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Biotron Limited

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FY2004 Annual Report · Biotron Limited
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Biotron Limited ABN 60 086 399 144

ANNUAL REPORT
for the year ended 30 June 2004

contents

chairman’s report

review of operations

corporate governance statement

directors’ report

statement of financial performance

statement of financial position

statement of cash flows

notes to the financial statements

directors’ declaration

independent audit report

additional ASX information

corporate directory

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T

he  past  year  has  seen  a  continued  focus  on
commercial  development  of  the  Company’s  two
major projects, Virion and C-Test. Major advances have
been  made  on  both  projects.  Virion's  substantial
progress  means  that  the  Company  is  well  placed  to
maximise  the  benefit  of  the  increased  value  of  this
world-class technology. 

in 

During  the  year  Biotron  was  successful 
its
applications  for  Biotechnology  Innovation  Fund  (BIF)
and  Start  grants  from  the  Federal  government. These
grants  will  provide  almost  $2  million  to  the  Company
over the next one to two years. Successful application
for the competitive grants is affirmation of the advances
the Company has made. 

The Virion antiviral technology has expanded to cover a
wide  range  of  economically  significant  viruses  in
addition to HIV-1. Outstanding research by our scientists
has  unveiled  a  potential  new  therapy  for  currently
untreatable  viral  diseases  including  Hepatitis  C,  SARS
and  Dengue.  Development  of  therapeutics  for  these
viruses  has  progressed  rapidly  and  we  anticipate  that
this rapid progress will continue. One of the benefits of
having a true platform technology is that the preclinical
and  clinical  studies  undertaken  for  the  HIV  technology
will  facilitate  development  of  therapeutics  which  can
target  the  other  viral  diseases  currently  being
researched by the Company.

The  Virion  anti-HIV  technology  has  progressed  to
preclinical  testing  and  the  Company  is  well  along  the
path to clinical studies in humans. Biotron’s compounds
show characteristics that are essential for good clinical
candidates,  a  significant  advance  which  should  not  be
underestimated.

chairman’s report

The  competitive  position  of  C-Test  has  been
significantly increased by improvements to methods of
detection,  resulting 
in  decreased  variability  and
increased  sensitivity. Together  with  previous  advances
in 
sample  processing  and  algorithm/software
development, the C-Test cancer diagnostic test format is
well  placed  to  take  advantage  of  recent  upsurge  in
interest  in  biomarkers  for  disease  diagnosis  by  the
international scientific and medical community.

During 2004/05, the Company looks forward to reaping
the  benefit  of  these  key  advances  in Virion  and  C-Test,
with the aim of maximising returns to shareholders. The
Company is intent on achieving a commercial outcome
for  these  technologies  while  continually  exercising
rigorous control of costs. 

On behalf of the shareholders and Directors, I would like
to thank all Biotron staff for their untiring efforts during
the  year. Thanks  to  their  commitment  and  dedication,
your Company is well placed to meet the next stage of
its development.

Yours sincerely

Michael J. Hoy

Chairman

ANNUAL REPORT 2004 

1

review of operations

OVERVIEW

D

uring the year ended 30 June 2004 there has been
a continued focus on the commercial development
of the key biomedical projects managed and funded by
the Company.

The  following  significant  events  were  achieved  during
the year under review:
• Demonstration 

ion  channel  activity
associated with the p7 protein of Hepatitis C virus
can  be  blocked  by  Biotron’s  small  molecule
compounds,  opening  up  a  potential  new
therapeutic approach to this disease.

that 

• Demonstration  that  the  E  protein  of  SARS
coronavirus  forms  an  ion  channel  and  that  this
activity  can  be  blocked  by  Biotron’s  small
molecule  compounds,  opening  up  a  potential
therapy for SARS.

• Demonstration  that  the  M  protein  of  Dengue
virus forms an ion channel and that this activity
can  be  blocked  by  Biotron’s  small  molecule
compounds,  opening  up  a  potential  therapy  for
Dengue and related flaviviruses.

• Awarded a Biotechnology Innovation Fund grant
the  Australian  Federal

from 

of  $250,000 
Government.

• Publication  of  two  manuscripts  describing  of
Biotron research into potential new therapeutics
for HIV and for Hepatitis C virus in international,
prestigious, peer-reviewed scientific journals.
• Awarded  a  Start  grant  of  $1.7  million  for
preclinical  development  of  the  Virion  anti-HIV
technology.

• Successful  completion  of  the  first  stage  of
preclinical  toxicity  testing  of  Biotron’s  lead
antiviral compounds.

BIOTRON’S PROJECTS

As stated in the Financial Report for year ended 30 June
2003  and  re-iterated  in  the  Update  to  Shareholders
earlier  this  year,  the  Company’s  efforts  are  currently
focused  on  commercial  development  of  the Virion  and
C-test Projects. These projects the most advanced within
the  Company,  and  address  unmet  medical  needs  and
have  enormous  commercial  potential.  Both  have  the
potential to generate returns in a shorter time frame. 

During  the  2003-2004  financial  year,  Biotron  has  been
successful 
for  Biotechnology
Innovation Fund (BIF) and Start grants from the Federal
government. These grants will provide almost $2 million 

its  applications 

in 

2

ANNUAL REPORT 2004 

to  the  Company  over  the  next  one  to  two  years.
Successful  application  for  the  grants  required  Biotron 
to  satisfy  independent  review  committees  of  the
international 
and
commercial potential of the projects. 

competitiveness, 

innovation, 

Biotron’s  model  is  to  take  projects  such  as  C-Test 
and  Virion  through  proof-of-concept  studies  into 
preclinical  and  early-stage  clinical  development.  The
Company then aims to form partnerships and alliances
with  international  pharmaceutical  or  biotechnology
companies  for  further  late-stage  clinical  development
and marketing of products. Income received from such
alliances  will  be  committed  to  further  the  commercial
development of existing and new Tier 2 Projects.

Virion Project

The  Virion  Project  is  aimed  at  developing  antiviral
agents  that  will  interact  with  viral  proteins  in  several
significant  viral  diseases.  Over  the  last  12  months,  the
scope of the Virion technology has expanded from HIV
alone,  to  include  a  wide  range  of  other  viral  diseases.
We have been able to demonstrate that the technology
has potential to treat viruses such as SARS coronavirus,
Hepatitis C virus, Dengue virus, and a number of viruses
that cause the common cold. We are confident that the
technology will have application against an even wider
range of viral diseases. 

The  most  advanced  project  with Virion  is  the  anti-HIV
program,  developing  small  molecule  inhibitors  of  the
Vpu  protein  of  HIV-1,  a  new  drug  target  in  the  fight
against  HIV. Vpu  plays  important  roles  in  the  budding
and release of newly formed viruses from infected cells,
a process that is crucial for the progression of infection.

As of the end of 2003, an estimated 37.8 million people
worldwide  were  living  with  AIDS,  with  more  than  4.8
million new HIV infections occurring worldwide during
2003. 

Current  anti-AIDS  drug  therapies  primarily  target  the
HIV-1  reverse-transcriptase  and  protease  enzymes. To
counteract the ability of the HIV-1 virus to rapidly mutate
and develop resistance, patients are given a cocktail of
drugs 
Active 
of 
Highly 
Anti-Retroviral  Therapy 
(HAART).  Discovery  and
development  of  new  anti-HIV-1  drugs  that  attack
different  parts  of  the  virus  life  cycle  is  essential  in  the
continuing fight against resistance.

part 

as 

a 

There  is  a  particular  need  for  therapeutics  that 
target  HIV  in  a  particular  type  of  cell  known  as
monocyte/macrophages.  Recent  studies  have  shown
that these cell types act as pools or reservoirs of virus in
HIV-infected  individuals.  Existing  regimens  of  HAART
are ineffective at attacking HIV-1 in those cells. 

review of operations

Over the past 12 months, Biotron has designed, synthesized and screened more than 160 compounds with the potential
to target specific viral proteins, starting from the design of the initial BIT009 compound. This process of iterative design
and  testing  for  activity  has  generated  a  focused  library  of  compounds  with  significantly  improved  anti-Vpu  activity
compared to BIT009. Six of the most promising lead candidates have been independently tested overseas and shown
to be able to inhibit replication of HIV-1 virus. 

An  ongoing  preclinical  development  program 
is
underway to ensure the compounds' safety and efficacy,
leading up to a Phase I/IIa clinical trial in humans. These
steps  all  form  part  of  an  ordered  drug  development
program  to  maximise  returns  to  shareholders  in  the
commercialisation  of  the  Virion  Project  by  way  of
collaboration  with  a  pharmaceutical  company.  The
Company is currently in the process of selecting a lead
candidate for the HIV study. It is essential that the best
lead is selected to maximise the chance of successfully
passing  through  the  rigorous  safety  testing  that  is
required by regulatory authorities before the compound
can  be  tested  in  human  trials.  To  assist  in  the  lead
candidate  selection,  the  Company  has  retained  the
services  of  expert  consultants  with  extensive  and
proven  experience  in  drug  development.  We  are  well
advanced  in  this  lead  candidate  selection  process  and
all results to date are very encouraging, indicating that
the compounds have good, “druggable” characteristics
(ie the compounds have characteristics that are essential
if a drug is to specifically work against a given target in
humans).

As  part  of  a  preclinical  testing  program,  acute  toxicity
studies have been undertaken in mice to determine the
'no  observed  adverse  effect  levels'  (NOAEL)  of  the  six
independently  tested  lead  drug  candidates. The  results
to  date  have  indicated  that  all  six  compounds  tested
were metabolised by the mice after oral dosing; and that
toxicity  levels  were  within  acceptable  limits.  These
results  are  indicative  of  the  druggable  potential  of  the
compounds, and move the Company one step closer to
selection of a lead drug candidate. 

Discussions  are  underway  with  doctors  specialising 
in 
trial
treatment  of  HIV  as  well  as  clinical 
consultants,  regarding  the  design  and  location  of  a
Phase  I/IIa  clinical  trial  in  humans.  Consultations  with
appropriate regulatory authorities are also in progress.
The  Start  grant  ($1.7  million)  will  expedite  the
development  of  an  HIV  therapeutic  through  preclinical
testing  and  a  Phase  I/IIa  trial  in  man  which  will  be
undertaken  prior  to  partnering  with  an  international
pharmaceutical company for further development.

ANNUAL REPORT 2004 

3

review of operations

A

B

A > Biotron’s  proprietary  screening  assay  has  identified  drugs  that
work against the SARS coronavirus. Compounds 4 and 5 (*) strongly
inhibit SARS E protein ion channel activity.  Drugs are spotted on
the plate, if the drug inhibits the E protein ion channel there is a
halo of growth.

B > The antiviral activity of the drugs is then confirmed by testing for
their  ability  to  inhibit  growth  of  viruses  in  plaque  assays.    The
figure above shows one Biotron’s drugs preventing growth of a
human coronavirus strain. 

One of the benefits of having a true platform technology
is that the preclinical and  clinical  studies  undertaken  for 
the  HIV  technology  will  facilitate  development  of
therapeutics  which  can  target  the  other  viral  diseases
currently being researched by the Company.

During the last 12 months, the Virion project has evolved
into a true platform technology, based on the discovery
that  Biotron’s  compounds  inhibit  ion  channel  activity
associated  with  several  other  proteins  from  different
viruses  including  Hepatitis  C  virus,  SARS  coronavirus
and  Dengue  virus. This  discovery  opens  up  potential
antiviral  therapies  for  these  currently  untreatable
viruses.  Each  is  a  medically  significant  virus,  affecting
very large numbers of people around the world. In late
2003,  Biotron  was  awarded  a  $250,000  BIF  grant  to
advance its work on viruses other than HIV. Over recent
months, enormous progress has been made in this area,
independent  antiviral  studies
with  results 
undertaken  both  overseas  and  within  Australia
demonstrating that the compounds do inhibit growth of
target  viruses.  Additional  antiviral  testing  against  a
broader  range  of  viruses  is  currently  underway  in
conjunction with researchers at the National Institute of
Health (NIH) in the USA. 

from 

Biotron’s  proprietary  screening  assays  are  important
components  of  the  Company’s  technology  portfolio.
Over the last 12 months, Biotron scientists have set up
rapid  screening  assays  covering  all  current  viral  target
proteins,  in  addition  to  the  original  Vpu-based  assay.
These  proprietary  assays  have  proved  invaluable  in
rapidly  screening  new  compounds  for  activity  against
the  various  viral  targets,  and  significantly  increase 
the value of the Virion technology. Most antiviral assays
are  very  time-consuming  and  labour-intensive,  so
access to rapid, high-throughput screens is a significant
advantage in terms of time and money. 

During  the  year,  on-going  discussions  have  been  held
with potential partners regarding the Virion technology.
Whilst keen to secure a partner to take the compounds
through  into  clinical  development,  Biotron  can  vastly

4

ANNUAL REPORT 2004 

increase the value of the technology by undertaking the
proposed early (Phase I/IIa) clinical trial before forming
an alliance. This will translate into much higher returns
to the Company in the form of upfront payments as well
as  increased  milestone  and  royalty  payments  in  the
future.

C-Test

Cancer  cells  have  a  number  of  characteristics  that
distinguish  them  from  normal  cells.  Most  tumour
markers  are  neither  sensitive  nor  specific  enough  to
screen  for  cancer  or  to  diagnose  cancer  without  the
support  of  other  clinical  findings.  While  a  number  of
different  tumour  markers  have  been  identified,  they
have  generally  been  found  to  lack  sensitivity  and
specificity  for  specific  cancers. There  is  a  real  need  for
new tests that allow unambiguous cancer diagnoses to
be made at an early stage. The best tests will be simple
and  non-invasive  assays  that  allow  rapid  and  accurate
diagnosis of the type of cancer and its stage.

The  C-Test  project  is  developing  sensitive,  rapid,  non-
invasive assays to detect and diagnose specific types of
cancer. The  tests  are  based  on  detection  of  a  range  of
small  molecules,  including  carbohydrates,  in  the  blood
of  patients. The  expression  of  these  molecules  differs
between patients with specific types of cancer and those
without cancer. 

Whilst C-Test has received a lower priority recently due
to the Company's focus on the Virion project, excellent
progress  has  been  made.  As  reported  previously,
Biotron  scientists  have  developed  a  simplified,  robust
method for preparing blood samples for analysis, which
is more readily adaptable for automation in a pathology
laboratory.  Progress  has  also  been  made  on  the
development of software for analysis of the samples into
a more user-friendly interface. 

Over the last 12 months, work has focused on reducing
the variability inherent in the methods used to analyse
the blood samples as well as improve the sensitivity of
the  system  for  detection  of  the  specific  molecules  of
interest.  As  a  result  of  this  work,  the  Company  has  a
reliable, reproducible assay that reflects the underlying
disease status of the patient. Biotron’s primary aim is to
generate a commercialisable product that can be moved
into the marketplace as rapidly as possible. 

Chromatogram  showing  profiles  of  blood  from  cancer  vs
healthy patient. Arrow shows peak of interest

Analysis  of  biomarkers  in  the  blood  for  diagnosis  of
diseases such as cancer is receiving increased attention
in the scientific and medical field. Biotron’s technology is
well placed to take advantage of this upsurge of interest
internationally. 

Tier 2 Projects

The  remaining,  Tier  2  Projects  are  underpinned  by 
a  platform  technology,  research  on  ion  channels 
in  membranes,  which  allows  several  scientists  to  work
in  different,  yet  related,  areas  of  research  with  the
results  of  work  in  one  area  providing  benefits  to  other
research activities. These projects are at an earlier stage
of  development  than  the  Virion  and  C-Test  Projects 
and,  in  accordance  with  the  Company's  focus  on 
the  commercial  development  of  the  Virion  and 
C-test  Projects,  limited  resources  are  committed  to 
the  Tier  2  Projects  at  this  stage.  As  these  projects
develop  and  resources  become  available  through  the
commercialisation of the more advanced Tier 1 Projects,
additional  resources  will  be  committed  as  they  reach
specific commercially-focused milestones. 

Research has progressed throughout the year on the Tier
2 Projects as discussed below. 

Muscion

Contraction of muscle, including heart muscle, depends
on  release  of  calcium  from  stores  inside  cells  through
calcium  channels  called  ryanodine  receptors.  The
Muscion  Project  team  is  identifying  compounds  that
selectively  target  ryanodine  receptors  in  heart,  skeletal
and  insect  muscle.  Biotron  researchers  are  developing
drugs to boost the output of a damaged or failing heart
muscle,  and  as  part  of  this  process  have  identified
peptides that stimulate heart muscle contraction in vitro. 

During the past year, work has continued to be focused
on  the  design,  synthesis  and  testing  of  non-peptide
compounds  which  mimic  the  activity  of  the  previously
identified  peptides  that  target  the  cardiac  ryanodine
receptors. Additional  small  molecule  compounds  have
been  identified  that  have  increased  activity  against  the
target  ryanodine  receptor.  Work  is  on-going,  testing
these compounds for activity in different in vitro model
systems, 
them  as  potential
therapeutics for cardiovascular disease. 

further  develop 

to 

Hypoxion

The  Hypoxion  project  involves  developing  compounds
that will reduce damage in cells deprived of their blood
supply (eg following heart attack or stroke). When blood
supply is compromised, cells are starved of oxygen. The

review of operations

consequent  build-up  of  calcium  in  cells  exposed  to
hypoxia kills them. The aim is to significantly reduce the
patient death/disablement rate by stopping the build-up
of calcium and saving cells.

The  project  has  two  approaches,  both  aimed  at
preventing the flow of sodium ions through ‘persistent’
sodium  channels  that  they  have  found  are  opened  by
hypoxia. The first approach is to screen for compounds
that  can  specifically  block  persistent  sodium  channels.
The second line of research that is in progress aims to
find  a  way  to  break  the  link  between  hypoxia  and  the
opening of persistent sodium channels.

GeneTrans

The GeneTrans project has focused on a drug transport
protein  called  MRP2.  Drug  transport  proteins  have
utility in drug screening tests that will help predict the
metabolism  and  safety  of  new  pharmaceuticals.
Screening tests are a vital part of the drug development
process.  If  toxicity  is  detected  in  the  early  pre-clinical
stage  of  testing,  further  testing  on  animals  is  avoided
and  the  cost  of  drug  development  is  significantly
decreased.  Biotron  has  generated  a  novel  cell  line
expressing MRP2 and has developed a drug screening
assay using this technology. Discussions are underway
with potential licensees for this technology.

Gabion

The  Gabion  Project  team  is  researching  the  effects  of
known  compounds  that  act  on  the  GABAA  receptor.
Research  undertaken  as  part  of  the  Gabion  Project  to
determine  the  effects  of  GABA  receptor  associated
protein  on  expressed  receptors  is  providing  important
new information about drug effects on these receptors
and  has  implications  for  the  development  of  high
throughput  screens  that  will  assist  and  accelerate  the
drug discovery process.

PATENT APPLICATION DEVELOPMENTS

Biotron  recognises  that  the  key  to  establishment 
of  partnerships  is  the  expansion  and  continued
strengthening  of  Biotron’s  intellectual  property  (IP)
portfolio.  Strong,  defensible,  international  patents  are
essential to attract partners and to ensure a competitive
advantage for our products in the marketplace. Due to
the  amount  of  interest  now  being  shown  by  research
groups  around  the  world  in  the  viral  ion  channel  area,
Biotron  continues  to  build  a  strong  defensible  wall  of
patents around the Company’s IP to maximise the value
of  the  technology  and  to  ensure  Biotron's  competitive
position.

ANNUAL REPORT 2004 

5

review of operations

A summary of Biotron patent portfolio and status of patent applications is set out in the table below.

APPLICATION/ PATENT NO.

STATUS

11370/00

Under examination

TITLE

A method of modulating ion 
channel functional activity

A method of determining ion
channel activity of a substance

Antiviral compounds and methods

Method of identifying cancer
markers and uses therefore in the
diagnosis of cancer

A novel cancer marker and uses
therefore in the diagnosis of cancer

Modified proteins, isolated novel
peptides, and uses therefor

Method of modulating the activity of
calcium channels in cardiac cells and
reagents therefor

COUNTRY

Australia

New Zealand

Canada

Europe

China

Japan

USA

Australia

USA

Canada

Europe

Japan

Australia
(provisional)

Australia

New Zealand

USA

Europe

Canada

Japan

China

Brazil

Singapore

Australia

New Zealand

USA

Europe

Canada

Japan

China

Brazil

Australia

USA

Europe

Japan

Australia

510437

2345896

99970324

99812019

575514/00

09/807277

724870

6355413

12266334

97918844

515070/1998

2003903251 
June 2004

200172220/01

524197

10/333348

1951237

2416375

2002514403

1814937

PI0112644

200300370-4

2002313402

531450

10/212856

752896

2457437

PI011697

2001285578

10/363112

2002252850

New Zealand

529940

USA

Europe

Brazil

Canada

Japan

China

2721869

PI0210902

2446839

2002-589036

2812056

6

ANNUAL REPORT 2004 

Awaiting examination

Awaiting examination

Awaiting examination

Requested examination

Requested examination

Under examination

Granted

Granted

Requested examination

Awaiting examination

Awaiting Official action

Filed PCT application in 

Requested examination

Filed

Awaiting examination

Awaiting examination

Awaiting examination

Awaiting examination

Awaiting Official action

Awaiting Official action

Awaiting examination

Awaiting examination

Under examination

Requested examination

Requested examination

Awaiting examination

Awaiting examination

Requested examination

Awaiting Official actio

Requested examination

Awaiting examination

Awaiting examination

Awaiting examination

Awaiting examination

Awaiting examination

Awaiting examination

Awaiting examination

Awaiting examination

Requested examination

Awaiting examination

Awaiting Official action

corporate governance statement

T

his  statement  outlines  the  main  Corporate
in  place
Governance  practices 
throughout  the  financial  year,  which  comply  with 
the  Australian  Stock  Exchange  (‘ASX’)  Corporate
Governance  Council 
recommendations,  unless
otherwise stated.

that  were 

Board of Directors

The  board  of  directors  is  responsible  for  the  overall
corporate  governance  of  the  Company  including  its
strategic  direction,  setting  remuneration,  establishing
goals for management and monitoring the achievement
of  these  goals  and  ensuring  the  integrity  of  internal
control and management information systems. It is also
responsible for approving and monitoring financial and
other reporting.

The  composition  of  the  board  has  been  determined 
on the basis of providing the Company with the benefit
of  a  broad  range  of  technical,  administrative  and
financial  skills,  combined  with  an  appropriate  level  of
experience  at  a  senior  corporate  level. The  names  and
further  information  regarding  the  skills,  experience,
qualifications and relevant expertise of the directors are
set out in the Directors’ Report. The board is composed
of a minimum of two directors.

The  composition  of  the  board  is  monitored  constantly
to  ensure  that  it  provides  the  Company  with  the
appropriate levels of both expertise and experience. The
board  comprises  a  majority  of  non-executive  directors
including the Chairperson, all of whom are considered
to  be  independent. The  independence  of  directors  is
based on their capacity to put the best interests of the
Company  and  its  shareholders  ahead  of  all  other
interests.

When  a  vacancy  exists,  through  whatever  cause,  or
where it is considered that the board would benefit from
the services of a new director with particular skills, the
board identifies a panel of candidates with appropriate
expertise and experience. A selection procedure is then
completed  and  the  board  appoints  the  most  suitable
candidate  who  must  stand  for  election  at  the  next
general meeting of shareholders.

Each  director  has  the  right  to  seek  independent
professional  advice  at  the  Company's  expense.  Prior
approval of the Chairman is required, but such approval
is  not  unreasonably  withheld.  A  copy  of  the  advice
received  by  the  director  is  made  available  to  all  other
members of the board.

In  the  event  that  a  potential  conflict  of  interest  may
arise,  involved  directors  must  withdraw  from  all
deliberations concerning the matter.

The remuneration of the directors is determined by the
board as a whole, with the director to whom a particular
decision relates being absent from the meeting during
the  time  that  the  remuneration  level  is  discussed  and
decided upon. Further information and the components
of  remuneration  for  directors  are  set  out  in  the
Director’s Report.

Due  to  the  size  of  the  Company  and  the  board,  a
Nomination  Committee,  a  Remuneration  Committee
and an Audit Committee have not been established.

Directors, officers and employees are permitted to trade
in the Company's securities only in accordance with the
provisions  of  the  Corporations  Act  and  ASX  Listing
Rules. The  directors  are  under  an  obligation  to  report
any dealings by them in the Company's securities.

Internal Controls

it 

The  board  of  directors  acknowledges  that 
is
responsible  for  the  overall  internal  control  framework,
but  recognises  that  no  cost  effective  internal  control
system  will  preclude  all  errors  and  irregularities. The
system  of  internal  control  adopted  by  the  Company
seeks 
to  provide  an  appropriate  division  of
responsibility  and  careful  selection  and  training  of
personnel  relative  to  the  level  of  activities  and  size  of
the Company.

The  full  board  takes  responsibility  for  reviewing
financial reporting procedures, internal controls and the
performance  of  the  financial  management.  Selected
internal  control  mechanisms  employed  to  support  the
business include:

• Investment  appraisal  –  the  Company  has
documented  guidelines  for  capital  expenditure
and investment appraisals. These include annual
budgets,  expenditure  review  procedures  and
appropriate levels of authority.

• Business Planning, Budgeting and Reporting – A
comprehensive  business  planning  process
includes evaluation of strategies, objectives, and
risks resulting in an annual budget approved by
the  board.  Monthly  actual  performance  is
reported  against  budget  and  revised  forecasts
for the year are prepared regularly.

• Quality  and  integrity  of  employees  –  there  are
clearly  defined  accountabilities,  performance
measures,  and  reinforcement  of  values  and
ethics by management.

ANNUAL REPORT 2004 

7

corporate governance statement

• Lodgement  of  the  half  yearly  report  with  the
Australian  Stock  Exchange,  which  contains
summarised  and  audit  reviewed 
financial
information.  Copies  of  half  yearly  financial
statements  prepared  in  accordance  with  the
to  any
Corporations  Act  are  available 
shareholder on request.

• Lodgement  of  quarterly  reports  with 
the
Australian  Stock  Exchange  which 
show
summarised financial information for the quarter.
Copies  of  these  reports  are  available  to
shareholders on request.

• Announcements 

to 

the  Australian  Stock 
Exchange  concerning  any  significant  development
in  the  Company's  operations,  financing  and
administration. All announcements are immediately
available to the general public. 

External Auditors

Board nominees review the performance of the external
auditors  and  meet  with  them  during  the  half  yearly
review and annual audit to discuss any issues that have
arisen  with  respect  to  accounting  policies,  any
significant  operational  issues  and  level  of  proposed
audit fees.

KPMG,  the  Company's  auditors,  were  appointed  on  20
November 2001.

Audit Committee

As  at  the  date  of  the  Directors'  Report,  there  was  no
Audit Committee. An Audit Committee is not considered
to  be  warranted  because  the  involvement  of  the  full
board of directors in the activities of the Company.

Ethical Standards

the  utmost 

All directors, managers and employees are expected to
act  with 
integrity  and  objectivity,
endeavouring  at  all  times  to  enhance  the  performance
and  reputation  of  the  Company.  Every  employee  has
direct access to a director to whom they may refer any
ethical issues that may arise from their employment.

The Role of Shareholders

The  board  ensures  that  the  shareholders  are  informed
of all major developments affecting the Company by the
following means:

• The annual report is distributed to all shareholders
(unless a shareholder has specifically requested
not to receive the document).

• Disclosure  of  all  major  announcements  to  the
Australian  Stock  Exchange  on  the  Company’s
website.

• The  Annual  General  Meeting 

is  the  main
opportunity  for  the  shareholders  to  hear  the
Managing  Director  and  Chairman  provide
updates  on  the  Company’s  performance,  ask
questions of the Board and to express views and
vote  on  various  matters  of  business  on  the
agenda.

Risk Management

The Board oversees the establishment, implementation
and ongoing review of the Company’s risk management
and internal control system. The internal control system
covers financial, operational and compliance risks.

Recommendations made by external auditors and other
external  advisers  are  investigated  by  the  Board,  and
where  necessary  appropriate  action  is  taken  to  ensure
that the Company has the internal control environment
to  manage  the  key  risks  identified. Ways  of  enhancing
existing 
including
risk  management  strategies, 
segregation  of  duties,  employment  and  training  of
suitably  qualified  and  experienced  personnel  are
investigated by the Board.

• Distribution  of 

the  annual  report 

to  all
shareholders which contains relevant information
about the operations of the Company during the
year  in  addition  to  disclosures  required  by  the
Corporations Act 2001.

8

ANNUAL REPORT 2004 

directors‘ report

T

he directors present their report together with the
financial report of Biotron Limited (‘the Company’)
for the year ended 30 June 2004 and the auditors' report
thereon.

the  government  in  1982  for  research  on  nerve  and
muscle ion channels.

He has been a Director since 23 February 1999.

Directors

The  names  of  the  directors  of  the  Company  holding
office at any time during or since the end of the financial
year are:

Mr Michael J. Hoy
Independent and Non-Executive Chairman

Mr  Hoy  has  more  than  30  years'  corporate  experience
in  Australia,  the  United  Kingdom,  USA  and  Asia.  He
is  Chairman  of  Cityprint  Holdings  Pty  Ltd  and
Motoron.com  Pty  Ltd.  and  a  former  director  of  John
Fairfax Holdings Limited and FXF Trust.

He  has  been  a  Director  since  7  February  2000  and
Chairman since 16 March 2000.

Dr Michelle Miller, BSc, MSc, PhD
Managing Director

Dr  Miller  has  over  20  years  in  the  bioscience  industry,
with  extensive  experience  in  managing  commercial
bioscience  research.  She  completed  her  PhD 
in 
the  Faculty  of  Medicine  at  Sydney  University
investigating molecular models of cancer development.
Her experience includes a number of years at Johnson
and  Johnson  developing  anti-HIV  gene  therapeutics
through  preclinical  research  to  clinical  trials.  She  has
experience  in  early-stage  start-ups  from  time  spent  as
Investment  Manager  with  a  specialist  bioscience
venture capital fund. 

She was appointed as Managing Director on 21 June 2002.

Professor Peter W. Gage, MB ChB, PhD, DSc FAA
Research Director

Professor Gage is a professor of Physiology at the John
Curtin  School  of  Medical  Research  at  the  Australian
National  University  and  President  of  the  Australian
Physiological and Pharmacological Society.

He  has  more  than  35  years'  experience  in  medical
research, 
including  training  medical  researchers,
particularly  PhD  students.  For  the  past  25  years  his
research focus has been on ion channels.

Professor  Gage  was  admitted  as  a  fellow  of  the
Australian  Academy  of  Science  in  1977  and  was  the
recipient  of  an Award  of  a  Special  Research  Centre  by 

Dr Michael S. Hirshorn, MBA, MB, BS
Independent and Non-Executive Director

Dr  Hirshorn  has  over  20  years'  experience  in  the
commercialisation of Australian Technology, particularly in
the  medical  device  industry,  and  extensive  experience
in collaboration with Australian research institutes.

He  played  a  major  role  in  all  commercial  aspects  of
Cochlear  Limited's  development,  was  a  founding
director of Resmed Inc., and Chief Executive Marketing
for Polartechnics Limited.

He  has  served  on  numerous  government  advisory
committees, including the Start IT and T Committee, the
Start  Grants  Biological  Sciences  Committee  of  the
Department  of  Industry,  Science  and  Resources  and  is
currently an Investment Manager with a venture capital
firm, Nanyang Ventures.

Dr Hirshorn was appointed as a Director on 16 March 2000.

Mr Bruce Hundertmark, BE, BEc
Independent and Non-Executive Director

Mr  Hundertmark  is  an  independent  businessman  and
company  director  with  a  wide  range  of  experience  in
high  technology  based  company  start-up  operations
and  promoting  the  formation  of  venture  capital
companies,  including  News  Datacom  Limited  in  Israel
and PT Indo Bio Products in Indonesia.

He  has  been  a  director  of  News  International  PLC,
Insurance  Limited  and  was
Prudential  Cornhill 
Managing Director of IMFC Limited, a merchant bank.

Mr  Hundertmark  was  appointed  as  a  Director  on
16 March 2000.

Mr Peter G. Scott
Non-Executive Director

Mr Scott is a founding director of Biotron Limited with
more than 30 years of commercial and entrepreneurial
experience in Australia.

He is a director of Scott’s Acorn Pty Ltd and was formerly
Chairman  and  Managing  Director  of  Scottcom  Pty  Ltd
and  Managing  Director  of  ICAM  Pty  Ltd,  audio  visual
and multimedia companies.

Mr Scott has been a Director since 23 February 1999.

ANNUAL REPORT 2004 

9

directors’ report

Directors’ Meetings

The number of directors’ meetings and number of meetings attended by each of the directors of the Company during
the year are:

Director

Michael J. Hoy
Michelle Miller
Peter W. Gage
Michael S. Hirshorn
Bruce Hundertmark
Peter G. Scott

Board Meetings

Held

Attended

6
6
6
6
6
6

6
6
4
5
6
6

Directors’ Interests

At the date of this report, the interests of each director of the Company in the issued share capital and options of the
Company are:

Fully Paid
Ordinary 
Shares

30 September 2005
$0.50
Options

14 January 2007
$0.60
Options

14 January 2007
$0.75
Options

14 January 2007
$1.00
Options

Michael J. Hoy

1,000,000

500,000

-

-

-

Michelle Miller

-

Peter W. Gage

9,400,000

Michael S. Hirshorn

Bruce Hundertmark

-

-

-

-

200,000

200,000

Peter G. Scott

8,550,000

-

250,000

500,000

500,000

-

-

-

-

-

-

-

-

-

-

-

-

Total

18,950,000

900,000

250,000

500,000

500,000

Option holdings

The movement during the reporting period in the number of options over ordinary shares in the Company held directly,
indirectly or beneficially, by each specified director, including their personally-related entities, is as follows

Michael J. Hoy

Michelle Miller

Held at
1 July 2003

500,000

750,000

Granted as
remuneration

-

500,000

Peter W. Gage

-

Michael S. Hirshorn

200,000

Bruce Hundertmark

200,000

Peter G. Scott

-

-

-

-

-

Exercised

Held at
30 June 2004

Vested and 
exercisable at
30 June 2004

-

-

-

-

-

-

500,000

500,000

1,250,000

1,250,000

-

200,000

200,000

-

-

200,000

200,000

-

10

ANNUAL REPORT 2004 

directors’ report

Equity holdings and transactions

The movement during the reporting period in the number of ordinary shares in the Company held directly, indirectly or
beneficially, by each specified director, including their personally-related entities, is as follows

Michael J. Hoy

Michelle Miller

Held at
1 July 2003

1,000,000

-

Peter W. Gage

9,400,000

Michael S. Hirshorn

Bruce Hundertmark

-

-

Peter G. Scott

8,550,000

Purchased

Received on
exercise of
options

-

-

-

-

-

-

-

-

-

-

-

-

Sales

-

-

-

-

-

-

Held at 
30 June 2004

1,000,000

-

9,400,000

-

-

8,550,000

Directors’ and Senior Executives’ Emoluments

The policy of remuneration of directors and senior executives is to ensure the remuneration package properly reflects
the  person's  duties  and  responsibilities,  and  that  remuneration  is  competitive  in  attracting,  retaining  and  motivating
people of the highest quality. The Board is responsible for reviewing its own performance. The non-executive directors
are responsible for evaluating the performance of the executive directors who, in turn, evaluate the performance of all
other  senior  executives. The  evaluation  process  is  intended  to  assess  the  Company's  business  performance,  whether
long term strategic objectives are being achieved and the achievement of individual performance objectives.

Remuneration generally comprises salary and superannuation. Longer term incentives are able to be provided through
the Company's Incentive Option Plan which acts to align the directors and senior executives' actions with the interests
of the shareholders. The emoluments disclosed below represent the cost to the Company for the services provided under
these arrangements.

Details of options granted to directors and senior executives as part of their remuneration and the nature and amount
of each major element of the emoluments of each director and senior executive of the Company are:

Base
Emolument
$

Service 
Charge
$

Super
Contributions
$

Options
$

Total
$

Directors

Executive

Michelle Miller
Peter W. Gage

Non-Executive

Michael J. Hoy
Michael S. Hirshorn
Bruce Hundertmark
Peter G. Scott

Executive Officer

152,500
30,000

-
40,000

60,000
30,000
30,000
30,000

-
-
-
-

13,725
2,700

5,400
2,700
2,700
2,700

Peter J. Nightingale

-

66,000

-

5,000
-

171,225
72,700

-
-
-
-

-

65,400
32,700
32,700
32,700

66,000

Each option entitles the holder to purchase one ordinary share in the Company. During the financial year ended 30 June
2003,  a  fair  value  of  options,  totalling  $19,000,  has  been  estimated  at  the  date  of  granting,  using  the  Black-Scholes
options pricing formula, of which $5,000 has been included in directors' emoluments during the financial year ended 30
June 2004.

ANNUAL REPORT 2004 

11

directors‘ report

Options

At the date of this report, unissued ordinary shares of the Company under option are:

Number of Options

Exercise Price

Expiry Date

900,000

250,000

500,000

500,000

$0.50

$0.60

$0.75

$1.00

30 September 2005

14 January 2007

14 January 2007

14 January 2007

The options do not entitle the holder to participate in any share issue of the Company or any other body corporate.

Principal Activities

Likely Developments

The  principal  activities  of  the  Company  during  the
financial  year  were  the  funding  and  management  of
intermediate  and  early  applied  biotechnology  research
and development projects.

Financial Result and Review of Operations

The operating loss of the Company for the financial year
after income tax was $2,805,115 (2003 - $2,728,701).

The operations of the Company for the year are set out
in the Review of Operations.

During  the  year  ended  30  June  2004,  the  Company
continued  to  fund  and  manage  its  research  and
development  projects.  The  success  of  these  research
projects,  which  cannot  be  assessed  on  the  same
fundamentals as trading and manufacturing enterprises,
will determine future likely developments.

In  the  opinion  of  the  directors,  it  would  prejudice  the
interests  of  the  Company  to  provide  additional
information,  except  as  reported  in  this  Annual  Report,
relating to likely developments in the operations of the
Company.

Dividends

The  directors  recommend  that  no  dividend  be  paid  by
the  Company.  No  dividend  has  been  paid  or  declared
since the end of the previous financial year.

State of Affairs

This  report  has  been  signed  in  accordance  with  a
resolution of the directors and dated 9 September 2004:

There were no significant changes in the state of affairs
of the Company that occurred during the financial year
under review.

Michael J. Hoy
Director

Michelle Miller
Director

Environmental Regulation

The Company’s operations are not subject to significant
environmental  regulations  under  Commonwealth  or
State legislation in relation to its research projects.

Events Subsequent to Balance Date

There has not arisen in the interval between the end of
the  financial  year  and  the  date  of  this  report  any  item,
transaction  or  event  of  a  material  and  unusual  nature
likely, in the opinion of the directors of the Company, to
affect  significantly  the  operations  of  the  Company,  the
results of those operations, or the state of affairs of the
Company, in future financial years.

12

ANNUAL REPORT 2004 

statement of financial performancefor the year ended 30 June 2004

Other revenues from ordinary activities

Total revenue

Administration and consultants' expenses
Depreciation
Employee and director expenses
Direct research and development expenses
Rent and outgoings expenses
Legal expenses
Other expenses from ordinary activities

Loss from ordinary activities before related income tax expense

Income tax expense relating to ordinary activities

Net Loss

Basic loss per share

Diluted loss per share

Note

2004
$

2003
$

2

3

3

5

4

4

707,428

299,407

707,428

299,407

(462,773)
(182,848)
(431,056)
(2,081,410)
(119,957)
(16,710)
(217,789)

(474,832)
(211,582)
(371,306)
(1,197,012)
(81,605)
(60,636)
(256,799)

(2,805,115)

(2,354,365)

- 

(374,336)

(2,805,115)

(2,728,701)

4.38 cents

4.26 cents

4.38 cents

4.26 cents

ANNUAL REPORT 2004 

13

statement of financial positionas at 30 June 2004

Note

2004
$

2003
$

6
7
8

9

10
11

12
13
14

2,617,629
65,502
64,590
-

5,375,413
66,685
65,511
10,399

2,747,721

5,518,008

361,509

391,080

361,509

391,080

3,109,230

5,909,088

121,166
32,167

132,844
15,232

153,333

148,076

153,333

148,076

2,955,897

5,761,012

11,444,960
110,850
(8,599,913)

11,444,960
110,850
(5,794,798)

2,955,897

5,761,012

CURRENT ASSETS
Cash assets
Receivables
Inventories
Other

Total Current Assets

NON-CURRENT ASSETS
Plant and equipment

Total Non-Current Assets

Total Assets

CURRENT LIABILITIES
Payables
Provisions

Total Current Liabilities

Total Liabilities

Net Assets

EQUITY
Contributed equity
Reserves
Accumulated losses

Total Equity

14

ANNUAL REPORT 2004 

statement of cash flowsfor the year ended 30 June 2004

Cash flows from operating activities

Cash receipts in the course of operations
Cash payments in the course of operations
Interest received
Payments for research and development

Note

2004
$

2003
$

572,218
(1,075,747)
187,230
(2,289,551)

-
(1,223,982)
299,407
(1,197,012)

Net cash used in operating activities

15

(2,605,850)

(2,121,587)

Cash flows from investing activities

Proceeds from sale of asset
Payments for plant and equipment

Net cash used in investing activities

Net decrease in cash held

Cash at the beginning of the financial year

3,018
(154,952)

-
(80,479)

(151,934)

(80,479)

(2,757,784)

(2,202,066)

5,375,413

7,577,479

Cash at the end of the financial year

15

2,617,629

5,375,413

FINANCIAL REPORT 2004 

15

notes to the financial statementsfor the year ended 30 June 2004

1. STATEMENT OF SIGNIFICANT

ACCOUNTING POLICIES

The significant policies which have been adopted in the
preparation of this financial report are:

Basis of preparation

This financial report is a general purpose financial report
which has been prepared in accordance with Accounting
Standards, Urgent Issues Group Consensus Views, other
the  Australian
authoritative  pronouncements  of 
Accounting  Standards  Board  and  the  Corporations Act
2001.

It has been prepared on the basis of historical costs and,
except  where  stated,  does  not  take  into  account
changing  money  values  or  fair  values  of  non-current
assets.

These  accounting  policies  have  been  consistently
applied  and,  except  where  there  is  a  change  in
accounting  policy,  are  consistent  with  those  of  the
previous year.

Revenue recognition

Interest revenue

Interest revenue is recognised as it accrues.

Research and development grants

Where  a  grant  is  received  relating  to  research  and
development costs that have been expensed, the grant
is recognised as revenue on a cash receipts basis.

Taxation

Income tax

The  Company  adopts  the  liability  method  of  tax  effect
accounting.  Income  tax  expense  is  calculated  on
operating  profit  adjusted  for  permanent  differences
between taxable and accounting income. The tax effect
of  timing  differences,  which  arise  from  items  being
brought  to  account  in  different  periods  for  income  tax
and  accounting  purposes,  is  carried  forward  in  the
statement  of  financial  position  as  a  future  income  tax
benefit or a provision for deferred income tax.

Future  income  tax  benefits  are  not  brought  to  account
unless  realisation  of  the  asset  is  assured  beyond
reasonable doubt. Future income tax benefits relating to
tax  losses  are  only  brought  to  account  when  their

realisation  is  virtually  certain. The  tax  effect  of  capital
losses  is  not  recorded  unless  realisation  is  virtually
certain.

Goods and services tax

Revenues,  expenses  and  assets  are  recognised  net  of
the  amount  of  goods  and  services  tax  (GST),  except
where  the  amount  of  GST  incurred  is  not  recoverable
from  the  Australian  Tax  Office  (ATO). 
In  these
circumstances the GST is recognised as part of the cost
of  acquisition  of  the  asset  or  as  part  of  an  item  of  the
expense.

Receivables and payables are stated with the amount of
GST included.

The net amount of GST recoverable from or payable to,
the ATO is included as a current asset or liability in the
statement of financial position. 

Cash flows are included in the statement of cash flows
on  a  gross  basis. The  GST  components  of  cash  flows
arising from investing and financing activities which are
recoverable  from,  or  payable  to,  the ATO  are  classified
as operating cash flows.

Earnings per Share

Basic earnings per share (EPS), is calculated by dividing
the  net  profit  for  the  reporting  period  by  the  weighted
average number of ordinary shares of the company.

Research and development costs

Research and development expenditure is expensed as
incurred  except  to  the  extent  that  its  recoverability  is
assured  beyond  reasonable  doubt,  in  which  case  it  is
deferred and amortised on a straight line basis over the
period in which the related benefits are expected to be
realised.

Plant and equipment

Items  of  plant  and  equipment  are  initially  recorded  at
cost  and  are  depreciated  over  their  estimated  useful
lives using the reducing balance method from the date
of acquisition at rates between 13% and 40% per annum.

Accounts payable

Liabilities are recognised for amounts to be paid in the
future  for  goods  or  services  received,  whether  or  not
billed  to  the  Company.  Trade  accounts  payable  are
normally settled within 60 days.

Incentive option plan

16

ANNUAL REPORT 2004 

notes to the financial statementsfor the year ended 30 June 2004

Where options are issued as remuneration for services rendered, the difference between the fair value of the options
issued  and  the  consideration  received,  if  any,  is  expensed  and  the  fair  value  of  the  options  is  recorded  in  the  option
premium reserve.

Inventories

Stock is carried at the lower of cost allocated and net realisable value.

Employee Benefits

Wages, Salaries, Annual Leave and Sick Leave

Liabilities for employee benefits for wages, salaries, annual leave and sick leave represent present obligations resulting
from employees’ services provided to reporting date, calculated at undiscounted amounts based on remuneration wage
and  salary  rates  that  the  company  expects  to  pay  as  to  reporting  date  including  related  on-costs,  such  as  workers
compensation insurance and superannuation.

2. REVENUE FROM ORDINARY ACTIVITIES

Other revenues:
From operating activities

Interest - other parties
Research and development grants

Total revenue from ordinary activities

3. LOSS FROM ORDINARY ACTIVITIES BEFORE INCOME TAX EXPENSE

Loss from ordinary activities before income tax expense has
been arrived at after charging the following items:
Auditors' remuneration paid to KPMG

- Audit and review of financial reports
- Other audit services

Depreciation

- Office equipment
- Plant and equipment

Direct research and development expenditure
expensed as incurred
Provision for employee entitlements
Loss on sale of non-current assets

4. EARNINGS PER SHARE

2004
$

2003
$

187,230
520,198

299,407
- 

707,428

299,407

16,233
3,000

16,721 
166,127

2,081,410
16,935
1,343

15,234
-

21,095
190,487

1,197,012
9,831
-

Basic and diluted loss per share has been calculated using:
Net loss for the year

2,805,115

2,728,701

Weighted average number of ordinary shares

64,055,750

64,055,750

Options  disclosed  in  the  Contributed  Equity  note  below  are  potential  ordinary  shares,  but  are  not  included  in  the
calculation of diluted loss per share as they are not dilutive.

ANNUAL REPORT 2004 

17

notes to the financial statementsfor the year ended 30 June 2004

5. INCOME TAX EXPENSE

Prima facie income tax benefit on operating loss at 30% (2003 - 30%)

841,535

706,310

2004
$

2003
$

Tax effect of:

Tax losses not brought to account
Permanent differences

Income tax underprovided in prior year
Income tax benefit/(expense) attributable to profit 
from ordinary activities

(840,202)
(1,333)

-

-

(705,243)
(1,067)

-

(374,336)

The following potential income tax benefit calculated at 30% (2003 - 30%)
arising from tax losses has not been recognised as an asset because recovery
is not virtually certain.

Tax losses

2,810,416

1,970,214

The potential future income tax benefit will only be obtained if:

(a)

the Company derives future assessable income of a nature and of an amount sufficient to enable the benefit to 
be realised;
the Company continues to comply with the conditions for deductibility imposed by law; and

(b)
(c) no changes in tax legislation adversely affect the Company in realising the benefit.

The Company has no franking credits.

6. RECEIVABLES

Other debtors

7. INVENTORIES

Stores - at cost

8. OTHER CURRENT ASSETS

Prepayments

18

ANNUAL REPORT 2004 

65,502

66,685

64,590

65,511

-

10,399

notes to the financial statementsfor the year ended 30 June 2004

9. PLANT AND EQUIPMENT

Office equipment - at cost
Accumulated depreciation

Plant and equipment - at cost
Accumulated depreciation

2004
$

91,227
(63,019)

2003
$

87,658
(49,990)

28,208

37,668

892,480
(559,179)

746,464
(393,052)

333,301

353,412

Total plant and equipment - net book value

361,509

391,080

Reconciliations
Reconciliations of the carrying amounts for each class of plant and
equipment are set out below:

Office equipment 
Carrying amount at beginning of year
Additions
Disposals
Depreciation

37,668
8,936
(1,675)
(16,721)

49,612
9,151
-
(21,095)

Carrying amount at end of year

28,208

37,668

Plant and equipment
Carrying amount at beginning of year
Additions
Depreciation

Carrying amount at end of year

10. PAYABLES

Current
Other creditors and accruals

11. PROVISIONS

Current
Employee entitlement provisions

Number of employees at year end

353,412
146,016
(166,127)

472,571
71,328
(190,487)

333,301

353,412

121,166

132,844

32,167

12

15,232

2

ANNUAL REPORT 2004 

19

notes to the financial statementsfor the year ended 30 June 2004

12. CONTRIBUTED EQUITY

Issued and paid up capital

2004
$

2003
$

64,055,750 (2003 - 64,055,750) fully paid ordinary shares

11,444,960

11,444,960

Holders of ordinary shares are entitled to receive dividends as declared from time to time and are entitled to one vote
per  share  at  shareholders'  meetings.  In  the  event  of  winding  up  of  the  Company,  ordinary  shareholders  rank  after
creditors and are fully entitled to any proceeds of liquidation.

Options

The following options were on issue at 30 June 2004, each exercisable to acquire one fully paid ordinary share:

900,000 (2003 - 900,000) at $0.50 each at any time up to 30 September 2005.
250,000 (2003 - 250,000) at $0.60 each at any time up to 14 January 2007.
500,000 (2003 - 500,000) at $0.75 each at any time up to 14 January 2007.
500,000 (2003 - 500,000) at $1.00 each at any time up to 14 January 2007.

13. RESERVES

Option premium reserve

Balance at beginning of year
Issue of options at a premium
Transfer to accumulated losses on lapse of options

Balance at end of year

This reserve represents the fair value, at the date of issue, of options on issue.

14. ACCUMULATED LOSSES

Accumulated losses at beginning of year
Net loss attributable to members of the Company

Accumulated losses at end of year

110,850
-
-

110,850

110,850
-
-

110,850

5,794,798
2,805,115

8,599,913

3,066,097
2,728,701

5,794,798

20

ANNUAL REPORT 2004 

notes to the financial statementsfor the year ended 30 June 2004

15. STATEMENT OF CASH FLOWS

Reconciliation of operating loss after tax to net cash used in operating activities
Operating loss after tax

(2,805,115)

(2,728,701)

2004
$

2003
$

Items classified as investing/financing activities
Gain on disposal of non-current assets

Non-cash items

Depreciation
Provisions

Changes in assets and liabilities

(Increase)/decrease in prepayments
(Increase)/decrease in receivables
(Increase)/decrease in inventories
(Decrease)/increase in payables

Net cash used in operating activities

Reconciliation of cash

(1,343)

- 

182,848
16,935

10,399
1,183
921
(11,678)

211,582
9,831

19,353
346,054
24,944
(4,650)

(2,605,850)

(2,121,587)

For the purposes of the Statement of Cash Flows, cash includes cash 
on hand and at bank and cash on deposit net of bank overdrafts and
excluding security deposits. Cash at the end of the financial year as
shown in the Statement of Cash Flows is reconciled to the related
items in the Statement of Financial Position as follows:

Cash

2,617,629

5,375,413

ANNUAL REPORT 2004 

21

notes to the financial statementsfor the year ended 30 June 2004

16. DIRECTOR AND EXECUTIVE DISCLOSURE FOR DISCLOSING ENTITIES

Directors’ Remuneration

Remuneration levels are competitively set to attract and retain appropriately qualified and experienced directors and
senior executives and to properly reflect the person's duties and responsibilities. Remuneration packages include a mix
of fixed remuneration, performance-based remuneration, and equity-based remuneration. The non-executive directors
are responsible for evaluating the performance of the executive directors who, in turn, evaluate the performance of all
other senior executives. 

Directors' base fees are presently up to $30,000 per annum. The Chairperson receives up to twice the base fee and the
Managing director receives up to five times the base fee. Director's fees cover all main board activities.

Options are issued under the Company's Incentive Option Plan which acts to align the directors and senior executives'
actions with the interests of the shareholders.

The  following  table  provides  the  details  of  all  directors  (‘specified  directors’)  of  the  Company  and  the  executives
(‘specified executives’) with the greatest authority and the nature and amount of the elements of their remuneration for
the year ended 30 June 2004.

Specified directors
Non-executive
Michael J. Hoy (Chairperson)

Michael S. Hirshorn

Bruce Hundertmark

Peter G. Scott

Executive
Michelle Miller 
(Managing Director)
Peter W. Gage

Total, all specified directors

Specified executives
Peter J. Nightingale 
(Company Secretary)

Total, all specified executives

Primary

Salary and 
fees
$

Post-
employment
Superannuation
benefits
$

Equity
compensation
Value of
options
$

Total

$

2004
2003
2004
2003
2004
2003
2004
2003

2004
2003
2004
2003

2004
2003

2004
2003

2004
2003

60,000
60,000
30,000
30,000
30,000
30,000
30,000
30,000

152,500
125,039
70,000
70,000

372,500
345,039

66,000
65,000

66,000
65,000

5,400
5,400
2,700
2,700
2,700
2,700
2,700
2,700

13,725
11,244
2,700
2,700

29,925
27,444

- 
- 

- 
- 

- 
- 
- 
- 
- 
- 
- 
- 

5,000
19,000
- 
- 

5,000
19,000

- 
- 

- 
- 

65,400
65,400
32,700
32,700
32,700
32,700
32,700
32,700

171,225
155,283
72,700
72,700

407,425
391,483

66,000
65,000

66,000
65,000

22

ANNUAL REPORT 2004 

notes to the financial statementsfor the year ended 30 June 2004

16. DIRECTOR AND EXECUTIVE DISCLOSURE FOR DISCLOSING ENTITIES (continued)

Options and rights over equity instruments granted as remuneration

During the reporting period, the following options over ordinary shares were granted and vested during the current year
under the Incentive Option Plan.

Specified director
Michelle Miller

Number of
options granted 
during the year

Number of
options vested
during the year

-

500,000

The options vested in the current year were vested on 30 June 2004, have an expiration date of 14 January 2007, an
exercise price of $1.00 per share, and a fair value of $0.19 per share at vesting date. No options have been granted since
the end of the financial year. The options were provided at no cost to the recipient.

17. RELATED PARTY DISCLOSURES 

Directors
The name of each person holding the position of director of the Company during the financial year is Michael J. Hoy,
Michelle  Miller,  Peter  W.  Gage,  Michael  S.  Hirshorn,  Bruce  Hundertmark,  and  Peter  G.  Scott.  Details  of  directors'
remuneration are set out above.

Details of relevant interests of directors of the Company and their director-related entities in shares and options of the
Company at year end are as follows:

Fully paid ordinary shares
30 September 2005 $0.50 options
14 January 2007 $0.60 options
14 January 2007 $0.75 options
14 January 2007 $1.00 options

2004
Number
18,950,000
900,000
250,000
500,000
500,000

2003
Number
18,950,000
900,000
250,000
500,000
500,000

During  the  year  ended  30  June  2004,  directors  and  director-related  entities  did  not  purchase  any  fully  paid  ordinary
shares or options and disposed of 100,000 fully paid ordinary shares for no consideration as a charitable contribution.

During the year ended 30 June 2004, Michael J. Hoy had an interest in an entity, CityPrint Pty Limited, which provided
printing services to the Company. Payments to CityPrint Pty Limited, which were in the ordinary course of business and
on normal terms and conditions, amounted to $16,123 (2003 - $22,377).

18. EMPLOYEES AND INCENTIVE OPTION PLAN

At 30 June 2004, the Company had 12 employees (2003 - 2). All other personnel are contracted by the Company on a
consultancy basis.

The Company has an Incentive Option Plan to provide eligible persons, being employees or directors, or individuals
whom  the  Plan  Committee  determine  to  be  employees  for  the  purposes  of  the  Plan,  with  the  opportunity  to  acquire
options over unissued ordinary shares in the Company. The number of options granted or offered under the Plan will
not exceed 10% of the Company's issued share capital and the exercise price of options will be the greater of the market
value of the Company's shares as at the date of grant of the option or such amount as the Plan Committee determines.
Options have no voting or dividend rights.

ANNUAL REPORT 2004 

23

notes to the financial statementsfor the year ended 30 June 2004

18. EMPLOYEES AND INCENTIVE OPTION PLAN (continued)

In the event that the employment or office of the optionholder is terminated, any options which have not reached their
exercise  period  will  lapse  and  any  options  which  have  reached  their  exercise  period  may  be  exercised  within  three
months of the date of termination of employment. Any options not exercised within this three month period will lapse.

No options were granted pursuant to the Incentive Option Plan during the year ended 30 June 2004. No ordinary shares
have been issued as a result of the exercise of any options granted pursuant to the Incentive Option Plan.

These options are not listed and accordingly have no market value at year end. The market value of the ordinary shares
under  option  at  30  June  2004  was  $0.19  (2003  -  $0.31)  each. The  amount  recognised  in  the  financial  statements  in
relation to the Incentive Option Plan during the financial year was $5,000 (2003 - $19,000). Options issued pursuant to
the plan are summarised below:

Grant
Date

24/01/03
06/02/02
28/06/03
28/06/03

Exercise 
Date

24/01/03
06/02/02
30/06/03
30/06/04

Expiry
Date

30/09/05
14/01/07
14/01/07
14/01/07

Exercise
Price

30 June 2003
On Issue

Number of Options 
30 June 2004
On Issue

$0.50
$0.60
$0.75
$1.00

900,000
250,000
500,000
500,000

900,000
250,000
500,000
500,000

30 June 2004
Vested

900,000
250,000
500,000
500,000

2,150,000

2,150,000

2,150,000

19. FINANCIAL INSTRUMENTS DISCLOSURE

Interest rate risk

The Company’s exposure to interest rate risk and the effective weighted average interest rate for classes of financial
assets and financial liabilities is as follows:

Note

Weighted
average interest
rate % 

Floating
interest 
rate
$

Non-
interest
bearing
$

Total
$

6

4.38
-

2,617,629
-

-
65,502

2,617,629
65,502

10 and 11

-

-

153,333

153,333

Note

Weighted
average interest
rate % 

Floating
interest 
rate
$

Non-
interest
bearing
$

Total
$

6

4.62
-

5,375,413
- 

-
66,685

5,375,413
66,685

10 and 11

-

- 

148,076

148,076

2004
Financial assets
Cash assets
Receivables

Financial liabilities
Payables and provisions

2003
Financial assets
Cash assets
Receivables

Financial liabilities
Payables and provisions

24

ANNUAL REPORT 2004 

notes to the financial statementsfor the year ended 30 June 2004

19. FINANCIAL INSTRUMENTS DISCLOSURE (continued)

Credit risk exposure
The credit risk exposure on financial assets of the Company which have been recognised in the statement of financial
position is the carrying amount, net of any provision for doubtful debts.

Credit risk on cash assets is minimised by dealing with Australian regulated banks.

Net fair values of financial assets and liabilities
The carrying amounts of financial assets and liabilities approximate their net fair values.

20. FINANCIAL REPORTING BY SEGMENTS

The Company operates in the biotechnology industry in Australia.

21. EVENTS SUBSEQUENT TO REPORTING DATE

International Financial Reporting Standards

For  reporting  periods  beginning  on  or  after  1  January  2005,  the  Company  must  comply  with  International  Financial
Reporting Standards (IFRS) as issued by the Australian Accounting Standards Board.

This financial report has been prepared in accordance with Australian accounting standards. The differences between
Australian accounting standards and IFRS identified to date as potentially having a significant effect on the Company's
financial performance and financial position are summarised below. The summary should not be taken as an exhaustive
list of all the differences between Australian accounting standards and IFRS. No attempt has been made to identify all
disclosure, presentation or classification differences that would affect the manner in which transactions or events are
presented.

The potential impacts on the Company’s financial performance and financial position of the adoption of IFRS have not
been  quantified  as  at  the  transition  date  of  1  July  2004  due  to  the  short  timeframe  between  finalisation  of  the  IFRS
standards and the date of preparing this report. The impact on future years will depend on the particular circumstances
prevailing in those years.

The key potential implications of the conversion to IFRS on the Company are as follows:
• Income tax will be calculated based on the "balance sheet" approach, which will result in more deferred tax assets
and liabilities and, as tax effects follow the underlying transaction, some tax effects will be recognised in equity.
• Changes  in  accounting  policies  will  be  recognised  by  restating  comparatives  rather  than  making  current  year

adjustments with note disclosure of prior year effects.

• Internally  generated  assets  (other  than  development  phase  expenditure  in  certain  circumstances)  will  not  be

recognised as assets. Start-up costs may not be capitalised. Research costs must be expensed.

• Equity-based compensation in the form of shares and options will be recognised as expenses in the periods during

which the employee provides related services.

The Company's application of Australian accounting standards in the preparation of this financial report complies with
the IFRS.

ANNUAL REPORT 2004 

25

directors’ declaration

In the opinion of the directors of Biotron Limited:

(a) the  financial  statements  and  notes,  set  out  on  pages  13  to  25,  are  in  accordance  with  the  Corporations Act  2001,

including:

(i) giving a true and fair view of the financial position of the Company as at 30 June 2004 and of its performance, as

represented by the results of its operations and its cash flows for the year ended on that date; and

(ii) complying with Accounting Standards in Australia and the Corporations Regulations 2001; and

(b) there are reasonable grounds to believe that the Company will be able to pay its debts as and when they become

due and payable.

This report has been signed in accordance with a resolution
of the directors and dated 9 September 2004:

Michael J. Hoy
Director

Michelle Miller
Director

26

ANNUAL REPORT 2004 

independent audit report to the members of Biotron Limited

Scope

We have  audited  the  financial  report  of  Biotron  Limited  for  the  financial  year  ended  30  June  2004,  consisting  of  the
statement of financial performance, statement of financial position, statement of cash flows, accompanying notes, and
the directors’ declaration set out on pages 13 to 26. The Company’s directors are responsible for the financial report. We
have conducted an independent audit of this financial report in order to express an opinion on it to the members of the
Company.

Our  audit  has  been  conducted  in  accordance  with  Australian  Auditing  Standards  to  provide  reasonable  assurance
whether the financial report is free of material misstatement. Our procedures included examination, on a test basis, of
evidence supporting the amounts and other disclosures in the financial report, and the evaluation of accounting policies
and significant accounting estimates. These procedures have been undertaken to form an opinion whether, in all material
respects,  the  financial  report  is  presented  fairly  in  accordance  with  Accounting  Standards  and  other  mandatory
professional reporting requirements in Australia and statutory requirements so as to present a view which is consistent
with  our  understanding  of  the  Company's  financial  position,  and  performance  as  represented  by  the  results  of  its
operations and its cash flows.

The audit opinion expressed in this report has been formed on the above basis.

Audit Opinion

In our opinion, the financial report of Biotron Limited is in accordance with:

(a) the Corporations Act 2001, including:

(i) giving a true and fair view of the Company’s financial position as at 30 June 2004 and of its performance for the

year ended on that date; and

(ii) complying with Accounting Standards in Australia and the Corporations Regulations 2001; and

(b) other mandatory professional reporting requirements in Australia.

KPMG

S. J. Board
Partner

Brisbane
9 September 2004

ANNUAL REPORT 2004 

27

additional stock exchange information

Home Exchange
The Company is listed on the Australian Stock Exchange Limited. The home exchange is Sydney.

Use of Cash and Assets
Since  the  Company's  listing  on  the Australian  Stock  Exchange,  the  Company  has  used  its  cash  and  assets  in  a  way
consistent with its stated business objectives.

Class of Shares and Voting Rights
There is only one class of shares in the Company, fully paid ordinary shares.

The rights attaching to shares in the Company are set out in the Company's Constitution. The following is a summary of
the principal rights of the holders of shares in the Company.

Every holder of shares present in person or by proxy, attorney or representative at a meeting of shareholders has one
vote on a vote taken by a show of hands, and, on a poll every holder of shares who is present in person or by proxy,
attorney or representative has one vote for every fully paid share registered in the shareholder's name on the Company's
share register.

A poll may be demanded by the chairperson of the meeting, by at least 5 shareholders entitled to vote on the resolution
or shareholders with at least 5% of the votes that may be cast on the resolution on a poll.

Substantial Shareholders
As at the date of the Directors' Report, the Register of Substantial Shareholders showed the following:

Peter Gage
Australian National University
Peter G. Scott
Gail S. Scott

9,400,000 fully paid ordinary shares
6,000,000 fully paid ordinary shares
4,250,000 fully paid ordinary shares
4,249,550 fully paid ordinary shares

Distribution of Equity Securityholders
As at 23 August 2004, the distribution of each class of equity was as follows:

Range

Fully Paid
Ordinary Shares

30 September 2005
$0.50 Options

14 January 2007
$0.60 Options

14 January 2007
$0.75 Options

14 January 2007
$1.00 Options

1- 1,000

1,001 - 5,000

5,001 - 10,000

10,001 – 100,000

100,001 and over

64

731

419

408

48

1,670

-

-

-

-

3

3

-

-

-

-

1

1

-

-

-

-

1

1

At 23 August 2004, 138 shareholders held less than a marketable parcel of 1,588 shares.

Twenty Largest Quoted Shareholders
At 23 August 2004 the twenty largest fully paid ordinary shareholders held 64% of fully paid ordinary as follows:

Name

%

Name

Fully Paid 
Ordinary
Shares

Fully Paid 
Ordinary
Shares

-

-

-

-

1

1

%

1

Peter Gage

9,400,000

14.7

11

J P Morgan Nominees 
Australia Limited

1,000,000

1.6

Peter Scott

2 Australian National University
3
4 Gail Scott
5 Angela Dulhunty
6 Chris and Bhama Parish
7 Carrington Services Pty Ltd
8
Phil and Marylyn Board
9 Altinova Nominees Pty Limited
10 Michael Hoy

6,000,000
4,250,000
4,249,550
2,500,000
2,100,000
2,000,000
1,799,950
1,326,668
1,000,000

9.3
6.6
6.6
3.9
3.2
3.1
2.8
2.0
1.6

There are no current on-market buy-backs.

12 Tom Mann
13 Peter Nightingale
14
Lujeta Pty Ltd
15 CBDF Pty Limited
16 Dr Gary Dinneen Ewart
Jey Investment Pty Ltd
17
18 Tomas Forseberg
19 Mr Christopher David Hammer
20

LPA No 2 Pty Ltd

1,000,000
1,000,000
557,078
550,000
500,000
495,866
449,527
442,736
410,844

1.6
1.6
0.9
0.9
0.8
0.8
0.7
0.7
0.6

ANNUAL REPORT 2004 

28

corporate directory

Directors:

Mr Michael J. Hoy (Chairman)
Dr Michelle Miller (Managing Director)
Professor Peter W. Gage (Research Director)
Dr Michael S. Hirshorn
Mr Bruce Hundertmark
Mr Peter G. Scott

Company Secretary:

Mr Peter J. Nightingale

Registered Office:

Level 8, 261 George Street
SYDNEY  NSW  2000
Phone: 61-2 9247 8212
Fax:
61-2 9247 3932
E-mail: enquiries@biotron.com.au
Homepage: www.biotron.com.au

Share Registrar:
Computershare Investor Services Pty Limited
Level 27, Central Plaza One
345 Queen Street
BRISBANE  QLD  4000
Phone: 61-7 3237 2100
Fax: 61-7 3229 9860

Auditors:

KPMG
Level 30, Central Plaza One
345 Queen Street
BRISBANE  QLD  4000

Home Exchange:

Australian Stock Exchange Limited
20 Bridge Street
SYDNEY  NSW  2000

Solicitors:
Minter Ellison
88 Phillip Street
SYDNEY NSW 2000

Biotron Limited, incorporated and domiciled in Australia, is a
publicly listed company limited by shares.

Level 8  >  261 George Street  >  Sydney NSW 2000  >  Australia