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
IR FMGZLNKKGVZM
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