Concepta plc (AIM: CPT) the UK healthcare company and developer of a proprietary product targeted at the mobile health market and with a primary focus on women's fertility, announces its results for the year ended 31 December 2017.

2017 Highlights

• Received first order from Huan Zhong Biotech Co Ltd (£225,000) and delivered first shipment of products
• Successfully completed hospital evaluation in China in November 2017 and held the first distributor meeting in Shanghai to commence launch of product into the Chinese market
• Completed £1.9m (net) fund raise
• Appointment of Neil Mesher as Non-Executive Director in March 2017
• Appointment of David Darrock as Site Director, subsequently promoted to COO in February 2018
• Appointment of Zhang Zhi Gang as Head of China Operations

Financial Overview

• Revenue of £108,115
• EBITDA loss £2.237m
• Cash at year end £1.537m
• £1.9m (net of issue expenses) share placing secured in November 2017

A copy of the annual report & accounts for year ended 31 December 2017 will be sent to shareholders shortly and will be available from the Company's website www.conceptaplc.com 

CHAIRMAN'S STATEMENT

Business Progress

During the year Concepta faced a number of challenges but also made good progress towards the launch of its myLotus fertility product in China.  Launching a new product into a new market is a complex process and, although progress has been slower than anticipated, we have built robust foundations in China and are well on our way to launching in the EU. 

The hospital trials undertaken in China were hugely successful, demonstrating that myLotus offers exceptional correlation with laboratory blood tests and that it can help women who experience weaker positives to determine when they are most fertile. This places myLotus in a class of its own compared to existing commercially available home tests.  The results from the hospital evaluation of the myLotus pregnancy testing were equally impressive.

Strategy review - operational focus and market entry

The progress of Concepta during 2017 has been solid and the focus has been on optimising operations at our manufacturing sites, both in China and the UK, whilst delivering high quality products.  There have, however, been a number of challenges both internally and externally. This included an issue with the supply of raw materials in China which has impacted our ability to deliver products in a timely manner, namely the order from ShanDong WeiHei HaiChen Pharmaceutical Co. Ltd.  Product will be delivered against this order upon receipt of payment, and although the order from ShanDong WeiHei HaiChen Pharmaceutical Co. Ltd has not been cancelled, payment has not been received to date and therefore this order has not been additive in Q1.

The supply chain has now been fully audited and reviewed to ensure that all future orders will be delivered on time. Following an internal review of the distribution channels and associated risk of being over reliant on existing relationships, we are establishing other distribution channels.  We are now confident our focus on securing a few key successful distribution channels will deliver robust revenue growth in 2018.

Managerial expertise

As the Company enters the launch phase for myLotus, the transition to larger scale manufacturing requires additional skills and knowledge that we have addressed with personnel changes.  The appointment of David Darrock as COO, as of February 2018, has enhanced Concepta's operational expertise and resulted in a significant improvement in the supply chain and manufacturing facilities. 

The China team has also been strengthened by both additional input from Zhang Zhi Gang as our Head of China Operations and the appointment of Michelle Yao as China General Manager, both of whom have significant operational experience within the Chinese market. The team is now making inroads into the complex and extensive Chinese distributor network with some 180,000 MedTech distributors.  Since joining Concepta, Michelle has negotiated and secured an agreement with Sinopharm, one of the largest state owned pharmaceutical companies in China, with annual sales in excess of £23bn. This agreement is not only an endorsement of Concepta's ability to engage with organisations of such high calibre but also highlights our decision to focus on a few key strategic partners in China.

Financial position

In November 2017, the Company raised £1.9m after costs via a placing.  Commercially, the Group has reported a loss in the period of £2.345m with funds being deployed to support future operations for manufacture, selling and marketing of myLotus products.  

Outlook

Concepta has established a solid foundation and now looks to accelerate the launch of myLotus in 2018.  We have a cutting-edge product in a global marketplace and, in addition to China, we believe the launch into Europe in Q4 will be core to the future business and provide a valuable secondary revenue stream.

Building a scientific manufacturing business from scratch is never easy and I'm pleased to report that in 2017 we have acted to rectify the initial challenges we faced. Our overheads are low, our product is unique and we have a substantial market with regulatory approval to sell into, thus we expect 2018 to be a positive year for the Company.

Adam Reynolds

Chairman
 

CHIEF EXECUTIVE'S REVIEW

Concepta's myLotus brand starts with the premise that everyone is different. Existing at-home fertility tests tend to be based on what is "normal" in a large group of women. As a result, there are a considerable number of women who are not helped by traditional qualitative tests. The uniqueness of the myLotus platform is that it allows monitoring of personal hormone levels at home, something that would ordinarily require daily visits to the doctor to have blood tests. The latter is often too expensive and inconvenient so this has, until now, been out of reach for women with unexplained infertility.

Over the course of this year we have made a significant push into our initial market of China. After obtaining cFDA registration for our products and establishing our manufacturing infrastructure we also conducted two very successful hospital evaluations. The results showed near perfect correlation between myLotus urine testing and clinical laboratory testing in blood samples. This excellent result gave us proof of concept to then increase our expansion efforts. It also demonstrates the usefulness of the platform for Personalised Healthcare, a key development for sustainable healthcare provision.

Strategy

Our initial product offering in fertility is simple: myLotus can increase your chances to conceive if you have been trying for 6 months or longer. The issue of infertility is largely unaffected by demographics, the product offering is therefore universal and the target group is highly motivated. Our primary focus remains on this area of mobile health and presents a sizeable market opportunity for us.

Over the course of this year we plan to expand our manufacturing capability in the UK and China. We have worked hard to ensure all of the necessary patents are in place and are confident that myLotus will remain a leading-edge product on the market offering simple quantitative and qualitative hormone measurement at home.

In 2017 we achieved ISO13485 certification and are now audited annually to these standards. We have now commenced the CE-marking process which will be the final requirement for us to sell in the UK and all EU markets and hope to have this in place by H2 2018.

We have already begun our digital marketing strategy in the UK ahead of launch and will be rolling out our full marketing effort over the next few months. We will be able to apply what we learn in the UK to subsequent EU regions; however, our initial focus remains on the Chinese and UK markets. Our infrastructure and manufacturing capabilities will be increased in line with geographical expansion.

Products

Our focus in 2017 has been to optimise the existing fertility product range. However, parallel to this we have been exploring the capabilities of the myLotus platform, including the samples that can be used for testing, the analytes we can test for, the patient's need for the application and its commercial viability.

We have identified a number of additional factors which we can measure to add further detail for users on what is happening in their bodies and the subsequent impact on not only their fertility but also their general wellbeing. This allows the user to take greater control over their personal healthcare.

We also plan to make full use of advancements in mobile technology, which are opening up myriad opportunities for product development and collaboration with the healthcare industry. Our technology has the potential for remote monitoring, with doctors having access to test results. We envisage that doctors could make decisions based on physiological monitoring rather than symptoms and that this could eliminate large amounts of unnecessary doctor visits.

We have produced a large and interesting list of innovative products for potential development. To avoid dilution of effort and resources in Concepta's early stage of commercialisation, exploration of further applications will be undertaken through the use of potential grants and collaboration with third parties.

Outlook

There is increasing momentum in the development of Digital Health initiatives. Healthcare systems are finding it increasingly difficult to provide desired standards of care within their resource constraints.

A move towards Personalised Healthcare implies a shift in control from the medical sector to the individual. This involves serious debate around patient safety, legal implications and the psychological aspects of the medical sector having to "let go" of some of their authority.

We are well positioned in this space to adapt our platform to the rapidly changing landscape in digital healthcare and are confident that Concepta can be a part of this trend. Whilst we remain focused on delivering our initial fertility product, we are unique in our ability to develop low-cost personal health monitoring and are confident that we will play a major part in this shifting dynamic.

Erik Henau

Chief Executive Officer

FINANCIAL REVIEW

Income statement

During the year 2017 the Group's loss after taxation was £2,344,949 (11 months to December 2016: £2,415,226). 

The administration costs incurred during the period for the year ended 31 December 2017 of £2,035,005 included no one-off costs. (11 months to December 2016: £2,525,342 included one-off costs of £1,484,406).

Other administration costs of £1,925,482 (11 months to December 2016: £966,896) included £427,113 (11 months to December 2016: £222,225) research and development costs (net of capitalised development costs), staff costs and head office costs.

The tax credit of £104,818 (11 months to December 2016: £149,221) included research and development tax credit of £104,818 (11 months to December 2016: £96,221) and deferred tax of £nil (11 months to December 2016: £53,000 credit).

One-off costs and non-cash items

Included in the administration costs of the Group, no one-off costs (11 months to December 2016: £1,484,406) were incurred, of which none (11 months to December 2016: £843,448) were expenses associated with AIM admission and fundraising costs and previous period also included deemed cost of the reverse acquisition of £640,958. See note 5 - loss from operations in the notes to the financial statements for more details.

Loss per share

The basic and diluted loss per share was £0.02 (2016: £0.03).

Financial Position

The Group net assets at 31 December 2017 were £2,939,935 (2016: £3,311,270). This comprised total assets of £3,481,351 and total liabilities of £541,416.

The total assets included property, plant and equipment, intangible assets (capitalised development costs and patent costs) of £863,990 (2016: £402,926), of which £174,750 represents additional development costs capitalised net of amortisation, equipment spend net of sale and leaseback transaction of £312,170 and leasehold improvements spend of £117,863 on the Doncaster factory facility  during the year and cash and cash equivalents of £1,537,759 (2016: £2,708,477).

Cashflow

The Group's cash balance at the period end was £1,537,759.

During the period the net cash used in operations was £2,439,684 (2016: £1,288,414) and total spend on property, plant and equipment and intangible assets of £670,292, with financing activities generating net proceeds of £1,939,258 (2016: £4,027,405).

Dividends

No dividend is recommended (2016: £nil) due to the early stage of the development of the Group.

Capital management

The Board's objective is to maintain a balance sheet that is both efficient and delivers long term shareholder value.  The Group had cash balances of £1,537,759 at 31 December 2017 and has a 5-year sale and leaseback financing for one of its manufacturing equipment. The Board continues to monitor the balance sheet to ensure it has an adequate capital structure.

Events after the reporting period

Events after the reporting period are described in Note 23 to the financial statements.

Barbara Spurrier

Chief Financial 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 30 April 2018 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.

CONSOLIDATED STATEMENT OF CASH FLOWS

¹ The cash inflow on acquisition (net of cash acquired) relates to the cash and cash equivalent of Concepta PLC as at date of acquisition (26 July 2016).

Significant non-cash transactions

On 26 July 2016 Concepta PLC acquired the entire issued share capital of Concepta Diagnostics Limited for a consideration of £3,025,916, satisfied by the issue of shares of £2,275,796 (non-cash transaction) and cash of £750,120.  Also, shares were issued in settlement of Concepta Diagnostics Limited's debt of £650,000. No significant non-cash transaction in 2017.

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