RNS Number:6306P
Profile Therapeutics PLC
11 September 2003


For Immediate Release                             Thursday, 11th September 2003



                            Profile Therapeutics plc

              Preliminary Results for the year ended 30 June 2003


Profile Therapeutics plc ("Profile"), which develops and commercialises
specialist-inhaled therapies to improve the treatment of respiratory patients,
today announces its preliminary results for the year ended 30 June 2003.


Highlights


Financial

* Turnover increased by 8.7% to #13.8m (2002: #12.68m)

* Operating loss decreased by 19% to #4.7m (2002: #5.8m)

* Research and development expenditure for the year was #3.3m (2002: #5.0m) in 
  line with expectations

* Net cash at 30 June 2003 ahead of expectations at #5.0m (2002: #8.3m)


Business

* Conventional respiratory equipment and services
  - Excellent year for Profile Respiratory Systems - sales up 9%, gross margins 
    up at 50%, gross profit up 11%, new service products for sleep therapy

* Medicines delivered through Profile's patented AAD systems
  - Successful launch of Prodose; continued development of Prodose HandHeld for 
    launch in H1 2004
  - Joint Venture with Breath to develop and market a range of respiratory 
    products to be delivered through Prodose HandHeld in the US market - the 
    most important development in 2003
  - Regulatory approval and launch of Promixin(R), an inhaled antibiotic for 
    patients with cystic fibrosis


Mark Kirby, Chairman, commenting on the results, said:


"This year has seen important developments in each of our businesses. The most
significant step has undoubtedly been the formation of our Joint Venture with
Breath for the US market.


Profile is now at a critical stage of its development that is both exciting and
challenging. The excitement lies in the excellent performance of our Profile
Respiratory Systems business, the introduction of new products and our
developing commercial relationships in the US and Europe. The challenges for the
year ahead relate chiefly to identifying the right partners to maximise the
value of our assets. This will be the prime determinant of the timing of our
principal milestone - profitability.


This will be a pivotal year for Profile and I look forward to updating you on
our progress."



For further information, please contact:

Profile Therapeutics                       On 11.09.03       Tel: 020 7466 5000
John Lisle, Chief Executive Officer         Thereafter       Tel: 0870 770 2000
John Ward, Chief Financial Officer

Buchanan Communications
Tim Anderson / James Strong                                  Tel: 020 7466 5000





                              CHAIRMAN'S STATEMENT


2002/3 has been a year of both significant progress and important changes for
Profile Therapeutics. We have appointed a new Chief Executive and much has been
achieved. In particular, we have sharpened Profile's focus on realising value by
associating our patented technology with medicines:

* the US market in particular is crucial to our strategy and I am delighted to 
  report that we have made significant progress in both our existing
  and new businesses in this market. I believe that the most significant
  development is the formation of our joint venture with Breath on 9 July 2003, 
  to address the exciting opportunities of the North American respiratory 
  market. Discussions are well advanced with our preferred marketing partner;

* this will be supported by Prodose HandHeld - our unique intelligent inhaler 
  system - which is at the final design stage; and

* we have successfully brought to market our first medicine: Promixin(R),
  a treatment for respiratory infections in patients with cystic fibrosis.
  Promixin is supported by the launch of Prodose, which is preferred by patients
  because of its faster delivery, precision dosing and clear feedback.


All this has been against a background of good growth in our established
business. The financial performance in the year has been strong. Turnover was up
8.7% to #13.8m and the Group operating loss was reduced 19% to #4.7m. Profile
Respiratory Systems was the main contributor with revenue up 9.3% to #13.6m,
giving us the resources to develop our proprietary intelligent inhaler and
associated pharmaceutical products. A closing cash balance of #5m, together with
Profile's committed, undrawn, credit facility of up to #5m with Bank of
Scotland, is a positive starting point for the coming year.


Board


At the end of October 2002 we welcomed John Lisle as the new Chief Executive
Officer of Profile. John joined us from GlaxoSmithKline where he was National
Business Director with responsibility for commercialising the respiratory and
migraine portfolio of medicines. Following this appointment I became first
executive, and now, following a period of handover, non-executive Chairman.


In March 2003 we announced the departure of Simon Shaw after six years with
Profile, most recently as Chief Operating Officer, and also the appointment of
John Ward, Chief Financial Officer, to the Board. David Bloxham also resigned as
a non-executive Director after two years' service. We would like to thank both
Simon and David for their significant contributions to the development of
Profile Therapeutics.


The Board has welcomed two new non-executive Directors - John Padfield and Simon
Constantine - who both bring highly valuable experience and insight to Profile.
This completed the reshaping of the Board. The team is strong and experienced
and relishing the opportunities and challenges of taking Profile to the next
stage of its development.


Outlook

Profile is now at a critical stage of its development, which is both exciting
and challenging. Over the next year, we anticipate:

* selecting our sales and marketing partner for development of the North 
  American market and the submission by our joint venture partner of the first 
  two medicines to the Food and Drug Administration (FDA) in the US for 
  regulatory approval;

* commencing production of the Prodose HandHeld intelligent inhaler,
  ready for launch in 2004;

* receiving regulatory approval for Promixin in Europe and selecting our
  sales and marketing partner; and

* commencing the sale and support of Prodoses to Schering AG and agreeing terms 
  for support of a US product for pulmonary hypertension.

The challenges relate principally to identifying the right partners to maximise
the value of the assets we are developing. This will be the prime determinant of
the timing of our principal milestone - profitability.


This will be a pivotal year for Profile and I look forward to updating you on
our progress.

Mark Kirby
Chairman


                            CHIEF EXECUTIVE'S REVIEW


This is my first Annual Review as Chief Executive of Profile Therapeutics and I
am pleased to be able to report on substantial progress in the year across
Profile's core business activities:

* Conventional Respiratory Equipment and Services
  Profile Respiratory Systems is a profitable developer, manufacturer and 
  supplier to the UK and international markets of respiratory therapy equipment 
  and related services for both home and hospital use. It is the market leader 
  in the UK.

* Medicines delivered through Profile's proprietary Adaptive Aerosol Delivery 
  (AAD) systems
  Profile Drug Delivery develops intelligent inhaler systems, utilising its
  proprietary AAD technology, for the treatment of chronic respiratory 
  conditions. The technology is exploited directly with medicines developed and 
  marketed by Profile Pharma, or indirectly through licensing to others and 
  partnering. Current therapy areas include cystic fibrosis, severe asthma, 
  Chronic Obstructive Pulmonary Disease (COPD) and pulmonary hypertension.


Particular highlights include:

* an excellent year for Profile Respiratory Systems with continued growth in 
  both sales and margins and the establishment of new service products for sleep 
  therapy;

* regulatory approval and launch of our first medicine, Promixin;

* successful launch of Prodose, our second-generation intelligent inhaler; and

* continued development of Prodose HandHeld.


However, I believe the most significant step this year has been the formation of
a joint venture to address the US market between Profile and Breath. Breath is a
subsidiary of Arrow Group, a rapidly growing generics pharmaceutical company.
Under the terms of the Joint Venture, Profile and Breath will develop and market
a range of respiratory products to be delivered through Profile's Prodose
HandHeld across the North American market.


Conventional Respiratory Equipment and Services


Profile Respiratory Systems develops, manufactures and markets aerosol, oxygen
therapy, sleep and ventilation equipment and other related services for both
home and hospital use. We have a sound, profitable and growing business
operating within a very competitive market. Within the UK, where we are market
leaders, distribution and marketing are direct and well established.
Internationally, we use established distribution partners. Both areas of the
business continue to grow.


I am pleased to report that Profile Respiratory Systems had a very good year. It
enjoyed overall revenue growth of 9% to #13.6m from #12.4m in 2001/2. Of this,
we enjoyed #0.9m sales growth in the UK and #0.3m overseas. Gross margins also
improved from 49.3% to 50.0%, taking gross profit to #6.8m, an increase of 11%
over the prior year (#6.1m). This is especially encouraging in the context of
continuing NHS budgetary constraints with respect to capital equipment
purchases, and demonstrates the strength of our consumable products in
particular.


Highlights of the performance include:

* 9% growth in supply to UK NHS Logistics;

* 19% growth in supply of products and services to UK sleep market;

* 70% increase in US sales;

* an increased rate in the introduction of new products to UK and
  international markets;

* 7% increase in Homecare sales; and

* 0.7% improvement in gross margin.


Aerosol Therapy

This is an area of core competence for Profile Respiratory Systems. During the
year, we consolidated our position as one of the top 100 suppliers to the NHS by
increasing our sales to NHS Logistics by 9%. In October we were also able to
raise prices to the NHS, the first time that this has been possible for three
years. This is an important indication of the strength of our products in a
market where tendering processes usually erode margins over time.


In February we received confirmation that we had been successful in three NHS
tenders - retaining contracts in oxygen/nebuliser therapy and respiratory
therapy, and gaining a new contract in anaesthesia and circuitry. These
contracts will run for the next three years.


The ongoing development of new products and innovative supply mechanisms
continues to strengthen our relationships in the NHS at Logistics, Trust and
individual hospital levels.


Sleep Therapy

Sleep Disordered Breathing (SDB) is one of the fastest growing segments in UK
healthcare, currently growing at approximately 13% per annum. During the year,
as a result of new products, greater focus and a number of innovative supply
mechanisms, we increased our sales by 19%. Our growth has been secured by
gaining agreement from a number of leading sleep therapy centres to adopt our
range of sleep therapy products and services. This will remain an area of
particular focus for the business in the future.


Profile Respiratory Systems intends to develop further the UK Sleep market and
to assist in this, we presented three abstracts at the 7th World Congress on
Sleep Apnoea held recently in Helsinki. These abstracts demonstrate a clear
benefit for patients managed with Profile's MOST(R) (Management Of Sleep Therapy)
programme. They will help to raise our profile in the clinical community
concerned with sleep disorders and raise awareness of the benefits of our MOST
programme as a new approach to managing patients on Continuous Positive Airway
Pressure (CPAP) therapy.

US Sales

Our 70% growth in US sales was principally the result of an increase in business
with Invacare Corporation for durable Sidestream nebulisers. This was driven by
a supply contract between Invacare and a major US homecare company. We
anticipate that Invacare will have further success in this area with other
homecare suppliers, which will expand Profile's US revenues.


Profile Respiratory Systems continues to use a combination of new product
introduction, greater marketing resource and the identification of additional
marketing partners to extend its penetration into the US healthcare market.


New product development

In line with our strategy of distributing complementary infill products that
utilise existing sales and marketing capacity, whilst reducing the effects of
seasonality on the business, Profile Respiratory Systems has introduced a number
of innovative proprietary and distributed products during the year:

* in July 2002 we started to distribute a range of non-invasive
  cardio-pulmonary monitoring, pulse oximetry and capnography equipment supplied
  by Novametrix Inc., a wholly owned subsidiary of Respironics Inc. Respironics
  has been a long-term partner of the company for some 20 years;

* in January 2003 we launched Portaneb Lite, our new, lower-cost, more
  compact compressor for nebulisation, into a number of overseas markets;

* in March 2003 we launched the Vapotherm 2000 in the UK and six
  European markets. This is a novel device for conditioning high-flows of oxygen
  in a number of acute applications;

* in June 2003 we launched the new Esprit ventilator, a novel invasive/
  non-invasive ventilator developed by Respironics Inc.; and

* during the year, we also established the Patient Support Programme
  service which provides training and support for patients being prescribed
  Promixin, and services in customer support, production and logistics to our
  other businesses.


At the European Respiratory Society Congress in September 2003, we are launching
a new, patented, nebuliser - the Smartstream - which offers a further step
forward from our existing and very successful Ventstream and Sidestream
nebulisers. The Smartstream is breath-activated and enables oxygen to be
delivered during nebulisation, thereby preventing patient desaturation. In late
2003 we will also launch Respirate, a handheld respiratory rate meter, and an
upgraded version of the Ventstream nebuliser.


Homecare Sales

Homecare sales are particularly important to Profile Respiratory Systems, not
only because they are the highest margin sales sector, characterised by up-front
cash payments but also, crucially, because they keep our business close to the
end-users of our products. During the year, we increased sales by some 7%,
through the continuing strong sales of the Freeway Freedom nebuliser compressor
(launched in 2002) and sales of sleep products to end-users.


Margin Improvement

Profile Respiratory Systems operates a programme of continual margin improvement
as best business practice and as a mechanism to offset pricing pressures from
the UK and international markets. During the year, we began to realise the value
of the 2002 investment of some #0.3m on a suite of automated tooling and
assembly equipment for nebuliser production. During 2003, we also brought a Far
Eastern moulding supplier on-line for the supply of a number of moulded
components and products. We anticipate that these measures, together with future
planned activities aimed at margin improvement, will help to preserve gross
margins at around current levels.


Medicines delivered through Profile's proprietary Adaptive Aerosol Delivery
(AAD) systems


Profile Drug Delivery researches and develops intelligent inhaler systems using
a proprietary, patented technology known as Adaptive Aerosol DeliveryTM (AAD).
AAD is designed to ensure precise and reproducible dosing in the home
environment. It achieves this by responding to individual patients' breathing
patterns and delivering the medicine into the correct part of their respiratory
cycle. The key products are Prodose, which has now been launched in the UK, and
Prodose HandHeld, which is in development for launch in 2004.


Device Development


Prodose

In November 2002 we launched Prodose. This is our second-generation intelligent
inhaler using AAD and incorporates flexibility of dosing through the Prodose
Disc. The Disc is a small electronic chip inserted into Prodose, which
determines the dose to be delivered. Supplied with the medicine pack and
medicine-specific, the Disc also records information about each treatment taken
by the patient to give a full compliance record.


During the year, we have supplied Prodoses to a major pharmaceutical company
which has a requirement for precision dosing in dose-ranging studies of new
medicines.


Prodose HandHeld

We have continued to develop our third-generation system, Prodose HandHeld, and
expect to complete prototype testing and to finalise the design before the end
of 2003. Prodose HandHeld is a miniature, virtually silent, portable and fast
nebuliser that will significantly reduce the inconvenience of nebulised therapy,
whilst delivering a precise, reproducible dose. This device is central to our
strategy to gain market share in the US through the Joint Venture with Breath.
We anticipate that production of the device will commence in the first half of
2004, with US regulatory approval in the second half of the year.


Intellectual Property

We have recently been granted our fifth US patent relating to our core AAD
technology. This broadens and consolidates the intellectual property protection
for our AAD systems, and is a key foundation of our ambitions in the US market.
We have continued to strengthen our AAD patent portfolio in our principal
markets in the US and Europe. During the year, we have also filed two new
patents on enhanced AAD developments, which reduce the treatment time for
patients using either Prodose or Prodose HandHeld.


North American Joint Venture

We announced in March the signing of a Framework Agreement to form a joint
venture with Breath to address the market for nebulised medicines in North
America. The Joint Venture Company was established in early July.


This is of fundamental strategic importance for Profile as the US is the world's
largest pharmaceutical market and nebulised therapy is well established there.
In addition, the market is homogeneous and has potentially attractive levels of
reimbursement for our core products. The US currently represents the most
exciting opportunity for Profile, and will be our engine of growth in the medium
and longer term.


The Joint Venture is owned 50:50 by Profile and Breath. Profile will be
providing Prodose HandHeld technology to the Joint Venture, and Breath will
provide a range of key respiratory medicines. Initially these include:

* albuterol, a mainstay treatment of asthma;

* ipratropium, a principal treatment of COPD; and

* an inhaled corticosteroid, used in both asthma and COPD.

Additional products are planned, including combination products.


International Medical Statistics do not collect hospital or homecare data which
means that exact data on the market opportunity is not available. However,
Profile has worked with a homecare supplier to estimate these segments of the
market. These estimates are shown in Table 1. At average wholesale prices, these
indicate a market opportunity of greater than $1bn.


Table 1. Estimated US market size for core nebulised therapies (single-dose
vials per annum)

Product                    Retail volume    Homecare &          Total volume
                                            Hospital volume

Albuterol                  300 million      400 million         700 million
Ipratropium                200 million      300 million         500 million
Ipratropium/Albuterol      80 million       5 million           85 million
Inhaled corticosteroid     100 million      10 million          110 million
Total                      680 million      715 million         1,395 million


The products have been specifically developed for Prodose HandHeld which,
because it is highly efficient, requires a smaller initial volume of medicine
than a conventional nebuliser. As well as providing a convenient, fast, precise
dose for the patient, it significantly reduces both waste and the risk of
over-dosing.


Stability data has been generated on initial batches of the first two products.
Subject to due regulatory process, sales of these products should commence in
the summer of 2005.


The current focus of the Joint Venture Company is on establishing the necessary
partner agreements to market the medicines and Prodose HandHeld to the US
market. In particular, we are in discussions with US-based companies which
specialise in marketing pharmaceuticals to key target clinician segments.


Promixin

A major milestone was achieved in February 2003 when Profile Pharma was granted
a UK marketing authorisation for Promixin, its first product. The UK launch in
March 2003 has demonstrated Profile's ability to steer a clear path through the
regulatory processes for both medicine and device. This is an important proof of
concept for our development and partnering in the key US market.


Promixin, whose active product ingredient is colistin, is used in the treatment
of chronic infections in patients with cystic fibrosis. We estimate that there
are 6,500 patients with cystic fibrosis in the UK (30,000 in Europe), 50% of
whom suffer chronic pulmonary infections - the most common cause of death in
this patient group. The condition is commonly treated with inhaled antibiotic
therapies which aim to reduce the infection of the lungs. The total European
market for inhaled antibiotics in the treatment of patients with cystic fibrosis
is approximately #30m, with colistin accounting for around one-third of this.
For a modest premium to the cost of existing therapy, clinicians also get access
to Prodose and a full Patient Support Programme.


Delivering Promixin with Prodose has multiple advantages, including: shorter
treatment times, strong patient preference (giving rise to better compliance to
treatment) and precision dosing.


We now have formulary approval at 6 of the 40 key centres which treat patients
with cystic fibrosis in the UK and continue to make progress in others. A
further 13 centres have started initial patients on Promixin prior to formal
formulary approval by the Drugs and Therapeutics Committee.


The next opportunity for Profile Pharma is to obtain regulatory approval in
Europe through the Mutual Recognition Procedure. We have submitted our
documentation to the European Medicines Evaluation Agency and anticipate a
positive opinion in early 2004, with full grant following later in the first
half. We intend to launch the product in Europe with Prodose HandHeld.


Obtaining appropriate sales and marketing partners is a critical issue for
successful launch in Europe. Discussions are continuing with a potential partner
which has an existing pan-European presence in the cystic fibrosis market.


Pulmonary Hypertension

In late May Schering AG received a positive opinion from the European regulator
regarding its application for a marketing authorisation for Ventavis, its
inhaled prostacyclin product for pulmonary hypertension. We anticipate that
Schering will receive formal authorisation before the end of 2003 and that
Prodose will be included in the SmPC (summary of main product characteristics).
We have agreed pricing for Prodose and support services with Schering AG, but
uptake will be decided and driven on a geographical basis by market.


We are also in early-stage discussions regarding support for a pulmonary
hypertension product for the US market.


Other products

In March 2003 we announced that we had completed a Supply and Licence Agreement
with Breath for a range of generic respiratory medicines in Europe - salbutamol,
ipratropium and an inhaled corticosteroid. Due to the reimbursement pricing of
these products and the likely competitive landscape, we have decided to pursue
these as range extensions once a patient base is established if it is
commercially advantageous to do so and the appropriate partners are engaged.


Staffing

During the year our total staff numbers have reduced from 151 to 135. This
reflects the completion of some development projects, and the reorganisation and
streamlining of some key internal processes. I would like to take this
opportunity to thank all the staff for their time and commitment to Profile and
the collective effort shown to develop and grow the business.


John Lisle
Chief Executive Officer


                                FINANCIAL REVIEW


This Financial Review should be read in conjunction with the financial
information and the accompanying notes.


Profit and Loss Account

Group turnover increased by 8.7% to #13.78m and the Group operating loss
decreased to #4.69m (2002: #5.79m loss). The loss is in line with plan and
primarily relates to planned research and development expenditure on the Prodose
and Prodose HandHeld AAD systems and Profile Pharma project activities,
including the launch of Promixin in the UK, partially offset by profits from
Profile Respiratory Systems.


Profile Respiratory Systems

Revenues increased by 9% (as discussed above). Gross profit increased by 11% to
#6.80m (2002: #6.13m) and gross margin improved to 50.0% (2002: 49.3%) as a
result of an improved $/# exchange rate, a change in sales mix and reductions in
manufacturing costs. Overheads increased by 6% to #5.18m (2002: #4.90m),
primarily as a result of greater investment in the UK sales and marketing
resource. PRS's net operating margin increased from 9.9% to 11.9% and its
operating profit increased from #1.23m to #1.62m, an increase of 31%.


Profile Drug Delivery

Profile Drug Delivery revenues increased to #0.31m (2002: #0.25m). Development
fee income increased from #0.11m to #0.17m, with the balance of revenue being
attributable to Prodose revenues. Gross profit increased from #0.08m to #0.27m.
Gross profit in the prior year was depressed by the provision against excess
HaloLite component stocks. Overheads have been reduced from #6.60m to #5.25m.
This reduction reflects lower research and development expenditure following the
completion of the second-generation inhaler, the Prodose, lower clinical trial
costs and the conclusion in June 2002 of costs charged from a previously
capitalised development project.


Profile Pharma

As discussed above, in March 2003 Profile Pharma started to sell Promixin and
#0.06m of revenue was generated in sales to pharmaceutical wholesalers. Profile
Pharma places the Prodose with the patient and writes off the cost of the
delivery system when it is placed with the patient. The gross loss of #0.06m is
caused by this investment in Prodose systems. During the year, Profile Pharma's
overheads have increased from #0.50m to #1.27m as a result of the increase in
sales, marketing, regulatory and administrative costs associated with Promixin.
Profile Pharma has also borne its share of central costs.


Taxation

The Group has recognised a tax credit of #0.27m (2002: #0.23m) in respect of
research and development expenditure incurred during the year (which is expected
to be received in 2004) and an additional #0.16m in respect of the prior year,
which was received during 2003.


Balance Sheet and Cash Flow

The Group ended the year with shareholders' funds of #7.31m (2002: #11.32m),
including net cash balances of #5.01m (2002: #8.34m).


Fixed assets

During the year, the Group capitalised some #0.11m in respect of new patent and
trademark applications (2002: #0.10m). Moreover two joint patents reverted to
Profile's sole ownership. The Group has reduced the number of countries where it
will maintain these two patents and therefore has written off an amount of
#0.11m of capitalised costs relating to these discontinued countries. The Group
invested #0.79m (2002: #1.41m) in tangible fixed assets. The main items were
Prodose test and Disc programming equipment and additional product demonstration
stock for Profile Respiratory Systems.


Current assets and liabilities

At the year-end, the Group had #4.08m on short-term deposit (2002: #7.73m) and
current account balances of some #0.94m (2002: #0.62m). Current account balances
were higher than prior year levels because of the receipt of the research and
development tax credit payment of #0.39m immediately prior to the year-end.
Stock, debtor and creditor balance increases over the prior year-end are
attributable to increased activity levels.


Cash Flow

Net cash outflow before financing amounted to #3.32m (2002: #6.09m). The
principal elements of the cash flow were:

* operating cash outflow of #3.18m (2002: #5.59m);

* capital expenditure payments, net of sales proceeds, of #0.82m (2002:#1.47m);

* net interest and dividends received of #0.29m (2002: #0.68m);

* tax refunded of #0.39m (2002: #0.29m).


The reduction in the operating cash outflow from #5.59m to #3.18m is a function
of the lower operating loss (2003: #4.69m; 2002: #5.79m); higher depreciation
and amortisation (2003: #0.89m; 2002: #0.82m); and the changes in year-end
debtor, stock and creditor balances (2003: #0.62m generated; 2002: #0.62m
absorbed). Interest received has decreased from #0.53m to #0.23m as a result of
lower average cash balances and reduced interest rates. Dividends received were
lower because the prior year included dividend receipts in respect of two
financial years. The tax refund is the research and development tax credit
received on account of the year ended 30 June 2002.


In September 2002 the Group secured a three-year committed revolving credit
facility totalling up to #5 million from Bank of Scotland to fund, inter alia,
the future working capital needs associated with the growth of Profile Pharma.
The Group has not yet drawn down on this facility.


                         Group Profit and Loss Account



                                                          2003            2002
                                             Notes        #000            #000

TURNOVER                                          2     13,780          12,680
Cost of sales                                            6,777           6,476
                                                       ---------       ---------

GROSS PROFIT                                             7,003           6,204
                                                       ---------       ---------

Selling, marketing and distribution costs                3,622           3,206
Research and development expenses                        3,339           5,034
Administrative expenses                                  4,735           3,758
                                                       ---------       ---------

                                                        11,696          11,998
                                                       ---------       ---------

GROUP OPERATING LOSS                                    (4,693)         (5,794)
                                                       ---------       ---------

Income from investments                                     66              70
Interest receivable                                        234             496
Interest payable and similar charges                       (35)             (1)
                                                       ---------       ---------

                                                           265             565
                                                       ---------       ---------

LOSS ON ORDINARY ACTIVITIES BEFORE TAXATION             (4,428)         (5,229)
Tax on loss on ordinary activities                         428             383
                                                       ---------       ---------

LOSS ON ORDINARY ACTIVITIES AFTER TAXATION
AND RETAINED LOSS FOR THE YEAR                          (4,000)         (4,846)
                                                       =========       =========

Basic and diluted loss per ordinary share         3       (8.1)p          (9.9)p
(pence)




              Group Statement of Total Recognised Gains and Losses

                                                                2003      2002
                                                                #000      #000

Loss for the financial year attributable to members of
the parent company                                            (4,000)   (4,846)
Exchange difference on translation of overseas subsidiary
financial statements                                             (10)      (34)
                                                             ---------  --------

Total recognised losses for the year                          (4,010)   (4,880)
                                                             =========  ========




                              Group Balance Sheet

                                                             2003         2002
                                               Notes         #000         #000

FIXED ASSETS
Intangible assets                                             411          445
Tangible assets                                             1,605        1,633
Investments                                                   142          142
                                                          ---------     --------

                                                            2,158        2,220
                                                          ---------     --------

CURRENT ASSETS
Stocks                                                      1,082          908
Debtors                                                     2,840        2,514
Cash at bank and in hand                                      942          617
Short-term deposits                                         4,077        7,725
                                                          ---------     --------

                                                            8,941       11,764
CREDITORS: amounts falling due within
one year                                                    3,780        2,660
                                                          ---------     --------

NET CURRENT ASSETS                                          5,161        9,104
                                                          ---------     --------

TOTAL ASSETS LESS CURRENT LIABILITIES                       7,319       11,324
                                                          ---------     --------

CREDITORS: amounts falling due after more
than one year                                                   5            -
                                                          ---------     --------

NET ASSETS                                                  7,314       11,324
                                                          =========     ========

CAPITAL AND RESERVES
Called up share capital                                       983          983
Share premium account                                      24,436       24,436
Profit and loss account                                   (18,105)     (14,095)
                                                          ---------     --------

SHAREHOLDERS' FUNDS
- EQUITY INTERESTS                                   4      7,314       11,324
                                                          =========     ========




                           Group Cash Flow Statement

                                                            2003          2002
                                                Notes       #000          #000

NET CASH OUTFLOW FROM
OPERATING ACTIVITIES                                 5    (3,177)       (5,585)
                                                          --------     ---------

RETURNS ON INVESTMENTS AND
SERVICING OF FINANCE
Dividends received                                            66           149
Interest received                                            233           534
Interest paid                                                  -            (1)
Interest element of finance leases and hire
purchase
rental payments                                               (1)           (1)
Bank facility costs                                           (8)            -
                                                          --------     ---------

                                                             290           681
                                                          --------     ---------

TAXATION
Corporation tax refunded                                     389           285
                                                          --------     ---------

CAPITAL EXPENDITURE AND
FINANCIAL INVESTMENT
Payments to acquire intangible fixed assets                 (115)          (99)
Payments to acquire tangible fixed assets                   (780)       (1,406)
Receipts from sales of tangible fixed assets                  71            32
                                                          --------     ---------

                                                            (824)       (1,473)
                                                          --------     ---------

NET CASH OUTFLOW BEFORE MANAGEMENT
OF LIQUID RESOURCES AND FINANCING                         (3,322)       (6,092)

MANAGEMENT OF LIQUID RESOURCES
Decrease in short-term deposits                            3,648         6,509

FINANCING
Repayments of capital element of finance leases
and hire purchase contracts                                  (1)          (12)
                                                          --------     ---------

INCREASE IN CASH IN YEAR                             6       325           405
                                                          ========     =========



Notes


Basis of preparation


The financial information on the Group set out above does not constitute
"statutory accounts" within the meaning of Section 240 of the Companies Act
1985. The financial information for the years ended 30 June 2002 and 2003 has
been extracted from the Group's audited consolidated statutory accounts. The
statutory accounts for the year ended 30 June 2003 will be delivered to the
Registrar of Companies for England and Wales in due course and the accounts for
the year ended 30 June 2002 have been so delivered. The report of the auditors
on both sets of accounts was unqualified and did not contain a statement under
Section 237 (2) or (3) of the Companies Act 1985.


The annual report will be posted to shareholders in October 2003 and will be
laid before shareholders at the Annual General Meeting on 18 November 2003.


The accounts have been prepared in accordance with UK generally accepted
accounting principles on a basis which is consistent with those applied in
previous periods.


Segmental analysis

                                                        2003              2002
                                                        #000              #000
Turnover:
Profile Respiratory Systems                           13,588            12,431
Profile Drug Delivery                                    310               249
Profile Pharma                                            63                 -
Inter-segment turnover                                  (181)                -
                                                      --------         ---------

                                                      13,780            12,680
                                                      ========         =========

Gross profit:
Profile Respiratory Systems                            6,799             6,128
Profile Drug Delivery                                    274                76
Profile Pharma                                           (58)                -
Consolidation adjustment                                 (12)                -
                                                      --------         ---------

                                                       7,003             6,204
                                                      ========         =========

Operating profit/(loss):
Profile Respiratory Systems                            1,621             1,233
Profile Drug Delivery                                 (4,979)           (6,523)
Profile Pharma                                        (1,323)             (504)
Consolidation adjustment                                 (12)                -
                                                      --------         ---------

                                                      (4,693)           (5,794)
                                                      ========         =========


The consolidation adjustment relates to the elimination of profit in Profile
Pharma stock arising from purchases from Profile Respiratory Systems.


Loss per share


The calculation of the basic and diluted loss per ordinary share is based on a
loss of #4,000,000 (2002: #4,846,000 loss), and on 49,143,423 (2002: 49,143,423)
ordinary shares, being the weighted average number of ordinary shares in issue
during the year. Issued share options have an anti-dilutive effect and are
therefore excluded.


Reconciliation of movements in shareholders' funds

                                                            2003         2002
                                                            #000         #000

Retained loss for the year                                (4,000)      (4,846)
Other recognised losses relating to the year                 (10)         (34)
                                                         ---------    ---------

Net deduction from shareholders' funds                    (4,010)      (4,880)
Opening shareholders' funds                               11,324       16,204
                                                         ---------    ---------

Closing shareholders' funds                                7,314       11,324
                                                         =========    =========



Reconciliation of Group operating loss to net cash outflow from operating
activities

                                                            2003          2002
                                                            #000          #000

Group operating loss                                      (4,693)       (5,794)
Depreciation                                                 792           568
Amortisation of development expenditure                        -           217
Amortisation of patents and trademarks                       149            32
(Profit)/loss on disposal of fixed assets                    (50)            3
Increase in debtors                                         (254)         (549)
Increase in stocks                                          (174)         (125)
Increase in creditors                                      1,053            63
                                                         ---------     ---------

Net cash outflow from operating activities                (3,177)       (5,585)
                                                         =========     =========


Reconciliation of net cash flow to movement in net funds

                                                              2003       2002
                                                              #000       #000

Increase in cash in year                                       325        405
Decrease in short-term deposits                             (3,648)    (6,509)
Cash outflow from decrease in lease financing and hire
purchase contracts                                               1         12
                                                            --------   --------

Change in net funds resulting from cash flows               (3,322)    (6,092)
New hire purchase contracts                                     (7)         -
                                                            --------   --------

Movement in net funds                                       (3,329)    (6,092)
Net funds at 1 July                                          8,342     14,434
                                                            --------   --------

Net funds at 30 June                                         5,013      8,342
                                                            ========   ========




                      This information is provided by RNS
            The company news service from the London Stock Exchange

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