Picture of Rua Life Sciences logo

RUA Rua Life Sciences News Story

0.000.00%
gb flag iconLast trade - 00:00
HealthcareHighly SpeculativeMicro CapNeutral

REG - RUA Life Sciences - Interim results

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20221212:nRSL2931Ja&default-theme=true

RNS Number : 2931J  RUA Life Sciences PLC  12 December 2022

12 December 2022

RUA Life Sciences plc

("RUA", the "Company" or the "Group")

Interim Results

RUA Life Sciences, the holding company of a group of medical device businesses
focused on the exploitation of the world's leading long-term implantable
biostable polymer (Elast-Eon(TM)), today announces its unaudited interim
results for the six months ended 30 September 2022.

Highlights:

·      56% increase in revenues to £1,104,000 (H1 FY2022: £708,000)

·      Gross profit £875,000 - margin 79% up from H1 FY2022 75%

·      15% reduction in loss to £1,143,000 (H1 FY2022: £1,311,000)

·      Strong cash position at £2.5 million (30 September
2021: £4.8 million, 31 March 2022: £3 million)

·      Investment in development projects increased 7% to £908,000 (H1
FY2022: £849,000)

·      Progress made in regulatory pathway for Vascular business segment

·      Increased commercial opportunities within Contract Manufacturing
business segment

Bill Brown, Chairman of RUA Life Sciences, commented:

"The period has seen good progress made across the four business segments.
Biomaterials has continued its steady growth, Contract Manufacturing has
outperformed our expectations by delivering increases in sales of 66% at
improved margins. The Vascular business has made good progress with its
regulatory objectives whilst building on the foundations for a viable
commercial business. Structural Heart has identified a solution to the key
risks associated with polymeric heart valve leaflets and further strengthened
the Group's IP in this area. All business segments are primed for further
growth in value over the next few years."

The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the UK version of the EU
Market Abuse Regulation (2014/596) which is part of UK law by virtue of the
European Union (Withdrawal) Act 2018, as amended and supplemented from time to
time.

For further information contact:

 

RUA Life Sciences

Bill Brown, Chairman
                        Tel: +44 (0)1294 317073

Caroline Stretton, Group Managing Director
      Tel: +44 (0)1294 317073

 

Cenkos Securities plc  (Nominated Adviser and Broker)      Tel: +44 (0)20
7397 8900

Giles Balleny / Max Gould (Corporate Finance)

Michael Johnson (Sales)

 

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 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™'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 8 million implants and 16 years of successful
clinical use, RUA's polymers are proven in long-term life enabling
applications.

 

The Group's four business segments are:

 

 Contract Manufacturing:  End-to-end contract developer and manufacturer of medical devices and
                          implantable fabric specialist.
 Biomaterials:            Licensor of Elast-Eon(TM) polymers to the medical device industry.
 Vascular:                Development and commercialisation of the Group's Elast-Eon sealed Vascular
                          Graft products.
 Structural Heart:        Development of the Group's tri leaflet polymeric heart valves.

A copy of this announcement will be available shortly
at www.rualifesciences.com/investor-relations/regulatory-news-alerts
(http://www.rualifesciences.com/investor-relations/regulatory-news-alerts) .
 

 

 

CHAIRMAN'S STATEMENT

 

I am pleased to set out below an overview of the unaudited interim results of
RUA Life Sciences Plc for the six months to 30 September 2022. The period has
seen progress in all four business units and for the first time, the segmental
reporting of the business now reflects the split amongst Biomaterials,
Contract Manufacture, Vascular and Structural Heart.

 

Unaudited interim results for the six months to 30 September 2022

 

The results below are the consolidated figures for the entire group and are
further analysed in the relevant segmental update. The Group has maintained
the level of revenue growth seen from the first to the second half of the year
to March 2022. In the six months to September 2022 revenues of £1,104,000
were achieved representing an increase of £396,000 or 56% over revenues in
the six months to September 2021.

 

Gross margins remained high at 79% resulting in gross profit of £875,000
being reported against the £528,000 achieved last year thus contributing an
additional £347,000, an uplift of 66%. Investment in the talent base of the
business continued which contributed to the increase in administrative
expenses from £1,658,000 last year to £1,889,000. This increase includes
further investment into the Vascular business unit in particular.

 

The net impact of growth in turnover together with increased investment
resulted in a £168,000 reduction of the group loss to £1,143,000.

 

Working capital continues to be tightly managed with cash at the period end
amounting to £2,509,000 a reduction of £454,000 from the previous year end.
Not included in this cash flow or results for the interim period is the claim
for R&D Tax Credits for the year to 31 March 2022. Our policy is to
account for R&D Tax Credits on a cash basis and the £328,000 claimed has
yet to be received from HMRC.

 

Biomaterials

The Biomaterials business segment is the part of the business that holds the
Intellectual Property relating to Elast-Eon(TM) and related polymers, and
licences that IP to other medical device companies. The clinical performance
of Elast-Eon products continues to be excellent, particularly in the area of
Cardiac Rhythm Management leads, where over 8 million have been implanted
since 2006. The most recently published data indicate that the presence of
Elast-Eon lead insulation dramatically reduces the probability of abrasion
malfunction in tachycardia leads at 15 years by 80%, from around 5%
probability to only 1%.

 

The Biomaterials business saw royalty and license fee income increase by 20%
compared to the first half of last year rising from £156,000 to £187,000
with the growth driven by increased volumes of Elast-Eon being purchased by
licensees. The Biomaterials business is however very much second half weighted
as a result of the timings of when royalty fees are recognised. In the
financial year ended March 2022, 68% of Biomaterials revenue was recognised in
the second half of the year.

 

Net margins in Biomaterials remain high with the contribution to the Group
increasing from £116,000 (74%) last year to £154,000 (82%) in the current
period.

 

Contract Manufacturing

The Contract Manufacturing business segment is the end to end, third party
contract developer and manufacturer of medical devices that formed part of the
RUA Medical acquisition in 2020. This business has had a very successful
period growing revenues from £552,000 in the first half of last year to
£917,000, an increase of 66%. We do not specifically report on the gross
margins achieved in this business area but the net contribution to the group
during the period amounted to £384,000 being a net contribution of 42%.

 

We have implemented price increases within Contract Manufacturing for the
first time in almost ten years but the major growth driver was a result of
increased demand for product from the major customer. This increase in itself
was a result of two factors, one being the post Covid increase in hospital
procedures in the key US market in particular and the other being a stock
build for European markets in advance of the transition from MDD to MDR
regulations. During the second half year, we anticipate a continued growth in
US orders and maintaining steady levels of European orders whilst MDR stock
build is fully initiated.

 

Business development has progressed well within the Contract Manufacturing
business, with a new manufacturing contract signed with a global business for
the processing and supply of two components for its medical device portfolio.
First sales have now been achieved with the first batches manufactured, passed
QC and shipped to the customer under the terms of the supply agreement. There
will be a gradual ramp up in volumes over the next 12 months with sales
expected to stabilise between £10,000 and £12,000 a month. In addition, the
business is currently working on a number of requests for quotations for both
components and completed devices. These quotations are for devices that are
currently in the market and as such could convert to manufacturing revenue in
a relatively short period of time compared to development projects. The
annualised revenue potential from these quotations could more than double the
current scale of the Contract Manufacturing business.

 

Vascular

The Vascular business segment is currently in the development stages of
commercialising the Group's range of Elast-Eon sealed vascular grafts and
related products. Expensed investment into this area amounted to £619,000
during the period compared to £532,000 last year reflecting an increase in
investment for regulatory planning, manufacturing process and commercial
preparation.

 

Regulatory progress has been positive but time consuming. Data had previously
been submitted to the FDA on the large bore grafts which demonstrated that
there was a difference in the healing process to predicate textile grafts
currently in the market. These differences are arguably beneficial due to a
lower inflammatory response and little or no adhesion to the device when
tested in vivo. However, they were different enough for the FDA to want to
have a better understanding of the healing process before allowing the devices
to be marketed. Rather than convert the device to the longer and more costly
PMA process, the FDA has agreed to a continuance of the 510k pre-market
notification process but with additional work designed around providing
additional information on the healing process. The in vivo work historically
undertaken had data collected at the six-month end point and comparisons made
with the predicate device. At this point, the competitor grafts were adhered
to the perivascular tissue whereas the RUA grafts were encapsulated but were
not adhered to the perivascular tissue. In order to provide more information
on this healing process, further in vivo work will be undertaken to clarify
the healing process at one and three months in addition to the six-month end
point. Having agreed this process, the requirements for a human clinical study
were much reduced from what they could have been and in broad terms the study
will be of limited scale and utilise a single arm Performance Goal design,
with the primary end point of the trial being measured at six months post
operation. The regulatory team is currently working towards setting up this
trial and finalising the budget. While the preliminary in vivo work is
currently underway, we continue to assess the best time to start the clinical
trial. RUA will advise in more detail on the expected costs and revised
timescales in due course but in the meantime is actively exploring
opportunities to finance at least part of the clinical stages through
non-dilutive funding routes and grant finance.

 

Product development and the manufacturing process has made significant strides
over the period. The Quality Management System is in the process of being
transferred to a digital eQMS system along with the purchasing process,
providing both greater control and cost efficiencies that should increase with
the scale of the business. Importantly, the RUA ISO 13485 quality management
certification has been expanded to cover the entire group and the scope has
been expanded from contract manufacture to legal device manufacturer. This is
a major achievement in itself. With regard to manufacturing efficiencies, a
thorough review of process steps has resulted in a significant improvement in
manufacturing yield. These efficiencies should enable the current clean rooms
at Irvine to have sufficient capacity to provide for anticipated launch volume
requirements for straight grafts together with demand of up to 10% market
share in North America. The lessons learnt from this process are now being
applied to optimising the design of the larger cleanroom at the second Irvine
facility.

 

On the commercial developments, product costings indicate that after allowing
for distributor margin, RUA should be able to achieve a gross margin of around
80% on products sold. Average selling prices into hospitals range from around
$900 to $3,000 depending on the type of device. With regards to the sale of
grafts into hospitals in both the US and other key markets, it has always been
our strategy to work with distributors rather than establish a direct sales
force. We have been in discussions with a number of parties and are confident
that not only is our strategy correct but there is serious interest in
partnership opportunities.

 

 

Structural Heart

This is the business segment responsible for developing the Group's polymeric
heart valve technology. Expensed investment  in this area amounted to
£289,000, a 9% reduction on the same period last year. The reduction in spend
has come about through increasing the capacity of the in-house team being more
than offset by undertaking fewer tasks with outside contractors.

 

The focus over the past six months has been risk review and mitigation. All
biological valves fail and the medical profession even has a name for it -
Structural Valve Deterioration (SVD). In SVD however, the failure mode is
slow, and patients develop symptoms to allow the SVD to be recognised and
treated. Unlike biological valves, the failure rate of mechanical valves is
very low, the problem however is the failure can be catastrophic. This
phenomenon was witnessed during the 1980's with the unfortunate death of a
small number of patients implanted with the Bjork Shiley mechanical valve,
leading to closure of the Shiley valve business and ultimately to the market
dominance of the biological valve. Testing has shown that Elast-Eon is
exceptionally biostable, non-calcific and non-thrombogenic and as such has the
desirable properties to avoid or at least reduce the incidence of SVD. The
major task for a polymeric valve (assuming the polymer is suitable for long
term implantation) is to persuade regulators, surgeons and most importantly
patients that the valve should not be subject to catastrophic failure. Polymer
valves have been shown to pass long term durability testing yet there remains
a "fear of the new" that will need to be overcome. RUA has made major steps in
improving the manufacture of 100% polymeric leaflets but has been
concentrating this year on a safer, more durable alternative.

 

The in vivo studies carried out on the vascular grafts indicated that
Elast-Eon coating the fabric of the graft performed in an identical manner to
what would have been expected of pure Elast-Eon. The fatigue properties and
tear resistance of the graft material were however many times better than the
base Elast-Eon polymer. Based on this discovery, RUA has taken the coating
technology developed for the graft and, building upon that core IP, developed
a method of creating a true composite material that retains the proven blood
contacting properties of Elast-Eon with much improved mechanical properties.
Finite Element Analysis (FEA) modelling of the material has been very
promising, indicating the material should have the necessary flexibility
without the risk of delamination. The valve design developed for the 100%
Elast-Eon leaflets has been evolved to take advantage of the new material
properties and the initial prototypes have demonstrated very encouraging
hydrodynamic results, particularly with regards to the energy required to open
the valve. The final stage is to complete the engineering work on the
manufacture of the valves to replace the manual manufacturing process and
allow sufficient numbers of the desired quality to undergo durability testing.

 

 

Conclusion and Outlook

All four business units within the RUA portfolio have made good progress over
the year to date. Biomaterials has seen revenues grow in the half year with
the expectation of a similar second half weighting to performance as enjoyed
last year. The Contract Manufacturing business has successfully increased unit
pricing to customers and been able to increase volumes without having to
increase head count. Business development has resulted in first shipments to a
new global customer and the business has been asked to quote for further new
business which, if successful, could more than double turnover in this area.
The Vascular business has overcome the regulatory hurdles of last year and has
worked closely with the FDA towards a clear regulatory plan. The time taken
has been used to establish a robust manufacturing process from which the cost
of manufacture will allow a very attractive margin even from the pilot plant.
The commercial opportunity is in active discussion and our partnering strategy
will be the subject of future updates. Structural Heart has undertaken some
true inventive steps in the year to date and the device envisaged is being
designed to eliminate all of the objections that have been made about
polymeric heart valves.

 

RUA Life Sciences still has a way to go to meet all of its strategic
objectives but in considering the progress of each segment of the business,
each one has added value in the year to date and we look forward to this
continuing in the future.

Bill Brown, Chairman

12 December 2022

 

CONDENSED CONSOLIDATED INTERIM INCOME STATEMENT

Six months ended 30 September 2022

                                                                              Unaudited                  Unaudited                  Audited
                                                                        Note  Six months to 30 Sep 2022  Six months to 30 Sep 2021  Twelve months to 31 Mar 2022

                                                                              GB£000                     GB£000                     GB£000
 Revenue                                                                2     1,104                      708                        1,625
 Cost of sales                                                                (229)                      (180)                      (267)
 Gross profit                                                                 875                        528                        1,358
 Other income                                                                 98                         37                         66
 Administrative expenses                                                      (1,889)                     (1,658)                   (3,315)
 Other expenses:
 Share-based payments                                                         (46)                       (68)                       (145)
 Bad debt expense                                                             -                          -                          (3)
 Depreciation & amortisation                                                  (174)                      (145)                      (313)
 Total administrative expenses                                                (2,109)                    (1,871)                    (3,776)
 Operating loss                                                               (1,136)                    (1,306)                    (2,352)
 Finance income/(expense)                                                     (11)                       (9)                        (8)
 Loss before taxation                                                         (1,147)                    (1,315)                    (2,360)
 Taxation                                                                     4                          4                          293
 Loss attributable to equity holders of the parent company                    (1,143)                    (1,311)                    (2,067)
 Loss per share (basic and diluted) - GB Pence                                (5.15)                     (5.91)                     (9.32)

 

 

CONDENSED CONSOLIDATED INTERIM STATEMENT OF FINANCIAL POSITION

                                                                          Unaudited        Unaudited        Audited
                                                                    Note  30 Sep 2022      30 Sep 2021      31 Mar 2022

                                                                          GB£000           GB£000           GB£000
 Assets
 Non-current assets
 Goodwill                                                           3     301              301              301
 Other intangible assets                                            4     495              547              521
 Property, plant and equipment                                      5     2,543            2,231            2,597
 Total non-currents assets                                                3,339            3,079            3,419

 Current assets
 Inventories                                                              68               177              124
 Trade and other receivables                                              681              866              1,120
 Cash and cash equivalents                                                2,509            4,763            2,963
 Total current assets                                                     3,258            5,806            4,207

 Total assets                                                             6,597            8,885            7,626

 Equity
 Issued capital                                                     7     1,109            1,109            1,109
 Share premium                                                      7     11,729           11,729           11,729
 Capital redemption reserve                                               11,840           11,840           11,840
 Other reserve                                                            (1,507)          (1,629)          (1,552)
 Profit and loss account                                                  (17,685)         (15,786)         (16,542)
 Total equity attributable to equity holders of the parent company        5,486            7,263            6,584

 Liabilities
 Non-current liabilities
 Borrowings                                                               364              305              199
 Lease liabilities                                                        0                5                83
 Deferred tax                                                             71               159              75
 Other Liabilities                                                        140              204              174
 Total non-current liabilities                                            575              673              531

 Current liabilities
 Borrowings                                                               86               60               23
 Lease liabilities                                                        4                8                39
 Trade and other payables                                                 397              847              410
 Other liabilities                                                        49               34               39
 Total current liabilities                                                536              949              511

 Total liabilities                                                        1,111            1,622            1,042

 Total equity and liabilities                                             6,597            8,885            7,626

At 30 September 2022

 

                                                             Unaudited                  Unaudited                  Audited
                                                             Six months to 30 Sep 2022  Six months to 30 Sep 2021  Twelve months to 31 Mar 2022

                                                             GB£000                     GB£000                     GB£000
 Cash flows from operating activities
 Group loss after tax                                        (1,143)                    (1,311)                    (2,067)
 Adjustments for:
 Depreciation and amortisation                               174                        145                        312
 Share-based payments                                        46                         68                         145
 Interest (income) / expense                                 9                          7                          8
 Tax credit in year                                          -                          -                          (293)
 (Increase) / decrease in trade and other receivables        439                        563                        (53)
 (Increase) / decrease in inventories                        56                         (93)                       (39)
 Increase / (decrease) in taxation                           (4)                        (4)                        87
 Increase / (Decrease) in trade and other payables           (38)                       (471)                      (453)
 Net cash flow from operating activities                     (461)                      (1,096)                    (2,353)

 Cash flows from investing activities
 Purchase of property, plant & equipment                     (94)                       (397)                      (904)
 Interest received / (paid)                                  (9)                        (7)                        (8)
 Net cash flow from investing activities                     (103)                      (404)                      (912)

 Cash flows from financing activities
 Proceeds from borrowing                                     150                        -                          -
 Repayment of loans and lease liabilities                    (40)                       (31)                       (66)
 Net cash flow from financing activities                     110                        (31)                       (66)

 Net increase / (decrease) in cash and cash equivalents      (454)                      (1,531)                    (3,331)
 Cash and cash equivalents at beginning of period            2,963                      6,294                      6,294
 Cash and cash equivalents at end of period                  2,509                      4,763                      2,963

CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENT

 

 Six months ended 30 September 2022

 Condensed consolidated interim statement of changes in equity

                                                                 Issued share capital  Share premium  Capital redemption reserve              Other      Profit and loss account  Total equity

              GB£000

                                                                 GB£000                GB£000                                                 reserve    GB£000                   GB£000

                                                                                                                                              GB£000
 Balance at 31 March 2021                                        12,949                11,729                            -                    (1,697)    (14,475)                 8,506
 Transfer of deferred shares                                     (11,840)              -              11,840                                  -          -                        -
 Share-based payments                                            -                     -              -                                       68         -                        68
 Transactions with owners                                        (11,840)              -              11,840                                  68         -                        68
 Total comprehensive income for the period                       -                     -              -                                       -          (1,311)                  (1,311)
 Balance at 30 September 2021                                    1,109                 11,729         11,840                                  (1,629)    (15,786)                 7,263
 Share-based payments                                            -                     -              -                                       77         -                        77
 Issue of equity share capital - exercise of warrants            -                     -              -                                       -          -                        -
 Issue of equity share capital (net of issue costs) - fundraise  -                     -              -                                       -          -                        -
 Transactions with owners                                        -                     -              -                                       77         -                        77
 Total comprehensive loss for the period                         -                     -              -                                       -          (756)                    (756)
 Balance at 31 March 2022                                        1,109                 11,729         11,840                                  (1,552)    (16,542)                 6,584
 Transfer deferred share to capital redemption reserve           -                     -              -                                       -          -                        -
 Share-based payments                                            -                     -              -                                       46         -                        46
 Transactions with owners                                        -                     -              -                                       46         -                        46
 Total comprehensive loss for the period                         -                     -              -                                       -          (1,143)                  (1,143)
 Balance at 30 September 2022                                    1,109                 11,729         11,840                                  (1,506)    (17,685)                 5,487

 

 

 

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

1.   BASIS OF PREPARATION

 

General information

 

RUA Life Sciences plc is the ultimate parent company of the Group, whose
principal activities are contract design and manufacture of medical devices
and 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 2022 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 audited consolidated financial statements of the
Group for the year ended 31 March 2022.

 

The financial information for the six months ended 30 September 2022 and the
comparative figures for the six months ended 30 September 2021 are
unaudited.  They 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 2022 and, on the recognition, and measurement principles of
IFRS in issue as effective at 30 September 2022. The accounting policies
have been applied consistently throughout the Group for the purposes of
preparation of these condensed consolidated interim financial statements.

 

The figures for the year ended 31 March 2022 have been extracted from the
audited statutory accounts which were approved by the Board of Directors on 8
July 2022, prepared under IFRS. The Independent Auditor's Report on the Report
and Financial Statements for the year ended 31 March 2022 was unqualified but
did draw attention to Note 1 of those financial statements which explains that
the Group and Parent Company's ability to continue as a going concern is
dependent on the execution of its business plan together with its ability to
raise sufficient capital to meet capital and liquidity requirements.  The
auditors report did not contain any statements under sections 498(2) or 498(3)
of the Companies Act 2006.

 

These condensed consolidated interim financial statements were approved for
issue by the Board of Directors on 9 December 2022.

 

 

Going concern

 

The 2022 Annual Report audit report drew attention to the material uncertainty
relating to going concern as follows:

 

"We draw attention to the going concern accounting policy in note 1 of the
financial statements, which states that the RUA Life Sciences Group is
loss-making and cash-consumptive, and its revenue streams have been impacted
by the COVID-19 pandemic and the resulting macro-economic uncertainty and the
setback of a regulatory delay for the Vascular Graft Range. These events and
conditions may result in lower than forecasted revenues and increased costs
associated with the regulatory delay. This increases the risk that the group
will not be able to execute its business plan, which could adversely impact
its ability to generate profit or raise sufficient capital to meet capital and
liquidity requirements. As stated in note 1, these events or conditions,
together with the requirement for financing indicate that a material
uncertainty exists that may cast significant doubt on the company's ability to
continue as a going concern. Our opinion is not modified in respect of this
matter."

 

The Board and management have prepared and reviewed financial forecasts and
cashflow requirements. The review included key assumptions, sensitivities, and
contingency plans to cover eventualities, including the associated cash flow
projections. The review has been updated and also taken into consideration the
potential impact of changing market conditions and other risks and
uncertainty, paying particular attention to the impact of potential delays in
the regulatory process of our Vascular grafts.

The Directors concluded that given the combination of the cash balance of
£2.5m at 30 September 2022 and the forecast monthly cash utilisation, the
Group has sufficient liquidity throughout a period of at least 12 months from
the date of approval of this interim financial report.

As a result, the Directors have a reasonable expectation that the Group as a
whole has adequate resources to continue in operational existence for a period
of at least 12 months from the date of this interim financial report. For this
reason, they continue to adopt the going concern basis in preparing the
unaudited interim report for the half year ended 30 September 2022.

The financial statements do not include any adjustments that would be
necessary if the group or company was unable to continue as a going concern.

 

Principal Risks and Uncertainties

The principal risks and uncertainties affecting the business activities of the
Group remain those detailed on pages 19-22 of the Annual Report 2022, a copy
of which is available on the Company's website www.rualifesciences.com
(http://www.rualifesciences.com)

 

 

Loss per share

Loss per share has been calculated on the basis of the result for the period
after tax, divided by the weighted average number of ordinary shares in issue
in the period of 22,184,798.  (30 September 2021: 22,184,798 and 31 March
2022: 22,184,798).

 

2.   SEGMENTAL REPORTING

The principal activity of the RUA Life Sciences Group comprise exploiting the
value of its IP & know-how, medical device contract manufacturing and
development of cardiovascular devices.

 

Following the acquisition of RUA Medical Devices Ltd and an internal
organisation and reporting review, the Board has decided the business will
report by business unit segments, namely royalty and license income
(Biomaterials), Contract Manufacturing, product development (Vascular) &
product innovation (Structural Heart), rather than trading entities, which is
consistent with both how the business will be managed and reported internally
in the future.

 

The following analysis by segment is presented in accordance with IFRS 8 on
the basis of those segments whose operating results are regularly reviewed by
the Chief Operating Decision Maker (considered to be the executive chairman of
the board) to assess performance and make strategic decisions about the
allocation of resources. Segmental results are calculated on an IFRS basis.

 

A brief description of the segments of the business is as follows:

 

• Biomaterials - Licensor of Elast-Eon(TM) polymers to the medical device
industry.

• Contract Manufacturing - End-to-end contract developer and manufacturer of
medical devices and implantable fabric specialist.

• Vascular - Development and commercialisation of the Group's Elast-Eon
sealed Vascular Graft products.

• Structural Heart - Development of the Group's tri leaflet polymeric heart
valves.

 

Operating results which cannot be allocated to an individual segment are
recorded as central and unallocated.

 

 

 Analysis of revenue by income stream  Unaudited                  Unaudited                  Audited
                                       Six months to 30 Sep 2022  Six months to 30 Sep 2021  Twelve months to 31 Mar 2022

                                       GB£000                     GB£000                     GB£000
 Biomaterials                          187                        156                        487
 Contract Manufacture                  917                        552                        1,138
 Vascular                              -                          -                          -
 Structural Heart                      -                          -                          -
 Total                                 1,104                      708                        1,625

 

 

                                                Unaudited                  Unaudited                  Audited

 Analysis of revenue by geographical location
                                                Six months to 30 Sep 2022  Six months to 30 Sep 2021  Twelve months to 31 Mar 2022

                                                GB£000                     GB£000                     GB£000
 Europe                                         6                          43                         192
 USA                                            1,072                      643                        1,379
 RoW                                            26                         22                         54
 Total                                          1,104                      708                        1,625

 

 

 

 

The Group's revenue for six months to 30 September 2022 is segmented as
follows:

 

 Analysis of revenue by income stream
                                                       Unaudited            Unaudited             Unaudited  Unaudited         Unaudited                Unaudited
                                                       Biomaterials         Contract Manufacture  Vascular   Structural Heart  Central and unallocated  Total
                                                       GB£000               GB£000                GB£000     GB£000            GB£000                   GB£000
 Contract Design & Manufacture of Medical Devices      -                    917                   -          -                 -                        917
 Royalty revenue                                       187                  -                     -          -                 -                        187
 Total                                                 187                  917                   -          -                 -                        1,104

 

 

 Analysis of revenue by geographical location
                          Unaudited                Unaudited             Unaudited  Unaudited         Unaudited                Unaudited
                          Biomaterials             Contract Manufacture  Vascular   Structural Heart  Central and unallocated  Total
                          GB£000                   GB£000                GB£000     GB£000            GB£000                   GB£000
 Europe                   7                        -1                    -          -                 -                        6
 USA                      154                      918                   -          -                 -                        1,072
 RoW                      26                       -                     -          -                 -                        26
 Total                    187                      917                   -          -                 -                        1,104

 

 

 

Restatement of Analysis of revenue by income stream six month to 30 September
2021 is as follows:

 

 

 Analysis of revenue by income stream
                                                       Unaudited      Unaudited                   Unaudited     Unaudited             Unaudited                   Unaudited
                                                       Biomaterials   Contract Manufacture        Vascular      Structural Heart      Central and unallocated     Total
                                                       GB£000         GB£000                      GB£000        GB£000                GB£000                      GB£000
 Contract Design & Manufacture of Medical Devices      -              552                         -             -                     -                           552
 Royalty revenue                                       156            -                           -             -                     -                           156
 Total                                                 156            552                         -             -                     -                           708

 

 

 Analysis of revenue by geographical location
                  Unaudited        Unaudited                     Unaudited     Unaudited             Unaudited                   Unaudited
                  Biomaterials     Contract Manufacture          Vascular      Structural Heart      Central and unallocated     Total
                  GB£000           GB£000                        GB£000        GB£000                GB£000                      GB£000
 Europe           -                44                            -             -                     -                           44
 USA              134              508                           -             -                     -                           642
 RoW              22               -                             -             -                     -                           22
 Total            156              552                           -             -                     -                           708

 

 

 

 Segment Analysis for period to 30 September 2022
                                                      Unaudited          Unaudited             Unaudited  Unaudited         Unaudited                Unaudited
                                                      Biomaterials       Contract Manufacture  Vascular   Structural Heart  Central and unallocated  Total
                                                      GB£000             GB£000                GB£000     GB£000            GB£000                   GB£000
 Consolidated group revenues from external customers  187                917                   -          -                 -                        1,104
 Contributions to group operating loss                154                384                   (619)      (289)             (766)                    (1,136)
 Depreciation                                         -                  139                   -          8                 1                        148
 Amortisation of intangible assets                    -                  22                    -          -                 4                        26
 Segment assets                                       90                 4,012                 -          152               2,343                    6,597
 Segment liabilities                                  2                  897                   34         4                 174                      1,111
 Intangible assets - goodwill                         -                  301                   -          -                 -                        301
 Other intangible assets                              -                  419                   -          -                 76                       495
 Additions to non-current assets                      -                  94                    -          -                 -                        94

 

Restatement of Segment Analysis six month to 30 September 2021 is as follows:

 

 Segment Analysis 2021
                                                      Unaudited     Unaudited             Unaudited  Unaudited         Unaudited                Unaudited
                                                      Biomaterials  Contract Manufacture  Vascular   Structural Heart  Central and unallocated  Total
                                                      GB£000        GB£000                GB£000     GB£000            GB£000                   GB£000
 Consolidated group revenues from external customers  156           552                   -          -                 -                        708
 Contributions to group operating loss                116           79                    (532)      (317)             (652)                    (1,306)
 Depreciation                                         -             117                   -          -                 1                        118
 Amortisation of intangible assets                    -             22                    -          -                 5                        27
 Segment assets                                       167           3,763                 -          153               4,802                    8,885
 Segment liabilities                                  6             1,333                 44         26                213                      1,622
 Intangible assets - goodwill                         -             301                   -          -                 -                        301
 Other intangible assets                              -             462                   -          -                 85                       547
 Additions to non-current assets                      -             313                   -          -                 84                       397

 

 

 

 

3.     GOODWILL

 

The final valuation following the acquisition of RUA Medical Devices Limited
gave rise to adjustments being required to the value of intangibles recognised
in the Interim Report for the six months ended 30 September 2020 (as noted in
note 5 below), and lead to the following goodwill being recognised:

 

No impairment review has been carried out in the six-month period.

                                   GB£000
     Gross carrying amount
     Balance at 31 March 2021      301
     Balance at 31 March 2022      301
     Balance at 30 September 2022                301

 

 

 

4.     INTANGIBLE ASSETS

 

                              Development costs  Intellectual property  Customer related  Technology based  Total
 Gross carrying amount

 At 31 March 2021             337                3,325                  247               141               4,050
 At 30 September 2021         337                3,325                  247               141               4,050
 At 31 March 2022             337                3,325                  247               141               4,050
 At 30 September 2022         337                3,325                  247               141               4,050

 Amortisation and impairment
 At 31 March 2021             334                3,099                  29                14                3,476
 Charge for the period        2                  4                      14                7                 27
 At 30 September 2021         336                3,103                  43                21                3,503
 Charge for the period        1                  3                      15                7                 26
 At 31 March 2022             337                3,106                  58                28                3,529
 Charge for the period        -                  4                      15                7                 26
 At 30 September 2022         337                3,110                  73                35                3,555

 Net book value
 At 30 September 2021         1                  222                    204               120               547
 At 31 March 2022             -                  219                    189               113               521
 At 30 September 2022         -                  215                    174               106               495

 

 

 

5.   PROPERTY, PLANT AND EQUIPMENT

 

 

                       Land & Buildings      Plant & Machinery      Office Equipment  Motor Vehicles  Total
                       GB£000                GB£000                 GB£000            GB£000          GB£000
 Cost
 At 31 March 2021      944                   1,114                  63                28              2,149
 Additions             28                    361                    8                 -               397
 At 30 September 2021  972                   1,475                  71                28              2,546
 Additions             363                   139                    8                 (3)             507
 At 31 March 2022      1,335                 1,614                  79                25              3,053
 Additions             -                     80                     14                -               94
 At 30 September 2022  1,335                 1,694                  93                25              3,147

 Depreciation
 At 31 March 2021      58                    112                    18                9               197
 Charge                29                    79                     7                 3               118
 At 30 September 2021  87                    191                    25                12              315
 Charge                33                    96                     8                 4               141
 At 31 March 2022      120                   287                    33                16              456
 Charge                30                    106                    8                 4               148
 At 30 September 2022  150                   393                    41                20              604

 Net book value
 At 30 September 2021  885                   1,284                  46                16              2,231
 At 31 March 2022      1,215                 1,327                  46                9               2,597
 At 30 September 2022  1,185                 1,301                  52                5               2,543

 

 

 

 

Included in the net carrying amount of property plant and equipment are
right-of-use assets as follows:

 

 

                            30 September 2022
                            GB£000

 Plant & Machinery          131
 Motor vehicles             5
 Total right-of-use assets  136

 

 

7.  ISSUED SHARE CAPITAL

The Company's issued share capital at 30 September 2022 comprises 22,184,798
Ordinary Shares of which none are held in treasury.

 

 

8.  INTERIM ANNOUNCEMENT

The interim results announcement was released on 12 December 2022.  A copy of
this Interim Report is also available on the Company's website
www.rualifesciences.com.

 

 

 

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 (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  IR BKDBBOBDDKBD

Recent news on Rua Life Sciences

See all news