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ERGO Ergomed Plc

1,346.00
0.00 (0.00%)
Last Updated: 01:00:00
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Ergomed Plc LSE:ERGO London Ordinary Share GB00BN7ZCY67 ORD 1P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 1,346.00 0.00 01:00:00
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

Ergomed plc Unaudited Preliminary Results for 2016 (6771A)

28/03/2017 7:01am

UK Regulatory


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TIDMERGO

RNS Number : 6771A

Ergomed plc

28 March 2017

PRESS RELEASE

EMBARGOED FOR RELEASE

7.00am 28 MARCH 2017

Unaudited Preliminary Results for the year ended 31 December 2016

Top line revenue growth of 30%

Gross profit up 43%

New business won in 2016 increased 50% to GBP42 million

Contracted backlog at 1 January 2017 of GBP70 million

Multiple corporate milestones achieved in 2016

Post year-end positive Phase II results announced from insomnia study

London, UK - 28 March 2017: Ergomed plc, ('Ergomed', AIM: ERGO) a profitable UK-based group dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, today announces its unaudited Preliminary Results for the year ended 31 December 2016.

Commenting on the results, Miroslav Reljanovic MD, Chief Executive Officer of Ergomed plc, said:

"I am proud of our achievements in 2016, a transformational year. We met our financial targets, delivering increased revenue and gross profit and at the same time achieved a number of important corporate milestones. The Board remains focused on delivering significant shareholder value by the continuing development of Ergomed's exciting hybrid business model.

The acquisitions(1) of O+P and GASD strengthened our CRO service offering whilst the acquisition of PharmInvent consolidated our position as a leading international, fast growing provider of pharmacovigilance services. Positive Phase II results from our co-development partnership with Ferrer and the acquisition of Haemostatix underline the potential of our drug development pipeline and its potential to deliver very significant shareholder value in the medium term. Based on our GBP70 million contracted backlog and the opportunities in front of us I believe 2017 will be another exciting year for Ergomed."

Financial Highlights: Performance ahead of market expectations

   --      Revenues up 30% to GBP39.2 million (2015: GBP30.2 million) 
   --      Gross profit up 43% to GBP12.0 million (2015: GBP8.4 million) 

-- EBITDA (adjusted)(2) was GBP3.0 million (2015: GBP3.4 million) and EBITDA was GBP1.6 million (2015: GBP2.8 million), reducing principally due to inclusion of Haemostatix R&D (2016: GBP1.0 million, 2015: GBPnil) following its acquisition (note 12)

-- EPS (adjusted) was 7.1p (2015: 9.2p) and EPS was 1.3p (2015: 5.2p), again due to the inclusion of Haemostatix R&D following its acquisition in May 2016 (note 13)

-- Cash and cash equivalents of GBP4.4 million as at 31 December 2016 (2015: GBP4.0 million) with zero debt (2015: GBPnil)

-- New contracts won in 2016 up 50% with an initial value of GBP42 million (2015: GBP28 million)

-- Strong backlog of GBP70 million contracted revenue as of 1 January 2017 (1 January 2016: GBP59 million)

Notes:

1. The Company made four acquisitions during the year; Haemostatix Limited ("Haemostatix") in May 2016, Dr Oestreich+ Partner GmbH ("O+P") and Gesellschaft für angewandte Statistik + Datenanalyse mbH ("GASD") acquired together in June 2016 and European PharmInvent Services s.r.o. ("PharmInvent") in November 2016.

2. Adjustments are made to EBITDA for share-based payment charge, deferred consideration for acquisition, write-back of deferred consideration for acquisition, acquisition costs and exceptional items.

3. Adjustments are made to EPS for amortisation of acquired fair valued intangible assets, share-based payment charge, deferred consideration for acquisition, write-back of deferred consideration for acquisition, acquisition costs and exceptional items.

Operational Highlights: Significant corporate milestones achieved

   --      An institutional placing raising gross proceeds of GBP9.2 million (May 2016) 

-- Acquisition of Haemostatix, a company focused on developing innovative products for surgical bleeding based in Nottingham, UK (May 2016) (see note 6)

-- Acquisitions of O+P and GASD, respectively CRO and biostatistics companies, both based in Germany (June 2016) (see note 7)

-- Acquisition of PharmInvent, a leading pharmacovigilance and regulatory services business based in Czech Republic (November 2016) (see note 8)

-- An agreement with Asarina AB for the co-development of sepranolone for the treatment of PMDD (November 2016)

Post-year-end highlights

-- Ergomed's co-development partner, Ferrer, announced positive Phase II results of lorediplon for insomnia (February 2017)

-- Ergomed initiated a Phase IIb study of PeproStat, our wholly-owned development product and the first to come from the Haemostatix pipeline (March 2017)

Enquiries:

 
 Ergomed plc                                             Tel: +44 (0) 1483 503205 
 Miroslav Reljanovic (Chief Executive Officer) 
 Stephen Stamp (Chief Financial Officer) 
 
 Numis Securities Limited                                Tel: +44 (0) 20 7260 1000 
 Michael Meade / Freddie Barnfield (Nominated Adviser) 
 James Black (Joint Broker) 
 
 Stifel Nicolaus Europe Limited                          Tel: +44 (0) 20 7710 7600 
 Jonathan Senior / Ben Maddison (Joint Broker) 
 
 FTI Consulting - for UK enquiries                       Tel: +44 (0) 20 3727 1000 
 Simon Conway / Mo Noonan / Natalie Garland-Collins 
 
 MC-Services - for Continental European enquiries        Tel: +49 211 5292 5222 
 Anne Hennecke 
 

About Ergomed

Ergomed plc is a profitable UK-based business providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships. It operates in over 50 countries.

Ergomed provides clinical development, trial management and pharmacovigilance services to over 100 clients ranging from top 10 pharmaceutical companies to small and mid-sized drug development companies. Ergomed successfully manages clinical development from Phase I through to late phase programmes.

Ergomed has a wide therapeutic focus, with a particular expertise in oncology, neurology and immunology and the development of orphan drugs. Ergomed believes its approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed and the physicians involved in clinical trials.

As well as providing high quality clinical development services, Ergomed is building a portfolio of co-development partnerships with pharma and biotech companies which share the risks and rewards of drug development. Ergomed leverages its expertise and services in return for carried interest in the drugs under development. Lastly, Ergomed acquired a pipeline of proprietary development products for the treatment of surgical bleeding. For further information, visit: http://ergomedplc.com.

Forward Looking Statements

Certain statements contained within the announcement are forward looking statements and are based on current expectations, estimates and projections about the potential returns of Ergomed plc ("Ergomed") and industry and markets in which Ergomed operates, the Directors' beliefs and assumptions made by the Directors. Words such as "expects", "anticipates", "should", "intends", "plans", "believes", "seeks", "estimates", "projects", "pipeline" and variations of such words and similar expressions are intended to identify such forward looking statements and expectations. These statements are not guarantees of future performance or the ability to identify and consummate investments and involve certain risks, uncertainties, outcomes of negotiations and due diligence and assumptions that are difficult to predict, qualify or quantify. Therefore, actual outcomes and results may differ materially from what is expressed in such forward looking statements or expectations. Among the factors that could cause actual results to differ materially are: the general economic climate, competition, interest rate levels, loss of key personnel, the result of legal and commercial due diligence, the availability of financing on acceptable terms and changes in the legal or regulatory environment.

These forward-looking statements speak only as of the date of this announcement. Ergomed expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in Ergomed's expectations with regard thereto, any new information or any change in events, conditions or circumstances on which any such statements are based, unless required to do so by law or any appropriate regulatory authority.

Chief Executive Officer's Review

The Board of Ergomed is delighted to report on a transformational year. The Company exceeded its targets in terms of revenue and adjusted EBITDA, raised GBP9.2 million in an institutional placing, completed four acquisitions, of which O+P and GASD were acquired at the same time, and added another partnership to the co-development portfolio.

Services - another year of good growth

New business won in 2016 of GBP42 million, up 50% on 2015, drove overall Services revenue growth of 30%. Services growth was powered by Drug Safety & Medical Information revenues which grew at 63%, complemented by 18% growth from Clinical Research Services. Excluding acquisitions, overall revenue growth was 27%.

In June 2016, we announced the acquisitions of O+P and GASD based in Cologne and Neuss, Germany respectively. O+P is a full service contract research organisation that has also developed a proprietary FDA validated Electronic Data Capture (EDC) system called OPVERDI, which can be configured for individual trials on a multilingual basis. GASD offers data management, statistical analysis, biometric reporting and statistical consulting services for the pharmaceutical industry. In addition to a scalable EDC system and world-class biostatistics expertise, the acquisitions of O+P and GASD have brought greater access to the German speaking markets and have already resulted in several contract wins.

In November 2016, we announced the acquisition of PharmInvent based in Prague, Czech Republic. PharmInvent is led by an experienced, ex-regulatory agency team that offers drug safety and regulatory consultancy expertise. They also have an extensive network of international pharmacovigilance experts that provide advice and support on local product safety and offer integrated global support for pharma and generic companies' products. Combining PharmInvent's proven expertise with PrimeVigilance creates one of the largest international specialist service providers in the highly regulated drug safety sector. The enlarged business has a broad international client list offering significant opportunities to cross sell, as well as an expanded range of services to attract new customers.

Global demand for quality outsourced drug development and drug safety services remains strong and Ergomed continues to benefit from this trend. Ergomed ended 2016 with a total backlog of contracted work with a value to be invoiced in future years of approximately GBP70 million (2015: GBP59 million).

Products - Haemostatix and one more co-development partnership added

Ergomed is also in the distinct position of offering co-development partnerships and is committed to building its portfolio of co-development assets and delivering clinical data thereby creating significant potential shareholder value in the next few years.

As part of our co-development business development activities, we identified what we believe to be a particularly promising opportunity in Haemostatix. With solid pre-clinical and clinical evidence and a low cost yet fast development programme, we believe Haemostatix offers a rare opportunity to capture the full value of the product potential with reasonable risk. We acquired Haemostatix in May 2016, at the same time raising GBP9.2 million via an institutional placing. Since then, we have been preparing PeproStat, a liquid haemostat for a Phase IIb study and announced the start of the trial in March 2017. We expect to complete recruitment around the end of the year with topline results available in the first quarter of 2018. At the same time, ReadyFlow, a flowable gel haemostat, is in formulation development and is expected to be Phase I ready by the first quarter of 2018. With combined annual peak sales potential of up to $500 million, the Board believes the Haemostatix products have the capability to deliver very significant value to Ergomed shareholders not otherwise achievable in traditional co-development deals.

In November 2016 we signed a co-development agreement with Asarina AB for the Phase IIb clinical development of sepranolone as a targeted treatment for premenstrual dysphoric disorder (PMDD). The co-development deal with Asarina is Ergomed's second with a Karolinska Development spin-out company and brings the portfolio of co-development programmes to six in total. The status of Ergomed's current co-development partnerships is summarised as follows:

 
 Company               Study Overview                                                  Update 
--------------------  --------------------------------------------------------------  -------------------------------- 
 Ferrer                                                                                We were very pleased to 
  Private                    *    Phase IIa study in insomnia                          announce that the primary 
  www.ferrer.com                                                                       and many of the secondary 
                                                                                       endpoints for the Phase 
                             *    Lorediplon                                           II study were met, indicating 
                                                                                       that lorediplon was both 
                                                                                       safe and effective in insomnia 
                             *    145 patients                                         patients. Ferrer is currently 
                                                                                       exploring the full data 
                                                                                       set and will initiate 
                             *    11 clinical sites in 3 countries                     partnering 
                                                                                       activities. Whilst the 
                                                                                       product already has an 
                                                                                       Asian commercial partner, 
                                                                                       Ferrer will look to bring 
                                                                                       on board a commercial partner 
                                                                                       for US marketing and to 
                                                                                       support the ongoing clinical 
                                                                                       development. If Ferrer 
                                                                                       receive a payment at completion 
                                                                                       of this licensing deal, 
                                                                                       Ergomed will receive a 
                                                                                       share, along with a share 
                                                                                       of all future revenues 
                                                                                       received by Ferrer for 
                                                                                       the commercialisation of 
                                                                                       the product. 
--------------------  --------------------------------------------------------------  -------------------------------- 
 Aeterna Zentaris                                                                      In January 2017 Aeterna 
  (NASDAQ: AEZS;             *    Phase III Zoptrex(TM) pivotal study in endometrial   Zentaris announced completion 
  TSX: AEZ)                       cancer                                               of the study, with the 
  www.aezsinc.com                                                                      required number of patient 
                                                                                       outcomes. We are currently 
                             *    Zoptarelin doxorubicin                               in the process of collecting 
                                                                                       the final data points and 
                                                                                       the results of the study 
                             *    500 patients                                         are expected to be announced 
                                                                                       in April 2017. If successful, 
                                                                                       the next step for this 
                             *    115 clinical sites in 22 countries                   product would be registration. 
 
                                                                                       Aeterna Zentaris has entered 
                                                                                       into five marketing 
                                                                                       partnerships 
                                                                                       with Zoptrex for various 
                                                                                       territories in Asia, Israel, 
                                                                                       Australia and New Zealand. 
                                                                                       Ergomed has received a 
                                                                                       percentage of the upfront 
                                                                                       payments and will receive 
                                                                                       its share of further receipts 
                                                                                       according to our revenue 
                                                                                       share agreement. 
--------------------  --------------------------------------------------------------  -------------------------------- 
 CEL-SCI                                                                               Having reached the recruitment 
  (NYSE MKT:                   *    Phase III study in head and neck cancer            target but observed a lower 
  CVM)                                                                                 overall death rate, CEL-SCI 
  www.cel-sci.com                                                                      decided to submit a protocol 
                               *    Multikine(R)                                       amendment to include additional 
                                                                                       patients into the study. 
                                                                                       During the review of the 
                               *    880 patients                                       amendment, the FDA put 
                                                                                       the study on a partial 
                                                                                       clinical hold requesting 
                               *    105 clinical sites in 24 countries                 additional information. 
                                                                                       CEL-SCI is in a continuing 
                                                                                       dialogue with the FDA to 
                                                                                       try to resolve the questions 
                                                                                       posed and supply the FDA 
                                                                                       with supplemental information. 
                                                                                       Following a Type A meeting 
                                                                                       with the FDA, on 8 February 
                                                                                       2017, CEL-SCI announced 
                                                                                       that they were continuing 
                                                                                       with efforts to have the 
                                                                                       clinical hold released. 
--------------------  --------------------------------------------------------------  -------------------------------- 
 CEL-SCI                                                                               With the ongoing discussions 
  (NYSE MKT:                 *    Phase I peri-anal warts in HIV/HPV                    with the FDA regarding 
  CVM)                                                                                  the head and neck cancer 
  www.cel-sci.com                                                                       trail, CEL-SCI has temporarily 
                             *    Multikine(R)                                          suspended patient recruitment 
                                                                                        in the peri-anal warts 
                                                                                        study. All other activities, 
                             *    15 patients                                           including pre-screening 
                                                                                        activities to identify 
                                                                                        potential subjects are 
                             *    1 clinical site                                       ongoing. 
--------------------  --------------------------------------------------------------  -------------------------------- 
 Modus Therapeutics                                                                    The first interim analysis 
  Part of Karolinska         *    Phase II in vaso-occlusive crisis in patients with   was completed in November 
  Development                     sickle cell disease                                  2016, demonstrating a good 
  AB                                                                                   safety profile and the 
  (STO: KDEV)                                                                          study enrolment was extended 
  www.modustx.com            *    Orphan drug indication                               to adolescents. With this 
                                                                                       permission, Modus Therapeutics 
                                                                                       decided to adjust the 
                             *    Sevuparin                                            statistical 
                                                                                       assumptions and include 
                                                                                       150 patients (up from 77) 
                             *    Up to 154 patients                                   to give the study the strongest 
                                                                                       chance to reach a significant 
                                                                                       readout. It is planned 
                             *    11 clinical sites in 5 countries                     that this recruitment target 
                                                                                       will be reached by first 
                                                                                       quarter 2018 with study 
                                                                                       results released thereafter. 
--------------------  --------------------------------------------------------------  -------------------------------- 
 Asarina                                                                               PMDD is an extremely severe 
  Part of Karolinska         *    Phase IIb study in premenstrual dysphoric disorder    form of pre-menstrual syndrome 
  Development                     (PMDD) - protocol is under development with           where women are, on a regular 
  AB                                                                                    basis, unable to work or 
  (STO: KDEV)                                                                           live a normal life for 
  www.asarinapharma          *    235 patients planned from                             several days each cycle. 
  .com                                                                                  We are currently preparing 
                                                                                        the study protocol and 
                             *    14 sites in 5 countries                               expect the first patients 
                                                                                        to be recruited in the 
                                                                                        second half of 2017 with 
                                                                                        the study completing in 
                                                                                        2018. 
--------------------  --------------------------------------------------------------  -------------------------------- 
 

Outlook

The current backlog of services contracts means Ergomed is well positioned to deliver its revenue targets for 2017, although the market for clinical research out-sourcing remains highly competitive. Ergomed continues to seek focused acquisition opportunities to expand the services business. This expansion of our profitable service businesses remains the core component of Ergomed's strategy and the Board is prioritising this initiative.

We are on track to progress the Haemostatix pipeline in 2017 with the start of the Phase IIb clinical trial of PeproStat and the pre-clinical development of ReadyFlow. Our co-development business continues to gain traction as we seek more partnership opportunities to extend our diverse pipeline of development projects. Ergomed also anticipates further clinical updates from its existing partnerships with the next inflexion point being pivotal Phase III data on Zoptrex(TM) from our co-development partner Aeterna Zentaris in April 2017.

Miroslav Reljanovic M.D. - Chief Executive Officer

Financial Review

Key Performance Indicators

The Directors consider the principal financial performance indicators of the Group to be:

 
 GBPm                                     2016   2015 
 Revenue                                  39.2   30.2 
 Gross profit                             12.0    8.4 
  Research and development expenditure     1.0      - 
 EBITDA (adjusted) (note 12)               3.0    3.4 
 Cash and cash equivalents                 4.4    4.0 
 

The Directors consider the principal non-financial performance indicators of the Group to be:

-- The delivery of high quality services that continue to meet the highest industry standards as evidenced by internal and external quality audits

   --      The development or acquisition of new and/or the expansion of existing service offerings 

-- The expansion of the co-development portfolio with the addition of two new partnerships per year

Condensed Consolidated Statement of Comprehensive Income

Revenue for the year ended 31 December 2016 was GBP39.2 million (2015: GBP30.2 million), an increase of 30%, driven by 63% growth in drug safety and medical information, complemented by 18% growth from clinical research services. Excluding the impact of acquisitions, revenues grew at 27%.

Gross profit was GBP12.0 million and gross margin was 31% (2015: gross profit GBP8.4 million and gross profit margin 28%). Ergomed's gross margin fluctuates compared to a traditional clinical research organisation (CRO) service provider as Ergomed operates a hybrid model working with customers on a normal full priced basis as well as working with co-development partners where Ergomed is carrying out clinical studies at reduced fees in return for carried interests in the partnered product. The mix of full service work to co-development work in any given period therefore impacts the gross profit and gross margin in that period.

Administration expenses were GBP10.5 million (2015: GBP6.4 million), an increase of GBP4.1 million. Included in administrative expenses are increases in amortisation of acquired fair valued intangible assets of GBP0.2 million, share-based payment charge of GBP0.1 million, deferred consideration for acquisition of GBP0.7 million, acquisition costs of GBP0.3 million, exceptional items of GBP0.1 million offset by a write-back of deferred consideration for acquisition of GBP0.5 million. The increase in other administrative expenses of GBP3.1 million was driven by an additional GBP1.2 million of overhead in acquisitions, GBP0.7 million investments in improved corporate infrastructure, GBP0.3 million additional recruitment costs, GBP0.2 million increase in investor relations and public relations activities, GBP0.1 million increase in depreciation and GBP0.9 million provision for doubtful debts offset by foreign exchange gains of GBP0.4 million.

Research and development costs were GBP1.0 million (2015: GBPnil) relating to Haemostatix and included chemistry, manufacturing and controls (CMC) costs in preparation for a Phase IIb clinical trial of PeproStat and pre-clinical formulation development costs for ReadyFlow.

Deferred consideration for achieving 2016 financial targets of GBP0.7 million in respect of PharmInvent has been charged to profit and loss in the year because it is tied to the continued employment of the vendors.

The Company incurred acquisition costs totalling GBP0.6 million (2015: GBP0.3 million) in the year, primarily in respect of the Haemostatix, O+P and GASD and PharmInvent acquisitions. In addition, GBP0.2 million in respect of start-up costs for PrimeVigilance's US office was recognised as an exceptional item.

Included in finance charges is GBP0.3 million relating to the unwinding of the discount applied to contingent consideration for Haemostatix.

The Group's tax charge was reduced by an R&D tax credit of GBP0.2 million in the year.

Condensed Consolidated Balance Sheet

As at 31 December 2016 total assets less total liabilities amounted to GBP34.6 million (2015: GBP16.9 million) including cash and cash equivalents of GBP4.4 million (2015: GBP4.0 million).

The principal movements in the Condensed Consolidated Balance Sheet during the year were:

-- Acquisitions of Haemostatix, O+P and GASD and PharmInvent in May 2016, June 2016 and November 2016 respectively and the associated goodwill of GBP5.5 million and intangible assets of GBP19.3 million.

-- Increase in trade and other receivables by GBP5.4 million reflecting higher trading levels and a GBP0.5 million increase in clinical trial inventory.

-- An increase in deferred consideration, after unwinding of discount, of GBP8.2 million in respect of Haemostatix. Deferred consideration in respect of PharmInvent is recognised as incurred in the profit and loss account since it is tied to the continued employment by the vendors of that business.

-- An increase in deferred tax liability of GBP2.5 million, principally related to the acquisitions of Haemostatix, O+P and GASD and PharmInvent.

   --      An increase in share premium, arising from the Institutional Placing, net of costs. 

-- An increase in merger reserve, arising from the acquisitions of Haemostatix, O+P and GASD and PharmInvent.

Condensed Consolidated Cash Flow Statement

At present, the Group does not have any borrowings or long term debt apart from a few immaterial fixed asset finance leases.

Cash inflows from operating activities before changes in working capital in the year were GBP2.7 million (2015: GBP2.7 million). Changes in working capital included a GBP3.7 million increase in trade and other receivables, a GBP0.4 million increase in inventory and a GBP0.1 million decrease in trade and other payables.

Cash outflows from investing activities were GBP5.8 million including the acquisitions of Haemostatix, O+P and GASD and PharmInvent together with deferred consideration of GBP0.1 million for Sound Opinion, GBP0.4 million for the acquisition of tangible assets and GBP0.7 million for the acquisition of intangible assets.

The Group also paid taxation of GBP0.9 million in 2016 (2015: GBP0.6 million).

Financial Outlook

Ergomed's Board has set the objective of remaining profitable and cash generative. This is being achieved by running profitable services businesses alongside a managed portfolio of drug co-development partnerships where Ergomed contributes services at reduced prices in return for a carried interest in the potential commercial returns that may be generated in the future.

Ergomed currently had a strong contracted backlog of about GBP70 million at 1 January 2017. The overall trading environment for full service business is generally strong although still very competitive. Ergomed's Board believes it can continue to generate further growth and profits from both the Clinical Research and PrimeVigilance / PharmInvent businesses in 2017 and beyond whilst at the same time expanding the co-development portfolio on a selected basis.

Going concern

As at 31 December 2016 the Group had GBP4.4 million in cash or cash equivalents and a strong backlog of signed contracts. The Directors therefore expect Ergomed's services business to remain both profitable and cash generative. Taking into account existing cash resources and, after due consideration of cash flow forecasts, the Directors are of the view that Ergomed will continue to have access to adequate resources to allow the Group to continue trading on normal terms of business for no less than 12 months from the date of signing of the financial statements and have therefore prepared the financial statements on a going concern basis.

UNAUDITED PRELIMINARY RESULTS

Condensed Consolidated Income Statement

 
                                                      2016      2015 
                                           Notes   GBP000s   GBP000s 
 
REVENUE                                        2    39,233    30,178 
 
Cost of sales                                     (27,239)  (21,808) 
 
Gross profit                                        11,994     8,370 
 
Administrative expenses                           (10,483)   (6,379) 
---------------------------------------  -------  --------  -------- 
Administrative expenses comprises: 
Other administrative expenses                      (8,323)   (5,186) 
Amortisation of acquired fair 
 valued intangible assets                            (771)     (596) 
Share-based payment charge                           (398)     (288) 
Deferred consideration for acquisition         8     (690)         - 
Write-back of deferred consideration 
 for acquisition                                       460         - 
Acquisition costs                              9     (584)     (272) 
Exceptional items                             10     (177)      (37) 
---------------------------------------  -------  --------  -------- 
 
Research and development                           (1,040)         - 
Other operating income                                 127        81 
 
OPERATING PROFIT                                       598     2,072 
 
Investment revenues                                      2         1 
Finance costs                                  3     (274)       (1) 
 
PROFIT BEFORE TAXATION                                 326     2,072 
 
Taxation                                       4       153     (520) 
 
PROFIT FOR THE YEAR                                    479     1,552 
 
EARNINGS PER SHARE 
Basic                                          5      1.3p      5.4p 
 
Diluted                                        5      1.3p      5.2p 
 
 

All activities in the current and prior period relate to continuing operations.

Condensed Consolidated Statement of Comprehensive Income

 
                                           2016      2015 
                                        GBP000s   GBP000s 
 
Profit for the year                         479     1,552 
 
Items that may be classified 
 subsequently to profit or loss: 
Exchange differences on translation 
 of foreign operations                      680     (244) 
 
Other comprehensive income for 
 the period net of tax                      680     (244) 
 
Total comprehensive income for 
 the period                               1,159     1,308 
 
 

Condensed Consolidated Balance Sheet

 
                                             2016      2015 
                                  Notes   GBP000s   GBP000s 
 
Non-current assets 
Goodwill                                   12,285     7,488 
Other intangible assets                    19,842     2,819 
Property, plant and equipment                 717       335 
Investments                                   271       183 
Deferred tax asset                          1,448       365 
 
                                           34,563    11,190 
 
Current assets 
Trade and other receivables                14,958     9,528 
Clinical trial inventory                      450         - 
Cash and cash equivalents                   4,424     3,974 
 
                                           19,832    13,502 
 
Total assets                               54,395    24,692 
 
Current liabilities 
Borrowings                                    (3)       (5) 
Trade and other payables                  (7,077)   (5,955) 
Deferred revenue                          (1,393)     (795) 
Current tax liability                       (119)     (478) 
 
Total current liabilities                 (8,592)   (7,233) 
 
Net current assets                         11,240     6,269 
 
Non-current liabilities 
Borrowings                                    (5)       (7) 
Deferred consideration                    (7,772)         - 
Deferred tax liability                    (3,418)     (516) 
 
Total liabilities                        (19,787)   (7,756) 
 
Net assets                                 34,608    16,936 
 
Equity 
Share capital                                 406       288 
Share premium account(1)             14    17,957     9,361 
Merger reserve(1)                    14    10,264     2,981 
Share-based payment reserve                 1,048       650 
Translation reserve                           143     (537) 
Retained earnings                           4,790     4,193 
 
Total equity                               34,608    16,936 
 
 
   1.   Restated per note 14. 

Consolidated Statement of Changes in Equity

 
                         Share      Share    Merger  Share-based  Translation   Retained     Total 
                       capital    Premium   reserve      payment      reserve   earnings 
                                  account                reserve 
                                                         GBP000s 
                       GBP000s    GBP000s   GBP000s                   GBP000s    GBP000s   GBP000s 
 
  Balance at 
  31 December 
  2014                     288     12,342         -          362        (293)      2,640    15,339 
Correction 
 of accounting 
 treatment 
 (note 14)                   -    (2,981)     2,981            -            -          -         - 
 
As re-stated               288      9,361     2,981          362        (293)      2,640    15,339 
Profit for 
 the year                    -          -         -            -            -      1,552     1,552 
Other comprehensive 
 income for 
 the year                    -          -         -            -        (244)          -     (244) 
 
Total comprehensive 
 income for 
 the year                    -          -         -            -        (244)      1,552     1,308 
Share-based 
 payment charge 
 for the year                -          -         -          288            -          -       288 
Deferred tax 
 credit taken 
 directly to 
 equity                      -          -         -            -            -          1         1 
 
Balance at 
 31 December 
 2015                      288      9,361     2,981          650        (537)      4,193    16,936 
Profit for 
 the year                    -          -                      -            -        479       479 
Other comprehensive 
 income for 
 the year                    -          -         -            -          680          -       680 
 
Total comprehensive 
 income for 
 the year                    -          -         -            -          680        479     1,159 
Share-issue 
 for cash during 
 the year for 
 cash (net 
 of expenses)               66      8,596         -            -            -          -     8,662 
Share-issues 
 during the 
 year for non-cash 
 consideration              51          -     7,144            -            -          -     7,195 
Contingent 
 share-issues 
 for non-cash 
 consideration               1          -       139            -            -          -       140 
Share-based 
 payment charge 
 for the year                -          -         -          398            -          -       398 
Deferred tax 
 credit taken 
 directly to 
 equity                      -          -         -            -            -        118       118 
 
Balance at 
 31 December 
 2016                      406     17,957    10,264        1,048          143      4,790    34,608 
 
 

Condensed Consolidated Cash Flow Statement

 
                                               2016      2015 
                                            GBP000s   GBP000s 
 
Cash flows from operating activities 
Profit before taxation                          326     2,072 
 
Adjustment for: 
Amortisation and depreciation                 1,027       713 
(Gain)/loss on disposal of fixed 
 assets                                         (2)         4 
Share-based payment charge                      398       288 
Acquisition of shares for non-cash 
 consideration                                 (54)     (142) 
Exchange adjustments                            418     (251) 
Acquisition costs and deferred 
 consideration                                  726        54 
Write-back of deferred consideration          (414)         - 
Investment revenues                             (2)       (1) 
Finance costs                                   274         1 
 
Operating cash flow before changes 
 in working capital and provisions            2,697     2,738 
 
Increase in trade and other receivables     (3,667)   (2,898) 
Increase in inventory                         (405)         - 
(Decrease)/increase in trade 
 and other payables                            (58)     1,012 
 
(Cash utlised by)/generated from 
 operations                                 (1,433)       852 
 
Taxation paid                                 (941)     (588) 
 
Net cash (outflow)/inflow from 
 operating activities                       (2,374)       264 
 
Investing activities 
Investment revenues received                      2         1 
Acquisition of intangible assets              (705)     (285) 
Acquisition of property, plant 
 and equipment                                (404)     (270) 
Investment in joint venture and 
 other investments                                -       (1) 
Acquisition of subsidiary, net 
 of cash acquired                           (4,755)     (312) 
Receipts from sale of property, 
 plant and equipment                             31         2 
 
Net cash outflow from investing 
 activities                                 (5,831)     (865) 
 
 
Financing activities 
Issue of new shares                           9,185         - 
Expenses of fundraising                       (523)         - 
Finance costs paid                              (2)       (1) 
Increase in borrowings                            -         7 
Repayment of borrowings                         (5)       (7) 
 
Net cash inflow/(outflow)from 
 financing activities                         8,655       (1) 
 
Net increase/(decrease) in cash 
 and cash equivalents                           450     (602) 
 
Cash and cash equivalents at 
 start of the year                            3,974     4,576 
 
Cash and cash equivalents at 
 end of year                                  4,424     3,974 
 
 

ERGOMED PLC

NOTES TO THE UNAUDITED PRELIMINARY RESULTS

For the year ended 31 December 2016

   1.         BASIS OF PREPARATION 

The unaudited preliminary results for the year ended 31 December 2016 were approved by the Board of Ergomed plc on 27 March 2017. The unaudited preliminary results do not constitute the statutory financial statements within the meaning of section 434 of the Companies Act 2006, but are an extract from the financial statements. They are based on, and are consistent with, those in the Group's statutory accounts for the year ended 31 December 2016 and those financial statements will be delivered to the Registrar of Companies following the Company's Annual General Meeting. Financial statements for the year ended 31 December 2015 have been delivered to the Registrar of Companies, with an unmodified opinion.

While the financial information included in this preliminary announcement has been prepared in accordance with the recognition and measurement criteria of International Financial Reporting Standards, as adopted by the European Union (EU) (IFRS), this announcement does not in itself contain sufficient information to comply with IFRS.

The audited statutory financial statements for the year ended 31 December 2016 are expected to be distributed to shareholders in April 2017 and will be available at the registered office of the Company, 26-28 Frederick Sanger Road, Surrey Research Park, Guildford, Surrey, GU2 7YD. Details can also be found on the Company's website at: www.ergomedplc.com.

The Consolidated balance sheet for 2014 and 2015 has been re-stated. The re-statement had no impact on the Consolidated income statement, Consolidated cash flow statement or the net assets of the Group. This is detailed in note 14.

GOING CONCERN

The unaudited preliminary results have been prepared on the going concern basis, which assumes that the Group will have sufficient funds to continue in operational existence for the foreseeable future, being a period of no less than 12 months from the expected date of signing of the financial statements in April 2017. Having regard to the performance of the business, the Directors have a reasonable expectation that the Company and the Group have adequate resources to continue in operational existence for the foreseeable future. The Group is financed by funds generated from profitable operations and equity.

The Directors have reviewed a cash flow forecast ("the Forecast") for the period ending 31 December 2018. The Forecast represents the Directors' best estimate of the Group's future performance and necessarily includes a number of assumptions, including the level of revenues. The Forecast demonstrates that the Directors have a reasonable expectation that the Group will be able to meet its liabilities as they fall due, for a period of at least 12 months from the date of approval of the financial statements.

On the basis of the above factors and, having made appropriate enquiries, the Directors have a reasonable expectation that the Company and Group have adequate resources to continue in operational existence for the foreseeable future. Accordingly, they continue to adopt the going concern basis in preparing these unaudited preliminary results.

CRITICAL ACCOUNTING JUDGEMENTS AND KEY SOURCES OF ESTIMATION UNCERTAINTY

In the application of the Group's accounting policies, the Directors are required to make judgements, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.

The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period in which the estimate is revised if the revision affects only that period, or in the period of the revision and future periods if the revision affects both current and future periods.

Critical judgements in applying the Group's accounting policies

The following are the critical judgements, apart from those involving estimations (which are dealt with separately below), that the Directors have made in the process of applying the Group's accounting policies and that have the most significant effect on the amounts recognised in the unaudited preliminary results.

Revenue recognition

The amount of revenue to be recognised is based on, inter alia, management's estimate of the fair value of the consideration received or receivable, the stage of completion and of the point in time at which management considers that it becomes probable that economic benefits will flow to the entity (as the outcome is not always certain at the inception of a contract).

Key sources of estimation uncertainty

The key assumptions concerning the future, and other key sources of estimation uncertainty at the reporting period, that may have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year, are discussed below.

Bad debt provision

In determining the level of provisioning for bad debts, the Directors have considered the aging of trade receivables, and the payment history and financial position of debtors. The provision against trade receivables as at 31 December 2016 was GBP1,016,000 (2015: GBP233,000).

Impairment of Goodwill

Under IFRSs, goodwill is reviewed for impairment at least annually. Determining whether goodwill is impaired requires an estimation of the recoverable amount of the cash-generating units to which goodwill has been allocated. The calculation of the recoverable amount requires the entity to estimate the future cash flows expected to arise from the cash-generating unit and a suitable discount rate in order to determine whether the recoverable amount is greater than the carrying value. The impairment provision against goodwill as at 31 December 2016 was GBPnil (2015: GBPnil).

Fair value measurements

Some of the Group's assets and liabilities are measured at fair value for financial reporting purposes. In estimating the fair value of an asset or a liability, the Group uses market-observable data to the extent it is available. Where Level 1 inputs are not available, the Group engages third party qualified valuers to perform the valuation. The Directors work closely with the qualified external valuers to establish the appropriate valuation techniques and inputs to the model.

The Group incurs share-based payment charges in relation to share options awards made in the current and prior periods. This charge is based on the fair value of such share options for financial reporting purposes. In estimating the fair value of a share-based payment, the Group engages third party qualified valuers to perform the valuation. The Directors work closely with the qualified external valuers to establish the appropriate valuation techniques and inputs to the model.

   2.         OPERATING SEGMENTS 

Products and services from which reportable segments derive their revenues

The Directors are of the opinion that the Group operates as two business segments; clinical research services ("CRS") and drug safety and medical information services ("DS&MI"). The business segment, CRS includes the results of O+P and GASD which were acquired on 12 June 2016. DS&MI includes the results of PharmInvent which was acquired on 28 November 2016.

Geographical information

The Group's revenue from external customers by geographical location is detailed below:

 
         2016                                Revenue from external 
                                                    customers 
                                               CRS     DS&MI     Total 
                                           GBP000s   GBP000s   GBP000s 
 
         UK                                  3,330     4,746     8,076 
         Europe, Middle East and Africa     15,590     4,461    20,051 
         North America                       6,490     4,018    10,508 
         Asia                                  367        27       394 
         Australia                               -       204       204 
 
                                            25,777    13,456    39,233 
 
 
 
 
         2015                                Revenue from external 
                                                    customers 
                                               CRS     DS&MI     Total 
                                           GBP000s   GBP000s   GBP000s 
 
         UK                                  2,748     3,395     6,143 
         Europe, Middle East and Africa      9,407     2,878    12,285 
         North America                       7,945     1,874     9,819 
         Asia                                1,806         3     1,809 
         Australia                               -       122       122 
 
                                            21,906     8,272    30,178 
 
 
 
         2016                                                       Consolidated 
                                    CRS      DS&MI    Eliminations         total 
                                GBP000s    GBP000s         GBP000s       GBP000s 
 
         Revenue 
         Third party sales       25,777     13,456               -        39,233 
         Intersegment sales 
          and recharges             670          2           (672)             - 
 
         Total revenue           26,447     13,458           (672)        39,233 
 
 
 
         2016                                                             Consolidated 
                                          CRS      DS&MI    Eliminations         total 
                                      GBP000s    GBP000s         GBP000s       GBP000s 
 
         Segment result                   203      3,586               9         3,798 
 
         Research and development                                              (1,040) 
         Amortisation of acquired 
          fair valued intangible 
          assets                                                                 (771) 
         Share-based payment 
          charge                                                                 (398) 
         Deferred consideration 
          for acquisition                                                        (690) 
         Write back of deferred 
          consideration for 
          acquisition                                                              460 
         Acquisition costs                                                       (584) 
         Exceptional items                                                       (177) 
 
         Operating profit                                                          598 
         Investment revenues                                                         2 
         Finance costs                                                           (274) 
 
         Profit before tax                                                         326 
         Tax                                                                       153 
 
         Profit after tax                                                          479 
 
 
 
         2015                                                       Consolidated 
                                    CRS      DS&MI    Eliminations         total 
                                GBP000s    GBP000s         GBP000s       GBP000s 
 
         Revenue 
         Third party sales       21,906      8,272               -        30,178 
         Intersegment sales 
          and recharges              67          9            (76)             - 
 
         Total revenue           21,973      8,281            (76)        30,178 
 
 
 
         2015                                                             Consolidated 
                                          CRS      DS&MI    Eliminations         total 
                                      GBP000s    GBP000s         GBP000s       GBP000s 
 
         Segment result                 1,165      2,102             (2)         3,265 
 
         Amortisation of acquired 
          fair valued intangible 
          assets                                                                 (596) 
         Share-based payment 
          charge                                                                 (288) 
         Acquisition costs                                                       (272) 
         Exceptional items                                                        (37) 
 
         Operating profit                                                        2,072 
         Investment revenues                                                         1 
         Finance costs                                                             (1) 
 
         Profit before tax                                                       2,072 
         Tax                                                                     (520) 
 
         Profit after tax                                                        1,552 
 
 

The accounting policies of the reportable segments are the same as the Group's accounting policies. Segment profit represents the profit earned by each segment. This is the measure reported to the Group's Chief Executive Officer for the purpose of resource allocation and assessment of segment performance.

Segment net assets

 
                                              2016       2015 
                                           GBP000s    GBP000s 
 
         CRS                                16,489      5,913 
         DS&MI                              18,119     11,023 
 
         Consolidated total net assets      34,608     16,936 
 
 

For the purposes of monitoring segment performance and allocating resources between segments, the Group's Chief Executive Officer monitors the tangible, intangible and financial assets attributable to each segment. All assets are allocated to reportable segments.

Other segment information

 
                       Depreciation           Additions to 
                                and     non-current assets 
                       amortisation 
                     2016      2015        2016       2015 
                  GBP000s   GBP000s     GBP000s    GBP000s 
 
         CRS          528       286         705        238 
         DS&MI        499       427         404        317 
 
                    1,027       713       1,109        555 
 
 

Information about major customers

In 2016, the Group had two customers that contributed 10% or more to the Group's revenue. Revenues of approximately GBP5,479,000 and GBP4,771,000 were recognised from these customers respectively for clinical research services.

In 2015, the Group had two customers that contributed 10% or more to the Group's revenue. Revenues of approximately GBP5,219,000 and GBP5,181,000 were recognised from these customers respectively.

   3.     FINANCE COSTS 
 
                                                          2016       2015 
                                                       GBP000s    GBP000s 
 
         Interest payable                                  (2)        (1) 
         Finance charge for deferred consideration       (272)          - 
          for acquisition 
 
                                                         (274)        (1) 
 
 
   4.         TAXATION 
 
                                                    2016      2015 
                                                 GBP000s   GBP000s 
         Current tax 
         UK corporation tax (credit)/charge 
          for the year                             (181)       349 
         Overseas corporation tax                    180       308 
         Adjustment in respect of prior years       (16)        13 
 
         Current tax (credit)/charge                (17)       670 
 
         Deferred tax 
         Origination and reversal of timing 
          differences                               (40)     (143) 
         Effect of changes in tax rates             (96)       (7) 
 
         Tax (credit)/charge on profit             (153)       520 
 
 

The UK corporation tax credit for the year comprises an R&D tax credit.

In addition to the amounts charged to the income statement and other comprehensive income, the following amounts have been recognised directly in equity:

 
                                                          2016       2015 
                                                       GBP000s    GBP000s 
 
         Deferred tax 
         Change in estimated excess tax deductions 
          related to share-based payments                (118)        (1) 
 
         Total income tax credit recognised 
          directly in equity                             (118)        (1) 
 
 
   5.     EARNINGS PER SHARE 

The calculation of the basic and diluted earnings per share is based on the following data:

 
                                                                2016          2015 
                                                             GBP'000       GBP'000 
  Earnings for the purposes of basic 
   earnings per share being net profit 
   attributable to owners of the Company                         479         1,552 
  Effect of dilutive potential ordinary                            -             - 
   shares 
 
  Earnings for the purposes of diluted 
   earnings per share                                            479         1,552 
 
 
                                                                2016          2015 
                                                                 No.           No. 
  Number of shares 
           Weighted average number of ordinary 
            shares for the purposes of basic earnings 
            per share                                     35,573,733    28,750,000 
  Effect of dilutive potential ordinary 
   shares 
           Share options                                   1,484,600     1,015,223 
 
           Weighted average number of ordinary 
            shares for the purposes of diluted 
            earnings per share                            37,058,333    29,765,223 
 
 
   6.     ACQUISITION OF SUBSIDIARY - HAEMOSTATIX 

On 24 May 2016, Ergomed Plc acquired 100 per cent of the issued share capital of Haemostatix, a research and development company based in Nottingham, UK developing novel products for the surgical bleeding market. The acquisition of Haemostatix enhances Ergomed's portfolio of development products with the potential to generate significant shareholder value. The amounts provisionally recognised in respect of the identifiable assets acquired and liabilities assumed are as set out in the table below.

 
                                       Book    Fair value  Provisional 
                                  valuation   adjustments    valuation 
                                    GBP000s       GBP000s      GBP000s 
 
Intangible assets                         -        15,200       15,200 
Property, plant and equipment             4             -            4 
Deferred tax asset                        -         1,015        1,015 
 
Total non-current assets                  4        16,215       16,219 
 
Trade and other debtors                 164             -          164 
Clinical trial inventory                 45             -           45 
Cash and equivalents                     63             -           63 
 
Current assets                          272             -          272 
 
Trade and other creditors           (1,365)             -      (1,365) 
Deferred tax liability                    -       (2,736)      (2,736) 
 
Financial liabilities               (1,365)       (2,736)      (4,101) 
 
Total identifiable net 
 assets/(liabilities)               (1,089)        13,479       12,390 
Goodwill                             15,565      (13,479)        2,086 
 
Total consideration                  14,476             -       14,476 
 
Satisfied by: 
Cash                                    800             -          800 
Equity                                6,181             -        6,181 
Deferred consideration                7,495             -        7,495 
 
Total consideration                  14,476             -       14,476 
 
Net cash outflow arising 
 on acquisition 
Cash consideration                      800             -          800 
Less: cash and cash equivalent 
 balances acquired                     (63)             -         (63) 
Transaction costs (note 
 8)                                     370             -          370 
 
                                      1,107             -        1,107 
 
 

The provisional fair value of intangible assets relates to the in-process research and development of PeproStat(TM) and ReadyFlow(TM). The provisional fair value of the financial assets includes receivables with a fair value of GBP164,000 and a gross contractual value of GBP164,000. The best estimate at acquisition date of the contractual cash flows not to be collected is GBPnil.

Goodwill is provisionally valued at GBP2,086,000. None of the goodwill is expected to be deductible for income tax purposes. Deferred consideration represents the fair valuation of the additional consideration payable which could be an aggregate maximum of GBP20,000,000, subject to the future performance of the business.

Ergomed plc has a 12 month measurement period from the date of acquisition, and therefore the measurement period ends on 23 May 2017.

As a research and development company, Haemostatix is investing in its development portfolio and does not currently generate revenues. If the acquisition of Haemostatix had been completed on the first day of the financial year, group revenues for the year ended 31 December 2016 would have been unchanged and group profit before tax would have been GBP1,082,000 lower.

   7.         ACQUISITION OF SUBSIDIARY - O+P and GASD 

On 12 June 2016, Ergomed acquired 100 per cent of the issued share capital of O+P and GASD. O+P is a long established contract research organisation based in Cologne, Germany and GASD is a specialist data management and biostatistics company. The acquisition of O+P and GASD brings, among other things, a proprietary electronic data capture system and specialist biostatics expertise which can be deployed across the Ergomed global platform.

O+P and GASD were acquired as a single unit. The amounts provisionally recognised in relation to both entities in respect of the identifiable assets acquired and liabilities assumed are as set out in the table below.

 
                                       Book    Fair value  Provisional 
                                  valuation   adjustments    valuation 
                                    GBP000s       GBP000s      GBP000s 
 
Intangible assets                         -           615          615 
Property, plant and equipment            23             -           23 
 
Total non-current assets                 23           615          638 
 
Trade and other debtors                  91             -           91 
Accrued income                           71             -           71 
Corporation Tax receivable                6             -            6 
Cash and equivalents                    498             -          498 
 
Current assets                          666             -          666 
 
Trade and other creditors             (218)             -        (218) 
Tax payable                             (2)             -          (2) 
Deferred tax                              -         (164)        (164) 
 
Financial liabilities                 (220)         (164)        (384) 
 
Total identifiable net 
 assets                                 469           451          920 
Goodwill                                938         (451)          487 
 
Total consideration                   1,407             -        1,407 
 
Satisfied by: 
Cash                                    802             -          802 
Equity                                  190             -          190 
Deferred consideration                  415             -          415 
 
Total consideration                   1,407             -        1,407 
 
Net cash inflow arising 
 on acquisition 
Cash consideration                      802             -          802 
Less: cash and cash equivalent 
 balances acquired                    (498)             -        (498) 
Transaction expenses (note 
 8)                                      85             -           85 
 
                                        389             -          389 
 
 

The provisional fair value of the financial assets includes receivables with a fair value of GBP91,000 and a gross contractual value of GBP91,000. The best estimate at acquisition date of the contractual cash flows not to be collected is GBPnil.

Goodwill is provisionally valued at GBP487,000 and is attributable to the synergies and the enhanced offering of the Ergomed group following the acquisition. None of the goodwill is expected to be deductible for income tax purposes.

Deferred consideration represents the provisional fair valuation of the additional consideration payable, subject to the future performance of the business.

Ergomed plc has a 12 month measurement period from the date of acquisition, and therefore the measurement period ends on 11 June 2017.

If the acquisition of O+P and GASD had been completed on the first day of the financial year, group revenues for the year ended 31 December 2016 would have been GBP381,000 higher and group profit before tax would have been GBP134,000 lower.

   8.         ACQUISITION OF SUBSIDIARY - PHARMINVENT 

On 28 November 2016, Ergomed acquired 100 per cent of the issued share capital of PharmInvent. PharmInvent offers a comprehensive range of pharmacovigilance and regulatory services to over 100 clients in the global pharmaceutical industry. Pharmacovigilance services include an outsourced global network of 95 Qualified Persons for Pharmacovigilance (QPPVs) in 50 countries, case management, risk management, audit, training and consulting services on the establishment and maintenance of pharmacovigilance systems. Regulatory services include strategic advice on regulatory strategy, clinical trial and protocol design and medical writing of regulatory submissions.

The amounts provisionally recognised in respect of the identifiable assets acquired and liabilities assumed are as set out in the table below.

 
                                       Book    Fair value  Provisional 
                                  valuation   adjustments    valuation 
                                    GBP000s       GBP000s      GBP000s 
 
Intangible assets                         -         1,291        1,291 
Property, plant and equipment           161             -          161 
 
Total non-current assets                161         1,291        1,452 
 
Trade and other debtors                 786             -          786 
Cash and equivalents                    252             -          252 
 
Current assets                        1,038             -        1,038 
 
Trade and other creditors             (300)             -        (300) 
Tax payable                            (45)             -         (45) 
Deferred tax liability                    -         (245)        (245) 
 
Financial liabilities                 (345)         (245)        (590) 
 
Total identifiable net 
 assets                                 854         1,046        1,900 
Goodwill                              3,270       (1,046)        2,224 
 
Total consideration                   4,124             -        4,124 
 
Satisfied by: 
Cash                                  3,299             -        3,299 
Equity                                  825             -          825 
 
Total consideration                   4,124             -        4,124 
 
Net cash inflow arising 
 on acquisition 
Cash consideration                    3,299             -        3,299 
Less: cash and cash equivalent 
 balances acquired                    (252)             -        (252) 
Transaction expenses (note 
 8)                                     118             -          118 
 
                                      3,165             -        3,165 
 
 

The provisional fair value of the financial assets includes receivables with a fair value of GBP786,000 and a gross contractual value of GBP786,000. The best estimate at acquisition date of the contractual cash flows not to be collected is GBPnil.

Goodwill is provisionally valued at GBP2,224,000 and is attributable to the enhanced offering of the Ergomed group following the acquisition. None of the goodwill is expected to be deductible for income tax purposes.

In addition to the consideration identified above, deferred consideration is payable subject to the achievement of commercial milestones and conditional upon the continued employment of the vendors by the company. In accordance with IFRS 3 - Business Combinations, GBP690,000 has been charged to the profit and loss account in respect of deferred consideration relating to the year ended 31 December 2016.

Ergomed plc has a 12 month measurement period from the date of acquisition, and therefore the measurement period ends on 27 November 2017.

If the acquisition of PharmInvent had been completed on the first day of the financial year, group revenues for the year ended 31 December 2016 would have been GBP3,216,000 higher and group profit before tax would have been GBP593,000 higher.

   9.     ACQUISITION COSTS 
 
                                                  2016       2015 
                                               GBP000s    GBP000s 
 
         Acquisition of Sound Opinion 
          Limited                                    7         54 
         Acquisition of Haemostatix (note          370          - 
          5) 
         Acquisition of O+P and GASD (note          85          - 
          6) 
         Acquisition of PharmInvent (note          118          - 
          7) 
         Other M&A activities                        4        218 
 
                                                   584        272 
 
 

10. EXCEPTIONAL ITEMS

 
                                                2016       2015 
                                             GBP000s    GBP000s 
 
         Establishment of Taiwan office            -         37 
         Establishment of PrimeVigilance         177          - 
          U.S. office 
 
                                                 177         37 
 
 

11. RELATED PARTY TRANSACTIONS

Ergomed d.o.o., a company registered in Croatia, is under the control of Dr. Miroslav Reljanović, who is a Director and shareholder of the Company. During the year the Company and its subsidiaries were charged GBP240,000 (2015: GBP160,000) by Ergomed d.o.o. and its subsidiaries in respect of clinical research costs and other administrative services. At 31 December 2016 a balance of GBP37,000 was owed by the Company and its subsidiaries to Ergomed d.o.o. in respect of these costs (2015: GBP57,000). In addition, during the year, the Group sold medical equipment to a subsidiary of Ergomed d.o.o. for GBP33,000 (2015: GBPnil).

Chesyl Pharma Limited is a company owned by Rolf Stahel, who is a Director of the Company. During the year, the Company was charged consultancy fees of GBP52,000 (2015: GBP54,000) in relation to the services of Rolf Stahel. At 31 December 2016, amounts payable to Chesyl Pharma in relation to such consultancy services and associated expenses were GBP12,000 (2015: GBP5,000).

All transactions with related parties take place on an arm's length basis.

Balances and transactions between the Company and its subsidiaries, which are related parties, have been eliminated on consolidation and are not disclosed in this note.

12. EBITDA AND EBITDA (adjusted)

 
                                               2016      2015 
                                           GBP'000s  GBP'000s 
 
  Operating profit                              598     2,072 
 
  Adjust for: 
  Depreciation and amortisation charges 
   within Other administrative expenses         256       117 
  Amortisation of acquired fair valued 
   intangible assets                            771       596 
 
  EBITDA                                      1,625     2,785 
  Share-based payment charge                    398       288 
  Deferred consideration for acquisition        690         - 
  Write-back of deferred consideration 
   for acquisition                            (460)         - 
  Acquisition costs                             584       272 
  Exceptional items                             177        37 
 
  EBITDA (adjusted)                           3,014     3,382 
 
 

13. ADJUSTED EARNINGS PER SHARE

 
                                                     2016      2015 
                                                  GBP'000   GBP'000 
        Earnings for the purposes of basic 
         earnings per share being 
         net profit attributable to owners 
         of the Company                               479     1,552 
        Effect of dilutive potential ordinary           -         - 
         shares 
 
        Earnings for the purposes of diluted 
         earnings per share                           479     1,552 
 
        Adjust for: 
        Amortisation of acquired fair valued 
         intangible assets                            771       596 
        Share-based payment charge                    398       288 
        Deferred consideration for acquisition        690         - 
        Write-back of deferred consideration 
         for acquisition                            (460)         - 
        Acquisition costs                             584       272 
        Exceptional items                             177        37 
 
 
          Adjusted earnings for the purposes 
          of diluted earnings per share             2,639     2,745 
 
 
 
        ADJUSTED EARNINGS PER SHARE 
        Basic                         7.4p  9.5p 
 
        Diluted                       7.1p  9.2p 
 
 

14. RESTATEMENT OF PRIOR YEAR BALANCE SHEET

In July 2014, Ergomed plc acquired the entire issued share capital of PrimeVigilance Limited for consideration comprising GBP6,000,000 in cash, and 1,875,000 shares of GBP0.01 each, valued at GBP1.60 per share. The excess of share value over the nominal value of those shares was taken to the share premium account. However, under the Companies Act 2006, these amounts should have been posted to the merger reserve. An adjustment has been made to the Consolidated balance sheet as at 31 December 2014 and 31 December 2015. This adjustment has no impact on the net assets of the Group, the Consolidated income statement or the Consolidated cash flow statement. The impact on the Consolidated balance sheet is set out below.

 
                                       2015                      2015 
                                 Previously 
                                   reported    Adjustment   Re-stated 
                                   GBP'000s      GBP'000s    GBP'000s 
Non-current assets 
Goodwill                              7,488             -       7,488 
Other intangible assets               2,819             -       2,819 
Property, plant and equipment           335             -         335 
Investments                             183             -         183 
Deferred tax asset                      365             -         365 
 
                                     11,190             -      11,190 
 
Current assets 
Trade and other receivables           9,528             -       9,528 
Cash and cash equivalents             3,974             -       3,974 
 
                                     13,502             -      13,502 
 
Total assets                         24,692             -      24,692 
 
Current liabilities 
Borrowings                              (5)             -         (5) 
Trade and other payables            (5,955)             -     (5,955) 
Deferred revenue                      (795)             -       (795) 
Current tax liability                 (478)             -       (478) 
 
Total current liabilities           (7,233)             -     (7,233) 
 
Net current assets                    6,269             -       6,269 
 
Non-current liabilities 
Borrowings                              (7)             -         (7) 
Deferred tax liability                (516)             -       (516) 
 
Total liabilities                   (7,756)             -     (7,756) 
 
Net assets                           16,936             -      16,936 
 
Equity 
Share capital                           288             -         288 
Share premium account                12,342       (2,981)       9,361 
Merger reserve                            -         2,981       2,981 
Share-based payment reserve             650             -         650 
Translation reserve                   (537)             -       (537) 
Retained earnings                     4,193             -       4,193 
 
Total equity                         16,936             -      16,936 
 
 
 
                                       2014                      2014 
                                 Previously 
                                   reported    Adjustment   Re-stated 
                                   GBP'000s      GBP'000s    GBP'000s 
Non-current assets 
Goodwill                              7,282             -       7,282 
Other intangible assets               2,927             -       2,927 
Property, plant and equipment           185             -         185 
Investments                              39             -          39 
Deferred tax asset                      323             -         323 
 
                                     10,756             -      10,756 
 
Current assets 
Trade and other receivables           6,343             -       6,343 
Cash and cash equivalents             4,576             -       4,576 
 
                                     10,919             -      10,919 
 
Total assets                         21,675             -      21,675 
 
Current liabilities 
Borrowings                              (7)             -         (7) 
Trade and other payables            (5,010)             -     (5,010) 
Deferred revenue                      (594)             -       (594) 
Current tax liability                 (144)             -       (144) 
 
Total current liabilities           (5,755)             -     (5,755) 
 
Net current assets                    5,164             -       5,164 
 
Non-current liabilities 
Borrowings                              (6)             -         (6) 
Deferred tax liability                (575)             -       (575) 
 
Total liabilities                   (6,336)             -     (6,336) 
 
Net assets                           15,339             -      15,339 
 
 
Equity 
Share capital                           288             -         288 
Share premium account                12,342       (2,981)       9,361 
Merger reserve                            -         2,981       2,981 
Share-based payment reserve             362             -         362 
Translation reserve                   (293)             -       (293) 
Retained earnings                     2,640             -       2,640 
 
Total equity                         15,339             -      15,339 
 
 

This information is provided by RNS

The company news service from the London Stock Exchange

END

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(END) Dow Jones Newswires

March 28, 2017 02:01 ET (06:01 GMT)

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