IMMUPHARMA PLC — Earnings Release 2014

Apr 30, 2015

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RNS Number : 7653L

Immupharma PLC

30 April 2015

	30 APRIL 2015

PRELIMINARY RESULTS ANNOUNCEMENT

for the year ended 31 December 2014

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 2014.

Key Highlights:

·      LupuzorTM

o  Agreement signed with Simbec-Orion, an international clinical research organisation, to undertake crucial Phase III clinical trial including a commitment to reinvest a significant proportion of its fees in new ordinary shares at a fixed price of 150p per share, representing a premium of 191% over yesterday's closing mid-market price (post-period end).

o  Simbec-Orion agreement provides many options for the Company's future corporate strategy including the possibility of generating our own sales.

o  Granted an amended Special Protocol Assessment ("SPA") by the FDA in 2013 reducing the number of patients required to complete Phase III.

o  World class Scientific Advisory Board of prominent physicians and advisers in the field of lupus to provide guidance and support for LupuzorTM's phase III programme.

·      Nucant programme IPP-204106

o  Phase I/IIa clinical trial of the next generation "polyplexed Nucant" formulation in three European hospitals including the prestigious Institute Jules Bordet, Belgium, has now been completed.

o  Focus on angiogenesis applications in:

§ Cancer:  development of novel applications of the Nucant family of peptides targeting combination therapies.

§ Ophthalmology:  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 Centre Nationale de la Recherche Scientifique ("CNRS") to identify and patent novel peptide drugs 

o  Patented Urelix technology targeted to have first application in diabetes.

·      Successful share placement primarily with key institutional investors, which raised gross proceeds to the Company of £3.4 million in October.

·      Advance assurance received (post-period end) from HMRC that the Company qualifies for the Enterprise Investment Scheme.

·      Continued availability of Darwin £50 million equity finance facility

·     Cash position as at 31 December 2014 of £5.4m (2013: £5.4m)

·      Loss for the period of £2.9m (2013: £3.7m).

·      Basic and diluted loss per share was 3.43p (2013: 4.52p)

·     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: 

2014 has been a year of substantial progress on all fronts, and this has continued into 2015. Our recent deal with a leading Contract Research Organisation (Simbec-Orion) is a key part of our strategy to retain the rights to LupuzorTM until commercialisation.  This means that many options remain open including further corporate deals and commercialising ourselves in certain territories, following on the successful path of all the leading "big-biotech" companies.  The Nucant program and the new research facilities in collaboration with the CNRS in Bordeaux continue to provide further promise for the Group.  We were delighted to have received the additional backing of key institutional investors in October with a successful share placement of £3.4 million.  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 course of 2015.

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 (UK) Limited, NOMAD & Broker	+44 (0) 20 7886 2500
Hugh Morgan, Fred Walsh, Duncan Monteith, Corporate Finance Charles Leigh-Pemberton, Corporate Broking

ImmuPharma plc

Report of the Chairman, the Chief Executive Officer and the President

We are pleased to report on a number of exciting developments for the Group.  Post-period end, we announced an agreement with Simbec-Orion, an international clinical research organisation, to begin the pivotal Phase III clinical trial for LupuzorTM.  Further, we announced that the Phase I/IIa trial of our cancer program has been completed and further therapeutic applications have been identified.  In October, our French subsidiary, Ureka Sarl, was awarded a grant of approximately €400,000 to develop its proprietary UrelixTM technology.  Further, the Company concluded a successful share placement that month resulting in gross proceeds to the Company of approximately £3.4 million. In January 2015, the Company received advance assurance from HMRC (the UK tax authorities) that it would qualify for Enterprise Investment Scheme status.    

In January 2015, the Company finalised an agreement with Simbec-Orion, an international clinical research organisation, to undertake the crucial Phase III clinical trial for LupuzorTM.  This is a pivotal study designed to demonstrate the safety and efficacy of LupuzorTM and is the last step prior to the filing for approval.  Since reacquiring the rights to LupuzorTM from Cephalon, Inc arising from its acquisition by Teva Pharmaceuticals, ImmuPharma has been focused on assessing creative options to complete the final development phase.  The Company is delighted to be able to report that it is moving ahead into Phase III with Simbec-Orion.  This arrangement opens many options for our future strategy including further corporate deals in parallel with the possibility of following in the path of the "big biotechs" by generating our own sales.

LupuzorTM 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 LupuzorTM.  Importantly, this means that the total cost of Phase III is now greatly reduced.  

ImmuPharma has also reached a milestone with our nucleolin antagonist ("Nucant") peptide program with the completion of the Phase I/IIa clinical trial of the next generation "polyplexed Nucant" and the award of new patents for an "optically pure" version of the Nucant family.  The composition of matter patent provides longer exclusivity, additional protection of the Nucant program and a multitude of other indications in addition to cancer.  We anticipate being able to announce the results and future plans for the program in cancer particularly in the field of combination therapy.  In addition, the Nucant program has shown some modulation of angiogenesis with multiple applications in cancer as well as in non-cancerous but highly critical clinical indications including ophthalmology.  ImmuPharma has been awarded a grant to further investigate the Nucant's potential in this therapeutic area.   

ImmuPharma's collaboration with the CNRS (Centre National de la Recherche Scientifique), INSERM (Institut National de la Santé et de la Recherche Medicale) and the University of Bordeaux at the Institut Européen de Chimie et Biologie (IECB) has become well established during the year.  This collaboration filed a new patent controlling a breakthrough peptide technology called 'UrelixTM' which allows the mimicry of long natural peptides in the configuration used to bind their receptor and improve their stability to enzymatic degradation as well as greater efficacy.  The potential of this technology is substantial and has potential application in many serious diseases.  In October, the ImmuPharma subsidiary involved with this collaboration, Ureka sarl, was awarded a grant of approximately €400,000 to support this work. 

In October, we were delighted to have successfully completed a share placement of approximately £3.4 million principally through ImmuPharma's long standing institutional shareholders.  The funds raised are being used to support the Company as it progresses with the pivotal Phase III trial for LupuzorTM.   The Company also recently received advance assurance from HMRC that it will qualify for Enterprise Investment Scheme status.  This should provide the Company with further investor interest over the coming year.

During the year, the profile of LupuzorTM was featured at both the European Lupus Conference in Athens and through a presentation at the Immunology Frontier Research Center of Osaka University, an internationally renowned research center in the field of immunology in Japan.

ImmuPharma plc

Report of the Chairman, the Chief Executive Officer and the President (continued)

Our key objectives for 2015 are to work with our development partner Simbec-Orion on the final development phase of LupuzorTM, to advance our Nucant programme in cancer and other indications and to focus on our peptide technology collaboration in Bordeaux.  We value the support and look forward to enhancing our key relationship with the 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. 

The Board would like to thank its shareholders for their ongoing support as well as its corporate and scientific advisers and the CNRS in France for their collaboration.

Richard Warr                      Dimitri F. Dimitriou                           Dr Robert Zimmer

Chairman                               Chief Executive Officer                        President

ImmuPharma plc

Financial Review

During 2014, the Group focused on securing funding and/or a partner for LupuzorTM's Phase III trial, progressing our cancer program and establishing our peptide technology collaboration with the University of Bordeaux and the CNRS.

Income Statement

The overall loss for the year ended 31 December 2014 was £2.9 million down from £3.7 million for the year ended 31 December 2013.  The decrease in overall loss was mainly attributable to reduced expenditure on the Group's cancer program.  Research and development expenditure decreased to £1.5 million (2013: £2.1 million) due to the Group's cancer program completing the active phase of the Phase I/IIa trial during the year.  Administrative expenses were steady at £2.2 million (2013: £2.2 million).  Net finance income was £84,741 for 2014 including a gain on foreign exchange of £26,177.  This contrasts with net finance loss of £205,755 for 2013 including a loss on foreign exchange of £148,166.  Total comprehensive loss for the year was £3.1 million which was down from £3.5 million in 2013.

As in previous years, IFRS2, relating to share-based payments has had an impact on the Group's results.  There is a charge in the financial statements of £43,275 (2013: £8,844) which represents the remaining outstanding 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.  This is the final amount to be charged to the financial statements for these options. 

Balance Sheet

Cash and cash equivalents at 31 December 2014 amounted to £5.4 million (2013:  £5.4 million).  Financial borrowings were £0.8 million (2013: £1.1 million).  This balance 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 £50 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 LupuzorTM. 

Results

The Group recorded a loss for the year of £2.9 million (2013:  £3.7 million).  Basic and diluted loss per share was 3.43p (2013:  4.52p).  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 and/or funding to advance LupuzorTM and to maintain a tight control over cash resources whilst enabling controlled development of the product pipeline.  

Tracy Weimar

Vice President, Operations and Finance

ImmuPharma plc

CONSOLIDATED INCOME STATEMENT

FOR THE YEAR ENDED 31 DECEMBER 2014

	Notes	Year ended 31 December 2014		Year ended 31 December 2013
		£		£
Continuing operations
Revenue		184,815		-
Research and development expenses		(1,457,298)		(2,072,906)
Administrative expenses		(2,152,417)		(2,155,229)
Operating loss		(3,424,900)		(4,228,135)
Finance costs		(14,195)		(266,121)
Finance income		98,936		60,366
Loss before taxation		(3,340,159)		(4,433,890)
Tax		468,679		744,544
Loss for the year		(2,871,480)		(3,689,346)
Attributable to:
Equity holders of the parent company		(2,871,480)		(3,689,346)
Earnings per ordinary share
Basic	2	(3.43p)		(4.52p)
Diluted	2	(3.43p)		(4.52p)

ImmuPharma plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

FOR THE YEAR ENDED 31 DECEMBER 2014

	Year ended 31 December 2014		Year ended 31 December 2013
	£		£
Loss for the financial year	(2,871,480)		(3,689,346)
Other comprehensive income
Items that may be reclassified subsequently to profit or loss:
Exchange differences on translation of foreign operations	(230,357)		154,725
Other comprehensive (loss)/income for the year, net of tax	(230,357)		154,725
Total comprehensive loss for the year	(3,101,837)		(3,534,621)

ImmuPharma plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 31 DECEMBER 2014

		31 December 2014		31 December 2013
		£		£
Non-current assets
Intangible assets		560,537		602,070
Property, plant and equipment		366,363		97,149
Total non-current assets		926,900		699,219
Current assets
Trade and other receivables		721,410		1,109,737
Cash and cash equivalents		5,424,033		5,396,296
Total current assets		6,145,443		6,506,033
Current liabilities
Financial liabilities - borrowings		417,852		346,935
Trade and other payables		549,652		628,372
Provisions		23,468		56,600
Total current liabilities		990,972		1,031,907
Net current assets		5,154,471		5,474,126
Non-current liabilities
Financial liabilities - borrowings		375,989		769,601
Net assets		5,705,382		5,403,744
EQUITY
Ordinary shares		8,862,246		8,228,246
Share premium		10,490,920		7,764,720
Merger reserve		106,148		106,148
Other reserves		(3,647,195)		(3,460,113)
Retained earnings		(10,106,737)		(7,235,257)
Total equity		5,705,382		5,403,744

ImmuPharma plc

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE YEAR ENDED 31 DECEMBER 2014

		Share capital		Share premium		Merger reserve		Other reserves - Acquisition reserve		Other reserves - Translation Reserve		Other reserves- Equity shares to be issued		Retained Earnings		Total equity
		£		£		£		£		£		£		£		£
	At 1 January 2013	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
	Loss for the financial year	-		-		-		-		-		-		(2,871,480)		(2,871,480)
	Exchange differences on translation of foreign operations	-		-		-		-		(230,357)		-		-		(230,357)
	Share based payments	-		-		-		-		-		43,275		-		43,275
	New issue of equity capital	634,000		2,726,200		-		-		-		-		-		3,360,200
	At 31 December 2014	8,862,246		10,490,920		106,148		(3,541,203)		(1,809,372)		1,703,380		(10,106,737)		5,705,382
	Attributable to:-
	Equity holders of the parent company	8,862,246		10,490,920		106,148		(3,541,203)		(1,809,372)		1,703,380		(10,106,737)		5,705,382

ImmuPharma plc

CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE YEAR ENDED 31 DECEMBER 2014

	Notes			Year ended 31 December 2014		Year ended 31 December 2013
				£		£
Cash flows from operating activities
Cash used in operations	3			(3,231,366)		(4,211,836)
Tax				754,996		297,969
Interest paid				(14,195)		(55)
Net cash used in operating activities				(2,490,565)		(3,913,867)
Investing activities
Purchase of property, plant and equipment				(342,275)		(3,054)
Purchase of intangibles				(5,656)		-
Interest received				72,759		60,366
Net cash (used in)/ generated from investing activities				(275,172)		57,312
Financing activities
Decrease in bank overdraft				(146)		(25,041)
Loan repayments				(395,326)		(177,220)
Net proceeds from issue of new share capital				3,360,200		393,750
Net cash generated from financing activities				2,964,728		191,489
Net increase/(decrease) in cash and cash equivalents				198,991		(3,665,066)
Cash and cash equivalents at beginning of year				5,396,296		8,893,267
Effects of exchange rates on cash and cash equivalents				(171,254)		168,095
Cash and cash equivalents at end of year				5,424,033		5,396,296

ImmuPharma plc

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

FOR THE YEAR ENDED 31 DECEMBER 2014

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 2014 or 31 December 2013.

The financial information has been extracted from the statutory accounts for the years ended 31 December 2014 and 31 December 2013.  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 2014 and 31 December 2013 and did not include references to any matters to which the auditor drew attention by way of emphasis. 

The Group's statutory accounts for the year ended 31 December 2013 have been delivered to the Registrar of Companies, whereas those for the year ended 31 December 2014 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 2014 and the statutory accounts for the year ended 31 December 2013, which have been prepared in accordance with International Financial Reporting Standards ("IFRS").

The financial information is for the year ended 31 December 2014 and the comparatives are for the year ended 31 December 2013.

The Group's statutory accounts 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 2014 (continued)

2	EARNINGS PER SHARE	Year ended 31 December 2014		Year ended 31 December 2013
		£		£
	Earnings
	Earnings for the purposes of basic earnings per share being net loss after tax attributable to equity shareholders	(2,871,480)		(3,689,346)
	Number of shares
	Weighted average number of ordinary shares for the purposes of basic earnings per share	83,602,573		81,663,119
	Basic earnings per share	(3.43)p		(4.52)p
	Diluted earnings per share	(3.43)p		(4.52)p
	The Group has granted share options in respect of equity shares to be issued. There is no difference between basic earnings per share and diluted earnings per share as the share options are anti-dilutive.

ImmuPharma plc

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

FOR THE YEAR ENDED 31 DECEMBER 2014 (continued)

3	CASH USED IN OPERATIONS
									31 December 2014				31 December 2013
									£				£
	Operating loss								(3,424,900)				(4,228,135)
	Depreciation and amortisation								99,166				55,914
	Share-based payments								43,275				8,844
	Decrease in trade and other receivables								172,445				232,576
	Decrease in trade and other payables								(114,397)				(159,098)
	Increase/(decrease) in provisions								(33,132)				26,229
	Gain/(loss) on foreign exchange								26,177				(148,166)
	Loss on disposal of fixed asset investment								-				-
	Cash used in operations								(3,231,366)				(4,211,836)
4	SUBSEQUENT EVENTS
	In January 2015, the Group entered into a Collaboration Agreement with Simbec-Orion Group Limited, an international clinical research organisation, to execute the Group's pivotal phase III clinical study for LupuzorTM.  Simbec-Orion has agreed that it will reinvest a significant proportion of its fees in new ordinary shares at a fixed price of 150p per share.  It is expected that over the duration of the study, Simbec-Orion will subscribe for approximately 900,000 new ordinary shares.

This information is provided by RNS

The company news service from the London Stock Exchange

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