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 £11.6m

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 £11.6m (2017: £5.2m)

DermaPure - sales increased by 75% to £3.4m (2017: £1.9m) reflecting changes to sales strategy and infrastructure

Orthopaedics and Dental sales of BioRinse products grew 31% on a pro forma basis to £6.4m

GBM-v sales grew by 62% to £1.8m (2017: £1.1m)

•     Gross profit increased to £2.6m (2016: £0.7m)

•     Operating loss before exceptional items narrowed to £8.2m (2017: £9.7m)

•     Cash at 31 December 2018 of £7.8m

 

 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

Caitlin Pearson, Head of Communications  

Tel: 0330 430 3073 / 07920272 441

 

 

Stifel Nicolaus Europe Limited (Nominated Adviser and Broker)

Jonathan Senior / Alex Price / Ben Maddison

Tel:  0207 710 7600

 

 

 

FTI Consulting 

Brett Pollard / Victoria Foster Mitchell / Mary Whittow

Tel: 0203 727 1000

 

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®') 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®, 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 £11.6m (2017: £5.2m)

+47% pro forma, driven by;

−   DermaPure® sales grew by 75% on a reported basis, to £3.4m (2017: £1.9m)

−   CellRight contribution of £6.4m via Orthopaedics & Dental, +31% on a pro forma basis

−   Increased sales from GBM-V by 62% to £1.8m (2017: £1.1m)

 

Significantly reduced Group LBIT for the period £8.7m (2017: £10.8m)

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™ products into the UK, and over time, as a gateway to Europe

 

Integration activities

−   In-house manufacturing of DermaPure® commenced ahead of schedule

−   Global employee engagement programme launched - "Verto"

 

DermaPure® 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® clinical trial for urogynaecology in partnership with ARMS medical

−   Protocol for 100 patient prospective observational clinical trial for DermaPure® 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® product range we are starting to generate real commercial traction with our dCELL® 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 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 £7.8m, due to efficient management of working capital provisions and an improved LBIT of £8.7m.

 

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® 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® 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® 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 complications1, around 5% of the total number performed, DermaPure® 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® product tailored specifically for this application, which we hope to bring to market during 2019.

 

Improved DermaPure® Positioning

Orthopaedic trauma is another area in which we have seen significant clinician interest, with DermaPure® 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® can offer to both the patient and healthcare provider. This was highlighted by the world-renowned Cleveland Clinic which began using DermaPure® 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® 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® 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®, 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 portfolio, and was the first year in which we benefited from the CellRight acquisition for a full fiscal year. In addition to the BioRinse portfolio there is the potential for dCELL® products to also be utilized in this space, with orthopaedic trauma, sports medicine and foot and ankle applications for DermaPure® 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 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 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 manufacturing capacity through the commencement of a second shift within the San Antonio facility in Q1 2019.

 

dCELL® 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® and BioRinse 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 portfolio is being utilised in procedures such as ridge augmentation whilst DermaPure® 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 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 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® 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 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® 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® and BioRinse 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® portfolio encompassing both the core dCELL® Technology and individual product processes.

 

The BioRinse 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® 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 £11,619K (2017: £5,233K). Revenue from the legacy Tissue Regenix dCELL® product DermaPure® increased 75% to £3,381K (2017: £1,932k) 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 £6.4m (2017: £4.9m) 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 £1,842K (2017: £1,135K)

 

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 £5,917K (2017: £2,606K).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 £4,723K (2017: £2,039K) and third party commissions of £979K (2017: £588K).

 

Administrative Expenses

Administrative expenses increased by £1,184K from £13,422K to £14,606K. This included £423K (2017 £1,098K) of exceptional costs.

 

Admin expenses before exceptional items increased by £1,859K (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 £8,689K (2017: £10,816K).

 

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 £72K (2017: £47K) represents interest earned on cash deposits. Finance charges of £262K (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 £790K (2017: £1,348K). 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 £72K (2017: £nil) due to the profits of CellRight.

Gross tax losses carried forward in the UK were £43,352K (2017: £35,819K). 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 £8,259K (2017: Loss £9,421K). 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 £32,570K (2017: £39,522K) of which cash in hand totalled £7,816K (2017: £16,423K) which was ahead of expectations.

 

Intangible assets increased to £19,938k (2017: £19,305k) as foreign exchange revaluation exceeded amortisation. A further £116,000 of development costs were capitalised.

 

Net working capital increased slightly to £3,054k (2017: £2,596k) which reflect the continued growth of the business. The balance sheet includes corporations tax receivable of £1,200k (2017: £1,665k) in respect of UK research and development tax credits.

 

Cash absorbed by operations was £6,838K (2017: £9,786K) 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 £1,564K 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 £7,816k 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

 

 

Notes

Year to

31 December

2018

£000

Year to

31 December

2017

£000

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

 

Notes

31 December

2018

£000

31 December

2017

£000

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

 

 

Share capital

£000

Share premium

£000

 

 

Merger reserve

£000

Reverse acquisition reserve

£000

Reserve for own shares

£000

Share based payment reserve

£000

Retained earnings deficit

£000

Total

£000

Non-controlling interests

£000

Total equity

£000

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

 

Notes

Year to

31 December

2018

£000

Year to

31 December

2017

£000

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 END 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 £7,816k 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

 to

31 December

2018

£000

Year

 to

31 December

2017

£000

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.

 

 

BioSurgery

Orthopaedics & Dental

Cardiac

Other

Central

Total

Year to

31 Dec

2018

£000

Year to

31 Dec

2017

£000

Year to

31 Dec

2018

£000

Year to

31 Dec

2017

£000

Year to

31 Dec

2018

£000

Year to

31 Dec

2017

£000

Year to

31 Dec

2018

£000

Year to

31 Dec

2017

£000

Year to

31 Dec

2018

£000

Year to

31 Dec

2017

£000

Year to

31 Dec

2018

£000

Year to

31 Dec

2017

£000

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:

 

 

BioSurgery

Orthopaedics & Dental

Cardiac

Other

Central

Total

Year to

31 Dec

2018

£000

Year to

31 Dec

2017

£000

Year to

31 Dec

2018 £000

Year to

31 Dec

2017

 £000

Year to

31 Dec

2018

£000

Year to

31 Dec

2017

£000

Year to

31 Dec

2018

£000

Year to

31 Dec

2017

£000

Year to

31 Dec

2018

£000

Year to

31 Dec

2017

£000

Year to

31 Dec

2018

£000

 Year to

31 Dec

2017

£000

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

 

 

BioSurgery

Orthopaedics/ Dental

Cardiac

Other

Central

Total

2018

£000

2017

£000

2018

£000

2017

£000

2018

£000

2017

£000

2018

£000

2017

£000

2018

£000

2017

£000

2018

£000

2017

£000

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

31 December

2018

£000

Year to

31 December

2017

£000

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

31 December

2018

£000

Year to

31 December

2017

£000

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

31 December

2018

£000

Year to

31 December

2017

£000

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

31 December

2018

£000

Year to

31 December

2017

£000

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

 

 

Number

Share capital

£000

Share premium

£000

Merger reserve

£000

Reverse acquisition reserve

£000

Total

£000

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

 


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