LONDON, UK--(Marketwire - February 18, 2010) -
London, UK, and Cambridge, MA: 18 February 2010 Antisoma plc (LSE: ASM; USOTC: ATSMY) announces its interim financial information for the period ended 31 December 2009.
Highlights
Potential blockbuster ASA404 advancing with Novartis
* Enrolment completed in first-line lung cancer phase III trial
* First-line lung cancer phase III data expected in mid-2011 (announced today); Novartis plans filings in 2011
* Enrolment ongoing in second-line lung cancer phase III trial
* Plans announced for phase Ib/II trial in breast cancer
* Investigator-initiated trials started in other cancers (announced today)
Novel blood cancer treatment AS1413 leads US commercial strategy
* Positive final data reported from secondary AML phase II trial
* Secondary AML phase III trial now over half enrolled (announced today)
* Preparations underway for potential commercialisation in US
* Antisoma plans first filings in 2011
Aptamer AS1411 continues to show potential
* Clinical data suggest distinctive efficacy and safety profile
* Renal cancer phase II trial provides new evidence of activity
* Other indications prioritised over renal cancer for commercial reasons
* Plans announced for phase IIb trial in AML
Financial highlights
* Loss after tax of GBP18.3 million (H1 2008: loss after tax of GBP 5.0 million)
* Cash at 31 December 2009 of GBP 49.6 million (31 December 2008: GBP 52.7 million)
* No revenues in this period (2008: GBP 5.5 million); recognition of GBP 19.7 million from oral fludarabine divestment expected in half-year ended 30 June 2010
Glyn Edwards, CEO of Antisoma, said: “We now have two drugs - ASA404 and AS1413 - that are well into pivotal phase III trials. Success with either drug will enable us to make a rapid transition into a company directly involved in product commercialisation and capable of generating recurring revenues based on product sales.”
Eric Dodd, Antisoma’s CFO, added: “We continue to manage our cash resources prudently and to focus our investment on key products with potential to create significant value for shareholders.”
A webcast and conference call will be held today at 9.30 am GMT. The webcast can be accessed via Antisoma’s website at www.antisoma.com and the call by dialling +44 (0)20 7075 1520 and using the participant PIN code 468563#.
A second conference call will be held at 2.00 pm GMT/9.00 am EST. Call numbers are +44(0)20 7075 1520 or from the US (toll-free) 1 866 793 4273; the participant PIN code for this call is 468563#.
A recording of the webcast will be available afterwards on Antisoma’s website.
Enquiries:
Antisoma plc + 44 (0) 7909 915068 Glyn Edwards, Chief Executive Officer Eric Dodd, Chief Financial Officer Daniel Elger, VP, Marketing & Communications Buchanan Communications +44 (0)20 7466 5000 (All media enquiries) Mark Court, Lisa Baderoon, Catherine Breen The Trout Group +1 617 583 1308 (US investor enquiries) Seth Lewis
Except for the historical information presented, certain matters discussed in this statement are forward looking statements that are subject to a number of risks and uncertainties that could cause actual results to differ materially from results, performance or achievements expressed or implied by such statements. These risks and uncertainties may be associated with product discovery and development, including statements regarding the Group’s clinical development programmes, the expected timing of clinical trials and regulatory filings. Such statements are based on management’s current expectations, but actual results may differ materially.
Chairman’s report
Overview
During the past six months, our two most important products, ASA404 and AS1413, made substantial progress through their pivotal phase III studies. With Novartis funding all development work on ASA404 and the phase III trial of AS1413 over half way to completion, our need for further investment to reach key data on these drugs is now limited. As a result, we are able to devote some of our cash resources of almost GBP 50 million to investment in earlier stage programmes, which could enhance long-term value, and to the start of preparations for commercialisation of AS1413 in the US.
Significant progress for potential blockbuster ASA404
The key registration trial of ASA404 is the phase III ATTRACT-1 study testing the drug in combination with chemotherapy as a first-line treatment for non-small cell lung cancer. In September, we announced that this trial had completed enrolment of 1200 patients. We are now in the follow-up phase of the study. An interim look will take place soon, but unless this shows clear futility or dramatic early efficacy, neither of which we expect, the study will continue until its scheduled completion. Latest information, based on death rates in the study, indicates that data are likely to be available in mid- 2011. Novartis plans to file for marketing authorisations during 2011 if these data are positive.
Novartis is also conducting another phase III trial, called ATTRACT-2, in patients with non-small cell lung cancer who have already received treatment with other drugs. This study is designed to support applications to market ASA404 as a second-line treatment. Enrolment of 900 patients is ongoing.
At the company’s R&D Day in December, Novartis outlined plans to evaluate ASA404 in another major indication, HER2-negative metastatic breast cancer. A phase Ib/II trial combining ASA404 with taxanes will begin this year.
Investigator-initiated trials with ASA404 have begun. These include two phase II studies combining ASA404 with taxane-based regimens, one in bladder cancer and the other in small cell lung cancer, and a phase I study evaluating ASA404 combined with carboplatin, paclitaxel and cetuximab in patients with a variety of solid tumours.
Antisoma has the option to co-commercialise ASA404 with Novartis in the US, which fits with Antisoma’s plans to become directly involved in the commercialisation of its products. The arrangement with Novartis could yield substantial milestone payments based on the progress of ASA404 as well as royalties on all sales of the drug worldwide.
Exciting blood cancer drug AS1413 is on track
AS1413 is being tested in a pivotal phase III trial (ACCEDE) in patients with secondary acute myeloid leukaemia (secondary AML). This form of leukaemia follows previous bone marrow disease or treatment for other cancers, and it responds poorly to currently available treatments.
In December, we reported positive final data from a phase II trial of AS1413 in secondary AML. We saw an encouraging number of longer-term responders, and 30% of patients who achieved remission after treatment with AS1413 were still alive after 2 years. This adds to earlier findings from the trial showing a response rate of 39% that compares favourably with historical data in similar patients.
The ACCEDE study seeks to build on our promising phase II data. It is a randomised controlled trial that compares AS1413 plus cytarabine (the treatment given in our phase II trial) to standard current treatment for AML: daunorubicin plus cytarabine. We are now over half way towards the enrolment target of 450 patients, and expect to see the results of the trial in late 2010 or early 2011.
Should the ACCEDE study be positive, we plan to market the drug ourselves in the US while seeking partners for marketing in other territories.
AS1411 shows promise
In December, we announced that our phase II study of AS1411 in renal cancer had provided further evidence of activity in this setting, and reinforcement of the findings from previous trials that the drug is very well tolerated. Because of the now highly competitive nature of the renal cancer market, we have decided not to pursue further development of AS1411 for this indication. However, the latest data add to a picture of activity across various cancers.
In the immediate future, our focus with AS1411 is in AML, where we have reported positive data from a randomised phase II trial. A phase IIb trial combining AS1411 with cytarabine in patients with relapsed and refractory AML will start soon, and is intended to pave the way for a potential registration study in this setting.
Other pipeline developments
During the period, we discontinued development of AS1402 after early data from a phase II trial in breast cancer indicated that the drug would be unlikely to offer a significant benefit to patients. We are strong believers in running robust “go/no-go” trials during early development, so that our resources can be focused on drugs likely to offer real benefits to patients and consequent commercial success.
In August, we divested a phase I product, P2045, to Bryan Oncor, a company focusing on the development of radiopharmaceutical products.
Financial review
Overview
We have a solid financial position that reflects the careful use of the substantial cash resources we have built up, notably from last year’s divestment of oral fludarabine to sanofi-aventis and from payments made by Novartis, our development and commercialisation partner for ASA404. Novartis is funding all development work on ASA404 while we are investing in our other pipeline products, particularly AS1413, which is in a pivotal phase III trial.
Results of operations
The group had no revenues in the period.
Total operating expenses for the six months ended 31 December 2009 were £21.3 million (2008: £20.0 million). Research and development expenditure has increased by £1.3m, reflecting continued investment in the phase III trial of AS1413. Within administrative expenses, we have recognised impairment losses of £0.3 million, reflecting discontinuation of certain projects.
During the period, foreign exchange rates have been less volatile than in the previous year. We have made exchange gains of £1.3 million on translation of our US dollar and Euro balances into sterling (2008: £6.7 million).
Our loss of £18.3 million reflects the difference between our revenues, finance income and tax credit and our operating expenses, as we continue to invest in our cancer drug pipeline.
Liquidity and capital resources
Cash, cash equivalents and short-term deposits amounted to £49.6 million as at 31 December 2009 (30 June 2009: £67.0 million; 31 December 2008: £52.7 million). Net cash used in operating activities for the six months ended 31 December 2009 was £18.4 million (six months ended 31 December 2008: £19.2 million).
In managing our cash resources, we have maintained a conservative treasury policy with short deposit terms and diversified counterparty risk.
Taxation
We have recognised a credit of £1.5 million in respect of an R&D tax credit receivable for the first six months of the financial year.
Loss per share
The basic loss per share for the half-year ended 31 December 2009 was 3.0p. The loss per share for the half-year ended 31 December 2008 was 0.8p.
Outlook
We are moving forward with our plans to transition from a company focused on developing cancer drugs into one that can also successfully commercialise them. While our principal focus is the completion of phase III trials on ASA404 and AS1413, we also continue to advance the earlier stage products in our portfolio and to explore opportunities to add new drugs to the pipeline.
Barry Price Chairman Interim Report for the six months ended 31 December 2009 Consolidated Income Statement for the six months ended 31 December 2009 ----------------------------------------------------------------------- 6 months 6 months Year ended 31 ended 31 ended 30 December December June 2009 2008 2009 unaudited unaudited audited Notes £'000 £'000 £'000 ----------------------------------------------------------------------- Revenue - 5,514 25,230 Cost of sales - - (9,085) ----------------------------------------------------------------------- Gross profit - 5,514 16,145 Research and development expenditure (18,040) (16,775) (35,904) Administrative expenses (3,297) (3,208) (4,884) ----------------------------------------------------------------------- Total operating expenses (21,337) (19,983) (40,788) ----------------------------------------------------------------------- Operating loss (21,337) (14,469) (24,643) Finance income 4 1,555 8,011 5,055 ----------------------------------------------------------------------- Loss before taxation (19,782) (6,458) (19,588) Taxation 1,502 1,493 3,161 ----------------------------------------------------------------------- Loss for the period (18,280) (4,965) (16,427) ----------------------------------------------------------------------- Loss per ordinary share Basic 5 (3.0)p (0.8)p (2.7)p ----------------------------------------------------------------------- Diluted 5 (3.0)p (0.8)p (2.7)p ----------------------------------------------------------------------- Consolidated Statement of Comprehensive Income for the six months ended 31 December 2009 --------------------------------------------------------------------------- 6 months 6 months Year ended 31 ended 31 ended 30 December December June 2009 2008 2009 unaudited unaudited audited £'000 £'000 £'000 --------------------------------------------------------------------------- Loss for the period (18,280) (4,965) (16,427) Exchange translation difference on consolidation 447 12,484 8,923 --------------------------------------------------------------------------- Other comprehensive income for the period net of tax 447 12,484 8,923 --------------------------------------------------------------------------- Total comprehensive income for the period (17,833) 7,519 (7,504) --------------------------------------------------------------------------- Consolidated Statement of Financial Position as at 31 December 2009 -------------------------------------------------------------------------- As at 31 As at 31 As at 30 December December June 2009 2008 2009 unaudited unaudited audited Notes £'000 £'000 £'000 -------------------------------------------------------------------------- A ASSETS Non-current assets Goodwill 6,957 7,642 6,708 Intangible assets 51,615 62,653 51,257 Property, plant and equipment 1,960 2,282 1,967 -------------------------------------------------------------------------- 60,532 72,577 59,932 -------------------------------------------------------------------------- Current assets Trade and other receivables 1,947 1,904 1,701 Current tax receivable 4,984 1,493 3,484 Short-term deposits 42,267 10,000 27,824 Cash and cash equivalents 7,377 42,700 39,215 -------------------------------------------------------------------------- 56,575 56,097 72,224 LIABILITIES Current liabilities Trade and other payables (8,046) (9,740) (7,417) Current tax payable - (297) - Deferred income (19,690) - (19,690) Provisions (2,664) (477) (1,902) -------------------------------------------------------------------------- Net current assets 26,175 45,583 43,215 -------------------------------------------------------------------------- Total assets less current liabilities 86,707 118,160 103,147 -------------------------------------------------------------------------- Non-current liabilities Deferred tax liabilities (6,957) (7,642) (6,708) Provisions (454) (145) (224) -------------------------------------------------------------------------- (7,411) (7,787) (6,932) -------------------------------------------------------------------------- Net assets 79, 296 110,373 96,215 -------------------------------------------------------------------------- Shareholders’ equity Share capital 10,592 10,468 10,480 Share premium 122,015 119,649 119,783 Shares to be issued 6 - 2,273 2,273 Other reserves 47,366 50,480 46,919 Profit and loss account (100,677) (72,497) (83,240) -------------------------------------------------------------------------- Total shareholders’ equity 79,296 110,373 96,215 -------------------------------------------------------------------------- Consolidated Statement of Changes in Equity for the six months ended 31 December 2009 --------------------------------------------------------------------------- Shares Other Other Profit and Share Share to be reserve: reserve: loss Total capital premium issued retranslation merger account £'000 £'000 £'000 £'000 £'000 £'000 £'000 --------------------------------------------------------------------------- At 1 July 2008 10,467 119,629 2,273 (1,259) 39,255 (68,158) 102,207 Total comprehensive income for the period - - - 12,484 - (4,965) 7,519 New share capital issued 1 20 - - - - 21 Share options: value of employee services - - - - - 626 626 --------------------------------------------------------------------------- At 31 December 2008 10,468 119,649 2,273 11,225 39,255 (72,497) 110,373 --------------------------------------------------------------------------- At 1 July 2008 10,467 119,629 2,273 (1,259) 39,255 (68,158) 102,207 Total comprehensive income for the year - - - 8,923 - (16,427) (7,504) New share capital issued 13 154 - - - - 167 Share options: value of employee services - - - - - 1,345 1,345 --------------------------------------------------------------------------- At 30 June 2009 10,480 119,783 2,273 7,664 39,255 (83,240) 96,215 --------------------------------------------------------------------------- At 1 July 2009 10,480 119,783 2,273 7,664 39,255 (83,240) 96,215 Total comprehensive income for the period - - - 447 - (18,280) (17,833) New share capital issued 112 2,232 (2,273) - - - 71 Share options: value of employee services - - - - - 843 843 --------------------------------------------------------------------------- At 31 December 2009 10,592 122,015 - 8,111 39,255 (100,677) 79,296 --------------------------------------------------------------------------- Consolidated Statement of Cash Flows for the six months ended 31 December 2009 --------------------------------------------------------------------------- 6 months 6 months Year ended 31 ended 31 ended 30 December December June 2009 2008 2009 unaudited unaudited audited £'000 £'000 £'000 --------------------------------------------------------------------------- Cash flows from operating activities Loss for the period/year (18,280) (4,965) (16,427) Add back: Foreign exchange gain (187) (1,076) (2,238) Finance income (1,555) (8,011) (5,055) Tax credit (1,502) (1,493) (3,161) Depreciation of property plant and equipment 337 318 650 Impairment of intangible assets 343 - - Derecognition of an intangible asset - - 8,750 Share-based payments 843 626 1,345 --------------------------------------------------------------------------- Operating cash flows before movement in working capital (20,001) (14,601) (16,136) (Increase)/decrease in debtors (319) 1,237 385 Increase/(decrease) in creditors and provisions 1,643 (6,963) 12,829 --------------------------------------------------------------------------- Cash used in operations (18,677) (20,327) (2,922) Interest received 243 1,136 1,951 Income taxes received/(paid) 2 - (620) --------------------------------------------------------------------------- Net cash used in operating activities (18,432) (19,191) (1,591) --------------------------------------------------------------------------- Cash flows from investing activities Purchase of property, plant and equipment (330) (200) (232) Sale of property, plant and equipment - - 8 Purchase of intangible assets - (1,779) (1,779) Purchase of short-term deposits (14,443) - (17,824) --------------------------------------------------------------------------- Net cash used in investing activities (14,773) (1,979) (19,827) --------------------------------------------------------------------------- Cash flows from financing activities Proceeds from issue of ordinary share capital 71 21 167 --------------------------------------------------------------------------- Net cash generated from financing activities 71 21 167 --------------------------------------------------------------------------- Net decrease in cash and cash equivalents (33,134) (21,149) (21,251) Exchange gains/(losses) on cash and bank overdrafts 1,296 6,988 3,605 Cash and cash equivalents at beginning of the period 39,215 56,861 56,861 --------------------------------------------------------------------------- Cash and cash equivalents at end of the period 7,377 42,700 39,215 ---------------------------------------------------------------------------
Notes to the interim accounts
1. Basis of Preparation and Accounting Policies
The interim financial statements do not comprise statutory accounts within the meaning of Section 434 of the Companies Act 2006. Statutory accounts for the year ended 30 June 2009 were approved by the Board of Directors on 24 September 2009 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 498 of the Companies Act 2006. This condensed consolidated interim financial information has been reviewed, not audited.
This condensed consolidated half-yearly financial information for the six months ended 31 December 2009 has been prepared in accordance with the Disclosure and Transparency Rules of the Financial Services Authority and with IAS 34 - ‘Interim Financial Reporting’ as adopted by the European Union. This half- yearly condensed consolidated financial report should be read in conjunction with the annual financial statements for the year ended 30 June 2009, which have been prepared in accordance with IFRS as adopted by the European Union. Except as described below, the accounting policies adopted are consistent with those of the annual financial statements for the year ended 30 June 2009, as described in those financial statements.
Taxes on income in interim periods are accrued using the tax rate that would be applicable to total expected annual earnings.
The following new standards, amendments to standards or interpretations are mandatory for the first time for the financial year beginning 1 July 2009 and have been applied by the Group:
* IAS 1 (revised), ‘Presentation of financial statements’. The revised standard prohibits the presentation of items of income and expenses (that is ‘non-owner changes in equity’) in the statement of changes in equity, requiring ‘non-owner changes in equity’ to be presented separately from owner changes in equity. All ‘non-owner changes in equity’ are required to be shown in a performance statement. Entities can choose whether to present one performance statement (the statement of comprehensive income) or two statements (the income statement and statement of comprehensive income). The Group has elected to present two statements. The interim financial statements have been prepared under the revised disclosure requirements.
* IFRS 8, ‘Operating segments’. IFRS 8 replaces IAS 14, ‘Segment reporting’. It requires a ‘management approach’ under which segment information is presented on the same basis as that used for internal reporting purposes. Management considers that there is only one reportable segment: drug development. Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker has been identified as the Senior Management Team that makes strategic decisions. Assets, liabilities and overheads are allocated to this one segment.
* IFRS 2 (amendment), ‘Share-based payment’. IFRS 2 (amendment) deals with vesting conditions and cancellations. The amendment does not have a material impact on the Group’s financial statements.
* IAS 32 (amendment), ‘Financial instruments: Presentation’. The amendment does not have a material impact on the Group’s financial statements.
The following new standards, amendments to standards or interpretations are mandatory for the first time for the financial year beginning 1 July 2009 and have been applied by, but are not currently relevant to the Group:
* IAS 39 (amendment), ‘Financial instruments: Recognition and measurement’. The amendment does not have an impact on the Group’s financial statements.
* IFRS 3 (revised), ‘Business combinations’ and consequential amendments to IAS 27, ‘Consolidated and separate financial statements’, IAS 28, ‘Investments in associates’ and IAS 31, ‘Interests in joint ventures’, effective prospectively to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after 1 July 2009. The revised standard continues to apply the acquisition method to business combinations, with some significant changes.
There are no other new Standards likely to have an effect on the financial statements for the year ending 30 June 2010.
2. Segmental information
Antisoma’s operating segments are being reported based on the financial information provided to the Senior Management Team, which is used to make strategic decisions. The directors are of the opinion that under IFRS 8 - ‘Operating segments’ the Group has only one operating segment, being drug development.
The Senior Management Team assesses the performance of the operating segment on financial information which is measured and presented in a manner consistent with that in the financial statements.
All revenue is derived from customers whose operations are located in the US and Europe.
The following table shows the carrying value of segment assets by location of assets:
----------------------------------------------------------- 6 months 6 months ended ended Year ended 31 Dec 2009 31 Dec 2008 30 June 2009 £'000 £'000 £'000 ----------------------------------------------------------- Total assets UK 89,301 97,030 105,331 US 27,806 31,644 26,825 ----------------------------------------------------------- Total 117,107 128,674 132,156 -----------------------------------------------------------
Total assets are allocated based on where the assets are located.
The following table shows the costs in the period to acquire property, plant, equipment and intangibles by location of assets:
------------------------------------------------------------------ 6 months 6 months ended ended Year ended 31 Dec 2009 31 Dec 2008 30 June 2009
