TIDMTRX
RNS Number : 0077B
Tissue Regenix Group PLC
04 June 2019
Tissue Regenix Group plc
Annual Results for the year ended 31 December 2018
Revenues increase to 47% pro forma to GBP11.6m
Up to $20m credit facilities secured
Leeds, 4 June 2019 - Tissue Regenix Group (AIM:TRX) ("Tissue
Regenix" or "The Group") the regenerative medical devices company,
today announces its annual results for the period ending 31
December 2018.
Financial Highlights
-- Increased pro forma revenues by 47% to GBP11.6m (2017: GBP5.2m)
o DermaPure - sales increased by 75% to GBP3.4m (2017: GBP1.9m)
reflecting changes to sales strategy and infrastructure
o Orthopaedics and Dental sales of BioRinse products grew 31% on
a pro forma basis to GBP6.4m
o GBM-v sales grew by 62% to GBP1.8m (2017: GBP1.1m)
-- Gross profit increased to GBP2.6m (2016: GBP0.7m)
-- Operating loss before exceptional items narrowed to GBP8.2m (2017: GBP9.7m)
-- Cash at 31 December 2018 of GBP7.8m
Operational Highlights
-- Signed initial US distribution agreement with Arthrex, Inc.
for selected BioRinse products, which was extended in Q4 to include
Europe
-- Received Human Tissue Authority license for the import of
human tissue products from the US to UK facility to support
International sales growth
-- Successful technical transfer of DermaPure production to San
Antonio facility ahead of schedule
-- Two year clinical data for OrthoPure XT submitted for CE mark
-- Ongoing discussions with potential strategic partners
Corporate and Recent Highlights
-- Credit facilities of up to $20m secured to invest in
additional capital expenditure, to sustain future business growth,
generate further clinical and health economic real world data to
support brand differentiation within dCELL and BioRinse, and for
general corporate and working capital purposes, as announced
separately today
-- Secured additional GPO agreement; coverage now at 95%
-- Successful FDA audit of San Antonio facility
Current trading
The Company exited 2018 with a positive momentum and believes it
can deliver continued growth in 2019 and beyond. This growth will
be driven by its revised focus on the development of strategic
partnerships, identified opportunities in additional geographic
territories, and additional product launches in its pipeline. The
Company continues to trade in line with management expectations for
2019, with a significant weighting towards the second half of the
year due to a continued increase in supply across both the
BioSurgery and Orthopaedics divisions in Q2, a strong order book
and additional upcoming product launches.
Steve Couldwell, CEO, Tissue Regenix Group, commented:
"2018 was an extremely successful year for the Group, as we
continued to expand the attractiveness of our product portfolio
with both clinicians and procurement professionals.
During the year, we significantly grew our top line sales whilst
navigating through the integration of the acquisition of CellRight
technologies, which completed in August 2017. We are now beginning
to experience both commercial and operational synergies of
combining the businesses.
We have continued to develop our commercial partnerships and
have a strong pipeline of both new product launches and product
line extensions, which are expected in the near term. We remain
committed to optimising operations and have introduced new shift
patterns to meet increasing demand. We are optimistic these
benefits will continue into the future.
The additional capital secured through the credit facilities
allows us to focus on further scaling the manufacturing capacity of
the business and pursue further partnership opportunities, driving
the business trajectory towards self-sustainability. With the
commercial foundations now firmly set and the financial position of
the Group stronger, I look forward to another year of exciting
business development and continued business growth."
For more Information:
Tissue Regenix Group plc Tel: 0330 430 3073 /
Caitlin Pearson, Head of Communications 07920272 441
--------------------------------------------- ---------------------
Stifel Nicolaus Europe Limited (Nominated Tel: 0207 710 7600
Adviser and Broker)
Jonathan Senior / Alex Price / Ben Maddison
--------------------------------------------- ---------------------
FTI Consulting Tel: 0203 727 1000
Brett Pollard / Victoria Foster Mitchell
/ Mary Whittow
============================================= =====================
About Tissue Regenix
Tissue Regenix is a leading medical devices company in the field
of regenerative medicine. Tissue Regenix was formed in 2006 when it
was spun-out from the University of Leeds, UK. The company's
patented decellularisation ('dCELL(R) ') technology removes DNA and
other cellular material from animal and human soft tissue leaving
an acellular tissue scaffold which is not rejected by the patient's
body and can then be used to repair diseased or worn out body
parts. Current applications address many critical clinical needs
such as sports medicine, heart valve replacement and wound
care.
In November 2012 Tissue Regenix Group plc set up a subsidiary
company in the United States - 'Tissue Regenix Wound Care Inc.',
January 2016 saw the establishment of joint venture GBM-V, a multi-
tissue bank based in Rostock, Germany.
In August 2017 Tissue Regenix acquired CellRight Technologies(R)
, a biotech company that specializes in regenerative medicine and
is dedicated to the development of innovative osteoinductive and
wound care scaffolds that enhance healing opportunities of defects
created by trauma and disease. CellRight's human osteobiologics may
be used in spine, trauma, general orthopedic, foot & ankle,
dental, and sports medicine surgical procedures.
Highlights
Group sales increased to GBP11.6m (2017: GBP5.2m)
+47% pro forma, driven by;
- DermaPure(R) sales grew by 75% on a reported basis, to GBP3.4m (2017: GBP1.9m)
- CellRight contribution of GBP6.4m via Orthopaedics & Dental, +31% on a pro forma basis
- Increased sales from GBM-V by 62% to GBP1.8m (2017: GBP1.1m)
Significantly reduced Group LBIT for the period GBP8.7m (2017:
GBP10.8m)
Strategic partnerships signed
- Arthrex BioRinse OEM US distribution agreement
- Arthrex EU distribution agreement
- ARMS medical DermaPure distribution agreement
- A number of further strategic opportunities identified
HTA Licence
- Granted for the import of BioRinse(TM) products into the UK,
and over time, as a gateway to Europe
Integration activities
- In-house manufacturing of DermaPure(R) commenced ahead of schedule
- Global employee engagement programme launched - "Verto"
DermaPure(R) positioning
- GPO agreements signed- Premier three year extension
- Premier Supplier Horizon Award
- Commercial "Accelerator" programme established - "Narrow & Deep"
Clinical data programmes
- OrthoPure XT two year clinical data submitted to the regulatory body for CE mark approval
- DermaPure(R) clinical trial for urogynaecology in partnership with ARMS medical
- Protocol for 100 patient prospective observational clinical
trial for DermaPure(R) in orthopaedic trauma
R&D, Product pipeline
- Ongoing discussions with significant R&D partners, initial projects chartered
- SurgiPure XD commercial manufacturing commenced at Leeds facility
- Launch pathway for OrthoPure XT established
Governance
- QCA Corporate Governance Code implemented
- FDA audit Q1 2019 completed
- American Association of Tissue Banks audit Q1 2019
Chairman's statement
"We remain focused on delivering positive, sustainable growth
across all divisions of the business. Our strategic realignment has
been successful and having integrated CellRight Technologies into
the Group, we have achieved considerable commercial and operational
progress. We are well positioned to capitalise on these
achievements, as well as bring new products to the market
throughout the year."
Introduction
2018 was a successful and transformative year
Following the repositioning of the DermaPure(R) product range we
are starting to generate real commercial traction with our dCELL(R)
technology as the market recognises the benefits that these
products can offer both patients and the wider healthcare sector.
Following the acquisition of CellRight Technologies Inc in late
2017, our strategic approach has enabled us to integrate this
business effectively and realise the synergistic benefits that
BioRinse(TM) Technology can offer.
Our Strategy
Following the successful integration of the businesses
throughout 2018 we saw benefits through commercial catalysts such
as the Arthrex US, and laterally the UK distribution agreements;
the ARMS medical distribution agreement and further GPO approvals.
This year we expect that these milestones will act as the
foundations for us to drive momentum and deliver top line revenue
growth.
Financial Performance
We finished the year in line with Board expectations, posting
sales that have grown by 47% pro forma year-on-year across the
three operating divisions. We achieved a strong cash position of
GBP7.8m, due to efficient management of working capital provisions
and an improved LBIT of GBP8.7m.
The Board
In December we announced that Steve Couldwell, CEO would be
taking a leave of absence during Q1 for health reasons. I would
like to thank Gareth Jones, who joined the Company in Q4 and
stepped into the role of interim COO while Steve was away. Steve
continues to be central to our activities and I look forward to his
full return this month.
Corporate Governance
There were many changes implemented throughout 2018 with regard
to the Corporate Governance framework. Most notably, in September
2018, the changes to the AIM Rules for Companies. The Board have
implemented the Quoted Companies Alliance Corporate Governance
Code.
Our People
Through the continued hard work and commitment of our employees,
we have delivered a transformational year of growth and progress. I
would like to extend my thanks to all involved. Jesus Hernandez,
CEO of CellRight Technologies, retired as planned in April 2019. He
played a fundamental role in guiding the businesses through the
integration process and we wish him well in his future
endeavours.
We have appointed Daniel Lee, who has nearly 30 years of
experience within the industry, to the position of President of US
Operations, and since joining in Q1 2019, has already implemented
operational efficiencies within the San Antonio facility.
I would also like to take this opportunity to acknowledge the
achievements that have been made since Steve Couldwell was
appointed CEO. Steve has led the refinement of the commercial
strategy, as well as alignment of the businesses following the
acquisition, and the internal employee engagement initiatives.
His experience and hard-work has been invaluable and play a
fundamental part in the results that we can now report.
As a Board, we also understand that this progress would not be
possible without the dedication and motivation of our employees and
the responsibility that we hold to ensure that their development
and training allows us, as a business, to stay at the forefront of
regenerative medicine developments. Alongside this, we seek to
establish a supportive and innovative working environment allowing
for professional development. It is our responsibility to ensure
that the Company is supported by the correct calibre of people and
talent to secure its ongoing success.
Post balance sheet event
On 3 June 2019, the Group entered into a new loan facility
providing a total of $20m. $10.5m is available for immediate
drawdown with the remaining $9.5m available subject to the
satisfaction of certain conditions at a later date. We believe that
this provides the funding required to continue the growth and
expansion of the business in line with expectations. It will
provide the opportunity to expand our manufacturing capacity in
order to sustain future business growth, build our clinical and
health economic real world data to support brand differentiation,
as well as supporting the continued working capital expenditure as
we move towards self-sustainability in the near future.
Outlook
We have successfully delivered a strong financial performance
while building solid commercial foundations. With opportunities in
additional geographic territories, and additional product launches
in the pipeline, we believe that we can deliver continued growth in
2019 and beyond. We have grown the business in line with our
expectations and projections and the Board and I remain confident
that, with a revised focus on the development of strategic
partnerships, we can achieve sustainable profitability and enhance
shareholder returns. The Board remains confident in the performance
of the business and the commercial expectations for 2019.
Business review
We have an experienced and motivated management team. With
specialists leading each area, we ensure that we can execute
against the deliverable strategy outlined for each division.
Alongside this, we have Executive Directors with extensive
experience in the healthcare industry and the capital markets, and
an experienced and well balanced Board of Directors.
BioSurgery
2018 has been an exceptional year for the BioSurgery division,
growing revenue by 79% on a constant currency basis, highlighting
the increasing market demand for DermaPure(R) and the advantages of
our refined strategic focus.
Expanded GPO coverage and Strategic Partnerships
We have continued to expand our Group Purchasing Organization
(GPO) approvals and now have coverage in institutions accounting
for 95% of the total spend under these agreements. This has opened
up opportunities for us in the hospital arena, where we have seen
the utilisation of DermaPure(R) move into new indications within
the surgical suite, augmenting our historic woundcare
applications.
This was expedited by the ARMS medical agreement which was
announced in February 2018 moving DermaPure(R) into women's health
and particularly urogynecology applications. With an increasing
focus on the safety of alternative solutions, such as a mesh
treatments, where historically between 150,000-200,000 procedures
per year in the US result in serious complications(1) , around 5%
of the total number performed, DermaPure(R) offers advantages due
to its natural regenerative properties. The uptake that we have
seen has driven the advocacy of the product within this application
area with over 300 patients treated by mid-July and the demand in
this area has led to the ongoing development of a DermaPure(R)
product tailored specifically for this application, which we hope
to bring to market during 2019.
Improved DermaPure(R) Positioning
Orthopaedic trauma is another area in which we have seen
significant clinician interest, with DermaPure(R) being used in
tendon wrapping for the achilles tendon through to rotator cuff
repair in the shoulder. As we drive clinician conversion in this
area we are undertaking several case studies in order to strengthen
our clinical data. You can read a case study on page 15.
This verifies the benefits of our 'narrow & deep' sales
philosophy which we have implemented in targeted key institutions,
resulting in greater conversion of applicable physicians and has
also expanded our network of Key Opinion Leaders (KOLs) who are
driving the advocacy of the product throughout their peer
groups.
Surgeons are becoming increasingly aware of the benefits that
DermaPure(R) can offer to both the patient and healthcare provider.
This was highlighted by the world-renowned Cleveland Clinic which
began using DermaPure(R) in 2018, with a case series being shown at
the prestigious VEITH Symposium.
SurgiPure XD
SurgiPure XD, a porcine dermis for use in hernia repair was
previously granted 510(K) approval for the US and underwent a soft
launch at the end of 2018. SurgiPure XD will be manufactured at our
facility in Leeds and is the first commercial dCELL(R) product to
be manufactured there. We expect to engage multiple relevant
distributors for this product during 2019.
Outlook
2018 was a successful year for TRX BioSurgery having
repositioned DermaPure(R) in the hospital arena, forged key
distribution partnerships, increased the clinical application areas
and grown our clinician advocacy and clinical case studies. With
these foundations now in place we expect 2019 to deliver strong
returns as we look to augment our product portfolio with additional
sizes of DermaPure(R) , launch SurgiPure XD with distribution
partners and increase our GPO coverage accessing a new pool of
physicians and patients. In order to meet our projected level of
sales we have augmented our in-house manufacturing of DermaPure by
renewing our agreement with Community Tissue Services as a
third-party manufacturer, allowing us the capacity required to meet
our customers' expectations during 2019 and beyond.
Orthopaedics and Dental
The year to 31 December 2018 was again positive for the
orthopaedics and dental division, with a 31% pro forma increase in
revenue, primarily consisting of the BioRinse(TM) portfolio, and
was the first year in which we benefited from the CellRight
acquisition for a full fiscal year. In addition to the BioRinse(TM)
portfolio there is the potential for dCELL(R) products to also be
utilized in this space, with orthopaedic trauma, sports medicine
and foot and ankle applications for DermaPure(R) the opportunity
for collaboration between the operating divisions offers
opportunities to further our market penetration.
Strategic Partnerships
In March 2018 we announced the first of several notable
strategic partnerships with Arthrex, Inc. who took three of the
BioRinse(TM) portfolio under their own brand 'AlloSync' for
distribution in the US. Arthrex are one of the largest sports
medicine company's in the world having over 2,700 sales reps
globally. The US distribution agreement offers third-party
validation of the differentiation of the BioRinse(TM) technology
and strong advocacy to leverage when securing new customers.
We expanded the Arthrex relationship in November 2018 by
entering a branded distribution agreement in the EU, following the
approval of the Human Tissue Authority (HTA) license which allows
for the importation of our human tissue products from the US into
the UK. Initially our focus will be on the UK market before
expanding into additional European countries; the first training
for the Arthrex European sales reps was undertaken at the facility
in Leeds in Q1 2019, and we expect this agreement to gain traction
over the next 12-18 months as we continue with the education
process and physician conversion.
To accommodate the increasing demand for our products and the
scale of these new partnerships we expanded our BioRinse(TM)
manufacturing capacity through the commencement of a second shift
within the San Antonio facility in Q1 2019.
dCELL(R) Technology
OrthoPure XT continues to progress through the regulatory
approval process for a CE mark. We have collated the 2 year
clinical data which has been submitted to our notified body and
continues to show clinical evidence as a suitable choice for ACL
reconstruction, with biomechanical testing equivalent to current
graft choices, including allograft or autograft. During 2018 we
commenced discussions with the FDA around a pre-clinical trial for
OrthoPure XT in the US. After scoping this out the strategic
decision was made to keep our resources focussed on the E.U market
launch. Likewise, with increasing demand on our dCELL manufacturing
capacity the launch of pathfinder product OrthoPure HT has been
paused.
We remain confident in the clinical outcome and health economic
benefits provided by the product and are poised to commercialise as
soon as the approval is granted. Our launch timeline has been
delayed by the ongoing implementation of the Medical Device
Regulations across Europe and the additional strain that this has
placed on the notified bodies. Our initial focus will be the UK
market where we have several Key Opinion Leaders ready to utilise
the product, before further expanding into Europe, as we gain
country registrations, through a network of distributors.
Dental
In dental, we see huge potential for the use of both the
dCELL(R) and BioRinse(TM) portfolios. Throughout 2019 we will
concentrate on further penetration of the US market which accounts
for half of the total global market.
With a favourable reimbursement framework, consisting primarily
of cash payments dental is an area which we believe has a vast
market opportunity that we will be able to penetrate quickly with
both product portfolios. We see use across the dental market,
including general dentists and maxilliofacial specialists for
routine and complex or corrective cases. The BioRinse(TM) portfolio
is being utilised in procedures such as ridge augmentation whilst
DermaPure(R) provides a soft tissue covering following extraction
or in cases of receding gumlines.
A case study can be viewed on page 15.
Outlook
During 2018 we achieved several important commercial milestones
that allowed the orthopaedics and dental division to accelerate its
growth trajectory. The agreement with Arthrex offers third party
validation of the differentiation of the products and shows the
level of external confidence in our BioRinse(TM) products. With the
further expansion of this partnership into Europe offering
potential access to new markets by leveraging their commercial
experience and infrastructure and we are confident that this growth
will continue throughout 2019.
To maintain these important relationships, we appointed a number
of commercial heads in Q1 2019, including a VP of strategic
partnerships and two additional regional sales directors to support
our expected growth in this division.
Cardiac & GBM-V
Our cardiac division continues to develop a strong clinical data
portfolio from the collaborative work with Dr Francisco da Costa in
Brazil, with the data from a multicentre paediatric trial being
presented at the Heart Valve Society meeting in Sitges in April
2019. We are excited to share this data which further highlights
the advantages of our CardioPure products specifically in younger
patients who typically experience a higher instance of re-operation
or rejection.
The work with our colleagues at GBM-V continues to develop and
we are confident that after navigating the regulatory pathway we
will be able to launch the CardioPure product in Germany in 2020 as
planned.
In addition, GBM-V have established new supply agreements with
additional tissue banks ensuring that the supply of donor materials
is consistent to allow the cornea business to continue to grow,
evidenced in the top line revenue figures which increased by 62%.
This also allows a greater deal of cash self-sufficiency, an
important aspect of the Group reducing its overall cash dependency
and cash burn.
The main focus of GBM-V continues to be the regulatory clearance
and launch for the CardioPure product line.
Commercial
Invested in Operations and Management
In June 2018 we were awarded a Human Tissue Authority (HTA)
license for our facility in Leeds. This allows us to import the
BioRinse(TM) portfolio from the US into the UK for distribution
primarily under the Arthrex agreement. The UK facility will be used
as a hub to allow for further European distribution as individual
Country registrations are granted.
In the US, we transferred the processing of DermaPure(R)
in-house, allowing for end to end control of the manufacturing
process, product quality and product mix. As demand for the
products increased we sourced additional capacity and reduced our
manufacturing risk by engaging with Community Tissue Services to
assist with processing efficiency, donor yield and supplementary
supply.
Additionally, we commenced a second shift within the San Antonio
facility to increase the output of BioRinse(TM) products. This will
allow us to meet the increased demand driven by the throughput of
our partnership agreements in the short term whilst we explore
options to increase manufacturing capacity.
Clinical
In order to strengthen our product positioning and
differentiation we are enhancing the clinical data package to
highlight both the clinical and health economic advantages that
DermaPure(R) can offer. We increased our Key Opinion Leaders and
have undertaken a number of case studies in order to highlight its
use in the various procedures. During 2018 we established a
protocol for a multi-centre prospective observational study which
we intend to commence in the first half of 2019. In addition, we
augmented our clinical team adding an additional three clinical
affairs managers to ensure that commercial reps and distributors
have the required clinical support.
Alongside this, we are also running a number of case series for
both the dCELL(R) and BioRinse(TM) portfolios to enable peer to
peer discussions and the collection of real life, practical
examples.
Delivering new Product Development and I.P.
As we build relationships with strategic partners we also look
to align ourselves with their product development and R&D
functions. The Group has vast experience of bringing products from
concept to completion and has the agility to undertake these tasks
quickly. This allows us to identify opportunities and quickly
create a prototype for testing. Moving forward we look to develop
these skills further and deepen the relationships allowing us to be
positioned as an R&D partner to larger industry players.
We continue to protect and monitor our intellectual property by
maintaining several patents worldwide for the dCELL(R) portfolio
encompassing both the core dCELL(R) Technology and individual
product processes.
The BioRinse(TM) portfolio remains protected by know-how and we
continue to register trademarks for all relevant logos and trade
names.
As we look to expand the opportunities for each product
portfolio and exploit the Global market potential, we also look to
create efficiencies in the processing and manufacturing to allow
for a reduction in both the associated time and financial cost
while maintaining the integrity of the product to allow for
superior clinical outcomes.
Management
In November 2018 Gareth Jones joined as Group CFO and later
stepped into the interim role of COO whilst CEO Steve Couldwell
took a period of leave for health reasons.
Outlook
We focus ourselves around two platform technologies, in three
key clinical application areas with four strategic growth
drivers.
As we look to expand our commercial presence across the globe,
the opportunity for us to license our technology platforms to
potential strategic partners in new territories offers a route to
market, market expertise and access to scalability. This also
allows our direct sales and management team to remain focused on
key markets, in which we are seeing increasing market penetration
and a growth trajectory.
Our strategy around establishing strategic partnerships to help
scale our commercialisation efforts has proven fruitful throughout
2018 and we expect this to continue as we pursue further
partnership opportunities.
Outside of establishing these partnerships we have identified
several commercial synergies to leverage across our portfolio, for
example the use of DermaPure(R) in orthopaedic trauma and dental
procedures. This has also led to specific product specifications
being sought that we can bring to market quickly to address these
procedures.
The Group has made significant commercial progress throughout
the last year and we have positioned ourselves to continue to
develop and grow this momentum. Focusing on our identified
strategic drivers of growth we expect to continue to build strong
commercial foundations which will drive our success far into in the
future.
Financial overview
Revenue
In the year ended 31 December 2018 revenue increased by 122% to
GBP11,619K (2017: GBP5,233K). Revenue from the legacy Tissue
Regenix dCELL(R) product DermaPure(R) increased 75% to GBP3,381K
(2017: GBP1,932k) driven by increased GPO penetration, a strategic
partnership with ARMS Medical and a move into the Orthopaedic
trauma space. With these initiatives in their infancy, we expect
this growth to continue during 2019.
CellRight Technologies, reported under the Orthopaedics and
Dental division, grew revenue 31% year on year to GBP6.4m (2017:
GBP4.9m) on a pro forma basis. In March 2018 we announced a
strategic partnership with Athrex, one of the world's leading
orthopaedic and sports medicine companies, and later successfully
expanded this agreement. They initially took 3 BioRinse products
under their own brand 'AlloSync'. Following the approval of a Human
Tissue Authority License for the UK facility, we extended this
partnership to cover the EU and received our first orders in Q1
2019. This is a partnership we expect to continue to grow
substantially during FY 2019.
The remaining top line revenue growth was derived from GBM-v,
our controlled joint venture in Germany. GBM-v was able to
significantly increase the volume of corneas processed during the
year resulting in revenue growing by 62% to GBP1,842K (2017:
GBP1,135K)
Cost of sales and gross profit
The revenue growth and full year effect of CellRight has
resulted in a commensurate increase in gross profit by 127% to
GBP5,917K (2017: GBP2,606K).Gross margin percentage increased
marginally from 50% to 51% due to a combination of favourable
product mix and realised production efficiencies. As the business
continues to deliver products in greater quantities it has been
possible to realise synergies along with our in-house manufacturing
capabilities and the established nature of the CellRight
business.
Included in cost of sales is, cost of product of GBP4,723K
(2017: GBP2,039K) and third party commissions of GBP979K (2017:
GBP588K).
Administrative Expenses
Administrative expenses increased by GBP1,184K from GBP13,422K
to GBP14,606K. This included GBP423K (2017 GBP1,098K) of
exceptional costs.
Admin expenses before exceptional items increased by GBP1,859K
(mainly attributable to a full year effect of CellRight being in
the Group). Overheads included staff costs (53%), sales and
marketing (8%), research and development (12%), establishment and
administration costs (30%). Operating loss was narrowed to
GBP8,689K (2017: GBP10,816K).
Exceptional items
Cost relating to the settlement of a LifeNet litigation case are
accounted in the exceptional items, covering a final legal payment
and insurance upfront excess. There are no other costs to be
incurred relating to this case.
Finance income / charges
Finance income of GBP72K (2017: GBP47K) represents interest
earned on cash deposits. Finance charges of GBP262K (2017 - nil)
relate to the discounting of earnout consideration on the CellRight
acquisition in line with IFRS (discount rate of 10% applied).
Taxation
The Group submits enhanced research and development tax claims
and elects to exchange tax losses for a cash refund. The refund
receivable for the year ended 31 December 2018 is GBP790K (2017:
GBP1,348K). This fall was due to a reduction in tax credits claimed
as the Group commercialises additional products moving them out of
the R&D phase.
Corporation Tax payable in the US amounted to GBP72K (2017:
GBPnil) due to the profits of CellRight.
Gross tax losses carried forward in the UK were GBP43,352K
(2017: GBP35,819K). The Group does not currently pay tax in the UK.
A deferred tax asset has not been recognised as the timing and
recoverable value of the tax losses is uncertain.
Loss for the year
Loss for the year was GBP8,259K (2017: Loss GBP9,421K). The
number of shares in issue at the reporting date was 1,171,730,823
(2017:1,170,990,924) resulting in a basic loss per share of (0.70p)
(2017: loss (1.00p)).
Balance sheet
At 31 December 2018 the Group had net assets of GBP32,570K
(2017: GBP39,522K) of which cash in hand totalled GBP7,816K (2017:
GBP16,423K) which was ahead of expectations.
Intangible assets increased to GBP19,938k (2017: GBP19,305k) as
foreign exchange revaluation exceeded amortisation. A further
GBP116,000 of development costs were capitalised.
Net working capital increased slightly to GBP3,054k (2017:
GBP2,596k) which reflect the continued growth of the business. The
balance sheet includes corporations tax receivable of GBP1,200k
(2017: GBP1,665k) in respect of UK research and development tax
credits.
Cash absorbed by operations was GBP6,838K (2017: GBP9,786K) as
we continue to move towards breakeven and subsequent
profitability.
Following the acquisition of CellRight, the business
successfully achieved the revenue performance criteria necessary
for the payment of the first milestone. This was due following the
completion of revenue criteria in the first twelve months post
acquisition. This payment amounted to GBP1,564K and, at this stage,
it is currently expected that the second milestone, of equivalent
value, will be paid in full in September 2019.
Dividend
No dividend has been proposed for the year to 31 December 2018
(2017:Nil)
Accounting policies
The Group's consolidated financial information has been prepared
in accordance with International Financial Reporting Standards as
adopted in the EU. The Group's significant accounting policies
which have been applied consistently throughout the year are set
out on pages 50 to 54.
Going Concern
As at 31 December 2018, the Group had GBP7,816k of cash and cash
equivalents available to it. The Directors have considered their
obligation, in relation to the assessment of the going concern of
the Group and each statutory entity within it and have reviewed the
current budget cash forecasts and assumptions as well as the main
risk factors facing the Group as set out on pages 25 to 27.
As separately reported, the Group has successfully raised a debt
facility totalling $20m, of which $10.5m became available
immediately to the Group to drawdown at completion. The Directors
are therefore confident the Group has adequate financial resources
to fund its activities for the forthcoming period.
Principal risks and uncertainties
The principal risks and uncertainties facing the Group are set
out on pages 25 to 27.
Cautionary Statement
The Strategic report, containing the Strategic and Financial
reports of the Group, contains forward looking statements that are
subject to risk factors associated with, amongst other things,
economic and business circumstances occurring from time to time
within the markets in which the Group operates. The expectations
expressed within these statements are believed to be reasonable but
could be affected by a wide variety of variables out-with the
Group's control. These variables could cause the results to differ
materially from current expectations. The forward-looking
statements reflect the knowledge and information available at the
time of preparation.
Consolidated statement of comprehensive income
For the year ended 31 December 2018
Year to Year to
31 December 31 December
2018 2017
Notes GBP000 GBP000
---------------------------------------------- ----- ------------ ------------
REVENUE 2 11,619 5,233
Cost of sales (5,702) (2,627)
---------------------------------------------- ----- ------------ ------------
GROSS PROFIT 5,917 2,606
Administrative expenses before exceptional
items 2 (14,183) (12,324)
Exceptional items (423) (1,098)
---------------------------------------------- ----- ------------ ------------
Total administrative expenses (14,606) (13,422)
---------------------------------------------- ----- ------------ ------------
OPERATING LOSS (8,689) (10,816)
Finance income 72 47
Finance charges (262) -
---------------------------------------------- ----- ------------ ------------
LOSS BEFORE TAXATION (8,879) (10,769)
Tax 3 620 1,348
---------------------------------------------- ----- ------------ ------------
LOSS FOR YEAR (8,259) (9,421)
---------------------------------------------- ----- ------------ ------------
ATTRIBUTABLE TO:
Equity holders of the parent 4 (8,186) (9,221)
Non-controlling interests (73) (200)
---------------------------------------------- ----- ------------ ------------
(8,259) (9,421)
---------------------------------------------- ----- ------------ ------------
OTHER COMPREHENSIVE INCOME:
Foreign currency translation differences -
foreign operations 1,360 (614)
---------------------------------------------- ----- ------------ ------------
TOTAL COMPREHENSIVE EXPENSE FOR THE YEAR (6,899) (10,035)
---------------------------------------------- ----- ------------ ------------
ATTRIBUTABLE TO:
Equity holders of the parent (6,826) (9,835)
Non-controlling interests (73) (200)
---------------------------------------------- ----- ------------ ------------
(6,899) (10,035)
---------------------------------------------- ----- ------------ ------------
LOSS PER SHARE
Basic and diluted loss attributable to equity
holders of parent 4 (0.70)p (1.00)p
---------------------------------------------- ----- ------------ ------------
The loss for the period arises from the Group's continuing
operations.
The accompanying notes form an integral part of the financial
statements.
Consolidated statement of financial position
At 31 December 2018
31 December 31 December
2018 2017
Notes GBP000 GBP000
------------------------------------------------ ----- ----------- -----------
ASSETS
Non-current assets
Property, plant and equipment 2,828 2,994
Intangible assets 19,938 19,305
------------------------------------------------ ----- ----------- -----------
TOTAL NON-CURRENT ASSETS 22,766 22,299
------------------------------------------------ ----- ----------- -----------
Current assets
Inventory 2,330 2,872
Trade and other receivables 3,551 2,503
Corporation tax receivable 1,200 1,665
Cash and cash equivalents 7,816 16,423
------------------------------------------------ ----- ----------- -----------
TOTAL CURRENT ASSETS 14,897 23,463
------------------------------------------------ ----- ----------- -----------
TOTAL ASSETS 37,663 45,762
------------------------------------------------ ----- ----------- -----------
LIABILITIES
Non-current liabilities
Other payables - (635)
Deferred Tax (791) (824)
------------------------------------------------ ----- ----------- -----------
TOTAL NON-CURRENT LIABILITIES (791) (1,459)
------------------------------------------------ ----- ----------- -----------
Current liabilities
Trade and other payables (4,302) (4,781)
------------------------------------------------ ----- ----------- -----------
TOTAL CURRENT LIABILITIES (4,302) (4,781)
------------------------------------------------ ----- ----------- -----------
TOTAL LIABILITIES (5,093) (6,240)
------------------------------------------------ ----- ----------- -----------
NET ASSETS 32,570 39,522
------------------------------------------------ ----- ----------- -----------
EQUITY
Share capital 5 5,859 5,855
Share premium 5 86,398 86,398
Merger reserve 5 10,884 10,884
Reverse acquisition reserve 5 (7,148) (7,148)
Reserve for own shares (831) (831)
Share based payment reserve 1,129 1,186
Retained earnings deficit (63,239) (56,413)
------------------------------------------------ ----- ----------- -----------
EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF PARENT 33,052 39,931
Non-controlling interests (482) (409)
------------------------------------------------ ----- ----------- -----------
TOTAL EQUITY 32,570 39,522
------------------------------------------------ ----- ----------- -----------
Approved by the Board of Directors and authorised for issue on 3
June 2019.
Steven Couldwell
Chief Executive Officer
Company number: 5969271
Consolidated statement of changes in equity
For the year ended 31 December 2018
Attributable to equity holders of parent
-------------- -----------------------------------------------------------------------------------------------------------
Reserve Share
Reverse for based Retained
Share Share Merger acquisition own payment earnings Non-controlling Total
capital premium reserve reserve shares reserve deficit Total interests equity
GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
-------------- -------- ------- -------- ----------- ------- ------- --------- ------- --------------- ----------
At 31 December
2016 3,801 50,461 10,884 (7,148) (831) 1,156 (46,578) 11,745 (209) 11,536
-------------- -------- ------- -------- ----------- ------- ------- --------- ------- --------------- ----------
Loss for the
period - - - - - - (9,221) (9,221) (200) (9,421)
Other
comprehensive
expense - - - - - - (614) (614) - (614)
-------------- -------- ------- -------- ----------- ------- ------- --------- ------- --------------- ----------
Loss and total
comprehensive
expense for
the
period - - - - - - (9,835) (9,835) (200) (10,035)
Issue of
shares 2,000 38,000 - - - - - 40,000 - 40,000
Cost of issue
of
new equity - (2,318) - - - - - (2,318) - (2,318)
Exercise of
share
options 54 255 - - - - - 309 - 309
Share based
payment
expense - - - - - 30 - 30 - 30
-------------- -------- ------- -------- ----------- ------- ------- --------- ------- --------------- ----------
At 31 December
2017 5,855 86,398 10,884 (7,148) (831) 1,186 (56,413) 39,931 (409) 39,522
-------------- -------- ------- -------- ----------- ------- ------- --------- ------- --------------- ----------
Loss for the
period - - - - - - (8,186) (8,186) (73) (8,259)
Other
comprehensive
expense - - - - - - 1,360 1,360 - 1,360
-------------- -------- ------- -------- ----------- ------- ------- --------- ------- --------------- ----------
Loss and total
comprehensive
expense for
the
period - - - - - - (6,826) (6,826) (73) (6,899)
Exercise of
share
options 4 - - - - - - 4 - 4
Share based
payment
credit - - - - - (57) - (57) - (57)
-------------- -------- ------- -------- ----------- ------- ------- --------- ------- --------------- ----------
At 31 December
2018 5,859 86,398 10,884 (7,148) (831) 1,129 (63,239) 33,052 (482) 32,570
-------------- -------- ------- -------- ----------- ------- ------- --------- ------- --------------- ----------
Consolidated statement of cash flows
For the year ended 31 December 2018
Year to Year to
31 December 31 December
2018 2017
Notes GBP000 GBP000
------------------------------------------------- ----- ------------ ------------
OPERATING ACTIVITIES
Loss before taxation (8,879) (10,769)
Adjustment for:
Depreciation of property, plant and equipment 598 482
Amortisation of intangible assets 575 225
Share based payments (57) 30
Interest receivable (72) (47)
Interest payable 262 -
------------------------------------------------- ----- ------------ ------------
Operating cash outflow before working capital
movements (7,573) (10,079)
------------------------------------------------- ----- ------------ ------------
Decrease/(Increase) in inventory 542 (503)
(Increase) in trade and other receivables (1,188) (783)
(Decrease)/Increase in trade and other payables 156 38
------------------------------------------------- ----- ------------ ------------
Cash outflows from operations (8,063) (11,327)
------------------------------------------------- ----- ------------ ------------
Research & Development tax credit received 1,225 1,541
------------------------------------------------- ----- ------------ ------------
Net cash outflow from operations (6,838) (9,786)
------------------------------------------------- ----- ------------ ------------
INVESTING ACTIVITIES
Interest received 72 47
Purchases of property, plant and equipment (290) (130)
Capitalised development expenditure (116) (93)
Acquisition of subsidiary (including contingent
consideration) (1,564) (19,945)
------------------------------------------------- ----- ------------ ------------
Net cash (outflow) from investing activities (1,898) (20,121)
------------------------------------------------- ----- ------------ ------------
FINANCING ACTIVITIES
Proceeds from issue of share capital 5 - 37,682
Proceeds from exercised share options 4 309
------------------------------------------------- ----- ------------ ------------
Net cash inflow from financing activities 4 37,991
------------------------------------------------- ----- ------------ ------------
(Decrease)/Increase in cash and cash equivalents (8,732) 8,084
Foreign exchange translation movement 125 166
Cash and cash equivalents at start of period 16,423 8,173
------------------------------------------------- ----- ------------ ------------
CASH AND CASH EQUIVALENTS AT OF PERIOD 7,816 16,423
------------------------------------------------- ----- ------------ ------------
Notes to the financial statements
For the year ended 31 December 2018
1) Basis of Preparation
The Company is incorporated and domiciled in the United Kingdom
and its registered number is 5969271. The address of the registered
office is Unit 1 and 2 Astley Way, Astley Industrial Estate,
Swillington LS26 8XT. The Company was incorporated on 17 October
2006. The principle activity of Tissue Regenix Group is develop,
manufacture and commercialise biological medical devices.
The figures for the years ended 31 December 2018 and 2017 do not
constitute statutory accounts within the meaning of Section 434 of
the Companies Act 2006. The information contained within this
announcement has been extracted from the audited financial
statements which have been prepared in accordance with
International Financial Reporting Standards ('IFRS') as endorsed by
the European Union ('adopted IFRS'), and those parts of the
Companies Act 2006 applicable to companies reporting under adopted
IFRS. They have been prepared using the historical cost convention
except where the measurement of balances at fair value is required.
The information in this preliminary statement has been extracted
from the audited financial statements for the year ended 31
December 2018 and as such, does not contain all the information
required to be disclosed in the financial statements prepared in
accordance with IFRS.
The auditors have issued an unqualified opinion on the full
financial statements for the year ended 31 December 2018 which will
be made available for shareholders and delivered to the Registrar
of Companies in due course. The financial information for 2018 and
2017 does not comprise statutory financial statements within the
meaning of Section 434 of the Companies Act 2006. Statutory
financial statements for the year ended 31 December 2017, on which
the auditors gave an unqualified opinion, have been delivered to
the Registrar of Companies. No statement has been made by the
auditor under Section 498(2) or (3) of the Companies Act 2006 in
respect of either of these sets of accounts. Further copies of
these results, and the full financial statements when published,
will be available on the Company's website at
www.tissueregenix.com and at the Company's registered office:
Unit 1&2, Astley Way, Astley Lane Industrial Estate,
Swillington, Leeds.LS26 8XT
Going Concern
As at 31 December 2018, the Group had GBP7,816k of cash and cash
equivalents available to it and on 3 June 2019 the group entered
into a new debt facility providing total funds of $20m of which
$10.5m is available immediately, $5m is available from 2020 subject
to further equity funding, and $2.5m is available from 2021 on
achievement of sales targets, with a further $2m available to draw
down at any time. The new debt facility comprises a term loan of
$15m, repayable over four years from 2020 to 2024 and a revolving
credit facility of $5m.
The Directors have considered their obligation, in relation to
the assessment of the going concern of the Group and each statutory
entity within it and have reviewed the current budget cash
forecasts and assumptions through to 31 December 2020 as well as
the main risk factors facing the Group as set out on pages 26-27.
The Directors have also considered the mitigating actions that
could be taken in the event that the conditional elements of the
new debt facility do not become available.
After due enquiry and consideration, and taking account of the
currently available elements of the new debt facility, the
Directors consider that the Group has adequate financial resource
to continue in operational existence for at least 12 months from
the date of approval of these financial statements. Accordingly,
they have adopted the going concern basis in preparing the
financial statements.
2) Segmental Reporting
The following table provides disclosure of the Group's revenue
by geographical market based on location of the customer:
Year Year
to to
31 December 31 December
2018 2017
GBP000 GBP000
-------------- ------------ ------------
USA 9,434 4,098
Rest of world 2,185 1,135
-------------- ------------ ------------
11,619 5,233
-------------- ------------ ------------
Analysis of revenue by customer
During the year ending 31 December 2018 the Group had no
customers who individually exceeded 10% of revenue (2017:13% and
11%).
Operating segments
The Group is organised into BioSurgery, Orthopaedics &
Dental, Cardiac and Other divisions for internal management,
reporting and decision-making, based on the nature of the products
of the Group's businesses. Managers have been appointed within
these divisions, who report to the Chief Executive Officer. These
are the reportable operating segments in accordance with IFRS8
"Operating Segments". The Directors recognise that the operations
of the Group are dynamic and therefore this position will be
monitored as the Group develops.
In accordance with IFRS8, the Group has derived the information
for its operating segments using the information used by the Chief
Operating Decision Maker. The Group has identified the Chief
Executive Officer as the Chief Operating Decision Maker as he is
responsible for the allocation of resources to the operating
segments and assessing their performance.
Central overheads, which primarily relate to operations of the
Group function, are not allocated to the business unit.
Orthopaedics
BioSurgery & Dental Cardiac Other Central Total
----------------- ---------------- ---------------- --------------- --------------- ---------------- ------------------
Year Year Year Year Year Year Year Year Year Year Year Year
to to to to to to to to to to to to
31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec
2018 2017 2018 2017 2018 2017 2018 2017 2018 2017 2018 2017
GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
----------------- ------- ------- ------- ------- ------ ------- ------- ------ ------- ------- -------- --------
Revenue 3,381 1,932 6,396 2,166 - - 1,842 1,135 - - 11,619 5,233
Cost of sales (1,769) (916) (2,676) (829) - - (1,257) (882) - - (5,702) (2,627)
----------------- ------- ------- ------- ------- ------ ------- ------- ------ ------- ------- -------- --------
Gross Profit 1,612 1,016 3,720 1,337 - - 585 253 - - 5,917 2,606
Administrative
costs (4,169) (4,737) (4,992) (3,297) (428) (481) (551) (484) (4,043) (3,325) (14,183) (12,324)
Exceptional
costs - - - - - - - - (423) (1,098) (423) (1,098)
----------------- ------- ------- ------- ------- ------ ------- ------- ------ ------- ------- -------- --------
Operating
loss (2,557) (3,721) (1,272) (1,960) (428) (481) 34 (231) (4,466) (4,423) (8,689) (10,816)
Finance
income/(expense) - - - 3 - - - - (190) 44 (190) 47
----------------- ------- ------- ------- ------- ------ ------- ------- ------ ------- ------- -------- --------
Loss before
taxation (2,557) (3,721) (1,272) (1,957) (428) (481) 34 (231) (4,656) (4,379) (8,879) (10,769)
Taxation 73 372 543 722 102 254 - - (98) - 620 1,348
----------------- ------- ------- ------- ------- ------ ------- ------- ------ ------- ------- -------- --------
Loss for
the year (2,484) (3,349) (729) (1,235) (326) (227) 34 (231) (4,754) (4,379) (8,259) (9,421)
----------------- ------- ------- ------- ------- ------ ------- ------- ------ ------- ------- -------- --------
Revenue from all operating segments derives from the sale of
biologic medical devices.
Administrative costs are broken down as follows:
Orthopaedics
BioSurgery & Dental Cardiac Other Central Total
--------------- ---------------- ---------------- --------------- -------------- ---------------- ------------------
Year Year Year Year Year Year Year Year Year Year Year Year
to to to to to to to to to to to to
31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec 31 Dec
2018 2017 2018 2017 2018 2017 2018 2017 2018 2017 2018 2017
GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
--------------- ------- ------- ------- ------- ------ ------- ------ ------ ------- ------- -------- --------
Staff costs (2,936) (3,343) (2,639) (1,837) (222) (281) (297) (181) (1,365) (1,135) (7,459) (6,777)
--------------- ------- ------- ------- ------- ------ ------- ------ ------ ------- ------- -------- --------
Sales and
marketing
costs (901) (64) (125) (17) (25) (4) (20) (21) - - (1,071) (106)
--------------- ------- ------- ------- ------- ------ ------- ------ ------ ------- ------- -------- --------
Research and
development (164) (277) (1,307) (894) (164) (147) - (32) - - (1,635) (1,350)
--------------- ------- ------- ------- ------- ------ ------- ------ ------ ------- ------- -------- --------
Depreciation
and
amortisation (20) (25) (279) (97) - - (7) (25) (867) (560) (1,173) (707)
--------------- ------- ------- ------- ------- ------ ------- ------ ------ ------- ------- -------- --------
Establishment
and
administration
costs (148) (1,028) (642) (452) (17) (49) (227) (225) (1,811) (1,630) (2,845) (3,384)
--------------- ------- ------- ------- ------- ------ ------- ------ ------ ------- ------- -------- --------
Administrative
costs (4,169) (4,737) (4,992) (3,297) (428) (481) (551) (484) (4,043) (3,325) (14,183) (12,324)
--------------- ------- ------- ------- ------- ------ ------- ------ ------ ------- ------- -------- --------
Balance Sheet
Orthopaedics/
BioSurgery Dental Cardiac Other Central Total
------------ --------------- ---------------- --------------- ---------------- ---------------- ----------------
2018 2017 2018 2017 2018 2017 2018 2017 2018 2017 2018 2017
GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Non-current
assets
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Intangible
Assets 759 643 4,649 4,373 - - - - 14,530 14,289 19,938 19,305
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Property,
Plant &
Equipment 20 2 2,153 2,290 - - 101 69 264 503 2,538 2,864
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Additions 6 38 204 - - - 54 40 26 52 290 130
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Total
non-current
assets 785 683 7,006 6,663 - - 155 109 14,820 14,844 22,766 22,299
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Current
assets
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Inventory 222 648 1,957 2,123 - - 74 15 77 86 2,330 2,872
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Trade &
other
receivables 939 780 2,856 2,138 200 221 121 348 635 681 4,751 4,168
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Cash & cash
equivalents 170 254 409 89 2 6 35 47 7,200 16,027 7,816 16,423
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Total
current
assets 1,331 1,682 5,222 4,350 202 227 230 410 7,912 16,794 14,897 23,463
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Total assets 2,116 2,365 12,228 11,013 202 227 385 519 22,732 31,638 37,663 45,762
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Current
liabilities
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Trade &
other
payables (553) (697) (2,474) (1,998) (42) (22) (102) (271) (1,922) (3,252) (5,093) (6,240)
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Total
liabilities (553) (697) (2,474) (1,998) (42) (22) (102) (271) (1,922) (3,252) (5,093) (6,240)
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
Net Assets 1,563 1,668 9,754 9,015 160 205 283 248 20,810 28,386 32,570 39,522
------------ ------ ------- ------- ------- ------ ------- ------- ------- ------- ------- ------- -------
3) Taxation
Tax on loss on ordinary activities
Year to Year to
31 December 31 December
2018 2017
GBP000 GBP000
--------------------------------------------------------- ------------ ------------
Current tax:
UK corporation tax credit on losses of period (790) (1,348)
US corporation tax payable 72 -
--------------------------------------------------------- ------------ ------------
718 (1,348)
Deferred tax:
Origination and reversal of temporary timing differences 98 -
--------------------------------------------------------- ------------ ------------
Tax credit on loss on ordinary activities (620) (1,348)
--------------------------------------------------------- ------------ ------------
Factors affecting the current tax charges
The tax assessed for the year varies from the main rate of
corporation tax as explained below:
Year to Year to
31 December 31 December
2018 2017
GBP000 GBP000
----------------------------------------------------------- ------------ ------------
The tax assessed for the period varies from the small
company rate of corporation tax as explained below:
Loss on ordinary activities before tax (8,879) (10,769)
Tax at the standard rate of corporation tax 19% (2017:
19.25%) (1,687) (2,074)
Effects of:
Research and development tax credits received (583) (799)
Surrender of research and development relief for repayable
tax credit 792 1,098
Research and development enhancement (448) (621)
Prior period adjustment (141) (549)
Other 170 -
Unutilised tax losses 1,277 1,597
----------------------------------------------------------- ------------ ------------
Tax credit for the period (620) (1,348)
----------------------------------------------------------- ------------ ------------
Deferred Tax
Year to Year to
31 December 31 December
2018 2017
GBP000 GBP000
--------------------------------------------------------- ------------ ------------
Tax losses
Losses available to carry forward against future trading
profits 43,254 35,819
Deferred tax asset - unrecognised* 7,353 6,089
--------------------------------------------------------- ------------ ------------
*The Group has not recognised a deferred tax asset relating to
these losses as their recoverability is uncertain.
4) Loss Per Share (Basic and Diluted)
Basic loss per share is calculated by dividing the loss
attributable to equity holders of the parent by the weighted
average number of ordinary shares in issue during the period
excluding own shares held jointly by the Tissue Regenix Employee
Share Trust and certain employees. Diluted loss per share is
calculated by adjusting the weighted average number of ordinary
shares in issue during the year to assume conversion of all
dilutive potential ordinary shares.
Year to Year to
31 December 31 December
2018 2017
GBP000 GBP000
----------------------------------------------------- ------------ ------------
Total loss attributable to the equity holders of the
parent (8,186) (9,221)
----------------------------------------------------- ------------ ------------
No. No.
---------------------------------------------------- ------------- -----------
Weighted average number of ordinary shares in issue
during the year 1,171,633,442 920,506,514
---------------------------------------------------- ------------- -----------
Loss per share
Basic and diluted loss for the year (0.70)p (1.00)p
---------------------------------------------------- ------------- -----------
The Company has issued employee options over 53,577,615 (2017:
53,119,254) ordinary shares and there are 16,112,800 jointly owned
shares which are potentially dilutive. There is, however, no
dilutive effect of these issued options as there is a loss for each
of the periods concerned.
5) Share Capital and reserves
Reverse
Merger acquisition
Share capital Share premium reserve reserve Total
Number GBP000 GBP000 GBP000 GBP000 GBP000
------------------------ ------------- ------------- ------------- -------- ------------ -------
Total Ordinary shares
of 0.5 p each as at
31 December 2016 760,124,264 3,801 50,461 10,884 (7,148) 57,998
Issue of shares 400,000,000 2,000 35,682 - - 37,682
Share options exercised 10,866,660 54 255 - - 309
------------------------ ------------- ------------- ------------- -------- ------------ -------
Total Ordinary shares
of 0.5p each as at 31
December 2017 1,170,990,924 5,855 86,398 10,884 (7,148) 95,989
Share options exercised 739,899 4 - - - 4
------------------------ ------------- ------------- ------------- -------- ------------ -------
Total Ordinary shares
of 0.5p each as at 31
December 2018 1,171,730,823 5,859 86,398 10,884 (7,148) 95,993
------------------------ ------------- ------------- ------------- -------- ------------ -------
As permitted by the provisions of the Companies Act 2006, the
Company does not have an upper limit to its authorised share
capital. All shares are ordinary shares which are fully paid and
entitle the holder to full voting rights, to full participation or
distribution of dividends.
Directors and Officers
DIRECTORS
John Samuel (Chairman)
Steven Couldwell (Chief Executive Officer)
Gareth Jones (Chief Financial Officer)
Jonathan Glenn (Non-Executive Director)
Alan Miller (Non-Executive Director)
Randeep Singh Grewal (Non-Executive Director)
Shervanthi Homer-Vanniasinkam (Non-Executive Director)
COMPANY SECRETARY
Gareth Jones
COMPANY WEBSITE
www.tissueregenix.com
COMPANY NUMBER
05969271 (England & Wales)
REGISTERED OFFICE
Unit 1 & 2
Astley Way
Astley Lane Industrial Estate
Leeds
West Yorkshire
LS26 8XT
REGISTRAR
Link Asset Services
The Registry
34 Beckenham Road
Beckenham
Kent
BR3 4TU
AUDITOR
RSM UK Audit LLP
Central Square
29 Wellington Street
Leeds
LS1 4DL
LEGAL ADVISER
DLA Piper UK LLP
Princes Exchange
Princes Square
Leeds
LS1 4BY
NOMINATED ADVISER AND BROKER
Stifel Nicolaus Europe Ltd
150 Cheapside
London
EC2V 6ET
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
FR FJMTTMBJMTRL
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