TIDMIMM
RNS Number : 6323H
Immupharma PLC
21 May 2014
21 MAY 2014
PRELIMINARY RESULTS ANNOUNCEMENT
for the year ended 31 December 2013
ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the
specialist drug discovery and development company, is pleased to
announce its preliminary audited results for the year ended 31
December 2013.
Key Highlights:
-- Lupuzor(TM)
o Discussions continue with potential partners in parallel to
discussions with Contract Research Organisations and alternative
financing organisations for Lupuzor(TM) 's pivotal Phase III
programme - Special Protocol Assessment (SPA) and Fast Track
Designation granted by FDA.
o Granted an amended SPA by the FDA in 2013 reducing the number
of patients required to complete Phase III.
o Manufactured drug product for phase III. Plan to file the
non-clinical part (except DMF) of the NDA (New Drug Application) to
the FDA.
o Established world class Scientific Advisory Board of prominent
physicians and advisors in the field of lupus to provide guidance
and support for Lupuzor(TM) 's phase III programme.
-- Nucant programme IPP-204106
o Cancer: Phase I/IIa clinical trial ongoing with the next
generation "polyplexed Nucant" formulation in three European
hospitals including the prestigious Institute Jules Bordet in
Belgium.
o New exciting indications discovered:
-- Cancer: Development of novel applications of the Nucant
family of peptides targeting combination therapies.
-- Angiogenesis: age-related macular degeneration, diabetic
retinopathy.
-- CNRS Collaboration and the University of Bordeaux (co-owned patents):
o Collaboration established with the University of Bordeaux in
coordination with the CNRS to identify and patent novel peptide
drugs
o New technology patented with a target first application in
diabetes.
-- Darwin GBP50 million Equity Finance Facility
o Signed a GBP50 million equity finance facility with Darwin
Strategic Limited
-- Cash position as at 31 December 2013 of GBP5.4m (2012: GBP8.9m)
-- Loss for the period of GBP3.7m (2012: GBP3.8m)
-- Basic and diluted loss per share was 4.52p (2012: 4.71p)
-- Continued successful relationship with the CNRS, the largest
fundamental research institute in Europe
Commenting on the year's performance and outlook Dimitri
Dimitriou, Chief Executive Officer said:
2013 has been a year of substantial progress on all fronts. We
have been working hard to continue the clinical development of
Lupuzor(TM) and the cancer Nucant programme. We were pleased to
have obtained an amended SPA from the US FDA thereby reducing the
cost of Phase III for Lupuzor(TM) and manufactured enough drug
product for phase III and launch. Further, we have been delighted
with the appointment of such a prestigious group of experts in the
field of lupus on our Scientific Advisory Board. The GBP50 million
equity finance facility secured from Darwin Strategic has been a
key development, providing additional strength for the company and
the future advancement of Lupuzor(TM) . Our Nucant programme
continues to progress, and we look forward to providing more
information on its novel potential uses during 2014. Last but not
least, building on our long standing relationship with the CNRS and
our peptide expertise, we are capitalising on pioneering research
at the University of Bordeaux in France with some of the first
targets being in diabetes and virology. We would like to thank our
shareholders and the CNRS, our research partner, for their support
and we look forward to providing further updates during the
remainder of 2014.
For further information please contact:
ImmuPharma plc + 44 (0) 20 7152 4080
Dimitri Dimitriou, Chief Executive
Officer
Dr Robert Zimmer, President and Chief
Scientific Officer
Richard Warr, Chairman
Tracy Weimar, Vice President, Operations
and Finance
Lisa Baderoon, Head of Investor Relations + 44 (0) 7721 413496
Panmure, Gordon & Co., NOMAD & Broker +44 (0) 20 7886 2500
Hugh Morgan
Fred Walsh
Charles Leigh-Pemberton
Duncan Monteith
ImmuPharma plc
Report of the Chairman, the Chief Executive Officer and the
President
2013 has been a year of continued progress for ImmuPharma.
Lupuzor(TM) remains our primary focus. We have been conducting
discussions with a number of multinational pharmaceutical companies
with a view to obtaining a new partner for Lupuzor(TM) . In
parallel, we have been in discussions with Contract Research
Organisations and exploring alternative financing arrangements that
would enable ImmuPharma to retain rights until commercialisation by
pursuing Phase III development of Lupuzor(TM) . The successful
agreement of a GBP50 million equity financing facility with Darwin
Strategic has been a significant step forward in strengthening our
position. Of major significance is the establishment of a world
class Scientific Advisory Board of prominent physicians and
advisors in the field of lupus to provide guidance and support for
Lupuzor(TM) 's clinical development. Our Nucant programme in cancer
has continued to make progress in its ongoing Phase I/IIa clinical
trial.
Following the reacquisition of the rights to Lupuzor(TM) from
Cephalon, Inc arising from their acquisition by Teva
Pharmaceuticals, ImmuPharma has been focused on licensing and
development options to complete the final development phase.
Lupuzor(TM) has received approval from the US Food and Drug
Administration (FDA) to start Phase III with a Special Protocol
Assessment (SPA) as well as having received Fast Track designation.
ImmuPharma was granted an amended SPA during 2013. Under the new
SPA, the necessary number of patients for the Phase III programme
has been reduced. This number is lower than other lupus development
candidates in clinical trials and underpins the significant
efficacy shown by Lupuzor(TM) . Importantly, this means that the
total cost of Phase III is now greatly reduced. ImmuPharma has
manufactured the Phase III drug supplies as well as the CMC
(Chemistry Manufacturing and Controls) section of the regulatory
file proving appropriate stability of the drug product. Finally,
Torreya Partners, a leading specialist advisory firm for
pharmaceutical sector transactions, was appointed during the summer
to support our corporate discussions for Lupuzor(TM) .
ImmuPharma has also been moving forward with our nucleolin
antagonist ("Nucant") peptide programme, being tested in cancer
patients. Having received approval from the French regulatory
authorities, Agence Francaise de Securite Sanitaire des Produits de
Sante (AFSSAPS), we initiated an initial Phase I dose ranging
tolerability and safety study in three hospitals in France which
completed in 2012. Patients were suffering from different types of
cancer including breast, lung and bladder cancers which had all
metastasised. No serious drug related adverse events were reported.
6 out of the 14 patients had a proven stabilization and for 2 out
of the 6 the stabilization lasted for more than 6 months.
ImmuPharma initiated a Phase I/II study based on the next
generation "polyplexed Nucant", assessing the safety in a dose
ranging tolerability study with the new formulation and primary
efficacy. This trial is being conducted in three hospitals in
Europe including the prestigious Institute Jules Bordet, an
Integrated Multidisciplinary Centre which is the only autonomous
hospital in Belgium totally dedicated to cancer. The trial
continues to progress through its dose escalation phase, and we
hope to report on its progress during 2014. In parallel, novel
applications of the Nucant family of peptides have emerged and
these will be announced in the near future.
ImmuPharma has initiated the development of a novel and
innovative peptide technology platform in collaboration with the
University of Bordeaux and the CNRS. Further details will be
announced shortly.
We continue to work diligently to maintain and further raise
ImmuPharma's profile in the investment community and strive to
continue an effective dialogue with our investors through various
channels including group and one-to-one meetings as well as via our
investor website.
Our key objectives for 2014 are to initiate the final
development phase of Lupuzor(TM) , either with a licensing partner
or with supportive funding, to advance our Nucant programme in
cancer and other indications and to focus on the exciting projects
with the University of Bordeaux. We value the support and look
forward to enhancing our key relationship with the Centre National
de la Recherche Scientifique (CNRS), the largest fundamental
research institution in Europe. As in previous years, this is to be
achieved with solid financial management and carefully controlled
expenditure.
ImmuPharma is focused on achieving key milestones in 2014. The
Board would like to thank its shareholders for their ongoing
support as well as its corporate and scientific advisors and the
Centre Nationale de la Recherche Scientifique in France for their
collaboration.
Richard Warr Dimitri F. Dimitriou Dr Robert Zimmer
Chairman Chief Executive Officer President
ImmuPharma plc
Financial Review
The year ended 31 December 2013 was focused on securing a
sustainable future for Lupuzor(TM) and on ensuring the progress of
our cancer programme with the ongoing progress of its clinical
trial.
Income Statement
The overall loss for the year ended 31 December 2013 was GBP3.7m
(2012: GBP3.8m). During 2013, research and development expenditure
was GBP2.1m which is GBP0.45m more than that incurred in 2012. This
was primarily due to the manufacture of Phase III trial supplies
for Lupuzor(TM) and continued expenditure on our cancer trial
programme. Administrative expenses were GBP2.2m down from GBP2.6m
in 2012. This was mostly attributable to a reduction of
professional fees. The Group posted a GBP148,166 loss on foreign
exchange in 2013 compared to a loss of GBP76,327 on foreign
exchange in 2012. This arises from the translation of the US dollar
balance held by the Group's French subsidiaries. To date, the Group
has not entered into any formal hedging arrangements to protect
against such fluctuations. Total comprehensive loss for the period
was GBP3.5m (2012: GBP4.2m), GBP0.2m lower than the loss for the
year as a result of exchange gains on translation of foreign
operations.
In previous years, IFRS2, relating to share-based payments has
had an impact on the Group's results. There is a charge in the
accounts of GBP8,844 which represents the current year charge for
options previously granted. This is a notional amount stipulated by
IFRS2 (and calculated using a statistical model) as a result of
granting the options. A further GBP43,275 is due to be charged over
the next two years accounts under IFRS2, being the remainder of the
fair value charge. A further share based payment of GBP117,900 has
been recognised in finance costs in the year, following the issue
of warrants to Darwin Strategic Limited. The full charge has been
made in the current year.
Balance Sheet
Cash and cash equivalents at 31 December 2013 amounted to
GBP5.4m (2012: GBP8.9m). Financial borrowings were GBP1,117k (2012:
GBP1,288k). This is primarily the conditional advance, from the
French Government, for use in the development of our cancer
programme. No interest is payable.
Darwin Equity Finance Facility
In May 2013, ImmuPharma agreed a GBP50 million equity finance
facility with Darwin Strategic Limited. Although the facility has
not been utilised to date, it gives ImmuPharma increased
flexibility in securing the necessary support to begin Phase III
for Lupuzor(TM) .
Results
The Group recorded a loss for the year of GBP3.7m (2012:
GBP3.8m). Basic and diluted loss per share was 4.52p (2012: 4.71p).
No dividend is proposed.
Treasury Policy
The policy continues to be that surplus funds of the Group are
held in interest-bearing bank accounts on short or medium
maturities, until commitments to future expenditure are made, when
adequate funds are released to enable future expenditure to be
incurred. The Group's Treasury Policy and controls are
straightforward and approved by the Board.
Financial Strategy
The overall strategy is to successfully find a suitable partner
to advance Lupuzor(TM) and to maintain a tight control over cash
resources whilst enabling controlled development of the potential
product portfolio.
Tracy Weimar
Vice President, Operations and Finance
ImmuPharma plc
CONSOLIDATED INCOME STATEMENT
FOR THE YEAR ENDED 31 DECEMBER 2013
Notes Year ended Year ended
31 December 31 December
2013 2012
GBP GBP
Continuing operations
Revenue - -
Research and development
expenses (2,072,906) (1,620,331)
Administrative expenses (2,155,229) (2,554,722)
Operating loss 2 (4,228,135) (4,175,053)
Finance costs (266,121) (80,752)
Finance income 60,366 87,552
Loss before taxation (4,433,890) (4,168,253)
Tax 744,544 324,219
Loss for the year (3,689,346) (3,844,034)
Attributable to:
Equity holders of the parent
company (3,689,346) (3,844,034)
Earnings per ordinary share
Basic 3 (4.52p) (4.71p)
Diluted 3 (4.52p) (4.71p)
ImmuPharma plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEAR ENDED 31 DECEMBER 2013
Year ended Year ended
31 December 31 December
2013 2012
GBP GBP
Loss for the financial year (3,689,346) (3,844,034)
Other comprehensive income
Items that may be reclassified subsequently
to profit or loss:
Exchange differences on translation
of foreign operations 154,725 (311,193)
Other comprehensive income for the
year, net of tax 154,725 (311,193)
Total comprehensive loss for the
year (3,534,621) (4,155,227)
ImmuPharma plc
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 DECEMBER 2013
31 December 31 December
2013 2012
GBP GBP
Non-current assets
Intangible assets 602,070 627,677
Property, plant and equipment 97,149 114,834
Total non-current assets 699,219 742,511
Current assets
Trade and other receivables 1,109,737 873,620
Cash and cash equivalents 5,396,296 8,893,267
Total current assets 6,506,033 9,766,887
Current liabilities
Financial liabilities - borrowings 346,935 249,951
Trade and other payables 628,372 773,002
Provisions 56,600 30,371
Total current liabilities 1,031,907 1,053,324
Net current assets 5,474,126 8,713,563
Non-current liabilities
Financial liabilities - borrowings 769,601 1,038,203
Net assets 5,403,744 8,417,871
EQUITY
Ordinary shares 8,228,246 8,153,246
Share premium 7,764,720 7,445,970
Merger reserve 106,148 106,148
Other reserves (3,460,113) (3,682,632)
Retained earnings (7,235,257) (3,604,861)
Total equity 5,403,744 8,417,871
ImmuPharma plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 31 DECEMBER 2013
Other
Other Other reserves-
Merger reserves - reserves - Equity Retained
reserve Acquisition Translation shares Earnings
Share Share reserve Reserve to be Total
capital premium issued equity
GBP GBP GBP GBP GBP GBP GBP GBP
At 1 January
2012 8,153,246 7,445,970 106,148 (3,541,203) (1,422,547) 1,525,239 239,173 12,506,026
Loss for the
financial
year - - - - - - (3,844,034) (3,844,034)
Exchange
differences
on
translation
of foreign
operations - - - - (311,193) - - (311,193)
Share based
payments - - - - - 67,072 - 67,072
At 31
December
2012 8,153,246 7,445,970 106,148 (3,541,203) (1,733,740) 1,592,311 (3,604,861) 8,417,871
Loss for the
financial
year - - - - - - (3,689,346) (3,689,346)
Exchange
differences
on
translation
of foreign
operations - - - - 154,725 - - 154,725
Share based
payments - - - - - 126,744 - 126,744
New issue of
equity
capital 75,000 318,750 - - - (58,950) 58,950 393,750
At 31
December
2013 8,228,246 7,764,720 106,148 (3,541,203) (1,579,015) 1,660,105 (7,235,257) 5,403,744
Attributable
to:-
Equity
holders of
the parent
company 8,228,246 7,764,720 106,148 (3,541,203) (1,579,015) 1,660,105 (7,235,257) 5,403,744
ImmuPharma plc
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEAR ENDED 31 DECEMBER 2013
Notes Year ended Year ended
31 December 31 December
2013 2012
GBP GBP
Cash flows from operating
activities
Cash used in operations 4 (4,211,836) (3,448,910)
Tax 297,969 196,197
Interest paid (55) (4,425)
Net cash used in operating activities (3,913,867) (3,257,138)
Investing activities
Purchase of property, plant
and equipment (3,054) (12,632)
Interest received 60,366 87,552
Net cash generated from investing
activities 57,312 74,920
Financing activities
(Decrease)/increase in bank
overdraft (25,041) 21,741
New loans - 475,020
Loan repayments (177,220) (139,892)
Net proceeds from issue of 393,750 -
new share capital
Net cash generated from financing
activities 191,489 356,869
Net decrease in cash and cash
equivalents (3,665,066) (2,825,349)
Cash and cash equivalents
at beginning of year 8,893,267 12,164,784
Effects of exchange rates on
cash and cash equivalents 168,095 (446,168)
Cash and cash equivalents
at end of year 5,396,296 8,893,267
ImmuPharma plc
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2013
1 ACCOUNTING POLICIES
The financial information set out in this announcement does not
comprise the Group's statutory accounts as defined in section 434
of the Companies Act 2006 for the year ended 31 December 2013 or 31
December 2012.
The financial information has been extracted from the statutory
accounts for the years ended 31 December 2013 and 31 December 2012.
The auditors reported on those accounts; their reports were
unqualified and did not contain a statement under either Section
498(2) or Section 498(3) of the Companies Act 2006 in respect of
the years ended 31 December 2013 and 31 December 2012 and did not
include references to any matters to which the auditor drew
attention by way of emphasis.
The statutory accounts for the year ended 31 December 2012 have
been delivered to the Registrar of Companies, whereas those for the
year ended 31 December 2013 will be delivered to the Registrar of
Companies following the Company's Annual General Meeting.
The accounting policies are consistent with those applied in the
preparation of the interim results for the period ended 30 June
2013 and the statutory accounts for the year ended 31 December
2012, which have been prepared in accordance with International
Financial Reporting Standards ("IFRS").
The financial information is for the year ended 31 December 2013
and the comparatives are for the year ended 31 December 2012.
The Group's financial statements incorporate the financial
statements of ImmuPharma plc and other entities controlled by the
company ("the subsidiaries"). Control is achieved where the company
has the power to govern the financial and operating policies of an
investee entity so as to obtain benefits from its activities.
ImmuPharma plc
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2013 (continued)
2 OPERATING LOSS
- Group Year ended Year ended
31 December 31 December
2013 2012
GBP GBP
Operating loss is stated after charging/(crediting):
Share based payments charge 8,844 67,072
Employers National Insurance provision
in respect of share based payments
charge 26,229 (84,367)
Depreciation of property, plant and
equipment
- owned 23,270 19,553
Amortisation of intangible assets
- patents 32,644 31,370
Services provided by Company auditors:
- Audit services 39,500 39,000
- Other services relating to tax compliance
services 3,750 3,150
- Other services relating to taxation
advisory services 1,850 550
- Other services - interim review 7,750 7,250
Audit services provided by other auditors 11,541 10,625
============= =============
ImmuPharma plc
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2013 (continued)
3 EARNINGS PER SHARE Year ended Year ended
- Group 31 December 31 December
2013 2012
GBP GBP
Earnings
Earnings for the purposes of basic
earnings per share being net loss after
tax attributable to equity shareholders (3,689,346) (3,844,034)
Number of shares
Weighted average number of ordinary
shares for the purposes of basic earnings
per share 81,663,119 81,532,463
Basic earnings per share (4.52)p (4.71)p
Diluted earnings per share (4.52)p (4.71)p
The Group has granted share options in respect of equity
shares to be issued, the details of which are disclosed
in the full set of accounts.
There is no difference between basic earnings per share
and diluted earnings per share as the share options are
anti-dilutive.
ImmuPharma plc
ImmuPharma plc
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2013 (continued)
4 CASH USED IN OPERATIONS
Group Group
31 December 31 December
2013 2012
GBP GBP
Operating loss (4,228,135) (4,175,053)
Depreciation and
amortisation 55,914 50,923
Share-based payments 8,844 67,072
Decrease in trade
and other receivables 232,576 785,805
Decrease in trade
and other payables (159,098) (16,963)
Increase/(decrease)
in provisions 26,229 (84,367)
Loss on foreign exchange (148,166) (76,327)
Cash used in operations (4,211,836) (3,448,910)
This information is provided by RNS
The company news service from the London Stock Exchange
END
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