17:00 Thu 25 Sep 2014
Synairgen plc - Interim results for the six months ended 30 June
Press release
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Interim results for the six months ended
A period of transformation with lead programme out-licensed to AstraZeneca and novel assets identified for development
Operational highlights
· Global exclusive licence agreement signed in June with AstraZeneca for SNG001 (inhaled interferon beta) for all respiratory indications.
· Phase II clinical data published in the
· Screening of new development opportunities using
Financial highlights
· Upfront payment from AstraZeneca agreement of
· Research and development expenditure for the period was
· Post-tax profit for the period of
· Cash and deposit balances of
· Post period-end fundraising (
Commenting on this transformational period,
"During the period,
"This transformative deal was major news for our investors and world-leading experts. We delivered a successful fundraise as a result of the deal and are now screening, via our novel Biobank, a number of potentially very exciting respiratory assets to bring into our pipeline."
-Ends-
For further information, please contact:
Richard Marsden, Chief Executive Officer
John Ward, Finance Director
FinnCap Tel: + 44 (0) 20 7220 0500
Geoff Nash, Christopher Raggett (Corporate Finance)
Stephen Norcross, Simon Johnson (Corporate Broking)
Mary-Jane Elliott / Jessica Hodgson / Laura Thornton
synairgen@consilium-comms.com Tel: +44 (0) 20 3709 5701
Chairman's and Chief Executive Officer's Review
OPERATING REVIEW
Summary
The first six months of the year saw a transformation for Synairgen with two major achievements for the Company. Firstly, Synairgen signed a global, exclusive licensing agreement for the inhaled interferon (IFN) beta programme, SNG001, for asthma, COPD, and other indications to AstraZeneca; secondly, Synairgen's world-class respiratory team commenced the screening of more than 30 new programmes with the objective of bringing a number in to the pipeline. Beyond the period-end, the Company also delivered a successful fundraising in
Business model
Synairgen's business model continues to apply its proven human biology Biobank platform with its world-leading expertise in lung biology in order to take respiratory drugs from discovery through to clinical trials, and ultimately to out-license them to major pharmaceutical companies or niche respiratory players.
Inhaled IFN-beta, SNG001 and the licensing agreement with AstraZeneca
Synairgen developed an inhaled form of IFN-beta (SNG001), following on from a discovery by the academic team based at the
In SNG001's clinical development programme to date, Synairgen's Phase I trials showed that inhaled IFN-beta boosted the immune system and was well tolerated at varying dose levels. Supportive biomarker testing data was also revealed. In a Phase II trial, the results showed that lung function and asthma control were better in the 'more difficult to treat' asthma patients (representing approximately 15% of the asthma population). These patients also had fewer exacerbations.
These results have now been published in the
In
AstraZeneca is a major franchise holder in the respiratory field, with brands such as Symbicort® bringing in revenues of
Synairgen's advanced cell models and Biobank: a differentiating translational research platform
Synairgen, in collaboration with the
New programmes in respiratory medicine
In tandem with concluding the licensing discussions for SNG001, Synairgen, in conjunction with its world-class academic respiratory network, explored various assets that could potentially be brought into the Company for development. From a list of more than 100 opportunities, 30 were selected for more detailed assessment. The ideal programme for Synairgen is one that brings a novel therapeutic approach in areas of unmet clinical need. In this respect, Synairgen may exploit its proprietary Biobank of asthma and COPD ex vivo tissue to ensure that a given drug target is relevant to the disease. This asset permits the Company, at an early development stage, to minimise the development risk and maximise the benefit by improving the all-important bridge between the laboratory and clinical trials.
Synairgen intends to focus on a selected number of programmes that have the potential to play to the strengths of our unique capabilities and deliver substantial future value. These candidate programmes have not, as yet, been disclosed. Furthermore, to pursue its objectives in this context, Synairgen has, post period-end, raised a further
FINANCIAL REVIEW
Statement of Comprehensive Income
The profit from operations for the six months ended
Statement of Financial Position and cash flows
At
The principal elements of the
· Cash generated from operations of
· Research and development tax credits received of
· Share issue proceeds (net of costs) of
OUTLOOK
This has been a very exciting and transformative period for the Company, endorsing the novel respiratory drug discovery platform and business model. We have accomplished a valuable deal for our first programme with an ideal partner in AstraZeneca. We have identified and are screening new potential programmes, leveraging the unique combination of our Biobank platform and Synairgen's founder and KOL expertise in respiratory drug discovery and development, which we expect will yield exciting new treatment options and build substantial value to the Company over the next few years. We look forward to the future with great excitement and thank our investors and scientists for their support.
Simon Shaw Richard Marsden
Chairman Chief Executive Officer
Consolidated Statement of Comprehensive Income
for the six months ended
|
|
Unaudited Six months ended 30 June 2014 |
Unaudited Six months ended 30 June 2013 |
Audited Year ended 31 December 2013 |
|
||
|
Notes |
|
|
|
|
||
|
|
|
|
|
|
||
Revenue |
|
4,250 |
- |
- |
|
||
|
|
|
|
|
|
||
Research and development expenditure |
|
(1,266) |
(683) |
(1,292) |
|
||
Other administrative expenses |
|
(1,098) |
(519) |
(986) |
|
||
Total administrative expenses |
|
(2,364) |
(1,202) |
(2,278) |
|
||
|
|
|
|
|
|
||
Profit/(Loss) from operations |
|
1,886 |
(1,202) |
(2,278) |
|
||
|
|
|
|
|
|
||
Finance income |
|
4 |
7 |
11 |
|
||
Profit/(Loss) before tax |
|
1,890 |
(1,195) |
(2,267) |
|
||
|
|
|
|
|
|
||
Tax credit |
2 |
8 |
132 |
224 |
|
||
Profit/(Loss) and total comprehensive income/(loss) for the period attributable to equity holders of the parent |
|
1,898 |
(1,063) |
(2,043) |
|
||
|
|
|
|
|
|
||
Earnings/(Loss) per ordinary share |
3 |
|
|
|
|
||
Basic earnings/(loss) per share (pence) |
|
2.46p |
(1.41)p |
(2.72)p |
|||
Diluted earnings/(loss) per share (pence) |
|
2.30p |
(1.41)p |
(2.72)p |
|||
|
|
|
|
|
|
||
Consolidated Statement of Changes in Equity (unaudited)
|
Share capital |
Share premium |
Merger reserve |
Retained deficit |
Total |
|
|
|
|
|
|
|
|
|
|
|
|
At |
752 |
19,422 |
483 |
(17,241) |
3,416 |
Total comprehensive loss for the period |
- |
- |
- |
(1,063) |
(1,063) |
Recognition of share-based payments |
- |
- |
- |
106 |
106 |
At |
752 |
19,422 |
483 |
(18,198) |
2,459 |
Total comprehensive loss for the period |
- |
- |
- |
(980) |
(980) |
Recognition of share-based payments |
- |
- |
- |
100 |
100 |
Issuance of ordinary shares |
- |
- |
- |
- |
- |
At |
752 |
19,422 |
483 |
(19,078) |
1,579 |
Total comprehensive income for the period |
- |
- |
- |
1,898 |
1,898 |
Recognition of share-based payments |
- |
- |
- |
85 |
85 |
Issuance of ordinary shares |
34 |
1,468 |
- |
- |
1,502 |
Transaction costs in respect of share issues |
- |
(80) |
- |
- |
(80) |
At |
786 |
20,810 |
483 |
(17,095) |
4,984 |
Consolidated Statement of Financial Position
as at
|
|
Unaudited 30 June 2014 |
Unaudited 30 June 2013 |
Audited 31 December 2013 |
|
Notes |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
Non-current assets |
|
|
|
|
Intangible assets |
|
112 |
318 |
297 |
Property, plant and equipment |
|
16 |
22 |
15 |
|
|
128 |
340 |
312 |
Current assets |
|
|
|
|
Inventories |
|
57 |
238 |
199 |
Current tax receivable |
|
- |
98 |
190 |
Trade and other receivables |
|
161 |
101 |
43 |
Other financial assets - bank deposits |
4 |
1,001 |
857 |
458 |
Cash and cash equivalents |
|
5,078 |
1,279 |
834 |
|
|
6,297 |
2,573 |
1,724 |
Total assets |
|
6,425 |
2,913 |
2,036 |
Liabilities |
|
|
|
|
Current liabilities |
|
|
|
|
Trade and other payables |
|
(1,441) |
(454) |
(457) |
Total liabilities |
|
(1,441) |
(454) |
(457) |
|
|
|
|
|
Total net assets |
|
4,984 |
2,459 |
1,579 |
|
|
|
|
|
Equity |
|
|
|
|
Capital and reserves attributable to equity holders of the parent |
|
|
|
|
Share capital |
|
786 |
752 |
752 |
Share premium |
|
20,810 |
19,422 |
19,422 |
Merger reserve |
|
483 |
483 |
483 |
Retained deficit |
|
(17,095) |
(18,198) |
(19,078) |
Total equity |
|
4,984 |
2,459 |
1,579 |
Consolidated Statement of Cash Flows
for the six months ended
|
Unaudited Six months ended 30 June 2014 |
Unaudited Six months ended 30 June 2013 |
Audited Year ended 31 December 2013 |
|
|
|
|
|
|
|
|
Cash flows from operating activities |
|
|
|
Profit/(Loss) before tax |
1,890 |
(1,195) |
(2,267) |
Adjustments for: |
|
|
|
Finance income |
(4) |
(7) |
(11) |
Depreciation |
6 |
8 |
15 |
Amortisation |
24 |
27 |
47 |
Loss on derecognised intangible asset |
164 |
3 |
4 |
Share-based payment charge |
85 |
106 |
206 |
Cash flows from operations before changes in working capital |
2,165 |
(1,058) |
(2,006) |
Decrease/(Increase) in inventories |
142 |
(166) |
(127) |
(Increase)/Decrease in trade and other receivables |
(117) |
(26) |
32 |
Increase in trade and other payables |
984 |
63 |
66 |
Cash generated from/(used in) operations |
3,174 |
(1,187) |
(2,035) |
Tax credit received |
198 |
244 |
244 |
Net cash generated from/(used in) operating activities |
3,372 |
(943) |
(1,791) |
|
|
|
|
Cash flows from investing activities |
|
|
|
Interest received |
3 |
11 |
15 |
Purchase of property, plant and equipment |
(7) |
(3) |
(3) |
Purchase of intangible assets |
(3) |
(16) |
(16) |
(Increase)/Decrease in other financial assets |
(543) |
574 |
973 |
Net cash (used in)/generated from investing activities |
(550) |
566 |
969 |
|
|
|
|
Cash flows from financing activities |
|
|
|
Proceeds from issuance of ordinary shares |
1,502 |
- |
- |
Transaction costs in respect of share issues |
(80) |
- |
- |
Net cash generated from financing activities |
1,422 |
- |
- |
|
|
|
|
Increase/(Decrease) in cash and cash equivalents |
4,244 |
(377) |
(822) |
Cash and cash equivalents at beginning of period |
834 |
1,656 |
1,656 |
Cash and cash equivalents at end of period |
5,078 |
1,279 |
834 |
Notes to the Financial Statements
for the six months ended
1. Basis of preparation
Basis of accounting
The interim financial statements, which are unaudited, have been prepared on the basis of the accounting policies expected to apply for the financial year to
The interim financial statements do not include all of the information required for full annual financial statements and do not comply with all the disclosures in IAS 34 'Interim Financial Reporting'. Accordingly, whilst the interim statements have been prepared in accordance with IFRSs, they cannot be construed as being in full compliance with IFRSs.
The financial information for the year ended
Going Concern
The directors have prepared financial forecasts to estimate the likely cash requirements of the Group over the next twelve months. In preparing these financial forecasts, the directors have had to make certain assumptions with regards to the timing and amount of future expenditure and other key factors. The directors have attempted to take a balanced and prudent view in preparing these forecasts, however their accuracy is uncertain.
After due consideration and review of these financial forecasts and current cash resources, the directors consider that the Group has adequate financial resources to continue in operational existence for the foreseeable future (being a period of at least twelve months from the date of this report), and for this reason the financial statements have been prepared on a going concern basis.
The
2. Tax credit
The tax credit of
3. Earnings/(Loss) per ordinary share
|
Unaudited |
Unaudited |
Audited |
|
Six months |
Six months |
Year |
|
ended |
ended |
ended |
|
30 June |
30 June |
31 December |
|
2014 |
2013 |
2013 |
|
|
|
|
Profit/(Loss) attributable to equity holders of the Company ( |
1,898 |
(1,063) |
(2,043) |
Weighted average number of ordinary shares in issue |
77,165,989 |
75,184,336 |
75,186,742 |
Notes to the Financial Statements
for the six months ended
3. Earnings/(Loss) per ordinary share (continued)
At
4. Other financial assets
Other financial assets comprise Sterling fixed rate bank deposits of greater than three months' maturity at time of deposit.
5. Post balance sheet events
On
INDEPENDENT REVIEW REPORT TO SYNAIRGEN PLC
Introduction
We have been engaged by the company to review the interim set of financial statements in the half-yearly financial report for the six months ended
We have read the other information contained in the half-yearly financial report and considered whether it contains any apparent misstatements or material inconsistencies with the information in the interim set of financial statements.
Directors' responsibilities
The interim report, including the financial information contained therein, is the responsibility of and has been approved by the directors. The directors are responsible for preparing the interim report in accordance with the rules of the
Our responsibility
Our responsibility is to express to the company a conclusion on the interim set of financial statements in the half-yearly financial report based on our review.
Our report has been prepared in accordance with the terms of our engagement to assist the company in meeting the requirements of the rules of the
Scope of review
We conducted our review in accordance with International Standard on Review Engagements (UK and Ireland) 2410, ''Review of Interim Financial Information Performed by the Independent Auditor of the Entity'', issued by the
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the interim set of financial statements in the half-yearly financial report for the six months ended
Chartered Accountants and Registered Auditors
Southampton
United Kingdom
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