6-K: Report of foreign issuer [Rules 13a-16 and 15d-16]
Published on
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington. D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR I5d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of October 2004
Novogen Limited
(Translation of registrant's name into English)
140 Wicks Road, North Ryde, NSW, 2113, Australia
(Address of principal executive office)
[Indicate by check mark whether the registrant files or will file
annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F v Form 40-F
[Indicate by check mark whether the registrant by furnishing the
information contained in this Form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934. Yes No
[If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2 (b):
82- ________________ .1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized.
Novogen Limited
(Registrant)
Date 22 October,2004 By /s/Ronald Lea Erratt Company Secretary
Chairman's Address
2004 Annual General Meeting
Good Morning
I am very pleased to present the Chairman's report for the year
ended June 2004.
Initially I would like to recap on the financial result
for the year. I will then recall some of the important
milestones achieved during the period, and conclude with
my view of the next stage for the Company.
Our CEO Christopher Naughton will follow with the report
from management, then Professor Husband, our Research Director,
will address Research and Development issues,
and finally Professor Kelly will report on the position
with our clinical program in both the oncology and wound
healing areas.
After these reports on the operations of the Company,
I will be pleased to take questions from shareholders
on any aspects of the Company's activities.
The financial results:
At this meeting two years ago, I stressed that the major
financial measurement for a developing company such as ours
which is dealing in a new and exciting technology, was the
imperative to conserve cash reserves. Business planning would
have to be executed with the knowledge that obtaining new cash
inputs would be uncertain. Accordingly we insisted that our
cash position would be our first reporting item.
I am pleased to report that our Novogen consolidated
group cash position at the end of June 2004 was in excess
of A$ 55 million. This was up from A$ 28 million the
year before. The most significant cash input came from the
successful floatation on the NASDAQ US exchange of our US
oncology subsidiary Marshall Edwards, Inc. ("Marshall Edwards").
Mr Naughton will report further on the mechanics of that
development in his report. Suffice to say in this overview
that the Marshall Edwards IPO was an outstanding success.
The strategy, and implementation of that strategy was an
endorsement of the foresight and management capacity of the
Novogen executive and financial teams.
The second item of our financial reporting is the profit
and loss position attributable to members of the Company.
To the year ended June 2004, the loss was A$10.9 million up
slightly on the A$10.5 million of the prior year. For a growing
research and development company, this is a satisfactory result.
It is the view of the Board and management that the Company must
continue to invest in its core competencies and technologies.
You will hear from Professor Husband and Professor Kelly about
the status of the discovery, preclinical and clinical programs,
and I am sure you will be pleased with the progress that
we are making, with, what is by industry standards, very modest
expenditure.
The third headline item of financial reporting is the revenue
line. This showed a decrease to $A 16.4 million from last
year's $A 24.2 million, reflecting the realignment of the
Over-the-Counter ("OTC") business to join the Company's focus
on cash retention and the bottom line profit and loss position,
and a reduction in expenses of $A 5.9 million.
Despite the difficult and crowded market in within which
our OTC business competes, we do see some turnaround in sales
and we remain committed to the business as a potential cash
generator and as a strategic beneficiary of our future
pharmaceutical business.
Important events of the year:
We announced a number of significant progress milestones
n our clinical development program, and a number of major
corporate achievements. In fact our announcements regarding
research and development and patent matters have averaged one
every four weeks. And excluding procedural announcements
to the stock market, our corporate updates have averaged one
a month. In total, we have made a non-procedural announcement
on average once every two weeks. All of these announcements
have been important and of substance reflecting progress on a
broad front.
Despite the fact that drugs in clinical trials are not usually
the subject of progress reports from clinicians, we have
had progress reports that our anti-cancer drug phenoxodiol has
been accelerating through the clinical program. We had
the benefit during the year of an interim report from the
clinicians at Yale New Haven Hospital in the US. Their updates
were presented this year at the meeting of the American
Association for Cancer Research held in Florida, and at
the meeting of the Society of Gynecologic Oncologists held
in San Diego. We have learnt from those reports that our
expectations for phenoxodiol as both a monotherapy and as a
chemo-sensitiser are realistic. To have phenoxodiol in clinical
trials for ovarian, prostate, renal and cervical cancers
simultaneously is ambitious but we believe offers future patients,
and current shareholders a very real potential for success.
Also in the oncology arena we have announced the commencement
of the clinical program for NV-18. This event triggers the
opportunity for Marshall Edwards to make a bid for the licence
to the compound, and to then run the program in the way it is
currently managing the phenoxodiol development. Marshall Edwards
is now undertaking due diligence on NV-18 in order to ascertain
its position with regard to a licence. If Marshall Edwards
were to make a bid for the compound, it is then up to
Novogen to negotiate with Marshall Edwards or seek a better offer,
which Marshall Edwards has the opportunity to match if it chose
to so do.
This year our leading cardiovascular drug candidate entered
clinical trials in Melbourne. The compound, trans-NV-04, will
be tested in human subjects who are at risk of cardiovascular
disease, but are otherwise healthy. To have a third exciting
compound already in the clinic is tangible proof that unlike
many biotechs, Novogen is able to exploit opportunities for a
whole new class of compounds across a number of therapeutic areas.
Of great benefit to the Company is the news that we were one of
the major recipients of the Australian Government's Pharmaceutical
Partnership Program, known as "P3". This potential receipt
of $10 million over five years is not only a welcome financial
contribution to the Company's research, but a confirmatory
endorsement of the science and probable outcomes of the
Company's development programs and clinical trials.
It with great pleasure that I recall the announcement from
May that chronicled the appointment of the Company founder
and Executive Director, Graham Kelly, as an adjunct
professor of Sydney University.
The recognition of his achievements and contribution
to Australian science and his practical application of
medical research is to be applauded. On behalf of the
Company and all shareholders I congratulate Professor Kelly.
The view forward:
A great deal of effort has been expended by the Board
this year on the issue of corporate governance.
This matter is particularly pertinent for the Group,
as we have companies listed on three stock exchanges and
are regulated by the US, UK and Australian authorities.
The seemingly endless repetition of governance statements
often within the same document does in our view diminish the
impact these important declarations of company procedure and
supervision should have. We trust that as the supervisory
authorities become more confident with the intent of these
actions and statements, that these mandated statements themselves
will become more meaningful and pertinent to individual companies,
and perform the role of shareholder reassurance for which they
were intended.
The number of collaborations with which the Company manages
its clinical and research affairs will continue to increase.
The model that the Company uses to leverage its intellectual
property and maximise the intellectual contribution from
recognised experts around the world, has achieved timely results
and will continue.
Future corporate reorganisation and realignment of the type
we have seen this year with Marshall Edwards will depend on
the circumstances at the time. Our overall strategy of
out-licensing our compounds at or after phase II will drive
the structural necessities of the Company.
The Company recently put its audit work out for reappraisal.
This is part of an ongoing endeavour by the Board to subject
all our arrangements to scrutiny for their efficiency and
contemporary relevance to our internationally expanding
corporate structure. A motion will be put to the meeting
today to appoint new auditors, who we believe will match
the Company's needs for the future and represent value for
shareholders.
Under the variable definition of "biotechnology companies",
Novogen has now the largest market capitalisation on the
Australian stock exchange. But we are conscious of two
important factors here. One is that like Stephen Bradbury
at the Speed skating at the last winter Olympics,
it is possible to come first because everyone else has
fallen over. And secondly, in the US market we are just
a minnow in market capitalisation. This offers us a
tremendous upside in the US markets, with both Novogen
and Marshall Edwards listed on the NASDAQ in the US, we
have an increasing number of US investors who see our potential
in US terms.
The Board is determined to realise that potential and do
everything possible to meet both existing and new shareholder
expectations, by achieving success in our chosen field of
providing more effective treatments for the worldwide
patient population who suffer from degenerative diseases.
I would like to thank the staff of Novogen for their
continued initiative, enthusiasm and commitment.
Like many shareholders of Novogen, the employees have
a passion for assisting in an endeavour whose success
is likely to bestow a fundamental and lasting benefit
on mankind.
Philip Johnston
Chairman
Novogen Limited
22 October, 2004