TIDMRUA
RNS Number : 4365I
RUA Life Sciences PLC
11 December 2020
RUA Life Sciences plc
("RUA", the "Company" or the "Group")
Unaudited Interim Results
RUA Life Sciences plc (AIM: RUA), the holding company of a group
of medical device businesses focused on the exploitation of
Elast-Eon(TM), a long-term implantable biostable polymer ,
announces its unaudited interim results for the six months ended 30
September 2020.
Highlights
-- Industry trends highlighting opportunities for non-biogenic materials
-- Products on schedule for regulatory submission in 2021
-- Positive testing on polymeric heart valve
-- The Group's cash continues to be well managed with cash at 30
September 2020 of GBP1,009,000 (31 March 2020: GBP1,976,000) and
GBP1,440,000 at 30 November 2020
Bill Brown, Executive Chairman of RUA Life Sciences, said:
"A huge amount has been achieved by the team at RUA over the
period and the business is now poised to successfully commercialise
the vascular grafts and further develop our pioneering work in
polymeric heart valves ."
For further information contact:
RUA Life Sciences plc Tel: +44 (0)7730 718296
Bill Brown, Executive Chairman
Shore Capital Tel: +44 (0)20 7408 4090
Tom Griffiths / David Coaten
A copy of this announcement will be available shortly at www.
rualifesciences.com/investor-relations/regulatory-news-alerts .
About RUA Life Sciences
The RUA Life Sciences group was created in April 2020 when RUA
Life Sciences Plc (formerly known as AorTech International Plc)
acquired RUA Medical Devices Limited to create a fully formed
medical device business. RUA Life Sciences is the holding company
of the Group's four trading businesses, each exploiting the Group's
patented polymer technology.
Our vision is to improve the lives of millions of patients by
improving and enabling medical devices with Elast-Eon(TM) , the
world's leading long-term implantable polyurethane.
Whether it is licensing Elast-Eon(TM) , manufacturing a device
or component or developing next generation medical devices, a RUA
Life Sciences business is pursuing our vision.
Elast-Eon(TM)'s biostability is comparable to silicone while
exhibiting excellent mechanical, blood contacting and flex-fatigue
properties. These polymers can be processed using conventional
thermoplastic extrusion and moulding techniques. With over 7
million implants and over 14 years of successful clinical use,
RUA's polymers are proven in long-term life enabling
applications.
The Group's four business units are:
RUA Medical : End-to-end contract developer and manufacturer
of medical devices and implantable fabric specialist.
RUA Biomaterials Licensor of Elast-Eon(TM) polymers to the medical
: device industry.
RUA Vascular : Development of large bore polymer sealed grafts
and soft tissue patches.
RUA Structural Development of tri leaflet polymeric heart valves.
Heart :
CHAIRMAN'S STATEMENT
I am delighted to set out an overview of the unaudited
consolidated interim results of RUA Life Sciences Plc for the six
months to 30 September 2020 together with an update on more recent
progress. Over the period, RUA Life Sciences continued its
transformation into a fully integrated medical device business. We
are selling retail packaged medical devices to customers, licensing
what is widely accepted as the most biostable of all polyurethane
implantable materials, Elast-Eon(TM), and now commercialising our
own range of cardiovascular devices. Firstly, we set out below some
key observations on the wider drivers and trends within the
cardiovascular device sector.
Industry Issues
Elast-Eon(TM) was invented during the 1990's because of the
failure of polyurethane materials that had been used in pacing
leads. At the same time, the biomaterials sector was having to deal
with the impact of BSE being a cross species contamination from
sheep, through cows to man. This resulted in tight control of the
source of bovine material. The wider medical community is now faced
with another cross-species contamination threat through COVID-19
having been transmitted into man, then onto mink and back again.
Further infection into the bovine source of many medical device
components poses a major risk to the supply chains in the industry
and highlights the multiple benefits of non-biogenic material. RUA
Life Sciences is developing a number of cardiovascular devices that
will compete directly with products dependent on animal sourced
material at a pivotal time in the market.
The range of vascular grafts and cardiac and vascular patches,
which are now beyond the initial research and development stage and
remain scheduled for regulatory submission during the second
quarter of 2021, have entirely eliminated the need for animal
tissue through its replacement with Elast-Eon(TM) and are designed
as direct replacements for currently marketed devices.
The heart valve replacement market faces similar issues to the
vascular graft and patches markets. The industry has already
experienced a substantial shift in leaflet technology with
mechanical valves, which represented the lion's share of the market
in the 1990's, now down to less than 15%. There has been a trade
off between quality of life improvements of avoiding life-long drug
treatment with the risk of re-operation due to durability issues.
The flexible leaflet systems of tissue valves have enabled the
advent of trans catheter aortic valves and more recently trans
catheter mitral devices. The major companies in the heart valve
industry have invested billions of dollars in these technologies,
much through the acquisition of smaller early development stage
businesses. The Board believes that the next macro trend within the
heart valve industry will be a further move in flexible leaflet
technology away from animal tissue and into bio-stable polymers.
The recent "first in man" implantation of polymeric heart valves by
one of our competitors is being taken very seriously by both the
industry and the regulators and a member of the RUA team is
participating in a high-level industry and regulatory group.
The recently announced success in our own polymer valve project
is very encouraging as we have not only demonstrated the ability of
our novel manufacturing method to be able to create a flexible
leaflet system but the prototype valves produced were highly
consistent and exceeded our expectations by surpassing the minimum
hydro-dynamic testing requirements of ISO 5840. RUA Life Sciences
is therefore well placed to play a role in the future direction of
the industry.
Unaudited interim results for the six months to 30 September
2020
The results set out below have consolidated the results of RUA
Medical Devices Limited ("RUA Medical") which was acquired by the
group on 1 April 2020. The period started around the time the
global economy went into COVID-19 related lock down. As previously
reported, this has had an impact on the results for the six-month
period. Total revenues reported amount to GBP631,000 of which
GBP416,000 was represented by RUA Medical and GBP215,000 in polymer
licensing fees. As previously announced, we estimate the negative
impact of COVID-19 on the RUA Medical business during the first
half to be at least GBP300,000. Biomaterials' revenues were below
the Board's expectations mainly due to the timing of deliveries of
polymer on which licence fees are paid and reduced royalties on
device sales during the suspension of elective surgeries.
Other income of GBP239,000 was recognised during the period
(2018: GBP6,000). A major part of this increase relates to the
receipt of grant finance.
Despite the increase in administrative expenses from GBP451,000
in 2019 to GBP1,181,000 in the current period, costs were tightly
controlled whilst research and development activities continued to
accelerate. The majority of the increase can be attributed to the
inclusion of the new subsidiary, RUA Medical.
Amortisation and depreciation costs increased during the period
due to a combination of depreciation of fixed assets in RUA Medical
together with the amortisation of newly acquired intangible assets
as part of the RUA Medical acquisition.
Overall, the increased loss before tax for the period of
GBP622,000 (2019: GBP239,000) can be attributed to research and
development expenditure and COVID-19 related reduction in
revenue.
The most important balance sheet item remains cash which has
been well controlled and at the period end amounted to GBP1,009,000
compared to GBP1,976,000 at the last financial year end. One half
of this reduction is represented by the cash consideration and fees
payable on the acquisition of RUA Medical. At 30 November 2020,
cash had increased across the Group to GBP1,440,000.
Board Resignation
It has been separately announced today that Gordon Wright, the
founder of the predecessor AorTech business, has decided to retire
from the Board now that the business has been re-established with
an exciting future ahead of it. On behalf of the Board, I wish to
record our thanks to Gordon for his support and guidance over the
years and we look forward to working with him in his new role as
Honorary Life President.
Outlook
Covid-19 has impacted most businesses in the medical device
sector, particularly as a result of the suspension of elective
surgeries. RUA Medical went around three months without receiving
any orders and when they resumed, they trailed behind historic
levels. It is very pleasing however that recent orders have resumed
at pre-Covid levels and forward orders for delivery into the new
calendar year appear to include an element of catch up for missed
surgeries. The biomaterials business, which has mainly contracted
income, can be difficult to predict on a six-monthly basis, but
historically has provided a relatively stable income stream and
should have a better second half of the year.
Future Developments
The key focus over the next six months is the further
commercialisation of the Vascular business and submission of 510k,
pre-market notifications to the FDA for both the vascular grafts
and patches scheduled for early into the new financial year. We are
actively pursuing opportunities with both OEM customers and
distribution channels to ensure that commercial sales can commence
soon after regulatory approval for market launch is received.
Further announcements will be made in due course.
Bill Brown, Chairman
10 December 2020
CONDENSED CONSOLIDATED INTERIM INCOME STATEMENT
Six months ended 30 September 2020
Unaudited Unaudited Audited
Six months Six months Twelve months
to 30 Sept to 30 Sept to 31 March
2020 2019 2020
Note GBGBP000 GBGBP000 GBGBP000
------------ ------------ --------------
Revenue 4 631 299 489
Cost of sales (134) - -
------------ ------------ --------------
Gross profit 497 299 489
Other income 239 6 14
Administrative expenses (1,181) (451) (1,160)
Other expenses - share-based
payments - - (91)
Other expenses - depreciation
& amortisation (175) (93) (193)
------------ ------------ --------------
Operating loss (620) (239) (941)
Finance income/(expense) (2) - 44
Loss before taxation (622) (239) (897)
------------ ------------ --------------
Taxation 13 81 81
------------ ------------ --------------
Loss attributable to
equity holders of the
parent company (609) (158) (816)
------------ ------------ --------------
Loss per share (basic
and diluted) - GB Pence (3.76) (1.08) (5.55)
CONDENSED CONSOLIDATED INTERIM STATEMENT OF FINANCIAL
POSITION
At 30 September 2020
Unaudited Unaudited Audited
30 Sept 30 Sept 31 March
2020 2019 2020
Note GBGBP000 GBGBP000 GBGBP000
Assets
Non-current assets
Intangible assets 5 1,013 355 255
Tangible assets 6 1,630 2 5
---------- ---------- ----------
Total non-currents
assets 2,643 357 260
Current assets
Trade and other receivables 278 234 258
Inventories 114 0 0
Cash and cash equivalents 1,009 2,331 1,976
---------- ---------- ----------
Total current assets 1,401 2,565 2,234
---------- ---------- ----------
Total assets 4,044 2,922 2,494
---------- ---------- ----------
Equity
Share capital 7 12,650 12,574 12,574
Share premium 7 5,554 4,550 4,550
Other reserve (1,825) (1,916) (1,825)
Profit and loss account (13,633) (12,366) (13,024)
---------- ---------- ----------
Total equity attributable
to equity holders of
the parent company 2,746 2,842 2,275
---------- ---------- ----------
Liabilities
Non-current liabilities
Borrowings and lease 290 - -
liabilities
Deferred grant income 50 - -
Deferred tax 118 - -
---------- ---------- ----------
Total non-current liabilities 458 - -
Current liabilities
Trade and other payables 802 80 219
Lease liabilities 18 - -
Deferred grant income 20 - -
---------- ---------- ----------
Total current liabilities 840 80 219
---------- ---------- ----------
Total liabilities 1,298 80 219
---------- ---------- ----------
Total equity and liabilities 4,044 2,922 2,494
---------- ---------- ----------
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENT
Unaudited Unaudited Audited
Six months Six months Twelve months
to 30 to 30 to 31 March
Sept 2020 Sept 2019 2020
GBGBP000 GBGBP000 GBGBP000
Cash flows from operating
activities
Group loss after tax (609) (158) (816)
Adjustments for:
Fair value gain on acquisition (21) - -
of subsidiary
Other / rounding 2 - -
Depreciation and amortisation 175 93 194
Share-based payments - - 91
Interest income - - (7)
Interest expense 2 - -
Tax income - - (81)
(Decrease) in deferred tax (13) - -
provision
(Increase) / decrease in
trade and other receivables (44) 4 (20)
Increase / (Decrease) in
trade and other payables (47) (19) 120
Cash generated from operations (555) (80) (519)
Tax received - - 81
----------- ----------- --------------
Net cash flow from operating
actvities (555) (80) (438)
----------- ----------- --------------
Cash flows from investing
activites
Purchase of property, plant
& equipment (310) (1) (5)
Acquisition of subsidiary, (354) - -
net of cash acquired
Interest received - - 7
----------- ----------- --------------
Net cash flow from investing
activities (664) (1) 2
----------- ----------- --------------
Cash flows from financing
activities
Proceeds from loans 260 - -
Repayment of loans and lease (9) - -
liabilities
Proceeds of issue of share - - -
capital, net of issue costs
Interest paid 1 - -
----------- ----------- --------------
Net cash flow from financing 252 - -
activities
----------- ----------- --------------
Net increase / (decrease)
in cash and cash equivalents (967) (81) (436)
Cash and cash equivalents
at beginning of period 1,976 2,412 2,412
----------- ----------- --------------
Cash and cash equivalents
at end of period 1,009 2,331 1,976
----------- ----------- --------------
Six months ended 30 September 2020
CONDENSED CONSOLIDATED INTERIM STATEMENT OF CHANGES IN
EQUITY
Share Share Other Profit and Total
capital premium reserve loss account Equity
GBGBP000 GBGBP000 GBGBP000 GBGBP000 GBGBP000
---------- ---------- ---------- -------------- ----------
Balance at 01 April
2019 12,574 4,500 (1,916) (12,208) 3,000
---------- ---------- ---------- -------------- ----------
Transactions with - - - - -
owners
Loss for the period - - - (158) (158)
Total comprehensive
income for the
period - - - (158) (158)
---------- ---------- ---------- -------------- ----------
Balance at 30 September
2019 12,574 4,550 (1,916) (12,366) 2,842
---------- ---------- ---------- -------------- ----------
Share-based payments - - 91 - 91
Transactions with
owners - -- 91 - 91
---------- ---------- ---------- -------------- ----------
Loss for the period - - - (658) (658)
Total comprehensive
income for the
period - - - (658) (658)
---------- ---------- ---------- -------------- ----------
Balance at 31 March
2020 12,574 4,550 (1,825) (13,024) 2,275
Rounding 1 - - - 1
Transactions with
owners 75 1,004 - - 1,079
Loss for the period - - - (609) (609)
Total comprehensive
income for the
period 76 1,004 - (609) 471
---------- ---------- ---------- -------------- ----------
Balance at 30 September
2020 12,650 5,554 (1,825) (13,633) 2,746
---------- ---------- ---------- -------------- ----------
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL
STATEMENTS
1. BASIS OF PREPARATION
General information
RUA Life Sciences plc changed its name from Aortech
International plc on 16 June 2020. It is the ultimate parent
company of the Group, whose principal activities comprise
exploiting the value of its IP and know-how.
RUA Life Sciences plc is incorporated and domiciled in the UK
and its registered office is c/o Davidson Chalmers Stewart LLP, 163
Bath Street, Glasgow, G2 4SQ.
Basis of preparation
These condensed consolidated interim financial statements are
for the six months ended 30 September 2020 and have been prepared
with regard to the requirements of IAS 34 on "Interim Financial
Reporting". They do not include all of the information required for
full financial statements and should be read in conjunction with
the consolidated financial statements of the Group for the year
ended 31 March 2020.
These condensed consolidated interim financial statements have
been prepared in accordance with the accounting policies set out
below which are based on the recognition and measurement principles
of IFRS in issue as adopted by the European Union (EU) and
effective at 31 March 2019. They were approved for issue by the
Board of Directors on 10 December 2020.
Going concern
The Group will continue to incur further costs as it continues
to commercialise its vascular business and continues to pursue its
polymeric heart valve through clinical development. After making
enquiries, and assuming anticipated cash flows, the directors
expect that the Group's current financial resources will be
sufficient to support operations for at least the next 12 months
from the date of this announcement. The Group therefore continues
to adopt the going concern basis in the preparation of these
financial statements.
The financial information for the six months ended 30 September
2020 and the comparative figures for the six months ended 30
September 2020 are unaudited and have been prepared on the basis of
the accounting policies set out in the consolidated financial
statements of the Group for the year ended 31 March 2020.
These extracts do not constitute statutory accounts under
section 434 of the Companies Act 2006. The financial statements for
the year ended 31 March 2020, prepared under IFRS, received an
unqualified audit report, did not contain statements under sections
498(2) and 498(3) of the Companies Act 2006 and have been delivered
to the Registrar of Companies.
The accounting policies have been applied consistently
throughout the Group for the purposes of preparation of these
condensed consolidated interim financial statements.
Loss per share
Loss per share has been calculated on the basis of the result
for the period after tax, divided by the number of ordinary shares
in issue in the period of 16,186,608. The comparatives are
calculated by reference to the weighted average number of ordinary
shares in issue which were 14,686,608 for the year ended 31 March
2020.
2. ACQUISITION
On 1 April 2020 RUA Life Sciences plc acquired 100% of the share
capital and voting rights of RUA Medical Devices Ltd from David
Richmond (a related party, being a non-executive director of RUA
Life Sciences plc at the time). The acquisition provides the Group
with full-service medical device development and manufacturing
capabilities and facilities, and vertical integration to expand the
reach of its Elast-Eon (TM) products.
The agreed consideration was GBP2.45m, settled partly by the
issue of 1,500,000 new shares in RUA Life Sciences plc - valued at
GBP1 per share per the agreement (trading at 75p per share on the
acquisition date), plus a cash element of GBP0.95m, some of which
has been deferred. The fair value of the consideration is deemed to
be the trading price, less a discount of 3% in view of the trading
restrictions applied to those shares for the first year.
The exercise to determine the fair value of the assets acquired
is complex and is still being finalised. At the reporting date, the
draft findings of the valuation exercise reveals the following fair
values:
GBPm
Fair value of consideration 2.04
Fair value of assets acquired:
Tangible non-current assets 1.39
Intangible assets identified 0.83
Cash, Inventory, receivables, and
other current assets 0.39
Liabilities and provisions (0.35)
Deferred tax on acquisition (0.20)
Fair Value of Assets acquired 2.06
Profit on Bargain purchase 0.02
The valuation exercise will be complete by the end of the
financial year and any adjustments required to either the fair
value of the consideration or the assets acquired will be made in
the Annual Report.
3. RELATED PARTY TRANSACTION
As outlined in note 2 above, RUA Medical Devices Limited was
acquired from David Richmond, a non-executive director of the Group
at the time of the aquisiton and currently Group CEO. At the
reporting date the Group had a liability to David Richmond in
respect of deferred consideration to the sum of GBP425,000. There
is no interest payable on the outstanding balance.
4. SEGMENTAL REPORTING
The Company is an Intellectual Property (IP) holding company
whose principal activity is exploiting the value of its IP and
know-how.
All revenue and operating result originated in the United
Kingdom.
Analysis of revenue by income
stream
Unaudited Unaudited Audited
Six months Six months Twelve months
to 30 Sept to 30 Sept to 31 March
2020 2019 2020
GBGBP000 GBGBP000 GBGBP000
Medical devices 416 - -
License fees - services - 40 40
Royalty revenue 215 259 449
------------ ------------ --------------
Total 631 299 489
------------ ------------ --------------
Analysis of revenue by geographical
location
Unaudited Unaudited Audited
Six months Six months Twelve months
to 30 Sept to 30 Sept to 31 March
2020 2019 2020
GBGBP000 GBGBP000 GBGBP000
Europe 79 103 181
USA 533 174 266
RoW 19 22 42
------------ ------------ --------------
Total 631 299 489
------------ ------------ --------------
5. INTANGIBLE ASSETS
Acquired Intellectual Development Total
Intellectual property costs GBGBP000
property GBGBP000 GBGBP000
GBP000
At 01 April 2019 - 393 55 448
Additions - - - -
Amortisation - (80) (13) (93)
-------------- ------------- ------------ ----------
At 30 September 2019 - 313 42 355
-------------- ------------- ------------ ----------
Additions - - - -
Amortisation - (79) (21) (100)
-------------- ------------- ------------ ----------
At 01 April 2020 - 234 21 255
-------------- ------------- ------------ ----------
Acquisition through
business combination 834 - - 834
Amortisation (62) - (14) (76)
-------------- ------------- ------------ ----------
At 30 September 2020 772 234 7 1,013
-------------- ------------- ------------ ----------
6. TANGIBLE ASSETS
Land & Plant & Computer Fixtures Total
Buildings Equipment Equipment &
Fittings
GBGBP000 GBGBP000 GBGBP000 GBGBP000 GBGBP000
Gross carrying
amount
01 April 2020 - - 5 - 5
Acquisition
through
business
combination
at fair value 590 753 25 19 1,387
Additions 211 92 - - 303
IFRS 16
adjustment - 26 - - 26
Depreciation (28) (55) (6) (2) (91)
Gross carrying
amount
30 September
2020 773 816 24 17 1,630
--------------------- --------------------- --------------------- -------------------- --------------------
7. ISSUED SHARE CAPITAL
During the 6 month period to 30 September 2020, the Company
acquired RUA Medical Devices Limited as detailed in note 2 above.
The acquisition was partly settled by the issue of 1,500,000 5
pence ordinary shares, thereby increasing Issued Share Capital by
GBP75,003 and Share Premium by GBP1,078,928, net of costs.
8. INTERIM ANNOUNCEMENT
The interim results announcement was released on 11 December
2020. A copy of this Interim Report is also available on the
Company's website www.rualifesciences.com.
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