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 a manufacturing licence from 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
END
IR BDBDDSBDGGIX