CPT.L Regulatory News (CPT)

This announcement contains inside informationfor the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR)

Concepta PLC

("Concepta" or the "Company")

Half-year Report

Concepta PLC (AIM: CPT), the personalised healthcare company, announces its interim results for the six months to 30 June 2020, a period of successful corporate reorganisation allowing additional funds to be channelled into product and commercial development of its home-use personalised fertility tracking and pregnancy self-testing system relaunched under the MYLO® brand.

The myLotus® Fertility Monitor is the only consumer tracking product which allows and records both quantitative and qualitative home (self-test) test measurement of a woman's personal luteinizing hormone (LH) during ovulation and human chorionic gonadotropin (hCG) hormone level during pregnancy, to support conception rates and early identification of fertility issues. The proposition of MYLO® is to empower women to better understand their hormone levels and menstrual cycle and help women conceive naturally by identifying their precise and personal window of fertility and optimal time for conception.

Operational Highlights

· Commercial launch of MYLO® brand with digital marketing campaigns and full optimised search engine strategy to drive UK commercial sales

· Over 4,000 App downloads now reached

· Exclusive global licence agreement with Abingdon Health Limited for development of App Dx for pregnancy and fertility testing

· New product development focus now on superior App Dx opportunity and wider testing suite

· Outsourced the manufacturing for myLotus® allowing it to focus on product commercialisation and to be more agile in response to market requirements

· Corporate reorganisation and cost reductions to allow funds to be redeployed into commercial efforts:

- 30% reduction in operating overhead costs announced in January

- 50% cost reduction achieved by Head Office move to Cardiff (The Maltings, East Tyndall St, CF24 5EA)

- Facilities outgoing halved (exc. transfer costs) by outsourcing manufacturing to Abingdon Health

Financial Position

· £1.7m net funds raised in April 2020 at 0.8p per share

· Cash balance at 30 June 2020 of £1.35m (H1 2019: £1.5m)

· Loss for the period increased to £1.35m (H1 2019: £1.26m)

Penny McCormick, Chief Executive Officer, commented:

"I am very excited about the opportunity to take a leading role in influencing the ability to conceive in the pre-IVF space. I believe we have a market leading product and we look ahead to supporting more and more women and couples through their fertility pathway, as well as developing our products to ensure our customers have access to the best possible technology and user experience. Whilst we have a strong foundation in fertility tracking and pregnancy self-testing we also have an opportunity to grow Concepta's product portfolio into other areas of personalised health and female health products." 

Enquiries:

About Concepta PLC (www.conceptaplc.com)

Concepta PLC is an AIM-quoted pioneering UK healthcare company that has developed a proprietary product MYLO®, targeted at the personalised mobile health market, with a primary focus on hormone testing and increasing a woman's chances of naturally getting pregnant whilst providing insight to help overcome unexplained infertility.

MYLO® is the only consumer tracking product which allows and records both quantitative and qualitative home (self-test) test measurement of a woman's personal luteinizing hormone (LH) during ovulation and human chorionic gonadotropin (hCG) hormone level during pregnancy, to support conception rates and early identification of fertility issues. The proposition of MYLO® is to empower women to better understand their hormone levels and menstrual cycle and help women conceive naturally by identifying their window of fertility and precise, optimal time for conception.

MYLO® has received CE mark certification and is expected to be beneficial to users who have been unable to conceive after six months of trying. This highly motivated target group of women won't typically be offered medical intervention until after 12 months of unsuccessfully trying to conceive, with in-vitro fertilisation (IVF) not usually offered until after two years of trying to conceive. Research indicates couples start to take positive action ahead of this time typically with little medical support or guidance to help them do so.

Chairman's Statement

The first half of 2020 saw good progress where we looked to build a sustainable business ready for future growth and managing our resources to focus on the exciting commercial opportunity we have in the MYLO® brand.

Following the appointment of Penny McCormick as CEO and Maddy Kennedy as CFO at the back end of 2019, we began the new financial year working on the steps needed to shape our business properly to best execute our commercial strategy. In January we announced that we had already achieved a 30% cost reduction in our operating overheads and by outsourcing our manufacturing to Abingdon Health we were able to halve our facilities outgoing, setting aside transfer costs. Similarly, we were able to lock in a 50% reduction in Head Office overheads by closing our Bedfordshire office and relocating our Head Office function to Cardiff.

This has allowed us to work on a focused strategic planning programme allowing us to identify the key growth drivers, and carry out targeted commercial exploration of new territories, portfolios, vertical and horizontal expansion opportunities in the medium and longer term. This work will continue through the second half of the year prior to the development of our next generation self-test fertility product. In May we announced a partnership with Abingdon Health to integrate their App Dx IP with our MYLO® branded fertility monitor. The advantages of their App Dx technology are already being seen in the demand for their product in the lateral flow testing environment in which they specialise. Cutting edge software can transform a smartphone into a lateral flow reader and allow the transfer of real-time data and testing in any location. Our focus now is moving immediately to the development of our next generation MYLO® connected AI platform, rather than investing in further development of our MYLO® tracker, which we believe will provide us with a market leading advantage.

The CEO Report below provides an update on the progress made since Penny McCormick took over the reins as CEO at the end of 2019 in continuing to strengthen the business, the team and increase the brand recognition of MYLO® as a global, leading self-test fertility product.

I would like to thank our investors for their continued support. We appreciate there have been significant changes to the Company and strategy over the last 12 months, however we are confident that we have the opportunity and expertise to deliver a globally leading product to a rapidly growing home-testing diagnostic space. We remain firmly committed to delivering this for our investors.

Adam Reynolds

Non-Executive Chairman

25 September 2020

CEO Report: Update and Outlook

Our focus this year has been on embedding the business, brand and portfolio to support the long-term strategic plan for Concepta. Our commitment to helping women and couples conceive has led us to listen very carefully to our customers this year to ensure that our ongoing plans will meet their needs, and improve their experience as they embark on the journey to conception. Scalability and connectivity will be key to the success of Concepta as the market evolves at a fast pace. Concepta's ability to adapt, and to explore wider opportunities, will enable us to grow a business that is able to be responsive to the needs of our customer, and we are now well set up to harness new emerging technologies.

Following the announcement in May 2020 of the exclusive contract to utilize Abingdon Health's Smartphone technology (App Dx) for our next generation fertility product, we have been encouraged by the initial data set that has been shared in recent weeks by our development partner as we work through feasibility. We have gained a high level of confidence in the performance data that we have been seeing, and are on track with development to bring an innovative quantitative Smartphone reader to our customer base. It is our plan now to focus on bringing this product to market as the next version MYLO®, not only saving money that would be spent on the development of a version 2 of our current product, but also introducing a superior, connected, intuitive product with major advantages to our customers as our next new product introduction.

In continuing to evolve MYLO® by developing our education and new technology, we will continue to enhance the user experience by providing support at the fore and helping women to understand that they are not alone in their journey. Our customer onboarding has become key, and we have improved our software systems to enable responsive customer care whilst remaining committed to compliance in data protection. We are building a data store through our new connected platform to enable further development of data mining tools which will enable us to track the success of MYLO® in supporting conception and learning more about women's cycles, helping us to continually improve what's available to women in this space.

The experience of the lockdown due to the COVID-19 pandemic has supported our ethos of being a compact, focused and agile team, able to scale up proportionately as the business grows. Our focus has been, and continues to be, on building a team of talent with the right experience and energy, an appetite to really make a difference, and an ambitious attitude towards growth.

The refocus of the business has been supported by the divestment of the Doncaster manufacturing and supply chain facility to enable resources to be concentrated on the next generation development and laying the commercial foundations for the future. We also appreciate that we are building a business that has the potential to provide a platform for the successful expansion into other areas of personalised health and female health products. We have a number of interesting opportunities that we are pursuing, and we look forward to updating shareholders in due course.

Financial review

Revenues of £12,707 reflect the early stages of our commercial development. Total comprehensive loss for the six months to 30 June 2020 increased slightly to £1.35m (H1 2019: £1.26), although the deployment of our resources is now focussed on driving future commercial success, rather than servicing excess overhead costs. The basic and diluted loss per share was 0.40 pence (six months to 30 June 2019: loss 0.60 pence). The Company completed a £1.7m (net of expenses) placing at 0.8 pence per share in April to strengthen our cash position and to fund our digital marketing effort, and build and progress an innovative future development pipeline for the business. The cash balance at 30 June 2020 was £1.35m (30 June 2019: £1.5m).

During the reporting period we continued to maintain a tight cost control across all areas of spending whilst ensuring the essential requirements of transitioning the Company, from product introduction to its commercial phase of operation, were not compromised.

Outlook

When I joined the Company I was very excited about the prospects for our flagship self-test fertility product and I was delighted to join a business with such substantial upside opportunity. My enthusiasm remains undiminished and after just over 10 months we have made very quick progress in reshaping the Company to better address the strong commercial opportunity that we have before us. Moving forward our focus is on accelerating UK sales growth, expanding into new markets, developing our next-generation product and widening our portfolio to include a broader mix of female health and personalised healthcare products.

As a Board we continue to view the future with optimism and remain confident that we will deliver value to shareholders.

Penny McCormick

Chief Executive Officer

25 September 2020

Consolidated statement of comprehensive incomeFor the 6 months ended 30 June 2020

Consolidated statement of financial positionAs at 30 June 2020

The accompanying notes are an integral part of these financial statements.

Consolidated statement of changes in equity

For the 6 months ended 30 June 2020

The accompanying notes are an integral part of these financial statements.

Consolidated statement of cash flows

Notes to the unaudited interim financial information for the 6 months ended 30 June 2019

1. General information

Concepta PLC (the "Company") is a public limited company incorporated and domiciled in England and Wales. The registered office of the Company is The Maltings, East Tyndall Street, Cardiff CF24 5EA. The registered company number is 06573154.

The principal activity of the Company and its subsidiary is in the development and commercialisation of mobile health diagnostics medical devices. 

2. Significant accounting policies

Basis of preparation

The interim financial information for the six months ended 30 June 2020, which was approved by the Board of Directors on 25 September 2020, does not constitute statutory accounts as defined by section 434 of the Companies Act 2006.

These interim consolidated financial statements have been prepared in accordance with IAS 34 Interim Financial Reporting. They do not include all disclosures that would otherwise be required in a complete set of financial statements.

The financial information presented is unaudited and has been prepared using the same accounting policies as those adopted in the financial statements for the year ended 31 December 2019 and expected to be adopted in the financial year ending 31 December 2020. 

The interim financial information includes unaudited comparative figures for the unaudited 6 months to 30 June 2020 of Concepta Diagnostics Limited and comparatives for the year ended 31 December 2019 that have been extracted from the audited financial statements for that year.

The financial statements for the year ended 31 December 2019 were reported on by the Company's auditors and delivered to the Registrar of Companies. The report of the auditors was unqualified and did not contain an adverse statement under section 498 (2) or (3) of the Companies Act 2006.

In the opinion of the Directors, the interim financial information for the period presents fairly the financial position and the results from operations and cash flows for the period.

Going concern

The interim financial statements have been prepared under the going concern basis as the Directors have undertaken a review of the future financing requirements of the ongoing operation of the group and considers the Group is able to meet its working capital requirements.

The Directors have prepared a cash flow forecast covering a period extending beyond 12 months from the date of these financial statements and including the impact of Covid-19.

The Directors evaluation of financial forecasts indicated a cash requirement to take the Company through its next stage of development and commercialisation of the myLotus® product and commenced a fundraising in February 2020. The fundraising concluded on 24 April 2020 with a net raise of £1.7m providing adequate financial resources to ensure that the Company could meet its obligations for a 12 month period with reasonable certainty. Any future fundraising will be undertaken to support the expansion of the activities either through its product offering or global expansion.

Whilst the impact of Covid-19 has been substantial globally, the impact to the Group is not considered to be substantial since the forecasts were not dependent on significant revenues but focused on controlled, considered expenditure to meet its development and commercialisation objectives.

The forecast contains certain assumptions about the performance of the business including growth in future revenue, the cost model and margins; and importantly the level of cash recovery from trading. The directors are aware of the risks and uncertainties facing the business but the assumptions used are the Directors' best estimate of the future development of the business.

After considering the forecasts and the risks, the Directors have a reasonable expectation that the Group has adequate resources to continue in operational existence for the foreseeable future. For these reasons, they continue to adopt the going concern basis of accounting in preparing the annual financial statements. The financial statements do not include any adjustments that would result from the going concern basis of preparation being inappropriate.

3. Segment information

The Group has one operating segment which is involved in the provision of diagnostic healthcare products. The revenue for this operating segment for the period to 30 June 2020 is as reported in the Consolidated statement of comprehensive income.

4. Cost of sales

The cost of sales in the 6 months to June 2020 also includes the employees' costs and running costs of the manufacturing site at Doncaster.

5. Loss per share

Basic loss per share is calculated by dividing the loss attributable to equity holders of the Company by the weighted average number of ordinary shares in issue during the period.

Due to the loss in the periods the effect of the share options was considered anti-dilutive and hence no diluted loss per share information has been provided.

6. Taxation

The tax credit represents the research and development tax credit for current interim and prior periods.

7. Intangible assets

The Group capitalised development costs of £2,709 during the interim period.

8. Related Party Transactions

Fees paid to directors and other companies for directors' services and reimbursement of expenses for the period to 30 June 2020 were £180,786 (June 2019 £176,648: 31 December 2019: £265,168) and £4,719 (June 2019: £18,352; 31 December 2019: £691 ) were outstanding at period ended 30 June 2020.

This interim financial statement will be released in accordance with the AIM Rules for Companies, available shortly on the Company's website at www.conceptaplc.com. 

9. Placing and funds raised

On 24 April 2020, the Company raised £1,900,000 (before expenses) through a placing of 112,187,500 and subscription of 112,687,500 new Ordinary Shares at 0.8p per ordinary share and the subscription for £101,000 of Convertible Loan Notes. The Convertible Loan Notes have the following principal terms:

• Maturity Date: 27 April 2023

• Coupon: the interest rate on the Loan is 5%

• Security: the Loan is unsecured

• Repayment: The Company will redeem the full amount of the Loan together with all interest accrued and the Redemption Premium (to the extent not previously converted) on the Maturity Date

• Redemption Premium: a redemption premium of 30% of the aggregate value of the loan

• Conversion Price: the conversion price will be 0.8p or, if lower, the average closing price on AIM of the Ordinary Shares for the five business days preceding the relevant conversion date

On the same day, and as the price at which the Placing Shares and the Subscription Shares were to be issued is below the nominal value of 2.5p per ordinary share, each of the Existing Ordinary Shares of 2.5p was sub-divided into one New Ordinary Share of 0.1p and one Deferred Share of 2.4p. The Deferred Shares will not entitle their holders to receive notice of or to attend or vote at any general meeting of the Company, or to receive any dividend or other distribution. On a return of capital on a winding up or dissolution of the Company, the Deferred Shares will be entitled as a class to receive in aggregate the sum of £1 prior to any return on capital paid in respect of the Ordinary Shares. The holders of Deferred Shares are not entitled to any further right of participation in the assets of the Company. The Company shall have the right to purchase the Deferred Shares in issue at any time for an aggregate sum of £1. As such, the Deferred Shares effectively have no value. Share certificates have not and will not be issued in respect of the Deferred Shares, and they will not be admitted to trading on AIM. The Company intends to buy the Deferred Shares back as soon as reasonably practicable subject to Shareholders' approval.

The primary use of the net proceeds will be to strengthen and develop the digital marketing effort, appointing core marketing personnel and to provide the additional working capital requirements of the Company to refine its manufacturing provision and to target strategic commercial contracts to exploit the myLotus® product and technology nationally then internationally.

10. Divestment of assets

On 17 April 2020 the Company signed a Sales and Purchase Agreement with Abingdon Health to transfer to them its lateral flow test manufacturing site in Doncaster. As part of the asset purchase agreement, Concepta will assign the leases on the facility and machinery, transfer the staff, and will sell residual manufacturing equipment to Abingdon Health for a total cash consideration of approximately £0.3m.

To this end, the Company has signed agreements with Abingdon Health for the continual manufacture and supply myLotus® testing strips.