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Interim Results

26 Sep 2005 07:03

Plethora Solutions Holdings PLC26 September 2005 For Immediate Release 26 September 2005 PLETHORA SOLUTIONS HOLDINGS PLC INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 June 2005 Plethora Solutions Holdings PLC ("Plethora" or the "Company", AIM : PLE), aUK-based speciality pharmaceutical company, is pleased to announce its maideninterim results for the six months ended 30 June 2005. A summary of key pointsfollows: Financials • Admission to AIM raising £10m gross via placement of 7.4m shares to fund the current development pipeline • Loss after tax of £3.6m, in line with expectation - this includes a one-off payment of £1.6 m to Hoffman-La Roche • Cash and short term investments at 30 June 2005 of £7.9m Current product pipeline • PSD502 (treatment for premature ejaculation) - nearing completion of Phase II clinical trials, trials initiated on secondary use for the treatment of pain in burns and wounds • PSD503 (treatment of stress urinary incontinence - SUI) - expect to commence Phase II trials Q4 2005 • PSD506 (treatment of overactive bladder in both male and female patients) - signed license agreement with Hoffman-La Roche giving Plethora exclusive access to PSD506 for Phase II development in 2006 • PSD401 (novel device for use in diagnosis of premature ejaculation) - successful completion of clinical development programme - collaborative agreement with Johnson & Johnson for use of PSD401 in clinical trials for treatment for sexual dysfunction New Product • PSD597 - new programme initiated for the treatment of interstitial cystitis Stuart Wallis, Chairman of Plethora, commented : "The first half of 2005 has been an exciting period for Plethora with ourflotation on AiM and attainment of several key product development objectives.The Board believes that the next twelve months will be equally exciting as wemove through several key valuation milestones including the completion of PhaseII trials on PSD502 later this year and the commencement of other equallyimportant trials. We look forward to updating shareholders on our progress." For further information contact: Plethora Solutions Tel : 020 7269 8630Steven Powell, Chief ExecutiveBrad Hoy, Chief Financial Officer Collins Stewart Tel : 0207 523 8350Tim Mickley Buchanan Communications Tel : 020 7466 5000Tim Anderson, Isabel Podda Notes to Editor Plethora Solutions Holdings plc (Plethora) is a publicly quoted UK company whosegoal is to build a profitable, speciality pharmaceutical business. The Company'sprimary strategy is to develop products for the diagnosis, treatment andmanagement of urological disorders. Revenues will be generated by licensing onthe rights to Plethora products to pharmaceutical marketing partners followingthe successful completion of clinical trials. The Plethora business model is designed to minimise clinical risk and the costsassociated with taking such risk, enabling Plethora to pursue multiple clinicalprogrammes efficiently. The Company believes that this portfolio approach willincrease its probability of success significantly and minimise financingdilution to its shareholders. Chairman's and Chief Executive's Statement Overview The first half of 2005 has been an exciting period for Plethora. In March wecompleted a successful flotation on AiM, raising £10 million gross through theplacing of 7.4 million shares. These proceeds have given Plethora the financialresources to progress our current therapeutic programmes through Phase IIstudies and on to their licensing points. Since our flotation we have made great strides forward in developing ourpipeline with the completion of an in-licensing agreement with Hoffman-La Rochefor PSD506, a treatment for overactive bladder, and the completion of patientenrolment into the Phase II clinical trial of PSD502, a treatment for prematureejaculation. We have also commenced a series of clinical trials for the use ofPSD502 as a topical analgesic for the treatment of wounds and burns. Inaddition, we have also signed a collaborative agreement with Johnson & Johnsonfor the use of PSD401, our diagnostic for premature ejaculation, in theirclinical trials. In line with our stated strategy we have continued to seek new products and haveintroduced a new clinical stage programme, PSD597, for the treatment ofinterstitial cystitis (IC) and chronic pelvic pain (CPP) which affects over 38%of women in the USA alone. Product Update PSD502 The most advanced programme in the portfolio, PSD502, is an aerosol mix of twoknown marketed drugs being developed for the treatment of premature ejaculation(PE), a condition which is believed to afflict 25-30% of the male population ofthe USA and Western Europe. From recent reports from major pharmaceuticalcompanies and from comparisons with the established erectile dysfunction market,it is estimated that the PE market could be as large as $5 billion per annum. After conclusion of a promising clinical pilot study which demonstrated anincrease in ejaculation latency time after treatment with PSD502, together withan improvement in patient/partner satisfaction in evaluable patients, theproduct was transferred into a Phase II double blind, placebo controlled studyin eight centres in Europe. Recruitment in this study was completed in September2005 and full trial results are expected later in the year. Discussions havealready been initiated with potential marketing partners and we expect licensingactivity to gather pace once Phase II data is available. A significant development in the PSD502 programme was the identification of asecond but highly valuable indication. The product is a novel aerosolformulation of two analgesic compounds, Lidocaine and Prilocaine, which aremarketed in a number of pain indications. However, Plethora's aerosolformulation has a rapid onset of action and can be applied painlessly to woundsand burns. Having consulted with opinion leaders in the field who confirmed boththe medical need and commercial potential for such a product, the Company hasinitiated a series of clinical studies at wound and burns units in the UK todemonstrate the clinical efficacy of the product. Data is expected towards themiddle of 2006. PSD503 PSD503 is a novel formulation of an alpha agonist, which is being developed forthe treatment of stress urinary incontinence (SUI). There is no product approved globally for this widespread condition which isestimated to affect over 20 million women in North America and Western Europe.The annual market for stress incontinence products is estimated to exceed US$5billion. Having completed a small pilot study which demonstrated product safety, theCompany has now completed the design and preparation for a Phase II clinicalprogramme which is expected to commence in Q4, 2005. PSD506 Under an exclusive license agreement entered into with Hoffman-La Roche in 2005,Plethora intends to develop the subtype selective muscarinic receptor antagonistPSD506 (formerly RO3202904) as a treatment for overactive bladder and relatedsymptoms in men and women. The programme will benefit not only from extensiveclinical data generated by Roche but also from on-going support in the form ofsupply of drug materials and regulatory input. PSD506 has been evaluatedsuccessfully in three Phase I studies by Roche in men and women. These Phase Istudies involved multiple doses in healthy female and male volunteers. The drugwas shown to be well tolerated at potentially therapeutic doses. Plethoraintends to initiate three clinical studies in 2006 with the objectives offurther establishing the efficacy and safety of PSD506 and its superiority overmarketed anti-muscarinic drugs. Studies are planned in three patient groups:spinal injury patients experiencing spontaneous contraction of the bladdermuscles causing incontinence; patients with BPH and LUTS and in men and womenwith urge incontinence. PSD597 Subsequent to the reporting period, the Company announced the introduction of anew clinical stage programme, PSD597, for the treatment of interstitial cystitis(IC) and chronic pelvic pain (CPP). Approximately 38% of the female populationof the USA suffer from IC/CPP for which there is no effective treatment. In keeping with the business model, Plethora has licensed exclusive worldwiderights to a therapy undergoing early stage clinical development for thetreatment of IC from Dr. Richard Henry at Queen's University, Kingston, Ontario,Canada. This product utilises a drug marketed previously for other indications,therefore the company does not expect there to be any safety issues. The producthas already been employed in two clinical studies at Queen's which have reportedthat PSD597 reduced pain in chronic IC patients. This product will be moved into a full Phase II study early next year and,together with secondary indication studies for PSD502, provides a bridge into asecondary area of clinical expertise, namely pain management. Medical Devices Plethora has a small development portfolio of devices aimed at the diagnosis andmanagement of urological conditions. The most advanced of these products isPSD401, a device for the measurement of ejaculation time, used for studyingtreatments for PE. The preliminary development phase of this product wascompleted in the first half of 2005 and a collaborative agreement was signedwith Johnson & Johnson for use of the product in clinical studies. The Companywill continue to seek further, similar collaborations with both pharmaceuticalcompanies and medical device marketing companies. Financial Review In the six months ended 30 June 2005, Plethora recorded a loss before and aftertaxation of £3.6m, which is in line with expectations and includes a single,one-off licensing payment to Hoffman-La Roche of £1.6m. Cash outflow before financing for the period was £3.4m, reflecting the loss inthe period. With a strong cash position at 30 June 2005 of £7.9m following thesuccessful share placing and admission to AIM in March 2005, the Company hassufficient funds to take its lead products to the point at which they can belicensed on to pharmaceutical partners who will complete the development andcommercialisation of the products. Outlook In the next 12 months we expect to move through a number of key valuationmilestones. The most immediate will be the publication of clinical trial datafrom the PSD502 PE study and, with positive data, the subsequent licensing ofthe programme to a pharmaceutical partner. We have also demonstrated that thereis additional value in the 502 programme with the wound pain indication and theintroduction, post the reporting period, of PSD597 has created a modestfoundation in the secondary disease area of pain management. Within the coreurology franchise we look forward to moving PSD503 into a Phase II programme forthe treatment of Stress Urinary Incontinence. The Plethora team, although small in number, has achieved considerable momentumand everyone concerned should be congratulated on the progress made during ourfirst half year as a public entity and for showing such commitment in building aleading pharmaceutical product development operation. We look forward to updating shareholders on our progress in the months ahead. Stuart Wallis Steven PowellNon-Executive Chairman Chief Executive Officer PLETHORA SOLUTIONS HOLDINGS PLC CONSOLIDATED SUMMARISED PROFIT AND LOSS ACCOUNT For the six months ended 30 June 2005 6 months Year ended ended 30 June 31 December 2005 2004 Note Unaudited Audited £'000 £'000 Turnover - - Cost of sales - ------------------------ ------ ----------- ----------- Gross profit - - Administrative expensesResearch and development expenses (3,025) (1,955)Other administrative expenses (587) (693)----------------------- ------ ----------- -----------Operating loss (3,612) (2,648) Net interest receivable/(payable) andother charges 37 (110)----------------------- ------ ----------- ----------- Loss on ordinary activities before taxation (3,575) (2,758) Tax on loss on ordinary activities - ------------------------ ------ ----------- ----------- Loss on ordinary activities after taxation (3,575) (2,758) Dividends - ------------------------ ------ ----------- -----------Loss transferred from reserves 3 (3,575) (2,758)----------------------- ------ ----------- ----------- Basic loss per share 2 (20.5p) (26.1p)----------------------- ------ ----------- ----------- There were no recognised gains or losses other than the loss for the financialperiod. PLETHORA SOLUTIONS HOLDINGS PLC CONSOLIDATED SUMMARISED BALANCE SHEET AS AT 30 JUNE 2005 At At 30 June 31 December 2005 2004 Note Unaudited Audited £'000 £'000Fixed assetsTangible assets 60 43----------------------- ------ ------------ ----------- Current assetsDebtors 186 17Cash at bank and in hand 7,889 49----------------------- ------ ------------ ----------- 8,075 66 Creditors: amounts fallingdue within one year (575) (1,874)--------------------------- ------------ ----------- ----------- Net current assets/(liabilities) 7,500 (1,808)----------------------- ------ ------------ ----------- Total assets less current liabilities 7,560 (1,765)----------------------- ------ ------------ -----------Net assets/(liabilities) 7,560 (1,765)----------------------- ------ ------------ ----------- Capital and reservesCalled up share capital 222 -Share premium account 8,825 993Other reserves 4,846 -Profit and loss account (6,333) (2,758)----------------------- ------ ------------ -----------Equity shareholders' funds/(deficit) 3 7,560 (1,765)----------------------- ------ ------------ ----------- PLETHORA SOLUTIONS HOLDINGS PLC CONSOLIDATED SUMMARISED CASH FLOW STATEMENT For the six months ended 30 June 2005 6 months Year ended ended 30 June 31 December 2005 2004 Note Unaudited Audited £'000 £'000 Net cash (outflow) from operatingactivities 4 (3,423) (2,381) Returns on investments and servicingof finance Interest received 37 3----------------------- ------ ------------ -----------Net cash inflow from returns oninvestments and servicing of finance 37 3----------------------- ------ ------------ ----------- Capital expenditure and financialinvestmentPurchase of tangible fixed assets (24) (53)----------------------- ------ ------------ -----------Net cash (outflow) from capitalexpenditure and financial investment (24) (53)----------------------- ------ ------------ ----------- Cash outflow before financing (3,410) (2,431)----------------------- ------ ------------ ----------- FinancingIssue of ordinary share capital 14,063 1,000Share issue costs (1,163) (7)Loans advanced 2,000 1,487Loans repaid (3,650) ------------------------ ------ ------------ -----------Net cash inflow from financing 11,250 2,480----------------------- ------ ------------ ----------- Increase in cash 5 7,840 49----------------------- ------ ------------ ----------- PLETHORA SOLUTIONS HOLDINGS PLC NOTES TO THE INTERIM STATEMENT For the six months ended 30 June 2005 1. BASIS OF PREPARATION The consolidated interim financial statements have been prepared in accordancewith applicable accounting standards and under the historical cost convention.The principal accounting policies of the group have remained unchanged fromthose set out in Plethora Solutions Limited's 2004 annual report and financialstatements. In addition to those accounting policies adopted in the PlethoraSolution Limited's 2004 annual report and financial statements the followingaccounting policy has been added. Basis of consolidation The group financial statements consolidate those of the Company and of itssubsidiary undertaking. Profits or losses on intra-group transactions areeliminated in full. On 17th March 2005, as part of a group reorganisation, theCompany acquired the entire issued share capital of Plethora Solutions Limited,the consideration being satisfied by the issue of ordinary shares in theCompany. In preparing the consolidated financial statements merger accountinghas, therefore, been applied. The financial information set out in this interimreport does not constitute statutory accounts as defined by section 240 of theCompanies Act 1985. The figures for the year ended 31 December 2004 have beenextracted from the statutory financial statements of Plethora Solutions Limitedwhich have been filed with the Registrar of Companies. The auditors' report onthose financial statements was unqualified and did not contain a statement undersection 237(2) of the Companies Act 1985. 2. LOSS PER SHARE The calculation of the basic and diluted loss per share is based on the loss onordinary activities after tax and on the weighted average number of ordinaryshares in issue during the period. The impact of the share options andconvertible debt are anti dilutive. The loss and weighted average number ofshares used in the calculations are set out below: Weighted average LossBasic loss per share Loss number of per share £'000 shares pence Six months ended 30 June 2005 (3,575) 17,467,648 (20.5)--------------------- ---------- ---------- ---------- Year ended 31 December 2004 (2,758) 10,571,055 (26.1)--------------------- ---------- ---------- ---------- 3. RECONCILIATION OF MOVEMENTS IN SHAREHOLDERS' FUNDS/(DEFICIT) 6 months Year ended ended 30 June 31 December 2005 2004 Unaudited Audited £'000 £'000 Loss for the financial period (3,575) (2,758)Issue of ordinary share capital 12,900 993------------------------ ------------ -----------Net increase/(decrease) in shareholders'funds/(deficit) 9,325 (1,765)Shareholders' funds/(deficit) at beginningof period (1,765) ------------------------- ------------ -----------Shareholders' funds/(deficit) at endof period 7,560 (1,765)------------------------ ------------ ----------- 4. NET CASH INFLOW/(OUTFLOW) FROM OPERATING ACTIVITIES 6 months Year ended ended 30 June 31 December 2005 2004 Unaudited Audited £'000 £'000 Operating (loss) (3,612) (2,648)Depreciation 7 10(Increase) in debtors (169) (17)Increase in creditors 351 274------------------------ ------------ -----------Net cash (outflow) from operatingactivities (3,423) (2,381)------------------------ ------------ ----------- 5. RECONCILIATION OF NET CASH FLOW TO MOVEMENT IN NET (DEBT)/FUNDS 6 months Year ended ended 30 June 31 December 2005 2004 Unaudited Audited £'000 £'000 Increase in cash in the period 7,840 49Cash outflow from financing 1,650 (1,487)------------------------ ------------ -----------Change in net funds/(debt) resulting fromcash flows 9,490 (1,438)Non cash movements (131) (32)------------------------ ------------ -----------Movement in net funds/(debt) in the period 9,359 (1,470)Net (debt)/funds at beginning of period (1,470) ------------------------- ------------ -----------Net funds/(debt) at end of period 7,889 (1,470)------------------------ ------------ ----------- PLETHORA SOLUTIONS HOLDINGS PLC NOTES TO THE INTERIM STATEMENT For the six months ended 30 June 2005 INDEPENDENT REVIEW REPORT TO PLETHORA SOLUTIONS HOLDINGS PLC INTRODUCTION We have been instructed by the Company to review the financial information forthe six months ended 30 June 2005 which comprises the Summarised ConsolidatedProfit and Loss Account, Summarised Consolidated Balance Sheet, SummarisedConsolidated Cash Flow Statement and the related notes. We have read the otherinformation contained in the Interim Report which comprises only the Chairmanand Chief Executive's Statement and considered whether it contains any apparentmisstatements or material inconsistencies with the financial information. Ourresponsibilities do not extend to any other information. This report is made solely to the Company's members, as a body, in accordancewith guidance contained in APB Bulletin 1999/4 "Review of Interim FinancialInformation". Our review work has been undertaken so that we might state to theCompany's members those matters we are required to state to it in a reviewreport and for no other purpose. To the fullest extent permitted by law, we donot accept or assume responsibility to anyone other than the Company and theCompany's members as a body, for our review work, for this report or for theconclusion we have formed. Directors' responsibilitiesThe Interim Report, including the financial information contained therein, isthe responsibility of and has been approved by the directors. The directors areresponsible for preparing the interim report in accordance with the ListingRules of the Financial Services Authority, which require that the accountingpolicies and presentation applied to the interim figures should be consistentwith those applied in preparing the preceding annual accounts except where anychanges, and the reasons for them, are disclosed. Review work performedWe conducted our review in accordance with guidance contained in Bulletin 1999/4"Review of Interim Financial Information" issued by the Auditing Practices Boardfor use in the United Kingdom. A review consists principally of making enquiriesof management and applying analytical procedures to the financial informationand underlying financial data and, based thereon, assessing whether theaccounting policies and presentation have been consistently applied unlessotherwise disclosed. A review excludes audit procedures such as tests ofcontrols and verification of assets, liabilities and transactions. It issubstantially less in scope than an audit performed in accordance with UnitedKingdom auditing standards and therefore provides a lower level of assurancethan an audit. Accordingly, we do not express an audit opinion on the financialinformation. Review conclusionOn the basis of our review we are not aware of any material modifications thatshould be made to the financial information as presented for the six monthsended 30 June 2005. GRANT THORNTON UK LLPChartered AccountantsBirmingham23 September 2005 This information is provided by RNS The company news service from the London Stock Exchange
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