TIDMIMM
RNS Number : 8624B
Immupharma PLC
09 April 2013
FOR IMMEDIATE RELEASE 9 APRIL 2013
PRELIMINARY RESULTS ANNOUNCEMENT
for the year ended 31 December 2012
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 2012.
Key Highlights:
-- Lupuzor(TM)
o Discussions continue with potential partners in parallel to
discussions with Contract Research Organisations for Lupuzor's
pivotal Phase III programme - Special Protocol Assessment and Fast
Track Designation granted by FDA
o American College of Rheumatology Annual Conference - Abstract
presented confirms Lupuzor's superior safety and efficacy
profile
o The Centre National de la Recherche Scientifique (CNRS),
Europe's largest fundamental research institution, re-affirms the
effectiveness of Lupuzor(TM) (peptide P140)
-- Nucant cancer programme IPP-204106
o Phase I/IIa clinical trial continues with the next generation
"polyplexed Nucant" formulation in three European hospitals
including the prestigious Institute Jules Bordet in Belgium -
Interim data to be provided in H1 2013 followed by a Phase IIa
efficacy study
-- Voted 'Best Medical Research and Development Company, Europe
2012' at The New Economy Pharmaceutical & Healthcare Awards
2012
-- Strong cash position as at 31 December 2012 of GBP8.9m (2011: GBP12.2m)
-- Loss for the period of GBP3.8m (2011: GBP3.3m)
-- Basic and diluted loss per share was 4.71p (2011: 4.12p)
-- 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:
ImmuPharma would like to take this opportunity to provide
further insight into the Company's activities over 2012 and into
2013, particularly for Lupuzor(TM) , our lead compound and
potential blockbuster drug for Lupus, a chronic autoimmune
disease.
The Company is pursuing discussions on licensing deals such as
the one concluded with Cephalon Inc. in the past, which brought
ImmuPharma $45m in non-dilutive cash payments as part of a larger
deal, providing validation of Lupuzor(TM) and the management's
ability to deliver corporate deals. The pharmaceutical industry
and, in particular, the large multinational companies are facing a
gap in new products due to the loss of patent exclusivity of many
blockbuster drugs and the lack of enough new products being
discovered internally. As a result, ImmuPharma is at the centre of
the ever changing dynamics of this exciting yet challenging
industry and believe Lupuzor(TM) is an attractive asset as a
licensing opportunity.
In parallel with the Company's strategy of assessing potential
licensing deals, ImmuPharma is exploring the option of a
financially more attractive and creative deal to retain rights
until commercialisation by working closely with a specialist
Contract Research Organisation ('CRO') that may help in providing
funding with the key objective of completing Phase III of
Lupuzor(TM) , the final clinical trial programme, as agreed with
the FDA. The management team is committed to securing the best
outcome for shareholders on any deal structure based on the
potential returns we believe can be achieved on the approval and
commercialisation of Lupuzor.
We were delighted recently to see the article published in
Decision Resources, one of the world's leading research and
advisory firms for pharmaceutical and healthcare issues, that
surveyed U.S. and European rheumatologists who indicated that new
therapies for the treatment of Lupus have the potential to offer
substantial improvements, highlighting Lupuzor(TM) .
Shareholders and new investors should therefore not lose sight
of ImmuPharma's exciting investment proposition and stage of
development. Together with our continued strong cash position we
have two potential blockbuster compounds in clinical trials:
Lupuzor(TM) has been given the 'gold standard' approval from the
FDA with a SPA and Fast Track designation. Our cancer programme is
also progressing well in its second trial in cancer patients,
following the completion of a phase Ib/IIa trial last year. The
lead compound for cancer, IPP-204106, is expected to complete the
ongoing trial that takes place in leading oncology centres in
France and the prestigious Jules Bordet cancer Institute in
Brussels, prior to entering Phase II clinical trials and if
efficacy data are promising, this could also create interest from
potential licensing partners.
In summary, we would like to thank our shareholders and the
CNRS, our research partner, for their support and we look forward
to providing a further update in the near future.
For further information please contact:
+ 44 (0) 20 7152
ImmuPharma plc 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
Fred Walsh
Hannah Woodley
Cenkos Securities plc, Joint
Broker +44 (0) 20 7397 8900
Stephen Keys, Camilla Hume
Report of the Chairman, the Chief Executive Officer and the
President
2012 has been a year of solid progress for ImmuPharma. We have
initiated discussions with a large number of multinational
pharmaceutical companies as a new partner for Lupuzor(TM) . In
parallel, we have also opened discussions with some of the largest
and most competent Contract Research Organisations with the view of
retaining rights to Lupuzor(TM) and thereby generating maximum
shareholder return. Our exciting cancer programme has begun the
second Phase I/IIa clinical trial, with the newly discovered
polyplexed Nucant formulation in three European hospitals including
the prestigious Jules Bordet cancer institute in Belgium. We have
received a further EUR570,000 grant funding from French government
organisations to add to the EUR1.15m previously received to support
this cancer programme. Further, we were delighted to have been
voted 'Best Medical Research and Development Company, Europe 2012'
at The New Economy Pharmaceutical & Healthcare Awards 2012.
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.
In November, together with its key opinion leader co-authors,
ImmuPharma presented Lupuzor(TM) 's Phase IIb data at the American
College of Rheumatology annual conference. During 2012, numerous
discussions have been held with a variety of potential partners. We
expect to have further news on Lupuzor(TM) during 2013.
For reference, ImmuPharma entered into a corporate licensing
deal with Cephalon in 2008 while in the middle of our Phase IIb
study, which ImmuPharma designed, managed and funded. Cephalon paid
ImmuPharma $15m before the results of the phase IIb study for the
exclusive option to enter into the worldwide license. Following
positive results of the ImmuPharma phase IIb study in early 2009,
Cephalon exercised its option by paying a further $30m for an
exclusive worldwide license. This was part of an agreement worth
$500m in cash milestone payments plus royalties on product sales.
Upon completion of the license agreement, Cephalon assumed all
responsibilities and costs for the development and
commercialisation of Lupuzor(TM).
In May 2011, Cephalon agreed to a takeover bid by Teva. The
acquisition was finalized on October 14, 2011. Due to a change of
control provision and given the fact that Teva has a competing drug
candidate for Lupus (laquinimod), based on the key provisions of
the agreement between ImmuPharma and Cephalon, Immupharma requested
and was granted the return of the rights for Lupuzor(TM).
ImmuPharma regained Lupuzor(TM) at an exciting stage in its
development. The FDA has granted Lupuzor(TM) approval to start
Phase III with a Special Protocol Assessment (SPA) and Fast Track
designation.
ImmuPharma has also made promising progress with its anti-cancer
nucleolin antagonist ("Nucant") peptide programme. Having received
approval from the French regulatory authorities, Agence Francaise
de Securite Sanitaire des Produits de Sante (AFSSAPS), it initiated
an initial Phase I dose ranging tolerability and safety study in
three hospitals in France which is now complete. 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 to be
followed by a Phase II efficacy study designed to treat various
cancers in approximately 30 patients to identify appropriate
biomarkers. 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. Our further
intention is to conduct follow-up studies on patients showing the
appropriate biomarkers with glioblastoma (brain tumour), metastatic
melanoma, and pancreatic cancer where nuclear proteins play a key
role.
Additionally, we have been working to raise ImmuPharma's profile
in the investment community and strive to maintain an effective
dialogue with our investors. Further, we were pleased to have
launched a new company website to ensure that investors have access
to all key corporate information and to have launched a new
Lupuzor(TM) website to provide an in-depth look at this promising
potential product.
ImmuPharma plc
Report of the Chairman, the Chief Executive Officer and the
President
Our key objectives for 2013 are to initiate the final
development phase of Lupuzor(TM) , either with a licensing partner
or with a prestigious Contract Research Organisation, to advance
our cancer programme and to develop the rest of our asset base. 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 careful controlled expenditure.
ImmuPharma is looking forward to another promising year in 2013.
The Board would like to thank its shareholders for their ongoing
support as well as its 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
Financial Review
The year ended 31 December 2012 was a year focused on finding a
suitable partner for Lupuzor(TM) and on ensuring the progress of
our cancer programme with the initiation of the next clinical
trial. We were delighted to have received EUR570,000 of further
grant funding from French government organisations.
Income Statement
The overall loss for the year ended 31 December 2012 was GBP3.8m
(2011: GBP3.3m). During 2012, research and development expenditure
was GBP1.6m which is in line with that incurred in 2011.
Administrative expenses were GBP2.6m up from GBP2.2m in 2011. The
Group posted a GBP76,327 loss on foreign exchange in 2012 compared
to a gain of GBP0.2m on foreign exchange in 2011. 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 GBP4.2m (2011: GBP3.6m),
GBP0.3m greater than the loss for the year as a result of exchange
differences 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 GBP67,072 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 GBP52,120 is due to be charged over
the next two years accounts under IFRS2, being the remainder of the
fair value charge.
Balance Sheet
Cash and cash equivalents at 31 December 2012 amounted to
GBP8.9m (2011: GBP12.2m). Financial borrowings were GBP1,288k
(2011: GBP969k). This is primarily the conditional advance, from
the French Government, for use in the development of our cancer
programme. No interest is payable.
Results
The Group recorded a loss for the year of GBP3.8m (2011:
GBP3.3m). Basic and diluted loss per share was 4.71p (2011: 4.12p).
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
CONSOLIDATED INCOME STATEMENT
FOR THE YEAR ENDED 31 DECEMBER 2012
Notes Year ended Year ended
31 December 31 December
2012 2011
GBP GBP
Continuing operations
Revenue - 16,847
Research and development
expenses (1,620,331) (1,619,302)
Administrative expenses (2,554,722) (2,233,643)
Operating loss 2 (4,175,053) (3,836,098)
Finance costs (80,752) (818)
Finance income 87,552 224,013
Loss before taxation (4,168,253) (3,612,903)
Tax 324,219 257,523
Loss for the year (3,844,034) (3,355,380)
Attributable to:
Equity holders of the
parent company (3,844,034) (3,355,380)
Earnings per ordinary
share
Basic 3 (4.71p) (4.12p)
Diluted 3 (4.71p) (4.12p)
ImmuPharma plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEAR ENDED 31 DECEMBER 2012
Year ended Year ended
31 December 31 December
2012 2011
GBP GBP
Loss for the financial year (3,844,034) (3,355,380)
Other comprehensive income
Exchange differences on
translation of foreign operations (311,193) (255,899)
Other comprehensive income
for the period, net of tax (311,193) (255,899)
Total comprehensive income
for the period (4,155,227) (3,611,279)
ImmuPharma plc
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 DECEMBER 2012
Company No. 3929567
31 December 31 December
2012 2011
GBP GBP
Non-current assets
Intangible assets 627,677 665,647
Property, plant and equipment 114,834 125,444
Total non-current assets 742,511 791,091
Current assets
Trade and other receivables 873,620 1,323,293
Cash and cash equivalents 8,893,267 12,164,784
Total current assets 9,766,887 13,488,077
Current liabilities
Financial liabilities
- borrowings 249,951 142,020
Trade and other payables 773,002 689,317
Provisions 30,371 114,738
Total current liabilities 1,053,324 946,075
Net current assets 8,713,563 12,542,002
Non-current liabilities
Financial liabilities
- borrowings 1,038,203 827,067
Net assets 8,417,871 12,506,026
EQUITY
Ordinary shares 8,153,246 8,153,246
Share premium 7,445,970 7,445,970
Merger reserve 106,148 106,148
Other reserves (3,682,632) (3,438,511)
Retained earnings (3,604,861) 239,173
Total equity 8,417,871 12,506,026
ImmuPharma plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 31 DECEMBER 2012
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
2011 8,153,246 7,445,970 106,148 (3,541,203) (1,166,648) 1,378,405 3,594,553 15,970,471
Loss for the
financial
year - - - - - - (3,355,380) (3,355,380)
Exchange
differences
on
translation
of foreign
operations - - - - (255,899) - - (255,899)
Share based
payments - - - - - 146,834 - 146,834
At 31
December
2011 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
Attributable
to:-
Equity
holders of
the parent
company 8,153,246 7,445,970 106,148 (3,541,203) (1,733,740) 1,592,311 (3,604,861) 8,417,871
ImmuPharma plc
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEAR ENDED 31 DECEMBER 2012
Notes Year ended Year ended
31 December 31 December
2012 2011
GBP GBP
Cash flows from operating
activities
Cash used in operations 4 (3,448,910) (3,614,232)
Tax 196,197 247,895
Interest paid (4,425) (818)
Net cash used in operating
activities (3,257,138) (3,367,155)
Investing activities
Purchase of property,
plant and equipment (12,632) (65,724)
Interest received 87,552 61,377
Net cash used in investing
activities 74,920 (4,347)
Financing activities
Increase in bank overdraft 21,741 3,479
New loans 475,020 208,856
Loan repayments (139,892) (47,009)
Net cash generated from
financing activities 356,869 165,326
Net decrease in cash
and cash equivalents (2,825,349) (3,206,176)
Cash and cash equivalents
at beginning of year 12,164,784 15,592,941
Effects of exchange rates
on cash and cash equivalents (446,168) (221,981)
Cash and cash equivalents
at end of year 8,893,267 12,164,784
NOTES TO THE PRELIMINARY RESULTS
FOR THE YEAR ENDED 31 DECEMBER 2012
1 ACCOUNTING POLICIES
The financial information set out in this announcement does not
comprise the Group's statutory accounts for the year ended 31
December 2012 or 31 December 2011.
The financial information has been extracted from the statutory
accounts for the years ended 31 December 2012 and 31 December 2011.
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 2012 and 31 December 2011 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 2011 have
been delivered to the Registrar of Companies, whereas those for the
year ended 31 December 2012 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
2012 and the statutory accounts for the year ended 31 December
2011, which have been prepared in accordance with International
Financial Reporting Standards ("IFRS").
The financial information is for the year ended 31 December 2012
and the comparatives are for the year ended 31 December 2011.
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.
NOTES TO THE PRELIMINARY RESULTS
FOR THE YEAR ENDED 31 DECEMBER 2012 (continued)
2 OPERATING LOSS
- Group Year ended Year ended
31 December 31 December
2012 2011
GBP GBP
Operating loss is stated
after charging/(crediting):
Share based payments charge 67,072 146,834
Employers National Insurance
provision in respect of share
based payments charge (84,367) (19,765)
Depreciation of property,
plant and equipment
- owned 19,553 15,408
Amortisation of intangible
assets
- patents 31,370 31,487
Services provided by Company
auditors:
- Audit services 39,000 37,500
- Other services relating
to tax compliance services 3,150 11,525
- Other services relating 550 -
to taxation advisory services
- Other services - interim
review 7,250 7,250
Audit services provided by
other auditors 10,625 10,419
============= =============
NOTES TO THE PRELIMINARY RESULTS
FOR THE YEAR ENDED 31 DECEMBER 2012 (continued)
3 EARNINGS PER SHARE Year ended Year
- Group 31 December ended
2012 31 December
2011
GBP GBP
Earnings
Earnings for the purposes
of basic earnings per share
being net loss after tax attributable
to equity shareholders (3,844,034) (3,355,380)
Number of shares
Weighted average number of
ordinary shares for the purposes
of basic earnings per share 81,532,463 81,532,463
Basic earnings per share (4.71)p (4.12)p
Diluted earnings per share (4.71)p (4.12)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.
NOTES TO THE PRELIMINARY RESULTS
FOR THE YEAR ENDED 31 DECEMBER 2012 (continued)
4 CASH USED IN OPERATIONS Group Group
31 December 31 December
2012 2011
GBP GBP
Operating loss (4,175,053) (3,836,098)
Depreciation and amortisation 50,923 47,049
Share-based payments 67,072 146,834
Decrease/(increase)
in trade and other receivables 785,805 (391,939)
(Decrease)/increase
in trade and other payables (16,963) 278,543
Decrease in provisions (84,367) (19,765)
Gain/(loss) on foreign
exchange (76,327) 161,144
Inter-company release - -
Cash used in operations (3,448,910) (3,614,232)
This information is provided by RNS
The company news service from the London Stock Exchange
END
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