Interim Results
Intl. Biotechnology Trust PLC
20 April 2004
INTERNATIONAL BIOTECHNOLOGY TRUST Plc
The Board of International Biotechnology Trust Plc ('IBT') today announces its
unaudited Interim Results for the six months ended 29 February 2004.
Summary
• Net asset value per share rose by 13.2% to 127.7p
• NASDAQ Biotech Index fell 10.3% (sterling adjusted), Merrill Lynch Small
Cap Biotech Index rose by 3.0% (sterling adjusted) and the Bloomberg UK
Biotech Index rose by 10.7%
• The return on IBT's quoted portfolio was 31.8% calculated on a monthly
time-weighted return basis assuming mid-month cash flows, and 25.3% on an
unweighted basis (ignoring the timing of transactions)
• Eyetech and CancerVax completed IPOs on NASDAQ
• Write-downs of two unquoted companies amounted to a fall in net assets
of £2.8 million or 5% of net assets at 31 August 2003
• New investments in two quoted companies; sales of five quoted companies
• No new unquoted investments; follow-on investments in Genosis and Auxilium
• Two new unquoted investments subsequent to the end of the reporting
period - Dynogen and Archemix
• Total net assets at 29 February 2004: £61.1million (31 August 2003:
£53.9million)
Andrew Barker, Chairman, commented:
A number of biotech initial public offerings (IPOs) have taken place in the US.
I am delighted to report that two of IBT's unquoted holdings, CancerVax and
Eyetech, have completed IPOs during the period under review.
2003 was a good year for the biotech market with very positive newsflow from the
sector. Underlying fundamentals remain strong with a number of new product
launches, maturing product pipelines, access to capital and strong partnering
interest from large pharmaceutical companies. However, investor expectations for
the biotech sector are high and the biotech market is expected to continue to be
volatile, so a long term investment view is advised, in line with that of the
Board. That said, we remain optimistic about the prospects for the IBT
portfolio.
For further information, please contact:
International Biotechnology Trust plc
Andrew Barker, Chairman 020 7658 3206
Schroder Ventures Life Sciences
Kate Bingham / Josee Gray 020 7421 7070
Lansons Communications
Henrietta Guthrie / Amy Fisher 020 7490 8828
Website: www.internationalbiotrust.com
CHAIRMAN'S STATEMENT
PERFORMANCE
I am pleased to report that, during the six months to 29 February 2004 there was
an increase in the net asset value (NAV) per share of International
Biotechnology Trust plc (IBT) of 13.2% from 112.8p to 127.7p, and an 18.2% rise
in the share price from 85.0p to 100.5p. This increase, which builds on the rise
of 14.5% in NAV per share during the year to 31 August 2003, compares with a
fall in the NASDAQ Biotech Index (NBI) over the same period of 10.3%, a rise in
the Merrill Lynch Small Cap Biotech Index (MLSCI) of 3.0% and a 10.7% increase
in the Bloomberg UK Biotechnology Index (BUBI), all in sterling terms. Over the
six months under review the discount of the share price to NAV narrowed from
24.6% to 21.3% and at the time of writing, the discount is 20.8%.
A number of biotech initial public offerings (IPOs) have taken place in the US.
I am delighted to report that two of IBT's unquoted holdings, CancerVax and
Eyetech, have completed their IPOs during the period under review. Further
details of these are given in the Manager's report.
The increase in net asset value during the period was largely due to the
outstanding performance of the holding in Eyetech. As at 13 April 2004, the date
of the most recently published NAV, the investment in Eyetech comprised 16.8% of
NAV. The holding is valued at a 25% discount to the current share price in
accordance with BVCA guidelines.
The US Dollar was weak against other currencies and this had a significant
impact on the sterling value of our overseas holdings. Whilst the situation is
kept under regular review, it is not our current policy to hedge the currency
exposure.
The performance of IBT's quoted portfolio calculated on a time-weighted return
basis (assuming mid-month cash flows) showed a rise of 31.8%. On an unweighted
basis (ignoring the timing of transactions) the return was 25.3%. These
calculations include the changes in the discounted valuations of the CancerVax
and Eyetech holdings since their respective IPOs. This performance compares with
a rise in the MLSCI of 3.0%.
VALUATIONS
In the last annual report we outlined the basis of valuation of investments. We
continue to use this policy in the interim report, which is to apply the
Association of Investment Trust Companies' Statement of Recommended Practice
(SORP) and the British Venture Capital Association (BVCA) Valuation Guidelines.
Valuations are considered on an ongoing basis and information that impacts the
valuation of a private company or the discount applied to an investment in a
public company is incorporated into the valuation and if there is a material
impact on NAV, then a new NAV is released to the market.
NEW DIRECTOR
I am pleased to announce that on 2 March 2004, Dr David Clough, aged 57, was
appointed as a Director of the Company. He was Director of Research at Roche in
the UK between 1986 and 1999. He was responsible for over 300 staff with
departments covering chemistry, biology and pre-clinical development. During
this time, two products discovered by staff in the research group under Dr
Clough progressed to the market place, namely Inhibace and Invirase. Dr Clough
has received several national and international awards for his role in the
discovery of Invirase, including the UK and International Prix Galien, the PhRMA
Discoverers Award and the UK Millennium Product Award.
Dr Clough is currently on the Board of Fulcrum Pharma PLC and on the Scientific
Advisory Boards of Cambridge Antibody Technology, Anadys and Kinetique. He holds
a PhD from Glasgow University.
Share BUY BACK
During the period ended 29 February 2004, the Directors have not purchased
shares for cancellation and have not utilised the authority given to them at the
last Annual General Meeting. When shares are available in reasonable volumes and
at a high discount to net assets, we shall consider further purchases while
maintaining sufficient liquidity for existing commitments and for making new
investments.
PROSPECTS
2003 was a good year for the biotech market with very positive newsflow from the
sector. Underlying fundamentals remain strong with a number of new product
launches, maturing product pipelines, access to capital and strong partnering
interest from large pharmaceutical companies. However, investor expectations for
the biotech sector are high and the biotech market is expected to continue to be
volatile so a long term investment view is advised, in line with that of the
Board. That said, we remain optimistic about the prospects for the IBT
portfolio.
Andrew Barker
Chairman
Manager's Review
MARKET OVERVIEW
2003 was an excellent year for biotech. It was the second best financing year
for biotech since 2000, and sentiment was strong with good clinical data, a
bumper number of new drug approvals and sales and earnings numbers that
generally exceeded expectations. M&A activity continued and included the
announcement of an acquisition of IBT portfolio company, Esperion, by Pfizer for
$1.3bn in December 2003. The outperformance of the MLSCI in comparison with the
NBI illustrates the relative strength of the smaller biotech companies in
comparison to their larger peers during the six months under review.
At 29 February 2004, 68% of net assets were invested in the US. The weakness in
the dollar has dampened the returns from these investments to sterling-based
investors.
A number of biotech companies have gone public in the US, including CancerVax
and Eyetech from the IBT portfolio. These companies have tended to have
compounds in late stage clinical trials and some are already generating sales.
This is in contrast to the IPO boom of 2000 which was driven by the excitement
of genomics rather than pipelines and revenues. In March 2004, Ark Therapeutics
and Basilea Pharmaceutica completed the first biotech IPOs for a number of
years, in the UK and continental Europe respectively.
While the IPO window for biotech has opened, the performance of these stocks in
the aftermarket has been mixed. At the time of writing, the share price of
Eyetech has risen more than 59% from its IPO price, while the share price of
CancerVax is trading 15% below its IPO price.
The biotech indices were relatively weak in the fourth quarter of 2003 with
profit taking by investors. However the sector rallied strongly at the start of
2004, and, at the time of writing, has largely recovered from a fall in March
due to geopolitical concerns.
Expectations for the sector are higher now than at the start of the recent rally
in mid 2002, and there is some room for disappointment going forward. Continuing
financings may start to reverse the previously favourable supply demand balance
and it seems unlikely that the broad based, outsized gains of 2003 will be
repeated in 2004; performance is likely to be more selective and it may be
difficult to repeat the amount of good newsflow that drove the sector higher in
2003.
Dr Mark McClellan has recently left his post as Commissioner of the US Food and
Drug Administration (FDA). His record at the FDA has been impressive and he is
credited with reducing drug candidate review times. His departure, however, is
not expected to have a large impact on drug approvals. The current acting
commissioner, Lester Crawford, served as acting commissioner before McClellan
was appointed in late 2002.
At the time of writing there have been a number of regulatory approvals in the
US in 2004 including the high profile drug candidate, Avastin from Genentech,
for the treatment of first-line metastatic colorectal cancer. Regarding clinical
data, Biogen IDEC and Elan Corporation announced plans to submit applications
for the approval of Antegren for the treatment for multiple sclerosis in Europe
and the US, based on one-year data from ongoing two-year Phase III trials,
although this data has not yet been released. Consolidation has continued with
the announcement from Amgen in March 2004 that it was acquiring the remaining
shares of Tularik for $1.3bn in stock.
OUTLOOK
The fundamental backdrop for the biotech sector remains strong, although
expectations are high. 2004 may bring more details on the impact of Medicare
reimbursement changes, proposals for developing generic biologics and options
expensing, which could impact the sector negatively. The sales launches of
recently approved products and any trend in regulatory decisions by the FDA will
be key drivers for the sector.
IBT's portfolio companies are making good overall progress and are generally
well funded. Adolor expects to file for approval in the US for Entereg for the
management of postoperative ileus late in the first half of 2004 and Eyetech
plans to prepare and file for approval of Macugen in the third quarter of 2004
for the treatment of the wet form of age-related macular degeneration. In
addition, Indevus expects that Trospium will be reviewed by the FDA in May of
2004 for overactive bladder, and OSI and alliance partners Genentech and Roche,
are expected to report top-line Phase III data for Tarceva for the treatment of
relapsed non-small cell lung cancer in the second quarter of 2004.
PORTFOLIO NEWS
In October 2003 CancerVax priced its IPO at $12 a share, raising net proceeds of
approximately $66m. IBT's holding was valued at £1.9m at 29 February 2004 using
a liquidity discount of 25% to the mid-market price ($12.25). This compares with
a cost of £2.5m. The company's lead product candidate, Canvaxin, is a
therapeutic cancer vaccine and is currently being studied in two international
Phase III clinical trials for the treatment of patients with Stage III or IV, or
advanced-stage, melanoma.
In February 2004 Eyetech completed an IPO at $21 per share raising approximately
$146m before deducting offering expenses. Eyetech has reported results from the
first year of Phase II/III pivotal clinical trials for the use of its drug
candidate, Macugen, in the treatment of the wet form of age- related macular
degeneration (AMD), in which the 0.3 mg dose met the primary clinical endpoint.
Based on these results, Eyetech plans to prepare and file a New Drug Application
(NDA) with the FDA in the third quarter of 2004 seeking marketing approval for
the 0.3 mg dose for the treatment of all three subtypes of wet AMD. IBT's
holding was valued at £11.9m at 29 February 2004, using a liquidity discount of
25% to the mid-market price ($36.29). This compares with a cost of £3.4m.
Aderis filed to go public in August 2003 but withdrew its registration statement
in November 2003 due to prevailing market conditions and valuation. The company
remains well-financed with more than a year of cash remaining at the time of
writing. The company's partner, Schwarz Pharma, expects to file for marketing
approval for the Parkinson's patch (Rotigotine CDS) in the third quarter of 2004
and the company's other partnerships with Fujisawa and King Pharmaceuticals are
progressing well. King has initated a pivotal Phase III trial with binodenoson
for cardiac pharmacologic stress testing. Selodenoson IV is in development with
Fujisawa Healthcare and has completed Phase II for heart rate control in
patients with atrial fibrillation. The CEO left the company in the first quarter
of 2004 to pursue other interests and a search has been initiated for his
replacement.
In December 2003, Pfizer announced that it had entered into an agreement to
acquire IBT portfolio company Esperion, for $1.3bn, at a price of $35 per share.
This price represented a 54% premium over Esperion's average closing share price
during the prior 20 trading days. The acquisition of Esperion brings Pfizer a
novel approach to the emerging area of high density lipoprotein (HDL) therapy
and reverse lipid transport for the acute treatment of cardiovascular disease.
The cost of IBT's holding in Esperion at 31 August 2003 was £0.5m and the
investment was sold for £2.9m during the period under review.
In 2003, Essential won court approval to bring it out of Chapter 11 with its
plan of reorganisation. The effect of this was to turn Essential (renamed Trine
Pharmaceuticals), into a private company owned by the former preferred
stockholders and management. The newly formed private company had cash of $12m
in March 2004. This cash is being used to fund a small clinical and business
development team searching for drugs to in-license. The holding in Trine was
valued at £0.8m at 29 February 2004.
In October 2003 the FDA approved Forest Labs' drug candidate, Namenda, for the
treatment of moderate to severe Alzheimer's disease. Namenda was launched in the
US in January 2004.
Nektar is the developer of the inhalation device and formulation of insulin for
a version of inhaled insulin called Exubera. Exubera is being developed for
patients with type 1 and type 2 diabetes through a collaboration between Pfizer
and Aventis. In March 2004, Nektar reported that Pfizer and Aventis had
announced that the European Medicines Evaluation Agency had accepted the filing
of a marketing authorisation application for Exubera. Pfizer and Aventis have
been working with the FDA to determine the appropriate timing for submission of
the Exubera NDA in the US.
In October 2003 Genentech and XOMA announced that Raptiva had been approved by
the FDA for the treatment of chronic moderate-to-severe plaque psoriasis.
Genentech launched Raptiva in November 2003 in the US. In March 2004 preliminary
results from a Phase II study of Raptiva in psoriatic arthritis patients showed
that statistical significance was not reached for the primary endpoint of the
trial. Despite the approval and launch of Raptiva in the US, XOMA shares have
performed poorly during the period under review.
In January 2004 the investment in Micromet was written down to £1.7m (as
described in the valuation section) as a consequence of a contract dispute
arising in connection with a collaboration agreement for the development of the
company's anti-cancer antibody MT201 and consequent shortfall in 2004 income.
The company announced a realignment of operations and reduced headcount from 135
to 90 employees. In February 2004, Micromet started a Phase II study with MT201
in prostate cancer patients and in March 2004, a Phase II trial was intiated in
breast cancer patients. In March 2004 Christian Itin was promoted from Chief
Business Officer to the position of Chief Executive Officer (CEO). He succeeded
Erich Felber, who is a co-founder of Micromet and had served as CEO since
inception. Erich Felber stays an active member of the Executive Board and
continues to serve as President.
In February 2004 the holding in Axxima was written down to zero due to lack of
progress in the company's programs (see details in the valuation section).
In December 2003 Inspire announced that the FDA had issued an approvable letter
for the company's drug candidate, diquafasol, for the treatment of dry eye. The
FDA has requested that Inspire provide data from an additional clinical study.
The company plan to initiate a new study as quickly as possible.
In October 2003 OSI announced that two first-line Phase III studies of Tarceva,
in combination with chemotherapy, in metastatic non-small cell lung cancer
(NSCLC) did not meet their primary endpoints of improving overall survival.
Although the results were disappointing, investors were not completely surprised
based on the previous failure of a similar compound in this setting, and the
share price was little changed on the day of the announcement. Tarceva is being
evaluated in a clinical development program together with alliance partners,
Genentech and Roche. Top-line data are expected to be reported in the second
quarter of 2004 from a Phase III trial testing monotherapy Tarceva in a relapsed
NSCLC setting.
During the reporting period, Adolor reported data from a fourth Phase III trial
for Entereg (formerly known as alvimopan), for the management of postoperative
ileus. The results from this study did not meet the primary endpoint of the
trial. In two of the other Phase III trials, at least one of the dose levels
used did met the primary endpoint. The remaining Phase III trial had safety as
its primary objective and showed that Entereg was generally well tolerated.
Entereg has received Fast Track designation from the FDA for this indication,
and Adolor plans to file for regulatory approval in the US for Entereg late in
the first half of 2004.
In November 2003 Celltech announced that Pfizer wanted to renegotiate the
financial terms of a collaboration surrounding CDP 870, Celltech's PEGylated
anti-TNF-alpha antibody fragment, in development for Crohn's disease and
rheumatoid arthritis. In December 2003 the rights were returned to Celltech. In
March 2004 the company announced that it was in discussions with a view to
securing a new collaboration partner. Celltech also announced preliminary
results from the first Phase III trial in rheumatoid arthritis, showing that the
study met its primary endpoint.
PORTFOLIO SUMMARY AT 29 FEBRUARY 2004
IBT has investments in 33 companies - 24 quoted companies (representing 65.6% of
NAV) and nine unquoted companies (comprising 21.9% of NAV). The remaining 12.5%
is made up of cash, money market instruments and other net current assets.
Since the end of the period under review, cash has been invested into a
follow-on investment in Genosis (£0.4m) and new investments have been made in
the unquoted companies Archemix and Dynogen (at the time of writing £0.9 million
has been invested out of a total planned investment of £1.9m).
Members of Schroder Ventures Life Sciences (SVLS) sat on the Boards of nine of
the 33 portfolio companies at the end of the period under review - Aderis,
Affibody, CancerVax, Eyetech, Galen, Genosis, KuDOS, Micromet and Trine. Since
the period end, members of SVLS have taken board seats on both Archemix and
Dynogen.
In terms of the geographical split of the portfolio, at 29 February 2004, 67.5%
of NAV was invested in the US, 5.2% in Canada, 7.3% in the UK/Ireland and 7.5%
in Continental Europe. By sub-sector, 76.6% of NAV was invested in
biopharmaceuticals, 5.6% in drug delivery, 0.9% in medical devices and 4.4% in
other areas. The remaining 12.5% 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; nine companies have a product on the market, one has filed for
regulatory approval, eleven are in Phase III trials, six are in Phase II or
Phase I/II, and two are at a preclinical stage. Of the remaining four, one has
completed testing for a diagnostic device and the other three are platform
technology companies.
In terms of the cash positions of the portfolio companies, it is estimated that
at 29 February 2004, nine have two or more years of cash remaining (23% of net
assets less cash and money market instruments), twenty-one have between one and
two years of cash remaining (73% of net assets less cash and money market
instruments) and three have less than a year of cash remaining (4% of net assets
less cash and money market instruments).
The companies with less than a year of cash at the end of the period under
review are Axxima, Genosis and Micromet. The investment in Axxima has been
written down to zero, Genosis has raised £0.4m since 29 February 2004 in order
to provide further working capital and Micromet is exploring strategic and
fundraising options.
VALUATION
At 29 February 2004 IBT's unquoted portfolio (value £13.4m) represented 21.9% of
net assets, down from 42.1% at the end of the previous financial year (value
£22.7m). As CancerVax and Eyetech are both now public companies, the percentage
of NAV in unquoted investments has been reduced. The total carrying value of
these two investments was £5.3m at 31 August 2003. Follow on investments in
Genosis and Auxilium added £0.3m to unquoted investments during the reporting
period.
During the six months under review the net effect of the change in the
Directors' valuations of unquoted companies was a reduction in NAV for the
period of £2.8m. This represents 5% of net assets as at 31 August 2003.
In January 2004 the valuation of Micromet was written down by £1.9m (carrying
value at 31 August 2003 £3.7m) representing 50% of the cost of the investment in
Euro terms (cost £3.1m). At 29 February 2004 the investment was valued at £1.7m.
A currency loss of £0.1m accounts for the balance in the change of the valuation
of the investment during the reporting period. In February 2004 the holding in
Axxima was written down by £0.9m to zero (cost £1.4m and carrying value at 31
August 2003 £0.9m).
Currency losses decreased the valuation of the unquoted portfolio by £1.5m
during the period under review.
At 29 February 2004 the holdings in Aderis, Affibody, Auxilium, Genosis, KuDOS
and Sunesis were held at cost (total value £10.9m), the investments in Trine and
Micromet were written down from cost (total value £2.5m) and the holding in
Axxima was held at zero. This equates to 81.3% of the unquoted portfolio held at
cost and 18.7% written down (calculated by value). The unquoted portfolio is now
valued at 60.3% of original cost (excluding the costs of ValiGen and Entigen and
including the initial costs of Trine and Axxima).
The valuation of Trine was unchanged during the period under review in dollar
terms. The holding in Trine was valued at £0.8m at 29 February 2004 reflecting
the company's cash position and an assessment of the company's progress.
The unquoted investments made subsequent to the period end, Archemix and
Dynogen, are valued at cost (in dollar terms) at the time of writing.
Of the 24 quoted investments, seven were held at a discount to their mid market
prices at 29 February 2004 due to disposal restrictions, including limited
liquidity - AnorMED, CancerVax, Epimmune, Eyetech, Galen, Inflazyme and LION
Biosciences. The discounts range in size between 10% and 25% and the effect of
these discounts was to reduce the NAV by £5.8m at 29 February 2004.
At the time of writing, discounts are applied to the holdings in CancerVax,
Eyetech, Galen, Epimmune and LION.
INVESTMENT ACTIVITY
Unquoted Companies
As the percentage of NAV invested in unquoted investments was at a high level
for most of the period under review, no investments were made in new unquoted
companies during this period.
As outlined in the 2003 Annual Report, an investment of £0.2m was made in
September 2003 in the fertility diagnostics company Genosis, in order to fund
the external performance evaluations for the male fertility test (total
investment £0.7m). Genosis has received U.S. regulatory clearance for the female
fertility test and since the end of the period under review Genosis has
completed the male performance evaluation and the female fertility test has been
cleared for sale in Europe. Since 29 February 2004 a further investment of £0.4m
has been made in Genosis in order to provide further working capital (total
investment £1.1m).
In November 2003, a further £0.1m was invested in Auxilium (total investment
£0.8m) and the guarantee for a revolving line of credit was released.
Accordingly, the contingent liability in the accounts has also been removed.
Auxilium's testosterone gel, Testim has been approved for sale in the US and the
UK for use in treating men with low testosterone levels, and was launched in the
US in February 2003. The company recorded revenues of just under $12m in 2003
with approximately a 9% share of the testosterone gel market. Auxilium announced
a distribution agreement with Bayer for marketing Testim in Canada during
January 2004. New clinical results have shown that restorative increases in
testosterone levels directly correlate to improvements in sexual function and
muscle mass.
Since 29 February 2004, two new unquoted investments have been made. At the time
of writing, out of a planned total investment of £0.9m, £0.3m has been invested
in US-based company Archemix. Archemix is focused on the discovery and
development of aptamer-based therapeutics. Aptamers are oligonucleotides that
bind to drug targets in a similar way to antibodies. Eyetech's lead compound
Macugen is an example of an aptamer-based therapeutic. In January 2004 Archemix
announced a worldwide collaboration agreement with Nuvelo to develop and
commercialise Archemix's anti-thrombin aptamer, ARC 183, which is initially
being developed as an anticoagulant/anti-thrombotic for use in coronary artery
bypass graft (CABG) surgery. A Phase I clinical trial with ARC183 for use in
this procedure is expected to begin in the second half of 2004. Under the terms
of the agreement, Archemix will initially lead development and be responsible
for all clinical development activities. Nuvelo has the option to lead
commercialisation efforts in which both companies may participate. The two
companies will equally share all development and marketing costs and will have
50/50 ownership of the compound. Mike Ross of SVLS is on the Board of the
company.
In addition, at the time of writing, out of a planned total investment of £1.0m,
£0.6m has been invested in US-based company Dynogen. Dynogen is a
neuroscience-based company focused on genitourinary (GU) and gastrointestinal
(GI) disorders. The company is building a pipeline of development programs using
its knowledge of the nexus between neurology and GU/GI disorders and its
predictive pharmacology platforms.
Dynogen has two ongoing development programs, one for overactive bladder (OAB)
and another for irritable bowel syndrome (IBS). The company plans to advance its
OAB program into Phase IIa trials in the second quarter of 2004 and to enter the
clinic with its IBS program later this year. Kate Bingham of SVLS is on the
Board of the company.
Finally, as discussed previously, CancerVax and Eyetech completed IPOs during
the six months under review and are now quoted companies.
Quoted Companies
New investments were made in two quoted companies during the period under review
- AtheroGenics (£0.5m investment) and Kosan Biosciences (£0.3m investment).
AtheroGenics is a US-based company, focused on the discovery, development and
commercialisation of novel drugs for the treatment of chronic inflammatory
diseases. AtheroGenics' lead compound is being evaluated in a Phase III trial,
as an oral therapy for the treatment of heart disease (atherosclerosis). The
company's second clinical compound is an oral agent being tested in a Phase II
trial for the treatment of rheumatoid arthritis. An intravenous rheumatoid
arthritis treatment has completed a Phase I study and finally an agent is being
developed for the prevention of organ transplant rejection in collaboration with
Fujisawa.
Kosan Biosciences is a US-based company with two oncology product candidates in
the clinic, both of which are derived from an important class of natural
products called polyketides. KOS-862 is in Phase II trials and is partnered with
Roche in a global development and commercialisation agreement. KOS-862 inhibits
cancer cells by the same mechanism as the marketed drug, paclitaxel, and in
preclinical models was shown to be effective against paclitaxel-resistant
tumors. 17-AAG is being evaluated in multiple Phase I and Phase Ib trials in
collaboration with the National Cancer Institute. 17-AAG is an inhibitor of
Hsp90 and interrupts several biological processes implicated in cancer cell
growth and survival.
A further £0.4m was invested in Alexion (total investment £1.7m). Alexion has
completed a Phase III clinical study with its drug candidate pexelizumab in CABG
patients undergoing cardiopulmonary bypass, and two large Phase II studies with
pexelizumab in acute myocardial infarction (AMI) patients. Together with partner
Procter & Gamble Pharmaceuticals, Alexion is moving forward to initiate pivotal
Phase III studies with pexelizumab in CABG surgery patients and separately in
AMI patients receiving angioplasty. In addition, Alexion's drug candidate
eculizumab has completed Phase II trials in rheumatoid arthritis and membranous
nephritis, and has completed pilot programs for the treatment of paroxysmal
nocturnal hemoglobinuria (PNH) and dermatomyositis. The company is preparing to
initiate a Phase III program in PNH.
A further £0.3m was invested in Inspire (total investment £0.6m). Inspire was
described in the portfolio news section.
The holdings in Crucell, Esperion, Novuspharma, Sirna and Targeted Genetics were
sold in their entirety during the period under review.
International Biotechnology Trust
As at 29 February 2004
Ten Largest Equity Holdings
Company Value of % of Country Business Activity
Holdings Shareholders
£'000 Funds
1 Eyetech Pharmaceuticals 11,883 19.46 USA Eyetech specialises in the development
and commercialisation of novel
therapeutics to treat diseases of the
eye. The company's most advanced product
candidate is Macugen, which is being
developed for the treatment of the wet
form of age-related macular degeneration
and diabetic macular edema. Eyetech has
entered into a collaboration with Pfizer
to develop and commercialise Macugen for
the prevention and treatment of diseases
of the eye.
2 Encysive Pharmaceuticals 3,467 5.68 USA Argatroban, Encysive's first
FDA-approved product, is marketed by
GlaxoSmithKline for heparin-induced
thrombocytopenia. Encysive is in Phase
III development of the endothelin
antagonist, sitaxsentan, for pulmonary
arterial hypertension.
3 Affibody* 2,895 4.74 Sweden Affibody uses innovative
protein-engineering technologies for the
development of products in the core
business areas biotherapeutics,
proteomics and separomics. The Affibody
molecule mimics a monoclonal antibody in
many ways, and its properties make it a
superior choice for many applications.
4 Aderis Pharmaceuticals* 2,694 4.41 USA Aderis is engaged in small molecule drug
development to treat central nervous
system and cardiovascular disorders. The
company currently has four product
candidates in six clinical development
programs.
5 Sunesis Pharmaceuticals* 2,694 4.41 USA Sunesis is a research-based company that
applies fragment-based drug discovery to
create and develop superior therapeutics
addressing major diseases. Sunesis is
focusing its internal pipeline on
inflammation and oncology.
6 Nektar Therapeutics 2,053 3.36 USA Nektar provides industry-leading drug
delivery technologies, expertise and
manufacturing to enable the development
of high-value, differentiated
therapeutics. Nektar's advanced drug
delivery capabilities are designed to
enable the company's biotechnology and
pharmaceutical partners to solve drug
development challenges and realise the
full potential of their therapeutics,
from development of new molecular
entities to managing the lifecycles of
established products.
7 OSI Pharmaceuticals 1,985 3.25 USA OSI is focused on the discovery,
development and commercialisation of
high-quality, next-generation oncology
products that both extend life and
improve the quality-of-life for cancer
patients worldwide. OSI has a balanced
pipeline of oncology drug candidates
that includes both novel
mechanism-based, gene-targeted therapies
focused in the areas of signal
transduction and apoptosis and
next-generation cytotoxic chemotherapy
agents.
8 CancerVax 1,913 3.13 USA CancerVax is focused on the research,
development and commercialisation of novel
biological products for the treatment and
control of cancer. The company's lead
product candidate, Canvaxin, is one of a
new class of products being developed in
the area of specific active immunotherapy,
also known as therapeutic cancer vaccines.
9 Alexion Pharmaceuticals 1,765 2.89 USA Alexion is engaged in the discovery and
development of therapeutic products aimed
at treating patients with a wide array of
severe disease states, including
cardiovascular and autoimmune disorders,
inflammation and cancer. Alexion's two
lead product candidates, pexelizumab and
eculizumab, are currently undergoing
evaluation in several clinical development
programs.
10 Atrix Laboratories 1,736 2.85 USA Atrix Labs is an emerging specialty
pharmaceutical company focused on advanced
drug delivery. With unique patented
sustained release and topical
technologies, Atrix is currently
developing a diverse portfolio of
proprietary products, including oncology,
pain management, and dermatology products.
33,085 54.18 * Unquoted Investments
International Biotechnology Trust plc
Unaudited Preliminary Results
Unaudited Statement of Total Return (incorporating the Revenue Account)
Group Company
For the six months ended For the six months ended
29 February 2004 28 February 2003
Revenue Capital Total Revenue Capital Total
£'000 £'000 £'000 £'000 £'000 £'000
Gains/(losses) on
investments - 8,029 8,029 - (6,698) (6,698)
Exchange (losses)/gains
on currency balances - (333) (333) - 1 1
Income 72 - 72 58 - 58
Administrative
expenses (635) - (635) (566) - (566)
(Deficit)/ return before
taxation (563) 7,696 7,133 (508) (6,697) (7,205)
Taxation - - - - - -
(Deficit)/ return on
ordinary activities
after taxation (563) 7,696 7,133 (508) (6,697) (7,205)
(Deficit)/ return per
ordinary share (1.18)p 16.10p 14.92p (1.04)p (13.78)p (14.82)p
The revenue column of this statement is the profit and loss account of the Group
(where appropriate)
All revenue and capital items in the above statement derive from continuing
operations.
International Biotechnology Trust plc
Balance Sheets
29 February 2004 31 August 2003
Group Company Company
£'000 £'000 £'000
(unaudited) (unaudited) (audited)
Fixed assets
Investments 53,432 52,033 49,911
Investment in subsidiary undertaking - -
Current assets
Debtors 57 1,456 73
Investments 5,896 5,896 2,742
Cash at bank 2,028 2,028 1,615
7,981 9,380 4,430
Current liabilities
Creditors: amounts falling due
within one year 349 349 410
Net current assets 7,632 9,031 4,020
Net assets 61,064 61,064 53,931
Capital and reserves
Called up share capital 11,954 11,954 11,954
Capital redemption reserve 11,043 11,043 11,043
Share purchase reserve 66,467 66,467 66,467
Capital reserve (18,816) (18,816) (26,512)
Revenue reserve (9,584) (9,584) (9,021)
Equity shareholders' funds 61,064 61,064 53,931
Net asset value per share 127.71p 112.79p
International Biotechnology Trust plc
Unaudited Cash Flow Statement
Group Company
For the For the
six months ended six months ended
29 February 2004 28 February 2003
£'000 £'000
Operating activities
Income 19 25
Management fee paid (359) (319)
Other cash payments (320) (264)
Net cash outflow from operating
activities (660) (558)
Capital expenditure and
financial investment
Purchase of investments (1,845) (4,134)
Sale of investments 6,352 4,253
Net cash inflow from capital expenditure and
financial investment 4,507 119
Net cash inflow/(outflow) before management
of liquid resources and financing 3,847 (439)
Management of liquid resources (3,100) -
Financing
Stamp duty (1) -
Net cash outflow from financing (1) -
Net cash inflow/(outflow) 746 (439)
Notes
(1) These accounts consolidate the accounts of the Company 'International
Biotechnology Trust plc' and its wholly-owned subsidiary, IBT 2004 Limited. The
subsidiary was incorporated on 8 December 2003 and commenced operations on 3
February 2004. The Company subscribed £100 for the issued share capital of IBT
2004 Limited. These financial statements have been prepared using accounting
policies consistent with those used for the audited financial statements as at
31 August 2003. All Group operations are of a continuing nature
(2) The Interim Report will be mailed to registered shareholders in May 2004
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.
(3) Note on Merrill Lynch Small Cap Biotech Index (MLSCI)
The MLSCI represents stocks with market caps under US$1 billion. The Merrill
Lynch published report (BIO-STATS) as at 1 March 2004 states the movement in the
index in $ terms, for the period under review, to be 20.8%. The movement in £
terms has been calculated using the prevailing exchange rates at the start and
end of the reporting period, sourced from Factset and Bloomberg.
The data underlying the MLSCI changes regularly in line with changes in the
index constituents, price adjustments and corporate actions. The historic data
is then retrospectively adjusted. As a result the performance for the reporting
period, if calculated at a future date, is likely to be different from the
previously published number.
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The company news service from the London Stock Exchange