Corporate News

This announcement contains inside information which is disclosed in accordance with the Market Abuse Regulation which came into effect on 3 July 2016.

Concepta plc (AIM: CPT), the innovative UK healthcare company and developer of the proprietary home test platform ("myLotus") and suite of emerging test products targeting the personalised mobile health market with a primary focus on women's fertility announces its interim results for the six months to 30 June 2018.

Operational Highlights

• Preparing for UK launch and scale-up of myLotus
• Completion of CE-Mark submission - Awaiting CE-Mark certification
• Successful completion of clinical studies in UK and China further bolstering product confidence

Financial Position

• Completion of oversubscribed £2m placing @ 4p per share  (post 30 June)
• Cash balance at the period end was £248,172 (H1 2017 £1,234,974)
• Loss for the period of £1,490,349 (H1 2017 £1,083,905)
• Cash outlay for Doncaster factory facilities and equipment £441,039 (H1 2017 £512,686)

Chairman's Statement

Following my appointment in July 2018, I have spent the past few months carefully reviewing the business and strategy and I am pleased to report the half year results for the six months to 30 June 2018.  My report provides an update on the significant progress being made to strengthen the operational robustness of the business in advance of launching our first home test (self test) fertility product to the UK market.

As part of our UK product launch preparations we have recently completed our milestone clinical user testing studies and stability trials in support of our regulatory CE-mark submission. The CE-Mark Notified Body (BSI) have also completed their in-depth audit of our product. Pending receipt of the final certification we anticipate launching the myLotus product to the UK market over the coming months.

The UK product launch marks an important and exciting milestone in the Company's development. The Company has worked diligently towards this revenue generating goal and is now poised to deliver its first innovative product to an attractive UK fertility market.  

The myLotus UK user trial was carried out at the Clarence Medical Centre in North Wales and  independently tested our product proposition for fertility monitoring and menstrual cycle hormone assessment. The ability for women to home monitor (self test) their hormone profile over their cycle provides a level of fertility information which is unavailable today. It also provides women trying for a baby or specifically those with fertility issues a personal insight to help identify their optimal time to conceive and/or provide their doctors with information that may help better manage their fertility journey and early stage pregnancy.

Added to the successful North Wales user study we have also recently completed successful product assessment studies in Bedford, UK and Shanghai, China. Both these studies provided independent product assessment and benchmark validation against traditional laboratory-based tests.        

Progress in China has been disappointing and as a result we will be re-balancing our resource commitment to China. We will focus our prime attention on our UK home market and the subsequent roll-out of myLotus across Europe. Whilst the positive study results from the Changhai hospital, Shanghai have helped bolster our confidence in the China product, given our limited bandwidth and revenue growth objectives our efforts will be aligned to support the successful launch of myLotus in the UK.

Our UK sales and marketing channels are being developed across business-to-business (B2B) and business-to-consumer (B2C) channels. Our B2B channels include discussions with both large retail healthcare consumer groups as well as smaller fertility test providers and key opinion leaders. Our B2C offering is adopting a digital online marketing strategy with customers engaged via social media, content, email and search engine marketing enabling customers to acquire myLotus through our eCommerce platform.

Our Doncaster manufacturing facility has now completed the installation and validation of its automated production line for the manufacture of our ovulation and pregnancy tests. The previous small-scale test manufacturing capacity at our Colworth laboratories has also been successfully transferred to Doncaster. Scale up and production of our test monitor continues to strengthen and we anticipate improved margins and further efficiencies in cost improvement commensurate with our sales volume growth.   

Whilst recognising the myLotus monitor lends itself to the development of other fertility tests and health diagnostics, our efforts remain resolutely focused on realising the potential of our initial launch tests. Nevertheless, we remain open to collaborative research proposals and are in discussions with a number of groups to expand and accelerate our test and technology developments.

Following the recently announced Board changes with myself taking an active Executive Chairman role and Peter Dines providing his considerable industry expertise as Non Executive Director and representing our main investor (Mercia Technologies PLC), Erik Henau will step down from the Board as Chief Executive Officer with immediate effect and take up the role of Business Development Director to lead our new client sales drive. I am pleased to announce that David Darrock Chief Operating Officer, who has been instrumental to the delivery of the myLotus product, will be promoted to the Board with immediate effect. These changes reflect the Company entering a new stage of development as we transition from a laboratory-based research facility to a manufacturing and selling commercial company.

Financial review

• The Group's total comprehensive loss for the six months to 30 June 2018 was £1,490,350 (H1 2017 £1,083,905)
• Following the period end, the Company completed an oversubscribed £2m placing at 4p per share to bolster the Company's cash position.
• The basic and diluted loss per share was 1.1 pence (six months to 30 June 2017 loss 1.0 pence).
• Cash balance as at 30 June 2018 was £248,172 (30 June 2017 £1,234,974).

During the reporting period we have maintained a tight cost control across all areas of spending whilst ensuring the essential requirements of moving the company towards UK launch were not compromised. 

Outlook

The Company continues to strengthen from an early stage start up and is positioning itself to take advantage of the imminent UK product launch of myLotus. The Company's short-term outlook remains firmly focused on revenue growth and a determination to deliver improved investor returns. We anticipate the following deliverables over the next reporting period;

• UK product launch and revenues
• The emergence of a highly motivated 'fertility' target group with a clear need for our products
• Raised product profile and PR based on fertility demand for myLotus
• Marketing and planning to expand the myLotus product into new markets and test opportunities

 I would like to thank our investors for their support, patience and understanding. The Board recognise there have been delays in delivering our products to market but with the changes made to the organisation and our pending UK launch we have the opportunity and expertise to deliver a globally leading product to a rapidly growing home testing diagnostic space. We are committed to delivering this for our investors.

Matthew Walls

Chairman

Enquiries:

The Company

Matthew Walls, Chairman

Tel: +44 (0) 1234 866601

SPARK Advisory Partners Limited (Nomad)

Neil Baldwin / Mark Brady

Tel: +44 (0)20 368 3550

Novum Securities

Colin Rowbury

+44 (0) 20 7399 9400

Yellow Jersey PR Limited (Financial PR)

Georgia Colkin / Joe Burgess/Katie Bairsto

Tel: +44 (0) 776 932 5254

About Concepta Plc:

Concepta PLC is an AIM-quoted pioneering UK healthcare company that has developed a proprietary product, myLotus, targeted at the personalised mobile health market with a primary focus on fertility and unexplained infertility^† in women.

myLotus is currently the only consumer product which allows 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, facilitating higher conception rates and early diagnosis of fertility issues. The proposition of myLotus is to help women conceive naturally by identifying their window of fertility and optimal time for conception.

The Company anticipates receiving CE-mark certification for myLotus over the coming months and is preparing its B2C launch in the UK and Europe. The Company has identified a significant global market opportunity with revenue potential of the EU and Chinese unexplained infertility market estimated to be worth c.£600m per annum.

Concepta has also made progress in establishing relationships with a number of distributors in China where myLotus has been given cFDA approval. Concepta is initially targeting the traditional route to market in China through Chinese hospitals and plans to add the B2C route in the near future. 

^†Unexplained infertility refers to women that have been unable to conceive after 6 months of trying. This highly motivated target group of consumers won't typically be offered medical intervention until 12 months of unsuccessfully trying, with IVF not offered until two years. Research indicates couples start to take positive action ahead of this time and there is little medical support to help them do so.