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| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| Tissue Regenix Group Plc | LSE:TRX | London | Ordinary Share | GB00BNTXR104 | ORD 0.1P |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| -1.30 | -2.11% | 60.20 | 61.00 | 62.00 | 61.50 | 60.60 | 61.50 | 47,682 | 16:35:16 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| Pharmaceutical Preparations | 24.48M | -2.7M | -0.0382 | -16.10 | 43.4M |
From Apr 2019 to Apr 2024
TIDMTRX
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 GBP5.6m (H1 2017: GBP1.3m) +61% pro forma, driven by;
o DermaPure(R) sales grew by 73% on a reported basis, 96% in constant currency, to GBP1.5m (H1 2017: GBP0.9m)
o CellRight contribution of GBP3.2m under orthopaedics and dental, +46% pro forma
o Increased sales from GBM-V by 70% to GBP0.9m (H1 2017: GBP0.5m)
-- Gross margin increased by 12.1 percentage points to 56% -- Significantly narrowed Group EBITDA loss for the period GBP3.5m (GBP5.1m) -- Cash balance at 30 June 2018 GBP12.2m (H1 2017: GBP3.6m) -- Overall cash outflow reduced GBP4.3m (H1 2017: GBP4.6m)
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(R) 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(R), 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 Tel: 0330 430 3073 / Caitlin Pearson Head of Communications 07920272 441 ----------------------------------------- --------------------- Jefferies International Ltd Tel: 020 7029 8000 Simon Hardy / Christopher Binks ----------------------------------------- --------------------- FTI Consulting Tel: 0203 727 1000 Brett Pollard / Mo Noonan/ 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.', 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(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 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(R) TECHNOLOGY, ADDRESSING SOFT TISSUE NEEDS, AND BIORINSE(R), 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 GBP5.6m
DermaPure(R) sales grew by 73% on a reported basis, 96% in constant currency, to GBP1.5m (H1 2017: GBP0.9m)
Increased sales from GBM-V by 70% to GBP0.9m (H1 2017: GBP0.5m)
CellRight contribution of GBP3.2m under orthopaedics and dental
-- Group EBITDA loss for the period of GBP3.5m
Improvement from GBP5.1m loss in H1 2017
Cash balance at 30 June 2018 GBP12.2m (H1 2017: GBP3.6m)
-- 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 GBP1.5m (H1 2017: GBP0.9m).
CellRight products based on the complementary BioRinse Technology, contributed sales of GBP3.2m to our Orthopaedics and Dental division in the period.
Also, revenues from our Joint Venture, GBM-V, rose by 70% to GBP0.9m (H1 2017: GBP0.5m).
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(R) 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(R) 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
Hot Features
Premium
6 months 6 months
30 June 30 June
2018 2017
(Unaudited) (Unaudited) Change Change
GBP000 GBP000 GBP000 %
------------------------- ------------ ------------ ------- ------
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 GBP3,474K (H1 2017: GBP5,098K)
Adjusted loss before tax was GBP4,340K (H1 2017: GBP5,425K). A new charge of GBP267K was recognised in respect of the amortisation of the intangible assets recognised on the acquisition of CellRight.
Taxation of GBP47K represents estimated tax chargeable on the profits of CellRight. R&D tax credits of GBP352K (H1 2017: GBP660K) represent the estimated tax credit receivable together with a premium of 40%, on development costs.
Exceptional costs of GBP500K represent the legal fees and settlement costs of litigation.
Cash Flow
Cash outflow from operations was GBP4,166K (H1 2017: GBP4,557K). This includes GBP500K of exceptional costs detailed above.
Overall cash outflow was GBP4,257K (H1 2017: GBP4,565K). The cash balance at 30 June 2018 was GBP12,215K (H1 2017: GBP3,608K).
Steve Couldwell
Chief Executive Officer
Condensed Consolidated Statement of Comprehensive Income
For The six Months ended 30 June 2018
6 months 6 months Year
30 June 30 June 31 Dec
2018 2017 2017
(Unaudited) (Unaudited) (Audited)
Notes GBP000 GBP000 GBP000
------------------------------------------- ----- ------------ ------------ ----------
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
Share
Ordinary Reverse Reserve Based Retained Non-
0.5p Share Share Merger Acquisition For Own Payment Earnings controlling Total
Shares Capital Premium Reserve Reserve Shares Reserve Deficit Total Interests Equity
Number GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
-------------- ------------- ------- -------- ------- ----------- ------- ------- -------- ------- ----------- -------
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
Year
30 June 30 June 31 Dec
2018 2017 2017
(Unaudited) (Unaudited) (Audited)
Notes GBP000 GBP000 GBP000
----------------------------------------- ------- ------------ ------------ ----------
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
6 months 6 months Year
30 June 30 June 31 Dec
2018 2017 2017
(Unaudited) (Unaudited) (Audited)
Notes GBP000 GBP000 GBP000
--------------------------------------------------- ------- ------------ ------------ ----------
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 6 months Year
30 June 30 June 31 Dec
2018 2017 2017
GBP000 GBP000 GBP000
-------------- -------- -------- -------
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
Orthopaedics
BioSurgery & Dental Cardiac Other Central Total
GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
--------------------- ---------- ------------ ------- ------- ------- -------
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
Orthopaedics
BioSurgery & Dental Cardiac Other Central Total
GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
--------------------- ---------- ------------ ------- ------- ------- -------
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
Orthopaedics
BioSurgery & Dental Cardiac Other Central Total
GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
--------------------- ---------- ------------ ------- ------- ------- --------
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 6 months Year
30 June 30 June 31 Dec
2018 2017 2017
GBP000 GBP000 GBP000
--------------------------------------------------------- -------- -------- -------
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 6 months Year
30 June 30 June 31 Dec
2018 2017 2017
GBP000 GBP000 GBP000
---------------------------------------------------- ------------- ----------- -----------
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
Share Share
Capital Premium Merger Reserve Reverse Acquisition Total
Number GBP000 GBP000 GBP000 Reserve GBP000 GBP000
---------------------------- ------------- -------- -------- -------------- ------------------- --------
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 Reserve For
Earnings Own
Deficit Shares
GBP000 GBP000
----------------------------- --------- -----------
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(R) 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
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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