Antisoma's preliminary results for the year ended 30 June 2009
(Thomson Reuters ONE) - London, UK, and Cambridge, MA: 14 September 2009 Antisoma plc (LSE:ASM; USOTC: ATSMY) today announces its preliminary results for theyear ended 30 June 2009. These results have been prepared underInternational Financial Reporting Standards ('IFRS') as adopted foruse by the European Union.Highlights of 2008/2009ASA404 programme advances and expands * Strong partnership maintained with Novartis * Phase III trial in first-line lung cancer completes enrolment of 1200 patients (September 2009) * Phase III trial in second-line lung cancer initiated * Breast cancer selected as next indication for developmentAS1413 development gains momentum * Phase III trial in secondary AML expanded * Phase II trial shows durable responses in secondary AMLAS1411 programme advances * Positive data from phase II trial in AML * Plans announced for phase IIb development in AML * Phase II trial in renal cancer completes patient enrolmentValue realised from oral fludarabine asset * Drug approved by FDA * Divested to sanofi-aventis in USD 65 million dealStrong cash position * Oral fludarabine divestment extends cash runway to mid-2011 * Cash life now extends beyond expected timing of key phase III data * Cash and short-term deposits of GBP 67.0 million at 30 June 2009 * Full-year loss of GBP 16.4 millionCommenting on the results, Glyn Edwards, CEO of Antisoma, said: "Wehave made important progress this year, with gathering momentum onour two phase III programmes, positive phase II data for a thirdproduct and our first product approval from the FDA. With thepipeline maturing, we now have a dual focus on driving productstowards regulatory approvals and on building a strong platform forproduct commercialisation."Eric Dodd, Antisoma's CFO, added: "The successful divestment of oralfludarabine to sanofi-aventis has added significantly to our cashresources, further strengthening our balance sheet. We can now fundall our priority programmes until mid-2011, beyond the time we expectkey phase III data for ASA404 and AS1413."A webcast and conference call will be held today at 9:30 am BST. Thewebcast can be accessed via Antisoma's website athttp://www.antisoma.com/asm/media/webcast/ and the call by dialling+44 (0) 207 806 1964 UK Toll (US Toll +1 718 354 1390) and using theConfirmation Code: 9656482. A recording of the webcast will also beavailable afterwards on the Antisoma website.Enquiries:Antisoma plc +44 (0)7909 915 068Glyn Edwards, Chief Executive OfficerEric Dodd, Chief Financial OfficerDaniel Elger, VP, Marketing & CommunicationsBuchanan Communications +44 (0)20 7466 5000(All media enquiries)Mark Court, Lisa BaderoonThe Trout Group +1 617 583 1308(US investor enquiries)Seth LewisExcept for the historical information presented, certain mattersdiscussed in this statement are forward looking statements that aresubject to a number of risks and uncertainties that could causeactual results to differ materially from results, performance orachievements expressed or implied by such statements. These risks anduncertainties may be associated with product discovery anddevelopment, including statements regarding the Group's clinicaldevelopment programmes, the expected timing of clinical trials andregulatory filings. Such statements are based on management's currentexpectations, but actual results may differ materially.Joint Chief Executive and Chairman's statementOverviewWe have seen excellent progress this year on both of our phase IIIdrugs, ASA404 and AS1413. Our partner Novartis has advanced andexpanded the ASA404 programme in lung cancer. Meanwhile, we haveenlarged the AS1413 phase III trial in secondary acute myeloidleukaemia (secondary AML) and reported new data supporting thistrial. We have also presented positive phase II data for a thirdproduct, AS1411, and were successful in gaining FDA approval for -and then divesting - a non-core asset, oral fludarabine. With thefunds from this divestment, we have sufficient cash to fund all ourpriority programmes until mid-2011, which is after the time we expectkey phase III data for both ASA404 and AS1413. We are thereforeconfident in our ability to reach these two potentiallytransformational sets of results within the current cash life of thebusiness.ASA404 programme advances and expandsOur Tumour-Vascular Disrupting Agent, ASA404, is making good progressin the capable hands of our partner, Novartis. Earlier this month, weannounced that the 1200-patient phase III trial (ATTRACT-1) testingthe drug as a first-line treatment for non-small cell lung cancer(the main form of lung cancer) had completed patient enrolment.ATTRACT-1 builds on phase II data showing a five-month improvement inmedian survival when ASA404 was added to standard first-linechemotherapy for lung cancer. We expect that final data from theATTRACT-1 study will be available in late 2010 or early 2011 and thatfilings for marketing licences will follow during 2011 if these dataare positive.In January Novartis started a second, 900-patient phase III trial(ATTRACT-2), testing ASA404 in patients who have already received oneround of treatment for non-small cell lung cancer. This trial isdesigned to support applications to market ASA404 as a second-linetreatment. We are very pleased that Novartis has decided to evaluateASA404 in both the first-line and second-line settings, as this willensure that a broad spectrum of lung cancer patients could beeligible for treatment with the drug.During the year, the results of the two phase II trials supportingphase III development in lung cancer were published in the BritishJournal of Cancer and Lung Cancer. We also announced furtherencouraging findings from a phase II trial in prostate cancer.In February, we announced that Novartis had decided on priorities forthe further development of ASA404. After lung cancer, the nextpriority will be HER2-negative metastatic breast cancer. The decisionto expand the development programme to include breast as well as lungcancer underlines the broad potential of ASA404.In addition to the USD 100 million that we have already received fromNovartis, we can earn substantial further milestone payments based onprogress of ASA404 in development and achievement of sales targets.We will also earn royalties on all sales of the drug worldwide, andhave a strategically important option to co-commercialise ASA404 inthe US.AS1413 development gains momentumAS1413 is a novel chemotherapy drug with promising potential as atreatment for blood cancers. A key property of AS1413 is its abilityto evade multi-drug resistance mechanisms. These are molecular pumpsused by cancer cells to expel drugs, including some of the majorchemotherapies in use today. By evading these mechanisms, AS1413 hasthe potential to work in settings where other treatments arecompromised.We are developing AS1413 initially as a treatment for secondary acutemyeloid leukaemia (secondary AML), a form of AML that evolves fromprior bone marrow disease or develops following radiotherapy orchemotherapy for other cancers. Patients with secondary AML oftenhave multi-drug resistant disease and there are no drugs approvedspecifically for this condition.We are enrolling patients into a pivotal, randomised phase III trialof AS1413 in secondary AML. This trial, called ACCEDE, comparesAS1413 plus cytarabine with daunorubicin plus cytarabine, the mostcommon initial treatment for AML. It is being conducted under aSpecial Protocol Assessment (SPA) agreed with the US Food and DrugAdministration (FDA). During the period, we gained agreement from theFDA for an expansion of the trial to 450 patients. In tandem withthis expansion, we have increased the number of hospitals involved inthe study in the US and opened the trial to recruitment in a varietyof countries across Europe, Asia, Australia and Latin America.The ACCEDE study builds on data from an 88-patient phase II trial ofAS1413 in secondary AML. This reported a 39% complete remission ratein patients receiving AS1413 plus cytarabine, which comparesfavourably with rates of around 25% seen in secondary AML patientsreceiving daunorubicin plus cytarabine in two previous studies.Long-term follow up data from the AS1413 phase II trial werepresented at the American Society of Hematology (ASH) meeting inDecember. These included the highly encouraging finding that amongthose patients who showed a complete response to treatment, some 40%were still in remission 18 months after receiving AS1413.Data from the ACCEDE trial are expected to be available in late2010 or early 2011. Should results be positive, we plan to market thedrug ourselves in the US while seeking partners for marketing inother countries. We believe that beyond the initial opportunity insecondary AML, AS1413 could also have potential in a variety of otherblood cancer settings.AS1411 development advancesOur aptamer drug AS1411 has been the subject of considerable interestthis year, with the reporting of the first phase II data on the drugand further data expected in the near future.At the most recent ASH and ASCO meetings, we reported data from aphase II trial in AML - the first randomised trial to test an aptamerdrug as a treatment for cancer. Combination of AS1411 with high-dosechemotherapy increased the response rate compared with chemotherapyalone in patients with disease unresponsive to or relapsed afterother treatments. This was achieved without any significant increasein side effects. Following these positive findings, we are planningphase IIb studies with AS1411 in AML. These will be designed toidentify the best way for us to approach a pivotal study that wouldsupport applications for marketing.In parallel with the trial in AML, we have been running a single-armphase II trial in renal cancer. This completed patient enrolment inMay, and is expected to report initial data later this year and finaldata in the first half of 2010.Like AS1413, AS1411 is unpartnered. We plan to continue developmentthrough late-stage trials and to commercialise the product ourselvesin the US while seeking partners for other territories.Other pipeline developmentsWe have had a number of developments in our earlier stage pipeline.We discontinued development of our antibody drug AS1402 when itbecame clear that a phase II trial in breast cancer was very unlikelyto yield sufficiently positive efficacy data to support furtherdevelopment. Our antibody-cytokine fusion protein AS1409 completed aphase I trial in melanoma and renal cancer, providing encouragingevidence of anti-cancer activity which was presented at the ASCOmeeting in June. We are now considering next steps for this product.Our phase I radiolabelled peptide, P2045, was divested to BryanOncor, a company with a focus on radiopharmaceuticals. Finally, wecontinue to make progress with our pre-clinical programmes, includingAMPK activators licensed from Betagenon; PPM1D inhibitors beingdeveloped through a collaboration with The Institute of CancerResearch; and the Flt-3 programme in autoimmune diseases, acquiredlast year with Xanthus Pharmaceuticals.Value realised from oral fludarabine assetAntisoma acquired oral fludarabine with the acquisition of Xanthus inJune 2008. In December, we were successful in gaining FDA approvalfor the marketing of this drug in chronic lymphocytic leukaemia(CLL). This enabled us to conclude, as planned, a lucrativedivestment deal. In May, we sold our rights to market the drug in theUS to sanofi-aventis in return for an initial payment of USD 60million (GBP 39.4 million).Strong cash position maintainedAntisoma expects its cash resources to last until mid-2011, beyondthe time when data are expected from the key phase III studies ofASA404 and AS1413. Divesting of oral fludarabine has removed anypotential funding shortfall up to the phase III results. We finishedthe period with cash and short-term deposits of GBP 67.0 million,which is similar to last year (2008: GBP 66.9 million).Total revenues for the year ended 30 June 2009 were GBP 25.2 million,compared with GBP 39.5 million last year. This year's revenuesreflect recognition of the balance of the USD 100 million upfront andlung cancer phase III initiation milestones from Novartis (GBP 5.4million) and half of the USD 60 million upfront payment fromsanofi-aventis (GBP 19.7 million). The balance of the sanofi-aventisupfront payment is expected to be recognised in the financial year2009-2010.Total operating expenses have increased from GBP 28.7 million lastyear to GBP 40.8 million this year, mainly reflecting an increase inresearch and development (R&D) costs from GBP 22.2 million to GBP35.9 million. General and administrative costs were GBP 4.9 million(2008: GBP 6.5 million).We have recorded a full-year loss of GBP 16.4 million, compared witha profit of GBP 12.3 million last year. At this stage in ourdevelopment, profits and losses reflect the balance betweenrecognition of deferred revenues and our ongoing operating expenses.This year, operating expenses exceeded the revenues recognised fromthe Novartis and sanofi-aventis deals.Preparing for commercialisationIn line with our plan to become a company that markets as well asdevelops cancer drugs, we have made two appointments of individualswith significant commercial experience. Eric Dodd joined in Novemberas Chief Financial Officer, following a career in technologybusinesses, and Michael Lewis, a senior commercial executive at themedical device company Gambro, has joined our Board as aNon-Executive Director. The Board wishes to thank Raymond Spencer,our former Chief Financial Officer who left Antisoma in December2008, for his contribution to the development of the Company.OutlookWe anticipate important pipeline developments in the near future,notably the initiation by Novartis of trials to evaluate ASA404 in asecond major cancer indication, metastatic breast cancer. We willalso be reporting the first data from our phase II trial of AS1411 inrenal cancer before the end of the year, with final data to follow inthe first half of 2010.More broadly, we are moving forward with our plan to transformAntisoma from a drug development company into a business withmarketed oncology products. With two drugs now well into phase IIItesting, our pipeline is advancing in a manner that clearly fits withthis objective. The recent announcement that the key phase III trialof ASA404 in lung cancer is fully enrolled emphasises our proximityto potential marketing applications and opportunities to begingenerating sustainable revenues from product sales. We look forwardto the next period of evolution, confident in the knowledge that wehave the financial and human resources to support the advancement ofour key assets towards commercialisation.Glyn EdwardsChief Executive OfficerBarry PriceChairmanUnaudited consolidated income statementfor the year ended 30 June 2009 2009 2008[1] Notes GBP '000 GBP '000Revenue 2 25,230 39,527Cost of sales (9,085) -Gross profit 16,145 39,527Research and development expenditure (35,904) (22,249)Administrative expenses (4,884) (6,480)Total operating expenses (40,788) (28,729)Operating (loss)/profit (24,643) 10,798Finance income 5,055 2,578(Loss)/profit before taxation (19,588) 13,376Taxation 3,161 (1,047)(Loss)/profit for the year (16,427) 12,329(Loss)/earnings per ordinary shareBasic (2.7)p 2.7pDiluted (2.7)p 2.6pAll amounts arise from continuing operations.[1] Certain costs have been reclassified between research anddevelopment expenditure and administrative expenses as disclosed inNote 1.Unaudited consolidated statement of recognised income and expense for the year ended 30 June 2009 2009 2008 GBP '000 GBP '000(Loss)/profit for the year (16,427) 12,329Exchange translation difference on consolidation 8,923 (235)Total recognised (expense)/income for the year (7,504) 12,094Unaudited consolidated balance sheetas at 30 June 2009 2009 2008[1] Notes GBP '000 GBP '000ASSETSNon-current assetsGoodwill 6,708 5,559Intangible assets 51,257 47,149Property, plant and equipment 1,967 2,358 59,932 55,066Current assetsTrade and other receivables 1,701 2,113Current tax receivable 3,484 -Short-term deposits 27,824 10,000Cash and cash equivalents 39,215 56,861 72,224 68,974LIABILITIESCurrent liabilitiesTrade and other payables (7,417) (9,866)Current income tax liabilities - (297)Deferred income (19,690) (5,401)Provisions (1,902) (629)Net current assets 43,215 52,781Total assets less current liabilities 103,147 107,847Non-current liabilitiesDeferred income tax liabilities (6,708) (5,559)Provisions (224) (81) (6,932) (5,640)Net assets 96,215 102,207Shareholders' equityShare capital 10,480 10,467Share premium 119,783 119,629Shares to be issued 2,273 2,273Other reserves 46,919 37,996Profit and loss account (83,240) (68,158)Total shareholders' equity 3 96,215 102,207[1]Cash and cash equivalents and short-term deposits have beenreclassified as disclosed in Note 1.Unaudited consolidated cash flow statementfor the year ended 30 June 2009 2009 2008[1] GBP '000 GBP '000Cash flows from operating activities(Loss)/profit for the year (16,427) 12,329Adjustments for: Foreign exchange gain (2,238) - Finance income (5,055) (2,578) Tax (credit)/charge (3,161) 1,047 Depreciation of property plant and equipment 650 213 Derecognition of an intangible asset 8,750 - Share-based payments 1,345 1,051Operating cash flows before movement in workingcapital (16,136) 12,062Decrease in trade and other receivables 385 961Increase/(decrease) in trade and otherpayables and deferred income 12,829 (28,506)Cash used in operations (2,922) (15,483)Interest received 1,951 2,753Income taxes paid (620) -Research and development tax credit received - 2,011Net cash used in operating activities (1,591) (10,719)Cash flows from investing activitiesPurchase of property, plant and equipment (232) (1,969)Sale of property, plant and equipment 8 -Purchase of intangible assets (1,779) (1,605)Purchase of short-term deposits (17,824) (5,000)Net cash outflow in respect of acquisitions - (237)Net cash used in investing activities (19,827) (8,811)Cash flows from financing activitiesProceeds from issue of ordinary share capital 167 20,966Expenses paid in connection with issue of ordinaryshare capital - (980)Net cash generated from financing activities 167 19,986Net (decrease)/increase in cash and cashequivalents (21,251) 456Exchange gains/(losses) on cash and cashequivalents 3,605 (9)Cash and cash equivalents at beginning of year 56,861 56,414Cash and cash equivalents at end of year 39,215 56,861[1] Cash and cash equivalents and short-term deposits have beenreclassified as disclosed in Note 1Notes to the financial information for the year ended 30 June 20091. Basis of preparationThe financial information in this preliminary announcement has notbeen audited and does not constitute statutory accounts as defined inSection 435 of the Companies Act 2006. The information has beenextracted from the consolidated financial statements for the yearended 30 June 2009. The financial statements will be delivered to theRegistrar of Companies after the Annual General Meeting. Theconsolidated financial statements for the year ended 30 June 2008have been delivered to the Registrar of Companies and were given anunqualified audit opinion by the Company's auditors.The financial information in this statement has been prepared inaccordance with International Financial Reporting Standards ('IFRS')as endorsed by the European Union, International Financial ReportingInterpretation Committee ('IFRIC') interpretations and those parts ofthe Companies Act 2006 applicable to companies reporting under IFRS.There have been no new standards during the year that havesignificantly impacted the results of the Group.ReclassificationThe Directors have reviewed the classification of certain itemswithin the Income Statement and Balance Sheet and believe, in orderto aid comparison, it is more appropriate to classify the followingdifferently than was reported in prior periods:The Group's definition of cash and cash equivalents has been restatedto reflect more accurately the underlying substance of the deposits.Historically cash was classified as a deposit when its duration wasover 90 days whereas it now includes all cash deposited for more thanthree months. The impact of the change is to increase cash and cashequivalents and reduce short-term deposits by GBP nil (2008: GBP23,000,000). The relevant comparatives in the cash flow statementhave been amended to reflect this adjustment.Certain costs were previously included within administrative expensesand have been reclassified in Research & Development in order to beconsistent with industry sector accounting practices. The impact ofthe change is to increase research and development costs and reduceadministrative expenses by GBP 8,177,000 (2008: GBP 3,817,000).Reallocated costs include business development, facilities and aproportion of other overheads directly attributable to research anddevelopment activities. There is no impact on operating profit/lossor earnings/loss per share.2. Segmental informationPrimary reporting segment - business segmentThe Directors are of the opinion that under IAS 14 - 'Segmentalinformation' the Group has only one business segment, being drugdevelopment.Secondary reporting segment - geographical segmentThe Group's geographical segments are determined by location ofoperations.All revenue has been derived from external customers located in theUS and Europe. The principal sources of revenue for the Group in thetwo years ended 30 June 2009 were: 2009 2008 GBP '000 GBP '000USRecognition of income from the divestment of oralfludarabine sanofi-aventis 19,690 -EuropeRecognition of upfront and milestone payments on atime apportioned basis: Novartis 5,401 38,806 Other - 265R&D services and materialsrecharged: Novartis 139 456Total revenues 25,230 39,527The following table shows the carrying value of segment assets bylocation of assets: 2009 2008 GBP '000 GBP '000Total assetsUK 105,331 75,264US 26,825 48,776Total 132,156 124,040Total assets are allocated based on where the assets are located.The following table shows the costs in the period to acquireproperty, plant, equipment and intangibles by location of assets: 2009 2008 GBP '000 GBP '000Capital expenditureUK 1,875 3,574US 136 26,900Total 2,011 30,474Capital expenditure is allocated based on where the assets arelocated.3. Statement of changes in equityGroup Other Other Shares reserve: reserve: Profit Share Share to be and capital premium issued retranslation merger loss Total GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000At 1 July2007 8,795 100,451 - (1,024) 19,595 (81,538) 46,279Profit forthe year - - - - - 12,329 12,329New sharecapitalissued 1,672 20,158 - - 19,660 - 41,490Expenses onshare issuetaken toshare premium - (980) - - - - (980)Share capitalto be issued - - 2,273 - - - 2,273Shareoptions:value ofemployeeservices - - - - - 1,051 1,051Foreignexchangeadjustmentsonconsolidation - - - (235) - - (235)At 30 June2008 10,467 119,629 2,273 (1,259) 39,255 (68,158) 102,207At 1 July2008 10,467 119,629 2,273 (1,259) 39,255 (68,158) 102,207Loss for theyear - - - - (16,427) (16,427)New sharecapitalissued 13 154 - - - - 167Shareoptions:value ofemployeeservices - - - - - 1,345 1,345Foreignexchangeadjustmentsonconsolidation - - - 8,923 - - 8,923At 30 June2009 10,480 119,783 2,273 7,664 39,255 (83,240) 96,215ENDS---END OF MESSAGE---This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 14.09.2009 - 08:01 Uhr
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