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 15d-16 UNDER
THE
SECURITIES
EXCHANGE ACT OF 1934
For the
month of February, 2010
Commission
File Number ________________
Novogen
Limited
(Translation
of registrant’s name into English)
140 Wicks
Road, North Ryde, NSW, 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
x Form 40-F o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(l): o
Note:
Regulation S-T Rule 101 (b)( I) only permits the submission in paper of a Form
6-K if submitted solely to provide an attached annual report to security
holders.
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule lO1(b)(7): o
Note:
Regulation S-T Rule l01(b)(7) only permits the submission in paper of a Form 6-K
if submitted to furnish a report or other document that the registrant foreign
private issuer must furnish and make public under the laws of the jurisdiction
in which the registrant is incorporated, domiciled or legally organized (the
registrant’s “home country”), or under the rules of the home country exchange on
which the registrant’s securities are traded, as long as the report or other
document is not a press release, is not required to be and has not been
distributed to the registrant’s security holders, and, if discussing a material
event, has already been the subject of a Form 6-K submission or other Commission
filing on EDGAR.
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 l2g3-2(b) under the Securities Exchange Act of 1934. Yes o No x
If “Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):
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)
/s/ Ron
Erratt
Ronald
Lea Erratt
Company
Secretary
Date
26 February, 2010
NOVOGEN
LIMITED
ABN
37-063-259-754
www.novogen.com
140 Wicks
Road, NORTH RYDE, NSW 2113
Telephone:
02 9878 0088
APPENDIX
4D
incorporating
INTERIM
FINANCIAL REPORT
FOR
THE HALF-YEAR
31
DECEMBER, 2009
Lodged with the ASX under
Listing Rule 4.2A
This is a
half-yearly report. It is to be read in conjunction with the most recent annual
financial report.
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
RESULTS
FOR ANNOUNCEMENT TO THE MARKET
|
|
$’000
|
|||
|
Revenues
from ordinary activities
|
down
|
19.7%
|
to
|
5,116
|
|
Loss
from ordinary activities after tax attributable to members
|
down
|
33.7%
|
to
|
(5,940)
|
|
Net
Loss for the period attributable to members
|
down
|
33.7%
|
to
|
(5,940)
|
The
Directors do not propose to pay a dividend.
Refer to
Review of Operations shown in the attached Directors’ Report for an explanation
of the above disclosures.
1
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
Directors’
report for the half-year 31 December, 2009
Your
directors submit their report for the half-year ended 31 December,
2009.
Directors
The names
and qualifications of the directors that held office during the half-year and up
to the date of this report, unless otherwise indicated, are as
follows:-
Mr P A Johnston,
Chairman and Non-Executive Director – Dip Eng
(Production)
Mr C Naughton,
Managing Director – BEc, LLB (employment ceased 1 December,
2009)
Professor A J Husband,
Executive
Director – PhD, DSc, FASN
Mr G Leppinus,
Non-Executive Director – BEc, FCA
Professor P J Nestel,
Non-Executive Director – AO, MD, FTSE, FRACP, FAHA,
FCSANZ
Mr W D Rueckert,
Non-Executive Director
Mr P B Simpson,
Non-Executive Director – MPharm, PhC (retired 28 July,
2009)
Review
of operations
Cash
Resources
At the
end of December 2009, the Group had total funds of $20.3 million compared to
$33.3 million at 30 June, 2009. Cash was used to fund the Group’s
operations including the OVATURE clinical trial program for the anti-cancer drug
phenoxodiol being undertaken by Novogen’s US subsidiary Marshall Edwards, Inc.
(“MEI”), and in connection with the termination of employment of the Company’s
CEO in December 2009. The Company will continue to conserve its cash balances
and focus resources on the Company’s oncology program.
Revenue
The
Company earned gross revenues for the six months ended 31 December, 2009 of $5.1
million, a decrease of $1.3 million from $6.4 million for the same period last
year.
Sales of
consumer products decreased by $0.7 million to $3.7 million for the six months
ended 31 December, 2009 from $4.4 million for the six months ended 31 December,
2008. The decrease was due to the reduction in sales revenue associated with
Australia discontinuing sales of the Aliten weight loss product and decreased
consumer demand in the U.K. associated with the economic downturn. Sales, when
converted to A$, decreased in both the U.K. and Canadian business as a result of
a strengthening of the A$ compared to both the GBP and the CAD.
Other
revenue for the six months ended 31 December, 2009 reduced by $0.5 million to
$1.4 million from $1.9 million for the six months ended 31 December, 2008 due to
lower interest receipts on lower cash balances.
Net
Loss
The
operating loss attributable to Novogen shareholders for the six months ended 31
December, 2009, after allowing for losses attributable to non-controlling
interests of $1.5 million decreased by $3.1 million or 34% to $5.9 million
compared to $9.0 million in the previous corresponding period.
The net
loss from ordinary activities after income tax for the consolidated Group for
the six months ended 31 December, 2009 decreased by $3.2 million to $7.4 million
from $10.6 million for the same period last year. The decrease in our net loss
for the six months ended 31 December, 2009 was primarily due to cost saving
related to the termination of enrollment into the Phase III Ovature clinical
trial, combined with
2
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
reduced
marketing expenses associated with discontinuing sales of Aliten. Other savings
in administrative expenses were offset by the termination payment of $1.7
million made to Company’s CEO, in accordance with his employment contract, on
the cessation of his employment in December 2009.
Clinical
Trial Developments
Anti-Cancer
Phenoxodiol
Phenoxodiol
is being developed by the Company’s subsidiary MEI as a chemosensitising agent
in combination with platinum drugs for late stage, chemoresistant ovarian cancer
and as a monotherapy for prostate cancers. Phenoxodiol is an investigational
novel-acting drug that inhibits key pro-survival signalling pathways operating
within cancer cells causing selective cancer cell death and increased
susceptibility to drugs like platinum and taxane, to which most ovarian cancer
patients become resistant in late stage disease.
OVATURE
Phase III Clinical Trial
The
OVATURE trial is a major multi-centre international Phase III clinical trial of
orally-administered phenoxodiol in combination with carboplatin in women with
advanced ovarian cancer resistant or refractory to platinum-based drugs to
determine its safety and effectiveness when used in combination with
carboplatin.
In April,
2009, MEI announced the termination of enrolment into the OVATURE Phase III
trial and its intention to undertake an un-blinded analysis of the available
data from the trial. The patients currently enrolled in the trial have continued
their treatment according to the study protocol. However, MEI has ceased
recruiting new patients to participate in the OVATURE trial and the available
data from the 142 completed and current patients will be analysed for safety and
efficacy outcomes.
MEI
decided to terminate new enrolment into the OVATURE Phase III trial and assess
the available patient data, in part, because the global financial downturn makes
it unlikely that MEI will be able to raise the necessary capital through debt or
equity issuances in the near future to fund the trial to completion as
originally planned. Additionally, changes in the standard of care
over the period that the OVATURE trial has been in operation has resulted in
fewer women meeting the inclusion criteria of the OVATURE protocol, which slowed
patient recruitment rates.
Prostate
Phase II Clinical Trial
MEI has
completed a Phase II prostate cancer study in advanced hormone refractory
disease in Australia and is conducting another Phase II prostate cancer clinical
trial using phenoxodiol as first line treatment in men with early stage disease
(35 patients targeted with androgen dependent disease but rising PSA) compared
to patients with late stage hormone refractory disease (25 patients targeted
with chemotherapy naïve androgen independent disease). The study is being
conducted at Yale Cancer Center and the West Haven Veterans Administration
Hospital Connecticut in the US. Both of these patient groups represent areas of
unmet medical need in this common cancer.
Triphendiol
Triphendiol
is a synthetic investigational anti-cancer compound based on an isoflavan ring
structure and is being developed by MEI. Similar to phenoxodiol, triphendiol is
a signal transduction inhibitor.
3
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
Preliminary
screening studies have identified triphendiol as a candidate for product
development showing a favorable in
vitro toxicity profile against normal cells and broad activity against
cancer cells. Triphendiol is being developed initially in oral form for the
treatment of pancreatic and bile duct cancers.
Triphendiol
has completed two Phase I human trials in Australia which have demonstrated a
high safety profile and acceptable pharmacokinetics when administered by the
oral route.
Triphendiol
had been granted Orphan Drug status by the FDA for the treatment of pancreatic
cancer and for the treatment of cholangiocarcinoma, or bile duct cancer. As well
as for the treatment of Stage IIB through Stage IV malignant
melanoma.
An Orphan
Drug refers to a product that is intended for use in a disease or condition that
affects fewer than 200,000 individuals in the US. A grant of Orphan Drug status
provides seven years of market exclusivity for the orphan indication after
approval by the FDA, as well as study design assistance and eligibility for
grant funding from the FDA during its development. Triphendiol is in the early
stages of clinical development and it is anticipated that significant clinical
testing will be required to prove safety and efficacy before marketing
applications may be filed with the FDA.
In
January, 2009, MEI announced that triphendiol had been granted an
Investigational New Drug (IND) approval by the FDA to undertake clinical studies
with triphendiol as a chemosensitizing agent in combination with gemcitabine in
patients with unresectable locally advanced or metastatic pancreatic and bile
duct cancers.
NV-128
NV-128 is
a cancer compound which has been shown in pre-clinical studies to promote cancer
cell death in multi–drug resistant ovarian cancer cells by targeting the
AKT-mTOR pathway. Structurally, NV-128 is an analog of phenoxodiol and
triphendiol but in contrast to phenoxodiol, which induces caspase mediated
apoptosis, NV-128 has been shown to induce caspase-independent DNA degradation
and cancer cell death via the AKT-mTOR pathway.
Additionally,
NV-128, through its capacity to dephosphorylate mTOR appears to inhibit both
mTORC1 and mTORC2 activity showing an advantage over existing rapamycin analog
mTOR inhibitors which appear to target only mTORC1 making them less effective in
those cancer cells that have developed rapalog-resistance and which have a
dysfunctional apoptotic cascade.
Dividends
Paid or Recommended
The
Directors of Novogen Limited do not recommend the payment of a dividend. No
dividends were declared or paid during the six months ended 31 December,
2009.
Auditor's
Independence Declaration
A copy of
the Auditor's independence declaration as required under section 307C of the
Corporations Act 2001 is included following the Directors' Report.
Rounding
The
amounts and figures shown in this report have been rounded to the nearest
thousand dollars (where rounding is applicable) under the option available to
the Company under ASIC Class Order 98/0100. The Company is an entity to which
the Class Order applies.
4
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
Signed in
accordance with a resolution of the directors on behalf of the
board.
/s/
Philip Johnston
Philip
Johnston
Director
(Chairman)
Sydney,
25 February, 2010
5
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
DECLARATION
OF INDEPENDENCE BY SIMON COULTON
TO
THE DIRECTORS OF NOVOGEN LIMITED
As lead
auditor for the review of Novogen Limited for the half-year ended 31 December
2009, I declare that to the best of my knowledge and belief, there have
been:
|
•
|
no
contraventions of the auditor independence requirements of the Corporations
Act 2001 in relation to the review;
and
|
|
•
|
no
contraventions of any applicable code of professional conduct in relation
to the review.
|
This
declaration is in respect of Novogen Limited and the entities it controlled
during the period.
/s/ Simon
Coulton
Simon
Coulton
Director
/s/ BDO
Kendalls
BDO
Audit (NSW-VIC) Pty Ltd
Sydney,
February 25, 2010
6
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
|
STATEMENT
OF COMPREHENSIVE INCOME
|
||||||||||||
|
for
the half year ended 31 December 2009
|
||||||||||||
|
Notes
|
Consolidated
|
|||||||||||
|
2009
|
2008
|
|||||||||||
|
$'000
|
$'000
|
|||||||||||
|
Revenue
from continuing operations
|
2 | 5,116 | 6,375 | |||||||||
|
Expenses
|
2 | (12,514 | ) | (17,019 | ) | |||||||
|
Loss
before income tax
|
(7,398 | ) | (10,644 | ) | ||||||||
|
Income
tax expense
|
(5 | ) | (1 | ) | ||||||||
|
Loss
after tax from continuing operations
|
(7,403 | ) | (10,645 | ) | ||||||||
|
Loss
for the period
|
(7,403 | ) | (10,645 | ) | ||||||||
|
Other
comprehensive income/(loss)
|
||||||||||||
|
Net
exchange difference on translation of financial statements of foreign
controlled entities
|
(1,416 | ) | 10,097 | |||||||||
|
Other
comprehensive income/(loss)
|
(1,416 | ) | 10,097 | |||||||||
|
Total
comprehensive income/(loss)
|
(8,819 | ) | (548 | ) | ||||||||
|
Loss
attributable to:
|
||||||||||||
|
Non-controlling
interest
|
(1,463 | ) | (1,685 | ) | ||||||||
|
Novogen
Limited
|
(5,940 | ) | (8,960 | ) | ||||||||
| (7,403 | ) | (10,645 | ) | |||||||||
|
Total
comprehensive income/(loss) attributable to:
|
||||||||||||
|
Non-controlling
interest
|
(1,883 | ) | 1,201 | |||||||||
|
Novogen
Limited
|
(6,936 | ) | (1,749 | ) | ||||||||
| (8,819 | ) | (548 | ) | |||||||||
|
Basic
and diluted earnings/(loss) per share (cents)
|
(5.8 | ) | (8.8 | ) | ||||||||
The
above statement of comprehensive income should be read in conjunction with the
accompanying notes.
7
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
|
STATEMENT
OF FINANCIAL POSITION
|
||||||||
|
As
at 31 December 2009
|
||||||||
|
Consolidated
|
||||||||
|
December
|
June
|
|||||||
|
2009
|
2009
|
|||||||
|
$'000
|
$'000
|
|||||||
|
CURRENT
ASSETS
|
||||||||
|
Cash
and cash equivalents
|
20,265 | 33,338 | ||||||
|
Trade
and other receivables
|
2,822 | 2,252 | ||||||
|
Inventories
|
1,515 | 1,334 | ||||||
|
Other
current assets
|
420 | 565 | ||||||
|
Total
Current Assets
|
25,022 | 37,489 | ||||||
|
NON-CURRENT
ASSETS
|
||||||||
|
Property,
plant and equipment
|
246 | 353 | ||||||
|
Total
Non-Current Assets
|
246 | 353 | ||||||
|
TOTAL
ASSETS
|
25,268 | 37,842 | ||||||
|
CURRENT
LIABILITIES
|
||||||||
|
Trade
and other payables
|
4,103 | 8,059 | ||||||
|
Provisions
|
724 | 774 | ||||||
|
Total
Current Liabilities
|
4,827 | 8,833 | ||||||
|
NON-CURRENT
LIABILITIES
|
||||||||
|
Provisions
|
125 | 236 | ||||||
|
Total
Non-Current Liabilities
|
125 | 236 | ||||||
|
TOTAL
LIABILITIES
|
4,952 | 9,069 | ||||||
|
NET
ASSETS
|
20,316 | 28,773 | ||||||
|
EQUITY
|
||||||||
|
Contributed
equity
|
206,419 | 206,419 | ||||||
|
Reserves
|
(4,006 | ) | (3,010 | ) | ||||
|
Accumulated
losses
|
(185,350 | ) | (179,730 | ) | ||||
|
Parent
interest
|
17,063 | 23,679 | ||||||
|
Non-controlling
interest
|
3,253 | 5,094 | ||||||
|
TOTAL
EQUITY
|
20,316 | 28,773 | ||||||
The
above statement of financial position should be read in conjunction with the
accompanying notes.
8
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
|
Consolidated
|
Contributed
Equity
|
Accumulated
losses
|
Reserves
|
Total
|
Non-controlling
interest
|
Total
equity
|
||||||||||||||||||
|
$'000
|
$'000
|
$'000
|
$'000
|
$'000
|
$'000
|
|||||||||||||||||||
|
At
1 July 2008
|
200,432 | (162,251 | ) | (7,491 | ) | 30,690 | 4,947 | 35,637 | ||||||||||||||||
|
Loss
for the period
|
(8,960 | ) | (8,960 | ) | (1,685 | ) | (10,645 | ) | ||||||||||||||||
|
Exchange
differences on translation of foreign operations
|
7,211 | 7,211 | 2,886 | 10,097 | ||||||||||||||||||||
|
Total
comprehensive income for the half year
|
- | (8,960 | ) | 7,211 | (1,749 | ) | 1,201 | (548 | ) | |||||||||||||||
|
Issue
of share capital (4,531,633 shares)
|
5,527 | 5,527 | 5,527 | |||||||||||||||||||||
|
Issue
of share capital by subsidiary
|
3,438 | 3,438 | 3,438 | |||||||||||||||||||||
|
less
non-controlling interest
|
(2,909 | ) | (2,909 | ) | 2,909 | - | ||||||||||||||||||
|
Share-based
payments
|
363 | 363 | 39 | 402 | ||||||||||||||||||||
|
Share
of opening equity transferred to non-controlling interest due to issuance
of shares by subsidiary
|
(503 | ) | 368 | 55 | (80 | ) | 80 | - | ||||||||||||||||
|
Total
transactions with owners in their capacity as owners
|
5,553 | 731 | 55 | 6,339 | 3,028 | 9,367 | ||||||||||||||||||
|
At
31 December 2008
|
205,985 | (170,480 | ) | (225 | ) | 35,280 | 9,176 | 44,456 | ||||||||||||||||
|
At
1 July 2009
|
206,419 | (179,730 | ) | (3,010 | ) | 23,679 | 5,094 | 28,773 | ||||||||||||||||
|
Loss
for the period
|
(5,940 | ) | (5,940 | ) | (1,463 | ) | (7,403 | ) | ||||||||||||||||
|
Exchange
differences on translation of foreign operations
|
(996 | ) | (996 | ) | (420 | ) | (1,416 | ) | ||||||||||||||||
|
Total
comprehensive income for the half year
|
- | (5,940 | ) | (996 | ) | (6,936 | ) | (1,883 | ) | (8,819 | ) | |||||||||||||
|
Issue
of share capital
|
- | - | - | |||||||||||||||||||||
|
Share-based
payments
|
320 | 320 | 42 | 362 | ||||||||||||||||||||
|
Total
transactions with owners in their capacity as owners
|
- | 320 | - | 320 | 42 | 362 | ||||||||||||||||||
|
At
31 December 2009
|
206,419 | (185,350 | ) | (4,006 | ) | 17,063 | 3,253 | 20,316 | ||||||||||||||||
The
above statement of changes in equity should be read in conjunction with the
accompanying notes.
9
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
|
STATEMENTS
OF CASH FLOWS
|
||||||||
|
for
the half year ended 31 December 2009
|
||||||||
|
Consolidated
|
||||||||
|
2009
|
2008
|
|||||||
|
$'000
|
$'000
|
|||||||
|
Cash
flows from operating activities
|
||||||||
|
Net
(loss) before tax
|
(7,398 | ) | (10,644 | ) | ||||
|
Income
tax paid
|
(5 | ) | (1 | ) | ||||
|
Adjustments
to reconcile net (loss) to net cash used in operating
activities:
|
||||||||
|
Depreciation
and amortisation
|
110 | 149 | ||||||
|
Net
(gain)/loss on disposal of property, plant and equipment
|
4 | 2 | ||||||
|
Share-based
payments
|
362 | 402 | ||||||
|
Net
(gain)/loss on exchange rate changes
|
639 | (923 | ) | |||||
|
Changes
in operating assets and liabilities:
|
||||||||
|
(increase)/decrease
in trade receivables
|
243 | 284 | ||||||
|
(increase)/decrease
in other receivables
|
(813 | ) | (771 | ) | ||||
|
(increase)/decrease
in inventories
|
(181 | ) | (556 | ) | ||||
|
(increase)/decrease
in prepayments
|
145 | 146 | ||||||
|
increase/(decrease)
in trade and other payables
|
(3,956 | ) | 551 | |||||
|
increase/(decrease)
in provisions
|
(161 | ) | 86 | |||||
|
Net
cash flows used in operating activities
|
(11,011 | ) | (11,275 | ) | ||||
|
Cash
flows from investing activities
|
||||||||
|
Acquisition
of property, plant and equipment
|
(6 | ) | (57 | ) | ||||
|
Proceeds
from sale of plant and equipment
|
- | 1 | ||||||
|
Net
cash flows from/(used in) investing activities
|
(6 | ) | (56 | ) | ||||
|
Financing
Activities
|
||||||||
|
Proceeds
from the issue of ordinary shares
|
- | 5,527 | ||||||
|
Proceeds
from the issue of shares by subsidiary
|
- | 3,438 | ||||||
|
Net
cash provided by/(used in) financing activities
|
- | 8,965 | ||||||
|
Net
increase/(decrease) in cash and cash equivalents
|
(11,017 | ) | (2,366 | ) | ||||
|
Cash
and cash equivalents at beginning of period
|
32,338 | 34,386 | ||||||
|
Effect
of exchange rates on cash holdings in foreign currencies
|
(2,056 | ) | 11,023 | |||||
|
Cash
and cash equivalents at end of period *
|
19,265 | 43,043 | ||||||
|
*
Note: an additional $1,000,000 is held as secured cash and is not included
in cash equivalents in this cash flow statement
|
||||||||
The
above statement of changes in equity should be read in conjunction with the
accompanying notes.
10
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
Note
1. Basis of preparation
This
general purpose interim financial report, which incorporates the interim
financial statements, for the half-year ended 31 December, 2009 has been
prepared in accordance with the requirements of the Corporations Act 2001 and
the Australian Accounting Standard AASB 134: Interim Financial Reporting. The
interim financial statements have also been prepared on a historical cost basis
with all amounts presented in Australian dollars, unless otherwise
stated.
It is
recommended that this interim financial report be read in conjunction with the
annual financial report for the year ended 30 June, 2009 and any public
announcements made by Novogen Limited and its controlled entities during the
half-year in accordance with the continuous disclosure requirements arising
under the Corporations Act 2001. The half-year interim financial report does not
include full disclosures of the type normally included within the annual
financial report.
Reporting
Basis and Conventions
The
accounting policies and methods of computation followed in this interim
financial report are consistent with those applied in the annual report for the
year ended 30 June, 2009.
11
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
Note
2. Revenue and expenses
|
Profit
from Ordinary Activities Part 1 Revenue
|
||||||||
|
Consolidated
|
||||||||
|
2009
|
2008
|
|||||||
|
$'000
|
$'000
|
|||||||
|
Revenue
|
||||||||
|
Revenue
from the sale of goods
|
3,731 | 4,436 | ||||||
|
Bank
Interest
|
166 | 616 | ||||||
|
Royalties
|
1,219 | 1,323 | ||||||
| 1,385 | 1,939 | |||||||
|
Total
revenue
|
5,116 | 6,375 | ||||||
|
Consolidated
|
||||||||
|
2009
|
2008
|
|||||||
|
$'000
|
$'000
|
|||||||
|
Expenses
|
||||||||
|
Cost
of goods sold
|
(871 | ) | (1,337 | ) | ||||
|
Selling
& Distribution
|
(479 | ) | (562 | ) | ||||
|
Advertising
|
(370 | ) | (904 | ) | ||||
|
Marketing
|
(1,435 | ) | (2,672 | ) | ||||
|
Research
& development expenses
|
(3,846 | ) | (8,081 | ) | ||||
|
Administration
expenses
|
||||||||
|
Administration
- Net currency gains/(losses)
|
(639 | ) | 923 | |||||
|
Administration
- other expenses
|
(4,878 | ) | (4,361 | ) | ||||
|
Other
expenses
|
4 | (25 | ) | |||||
| (12,514 | ) | (17,019 | ) | |||||
|
Borrowing
costs
|
- | - | ||||||
|
Expenses
included in the numbers above, specifically disclosed:
|
||||||||
|
Depreciation
of non-current assets
|
||||||||
|
Plant
and equipment
|
(90 | ) | (138 | ) | ||||
|
Leasehold
improvements
|
(20 | ) | (11 | ) | ||||
|
Total
depreciation and amortisation expenses
|
(110 | ) | (149 | ) | ||||
|
Expense
of share-based payments
|
(362 | ) | (402 | ) | ||||
|
Employee
termination payments
|
(1,929 | ) | - | |||||
12
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
Note
3. Contingent assets and liabilities
In
relation to the claims received in connection with the termination of enrolment
into the OVATURE Phase III clinical trial, the Company has finalised
negotiations and signed a deed of release. The Company believes that it does not
have any liability in relation to claims previously received.
There
have been no other changes in contingent assets or contingent liabilities since
the end of the previous annual reporting period, 30 June, 2009.
Note
4. Operating Segments
Identification
of reportable segments
The Group
has identified its operating segments based on the internal reports that are
reviewed and used by the executive management team (the chief operating decision
makers) in assessing performance and in determining the allocation of resources.
Previously the Group reported segment information based on both geographic
location (Australia/NZ, North America and Europe) and business function,
however, it has now aligned the segments reported to be consistent with the way
in which the executive management team review operations.
The
operating segments indentified by management are based on the specific area of
targeted therapeutic treatment or the individual market in which products are
sold.
The Group
has identified four unique segments as follows:
1 – Drug
Development - includes the discovery of new compounds and the early stage
screening for bioactivity of such compounds through both in vivo and in vitro
testing.
2 – Oncology
Drug Program – involves the development of selected oncology drug
candidates which have indicated potential bioactivity against cancer cells
through clinical trial programs to assess safety and efficacy.
3 – Consumer
Business – a dietary supplement business based on red clover isoflavones
which are marketed and sold world wide
4 – Wound
Healing – a separate and unique technology based on Beta-1 Glucan to aid
in the management of wounds. This technology is currently being progressed
through a clinical trial program to assess safety and efficacy in order to
ultimately obtain marketing approval.
The
accounting policies used by the Group in reporting segments internally are
consistent with those applied to the consolidated accounts and contained in Note
1.
Corporate
costs have been allocated between segments and are therefore included in the net
profit/(loss) for each segment.
13
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
Segment
report
|
DRUG
DEVELOPMENT
|
ONCOLOGY
DRUG PROGRAM
|
CONSUMER
BUSINESS
|
WOUND
HEALING
|
TOTAL
|
||||||||||||||||||||||||||||||||||||
|
Actual
|
Last
Year
|
Actual
|
Last
Year
|
Actual
|
Last
Year
|
Actual
|
Last
Year
|
Actual
|
Last
Year
|
|||||||||||||||||||||||||||||||
|
(000's)
|
(000's)
|
(000's)
|
(000's)
|
(000's)
|
||||||||||||||||||||||||||||||||||||
|
Net
Sales
|
- | - | - | - | 3,731 | 4,436 | - | - | 3,731 | 4,436 | ||||||||||||||||||||||||||||||
|
Other
revenue
|
1,268 | 1,542 | 56 | 220 | 61 | 171 | - | 6 | 1,385 | 1,939 | ||||||||||||||||||||||||||||||
|
Total
Revenue
|
1,268 | 1,542 | 56 | 220 | 3,792 | 4,607 | - | 6 | 5,116 | 6,375 | ||||||||||||||||||||||||||||||
|
Net
(Loss)/Profit
|
(4,810 | ) | (1,653 | ) | (2,686 | ) | (4,941 | ) | 972 | (2,665 | ) | (879 | ) | (1,386 | ) | (7,403 | ) | (10,645 | ) | |||||||||||||||||||||
Total
assets, as reviewed and used by the executive management team, are not allocated
between segments where the segments are contained within the same legal entity.
The drug development segment and the consumer business segments combined have
total assets of $20,186,000 as at 31 December, 2009. The oncology drug program
segment and the wound healing segment have total assets of $14,337,000 and
$85,000 respectively as at 31 December, 2009. As at 30 June, 2009 the drug
development segment and the consumer business segments combined have total
assets of $22,880,000. The oncology drug program segment and the wound healing
segment have total assets of $23,856,000 and $365,000 respectively as at 30
June, 2009. Segment assets, as reviewed by the executive management team, are
before intersegment eliminations.
Note
5. Net tangible assets per share
|
Consolidated
|
||||
|
2009
|
2008
|
|||
|
Net
tangible asset backing per share
|
$0.20
|
$0.44
|
||
Note
6. Events subsequent to the end of the reporting period
On 9
February, 2010, Novogen’s subsidiary Marshall Edwards, Inc. announced that it
intends to effect a reverse share split of 1-for-10 subject to stockholder
approval. Upon stockholder approval, the Company intends to promptly effect the
1-for-10 reverse stock split so that 10 shares of issued and outstanding common
stock will convert into one share of common stock. The price of each common
share would increase by the same ratio so that a stockholder would have fewer
but higher priced shares, keeping the total investment the same when the market
opens on the date a split becomes effective. A reverse stock split would
not have any impact on the voting and other rights of stockholders. A
reverse stock split will have no impact on the Company’s business
operations.
There
have been no other significant events occurring after the end of the reporting
period which have had a material impact on the business.
14
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
Financial
report for the half-year ended 31 December, 2009
The
Directors declare that the financial statements and notes as set out on pages 7
to 14 are in accordance with the Corporations Act 2001; and
(a)
comply with Accounting Standard AASB 134 Interim Financial Reporting and the
Corporations Regulations 2001; and
(b) give
a true and fair view of the consolidated entity's financial position as at 31
December, 2009 and of its performance for the half-year ended on that
date.
In the
Directors' opinion 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
declaration is made in accordance with a resolution of Directors.
On behalf
of the board
/s/ Philip
Johnston
Philip
Johnston
Director
(Chairman)
Sydney,
25 February, 2010
15
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
INDEPENDENT
AUDITOR’S REVIEW REPORT TO THE
MEMBERS
OF NOVOGEN LIMITED
Report
on the Half-Year Financial Report
We have
reviewed the accompanying half-year financial report of
Novogen Limited, which comprises the statement of financial position
as at 31 December 2009, and the statement of comprehensive income, statement of
changes in equity and statement of cash flows for the half-year ended on that
date, a statement of accounting policies, other selected explanatory notes and
the directors’ declaration of
the consolidated entity comprising the disclosing entity and the entities it
controlled at the half-year end or from time to time during the
half-year.
Directors’
Responsibility for the Half-Year Financial Report
The
directors of the disclosing entity are responsible for the preparation and fair
presentation of the half-year financial report in accordance with Australian
Accounting Standards (including the Australian Accounting Interpretations) and
the Corporations
Act 2001. This responsibility includes establishing and maintaining
internal controls relevant to the preparation and fair presentation of the
half-year financial report that is free from material misstatement, whether due
to fraud or error; selecting and applying appropriate accounting policies; and
making accounting estimates that are reasonable in the
circumstances.
16
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
Auditor’s
Responsibility
Our
responsibility is to express a conclusion on the half-year financial report
based on our review. We conducted our review in accordance with Auditing
Standard on Review Engagements ASRE 2410 Review
of Interim and Other Financial Reports Performed by the Independent Auditor of
the Entity, in order to state whether, on the basis of the procedures
described, we have become aware of any matter that makes us believe that the
financial report is not in accordance with the Corporations
Act 2001 including: giving a true and fair view of the consolidated
entity’s financial position as at 31 December 2009 and its performance for the
half-year ended on that date; and complying with Accounting Standard AASB 134
Interim
Financial Reporting and the Corporations
Regulations 2001. As the auditor of Novogen Limited, ASRE 2410 requires
that we comply with the ethical requirements relevant to the audit of the annual
financial report.
A review
of a half-year financial report consists of making enquiries, primarily of
persons responsible for financial and accounting matters, and applying
analytical and other review procedures. A review is substantially less in scope
than an audit conducted in accordance with Australian Auditing Standards and
consequently does not enable us to obtain assurance that we would become aware
of all significant matters that might be identified in an audit. Accordingly, we
do not express an audit opinion.
Independence
In
conducting our review, we have complied with the independence requirements of
the Corporations
Act 2001. We confirm that the independence declaration required by the
Corporations
Act 2001 would be in the same terms if it had been given to the directors
at the time that this auditor’s review report was made.
17
Novogen
Limited
Appendix
4D Specific Requirements
31
December, 2009
Conclusion
Based on
our review, which is not an audit, we have not become aware of any matter that
makes us believe that the half-year financial report of Novogen Limited is not
in accordance with the Corporations
Act 2001 including:
|
(a) giving
a true and fair view of the consolidated entity’s financial position as at
31 December 2009 and of its performance for the half-year ended on that
date; and
|
|
(b) complying
with Accounting Standard AASB 134 Interim
Financial Reporting and the Corporations
Regulations 2001.
|
BDO
Audit (NSW-VIC) Pty Ltd
/s/ Simon
Coulton
Simon
Coulton
Director
Sydney,
25 February 2010.
18