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ERGO Ergomed Plc

1,346.00
0.00 (0.00%)
24 Apr 2024 - Closed
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 Half-year Report (7528K)

26/09/2016 7:00am

UK Regulatory


Ergomed (LSE:ERGO)
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TIDMERGO

RNS Number : 7528K

Ergomed plc

26 September 2016

PRESS RELEASE

Unaudited Interim results for the six months ended 30 June 2016

Strong first half financial performance - revenues up 21% and gross profit up 26%

GBP19 million new contracts signed resulting in a backlog of GBP60 million

Acquisitions of O+P and GASD strengthens service business

Acquisition of Haemostatix expands product pipeline potential significantly

Completion of GBP9.2 million fund raising

Guildford, UK - 26 September 2016: Ergomed plc, ('Ergomed', 'the Company', AIM: ERGO) a profitable UK-based company dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, today announces its interim results for the six months ended 30 June 2016.

Commenting on the results, Miroslav Reljanovic M.D., Chief Executive Officer of Ergomed plc, said:

"Ergomed has delivered another set of excellent results for the first half of 2016. We made significant progress against our strategic goals through the continued strong trading performance of our profitable, growing service businesses where overall top-line growth of 21% was driven by revenue growth of 53% in our subsidiary company PrimeVigilance and through the completion of two targeted acquisitions.

The acquisitions of O+P and GASD augment the continuing growth of our services businesses, adding immediate significant, tangible value including an in-house Electronic Data Capture system, "OPVERDI" and biostatistics and data management capabilities. We have already won our first service contract together for a clinical study with a European biotech company underlining the benefits of the acquisition.

We continue to believe we can create significant value by investing in-kind through carefully selected co-development partnerships and we are expecting important clinical data readouts from Ferrer and Aeterna Zentaris around the end of 2016 and early 2017 respectively. The Haemostatix acquisition is an exciting evolution of the co-development model and has the potential to be transformational for Ergomed through the rapid development of its novel treatment for surgical bleeding.

Overall, we continue to believe that our hybrid model of a growing, profitable services business combined with managed risk drug development has the potential to deliver significant shareholder value over the next few years with some exciting newsflow in the next 12 months."

Financial highlights (unaudited)

   --      Revenues up 21% to GBP17.6 million from GBP14.5 million in H1 2015 

o Including revenue growth of 53% to GBP5.5 million from GBP3.6 million in H1 2015 from PrimeVigilance

   --      Gross profit up 26% to GBP5.3 million from GBP4.2 million in H1 2015 

-- Adjusted EBITDA up 12% to GBP1.9 million from GBP1.7 million in H1 2015 excludes costs of GBP0.4 million relating to M&A activities and GBP0.1 million of R&D costs (note 11)

-- EBITDA before adjustments for share-based payment charge, M&A costs, exceptional items and R&D of GBP1.2 million compared with GBP1.4 million in H1 2015 (note 11)

   --      Placing of 6.63 million new ordinary shares raised GBP9.2 million before expenses 

-- Cash and cash equivalents of GBP9.9 million as of 30 June 2016 (30 June 2015: GBP4.9 million; 31 December 2015: GBP4.0 million)

-- Contribution in kind to co-development projects increased to GBP2.1 million in H1 2016 from GBP1.9 million in H1 2015

Operational highlights

-- Service contracts with a value of GBP19 million signed in H1 2016 (GBP15 million signed in H1 2015)

   --      Strong backlog of awarded contracts of approximately GBP60 million at the end of July 2016 

-- O+P and GASD, a contract research organisation with a proprietary electronic data capture system, OPVERDI, and a biostatistics and data management company respectively, were acquired on 13 June 2016 (note 8)

-- Opening of a new office in Boston, MA to support growth of PrimeVigilance in the US in June 2016

   --      Five ongoing clinical studies with co-development partnerships proceeding to plan 

-- Haemostatix, a UK company developing a proprietary platform to control surgical bleeding with two lead products, one of which is Phase IIb ready, was acquired on 24 May 2016 (note 7)

Enquiries:

For further information, please contact

 
 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 (Joint Broker) 
 
 FTI Consulting - for UK           Tel: +44 (0) 20 3727 1000 
  enquiries 
  Simon Conway / Mo Noonan 
  / Natalie Garland-Collins 
 
 MC Services - for Continental     Tel: +49 211 529252 22 
  European enquiries 
  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 successfully manages clinical development from Phase I through to late phase programmes, providing 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 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.

Ergomed's subsidiary, PrimeVigilance, is a leading independent pharmacovigilance and medical information business in Europe. PrimeVigilance offers a range of post-approval drug safety surveillance and ancillary services to the pharmaceutical industry. With a compound growth rate of 38% since 2011, PrimeVigilance won the Queens Award for Enterprise in 2014.

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 recently acquired Haemostatix, including a pipeline of proprietary development products for haemostasis in surgical settings. 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.

Interim Management Report

Introduction

Ergomed's hybrid business model has two key components: services and product development.

The Company's profitable services business includes the provision of pre-approval and post-approval services to the pharmaceutical and biotech industry. Services include all phases of clinical research as well as post-marketing drug safety surveillance and medical information through its subsidiary PrimeVigilance - one of the leading pharmacovigilance service providers in Europe and North America.

Ergomed is also building a portfolio of development products by providing in-kind clinical research services in return for minority carried interests in our partners' development products. Ergomed will receive a share of any future proceeds generated from the commercialisation of the partnered drug asset. The Company's product portfolio was enhanced with the acquisition of Haemostatix which includes full ownership of two proprietary lead products, one pre-clinical and one planned to enter Phase IIb in 2017.

Business update

We are very pleased with the continued progress Ergomed has made in the first half of 2016 and remain enthusiastic about the opportunities for growth, both organic and through acquisition. We made significant progress on both fronts in the first half of 2016.

Global demand for out-sourced clinical research and pharmacovigilance services remains very strong, growing at approximately 10% and 17% p.a. respectively. Ergomed's services business continues to benefit from these trends with H1 2016 vs H1 2015 growth rates of 10.6% for pre-approval clinical research services and 53.1% for drug safety monitoring and medical information services. Ergomed is also in the unique position of offering co-development partnerships to its clients and is committed to building its portfolio of co-development assets. Success from this portfolio is in addition to the value that is being generated through our growing, profitable service business.

In line with the strategy laid out at IPO to strengthen our clinical data management and biostatics capability, we acquired O+P and GASD on 13 June 2016. O+P is a full service contract research organisation offering services from Phase II through to Phase IV clinical studies. In its 25 year history, O+P has worked on more than 150 assignments for more than 60 clients and has developed a proprietary FDA validated Electronic Data Capture system called OPVERDI which has been used in 95 clinical trials and can be deployed across the Ergomed global platform. GASD, which specialises in biostatistics and data management, has undertaken more than 180 assignments in all phases of clinical research for over 50 clients and will significantly enhance Ergomed's in-house capabilities. The value of this deal has already been demonstrated through the winning of a substantial new clinical trial contract that will utilise O+P, GASD and Ergomed services.

Ergomed demonstrated its continued commitment to geographic expansion with the opening of a US office in Boston, MA to better serve its post-marketing services clients in the US. PrimeVigilance is already a leading independent pharmacovigilance and medical information provider in Europe with compound annual growth of 38% since 2011. Expansion in the US is expected to provide opportunities to drive this growth further.

We are actively pursuing acquisitions of services businesses which fulfill the criteria we set out at IPO; namely to become the global leader in pharmacovigilance services, the leading CRO in orphan drug development and strengthen our CRO network by filling in geographies and / or service offerings.

Stephen Stamp joined the Ergomed Board as Chief Financial Officer in January 2016 and Neil Clark was promoted to Chief Executive Officer, PrimeVigilance. Stephen brings with him more than 30 years of experience in corporate finance and general management in both public and private companies in the UK and the USA.

Co-Development update

Ergomed shares in the upside potential of promising products by contributing to the cost of clinical trials through significantly reduced fees in return for a carried interest in any future revenues of the product, including any out-licensing milestones and product sales.

The status of Ergomed's current partnerships is:

CEL-SCI (NYSE: CVM):

CEL-SCI's lead product Multikine(R) is an immunotherapeutic agent (a mixture of cytokines including interleukins, interferons, chemokines, and colony stimulating factors) being developed as a potential first-line head and neck cancer therapy and has the potential to be a first in class immunotherapy. As part of our co-development partnership, we are currently running the largest Phase III study in head and neck cancer and in a phase II for treatment for peri-anal warts in HIV/HPV co-infected patients. The phase III study has reached the initial recruitment target of 880 patients and CEL-SCI has announced its intention to extend the recruitment to add in additional patients.

Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ):

Zoptrex(TM) (or zoptaerlin doxorubicin) is the well-known chemotherapeutic agent doxorubicin conjugated to a peptide to help it localise to the tumour. The Phase III pivotal study comparing Zoptrex with standard of care for second line therapy for locally-advanced, recurrent or metastatic endometrial cancer has included all the patients and the study is due to complete towards the end of 2016 and report early in 2017. The Zoptrex(TM) study is being conducted at 115 sites in North America, Europe, Israel and other countries under a Special Protocol Assessment.

Ferrer:

Lorediplon is a novel, longer acting non-BZD hypnotic drug that modulates the GABAa receptor for the treatment of insomnia. Compared to similar products (such as zolpidem), lorediplon initial preclinical and clinical studies show a potent hypnotic profile and extended systemic half-life, properties that could confer potential clinical benefits in terms of sleep maintenance and sleep architecture. The Phase II study in insomnia has reached the recruitment target and is due to complete during 2016. Results are due towards the end of the year.

Dilaforette:

Sevuparin is an innovative, proprietary polysaccharide drug, which has potential to restore blood flow and prevent further microvascular obstruction in patients with Sickle-Cell Disease (SCD). Dilaforette was granted Orphan Drug Designation by the US Food and Drug Administration (FDA). The study is due to have its first interim analysis in October and we hope to complete the initial cohort of 77 patients in the first half of 2017. Dilaforette is part of the Karolinska Development AB (STO: KDEV) portfolio. Results from the first 77 patients should be available in H1 2017.

Haemostatix acquisition

We have been looking to enhance our co-development portfolio by striking deals which provide Ergomed with greater control over the development plans and monetisation of products with the expectation of a greater share of the upside in return for bearing more of the development costs. It was in this context we started discussions with Haemostatix, a company with a proprietary platform technology being used to develop products to address the $2.5 billion global market for haemostats in surgical bleeding. Closed on 24 May 2016, the Haemostatix acquisition represents a landmark event for Ergomed. In the Board's view, based on encouraging results from the Phase I study and a rapid clinical development programme with relatively low costs, it is an opportunity for strong value creation. It is also targeting an attractive market and we believe Haemostatix' platform has the potential to create significant shareholder value for Ergomed based on successful near term clinical milestones and longer term product sales.

Financial review of Condensed Consolidated Financial Statements

Consolidated revenues for H1 2016 increased by 21% to GBP17.6 million (H1 2015: GBP14.5 million). Consolidated revenue includes GBP12.0 million from pre-approval clinical research services (H1 2015: GBP10.9 million) and GBP5.6 million from drug safety monitoring and medical information services (H1 2015: GBP3.6 million).

Gross profit increased by 26% to GBP5.3 million from GBP4.2 million in H1 2015. Gross margin increased to 30% from 29% in H1 2015, largely driven by the continued high growth in the post-approval drug safety and medical information service business.

Administrative expenses increased by 37% to GBP3.6 million from GBP2.6 million in H1 2015, driven by strengthened management and corporate infrastructure to support increased M&A activity and other corporate initiatives.

Adjusted EBITDA was GBP1.9 million (H1 2015: GBP1.7 million) after being adjusted by GBP0.4 million relating to non-recurring M&A costs and GBP0.1 million relating to research and development activities.

Cash in hand as of 30 June 2016 was GBP9.9 million (30 June 2015: GBP4.9 million). Cash of GBP1.5 million was used in H1 2016 as part of the initial consideration payments for the acquisitions of Haemostatix in May and O+P and GASD in June. The Company raised GBP9.2 million, net of expenses in the placing in May.

Impact of Brexit vote

On 23 June 2016, in a referendum regarding its continued membership, the UK voted to leave the EU.

The devaluation of pounds sterling against both the Euro and US Dollar in the lead up to the referendum generally favoured the translation of foreign currency earnings in the six months ended 30 June 2016. The immediate impact of the referendum vote to leave the EU was a sharp devaluation of pounds sterling against both the Euro and US Dollar. To the extent that the pound sterling remains at current levels for the remainder of the year, there will be a net positive impact on the translation of foreign currency earnings in the six months ended 31 December 2016.

The impact of an exit from the EU on Ergomed longer term is unlikely to be significant since more than 75% of its revenues are generated outside the UK. Ergomed already has well established regulatory and legal capabilities through its fully staffed offices inside and outside of the EU in Europe and so can continue to provide full services if and when current rules are changed.

Current trading and Outlook

Ergomed is on track to deliver another year of strong trading performance. The Company has a strong balance sheet with its highest ever cash reserves and is profitable. The strong backlog of signed service contracts means that substantially all of 2016 planned revenues have been contracted. The Board is actively evaluating several potential service business acquisitions that would increase profitability and complement our current range of service offerings and/or expand our geographical coverage. We also have a number of leads under discussion for additional co-development partnerships. In summary, the Board remains confident on the outlook for Ergomed.

INDEPENT REVIEW REPORT TO ERGOMED PLC

We have been engaged by the Company to review the condensed set of financial statements in the half-yearly financial report for the six months ended 30 June 2016 which comprises the consolidated income statement, the consolidated statement of comprehensive income, the consolidated statement of financial position, the consolidated statement of changes in equity, the consolidated cash flow statement and related notes 1 to 11. We have read the other information contained in the half-yearly financial report and considered whether it contains any apparent misstatements or material inconsistencies with the information in the condensed set of financial statements.

This report is made solely to the Company in accordance with International Standard on Review Engagements (UK and Ireland) 2410 "Review of Interim Financial Information Performed by the Independent Auditor of the Entity" issued by the Auditing Practices Board. Our work has been undertaken so that we might state to the Company those matters we are required to state to it in an independent review report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the Company, for our review work, for this report, or for the conclusions we have formed.

Directors' responsibilities

The half-yearly financial report is the responsibility of, and has been approved by, the Directors. The Directors are responsible for preparing the half-yearly financial report in accordance with the AIM Rules of the London Stock Exchange.

As disclosed in note 1 the annual financial statements of the Group are prepared in accordance with IFRSs as adopted by the European Union. The condensed set of financial statements included in this half-yearly financial report have been prepared in accordance with the accounting policies the Group intends to use in preparing its next annual financial statements.

Our responsibility

Our responsibility is to express to the Company a conclusion on the condensed set of financial statements in the half-yearly financial report based on our review.

Scope of review

We conducted our review in accordance with International Standard on Review Engagements (UK and Ireland) 2410 "Review of Interim Financial Information Performed by the Independent Auditor of the Entity" issued by the Auditing Practices Board for use in the United Kingdom. A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing (UK and Ireland) and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

Conclusion

Based on our review, nothing has come to our attention that causes us to believe that the condensed set of financial statements in the half-yearly financial report for the six months ended 30 June 2016 is not prepared, in all material respects, in accordance with accounting policies the group intends to use in preparing its next annual financial statements and the AIM Rules of the London Stock Exchange.

Deloitte LLP

Chartered Accountants and Statutory Auditor

Cambridge, UK

25 September 2016

ERGOMED PLC

INTERIM STATEMENT

Condensed Consolidated Income Statement

For the six months ended 30 June 2016

 
                           Note    Unaudited    Unaudited       Audited 
                                  Six months   Six months          Year 
                                       ended        ended         ended 
                                     30 June      30 June   31 December 
                                        2016         2015          2015 
                                     GBP000s      GBP000s       GBP000s 
 
REVENUE                               17,553       14,484        30,178 
 
Cost of sales                       (12,276)     (10,292)      (21,808) 
 
Gross profit                           5,277        4,192         8,370 
 
Administrative expenses              (3,566)      (2,606)       (5,186) 
Research and development               (102)            -             - 
Other operating 
 income                                   73           52            81 
-------------------------  ----  -----------  -----------  ------------ 
Amortisation of 
 acquired intangible 
 assets                                (307)        (286)         (596) 
Share-based payment 
 charge                                (204)        (133)         (288) 
M&A costs                     9        (352)        (125)         (272) 
Exceptional items            10            -         (37)          (37) 
-------------------------  ----  -----------  -----------  ------------ 
 
OPERATING PROFIT                         819        1,057         2,072 
 
Investment revenues                        1            -             1 
Finance costs                              -            -           (1) 
 
PROFIT BEFORE TAXATION                   820        1,057         2,072 
 
Taxation                               (184)        (265)         (520) 
 
PROFIT FOR THE PERIOD                    636          792         1,552 
 
EARNINGS PER SHARE 
Basic                         2         2.0p         2.8p          5.4p 
 
Diluted                       2         2.0p         2.7p          5.2p 
 
 

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

Condensed Consolidated Statement of Comprehensive Income

For the six months ended 30 June 2016

 
                                 Unaudited    Unaudited       Audited 
                                Six months   Six months          Year 
                                     ended        ended         ended 
                                   30 June      30 June   31 December 
                                      2016         2015          2015 
                                   GBP000s      GBP000s       GBP000s 
 
Profit for the period                  636          792         1,552 
 
Items that may be classified 
 subsequently to profit 
 or loss: 
Exchange differences 
 on translation of foreign 
 operations                            474        (411)         (244) 
 
Other comprehensive 
 income for the period 
 net of tax                            474        (411)         (244) 
 
Total comprehensive 
 income for the period               1,110          381         1,308 
 
 

Condensed Consolidated Statement of Financial Position

At 30 June 2016

 
                                    Unaudited  Unaudited       Audited 
                              Note    30 June    30 June   31 December 
                                         2016       2015          2015 
                                      GBP000s    GBP000s       GBP000s 
 
Non-current assets 
Goodwill                         3     25,208      7,656         7,488 
Other intangible 
 assets                                 2,703      2,733         2,819 
Property, plant 
 and equipment                            436        242           335 
Investments                               262         37           183 
Deferred tax asset                        375        458           365 
 
                                       28,984     11,126        11,190 
 
Current assets 
Trade and other 
 receivables                     4     12,322      6,496         9,528 
Inventory                        5         67          -             - 
Cash and cash equivalents               9,876      4,947         3,974 
 
                                       22,265     11,443        13,502 
 
Total assets                           51,249     22,569        24,692 
 
Current liabilities 
Borrowings                                (2)        (3)           (5) 
Trade and other 
 payables                        6    (7,133)    (5,105)       (5,955) 
Deferred revenue                      (1,155)      (655)         (795) 
Taxation                                (148)      (333)         (478) 
Total current liabilities             (8,438)    (6,096)         (7,233) 
 
Net current assets                     13,827      5,347           6,269 
 
Non-current liabilities 
Borrowings                                (8)        (5)             (7) 
Deferred consideration 
 on acquisitions                      (9,069)          -               - 
Deferred tax liability                  (461)      (531)           (516) 
 
Total liabilities                    (17,976)    (6,632)         (7,756) 
 
Net assets                             33,273     15,937          16,936 
 
Equity 
Share capital                             399        288             288 
Share premium account                  20,938     12,342          12,342 
Merger reserve                          6,326          -               - 
Share option reserve                      854        495             650 
Translation reserve                      (63)      (704)           (537) 
Retained earnings                       4,819      3,516           4,193 
 
Total equity                           33,273     15,937          16,936 
 
 

Condensed Consolidated Statement of Changes in Equity

For the six months ended 30 June 2016

 
                         Share     Share     Share  Translation   Retained     Total 
                       capital   premium    option      reserve   earnings 
                                 account   reserve 
                       GBP000s   GBP000s   GBP000s      GBP000s    GBP000s   GBP000s 
 
Balance at 31 
 December 2014*            288    12,342       362        (293)      2,640    15,339 
Profit for the 
 six month period**          -         -         -            -        792       792 
Other comprehensive 
 income for the 
 period**                    -         -         -        (411)          -     (411) 
 
Total comprehensive 
 income for the 
 period**                    -         -         -        (411)        792       381 
Share-based 
 payment for 
 the period**                -         -       133            -          -       133 
Deferred tax 
 credit taken 
 directly to 
 equity**                    -         -         -            -         84        84 
 
Balance at 30 
 June 2015**               288    12,342       495        (704)      3,516    15,937 
 
 

* Audited

** Unaudited

 
                         Share     Share    Merger     Share  Translation   Retained     Total 
                       capital   premium   reserve    option      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 
 
  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 for 
 the year*                   -         -         -       288            -          -       288 
Deferred tax 
 credit taken 
 directly to 
 equity*                     -         -         -         -            -          1         1 
 
Balance at 31 
 December 2015*            288    12,342         -       650        (537)      4,193    16,936 
Profit for the 
 six month period**          -         -         -         -            -        636       636 
Other comprehensive 
 income for the 
 period**                    -         -         -         -          474          -       474 
 
Total comprehensive 
 income for the 
 period**                    -         -         -         -          474        636     1,110 
Share-issue 
 during the period 
 for cash (net 
 of expenses)**             66     8,596         -         -            -          -     8,662 
Share-issues 
 during the period 
 for non-cash 
 consideration**            45         -     6,326         -            -          -     6,371 
Share-based 
 payment for 
 the period**                -         -         -       204            -          -       204 
Deferred tax 
 charge taken 
 directly to 
 equity**                    -         -         -         -            -       (10)      (10) 
 
Balance at 30 
 June 2016**               399    20,938     6,326       854         (63)      4,819    33,273 
 
 

* Audited

** Unaudited

The balance on the merger reserve has arisen through the acquisition of Haemostatix Limited, Oestreich + Partner GmbH and Gesellschaft fur angewandte Statistik + Datenanalyse mbH (see notes 7 and 8)

Condensed Consolidated Cash Flow Statement

For the six months ended 30 June 2015

 
                                  Unaudited    Unaudited       Audited 
                                 Six months   Six months          Year 
                                      ended        ended         ended 
                                    30 June      30 June   31 December 
                                       2016         2015          2015 
                                    GBP000s      GBP000s       GBP000s 
 
Cash flows from operating 
 activities 
Profit before taxation                  820        1,057         2,072 
 
Adjustment for: 
Amortisation and depreciation           410          327           713 
(Gain)/loss on disposal 
 of fixed assets                        (4)            -             4 
Share-based payment 
 charge                                 204          133           288 
Acquisition of shares 
 for non-cash consideration            (54)            -         (142) 
Exchange adjustments                    339        (361)         (251) 
Acquisition costs                       349           53            54 
Investment revenues                     (1)            -           (1) 
Finance costs                             -            -             1 
 
Operating cash flow 
 before changes in working 
 capital and provisions               2,063        1,209         2,738 
 
Increase in trade and 
 other receivables                  (2,659)        (180)       (2,898) 
Increase in trade and 
 other payables                         132           21         1,012 
Increase in inventory                  (67)            -             - 
 
Cash (utilised in)/generated 
 from operations                      (531)        1,050           852 
 
Taxation paid                         (399)        (159)         (588) 
 
Net cash (outflow)/inflow 
 from operating activities            (930)        (891)           264 
 
Investing activities 
Investment revenues 
 received                                 1            -             1 
Acquisition of property, 
 plant and equipment                  (157)        (112)         (270) 
Acquisition of intangible 
 assets                               (197)         (93)         (285) 
Investments in joint 
 venture                                  -            -           (1) 
Acquisition of subsidiaries 
 including expenses of 
 acquisition                        (1,505)        (313)         (312) 
Receipts from sale of 
 property, plant and 
 equipment                               31            1             2 
 
Net cash outflow from 
 investing activities               (1,827)        (517)         (865) 
 
Financing activities 
Issue of new shares                   9,185            -             - 
Expenses of fundraising               (523)            -             - 
Finance costs paid                        -            -           (1) 
Increase in borrowings                    -            -             7 
Repayment of borrowings                 (3)          (3)           (7) 
 
Net cash inflow/(outflow) 
 from financing activities            8,659          (3)           (1) 
 
Net increase/(decrease) 
 in cash and cash equivalents         5,902          371         (602) 
 
Cash and cash equivalents 
 at start of the period               3,974        4,576         4,576 
 
Cash and cash equivalents 
 at end of period                     9,876        4,947         3,974 
 
 

Notes

   1.            GENERAL INFORMATION 

This condensed consolidated interim financial information does not comprise statutory accounts within the meaning of section 434 of the Companies Act 2006.

The condensed interim financial statements have been prepared using accounting policies and method of computation consistent with those used in the audited statutory financial statements for the year ended 31 December 2015 and International Reporting Standards (IFRSs) adopted for use in the European Union. While the financial information included in this interim statement has been compiled in accordance with the recognition and measurement principles of IFRSs, this announcement does not itself contain sufficient information to comply with IFRSs.

The information for the six month period ended 30 June 2016 is unaudited, but reflects all normal adjustments which are, in the opinion of the Board, necessary to provide a fair statement of results and the Group's financial position for and as at the period presented.

Statutory accounts for the year ended 31 December 2015 were approved by the Board of Directors and have been delivered to the Registrar of Companies. The audit report on those accounts was unqualified, did not draw attention to any matters by way of emphasis and did not contain any statement under section 498(2) or (3) of the Companies Act 2006.

At 30 June 2016 Ergomed had cash resources of GBP9.9 million (30 June 2015: GBP4.9 million; 31 December 2015: GBP4.0 million).

Risks and uncertainties

An outline of the key risks and uncertainties faced by the Group was described in the Company's AIM Admission Document from July 2014 which is located in the Company website (www.ergomedplc.com) in the Investors section. These risks include competition; dependence on a small number of customers; legislation and regulation of the pharmaceutical and biotechnology industries; licensees, approvals and compliance; and the potential for cancellation or delay of clinical studies by customers. It is anticipated that the risk profile will not significantly change for the remainder of the year. Risk is an inherent part of doing business and the profitability and strong cash position of the Group, along with the growth profile of the business, leads the Directors to believe that the Group is well placed to manage business risks successfully.

Going concern

The Directors have considered cashflow forecasts for the group, detailing cash inflows and outflows for the period ending 31 December 2017. Based on their review of these forecasts and consideration of the economic environment in which the group operates, the Directors are satisfied that the Company has sufficient resources to continue in operation for the foreseeable future, being a period of not less than 12 months from the date of this report. Accordingly, they continue to adopt the going concern basis in preparing the financial information for the six months ended 30 June 2016.

Business Combinations

Acquisitions of subsidiaries and businesses are accounted for using the acquisition method. The consideration transferred on acquisition is the fair value at the date of transaction for assets and liabilities transferred. All acquisition related costs are expensed as incurred.

Goodwill arises as the excess of acquisition cost over the fair value of the assets transferred at the date of transaction. Goodwill is reviewed for impairment annually, and is carried at cost less accumulated impairment losses. Impairment losses are not reversed in subsequent periods.

Goodwill arising on the acquisition of a foreign operation, including any fair value adjustments to the carrying amounts of assets or liabilities on the acquisition, are treated as assets and liabilities of that foreign operation in accordance with IAS 21 and as such are translated at the relevant foreign exchange rate at the statement of financial position date.

Adoption of new and revised standards

Amendments to IFRSs that are mandatorily effective for the current year

In the current year, the Group has applied a number of amendments to IFRSs issued by the International Accounting Standards Board (IASB) that are mandatorily effective for an accounting period that begins on or after 1 January 2015 (except as noted below). Their adoption has not had any material impact on the disclosures or on the amounts reported in these interim financial statements.

 
 Annual Improvements    The Group has adopted the amendments 
  to IFRSs 2010          to IFRSs included in the Annual 
  - 2012 Cycle           Improvements to IFRSs 2010 - 2012 
  (The amendments        Cycle for the first time in the 
  are effective          current year. 
  in the EU 
  for accounting         The majority of the amendments are 
  periods beginning      in the nature of clarifications 
  on or after            rather than substantive changes 
  1 February             to existing requirements. However, 
  2015. However,         the amendments to IFRS 8 Operating 
  earlier application    Segments - Aggregation of operating 
  is permitted           segments and IAS 24 Related Party 
  so that companies      Disclosures - Key management personnel 
  applying IFRSs         represent changes to existing requirements. 
  as adopted 
  in the EU              The amendments to IFRS 8 require 
  are able to            an entity to disclose the judgements 
  adopt the              made by management in applying the 
  amendments             aggregation criteria to operating 
  in accordance          segments, including a description 
  with the IASB          of the operating segments aggregated 
  effective              and the economic indicators assessed 
  date of 1              in determining whether the operating 
  July 2014)             segments have similar economic characteristics. 
 
                         The amendments to IAS 24 clarify 
                         that a management entity providing 
                         key management personnel services 
                         to a reporting entity is a related 
                         party of the reporting entity. Consequently, 
                         the reporting entity must disclose 
                         as related party transactions the 
                         amounts incurred for the service 
                         paid or payable to the management 
                         entity for the provision of key 
                         management personnel services. However, 
                         disclosure of the components of 
                         such compensation is not required. 
 
                         The application of the amendments 
                         has had no material impact on the 
                         disclosures or on the amounts recognised 
                         in the Group's consolidated interim 
                         financial statements. 
 Annual Improvements    The Group has adopted the amendments 
  to IFRSs 2011          to IFRSs included in the Annual 
  - 2013 Cycle           Improvements to IFRSs 2011 - 2013 
                         Cycle for the first time in the 
                         current year. 
 
                         The amendments are in the nature 
                         of clarifications rather than substantive 
                         changes to existing requirements. 
 
                         The application of the amendments 
                         has had no material impact on the 
                         disclosures or on the amounts recognised 
                         in the Group's consolidated interim 
                         financial statements. 
 

New and revised IFRSs in issue but not yet effective

At the date of authorisation of these interim financial statements, the following Standards and Interpretations which have not been applied in these interim financial statements were in issue but not yet effective (and in some cases had not yet been adopted by the EU):

 
 IFRS 9                 Financial Instruments 
 IFRS 15                Revenue from Contracts with Customers 
 IFRS 11 (amendments)   Accounting for Acquisitions of Interests 
                         in Joint Operations 
 IAS 1 (amendments)     Disclosure Initiative 
 IAS 16 and             Clarification of Acceptable Methods 
  IAS 38 (amendments)    of Depreciation and Amortisation 
                         IAS 16 and IAS 41 (amendments) Agriculture: 
                         Bearer Plants 
 IAS 27 (amendments)    Equity Method in Separate Financial 
                         Statements 
 IFRS 10 and            Sale or Contribution of Assets between 
  IAS 28 (amendments)    an Investor and its Associate or 
                         Joint Venture 
 IFRS 10, IFRS          Investment Entities: Applying the 
  12 and IAS             Consolidation Exemption 
  28 (amendments) 
 Annual Improvements    Amendments to: IFRS 5 Non-current 
  to IFRSs:              Assets Held for Sale and Discontinued 
  2012-2014              Operations, IFRS 7 Financial Instruments: 
  Cycle                  Disclosures, IAS 19 Employee Benefits 
                         and IAS 34 Interim Financial Reporting 
 

The Directors do not expect that the adoption of the Standards listed above will have a material impact on the financial statements of the Group in future periods, except that IFRS 9 will impact both the measurement and disclosures of financial instruments and IFRS 15 may have an impact on revenue recognition and related disclosures. Beyond the information above, it is not practicable to provide a reasonable estimate of the effect of IFRS 9 and IFRS 15 until a detailed review has been completed.

   2.         EARNINGS PER SHARE 

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

 
                                Unaudited      Unaudited        Audited 
                               Six months     Six months           Year 
                                    ended          ended          ended 
                                  30 June        30 June    31 December 
                                     2016           2015           2015 
                                  GBP000s        GBP000s        GBP000s 
 Earnings for the 
  purposes of basic 
  earnings per share 
  being net profit 
  attributable to owners 
  of the Company                      636            792          1,552 
 Effect of dilutive                     -              -              - 
  potential ordinary 
  shares 
 
 Earnings for the 
  purposes of diluted 
  earnings per share                  636            792          1,552 
 
 
                                      No.            No.            No. 
 Number of shares 
 Weighted average 
  number of ordinary 
  shares for the purposes 
  of basic earnings 
  per share                    31,116,420     28,750,000     28,750,000 
 Effect of dilutive 
  potential ordinary 
  shares 
 Share options                  1,368,600      1,043,764      1,015,223 
 
 Weighted average 
  number of ordinary 
  shares for the purposes 
  of diluted earnings 
  per share                    32,485,020     29,793,764     29,765,223 
 
 
   3.         GOODWILL 
 
                                        GBP000s 
Cost 
At 1 January 2015*                        7,282 
Arising on acquisition of subsidiary*       374 
 
At 30 June 2015**                         7,656 
 
 
 
                                           GBP000s 
Cost 
At 1 January 2015*                           7,282 
Arising on acquisition of subsidiary*          374 
Revaluation of provisional values in 
 accordance with IFRS 3*                     (168) 
 
At 31 December 2015*                         7,488 
Arising on acquisition of subsidiaries**    17,720 
 
At 30 June 2016**                           25,208 
 
Accumulated impairment losses 
1 January 2015*, 30 June 2015**, 31              - 
 December 2015* and 30 June 2016** 
 
Net book value 
At 30 June 2016**                           25,208 
 
At 30 June 2015**                            7,656 
 
At 31 December 2015*                         7,488 
 
 

* Audited

** Unaudited

The goodwill at 1 January 2015 related to the acquisitions of Ergomed Virtuoso Sarl on 30 September 2013 and PrimeVigilance Limited and its subsidiaries on 15 July 2014.

The goodwill arising during the period ended 30 June 2015 relates to the acquisition of Sound Opinion Limited on 26 May 2015.

The goodwill arising during the period ended 30 June 2016 relates to the acquisitions of Haemostatix Ltd on 24 May 2016 (see note 7) and Oestreich + Partner GmbH ('O+P') and Gesellschaft für angewandte Statistik + Datenanalyse mbH ('GASD') on 12June 2016 (see note 8).

   4.         TRADE AND OTHER RECEIVABLES 
 
                        Unaudited  Unaudited       Audited 
                          30 June    30 June   31 December 
                             2016       2015          2015 
                          GBP000s    GBP000s       GBP000s 
 
Trade receivables           8,358      4,383         6,412 
Amounts receivable 
 from related parties           -         33             - 
Other receivables             485        302           381 
Prepayments                   483        306           376 
Accrued income              2,774      1,416         1,989 
Corporation tax 
 receivable                   222         56           370 
 
                           12,322      6,496         9,528 
 
 
   5.         INVENTORY 
 
                          Unaudited  Unaudited       Audited 
                            30 June    30 June   31 December 
                               2016       2015          2015 
                            GBP000s    GBP000s       GBP000s 
 
Clinical trial material          67          -             - 
 
 
   6.         TRADE AND OTHER PAYABLES 
 
                      Unaudited  Unaudited       Audited 
                        30 June    30 June   31 December 
                           2016       2015          2015 
                        GBP000s    GBP000s       GBP000s 
 
Trade creditors           3,148      2,390         2,381 
Amounts payable 
 to related parties          29         11            71 
Social security 
 and other taxes            389        251           374 
Other payables              432        381           381 
Accruals                  3,135      2,072         2,748 
 
                          7,133      5,105         5,955 
 
 
   7.         ACQUISITION OF SUBSIDIARY - HAEMOSTATIX LIMITED 

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.

 
                                          Provisional 
                                            valuation 
                                              GBP000s 
 
Property, Plant and Equipment                       4 
 
Total non-current assets                            4 
 
Trade and other debtors                           114 
Cash and equivalents                               62 
 
Current assets                                    176 
 
Trade and other creditors                     (1,366) 
 
Net financial liabilities                     (1,190) 
 
Total identifiable net liabilities            (1,186) 
Goodwill                                       16,763 
 
Total consideration                            15,577 
 
Satisfied by: 
Cash                                              800 
Equity                                          6,181 
Deferred consideration                          8,596 
 
Total consideration                            15,577 
 
Net cash outflow arising on acquisition 
Cash consideration                                800 
Less: cash and cash equivalent balances 
 acquired                                        (62) 
Transaction costs (note 9)                        269 
 
                                                1,007 
 
 

The provisional fair value of the financial assets includes receivables with a fair value of GBP114,000 and a gross contractual value of GBP114,000. The best estimate at acquisition date of the contractual cash flows not to be collected is GBPnil.

Goodwill is provisionally valued at GBP16,763,000 which arises from the excess of purchase price of GBP15,577,000 over net liabilities GBP1,186,000 and is attributable to the development portfolio of the company. 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.

Owing to the limited time between acquisition and the presentation of these interim results, there has been insufficient time to complete an external valuation exercise. Accordingly, the amounts presented as goodwill represent the excess consideration above the value of net liabilities and a full fair value exercise of identifiable assets acquired and liabilities assumed will be performed within the measurement period which ends on 23 May 2017.

It is intended that an updated acquisition note showing any amendments arising from the valuation exercise will be included in the audited financial statements for the year ended 31 December 2016. Ergomed plc has a 12 month measurement period from the date of acquisition, and therefore the final results will be included in the financial statements for the year ended 31 December 2017.

As a research and development company, Haemostatix Limited 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 six months ended 30 June 2016 would have been unchanged and group profit would have been GBP1,493,000 lower.

   8.         ACQUISITION OF SUBSIDIARY - O+P and GASD 

On 12 June 2016, Ergomed acquired 100 per cent of the issued share capital of Oestreich + Partner GmbH ("O+P") and of Gesellschaft fur angewandte Statistik + Datenanalyse mbH ("GASD"). O+P is a long established contract research organization 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.

 
                                          Provisional 
                                            valuation 
                                              GBP000s 
 
Property, Plant and Equipment                      23 
 
Total non-current assets                           23 
 
Trade and other debtors                            91 
Accrued income                                     71 
Corporation Tax receivable                          6 
Cash and equivalents                              464 
 
Current assets                                    632 
 
Trade and other creditors                       (184) 
Tax payable                                       (2) 
 
Financial liabilities                           (186) 
 
Total identifiable net assets                     469 
Goodwill                                          957 
 
Total consideration                             1,426 
 
Satisfied by: 
Cash                                              802 
Equity                                            190 
Deferred consideration                            434 
 
Total consideration                             1,426 
 
Net cash inflow arising on acquisition 
Cash consideration                                802 
Less: cash and cash equivalent balances 
 acquired                                       (464) 
Transaction expenses (note 9)                      73 
 
                                                  411 
 
 

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 GBP957,000 which arises from the excess of purchase price of GBP1,426,000 over net assets of GBP469,000 and is attributable to the broadened customer base and 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.

Owing to the limited time between acquisition and the presentation of these interim results, there has been insufficient time to complete an external valuation exercise. Accordingly, the amounts presented as goodwill represent the excess consideration above net asset value and a full fair value exercise of identifiable assets acquired and liabilities assumed will be performed within the measurement period which ends on 12 June 2017.

It is intended that an updated acquisition note showing any amendments arising from the valuation exercise will be included in the audited financial statements for the year ended 31 December 2016. Ergomed plc has a 12 month measurement period from the date of acquisition, and therefore the final results will be included in the financial statements for the year ended 31 December 2017.

If the acquisition of O+P and GASD had been completed on the first day of the financial year, group revenues for the six months ended 30 June 2016 would have been GBP381,000 higher and group profit would have been GBP134,000 lower.

   9.         M&A COSTS 
 
                                  Unaudited     Unaudited        Audited 
                                 Six months    Six months           Year 
                                      ended         ended          ended 
                                    30 June       30 June    31 December 
                                       2016          2015           2015 
                                    GBP000s       GBP000s        GBP000s 
 
Acquisition of Haemostatix              269             -              - 
 (note 7) 
Acquisition of O+P & GASD                73             -              - 
 (note 8) 
Acquisition of Sound Opinion              7            54             54 
Other M&A activity                        3            71            218 
 
                                        352           125            272 
 
 
   10.       EXCEPTIONAL ITEMS 
 
                              Unaudited     Unaudited        Audited 
                             Six months    Six months           Year 
                                  ended         ended          ended 
                                30 June       30 June    31 December 
                                   2016          2015           2015 
                                GBP000s       GBP000s        GBP000s 
 
Establishment of Taiwan 
 office                               -            37             37 
 
                                      -            37             37 
 
 

In line with the way the Board and chief operating decision makers review the business, large one-off exceptional costs are separately identified and shown as exceptional costs. In the first half of 2015, these are directly related to the establishment of operations in Taipei, Taiwan.

   11.       EBITDA 
 
                                     Unaudited    Unaudited       Audited 
                                    Six months   Six months          Year 
                                         ended        ended         ended 
                                       30 June      30 June   31 December 
                                          2016         2015          2015 
                                      GBP'000s     GBP'000s      GBP'000s 
 
  Operating profit                         819        1,057         2,072 
 
  Adjust for: 
  Depreciation and amortisation 
   charges within Administrative 
   expenses                                103           42           117 
  Amortisation of acquired 
   intangible assets                       307          286           596 
 
  EBITDA                                 1,229        1,385         2,785 
  Share-based payment charge               204          133           288 
  M&A Costs                                352          125           272 
  Exceptional items                          -           37            37 
  R&D activity (Haemostatix)               102            -             - 
 
  Adjusted EBITDA                        1,887        1,680         3,382 
 
 

This information is provided by RNS

The company news service from the London Stock Exchange

END

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