Interim Results

RNS Number : 8000Z

Immupharma PLC

29 September 2009

 



For Immediate Release

29 September 2009

Interim Results for the six months ended 30 June 2009

ImmuPharma plc reports revenue of £21.6m

ImmuPharma plc (LSE:IMM), the specialist discovery and development pharmaceutical company is pleased to announce its interim results for the six months ended 30 June 2009.

INTERIM HIGHLIGHTS

• Revenue reported of £21.6m for the period following the receipt of $30m from Cephalon, Inc. as a license payment for LupuzorTM in February
• Basic and diluted earnings per share were 15.05p and 13.69p respectively (31 December 2008:  6.23p and 5.72p respectively)
• Strong cash position of £27m (as at 30 June 2009)
• Interim analysis of Phase IIb data for LupuzorTM showed statistically significant superiority over placebo
• Cephalon, Inc. exercised their right to license LupuzorTM with a $30m license payment with the potential for various future cash milestone payments totalling up to $500m as well as royalties on any future sales. Cephalon, Inc. will also assume responsibility for all future costs and activities for LupuzorTM.  
• Received 'Breakthrough of the Year 2009' European Mediscience Award 

Post Review Period

• A total of 12.5 million ordinary shares (16.1% of the issued share capital) was acquired at a price of 86 pence per share to institutional investors on 23 July 2009, including M&G Investments

Commenting on the progress to date and the outlook for ImmuPharma, Dimitri Dimitriou, Chief Executive Officer, said:

'The first half of 2009 has been a truly exciting time in the history of ImmuPharma. The promising interim analysis for LupuzorTM's Phase IIb data and its subsequent licensing to Cephalon, Inc. has been a big step forward in ImmuPharma's development. We look forward to building on this success during the rest of 2009 and in the coming years.'

For further information, please contact:

ImmuPharma PLC:

Dimitri Dimitriou, Chief Executive Officer            [phone]

Richard Warr, Chairman                    

Tracy Weimar, VP, Operations                    

Buchanan Communications

Lisa Baderoon                                                   [phone]

Panmure, Gordon & Co., NOMAD & Broker

Andrew Burnett                                                [phone]

  Chairman and Chief Executive Statement

Summary

The first six months of 2009 have been a momentous time for ImmuPharma with the announcement of an interim analysis of the Phase IIb data for LupuzorTM, our lead candidate for the treatment of Lupus, a chronic, life-threatening autoimmune disease, demonstrating statistically significant superiority over placebo and Cephalon Inc's exercise of their right to license LupuzorTM with a $30m license payment. The various future cash milestone payments upon the achievement of certain regulatory and sales milestones (including the option and license fees) may total up to approximately $500m. In addition to the cash milestone payments, ImmuPharma will receive royalties on commercial sales of LupuzorTM.  Furthermore, Cephalon, Inc. will assume responsibility for all future costs and activities associated with LupuzorTM's development and commercialisation.  The licensing of LupuzorTM has strengthened the Group's cash position and secures ImmuPharma's ability to progress our other compounds in the coming years. Furthermore, we have been delighted to add a number of blue chip, institutional investors to our shareholder base.

Our pipeline now includes 5 drug candidates.  The most advanced, LupuzorTM has been licensed to Cephalon, Inc. who will take over responsibility for its development and all associated costs. Another drug candidate, IPP-204106 is for the treatment of cancer and has been awarded grants totalling €1.15m by French government organisations. Three other earlier stage programmes are in preclinical development for - inflammatory disorders, moderate to severe pain and serious hospital infections. In addition to our lead compounds, our long-term pipeline includes a patented chemical library of over 300,000 small molecules and a technology for converting small peptides to drugs that can be applied to potentially generate further compounds for the Company.

Development Pipeline

LupuzorTM 

Early in the year, ImmuPharma announced that a planned interim analysis of the Phase IIb clinical trial comparing LupuzorTM to placebo in patients with systemic lupus erythematosus (also known as Lupus) demonstrated statistically significant superiority of LupuzorTM over placebo. This interim analysis was performed and reviewed by an independent Data Monitoring Committee according to ICH guidelines and was conducted after 125 randomised patients had completed the 12 week treatment period with half of them having also completed the additional 12 week follow-up. The primary efficacy measure was a 'SLEDAI response' defined as a decrease of at least 4 points in the SLEDAI score, a scale generally accepted by physicians as an assessment of the clinical activity of Lupus patients, a lower score representing lower disease activity.  Analysis of the data demonstrated that the 200mcg dose of LupuzorTM administered every four weeks was statistically significantly superior to placebo (p=0.015). LupuzorTM was generally well-tolerated with no significant drug related adverse events recorded.  This data followed on from the successful results of the Phase IIa trial.

Following on from the option agreement between Cephalon, Inc and ImmuPharma agreed in November, 2008 and based on the interim analysis of the Phase IIb data, Cephalon exercised their right to license LupuzorTM in February 2009. This brought an immediate license payment of $30m to the Group and holds the potential for a total of approximately $500m in future cash milestone payments upon the achievement of certain regulatory and sales milestones. In addition to the cash milestone payments, ImmuPharma will receive royalties on commercial sales of LupuzorTM.  

IPP-204106, treatment for cancer

IP-204106 is ImmuPharma's lead compound for cancer. The rights for this compound have been obtained through the Company's ongoing research collaboration with the Centre National de la Recherche Scientifique (CNRS), France's leading scientific research The molecule is a nucleolin antagonist and has a dual mechanism of action, acting both in preventing angiogenesis as well as proliferation. Preclinical data has shown that nucleolin antagonists inhibit the growth of tumours and metastasis in many cancer types.  Having confirmed the €1.15m of French government grants, the first half of 2009 has seen ImmuPharma move forward with the clinical development plans of IPP-204106.  

Other pipeline compounds

More limited progress has been made on ImmuPharma's other pipeline compounds for inflammation, pain, MRSA and other hospital-acquired infections during the period. The Group remains committed to their development either alone or with a partner.

Financial Review

There are several key highlights to the financial position of the Group for the first half of 2009.  ImmuPharma received $30m from Cephalon, Inc. as a license payment for LupuzorTM in February which is reflected in the Group's reported £21.6m revenue for the period.   This $30m payment added to the $15m received in November 2008 has ensured a strong cash position for the Group of £27m at the end of the period.   Basic and diluted earnings per share were 15.05p and 13.69p respectively (31 December 2008: 6.23p and 5.72p).  In line with the Company's current policy, no interim dividend is proposed.

The Group continues to use International Financial Reporting Standards as its accounting basis.

Operating profit for the period was £13.6m representing the license income received from Cephalon, Inc. as well as the royalty expense due to the Centre National Recherche Scientifique (CNRS) under the terms of an existing agreement for both the $15m option payment received in November 2008 and the $30m license payment received in February 2009.  Royalties attributable to both payments received have been included in royalty expense in these interim accounts under the terms of the agreement with the CNRS.  The $30m license payment received in 2009 is reported as revenue while for the $15m option payment received in November 2008 is reported as other income in the accounts for the year ended 31 December 2008.  The remaining amounts are principally the employment cost and overhead of maintaining the Group, together with expenditure on research carried out by Contract Research Organisations.

Cash and cash equivalents at 30 June 2009 were £27m compared to £12m at 31 December 2008.  The Group's strong cash position is due to the receipt from Cephalon, Inc. of an option payment of $15m in November 2008 and a license payment of $30m in February 2009. 

Outlook

With a strong cash position, the focus of the Group continues to be on the progression of its lead drug candidates, in particular our promising cancer compound, IPP-204106, and discovery pipeline. We are looking forward to announcing the final results of the Phase IIb trial for LupuzorTM in the coming months and will continue to work together with our partner, Cephalon, Inc. to ensure progression of LupuzorTM through its next phase of development and beyond. ImmuPharma is in discussions with a number of pharmaceutical and biotech companies for potential collaborations whilst also considering the option of progressing further the development of some of its assets alone.

Richard Warr, Chairman

Dimitri Dimitriou, Chief Executive Officer

ImmuPharma plc

CONSOLIDATED INCOME STATEMENT

FOR THE PERIOD ENDED 30 JUNE 2009

	Note	6 months ended  30 June 2009		Year  ended 31 December 2008		6 months ended  30 June 2008
		£		£		£
Continuing operations
Revenue	4	21,569,869		57,120		97,330
Royalty expense	4	(4,301,044)		-		-
Research and development expenses		(1,961,398)		(2,792,767)		(796,888)
Administrative expenses		(1,683,426)		(1,838,913)		(791,341)
Operating profit/(loss)		13,624,001		(4,574,560)		(1,490,899)
Other income	4	-		9,351,562		-
Finance costs		(1,747)		(8,078)		(4,787)
Finance income		31,006		94,755		43,236
Profit/(loss) before taxation		13,653,260		4,863,679		(1,452,450)
Tax		(1,992,325)		(186,220)		-
Profit/(loss) for the period		11,660,935		4,677,459		(1,452,450)
Attributable to:
Equity holders of the parent company		11,660,935		4,677,459		(1,452,450)
Earnings/(loss) per ordinary share
Basic	2	15.05p		6.23p		(2.00)p

Diluted	2	13.69p		5.72p		(2.00)p

ImmuPharma plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME 
FOR THE PERIOD ENDED 30 JUNE 2009

	6 months ended  30 June  2009		Year  ended 31 December 2008		6 months ended  30 June  2008
	£		£		£
Profit/(loss) for the financial period	11,660,935		4,677,459		(1,452,450)
Other comprehensive income
Exchange differences on translation of foreign operations	(1,495,946)		890,067		15,688
Other comprehensive income for the period, net of tax	(1,495,946)		890,067		15,688
Total comprehensive income for the period	10,164,989		5,567,526		(1,436,762)

ImmuPharma plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2009

		30 June 2009		31 December 2008		30 June 2008
		£		£		£
Non-current assets
Intangible assets		748,697		809,213		765,706
Property, plant and equipment		9,894		13,319		14,139
Total non-current assets		758,591		8,22,532		779,845
Current assets
Trade and other receivables		422,369		120,914		434,411
Cash and cash equivalents		27,123,016		12,458,417		1,176,031
Total current assets		27,545,385		12,579,331		1,610,442
Current liabilities
Financial liabilities - borrowings		42,207		29,611		29,251
Trade and other payables		4,317,812		1,106,357		308,486
Tax payable		1,881,169		202,648		-
Provisions		160,612		46,808		81,511
Total current liabilities		6,401,800		1,385,424		419,248
Net current assets		21,143,585		11,193,907		1,191,194
Non-current liabilities
Financial liabilities - borrowings		409,008		776,085		308,593
Net assets		21,493,168		11,240,354		1,662,446
EQUITY
Ordinary shares		7,748,118		7,748,118		7,277,615
Share premium		5,486,985		5,486,985		3,558,340
Merger reserve		106,148		106,148		106,148
Other reserves		(760,850)		647,271		(401,580)
Retained earnings		8,912,767		(2,748,168)		(8,878,077)
Total equity		21,493,168		11,240,354		1,662,446

ImmuPharma plc

CONCOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE PERIOD ENDED 30 JUNE 2009

		Share capital		Share premium		Merger reserve		Other reserves*		Retained Earnings		Total equity
		£		£		£		£		£		£
	At 1 January 2008	7,277,615		3,558,340		106,148		(466,133)		(7,425,627)		3,050,343
	Total comprehensive income for the period	-		-		-		15,688		(1,452,450)		(1,436,762)
	Share based payments	-		-		-		48,865		-		48,865
	At 30 June 2008	7,277,615		3,558,340		106,148		(401,580)		(8,878,077)		1,662,446
	At 1 January 2008	7,277,615		3,558,340		106,148		(466,133)		(7,425,627)		3,050,343
	Total comprehensive income for the year	-		-		-		890,067		4,677,459		5,567,526
	New issue of equity capital	470,503		2,306,317		-		-		-		2,776,820
	Less: expenses of new share issue	-		(377,672)		-		-		-		(377,672)
	Share based payments	-		-		-		97,730		-		97,730
	Equity shares to be issued	-		-		-		125,607		-		125,607
	At 31  December 2008	7,748,118		5,486,985		106,148		647,271		(2,748,168)		11,240,354
	Total comprehensive income for the period	-		-		-		(1,495,946)		11,660,935		10,164,989
	Share based payments	-		-		-		87,825		-		87,825
	At 30 June 2009	7,748,118		5,486,985		106,148		(760,850)		8,912,767		21,493,168

*    Other reserves as at 30 June 2009 comprises a reverse acquisition reserve £(3,541,203) (2008: £(3,541,203)), a translation reserve £(494,121) (2008: £1,001,825) and equity shares to be issued of £3,274,474 (2008: £3,186,649).

ImmuPharma plc

CONSOLIDATED STATEMENT OF CASHFLOWS

FOR THE PERIOD ENDED 30 JUNE 2009

	Notes			6 months ended  30 June 2009			Year  ended 31 December 2008		6 months ended  30 June  2008
				£			£		£
Cash flows from operating activities
Cash generated from/(used in) operations	3			17,446,000			(3,556,364)		(1,601,085)
Interest paid				(1,747)			(8,078)		(4,787)
Net cash generated from/(used in)  operating activities				17,444,253			(3,564,442)		(1,605,872)
Investing activities
Purchase of property, plant and equipment				(908)			(5,033)		(3,450)
Disposal of intangibles assets				(841)			(259)		-
Finance income				31,006			94,755		43,236
Net cash from investing activities				29,257			89,463		39,786
Financing activities
Net proceeds from share issue - Company				-			2,524,756		-
Decrease in bank overdraft				15,096			(932)		1,540
New loans				1,706			390,033		-
Loan repayments				(297,663)			(269,851)		(212,594)
Other income				-			9,351,562		-
Net cash (used in)/generated from financing activities				(280,861)			11,995,568		(211,054)
Effects of exchange rates on cash and cash equivalents			(2,528,050)			990,913			6,256
Net increase/(decrease) in cash and cash equivalents				14,664,599			9,511,502		(1,770,884)
Cash and cash equivalents at start of period				12,458,417			2,946,915		2,946,915
Cash and cash equivalents at end of period				27,123,016			12,458,417		1,176,031

ImmuPharma plc

NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2009

1.  ACCOUNTING POLICIES

Basis of preparation

The interim financial information in this report has been prepared using accounting policies consistent with IFRS as adopted by the European Union. IFRS is subject to amendment and interpretation by the International Accounting Standards Board (IASB) and the International Financial Reporting Interpretations Committee (IFRIC) and there is an ongoing process of review and endorsement by the European Commission.  The financial information has been prepared on the basis of IFRS that the Directors expect to be adopted by the European Union and applicable as at 31 December 2009.

Except as described below, the accounting policies applied are consistent with those of the annual financial statements for the year ended 31 December 2008.

The presentation of the primary financial statements has been modified in order to comply with IAS 1 (revised). However the revised standard has no impact on the reported results or financial position of the group.

Taxes on income in the interim periods are accrued using the tax rate that would be applicable to expected total annual earnings.

Non-Statutory accounts

The financial information for the year ended 31 December 2008 set out in this interim report does not constitute the Group's statutory accounts for that period.  The statutory accounts for the year ended 31 December 2008 have been delivered to the Registrar of Companies.  The auditors reported on those accounts; their report was unqualified, did not contain a statement under either Section 237 (2) or Section 237 (3) of the Companies Act 1985 and did not include references to any matters to which the auditor drew attention by way of emphasis.  The financial information for the 6 months ended 30 June 2009 and 30 June 2008 is unaudited.

Copies of this statement will be available on the Company's website - www.immupharma.com.

2.     EARNINGS PER SHARE

	6 months ended 30 June 2009		Year  ended 31  December 2008		6 months ended 30 June 2008
	£		£		£
Earnings
Earnings for the purposes of basic and diluted earnings per share being net profit/(loss) attributable to equity shareholders	11,660,935		4,677,461		(1,452,450)
Number of shares
Weighted average number of ordinary shares for the purposes of basic earnings per share	77,482,183		75,049,193		72,776,149
Effect of dilutive potential ordinary shares:
Share options	4,475,000		3,545,000		-
Warrants	3,245,280		3,245,280		-
	85,202,463		81,839,473		72,776,149
Basic earnings/(loss) per share	15.05p		6.23p		(2.00)p
Diluted earnings/(loss) per share	13.69p		5.72p		(2.00)p

3	CASH GENERATED FROM/(USED IN) OPERATIONS
				30 June  2009		31 December 2008		30 June  2008
				£		£		£
	Operating profit/(loss)			13,624,001		(4,574,560)		(1,490,899)
	Depreciation and amortisation			20,722		41,996		13,847
	Loss on sale of intangible assets			-		19,090
	Share-based payments			87,825		97,730		48,865
	Decrease/(increase) in debtors			316,928		348,113		(13,368)
	Increase/(decrease) in creditors			3,282,720		553,233		(156,102)
	Increase/(decrease) in provisions			113,804		(41,966)		(7,263)
	Cash generated from/(used in) operations			17,446,000		(3,556,364)		(1,601,085)

4	LUPUZORTM REVENUE AND ROYALTY EXPENSE
	In February 2009 Cephalon Inc exercised its option to license the exclusive worldwide rights to Lupuzor and has made a non refundable payment of $30million to the Group (disclosed as 'Revenue'), in addition to the non refundable upfront option payment of $15million made in November 2008 (shown  in the comparative figures as 'Other income'). Under the terms of the licence agreement, the Group is entitled to various future cash milestone payments and royalties on commercial sales of Lupuzor. Cephalon Inc will be responsible for all future costs and activities, including Phase III clinical trials, regulatory filing and the subsequent commercialisation and sale of the product worldwide. Under the terms of the existing arrangement in place with Centre National Recherche Scientifique (CNRS), upon Cephalon Inc exercising its option in connection with the exclusive license agreement referred to above, the Group is obliged to make payments of up to 15% of the payments received from Cephalon Inc. At the date of approval of these interim results, discussions are ongoing with CNRS in relation to the final amounts payable by the Group, and an amount of £4.3million has been accrued as a royalty expense in the period reflecting the Board's estimate of the maximum amount payable in respect of relevant income earned to date.

5	SUBSEQUENT EVENTS
	There have been no subsequent events since 30 June 2009.

 

END

 

 

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