Unaudited Interim Results

RNS Number : 4946Z
Tissue Regenix Group PLC
03 September 2018
 

 

 

 

Tissue Regenix Group plc

 

Unaudited Interim Results for the six months ended 30 June 2018

Group sales grow +61% (pro forma) year on year

Gross margin increased by 12.1 percentage points to 56%

 

Leeds, 03 September 2018 - Tissue Regenix Group (AIM:TRX) ("Tissue Regenix" or "The Group") the regenerative medical devices company today announces its unaudited interim results for the six months ended 30 June 2018.

 

Financial Highlights

•     Group sales increased to £5.6m (H1 2017: £1.3m) +61% pro forma, driven by;

DermaPure® sales grew by 73% on a reported basis, 96% in constant currency, to £1.5m (H1 2017: £0.9m)

CellRight contribution of £3.2m under orthopaedics and dental, +46% pro forma

Increased sales from GBM-V by 70% to £0.9m (H1 2017: £0.5m)

•     Gross margin increased by 12.1 percentage points to 56% 

•     Significantly narrowed Group EBITDA loss for the period £3.5m (£5.1m)

•     Cash balance at 30 June 2018 £12.2m (H1 2017: £3.6m)

•     Overall cash outflow reduced £4.3m (H1 2017: £4.6m)

 

Operational Highlights

 

•     Distribution agreements signed with Arthrex, inc. ARMS medical and Pennine Healthcare 

•     Human Tissue Authority licence granted for the import of the BioRinse portfolio into the UK

•     DermaPure® manufacturing successfully transferred into CellRight facility ahead of schedule

•     Additional GPO coverage for DermaPure, with an additional 3 year contract under Premier, Inc. 

•     Premier, Inc. 'Supplier Horizon Award' granted

•     R&D portfolio review undertaken, and operational efficiency initiatives implemented

 

Post Period 

•     Appointed Gareth Jones as Chief Financial Officer, to commence Q4 2018  

•     First commercial manufacture of SurgiPure XD for distribution into the US

 

Steve Couldwell, CEO, Tissue Regenix Group: "We have delivered a strong first half performance. I am pleased with the growing momentum across our business and we increased market penetration in our key clinical areas as a result of the good progress against our refined strategy.  Central to our commercial success has been the strategic distribution agreements with Arthrex, for US distribution of the BioRinse portfolio, ARMS medical for the exclusive distribution of DermaPure in the Urogynaecology space and Pennine Healthcare, the first UK distribution agreement for our enlarged Group. We continue to increase our focus on commercial execution to drive the sales of both dCELL®, through DermaPure, and the growing demand for the BioRinse portfolio from direct and OEM customers. 

We recently passed the first anniversary of the CellRight acquisition and have navigated through the integration process, successfully transferring the processing of DermaPure into the CellRight San Antonio facility, and leveraging the development, operational and commercial experience of the combined companies.

As the demand for our products continues to increase we are proactively reviewing our capacity capabilities to ensure that we can scale the business to meet future production requirements.  We have identified a number of potential new commercial opportunities which we are actively pursuing and anticipate our current momentum will continue. We remain committed to our objective of being break-even in 2020. "

 

 

 

 

For more Information:

 

Tissue Regenix Group plc

Caitlin Pearson                                 Head of Communications  

Tel: 0330 430 3073 / 07920272 441



Jefferies International Ltd

Simon Hardy / Christopher Binks  

Tel:  020 7029 8000

 



FTI Consulting 

Brett Pollard / Mo Noonan/ 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.', rebranded TRX BioSurgery in early 2018. 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 orthopaedic, foot & ankle, dental, and sports medicine surgical procedures.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TISSUE REGENIX GROUP PLC

interim financial report for the six months up to 30 june 2018

Who We Are

TISSUE REGENIX GROUP IS A PIONEERING, INTERNATIONAL MEDICAL TECHNOLOGY COMPANY, FOCUSING ON THE DEVELOPMENT OF REGENERATIVE PRODUCTS UTILISING OUR TWO PLATFORM TECHNOLOGIES, DCELL® TECHNOLOGY, ADDRESSING SOFT TISSUE NEEDS, AND BIORINSE®, PROVIDING INDUCTIVE BONE ALLOGRAFTS. WE ARE HELPING TO TRANSFORM THE TREATMENT OF PATIENTS IN FOUR KEY AREAS: BIOSURGERY, ORTHOPAEDICS (SPORTS MEDICINE/SPINE), DENTAL AND CARDIAC.

Highlights

·     Group sales increased to £5.6m

̶   DermaPure® sales grew by 73% on a reported basis, 96% in constant currency, to £1.5m (H1 2017: £0.9m)

̶   Increased sales from GBM-V by 70% to £0.9m (H1 2017: £0.5m)

̶   CellRight contribution of £3.2m under orthopaedics and dental 

·     Group EBITDA loss for the period of £3.5m

̶   Improvement from £5.1m loss in H1 2017

̶   Cash balance at 30 June 2018 £12.2m (H1 2017: £3.6m)

·     Significant strategic partnerships signed

̶   Long-term distribution agreement with Arthrex, Inc. for BioRinse portfolio

̶   Exclusive agreement with ARMS Medical for DermaPure

̶   UK distribution agreement for BioRinse portfolio with Pennine Healthcare

·     Integration highlights

̶   DermaPure manufacturing successfully transferred into CellRight facility ahead of schedule

̶   HTA License granted for import of BioRinse products into the UK.

Our Vision

To establish Tissue Regenix as a leader in the science and innovation of regenerative medicine and become our clinicians' partner of choice to meet growing clinical needs, transform patient care and deliver favourable health economic outcomes.

 

Chairman's Statement

John Samuel Chairman

Our strong first half performance is a direct result of delivering against our strategic objectives and the changes we implemented in our commercial focus.

We have invested to establish a foundation of novel regenerative technologies, generating a solid pipeline of products for commercial and technical development, and we maintain a healthy cash position.

Management and Personnel

We have strengthened our Board with the appointment of Gareth Jones as Chief Financial Officer who will join the Company in Q4 2018. Paul Below, interim CFO, will remain with the Company in order to facilitate an orderly transition period.

We would like to thank him for his support during this interim period.

Outlook 

We have carried our positive momentum into the second half of the year. The successful creation of partnership opportunities has reaffirmed our decision to evolve our strategic vision and we look to sign additional agreements by the end of the year.

In the period, efficiency initiatives within our R&D portfolio, BioSurgery infrastructure and the Leeds operational site has bolstered our cash position. We remain committed to our objective of break even in 2020.

Performance in the first half of the year reflects growing demand for our products and increasing commercial traction. Growth at the beginning of the second half of the year remains encouraging and with further strategic and commercial opportunities expected throughout the remainder of the year we expect this momentum to continue.

I would like to thank our employees and shareholders who remain dedicated to and supportive of the Company.

 

CEO Operational Review

Steven Couldwell, Chief Executive Officer

In the first half of 2018, we have continued to deliver the growth synergies identified at the time of our acquisition of CellRight Technologies whilst also increasing the commercial traction of our organic dCELL products.

Our US BioSurgery division continues to generate organic growth with an increase of 73% for sales of DermaPure in the US, 96% on a constant currency basis, resulting in an uplift to £1.5m (H1 2017: £0.9m).

CellRight products based on the complementary BioRinse Technology, contributed sales of £3.2m to our Orthopaedics and Dental division in the period.

Also, revenues from our Joint Venture, GBM-V, rose by 70% to £0.9m (H1 2017: £0.5m).

Business Review

Integration

These are the first results which incorporate a full six month period of the combined businesses and demonstrates the transformational effect of the acquisition. Our performance reflects the successful integration, and the compelling rationale behind the acquisition.

We completed several steps of the integration process ahead of schedule, a testament to the teams both in the UK and US, allowing us to maintain our focus on growing commercial traction. With the manufacturing of DermaPure successfully transferred into the CellRight facility, for the first time we have end to end control of the manufacturing process.

Demand for our products continues to increase and we are now reviewing our capacity capabilities to ensure that we can scale the business to meet the future production requirements.

Alongside leveraging these commercial opportunities we have commenced a global vision and culture programme for all employees to establish a consistent corporate culture across the Company. This initiative has been well received,and evidenced by collaborative working across the business units creating a cohesive approach to commercial opportunities presented.

Product Development & Pipeline

During the period we have undertaken a comprehensive review of our R&D portfolio in order to streamline our current programmes and focus our efforts on developing products with a clear market demand and commercialisation pathway. As we execute against our revised commercial strategy announced in March 2018, our product development expertise is being increasingly utilised by strategic partners for both OEM opportunities and as an extension of their own R&D capabilities. This has allowed us to initiate a number of workstreams that we would expect to come to fruition in the near future.

Operational Overview BioSurgery

Sales of DermaPure continue to gain traction in the Urogynaecology market through our exclusive distribution agreement with ARMS Medical. Over 300 patients having now benefited from the use of DermaPure in these procedures. We also continue to grow the organic business through our direct sales force and GPO coverage. In May we announced that we have been awarded a further three year contract under Premier, Inc. which became effective July 1st 2018, maintaining our access to the network of 3,900 hospitals and 150,00 provider organisations under Premiers' umbrella. Subsequently, in June TRX BioSurgery was awarded the 'Supplier Horizon Award' at Premiers Breakthrough conference. The Supplier Horizon Award recognizes suppliers that have been contracted with Premier for less than three years for exceptional local customer service and engagement, value creation through clinical excellence and commitment to lower costs. Notably the awards are voted upon by Premier members who have the first-hand experience of the products being used in clinical settings. This again highlights not only the differentiated clinical outcomes from the use of DermaPure, but also the health economic advantages of its' single application in many hospital settings, and re affirms our value proposition in the space. This has led to increased recognition of the TRX BioSurgery brand and subsequent growth of our DermaPure revenue stream.

SurgiPure XD, our dCELL xenograft dermis product, is ready for imminent launch into the US market through our BioSurgery division. Having received 510(k) clearance from the FDA we have undertaken our first batch of commercial manufacture for this product at the facility in Leeds and have established a commercial roll-out plan to penetrate the relevant markets. This demonstrates an opportunity that has been further realised due to the relationships and experience of the CellRight operational team.

Orthopaedics & Dental

The two year clinical data for OrthoPure XT, dCELL® xenograft tendon is expected at the end of September 2018 and we now anticipate that, in line with the original trial protocol, we will submit to the regulatory body for a CE mark by the end of the year with a potential commercialisation date in Q1 2019. This two year clinical data will strengthen not only our EU submission but will also prove useful in additional clinical trial applications.

Signing the Arthrex distribution agreement was a pivotal milestone for our BioRinse portfolio in the US, with three of the portfolio products being taken under Arthrex OEM brand 'Allosync'. We have also focussed on geographic expansion and the successful approval of the HTA licence in June will allow us to import and distribute the BioRinse products into the UK and, over time, throughout the EU. In order to expedite our route to market in these territories, we have signed a distribution agreement with Pennine Healthcare, a specialist orthopaedic distributor based in the UK, and we are currently engaged in a number of discussions for potential partners in other key European countries.

Through the acquisition of CellRight, Tissue Regenix entered the attractive Dental market. In the last year we have seen the demand for the BioRinse products in this area increase. We intend to leverage the favourable reimbursement framework and the need for new, novel products in this underserved clinical setting.

Cardiac

The trials for our dCELL® valves in Brazil continue to deliver good results. We are progressing development plans at our joint venture, GBM-V in Germany and we remain on track to gain manufacturing approval during 2019 with the additional marketing clearance allowing for commercialisation in 2020.

GBM-V continues to process the sales of Corneas, which offsets the operational costs of the facility as we continue with the development of the CardioPure products.

Strategic partnerships

During the first half of the year we announced significant partnerships in line with our revised commercial strategy. Initially in the first quarter with Arthrex for the BioRinse products, shortly followed by an exclusive deal with ARMS medical, a specialist urogynaecology distributor, for DermaPure in the US, and then our first UK distribution agreement for the enlarged Group with Pennine Healthcare, again for the BioRinse portfolio. We look to build out a network of key accounts and distributors to drive both revenues and build our reputation as a leader in regenerative medical products.

 

Financial Summary

For the six months ended 30 June 2018


6 months

30 June

2018

(Unaudited)

£000

6 months

30 June

2017

(Unaudited)

£000 

Change

£000

Change

%

Revenue

5,574

1,343

4,231

315%

Cost of Sales

(2,451)

(754)

(1,697)

225%

Gross Profit

3,123

589

2,534

430%






Other Operating Costs

(6,597)

(5,687)

(910)

16%






Adjusted LBITDA

(3,474)

(5,098)

1,624

-32%






Depreciation

(283)

(209)

(74)

35%

Amortisation

(267)

-

(267)

0%

Share-based payment

(212)

(135)

(77)

57%

Finance income

42

17

25

0%

Finance charges

(146)

-

(146)

0%






Adjusted Loss before tax

(4,340)

(5,425)

1,085

-20%






Taxation - payable

(47)

-

(47)

0%

Taxation - R&D credits

352

660

(308)

-47%






Adjusted Loss after tax

(4,035)

(4,765)

730

-15%






Exceptional items

(500)

-

(500)

0%






Statutory loss

(4,535)

(4,765)

230

-5%

The results for the half year to 30 June 2018 are not directly comparable as these include CellRight, which was acquired after the comparative half year for the period ended 30 June 2017.

In order to provide a clearer understanding of the performance of the business the loss in statutory format has been adjusted in the table above.

Loss before depreciation, amortisation, share-based payments, finance income and tax ("Adjusted LBITDA") in the six months ended 30 June 2018 improved to £3,474K (H1 2017: £5,098K)

Adjusted loss before tax was £4,340K (H1 2017: £5,425K). A new charge of £267K was recognised in respect of the amortisation of the intangible assets recognised on the acquisition of CellRight.

Taxation of £47K represents estimated tax chargeable on the profits of CellRight. R&D tax credits of £352K (H1 2017: £660K) represent the estimated tax credit receivable together with a premium of 40%, on development costs.

Exceptional costs of £500K represent the legal fees and settlement costs of litigation.

Cash Flow

Cash outflow from operations was £4,166K (H1 2017: £4,557K). This includes £500K of exceptional costs detailed above.

Overall cash outflow was £4,257K (H1 2017: £4,565K). The cash balance at 30 June 2018 was £12,215K (H1 2017: £3,608K).

Steve Couldwell

Chief Executive Officer

 

Condensed Consolidated Statement of Comprehensive Income

For The six Months ended 30 June 2018


Notes

6 months

30 June

2018

(Unaudited)

£000

6 months

30 June

2017

(Unaudited)

£000 

Year

31 Dec

2017

(Audited)

£000

Revenue


5,574

1,343

5,233

Cost of sales


(2,451)

(754)

(2,627)

Gross Profit


3,123

589

2,606

Administrative expenses before exceptional items


(7,359)

(6,031)

(12,324)

Exceptional items


(500)

-

(1,098)

Total administrative expenses


(7,859)

(6,031)

(13,422)

Operating loss


(4,736)

(5,442)

(10,816)

Finance income


42

17

47

Finance charges


(146)

-

-

LOSS BEFORE TAXATION


(4,840)

(5,425)

(10,769)

Taxation

3

305

660

1,348

LOSS FOR PERIOD


(4,535)

(4,765)

(9,421)






Attributable to:





Equity holders of the parent


(4,446)

(4,589)

(9,221)

Non-controlling interests


(89)

(176)

(200)



(4,535)

(4,765)

(9,421)






Other comprehensive income





Foreign currency translation differences - foreign operations


531

38

(614)

TOTAL COMPREHENSIVE EXPENSE FOR THE PERIOD


(4,004)

(4,727)

(10,035)






Attributable to:





Equity holders of the parent


(3,915)

(4,541)

(9,835)

Non-controlling interests

4

(89)

(186)

(200)



(4,004)

(4,727)

(10,035)






Loss per share





Basic and diluted on loss attributable to equity holders of the parent


(0.38)p

(0.60)p

(1.00)p

The loss for the period arises from the Group's continuing operations.

 

Condensed Consolidated Statement of Changes in Equity (Unaudited)

For the six months ended 30 June 2018


Ordinary 0.5p

Shares

Number

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

760,124,264

3,801

50,461

10,884

(7,148)

(831)

1,156

(46,578)

11,745

(209)

11,536

Loss for the period

-

-

-

-

-

-

-

(4,589)

(4,589)

(176)

(4,765)

Other comprehensive expense

-

-

-

-

-

-

-

48

48

(10)

38

Loss and total comprehensive expense for the year

-

-

-

-

-

-

-

(4,541)

(4,541)

(186)

(4,727)

Share based payment expense

-

-

-

-

-

-

136

-

136

-

136

Exercise of share options

1,295,632

4

44

-

-

-

-

-

48

-

48

At 30 June 2017

761,419,896

3,805

50,505

10,884

(7,148)

(831)

1,292

(51,119)

7,388

(395)

6,993

Loss and total comprehensive expense for the period

-

-

-

-

-

-

-

(5,294)

(5,294)

(14)

(5,308)

Issue of shares

400,000,000

2,000

38,000

-

-

-

-

-

40,000

-

40,000

Cost of issue of new equity

-

-

(2,318)

-

-

-

-

-

(2,318)

-

(2,318)

Exercise of share options

9,571,028

50

211

-

-

-

-

-

261

-

261

Share based payment expense

-

-

-

-

-

-

(106)

-

(106)

-

(106)

At 31 December 2017

1,170,990,924

5,855

86,398

10,884

(7,148)

(831)

1,186

(56,413)

39,931

(409)

39,522

Loss for the period

-

-

-

-

-

-

-

(4,446)

(4,446)

(89)

(4,535)

Other comprehensive expense

-

-

-

-

-

-

-

531

531

-

531

Loss and total comprehensive expense for the period

-

-

-

-

-

-

-

(3,915)

(3,915)

(89)

(4,004)

Exercise of share options

739,899

4

-

-

-

-

-

-

4

-

4

Share based payment expense

-

-

-

-

-

-

212

-

212

-

212

At 30 June 2018

1,171,730,823

5,859

86,398

10,884

(7,148)

(831)

1,398

(60,328)

36,232

(498)

35,734

 

Condensed Consolidated Statement of Financial Position

AS AT 30 June 2018


 

Notes

30 June

2018

(Unaudited)

£000

30 June

2017

(Unaudited)

£000

Year

31 Dec

2017

(Audited)

£000

NON-CURRENT ASSETS





Property, plant and equipment


2,879

953

2,994

Intangible assets


19,486

550

19,305

TOTAL NON-CURRENT ASSETS


22,365

1,503

22,299

CURRENT ASSETS





Inventory


2,540

532

2,872

Trade and other receivables


4,479

2,554

4,168

Cash and cash equivalents


12,215

3,608

16,423

TOTAL CURRENT ASSETS


19,234

6,694

23,463

TOTAL ASSETS


41,599

8,197

45,762

NON-CURRENT LIABILITIES





Trade and other payables


(3,713)

-

(635)

Deferred tax


(797)

-

(824)

TOTAL NON-CURRENT LIABILITIES


(4,510)

-

(1,459)

CURRENT LIABILITIES





Trade and other payables


(1,355)

(1,204)

(4,781)

TOTAL CURRENT LIABILITIES


(1,355)

(1,204)

(4,781)

TOTAL LIABILITIES


(5,865)

(1,204)

(6,240)

NET ASSETS


35,734

6,993

39,522

EQUITY





Share capital


5,859

3,805

5,855

Share premium


86,398

50,505

86,398

Merger reserve


10,884

10,884

10,884

Reverse acquisition reserve


(7,148)

(7,148)

(7,148)

Reserve for own shares


(831)

(831)

(831)

Share based payment reserve


1,398

1,291

1,186

Retained earnings deficit


(60,328)

(51,118)

(56,413)

EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE PARENT


36,232

7,388

39,931

Non-controlling interests


(498)

(395)

(409)

TOTAL EQUITY


35,734

6,993

39,522

Approved by the Board and authorised for issue on 3 September 2018.

Steve Couldwell

(Chief Executive Officer)

 

Condensed Consolidated Statement of Cash Flows

FOR THE six MONTHS ended 30 JUNE 2018


 

 

Notes

6 months

30 June

2018

(Unaudited)

£000

6 months

30 June

2017

(Unaudited)

£000

Year

31 Dec

2017

(Audited)

£000

Operating Activities





Operating loss


(4,736)

(5,442)

(10,816)

Adjustment for:





Depreciation of property, plant and equipment


283

209

482

Amortisation of intangible assets


267

-

225

Share based payments


212

135

30

Research tax credit received


1,047

153

1,541

Corporation tax paid


(28)



Operating cash outflow


(2,955)

(4,945)

(8,538)

(Increase)/Decrease in inventory


399

129

(503)

(Increase)/Decrease in trade and other receivables


(603)

1,084

(783)

Increase/(Decrease) in trade and other payables


(1,007)

(825)

38

Net cash outflow from operations


(4,166)

(4,557)

(9,786)

Investing activities





Interest received


42

17

47

Purchases of property, plant and equipment


(113)

(73)

(130)

Capitalised development expenditure


(24)

-

(93)

Acquisition of subsidiary


-

-

(19,945)

Net cash outflow from investing activities


(95)

(56)

(20,121)

Financing activities





Proceeds from issue of share capital


-

-

37,742

Proceeds from exercised share options


4

48

249

Net cash inflow from financing activities


4

48

37,991

Decrease in cash and cash equivalents


(4,257)

(4,565)

8,084

Foreign exchange translation movement


49

-

166

Cash and cash equivalents at start of period


16,423

8,173

8,173

Cash and cash equivalents at end of period


12,215

3,608

16,423

 

Notes to the Condensed Unaudited Financial Statements

FOR THE six MONTHS ended 30 JUNE 2018

1) BASIS OF PREPARATION AND ACCOUNTING POLICIES

The condensed financial statements are not statutory accounts, have not been audited and, as permitted under the AIM Rules, do not comply with IAS 34 "Interim Financial Reporting". The accounting policies adopted are in accordance with international Financial Reporting Standard and are consistent with those followed in the preparation of the financial statements for the period year end in exception to the following standards that were adopted on 1st January 2018:

·     IFRS 15 Revenue from contracts from customer

·     IFRS 9 Financial Instruments

The comparative figures for the year ended 31 December 2017 are from the statutory accounts. Those accounts have been reported on by the Company's Auditor and delivered to the Registrar of Companies. The report of the Auditor was unqualified, did not include reference to any matters by way of emphasis and did not contain a statement under section 498 of the Companies Act 2006.

This is the first set of results since the adoption of IFRS 15 and IFRS 9 which has caused no material impact to the Group's financial statements, the Group has taken the Cumulative effect method.

2) GEOGRAPHICAL MARKET AND SEGMENTAL REPORTING

Revenue by geographical market


 

 

6 months

30 June

2018

£000

6 months

30 June

2017

£000

Year

31 Dec

2017

£000

USA


4,559

820

4,098

Rest of world


1,015

523

1,135



5,574

1,343

5,233

Segmental Analysis

Six months ended 30 June 2018


BioSurgery

£000

Orthopaedics & Dental

£000

Cardiac

£000

Other

£000

Central

£000

Total

£000

Revenue

1,478

3,205

-

891

-

5,574

Cost of sales

(732)

(1,115)

-

(604)

-

(2,451)

Gross Profit

746

2,090

-

287

-

3,123

Administrative costs

(2,042)

(2,835)

(224)

(272)

(1,986)

(7,359)

Exceptional costs

-

-

-

-

(500)

(500)

Operating loss

(1,296)

(745)

(224)

15

(2,486)

(4,736)

Finance income

-

-

-

-

42

42

Finance charges

-

-

-

-

(146)

(146)

Loss before taxation

(1,296)

(745)

(224)

15

(2,590)

(4,840)

Taxation

(6)

259

52

-

-

305

Loss for the period

(1,302)

(486)

(172)

15

(2,590)

(4,535)

Six months ended 30 June 2017


BioSurgery

£000

Orthopaedics & Dental

£000

Cardiac

£000

Other

£000

Central

£000

Total

£000

Revenue

820

-

-

523

-

1,343

Cost of sales

(494)

-

-

(260)

-

(754)

Gross Profit

326

-

-

263

-

589

Administrative costs

(2,434)

(1,288)

(270)

(445)

(1,594)

(6,031)

Operating loss

(2,108)

(1,288)

(270)

(182)

(1,594)

(5,442)

Finance income


-

-

-

17

17

Loss before taxation

(2,108)

(1,288)

(270)

(182)

(1,577)

(5,425)

Taxation

133

353

174

-

-

660

Loss for the period

(1,975)

(935)

(96)

(182)

(1,577)

(4,765)

Year ended 31 December 2017


BioSurgery

£000

Orthopaedics & Dental

£000

Cardiac

£000

Other

£000

Central

£000

Total

£000

Revenue

1,932

2,166

-

1,135

-

5,233

Cost of sales

(916)

(829)

-

(882)

-

(2,627)

Gross Profit

1,016

1,337

-

253

-

2,606

Administrative costs

(4,737)

(3,297)

(481)

(484)

(3,325)

(12,324)

Exceptional costs

-

-

-

-

(1,098)

(1,098)

Operating loss

(3,721)

(1,960)

(481)

(231)

(4,423)

(10,816)

Finance income

-

3

-

-

44

47

Loss before taxation

(3,721)

(1,957)

(481)

(231)

(4,379)

(10,769)

Taxation

372

722

254

-

-

1,348

Loss for the period

(3,349)

(1,235)

(227)

(231)

(4,379)

(9,421)

3) TAXATION


6 months

30 June

2018

£000

6 months

30 June

2017

£000

Year

31 Dec

2017

£000

Current Tax:




UK corporation tax credit on research and development costs in the period

(352)

660

1,348

US corporation tax

47

-

-


(305)

660

1,348

Deferred tax:




Origination and reversal of temporary timing differences

-

-

-

Tax credit on loss on ordinary activities

(305)

660

1,348

The Group has accumulated losses available to carry forward against future trading profits. No deferred tax asset has been recognised relating to these losses as their recoverability is uncertain.

4) LOSS PER SHARE


6 months

30 June

2018

£000

6 months

 30 June

2017

£000

Year

31 Dec

2017

£000

Total loss attributable to the equity holders
of the parent

(4,446)

(4,589)

(9,221)






Number

Number

Number

Weighted average number of ordinary shares in issue during the period

1,171,534,448

760,724,355

920,506,514

Loss per share (basic and diluted)




Basic and diluted on loss for the period

(0.38)p

(0.60)p

(1.00)p

The Company has issued employee options over 54,157,073 Ordinary shares and there are 16,112,800 jointly owned shares which are potentially dilutive. There is no dilutive effect as there is a loss for each of the periods concerned.

5) SHARE CAPITAL


Number

Share

Capital

£000

Share

Premium

£000

Merger Reserve £000

Reverse Acquisition Reserve £000

 

Total

£000

Total Ordinary shares of 0.5p at 31 December 2016

760,124,264

3,801

50,461

10,884

(7,148)

57,998

Issued on exercise of share options

1,295,632

4

44

-

-

48

Total Ordinary shares of 0.5p at 30 June 2017

761,419,896

3,805

50,505

10,884

(7,148)

58,046

Issue of shares

400,000,000

2,000

35,682

-

-

37,682

Issued on exercise of share options

9,571,028

50

211

-

-

261

Total Ordinary shares of 0.5p at 31 December 2017

1,170,990,924

5,855

86,398

10,884

(7,148)

95,989

Issued on exercise of share options

739,899

4

-

-

-

4

Total Ordinary shares of 0.5p at 30 June 2018

1,171,730,823

5,859

86,398

10,884

(7,148)

95,993

6) Movement in retained earnings and reserve for own shares


Retained

Earnings

Deficit

£000

Reserve For Own

Shares

£000

At 31 December 2016

(46,578)

(831)

Loss for the period

(4,765)

-

Foreign translation movement

38

-

Minority interest

186

-

At 30 June 2017

(51,119)

(831)

Loss for the period

(4,656)

-

Foreign translation movement

(652)

-

Minority interest

14

-

At 31 December 2017

(56,413)

(831)

Loss for the period

(4,535)

-

Foreign translation movement

531

-

Minority interest

89

-

At 30 June 2018

(60,328)

(831)

 

Glossary

The following terms used in this document have the following meanings:

"Allograft"

human bone or tissue

"BioRinse"

a novel process that transforms human bone into a malleable type 1 collagen scaffold in a manner which preserved the native bone morphogenic proteins and growth factors.

"CardioPure"

a decelluralised human heart valve

"dCELL® Technology"

the proprietary soft tissue decellularisation process, which removes DNA and cellular material leaving intact an acellular matrix, which is comprised within the Company's owned and licensed patents and its unpublished information and know

"DermaPure"

a decellularised allograft dermis for use in chronic and acute wounds

"FDA"

Food and Drug Administration

"GPO"

Group Purchasing Organisation, is created to leverage the purchasing power of a group of healthcare providers e.g. hospitals

"Medicare"

Medicare is the US federal health insurance program for people who are 65 or older and certain younger people with disabilities

"OrthoPure XT"

the decelluralised porcine tendon for use in anterior cruciate ligament repair

"Osteoinductive"

the ability of graft material to recruit stem cells and develop into bone-forming cells

"SurgiPure XD"

a decellularised porcine dermis tissue matrix targeted for the repair of hernias and body wall defects

"Xenograft"

tissue sourced from a different species to the recipient

"510k process"

a 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as, that is, substantially equivalent to, a legally marketed device that is not subject to pre-market approval. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims

 

Directors and Officers

DIRECTORS

John Samuel                                                      (Chairman)

Steven Couldwell                                               (Chief Executive 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

Paul Below

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

AUDITOR

KPMG LLP

1 Sovereign Square

Sovereign Street

Leeds

LS1 4DA

REGISTRAR

Link Asset Services

The Registry

34 Beckenham Road

Beckenham

Kent

BR3 4TU

LEGAL ADVISER

DLA Piper UK LLP

Princes Exchange

Princes Square

Leeds

LS1 4BY

NOMINATED ADVISER AND BROKER

Jefferies International Ltd

Vintners Place

68 Upper Thames Street

London

EC4V 3BJ

 


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