Interim Results

Ardana PLC 19 December 2006 Ardana: Interim Results for the six months ended 30 September 2006 Ardana plc (LSE: ARA) the pharmaceutical company focused on improving human reproductive health, today announces its Interim Results for the six months ended 30 September 2006. Highlights in the period • Agreement with Novartis Pharmaceuticals UK Ltd for Ardana to launch and promote Emselex(R) in the UK for the symptomatic treatment of overactive bladder (OAB) • Teverelix Long Acting (LA) - US patent granted - Positive preliminary results in Phase I trial for the treatment of endometriosis • Testosterone Cream - Positive preliminary results in Phase II trial Key Financials • Total cash and cash equivalents at 30 September 2006 of £13.7 million (31 March 2006: £19.1 million) • Loss before tax for the six months ended 30 September 2006 of £5.5 million (six months ended 30 September 2005: £3.6 million) Post period events • Launch of Emselex(R) • Placing and Open Offer in October 2006 raised an additional £9.9 million after expenses Dr Maureen Lindsay, CEO, commented 'The last six months have seen us make significant progress across all aspects of Ardana's business. Our agreement with Novartis for Ardana on Emselex(R) is a tremendous endorsement of our sales and marketing capabilities. Our compounds in clinical development, including our lead compound Teverelix LA and Oral GHS, are progressing well, and we look forward with confidence to building on the achievements of the first six months and reporting on the development of our pipeline and progress in our commercialisation activities.' Enquiries For more information contact: Maureen Lindsay + 44 (0) 131 226 8550 Ardana Julia Phillips/John Gilbert +44 (0)20 7831 3113 Financial Dynamics (corporate and financial media relations) About Ardana Ardana plc is a pharmaceutical company focused on the discovery, development and marketing of innovative products to improve human reproductive health, a $25.5 billion market*. Since its foundation, Ardana has maintained a broad and balanced portfolio to manage risk and actively pursues product and technology in-licensing and out-licensing to maintain a robust pipeline. Ardana's four lead products are summarised below: • Emselex(R), a once a day treatment for the symptoms of overactive bladder which Ardana has exclusive UK marketing and promotion rights and is being distributed in collaboration with Novartis Pharmaceuticals UK Limited; • StriantTM SR, a testosterone replacement therapy that has been launched by Ardana through its own sales force in the UK and through marketing partners in certain European countries, as a treatment for men with confirmed hypogonadism; • Invicorp, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe; • Teverelix LA, in development for three initial indications (prostate cancer, BPH and endometriosis); • Testosterone Cream, a transdermal testosterone delivery system in development for the treatment of male hypogonadism, in Phase II trials; and • Oral GHS (EP01572) a oral growth hormone secretagogue in late stage development in the first indication for the diagnosis of growth hormone deficiency and in early stage development in a second indication. In addition, Ardana has a strong portfolio of follow-on products in development. Ardana is listed on the Main Market of the London Stock Exchange. For further information please see www.ardana.co.uk *Source: IMS Retail Drug Monitor November 2005. Statements contained within this press release may contain forward-looking comments which involve risks and uncertainties that may cause actual results to vary from those contained in the forward-looking statements. In some cases, you can identify such forward-looking statements by terminology such as 'may', ' will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', ' estimates', 'predicts', 'potential', or 'continue'. Predictions and forward-looking references in this press release are subject to the satisfactory progress of research which is, by nature, unpredictable. Forward projections reflect management's best estimates based on information available at the time of issue. CHIEF EXECUTIVE'S STATEMENT Introduction I am pleased to report that during the first half of the financial year we have made significant progress across all areas of Ardana's business. In September 2006 we reached agreement with Novartis Pharmaceuticals UK Ltd (' Novartis') for Ardana to be granted sole and exclusive rights to launch and promote Emselex(R) for the symptomatic treatment of overactive bladder (OAB) in the UK for a 10 year term. Emselex(R) was launched by Ardana in November 2006. In October 2006 we completed a Placing and Open Offer, which raised £9.9 million after expenses. The net proceeds will be used to launch and promote Emselex(R) and to invest in the clinical development of Ardana's Oral Growth Hormone Secretagogue (GHS) in its first indication for the diagnosis of growth hormone deficiency and in the first therapeutic indication. Clinical development progressed satisfactorily across our product pipeline, including our lead compound Teverelix LA. Ardana is in discussions with potential partners to collaborate on the future development and commercialisation of Teverelix LA. The Directors intend to have agreements in place before the start of the first Phase III trials. We are also particularly pleased with the progress of Testosterone Cream, which we expect to be ready for launch in 2008. Marketed Products Emselex(R) Ardana will be responsible for the launch and ongoing sales and marketing of Emselex(R) whilst Novartis will be responsible for distribution, medical and pharmacovigilance activities. Emselex(R) has shown favourable efficacy, a low incidence of cardiovascular adverse events and in elderly healthy volunteers did not significantly impair memory function. We believe that Emselex(R) will offer health professionals an effective and well tolerated new treatment option for patients who experience overactive bladder symptoms and is an important addition to Ardana's portfolio. Emselex(R), which Novartis has launched in collaboration with Bayer Vital GmbH in Germany and Procter and Gamble Pharmaceuticals Inc. in the US (where the product is known as Enablex(R)), is a product which fits extremely well with Ardana's therapeutic focus of human reproductive health. An additional marketed product in the UK will leverage the current sales force who are currently promoting StriantTM SR to endocrinologists and urologists. Emselex(R) is an oral once-daily muscarinic M3 selective receptor antagonist (M3 SRA) for the treatment of OAB. Symptoms of OAB include urinary urgency (a sudden and compelling desire to pass urine) with, or without, urge urinary incontinence (involuntary leakage accompanied or immediately preceded by urgency), usually with urinary frequency (voiding the bladder too often), and nocturia (waking at night one or more times to void the bladder). On 16 November 2006 we commenced the marketing of Emselex(R) in the UK. Part of the net proceeds of the Placing and Open Offer will be used to launch and promote this product. StriantTM SR StriantTM SR is a mucoadhesive buccal (gum surface) testosterone replacement therapy for confirmed male hypogonadism. StriantTM SR is marketed to urologists and endocrinologists in the UK by Ardana's own sales force and in Germany, the Nordic Region and the Republic of Ireland by our partners. We will continue to develop our distribution capability around Europe with the appointment of further strategic partners. Product Pipeline InvicorpTM InvicorpTM is an injectable treatment for erectile dysfunction and is currently available under a special licence in the UK. The European Mutual Recognition Procedure (MRP) to obtain marketing authorisation in other European territories is expected to commence during the first half of 2007. Marketing Authorisations for InvicorpTM have been granted in Denmark and Ardana intends to launch there imminently. Testosterone Cream Testosterone Cream is a transdermal testosterone delivery system based on our Bi-Gel technology, which is in development for the treatment of male hypogonadism. In September 2006 we announced preliminary results of a Phase II study in hypogonadal men. The open-label, randomised study involved 16 patients diagnosed with male hypogonadism i.e. testosterone deficiency. A preliminary analysis of the data confirms that Ardana's Testosterone Cream is effective in restoring testosterone levels to the normal range in hypogonadal men when administered as a single dose of 2.25g or 4.5g on a daily basis. Furthermore, the data suggests that even before dose titration the low dose should meet efficacy criteria set by the United States Food & Drug Administration (FDA). A Phase II long-term dose-titration study in hypogonadal men is currently ongoing. Also a Phase I study, conducted in the US under an Investigational New Drug (IND) application, is ongoing, investigating the effect of showering on the absorption of testosterone. A pivotal Phase III registration study in the US is currently being prepared. We are very encouraged by our progress in the development of Ardana's novel Testosterone Cream. The preliminary data from the study announced in September meets our expectations for the product and we look forward to moving into Phase III. Oral GHS (EP01572) Proceeds of the Placing and Open Offer will also be used to develop Ardana's Oral Growth Hormone Secretagogue (EP01572). EP01572 (Oral GHS) is an oral formulation of a growth hormone secretagogue (GHS). This is a novel small molecule size peptidomimetic agent (a compound that mimics the biological action of a peptide). Based on clinical results to date we believe that Oral GHS can directly stimulate growth hormone secretion from the pituitary gland and/or indirectly via stimulation of growth hormone releasing peptide (GHRP) from the hypothalamus. The Company considers Oral GHS to be an asset with significant near and long term potential. Potential applications include the diagnosis and treatment of growth hormone deficiency (GHD) disorders and frailty of the elderly, as well as metabolic complications associated with critical illness, such as cancer, trauma, uremia and AIDS-associated cachexia and lipodystrophy. The current worldwide market for growth hormone products is worth approximately US$3.1 billion, and forecast to grow to US$3.87 billion by 2010, representing a Compound Annual Growth Rate (CAGR) of 4.1 per cent (Wood Mackenzie Product View, April 2006). The majority of the current sales (approximately 80 per cent) are for paediatric indications. The market is currently served by injectable recombinant human growth hormone. We believe our compound has the potential to be the first oral product in this market. Following a positive pre-IND meeting with the FDA, we are developing Oral GHS in a niche indication with near-term potential in the diagnosis of growth hormone deficiency. Ardana will invest in a US registration trial for Oral GHS as a diagnostic in the indication of growth hormone deficiency. Subject to the outcome of the trial and regulatory approval, the launch of the diagnostic indication could be as early as H1 2008 in the US and H2 2008 in the EU. It is expected that an early market entry of Oral GHS as a diagnostic would provide Ardana with a strong platform from which to develop Oral GHS as a therapeutic agent and will also generate near term revenues. The Company also intends to undertake further early stage clinical trials for a first potential therapeutic indication. This would allow Ardana to compete in this US$3.1 billion therapeutic market once approved. There is a good strategic fit with our current portfolio as patients suffering from growth hormone deficiency are treated by endocrinologists, a group of physicians already targeted by Ardana's sales and marketing organisation. Teverelix LA - Overview Ardana is developing the long acting formulation of its Gonadotrophin Releasing Hormone (GnRH) antagonist, Teverelix LA, to treat three indications; prostate cancer, benign prostatic hyperplasia (BPH) and endometriosis. On 31 August 2006 we were delighted to announce that we have been granted a US patent covering the long acting formulation of our GnRH antagonist, Teverelix (Teverelix LA). The patent is subject to a US patent term extension, which means that it is not due to expire in the US until April 2023. Ardana is in discussions with potential partners to collaborate on the future development and commercialisation of Teverelix LA. The Directors expect to have agreements in place before the start of the first Phase III trials. Teverelix LA - Prostate Cancer Ardana has reached agreement with the FDA on the path forward for the development of Teverelix LA for the treatment of prostate cancer. The IND was opened in April 2006 and the first study under the IND is ongoing. The use of Teverelix LA in the treatment of prostate cancer will be the subject of further Phase II clinical trials for optimisation of the dose regimen and these are either ongoing or planned. On completion of the Phase II programme, if the results are positive, Ardana intends to commence Phase III clinical trials, subject to the appointment of a partner, with an anticipated product launch date, at the earliest, towards the end of 2009. Teverelix LA - Benign Prostatic Hyperplasia (BPH) Ardana has had a pre-IND application meeting with the FDA at which consensus on the Company's development plan for the therapy was reached. An IND was submitted in July 2006 and opened in August 2006. Further longer term Phase II studies have been undertaken during 2006 and data is expected imminently. Ardana expects to commence Phase III clinical trials around mid-2007, subject to the appointment of a partner, and it is anticipated that this product could now reach the market as early as 2010, initially in the US. Teverelix LA - Endometriosis On 7 September 2006 we announced preliminary results of a Phase I study of the GnRH antagonist, Teverelix LA in healthy female subjects. Preliminary data from this Phase I, randomised, single-blind, placebo-controlled study of a single subcutaneous injection of Teverelix LA, at one of two doses to 24 healthy female subjects, indicates that Teverelix LA can reduce oestrogen levels to a desired level at the lower end of the normal range which should help to avoid menopausal signs and symptoms including bone loss. The effect of Teverelix LA on certain bone absorption markers were also investigated in the study. On the basis of the available data these markers appear unaffected by Teverelix LA. Additional data analysis is ongoing. This study provides data to support the further development of Teverelix LA in endometriosis, a condition with an unmet medical need, and a Phase II study is currently planned to start shortly. Financial review The unaudited financial information for the six months ended 30 September 2006 is prepared in accordance with the group's accounting policies based on International Financial Reporting Standards (IFRSs) as adopted by the European Union. On 30 September 2006, Ardana had cash and cash equivalents of £13.7 million (31 March 2006: £19.1 million). Net cash used by operating activities in the six months ended 30 September 2006 was £5.8 million (six months ended 30 September 2005: £5.0 million) due principally to the investment in research and development during the period. Research and development expenditure for the six months ended 30 September 2006 was £4.1 million (six months ended 30 September 2005: £2.4 million). This increase in costs reflects the additional clinical activity undertaken across the portfolio during this period. Total product sales of StriantTM SR for the six months ended 30 September 2006 were £130,000 (six months ended 30 September 2005: £164,000). Sales of StriantTM SR in Europe represent bulk sales to partners. The timing of deliveries to partners are not evenly spaced over each period. Operating loss for the six months ended 30 September 2006 was £5.8 million (six months ended 30 September 2005: £4.2 million), which is driven by research and development expense activity. Outlook The £9.9 million after expenses, raised on the successful completion of our Placing and Open Offer in October 2006, gives us the opportunity to deliver value for our shareholders in two exciting areas: the launch and promotion of Emselex(R) and the development of Ardana's Oral GHS, EP01572. We are delighted that Novartis has chosen Ardana to launch Emselex(R) in the UK market which we think is a tremendous endorsement of our sales and marketing capabilities. Furthermore, this agreement presents an opportunity for the Group to grow its sales and marketing infrastructure in time for the launch of Testosterone Cream and GHS as a diagnostic, both of which could enter the market in 2008. We have always believed that the GHS programme represented significant potential value for Ardana. If approved by the relevant authorities GHS has the potential to be the first oral therapy in the growth hormone market and could capture a significant share of this $3.1 billion market. We look forward with confidence to building on the achievements of the first six months and reporting on the development of our pipeline and progress in our commercialisation activities. Consolidated income statement (unaudited) 6 months ended 30 September 2006 Notes 6 months ended 6 months ended Audited 30 September 30 September Year ended 2006 2005 31 March 2006 £'000 £'000 £'000 Revenue: continuing operations Product revenue 130 164 384 Revenue from sale of services - 106 106 _____ _____ _____ Total revenue 4 130 270 490 Operating expenses Cost of product sales (34) (66) (142) Research and development (4,094) (2,363) (6,359) Other operating expenses (1,829) (2,026) (4,021) _____ _____ _____ Total operating expenses (5,957) (4,455) (10,522) _____ _____ _____ Operating loss: continuing operations 5 (5,827) (4,185) (10,032) Gain on sale of available-for-sale-investment - - 229 Interest received 358 623 1,002 _____ _____ _____ Loss on ordinary activities before taxation (5,469) (3,562) (8,801) Taxation 291 254 633 _____ _____ _____ Loss on ordinary activities after taxation (5,178) (3,308) (8,168) attributable to equity shareholders _____ _____ _____ Basic loss per share 3 (9.3p) (5.9p) (14.7p) _____ _____ _____ Consolidated balance sheet (unaudited) At 30 September 2006 Notes 30 September 30 September Audited 2006 2005 31 March 2006 £'000 £'000 £'000 Non-current assets Intangible assets 2 600 - - Property, plant and equipment 9 26 15 _____ _____ _____ 609 26 15 Current assets Inventories 40 38 76 Trade and other receivables 1,886 1,522 1,619 Available-for-sale investment - 10,118 - Cash and cash equivalents 13,737 14,721 19,051 _____ _____ _____ 15,663 26,399 20,746 _____ _____ _____ Total assets 16,272 26,425 20,761 _____ _____ _____ Current liabilities Trade and other payables (3,811) (2,750) (3,360) _____ _____ _____ Non-current liabilities Trade and other payables - (1,363) - _____ _____ _____ Total liabilities (3,811) (4,113) (3,360) _____ _____ _____ Net assets 12,461 22,312 17,401 _____ _____ _____ Equity Share capital 557 556 556 Other equity 290 173 240 Share premium account 27,048 26,949 26,949 Merger reserve 34,451 34,451 34,451 Own shares (13) (95) (95) Retained earnings (49,872) (39,722) (44,700) _____ _____ _____ Total equity 12,461 22,312 17,401 _____ _____ _____ Group cash flow statement (unaudited) 6 months ended 30 September 2006 Notes 6 months 6 months Audited ended 30 ended 30 Year ended September September 31 March 2006 2005 2006 £'000 £'000 £'000 Cash flows from operating activities Cash used by operations 5 (6,258) (5,271) (11,775) Corporation tax received 491 267 418 _____ _____ _____ Net cash used by operating activities (5,767) (5,004) (11,357) _____ _____ _____ Investing activities Interest received 344 546 1,002 Realised gain on available-for-sale investment - - 229 Purchases of property, plant and equipment (3) (9) (11) Investment in available-for-sale investment - (10,000) - _____ _____ _____ Net cash from/ (used in) investing activities 341 (9,463) 1,220 _____ _____ _____ Financing activities Issue of shares 30 - - Sale of own shares 82 6 6 _____ _____ _____ Net cash from financing activities 112 6 6 _____ _____ _____ Net decrease in cash and cash equivalents (5,314) (14,461) (10,131) Cash and cash equivalents at beginning of period 19,051 29,182 29,182 _____ _____ _____ Cash and cash equivalents at end of period 13,737 14,721 19,051 _____ _____ _____ Consolidated statement of changes in equity (unaudited) 6 months ended 30 September 2005 Share Other Share Merger Retained Own Total capital equity premium reserve earnings shares £'000 £'000 £'000 £'000 £'000 £'000 £'000 Opening balances 1 April 2005 556 93 26,949 34,451 (36,532) (101) 25,416 _____ _____ _____ _____ _____ _____ _____ Recognised directly in equity Movement in own shares - - - - - 6 6 Share-based payment - 80 - - - - 80 _____ _____ _____ _____ _____ _____ _____ Net change directly in equity - 80 - - - 6 86 _____ _____ _____ _____ _____ _____ _____ Loss for the period - - - - (3,190) - (3,190) _____ _____ _____ _____ _____ _____ _____ Total movements - 80 - - (3,190) 6 (3,104) _____ _____ _____ _____ _____ _____ _____ Equity at the end of the period 556 173 23,949 34,451 (39,722) (95) 22,312 _____ _____ _____ _____ _____ _____ _____ Consolidated statement of changes in equity (unaudited) 6 months ended 31 March 2006 Share Other Share Merger Retained Own Total capital equity premium reserve earnings shares £'000 £'000 £'000 £'000 £'000 £'000 £'000 Opening balances 1 October 2005 556 173 26,949 34,451 (39,722) (95) 22,312 _____ _____ _____ _____ _____ _____ _____ Recognised directly in equity Share-based payment - 67 - - - - 67 _____ _____ _____ _____ _____ _____ _____ Net change directly in equity - 67 - - - - 67 _____ _____ _____ _____ _____ _____ _____ Loss for the period - - - - (4,978) - (4,978) _____ _____ _____ _____ _____ _____ _____ Total movements - 67 - - (4,978) - (4,911) _____ _____ _____ _____ _____ _____ _____ Equity at the end of the period 556 240 26,949 34,451 (44,700) (95) 17,401 _____ _____ _____ _____ _____ _____ _____ Consolidated statement of changes in equity (unaudited) 6 months ended 30 September 2006 Share Other Share Merger Retained Own Total capital equity premium reserve earnings shares £'000 £'000 £'000 £'000 £'000 £'000 £'000 Opening balances 1 April 2006 556 240 26,949 34,451 (44,700) (95) 17,401 _____ _____ _____ _____ _____ _____ _____ Recognised directly in equity New share capital subscribed 1 - 99 - - - 100 Movement in own shares - - - - - 82 82 Gain on sale of EBT shares - - - - 6 - 6 Share-based payment - 50 - - - - 50 _____ _____ _____ _____ _____ _____ _____ Net change directly in equity 1 50 99 - 6 82 238 _____ _____ _____ _____ _____ _____ _____ Loss for the period - - - - (5,178) - (5,178) _____ _____ _____ _____ _____ _____ _____ Total movements 1 50 99 - (5,172) 82 (4,940) _____ _____ _____ _____ _____ _____ _____ Equity at the end of the period 557 290 27,048 34,451 (49,872) (13) 12,461 _____ _____ _____ _____ _____ _____ _____ Notes to the Interim Financial Information (unaudited) 6 months ended 30 September 2006 1. Basis of Preparation The results for the six months ended 30 September 2006 have been prepared on the basis of the accounting policies set out in Ardana plc's 2006 Annual Report which were prepared in accordance with International Financial Reporting Standards (IFRSs). The results for the six months ended 30 September 2006 and 2005 are unaudited but have been reviewed by the auditor, Deloitte and Touche LLP. The interim accounts do not constitute statutory accounts as defined in section 240 of the Companies Act 1985. The results for the full year 2006 have been taken from the Group's 2006 Annual Report which have been filed with the Registrar of Companies. The auditor has reported on the 2006 accounts and the report was unqualified and did not contain a statement under section 237(2) or (3) of the Companies Act 1985. The Group has not applied IAS 34 'Interim financial reporting', which is not mandatory for UK groups, in the preparation of these financial statements. 2. Intangible assets Product rights and other intangible assets are initially recorded at cost and amortised over their useful life on a straight line basis from the date of the commercial launch. In the current period, £0.6 million has been capitalised in relation to the acquired product rights for Emselex(R) in the UK. 3. Loss per share Basic loss per share is calculated by dividing the loss for the financial period after taxation by the weighted average number of ordinary shares in issue during the year. The basic loss per share is calculated as follows:- 6 months 6 months Year ended ended 30 ended 30 31 March September September 2006 2005 2006 £'000 £'000 £'000 Loss after taxation (£'000) (5,178) (3,308) (8,168) Weighted average number of ordinary shares in issue 55,570,020 55,562,806 55,562,806 _____ _____ _____ Basic loss per share (pence) (9.3) (5.9) (14.7) _____ _____ _____ IAS requires presentation of diluted earnings per share when a company could be called upon to issue shares that would decrease net profit or increase net loss per share. For a loss making company with outstanding share options, net loss per share would only be increased by the exercise of out-of-money options. Since it seems inappropriate to assume that option holders would exercise out-of-money options, no adjustment has been made to diluted loss per share for out-of-money share options. 4. Business and Geographical Segments Primary reporting format - business segments The Directors consider that the primary reporting format is by business segment. The Group discovers, develops and markets a range of pharmaceutical products. The Directors consider that there is only one business segment, being pharmaceuticals. A key part of the Company's strategy is to realise the value of its intellectual property portfolio through co-development and outlicensing opportunities which may generate significant revenue in the future. Secondary reporting market - geographical segments The Group's operations are located in the UK, with commercialisation and development activities being carried out in the UK and the Rest of Europe. The following table provides an analysis of the Group's revenue by geographical market. Revenue from external customers by geographical market 6 months 6 months Year ended ended 30 ended 30 31 March September September 2006 2006 2005 £'000 £'000 £'000 UK 51 154 207 Rest of Europe 79 116 283 _____ _____ _____ 130 270 490 _____ _____ _____ The following table is an analysis of the carrying amount of segment assets. Total assets by geographical market 6 months 6 months Year ended ended 30 ended 30 31 March September September 2006 2006 2005 £'000 £'000 £'000 UK 12,461 22,312 17,401 Rest of Europe - - - _____ _____ _____ 12,461 22,312 17,401 _____ _____ _____ 5. Net cash used by operating activities 6 months 6 months Year ended ended 30 ended 30 31 March September September 2006 2006 2005 £'000 £'000 £'000 Operating loss (5,827) (4,185) (10,032) Depreciation 9 16 29 Decrease in inventories 36 69 31 Increase in trade and other receivables (383) (150) (96) Decrease in trade and other payables (149) (1,101) (1,854) Share-based payments 50 80 147 Gain on sale of EBT shares 6 - - _____ _____ _____ Net cash used by operating activities (6,258) (5,271) (11,775) _____ _____ _____ 6. Post balance sheet events On 12 October 2006 the Company announced the successful conclusion of a Placing and Open Offer of 9,585,380 shares with institutional investors and existing shareholders at a price of 115 pence per share, raising £9.9 million after expenses. The Placing and Open Offer represents 17.2 per cent. of the Company's existing share capital. This information is provided by RNS The company news service from the London Stock Exchange

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