We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Register for real-time alerts, custom portfolio, and market movers
| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| Shield Therapeutics Plc | LSE:STX | London | Ordinary Share | GB00BYV81293 | ORD 1.5P |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 1.425 | 1.40 | 1.45 | 1.425 | 1.425 | 1.425 | 596,675 | 08:00:00 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| Pharmaceutical Preparations | 4.47M | -40.44M | -0.0522 | -0.27 | 11.01M |
From Apr 2019 to Apr 2024
TIDMSTX
RNS Number : 2248B
Shield Therapeutics PLC
19 September 2018
Shield Therapeutics plc
("Shield" or the "Company" or the "Group")
Interim Report for the Six Months Ended 30 June 2018
London, UK, 19 September 2018. Shield Therapeutics plc (LSE:STX), a specialty pharmaceutical company focused on secondary care, today announces its unaudited interim results for the six months ended 30 June 2018.
Highlights (including post period end)
Operational
Feraccru(R) highlights
-- Exclusive licence agreement announced with Norgine BV
-- Marketing authorisation in Europe extended to cover iron deficiency (ID) in adults with or without anaemia
-- Phase III AEGIS-CKD achieved statistically significant response against primary endpoint -- US NDA submission remains on course to be filed in 2018 -- AEGIS-H2H recruitment completed -- Revenues maintained despite reductions in manpower and promotional activity
Financial
-- Revenues of GBP495k (H1 2017: GBP142k) -- Net loss of GBP8.0m (H1 2017: GBP9.6m) -- Adjusted net loss (excluding exceptional items) of GBP6.8m (H1 2017: GBP8.4m) -- Net cash of GBP3.5m (31 December 2017: GBP13.3m) -- GBP11m upfront from Norgine licence agreement extends cash runway significantly
Board changes
Dr Andrew Heath resigned as Chairman and from the Board in June 2018 in order to focus on other business interests. Rolf Hoffman and Hans-Peter Hasler joined the Board as non-executive directors in April and July 2018 respectively.
Commenting on the interim results, Carl Sterritt, CEO of Shield Therapeutics plc, said: "I am pleased to be able to report that the business has continued to develop positively. Full analysis of the AEGIS-CKD data showed a statistically significant response against the primary endpoint, we gained a much broader approval for Feraccru(R) in Europe, and we are on track to file a US NDA submission in 2018. The licence agreement with Norgine announced today is an important step forward for the Group which will accelerate the commercialisation of Feraccru(R) and extend our cash runway. Although we have had to adapt during the first half of the year, I remain confident that we will be able to build a valuable business and bring benefits to many patients worldwide who suffer today from iron deficiency."
Conference call for analysts
A conference call for analysts will be held at 11.30am BST on 19 September 2018
Dial in details:
Participant local dial-in: +44 (0) 2071 928000
Participant free phone dial-in: 08003767922
Participant code: 8426797
To access the presentation, please visit Shield's investor relations page https://www.shieldtherapeutics.com/investors/presentations/
An audio replay file will be made available shortly afterwards via the Company website: www.shieldtherapeutics.com
For further information please contact:
Shield Therapeutics plc
+44 (0)207 186 8500
Carl Sterritt, Chief Executive Officer
Tim Watts, Interim Chief Financial Officer
Nominated Advisor and Joint Broker +44 (0)203 100 2222
Liberum Capital Limited
Christopher Britton/Steve Pearce
Joint Broker
+44 (0)207 418 8900
Peel Hunt LLP
James Steel/Christopher Golden
Financial PR Advisor
+44 (0)203 709 5700
Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal
About Shield Therapeutics plc
Shield Therapeutics is a commercial stage pharmaceutical company, delivering innovative specialty pharmaceuticals to address patients' unmet medical needs. Our clear purpose is to help our patients become people again, by enabling them to enjoy the things that make the difference in their everyday lives. The Group has a marketed product, Feraccru(R), for the treatment of adults with iron deficiency with or without anaemia which has exclusive IP rights until the mid-2030's. For more information please visit www.shieldtherapeutics.com.
Note
This announcement is released by Shield Therapeutics plc and contains inside information for the purposes of the Market Abuse Regulation (EU) 596/2014 ("MAR") and is disclosed in accordance with the Company's obligations under Article 17 of MAR. The person who arranged for the release of this announcement on behalf of Shield Therapeutics plc was Carl Sterritt, Chief Executive Officer.
Operational Review
Feraccru(R)
In February 2018 the Company announced preliminary topline data from the Feraccru(R) AEGIS-CKD clinical study which suggested that the study had not met its primary endpoint. Subsequent detailed analysis, which was announced in March 2018, showed that the study had, in fact, achieved a statistically significant response (p=0.0149) against the primary endpoint of haemoglobin levels after 16 weeks of treatment. However, the adverse market reaction to the initial announcement led the Company to adapt its strategy so as to out-license Feraccru(R) in Europe and to reduce the organisation and cost base substantially.
Since March 2018 there has been good progress on several fronts, as shown below.
Broad label in Europe
In March the European Commission (EC) approved a much broader indication for Feraccru(R), which can now be used across Europe to treat iron deficiency (ID) with or without anaemia in adults. This decision was a very significant event for Feraccru(R) as it provides a significantly broader commercial opportunity in Europe, where 40 million people are estimated to be iron deficient as compared to less than half a million with iron deficiency anaemia (IDA) associated with inflammatory bowel disease (IBD).
Licence agreement with Norgine B.V.
The Company has announced today that it has entered into an exclusive licence agreement with Norgine for the commercialisation of Feraccru(R) in Europe, Australia and New Zealand. Under the terms of the agreement, Shield will receive an immediate GBP11 million upfront payment, is eligible to receive up to EUR4.5 million in development milestones and up to EUR50 million in sales milestones upon the achievement of specified targets. Shield will also receive tiered royalties ranging from 25% to 40% of net sales of Feraccru(R). This agreement is the result of an extensive process involving several potential partners.
US New Drug Application (NDA) submission
Following the Company's detailed analysis of the positive data from the placebo-controlled period of the AEGIS-CKD study, in March a pre-planned pre-NDA submission meeting with the FDA took place. This gave the Company an opportunity to present and discuss the positive AEGIS-CKD study results together with a broader discussion regarding the Company's intention to file an NDA for Feraccru(R). The feedback received from the FDA has meant we have continued preparations for the NDA submission, which remains on course to occur in the second half of 2018 and could lead to an approval decision being made by the FDA during Q4 2019.
Development progress
AEGIS-CKD study: In March, following a detailed review of all enrolled subjects who completed the initial 16-week pivotal period of the Phase III AEGIS-CKD study, we announced Feraccru(R) had achieved a statistically significant response (p=0.0149) in haemoglobin levels after 16 weeks of treatment compared to placebo. Statistically significant results were also achieved across a range of secondary iron parameters (TSAT, Ferritin levels, serum iron levels). Following announcement of these positive pivotal results our focus has been on finalising the Clinical Study Report such that the study results can be incorporated into the NDA submission. At the same time, we have been continuing to progress the long term 36-week open-label phase of the study, which will complete active patient involvement by the end of the year.
AEGIS-H2H study: As announced on 13 September 2108, recruitment into this study has been completed. The Feraccru AEGIS-H2H study is a Phase 3b trial comparing the change in haemoglobin (Hb) from baseline at 12 weeks after oral Feraccru 30mg twice daily for 12 weeks versus IV ferric carboxymaltose dosed in line with its commercially approved dosing regimen. The primary endpoint is non-inferiority of Hb response at 12 weeks with preliminary results anticipated in Q1 2019.
Paediatric PK Study: In June we reported positive data from our first paediatric study of Feraccru(R), the AEGIS-Paeds PK study. This pharmacokinetics (PK) study of Feraccru(R) was conducted in 36 subjects aged 12-17 years and saw Feraccru(R) achieve all the pre-defined goals of the protocol, including demonstrating positive effects on serum iron parameters over the duration of the study and showing good tolerance at all dosing levels. Completion of this study signified delivery of the first major milestone in Feraccru's paediatric development plan as agreed with the EMA and allows for selection of an optimal dosing schedule for the Phase III pivotal study in children that will follow in due course.
Real World Data: The first half of 2018 also saw two independently published reports of the efficacy and cost-effectiveness of Feraccru(R) in real world settings. The FRESH (Feraccru(R) Real World Effectiveness Study in Hospital Practice) study presented at the 2018 meeting of the British Society of Gastroenterology and a health economics analysis reported at the 2018 European Haematology Society meeting by physicians from the London North West University Healthcare NHS Trust have both provided independent data supporting the clinical and cost effectiveness of Feraccru(R), all of which adds to the growing body of evidence supporting its use. We anticipate that as prescriber experience of Feraccru(R) grows, further positive real world data will be reported at scientific congresses.
Organisational changes
As a result of the adverse consequences following the preliminary results of the AEGIS-CKD study, the Group has reduced the number of permanent employees from 50 at 31 December 2017 to 20 at 30 June 2018 (and 15 at the end of August 2018). This includes the closure of the sales and marketing teams in the UK and Germany.
Outlook
Shield Therapeutics has made considerable progress during the first half of 2018, despite the setback in February caused by the preliminary data from the AEGIS-CKD study. With the broad label for Feraccru(R) now approved in Europe, the licence agreement with Norgine, the completion of the head-to-head study and the impending filing of the US NDA, the Group intends to build on this momentum in the coming months. The paediatric Phase III study will be started and focus will turn to the commercialisation of Feraccru(R) in other parts of the world, in particular the USA. Shield is now funded for at least 12 months and therefore well placed to deliver value to shareholders.
Financial Review
Revenue
Revenue of GBP495k was recorded during the period (H1 2017 : GBP142k), of which GBP107k related to sales in the UK and GBP388k to sales in Europe. European sales revenue includes a milestone payment of GBP61k from a commercial partner. Despite the closure of the UK and German sales and marketing teams during H1 2018, revenue in the period was unchanged from the GBP495k generated in H2 2017.
Selling, general and administrative expenses
Selling costs reduced from GBP3.9m in H1 2017 (and GBP5.3m in H2 2017) to GBP2.6m in the period, largely as a consequence of decisions taken following February 2018 to rationalise the Group's commercial structure and extend its cash runway.
Other costs remained broadly steady, with general and administrative expenses at GBP2.6m compared to GBP2.7m in H1 2017 (and GBP2.4m in H2 2017) and depreciation and amortisation of GBP1.2m in both H1 2018 and H1 2017.
Research and development expenditure
Research and development costs of GBP2.1m in the statement of profit and loss included expenditure on the Group's AEGIS-CKD study, and other continuing clinical and regulatory activities.
In addition, GBP2.7m of costs were capitalised as intangible assets, including GBP2.5m spent on the Head to Head and paediatric studies and GBP0.2m on improved patent protection.
Exceptional items
Exceptional items, which are set out in Note 6, are non-cash charges included in expenditure (IP amortisation and share-based payment charges) which the Directors consider should be disclosed separately in order to give a fuller understanding of the performance of the Group. The H1 2018 charge of GBP1.3m is broadly comparable with GBP1.2m in H1 2017.
Operating loss
The operating loss after exceptional items of GBP8.1m is a reduction from the GBP9.6m loss in H1 2017 and GBP11.3m loss in H2 2017. The reduction in the loss in the most recent period is due mainly to the reduction in selling costs.
Balance sheet
Net assets at 30 June 2018 were GBP33.5m (31 December 2017 : GBP41.2m), including intangible assets of GBP31.5m (31 December 2017 : GBP30.0m) and cash of GBP3.5m (31 December 2017 : GBP13.3m).
GBP22.4m of the intangible assets balance relates to the intellectual property acquired with Phosphate Therapeutics Limited in 2016. A further GBP9.1m of intangible assets relate to Feraccru(R), including GBP1.3m strengthening the Group's patent protection and GBP7.8m of development cost expenditure in relation to the Group's Head to Head and paediatric studies, together with initial Marketing Authorisation costs.
Cash
The Group's cash at 30 June 2018 was GBP3.5m (31 December 2017 : GBP13.3m). Cash burn (net cash outflow from operating and investing activities) was GBP9.8m (H1 2017 : GBP11.0m), primarily in relation to key research and development activities and commercialisation.
Financial Outlook
As discussed above the Group has substantially rationalised its cost base and headcount such that selling and administration costs are significantly reduced. With the receipt of the GBP11 million upfront from the Norgine licence upfront payment, funding the business for at least 12 months, and with the prospects of future development milestones and the start of royalty payments, the Group is now financially well placed to undertake the paediatric Phase III study and to pursue the approval of Feraccru(R) in the USA.
Consolidated statement of profit and loss and other comprehensive income
for the six months ended 30 June 2018
Hot Features
Premium
Six months Year
Six months
ended ended ended
30 June 30 June 31 December
2018 2017 2017
(unaudited) (unaudited) (audited)
Note GBP000 GBP000 GBP000
----------------------------------- ----- -------------- -------------- -------------
Revenue 4 495 142 637
Cost of sales (131) (38) (155)
----------------------------------- ----- -------------- -------------- -------------
Gross profit 364 104 482
Operating costs - selling,
general and administrative
expenses 5 (6,301) (7,787) (16,722)
Operating loss before research
and development expenditure (5,937) (7,683) (16,240)
Research and development
expenditure (2,146) (1,941) (4,711)
Operating loss (8,083) (9,624) (20,951)
----------------------------------- ----- -------------- -------------- -------------
Analysed as:
Operating loss before exceptional
items (6,806) (8,434) (18,380)
Exceptional items 6 (1,277) (1,190) (2,571)
----------------------------------- ----- -------------- -------------- -------------
Operating loss (8,083) (9,624) (20,951)
----------------------------------- ----- -------------- -------------- -------------
Financial income 58 10 15
Financial expense (12) (14) (58)
----------------------------------- ----- -------------- -------------- -------------
Loss before tax (8,037) (9,628) (20,994)
Taxation (8) - 1,406
----------------------------------- ----- -------------- -------------- -------------
Loss for the period (8,045) (9,628) (19,588)
----------------------------------- ----- -------------- -------------- -------------
Attributable to:
Equity holders of the parent (8,045) (9,628) (19,588)
Other comprehensive income
Items that are or may be
reclassified subsequently
to profit or loss:
Foreign currency translation
differences - foreign operations 1 (23) (41)
----------------------------------- ----- -------------- -------------- -------------
Total comprehensive expenditure
for the period (8,044) (9,651) (19,629)
----------------------------------- ----- -------------- -------------- -------------
Attributable to:
Equity holders of the parent (8,044) (9,651) (19,629)
Total comprehensive expenditure
for the period (8,044) (9,651) (19,629)
----------------------------------- ----- -------------- -------------- -------------
Earnings per share
Basic and diluted loss per GBP(0.07)
share 7 GBP(0.09) GBP(0.17)
----------------------------------- ----- -------------- -------------- -------------
Non-GAAP measure
Adjusted loss per share 7 GBP(0.06) GBP(0.08) GBP(0.15)
----------------------------------- ----- -------------- -------------- -------------
Group balance sheet
at 30 June 2018
30 June 30 June 31 December
2018 2017 2017
(unaudited) (unaudited) (audited)
Note GBP000 GBP000 GBP000
------------------------------- ----- -------------- --------------- -------------
Non-current assets
Intangible assets 8 31,511 29,870 29,961
Property, plant and equipment 10 16 13
------------------------------- ----- -------------- --------------- -------------
31,521 29,886 29,974
------------------------------- ----- -------------- --------------- -------------
Current assets
Inventories 151 138 125
Trade and other receivables 1,256 2,104 1,572
Cash and cash equivalents 3,508 21,521 13,299
------------------------------- ----- -------------- --------------- -------------
4,915 23,763 14,996
------------------------------- ----- -------------- --------------- -------------
Total assets 36,436 53,649 44,970
------------------------------- ----- -------------- --------------- -------------
Current liabilities
Trade and other payables (2,720) (2,634) (3,501)
Other liabilities (194) (197) (262)
------------------------------- ----- -------------- --------------- -------------
(2,914) (2,831) (3,763)
------------------------------- ----- -------------- --------------- -------------
Total liabilities (2,914) (2,831) (3,763)
------------------------------- ----- -------------- --------------- -------------
Net assets 33,522 50,818 41,207
------------------------------- ----- -------------- --------------- -------------
Equity
Share capital 9 1,746 1,746 1,746
Share premium 88,338 88,338 88,338
Merger reserve 28,358 28,358 28,358
Currency translation reserve 33 50 32
Retained earnings (84,953) (67,674) (77,267)
------------------------------- ----- -------------- --------------- -------------
Total equity 33,522 50,818 41,207
------------------------------- ----- -------------- --------------- -------------
Group statement of changes in equity
for the six months ended 30 June 2018
Currency
Share Share Warrants Merger translation Retained
capital premium reserve reserve reserve earnings Total
GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
------------------------------ --------- --------- ----------- --------- ------------- ---------- ---------
Balance at 1 January 2017
(audited) 1,622 77,963 2,760 28,358 73 (62,380) 48,396
Loss for the year - - - - - (19,588) (19,588)
Other comprehensive income:
Foreign currency translation
differences - - - - (41) - (41)
------------------------------ --------- --------- ----------- --------- ------------- ---------- ---------
Total comprehensive expense
for the year - - - - (41) (19,588) (19,629)
Transactions with owners,
recorded directly in equity
Share issue - exercise of
Warrants 108 10,235 (2,760) - - 2,760 10,343
Share issue - placing 15 - - - - 1,381 1,396
Share issue - subscription 1 140 - - - - 141
Equity-settled share-based
payment transactions - - - - - 560 560
------------------------------ --------- --------- ----------- --------- ------------- ---------- ---------
Balance at 31 December 2017
(audited) 1,746 88,338 - 28,358 32 (77,267) 41,207
------------------------------ --------- --------- ----------- --------- ------------- ---------- ---------
Loss for the period - - - - - (8,045) (8,045)
Other comprehensive income:
Foreign currency translation
differences - - - - 1 - 1
------------------------------ --------- --------- ----------- --------- ------------- ---------- ---------
Total comprehensive expense
for the period - - - - 1 (8,045) (8,044)
Transactions with owners,
recorded directly in equity
Equity-settled share-based
payment transactions - - - - - 359 359
------------------------------ --------- --------- ----------- --------- ------------- ---------- ---------
Balance at 30 June 2018
(unaudited) 1,746 88,338 - 28,358 33 (84,953) 33,522
------------------------------ --------- --------- ----------- --------- ------------- ---------- ---------
Group statement of cash flows
for the six months ended 30 June 2018
Six months Six months Year
ended ended ended
30 June 30 June 31 December
2018 2017 2017
(unaudited) (unaudited) (audited)
GBP000 GBP000 GBP000
---------------------------------------------------- -------------- -------------- --------------
Cash flows from operating activities
Loss for the period (8,045) (9,628) (19,588)
Adjustments for:
Depreciation and amortisation 1,161 1,186 2,437
Equity-settled share-based payment expenses 421 193 560
Financial income (4) (10) (15)
Financial expense 12 10 17
Unrealised foreign exchange losses 1 49 39
Income tax 8 - (1,406)
---------------------------------------------------- -------------- -------------- --------------
(6,446) (8,200) (17,956)
(Increase)/decrease in inventories (26) 280 293
Decrease/(increase) in trade and other receivables 320 (221) (171)
Decrease in trade and other payables (786) (1,409) (409)
(Decrease)/increase in other liabilities (130) 36 101
Financial income 4 10 15
Financial expense (12) (10) (17)
Income tax received (8) 587 1,993
---------------------------------------------------- -------------- -------------- --------------
Net cash flows from operating activities (7,084) (8,927) (16,151)
---------------------------------------------------- -------------- -------------- --------------
Cash flows from investing activities
Acquisitions of intangible assets (118) (175) (235)
Capitalised development expenditure (2,589) (1,894) (3,173)
Net cash flows from investing activities (2,707) (2,069) (3,408)
---------------------------------------------------- -------------- -------------- --------------
Cash flows from financing activities
Proceeds of warrants exercise - 10,306 10,792
Proceeds of placing - 1,500 1,500
Proceeds of subscription - 145 144
Share issue costs - (413) (556)
Net cash flows from financing activities - 11,538 11,880
---------------------------------------------------- -------------- -------------- --------------
Net (reduction)/increase in cash (9,791) 542 (7,679)
Cash and cash equivalents at beginning period 13,299 20,978 20,978
Effects of currency translation on cash and - 1 -
cash equivalents
---------------------------------------------------- -------------- -------------- --------------
Cash and cash equivalents at period end 3,508 21,521 13,299
---------------------------------------------------- -------------- -------------- --------------
Notes
for the six months ended 30 June 2018
1. General information
Shield Therapeutics plc (the "Company") is incorporated in England and Wales as a public limited company. The Company trades on the London Stock Exchange's AIM market.
The Company is domiciled in England and the registered office of the Company is at Northern Design Centre, Baltic Business Quarter, Gateshead Quays NE8 3DF.
This interim report, which is not audited, has been prepared in accordance with the measurement and recognition criteria of EU Adopted International Financial Reporting Standards. It does not include all the information required for full annual financial statements and should be read in conjunction with the financial statements of the Company and its subsidiaries (the "Group") as at and for the year ended 31 December 2017. This financial information does not constitute statutory financial statements as defined in Section 435 of the Companies Act 2006. The comparative figures for the year ended 31 December 2017 are not the Company's statutory accounts for that financial year. Those accounts have been reported on by the Company's auditor and delivered to the Registrar of Companies. The report of the auditors was unqualified. The auditor has reported on those accounts; their report was unqualified and did not contain a statement under Section 498 (2) or (3) of the Companies Act 2006; though it did include a reference to a matter to which the auditor drew attention by way of emphasis without qualifying their report in relation to going concern. It does not comply with IAS 34 Interim financial reporting, as is permissible under the rules of AIM.
The interim report was approved by the board of directors on 18 September 2018.
2. Accounting policies
The accounting policies applied in these interim financial statements are consistent with those of the annual financial statements for the year ended 31 December 2017, as described in those annual financial statements, except as explained in Accounting Developments below.
Accounting developments
The Directors have considered all new standards, amendments to standards and interpretations which are mandatory for the first time for the financial year beginning 1 January 2018. From 1 January 2018 the Company adopted IFRS 15 Revenue from contracts with customers. The Company has also adopted IFRS 9 Financial Instruments. No adjustments have been required as a consequence of these standards' adoption, as the impact is immaterial. There are no other new or amended standards which impact the Group in the period.
The Group is continuing to assess the impact of IFRS 16 Leases and does not expect its introduction to have a material impact based on an initial assessment.
3. Critical accounting judgments and key sources of estimation uncertainty
In the application of the Group's accounting policies, management is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources.
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods. The significant judgments and estimates which may lead to material adjustment in the next accounting period are:
Going concern
Following the receipt of the GBP11 million upfront on signing the licence agreement with Norgine, the Directors are of the opinion that the Group has sufficient working capital for its present requirements, that is for at least 12 months from the date of this announcement. The Directors therefore consider it appropriate to adopt the going concern basis of accounting in preparing the interim financial information.
Notes (continued)
for the six months ended 30 June 2018
Valuation of intellectual property acquired with Phosphate Therapeutics Limited - GBP22.4m
The valuation of intellectual property acquired with Phosphate Therapeutics Limited is based on cash flow forecasts for the underlying business and an assumed appropriate cost of capital and other inputs in order to arrive at a fair value for the asset. The realisation of its value is ultimately dependent on regulatory approval and successful commercialisation of the asset. Work on the development of a suitable commercial formulation of the drug product is ongoing and a strategic commercial/co-development partner for the asset is being sought in order to provide the funding required to successfully commercialise the asset. In the event that commercial returns are lower than current expectations or partner or alternative funding is not available this may lead to an impairment. No impairment has been recognised to date.
Valuation of intellectual property associated with Feraccru(R) - GBP9.1m
The valuation of intellectual property associated with Feraccru(R) (including patents, development costs and the Company's investment in Shield TX (Switzerland) AG) is based on cash flow forecasts for the underlying business and an assumed appropriate cost of capital and other inputs in order to arrive at a fair value for the asset. The realisation of its value is ultimately dependent on the successful commercialisation of the asset. A strategic commercial partner for the asset is currently being sought in Europe in order to provide the funding required to successfully commercialise the asset. In the event that commercial returns are lower than current expectations or partner or alternative funding is not available this may lead to an impairment. No impairment has been recognised to date.
Deferred tax assets
No deferred tax asset has been recognised as at 30 June 2018 as there has been no certainty of future profitability.
4. Segmental reporting
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 Board of Directors) 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:
-- Feraccru(R) - development and supply of the Group's lead Feraccru(R) product -- PT20 - development of the Group's secondary asset
Operating results which cannot be allocated to an individual segment are recorded as central and unallocated.
Six months Year
ended ended
30 June 31
2018 December
(unaudited) 2017
(audited)
Central Central
Feraccru(R) PT20 and Total Feraccru(R) PT20 and Total
GBP000 GBP000 unallocated GBP000 GBP000 GBP000 unallocated GBP000
GBP000 GBP000
----------- ------------- ------------- ------------- -------- ------------- ----------- ------------- ---------
Revenue 495 - - 495 637 - - 637
----------- ------------- ------------- ------------- -------- ------------- ----------- ------------- ---------
Operating
loss (6,207) (919) (957) (8,083) (16,718) (2,047) (2,186) (20,951)
----------- ------------- ------------- ------------- -------- ------------- ----------- ------------- ---------
Net
foreign
exchange
losses 54 (41)
Financial
income 4 15
Financial
expense (12) (17)
Tax (8) 1,406
Loss for
the
period (8,045) (19,588)
----------- ------------- ------------- ------------- -------- ------------- ----------- ------------- ---------
Notes (continued)
for the six months ended 30 June 2018
4. Segmental reporting (continued)
The revenue analysis in the table below is based on the country of registration of the fee paying party. GBP61,000 (2017 - GBPNil) of revenue is derived from a milestone payment from a commercial partner. The remainder of revenue is derived from the sale of goods.
Year
Six months Six months ended
ended ended 31 December
30 June 30 June 2017
2018 2017 Restated
(unaudited) (unaudited) (unaudited)
GBP000 GBP000 GBP000
-------- -------------- -------------- -------------
UK 107 - 70
Europe 388 142 567
495 142 637
-------- -------------- -------------- -------------
Segment assets and liabilities
Central
Six months ended 30 June 2018 (unaudited) Feraccru(R) PT20 and unallocated Total
GBP000 GBP000 GBP000 GBP000
--------------------------------------------- -------------- --------- ------------------ ---------
Segment assets 11,030 22,532 2,873 36,436
Segment liabilities (2,700) (6) (208) (2,914)
--------------------------------------------- -------------- --------- ------------------ ---------
Total net assets 8,330 22,526 2,664 33,522
--------------------------------------------- -------------- --------- ------------------ ---------
Depreciation, amortisation and impairment 243 918 - 1,161
--------------------------------------------- -------------- --------- ------------------ ---------
Capital expenditure - - - -
--------------------------------------------- -------------- --------- ------------------ ---------
Capitalised development costs 2,589 - - 2,589
--------------------------------------------- -------------- --------- ------------------ ---------
Central
Feraccru(R) PT20 and unallocated Total
Year ended 31 December 2017 (audited) GBP000 GBP000 GBP000 GBP000
------------------------------------------- -------------- --------- ------------------ ---------
Segment assets 9,623 23,451 11,896 44,970
Segment liabilities (3,570) (16) (177) (3,763)
------------------------------------------- -------------- --------- ------------------ ---------
Total net assets 6,053 23,435 11,719 41,207
------------------------------------------- -------------- --------- ------------------ ---------
Depreciation, amortisation and impairment 421 2,016 - 2,437
------------------------------------------- -------------- --------- ------------------ ---------
Capital expenditure - - - -
------------------------------------------- -------------- --------- ------------------ ---------
Capitalised development costs 3,173 - - 3,173
------------------------------------------- -------------- --------- ------------------ ---------
All material segmental non-current assets are located in the UK.
Notes (continued)
for the six months ended 30 June 2018
5. Operating costs - selling, general and administrative expenses
Operating costs are comprised of:
Six months Six Year
ended months ended
30 June ended 31 December
2018 30 June 2017
2017
(unaudited) (unaudited) (audited)
GBP000 GBP000 GBP000
------------------------------------- -------------- -------------- --------------
Selling costs 2,575 3,859 9,133
General and administrative expenses 2,565 2,742 5,152
Depreciation and amortisation 1,161 1,186 2,437
6,301 7,787 16,722
------------------------------------- -------------- -------------- --------------
6. Exceptional items
Exceptional items are separately disclosed on the basis that the Directors believe this is necessary to enable a fuller understanding of the performance of the Group. The Directors define exceptional items as:
-- Material items that are unusual by size or incidence; or
-- Non-cash charges which, whilst recurring in nature, at this stage in the Group's development, are of a disproportionate size relative to the Group's other expenditure - this includes the amortisation of the Phosphate Therapeutics licences and share-based payment charges.
Six months Six months Year
ended 30 ended ended
June 2018 30 June
2017
(unaudited) (unaudited) 31 December
2017
GBP000 GBP000 (audited)
GBP000
------------------------------------------ ------------------ ------------------ --------------
Phosphate Therapeutics Ltd. intellectual
property amortisation 918 997 2,011
Share-based payments charge 359 193 560
------------------------------------------ ------------------ ------------------ --------------
1,277 1,190 2,571
------------------------------------------ ------------------ ------------------ --------------
7. Loss per share
The basic loss per share of GBP0.07 (H1 2017: GBP0.09) has been calculated by dividing the loss for the period by the weighted average number of shares of 116,426,000 in issue during the six months ended 30 June 2018 (six months ended 30 June 2017: 108,223,000).
The basic adjusted loss per share of GBP0.06 (H1 2017: GBP0.08) has been calculated by dividing the adjusted loss for the period of GBP6,768,000 (H1 2017: GBP8,438,000), after adding back the exceptional items in Note 6, by the weighted average number of shares of 116,426,000 in issue during the six months ended 30 June 2018 (six months ended 30 June 2017: 108,223,000).
Although there are potentially-dilutive ordinary shares these would not serve to increase or reduce the loss per ordinary share, as the Group is loss-making. There is therefore no difference between the loss per ordinary share and the diluted loss per ordinary share.
Notes (continued)
for the six months ended 30 June 2018
8. Intangible assets
Phosphate
Patents Development Therapeutics
Group and trademarks costs licences Total
GBP000 GBP000 GBP000 GBP000
--------------------------------------- ----------------- -------------- --------------- ---------
Cost
Balance at 1 January 2017 (audited) 1,440 2,639 27,047 31,126
Additions - externally purchased 235 - - 235
Additions - internally developed - 3,173 - 3,173
Balance at 31 December 2017 (audited) 1,675 5,812 27,047 34,534
--------------------------------------- ----------------- -------------- --------------- ---------
Additions - externally purchased 118 - - 118
Additions - internally developed - 2,589 - 2,589
Balance at 30 June 2018 (unaudited) 1,793 8,401 27,047 37,241
--------------------------------------- ----------------- -------------- --------------- ---------
Accumulated amortisation
Balance at 1 January 2017 (audited) 325 115 1,702 2,142
Charge for the period 92 327 2,012 2,431
--------------------------------------- ----------------- -------------- --------------- ---------
Balance at 31 December 2017 (audited) 417 442 3,714 4,573
Charge for the period 32 207 918 1,157
Balance at 30 June 2018 (unaudited) 449 649 4,632 5,730
--------------------------------------- ----------------- -------------- --------------- ---------
Net book values
30 June 2018 (unaudited) 1,344 7,752 22,415 31,511
--------------------------------------- ----------------- -------------- --------------- ---------
31 December 2017 (audited) 1,258 5,370 23,333 29,961
--------------------------------------- ----------------- -------------- --------------- ---------
9. Share capital
Six months Six months Year Year
ended ended ended ended
30 June 30 June 31 December 31 December
2018 2018 2017 2017
Number Number
000 GBP000 000 GBP000
--------------------------------------------- ------------- ------------- -------------- --------------
At beginning of period 116,426 1,746 108,135 1,622
Exercise of Warrants - - 7,194 108
Issuance of shares pursuant to placing - - 1,000 15
Issuance of shares pursuant to subscription - - 97 1
--------------------------------------------- ------------- ------------- -------------- --------------
At end of period 116,426 1,746 116,426 1,746
--------------------------------------------- ------------- ------------- -------------- --------------
On 28 June 2017 the Company issued an additional 1,000,000 Ordinary Shares to participants in a placing, raising gross proceeds of GBP1.5m. The placing was undertaken by means of a cash box structure. Consequently, relief was available under s612 of the Companies Act 2006 from recording share premium and the difference between net proceeds and the nominal value of shares issued was transferred to retained earnings. As part of the 2016 listing process 11,666,658 of Warrants were issued to participants in the placing. During June 2017 7,193,766 Warrants were exercised at a strike price of GBP1.50, raising gross proceeds of GBP10.8m. The remaining 4,472,892 Warrants lapsed at 30 June 2017. On 28 June 2017 the Company's directors and senior management subscribed to an issue of 96,669 Ordinary Shares, raising gross proceeds of GBP145,000. Expenses of GBP0.5m were incurred in the course of the exercise of Warrants, placing and subscription.
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
IR LIFIRATIALIT
(END) Dow Jones Newswires
September 19, 2018 02:12 ET (06:12 GMT)
1 Year Shield Therapeutics Chart |
1 Month Shield Therapeutics Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions
