Interim Results

RNS Number : 0642R

Concepta PLC

19 September 2017

 

19 September 2017

Concepta plc ("Concepta" or the "Company")

Interim Results

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 interim results for the six months to 30 June 2017.

Operational Highlights

·     Continuing to progress flagship myLotus fertility product towards market launch in China and Europe

·     Signed the first distributor agreement in China with Beijing ThinkBrio Medical Technology Consulting Co Ltd ("ThinkBrio")

·     First myLotus sales order of £225,000 received from HuanZhong Biotech Co Ltd ("HZ Biotech")

·     First shipment of myLotus products from UK production sent to China as part of first sales order to HZ Biotech

·     Appointed founding member of Concepta, Zhang Zhi Gang, as Head of China Operations

·     Achieved ISO13485 accreditation for myLotus for commercial launch in UK and Europe

·     Signed technology transfer agreement with Selective Antibodies to develop stress test for myLotus fertility product

·     Appointed Neil Mesher, CEO of Philips (UK and Ireland), as Non Executive Director

Financial Position

·     Cash balance at the period end was £1,234,974 (H1 2016 £341,249)

·     Loss for the period of £1,083,905 (H1 2016 £414,589)

·     Cash outlay for Doncaster factory facilities and equipment was £512,686

Chairman's Statement

I am pleased to report Concepta's half year results for the six months to 30 June 2017. During this period, the Company has made significant inroads towards the launch of its flagship myLotus product in China and towards setting up the infrastructure and resources, both in the UK and China, to support the future scale-up of production and sales.

We have been working hard on the complex process of moving from laboratory prepared product to ISO 13485 certified production facilities and the fit out of the new manufacturing facility in Doncaster, UK has been progressing well. The recruitment of site management and staff, and the installation of equipment, and associated infrastructure has resulted in the expectation that the new facilities in Doncaster will be fully operational by the end of 2017.  During this period, limited production has been facilitated at our Colworth site and the first product for sale has been shipped to China. 

In addition to preparation for the launch of our myLotus fertility product in China, the on-going process of achieving CE marking for Europe continues, with clinical and stability trials starting in September 2017.  The CE marking accreditation is expected to be achieved by the end of 2017, allowing the launch of myLotus into the UK and German markets in the first half of 2018. 

 Whilst having made significant progress towards commercial launch in both China and in Europe of our myLotus product, some of the key milestones in our development towards these goals during the period have been slower to materialise than expected and this was highlighted in our June statement.  These related to changes to the Chinese regulatory framework on health apps, which necessitated additional development work and a delay in our new Doncaster facility becoming fully operational. However, post the period end, both of these issues have been dealt with and we have seen a significant increase in enquiries from various new potential distributors in China and we will keep shareholders fully informed with progress.

Our primary focus during the period has been on the preparation for scale up and production of myLotus, we have also been busy with the development of new products to complement our myLotus range. This includes a stress test, which enables users to monitor stress through quantitative measurement of their levels of stress hormones, of which cortisol is the key one.  This new product development has been progressed by utilising the resources of Selective Antibodies, following the technology transfer and licence agreement we signed and announced on 7 February 2017.   The development of this new product will take several years to bring to market, but as it extends the product range, it will support ongoing growth in future years.

To support our future plans, the Board of Directors has also been strengthened with the appointment of Neil Mesher, CEO of Philips UK & Ireland, who has brought his significant experience and industry knowledge to contribute to our strategic planning process.

Financial review

·     The Group's total comprehensive loss for the six months to 30 June 2017 was £1,083,905 (30 June 2016 £414,589)

·     The basic and diluted loss per share was £(0.01) (six months to 30 June 2016 £(0.01)

·     Cash balance as at 30 June 2017 was £1,234,974 (30 June 2016 £341,249)

During the period, tight cost control has been implemented and finance facilities for the plant and equipment required for the Doncaster factory has been agreed. 

As the Company is at an early stage of development, it is not anticipated that there will be sufficient earnings arising in the short term that will enable the Board to make the recommendation or pay any dividends.

Outlook

Concepta is focused on delivering immediate milestones that are linked to the manufacture, marketing and sales of the initial myLotus product offering in the fertility area.  The potential of the myLotus platform playing a role in the shift towards Personalised Health is being recognised outside of the Company and we have started to explore the opportunities and to match them to the requirements that will be linked to the rate of growth.

The immediate focus is the launch of myLotus in China and the CE marking to allow its launch into Europe.  Following on from the progress in the first half of 2017, the Company expects to achieve both these objectives by the first half of next financial year and in turn begin to generate revenues for the Company.  The certification of the Doncaster production facility is expected to be complete by the end of 2017 and to support the planned manufacturing scale up, David Darrock will be joining the Company as Site Manager (COO designate).  David has significant experience in the full manufacturing processes in this industry.

Whilst our initial product offering is focused on helping women to conceive, we are currently running a hospital evaluation process in China to extend the use of the myLotus product into early pregnancy monitoring, as there is a very high demand for information on the healthy progression of the pregnancy in the early stages. Depending on the results, the potential application of the product would be utilised by up to 18 million births per year in China and would increase our opportunities to add this product to every market we launch into. Additionally, it would create an additional earnings stream for the Group, and the benefits would be demonstrated during the 2018 financial year.

The transition from a start-up to a fully operational company is always a challenging one. However, despite delays to the initial launch of our myLotus product, I believe that we have made positive progress over the period, laying the foundations required for ongoing rapid growth and, in turn, a successful myLotus product launch and penetration into the Chinese and European markets by the end of this year and 2018 respectively.

Adam Reynolds

Chairman

**ENDS**

Enquiries:

The Company

Adam Reynolds, Chairman

Tel: [phone]

SPARK Advisory Partners Limited (Nomad)

Neil Baldwin / Mark Brady

Tel: [phone]

Beaufort Securities Limited (Broker)

Jon Belliss

Tel: [phone]

Yellow Jersey PR (Financial PR)

Felicity Winkles / Joe Burgess

Tel: [phone]

About Concepta Plc:

Concepta plc is a pioneering UK healthcare company that has developed a proprietary platform and products targeted at the personalised mobile health market with a primary focus on women's fertility and specifically unexplained infertility*.

Founded in 2013, Concepta has developed a revolutionary flagship product 'MyLotus' for home self-testing that helps women with unexplained infertility to conceive.  

MyLotus is the only consumer product which allows both quantitative and qualitative measurements of measurement of a woman's personal hCG and LH hormone levels in an easy to use home test to facilitate higher conception rates and early diagnosis of any fertility problems.  Competitor products currently only allow qualitative measurement and are based on the 'average woman'.  

Concepta has a defined route to market for its new 'My Lotus' product with Regulatory approvals for launch in China in place for 2016 and CE-Marking for UK and Europe to follow in 2017 where the revenue potential of the Chinese and EU infertility market is worth c.£600m per annum for the company.

*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.

Consolidated statement of comprehensive income
For the 6 months ended 30 June 2017

		Unaudited 6 months to	Unaudited 5 months to	Audited 11 months to
		30 June 2017	30 June 20161	31 December 2016
	Notes	£	£	£
Revenue	3	-	-	-
Cost of sales	4	(172,996)	(3,511)	(37,972)
Gross loss		(172,996)	(3,511)	(37,972)
Other administrative expenses		(959,547)	(388,848)	(966,896)
AIM admission expenses		-	(10,000)	(843,448)
Deemed cost of reverse acquisition		-	-	(640,958)
Share-based payments		(19,173)	(12,364)	(74,040)
Administrative expenses		(978,720)	(411,212)	(2,525,342)
Operating loss		(1,151,716)	(414,723)	(2,563,314)
Finance income		3	134	222
Finance expenses		-	-	(1,355)
Loss before income tax		(1,151,713)	(414,589)	(2,564,447)
Tax credit	6	67,808	-	149,221
Loss for the period		(1,083,905)	(414,589)	(2,415,226)
Attributable to owners of the parent:		(1,083,905)	(414,589)	(2,415,226)
Loss per ordinary share - basic and diluted (£)	5	(0.01)	(0.01)	(0.03)

¹   Unaudited 5 months to 30 June 2016 relates to Concepta Diagnostics Limited only (prior to reverse takeover of Concepta plc on26 July 2016).

Consolidated statement of financial position
As at 30 June 2017

		Unaudited 30 June 2017	Unaudited 30 June 2016	Audited 31 December 2016
	Notes	£	£	£
Non-current assets
Property, plant and equipment	7	646,983	214,492	186,933
Intangible assets	8	305,797	-	215,993
Total non-current assets		952,780	214,492	402,926
Current assets
Inventories		200,226	-	70,500
Trade and other receivables		172,116	60,617	215,103
Corporation tax receivable		67,808	178,147	96,221
Cash and cash equivalents		1,234,974	341,249	2,708,477
Total current assets		1,675,124	580,013	3,090,301
Total assets		2,627,904	794,505	3,493,227
Current liabilities
Trade and other payables		381,366	103,359	181,957
Deferred tax liability		-	53,000	-
Loans and borrowings		-	680,000	-
Total current liabilities		381,366	836,359	181,957
Total liabilities		381,366	836,359	181,957
Net assets/(liabilities)		2,246,538	(41,854)	3,311,270
Share capital		2,740,631	425	2,740,631
Share premium account		8,663,326	2,305,374	8,663,326
Capital redemption reserve		1,814,674	-	1,814,674
Retained earnings		(5,488,438)	(2,403,896)	(4,404,533)
Reverse acquisition reserve		(6,044,192)	-	(6,044,192)
Share-based payment reserve		560,537	56,243	541,364
Total equity		2,246,538	(41,854)	3,311,270

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

Consolidated statement of changes in equity

For the months ended 30 June 2017

	Share capital	Deferred shares & 'A' deferred shares	Share Premium	Capital redemption reserve	Retained earnings	Reverse acquisition reserve	Share-based payment reserve	Total
	£	£	£	£	£	£	£	£
Concepta Diagnostics Limited - unaudited
Equity as at 1 February 2016	425	-	2,305,374	-	(1,989,307)	-	43,879	360,371
Loss for the year	-	-	-	-	(414,589)	-	-	(414,589)
Total comprehensive loss	-	-	-	-	(414,589)	-	-	(414,589)
Share-based payments	-	-	-	-	-	-	12,364	12,364
Equity as at 30 June 2016	425	-	2,305,374	-	(2,403,896)	-	56,243	(41,854)
Concepta plc - consolidated - audited
Equity as at 1 February 2016	361,999	1,488,875	3,672,903	-	(1,989,307)	-	369,218	3,903,688
Loss for the period	-	-	-	-	(2,415,226)	-	-	(2,415,226)
Total comprehensive loss	-	-	-	-	(2,415,226)	-	-	(2,415,226)
Issue of shares net of expenses	2,433,597	-	4,611,257	-	-	-	-	7,044,854
Loan notes converted to shares	270,834	-	379,166	-	-	-	-	650,000
Reverse acquisition reserve	-	-	-	-	-	(6,044,192)	-	(6,044,192)
Transfer to A Deferred Shares	(325,799)	325,799	-	-	-	-	-	-
Buyback & Cancellation of Shares	-	(1,814,674)	-	1,814,674	-	-	-	-
Reversal of share based payment to RTO Reserve	-	-	-	-	-	-	(325,339)	(325,339)
Share-based payments	-	-	-	-	-	-	497,485	497,485
Equity as at 31 December 2016	2,740,631	-	8,663,326	1,814,674	(4,404,533)	(6,044,192)	541,364	3,311,270

	Share capital	Deferred shares & 'A' deferred shares	Share Premium	Capital redemption reserve	Retained earnings	Reverse acquisition reserve	Share-based payment reserve	Total
	£	£	£	£	£	£	£	£
Concepta plc - consolidated - unaudited
Equity as at 1 January 2017	2,740,631	-	8,663,326	1,814,674	(4,404,533)	(6,044,192)	541,364	3,311,270
Loss for the period	-	-	-	-	(1,083,905)	-	-	(1,083,905)
Total comprehensive loss	-	-	-	-	(1,083,905)	-	-	(1,083,905)
Share-based payments	-	-	-	-	-	-	19,173	19,173
Equity as at 30 June 2017	2,740,631	-	8,663,326	1,814,674	(5,488,438)	(6,044,192)	560,537	2,246,538

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

Consolidated statement of cash flows

	Unaudited 6 months to	Unaudited 5 months to	Audited 11 months to
	30 June 2017	30 June 2016	31 December 2016
		(Concepta Diagnostics only)
	£	£	£
Cash flows from operating activities
Loss before taxation	(1,151,713)	(414,589)	(2,564,447)
Adjustments for:
Deemed cost of reverse acquisition	-	-	640,958
Depreciation and amortisation	79,980	38,776	104,153
Finance expenses	-	-	1,355
Finance income	(3)	(134)	(222)
Share-based payments	19,173	12,364	497,485
Operating loss before working capital changes	(1,052,563)	(363,583)	(1,320,718)
Changes in working capital
Increase in inventory	(129,726)	-	(70,500)
Decrease in trade and other receivables	42,987	(40,607)	81,712
Decrease in trade and other payables	199,410	(5,084)	(157,054)
Cash used in operations	(939,892)	(409,274)	(1,466,560)
Tax received	96,221	-	178,146
Net cash outflow from operating activities	(843,671)	(409,274)	(1,288,414)
Investing activities
Purchase of property, plant and equipment	(512,686)	-	(19,848)
Purchase of intangible assets	(117,149)	-	(233,963)
Interest received on bank deposit account	3	134	222
Payment for the acquisition of Concepta Diagnostics Limited	-	-	(750,120)
Acquisition, net of cash acquired1	-	-	872,806
Net cash flows used in investing activities	(629,832)	134	(130,903)
Financing activities
Issue of ordinary shares (net of issue expenses)	-	-	3,408,760
Interest paid on loans and borrowings	-	-	(1,355)
Proceeds from loans and borrowings	-	650,000	650,000
Repayment of loans and borrowings	-	-	(30,000)
Net cash flows from financing activities	-	650,000	4,027,405
Net change in cash and cash equivalents	(1,473,503)	240,860	2,608,088
Cash and cash equivalents at the beginning of the period	2,708,477	100,389	100,389
Cash and cash equivalents at the end of the period	1,234,974	341,249	2,708,477

¹ The cash inflow on acquisition (net of cash acquired) in 31 December 2016 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.

Notes to the audited interim financial information for the 6 months ended 30 June 2017

1.    General information

Concepta PLC (the "Company", formerly, Frontier Resources International PLC until 26 July 2016) is a public limited company incorporated and domiciled in England and Wales. The registered office of the Company is 1 Park Row, Leeds, England, LS1 5AB.   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 2017, which was approved by the Board of Directors on 18 September 2017, does not constitute statutory accounts as defined by section 434 of the Companies Act 2006.

The financial statements have been prepared in accordance with International Financial Reporting Standards, International Accounting Standards and Interpretations (collectively IFRSs), as adopted by the European Union ("adopted IFRSs") and with those parts of the Companies Act 2006 applicable to companies reporting under IFRS.

The financial information presented is unaudited and has been prepared using the same accounting policies as those adopted in the financial statements for the period ended 31 December 2016 and expected to be adopted in the financial year ending 31 December 2017. 

The interim financial information include unaudited comparative figures for the unaudited 5 months to 30 June 2016 of Concepta Diagnostics Limited (prior to reverse takeover on 26 July 2017) and comparatives for the year ended 31 December 2016 that have been extracted from the audited financial statements for that year.

The financial statements for the year ended 31 December 2016 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 statements for the period present fairly the financial position and the results from operations and cash flows for the period.

No new IFRS standards, amendments or interpretations became effective in the six months to the 30 June 2017 which had a material effect on this consolidated interim financial information.

Going concern

The Directors have prepared a cash flow forecast covering a period extending beyond 12 months from the date of these financial statements.

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 information does 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 operating segment has no revenue reported for the period to 30 June 2017 as it is in an early stage of its operation.

4.    Cost of sales

The cost of sales in the 6 months to June 2017 relates to costs incurred in the running of batches of products for trial testing, employees and contractors costs and running costs of the new manufacturing site at Doncaster.

5.    Earnings per share

	Unaudited 6 months to 30 June 2017	Unaudited 5 months to 30 June 2016	Audited 11 months to 31 December 2016
Basic and diluted
Loss for the period and earnings used in basic & diluted EPS (£)	(1,083,905)	(414,589)	(2,415,226)
Weighted average number of shares used in basic and diluted EPS	109,625,247	30,343,950	93,609,848
Loss per share (£)	(0.01)	(0.01)	(0.03)

Basic earnings 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.  The weighted average number of shares for the current and prior years included 30,343,950 shares issued by Concepta PLC as consideration for the acquisition of Concepta Diagnostics Limited as if they had always been in issue. 

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

	Unaudited 6 months to 30 June 2017	Unaudited 5 months to 30 June 2016	Audited 11 months to 31 December 2016
	£	£	£
The tax credit is as follows:
UK Corporation tax
Tax credit - current period	67,808	-	96,221
Total current tax	67,808	-	96,221
Deferred tax
Origination and reversal of timing differences	-	-	53,000
Total tax credit	67,808	-	149,221

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

7.    Property, plant and equipment

During the period the Group spent £117,863 for the fit-out of the new manufacturing site at Doncaster and purchase of new plant and equipment of £394,823.  

8.    Intangible assets

The Group capitalised development costs of £117,149 during the interim period.

9.    Related Party Transactions

During the period, the Company entered into the following transactions with related parties:

			Unaudited 6 months to  30 June 2017	Unaudited 5 months to  30 June 2016	Audited 11 months to  31 December 2016
Related party	Transaction	Note	£	£	£
Stowheath Limited	Paid for director fees & expenses	1	-	3,000	3,000
Adaxis Limited	Consultancy fees & related costs	2	170	41,800	41,800
Reyco Limited	Non-executive director fees  and expenses	3	26,080	-	26,738
CFPro Limited	Accounting, consultancy fees and rent	4	67,516	-	58,219
Cambridge Financial Partners LLP	Travel & telephone expenses	4	1,022	-	844
Cambrian Limited	Non-executive director fees	5	12,500	-	22,916
Mercia Investments	Non-executive director fees	6	18,717	-	-

        Amount outstanding at year end (included in Trade and other payables)

Adaxis Limited	-	30,000	-
Reyco Limited	5,222	-	5,222
CFPro Limited	11,007	-	9,176
Cambridge Financial Partners LLP	322	-	241
Cambrian Limited	-	-	7,500
Mercia Investments	-	-	8,668

1.     Dr. Ian Gilham has an interest in Stowheath Limited. He resigned as a director of Concepta Diagnostics Limited on 25 July 2016.

2.     Mr. Erik Henau has an interest in Adaxis Limited. The fees paid for the period 30^th June 2016 and 31^st December 2016 were for his consultancy work on the reverse takeover transaction before he was employed by Concepta PLC. Mr Henau is a director of Concepta PLC and Concepta Diagnostics Limited.

3.     Mr. Adam Reynolds, a non-executive director of Concepta PLC is a director of and has an interest in Reyco Limited. 

4.     Service fees were paid to CFPro Limited and Cambridge Financial Partners LLP for accounting and consultancy support, companies in which Barbara Spurrier has an interest. Barbara Spurrier is a director of Concepta PLC.

5.     Mr. Neil Herbert, a non-executive director of Concepta PLC has an interest in Cambrian Limited.

6.     Dr. Mark Wyatt, a non-executive director of Concepta plc has an interest in Mercia Investments Limited.

 

END

 

 

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