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Reliance GeneMedix (GMX)

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Tuesday 23 December, 2008

Reliance GeneMedix

Half Yearly Report

RNS Number : 6922K
Reliance GeneMedix PLC
23 December 2008
 




FOR IMMEDIATE RELEASE                                                                                                     23 December 2008



Reliance GeneMedix plc

Results for the 6 month period ended 30 September 2008


Reliance GeneMedix plc (the 'Company'), the AIM listed biopharmaceutical company, which is part of the Reliance Life Sciences Group ('RLS'), announces its unaudited interim results for the 6 month period ended 30 September 2008.


Highlights


  • Progress of EPO clinical trials in the EU on track 

  • EPO marketed and launched in India 

  • Receipt of G-CSF clinical manufacturing licence in the EU

  • Change of name to Reliance GeneMedix plc

  • Results in line with budget


Vinay Ranade, CEO of Reliance GeneMedix plc, commented:


'The commercial benefits of the relationship with RLS are already apparent.  EPO has been successfully launched in India and G-CSF, a product originally developed by RLS, is being developed for the European market.'  



ENQUIRIES:

Reliance GeneMedix plc                        Tel: +353 57 932 3572

Vinay Ranade, Chief Executive Officer


Deloitte Corporate Finance                    Tel: +44 (0)20 7936 3000

Jonathan Hinton, John Ball 


Lothbury Financial                                   Tel: +44 (0)20 7011 9411

Michael Padley, Louise Davis


  Chief Executive Officer's Report


We are pleased to present the results for the six month period ended 30 September 2008 during which the Company has advanced the development programmes of both of its biosimilar products in the EU, namely Erythropoietin (EPO) and Granulocyte Colony Stimulating Factor (G-CSF)


Business overview

EPO clinical studies in the EU are progressing according to plan and timetable. The Company is continuing to work on various validation studies to meet regulatory requirements in the EU and to develop further and strengthen its production techniques and processes.


During the period, the Company obtained manufacturing licencfrom the Irish Medicines Board for clinical lots of G-CSF. The Company has also finalised its strategy for the development programme of G-CSF in order to manufacture clinical lots and initiate clinical development in the EU in the coming year.  G-CSF would be our second biosimilar product.


The commercial benefits of the relationship with RLS are already becoming apparent:  EPO has been launched in the Indian market and has received a positive response and the Company has already started to develop G-CSF in the EU. G-CSF was originally developed by RLS.


Financial review

Operating losses of Euro 2.05 million for the period are in line with the Company's expectations and reflect the planned levels of expenditure.  The Company recorded, though on a modest scale, its first revenues through the sale of EPO in the Indian market.


The Company has capitalised development expenditure of Euro 3.51 million, which was incurred during the period on the EPO development programme The level of current assets and liabilities is in line with our expectation and the current activities of the Company.


The entire operational expenditure during the period continued to be financed through the investment from RLS 

  Consolidated Income Statement

For the six months ended 30 September 2008

 
 
Notes
6 months ended
30 September
2008
6 months
ended
30 September 2007

Year ended
31 March
2008
 
 
Unaudited
€’000
Unaudited
€’000
Audited
€’000
Revenue
5
235
-
-
Cost of sales
 
(235)
-
-
 
 
__________
__________
__________
Gross profit
 
-
-
-
 
 
__________
__________
__________
 
 
 
 
 
Research and development
6
(16)
(3,241)
(3,298)
Administrative expenses
 
(2,004)
(1,844)
(4,221)
 
 
__________
__________
__________
Total operating expenses
 
(2,020)
(5,085)
(7,519)
 
 
__________
__________
__________
 
 
 
 
 
Operating loss
 
(2,020)
(5,085)
(7,519)
Finance income
 
31
284
477
Finance costs
 
(64)
(42)
(142)
Other income
 
-
-
58
 
 
__________
__________
__________
Loss before taxation
 
(2,053)
(4,843)
(7,126)
Taxation
 
-
-
-
 
 
__________
__________
__________
Loss for the period
 
(2,053)
(4,843)
(7,126)
 
 
__________
__________
__________
 
 
 
 
 
Loss per share – basic and diluted
8
(1.3c)
(3.1c)
(4.6c)
 
 
__________
__________
__________


  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Consolidated Balance Sheet

As at 30 September 2008

 
Notes
30 September
 2008
30 September
2007
31 March
2008
 
 
Unaudited
€’000
Unaudited
€’000
Audited
€’000
ASSETS
 
 
 
 
Non-current assets
 
 
 
 
Intangible assets
 
6,351
563
2,840
Property, plant and equipment
 
3,921
4,493
4,202
Investment at cost
 
10
-
10
 
 
________
________
________
 
 
10,282
5,056
7,052
 
 
________
________
________
Current assets
 
 
 
 
Inventories
 
666
325
520
Other receivables
 
827
1,287
1,253
Restricted cash
 
204
179
203
Cash and cash equivalents
 
285
9,038
3,303
 
 
________
________
________
 
 
1,982
10,829
5,279
 
 
________
________
________
LIABILITIES
 
 
 
 
Current liabilities
 
 
 
 
Trade and other payables
 
(2,163)
(2,642)
(2,106)
Borrowings
 
(1,453)
-
(1,329)
 
 
________
________
________
 
 
(3,616)
(2,642)
(3,435)
 
 
________
________
________
Net current (liabilities)/assets
 
(1,634)
8,187
1,844
 
 
________
________
________
Total assets less current liabilities
 
8,648
13,243
8,896
 
 
________
________
________
Non-current liabilities
 
 
 
 
Borrowings
 
-
(1,394)
-
 
 
________
________
________
 
 
-
(1,394)
-
 
 
________
________
________
Net assets
 
8,648
11,849
8,896
 
 
________
________
________
Shareholders’ equity
 
 
 
 
Share capital
 
22,305
22,305
22,305
Shares to be issued
9
1,798
-
-
Share premium
 
39,538
39,538
39,538
Other reserves
 
3,963
4,620
3,957
Retained losses
 
(58,956)
(54,614)
(56,904)
 
 
________
________
________
Total shareholders’ equity
 
8,648
11,849
8,896
 
 
________
________
________


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Consolidated Cash Flow Statement

For the six months ended 30 September 2008



 
Notes
6 months to
30 September
 2008
6 months to 30 September
2007
Year to
31 March
2008
 
 
Unaudited
€’000
Unaudited
€’000
Audited
€’000
Cash flows from operating activities
 
 
 
 
Cash used in operations
7
(1,138)
(4,716)
(7,407)
Interest paid
 
(36)
(3)
(4)
 
 
________
________
________
Net cash flows used in operating activities
 
(1,174)
(4,719)
(7,411)
 
 
________
________
________
Cash flows from investing activities
 
 
 
 
Purchase of plant and equipment
 
(214)
(238)
(431)
Purchase of intangible assets
 
(3,511)
(530)
(2,809)
Interest received
 
64
294
493
Proceeds from disposal of subsidiary
 
-
1,114
1,114
Payments for investments
 
-
-
(10)
Increase in restricted cash
 
(1)
-
(23)
 
 
________
________
________
Net cash flows (used in)/generated from investing activities
 
 
(3,662)
 
640
 
(1,666)
 
 
________
________
________
Cash flows from financing activities
 
 
 
 
Proceeds from share warrant
 
1,798
-
-
 
 
________
________
________
Cash flows generated from financing activities
 
1,798
-
-
 
 
________
________
________
 
 
 
 
 
Net decrease in cash and cash equivalents
 
(3,038)
(4,079)
(9,077)
Cash and cash equivalent at start of period
 
3,303
13,115
13,115
Exchange gain/(loss)
 
20
2
(735)
 
 
________
________
________
Cash and cash equivalents
 
285
9,038
3,303
 
 
________
________
________
 
 
 
 
 

  Consolidated Statement of Changes in Equity

For the six months ended 30 September 2008


 
 
 
 
Other reserves
 
 
 
 
Share capital
 
Share premium
 
Shares to be issued
 
Warranty reserve
 
Capital reserve
Cumulative translation reserve
 
Retained loss
 
 
Total
 
€’000
€’000
€’000
€’000
€’000
€’000
€’000
€’000
Balance at 1 Apr 2007
22,305
39,538
-
4,183
437
-
(49,785)
16,678
Loss for the period
-
-
-
-
-
-
(4,843)
(4,843)
Share option charge
-
-
-
-
-
-
14
14
 
______
______
______
______
______
______
______
______
Balance at 30 Sep 2007
22,305
39,538
-
4,183
437
-
(54,614)
11,849
 
______
______
______
______
______
______
______
______
Loss for the period
-
-
-
-
-
-
(2,283)
(2,283)
Currency translation difference
 
-
 
-
 
-
 
-
 
-
 
(663)
 
-
 
(663)
Share option charge
-
-
-
-
-
-
(7)
(7)
 
______
______
______
______
______
______
______
______
Balance at 31 Mar 2008
22,305
39,538
-
4,183
437
(663)
(56,904)
8,896
 
______
______
______
______
______
______
______
______
Loss for the period
-
-
-
-
-
-
(2,053)
(2,053)
Currency translation difference
 
-
 
-
 
-
 
-
 
-
 
6
 
-
 
6
Shares in respect of share warrant
 
-
 
-
 
1,798
 
-
 
-
 
-
 
-
 
1,798
Share-based payment
-
-
-
-
-
-
1
1
 
______
______
______
______
________
______
______
______
Balance at 30 Sep 2008
22,305
39,538
1,798
4,183
437
(657)
(58,956)
8,648
 
______
______
______
______
________
______
______
______


Notes to the Consolidated Interim Financial Statements
 
These financial statements are the unaudited consolidated interim financial information of Reliance GeneMedix plc, a public limited company incorporated and domiciled in the United Kingdom, with its registered office at Tower 42, 20th Floor, 25 Old Broad Street, London EC2N 1HQ , and its subsidiaries (together, “the Group”) for the six months ended 30 September 2008.
The Company is a subsidiary of Reliance Life Sciences Private Limited, India.
The Company has its primary listing on the Alternative Investment Market (AIM) of the London Stock Exchange.
The consolidated financial information for the six months ended 30 September 2008 has not been audited.
The condensed consolidated interim financial statements do not comprise statutory accounts within the meaning of section 240 of the Companies Act 1985. Statutory accounts for the year ended 31 March 2008 were approved by the Board of Directors on 30 August 2008 and delivered to the Registrar of Companies. The report of the auditors on those accounts was unqualified, did not contain an emphasis of matter paragraph and did not contain any statement under section 237 of the Companies act 1985.
2.    Basis of preparation
This condensed consolidated interim financial information for the six months ended 30 September 2008 has been prepared in accordance with IAS 34, ‘Interim Financial Reporting’ as adopted by the European Union. The condensed consolidated interim financial information should be read in conjunction with the annual financial statements for the year ended 31 March 2008, which have been prepared in accordance with IFRSs as adopted by the European Union.
The accounting policies applied are consistent with those of the annual financial statements for the year ended 31 March 2008, as described in those annual financial statements.
3.    Principal risks
The principal risks and uncertainties which could impact the Group have not changed since 31 March 2008. A detailed explanation of those risks and uncertainties can be found in the Directors’ Report section of the Annual Report for the year ended 31 March 2008.


 

 
4.    Segment information
The Group only has only one business segment.
Segmental geographic information is set out below:
 

 
UK
Ireland
Total
 
_________________________
________________________
________________________
 
6 months to 30 Sep
2008
6 months to 30 Sep
2007
Year to  
31 Mar
2008
6 months to 30 Sep
2008
6 months to 30 Sep 2007
Year to
31 Mar
2008
6 months to 30 Sep
2008
6 months to 30 Sep
2007
Year  to
31 Mar
2008
 
€’000
€’000
€’000
€’000
€’000
€’000
€’000
€’000
€’000
Revenue
-
-
-
235
-
-
235
-
-
Cost of sales
-
-
-
(235)
-
-
(235)
-
-
 
______
______
______
______
______
________
______
______
______
Gross profit
-
-
-
-
-
-
-
-
-
Research & Development costs
 
(16)
 
(1,419)
 
(1,476)
 
-
 
(1,822)
 
(1,822)
 
(16)
 
(3,241)
 
(3,298)
Administrative expenses
 
(188)
 
(750)
 
(1,545)
 
(1,816)
 
(1,094)
 
(2,676)
 
(2,004)
 
(1,844)
 
(4,221)
 
______
______
______
______
______
________
______
______
______
Total operating loss
 
(204)
 
(2,169)
 
(3,021)
 
(1,816)
 
(2,916)
 
(4,498)
 
(2,020)
 
(5,085)
 
(7,519)
Finance income
31
284
477
-
-
-
31
284
477
Finance costs
(64)
(45)
(145)
-
3
3
(64)
(42)
(142)
Other income
-
-
58
-
-
-
-
-
58
 
______
______
______
______
______
________
______
______
______
Segment loss before & after tax
 
(237)
 
(1,930)
 
(2,631)
 
(1,816)
 
(2,913)
 
(4,495)
 
(2,053)
 
(4,843)
 
(7,126)
 
______
______
______
______
______
________
______
______
______
Other information
 
 
 
 
 
 
 
 
 
Depreciation
35
53
120
460
431
859
495
484
979
Amortisation
-
2
3
-
-
-
-
2
3
Impairment
-
69
69
-
-
-
-
69
69
 
______
______
______
______
______
________
______
______
______
Balance Sheet
 
 
 
 
 
 
 
 
 
Total assets
1,273
10,917
4,999
10,991
4,968
7,332
12,264
15,885
12,331
Total liabilities
1,175
3,150
1,940
2,441
886
1,495
3,616
4,036
3,435
Capital Expenditure
 
-
 
113
 
232
 
3,725
 
655
 
3,008
 
3,725
 
768
 
3,240
 
______
______
______
______
______
________
______
______
______
 
 
5.    Revenue
During the period, EPO was successfully launched in the Indian market. In order to penetrate the market quickly and build a market share, EPO was introduced at an attractive price which reflects the current competitiveness of the Indian market.
 
 
 
 
 
6.    Analysis of research and development costs
 

 
 
6 months to
30 September
 2008
6 months to 30 September
2007
Year to
31 March
2008
 
 
Unaudited
€’000
Unaudited
€’000
Audited
€’000
 
 
 
 
 
Gross research and development spend
 
3,527
3,771
6,107
Deduct: capitalised development costs
 
(3,511)
(530)
(2,809)
 
 
________
________
________
Research and development costs expensed
 
16
3,241
3,298
 
 
________
________
________
 
 
 
 
 
 
 
7.    Cash used in operations
 

 
 
6 months to
30 September
 2008
6 months to 30 September
2007
Year to
31 March
2008
 
 
Unaudited
€’000
Unaudited
€’000
Audited
€’000
 
 
 
 
 
Loss for the period
 
(2,053)
(4,843)
(7,126)
Adjustments for:
 
 
 
 
- Finance income
 
(31)
(284)
(477)
- Finance costs
 
64
42
142
- Other income
 
-
-
(58)
- Depreciation of property, plant and equipment
 
495
484
979
- Impairment of acquired intellectual property rights
 
-
69
69
- Amortisation of intangible assets
 
-
2
3
- Share option charges
 
1
14
7
 
 
________
________
________
Operating cash flows before movement in working capital
 
 
(1,524)
 
(4,516)
 
(6,461)
Increase in inventories
 
(145)
(139)
(335)
Decrease/(increase) in debtors
 
378
(138)
12
Increase/(decrease) in creditors
 
153
77
(623)
 
 
________
________
________
Cash used in operations
 
(1,138)
(4,716)
(7,407)
 
 
________
________
________
 
 
 
 
 
 
 
 
8.    Loss per share
Basic loss per share is calculated by dividing the loss attributable to ordinary shareholders by the weighted average number of ordinary shares outstanding during the period. For diluted loss per share, the weighted average number of ordinary shares in issue is adjusted assuming conversion of all dilutive potential ordinary shares.
The earnings and weighted average number of ordinary shares used in the calculation of basic loss per share are as follows:

 
 
6 months to
30 September
2008
6 months to
30 September
2007
Year to
31 March 2008
Loss for the period (€’000)
 
(2,053)
(4,843)
(7,126)
Weighted average number of shares (‘000)
 
155,718
155,718
155,718
 
 
__________
__________
__________
Loss per share – basic and diluted
 
(1.3c)
(3.1c)
(4.6c)
 
 
__________
__________
__________
 
9.    Related party transactions
During the period, the Company received an amount of €1.8 million from its parent company, Reliance Life Sciences Private Limited as application money towards warrants.  
10.   Events occurring after the balance sheet date
There is no event after 30 September 2008 that requires disclosure or adjustment to these financial statements.
11. Statement of Directors’ Responsibilities
The directors confirm that this condensed consolidated interim financial information has been prepared in accordance with IAS 34 as adopted by the European Union.
 
A list of current directors of the Company is maintained on the Reliance GeneMedix plc website: www.genemedix.com.
By order of the Board
Vinay Ranade
Chief Executive Officer
23 December 2008
 

 


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