28 Sep 2018 17:40
Premaitha Health PLC
("Premaitha," the "Company" or the "Group")
Full year results to 31 March 2018 and half-year trading update
Manchester, UK - 28 September 2018: Premaitha (AIM: NIPT), a leading international molecular diagnostics group, announces its full year results for the twelve months ended 31 March 2018; and provides an update on trading in the current financial year to date.
Financial highlights
· Revenues increased by 100% to £6.15m (2017: £3.08m), including the first full year of contribution from Yourgene Bioscience ("Yourgene"), which was acquired in March 2017
- Revenues increased by 35% on a like-for-like basis
· Gross profit increased by 250% to £3.17m (2017: £1.28m)
· Gross margin improved 10 points to 52% (2017: 42%) due to benefits of scale, geographic mix and reduced product costs
· General administrative expenses increased 27% to £8.96m (2017: £7.08m), due to the full year inclusion of Yourgene
o Total administrative expenses £11.80m (2017: £8.89m) after litigation expenses, share-based payments and acquisition costs
· Operating loss before litigation expenses reduced by 18% to £5.91m (2017 loss: £7.22m)
- Operating loss after litigation expenses increased to £8.60m (2017: £7.60m)
- Litigation settled post year end as announced on 19 September 2018
· Cash of £0.28m at 31 March 2018 (31 March 2017: £1.30m)
- Additional £3.0m equity raised in May 2018
- £2.0m loan funding secured from Thermo Fisher in February 2018
- Further £2.5m raise announced today
Operational highlights
· IONA® test volumes increased by 108% to 50,000 (2017: 24,000)
· Successfully expanded footprint, with strong contract momentum, including in new territories in Asia, the Middle East and Africa
· Launch of Sage™ by Yourgene, a cost-effective, flexible non-invasive prenatal testing ("NIPT") solution incorporating additional prenatal screening analysis tools
· Post period-end:
- Signed agreement with clinical laboratory group in India to provide a bespoke, high quality and scalable NIPT solution to the Indian market
- Appointed Mr Lyn Rees as Chief Executive Officer of the Group
- Premaitha announced a legal settlement and licence agreement (the "Agreements") with Illumina, resolving the current NIPT patent infringement litigation
- Appointment of Hayden Jeffreys to a senior commercial role within the Group
Trading update
· Six month revenues to 30 September 2018 expected to be up approximately 40% to £3.8m (H1 2017: £2.6m)
· Test volumes for the first half are expected to be in excess of 34,000 (H1 2017: 22,000), demonstrating significant momentum
· Continue to expand geographic footprint, securing agreements in Kenya and India in the first six months
· Settlement agreements signed with Illumina removes the litigation overhang from the business and opens up a significantly larger addressable market for a multi-partner business model
Adam Reynolds, Non-executive Chairman of Premaitha Health, commented:
"I am delighted with the strategic and commercial progress that we have achieved in the period, having doubled revenues, increased gross profit by 250%, and continued our significant geographic expansion.
"Previously, the litigation has detracted from this progress, but the partnership agreement secured post period-end with Illumina, means that we are now free to operate globally in the NIPT market, and can fully focus on growing the business. We now have the optimal team in place and are extremely well-positioned to execute on our growth strategy in order to capitalise on the opportunity that exists for Premaitha both in the rapidly expanding market for NIPT, and beyond."
A copy of the 2018 Annual Report and Accounts has been uploaded to the Company's website at https://www.premaitha.com/.
For shareholders who have opted to received printed copies of the Annual report and Accounts, these are being posted today.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
For more information, please contact: | |
Premaitha Health PLCLyn Rees, Chief Executive Officer Barry Hextall, Chief Financial Officer Joanne Cross, Head of Marketing investors@premaitha.com
| Tel: +44 (0)161 667 1053
|
Cairn Financial Advisers LLP (NOMAD)Liam Murray / James Caithie | Tel: +44 (0)20 7213 0880 |
finnCap (Broker) Geoff Nash / Matthew Radley (Corporate Finance) Tim Redfern (Corporate Broking) | Tel: +44 (0)20 7220 0500 |
Vigo Communications Ben Simons / Fiona Henson / Antonia Pollock premaitha@vigocomms.com
| Tel: +44 (0)20 7390 0234
|
About Premaitha
Premaitha is an international molecular diagnostics group which uses the latest advances in DNA analysis technology to develop safer, faster and regulatory approved genetic screening tests.
The Group's current primary focus is on non-invasive prenatal tests (NIPT) for pregnant women - an emerging, multi-billion dollar global market - although the Group intends to expand its product range into other areas of clinical genetics.
Premaitha's first product, the IONA® test was launched in 2015 as the first CE-IVD NIPT test in Europe. It enables laboratories and healthcare practitioners to offer a complete CE-marked NIPT system in-house. The IONA® test is performed on a maternal blood sample - which contains traces of fetal DNA - and estimates the risk of a fetus being affected with Down's syndrome or other genetic conditions.
Unlike existing prenatal screening methods, due to its high level of accuracy, the IONA® test can significantly reduce the number of women subjected to unnecessary invasive follow up diagnostic procedures, such as amniocentesis, which are costly, resource intensive and carry a risk of miscarriage.
In March 2017, Premaitha acquired Yourgene Bioscience, a specialist next generation sequencing and bioinformatics company based in Taiwan, with its own NIPT screening solution that operates on the same Thermo Fisher next-generation sequencing platform as Premaitha's IONA® test. Yourgene brings significant benefits to the Group through expanded market access in Asia - the world's fastest growing NIPT market - as well as opportunities for cross-selling and the ability to jointly develop expanded test content both within NIPT and beyond.
From May 2018, the Group will trade as Yourgene Health outside of Europe (but remaining as Yourgene Bioscience in Taiwan) reflecting the increased scope of the business in other areas of clinical genetics further to reproductive health; but will maintain the Premaitha Health brand within Europe.
Premaitha is headquartered in Manchester, England, with Yourgene offices in Taipei and Singapore. Its shares trade on the AIM market of the London Stock Exchange (AIM: NIPT). For further information, please visit www.premaitha.com. Follow us on twitter @PremaithaHealth.
Chairman's Statement
During the reporting period the Group has made substantial progress with the integration of Yourgene Bioscience (acquired in March 2017), significant geographic expansion, a 100% increase in revenues, a continued drive towards profitability through scale and the recent exciting partnership entered into with Illumina. Premaitha is now a leading international molecular diagnostics group with strong market footprint in many regions of the world and with considerable growth potential. The product range is continually broadening to meet the needs of clinicians and laboratory partners, and our distribution network has expanded with the addition of some highly respectable partners.
The ongoing intellectual property dispute with Illumina had a significant impact on our share price and in many respects has overshadowed the impressive progress the Group is making. The litigation was also a significant distraction and uncertainty for the business, but we have continued to de-risk the Group through international expansion and product diversification. Despite mounting a very strong defence in the UK, the Courts adopted a broad interpretation of the patents at issue. The Board has therefore decided that multi-platform partnerships are essential in this NIPT intellectual property landscape and we are pleased to have recently announced a settlement with Illumina in various territories. Settling the litigation has removed a significant distraction to management and we now look forward to focusing on business growth. This new partnership opens up new markets where we had previously assessed the IP risk too great and we look forward to working with our new partners, as well as continuing our fruitful relationship with Thermo Fisher.
Commercial progress
In the last year the Group has continued to expand its international presence in Europe, Asia, the Middle East and into Africa whilst building on its strong bases in the UK, France and Taiwan. We have also focused on developing our product suite, launching the MyNIPT® portal and Sage™ prenatal screening solutions while we continue to develop the IONA® test. We are making significant strides in leveraging Yourgene's customer base across South East Asia to accelerate the Group's growth trajectory.
Litigation
The legal context in which we operate remained challenging throughout the reporting period with an additional patent infringement claim filed by Illumina and Sequenom in September 2017, an adverse ruling in the UK High Courts on earlier patent infringement claims received in November 2017 and slow progress on EU anti-trust complaints. We were granted leave to appeal in the UK but the prospect of further litigation, however unjust we deem it, would continue to act as a brake on the business and on shareholder and customer perceptions. Ultimately, our goal is to offer effective screening solutions to patients and the specific technology underlying our tests is a secondary consideration. Therefore, the Board decided to seek a negotiated settlement which I am pleased to report has now been reached. We can now focus our considerable capabilities on building a stronger and more diverse international group without the distraction, resource-drain or uncertainty of litigation.
Financial position
We continue on our journey to becoming profitable, despite the litigation-related uncertainties described elsewhere in this report. The Company remains encouraged by the significant support and facilities we continue to receive from our shareholders and industry partners, reinforcing both the Group's strategy and exciting potential. I would also like to thank our shareholders and directors for their confidence as demonstrated in the fundraise completed in May 2018. The Board remain confident that the positive post-settlement business outlook and strong management track record will enable the Group to secure sufficient funding to realise the significant opportunity ahead.
Strategic relationships
The relationship with Thermo Fisher has continued to strengthen throughout the year with effective collaboration on commercial and product development initiatives as well as with the additional funding provided by Thermo Fisher in June 2017 and January 2018. The new partnership with Illumina also significantly broadens the Group's opportunity scope.
Board changes
Shortly after the end of the reporting period I announced a number of Board changes designed to prepare the business for its next phase of development. I announced the departure of Dr William Denman and Alan Chang from the Board as they pursue their other business interests and I thank them both for their roles in developing the Group. Dr Stephen Little has now moved to the role of Vice Chairman from where we can enjoy his continued innovative and entrepreneurial experience. At the same time Lyn Rees was appointed as Chief Executive Officer which will bring his extensive experience of commercially-led business growth to the Group. Keng Hsu has also joined the Board as Chief Operating Officer Asia, in recognition of his role in building the commercial and business footprint of the Group's Asian activities. In October 2018 we plan to appoint Hayden Jefferys to the Board as Group Commercial Director to drive the commercial partnerships and additional content that will seize the opportunity ahead for the Group.
People
In the last year we have experienced significant commercial success and also strong legal headwinds. Throughout this period our colleagues across the world have been resolutely upbeat and energetic and have remained very focused on building a highly respected business. I would like to express my personal thanks to them all for their continued impressive efforts.
Outlook
With our growing scale, Premaitha is now working to extend its footprint, both through the acquisition of new customers and by ensuring existing laboratory customers are successful in their markets to grow demand for both our IONA® and SAGE™ products and services.
The markets in which we now operate offer significant growth opportunities and whilst continuing to focus on these core markets, we will remain alert to opportunities in the Americas and for the next wave of products in adjacent sectors to NIPT.
With the legal headwinds removed the Company can now apply all its energies to work with its key partners to develop and commercialise genetic products and services to a widening section of the global population. I remain as confident as ever that the Group will continue its substantial pace of growth in 2018/19 and beyond.
Adam Reynolds
Chairman
28 September 2018
Chief Executive's review
I am delighted to have joined Premaitha as CEO in July 2018 after the end of the reporting period. The Group has come a long way in a short period of time despite some significant legal headwinds and I am very excited to be leading the Group through its next phase of ambitious growth. I would like to thank the Board for the opportunity and am pleased that Steve Little will remain as Executive Vice Chairman to help build on the foundations he has laid. My approach is to deliver rapid business growth through collaborative partnerships between our own excellent teams and with partners who are technological and commercial leaders in their respective industry sectors.
Strategy
Since my arrival we have commenced a strategic review of the business with a view to identifying the key drivers of future growth and to organise ourselves around them. This strategy will have as core principles a desire to become a customer-centred group offering multi-platform technology solutions across a range of genetic clinical indications with the high standards of product quality and support with which we have become known.
Geographic expansion
Expanding our geographic footprint has been a primary focus for the Group in the reporting period and we are now well established in significant parts of Europe, the Middle East, India, South East Asia and East Asia. We have also commenced operations in Africa with a partner in South Africa plus laboratory installs under way in Kenya and Egypt. Operating in territories with significant populations with sometimes limited access to healthcare provision for many but also world-class medical facilities in the significant centres is highly rewarding and drives our product development agenda.
In light of the legal settlement with Illumina (see below) we will continue to target expansion into more global markets in the coming years, with greater confidence that competitive rather than legal positioning will determine success.
Product development
Development of IVD-grade tests is a multi-year process and our development programmes continue to encompass five related areas all designed to improve and extend the range of products available to our customers. The goals of these programmes remain:
· Reduce the costs of the test to the clinician and ultimately the patient;
· Extend the breadth of the test as medical practice and clinical research broadens its range;
· Improve the ease of use the test and its flexibility to work on different technology platforms;
· Explore novel approaches for NIPT; and
· Develop new products outside of NIPT.
Operations
Key performance indicators (KPIs)
The Board recognises the importance of financial and non-financial KPIs in driving appropriate behaviours and enabling the monitoring of Group performance. For the current financial year the primary KPIs were the number of tests sold or performed in-house, and net cash balances.
Tests performed is a direct measure of marketing effectiveness and take-up rates for NIPT, as well as driving revenues and gross profits. In the 2018 reporting period over 50,000 (2017: 24,000 tests, including one month of Yourgene Bioscience). This is an increase of over 100% in only our third trading year, due to an expanding customer base.
Net cash balances is a combined measure of the Group's ability to drive operating cashflows and manage working capital effectively while continuing to invest in future capabilities and attract appropriate funding into the business. Cashflows are cyclical and in the reporting period net cash balances reduced to £0.3m (2017: £1.3m) at the period end, as we funded business growth and litigation costs. We are appreciative of our financial backers for supporting our strategic ambitions with loan finance from Thermo Fisher during the year and an equity raise in May 2018. We are making excellent progress towards achieving positive cashflows in the near future.
As part of the strategic review we will be identifying further KPIs to monitor delivery against our strategic growth targets and these will be communicated to shareholders in due course.
Geographic footprint
Premaitha is focusing heavily on increasing its revenue-generating capabilities and has continued to expand its international laboratory customer base through direct sales in Northern Europe, Taiwan and India plus distributor sales in other regions of the world. The core, highly experienced sales team remains focused on direct sales and distributor support, and we are working closely with instrumentation and distribution partners to compete effectively with our larger competitors and to offer integrated end to end solutions to our laboratory and clinical partners.
Application support
Our training and application support services are critical to customer laboratories and the feedback has been extremely positive as we endeavour to routinely outperform our competitors.
Delivering great customer service will be vitally important in retaining and growing customers as the NIPT market matures and we believe we have market-leading capabilities in this regard.
Clinical service laboratory
The Premaitha clinical service laboratory in Manchester and the Yourgene equivalent in Taipei have continued to deliver outstanding service performance to an increasing number of hospitals and medical professionals across the world. The laboratory back-up service has been invaluable to customers in the process of installing laboratories, experiencing workflow problems, spikes in demand and cover for religious or national holiday periods.
Supply chain
Our supply chain and next-generation sequencing (NGS) platform partners coupled with our in-house operational capabilities have coped well with the scaling up of activities and we are confident there is headroom for significant further growth.
Group branding
To Group is introducing a new global brand identity, Yourgene Health, to reflect the integrated capabilities of the former Premaitha Health and Yourgene Bioscience businesses and to signify to customers and partners our ambitions to become a major player in the wider field of genetic health.
Lyn Rees
Chief Executive Officer
Financial Report
Income statement
In the trading year revenues were up 100% at £6,147k (2017: £3,079k). The prior period revenues include one month of Yourgene sales after the acquisition which completed on 2 March 2017. On a like for like basis that includes the acquired Yourgene Bioscience business for the whole of the prior reporting period, revenues were +35%.
Gross profit was £3,173k (2017: £1,282k) representing a gross margin of 52% (2017: 42%) due to scale benefits and product cost reductions. General administrative expenses of £8,956k (2017: £7,079k) increased by 22% due principally to the full year inclusion of Yourgene Bioscience costs. Research and development tax credits are anticipated to be £629k (2017: £806k) reflecting our ongoing commitment to developing high quality products. Total administrative expenses were £11,803k (2017: 8,886k) after separately disclosed items as explained below.
Separately disclosed items
Significant items within administrative expenses have been shown separately in the Consolidated statement of comprehensive income, with further detail in Note 5. Litigation expenses of £2,693k (2017: £388k) including litigation costs awarded against the Company in a Court decision in January 2018 plus other litigation expenses and provision increases (see notes). Other separately disclosed items are non-cash accounting charges for share-based payments and warrant expenses and a few residual costs associated with the acquisition of Yourgene Bioscience in March 2017.
Operating loss
There is a resultant operating loss after total administrative expenses of £8,602k (2017: £7,603k).
Finance income/(expenses)
During the period the Group incurred a net finance charge of £937k (2017: £247k), with interest and unwinding discounts on the Thermo Fisher loan instrument offsetting interest earned on cash balances.
Taxation and foreign exchange
The loss on ordinary activities after taxation of £9,483k (2017: £7,859k) generated a tax loss the benefit of which will not be recognised until the Group can be more certain of recoverability through future profitability.
The Group made a loss of £121k (2017: £24k) on translation of its foreign subsidiaries and foreign currency balances to the presentational currency.
Loss per share
The total comprehensive loss of £9,604k (2017: £7,883k) represents a loss per share of 3 pence (2017: 3 pence).
Statement of financial position
At the balance sheet date the Group had total assets of £14,587k (2017: £17,563k). Property, plant and equipment reduced to £1,919k (2017: £2,890k) due to the depreciation of test workflow equipment supplied to customers in the first trading year of the Company to encourage adoption of the IONA® test. Current assets reduced to £4,269k (2017: £6,119k) due to cash consumption and the issuance of warrants to Thermo Fisher under an earlier loan agreement which had previously been classified as a prepayment (see notes for more details).
Total equity and liabilities reduced to £14,587k (2017: £17,563k) due to a combination of the year's comprehensive loss and increased borrowings from Thermo Fisher (see notes). The opening litigation provision of £3,322k was fully utilised against the defence costs associated with the July 2017 trial and subsequent hearings. A further provision of £938k was raised in the year to reflect anticipated costs of fighting an appeal against the first instance ruling, a prudent presumption that damages would become payable after that appeal and to defend a new patent claim filed by Illumina in September 2017. Some of this new provision was utilised in the reporting period to give an overall provision utilisation of £3,480k.
The litigation settlement announced in September 2018 will utilise all the resulting £780k provision.
Cashflow
The Group had an opening cash position of £1,301k (2017: £5,337k) and expended £1,018k (2017: £4,036k). Cash and cash equivalents at the end of the period were £282k (2017: £1,031k). During the period the Group used £9,596k (2017: £7,862k) of cash in operating activities due principally to the litigation costs awarded against the company in the first instance ruling. Cash used in investing activities was £634k (2017: neutral at £2k) due to classification of an unused escrow facility as a short-term financial assets. Financing activities generated a surplus of £9,186k (2017: £3,832k) arising from Thermo Fisher loan funding.
As with all businesses at this early stage of development, the Board assesses carefully the Group's ability to operate as a going concern and has detailed plans for revenue growth, margin improvement and cashflow control which are intended to achieve positive cashflows in the 2019 financial year. More detail on these plans can be found in the notes.
In May 2018 the Group secured additional equity funding from investors and directors via a share placing of £3.0m paid as £2.5m cash plus £0.5m in settlement of outstanding fees.
Further fundraising is planned to enable the business to realise its business objectives until such time as financial self-sufficiency is achieved (see the Going concern section in the notes for more information).
Dividends
No dividend is recommended (2017: £nil) due to the early stage nature of the Group.
Capital management
The Board's objective is to maintain a balance sheet that is both efficient at delivering long-term shareholder value and also safeguards the Group's financial position in light of variable economic cycles and the principal risks and uncertainties outlined in this report. As at 31 March 2018 the Group had cash of £282k (2017: £1,301k). Business growth, settlement of the UK patent litigation and planned fundraising is expected to enable the Group to operate as a going concern for the foreseeable future.
Post-balance sheet events
After the balance sheet date there was an equity fundraise of £3.0m as noted above and in September 2018 the Company announced it had reached a settlement with Illumina for the UK patent litigation that had been overhanging the Company since March 2015.
Barry Hextall
Chief Financial Officer
Consolidated Statement of Comprehensive Income
2018 | 2017 | ||||
£ | £ | £ | £ | ||
Revenue | 6,146,863 | 3,078,744 | |||
Cost of sales | (2,973,730) | (1,796,334) | |||
Gross profit | 3,173,133 | 1,282,410 | |||
Other operating income | 28,350 | 263 | |||
Administrative expenses | |||||
General administrative expenses | (8,956,324) | (7,079,130) | |||
Litigation expenses | (2,692,556) | (387,983) | |||
Share-based payments and warrant expenses | (144,247) | (332,261) | |||
Costs associated with the acquisition of subsidiary | (10,084) | (301,216) | |||
Provision for doubtful trade receivables | - | (785,317) | |||
Total administrative expenses | (11,803,211) | (8,885,907) | |||
Operating loss | (8,601,728) | (7,603,234) | |||
Financing income | 45,264 | 45,374 | |||
Financing expenses | (981,979) | (292,243) | |||
Loss on ordinary activities before taxation | (9,538,443) | (7,850,103) | |||
Tax on loss on ordinary activities | 55,516 | (8,943) | |||
Loss for the year | (9,482,927) | (7,859,046) | |||
Other comprehensive expense | |||||
Exchange translation differences | (121,096) | (24,323) | |||
Loss and total comprehensive loss for the year | (9,604,023) | (7,883,369) | |||
Loss per share (£) | |||||
Basic | 0.03 | 0.03 | |||
Diluted | 0.03 | 0.03 | |||
Consolidated Statement of Financial Position
2018 | 2017 | ||||
£ | £ | ||||
Assets | |||||
Non-current assets | |||||
Goodwill | 7,014,447 | 7,014,447 | |||
Intangible assets | 1,384,160 | 1,539,392 | |||
Property, plant and equipment | 1,919,406 | 2,890,446 | |||
Total non-current assets | 10,318,013 | 11,444,285 | |||
Current assets | |||||
Inventories | 276,766 | 427,925 | |||
Other short-term assets | 475,385 | - | |||
Trade and other receivables | 2,075,301 | 3,289,012 | |||
Tax asset | 1,158,765 | 1,101,345 | |||
Cash and cash equivalents | 282,432 | 1,300,667 | |||
Total current assets | 4,268,649 | 6,118,949 | |||
Total assets | 14,586,662 | 17,563,234 | |||
Equity and liabilities attributable to equity holders of the company | |||||
Equity | |||||
Called up share capital | 32,266,188 | 32,266,188 | |||
Share premium account | 28,482,061 | 28,482,061 | |||
Merger relief reserve | 10,012,644 | 10,012,644 | |||
Reverse acquisition reserve | (39,947,033) | (39,947,033) | |||
Foreign exchange translation reserve | (179,460) | (58,364) | |||
Warrants reserve | 4,085,546 | 3,069,382 | |||
Retained losses | (37,318,758) | (27,980,078) | |||
Total equity | (2,598,812) | 5,844,800 | |||
Current liabilities | |||||
Trade and other payables | 3,792,112 | 3,490,269 | |||
Current tax liabilities | 9,487 | 7,638 | |||
Borrowings | 59,344 | 119,087 | |||
Provisions | 780,000 | 3,321,995 | |||
Total current liabilities | 4,640,943 | 6,938,989 | |||
Non-current liabilities | |||||
Borrowings | 12,098,883 | 4,310,543 | |||
Deferred tax liabilities | 262,990 | 294,942 | |||
Long term provisions | 182,658 | 173,960 | |||
Total non-current liabilities | 12,544,531 | 4,779,445 | |||
Total equity and liabilities | 14,586,662 | 17,563,234 | |||
Statement of Changes in Equity
Share capital | Share premium account | Merger relief reserve | Warrants reserve | Reverse acquisition reserve | Foreign exchange reserve | Retained losses | Total | ||||||||||
£ | £ | £ | £ | £ | £ | £ | £ | ||||||||||
Balance at 1 April 2016 | 32,173,133 | 27,023,661 | 954,545 | 1,770,363 | (39,947,033) | (34,041) | (20,453,293) | 1,487,335 | |||||||||
Year ended 31 March 2017: | |||||||||||||||||
Loss for the year | - | - | - | - | - | - | (7,859,046) | (7,859,046) | |||||||||
Other comprehensive loss | - | - | - | - | - | (24,323) | - | (24,323) | |||||||||
Total comprehensive loss for the year | - | - | - | - | - | (24,323) | (7,859,046) | (7,883,369) | |||||||||
Transactions with owners | |||||||||||||||||
Issue of share capital | 17,000 | 1,470,500 | - | - | - | - | - | 1,487,500 | |||||||||
Share issue expenses | - | (12,100) | - | - | - | - | - | (12,100) | |||||||||
Issue of share capital on acquisition | 76,055 | - | 9,058,099 | - | - | - | - | 9,134,154 | |||||||||
Share-based payments | - | - | - | - | - | - | 332,261 | 332,261 | |||||||||
Warrants issued | - | - | - | 1,299,019 | - | - | - | 1,299,019 | |||||||||
Total transactions with owners | 93,055 | 1,458,400 | 9,058,099 | 1,299,019 | - | - | 332,261 | 12,240,834 | |||||||||
Balance at 31 March 2017 | 32,266,188 | 28,482,061 | 10,012,644 | 3,069,382 | (39,947,033) | (58,364) | (27,980,078) | 5,844,800 | |||||||||
Statement of Changes in Equity (Continued)
Share capital | Share premium account | Merger relief reserve | Warrants reserve | Reverse acquisition reserve | Foreign exchange reserve | Retained losses | Total | ||||||||||
£ | £ | £ | £ | £ | £ | £ | £ | ||||||||||
Balance at 1 April 2017 | 32,266,188 | 28,482,061 | 10,012,644 | 3,069,382 | (39,947,033) | (58,364) | (27,980,078) | 5,844,800 | |||||||||
Year ended 31 March 2018: | |||||||||||||||||
Loss for the year | - | - | - | - | - | - | (9,482,927) | (9,482,927) | |||||||||
Other comprehensive loss | - | - | - | - | - | (121,096) | - | (121,096) | |||||||||
Total comprehensive loss for the year | - | - | - | - | - | (121,096) | (9,482,927) | (9,604,023) | |||||||||
Transactions with owners | |||||||||||||||||
Share-based payments | - | - | - | - | - | - | 144,247 | 144,247 | |||||||||
Warrants issued | - | - | - | 1,016,164 | - | - | - | 1,016,164 | |||||||||
Total transactions with owners | - | - | - | 1,016,164 | - | - | 144,247 | 1,160,411 | |||||||||
Balance at 31 March 2018 | 32,266,188 | 28,482,061 | 10,012,644 | 4,085,546 | (39,947,033) | (179,460) | (37,318,758) | (2,598,812) | |||||||||
Consolidated statement of cash flows
2018 | 2017 | ||||
£ | £ | £ | £ | ||
Cashflow from operating activities | |||||
Loss for the year after tax | (9,482,927) | (7,859,046) | |||
Adjustments for: | |||||
Taxation (credited)/charged | (55,516) | 8,143 | |||
Finance costs | 981,979 | 292,243 | |||
Investment income | (45,264) | (45,374) | |||
Loss on disposal of subsidiaries | - | 7,596 | |||
Depreciation and impairment of property, plant and equipment | 1,046,951 | 724,028 | |||
Amortisation of intangible non-current assets | 155,232 | 12,936 | |||
Loss on disposal of property, plant and equipment | 16,293 | - | |||
Foreign exchange movements | (357,127) | (24,323) | |||
Share based payment and warrant expense | 144,247 | 332,261 | |||
Decrease in provisions | (2,533,298) | (2,052,054) | |||
Movements in working capital: | |||||
Decrease in inventories | 151,159 | 118,271 | |||
(Increase)/Decrease in trade and other receivables | 137,961 | 182,063 | |||
Increase in trade and other payables | 301,843 | 447,132 | |||
Increase in tax asset | (57,420) | (6,702) | |||
Cash used by operations | (9,526,620) | (7,862,826) | |||
Tax (credited)/paid | 25,413 | (7,018) | |||
Investing activities | |||||
Net outflow on disposal of subsidiary undertaking | - | (2,557) | |||
Net inflow on acquisition of subsidiary undertaking | - | 400,294 | |||
Purchase of property, plant and equipment | (163,268) | (406,236) | |||
Proceeds on disposal of property, plant and equipment | 4,500 | - | |||
Investment in short-term financial assets | (475,385) | - | |||
Interest received | - | 10,824 | |||
Net cash (used in)/generated from investing activities | (634,153) | 2,325 | |||
Financing activities | |||||
Net proceeds from issue of shares | - | 1,475,400 | |||
Proceeds from borrowings | 9,388,732 | 2,356,986 | |||
Repayment of borrowings | (185,922) | - | |||
Interest paid | (16,418) | (1,059) | |||
Net cash generated from financing activities | 9,186,392 | 3,831,327 | |||
Net decrease in cash and cash equivalents | (1,018,235) | (4,036,192) | |||
Cash and cash equivalents at beginning of year | 1,300,667 | 5,336,859 | |||
Cash and cash equivalents at end of year | 282,432 | 1,300,667 | |||
| Accounting policies |
| Basis of preparation |
|
| The financial information set out in this preliminary announcement does not constitute statutory accounts as defined by section 434 and 435 of the Companies Acct 2006. The financial information for the year ended 31 March 2018 has been extracted from the Group's financial statements upon which the auditor's opinion is unmodified and does not include any statement under section 498(2) or (498(3) of the Companies Act 2006.
The financial information has been prepared in accordance with International Financial Reporting Standards (IFRS), adopted for use in the European Union and including IFRIC interpretations issued by the International Accounting Standards Board (IASB) and the Companies Act (2006).
The consolidated financial information has been prepared on the basis of accounting policies set out in the Group's financial statements for 2018. | |
| Going concern In their assessment of the Group's and Company's ability to continue as a going concern, the directors have focused on the implications of the recently settled patent infringement legal cases, the rate of growth of revenue, decisions available to them for management of the cost base of the Group and the potential for future fundraising. A fundraising round is currently being conducted by professional advisers and is due to be completed in early October 2018. Although there can be no certainty, the Directors are confident that this fundraising will complete successfully in October 2018. The new CEO is currently leading a strategic planning process which is due to deliver a revised business plan in the coming months, when the directors anticipate that further fundraising will be required to support the execution of that growth strategy and also ensure sufficient liquidity for the business. The Directors are confident that this can be achieved due to their strong track record of successful fundraising and their understanding of current levels of investor interest, along with the new management team and the ongoing support of investors now that the litigation risks have been resolved.
As described in the Strategic Report, the Group has made progress towards achieving positive cashflows through growth in revenues since launching the IONA® test in February 2015 and acquiring Yourgene Bioscience in March 2017. The Group has however reported a loss for the year; which reflects that break-even levels of revenues have not yet been reached. The Group's forecasts include assumptions of further growth in revenue; which are key in achieving positive cashflows. The Directors have also assessed the Group's and Company's cost structure following the settlement with Illumina.
There is an ongoing commitment to keep costs and working capital under control so that increasing gross profits can drive positive cashflows. Detailed sensitivity analysis has been performed to assess the potential impact on the Group's liquidity caused by delays in revenue growth against expected levels along with potential mitigating actions which can be taken to safeguard the Group's cash position. These include working capital controls and reductions in discretionary spending. If events transpire differently to this assessment, for example if revenues fail to grow at the anticipated pace, then there could be lower cash headroom or even a cash shortfall. In this situation, the Group and Company will need to secure additional finance through either the issue of additional shares or obtaining additional external borrowing.
If events transpire differently to this assessment, for example if the fundraising round currently being conducted fails to raise the expected funds, or if revenues fail to grow at the anticipated pace, there could be lower cash headroom or even a cash shortfall. In this situation, the Group and Company will need to secure additional finance through alternative means. The availability of alternative sources of finance is inherently uncertain.
The Directors have concluded that the combination of these circumstances represent a material uncertainty that, if they were to transpire adversely, may cast significant doubt upon the Group's and Company's ability to continue as a going concern and, therefore, that it may be unable to realise its assets and discharge its liabilities in the ordinary course of business. Nevertheless, after making enquiries, and considering the uncertainties described above and mitigation strategies in place, the Directors have a reasonable expectation that the Group and Company will have adequate resources to continue in operational existence for the foreseeable future. For these reasons, they continue to adopt the going concern basis in preparing the Annual Report and Accounts.
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| Impact of the application of IFRS15 |
|
IFRS 15 Revenue from Contracts with Customers, becomes effective for annual reporting periods beginning on or after 1 January 2018. The standard, which replaces IAS 18, covering contracts for goods and services and IAS 11, covering construction contracts, addresses the recognition of revenue. The new standard is based on the principle that revenue is recognised to depict the satisfaction of performance obligations stated explicitly or implied in customer contracts in amounts that reflect the consideration to which the Group expects to be entitled in exchange for those goods or services. The Group will adopt the new standard as at 1 April 2018 and apply the modified retrospective approach. Comparatives for the year ended 31 March 2018 will not be restated and the cumulative impact of adoption will be recognised in retained earnings as at 1 April 2018.
The Group has participated in IFRS15 education events and is reviewing the impact of adopting IFRS15 across its business, with reference to underlying contractual terms and their underlying performance obligations. The Group do not believe there will be any material profit impact arising and nor will there be any cashflow impact from the adoption of IFRS15. This review is still ongoing and the Group continues to assess the impact of IFRS 15 prior to its adoption in the 2019 accounts.
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Critical accounting estimates and judgements | |
In the application of the Group's accounting policies, the directors are required to make judgements, estimates and assumptions about the carrying amount of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.
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 estimates and assumptions which have a significant risk of causing a material adjustment to the carrying amount of assets and liabilities are outlined below.
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Critical judgements | |
Treatment of Thermo Fisher concurrent loan and warrant arrangements | |
In December 2015, the Group entered into a loan arrangement with Life Technologies Limited, a company in the Thermo Fisher Scientific Group ("Thermo Fisher"), under the terms of which Thermo Fisher provided a loan facility of £5m to the Group. On the same day, the Group entered into a share warrant agreement with Thermo Fisher ("2015 warrants"). During the current year, the Group entered into an amended and restated loan facility granted by Thermo Fisher. In return for an increase in the facility of £4m, Premaitha granted two tranches of warrants to Thermo Fisher ("2016 and first 2017 warrants"). In June 2017 a further increase of $5m was agreed in return for two further tranches of warrants (the "second 2017 warrants" and the "2018 warrants")
The Group assessed the accounting treatment of the loans and warrant agreements and have concluded that, although they are separate financial instruments, it is necessary to allocate the initial proceeds received between the loan and the warrants based on their fair values, because the instruments were entered into at the same time.
Having considered the terms of the 2015, 2016, 2017 and 2018 warrants, it has been concluded that they represent equity instruments. The warrants are accounted for at fair value on inception in accordance with IAS 32. The loan is initially recognised at fair value on inception and subsequently measured at amortised cost using the effective interest rate method, in accordance with IAS 39.
Prior to drawdown of the relevant facilities, the value of the warrants when issued are treated as a commitment fee for the advancement of the increased loan facility. The commitment fee is reflected within prepayments and is released against the loan facility balance as the facilities are drawn by the Group.
| |
Key sources of estimation uncertainty | |
Acquired intangibles
| |
Intangible assets (customer relationships) have been acquired as part of the net assets of Yourgene Bioscience. These intangible assets were capitalised at their fair value at the date of acquisition. Determining the value of acquired intangibles required the calculation of estimated future cash flows expected to arise from the intangible assets at a suitable discount rate in order to calculate their present value. In addition, an estimate of the useful life of the intangible asset has to be made over the period in which the cash flows were expected to be generated. The carrying amount of the acquired intangibles at the reporting date was £1,384,160 (2017: £1,539,392). | |
Key sources of estimation uncertainty | |
Patent infringement litigation provision | |
Premaitha has been defending patent infringement litigation claims filed in the English courts which claimed that Premaitha's non-invasive pre-natal test infringed patents owned or licensed by the claimants. The first claim was filed in March 2015 by the claimants Illumina, Inc., Sequenom, Inc. and Stanford University. The second claim was filed in September 2015 by the claimants Illumina, Inc. and the Chinese University of Hong Kong. The cases were heard in the UK High Court in July 2017 and a first instance judgement was handed down in November 2017 and confirmed at a Final Order hearing in January 2018 at which claimants' costs of £2m were awarded against Premaitha. All costs awarded against Premaitha have been charged to the Income Statement even though an Appeal was been granted and was due to be heard in November 2018. A third claim was received in September 2017, for which a trial date was set for May 2019. Subsequent to the reporting period end Premaitha and Illumina have announced a settlement of this litigation in its entirety and have entered into a new licence and supply partnership.
The Group has assessed the expected costs up to and including the settlement and has provided in full for defending these claims up to the settlement date, the court-imposed royalty payments up to the settlement date and the costs of concluding the settlement. | |
Impairment of goodwill | |
The Group's management undertakes an impairment review annually, or more frequently if events or changes in circumstances indicate that the carrying value may not be recoverable.
Growth rates The value in use of the intangible assets is calculated from cash flow projections for the relevant business activities based on the latest financial projections covering covering the anticipated useful economic life of the intangible assets.
Discount rates The pre-tax discount rate used to calculate value is determined in relation to the relevant business activities and their geographic location, using external benchmarks where possible to arrive at a relevant weighted average cost of capital.
Cashflow assumptions The key assumptions for the value in use calculations are those regarding discount rates, growth rates and expected cashflows. Changes in revenues and expenditures are based on past experience and expectations of future growth.
| |
Segment reporting |
| |
Revenue |
| |
In the opinion of the Directors, the Group has one class of business in three geographic areas, a molecular diagnostics business sells into the UK, Europe and other countries referred to as "International".
The Group is therefore considered to have a single operating segment which is monitored by the Group's chief operating decision makers. Strategic decisions are made on the basis of unadjusted operating results.
Revenue, analysed by category, was as follows:
|
| |
| ||
2018 | 2017 | |||
£ | £ | |||
Turnover | ||||
Sales of goods | 3,554,048 | 2,425,157 | ||
Rendering of services | 2,592,815 | 653,587 | ||
6,146,863 | 3,078,744 | |||
Other significant revenue | ||||
Interest income | 45,264 | 45,374 |
Revenue analysed by geographical market | ||||
2018 | 2017 | |||
£ | £ | |||
UK | 1,014,723 | 1,018,359 | ||
Europe | 1,213,773 | 1,060,736 | ||
International | 3,918,367 | 999,649 | ||
6,146,863 | 3,078,744 | |||
During 2018, the third year of trading revenues for the Group, £1,449,535 (23.5%) (2017: £2,140,450) of the Group's revenue depended on a total of two (2017: five) customers who each represented more than 10% of Group revenues.
| ||||
Non-current assets | ||||
The Group's non-current assets are located in the following geographic regions | ||||
2018 | 2017 | |||
£ | £ | |||
UK | 10,538,301 | 11,136,961 | ||
Europe | - | - | ||
International | 921,170 | 1,293,550 | ||
Intra-group eliminations | (1,141,518) | (986,226) | ||
10,318,013 | 11,444,285 | |||
Separately disclosed items | ||||
2018 | 2017 | |||
£ | £ | |||
Litigation expenses | (2,692,556) | (387,983) | ||
Share-based payments and warrant expenses | (144,247) | (332,261) | ||
Costs associated with the acquisition of subsidiary | (10,084) | (301,216) | ||
Provision for doubtful trade receivables | - | (785,317) | ||
(2,846,887) | (1,806,777) | |||
Litigation expenses includes a decrease in the brought forward provision, and an additional provision provided for the expected total costs of defending the Group and subsequently settling a claim of patent infringement (see notes below) as well as costs incurred by the Group in pursuing a claim against a former customer who has now entered administration, and other litigation costs not included within the scope of the above provision.
Share-based payments and warrant expenses relate to the provision made in accordance with IFRS 2 'Share-based payment' following the issue of share options and warrants to employees and other parties subsequent to admission to AIM.
Costs associated with the acquisition of subsidiaries represents costs incurred during the acquisition of the Yourgene companies during the comparative period ended 31st March 2017.
The provision for doubtful trade receivables relates to a provision against amounts due from the Group's Swiss customer, Genoma.
| ||||
Operating loss | ||||
2018 | 2017 | |||
£ | £ | |||
Operating loss for the year is stated after charging/(crediting): | ||||
R&D costs | 501,438 | 815,753 | ||
R&D tax credit | (628,688) | (806,301) | ||
Depreciation of property, plant and equipment | 1,046,951 | 724,030 | ||
Loss on disposal of property, plant and equipment | 16,293 | - | ||
Amortisation of non-current intangible assets | 155,232 | 12,936 |
Income tax expense | ||||
2018 | 2017 | |||
£ | £ | |||
Current tax | ||||
UK corporation tax on profits for the current period | - | - | ||
Foreign corporation tax | (23,564) | 8,943 | ||
Deferred tax | ||||
Origination and reversal of temporary differences | (31,952) | - | ||
Total tax (credit)/charge | (55,516) | 8,943 |
Income tax expense | ||||
The (credit)/charge for the year can be reconciled to the loss per the income statement as follows: | ||||
2018 | 2017 | |||
£ | £ | |||
Loss before taxation | (9,538,443) | (7,850,103) | ||
Expected tax credit based on a corporation tax rate of 19% (2017: 20%) | (1,812,304) | (1,570,021) | ||
Effect of expenses not deductible in determining taxable profit | (462,422) | (334,907) | ||
Unutilised tax losses carried forward | 1,795,414 | 1,552,176 | ||
Change in unrecognised deferred tax assets | 144,701 | 55,150 | ||
Effect of overseas tax rates | 26,787 | (46,958) | ||
R&D tax credit | 284,260 | 353,503 | ||
Deferred tax | (31,952) | - | ||
Taxation (credit)/charge for the year | (55,516) | 8,943 | ||
The Research and development tax credit of £628,688 (2017: £806,301) is shown as a deduction against general administrative expenses. Of the current year figure, £130,688 was an under-accrual of the final tax claim from the prior period.
The Group is required to estimate the income tax in each of the jurisdictions in which it operates. This requires an estimation of the current tax liability together with an assessment of the temporary differences which arise as a consequence of different accounting and tax treatments. These temporary differences result in deferred tax assets or liabilities which are included within the statement of financial position. Deferred tax assets and liabilities are measured using substantially enacted tax rates expected to apply when the temporary differences reverse. Management judgement is required to determine the total provision for income tax. Amounts accrued are based on management's interpretation of country specific tax law and the likelihood of settlement.
Factors that may affect future tax charges The Group has estimated trading losses of £13,517,081 (2017: £10,935,615), estimated excess management fees of £16,230,660 (2017: £9,983,984), non-trade loan relationship deficits of £1,033,214 (2017: £411,808) and capital losses of £1,934,399 (2017: £1,934,399). The tax losses have resulted in a potential deferred tax asset of approximately £6,215,917 (2017: £4,443,988) which has not been recognised as it is uncertain the future taxable profits will be sufficient to utilise the losses. | ||||
Loss per share | ||||
Basic Basic loss per share is calculated by dividing the total comprehensive loss for the period of £9,604,023 (2017: loss £7,883,369) by the weighted average number of ordinary shares in issue during the period 321,218,709 (2017: 236,277,783).
Diluted Diluted earnings per share dilute the basic earnings per share to take into account share options and warrants. The calculation includes the weighted average number of ordinary shares that would have been issued on the conversion of all the dilutive share operations and warrants into ordinary shares. 131,206,885 options and warrants (2017: 76,463,906) have been excluded from this calculation as the effect would be anti-dilutive.
| ||||
Intangible assets | ||||||
Goodwill | Customer Relationships | Total | ||||
£ | £ | £ | ||||
Cost | ||||||
At 1 April 2016 | - | - | - | |||
Additions | 7,014,447 | 1,552,328 | 8,566,775 | |||
At 31 March 2017 | 7,014,447 | 1,552,328 | 8,566,775 | |||
At 31 March 2018 | 7,014,447 | 1,552,328 | 8,556,775 | |||
Amortisation and impairment | ||||||
Charge for the year | - | 12,936 | 12,936 | |||
At 31 March 2017 | - | 12,936 | 12,936 | |||
Charge for the year | - | 155,232 | 155,232 | |||
At 31 March 2018 | - | 168,168 | 168,168 | |||
Carrying amount | ||||||
At 31 March 2017 | 7,014,447 | 1,539,392 | 8,553,839 | |||
At 31 March 2018 | 7,014,447 | 1,384,160 | 8,398,607 |
The customer relationship asset acquired as part of the Yourgene Bioscience acquisition in March 2017 is amortised over its useful economic life which was deemed, upon acquisition, to be 10 years. 8 years and 11 months of this useful life remains unamortised.
Intangible assets are subject to an annual impairment test to ascertain if the value in use is greater than the carrying value in the financial statements. The intangible assets arising from the acquisition of Yourgene Bioscience in March 2017 were tested over a 5 year forecast period plus a terminal value to represent their remaining useful economic life. Growth was forecast on a declining rate from an initial 30% per annum down to 5% per annum for the terminal value estimation. Discount rates were set at 13%, being the representative cost of capital. The headroom compared to the carrying value was £3.0m. Increasing the discount rate to 16% would lead to the recoverable amount being equal to the carrying value of the intangible assets.
|
Borrowings | ||||
2018 | 2017 | |||
£ | £ | |||
Unsecured borrowings at amortised cost | ||||
Bank loans | 430,244 | 616,166 | ||
Other loans | 11,727,983 | 3,813,464 | ||
12,158,227 | 4,429,630 | |||
Other loans represent the liability element of borrowings from Thermo Fisher which are detailed further in note 30. | ||||
Analysis of borrowings | ||||
Borrowings are classified based on the amounts that are expected to be settled within the next 12 months and after more than 12 months from the reporting date, as follows: | ||||
2018 | 2017 | |||
£ | £ | |||
Current liabilities | 59,344 | 119,087 | ||
Non-current liabilities | 12,098,883 | 4,310,543 | ||
12,158,227 | 4,429,630 | |||
Other loans represent the liability element of borrowings from Thermo Fisher which are detailed further in note 30.
The secured loan provided by Life Technologies Corporation (LTC), part of the Thermo Fisher Scientific Group, is accruing interest at a rate of 6% on the principal capital balance and is secured by way of a fixed and floating charge over intellectual property of the Group. This loan is wholly repayable in more than five years.
This loan is part of the provision of a total of £13,317,833 (2017: £5,726,861) of secured loan facilities from LTC to the Group with £1,770,363 recognised as the fair value on grant of 20,325,204 warrants to the lender in 2015, and £2,281,837 of further prepaid commitment fees released to the loan on the drawdown of additional facilities linked to the 2016 and 2017 warrants (see notes).
A further £2,100,000 was transferred into an ESCROW account in the current year, the balance of which is recognised within other short-term financial assets. | ||||
Provisions for liabilities | ||||
Dilapidation provision As part of the Group's property leasing arrangements there was an obligation to return certain premises in the same state that they were received and repair damages which incur during the life of the lease, such as wear and tear. The cost is charged to profit and loss as the obligation arises.
Litigation provision Premaitha has been involved in litigation to defend itself against three patent infringement claims filed in the English courts which claim that Premaitha's non-invasive prenatal test infringes patents owned or exclusively licensed by the claimants. The first claim was filed in March 2015 by Illumina, Inc., Sequenom, Inc. and Stanford University. The second claim was filed in September 2015 by Illumina, Inc. and the Chinese University of Hong Kong. These two cases were combined into a combined action by the courts as they involve three patent families and a complicated series of inter-related claims. As part of these actions the Company filed counterclaims of non-infringement for potential alternative processes. The first instance judgement was handed down in January 2018 and was largely in favour of the claimants. Leave to appeal on all points was granted and the Appeal was to be heard in November 2018. A third claim was filed in September 2017 and this was to be heard by the Courts in May 2019. All this litigation was settled between the parties in September 2018.
The Group has assessed the expected costs of defending and ultimately settling these claims and has provided for the expected litigation costs up to the settlement, plus the costs of the settlement itself. In the current year, management have further re-assessed the Group's litigation and settlement costs expected to be incurred and an additional provision of £780,000 has been recognised. Additional litigation cost were charged directly to the Consolidated Income Statemement as explained in the notes above.
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Thermo Fisher Scientific loan and warrants | ||||
Thermo Fisher 2015 warrants On 11 December 2015, the Group entered into a loan agreement with Life Technologies Limited ("Thermo Fisher"), under the terms of which Thermo Fisher provided a loan facility of £5m to the Group subject to their approval over the usage of drawn funds. The term of the loan is 8 years and the rate of interest applied to the loan is 6%. The loan is secured by a fixed and floating charge against the intellectual property of the Group.
The Group simultaneously entered into a share warrant agreement with Thermo Fisher, issuing warrants over 20,325,204 shares to Thermo Fisher. The warrants have an exercise price of 24.6p per share, and have a term of eight years.
Initial consideration received was £2,760,000. The Group allocated the proceeds of the 2015 warrant, according to the respective fair values of the loan and warrant instruments as follows: | ||||
£ | ||||
Loan | 989,637 | |||
Warrants | 1,770,363 | |||
Thermo Fisher 2016 & March 2017 warrants On 22 September 2016, Premaitha entered into an amended and restated 8-year loan facility granted by Thermo Fisher. In return for an increase in the facility of £4m, Premaitha granted two tranches of warrants to Thermo Fisher. These are respectively the 2016 and March 2017 warrants.
The 2016 warrants issued by the Group on 22 September 2016 are over 17,094,018 shares with an exercise price of 11.7p per share and a term of 7.25 years.
The March 2017 warrants issued by the Group on 31 March 2017 are over 16,913,319 shares with an exercise price of 11.825p per share and a term of 6.75 years.
July 2017 warrants and February 2018 warrants On 11 July 2017 the Group entered into a USD loan facility agreement with Thermo Fisher. The Group also issued warrants over 28,938,797 shares to Thermo Fisher with an exercise price of 10.625p per share and a term of 6.5 years, being the July 2017 warrants.
Premaitha also simultaneously issued an additional tranche of warrants, being the February 2018 warrants, for which the exercise price and quantity of warrants were set on the later grant date of 9 February 2018. The exercise price is 5.775p and the number of warrants issued totalled 12,417,368.
Application of IAS 32/IAS 39 The Group assessed the accounting treatment of the loans and warrant agreements and have concluded that, although they are separate financial instruments, it is necessary to allocate the initial proceeds received between the loan and the warrants based on their fair values, because the instruments were entered into at the same time.
Having considered the terms of all of the warrants, it has been concluded that they represent equity instruments. The warrants are accounted for at fair value on inception in accordance with IAS 32. The loan is initially recognised at fair value on inception and subsequently measured at amortised cost using the effective interest rate method, in accordance with IAS 39.
Prior to drawdown of the relevant facilities, the value of the warrants when issued are treated as a commitment fee for the advancement of the increased loan facility. The commitment fee is reflected within prepayments and is released against the loan facility balance as the facilities are drawn by the Group.
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Thermo Fisher Scientific loan and warrants | ||||
The 2015 warrants are accounted for, as noted above, as an equity instrument under IAS 32, and are not subsequently re-measured. As the loan is subsequently measured at amortised cost using the effective interest rate method, an accretion charge is recognised over the life of the loan to restore its carrying value to the amount drawn down. The charge recognised in the year is as follows: | ||||
£ | ||||
Fair value brought forward | 3,813,464 | |||
Amounts drawn down in the year | 9,388,732 | |||
USD loan revaluation | (302,596) | |||
Interest charged to 31 March 2018 | 628,310 | |||
Accretion charge to 31 March 2018 | 338,876 | |||
Commitment fee released | (2,138,803) | |||
Carrying value at 31 March 2018 | 11,727,983 | |||
The total amounts included in prepayments as a commitment fee for the undrawn increased facility in respect of the fair values of the various warrants totalled £33,346 (2017: £1,069,417) as at the balance sheet date. This represents the fair value of the equity instrument issued in respect of the February 2018 warrants of £195,316, less an amount of £161,970 released against the balance of the loan on drawdown of amounts against the additional facility of $973,730. | ||||
At 31 March 2018, the following warrants were outstanding in respect of Ordinary shares: | ||||||
2018 | 2017 | |||||
Date of grant | Exercise period | No. | No. | |||
11 December 2015 | 11 December 2015 to 10 December 2023 | 20,325,204 | 20,325,204 | |||
22 September 2016 | 22 September 2016 to 10 December 2023 | 17,094,018 | 17,094,018 | |||
31 March 2017 | 31 March 2017 to 10 December 2023 | 16,913,319 | 16,913,319 | |||
11 July 2017 | 11 July 2017 to 10 December 2023 | 28,938,797 | - | |||
9 February 2018 | 9 February 2018 to 10 December 2023 | 12,417,368 | - | |||
The fair values of the warrants granted were determined using a variation of the Black-Scholes model, incorporating the dilutive effects of the warrants. The following principal assumptions were used in the valuations: | ||||||
2015 | 2016 | 2017 | July 2017 | Feb 2018 | |||||||
warrants | warrants | warrants | warrants | warrants | |||||||
Share price | 20.63p | 10.625p | 11.625p | 10.725p | 5.20p | ||||||
Volatility | 68% | 48.63% | 59% | 52.9% | 50.06% | ||||||
Dividend yield | 0% | 0% | 0% | 0% | 0% | ||||||
Risk-free interest rate | 1.74% | 0.6% | 0.979% | 1.08% | 1.43% | ||||||
Expected option life | 8 years | 7.25 years | 6.75 years | 6.5 years | 6 years | ||||||
Options and weighted average exercise prices are as follows for the reporting periods presented: |
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| ||||||
Number of share options | Weighted average exercise price |
| ||||
No. | p |
| ||||
| ||||||
Outstanding at 1 April 2017 | 54,332,541 | 17 |
| |||
Granted | 41,356,165 | 9 |
| |||
Outstanding at 31 March 2018 | 95,688,706 | 13 |
| |||
| ||||||
Exercisable at 31 March 2018 | 95,688,706 | 13 |
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In January 2018 Premaitha entered into a Secured Loan Facility with Thermo Fisher. The Facility from Thermo Fisher provides up to £2.1m to fund costs related to the ongoing Illumina litigation against Premaitha. Thermo Fisher is not a party to the litigation. The Facility is provided on a commercial basis consistent with previous loans and is secured on the shares of the Company's Taiwanese subsidiary undertaking - Yourgene Bioscience Co., Ltd ("Yourgene"). There are no share warrants attached to the loan facility. If any of the Facility is not utilised, then the funds will be returned to the lender with no residual liabilities or charges. At the reporting date £1,624,615 of the facility had been utilised.
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Events after the reporting date |
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After the balance sheet date the Company completed a fundraising exercise in May 2018. The Company issued 55,527,784 new ordinary shares with a number of investors and directors at a price of 4.5 pence per share, raising £2.5m before costs. These funds are intended to fund continued international expansion of Premaitha's sales channels, further product development in NIPT and other clinical applications, and adaptation of the current products to provide a range of general purpose development tools for potential partners in other areas of clinical genetics. In addition, 10,097,460 shares were issued in lieu of £0.5m of amounts owed principally to directors.
On 19 September 2018 the Company announced a settlement of all UK patent litigation with Illumina Inc and others. Under the terms of the settlement Premaitha has taken a licence under Illumina's patent pool for NIPT and is now free to operate in countries where Illumina holds rights to relevant granted patents, including the countries of the European Patent Convention and selected other territories. During a transition period of 15-18 months Premaitha will develop an IONA® test that runs on Illumina sequencing technology, to be launched in early 2020. Once this test is developed Premaitha will work with its customers in the licensed territories to migrate to the IONA® test based on Illumina sequencing technology.
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Auditor's report: material uncertainty relating to going concern | ||||||
The Auditor's report includes a material uncertainty relating to going concern. Extracts from the Auditor's report are reproduced below.
In forming our opinion on the financial statements, which is not modified, we have considered the adequacy of the disclosure made in note 1 of the financial statements concerning the group's and parent company's ability to continue as a going concern. The group incurred a loss in the year of £9,482,927 and, at that date, the group had current assets of £4,268,649 and current liabilities of £4,640,943. In their assessment of the group and parent company's ability to continue as a going concern, the directors have focused on the potential for future fundraising, assessing both the expected outcome of the fundraising round in progress at the time of signing the financial statements, and the requirement for a further fundraise in the coming months. The directors have also focused on the rate of growth of revenue in making their assessment.
These considerations, in particular the assumed successful outcome of the fundraising currently in progress and the assumed successful outcome of the next fundraising round to be completed within 12 months, along with the other matters explained in note 1 to the financial statements, indicate the existence of a material uncertainty which may cast significant doubt about the group's and parent company's ability to continue as a going concern. The financial statements do not include the adjustments that would result if the group and parent company were unable to continue as a going concern. | ||||||