Concepta plc (AIM:CPT), the pioneering UK healthcare company and developer of a proprietary platform and suite of products targeted at the personalised mobile health market with a primary focus on women's fertility and specifically unexplained infertility, announces its results for the year ended 31 December 2016.

2016 HIGHLIGHTS

• Significant progress made advancing flagship myLotus fertility product towards market launch in China and Europe
  
• Manufacturing Agreement signed with a leading Chinese manufacturer Shijiazhuang Huanzhong Biotech Limited to assemble and package myLotus
  
• Appointment of China Country Manager Kevin Su Wei to build distributor network in China
  
• Opening of new UK headquarters in Bedfordshire - doubling the size of Concepta's laboratory operational headquarters to increase R&D capacity
  
• 10 year lease signed for new manufacturing facility in Doncaster, Yorkshire
  
• Achievement of ISO13485 accreditation - a key step in attaining CE marking for EU and UK launch of myLotus
  
• New product development - signing of technology transfer and licence agreement with Selective Antibodies Limited to develop stress test for myLotus fertility product

Financial Overview

• EBITDA loss £1.82m excluding deemed reverse takeover costs (£2.46m including deemed reverse takeover costs)
  
• Cash at year end £2.7m
  
• £3.4m (net of issue expenses) share placing secured in July 2016

A copy of the annual report & accounts for year ended 31 December 2016 will be sent to shareholders shortly and will be available from the Company's website www.conceptaplc.com

CHAIRMAN'S STATEMENT

Business Progress

It gives me great pleasure to report a successful start for Concepta since it joined AIM in July 2016, and on the progress it has made during the period under review as it builds itself into a leading health diagnostics company focused on women's fertility and specifically unexplained infertility. It has been an exciting year for Concepta following its reverse takeover and admission to AIM in July 2016, having successfully raised £3.4 million with the aim to launch our proprietary fertility product myLotus into China in 2017 and thereafter into the UK and Europe.

To this end, we enjoyed an active second half of 2016 which saw us setting up product manufacturing and logistics in both the UK and China and making a number of necessary preparations ahead of myLotus' launch. In tandem with this we have continued to build on the scope of our product offering through continued research and new product development and have forged partnerships with players in the same space in this respect.

A significant market opportunity exists to develop a 'best in class' product to help women with unexplained infertility to conceive. We believe our myLotus product delivers this being the only product that allows both quantitative and qualitative measurement of a woman's personal LH and hCG hormone levels to help increase conception probability. Concepta's platform allows the measurement of hormones and small molecules in the consumer's home. The ability to see quantitative as well as qualitative results, and the link with a mobile app, make us unique within the rapidly growing mobile health market. It is our intention to capitalise upon this opportunity and deliver value for shareholders as we continue to build this Group in 2017 and beyond.

Our initial focus is on helping women / couples with unexplained infertility, a highly motivated group but with very few medical options available to them. myLotus provides them with unique and personal information that allows them to increase their chances to conceive.

Strategy underpinned by results-driven operational focus

Our growth strategy is focused on the commercial launch of our flagship myLotus product in the highly lucrative Chinese and EU infertility space where we see an addressable market of £600m. We have a defined route to market for myLotus with regulatory approvals for launch in China already secured and the process of obtaining CE-Marking for the UK and Europe well underway for a 2017 launch. Our primary focus on unexplained infertility presents a fantastic opportunity to grow our market share in the personalised mobile health space; the issue of infertility is universal and largely unaffected by demographics, resulting in a target consumer that is highly driven.

As we progress towards the launch of myLotus we plan to increase the scope of the product's applications through research and development, creating new means by which we can capitalise on the profitability of the mobile health sector; a huge global market which is set to grow at an exponential rate. We remain dedicated to engaging in partnerships which complement our business model and further our ability to provide products that tackle the issue of unexplained infertility.

Our platform is currently unique and offers the potential to develop a wide range of additional tests that could dramatically change how we look after our own health.

Within Concepta PLC our structure initially centered on its fertility focused subsidiary, Concepta Diagnostics Limited, and as a result with cFDA product registration achieved in China, we are starting commercialisation in this large and important market. We aim to maximize fertility sales in China and then launch in subsequent markets, allowing us to develop other opportunities in parallel.

Managerial expertise

We have assembled a management team with many years of experience in Women's Health across many areas and, in particular, international product development within Asia.

The Sales & Marketing team has substantial experience of gaining consumer insights and have contributed to the development of products that are unique and highly relevant to our target group.

Financial position

Financially, the Group is in the early stages of it's development, and in 2016 concentrated on the steps required to launch the myLotus product in China. The funds raised in July 2016, supported by Mercia Technologies PLC, underpin the Group's Business Plan for the commercialisation of its products and the R&D on its next generation of products.

Outlook

Our strategy remains unchanged and we expect to continue to focus our efforts on the Chinese and European launch of our myLotus product. We believe we are well positioned to deliver strong, organic growth from our myLotus product and also plan to continue concentrating additional efforts on research and development to expand the breadth and depth of the platform's features, building ourselves as a highly cash generative healthcare company and market leaders within the growing market for personalised mobile health.

A key challenge for companies is the transition from laboratory-based small volume manufacturing, to full-scale commercial manufacturing. Concepta is setting up a dedicated manufacturing facility in Doncaster, with initial manual assembly progressing to automated assembly, making us far less dependent on the lead times of our supply chain.

The Group has made huge strides since its admission to AIM in July 2016 and it goes without saying that we couldn't have done this without the help and support of our employees, shareholders and advisors. We have no doubt that Concepta will continue to excel and deliver on its objectives from here onwards.

We are building a business that has an exciting future and I look forward to the journey of building an international mobile health business.

Board change

We are pleased to welcome Neil Mesher to the Board as Non-Executive Director, who joined with effect from 29 March 2017. His experience and insight within the healthcare industry and consumer electronics in particular will complement our existing expertise in diagnostics and will also supplement our efforts to diversify our offering to improve users' ability to manage a range of conditions beyond our current core fertility business.

Finally, I would like to take this opportunity to thank Neil Herbert for remaining as a Non-Executive Director during the reverse takeover and over the previous 2 years.

Adam Reynolds

Chairman

CHIEF EXECUTIVE'S REVIEW

Millions of women worldwide find it difficult to conceive. The medical profession cannot find anything physically wrong with them or their partner. They enter an agonising and frustrating period of waiting or contemplate IVF.

Concepta is addressing common factors that can affect fertility in any given cycle. The initial product range offers personalised measurement of hormones at home and the ability to see whether they may be the cause of the lack of success.

myLotus is the only known home platform to offer both qualitative and quantitative results.

In 2013 the idea for the products grew out of a lack of solutions that targeted the women most at need: those with unexplained infertility rather than the "average woman".

The idea for the product grew into a prototype and, after an initial fundraising in April 2014, Concepta Diagnostics Limited was formed to further develop and commercialise the product.

The myLotus brand name was created, laboratory testing refined the product and thanks to founder member contacts we put the products through cFDA registration in China.

We achieved product registration for China in January 2016 and sought funding to start commercialisation. After listing on AIM in 2016 we obtained the funding to put a commercial organisation in place. We signed a manufacturing agreement for the final products in China, set up a manufacturing site in Doncaster to manage the production of the medical devices in the UK and are in the final stages of non-regulatory trials prior to obtaining our first order from China.

Strategy

Whilst the system was designed to support fertility it became apparent that we had a platform that fits in perfectly with the aims of mobile health: provide better patient outcomes at home at a reduced cost to healthcare systems.

The ability to monitor what is wrong with you and have results sent to a medical professional through the app is appealing in a variety of conditions.

Unexplained infertility is a global issue. We will roll the products out to other markets after appropriate regulatory approvals. Where possible we will handle the operations directly.

Our product developments are initially focused on addressing different parameters that can affect women with unexplained infertility. We aim to offer cumulatively improved chances of conception through an understanding of issues linked to unexplained infertility.

Our ability to develop quantitative home tests could take us outside the industries we are familiar with. Where this is in the interest of creating shareholder value we will evaluate the merits of OEM opportunities. Our structure is such that this would not detract from our core fertility business.

Markets

Our initial product offering in fertility offers a simple message to a motivated target group: the potential to increase your chances to conceive if you have been trying for 6 months or longer.

The technology of using urine tests is well established and consumers are used to obtaining these products directly.

In many markets we can reach these women without the need for an expensive infrastructure. We will establish learning of the sales & marketing activities that work best before rolling out to additional markets.

Both the rate of sale and production capacity will be managed to avoid out of stock periods or large overcapacity.

Products

We have announced that our next product in development is a test to differentiate chronic stress from acute stress.

The impact of chronic stress on both male and female fertility is well documented. Monitoring this will allow the couple to help manage their stress levels and the impact this is having on them.

A chronic stress test would also have large applications outside of fertility.

We will continue to develop our own Intellectual Property but will enter into collaborative deals as and when appropriate.

Scientific support

The management team has many years of experience in Women's Health in a variety of functions.

Our technology allows us to move outside of the classic tests available. We plan to assemble an advisory board to stimulate scientific debate around the areas we enter and also ensure that all claims are supported.

Outlook

There are several independent industry reports on mobile health and the potential benefits it can deliver to individuals, healthcare systems and the whole of society.

This will be a multi-faceted development involving infrastructure as well as ethical debates and control systems.

We believe that we are very well placed to play a role in this development. We have a platform that is easy to understand, easy to use, economical and applicable for a wide variety of tests.

We will collaborate with healthcare initiatives to make the most of our offering in this exciting new world of personalised healthcare.

Erik Henau

Chief Executive Officer

FINANCIAL STATEMENTS

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

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

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

These financial statements were approved and authorised for issue by the board of directors on 25 April 2017 and were signed on its behalf by:

Erik Henau

Chief Executive Officer

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

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

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