PROTHERICS PLC NTERIM RESULTS FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2002
Protherics plc, the UK biopharmaceutical company, today announces interim
results for the six months to 30 September 2002. Protherics also announces the
launch of its BSE testing technology in Germany.
HIGHLIGHTS
• Turnover from continuing operations increased by £0.5 million over the
same period last year to £5.3 million, driven by:
• continuing strong sales of CroFab(TM) and DigiFab(TM) .
• revenues from BSE test, now marketed internationally.
• Gross profit on continuing operations before exceptional items up 68% over
the same period last year to £2.0 million.
• R&D expenditure increased to further the development of Angiotensin
vaccine following successful early Phase II trials.
• Balance Sheet strength maintained. Cash in hand £5.4 million and net
assets of £9.3 million.
• Healthy order book following increased demand for CroFab(TM) and DigiFab(TM).
Commenting on the results, Stuart Wallis, Chairman, said:
'Protherics now has a strong balance sheet, good revenue streams following two
FDA approvals, and a healthy pipeline of products under development. The company
has strengthened the management team with the appointment of an experienced
Business Development Director and is actively pursuing partners with which to
complete late-stage clinical developments from our R&D pipeline. We are now well
on the way to reaching our goal of becoming a self-sustaining biopharmaceutical
business.'
INTERIM STATEMENT
The excellent progress made by Protherics last year has been maintained with a
positive first half, underlining the Group's transformation into a focused
immunotherapeutics business. Turnover from continuing operations in the first
six months to 30 September 2002 was £5.3 million, an increase of 10.5% over the
same period last year, driven by the continuing success of our two FDA-approved
products, CroFab(TM) and DigiFab(TM), and the revenues from our BSE test.
Cost of sales for continuing operations, before exceptionals, fell significantly
as a result of our focus on increasing manufacturing efficiencies in our own
plant in Wales. This contributed to a 68% increase in Gross Profit over the
prior period, which allowed us to significantly increase R&D expenditure while
still slightly reducing our operating loss.
As we outlined at the time of the AGM, we expect the second half of the year to
be stronger than the first, and a healthy order book gives us confidence in
meeting our targets.
Marketed Products
Sales of CroFab(TM) were £3.9 million, recovering strongly from the brief
interruption to supply at the end of last year. Production capacity has now been
increased significantly in order to fulfil increased demand from physicians, as
CroFab(TM) is being administered earlier, more often and in milder snakebites than
the previous product. This has expanded the market opportunity for rattlesnake
antivenin in the US to an estimated $75 million per annum. Meeting the demand
for human use remains our priority and we will ensure this need is met in full
before introducing CroVet, the veterinary treatment for animals bitten by
rattlesnakes.
Sales of DigiFab(TM) were £0.6 million in the first 6 month period since its
introduction into the US market in February 2002. In the US market, DigiFab(TM)
offers a significant price advantage over the only competitive product on the
market, DigiBind(R), for the treatment of Digoxin overdose. We also have a
market in Sri Lanka where DigiFab(TM) offers a highly effective treatment for
Oleander poisoning.
BSE test launched in Germany
BSE is now recognised as a global problem and testing is now mandatory in Europe
for all carcasses of cattle aged over 30 months entering the food chain. The BSE
test, developed by Enfer Scientific Limited using technology licensed by
Protherics, has recently been launched in Germany by Abbott Diagnostics, Enfer's
distributor outside of Ireland, and take-up is expected to be significant.
Further international launches of the test are expected to follow. We are
beginning to see an increase in revenues from the BSE test in Europe, which have
compensated for a decline in the Irish market. Revenues in the half year and
prior period were £0.6 million.
R&D pipeline
Our Angiotensin Vaccine for the treatment of high blood pressure has
successfully completed early stage II trials. These trials clearly indicate that
our vaccine is effective at inducing antibodies against angiotensin, an
important hormone target for the treatment of hypertension. The continued
development of this vaccine, targeted at the largest single pharmaceutical
market worth more than US $30 billion, is a priority and accounted for most of
the increase in R&D expenditure. The next stage is to complete trials aimed at
reformulating the vaccine ahead of a much larger proof of principle trial, to
determine the effect on blood pressure in patients with hypertension.
CytoFab(TM) is indicated for the treatment of sepsis, a condition affecting
750,000 people in the US every year. The results of our Phase IIb trial showed
that CytoFab(TM) shortens treatment times in intensive care and we are actively
seeking the right partner to commence a much larger Phase III programme.
Protherics has two other significant research projects underway. The most
advanced is a vaccine designed to slow the spread of primary cancer. The vaccine
works by targeting Vascular Epithelial Growth Factor (VEGF) which is involved in
angiogenesis, the development and spread of new blood vessels. Angiogenesis has
been implicated as an important factor in the spread and growth of secondary
cancers. Patents were filed in June to protect our interest in the immunogens
used in this vaccine development. The second project is a vaccine aimed at
preventing kidney failure.
Operations
We continue to seek partners to complete the development of CytoFab(TM) and
Angiotensin Vaccine, in addition to other collaborative efforts. The
appointment, in June, of Dr Ian Scoular as Business Development Director greatly
strengthens our capability in this area.
Our FDA approved manufacturing facility in Wales provides a strong competitive
advantage to Protherics. In recent months we have concentrated on increasing our
manufacturing capacity to keep pace with anticipated demand while continuing to
focus on manufacturing efficiency in order to control costs to the benefit of
our margins.
At the start of the current financial year, a batch of CroFab(TM) yielded under
2000 vials of product. This has now been increased to 3200, and by the end of
the year is planned to be over 4000. As part of our ongoing risk management
process, we are working hard with the FDA on qualifying a second filling and
freeze-drying contractor.
Finance
The operating loss for the period before exceptional items and discontinued
operations was £1.2 million, slightly ahead of the £1.3 million recorded in the
corresponding 6 months to 30 September 2001. This is despite the increase in
research and development expenditure to £1.1 million against the prior period
figure of £0.6 million for continuing operations. Loss for the period before and
after taxation was £1.2 million. In the corresponding period to 30 September
2001, a profit before and after taxation, before exceptionals of £3.7 million
was generated. This included a profit of £5.0 million on the sale of the
Computer Aided Molecular Design (CAMD) division.
Net cash outflow from operating activities was £0.6 million in the half year,
down from £1.5 million in the corresponding 6 month period.
Cash balances at 30 September 2002 were £5.4 million as against £6.2 million at
31 March 2002. We plan to use some of our cash resources to increase production
at our manufacturing facilities to meet orders in hand. Stocks have increased
from £4.0 million to £4.9 million at 30 September 2002 reflecting the increasing
production. The increase in creditors due within one year from £6.2 million at
31 March 2002 to £7.4 million, represents cash advanced against increased
orders, placed by our U.S. distributors, Altana. Net assets remain strong, at
£9.3 million, against £10.1 million at 31 March 2002.
Since September we have announced the redemption of the remaining Convertible
Debentures option, removing an element of uncertainty for investors.
Protherics now has a strong balance sheet, good revenue streams following two
FDA approvals, and a healthy pipeline of products under development. The company
has strengthened the management team with the appointment of an experienced
Business Development Director and is actively pursuing partners with which to
complete late-stage clinical developments from our R&D pipeline. We are now well
on the way to reaching our goal of becoming a self-sustaining biopharmaceutical
business.
FOR FURTHER INFORMATION CONTACT:
Protherics PLC +44 (0) 20 7268 9950
Andrew Heath Chief Executive mobile 07768 256595
Barry Riley Finance Director mobile 07770 714796
The Maitland Consultancy +44 (0) 20 7379 5151
Brian Hudspith
Simone Cheetham
Protherics PLC
Protherics PLC was formed in September 1999 from the merger of Proteus
International plc and Therapeutic Antibodies Inc. Protherics is an international
biopharmaceutical company, whose platform technology is the development and
production of immunotherapeutics.
The Company's ordinary shares are listed on the Official List of the UK Listing
Authority and are traded on the London Stock Exchange.
An electronic version of this will be available at:
www.protherics.com |
