Interim Results

RNS Number : 5579T
Immupharma PLC
30 September 2010
 



For Immediate Release

30 September 2010

 

Immupharma plc

INTERIM RESULTS ANNOUNCEMENT

For the six months ended 30 June 2010

 

ImmuPharma plc (LSE:IMM) ("Immupharma" or the "Company" or the "Group"), the specialist discovery and development pharmaceutical company is pleased to announce its interim results for the six months ended 30 June 2010.

 

INTERIM HIGHLIGHTS

 

·     First patients dosed with IPP-204106, ImmuPharma's anti-cancer compound with a novel and promising mechanism of action, in a Phase IIa cancer trial, after receipt of an Investigational New Drug (IND) approval from AFSSAPS, Agence Francaise de Securite Sanitaire des Produits de Sante.

·     Cephalon, Inc (Cephalon), ImmuPharma's partner for Rigerimod (LupuzorTM),  commenced the recruitment of lupus patients for a Phase IIb trial being conducted largely in the US.  This study has been designed to provide US-based investigators and the US FDA with clinical data obtained mainly in the USA.  The data generated from this trial will be part of the package to be submitted to the FDA and other regulatory authorities for approval.  Positive Phase IIb data from outside the USA has previously been announced.

·     Cephalon has also initiated development of LupuzorTM in Japan through its partner Symbio Pharmaceuticals.

·     ImmuPharma remains committed to its other compounds in R&D.

·     Strong cash position of £20m (as at 30 June 2010)

·     Received Best Drug Development Company in Europe 2010 Award from the New Economy

·     Basic and diluted loss per share were 0.10p and 0.10p respectively (31 December 2009:  basic and diluted earnings per share 10.46p and 9.99p respectively)

 



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

 

"The first half of 2010 has seen ImmuPharma build on the success of 2009 with Cephalon, our partner for LupuzorTM, moving ahead with a large trial in the US.  At the same time, we are focusing our own efforts on our promising cancer drug and are proud to have initiated a clinical trial dosing cancer patients in France.  We look forward to building on this success during the rest of 2010 and in the coming years."

 

 

Richard Warr, ImmuPharma's Chairman added:

 

"The entry of our cancer compound into clinical trials is a landmark event for ImmuPharma.  The company now has two potential blockbuster drugs in the clinic and a strong corporate partnership with Cephalon.  In addition ImmuPharma is pleased to report a strong balance sheet and an enviable cash position."

 

 

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, Mark Court, George Prassas                               +44 20 7466 5000

 

Panmure, Gordon & Co., NOMAD & Broker

Andrew Burnett                                                                         +44 20 7459 3600

 

Execution Noble & Co, Joint Broker

James Bromhead                                                                       +44 20 7456 9191

 

 

 

 


ImmuPharma plc

 

Statement from the Chairman and the Chief Executive Officer

 

 

INTERIM HIGHLIGHTS

 

Summary

 

The first half of 2010 has seen ImmuPharma progress after the successful licensing of LupuzorTM to Cephalon in 2009.  The Group has made great strides in developing our partnership with Cephalon as well as advancing plans for our other promising programmes.  While Cephalon moves forward with a large Phase IIb trial for LupuzorTM in the US and Europe, ImmuPharma received an Investigational New Drug (IND) approval from AFSSAPS, Agence Francaise de Securite Sanitaire des Produits de Sante, for a Phase IIa study in patients of  IPP-204106, our anti-cancer compound with a novel and promising mechanism of action.  The first patients have been dosed and the trial is progressing well.  We were also delighted to receive the award for Best Drug Development Company in Europe 2010 from the New Economy.

 

Our pipeline now includes 5 drug candidates.  The most advanced, LupuzorTM has been licensed to Cephalon, Inc. who has taken over responsibility for its development and all associated costs.  Our next priority program is IPP-204106 for the treatment of cancer.  It 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

 

Since licensing LupuzorTM to Cephalon in 2009, ImmuPharma has placed a priority on developing the working relationship with our partner.  Cephalon has started the recruitment of lupus patients for a Phase IIb trial in the US and Europe.  This study was designed to allow US-based investigators and the FDA to evaluate Rigerimod (LupuzorTM) as a treatment for lupus on the basis of data derived mainly from the USA.  A large number of centres are involved and the data generated from this trial will be part of the package to be submitted to the FDA and other regulatory authorities for approval.  In addition to the US trial and in order to prepare for the commercial development in Japan, Cephalon has also initiated development of LupuzorTM in Japan through its partner Symbio Pharmaceuticals.  Under the agreement, Cephalon retains all commercialisation rights to Rigerimod (LupuzorTM) in Japan, and Symbio is granted an exclusive right to conduct a Japanese-based Phase I clinical study which is mandatory for a future filing of Rigerimod (LupuzorTM) with Japanese regulatory bodies. 

 

·      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 organisation.  The molecule is a nucleolin antagonist and has a promising and novel 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.  In June, ImmuPharma received an Investigational New Drug (IND) approval from AFSSAPS, Agence Francaise de Securite Sanitaire des Produits de Sante, for a Phase IIa study.  The first patients have been dosed and the trial is progressing.

 

 

ImmuPharma plc

 

Statement from the Chairman and Chief Executive Officer

 

Development Pipeline (continued)

 

 

·      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

 

After the cash inflow attributable to the Cephalon license agreement in 2009, the first six months of 2010 demonstrate ImmuPharma's refocused priorities on the development of its other pipeline candidates.  ImmuPharma's cash balance remains strong at £20 million (£22.5 million at 31 December 2009).  Basic and diluted loss per share was 0.10p and 0.10p respectively (31 December 2009: earnings per share 10.46p and 9.99p).  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 loss for the period was £2,521,050.  Research and development expense was £975,454 reflecting primarily the activities around the development of IPP-204106, our anti-cancer compound.  Administrative expenses were £1,545,713.

 

On 2 March 2010 ImmuPharma (UK) Limited, a 100% owned subsidiary of ImmuPharma plc, was entered in to a Members Voluntary Liquidation.

 

Outlook

 

With a strong cash position, the focus of the Group is on continuing the development of our strong relationship with our license partner for LupuzorTM, Cephalon, and the development of our other pipeline candidates, in particular our promising cancer compound, IPP-204106, and discovery pipeline.  We are looking forward to announcing the preliminary results of the Phase IIb trial for LupuzorTM and our Phase IIa trial for IPP-204106 in the coming months.  Furthermore, in an effort to maximise the value of our development pipeline, ImmuPharma continues to be in discussions with a number of pharmaceutical and biotech companies for potential collaborations.

 

 

 

 

 

 

Richard Warr, MA, Chairman                         Dimitri Dimitriou, MSc, Chief Executive Officer

 

29 September 2010


 

 

ImmuPharma plc

 

CONSOLIDATED INCOME STATEMENT

FOR THE PERIOD ENDED 30 JUNE 2010

 

 

 

 

 

Note

 

6 months ended

30 June 2010

 

 

Year

 ended 31 December

2009

Restated

 

 

6 months ended

30 June 2009

Restated

 

 

£

 

£

 

£

Continuing operations

 

 

 

 

 

 

Revenue

4

117

 

22,054,544

 

21,569,869

Royalty expense

4

-

 

(4,155,765)

 

(4,301,044)

Research and development expenses

 

(975,454)

 

(4,034,173)

 

(1,961,398)

Administrative expenses

 

(1,545,713)

 

(3,564,833)

 

(1,532,255)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating (loss)/profit

 

(2,521,050)

 

10,299,773

 

13,775,172

 

 

 

 

 

 

 

Finance costs

 

(1,190)

 

(1,260,190)

 

(152,918)

Finance income

 

2,444,845

 

61,243

 

31,006

 

 

 

 

 

 

 

 

 


 

 

 


(Loss)/profit before taxation

 

(77,395)

 

9,100,826

 

13,653,260

 

 

 

 

 

 

 

Tax

 

(181)

 

(997,448)

 

(1,992,325)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Loss)/profit for the period

 

(77,577)

 

8,103,378

 

11,660,935

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Attributable to:

 

 

 

 

 

 

Equity holders of the parent company

 

(77,577)

 

8,103,378

 

11,660,935

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Loss)/earnings per ordinary share

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

2

(0.10)p

 

10.46p

 

15.05p

 

 

 

 

 

 

 

 

Diluted

2

(0.10)p

 

9.99p

 

13.69p

 

 

 

 

 

 

 

 


ImmuPharma plc

 

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE PERIOD ENDED 30 JUNE 2010

 

 

 

6 months ended

30 June

 2010

 

Year

 ended 31 December

2009

 

6 months ended

30 June

 2009

 

£

 

£

 

£

 

 

 

 

 

 

Profit/(loss) for the financial period

(77,577)

 

8,103,378

 

11,660,935

 

 

 

 

 

 

 


 

 

 


Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

Exchange differences on translation of foreign operations


(1,101,186)

 


(1,644,702)

 


(1,495,946)

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income for the period, net of tax


(1,101,186)

 


(1,644,702)

 


(1,495,946)

 

 

 

 

 

 

 

 

 

 

 

 

Total comprehensive income for the period

(1,178,763)

 

6,458,676

 

10,164,989

 

 

 

 

 

 

 

 

 

 

 


ImmuPharma plc

 

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2010

 

 

 

 

 

30 June 2010

 

31 December

2009

 

30 June 2009

 

 

£

 

£

 

£

Non-current assets

 

 

 

 

 

 

Intangible assets

 

705,108

 

746,705

 

748,697

Property, plant and equipment

 

12,378

 

9,336

 

9,894

 

 

 

 

 

 

 

 

 


 

 

 


Total non-current assets

 

717,486

 

756,041

 

758,591

 

 

 

 

 

 

 

 

 


 

 

 


Current assets

 

 

 

 

 

 

Trade and other receivables

 

1,172,703

 

1,361,458

 

422,369

Cash and cash equivalents

 

20,008,493

 

22,525,509

 

27,123,016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total current assets

 

21,181,196

 

23,886,967

 

27,545,385

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Financial liabilities - borrowings

 

30,682

 

32,549

 

42,207

Trade and other payables

 

4,021,735

 

5,306,660

 

4,317,812

Tax payable

 

-

 

620,275

 

1,881,169

Provisions

 

81,448

 

174,529

 

160,612

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total current liabilities

 

4,133,866

 

6,134,013

 

6,401,800

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net current assets

 

17,047,330

 

17,752,954

 

21,143,585

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-current liabilities

 

 

 

 

 

 

Financial liabilities - borrowings

 

759,370

 

425,671

 

409,008

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net assets

 

17,005,446

 

18,083,324

 

21,493,168

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EQUITY

 

 

 

 

 

 

Ordinary shares

 

8,109,146

 

8,109,146

 

7,748,118

Share premium

 

7,302,645

 

7,302,645

 

5,486,985

Merger reserve

 

106,148

 

106,148

 

106,148

Other reserves

 

(3,888,675)

 

(2,888,375)

 

(760,850)

Retained earnings

 

5,376,182

 

5,453,759

 

8,912,767

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total equity

 

17,005,446

 

18,083,324

 

21,493,168

 

 

 

 

 

 

 

 


ImmuPharma plc

 

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE PERIOD ENDED 30 JUNE 2010

 


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 2009

 



 

Total comprehensive income for the

year

 

 

-

 

Share based payments

-

 



 

At 30 June 2009

 



 


 

At 1 January 2009

 



 

Total comprehensive income for the

year

 

 

-

 

New issue of equity capital

 

36,500

 

Share based payments

-

 

Share option exercise

-

 

 

Exercise of warrants

 

324,528

 



 



 

At 31 December 2009

 



 

Total comprehensive income for the

year

 

 

-

 

Share based payments

-

 



 



 

At 30 June 2010

 



 

Attributable to:-


 



 

Equity holders of the parent company

 



 




ImmuPharma plc

 

CONSOLIDATED STATEMENT OF CASHFLOWS

FOR THE PERIOD ENDED 30 JUNE 2010

 

 

Notes

6 months ended

30 June 2010

 

Year

 ended 31 December

2009

Restated

 

6 months ended

30 June

 2009

Restated

 

 

£

 

£

 

£

Cash flows from operating activities

 

 

 

 

 

 

Cash (used in)/generated from operations

 

3

 

(3,194,309)

 

13,735,260

 

 

17,597,171

Tax paid

 

(594,679)

 

(510,591)

 

-

Interest paid

 

(1,190)

 

(1,260,190)

 

(152,918)

 

 

 

 

 

 

 

 

 


 

 

 


Net cash (used in)/generated from operating activities

 

(3,790,178)

 

 

11,964,479

 

17,444,253

 

 

 

 

 

 

 

 

 


 

 

 


Investing activities

 

 

 

 

 

 

Purchase of property, plant and equipment

 

(6,434)

 

(3,611)

 

(908)

Purchase of  intangibles assets

 

(1,696)

 

(779)

 

(841)

Finance income

 

2,444,844

 

61,243

 

31,006

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net cash from investing activities

 

2,436,714

 

56,853

 

29,257

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financing activities

 

 

 

 

 

 

Net proceeds from share issue - Company

 

-

 

155,124

 

-

Decrease in bank overdraft

 

(276)

 

1,546

 

15,096

New loans

 

383,618

 

3,796

 

1,706

Loan repayments

 

-

 

(303,962)

 

(297,663)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net cash generated from/(used in) financing activities

 

 

383,342

 

 

(143,496)

 

 

(280,861)

 

 

 

 

 

 

 

Effects of exchange rates on cash and

cash equivalents

 

(1,546,894)

 

 

(1,810,744)

 

 

(2,528,050)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net (decrease)/increase in cash and cash equivalents

 

(2,517,016)

 

10,067,092

 

14,664,599

 

 

 

 

 

 

 

Cash and cash equivalents at start of period

 

22,525,509

 

12,458,417

 

12,458,417

 

 

 

 

 

 

 

 

Cash and cash equivalents at end of period

 

 

20,008,493

 

22,525,509

 

 

27,123,016

 

 

 

 

 

 

 

 

 


ImmuPharma plc

 

NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2010

 

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 2010.

 

For the period ended 30 June 2010 the Group is required to adopt IFRS 3 Business Combinations (revised) and IAS 27 Consolidated and Separate Financial Statements (revised). The adoption of these revised standards has had no impact on the financial information for the six months ended 30 June 2010, the year ended 31 December 2009 or the six months ended 30 June 2009.

 

The Directors have considered the accounting policy with respect to the treatment of foreign exchange gains and losses on foreign currency cash balances and consider it appropriate to change the policy to reflect such foreign exchange gains and losses within Finance Income and Finance Costs respectively rather than within Administrative Expenses. The Directors consider that this presentation provides more relevant information about the group's financial performance. This adjustment has decreased Administrative Expenses and increased Finance Costs for the periods ended 30 June 2009 or 31 December 2009 by £151,171 and £1,257,212 respectively. This has had no impact on the profit for the periods ended 30 June 2009 or 31 December 2009 or on the total equity of the group as at those dates.

 

Income tax

 

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 2009 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 2009 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 498 (2) or Section 498 (3) of the Companies Act 2006 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 2010 and 30 June 2009 is unaudited.

 

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

 

 

 

 

 

 



 

ImmuPharma plc

 

NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2010

(continued)

 

 

2              EARNINGS PER SHARE

               

 

 


6 months ended 30 June 2010

 

Year ended 31 December

2009

 


6 months ended 30 June 2009

 

£

 

£

 

£

 

 

 

 

 

 

Earnings

 

 

 

 

 

Earnings for the purposes of basic and diluted earnings per share being net (loss)/profit attributable to equity shareholders

(77,577)

 



8,103,378

 

11,660,935

 

 

 

 

 

 

 


 

 

 


Number of shares

 

 

 

 

 

Weighted average number of ordinary shares for the purposes of basic earnings per share

81,092,463

 

77,498,096

 

77,482,183

 

 

 

 

 

 

 

Effect of dilutive potential ordinary shares:

 

 

 

 

 

Share options

2,853,842

 

2,922,796

 

4,475,000

Warrants

685,540

 

685,540

 

3,245,280

 

 

 

 

 

 

 

 

 

 

 

 

 

84,631,845

 

81,608,096

 

85,202,463

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic (loss)/earnings per share

(0.10)p

 

10.46p

 

15.05p

 

 

 

 

 

 

 


 

 

 


 

 

 

 

 

 

Diluted (loss)/earnings per share

(0.10)p

 

9.99p

 

13.69p

 

 

 

 

 

 

 

 

 

 

 

 

               

 

 



ImmuPharma plc

 

NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2010

(continued)

 

3

CASH GENERATED FROM/(USED IN) OPERATIONS

 

 

 

 

 

30 June 2010

 

31 December 2009

Restated

 

30 June 2009

Restated

 

 

 

 

£

 

£

 

£

 

 

 

 

 

 

 

 

 

 

Operating (loss)/profit

 

 

(2,521,050)

 

10,299,773

 

13,775,172

 

Depreciation and amortisation

 

18,908

 

40,739

 

20,722

 

Share-based payments

 

 

100,886

 

229,169

 

87,825

 

Decrease/(increase) in debtors

 

 

174,532

 

(1,284,377)

 

316,928

 

(Decrease)/increase in creditors

 

 

(874,504)

 

4,322,235

 

3,282,720

 

(Decrease)/increase in provisions

 

 

(93,081)

 

127,721

 

113,804

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash (used in)/generated from operations

 

 

 

(3,194,309)

 

13,735,260

 

 

17,597,171

 

 

 

 

 

 

 

 

 

 

4

LUPUZORTM REVENUE AND ROYALTY EXPENSE

 

 

In February 2009 Cephalon Inc exercised its option to license the exclusive worldwide rights to Lupuzor and made a non refundable payment of $30million to the Group.

 

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.

 

 

 

 

5

SUBSEQUENT EVENTS

 

 

 

 

There have been no subsequent events since 30 June 2010.

 

 

 

 

 


This information is provided by RNS
The company news service from the London Stock Exchange
 
END
 
 
IR EAXNNAASEEFF

Companies

Immupharma (IMM)
UK 100

Latest directors dealings