Final Results
Intl. Biotechnology Trust PLC
29 October 2002
Strictly embargoed for publication until 7.00 a.m. on 29 October 2002
INTERNATIONAL BIOTECHNOLOGY TRUST Plc
The Board of International Biotechnology Trust Plc today announces its unaudited
Preliminary Results for the year ended 31 August 2002.
SUMMARY
• Net asset value per share fell by 51.5% to 98.5p
• NASDAQ Biotech Index fell 47.7% (in sterling terms) and the Bloomberg
UK Biotech Index fell by 46.4%
• As announced at the half year, write-downs in unquoted companies
resulted in a fall in net assets for the year of £6.1 million or 6.2%
of net assets at 31 August 2001
• Total net assets at 31 August 2002: £47.9 million (31 August 2001:
£98.7m)
• New investments in 6 quoted companies and 4 unquoted companies
• Sales of 7 quoted holdings and 2 unquoted companies
Andrew Barker, Chairman, commented:
'It was another year of significant stock market falls, particularly in the
biotech sector, and our results reflect these difficult times. Continuing market
declines have resulted in attractive valuations for many good quality biotech
companies and IBT has taken advantage of this value and made a number of new
investments. This has further strengthened the portfolio, which provides
investors with an exposure to a dynamic industry through an exciting set of
companies with strong upside potential, spread across the private and public
markets, different clinical areas and varying stages of clinical development.
However, both biotech and IBT remain more suited to the longer-term investor who
is willing to weather the volatility, which looks set to continue, at least in
the short-term.'
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, Emily Morris/ Annabel O'Connor 020 7072 4200
Website: www.internationalbiotrust.com
CHAIRMAN'S STATEMENT
Performance
It was another year of significant stock market falls, particularly in the
biotech sector, and our results reflect these difficult times. During the year
to 31 August 2002, the net asset value ('NAV') per share of International
Biotechnology Trust plc ('IBT') fell by 51.5% from 203.1p to 98.5p alongside a
fall in the share price of 56.7% from 176.5p to 76.5p. This is in comparison to
a fall in the NASDAQ Biotechnology Index ('NBI') of 47.7% in sterling terms and
a fall in the Bloomberg UK Biotechnology Index of 46.4% during the same period.
Whilst the fall in NAV was predominantly due to the fall in the biotech market,
an element was due to write-downs in the values of some of the inherited
unquoted companies in the portfolio, as announced at the half year. Changes in
the valuations of unquoted companies have resulted in a net fall in net assets
for the year of £6.1 million or 6.2% of net assets at 31 August 2001. The fall
in NAV during the year under review was 45.3% excluding these write-downs.
Review
The year under review has been disappointing in performance terms for IBT.
However, this should be viewed in the context of the weak overall market
conditions, which have reduced investor tolerance for the type of risk found in
the biotech sector. The biotech market typically goes through extreme cycles and
the fall in the NBI during the last year follows the boom years of 1999 and 2000
when the index (in US dollar terms) rose from 437 and peaked at around 1600. At
the end of the period under review the NBI had fallen back down to 489, close to
the levels of early 1999.
Sentiment towards the sector seems worse than at any time in recent history with
investors focusing on a number of high profile disappointments, and largely
ignoring recent successes. The widening of the discounts for the biotech-focused
investment trusts reflects this poor sentiment. At the time of writing, shares
in IBT are trading on a discount of 31% to NAV, after widening from 13% to 22%
during the reporting period.
IBT has a number of holdings in smaller quoted companies with very early stage
pipelines, and these companies have been hit particularly hard as investor focus
has moved towards the larger, profitable companies or those with projected near
term earnings.
At 31 August 2002 the percentage of NAV in unquoted companies was 43%. Whilst
new investments during the reporting period account for some of this increase, a
large part is due to the falls in share prices of the quoted companies in the
portfolio. Given that the guideline for unquoted investments was originally set
at approximately 25% NAV, further unquoted investments are not planned in the
near term. The Board keeps this matter under regular review, which includes
monitoring the progress of the unquoted investments. If concerns arise regarding
the valuation of these investments, appropriate action is taken immediately.
Valuation
As is practice in the venture capital industry, the IBT portfolio is valued in
accordance with the British Venture Capital Association (BVCA) guidelines. In
certain circumstances quoted holdings are valued at discounts to their mid
market prices. 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.
Ahead of each investment considerable due diligence is undertaken, making use of
a comprehensive network of scientific and clinical advisers, with particular
focus on management, science and valuation. Members of Schroder Ventures Life
Sciences ('SVLS'), the investment adviser, currently have board seats on ten of
the portfolio companies. This allows the performance of these companies to be
closely monitored and the input of strategic and financial advice drawing on the
experience of the SVLS team and their network of advisers.
Scientific Advisory Board ('SAB')
The SAB has been expanded during the reporting period and now numbers four,
providing IBT with a very valuable resource upon which to draw both scientific
and clinical expertise. This advice is used to help identify new investment
opportunities and in the management of portfolio companies. I would like to
extend my congratulations to the Chairman of the SAB, Dr. Sydney Brenner, on
sharing this year's Nobel Prize in Physiology and Medicine.
Share Buy-Back Facility
To date, the Directors have not utilised the authority given to them at the 2001
Annual General Meeting to purchase shares for cancellation. Your Board will,
however, continue to consider opportunities to purchase shares for cancellation
in appropriate market conditions, at prices that would usefully enhance the net
asset value for remaining shareholders. A resolution to renew the share buyback
authority is included in the notice of the Annual General Meeting.
Annual General Meeting
The Annual General Meeting will be held at 31 Gresham Street, London EC2V 7QA on
Thursday 19th December 2002 at 12 noon. A presentation will be made by SVLS.
Outlook
Continuing market declines have resulted in attractive valuations for many good
quality biotech companies. IBT has taken advantage of this value and made a
number of new investments. This has further strengthened the portfolio, which
provides investors with an exposure to a dynamic industry through an exciting
set of companies with strong upside potential, spread across the private and
public markets, different clinical areas and varying stages of clinical
development.
The fundamentals of the biotech sector remain compelling and while other sectors
suffer declining earnings, more and more biotech companies are turning
profitable and product pipelines continue to both widen and mature. Biotech
companies have generated nearly a quarter of the drug candidates currently in
development and are set to become the research and development engine of the
drug industry.
We have experienced an extreme downturn in the biotech market and the timing of
an upturn is difficult to predict. Investment in the both the biotech sector and
IBT remain more suited to the longer-term investor who is willing to weather the
volatility, which looks set to continue, at least in the short-term. That said,
I continue to believe that we have a leading team of advisers in SVLS, with
considerable depth of skill, experience and resources, which should be reflected
in our results in due course.
Andrew Barker
Chairman
INVESTMENT ADVISERS REVIEW
Schroder Ventures Life Sciences
Schroder Ventures advised funds have invested in the life sciences industry
since the early 1980's and to date have backed over 100 life science companies
internationally. Schroder Ventures Life Sciences ('SVLS') was established in
1993 and currently has offices in Boston, London and San Francisco, in order to
take advantage of the global nature of life sciences opportunities. The SVLS
team is comprised of 24 professionals with a deep base of scientific, clinical,
operational and life sciences investment experience.
In addition to IBT, SVLS advises three private equity funds with total
commitments of approximately $680m, focused on providing seed, start-up, early
stage and expansion capital to life sciences companies primarily in the US and
Europe.
Market Review
The year under review has seen a severe correction in the biotech market with
the NASDAQ biotech index falling by 47.7% in sterling terms. The backdrop to
this poor performance has been a slump in the general markets and the growing
intolerance of risk by investors. Technology stocks have generally held up
better than biotech with the NASDAQ composite index falling by 31.7% in sterling
terms during the reporting period.
The fall in the sector follows a frenzy of initial public offerings ('IPO's')
and high valuations in 2000, which were driven by strong global market
conditions and by the sequencing of the human genome and the perception that
this would result in the rapid development of new therapeutics, driving earnings
and profitability at a fast pace. The reality of the genomics revolution is that
it is transformational but the fruits of this knowledge will not be
commercialised for some years to come.
There have only been three biotech IPOs this year and the IPO window looks
firmly closed for the coming months. A portfolio company, Aderis
Pharmaceuticals, completed a series of investor roadshows in preparation for an
IPO earlier this year, but the listing did not go ahead. Investor confidence in
the IPO market was soured by the poor performance of the listing of DOV
Pharmaceuticals, immediately before the Aderis listing was to become effective.
This was disappointing but Aderis continues to make progress with its product
pipeline and is well financed.
The biotech sell-off has contracted earnings multiples for profitable companies
and lowered technology values for development stage companies. For loss-making
companies, attention is focused on current cash positions and burn rates, with
little value being accorded to future products. Many companies (including a
number of portfolio companies) are trading at a discount to cash asset values
and a number of companies have restructured to focus on their lead programs in
order to conserve cash in the face of difficult market conditions. Overall,
companies within the IBT portfolio remain generally well financed with
twenty-two companies having two or more years of cash, seven with one or more
and five with less than a year of cash. The remaining two companies have been
written off. Of the five with less than a year of cash, one is expecting to
start commercialisation of a product within the next year and to sign a
marketing agreement, two are currently raising money, one is looking to partner
out early stage programs and another has been sold since the end of the
reporting period.
The most extreme falls in share prices have been seen in companies with very
small market capitalisations (microcaps) and early stage pipelines, despite good
operational progress in many cases. In times of uncertainty investor interest
concentrates on the larger, profitable companies or those with very late stage
product pipelines and a near term chance of earnings. This has severely impacted
the performance of IBT. An example of this is Essential Therapeutics, which is
trading at a dollar a share, down from just under four dollars at the start of
the period under review. This is despite a planned restructuring to focus on
clinical development rather than earlier stage research, and an acquisition that
brought in an interesting compound that is already in the clinic.
Positive news has tended to be overlooked by investors and there has been a
spate of bad news from the sector, which has depressed sentiment. This included
the ImClone scandal and concerns over Elan's accounting practices. In addition
there have been a number of late stage product failures including Cubist's
injectable antibiotic for pneumonia and Emisphere's oral heparin formulation.
These failures have reminded investors of the risks of drug development
although, given that there are more late-stage drugs in the pipeline than ever
before, more late-stage failures should be expected.
The FDA appears to be taking a more cautious approach to the approval of drugs
following a series of product withdrawals. The perceived increase in regulatory
risk has increased the discount rate that investors use to value biotech stocks,
however, history has shown that many of the drug candidates initially held up by
the FDA, are ultimately approved. Recent drug approvals have largely been
ignored by investors, for example Gilead's HIV drug Viread, IDEC's Zevalin for
Non-Hodgkins Lymphoma and portfolio company, Atrix Labs' two formulations of
Eligard for the treatment of advanced prostate cancer.
However, more recently newsflow from the sector has begun to improve with good
earnings numbers from the larger biotech companies and two well-subscribed
follow-ons for Telik and Trimeris. In addition Biogen's Amevive for psoriasis
and AstraZeneca's oral cancer drug Iressa both received positive reviews from
FDA advisory panels. Most importantly for sentiment, a new Commissioner for the
FDA was nominated in September. The Agency has been without a Head since
President Bush came to office and this new leadership may help reduce some of
the delays in decision-making. In addition the third Prescription Drug User Fee
Act was passed in June, which should improve funding for the agency and increase
the number of reviewers and external advisers.
Fundamentals
The correction in the biotech market overshadows strong fundamentals for the
sector; an increasing supply of new potential drugs driven by scientific
innovation, high barriers to entry for competition and the demand dynamics of an
ageing population coupled with increased drug usage. Biotechnology drugs
generally treat serious, life-threatening, and unmet medical needs, so revenues
and earnings are generally insensitive to changes in the macroeconomic
environment. The industry comprises an unprecedented and growing number of
profitable companies, a plethora of products on the market and more than 350
products in late-stage clinical trials (Phase II or beyond) and while many of
these products will not succeed, many of them will.
Pharmaceutical companies are relying more and more on biotech companies to
supply them with in-licensing opportunities in order to meet double-digit
earnings growth expectations. Their own pipelines are generally lacklustre and
they face looming key patent expiries and declining R&D productivity. There is
typically strong competition to in-license late stage products and the balance
of power in negotiating these deals has swung firmly in favour of biotech
companies. An example of a significant late stage transaction is
GlaxoSmithKline's $270m licensing of portfolio company Adolor's Phase III
compound Alvimopan. Given the nature of this competition, pharma companies may
start in-licensing some of the more plentiful earlier stage compounds, which
should translate into richer incentives for biotech to partner out these
programs. This could allow biotech companies to bolster their increasingly
precious cash piles and to reduce risk by diversifying pipelines whilst
retaining more of the rewards of a successful product candidate.
Mergers and Acquisitions
Following the consolidation seen in the sector last year, which saw major
acquisitions by Amgen, Medimmune, and Millennium, merger and acquisitions ('M&A
') activity has been slow in 2002 and the few deals that have been announced
have not materially helped the performance of the biotech market.
However, there are reasons why M&A may start to pick up. The weak equity market
conditions make it difficult for companies to raise cash, which should increase
the pressure for consolidation. This is most likely to occur between cash rich
companies seeking to expand their pipelines and those companies with interesting
products but limited financing. Well-funded private companies wanting to gain a
listing but restrained by the lack of an IPO window could also benefit from the
acquisition of a cash-strapped public company. In addition the need to bolster
product pipelines, bring in new capabilities and to increase liquidity and
critical mass to attract large investors continue to be compelling reasons for M
&A. Examples from the portfolio include Essential's purchase of Maret
Pharmaceuticals to bring in a clinical stage compound, the acquisition of
ChemOvation by KuDOS to bring chemistry capabilities in-house and the purchase
of Cell-Matrix by CancerVax to broaden its oncology pipeline.
INVESTMENT ACTIVITY
Summary
During the reporting period investments were made in six new quoted companies -
Adolor, Esperion Therapeutics, Essential Therapeutics, Crucell, Alexion
Pharmaceuticals and 3-Dimensional Pharmaceuticals. Following the end of the
reporting period an investment was made in the quoted company, XOMA. Further
investments were made in five existing quoted holdings - Epimmune, Aspect
Medical, AnorMED, Novuspharma and Atrix Labs. Seven quoted holdings were sold
and four quoted holdings were reduced in size.
In the unquoted portfolio four new investments were made - KuDOS
Pharmaceuticals, Genosis, Auxilium Pharmaceuticals and CancerVax, and there were
two follow-on investments in Axxima Pharmaceuticals and Eyetech Pharmaceuticals.
Subsequent to the reporting period a follow-on investment was made in Affibody.
Two unquoted companies were sold.
Quoted Companies
New Investments
Adolor (£0.4m investment) is a US-based company focused on the reduction of side
effects of currently marketed opioids used for pain relief. The lead compound is
called Alvimopan and is in Phase III clinical trials for two indications:
post-operative ileus (loss of bowel function following surgery) and opioid bowel
dysfunction (severe constipation in chronic opioid users), both of which
represent large unmet medical needs. Data from these trials is expected in the
first half of 2003 and Adolor hope to file a New Drug Application (NDA) with the
FDA by the end of 2003 for the surgical indication.
Alvimopan is partnered with GlaxoSmithKline ('GSK'), which provides a strong
endorsement of the compound and will allow Adolor to tap into GSK's extensive
marketing infrastructure. Since 31 August 2002, a further £0.1m has been
invested in the company, increasing the total invested to £0.5m.
Esperion Therapeutics (£0.1m investment) is a US-based company with a broad
pipeline of clinical and preclinical drug candidates for the treatment of
cardiovascular and metabolic diseases. The focus of the company is to enhance
the effects of HDL (high density lipoproteins, the so-called good cholesterol)
and several different drug candidates have been developed to mimic and enhance
naturally occurring biological processes that remove excess cholesterol from the
walls of arteries and transport it to the liver where it is eliminated from the
body.
Traditional management of elevated cholesterol focuses on reducing levels of LDL
(low density lipoproteins) and uses statins in an outpatient setting, which are
good at reducing LDL but may increase HDL in some cases. There are few drugs on
the market for the treatment of low HDL and the drug candidates in development
at Esperion have been designed to act as complementary therapy with the current
agents for cholesterol therapy. Specifically, two products are in Phase II
trials, one is entering Phase II and an IND is expected to be filed for another
by the end of the year.
Esperion has a seasoned management team with impressive depth. The management
team includes several members from major pharma companies, such as Parke Davis,
Pfizer and Bristol-Myers Squibb, who have had prior success with development and
launch of several cholesterol management medications in use today. The CEO Roger
Newton was the co-discoverer of Lipitor, a statin with sales of $6 billion in
2001.
Since 31 August 2002, a further £0.7m has been invested in the company,
increasing the total invested to £0.8m.
As detailed in the previous Annual Report a commitment was made in August 2001
to invest £5.3m in Essential Therapeutics and this was completed in October
2001. Essential now has an emerging pipeline of product candidates in the
anti-infective and haematology/oncology areas. Since the investment, there has
been a broadening of the management team and the pure research capability has
been significantly cut back in order to focus resources on preclinical and
clinical development. In March 2002, Essential announced the acquisition of
Maret Pharmaceuticals bringing in a Phase I stage compound. This may have uses
in the prevention of thrombocytopenia, anaemia and infection in patients
following chemotherapy or bone marrow transplantation and three Phase II trials
are planned. The company has also entered into a new collaborative agreement
with Fujisawa Pharmaceutical in the area of novel antibiotics, and J&J has
initiated Phase I clinical trials with Essential's cephalosporin candidate.
The final three new investments were described in the interim report - Crucell,
Alexion Pharmaceuticals and 3-Dimensional Pharmaceuticals ('3DP').
Crucell (£1.9m investment) is a Dutch biotechnology company focused on the
discovery and development of novel antibodies and vaccines. It has announced a
number of smaller partnerships and licences since the investment was made but a
partner for its flu vaccine program or another interesting antibody deal is
required to drive the share price higher.
Alexion Pharmaceuticals (£1.8m investment) is a US-based company focused on the
development of a novel class of anti-inflammatory compounds known as complement
inhibitors. The lead compound is in Phase III trials for the reduction of
complications during coronary artery bypass graft surgery with cardiopulmonary
bypass, and Phase II myocardial infarction trials. Data in the latter indication
is expected later this year.
3DP (£1.9m investment) is a chemistry-focused drug discovery company based in
the USA. 3DP uses its drug discovery platform to find orally available small
molecule drug candidates. The interesting product pipeline is at very early
stage and the share price should be driven higher as the pipeline broadens and
matures.
Subsequent to the end of the reporting period £0.4m was invested in the US-based
company, XOMA. XOMA has expertise and capabilities in the development and
manufacture of antibody therapeutics and has a healthy pipeline of biologics.
Risk is diversified by partial ownership of a number of different compounds and
deals are in place with Genentech, Onyx and Millennium. The company's lead
candidate is Raptiva, which was originated by Genentech. Raptiva is a humanized
monoclonal antibody in Phase III for moderate to severe psoriasis and Phase II
for rheumatoid arthritis. Favorable Phase III trial results in psoriasis were
reported in 2001, however, in April of this year Genentech announced that the
filing for regulatory approval of Raptiva would be delayed due to discrepancies
in pharmacokinetic properties between material produced at small and commercial
scales. In September 2002, the companies announced that a Phase III trial using
solely commercial material achieved its primary endpoint and that they plan to
file for approval by the end of 2002.
Follow-on Investments
In December 2001, IBT participated in a PIPE (public investment in private
equity) in Epimmune, increasing its investment by £1.4m to £6.2m. Epimmune has
designed therapeutic drug candidates to treat disease by stimulating the body's
immune system to respond aggressively to infections and certain types of tumour.
The company has also designed preventative drug candidates to protect against
disease by teaching the immune system to react quickly when exposed to
infectious agents. Epimmune has started a Phase I/II HIV vaccine trial and
expects to file an IND for a lung and colorectal cancer vaccine early in 2003.
A further £2.7m was invested in Aspect Medical (total investment £3.4m), £1.1m
in AnorMED (total investment £5.8m but subsequent sales reduced this to £5.0m),
£0.7m in Novuspharma (total investment £2.6m), and £0.6m in Atrix Laboratories
(total investment £2.0m).
Sales
The holdings in Biocompatibles, Biogen and Elan were sold in their entirety
during the period, along with the remaining holdings in CeNeS Pharmaceuticals,
Onyx Pharmaceuticals and Vernalis Group. In December 2001, Medimmune acquired
Aviron, which resulted in a net gain of £1.1m for IBT.
The holdings in OSI Pharmaceuticals, Corvas, Ribozyme Pharmaceuticals, and
Forest Labs were reduced in size during the period under review.
Unquoted Companies
New investments
In March 2002, as reported in the interim report, IBT invested £2.1m in
CancerVax, an unquoted US-based company. CancerVax's CANVAXIN is a therapeutic
cancer vaccine containing at least 30 known tumour and melanoma-associated
antigens which are believed to enhance the overall immune response to cancer.
CANVAXIN has been administered to over 2,000 patients and is currently in Phase
III clinical trials for the treatment of advanced stage melanoma, a disease with
few effective or well-tolerated treatments. In May of this year the FDA put a
hold on enrollment in the PIII trial and asked for certain information related
to the production, characterisation and testing of the vaccine. We do not
believe that the hold on new patient enrollment is the result of clinical
practice or safety concerns related to the vaccine as patients already receiving
CANVAXIN were permitted to continue to do so and patients already deemed to have
met the eligibility criteria for the trial were allowed to receive the vaccine.
Earlier in the year CancerVax brought in additional early stage product
candidates for the treatment of solid tumour cancers through the acquisition of
the private company Cell-Matrix. These include several monoclonal antibodies
that appear to inhibit angiogenesis, the blood vessel development necessary for
tumour growth.
In May 2002 IBT invested £0.6m in the US based company Genosis in a financing
round of £1.2m where the price of the financing was set by a new external
investor. SVLS was involved in the founding of the company in April 1999 and
Mike Carter of SVLS is on the Board of the company.
The company is developing an over-the-counter ('OTC') screening kit for male and
female infertility under the brand name Fertell. Fertell contains a male test
capable of measuring the concentration of active sperm, an established marker of
male infertility, and a female test which measures follicle stimulating hormone
(FSH) as an indicator of ovarian reserve. It is intended that each of these
tests will be performed concurrently, at home without prescription, supervision
by a physician or laboratory involvement. To our knowledge there are currently
no home use OTC products or devices available to diagnose infertility for
couples.
There are currently over 500 million couples of reproductive age worldwide and
one in six of these are infertile. The current screen for infertility is simply
to wait and try to conceive for twelve months. By providing earlier diagnosis of
male and female infertility, Fertell helps to identify couples likely to require
medical intervention so they can be directed to the most appropriate form of
treatment as early as possible.
In June 2002, IBT invested £0.7 million in the US-based company Auxilium
Pharmaceuticals as part of a £10 million private placement. Another Fund advised
by SVLS has an investment in Auxilium and invested in this round, in which the
price was set by a new external investor.
Auxilium is a specialty pharmaceutical company focused on the development and
commercialisation of medicines to maintain functionality in ageing individuals.
The company's lead product is a testosterone gel (Testim) that has successfully
completed Phase III studies in the USA and Europe. The company has filed for
approval in the USA and the UK for the use of Testim to normalise testosterone
levels in testosterone deficient men. Auxilium anticipate the launch of Testim
in early 2003.
Testosterone is a male sex hormone, the levels of which have been found to
decline in men from about the age of 40 onwards. In a proportion of men this can
result in clinical hypogonadism which is associated with osteoporosis, decreased
sexual function and loss of body mass. Testim is a clear gel that is convenient
to apply to the skin. The testosterone contained in the gel is very effectively
absorbed through the skin, normalising testosterone levels.
Follow-on products will concentrate on male health, treatment of peri-menopausal
disorders in women and pain management. Furthermore, the company is actively
pursuing in-licensing opportunities for other interesting compounds as well as
evaluating opportunities to purchase more mature products.
In August 2002 IBT invested £1.4m in a £30m financing round in UK-based KuDOS
Pharmaceuticals where the price of the financing was set by a new external
investor. SVLS was involved in the initial funding of the company in May 1999
and Mike Carter of SVLS is on the Board.
KuDOS is a leader in the discovery and development of novel small molecule drugs
that inhibit DNA repair enzymes and signaling pathways for the treatment of
cancer. The company retains strong links with the academic laboratory of
Professor Stephen Jackson of the Wellcome/Cancer Research UK Institute in the
University of Cambridge, a world-renowned authority in DNA repair, on whose
initial work the KuDOS programs are based.
The two lead compounds are PaTrin-2 and AQ4N. PaTrin-2 is an inhibitor of the
DNA repair enzyme AGT, and appears to enhance the efficacy of certain types of
cytotoxics in treating cancer. Two Phase II trials will be conducted using
PaTrin-2 in metastatic melanoma and colorectal cancer. AQ4N is a potent killer
of cells for use in cancer therapy but is only activated in the hypoxic cells
within solid tumours. These cells are not killed by radiotherapy or the
chemotherapy regimens used today and are recognised as a major cause of
resistance. AQ4N is currently in Phase I clinical trials.
KuDOS also has earlier drug discovery programs and has discovered several
potent, highly selective, small molecule inhibitors of the DNA repair enzymes
ATM, DNA-PK and PARP. KuDOS expects to be able to select lead candidate
compounds from these programs to enter pre-clinical development in 2003.
Follow-on investments
In October 2001 a follow-on investment of £0.3m was made in the German company,
Axxima Pharmaceuticals, as part of a £21m financing round. This increased IBT's
total investment in Axxima to £1.4m. Axxima is an infectious disease, drug
discovery company focused on small molecule compounds to block critical signal
transduction pathways required by pathogens for survival. Axxima is searching
for drug candidates in the areas of HIV, Hepatitis B and C, influenza, human
cytomegalovirus, and tuberculosis.
In August 2001, IBT made an investment of £1.8m in Eyetech Pharmaceuticals and a
commitment to invest a further £1.6m in August 2002, subject to milestones.
Eyetech's lead product, Macugen, is designed to inhibit the biological pathway
that causes vision loss in age-related macular degeneration (AMD) and diabetic
macular edema (DME), two of the leading causes of blindness in the adult
population. Enrollment was completed in the pivotal Phase II/III trials for AMD
in August 2002, enrolling 1,196 patients at 117 sites worldwide. This triggered
the second installment of the financing agreed in August 2001. Eyetech is also
conducting Phase II trials with Macugen for DME. Alternative delivery systems
for Macugen are under development as it is currently administered via injection
into the eye. Eyetech has also in-licensed other promising compounds for
treating diseases of the back-of-the-eye.
Also in August 2001, IBT invested £1.3m in the Swedish company Affibody and
committed to invest a further £1.4m a year later. This second tranche was
invested in September 2002, following the end of the reporting period. Affibody
uses cutting-edge combinatorial protein technology to create Affibodies. These
are small, novel, robust ligands, which can be engineered to bind to any desired
protein. Affibodies mimic monoclonal antibodies in many ways and their unique
properties make them a preferred choice for a number of diagnostic, proteomic
and therapeutic applications. Since the initial investment was made there have
been significant advances in the production and characterisation of Affibodies
and the library of these ligands has increased in size to around three billion
variants. The strategic partnership with Amersham Biosciences in the area of
separations has been broadened and lengthened. In addition Dr Hakan Mogren, the
former CEO of Astra has joined as Chairman. Preclinical experiments are ongoing
to test the possibility of using Affibodies as therapeutics; much of this data
should be gathered by the end of the year.
Sales
As outlined in the interim report, two of the unquoted US-based companies in the
portfolio were sold to trade buyers during the year, however the returns on both
investments were disappointing. Elan announced that Delsys Pharmaceuticals would
merge with one of its subsidiaries, realising £1.2m for IBT (cost £6.3m). This
resulted in a write-up for IBT of £1.2m during the period under review as the
holding had previously been written down to nil. Netgenics was sold to the
German company Lion Bioscience, and IBT received stock worth £1.1m at the time
of the transaction (write-down £3.7m, cost £3.6m).
PORTFOLIO SUMMARY AT 31 AUGUST 2002
IBT has investments in 36 companies - 24 quoted companies (making up 48% of NAV)
and 12 unquoted companies (making up 43% of NAV). The remaining 9% of NAV is
made up of cash, money market instruments and other net current assets.
The new investments and follow-ons in unquoted companies have increased the
weighting of the unquoted portion of the portfolio. The correction in the public
markets has also meant that the percentage in unquoted companies has increased
due to the falling share prices in the quoted portion of the portfolio.
A member of SVLS sits on the Board of 10 of the 36 portfolio companies - Aderis
Pharmaceuticals, Affibody, Auxilium, CancerVax, Epimmune, Essential
Therapeutics, Eyetech Pharmaceuticals, Genosis, KuDOS and Micromet.
As planned, the concentration in the top ten quoted stocks has been reduced in
order to increase the diversification within the portfolio and they now account
for 31% of NAV in comparison with 45% a year ago.
In terms of the geographical split of the portfolio, 60% of NAV is invested in
the US, 3% in Canada, 8% in the UK/Ireland and 20% in Continental Europe. By
sub-sector, 73% of NAV is invested in biopharmaceuticals, 7% in drug delivery,
3% in medical technology and 8% in other areas. The remaining 9% of NAV is made
up of cash, money market instruments and other net current assets.
Analysing the 36 investments by the stage of their most advanced product in drug
development; four companies have products on the market, one has filed for
approval, nine are in Phase III trials, four are in Phase II, eight are in Phase
I, one is in pre-clinical development and two have been written off. Of the
remaining seven, one is commercialising an anaesthesia monitoring device,
another is about to enter late stage testing for a diagnostic device, four are
platform technology companies and one is focused on drug delivery.
The portfolio gives investors a broad spread of exposure to different stages of
clinical development across a variety of different clinical areas - cancer,
infectious disease, diabetes, central nervous system disorders, cardiovascular
complications, rheumatoid arthritis, asthma, blindness, low testosterone levels
and management of the side effects of opioids for pain relief.
VALUATION
During the reporting period the net effect of the change in the Directors
valuations of unquoted companies was a reduction in net assets for the year of
£6.1m. This included a write up of Delsys Pharmaceuticals following a sale for
£1.2m, after a write-down to nil at the last year end. Axxima and Micromet were
written up following financing rounds with prices set by new external investors.
Entigen and ValiGen were written off resulting in write-downs of £1.7m and £2.4m
respectively. Netgenics was acquired and IBT received shares in Lion Bioscience
resulting in a write-down of £3.7m. The remaining unquoted companies in the
portfolio are held at cost - Aderis, Affibody, Auxilium, CancerVax, Eyetech,
Genosis, KuDOS and Sunesis.
Within the quoted portfolio, five holdings are held at a discount to their mid
market prices - Essential Therapeutics and Epimmune due to restrictions on sale
due to SVLS presence on the Board; Targeted Genetics and Inflazyme due to
liquidity constraints given the size of the holdings; and, in the case of Lion
Bioscience, a portion of the shares are to be held in ESCROW for a year
following the acquisition of Netgenics. The effect of these discounts is to
reduce the valuation of quoted investments by £1.3m at 31 August 2002.
OUTLOOK
The biotech sector is strongly underpinned but a sustained series of positive
news events is needed for a broad-based recovery in the market. The nomination
of an FDA commissioner is positive, and should go someway to allay fears about
the regulatory climate. However a lasting improvement in confidence is likely to
require strong clinical data as well as new product approvals and successful
launches of new blockbuster drugs. An increase in M&A activity and further
signings of large biotech collaborations may also help sentiment.
Valuations in the biotech sector are at an attractive level and it is a good
time to be making investments for the long term. However volatility looks set to
continue and it is difficult to see how the biotech market will stage a
significant recovery without a pick up in the overall markets, which will
require a marked improvement in the macroeconomic picture.
International Biotechnology Trust plc
Unaudited Preliminary Results
Unaudited Statement of Total Return (incorporating the Revenue Account)
For the year end 31 August 2002 For the year end 31 August 2001
Revenue Capital Total Revenue Capital Total
£'000 £'000 £'000 £'000 £'000 £'000
Realised (losses)/ gains
on investments - (16,865) (16,865) - 50,942 50,942
Performance fee
and termination costs - - - - (2,160) (2,160)
Increase in unrealised
depreciation on
investments - (32,667) (32,667) - (173,782) (173,782)
Exchange loss on currency
balances - (28) (28) - (1,359) (1,359)
Income 278 - 278 2,700 - 2,700
Management fees (804) - (804) (2,171) - (2,171)
Administrative
expenses (758) - (758) (1,690) - (1,690)
Net deficit on ordinary
activities before finance
costs and taxation (1,284) (49,560) (50,844) (1,161) (126,359) (127,520)
Interest payable and
similar charges - - - (15) - (15)
Net deficit on ordinary
activities before
taxation (1,284) (49,560) (50,844) (1,176) (126,359) (127,535)
Tax on ordinary
activities - - - - - -
Net deficit on ordinary
activities after taxation (1,284) (49,560) (50,844) (1,176) (126,359) (127,535)
Transfer from
reserves (1,284) (49,560) (50,844) (1,176) (126,359) (127,535)
Deficit per share (2.64)p (101.94)p (104.58)p (1.86)p (199.60)p (201.46)p
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 as at 31 August
2002 2002 2001 2001
£'000 £'000 £'000 £'000
Fixed assets
Investments 43,584 88,524
Current assets
Debtors 153 219
Investments 1,889 4,677
Cash at bank 2,912 7,157
4,954 12,053
Creditors: amounts falling due within one year 643 1,838
Net current assets 4,311 10,215
Net assets 47,895 98,739
Capital and reserves
Called up share capital 12,154 12,154
Capital redemption reserve 10,843 10,843
Share premium account 67,083 67,083
Capital reserve (34,178) 15,382
Revenue reserve (8,007) (6,723)
Equity shareholders' funds 47,895 98,739
Net asset value per share 98.52p 203.10p
International Biotechnology Trust plc
Unaudited Cash Flow Statement
For the year ended For the year ended
31 August 2002 31 August 2001
£'000 £'000
Operating activities
Dividend income received _ 2
Current asset investment income received 256 2,639
Deposit interest received 27 504
Management fee paid (852) (3,043)
Performance fee _ (4,440)
Other cash payments (729) (2,138)
Net cash outflow from operating
activities (1,298) (6,476)
Servicing of finance
Interest paid _ (15)
Cash outflow from servicing of finance _ (15)
Taxation
UK income tax recovered/(suffered) 67 (67)
Tax recovered/(paid) 67 (67)
Capital expenditure and financial
Investment
Purchase of investments (25,579) (49,124)
Disposal of investments 19,816 101,152
Net cash (outflow)/inflow from capital expenditure and financial (5,763) 52,028
investment
Net cash (outflow)/inflow before management of liquid resources and (6,994) 45,470
financing
Management of liquid resources 2,777 85,319
Financing
Repurchase of shares following Tender _ (121,828)
Offer
Stamp duty _ (609)
Net cash outflow from financing _ (122,437)
Net cash (outflow)/inflow in the year (4,217) 8,352
Notes:
1. Audit status
The financial information set out in the announcement does not constitute the
Company's statutory accounts for the year ended 31 August 2002 or 31 August
2001. The financial information for the year ended 31 August 2001 is derived
from the statutory accounts for that year which have been delivered to the
Registrar of Companies. The auditors reported on those accounts; their report
was unqualified and did not contain a statement under section 237(2) or (3) of
the Companies Act 1985. The statutory accounts for the year ended 31 August 2002
will be finalised on the basis of the financial information presented by the
Directors in this preliminary announcement and will be delivered to the
Registrar of Companies following the Company's Annual General Meeting.
This announcement is prepared on the basis of the accounting policies as set out
in the most recently published set of annual financial statements.
2. Annual General Meeting
The Annual General Meeting of International Biotechnology Trust plc will be held
at 12.00 noon on Thursday 19 December 2002 at 31 Gresham Street, London, EC2V
7QA.
3. Annual Report and Accounts
The Annual Report and Accounts will be mailed to registered shareholders at
their registered addresses in November 2002 and from the date of release copies
of the Annual Report will be made available to the public at the Company's
registered office, 31 Gresham Street, London EC2V 7QA.
This information is provided by RNS
The company news service from the London Stock Exchange