for all
flu strains. The technology behind FLU-v works by targeting
conserved internal proteins common to all flu viruses to activate T
and B-cells, key components of the human immune system
response.
Work on the Phase IIa FLU-v trial design commenced immediately
after the Imutex transaction completed in April 2016. hVIVO
conducted a Phase Ib study with FLU-v in 2010, using hVIVO's H3N2
Wisconsin virus strain, and so the focus of the 2016 POC trial
involves a different flu virus, H1N1, in order to demonstrate the
vaccine works against multiple virus strains. Accordingly, hVIVO
has had the pleasure of collaborating closely with both SEEK and
NIAID, on designing a precedent-setting two-part trial, aimed at
providing POC as well as a comparison of FLU-v against the annual
vaccine. The trial commenced at hVIVO in August 2016, and we
anticipate completion of Part I of the trial in early 2017.
In addition, a second FLU-v study has commenced in conjunction
with Universal Vaccines Secured consortium (UNISEC). UNISEC is a
European consortium consisting of three academic partners, five
National Health Institutes and three subject matter experts (SMEs),
founded in 2013. In this study, dosing and formulations will be
tested to identify the most efficacious combination. The first
subjects were vaccinated in August 2016 and the study is expected
to be completed in 2017. The results of these studies then will
help identify appropriate biomarkers and support designing our
FLU-v Phase III program.
AGS-v Mosquito-Borne Disease Vaccine Platform
In 2015 mosquito-borne flavivirus Zika burst on the scene in
Brazil, infecting thousands and causing birth defects
(microcephaly) and nervous disorders (Guillain Barré) at an
alarming rate. Unlike its close-relatives dengue and West Nile,
most people infected with Zika do not have symptoms, making it
difficult to track. Due to its risks to unborn babies, lack of
treatment, and rapid spread, WHO declared Zika a Public Health
Emergency in February 2016 and today more than 70 countries have
reported mosquito-borne transmission of this disease. In the US
alone there are more than 20,000 cases reported, more than 3,000 on
the mainland alone, with local mosquito transmission confirmed in
the state of Florida, and a recent study estimated over 2 billion
people in Africa and Asia were at risk. AGS-v is a mosquito-borne
disease vaccine with a novel proposed dual action mechanism:
preventing infection in humans whilst controlling the mosquito
population. AGS-v works by creating an anti-saliva immune response
in humans that prevents infection. After the mosquito bites a
vaccinated human host, antibodies from the human attack the gut and
salivary glands of the mosquito, which reduces the survival of the
mosquito.
Given the emergent nature of the Zika outbreak, SEEK and hVIVO
are working at an accelerated pace with NIAID to advance testing of
AGS-v against Zika. In the first half of 2016, we designed a FIM
study that will also leverage an ex vivo component to evaluate
mosquito survival, providing early indications of vaccine efficacy.
In addition, we worked with NIAID and the FDA to arrive at an
agreed truncated pre-clinical package, which, along with
accelerated vaccine manufacturing, we have progressed over the
summer. Originally we had hoped to be conducting the FIM study by
September, but some delays in our manufacturing timelines have
pushed back the start to the October/ November timeframe. We still
are aiming for the trial to read out by Spring 2017.
If successful in Zika, Imutex will look to further develop the
vaccine in other mosquito-borne illnesses, such as malaria, dengue
and West Nile.
First Pathomics Patent Filed - Severe Flu
In late 2014, hVIVO began its journey to fully exploit the power
of the hVIVO platform to illuminate the underlying biology of
disease in order to discover better treatments and diagnostics in
areas of stubborn and persistent unmet medical need. We determined
that our initial foray into the mining our 'disease in motion'
samples would be in flu, given that hVIVO has more than 25 years of
experience researching flu and there are significant gaps in
existing treatments and vaccines which we believe can be overcome
by better understanding the human body's response to flu infection.
In particular, we noted that there were no treatments for severe
flu and indeed, no universal clinical definition for it either.
This translates into a staggering economic reality: in the US
alone, there are 200,000 cases of severe flu annually, 20% of which
develop acute respiratory distress syndrome (ARDS) and cause $13.8
billion in hospital costs alone. These figures can be expected to
increase exponentially in pandemic outbreaks. As such, hVIVO turned
the power of the platform on severe flu, in order to illuminate the
correct drug targets we should be focusing on to produce a positive
therapeutic effect.
Within short order, our Discovery team produced a map of the
pathophysiology associated with 'normal' flu (i.e. what should
happen in flu when humans get sick and then recover on their own
without intervention). We coined the term 'pathomics' to describe
this process of describing the underlying biological pathways
associated with a given disease state. Once we knew the pathways
associated with recovery, we collected 'field' samples (in 2015)
from people with severe flu or who were hospitalised with flu. We
then compared the difference to zero in on the pathways most
associated with severe flu. From this informed vantage point, we
commenced a rigorous qualification process involving in vitro and
ex vivo laboratory studies that read out in March 2016. We
consulted world leading clinicians, scientists and opinion leaders
in influenza along the journey to ensure the clinical plausibility,
and utility, of our candidate pathways and our qualification
process. Through our industrialised pathomics process, we arrived
at a qualified pathway component for our severe flu drug target in
under 18 months.
We then began in April 2016 the patenting process for our
discoveries, the first of which was filed in early July 2016. Our
initial patent concerns our pathomics-informed drug target and an
existing class of drug. Additional patents will follow in the
coming months to address novel and inventive use of the associated
pathway and disease activities biomarkers. We are currently in the
compound selection stage, fortified with what we believe is the
first human data enriched preclinical package for a drug candidate
that is based on both in vitro and human ex vivo disease relevant
assays. We anticipate moving forward into early clinical
development next year for one of the first ever treatments for
severe flu. This is a pivotal moment for hVIVO, as it represents
the first step towards productising our pathomics insight. We are
also fortunate in our timing: there has been an intense surge of
interest in severe flu recently. In a current Broad Agency
Announcement (BAA) issued by Biomedical Advanced Research and
Development Authority (BARDA) within the US Department of Health
and Human Services, the US agency stresses, 'because there are no
treatments approved for severely ill, hospitalised influenza
patients, the strongest proposals will include a clinical
development plan that addresses treatment of this population.' In
addition, at the European Respiratory Society International
Congress 2016 conference in London in September 2016, there was a
symposium that focused on the problem of severe flu, to our
knowledge the first time this acute medical need has featured at
this prestigious congress. We believe our pathomics insight and our
efforts over the past 18 months to isolate the pathways involved in
severe flu positions hVIVO to lead the charge in defining and
treating this area of high unmet medical need.
Financial Review
Condensed Consolidated Statement of Comprehensive Income
Revenue for the six months ended 30 June 2016 was GBP8.6 million
(H1'15: GBP2.9 million; 2015: GBP7.7 million). Gross profit was
GBP0.8 million and gross margin 9.4% (H1'15: GBP0.9 million and
29.9%; 2015: GBP2.5 million and 31.8%).
The PrEP-001 flu study completed in H1'16, enabling the
recognition of revenue and costs attributable from the flu licence
arrangement on a "completed" basis. The PrEP-001 asthma study is
expected to complete in H2'16 when the fee from asthma licence
arrangement will be recognised as revenue. The third PrEP-001
durability study is a standard clinical trials agreement and
revenue accounted for on a "work done basis".
Gross profit was GBP0.8 million and gross margin 9.4% (H1'15 -
GBP0.9 million and 29.9%) reflecting a greater mix of workload from
our equity investments and a postponed client engagement from H1'16
into H2'16. 2016 gross margin is expected to be 15.0%, due to
higher utilisation of the quarantine unit in H2'16 from the
postponed client engagement and the studies with our equity
investments.
Research and development expense was GBP3.0 million (H1'15:
GBP7.4 million; 2015: GBP10.2 million) from hVIVO's continued
investment in discovery research and product validation
capabilities. The spend is expectedly lower in H1'16 compared to
previous periods, which had greater spend from undertaking the
sample studies and the subsequent third-party transcriptomic
analysis, etc. due to the timing of phases and weightings of cost
of our various discovery research programmes.
Administration expense was GBP6.3 million, consistent with prior
periods (H1'15: GBP6.6 million; 2015: GBP13.7m) and reflecting
hVIVO's ongoing initiatives to manage the efficiency of our
resources.
Gain on provision of services to joint venture was GBP114,000
(H1'15: GBPnil; 2015: GBPnil) being the start-up work associated
with the SEEK FLU-v study, with the study commencing in our
platform in August 2016. Due to the linked nature of hVIVO's equity
investment in Imutex and the clinical services engagement with
SEEK, the equity investment has been accounted for as GBP1.5
million consideration in cash and an obligation to provide services
of GBP5.5 million. The obligation to provide services is presented
as a liability in the balance sheet, within trade and other
payables, and the liability will reduce as the services are
performed.
Share of loss of associates was GBP3.9 million (H1'15: GBPnil;
2015: GBP0.1 million), which reflects the share of results of
hVIVO's investments in PrEP Biopharm (November 2015) and Imutex
(April 2016).
Loss before taxation was GBP11.8 million (H1'15 - GBP12.0
million; 2015 - GBP21.6 million).
Condensed Consolidated Statements of Financial Position and Cash
Flows
As at 30 June 2016 net assets amounted to GBP54.0 million
(H1'15: GBP51.7 million; 2015: GBP63.6 million), including short
term deposits and cash and cash equivalents of GBP34.1 million
(H1'15: GBP42.5 million; 2015: GBP51.2 million). 2015 R&D tax
credit refund of GBP4.6 million was received from HM Revenue &
Customs on 1 July 2016, the day following the end of the H1'16
financial period.
Net cash used in operating activities over the six months to 30
June 2016 was GBP10.1 million
(H1'15: GBP8.2 million; 2015: GBP9.8 million).
Summary and Outlook
hVIVO is a speciality biopharma company with two distinct ways
that our proprietary platform can be used: to mine biological
insight to develop new products, and to test products rapidly and
effectively such that late phase surprises and sets backs are
minimised. By putting a 'human in a lab,' hVIVO is able to see
disease in motion in order to get at the true biological levers of
disease that are normally hidden from view. And through the very
same 'human lab' approach, hVIVO is able to generate 'disease in
motion' in order to test therapeutic interventions against that
disease. Unlike other early stage testing methods, the hVIVO
approach is not a surrogate (like an allergen challenge), it is the
real thing. The viruses we use to generate disease states are not
altered, they are the same viruses one picks up on crowded trains,
or that our kids bring home from school. This small but significant
distinction helps to better frame the results we get in the hVIVO
platform, and also speaks directly to the quality of the insight we
gain from mapping our bodies' reactions to an hVIVO induced viral
infection.
And it is this small but profound distinction that fuels the
power of the hVIVO platform: it works as a divining rod to sift out
the right drug targets, and it works to reveal the products that
have the desirable therapeutic effect. Much stands in the way of a
drug ultimately reaching market, and whilst by no means a
guarantee, using a real virus on a human in a controlled setting
goes a very long way to minimising later stage failures.
In hVIVO' s early days as a listed Company, we cultivated market
adoption of our platform by providing services to the existing
assets of our pharma and biotech customers. After achieving that in
only a few years, we expanded our engagement options with our
customers, such that we could selectively partner with them and
secure a more representative share of the value the hVIVO platform
was bringing to the product. Two key collaborations have come out
of this approach: PrEP Biopharm and our most recent, Imutex. Both
were made possible because of our platform. As a result, in less
than a year, hVIVO has cultivated a drug development pipeline with
three clinical stage assets whilst we continue to build a wealth of
biological insight into flu and asthma for future product
development.
Our progress with all three clinical assets in the first half of
2016 reflects the speed and agility the industry has come to expect
of an hVIVO clinical programme: four Phase IIa clinical studies
were advanced, one finished, with the remaining three expected to
be completed in late 2016 and early 2017. In addition, we expedited
the pre-clinical preparation of our Zika vaccine candidate, and
will be commencing the FIM study in the October/November
timeframe.
Through Imutex, we are working closely with NIAID and have
increased our interaction with other leading US government agencies
who share our goal to find more effective treatments and vaccines
for Flu. With our first pathomics - informed patent securely filed,
we are now able to leverage our insight into severe flu, and will
be focusing the remainder of 2016 on selecting a compound for
development in this indication. In addition, we continue to mine
our flu data, but this time, looking for molecular signatures and
time course events that can inform algorithms and serve as
predictor tools. We are searching for ways to predict who will get
a severe version of flu, as well as a whole host of currently
unanswered questions that plague clinicians working with high risk
patient populations when they suffer from infections. Readouts from
this work are expected to begin in October 2016 and will complete
mid-2017.
The second half of 2016 saw us kick off our highly anticipated
landmark asthma stratification project, with our first subject
enrolled in August 2016. This dynamic phenotyping project aims to
characterise asthma not only in the static or baseline state, but
also throughout the evolution of an exacerbation following viral
infection. These results will help us characterise asthma patients
according to clinical and biomarker phenotypes to differentiate
subtypes of asthma patients- enabling the development of targeted
therapies, disease biomarkers and predictive tools. An interim
analysis is slated for mid-2017, at which time we will examine what
differentiators we are picking up, and which will set the course
for the remainder of the project. We will be following the
pathomics methodology we developed with our flu work, with similar
timeframes for output based on completion of the sample collection
phase.
As we are beginning this critical phenotype characterisation, we
are further developing our asthma viral-induced exacerbation model
for wider commercial use. In early September we completed the
dosing phase of the first study in our model, with results expected
in early 2017. Early stage efficacy testing for asthma products has
many of the challenges reminiscent of those we encountered when
hVIVO was pioneering our respiratory syncytial virus (RSV) disease
model, which has since become the gold standard for early phase
testing in RSV. With the advent of asthma biologics, the challenges
only increase, as seen in the lack of validated and meaningful
endpoints critical to pioneering new drug classes. hVIVO is working
with customers and key opinion leaders alike to expand our existing
model to address these challenges. The end product (expected in
November 2016) will be a suite of exacerbation models, both viral
and allergen that we believe will fill a vital gap in asthma
product testing. In this fashion, hVIVO is following for asthma the
path the Company blazed with flu and RSV: develop meaningful
commercial models to overcome the product testing barriers in these
difficult to research indications, engender market adoption of the
approach via service use of the model, and then springboard that
model into a product discovery engine for the Company's own
development.
As we come into the last quarter of 2016, our testing facilities
will be leveraged to their highest capacity of the year, with the
start of the expanded SEEK FLU-v study, the completion of PrEP's
asthma and dose duration trials, and wrap up of the dosing phase of
a client trial that was delayed in the first half of the year. In
order to accommodate our client, we are juggling workload
requirements to do our best to make up the lost time in their
development plan. We continue to see demand rebuilding for flu,
with strong funding opportunities coming particularly from US
government agencies. Our RSV model continues to be in demand, with
multiple next generation RSV treatments advancing in 2017. The race
to be first-to-market continues, with the field wide-open given the
recent late stage failure of an RSV product - one that was not
tested nor analysed in hVIVO's early phase RSV model. We continue
to flex our platform's capacity between engagements with our equity
investments, our strategically important clients, and our discovery
work, such that we achieve the optimum mixture of work type to
advance our products and progress adoption of our models depending
on priority and best value. Q4 2016 is also pivotal for the
progress we wish to make in the effort to tame the Zika outbreak:
the AGS-v FIM study, conducted at the NIH, will test the product's
safety and early efficacy in Zika in the last months of 2016. This,
coupled with our patent filing for severe flu, puts hVIVO within
striking distance of advancing multiple products into late phase
within the next 18 months.
I look forward to updating you further as we achieve key
milestones, and I would like to thank our staff, patients,
customers, partners and investors for their invaluable support in
making all of our 2016 achievements possible.
Kym Denny
Chief Executive Officer
21 September 2016
hVIVO plc
Condensed Consolidated Statement of Comprehensive Income
For the six months ended 30 June 2016
6 months 6 months Year
ended ended ended
30 June 30 June 31 December
2016 2015 2015
Unaudited Unaudited Audited
Note GBP'000 GBP'000 GBP'000
---------- ---------- --------------
Revenue 2 8,607 2,888 7,717
Cost of sales (7,800) (2,025) (5,266)
Gross profit 807 863 2,451
Other income 3 147 1,002 1,187
Research and development
expense (3,006) (7,392) (10,199)
Release of/(provision against)
virus inventory 120 (3) (1,617)
Administrative expense (6,256) (6,625) (13,671)
Gain on provision of services
to joint venture 4 114 - -
Share of loss of associates
and joint ventures 5 (3,868) - (146)
Loss from operations (11,942) (12,155) (21,995)
Finance income 188 200 387
Finance costs (9) (9) (17)
------------------------------------ ----- ---------- ---------- ------------
Loss before taxation (11,763) (11,964) (21,625)
Taxation 6 2,098 2,181 3,716
------------------------------------ ----- ---------- ---------- ------------
Loss for the period (9,665) (9,783) (17,909)
Other Comprehensive income
Items that may be reclassified
subsequently to profit or
loss
Share of other comprehensive
income of associate (29) - (5)
Exchange differences arising
on translating foreign operations 8 - 1
----- ---------- ---------- ------------
Total comprehensive loss for
the period attributable to owners
of the parent (9,686) (9,783) (17,913)
------------------------------------------- ---------- ---------- ------------
Loss per share - basic (pence) 7 (12.4p) (14.4p) (26.0p)
Loss per share - diluted
(pence) 7 (12.4p) (14.4p) (26.0p)
------------------------------------ ----- ---------- ---------- ------------
All results derive from continuing
operations.
The accompanying notes are an integral part of
the Condensed Consolidated Statement of Comprehensive
Income.
hVIVO plc
Condensed Consolidated Statement of Financial Position
As at 30 June 2016
30 June 30 June 31 December
2016 2015 2015
Unaudited Unaudited Audited
Note GBP'000 GBP'000 GBP'000
------------------------------- ----- ---------- ---------- ------------
Assets
Non-current assets
Goodwill 1,722 1,722 1,722
Intangible assets 3,184 3,075 3,030
Property, plant and equipment 2,081 2,894 2,679
Investment in associates
and joint ventures 8 17,496 - 14,254
24,483 7,691 21,685
------------------------------- ----- ---------- ---------- ------------
Current assets
Inventories 2,027 3,902 2,141
Current intangible asset 9 1,394 - 2,935
Trade and other receivables 3,539 3,073 2,642
Research and development
tax credit receivable 6,369 2,379 4,101
Short-term deposits 25,022 18,020 37,031
Cash and cash equivalents 9,063 24,507 14,205
---------- ---------- ------------
47,414 51,881 63,055
---------- ---------- ------------
Total assets 71,897 59,572 84,740
------------------------------- ----- ---------- ---------- ------------
Equity and liabilities
Equity
Share capital 3,904 3,447 3,903
Share premium account 93,180 73,591 93,145
Other reserve 211 211 211
Share-based payment reserve 201 87 144
Merger reserve 4,199 4,199 4,199
Retained deficit (47,665) (29,849) (37,979)
------------------------------- ----- ---------- ---------- ------------
Total equity 54,030 51,686 63,623
------------------------------- ----- ---------- ---------- ------------
Non-current liabilities
Other payables 438 513 475
Provisions 2,638 2,521 3,140
3,076 3,034 3,615
------------------------------- ----- ---------- ---------- ------------
Current liabilities
Trade and other payables 10 14,791 4,852 17,502
------------------------------- ----- ---------- ---------- ------------
14,791 4,852 17,502
------------------------------- ----- ---------- ---------- ------------
Total liabilities 17,867 7,886 21,117
------------------------------- ----- ---------- ---------- ------------
Total liabilities and equity 71,897 59,572 84,740
------------------------------- ----- ---------- ---------- ------------
The accompanying notes are an integral part of the Condensed
Consolidated Statement of Financial Position.
The Interim Condensed Consolidated Financial Statements of hVIVO
plc (registered company number 08008725) were approved by the Board
of Directors and authorised for issue on 21 September 2016 and
signed on its behalf by:
Graham E Yeatman
Chief Financial & Business Officer
hVIVO plc
Condensed Consolidated Statement of Changes in Equity
As at 30 June 2016
Share-
Share based
Share premium payment Merger Other Retained Total
capital account reserve reserve reserve deficit equity
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
-------- -------- -------- -------- -------- --------- ---------
As at 1 January
2015 3,383 72,498 249 4,199 921 (20,066) 61,184
Proceeds from
shares issued:
Acquisition
of subsidiary 11 699 - - (710) - -
Exercise of
warrants and
share options 52 360 (183) - - - 229
Issue of new
shares 1 67 - - - - 68
Placing net
of related expense 456 19,521 - - - - 19,977
--------------------- -------- -------- -------- -------- -------- --------- ---------
Total transactions
with owners
in their capacity
as owners 520 20,647 (183) - (710) - 20,274
Loss for the
period - - - - - (17,909) (17,909)
Other comprehensive
income (4) (4)
Share-based
payment expense - - 78 - - - 78
--------------------- -------- -------- -------- -------- -------- --------- ---------
As at 31 December
2015 3,903 93,145 144 4,199 211 (37,979) 63,623
Loss for the
period - - - - - (9,665) (9,665)
Other comprehensive
income (21) (21)
Issue of new
shares 1 35 - - - - 36
Share-based
payment expense - - 57 - - - 57
As at 30 June
2016 3,904 93,180 201 4,199 211 (47,665) 54,030
--------------------- -------- -------- -------- -------- -------- --------- ---------
As at 1 January
2015 3,383 72,498 249 4,199 921 (20,066) 61,184
Acquisition
of subsidiary 11 699 - - (710) - -
Exercise of
warrant and
share options 52 360 (183) - - - 229
Loss for the
period - - - - - (9,783) (9,783)
Issue of new
shares 1 34 - - - - 35
Share-based
payment expense - - 21 - - - 21
As at 30 June
2015 3,447 73,591 87 4,199 211 (29,849) 51,686
--------------------- -------- -------- -------- -------- -------- --------- ---------
The accompanying notes are an integral part of the Condensed
Consolidated Statement of Changes in Equity.
hVIVO plc
Condensed Consolidated Statement of Cash Flows
For the six months ended 30 June 2016
6 months 6 months Year ended
ended ended
30 June 30 June 31 December
2016 2015 2015
Unaudited Unaudited Audited
GBP'000 GBP'000 GBP'000
--------------------------------- --- ---------- ---------- ------------
Net cash used in operating
activities 11 (10,136) (8,227) (9,846)
Cash flows from investing
activities
Acquisition of intangible
assets (312) (15) (15)
Acquisition of property,
plant and equipment (84) (400) (869)
Decrease/(increase) in balances
on short-term deposit 12,009 9,987 (9,024)
Acquisition of associate
and joint venture 12 (6,792) - (9,405)
Finance income 138 146 398
---------- ---------- ------------
Net cash generated from/(used
in) investing activities 4,959 9,718 (18,915)
Cash flows from financing
activities
Net proceeds from issue
of shares - 228 20,205
Other payables repaid (37) (38) (75)
Net cash generated from/(used
in) financing activities (37) 190 20,130
--------------------------------- --- ---------- ---------- ------------
Net increase/(decrease)
in cash and cash equivalents (5,214) 1,681 (8,631)
Exchange gain on cash and
cash equivalents 72 - 10
Cash and cash equivalents
at the start of financial
period 14,205 22,826 22,826
Cash and cash equivalents
at the end of financial
period 9,063 24,507 14,205
--------------------------------- --- ---------- ---------- ------------
The accompanying notes are an integral part of the Condensed
Consolidated Statement of Cash Flows.
hVIVO plc
Notes to the Condensed Consolidated Interim Financial
Statements
1. Accounting policies
Basis of preparation and approval of the Interim Financial
Statements
The accounting policies adopted in the preparation of the
Interim Financial Statements are consistent with those set out in
the Group's Annual Report and Financial Statements 2015, which were
prepared in accordance with International Financial Reporting
Standards ("IFRS") as adopted by the European Union and as issued
by the International Accounting Standards Board ("IASB"), and are
expected to be consistent with the accounting policies that will be
applied in the Group's Annual Report and Financial Statements
2016.
The Interim Financial Statements for the six months ended 30
June 2016 do not include all of the information required for full
Annual Financial Statements and should be read in conjunction with
the Consolidated Financial Statements for the year ended 31
December 2015. The financial information for the six months ended
30 June 2016 and for the six months ended 30 June 2015 is
unaudited.
The Interim Financial Statements do not comprise statutory
accounts within the meaning of Section 434 of the Companies Act
2006. Statutory accounts for the year ended 31 December 2015 were
approved by the Board on 19 April 2016 and delivered to the
Registrar of Companies. The report of the auditors on those
accounts was unqualified, did not contain an emphasis of matter
paragraph and did not contain any statement under Section 498(2) or
Section 498(3) of the Companies Act 2006.
The Interim Financial Statements have been prepared on a going
concern basis which the Directors believe is appropriate for the
following reason:
The Directors have prepared cash flow forecasts which show the
Group expects to meet its liabilities as they fall due for a period
of not less than twelve months from the date of approval of the
Interim Financial Statements. Management prepares detailed working
capital forecasts which are reviewed by the Board on a regular
basis. The forecasts include assumptions regarding the status of
client engagements and sales pipeline, future revenues and costs
together with various scenarios which reflect growth plans,
opportunities, risks and mitigating actions. The forecasts also
include assumptions regarding the timing and quantum of investment
in the Group's research and development programme. Whilst there are
inherent uncertainties regarding the cash flows associated with the
development of the hVIVO platform, together with the timing of
signature and delivery of client engagements, the Directors are
satisfied that there is sufficient discretion and control as to the
timing and quantum of cash outflows to ensure that the Group is
able to meet its liabilities as they fall due for the foreseeable
future. At 30 June 2016, the Group had cash and short-term deposits
of GBP34.1 million.
The Company is a limited liability company incorporated and
domiciled in England & Wales and whose shares are quoted on
AIM, a market operated by The London Stock Exchange. The Group
Financial Statements are presented in pounds Sterling (GBP), which
is the Group's presentational currency, and all values are rounded
to the nearest thousand (GBP'000) except where indicated
otherwise.
The Interim Financial Statements were approved by the Board of
Directors on 21 September 2016.
2. Segmental information
The Group's Chief Operating Decision Maker, the Chief Executive
Officer, is responsible for resource allocation and the assessment
of performance. In the performance of this role, the Chief
Executive Officer reviews the Group's activities, in the aggregate.
The Group has therefore determined that it has only one reportable
segment under IFRS 8 Operating Segments, which is "medical and
scientific services".
The Group carries out its main activities from the United
Kingdom. The Group conducts sales activities in the US and in
Europe which are carried out through hVIVO Inc and hVIVO Services
Limited respectively. All revenue is derived from activities
undertaken in the UK.
Revenue from related party transactions with PrEP Biopharm
Limited, an associate company, during the six months ended 30 June
2016 totalled GBP5,246,000 (six months ended 30 June 2015: GBPnil,
year ended 31 December 2015: GBP200,000).
3. Other income
Other income is in respect of R&D Expenditure Credit (RDEC).
The comparatives stated for the six months ended 30 June 2015 and
the year ended 31 December 2015 included GBP0.8m in respect of an
RDEC claim for the 2014 period. No such claims for RDEC were
submitted in prior periods and therefore the asset was not
recognised in the 2014 period.
4. Gain on provision of services to joint venture
During the six months ended 30 June 2016, the Group entered into
a joint venture with PepTcell Limited and acquired 49% of the share
capital of Imutex Limited (see Note 8). Due to the linked nature of
hVIVO plc's equity investment in Imutex Limited and the clinical
services contracted to be provided by hVIVO Services Limited to
PepTcell Limited, the contracted services of GBP5.5 million is
recorded as an obligation to provide services which is extinguished
through delivery of services with any resulting gains being
recognised in the income statement. In delivering the services
performed to 30 June 2016, hVIVO generated a gain of GBP114,000
which has been recognised in the income statement as a gain on
provision of services to joint venture.
5. Share of loss of associates and joint ventures
hVIVO plc holds equity investments in development stage
biopharmaceutical companies. As the invested companies are
incurring expenditure to develop products, no revenue will be
generated and losses will be presented. Revenue and profits will
not be generated within these companies until the products are
successfully developed.
At 30 June 2016 the Group held an investment in one associate,
PrEP Biopharm Limited, and one joint venture, Imutex Limited (see
Note 8).
The Group's share of after tax losses of associates and joint
ventures is set out below:
6 Months 6 Months Year
ended ended ended
30 Jun 30 Jun 31 Dec
2016 2015 2015
Unaudited Unaudited Audited
GBP'000 GBP'000 GBP'000
Share of loss of
associate and joint
venture (3,868) - (146)
Share of comprehensive
income (29) - (5)
------------------------------ ----------- ----------- ------------
Share of total comprehensive
income (3,897) - (151)
------------------------------ ----------- ----------- ------------
Summarised combined income statement information in respect of
PrEP Biopharm Limited and Imutex Limited is set out below:
6 Months 6 Months Year
ended ended ended
30 Jun 30 June 31 Dec
2016 2015 2015
Unaudited Unaudited Audited
GBP'000 GBP'000 GBP'000
Revenue - - -
R&D Expenditure (6,301) - (215)
Loss after taxation (6,231) - (233)
Comprehensive income (46) - (8)
Total comprehensive
income (6,277) - (241)
---------------------- ----------- ----------- ---------
6. Taxation
6 Months 6 Months Year
ended ended ended
30 Jun 30 Jun 31 Dec
2016 2015 2015
Unaudited Unaudited Audited
GBP'000 GBP'000 GBP'000
------------------------ ----------- ----------- ---------
Tax Benefit:
R&D tax credit (1,649) (2,212) (3,749)
Adjustments in respect
of prior periods (473) 31 31
Foreign current tax 24 - 2
------------------------ ----------- ----------- ---------
(2,098) (2,181) (3,716)
------------------------ ----------- ----------- ---------
The Group continues to account for its recurring annual SME
R&D tax credit as an income tax benefit due to the requirement
to surrender tax losses in exchange for recoverable R&D
credits.
The Group has not recognised any deferred tax assets including
carried forward losses and other temporary differences. These
deferred tax assets have not been recognised as the Group's
management considers that there is insufficient taxable income,
taxable temporary differences and feasible tax planning strategies
to utilise all of the cumulative losses and it is probable that the
deferred tax assets will not be realised in full.
7. Loss per share (LPS)
The calculation of the basic and diluted LPS is based on the
following data:
6 Months 6 Months Year
ended ended ended
30 Jun 30 Jun 31 Dec
2016 2015 2015
Unaudited Unaudited Audited
GBP'000 GBP'000 GBP'000
------------------------- ----------- ----------- -----------
Loss:
Loss for the period (9,665) (9,783) (17,909)
------------------------- ----------- ----------- -----------
Number of shares:
Weighted average
number of ordinary
shares for the purpose
of basic LPS 78,064,355 68,106,047 68,943,581
Effect of dilutive
potential ordinary
shares:
- share options - - -
- warrants - - -
------------------------- ----------- ----------- -----------
Weighted average
number of ordinary
shares for the purpose
of diluted LPS 78,064,355 68,106,047 68,943,581
------------------------- ----------- ----------- -----------
In the six months ended 30 June 2016 and in the comparative
periods presented, the potential ordinary shares were not treated
as dilutive as the Group is loss making, therefore the weighted
average number of ordinary shares for the purposes of the basic and
diluted loss per share were the same.
8. Investment in associates and joint ventures
At 30 June 2016 the Group held investments in one associate,
PrEP Biopharm Limited, and one joint venture, Imutex Limited. A
reconciliation of the carrying value of the Group's investments in
joint ventures and associates is as follows:
2016 2015
GBP'000 GBP'000
--------------------------------- --------------- --------------
At 1 January 14,254 -
Additions 7,139 -
Loss after tax recognised
in the consolidated statement
of comprehensive income (3,868) -
Other comprehensive income
recognized in the consolidated
income statement (29) -
--------------------------------- --------------- --------------
At 30 June 17,496 -
--------------------------------- --------------- --------------
2015
GBP'000
--------------------------------- --------------- --------------
At 1 January -
Additions 14,405
Loss after tax recognised
in the consolidated statement
of comprehensive income (146)
Share of other comprehensive
loss (5)
-------------------------------------------------- --------------
At 31 December 14,254
-------------------------------------------------- --------------
Summarised combined balance sheet information in respect of PrEP
Biopharm Limited and Imutex Limited as at 30 June 2016, 31 December
2015 and 30 June 2015 is shown below:
30 June 30 June 31 Dec
2016 2015 2015
Unaudited Unaudited Audited
GBP'000 GBP'000 GBP'000
----------------------- ----------- ----------- ---------
Current assets 12,342 - 15,298
Non-current assets 17,314 - 5,076
Current liabilities (1,436) - (123)
----------------------- ----------- ----------- ---------
Net assets 28,220 - 20,251
Interest in associate
and joint venture 15,765 - 12,681
Goodwill 1,731 - 1,573
----------------------- ----------- ----------- ---------
Carrying value of
Group's interest
in associate and
joint venture 17,496 - 14,254
----------------------- ----------- ----------- ---------
In assessing the level of control hVIVO holds in respect of
equity investments, management consider a number of factors
including control of voting rights at board level and the power to
direct relevant activities.
PrEP Biopharm Limited
On 1 November 2015 hVIVO acquired 62.62% of the share capital of
PrEP Biopharm Limited for cash consideration of GBP14.0 million.
Acquisition costs of GBP0.4 million have been capitalised as part
of the cost of investment. PrEP Biopharm Limited is a UK based,
development stage biopharmaceutical company which is developing
infectious disease products. At the same time as the transaction,
PrEP Biopharm Limited entered into contractual arrangements with
hVIVO Services Limited to the value of GBP10.0 million. Revenue
recognised by hVIVO in respect of these contractual arrangements is
disclosed within Note 2 as revenue from related party
transactions.
Although hVIVO holds more than 50% of the equity of PrEP
Biopharm Limited, hVIVO's voting rights are limited to 49.98% under
the Investment and Shareholders' Agreement ("ISHA"). The effect is
that the voting rights hVIVO is entitled to exercise are less than
half of the total voting rights that are able to be exercised.
As at 30 June 2016, hVIVO had appointed two of the four
Directors of PrEP, including the Chair, with equal votes and no
casting vote. Accordingly, hVIVO does not control the Board. On 9
August 2016, the Board was expanded to five Directors, with hVIVO
continuing to be represented by two Directors.
hVIVO has concluded that despite having significant influence,
the terms of the ISHA mean that it does not have the power to
direct the relevant activities of PrEP Biopharm Limited.
Accordingly, hVIVO's investment in PrEP Biopharm Limited has been
accounted for as an investment in an associate.
Imutex Limited
On 21 April 2016 hVIVO acquired 49.0% of the share capital of
Imutex Limited for GBP7.0 million consideration under the terms of
a Joint Venture Arrangement with PepTcell Limited. Acquisition
costs of GBP0.2 million have been capitalised as part of the
investment. Imutex Limited is UK based company developing vaccines
against influenza and mosquito borne diseases. As part of the
transaction PepTcell Limited entered into a contractual arrangement
with hVIVO Services Limited for a clinical study to the value of
GBP5.5 million.
Due to the linked nature of hVIVO plc's equity investment in
Imutex Limited and the clinical services contracted to be provided
by hVIVO Services Limited to PepTcell Limited, the consideration of
the GBP7.0 million equity investment in Imutex Limited has been
accounted for as GBP1.5 million consideration settled in cash,
combined with an obligation to provide services of GBP5.5 million.
The obligation to perform these services is presented in trade and
other payables.
hVIVO holds 49.0% of the equity of Imutex Limited and, under the
terms of the Joint Venture Agreement, appoints two of the current
four Directors. hVIVO management have concluded that the relevant
activities of Imutex Limited are jointly controlled by the
investors and therefore it is appropriate for hVIVO to equity
account for the investment as a joint venture with joint
control.
9. Current intangible asset
30 Jun 30 Jun 31 Dec
2016 2015 2015
Unaudited Unaudited Audited
GBP'000 GBP'000 GBP'000
--------------------- ----------- ----------- ---------
Opening Balance 2,935 - -
Additions 1,982 - 2,935
Released to cost of (3,523) - -
sales
Closing balance 1,394 - 2,935
--------------------- ----------- ----------- ---------
During 2015 hVIVO commenced two clinical studies with a view to
the study data generating future economic benefit through licensing
agreements. Accordingly, the cost of performing these studies has
been capitalised where the future economic benefit is forecast to
be greater than cost. As revenue is recognised on completion of the
study, the cost is released to cost of sales.
10. Trade and other payables
30 Jun 30 Jun 31 Dec
2016 2015 2015
Unaudited Unaudited Audited
GBP'000 GBP'000 GBP'000
------------------------ ----------- ----------- ---------
Trade payables 1,903 1,941 2,265
Other taxes and social
security 367 360 382
VAT payable 233 - 984
Other payables 89 79 5,134
Accruals 1,023 1,224 1,303
Obligation to provide 5,233 - -
services
Deferred income 5,943 1,248 7,434
14,791 4,852 17,502
------------------------ ----------- ----------- ---------
As at 31 December 2015, other payables included deferred
consideration of GBP5.0 million in respect of the equity investment
in PrEP Biopharm Limited. The deferred consideration was paid in
January 2016.
Deferred income as at 30 June 2016 includes GBP4.6 million in
respect of licensing and service arrangements with PrEP Biopharm
Limited (30 June 2015: GBPnil, 31 December 2015: GBP6.8
million).
Obligation to provide services is part consideration for hVIVO's
equity investment in Imutex Limited (see Note 8).
11. Net cash used in operations
6 months 6 months Year
ended ended Ended
30 June 30 June 31 December
2016 2015 2015
Unaudited Unaudited Audited
GBP'000 GBP'000 GBP'000
----------------------------- ---------- ---------- ------------
Cash flow from operating
activities
Loss before taxation (11,763) (11,964) (21,625)
Adjustments for:
Gain on provision of (114) - -
services to joint venture
Share of loss of associate 3,868 - 146
Depreciation of property,
plant and equipment 682 658 1,342
Amortisation of intangible
assets 158 273 318
Share-based payment
expense 57 22 78
Payment of Non-Executive
Director fees by issue
of shares 36 35 68
Finance costs 9 9 17
Finance income (188) (200) (387)
Gain on foreign exchange (64) - (8)
(Decrease)/increase
in provisions (502) (609) 10
Changes in working
capital:
Decrease/(increase)
in inventories 114 (171) 1,590
Decrease/(Increase)
in current intangible
asset 1,541 - (2,935)
Increase in R&D Expenditure
Credit asset (170) (167) (352)
(Increase)/decrease
in trade and other
receivables (847) (114) 249
(Decrease)/increase
in trade and other
payables (2,944) 235 7,885
Cash used in operations (10,127) (11,993) (13,604)
Finance costs (9) (9) (17)
Income tax refund - 3,775 3,775
----------------------------- ---------- ---------- ------------
Net cash used in operating
activities (10,136) (8,227) (9,846)
----------------------------- ---------- ---------- ------------
12. Acquisition of associate and joint venture
6 Months 6 Months Year
ended ended Ended
30 June 30 June 31 December
2016 2015 2015
Unaudited Unaudited Audited
GBP'000 GBP'000 GBP'000
------------------------ ----------- ----------- -------------
Acquisition cash flows
of associate 5,000 - 9,405
Acquisition cash flows 1,792 - -
of joint venture
6,792 - 9,405
------------------------ ----------- ----------- -------------
In January 2016, hVIVO paid GBP5.0 million cash as deferred
consideration in respect of the equity investment in its associate,
PrEP Biopharm Limited.
On 21 April 2016 hVIVO acquired 49.0% of the share capital of
Imutex Limited for GBP7.0 million consideration under the terms of
a Joint Venture Arrangement with PepTcell Limited (see Note 8). The
acquisition cash flows of joint venture are GBP1.5 million cash
consideration plus legal expenses, together with the costs of
performing services in kind in the period.
Independent review report to hVIVO plc
We have been engaged by the Company to review the condensed set
of Financial Statements in the interim financial report for the six
months ended 30 June 2016 which comprise the Condensed Consolidated
Statement of Comprehensive Income, the Condensed Consolidated
Statement of Financial Position, the Condensed Consolidated
Statement of Changes in Equity, the Condensed Consolidated
Statement of Cash Flows and related notes 1 to 12. We have read the
other information contained in the interim financial report and
considered whether it contains any apparent misstatements or
material inconsistencies with the information in the condensed set
of interim Financial Statements.
This report is made solely to the Company in accordance with
International Standard on Review Engagements (UK and Ireland) 2410
"Review of Interim Financial Information Performed by the
Independent Auditor of the Entity" issued by the Auditing Practices
Board. Our work has been undertaken so that we might state to the
Company those matters we are required to state to it in an
independent review report and for no other purpose. To the fullest
extent permitted by law, we do not accept or assume responsibility
to anyone other than the Company, for our review work, for this
report, or for the conclusions we have formed.
Directors' responsibilities
The interim financial report is the responsibility of, and has
been approved by, the directors. The directors are responsible for
preparing the interim financial report in accordance with the AIM
Rules of the London Stock Exchange. As disclosed in note 1, the
annual Financial Statements of the Group are prepared in accordance
with IFRSs as adopted by the European Union. The condensed set of
Financial Statements included in this half-yearly financial report
has been prepared in accordance with International Accounting
Standard 34, "Interim Financial Reporting," as adopted by the
European Union.
Our responsibility
Our responsibility is to express to the Company a conclusion on
the condensed set of Financial Statements in the interim financial
report based on our review.
Scope of review
We conducted our review in accordance with International
Standard on Review Engagements (UK and Ireland) 2410 "Review of
Interim Financial Information Performed by the Independent Auditor
of the Entity" issued by the Auditing Practices Board for use in
the United Kingdom. A review of interim financial information
consists of making inquiries, primarily of persons responsible for
financial and accounting matters, and applying analytical and other
review procedures. A review is substantially less in scope than an
audit conducted in accordance with International Standards on
Auditing (UK and Ireland) and consequently does not enable us to
obtain assurance that we would become aware of all significant
matters that might be identified in an audit. Accordingly, we do
not express an audit opinion.
Conclusion
Based on our review, nothing has come to our attention that
causes us to believe that the condensed set of Financial Statements
in the interim financial report for the six months ended 30 June
2016 is not prepared, in all material respects, in accordance with
International Accounting Standard 34 as adopted by the European
Union and the AIM Rules of the London Stock Exchange.
Deloitte LLP
Chartered Accountants and Statutory Auditor
Reading, United Kingdom
21 September 2016
This information is provided by RNS
The company news service from the London Stock Exchange
END
IR LFLLLQKFEBBQ
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September 22, 2016 02:01 ET (06:01 GMT)
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