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

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Tissue Regenix (LSE:TRX)
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From May 2024 to Jun 2024 Click Here for more Tissue Regenix Charts.
Tissue Regenix (LSE:TRX)
Historical Stock Chart
From Jun 2023 to Jun 2024 Click Here for more Tissue Regenix Charts.