Interim Results

Intl. Biotechnology Trust PLC 28 April 2003 28 April 2003 INTERNATIONAL BIOTECHNOLOGY TRUST Plc The Board of International Biotechnology Trust Plc ('IBT') today announces its unaudited Interim Results for the six months ended 28 February 2003. Summary • Net asset value per share fell 15.0% to 83.70p • NASDAQ Biotech Index fell 3.8% (sterling adjusted) and the Bloomberg UK Biotech Index fell 31.4% • Valuations of unquoted companies were unchanged • Total net assets at 28 February 2003: £40.7 million (31 August 2002: £47.9 million) • New investments in three quoted companies - Inspire Pharmaceuticals, Galen Holdings and XOMA • Sales of five quoted companies - Arqule, Aspect Medical, Corvas, 3-Dimensional Pharmaceuticals and Weston Medical • No new unquoted investments were made Andrew Barker, Chairman, commented: 'Most of the companies in our portfolio continue to make progress in the development of their businesses, thereby building longer term shareholder value. The timing of the stock market upturn remains hard to predict but I do believe that in time the progress made by our portfolio companies will be reflected in higher share prices and an increase in IBT's net asset value per share. In a sector where the development times for businesses are quite extended, the importance of taking a long term view should be stressed.' For further information, please contact: International Biotechnology Trust plc, Andrew Barker, Chairman 020 7658 3206 Schroder Ventures Life Sciences, Kate Bingham/ Jodie Van Elst 020 7421 7070 GCI Financial, Annabel O'Connor 020 7072 4287 Website: www.internationalbiotrust.com Chairman's Statement PERFORMANCE During the six months to 28 February 2003, net asset value ('NAV') per share fell 15.0% from 98.5p to 83.7p which compares to a fall in the NASDAQ Biotechnology Index of 3.8% in sterling terms and a fall in the Bloomberg UK Biotechnology Index of 31.4%. Market conditions in the biotech sector have been extremely difficult for investors despite encouraging news from some companies. In spite of this, the NASDAQ Biotechnology Index has held up reasonably well, largely due to the good relative performance of the shares of the larger, later stage and profitable companies in the Index. The smaller, earlier development stage companies, where IBT has a greater exposure, and which we believe have exciting longer term prospects, have continued to fall in value, which has negatively impacted the results. More details about our investments appear in the Investment Review. As I mention below, overall the unquoted investments have continued to make good progress and their valuations have not been changed during the period under review. At the end of February 2003 unquoted investments represented 55% of NAV. SHARE PRICE AND BUYING BACK SHARES In this difficult stock market environment discounts to net asset value across biotechnology investment trusts have continued to widen and the share price of International Biotechnology Trust plc fell by 27.5% from 76.5p to 55.5p, leaving the shares selling at a discount to NAV of 33.7% at the end of the period. To date, the Board has not utilised the authority given to them at the Annual General Meeting in December 2002 to purchase shares. Your Board will continue to review the situation on a regular basis. Our decision will be influenced by the market conditions at the time, the discount to net asset value and availability of stock. OUTLOOK We believe that the fundamentals of the biotech sector remain compelling with favourable economics for new product launches for unmet medical needs and broader, more mature product pipelines. Recent acquisitions and licensing deals continue to demonstrate the importance of biotechnology products to the pharmaceutical industry, with increasing competition for the best drug candidates giving biotech companies the upper hand in negotiations. At the same time we should recognise that it is unlikely that share prices within the biotech sector will show a lasting improvement without a better stock market environment. I would like to emphasise the point made in the Investment Review, namely that most of the companies in our portfolio continue to make good progress in the development of their businesses, thereby building longer term shareholder value. The timing of the stock market upturn remains hard to predict, but I do believe that in time the progress made by our portfolio companies will be reflected in higher share prices and an increase in IBT's NAV per share. In a sector where the development times for businesses are quite extended, the importance of taking a long term view should be stressed. Andrew Barker Chairman Investment Review MARKET OVERVIEW Market conditions have remained weak, with poor economic numbers and the war in Iraq weighing heavily on investor sentiment. More volatile sectors such as biotech remain out of favour and within the sector investors are focusing attention on the larger, later stage and profitable companies, with little value being attributed to smaller companies with earlier stage pipelines. This has left many of these companies trading at valuations below net cash levels. The IPO window remains closed and looks likely to remain so, at least for the remainder of this year. Newsflow from the biotech sector during the period under review has been broadly encouraging. The profitable biotech companies have reported good earnings numbers and a further positive sign has been the ability of a number of companies to raise capital through secondary placings, although this has been largely restricted to companies with Phase III stage products. The Food and Drug Administration ('FDA') has approved several new drugs in recent months including Biogen's Amevive for psoriasis and Trimeris' Fuzeon for HIV. Whilst it is too early to determine the impact of the appointment of the new FDA commissioner on the regulatory process, there are a number of promising drug candidates which are expected to come up for approval and potential launch in 2003, including portfolio company XOMA's Raptiva for psoriasis. On the corporate partnering front there have been several interesting large deals between biotech and pharmaceutical companies, such as the deal between IBT portfolio company EyeTech and Pfizer, outlined in the Investment Review, and a similar deal between Neurocrine and Pfizer for a Phase III insomnia compound, Indiplon. These agreements clearly demonstrate the leverage that the biotech industry has over the pharmaceutical industry when negotiating later stage deals. There has been some high profile mergers and acquisitions ('M&A') activity including the $2.4bn acquisition of Scios by Johnson & Johnson and the acquisition of Triangle Pharmaceuticals by Gilead for $464m. In both cases the purchases have helped to broaden out the pipelines of the acquirers. Two quoted portfolio companies, Corvas and 3-Dimensional Pharmaceuticals ('3DP'), were acquired during the period under review. Consolidation has also started to pick up in the UK, with the acquisition of Ribotargets by British Biotech and, at the time of writing, Celltech looking set to buy Oxford GlycoSciences. PORTFOLIO NEWS News from the portfolio companies has been generally positive, however the fall in share price of Essential Therapeutics has been disappointing, accounting for almost one third of the 15.0% fall in NAV during the period. Essential has been delisted by NASDAQ because it does not meet the listing requirements of a minimum of $10m in stockholders equity. This is partly due to goodwill charges resulting from recent acquisitions, and partly due to charges resulting from the elimination of some early stage programmes. In August 2001, IBT participated in a $60m Series B convertible redeemable preference stock issue (which does not count towards the $10m minimum in stockholders equity). Following the delisting, holders of the Series B stock will have the right to redeem their stock and demand the return of the $60m. However Essential only had $34m in cash at the end of 2002, so it may be necessary for the company to initiate actions that could result in dissolution, insolvency or bankruptcy. These developments combined with poor market conditions for smaller companies have led to a collapse in the share price of the company. We remain strongly supportive of management and hope to find a solution to this difficult position. There have also been a number of positive developments within portfolio companies during the six months under review. In the unquoted portfolio, Auxilium received marketing approval in the US for its testosterone replacement gel, Testim, and the product was launched in the US in February 2003. The company estimates that the market for testosterone replacement therapy could exceed $2bn by 2008, as awareness grows of the potential to treat many of the symptoms associated with low testosterone levels. EyeTech announced a co-development and co-marketing agreement with Pfizer for Macugen, its potential treatment for age-related macular degeneration and diabetic macular edema, both leading causes of blindness. Pfizer will fund most of the remaining development costs and will make an upfront payment of $100 million, with a potential additional $645 million in milestones based on regulatory submissions, approvals and sales levels. EyeTech has co-promotion rights in the US and Pfizer will market Macugen exclusively under a royalty-bearing license outside of the US. Micromet and Novuspharma announced an alliance to co-develop an anti-cancer antibody and Sunesis and Merck & Co. announced a drug discovery collaboration in the area of Alzheimer's disease. Amongst the quoted companies, Adolor announced positive Phase III results for the use of Alvimopan in the reduction of constipation resulting from opioid use for pain relief in the post-operative setting. Alexion announced encouraging Phase II data in acute myocardial infarction patients, showing a reduction in mortality in those who had undergone primary angioplasty, despite missing the primary endpoint of the trial. AnorMED started a Phase II trial to evaluate a new agent in stem cell transplantation in cancer patients. Atrix Labs announced the approval and launch of their 4-month prostate cancer product, Eligard. Johnson & Johnson announced the acquisition of 3DP for $130m, and Dendreon made a bid for Corvas, worth $73m at the time of announcement. Both of these bids were at a premium of more than 80% to the market prices of the target companies before the announcements. Inflazyme expanded its collaboration with Aventis to develop novel therapeutics for respiratory diseases. Epimmune announced a preliminary agreement to merge with a private company called Anosys, which would bring in a novel delivery technology and broaden out its pipeline. XOMA reported encouraging Phase III data for Raptiva in psoriasis and filings for approval in the US and Europe. News from Weston Medical and Crucell was less encouraging, with Weston announcing that manufacturing issues with its needle-free drug delivery device would delay launch by at least two years, which resulted in a collapse in the share price. Crucell had a difficult year, with rights to an antibody returned by Centocor and difficulty in signing new antibody deals. The company is now focusing on vaccine development and recently signed a deal with Aventis Pasteur. OUTLOOK Despite the poor share price performance of many smaller, biotech companies during the period, investee companies have generally made significant operational progress. Valuations of the smaller, earlier stage biotech companies continue to look attractive and this is where the investment focus of IBT remains. INVESTMENT ACTIVITY QUOTED COMPANIES New investments were made in Inspire (£0.1m), Galen Holdings (£0.2m) and XOMA (£1.0m). Inspire is a US based company that discovers and develops new drugs to treat diseases involving impaired protection and cleaning of the body's mucosal surfaces and other non-mucosal disorders. The company's lead compound, diquafasol, is for the treatment of dry eye, which affects approximately 30 million people in the major markets worldwide. Diquafasol has completed Phase III trials and Inspire plans to file for approval in the US in mid 2003. If diquafasol is approved the company will co-promote the compound in the US with Allergan, in conjunction with Allergan's drug, Restasis. Restasis is the only currently approved treatment for dry eye and the combined market size for the two compounds is estimated to be $1billion. Inspire has a broad, promising pipeline behind Diquafasol with compounds in Phase III trials for allergic rhinitis and lung cancer diagnosis, and Phase II trials for cystic fibrosis and retinal detachment. Galen Holdings is a UK headquartered specialist pharmaceutical company, although most of its sales are in the US. It is focused on women's health, dermatology and urology. To date Galen has predominantly grown through in-licensing products from pharmaceutical companies, but further growth is also expected through line extensions of existing brands and its proprietary pipeline. Galen's first proprietary product, an intravaginal ring for delivery of hormone replacement therapy ('HRT'), was launched in the UK in 2001 and was recently approved in the US. Two recent deals have enhanced the company's position in women's health. In December 2002 Galen bought the US rights to the Eli Lilly drug Sarafem, which is approved for the treatment of pre-menstrual dysphoric disorder, and in March 2003 it agreed to buy two oral contraceptives, Estrostep and Loestrin, and the HRT treatment femhrt, from Pfizer. XOMA was described in detail in the 2002 Annual Report. The company's lead candidate, Raptiva, is for the treatment of psoriasis and is partnered with Genentech. It has shown good efficacy in clinical trials with limited side effects and has a convenient once weekly, intravenous dosing schedule. In December 2002, Genentech and XOMA filed for approval of Raptiva in the US and Genentech expects a response from the FDA in 2003. Serono is Genentech's marketing partner outside the US and Japan, and in February 2003 it announced that a marketing authorization application had been filed in Europe. A further £0.1m was invested in Adolor (total investment £0.5m) and £0.7m in Esperion Therapeutics (total investment £0.8m). The holdings in Arqule, Aspect Medical, 3DP and Weston Medical were sold in their entirety during the period, along with the remaining holding in Corvas. Partial sales were made of holdings in AnorMED, Ribozyme and Targeted Genetics. UNQUOTED COMPANIES As discussed in the 2002 Annual Report the percentage of NAV invested in unquoted companies remains high and as a result no new unquoted investments were made during the period. In September 2002 a second tranche of £1.4m (originally committed in August 2001) was invested in Affibody (total investment £2.7m). PORTFOLIO SUMMARY AT 28 FEBRUARY 2003 IBT has investments in 32 companies - 22 quoted companies (making up 35% of the NAV) and 10 unquoted companies (making up 55% of the NAV). The remaining 10% of the NAV is made up of cash, money market instruments and other net current assets. A member of the Schroder Ventures Life Sciences (SVLS) team is on the Board of 10 of the 32 portfolio companies - Aderis Pharmaceuticals, Affibody, CancerVax, Epimmune, Essential Therapeutics, EyeTech Pharmaceuticals, Galen Holdings, Genosis, KuDOS Pharmaceuticals and Micromet. In terms of the geographical split of the portfolio, 55% of the NAV is invested in the US, 3% in Canada, 7% in the UK/Ireland and 25% in Continental Europe. By sub-sector, 77% of the NAV is invested in biopharmaceuticals, 3% in drug delivery, 1% in medical devices, and 9% in other areas. The remaining 10% of the NAV is made up of cash, money market instruments and other net current assets. Analysing the investments by the stage of their most advanced product in drug development; six companies have products on the market, one has filed for approval, 10 are in Phase III trials, eight are in Phase I/II or Phase II, one is in Phase I and two are in pre-clinical development. Of the remaining four, one is in late stage testing for a diagnostic device and the other three are platform technology companies. In terms of the cash positions of the portfolio companies, 21 have two or more years of cash, six have between one and two years of cash and five have less than a year of cash remaining. VALUATIONS The valuations of unquoted companies were unchanged during the period under review. To recap, Aderis, Affibody, Auxilium, CancerVax, EyeTech, Genosis, KuDOS and Sunesis are held at cost and Axxima and Micromet were written up in the year ended 31 August 2002 following financing rounds with prices set by new external investors. The carrying valuations of unquoted companies are reviewed weekly and incorporate consideration of the progress of the underlying company against milestones made at the time of investment and any upcoming need to raise capital. Of the 22 quoted investments five are held at a discount to their mid market prices due to disposal restrictions, including SVLS presence on the Board and limited liquidity. The effect of these discounts was to reduce the valuation of the quoted investments by £0.5m at 28 February 2003. Ten Largest Equity Holdings Value of % of Company Holdings Shareholders' Country Business Activity £'000 Funds Micromet* 3,606 8.86 Germany Micromet develops novel drugs to empower the patients' immune system. The company's BiTE compounds ('Bispecific T cell engagers') combine the power of T cells with the selectivity of antibodies to specifically target diseased cells. Sunesis 3,174 7.80 USA Sunesis has developed and implemented novel Pharmaceuticals* technologies that reproducibly deliver high-affinity, small-molecule, non-peptidic ligands to important drug targets in a rapid time frame. Aderis 3,174 7.80 USA Aderis is engaged in small molecule drug Pharmaceuticals* development to treat central nervous system and cardiovascular disorders. The company's most advanced product candidate is in Phase III trials for Parkinson's disease. EyeTech 3,174 7.80 USA EyeTech's lead product Macugen is a potential Pharmaceuticals* treatment for the two leading causes of blindness in the adult population, namely age-related macular degeneration ('AMD') and diabetic macular edema. Macugen is currently in pivotal Phase II/ III clinical trials for AMD. Affibody* 2,984 7.33 Sweden Affibody is a leader in the field of combinatorial protein engineering and is using this cutting edge technology to create a new generation of antibodies called Affibodies: small, novel, robust ligands which can be engineered to bind to any desired target protein. Axxima 1,995 4.90 Germany An infectious disease, small molecule drug Pharmaceuticals* discovery company which seeks novel chemicals to block signal transduction pathways required by pathogens for their survival in the host. CancerVax * 1,905 4.68 USA CancerVax's lead product candidate, CANVAXIN, is a therapeutic cancer vaccine in Phase III clinical trials for the treatment of advanced stage melanoma, a disease with few effective or well-tolerated treatments. Forest Laboratories 1,771 4.35 USA Forest Labs is a specialty pharmaceutical company that develops, manufactures and sells both branded and generic forms of pharmaceutical products. OSI Pharmaceuticals 1,408 3.46 USA OSI's lead compound is a small molecule anti-cancer compound called Tarceva. It is in Phase III trials for non-small cell lung cancer and pancreatic cancer and is partnered with Genentech and Roche. KuDOS 1,400 3.44 UK KuDOS is a leader in the discovery and development Pharmaceuticals* of novel small molecule drugs that inhibit DNA repair enzymes and signalling pathways for the treatment of cancer. The company's lead compound, Patrin, is in Phase II trials for metastatic melanoma. 24,591 60.42 * Unquoted investments International Biotechnology Trust As at 28 February 2003 Investments by Stage % of NAV Quoted 34.6 Unquoted 55.4 Net cash 10.0 100.00 Investments by Sub Sector % of NAV Biopharmaceuticals 77.4 Drug delivery 2.9 Medical devices 1.3 Other 8.4 Net cash 10.0 100.00 Investments by Geographical Sector % of NAV USA 55.2 Canada 3.3 UK/Ireland 6.6 Continental Europe 24.9 Net cash 10.0 100.00 Note: Net cash is defined as cash and other current assets less current liabilities. International Biotechnology Trust plc Unaudited Preliminary Results Unaudited Statement of Total Return (incorporating the Revenue Account) For the six months ended For the six months ended 28 February 2003 28 February 2002 Revenue Capital Total Revenue Capital Total £'000 £'000 £'000 £'000 £'000 £'000 Losses on investments - (6,698) (6,698) - (22,510) (22,510) Exchange gains on currency balances - 1 1 - 169 169 Income 58 - 58 147 - 147 Administrative expenses (566) - (566) (777) - (777) Deficit before taxation (508) (6,697) (7,205) (630) (22,341) (22,971) Taxation - - - - - - Deficit on ordinary activities after taxation (508) (6,697) (7,205) (630) (22,341) (22,971) Deficit per (1.04)p (13.78)p (14.82)p (1.30)p (45.95)p (47.25)p ordinary share The revenue column of this statement is the profit and loss account of the Company. All revenue and capital items in the above statement derive from continuing operations. International Biotechnology Trust plc Unaudited Balance Sheet 28 February 31 August 2003 2002 £'000 £'000 Fixed assets Investments 36,637 43,584 Current assets Debtors 45 153 Investments 1,924 1,889 Cash at bank 2,474 2,912 4,443 4,954 Current liabilities Creditors: amounts falling due within one year 390 643 Net current assets 4,053 4,311 Net assets 40,690 47,895 Capital and reserves Called up share capital 12,154 12,154 Capital redemption reserve 10,843 10,843 Share purchase reserve 67,083 67,083 Capital reserve (40,875) (34,178) Revenue reserve (8,515) (8,007) Equity shareholders' funds 40,690 47,895 Net asset value per share 83.70p 98.52p International Biotechnology Trust plc Unaudited Cash Flow Statement For the For the six months ended six months ended 28 February 2003 28 February 2002 £'000 £'000 Operating activities Dividend income received 1 - Current asset investment income received 8 63 Income from directorships 7 - Deposit interest received 9 16 Management fee paid (319) (389) Other cash payments (264) (387) Net cash outflow from operating activities (558) (697) Capital expenditure and financial investment Purchase of investments (4,134) (15,654) Sale of investments 4,253 15,076 Net cash inflow/(outflow) from capital expenditure and financial investment 119 (578) Net cash outflow before management of liquid resources and financing (439) (1,275) Management of liquid resources - (3,046) Net cash outflow (439) (4,321) Notes The Interim Report will be mailed to registered shareholders in May 2003 and from the date of release copies of the Interim Report will be made available to the public at the Company's Registered Office at 31 Gresham Street, London EC2V 7QA. This announcement is prepared on the basis of the accounting policies as set out in the most recently published set of annual financial statements. This information is provided by RNS The company news service from the London Stock Exchange
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