Immupharma Regulatory News (IMM)

29 Sep 2009 07:00



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

Post Review Period

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 +44 20 7152 4080

Richard Warr, Chairman

Tracy Weimar, VP, Operations

Buchanan Communications

Lisa Baderoon +44 20 7466 5000

Panmure, Gordon & Co., NOMAD & Broker

Andrew Burnett +44 20 7459 3600

  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

ImmuPharma plc

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

ImmuPharma plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2009

ImmuPharma plc

CONCOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE PERIOD ENDED 30 JUNE 2009

* 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

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