20-F/A 1 form20f200912.htm FORM 20F 2009 12 31 form20f200912.htm


UNITED STATES
 
SECURITIES AND EXCHANGE COMMISSION
 
WASHINGTON, D.C. 20549
 
FORM 20-F/A
 
 
 
[  ]
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b)
 
 
OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
 
OR
 
       [X]     ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
 
        OF THE SECURITIES EXCHANGE ACT OF 1934
 
        For the fiscal year ended June 30, 2009
 
OR
 
       [  ]      TRANSITION REPORT PURSUANT TO SECTION 13 OR
 
         15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
OR
 
       [  ]       SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR
 
         15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
         Date of event requiring this shell company report…………….
 

 
         For the transition period from................... to...................
 
 
Commission file number 0-29962
 
Novogen Limited
 
ACN 063 259 754
 
(Exact name of Registrant as specified in its charter)
 
Not Applicable
 
(Translation of Registrant’s name into English)
 
New South Wales, Australia
 
(Jurisdiction of incorporation or organization)
 
140 Wicks Road, North Ryde, New South Wales 2113, Australia
 
(Address of principal executive offices)
 
Securities registered or to be registered pursuant to Section 12(b) of the Act.
 
None
 
Securities registered or to be registered pursuant to Section 12(g) of the Act.
 
Ordinary Shares*
 
American Depositary Shares, each representing five Ordinary Shares
 
_______________________________________

*
Not for trading, but only in connection with the registration of American Depositary Shares.
________________________________
 
 
 
 
 
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.
 
Not Applicable
 

 
The number of outstanding Ordinary Shares of the issuer as at June 30, 2009 was 102,125,894.
 

 
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
 
Yes         [   ]                                                  No        [X ]
 
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
 
Yes         [   ]                                                   No        [X]
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
 
Yes         [X]                                                    No        [  ]
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
 
Yes         [  ]                                                      No        [  ]
 
Indicate by check mark if the registrant is a large accelerated filer, an accelerated filer or non-accelerated filer.
 
Large accelerated filer [  ]          Accelerated filer [X]          Non-accelerated filer [  ]
 

 
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing
 

 
U.S. GAAP [  ]                                                                                                                                   
 
International Financial Reporting Standards as issued              
by the International Accounting Standards Board    [X]
 
Other [  ]
 
If ‘Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.
 
Item 17   [  ]                                                      Item 18 [  ]
 
If this is an annual report, indicate by a check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
 
Yes         [  ]                                                      No        [X]
 
 
 
 
 
 
 
EXPLANATORY NOTE

This Form 20-F/A hereby amends Item 3 and the Financial Statements, which are incorporated into Item 18, of Novogen Limited’s Annual Report on Form 20-F for the fiscal year ended June 30, 2009, which was filed with the Securities and Exchange Commission on December 15, 2009 (the Original Report); to i) add an explicit statement that the financial statements of Novogen Limited were prepared in accordance with the International Financial Reporting Standards as issued by the International Accounting Standards Board and ii) revise the disclosure in Item 3 to state that cost of sales includes only costs associated with the sale of goods and the reasons the percentage decrease in cost of sales was higher than the percentage decrease in revenues for the applicable periods. This Form 20-F/A does not otherwise revise, update, amend or restate the information presented in the Original Report or reflect any events that have occurred after the Original Report was filed on December 15, 2009.

 
 
 
 
 
TABLE OF CONTENTS


Forward Looking Statements
1
   
PART I
 
   
ITEM 1.                 Identity of Directors, Senior Management and Advisors
3
ITEM 2.                 Offer Statistics and Expected Timetable
3
ITEM 3.                 Key Information
3
ITEM 4.                 Information on the Company
15
ITEM 4A                 Unresolved Staff Comments
32
ITEM 5.                 Operating and Financial Review and Prospects
33
ITEM 6.                 Directors, Senior Management and Employees
42
ITEM 7.                 Major Shareholders and Related Party Transactions
58
ITEM 8.                 Financial Information
60
ITEM 9.                 Offer and Listing Details
61
ITEM 10.               Additional Information
63
ITEM 11.               Quantitative and Qualitative Disclosures about Market Risk
68
ITEM 12.               Description of Securities other than Equity Securities
69
   
PART II
 
ITEM 13.                Defaults, Dividend Arrearages and Delinquencies
70
ITEM 14.      Material Modifications to the Rights of Security Holders and the Use of Proceeds
 
70
ITEM 15.                Controls and Procedures
70
ITEM 16.                Reserved
71
ITEM 16A.             Audit Committee Financial Expert
71
ITEM 16B              Code of Ethics
71
ITEM 16C              Principal Accountant Fees and Services
72
ITEM 16D              Exemptions from the Listing Standards for Audit Committees
73
ITEM 16E     Purchases of Equity Securities by the Issuer and Affiliated Purchases
 
73
ITEM 16G              Corporate Governance
73
   
PART III     
 
ITEM 17.               Financial Statements – Not Applicable
75
ITEM 18.               Financial Statements
75
ITEM 19.               Exhibits
75

 
 
 
 
 
FORWARD-LOOKING STATEMENTS
 

This Annual Report on Form 20-F includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Annual Report, including statements regarding the future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “believe”, “may”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “should”, “plan”, “expect”, and similar expressions, as they relate to Novogen Limited (“Novogen”, the “Company” or the “Group”), are intended to identify forward-looking statements. The Company has based these forward-looking statements largely on current expectations and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, without limitation, those described in “Risk Factors” and elsewhere in this Annual Report on Form 20-F (the “Annual Report”), including, among other things:

·  
the inability of the Company to obtain any additional required financing or financing available to it on acceptable terms, particularly in the context of the current global financial crisis;
·  
the failure of the Company’s majority owned subsidiary Marshall Edwards, Inc. (“MEI” or “Marshall Edwards”) to achieve satisfactory clinical outcomes from the OVATURE clinical trial of phenoxodiol;
·  
the ability of MEI to continue its development of triphendiol, NV-128 and NV-143;
·  
the ability of the Company’s majority owned subsidiary Glycotex, Inc.  (“Glycotex”) to continue its clinical development of GLYC-101;
·  
the failure to locate, hire, assimilate and retain qualified personnel;
·  
the failure of the Company to successfully commercialize its products;
·  
costs and delays in the development and/or receipt of U.S. Food and Drug Administration (“FDA”) or other required governmental approvals, or the failure to obtain such approvals, for the Company’s products;
·  
uncertainties in clinical trial results;
·  
the inability to maintain or enter into, and the risks resulting from dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products;
·  
competition and competitive factors;
·  
the inability to enforce the Company’s patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate the business;
·  
the inability to operate the business without infringing upon the patents and proprietary rights of others;
·  
the failure of any product candidate to gain market acceptance;
·  
general economic conditions;
·  
government regulation generally and the receipt of regulatory approvals;
·  
changes in industry practice; and
·  
one-time events.
 

 
 
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These risks are not exhaustive. Other sections of the Annual Report may include additional factors which could adversely impact the Company’s business and financial performance. Moreover, the Company operates in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for the Company to predict all risk factors, nor can the Company assess the impact of all factors on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

You should not rely upon forward looking statements as predictions of future events. The Company cannot assure you that the events and circumstances reflected in the forward looking statements will be achieved or occur. Although the Company believes that the expectations reflected in the forward looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements.
 

 
2
 
 
PART I

Item 1.                 Identity of Directors, Senior Management and Advisors

Item 1 details are not required to be disclosed as part of the Annual Report.

Item 2.                 Offer Statistics and Expected Timetable

Item 2 details are not required to be disclosed as part of the Annual Report.

Item 3.                 Key Information

Selected Financial Data

The selected financial data at June 30, 2009 and 2008 and for the years ended June 30, 2009, 2008 and 2007 have been derived from the Consolidated Financial Statements of the Company included in this Annual Report and should be read in conjunction with, and are qualified in their entirety by, reference to those statements and the notes thereto.

This financial report complies with International Financial Reporting Standards (IFRS) as adopted by the International Accounting Standards Board (IASB).

The Consolidated Financial Statements have been audited in accordance with generally accepted auditing standards in the United States by the Company’s independent registered public accountants.
 
The Company’s fiscal year ends on June 30. As used throughout this Annual Report, the word “fiscal” followed by a year refers to the 12 month period ending on June 30 of that year. For example, the term “fiscal 2009” refers to the 12 months ended June 30, 2009. Except as otherwise indicated, all dollar amounts referred to in this Annual Report are at the consolidated level and exclude inter-company amounts.

 
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Summary of Consolidated Income Statements
 
(AIFRS)
 
                                     
   
2005
   
2006
   
2007
   
2008
   
2009
   
2009
 
Continuing operations
 
(A$'000)
   
(A$'000)
   
(A$'000)
   
(A$'000)
   
(A$'000)
   
(US$'000)
 
                                     
Revenue from sale of goods
    13,404       13,500       10,709       9,400       8,333       6,712  
Other revenue
    3,985       3,945       6,586       3,883       2,814       2,267  
Total revenue
    17,389       17,445       17,295       13,283       11,147       8,979  
                                                 
Net loss before income tax
    (12,682 )     (17,912 )     (24,295 )     (24,773 )     (23,786 )     (19,160 )
                                                 
Net loss attributable to members of Novogen Limited
    (11,532 )     (16,220 )     (19,981 )     (20,264 )     (18,928 )     (15,247 )
                                                 
                                                 
Basic and diluted earnings/(loss) per share (cents per share)
    (11.9 )     (16.7 )     (20.5 )     (20.8 )     (18.6 )     (15.0 )
                                                 
Weighted average number of Ordinary Shares used to calculate earnings per share
    96,839,570       97,207,053       97,567,399       97,594,261       101,741,016       101,741,016  
                                                 
Number of outstanding Ordinary Shares at year end
    97,045,662       97,294,054       97,594,261       97,594,261       102,125,894       102,125,894  

 
Summary of Consolidated Balance Sheets
 
(AIFRS)
 
                                     
   
2005
   
2006
   
2007
   
2008
   
2009
   
2009
 
   
(A$'000)
   
(A$'000)
   
(A$'000)
   
(A$'000)
   
(A$'000)
   
(US$'000)
 
                                     
Cash and Cash
                                   
Equivalents
    47,260       33,513       39,511       35,386       33,338       26,854  
                                                 
Total Assets
    67,485       51,098       51,357       43,401       37,842       30,482  
                                                 
Net Assets
    60,492       44,578       44,626       35,637       28,773       23,177  
                                                 
Capital Stock
    176,235       176,989       191,876       200,432       206,419       166,271  
                                                 
 
No dividends have been declared by the Company in the fiscal years included in this Annual Report.

The Company publishes its Consolidated Financial Statements expressed in Australian dollars. In this Annual Report, references to “U.S. dollars” or “US$” are to the currency of the United States of America (“U.S.”) and references to “Australian dollars” or “A$” are to the currency of Australia. For the convenience of the reader, this Annual Report contains translations of certain Australian dollar amounts into U.S. dollars at specified rates. These translations should not be construed as representations that the Australian dollar amounts actually represent such U.S. dollar amounts or could be converted into U.S. dollars at the rate indicated. Unless otherwise stated, the translations of Australian dollars into U.S. dollars have been made at the rate of US$0.8055  = A$1.00, the noon market buying rate in New York City for cable transfers in Australian Dollars as certified for customs purposes by the Federal Reserve Bank of New York (the noon buying rate) on June 30, 2009.
 
 
4
 
 
 
The noon buying rate on November 30, 2009 was US$0.9143 = A$1.00
 
Exchange Rates for the six months to November 2009
A$ versus US$
   
       
Month
High
Low
 
June
$0.8195
$0.7851
 
July
$0.8339
$0.7751
 
August
$0.8439
$0.8201
 
September
$0.8824
$0.8306
 
October
$0.9275
$0.8656
 
November
$0.9369
$0.8985
 
 
Fiscal Year Average  
Ended June 30      Rate  
2005   $0.7529  
2006   $0.7472  
2007   $0.7862  
2008   $0.8968  
2009   $0.7455  

 




 
5
 
 
Risk Factors

The following risk factors, in addition to the other information and financial data contained in this Annual Report, should be considered carefully in evaluating the Company and its business. The risks described below and elsewhere in this Annual Report are not intended to be an exhaustive list of the general or specific risks involved, but merely identify certain risks that are now foreseen by the Company. It must be recognized that other risks, not now foreseen, might become significant in the future and that the risks which are now foreseen might affect the Company to a greater extent than is now foreseen or in a manner not now contemplated.

 The Company will need additional funds in order to finance its future operations and its clinical development programs. The actual amount of funds that the Company will need will be determined by a number of factors, some of which are beyond its control.

The Company’s funding requirements have been, and will continue to be, significant. The Company anticipates that its existing cash resources will be adequate to fund the Company's operating requirements through the next 12 months based upon the Company's current business plan.

The Company’s 71.3% owned U.S. subsidiary company MEI will need additional funds to progress the development program for the drug candidates triphendiol, NV-128  and NV-143.

The Company’s 80.7% owned U.S. subsidiary company Glycotex will also need additional funds to further the clinical development of its investigational wound healing compound GLYC-101.

The Company's operating cash requirements may vary materially from those now planned due to a number of factors. These factors include the success of the Company's research and development efforts, the ability of the Company to satisfy applicable regulatory requirements, the extent of the Company's ability to produce its products in a cost-effective manner, the rate at which the Company can introduce its products into new markets and the market acceptance and competitive position of the Company's products.

There can be no assurance that additional financing will be available when needed on terms acceptable to the Company, or at all. If additional funds are raised by issuing equity securities, further dilution to existing shareholders will result and future investors may be granted rights superior to those of existing shareholders. Insufficient funds may prevent the Company from implementing its business strategy or may require the Company to limit its operations significantly.

 
6
 
 
The recent global financial crisis may negatively impact the Company’s liquidity and clinical trials, as well as the liquidity and clinical trials of the Company’s subsidiaries, by precluding the Company and its subsidiaries from raising funds through equity and/or debt investments or third party loans on favorable terms or at all.

The Company and its subsidiaries have traditionally raised capital through the sale of equity securities to investors.  Recently, the financial services industry and credit market have experienced a period of unprecedented turmoil characterized by bankruptcy, failure and collapse or sale of various financial institutions.  Although the ultimate outcome of these events cannot be predicted, they may preclude the Company and its subsidiaries from raising the capital necessary to finance their business operations.  In particular, MEI may not be able to raise the capital necessary to progress the clinical program for phenoxodiol, triphendiol, NV-128 and NV-143 and Glycotex may not be able to raise the capital necessary to progress the clinical program for GLYC-101.  The Company and its subsidiaries may need to rely upon collaboration and/or licensing opportunities with third parties to obtain the funding necessary to conduct their business operations.

The Company cannot assure you that it or its subsidiaries will be able to raise the funds necessary to complete their clinical trials and research programs or find appropriate collaboration and/or licensing opportunities.

The Company has incurred operating losses since its inception, and is likely to incur operating losses for the foreseeable future.

The Company has incurred net losses of A$204,584,000 since its inception, including net losses of A$23,787,000, A$24,777,000, and A$24,296,000 for the years ended June 30, 2009, 2008, and 2007, respectively. The Company anticipates that it will incur operating losses and negative cash flow for the foreseeable future.

MEI has terminated new enrollment into the OVATURE Phase III clinical trial and may not be able to pursue commercialization of phenoxodiol at this time.

MEI has terminated new enrollment into the OVATURE Phase III clinical trial, 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. MEI has ceased recruiting the necessary number of additional patients to complete the trial as originally planned. As a result of the termination of new enrollment into the OVATURE Phase III clinical trial, MEI may not be able to pursue commercialization of phenoxodiol at this time.
 
 
If the un-blinded data analysis of the patient data from the OVATURE Phase III clinical trial does not demonstrate the safety and efficacy of phenoxodiol for the treatment of platinum-resistant late-stage ovarian cancer, MEI may be unable to out-license phenoxodiol to third parties for this purpose.

MEI has decided to undertake an un-blinded analysis of the available data from the 142 completed or current patients in the OVATURE Phase III clinical trial to assess the
 
 
7
 
 
safety and efficacy of phenoxodiol for the treatment of platinum-resistant late-stage ovarian cancer. If the analysis demonstrates the safety and efficacy of phenoxodiol, MEI may be able to out-license phenoxodiol to third parties and receive licensing revenues. If, however, the analysis shows that phenoxodiol is not safe and/or not effective, MEI may not be able to out-license phenoxodiol to third parties.

 If the data from the Company’s clinical trial program do not demonstrate the safety and efficacy of the phenolic drug candidates to the satisfaction of the FDA and other regulatory authorities, the Company will not receive approval to market its drug candidates in the U.S. or other jurisdictions.

Phenolic drug development is an entirely novel and unproven field of pharmaceutical drug development and there is limited scientific understanding of phenolic technology on which the Company’s drug program is based. There can be no assurance that any of the compounds under development by the Company will prove to be sufficiently efficacious, safe and cost-effective to be commercially viable. The commercialization process of the products currently in clinical development includes the anti-cancer drug candidates phenoxodiol and triphendiol being developed by the Company’s subsidiary MEI. The commercialization process of the foregoing drug candidates may be delayed if the FDA or another regulatory authority requires the expansion in the size and scope of any clinical trial or if MEI fails to achieve satisfactory clinical outcomes from the OVATURE clinical trial of phenoxodiol. It may take many years to complete the testing and failure can occur at any stage in the process. Negative or inconclusive results or adverse medical events during a clinical trial could cause the Company to delay or terminate development efforts.

Any failure in the clinical trial program could impair the commercial prospects of the Company’s entire phenolic drug program.

Clinical trials have a high risk of failure. A number of companies have suffered significant setbacks in advanced clinical trials even after achieving promising results in earlier trials. If the Company experiences delays in the testing or approval process or if further clinical trials or clinical trials involving a larger number of patients are required, the commercial prospects of the drugs under development could be impaired.

If the Company does not receive marketing approval for its phenolic drug candidates, or regulatory approval is withdrawn for the Company’s dietary supplements, the Company will not be able to commercialize its products and product candidates.

Marketing approval is needed in order to commercialize the Company’s phenolic drug candidates. The Company may never receive marketing approval for any of its phenolic drug candidates. If the Company does receive marketing approval, such approval will be limited to those disease states and conditions for which phenolic drug candidates have been proven to be safe and effective.

 
8
 
 
In order for the Company to market its products, the Company must obtain required marketing approvals or clearances and otherwise comply with extensive regulations regarding safety, manufacturing processes and quality. There can be no assurance that the Company will be able to obtain or maintain regulatory approvals or clearances or that it will not be required to incur significant costs in obtaining or maintaining its foreign regulatory approvals or clearances.

The FDA and other governmental approvals that may be granted to the Company will be subject to continual review, and later discovery of previously unknown problems may result in withdrawal of products from the market.

Moreover, if and when any FDA or other governmental approval is obtained, the marketing and manufacture of the Company’s products will remain subject to extensive regulatory requirements administered by the FDA and other regulatory bodies. Failure to comply with these regulatory requirements may, among other things, result in fines, suspensions or withdrawal of marketing approvals, operating restrictions and criminal prosecution.

 The Company has no direct control over the cost of the pharmaceutical drug manufacturing costs and the Company will be relying on third parties to manufacture commercial quantities of pharmaceutical drug candidates as well as drug supplies for larger scale clinical trials.

The Company will rely on third parties to manufacture commercial quantities of its pharmaceutical drug candidates as well as drug supplies for larger scale clinical trials. There can be no assurance that third party manufacturers will devote the resources necessary to meet demand for the Company’s products. Also, if the costs of manufacturing increases, or the costs of materials used in manufacturing increases, these costs will be passed onto the Company making the cost of conducting clinical trials more expensive. In addition, increases in manufacturing costs could adversely affect the Company’s future profitability if it is unable to pass on the increased costs to its customers.
 
 The Company has no direct control over the cost of red clover isoflavone extract or the formulation and packaging of its dietary supplement products.
 
The Company relies on third parties to (i) supply its active raw materials (isoflavones), (ii) manufacture and package its dietary supplement products to satisfy performance and quality standards and (iii) dedicate sufficient production capacity to meet demand and delivery times.

In addition, the facilities where the Company’s products are manufactured are subject to periodic inspection by regulatory authorities for compliance with the Current Good Manufacturing Practice (cGMP) regulations. There can be no assurance that these authorities will not, during the course of an inspection of existing or future facilities, identify what they consider to be deficiencies in cGMP or other requirements and
 
 
9
 
 
request, or seek, remedial action. Failure to comply with such regulations or delay in attaining compliance may adversely affect the Company’s manufacturing activities and could result in, among other actions, warning letters, injunctions, civil penalties, refusal to grant approvals or clearances of future or pending product submissions, fines, recalls or seizure of products, total or partial suspensions of production and criminal prosecution. If any of the foregoing events occur, the Company’s products may not be available to supply the market demand and the Company’s sales revenues may be adversely affected.
 
 
 The Company’s success is largely dependent on its ability to obtain patent protection and preserve trade secrets, which cannot be guaranteed.

The Company’s success is dependent to a significant degree on whether it can obtain patents, maintain trade secret protection and operate without infringing on the proprietary rights of third parties. If it were determined that the Company was infringing upon any third party patent, the Company could be required to pay damages, alter its products or processes, obtain licenses or to cease certain operations. If the Company is required to obtain any licenses, there can be no assurance that the Company will be able to do so on commercially favorable terms, if at all. The Company’s failure to obtain a license for any technology that it may require to commercialize its products could have a material adverse effect on the Company’s business, financial condition and results of operations.

Litigation relating to patent infringement could result in substantial costs to, and diversion of effort by, the Company, and may also be necessary to enforce any patents issued or licensed to the Company or to determine the scope and validity of third party proprietary rights. The Company is currently involved in a number of litigation proceedings against companies which it believes were infringing certain of the Company’s patents related to dietary supplements.

If competitors, claim technology also claimed by the Company, prepare and file patent applications in the U.S., the Company may have to participate in interference proceedings in the U.S. Patent and Trademark office to determine priority of invention, which could result in substantial cost to, and diversion of effort by, the Company, even if the eventual outcome is favorable to the Company.

Any such litigation or interference proceedings, regardless of outcome, could be expensive and time consuming. Litigation could subject the Company to significant liabilities to third parties, requiring disputed rights to be licensed from third parties to the Company or requiring the Company to cease using certain technologies and, consequently, could have a material adverse effect on the Company’s business, financial condition and results of operations.

In addition to patent protection, the Company relies on trade secrets and proprietary technological expertise. There can be no assurance that others will not independently develop or acquire substantially equivalent technologies, or otherwise gain access to the
 
 
10
 
 
Company’s trade secrets or technological expertise or disclose such trade secrets. There can be no assurance that the Company can ultimately protect its right to such un-patented trade secrets and technological expertise. The Company relies, in part, on confidentiality agreements with its marketing partners, employees, advisors, vendors and consultants to protect its trade secrets and proprietary technological expertise. There can be no assurance that these agreements will not be breached, that the Company will have adequate remedies for any breach or that the Company’s un-patented trade secrets and proprietary technological expertise will not otherwise become known or independently discovered by competitors.

 The Company’s commercial opportunity will be reduced or eliminated if competitors develop and market products that are more effective or less expensive than the Company’s products.

In developing its technology and products, the Company competes with many domestic and foreign competitors in various rapidly evolving and technologically advanced fields, including pharmaceutical, biotechnology and biopharmaceutical companies.

Many of the Company’s competitors and potential competitors have substantially greater financial, technological, research and development, marketing and personnel resources than the Company. There can be no assurance that the Company’s competitors will not succeed in developing alternate technologies and products that are more effective, easier to use or more economical than those which have been developed by the Company or that would render the Company’s technologies and products obsolete and non-competitive in these fields. These competitors may also have greater experience in developing products, conducting clinical trials, obtaining regulatory approvals or clearances and manufacturing and marketing such products or technologies. These competitors may obtain patent protection, approval or clearance earlier than the Company, which could adversely affect the Company’s business, financial condition and results of operations. Furthermore, the Company will also be competing with respect to manufacturing efficiency and marketing capabilities, areas in which it currently has limited experience.

The Company’s commercial opportunities will be reduced or eliminated if competitors develop and market products that are more effective, have fewer side effects or are less expensive.
 
The Company may not be able to establish the strategic licensing partnerships necessary to develop, market and distribute its pharmaceutical product candidates.

A key part of the Company’s business plan is to out license its pharmaceutical product candidates to strategic business partners. The Company has not yet established any strategic licensing partnerships. The relative attractiveness to potential licensing partners and, consequently, the ability to negotiate acceptable terms in any partnership agreement, will be affected by the results of the clinical programs. Successful clinical
 
 
11
 
 
outcomes may generate greater interest from potential partners than if the Company’s product candidates are demonstrated to be less effective. There is no assurance that the Company will be able to negotiate commercially acceptable licensing or other agreements for the future exploitation of its product candidates. If the Company is unable to successfully enter into licensing arrangements it may have to delay the commercialization program for its product candidates which will adversely affect its ability to generate operating revenues.

 The Company may not be able to establish or maintain the strategic partnerships necessary to market and distribute its dietary supplement products.

The Company relies on its own marketing staff for the marketing and sale of its current and proposed dietary supplement products in Australia, Canada, and the U.K. The Company presently has limited marketing and sales staff. Achieving market acceptance for the Company’s products will require extensive and substantial efforts by experienced personnel as well as expenditure of significant funds. There can be no assurance that the Company will be able to establish sufficient marketing, distribution and sales capabilities necessary to achieve market penetration in these geographical areas.

In other markets, the Company intends to appoint licensees and/or marketing partners who will be responsible in large part for sales, marketing and distribution. While the Company will endeavor to appoint licensees and/or marketing partners with proven abilities in these areas, the amount and timing of resources, which may be devoted to the performance of their contractual responsibilities by these partners, are not within the control of the Company. There can be no assurance that such marketing partners will perform their obligations as expected, pay any additional option or license fees to the Company or market any products under any agreement. There can be no assurance that the Company will derive any revenue from such arrangements. Moreover, the other contracting parties may have rights of termination under these agreements. Exercise of such termination rights by such other parties may have an adverse effect on the Company’s business, financial condition and results of operations. There can be no assurance that the interests of the Company will continue to coincide with those of its partners or that such partners will not develop independently, or with third parties, products or technologies which could compete with the Company’s products, or that disagreements over rights, technologies or other proprietary interests will not occur. To the extent that the Company chooses not to, or is unable to, enter into future agreements, the Company will experience increased capital requirements to undertake the marketing or sale of its current or future products. There can be no assurance that the Company will be able to market or sell its technology or its current or future products independently in the absence of such agreements.
 
The Company faces the risk of product liability claims and may not be able to obtain adequate insurance.

The Company’s business exposes it to the risk of product liability claims. This risk is inherent in the manufacturing, testing and marketing of human pharmaceutical products.
 
 
12
 
 
The Company has product liability insurance coverage of up to approximately A$20 million. Although the Company believes that this amount of insurance coverage is appropriate for its business at this time, the insurance coverage is subject to deductibles and coverage limitations, and the market for such insurance is becoming more restrictive. The Company may not be able to obtain or maintain adequate protection against potential liabilities. If the Company is unable to sufficiently insure against potential product liability claims, it will be exposed to significant liabilities, which may materially and adversely affect the business development and commercialization efforts.
 
 Enforceability of civil liabilities under the federal securities laws against the Company’s officers and directors may be difficult.

The Company is a public company limited by shares and is registered and operates under the Australian Corporations Act 2001. Five out of the Company's six directors and all of the officers named in this Annual Report reside outside the U.S. Substantially all of the assets of those persons are located outside the U.S. As a result, it may not be possible to affect service on such persons in the U.S. or to enforce, in foreign courts, judgments against such persons obtained in U.S. courts and predicated on the civil liability provisions of the federal securities laws of the U.S. Furthermore, substantially all of the directly owned assets of the Company are outside the U.S., and, as such, any judgment obtained in the U.S. against the Company may not be collectible within the U.S. There is doubt as to the enforceability in the Commonwealth of Australia, in original actions or in actions for enforcement of judgments of U.S. courts, of civil liabilities predicated solely upon federal or state securities laws of the U.S., especially in the case of enforcement of judgments of U.S. courts where the defendant has not been properly served in Australia.

The trading price of the Company’s ordinary shares and American Depository Receipts (“ADRs”) could decline in value if the trading price of the shares of common stock of its listed subsidiary company, Marshall Edwards, declines.

Novogen currently owns 71.3% of its subsidiary Marshall Edwards, whose shares are traded on the Nasdaq Global Market. If the trading price of MEI’s shares declines or its business does not achieve its objectives or its product development program is delayed, it could have an adverse affect on Novogen’s share price.


The trading price of the Company’s ordinary shares and ADRs is highly volatile. Your investment could decline in value and the Company may incur significant costs from class action litigation.

The trading price of the Company’s ordinary shares and ADRs is highly volatile in response to various factors, many of which are beyond the Company’s control, including:

 
13
 
 
·  
announcements of technological innovations by the Company and its competitors;
·  
new products introduced or announced by the Company or its competitors;
·  
changes in financial estimates by securities analysts;
·  
actual or anticipated variations in operating results;
·  
expiration or termination of licenses, research contracts or other collaboration agreements;
·  
conditions or trends in the regulatory climate in the biotechnology, pharmaceutical and genomics industries;
·  
changes in the market values of similar companies;
·  
the liquidity of any market for the Company’s securities; and
·  
additional sales by the Company of its shares.

In addition, equity markets in general and the market for biotechnology and life sciences companies in particular, have experienced substantial price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the companies traded in those markets. Further changes in economic conditions in Australia, the United States, Europe, or globally, could impact the Company’s ability to grow profitably. Adverse economic changes are outside the Company’s control and may result in material adverse effects on the Company’s business or results of operations. These broad market and industry factors may materially affect the market price of the Company’s ordinary shares and ADRs regardless of its development and operating performance. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted against that company. Such litigation, if instituted against the Company, could cause it to incur substantial costs and divert management’s attention and resources.

If the market price of the Company’s ADRs remains below $5.00 per share, under stock exchange rules, the Company’s stockholders will not be able to use such ADRs as collateral for borrowing in margin accounts. This inability to use ADRs as collateral may depress demand as certain institutional investors are restricted from investing in securities priced below $5.00 and may lead to sales of such ADRs creating downward pressure on and increased volatility in the market price of the Company’s ordinary shares and ADRs.

In addition, under the rules of The Nasdaq Stock Market, listed companies are required to maintain a share price of at least $1.00 per share and if the share price declines below $1.00 for a period of 30 consecutive business days, then the listed company would have 180 days to regain compliance with the $1.00 per share minimum. In the event that the Company’s share price declines below $1.00, it may be required to take action, such as a reverse stock split, in order to comply with the Nasdaq Stock Market rules that may be in effect at the time in order to avoid delisting of the Company’s common stock and the associated decrease in liquidity in the market for the Company’s common stock.
 
 
14
 
 
Item 4.                 Information on the Company

History and development of the Company

Novogen Limited, a public company limited by shares, was incorporated in March 1994 under the jurisdiction of the laws of New South Wales, Australia. Novogen is registered and operates under the Australian Corporations Act. Novogen has its registered office at 140 Wicks Rd, North Ryde, New South Wales 2113. Its telephone number and other contact details are: Phone 61-2-9878-0088; Fax 61-2-9878-0055; and website, www.novogen.com (the information contained in the website does not form part of the Annual Report). The Company’s Ordinary Shares are listed on the Australian Stock Exchange (“ASX”) under the symbol “NRT” and its ADRs, each representing five ordinary shares, trade on the Nasdaq Global Market under the symbol “NVGN”. The Company’s agent in the U.S. for ADR’s is the Bank of New York, 101 Barclay Street 22W New York, N.Y. 10286.

Capital expenditures
The Company made no major investments of a capital nature during fiscal 2009. Future facilities will be developed where appropriate. Current capacity at the pilot plant at North Ryde NSW is sufficient to meet demand for the short to medium term.

Business overview

Nature of the Business

The Company is a pharmaceutical company involved in the discovery, development, manufacture and marketing of products based on the emerging field of isoflavonoid technology. The Company’s product development program embraces both a novel range of pharmaceuticals based on a range of phenolic compounds and a range of consumer health care products based on plant compounds known as isoflavones. A key element of the Company’s strategy is to continue to advance its research and development in more advanced pharmaceuticals in the area of human phenolic compound technology. With the current economic climate making capital raising for extended clinical development programs difficult, the Company is relying on its internal resources to concentrate on the expanding oncology portfolio, particularly, the triphendiol human clinical development program and the pre-clinical development program for NV-128 that is currently underway.


 
15
 
 
Clinical development

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 and cervical 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 enrollment 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 enrollment 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.

The termination of patient enrollment into the OVATURE study and unblinded analysis of the available data from the trial have been discussed with FDA, because the analysis will not be performed as described in the approved Special Protocol Assessment (“SPA”) agreement.

Prostate Phase II Clinical Trial

MEI has completed a Phase II prostate cancer study in advanced hormone refractory disease in Australia, and in October 2007, MEI announced that it is conducting another Phase II prostate cancer clinical trial using phenoxodiol as first line treatment in men with early stage disease (35 patients with androgen dependent disease but rising PSA) compared to patients with late stage hormone refractory disease (25 patients 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.

 
16
 
 
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. 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 an acceptable 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 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) status by the FDA to undertake clinical studies in the U.S. 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.
 
GLYC-101

In April, 2009, Glycotex, Inc. announced the completion of a scheduled interim analysis in a Phase II study evaluating the effect of investigational GLYC-101 gel on complete wound closure and cosmetic outcomes in cosmetic surgery patients undergoing carbon dioxide laser skin resurfacing on the lower eyelid area. 

 
17
 
 
The interim analysis was conducted after 26 subjects completed the study. The comparison of each active arm to placebo with respect to the primary endpoint (time to complete wound closure) shows positive results when considering the full dataset of patient data from all treatment combinations.

GLYC-101 is intended to stimulate and modulate the natural cascade of wound healing activities in several cell populations. The product candidate is a topical gel formulation to be applied directly on the wound surface. The strategic priorities for GLYC-101 include wound healing following laser ablation, burn wounds, surgical wounds, venous ulcers and diabetic ulcers.
 
 
Consumer health care

The Company launched its first dietary supplement product, Promensil, in September 1997 in Australia.

Promensil and Trinovin are “dietary supplements” that deliver standardized levels of all four isoflavones — daidzein, genistein, formononetin and biochanin. In addition, the Company has introduced dietary supplement line extensions including Promensil Vitality and Promensil Double Strength.

The Company has established 100% owned subsidiary companies in Canada, and the U.K. to market and distribute its range of dietary supplements. The Company has also entered into agency agreements to distribute its dietary supplements in Singapore, China, Malaysia, Indonesia, Taiwan, South Africa, Ireland, Austria, Netherlands, Switzerland, Belgium, Portugal, Italy, Malta, Korea, Brazil and UAE. In 2006, the Company licensed the U.S. rights to market Promensil and Trinovin brands to Natrol, Inc.

The following table is an analysis of revenue from sales and other sources during the past three fiscal years by categories of activity and by geographical market. Other revenue consists principally of interest income, grants received and royalty receipts.  See Note 2 to the Consolidated Financial Statements.


 
18
 
 
 
Category of Activity                  
                   
    2007     2008     2009  
    (A$'000)     (A$'000)     (A$'000)  
                   
                   
Revenue from sale of goods     10,709       9,400       8,333  
                         
Other revenue     6,586       3,883       2,814  
                         
Total Revenue     17,295       13,283       11,147  
                         
Geographical Markets                        
                         
      2007       2008       2009  
       (A$'000)         (A$'000)         (A$'000)  
                         
Revenue from sale of goods                        
                         
Australia/NZ     4,453       4,755       4,902  
                         
Europe     3,104       2,217       1,363  
                         
North America     3,152       2,428       2,068  
                         
      10,709       9,400       8,333  
                         
Other revenue                        
                         
Australia/NZ     5,751       3,145       2,528  
                         
Europe     7       5       1  
                         
North America     828       733       285  
                         
      6,586       3,883       2,814  
                         
Total Revenue     17,295       13,283       11,147  





 
19
 
 
Source and Availability of Raw Materials

 Phenolic Pharmaceutical Compounds

Small quantities of the synthetic phenolic compounds used in the Company’s pre-clinical studies and clinical trials are currently being manufactured at the Company’s pilot facility located at North Ryde, Australia, and through contracted third party manufacturers. The pilot plant facility has the capability to provide sufficient product for pre-clinical and initial clinical trial purposes. The Company has taken the strategic decision not to manufacture compounds for larger clinical trials or commercial scale Active Pharmaceutical Ingredients (API) for its drug candidates, including phenoxodiol and triphendiol as these can be more economically supplied by third parties with particular expertise in this area.

Isoflavones

Isoflavones for use in consumer health care products are supplied under contract entered into with a third party supplier. The Company also uses contract formulators and packers in Australia to tablet and pack the final product for supply to world markets.

Marketing Channels

The Company’s marketing strategy is to continue to be responsible for the direct marketing of its consumer health care products in Australia, Canada and the U.K. The Company has entered into third party distribution arrangements for other international territories.

Patent Protection

The most important area of the intellectual property (“IP”) of the Company is the Company’s discovery that isoflavonoid-derived phenolic compounds have biological activity. This is the basis of the Company’s drug discovery and development program. A number of these phenolic compounds have been identified by the Company as offering significant commercial potential as new pharmaceuticals and these are currently under development. The Company has multiple PCT (Patent Cooperation Treaty) applications pending relating to these compounds and a wide range of therapeutic indications.

The Company pursues a broad patent application filing strategy, and filing PCT patent applications can be used to pursue patent protection in member countries with significant markets for the Company’s products. All current patent applications are filed in the name of, or assigned to either Novogen Inc., Novogen’s wholly-owned U.S. subsidiary, or Novogen Research Pty Ltd, one of Novogen’s wholly-owned Australian subsidiaries.

The areas with expanding patent cover include novel dimeric and novel aminated isoflavones, isoflavone formulations and various uses, combined isoflavone/chemotherapy and isoflavone/ radiotherapy treatments and glucan preparation and uses.

 
20
 
 
During the year 18 patents, and one reissue patent were granted as follows:
 
AUSTRALIA
 Patent # 2004202747
Compositions and Therapeutic Methods Involving Isoflavones and Analogues Thereof
 
Patent # 2003264176
Skin Photoageing and Actinic Damage Treatment
 
Patent # 2003265737
Combination Chemotherapy Compositions and Methods
 
Patent # 2007201390
Combination Chemotherapy Compositions and Methods

 
CANADA
 
Patent # 2562918
Process for Glucan Preparation and Therapeutic Uses of Glucan

 
MEXICO
 
Patent # 261510
Preparation of Isoflavones from Legumes
 
Patent # 258618
Dimeric Isoflavones
 
Patent # 262896
Aminated Isoflavonoid Derivatives and Uses Thereof
 
Patent # 252511
Skin Photoageing and Actinic Damage Treatment
 
Patent # 254945
Compositions and Therapeutic Methods Involving Isoflavones and Analogues Thereof

 
NEW ZEALAND
 
Patent # 539034
Aminated Isoflavonoid Derivatives and Uses Thereof
 
Patent # 538583
Combination Chemotherapy Compositions and Methods

 
NORWAY
 
Patent # 325681
Therapeutic Methods and Compositions Involving Isoflavones

 
UNITED STATES
 
Patent # 7419998
Therapeutic Methods and Compositions Involving Isoflavones
 
Patent # 7488494
Compositions and Therapeutic Methods Involving Isoflavones and Analogues Thereof
 
Patent # RE40,792
Health Supplements Containing Phyto-Oestrogens, Analogues of Metabolites Thereof (Re-issue of Patent # 5830887)
 
 
 
JAPAN
 
Patent # 4197736
Process for Glucan Preparation and Therapeutic Uses of Glucan
 
Patent # 4256679
Treatment of Restenosis

 
CHINA
 Patent # ZL02809019.5
Dimeric Isoflavones

 
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These grants bring the number of patents issued to 108.

Trademark Protection

The Company also seeks IP protection through trademark registration of product names and corporate logos. The Company has an active program of registering all product trademarks in significant markets.

Licensing Arrangements

In 1997, the Company granted an exclusive royalty-bearing license, with the right to grant sublicenses, to Protein Technologies International, then a subsidiary of Ralston Purina Company (“PTI”), covering three of the Company’s patent applications (and U.S. patents arising from such applications) for the development and commercialization of prescription and non-prescription drug products and dietary health supplements in which the biologically active component is derived from soy and consists of at least one isoflavone covered by one of the licensed patent applications (or U.S. patents arising from such applications). Subsequent to the Company’s grant of the license, U.S. patents were issued for all three patent applications. The geographical territory of the license is worldwide, with the exception of Australia and New Zealand. In 1997, Dupont acquired PTI and PTI subsequently changed its name to Solae LLC (“Solae”) in connection with a joint venture that it entered into with Bunge Ltd. In 2004, the parties amended the license to revise the schedule of minimum annual payments and to provide for payment to be made by Solae to the Company in the event that Solae sells its isoflavone drug program. The license was transferred to Archer Daniels Midland Company (“ADM”) in 2005.

Under the terms of the transfer, ADM assumed the rights and obligations formally held by Solae, including the obligation to make minimum annual payments and royalty payments to the Company. Notwithstanding the transfer of the license agreement, Solae remains obligated to make payment to the Company in the event that Solae sells its isoflavone drug program. The license agreement will terminate upon the expiration or invalidation of the last of the patent applications and/or patent rights that it covers.

The Company received minimum annual payments from ADM of U.S. $1,250,000 and U.S. $1,320,000 in the calendar years 2007 and 2008, respectively. ADM is also required to make the following future minimum annual payments to the Company:

 
(i)
U.S. $1,430,000 due by December 31, 2009;

 
(ii)
U.S. $1,540,000 due by December 31, 2010;

 
(iii)
U.S. $1,670,000 due by December 31, 2011; and

 
(iv)
U.S. $2,000,000 by December 31, 2012 and annually thereafter for so long as the agreement is in effect.

The annual royalties payable under the terms of the agreement are computed at various percentages of ADM’s cumulative net sales of prescription and non-prescription drug products and dietary health supplements covered by the licensed patents.  ADM must pay the Company a certain percentage of its cumulative net sales of the covered
 
 
22
 
 
products as annual royalties until the cumulative net sales reach a certain dollar amount.  Thereafter, as the cumulative net sales increase to certain specified dollar amount tiers, the percentage payable as royalties decreases with each tier. In connection with agreement, the Company received royalty income from ADM of A$1.6 million and A$1.4 million in fiscal years 2009 and 2008, respectively.

Australian Government

The activities of the Company are subject to numerous Australian laws and regulations, including those described below.

The Australian Corporations Law is the main body of law governing companies incorporated in Australia, such as Novogen and its Australian subsidiaries. The Australian Securities and Investments Commission is an Australian Government organization which administratively enforces legislation covering matters such as directors’ duties and responsibilities, preparation of accounts, auditor control, issue and transfer of shares, control of shareholders’ meetings, rights of minority interests, amendments to capital structure, preparation and filing of public documents such as annual reports, changes in directors and changes to capital.

The ASX imposes listing rules on all listed companies, such as Novogen. The rules cover issues such as continuous and immediate disclosure to the market of relevant information, periodic financial reporting and the prior approval of reports to shareholders.

The Company believes that it materially complies with the foregoing Australian laws and regulations pertaining to public and private companies.

The Company’s products and manufacturing facilities also are regulated by various Australian federal and state authorities. The Company’s manufacturing facilities hold the appropriate licenses concerning the manufacture of health products.

Regulatory Requirements

Australian Regulatory Requirements
 
The Therapeutic Goods Act 1989, or 1989 Act, sets out the legal requirements for the import, export, manufacture and supply of pharmaceutical products in Australia. The 1989 Act requires that all pharmaceutical products to be imported into, supplied in, manufactured in or exported from Australia be included in the Australian Register of Therapeutic Goods, or ARTG, unless specifically exempted under the Act.
 
Medicines with a higher level of risk (prescription medicines, some non-prescription medicines) are evaluated for quality, safety and efficacy and are registered on the ARTG. Medicines with a lower risk (over the counter medicines including vitamins) are assessed only for quality and safety. Medicines included in the ARTG can be identified by the AUST R number (for registered medicines) or an AUST L number (listed medicines) that appears on the packaging of the medicine.

 
23
 
 
In order to ensure that a product can be included in the ARTG, a sponsoring company must make an application to the Therapeutic Goods Administration, or TGA. The application usually consists of a form accompanied by data (based on the European Union requirements) to support the quality, safety and efficacy of the product for its intended use and payment of a fee. Application details are available on the TGA website http://www.tga.gov.au.

The TGA requires a 26B certificate from Applicants who are required to submit safety and efficacy data when making their application, and who, when making their application, rely on data previously submitted to the TGA by another person in relation to an approved product. This certificate states that the applicants will not enter the market with a product that would infringe a patent on the product; or, that they have notified the patent owner of their intention to enter the market before the expiry of any applicable patent. All other applicants may provide notice that such a certificate is not required.

The first phase of evaluation, known as the Application Entry Process, is usually a short period during which an application is assessed on an administrative level to ensure that it complies with the basic guidelines. The TGA may request further details from the applicant, and may agree with sponsors that additional data (which while not actually required by the application, could enhance the assessment outcome) may be submitted later at an agreed time. The TGA must decide within at least 40 working days whether it will accept the application for evaluation.

Once an application is accepted for evaluation, aspects of the data provided are allocated to evaluators within the different relevant sections, who prepare clinical evaluation reports. Following evaluation, the chemistry and quality control aspects of a product may be referred to a Pharmaceutical Sub-Committee (PSC), which is a sub-committee of the TGA prescription medicine expert advisory committee, the Australian Drug and Evaluation Committee (ADEC) to review the relevant clinical evaluation reports.

The clinical evaluation reports (along with any resolutions of the ADEC sub-committee) are then sent to the sponsoring company who then has the opportunity to comment on the views expressed within the evaluation report, provide corrections and to submit supplementary data to address any issues raised in the evaluation reports.

Once the evaluations are complete, the TGA prepares a summary document on the key issues on which advice will be sought from the either the ADEC (for new medicines) or from the Peer Review Committee (PRC) for existing or generic products. This summary is sent to the sponsoring company which is able to submit a response to the ADEC or PRC dealing with issues raised in the summary and those not previously addressed in the evaluation report. The ADEC/PRC provide independent advice on the quality, risk-benefit, effectiveness and access of the product and conduct medical and scientific evaluations of the application.
 
 
24
 
 
The ADEC meets every 2 months to examine the applications referred by the TGA and its resolutions are provided to the sponsoring company after 5 working days after the ADEC meeting.

The TGA takes into account the advice of the ADEC or PRC in reaching a decision to approve or reject a product. Any approval for registration on the ARTG may have conditions associated with it.

From the time that the TGA accepts the initial application for evaluation, the TGA must complete the evaluation and make a decision on the registration of the product within at least 255 working days. If not completed within 255 working days, the TGA forfeits 25% of the evaluation fee otherwise payable by the sponsor, but any time spent waiting for a response from the sponsor is not included in the 255 working days. The TGA also has a system of priority evaluation for products that meet certain criteria, including where the product is a new chemical entity that it is not otherwise available on the market as an approved product, and is for the treatment of a serious, life-threatening illness for which other therapies are either ineffective or not available.
 
 
U.S. Regulatory Requirements
 
The FDA, and comparable regulatory agencies in other countries, regulate and impose substantial requirements upon the research, development, pre-clinical and clinical testing, labeling, manufacture, quality control, storage, approval, advertising, promotion, marketing, distribution and export of pharmaceutical products including biologics, as well as significant reporting and record-keeping obligations. State governments may also impose obligations in these areas.

In the U.S., pharmaceutical products are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act or FDCA and other laws including in the case of biologics, the Public Health Service Act. The Company believes, but cannot be certain, that its products will be regulated as drugs by the FDA. The process required by the FDA before drugs may be marketed in the U.S. generally involves the following:


·  
pre-clinical laboratory evaluations, including formulation and stability testing, and animal tests performed under the FDA’s Good Laboratory Practices regulations to assess potential safety and effectiveness;

·  
submission and approval of an Investigational New Drug Application, or IND, including results of pre-clinical tests, manufacturing information and protocols for clinical studies, which must become effective before clinical trials may begin in the U.S.;

·  
obtaining approval of Institutional Review Boards, or IRB’s, to administer the products to human subjects in clinical trials;
 
 

 
 
25
 
 
·  
adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for the product’s intended use;
 
·  
development of manufacturing processes which conform to FDA current Good Manufacturing Practices, or cGMPs, as confirmed by FDA inspection;

·  
submission of pre-clinical and clinical studies results, and chemistry, manufacturing and controls, or CMC, information on the product to the FDA in a New Drug  Application, or NDA; and

·  
FDA review and approval of a NDA, prior to any commercial sale or shipment of a product.

The testing and approval process requires substantial time, effort, and financial resources, and the Company cannot be certain that any approval will be granted on a timely basis, if at all.

Pre-clinical tests and studies can take several years to complete, and there is no guarantee that an IND the Company or its subsidiaries submit based on such tests and studies will become effective within any specific time period, if at all.

Human clinical trials are typically conducted in three sequential phases that may overlap.

    Phase I: The drug is initially introduced into healthy human subjects or patients and tested for safety and dosage tolerance. Absorption, metabolism, distribution, and excretion testing is generally performed at this stage.

    Phase II: The drug is studied in controlled, exploratory therapeutic trials in a limited number of subjects with the disease or medical condition for which the new drug is intended to be used in order to identify possible adverse effects and safety risks, to determine the preliminary or potential efficacy of the product for specific targeted diseases or medical conditions, and to determine dosage tolerance and the optimal effective dose.

    Phase III: When Phase II studies demonstrate that a specific dosage range of the drug is likely to be effective and the drug has an acceptable safety profile, controlled, large-scale therapeutic Phase III trials are undertaken at multiple study sites to demonstrate clinical efficacy and to further test for safety in an expanded patient population.

The Company cannot be certain that it will successfully complete Phase I, Phase II, or Phase III testing of its products within any specific time period, if at all. Furthermore, the FDA, the IRB or the Company may suspend or terminate clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.

 
26
 
 
Results of pre-clinical studies and clinical trials, as well as detailed information about the manufacturing process, quality control methods, and product composition, among other things, are submitted to the FDA as part of a NDA seeking approval to market and commercially distribute the product on the basis of a determination that the product is safe and effective for its intended use. Before approving a NDA, the FDA will inspect the facilities at which the product is manufactured and will not approve the product unless cGMP compliance is satisfactory. If applicable regulatory criteria are not satisfied, the FDA may deny the NDA or require additional testing or information. As a condition of approval, the FDA also may require post-marketing testing or surveillance to monitor the product’s safety or efficacy. Even after a NDA is approved, the FDA may impose additional obligations or restrictions (such as labeling changes), or even suspend or withdraw a product approval on the basis of data that arise after the product reaches the market, or if compliance with regulatory standards is not maintained. The Company cannot be certain that any NDA the Company or its subsidiaries submit will be approved by the FDA on a timely basis, if at all. Also, any such approval may limit the indicated uses for which the product may be marketed. Any refusal to approve, delay in approval, suspension or withdrawal of approval, or restrictions on indicated uses could have a material adverse impact on the Company’s business prospects.

Each NDA must be accompanied by a user fee, pursuant to the requirements of the Prescription Drug User Fee Act, or PDUFA, and its amendments. According to the FDA’s fee schedule, effective on October 1, 2008 for the fiscal year 2009, the user fee for an application requiring clinical data, such as a NDA, is $1,247,200. The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also imposes an annual product fee for prescription drugs and biologics ($71,520), and an annual establishment fee ($425,600) on facilities used to manufacture prescription drugs and biologics. A written request can be submitted for a waiver for the application fee for the first human drug application that is filed by a small business, but there are no waivers for product or establishment fees. The Company is not at the stage of development of its products where the Company is subject to these fees, but they are significant expenditures that may be incurred in the future and must be paid at the time of application submissions to FDA.

Satisfaction of FDA requirements typically takes several years. The actual time required varies substantially, based upon the type, complexity, and novelty of the pharmaceutical product, among other things. Government regulation imposes costly and time-consuming requirements and restrictions throughout the product life cycle and may delay product marketing for a considerable period of time, limit product marketing, or prevent marketing altogether. Success in pre-clinical or early stage clinical trials does not ensure success in later stage clinical trials. Data obtained from pre-clinical and clinical activities are not always conclusive and may be susceptible to varying interpretations that could delay, limit, or prevent marketing approval. Even if a product receives marketing approval, the approval is limited to specific clinical indications. Further, even after marketing approval is obtained, the discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.

 
27
 
 
After product approval, there are continuing significant regulatory requirements imposed by the FDA, including record-keeping requirements, obligations to report adverse side effects in patients using the products, and restrictions on advertising and promotional activities. Quality control and manufacturing procedures must continue to conform to cGMPs, and the FDA periodically inspects facilities to assess cGMP compliance. Additionally, post-approval changes in ingredient composition, manufacturing processes or facilities, product labeling, or other areas may require submission of a NDA Supplement to the FDA for review and approval. New indications will require additional clinical studies and submission of a NDA Supplement. Failure to comply with FDA regulatory requirements may result in an enforcement action by the FDA, including warning letters, product recalls, suspension or revocation of product approval, seizure of product to prevent distribution, impositions of injunctions prohibiting product manufacture or distribution, and civil and criminal penalties. Maintaining compliance is costly and time-consuming. The Company cannot be certain that the Company, or its present or future suppliers or third-party manufacturers, will be able to comply with all FDA regulatory requirements, and potential consequences of noncompliance could have a material adverse impact on the Company’s business prospects.

The FDA’s policies may change, and additional governmental regulations may be enacted that could delay, limit, or prevent regulatory approval of the Company’s products or affect the Company’s ability to manufacture, market, or distribute its products after approval. Moreover, increased attention to the containment of healthcare costs in the U.S. and in foreign markets could result in new government regulations that could have a material adverse effect on the Company’s business. The Company’s failure to obtain coverage, an adequate level of reimbursement, or acceptable prices for its future products could diminish any revenues the Company may be able to generate. The Company’s ability to commercialize future products will depend in part on the extent to which coverage and reimbursement for the products will be available from government and health administration authorities, private health insurers, and other third-party payers. European Union member states and U.S. Government and other third-party payers increasingly are attempting to contain healthcare costs by consideration of new laws and regulations limiting both coverage and the level of reimbursement for new drugs. The Company cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad.

The Company’s activities also may be subject to state laws and regulations that affect the Company’s ability to develop and sell its products. The Company is also subject to numerous federal, state, and local laws relating to such matters as safe working conditions, clinical, laboratory, and manufacturing practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances. The Company may incur significant costs to comply with such laws and regulations now or in the future, and the failure to comply may have a material adverse impact on its business prospects.

 
28
 
 
The FDCA includes provisions designed to facilitate and expedite the development and review of drugs and biological products intended for treatment of serious or life-threatening conditions that demonstrate the potential to address unmet medical needs for such conditions. These provisions set forth a procedure for designation of a drug as a “fast track product.” The fast track designation applies to the combination of the product and specific indication for which it is being studied. A product designated as fast track is ordinarily eligible for additional programs for expediting development and review, but products that are not in fast track drug development programs may also be able to take advantage of these programs. These programs include priority review of NDAs and accelerated approval. Drug approval under the accelerated approval regulations may be based on evidence of clinical effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. A postmarketing clinical study will be required to verify clinical benefit, and other restrictions to assure safe use may be imposed.

Under the Drug Price Competition and Patent Term Restoration Act of 1984 a sponsor may obtain marketing exclusivity for a period of time following FDA approval of certain drug applications, regardless of patent status, if the drug is a new chemical entity or if new clinical studies were required to support the marketing application for the drug. This marketing exclusivity prevents a third party from obtaining FDA approval for an identical or nearly identical drug under an Abbreviated New Drug Application or a “505(b)(2) New Drug Application.” The statute also allows a patent owner to obtain an extension of applicable patent terms for a period equal to one-half the period of time elapsed between the filing of an IND and the filing of the corresponding NDA plus the period of time between the filing of the NDA and FDA approval, with a five year maximum patent extension. The Company cannot be certain that it will be able to take advantage of either the patent term extension or marketing exclusivity provisions of these laws.

The Best Pharmaceuticals for Children Act, or BPCA, signed into law on January 4, 2002, was reauthorized and amended by the FDA Amendments Act of 2007 or FDAAA.  The reauthorization of BPCA provides an additional six months of patent protection to NDA applicants that conduct acceptable pediatric studies of new and currently-marketed drug products for which pediatric information would be beneficial, as identified by FDA in a Pediatric Written Request. The Pediatric Research Equity Act, or PREA, signed into law on December 3, 2003, also was reauthorized and amended by FDAAA.  The reauthorization of PREA requires that most applications for drugs and biologics include a pediatric assessment (unless waived or deferred) to ensure the drugs' and biologics' safety and effectiveness in children.  Such pediatric assessment must contain data, gathered using appropriate formulations for each age group for which the assessment is required, that are adequate to assess the safety and effectiveness of the drug or the biological product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the drug or the biological product is safe and effective.  The pediatric assessments can only be deferred provided there is a timeline for the completion of such studies.  The FDA may waive (partially or fully) the pediatric assessment requirement for several reasons, including if the applicant can demonstrate that reasonable attempts to produce a pediatric formulation necessary for that age group have failed.

 
29
 
 
European Union Regulatory Requirements

Outside the U.S., the Company’s ability to market products will also be contingent upon receiving marketing authorizations from the appropriate regulatory authorities and compliance with applicable post-approval regulatory requirements. Although the specific requirements and restrictions vary from country to country, as a general matter, foreign regulatory systems include risks similar to those associated with FDA regulation, described above. Under EU regulatory systems, marketing authorizations may be submitted either under a centralized or a national procedure. Under the centralized procedure, a single application to the European Medicines Agency (EMEA) leads to an approval granted by the European Commission which permits the marketing of the product throughout the EU. The centralized procedure is mandatory for certain classes of medicinal products, but optional for others. For example, all medicinal products developed by certain biotechnological means, and those developed for cancer and other specified diseases and disorders, must be authorized via the centralized procedure. The Company assumes that the centralized procedure will apply to its products that are developed by means of a biotechnology process. The national procedure is used for products that are not required to be authorized by the centralized procedure. Under the national procedure, an application for a marketing authorization is submitted to the competent authority of one member state of the EU. The holders of a national marketing authorization may submit further applications to the competent authorities of the remaining member states via either the decentralized or mutual recognition procedure. The decentralized procedure enables applicants to submit an identical application to the competent authorities of all member states where approval is sought at the same time as the first application, while under the mutual recognition procedure, products are authorized initially in one member state, and other member states where approval is sought are then requested to recognize the original authorization based upon an assessment report prepared by the original authorizing competent authority. Both the decentralized and mutual recognition procedures should take no longer than 90 days, but if one member state makes an objection, which under the legislation can only be based on a possible risk to human health, the application will be automatically referred to the Committee for Medicinal Products for Human Use (CHMP) of the EMEA. If a referral for arbitration is made, the procedure is suspended. However, member states that have already approved the application may, at the request of the applicant, authorize the product in question without waiting for the result of the arbitration. Such authorizations will be without prejudice to the outcome of the arbitration. For all other concerned member states, the opinion of the CHMP, which is binding, could support or reject the objection or alternatively could reach a compromise position acceptable to all EU countries concerned. The arbitration procedure may take an additional year before a final decision is reached and may require the delivery of additional data.
 
As with FDA approval the Company may not be able to secure regulatory approvals in Europe in a timely manner, if at all. Additionally, as in the U.S., post-approval regulatory requirements, such as those regarding product manufacture, marketing, or distribution, would apply to any product that is approved in Europe, and failure to comply with such obligations could have a material adverse effect on the Company’s ability to successfully commercialize any product.
 
 
30
 
 
The conduct of clinical trials in the European Union is governed by the European Clinical Trials Directive (2001/20/EC), which was implemented in May 2004. This Directive governs how regulatory bodies in member states control clinical trials. No clinical trial may be started without a clinical trial authorization granted by the national competent authority and favorable ethics approval.
 
Accordingly, there is a marked degree of change and uncertainty both in the regulation of clinical trials and in respect of marketing authorizations which face the Company for its products in Europe.

 
31
 
 
Organizational Structure

Corporate Structure
Novogen Limited is a company limited by shares and is incorporated and domiciled in Australia. Novogen Limited and its controlled entities “Novogen” or the “Group” have prepared a consolidated financial report incorporating the entities that Novogen Limited controlled during fiscal 2009, which included the following controlled entities:


Name of Entity
Country of Incorporation
Ownership % +
Novogen Laboratories Pty Ltd
Australia
100
Novogen Research Pty Ltd
Australia
100
Novogen Inc
U.S.A.
100
Glycotex, Inc
U.S.A.
80.7
Novogen Limited(U.K.)
U.K.
100
Promensil Limited
U.K.
100
Novogen BV
Netherlands
100
Novogen New Zealand Limited
New Zealand
100
Novogen Canada Limited
Canada
100
Marshall Edwards, Inc.
U.S.A.
71.3
Marshall Edwards Pty Limited
Australia
71.3
 

* Indirect ownership through Marshall Edwards, Inc.
+ Ownership % at June 30, 2009.

Property, Plant and Equipment

The pilot plant used for the manufacture of the small scale synthetic drug compounds  is located in the Company’s leased premises in North Ryde, Sydney. The North Ryde premises occupies 1,088 square meters. These premises are also used as Novogen’s corporate headquarters. The Company owns the equipment used in the pilot plant. The plant has enough capacity to produce clinical trial quantities up to Phase II of the Company’s product candidates.

The Company’s major isoflavone extraction manufacturing plant was located in Wyong in New South Wales. This plant was used to manufacture the active raw material used in the Company’s dietary supplement products. The Company owned the land and buildings at Wyong site which covers an area of approximately 3.37 hectares. The Company also owned the equipment used in the extraction process and laboratories.  In May 2007 the Company announced that it had entered into new arrangements for the worldwide supply of isoflavones used in its consumer dietary supplement products. As a result, the extraction facility located at Wyong NSW was decommissioned and the property sold.  The sale of the Wyong facility was concluded on October 10, 2007.  The Company received gross proceeds of A$4.0 million from the sale.

Item 4A.                      Unresolved Staff Comments

None

 
32
 
 
Item 5.                 Operating and Financial Review and Prospects

The following discussion and analysis should be read in conjunction with “Item 18. Financial Statements” included below. Operating results are not necessarily indicative of results that may occur in future periods. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in the forward-looking statements as a result of many factors including, but not limited to, those set forth under “Forward-Looking Statements” and “Risk Factors” in Item 3. “Key Information” included above in this Annual Report. All forward-looking statements included in this document are based on the information available to the Company on the date of this document and the Company assumes no obligation to update any forward-looking statements contained in this Annual Report.

Application of Critical Accounting Policies

The significant accounting policies are summarized in Note 1 to the Consolidated Financial Statements under Item 18 of this Annual Report.

Revenue Recognition

Revenue is recognised to the extent that it is probable that the economic benefits will flow to the Group and the revenue can be reliably measured.  In determining the economic benefits, provisions are made for certain trade discounts and returned goods.

Returns

Over the last three years, returns and estimates of return liability were not considered material and are detailed below.

  Balance at Beginning of year Charged to Cost and Expense Actual Returns Balance at End of Year
  A$'000 A$'000 A$'000 A$'000
Allowance for Sales returns:        
Year ended June 30, 2007 96 380 351 125
Year ended June 30, 2008 125 145 223 47
Year ended June 30, 2009 47 277 288 36
 

 
 
33
 
 
Discounts

Discounts are generally calculated as deductions off the Company’s invoice price and as such do not require significant judgment in determining accrual amounts.  Over the last three years, the discounts and estimate of claims were not considered material and are detailed below:
 
         
  Balance at Beginning of year Charged to Cost and Expense Actual Discounts Balance at     End of Year
  A$'000 A$'000 A$'000 A$'000
Allowance for Sales discounts:        
Year ended June 30, 2007 137 688 708 117
Year ended June 30, 2008 117 554 592 79
Year ended June 30, 2009 79 647 584 142

 

Inventory Adjustments

Inventories are measured at the lower of cost or net realizable value. The Company reviews the components of inventory on a regular basis for excess, obsolete and impaired inventory based on estimated future usage and sales. The likelihood of any material inventory write-downs is dependent on rapid changes in customer demand or new product introductions by competitors.
 
 
For additional information on significant accounting policies refer to Item 18 “Financial Statements” - Note 1 – “Summary of Significant Accounting Policies”.

 
34
 
 
Results of Operations

The following table provides a summary of revenues and expenses to supplement the more detailed discussions below:
 
INCOME STATEMENTS
                       
for the year ended June 30, 2009
                       
   
Consolidated
 
   
2009
   
2008
   
2007
   
2009
 
   
A$'000
   
A$'000
   
A$'000
   
US$'000
 
Continuing Operations
                       
Revenue
    11,147       13,283       17,295       8,979  
Cost of sales
    (2,523 )     (4,090 )     (6,945 )     (2,032 )
                                 
Gross profit
    8,624       9,193       10,350       6,947  
                                 
Other income
    -       1,623       2,710       -  
                                 
Research & development expenses
    (18,788 )     (18,811 )     (16,134 )     (15,134 )
Selling & promotional expenses
    (6,572 )     (6,134 )     (7,908 )     (5,294 )
Shipping and handling expenses
    (341 )     (300 )     (392 )     (275 )
General and administrative expenses
    (6,671 )     (9,792 )     (12,902 )     (5,373 )
Other expenses
    (27 )     (528 )     (17 )     (21 )
Finance costs
    (11 )     (24 )     (2 )     (9 )
                                 
Loss before income tax
    (23,786 )     (24,773 )     (24,295 )     (19,159 )
                                 
Income tax expense
    (1 )     (4 )     (1 )     (1 )
                                 
                                 
Loss for the period
    (23,787 )     (24,777 )     (24,296 )     (19,160 )
                                 
Loss attributable to minority interest
    4,859       4,513       4,315       3,914  
                                 
Loss attributable to members of Novogen Limited
    (18,928 )     (20,264 )     (19,981 )     (15,246 )
                                 
Basic and diluted earnings/(loss) per share (cents)
    (18.6 )     (20.8 )     (20.5 )     (15.0 )

 
 
35
 
 
Operating Results – Fiscal 2009 compared to Fiscal 2008

Revenue

The Group earned gross revenues for the year ended June 30, 2009 of A$11.1 million versus A$13.3 million in the previous corresponding period, a reduction of A$2.2 million. The reduction in revenue was due to decreased sales of the Group’s consumer health care products of A$1.1 million or 12%. Other revenue also reduced by A$1.1 million to A$2.8 million verses A$3.9 million for the previous corresponding period. The decrease in other revenue was mainly due to the reduced interest received on cash balances reflecting lower global interest rates.

Consumer product sales

Sales of consumer health care products decreased by A$1.1 million to A$8.3 million for the twelve months ended June 30, 2009 from A$9.4 million for the twelve months ended June 30, 2008.

Sales in Australasia (including sales to export markets) for the year ended June 30, 2009 were A$4.9 million, an increase of A$0.1 million or 2% from A$4.8 million for the previous year. Canadian sales for the year ended June 30, 2009 reduced by A$0.2 million to A$2.1 million from A$2.3 million for the previous 12 month period. The reduction was due to difficult market conditions and a significant downturn in the consumer market for menopause products. Sales revenue in the UK decreased by A$0.3 million to A$1.4 million for the twelve month period to June 30, 2009 compared to A$1.7 million for the same period last year. The UK sales decline was caused by the economic downturn with consumers turning away from premium brands and a reduction in the supplement market for menopause.


Costs and expenses

Total expenses before interest and tax decreased by A$4.8 million to A$34.9 million for the year ended June 30, 2009 compared to A$39.7 million for the year ended June 2008. Cost of sales, which includes only costs associated with the sale of goods, decreased A$1.6 million corresponding with reduced sales from Europe and Canada and improved gross margins on consumer product sales through sourcing active ingredients from a lower cost third party manufacturer, following the decision to close the Company’s production facility at Wyong NSW in 2007. Sales of product manufactured from lower cost active commenced during fiscal year 2008 having a favourable impact on cost of sales for part of that year. Cost of sales as a percentage of sales in fiscal year 2009 continued to decline due to the annualized impact of a lower cost active ingredient. General and Administrative Expenses were favourably impacted by A$3.1 million due primarily to favourable currency movements. These savings were partially offset by an increase in selling and promotional expense of A$0.4 million. This increase was due to expenses associated with a decision to discontinue the weight loss product Aliten following disappointing consumer uptake post launch.
 
Net loss
 
The operating loss attributable to Novogen shareholders for the financial year, after allowing for losses attributable to minority interests of A$4.9 million, reduced by A$1.4 million to A$18.9 million from a loss of A$20.3 million for the previous year.

The net loss from ordinary activities after income tax for the consolidated Group for the year ended June 30, 2009 reduced by A$1.0 million to $23.8 million from A$24.8 million for the previous year. The reduction in the Group’s net loss for the year ended June 30, 2009 was due to reduced revenues and other incomes being offset by reduced expenditures.

 
36
 
 
Operating Results – Fiscal 2008 compared to Fiscal 2007

Revenue

The Group earned gross revenues for the year ended June 30, 2008 of A$13.3 million versus A$17.3 million in the previous corresponding period, a reduction of A$4.0 million. The reduction in revenue was due to decreased sales of the Group’s consumer health care products of A$1.3 million or 12%. The decrease in sales in fiscal 2007 to fiscal 2008 was mainly due to the Company’s licensing of its U.S. consumer health care products to Natrol, Inc. in 2007. Other revenue for the fiscal year ended June 30, 2008 was A$3.9 million, which represented a decrease of A$2.7 million from A$6.6 million for the fiscal year ended June 30, 2007.  Other revenue was higher in fiscal 2007 than fiscal 2008 due to the Company’s receipt of one time license fees from Natrol Inc. and litigation settlement amounts from Sante Naturelle and Chattem Inc. in connection with license and patent infringement in the U.S. and Canada.

Consumer product sales

Sales of consumer health care products decreased by A$1.3 million to A$9.4 million for the twelve months ended June 30, 2008 from A$10.7 million for the twelve months ended June 30, 2007.

Sales in Australasia (including sales to export markets) for the year ended June 30, 2008 were A$4.8 million, an increase of A$0.3 million or 7% from A$4.5 million for the previous year. The increase was due to the launch of Promensil Double Strength formulation and Promensil Vitality products. There was no sales revenue from the U.S. as consumer products were licensed to Natrol, Inc. from the end of October 2006 and this represents a reduction of A$1.4 million for the twelve month period to June 30 last year. Canadian sales for the year ended June 30 2008 increased by A$0.6 million to A$2.3 million up from A$1.7 million for the previous 12 month period, due to the launch of Promensil Double Strength formulation and increased volume sales as a result of promotional programs. Sales revenue in Europe decreased by A$0.9 million to A$2.2 million for the twelve month period to June 30, 2008 compared to A$3.1 million for the same period last year. The European sales decline was caused by a reduction in the supplement market for menopause.

During the year ended June 30, 2008 the Group expanded its consumer health care business with the introduction of Promensil into Belgium. The Company also entered into a third party distribution agreement in the Netherlands in an effort to maximise the contribution from the territory.

Costs and expenses

Total expenses before interest and tax decreased by A$4.6 million to A$39.7 million for the year ended June 30, 2008 compared to A$44.3 million for the year ended June 30, 2007. Cost of sales, which includes only costs associated with the sale of goods, decreased A$2.9 million corresponding with reduced sales from the licence of the U.S. health products.
 
 
37
 
 
Savings were also achieved as a result of disposing of the Wyong production facility and sourcing active ingredients from a lower cost third party manufacturer. This resulted in improved gross margins on consumer product sales and a reduction in cost of sales as a percentage of sales in fiscal year 2008 compared to the prior year. Selling and promotional expenses decreased by A$1.8 million to A$6.1 million which was also related to the licence of the U.S. health products in the prior year with U.S. expenses not recurring in fiscal 2008. Research and development expenses increased by A$2.7 million compared to the corresponding period last year. The increase was primarily due to expenses associated with the Phase III OVATURE clinical trial being conducted by MEI. Research and development expenses also reflected an increase in costs associated with the development of glucoprime the Company’s glucan based product being developed by Novogen’s subsidiary Glycotex. General and administration expenses were reduced by A$3.1 million due to one-off amounts of A$2.1 million representing non-cash, share based payments incurred by MEI in establishing the Standby Equity Distribution Agreement (“SEDA”) and a A$1.4 million employee termination payment which were incurred in the financial year ended June 30, 2007 and which were not incurred in the June 30, 2008 year.

Net loss
 
The operating loss attributable to Novogen shareholders for the financial year, after allowing for losses attributable to minority interests of A$4.5 million, increased by A$0.3 million to A$20.3 million from a loss of A$20.0 million for the previous year.

The net loss from ordinary activities after income tax for the consolidated group for the year ended June 30, 2008 increased by A$0.5 million to A$24.8 million from A$24.3 million for the previous year. The increase in the Group’s net loss for the year ended June 30, 2008 was due to reduced revenues and other incomes being largely offset by reduced expenditures.

Liquidity and capital resources

The Company has continued to finance its operations primarily from equity capital.
 
 
Cash resources

At June 30, 2009 the Group had total funds of A$33.3 million a reduction of A$4.1 million from the previous year’s balance of A$37.4 million.

During fiscal 2009, the Company had net cash outflows from operating activities of A$20.6 million compared to cash outflows of A$20.1 million in fiscal 2008. Cash was used to fund the Group’s operations including the OVATURE clinical trial program for the investigational anti-cancer drug phenoxodiol being undertaken by MEI and the clinical development of the investigational wound healing compound GLYC-101 by Glycotex. Cash resources were also used to fund the ongoing programs in the areas of cardiovascular and anti-inflammatory research and development.

On July 28, 2008 MEI entered into a securities subscription agreement with Oppenheimer Funds, Inc. and Novogen Limited pursuant to which MEI sold 1,700,000 and 2,908,295 shares of common stock to Oppenheimer and Novogen respectively, at a purchase price of US$2.17 per share.
 
 
38
 
 
The aggregate proceeds to MEI from the sale of shares was US$10,000,000. The shares are registered under the U.S. Securities Act of 1933, as amended, pursuant to an effective shelf registration statement. On July 30, 2008 MEI filed a Prospectus Supplement to the registration statement covering the sale of shares to Oppenheimer and Novogen.

On July 29, 2008 the Company entered into a Share Subscription Agreement with El Coronado Holdings LLC for the placement of 4,531,633 ordinary shares at a purchase price of A$1.2215 per share raising gross proceeds of A$5,535,390. Following the placement El Coronado Holdings LLC holds 19.9% of the Company’s issued and outstanding shares.

In February 2009, the Company announced that it would focus its activities on its oncology program. 

With the current economic climate making capital raising for extended programs difficult, the Company is relying on its internal resources to concentrate on the expanding oncology portfolio. 

Along with this decision, the Company has taken several steps to reduce costs so that existing cash reserves are devoted to maintaining the significant potential of the oncology program. 

Among cost reduction measures are: 

 
·  
outsourcing of the scale-up manufacturing of clinical stage compounds;
 
 
·  
putting on hold the cardiovascular and anti-inflammatory programs;
 
 
·  
reducing world wide staff numbers from 62 to 48;
 
 
·  
fee and income reductions of 20 per cent for the Board and executive management.
 

The Company invests its cash and cash equivalents in interest bearing facilities with various maturity dates. At the end of fiscal 2009, deposits amounting to A$5.5 million had a weighted average interest rate of 3.62% and cash deposits of A$27.8 million had a weighted average interest rate of 0.58%.

The Company has arranged a multi option facility with St George Bank Limited, an Australian commercial bank, of A$1.0 million, A$0.5 million of which was unused at the end of fiscal 2009.

As of June 30, 2009, the Group did not hold derivative financial instruments in managing its foreign currency, however, the Company may from time to time enter into hedging arrangements where circumstances are deemed appropriate.
 
 The Company believes that the proceeds from the July 2008 share placement  and savings generated by MEI ceasing new enrolment into the OVATURE Phase III clinical trial will provide sufficient cash resources to fund operations over the next twelve months.

 
39
 
 
The Company will require additional funds in order complete the planned clinical development programs beyond the current objectives. As a result of the uncertainty in the financial markets, the Company does not anticipate being able to raise additional funds through the equity markets in the short term. In order to obtain the additional funding necessary to conduct the business, the Company may need to rely on collaboration and /or licensing opportunities.

The Company cannot assure you that it will be able to raise the funds necessary to complete the OVATURE clinical trial and other research programs, or find appropriate collaboration or licensing opportunities.

There are no commitments for capital expenditure outstanding at the end of the financial year.

See Note 18 to the Financial Statements “Financial Instruments” for disclosures about financial risk management including interest rate risk, foreign currency risk and liquidity risk.

Research and Development

Research and development policy

Expenditure during the research phase of a project is recognised as an expense when incurred. Development costs are capitalised only when technical feasibility studies identify that the project will deliver future economic benefits and these benefits can be measured reliably.

Development costs have a finite life and are amortised on a systematic basis matched to the future economic benefits over the useful life of the project.

The Company spent A$18.8 million, A$18.8 million and A$16.1 million on gross research and development expenditure during fiscal 2009, 2008 and 2007 respectively.
 
 
Due to the nature and uncertainty of the research and development projects being undertaken by the Company, it is not possible to reasonably estimate the cost and timing of project completion. The costs of research and development projects are not estimated on a project by project basis. An analysis of costs between projects may only be performed on an arbitrary and subjective basis.

The progress on research and development projects and expenses is monitored and controlled in a number of ways:

·  
All third party research and development, including the conduct of clinical trials, are carried out under contract. The contract details include project milestones and expenditure budgets. Senior Novogen research and development staff monitor the projects to ensure that milestones are achieved in a timely manner.
 

 
 
40
 
 
·  
In-house research and development is managed by the Research and Development Director and senior research and development staff. Budgets are prepared annually and agreed upon by the Novogen Board. Expenses are monitored monthly, actual versus budget by expense line and in total.

Trend Information

The Company expects to consume cash and incur operating losses for the foreseeable future. The Company also expects to continue its expenditure on advancing its research initiatives in discovering new and more advanced pharmaceutical compounds in the area of phenolic compound technology.

With the current economic climate making capital raising for extended clinical development programs difficult, the Company is relying on its internal resources to concentrate on the expanding oncology portfolio particularly the triphendiol human clinical development program and the pre-clinical development program for NV-128 that is currently underway. 

The impact on cash resources and results from operations will vary with the extent and timing of the future clinical trial program. It is not possible to make accurate predictions of future operating results.

Off-Balance Sheet Arrangements

The Company does not have any off-balance sheet arrangements.

Table of Contractual Obligations

The following table summarizes the Company’s future payment obligations and commitments as at June 30, 2009.
 
         
Payments due by period
 
In A$000's
 
Total
   
Less than 1 year
   
1-3 years
   
4-5 years
   
After 5 years
 
                               
                               
Operating Leases
    574       490       84             -  
Other Expenditure Commitments *
    2,639       1,797       842       -       -  
                                         
Total Contractual Cash Obligations
    3,213       2,287       926       -       -  
                                         
                                         
* represents research and development contracts for services to be rendered.
                 
 
 
 
41
 
 
Item 6.                 Directors, Senior Management and Employees.

DIRECTORS

The names and details of the Company’s Directors during the financial year and up to the date of this report are as follows:
 
Mr. Philip A. Johnston (Chairman)
Mr. Christopher Naughton (Managing Director) – employment ceased December 1, 2009
Professor Alan J. Husband (Executive Director)
Mr. Geoffrey M. Leppinus
Professor Paul J. Nestel AO
Mr. Peter B. Simpson – Retired July 28, 2009
Mr William D Rueckert – Appointed March 20, 2009

Directors were in office for the entire period unless otherwise stated.

Names, qualifications, experience and special responsibilities

Philip A Johnston Non-executive Chairman
Dip Eng (Production)

Non-executive Director since 1997, Mr Johnston was elected Chairman of Novogen Limited with effect from January 2001. Mr Johnston has extensive experience in the pharmaceutical industry including 9 years as an Executive Director of Wellcome Australia Limited. He was previously a Director of two subsidiary Companies of GlaxoWellcome. He has had responsibility for production, distribution, quality assurance and consumer product development and has been directly involved in the establishment of strategic alliances and joint ventures. He has completed a number of executive development programs including the University of NSW and the London Business School.

Other current and former directorships held in the last three years

During the last three years Mr Johnston has served as a Director of the ASX listed company, Lipa Pharmaceuticals Limited and is currently a Director of NASDAQ listed, Novogen subsidiary, Marshall Edwards, Inc. Mr Johnston’s directorship of Lipa ceased in November 2007 following a scheme of arrangement which saw Lipa ceasing as a public company at that time.

Special responsibilities

Chairman of the Board
Chairman of the Remuneration Committee
Member of the Audit Committee

Christopher Naughton Managing Director
BEc, LLB

Managing Director from March, 1997 until December 2009, Mr Naughton joined Novogen in 1996 as Commercial Director. Mr Naughton has degrees in Economics from the ANU and in Law from the UNSW.
 
 
42
 
 
He has completed the Program for Management Development at the Harvard Business School, and is an Attorney in New South Wales. After working in merchant banking, he has over 20 years experience in the pharmaceutical industry, including appointments as a Director of Wellcome Australia Limited and in worldwide business development with The Wellcome Foundation Limited in the UK.


Other current and former directorships held in the last three years

During the last three years Mr Naughton has served as CEO and Director and is currently Director of the NASDAQ listed, Novogen subsidiary, Marshall Edwards, Inc.

Special responsibilities

Chief Executive Officer
 
 
Professor Alan J Husband Executive Director
PhD, DSc, FASM

Professor Husband was appointed as a Director of Novogen Limited in May, 2006. Professor Husband has over 30 years experience in basic and applied scientific research and research management. His academic research interests in immunology and pathology have been reflected in the publication of over 200 scientific papers and several books. He currently holds a professorial appointment at the University of Sydney. These activities in basic and applied research, coupled with experience in the biotechnology industry, provided the foundations for his current appointment as Group Director of Research for the Novogen Group of companies. In this position Professor Husband is responsible for the development of the Group’s flavonoid drug technology platform. Professor Husband commenced working with the Company in 1996 and has managed the scientific discovery and clinical trial programs, including development of novel oncology, cardiovascular and anti-inflammatory therapeutics as well as wound healing technologies.

Special responsibilities

Group Director of Research

Geoffrey M Leppinus Non-executive Director
BEc, FCA

Non-executive Director since February 2005, Mr Leppinus was, until July 2002, a Senior Audit and Advisory partner of KPMG with over 30 years experience in professional accounting and auditing. At KPMG he was responsible for the audit of a number of large public companies and the Australian subsidiaries of U.S. listed public corporations. Mr Leppinus has experience in the assessment of systems of internal control over financial reporting and the financial reporting requirements applicable to listed public companies. He has also had a wide range of experience in conducting due diligence for business acquisitions. Mr Leppinus has served as a member of the Australian Auditing Standards Board and member of the State Council of the Institute of Chartered Accountants in Australia.

 
43
 
 
Special responsibilities

Chairman of the Audit Committee
Member of the Remuneration Committee

Professor Paul J Nestel Non-executive Director
AO, MD, FTSE, FRACP, FAHA, FCSANZ

Professor Nestel is currently on the Senior Faculty at the Baker Heart Research & Diabetes Institute, Melbourne. Professor Nestel is also a Consultant Physician at the Alfred Hospital, Melbourne. He is Honorary Professor of Medicine at Deakin University, Melbourne. He was formerly Clinical Professor in Medicine, The Flinders University of South Australia. Professor Nestel has been closely involved in national and international pharmaceutical trials of cardiovascular drugs. He has been and remains a member of national and international committees for research and policy on cardiovascular disease. He has published over 420 scientific and medical papers and is a Fellow of the Australian Academy of Technological Sciences and Engineering, the Royal Australasian College of Physicians, a Fellow of the American Heart Association and a Fellow of the Cardiac Society of Australia and New Zealand. Professor Nestel is an Officer of the Order of Australia and recipient of the Centenary Medal.

Other current and former directorships held in the last three years

During the last three years Professor Nestel has served as a Director and is currently a Director for the NASDAQ listed, Novogen subsidiary, Marshall Edwards, Inc.

Special responsibilities

Member of the Remuneration Committee
Member of the Audit Committee

Peter B Simpson Non-executive Director
MPharm, PhC

Non-executive Director since 1994, Mr Simpson has extensive experience in the development of pharmaceutical products for international markets. He was Research and Development Manager with David Bull Laboratories for 8 years prior to being appointed Chief Executive Officer of Biota Holdings Limited in 1987. At Biota he oversaw the research and development of an effective cure for influenza and the licensing of that discovery to Glaxo Limited. Mr Simpson is currently associated with a wide range of biotechnology and pharmaceutical interests, predominately associated with the conduct of late stage clinical studies and the commercialisation of Australian biomedical discoveries. Mr Simpson is also the Chairman of Biogenerics Australia Pty Ltd.

Special responsibilities

Member of the Remuneration Committee
Member of the Audit Committee


 
44
 
 
William D. Rueckert Non-executive Director

Mr Rueckert has been director of the Company since March, 2009 and has been a Director of Marshall Edwards, Inc. between March, 2007 and March, 2009. Mr Rueckert is the Managing Member of Oyster Management Group LLC an investment fund specialising in community banks. Mr Rueckert was appointed a Director of Chelsea Therapeutics International, Ltd. in July of 2009. From 1991 to 2006 he was President and Director of Rosow & Company, a private investment firm based in Connecticut. Mr Rueckert has been President and Director of Eastern Capital Development, LLC from 1999 to 2005, treasurer of Moore & Munger, Inc., a company with interests in the petroleum and resort development industries, from 1988 until 1990, and was President of United States Oil Company, a publicly traded oil exploration business, from 1981 to 1988. Among his many civic associations, Mr Rueckert is Director and President of the Cleveland H. Dodge Foundation, a private philanthropic organisation in New York City and Chairman of the Board of the Trustees of Teachers College, Columbia University.

Other current and former directorships held in the last three years

During the last three years Mr Rueckert has served as a Director for Emergency Filtration Products, Inc., Chelsea Therapeutics International, Ltd. and the NASDAQ listed, Novogen subsidiary, Marshall Edwards, Inc.

Executive Officers’ profiles

David R. Seaton – Chief Financial Officer
B Bus, M Com, CPA

Mr. Seaton has been the Chief Financial Officer of Novogen Limited since 1999. Mr. Seaton is a graduate in Business Studies and holds a Master of Commerce degree from the University of New South Wales. He has completed Management Development programs at Northwestern University in Chicago, Illinois, Duke University in Durham, North Carolina and the London Business School. He has had over 20 years experience in the pharmaceutical industry. Prior to joining Novogen Limited he was the Finance Director of GlaxoWellcome Australia Ltd. Mr. Seaton was also Finance Director of Wellcome Australia Limited prior to its merger with Glaxo in 1995.

Mr. Seaton has been the Chief Financial Officer and Secretary of Marshall Edwards since 2000.  He has been a Director and the Secretary of Glycotex, Inc since September 2005.  Mr. Seaton was appointed Chief Financial Officer of Glycotex, Inc. in November 2006. Mr. Seaton was appointed acting CEO of Novogen Limited and Marshall Edwards, Inc. on December 1, 2009.

 
45
 
 
Warren Lancaster – Vice President Commercial and Corporate Development
BSc, MBA

Mr. Lancaster is a graduate in Physics and holds a Masters Degree in Business Administration from the Australian Graduate School of Management (Sydney). Mr. Lancaster worked as a business strategy and management consultant with an Australian consulting firm before joining Novogen Limited in March 1997

Bryan Palmer – Operations General Manager

Mr. Palmer joined Novogen in 1993. Since that time he has held a number of senior management positions within the Company. He completed the Program for Management Development at the Harvard Business School in 2001.

Craig Kearney – General Manager Consumer Business
BMS Waikato.

Mr. Kearney joined Novogen Limited in December 2001 as the General Manager of the Consumer Business. He has a Bachelor of Management Studies from Waikato University in New Zealand and has subsequently completed managerial development programmes at London School of Business and Duke University in Durham, North Carolina. He has worked 18 years in the Over The Counter (OTC) consumer pharmaceutical category, including 10 years for Wellcome New Zealand and Wellcome Australia, and 6 years for Parke Davis/Warner Lambert Australia. Prior to joining Novogen Limited, Mr. Kearney worked for Pfizer Australia. He held senior sales, marketing and business management roles for all three companies.

Ronald L Erratt
FINA

Mr. Erratt has been the Company Secretary of Novogen Limited since it floated on the ASX in 1994. He is also the Company Secretary for all of the wholly owned subsidiaries of Novogen. Mr Erratt has over 30 years experience in accounting and commercial roles. Prior to joining Novogen, he was the Director of Superannuation Fund Administration at Towers Perrin, an international firm of Actuaries and Management Consultants.


Compensation

Principles used to determine the nature and amount of remuneration

Remuneration philosophy

Remuneration is assessed for Directors and senior executives with the overall objective of ensuring maximum stakeholder benefit from the retention of a high quality executive team. The appropriateness and nature of remuneration is assessed by reference to employment market conditions.
 
 
46
 
 
The financial and non-financial objectives of the Company are also considered when assessing the remuneration of Directors and other key management personnel, however, Directors and other key management personnel’s annual remuneration has no variable performance bonus elements that are directly linked to Company financial performance with the exception of the CEO of Glycotex, Inc. Refer to “Employment Agreements” for details of performance bonus.

The Board has established a Remuneration Committee which is responsible for determining and reviewing compensation arrangements for the Managing Director, Executive Director and other key management personnel.

Director’s fees

The Constitution of the Company and the ASX Listing Rules specify that the aggregate remuneration of Non-executive Directors shall be determined from time to time by General Meeting. The latest determination for Novogen Limited was at the Annual General Meeting held on October 28, 2005 when the shareholders approved an aggregate remuneration of A$560,000. The total Non-executive Director remuneration of Novogen Limited for the year ended June 30, 2009 utilised A$260,000, (2008: A$274,000) of this authorised amount.

The amount of aggregate remuneration sought to be approved by shareholders and the manner in which it is apportioned amongst Directors is reviewed periodically.

Non-executive Director remuneration

Fees to Non-executive Directors reflect the demands which are made on, and the responsibilities of the Directors. Non-executive Directors’ fees are reviewed periodically by the Board. In conducting these reviews the Board considers independent remuneration surveys to ensure Non-executive Directors’ fees are appropriate and in line with the market.

Each Non-executive Director receives a fee for being a Director of the Company. An additional fee is also paid for each Board committee on which a Director sits. The payment of additional fees for serving on a committee recognises the additional time commitment required by Non-executive Directors who serve on one or more committees.

Due to the impact of the global financial crisis and the need for the Company to conserve cash, the Company’s Non-executive Directors voluntarily reduced Director’s fees by 20% with effect from February 1, 2009.

Executive Directors and other key management personnel remuneration

The Remuneration Committee of the Board of Directors is responsible for determining and reviewing compensation arrangements for the Managing Director, Executive Director and other key management personnel. The Remuneration Committee assesses the appropriateness of the nature and amount of remuneration of such Officers on a periodic basis by reference to relevant employment market conditions with the overall objective of ensuring maximum stakeholder benefit from the retention of a high quality executive team. Such officers are given the opportunity to receive their base remuneration, which is structured as a total employment cost package, in a variety of forms including cash and prescribed non-financial benefits. It is intended that the manner of payment chosen will be optimal for the recipient without creating undue cost for the Group.

 
47
 
 
Due to the impact of the global financial crisis and the need for the Company to conserve cash, effective from February 1, 2009, the Company’s Executive Directors and key management personnel entered into an agreement to voluntarily reduce their working hours effecting a corresponding reduction of 20% in paid remuneration.

Long-term incentives.

All Executive Directors and executives have the opportunity to qualify for participation in the Employee Share Option Plan, described below, after achieving a qualifying service period.


Employment Agreements

Novogen Executive Directors and key management executives (standard contracts)

It is the Remuneration Committee policy that employment contracts are entered into with the Chief Executive Officer, the Research Director, and each of the executives who are considered key management personnel. These contracts for service commenced in June, 2006 and were for terms of three years with a notice period of six months. The initial three year term expired in June, 2009 and the contracts continue until terminated by either party under the terms of the contract. Under the terms of the contracts, the amount of remuneration may be reviewed from time to time at the discretion of the Remuneration Committee. Key management executives are given the opportunity to receive their base remuneration, which is structured as a total employment cost package, in a variety of forms including cash and prescribed non financial benefits.

In the event of the Company terminating the employment without cause under the terms of the contract the minimum payable on termination by the Company will be eighteen months remuneration. The Company may terminate the contracts at anytime without notice if serious misconduct has occurred. Where such termination “with cause” occurs, there is no entitlement to termination payments under the contract. On termination, any unvested options issued under the Employee Option scheme are immediately forfeited.

Effective from February 1, 2009, the Company’s Executive Directors and key management personnel entered into an agreement to voluntarily reduce their working hours effecting a corresponding reduction of 20% in paid remuneration. This agreement will remain in effect until terminated by the employee. The agreement will also terminate in the event of a merger and/or acquisition event, an insolvency event or termination by the Company.

Each of the foregoing employment contracts, other than the employment contract with Warren Lancaster, were filed as exhibits to the Company’s Annual Report on Form 20-F for the fiscal year ended June 30, 2006 filed with the U.S. Securities and Exchange Commission (the “SEC”) on November 29, 2006.  The employment contract with Warren Lancaster was filed as an exhibit to the Company’s Annual Report on Form 20-F for the fiscal year ended June 30, 2007 filed with the SEC on December 14, 2007.


 
48
 
 
Details of Remuneration

Details of the remuneration of the Directors of Novogen Limited, other key management personnel and group executives of the Novogen Group are set out in the following table. Unless otherwise stated all Directors, other key management and Group executives were in office for the whole of the financial year ended June 30, 2009.

Remuneration of key management personnel and other Group Executives
(includes movements in executive leave provisions for untaken annual and long service leave).
   
Short term benefits
   
Post employment
   
Long term benefits
   
Share based payments
   
Total
 
2009
 
Salary & fees
   
Cash bonus
   
Non-monetary benefits
   
Superan-nuation
   
Long Service Leave
   
Options
       
    $   $   $   $   $    $       %     $
Key management personnel
                                                             
Non-executive Directors
                                                             
PA Johnston (i)
    105,319       -       -       90,458       -       -       -       195,777  
GM Leppinus
    50,457       -       -       4,543       -       -       -       55,000  
PJ Nestel AO (ii)
    94,791       -       -       -       -       -       -       94,791  
WD Rueckert (i)
    111,294       -       -       -       -       -       -       111,294  
PB Simpson
    48,774       -       -       4,392       -       -       -       53,166  
                                                                 
Executive Directors
                                                               
C Naughton (iii)
    709,761       -       51,594       100,000       (55,755 )     73,708       8.4 %     879,308  
AJ Husband
    270,113       -       50,420       100,000       4,562       53,449       11.2 %     478,544  
                                                                 
Executives
                                                               
DR Seaton (iii)
    366,937       -       47,677       100,000       4,635       71,911       12.2 %     591,160  
WJ Lancaster (US)
    234,068       -       23,127       -       -       32,350       11.2 %     289,545  
BM Palmer
    179,720       -       39,500       15,540       (9,614 )     39,074       14.8 %     264,220  
CD Kearney
    194,898       -       21,532       17,357       2,746       40,277       14.6 %     276,810  
RL Erratt
    72,633       -       32,416       100,000       1,198       37,152       15.3 %     243,399  
                                                                 
Other Group executives
                                                               
R Koenig (US) (iv)
    413,798       67,069       26,244       15,678       -       527,775       50.2 %     1,050,564  
      2,852,563       67,069       292,510       547,968       (52,228 )     875,696       19.1 %     4,583,578  

 (i) Remuneration includes Marshall Edwards and Glycotex Director’s fees of A$108,694.
 (ii) Remuneration includes Marshall Edwards Director’s fees of A$41,625.
 (iii) Remuneration includes Glycotex Director’s fees of A$67,069.
 
(iv) Remuneration includes performance milestone bonus of US$50,000 or 6.4% of total remuneration.

The elements of remuneration have been determined on the basis of the cost to the Company and the consolidated entity.

Share Based Compensation

Employee share option plan

All Executive Directors, Executives and other staff have the opportunity to qualify for participation in the Employee Share Option Plan after achieving a qualifying service period. The qualifying service period is determined from time to time by the Board under the terms of the Employee Share Option Plan and employees are currently required to have completed one year service before they are eligible for a grant of options. The amount and timing of options issued under the terms of the Employee Share Option Plan is entirely at the discretion of the Board.

 
49
 
 
Each option issued under the Employee Share Option Plan entitles its holder to acquire one fully paid ordinary share and is exercisable at a price equal to the weighted average price of such shares at the close of trading on the ASX for the five days prior to the date of issue. Options vest equally over a four year period from date of grant and expire five years after grant date. No performance conditions apply to the options granted, however, the unvested option lapses if the employee ceases to be an employee during the vesting period. Options are not transferable and can not be settled by the Company in cash. The Employee Share Option Plan provides that in the event of a change of control of the Company or in the event that the Company is taken over, outstanding options become exercisable regardless of vesting status.

There are no performance criteria relating to employee share options because the philosophy behind the Employee Share Option Plan is to encourage a general level of ownership in the Company by employees and align their interests with those of shareholders. The Employee Share Option Plan is modest in scale and is principally designed to foster teamwork and the benefits of pursuing shared goals.

Options granted as part of Director and Executive emoluments have been valued using the binomial option pricing model, which takes account of factors such as the option exercise price, the volatility of the underlying share price, the risk free interest rate, expected dividends, the current market price of the underlying share and the expected life of the option.

The fair value of such grants amortised are disclosed as part of Director and Executive emoluments on a straight-line basis over the vesting period. No adjustments have been made or will be made to reverse amounts in relation to options that never vest (i.e. forfeitures).

Fair values of options:

The fair value of each option is estimated on the date of grant using a binomial option-pricing model with the following assumptions used for grants made on:

   
6 March,
   
31 October,
   
1 March,
   
26 October,
 
   
2009
   
2008
   
2008
   
2007
 
Exercise price
    0.5256       1.06       1.06       2.41  
Share price at grant date
    0.51       0.95       1.07       1.62  
Dividend yield
    0 %     0 %     0 %     0 %
Expected volatility
    73 %     66 %     57 %     55 %
Historical volatility
    73 %     66 %     57 %     55 %
Risk-free interest rate
    3.61 %     4.76 %     6.35 %     6.41 %
Expected life of option
 
5 years
   
4.3 years
   
5 years
   
4.4 years
 
Option fair value
    0.31       0.51       0.60       0.66  
 

 
 
50
 
 
The dividend yield reflects the assumption that the current dividend payout, which is zero, will continue with no anticipated increases. The expected life of the options is based on historical data and is not necessarily indicative of exercise patterns that may occur. The expected volatility reflects the assumption that the historical volatility is indicative of future trends, which may also not necessarily be the actual outcome.

Further detail on the remuneration of Directors and Executives are also provided in Note 19 to the financial statements.

Arrangements and Relationships

There are no arrangements (other than standard employment remuneration arrangements) by which any Director or Executive Officer was appointed to his position. There are no family relationships between any of the Directors or Executive Officers.

No Director has received or has become entitled to receive, during or since the end of the fiscal year ended 2009, a benefit because of a contract made by Novogen Limited, a controlled entity, or a related body corporate with a Director, a firm of which a Director is a member or an entity in which a Director has a substantial financial interest.

Pension Benefits

The Company has paid A$1,139,000 during fiscal 2009 for employee superannuation benefits and pension benefits.


Board Practices


Novogen Board of Directors
       
Name
Postion Held
Year First Appointed
Current Term Expires
       
       
P. A. Johnston
Chairman
1997
October-2012
C. Naughton
Managing Director
1997
Employment ceased December 1, 2009
P. B. Simpson
Director
1994
Retired July ,2009
P. J. Nestel
Director
2001
October-2012
G. M. Leppinus
Director
2005
October-2010
A. J. Husband
Executive Director
2006
October-2011
W.D. Rueckert
Director
2009
October-2012

 
 
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Term of Directors

The term for each Director (excluding the Managing Director) is three years at which time that Director retires from office and offers himself/herself for re-election at the next Annual General Meeting. For more information about the term and details of the Managing Director’s term refer to the employment contract attached filed as Exhibit 4.1 to the Company’s Annual Report on Form 20-F for fiscal year ended June 30, 2007 filed with the SEC on November 29, 2007.

The Board of Directors has the power to appoint any person to be a director either to fill a casual vacancy or as an additional Director (up to a maximum of 10). Any Director so appointed may hold office only until the next Annual General Meeting when he or she shall be eligible for election by the Company shareholders.

Board of Directors

The Board of Directors of Novogen Limited is elected by and accountable to shareholders. The Board monitors and directs the business and is responsible for the corporate governance of the Company. The Managing Director, who is accountable to the Board, is responsible for managing the development of the Company consistent with the objective of enhancing long term shareholder value.

The Board is comprised of six Directors four of whom are non-Executive Directors. In addition, the Board has established an Audit Committee and a Remuneration Committee.

There are also Scientific Advisory Boards whose membership includes the Executive Director which advises on clinical and scientific strategy and direction.


Structure of the Board of Directors

The skills, expertise and experience relevant to the position of Director held by each Director in office at the date of this Annual Report is included in Item 6 beginning on page 42. Directors are considered to be independent when they are independent of management and free from any business or other relationship that could materially interfere with, or could reasonably be perceived to materially interfere with, the exercise of their unfettered and independent judgement.

In the context of Director independence, “materiality” is considered from both the Company and individual Director perspective. In determining whether a non-Executive Director is independent, he or she must not hold more than 5% of the Company’s outstanding shares.
 
 
 
 

 
52
 
 
 
Also, the following qualitative factors, among others, are considered:
 
·  
whether the director has been a principal of a material professional advisor or consultant of the Company;
·  
whether the director has a material contractual relationship with the Company;
·  
whether the director has served on the Board of Directors for a period which could be perceived to interfere with his or her ability to act in the best interests of the Company; and
·  
whether the director has any business interests which could be perceived to interfere with his or her ability to act in the best interests of the Company.

In accordance with the definition of independence above, and the materiality thresholds set, the following Directors of Novogen Limited are considered to be independent:
 
Name                                                         Position

Philip A. Johnston                                                   Non-Executive Chairman
Professor Paul J. Nestel AO                                                   Non-Executive Director
Peter B. Simpson                                                    Non-Executive Director – retired July, 2009
Geoffrey M. Leppinus                                                         Non-Executive Director
William D. Rueckert                                                            Non-Executive Director – appointed March, 2009

There are procedures in place, agreed upon by the Board of Directors, to enable Directors in the furtherance of their duties, to seek independent professional advice at the Company’s expense.

For additional details regarding appointments to the Board of Directors please refer to the Company’s web site.

Audit Committee

The Board of Directors has an Audit Committee, which operates under a charter approved by the Board. It is the Board’s responsibility to ensure that an effective internal control framework exists within the Group. This includes internal controls to deal with both the effectiveness and efficiency of significant business processes, the safeguarding of assets, the maintenance of proper accounting records and the reliability of financial information as well as non-financial considerations such as bench marking of operational key performance indicators. The Board of Directors has delegated the responsibility for the establishment and maintenance of a framework of internal control and ethical standards for the management of the consolidated entity to the Audit Committee. The Audit Committee is responsible for the hiring, termination and compensation of the independent auditors and approving any non-audit work performed by the auditors.

The Audit Committee also provides the Board with additional assurance regarding the reliability of financial information for inclusion in the financial reports. All members of the Audit Committee are independent Non-Executive Directors.  The members of the Audit Committee during the fiscal year 2009 were Mr. Geoffrey Leppinus (Chairman), Professor Paul J. Nestel, Mr. Philip A. Johnston and Mr. Peter B. Simpson.

 
53
 
 
Performance

The performance of the Board of Directors and the key Executives is reviewed regularly against both measurable and qualitative indicators. During the reporting period the Board of Directors conducted a performance evaluation which involved the assessment of each Board member’s and key Executive’s performance. The performance criteria against which Directors and Executives are assessed have regard to the financial and non-financial objectives of Novogen Limited.

Remuneration Committee

The Remuneration Committee of the Board of Directors is responsible for determining and reviewing compensation arrangements for the Directors, the Managing Director, Executive Director and senior Executives.
 
The Remuneration Committee assesses the appropriateness of the nature and amount of emoluments of such officers on a periodic basis by reference to relevant employment market conditions with the overall objective of ensuring maximum shareholder benefit from the retention of a high quality executive team.

The members of the Remuneration Committee during the fiscal year 2009 were Mr. Philip A. Johnston (Chairman), Mr. Geoffrey Leppinus, Professor Paul J. Nestel, and Mr. Peter B. Simpson.


Employees

The Company employed 48 people at June 30, 2009, 68 people at June 30, 2008 and 66 people at June 30, 2007 as follows

Category of Activity
 
            Number of People
     
2009
2008
2007
 
Research and development
17
30
27
 
Production
   
9
14
14
 
Sales and marketing
 
11
12
13
 
Finance and administration
11
12
12
 
Total
   
48
68
66
 


 
54
 
 
 
Geographic Location
 
             Number of People
   
2009
2008
2007
 
Australasia
 
43
63
63
 
North America
 
3
3
2
 
Europe
 
2
2
1
 
Total
 
48
68
66
 
 
Share Ownership

Directors' holdings of shares and options in the Company

The table below shows the number of ordinary shares and options to purchase Ordinary Shares held directly or indirectly by the Directors of the Company as of November 30, 2009. The ordinary shares held by Directors do not entitle them to voting rights different from those of the Company’s shareholders.
 
             
 
Ordinary shares
fully paid
Options *
     
Number outstanding
 
Exercise price
Expiry date
             
PA Johnston
73,594
 
                                   -
 
                                   -
-
C Naughton
633,511
 
91,196
**
                                2.41
30/03/2012
     
218,664
**
                                1.06
1/03/2013
AJ Husband
102,920
 
22,592
 
                                4.90
16/03/2010
     
30,436
 
                                3.64
21/04/2011
     
50,472
 
                                2.41
30/03/2012
     
126,928
 
                                1.06
1/03/2013
             
PJ Nestel  AO
32,000
 
                                   -
 
                                   -
-
GM Leppinus
11,883
 
                                   -
 
                                   -
-
WD Rueckert
             5,000
         
 
858,908
 
540,288
     
 
* Each option represents the right to purchase one ordinary share.
** Options forfeited December 1, 2009.

The tables below shows the number of ordinary shares and options to purchase ordinary shares held directly or indirectly by the named Executives of the Company as of November 30, 2009. The ordinary shares held by the named Executives do not entitle them to voting rights different from those of the Company’s shareholders.

 
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Shares held

         
   
Ordinary shares fully paid
% Total shares
on issue
 
D.R. Seaton
           37,378
                  -
 
B.M. Palmer
          205,636
                 0.2
 
C.D. Kearney
             8,850
                  -
 
R.L. Erratt
 
          271,368
                 0.3
 
 
 

Options granted to and held by named Executives


Total
options
 Eligible executives
participating
Exercise price
Grant date
Expiry date
 
   
(A$)
     
           
        69,560
5
       4.90
16/03/2005
16/03/2010
 
        93,632
5
       3.64
21/04/2006
21/04/2011
 
       157,728
5
       2.41
30/03/2007
30/03/2012
 
       379,772
5
       1.06
1/03/2008
1/03/2013
 
       659,552
5
       0.53
6/03/2009
6/03/2014
 

Each option represents the right to purchase one ordinary share.

Exemptions from Certain Corporate Governance Rules of the NASDAQ Stock Market, LLC

Exemptions from the corporate governance standards of the NASDAQ Stock Market, LLC (“Nasdaq”) are available to foreign private issuers such as Novogen when those standards are contrary to a law, rule or regulation of any public authority exercising jurisdiction over such issuer or contrary to generally accepted business practices in the issuer's country of domicile. In connection with Novogen's National Market Listing Application, Nasdaq granted Novogen exemptions from certain corporate governance standards that were contrary to the laws, rules, regulations or generally accepted business practices of Australia. These exemptions and the practices followed by Novogen are described below:

·  
Novogen is exempt from Nasdaq's quorum requirements applicable to meetings of ordinary shareholders. In keeping with the law of Australia and generally accepted business practices in Australia, Novogen's Constitution requires a quorum of three shareholders for a shareholders' meeting.

 
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·  
Novogen is exempt from Nasdaq's requirement that each Nasdaq issuer shall require shareholder approval of a plan or arrangement in connection with the acquisition of the stock or assets of another company if "any director, officer or substantial shareholder of the issuer has a 5 percent or greater interest (or such persons collectively have a 10 percent or greater interest), directly or indirectly, in the Company or assets to be acquired or in the consideration to be paid in the transaction or series of related transactions and the present or potential issuance of common stock, or securities convertible into or exercisable for common stock, could result in an increase in outstanding common shares or voting power of 5 percent or more".

Novogen is listed on the ASX and subject to Chapter 10 of the ASX listing rules which requires shareholder approval for an acquisition from or disposal to a "related party" (including a director) or "substantial shareholder" (who is entitled to at least 10% of the voting securities) of "substantial assets". The Australian Corporations Act to which Novogen is also subject generally requires shareholder approval for a transaction with a director or director-controlled entity unless on arm's length terms.
 
 
 
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Item 7.                 Major Shareholders and Related Party Transactions

Major Shareholders

Josiah T. Austin and El Coronado Holdings, LLC (beneficially owned by Mr. Austin) – hold 20,318,053 Ordinary Shares representing 19.9% of the outstanding Ordinary Shares.

Oppenheimer holds 12,744,689 ordinary shares representing 12.5% of the outstanding ordinary shares.

The major shareholders do not have voting rights that differ from those other shareholders of the Company.

At November 30, 2009 there were 10,013,650 of the Company’s ADRs outstanding, representing 50,068,250 Ordinary Shares (or 49.0% of the then outstanding Ordinary Shares). At November 30, 2009 there were 40 registered holders of the Company’s ADRs.

On July 29, 2008 the Company entered into a share subscription agreement with El Coronado holdings LLC for the placement of 4,531,633 ordinary shares at a purchase price of A$1.2215 per share raising gross proceeds of A$5,535,390. Following the placement El Coronado LLC holds 19.9% of the Company’s issued and outstanding ordinary shares.
 
On August 1, 2007, El Coronado and certain other accredited investors entered into a securities subscription agreement with Marshall Edwards pursuant to which El Coronado purchased 700,000 shares of Marshall Edwards’ common stock at a purchase price of US$3.00 per share for an aggregate purchase price of US$2,100,000.  El Coronado also received a warrant to purchase an additional 4 shares of common stock for every block of 10 shares of common stock purchased.  As a result, El Coronado received a warrant to purchase 70,000 shares of common stock.  All of the warrants have an exercise price of US$3.60 per share.  The exercise price and number of shares issuable upon exercise of the warrants are subject to adjustment in the event of stock dividends, stock splits and other similar events. The warrants may be exercised beginning February 6, 2008 and will expire five years from the date of issuance, or August 6, 2012.

On August 1, 2007, Oppenheimer and certain other accredited investors entered into a securities subscription agreement with Marshall Edwards pursuant to which Oppenheimer purchased 764,000 shares of Marshall Edwards common stock at a purchase price of US$3.00 per share for an aggregate purchase price of US$2,292,000.  Oppenheimer also received a warrant to purchase an additional 4 shares of common stock for every block of 10 shares of common stock purchased.  As a result, Oppenheimer received warrants to purchase 305,600 shares of common stock.  All of the warrants have an exercise price of US$3.60 per share.  
 
 
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The exercise price and the number of shares issuable upon exercise of the warrants are subject to adjustment in the event of stock dividends, stock splits and other similar events.  The warrants may be exercised beginning February 6, 2008, and will expire five years from the date of issuance, or August 6, 2012.

On July 28, 2008, Oppenheimer entered into a securities subscription agreement with Marshall Edwards pursuant to which Oppenheimer purchased 1,700,000 shares of Marshall Edwards common stock at a purchase price of US$2.17 per share for an aggregate purchase price of US$3,698,000. The shares are registered under the Securities Act pursuant to an effective shelf registration statement.  On July 30, 2008, Marshall Edwards filed a prospectus supplement to the shelf registration statement covering the sale of the shares to Oppenheimer.

There have been no other significant changes to the shareholdings of the known major shareholders over the last three years.



 
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Item 8.                 Financial Information
 
Consolidated financial statements are included in “Item 18 – Financial Statements” on pages 81 through 132.
 
Export Sales
 
Export sales to third parties from Australia were $1.2 million which represents 14.4% of total sales. The details of sales by geographic region are contained in “Item 4 – “Information on the Company”.

Legal Proceedings

There are no pending legal proceedings which either individually or in the aggregate will have a significant effect on the Company’s financial position or loss, nor have any such proceedings had any impact in the recent past, except that the Company is continuing to prosecute its IP rights and in June 2007 announced that the Vienna Commercial Court had upheld a provisional injunction against an Austrian company, APOtrend. The Company has provided a guarantee to the value of €250,000 with the court to confirm its commitment to the ongoing enforcement process.

Dividends

The Company has incurred losses since its inception and as a result has not declared any dividends. Any dividends declared in the future will be paid in Australian dollars.

Significant Changes After Balance Sheet Date

In August, 2009 the Company entered into a licence agreement with Marshall Edwards Pty Ltd (“MEPL”) granting an exclusive world-wide, non-transferable licence, under the Novogen patent rights, to conduct clinical trials and commercialise and distribute all forms of administering NV-128, except topical applications. The agreement covers uses of NV-128 in the field of prevention, treatment or cure of cancer in humans. NV-128 is currently in pre-clinical development stage.

In consideration of the license granted, MEPL paid Novogen a licence fee of US$1,500,000 on August 7, 2009.

In November 2009, MEPL finalised negotiations and signed a Deed of Release in relation to claims received in connection with the termination of enrolment into the OVATURE Phase III clinical trial. As a result of receiving the Deed of Release, the final amount agreed to be paid in connection with the claims was $477,000 less than management’s estimates which were accrued in the accounts at June 30, 2009. Management does not believe this amount has a material impact on the financial statements.

On December 1, 2009, Novogen’s Managing Director Christopher Naughton ceased his employment with the Company. The termination payment of approximately $1.7 million was made in accordance with Mr. Naughton’s employment contract.

 
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There have been no other significant events occurring after balance sheet date which have had a material impact on the business.
 

 
Item 9.                 Offer and Listing Details

Trading Markets

Novogen’s principal listing exchange and the exchange upon which its Ordinary Shares are quoted is the ASX. The trading symbol on ASX is “NRT”.

American Depositary Receipts
 
Novogen’s Ordinary Shares trade in the U.S. in the form of ADRs on the Nasdaq Global Market. Each ADR represents five Ordinary Shares of Novogen. The trading symbol on the Nasdaq Global Market is "NVGN”. Novogen has entered into a Deposit Agreement with the Bank of New York under which the Bank of New York, acting as depositary, issues the ADRs.
 
The following table sets forth, for the calendar periods indicated, the high and low market quotations for Novogen’s Ordinary Shares, as quoted on the ASX, and Novogen's ADRs, as quoted on the Nasdaq Global Market.

 
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NOVOGEN LIMITED SHARE PRICE HISTORY

             
Period
 
Per Ordinary Share (A$)
 
   Per ADR (US$)
   
  High
Low
 
High
Low
             
Year Ended
           
             
June 2005
 
              6.25
              4.15
 
            24.35
            14.85
June 2006
 
              6.00
              2.14
 
            22.08
              8.03
June 2007
 
              3.80
              1.81
 
            13.25
              8.14
June 2008
 
              2.14
              0.83
 
            10.13
              3.89
June 2009
 
              1.70
              0.37
 
              7.45
              1.23
             
Quarter Ended
         
September 2007
 
              2.14
              1.70
 
              8.97
              6.82
December 2007
 
              1.88
              1.10
 
              8.53
              4.57
March 2008
 
              1.32
              0.83
 
              6.75
              3.89
June 2008
 
              1.84
              1.01
 
            10.13
              4.88
             
September 2008
 
              1.70
              0.98
 
              7.45
              4.19
December 2008
 
              1.15
              0.66
 
              5.07
              1.86
March 2009
 
              1.01
              0.37
 
              3.27
              1.23
June 2009
 
              1.26
              0.44
 
              7.00
              1.38
             
September 2009
 
              0.89
              0.52
 
              5.24
              2.02
             
Month Ended
           
             
June 2009
 
0.87
0.52
 
              3.43
              2.05
July 2009
 
0.89
0.52
 
              5.24
              2.02
August 2009
 
0.82
0.65
 
              3.40
              2.81
September 2009
 
0.75
0.63
 
              4.00
              2.40
October 2009
 
0.72
0.59
 
              3.21
              2.65
November 2009
 
0.60
0.47
 
              2.87
              2.07
 
 
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Item 10.                 Additional Information

Constitution

The Company’s Constitution is incorporated by reference to the Registration Statement on Form 20-F filed with the SEC on December 24, 1998 (File No. 0-29962).

Material Contracts

There have been no material contracts entered into in the last two years by the Company or any of its subsidiaries other than in the normal course of business.   

See “Item 4. Information on the Company – Patent Protection – Licensing Arrangements” for a description of the Company’s Patent License Agreement with Solae LLC (formally Protein Technologies International Inc.)

Exchange Controls

Australia has largely abolished exchange controls on investment transactions. The Australian dollar is freely convertible into U.S. dollars. In addition, (other than as specified under “taxation” below and certain restrictions imposed under Australian law in relation to dealings with the assets of and transactions with, designated countries, entities and persons specified by the Reserve Bank of Australia from time to time, including, persons connected with terrorism) there are currently no specific rules or limitations regarding the export from Australia of profits, dividends, capital, or similar funds belonging to foreign investors, except that certain payments to non-residents must be reported to the Australian Transaction Reports and Analysis Centre, which monitors such transactions. However, as mentioned above, the Reserve Bank of Australia does retain discretion to prevent foreign exchange dealings in certain circumstances under the Australian Banking (Foreign Exchange) Regulations 1959.
 
Under Australian law, foreign persons are prohibited from acquiring more than a limited percentage of the interests in an Australian company without approval from the Australian Treasurer or in certain other limited circumstances. These limitations are set forth in the Australian Foreign Acquisitions and Takeovers Act 1975 (the “Foreign Takeovers Act”).
 
Under the Foreign Takeovers Act, as currently in effect, any foreign person, together with associates, is prohibited from acquiring, without prior approval from the Australian Treasurer, 15% or more of the voting power (including potential voting power) or issued shares (including rights to issued shares) ("Substantial interest") of an entity such as Novogen, whose total share value or gross assets exceed A$219 million, unless the person is a U.S. investor, in which case a threshold of A$953 million rather than A$219 million threshold applies.  Where an acquisition is made in breach of these requirements, the Australian Treasurer may make an order requiring the acquirer to dispose of its Substantial Interest within a specified period of time. In addition, if a foreign person acquires a Substantial Interest in Novogen in circumstances where the above thresholds would be exceeded and as a result the total holdings of all foreign persons and their associates exceeds 40% in aggregate without the approval of the Australian Treasurer, then the Australian Treasurer may make an order requiring the acquirer to dispose of its Substantial Interest within a specified time.
 
 
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The same rule applies if the total holdings of all foreign persons and their associates already exceeds 40% and a foreign person (or its associate) acquires any further interests, including in the course of trading in the secondary market of the ADRs.
 
Under the current Australian foreign investment policy, it is unlikely that the Australian Treasurer would make such an order in relation to an acquisition that contravenes the Foreign Takeovers Act where the level of foreign ownership exceeds 40% in the ordinary course of trading, unless the Australian Treasurer is satisfied that the acquisition is contrary to the national interest. The Foreign Takeovers Act allows foreign persons to seek prior approval of acquisitions of Novogen interests which could otherwise result in the Australian Treasurer making an order requiring the foreign person to dispose of any Substantial Interest.
 
If a foreign person holds more than 15% of the interests of Novogen or if the level of aggregate foreign ownership of Novogen exceeds 40% at any time, Novogen would be considered a foreign person under the Foreign Takeovers Act. In such event, Novogen would be required to obtain the approval of the Australian Treasurer for Novogen, together with its associates, to acquire: (i) more than 15% of an Australian company or business with a share value or gross assets totaling over A$219 million; or (ii) any direct or indirect ownership interest in Australian urban land.  However, as mentioned above, proposals by U.S. investors for investment in non-sensitive sectors do not require notification to the Australian Treasurer or the Australian Treasurer's approval unless the amount to be invested or the value of the target Australian company or business exceeds A$953 million.
 
The percentage of foreign ownership of Novogen would also be included in determining the foreign ownership of any Australian company or business in which it may choose to invest. Novogen has no current plans for any such acquisitions. The Company’s Constitution does not contain any additional limitations on a non-resident’s right to hold or vote the Company’s securities.
 
Taxation
 
The following discussion is a summary of the Australian taxes generally applicable to U.S. Holders of ADRs. For the purposes of this discussion, “U.S. Holder” means a beneficial owner of ADRs who:
 
(a) for U.S. federal income tax purposes is a U.S. resident, a U.S. citizen, a domestic corporation, a domestic partnership, or a non-foreign estate or trust;
 
(b) are not residents of Australia for Australian income tax purposes; and
 
(c) has not owned, at any time directly, indirectly or constructively, 10% or more of the voting stock of the Company.
 
Prospective investors are urged to consult their own tax advisers regarding the U.S. and Australian tax consequences of owning and disposing of Ordinary Shares and ADRs, including in relation to state and local tax laws. Further, prospective investors who are residents of jurisdictions other than the U.S. should consult their tax advisers as to the tax consequences of investing in the ADRs or shares under the laws of their jurisdictions of residence.
 
 
64
 
 
This taxation discussion is intended only as a descriptive summary and does not purport to be a complete technical analysis or listing of all potential tax effects to U.S. Holders, and does not address the Australian taxes applicable to special classes of U.S. Holders. Except as otherwise noted, the statements of Australian tax laws set out below are based on the laws as of the date of this Annual Report, including the bilateral taxation convention between Australia and the U.S. (the “Treaty”) and are subject to any changes in law occurring after that date.
 
Distributions
 
Under Australian law, non-residents of Australia may be subject to withholding tax of up to 30% in respect of dividends received on shares in Australian companies.
 
In accordance with the Treaty, dividends derived by a non-resident of Australia who is a resident of the U.S. for the purposes of Treaty (which may not include all U.S. Holders) may be taxed on those dividends in Australia, but such withholding tax is limited to 15% of the gross amount of dividends unless the dividend is derived by a non-resident of Australia who has or is deemed to have a permanent establishment in Australia. In this case, the non-resident may be taxed at the rate applicable to them.  Some U.S. resident companies may be entitled to a withholding rate of 5% if they hold at least 10% of the voting power of the Australian company.

In some instances withholding tax may not apply. Under the Australian dividend imputation system, dividends that are paid out of income on which Australian income tax has been levied may be wholly or partly "franked". No withholding tax is payable in respect of any franked portion of a dividend.

Under the conduit foreign income rules, the unfranked portion of a dividend paid to a non-resident of Australia is not subject to withholding tax to the extent that the amount is declared to be conduit foreign income ie an amount calculated by reference to certain foreign source income earned by the Australian company on which no Australian tax is payable.
 
Dispositions

Upon disposal of shares or ADRs, a capital gain or a capital loss may be made. A capital gain is calculated as the difference between the disposal proceeds and the cost base of the shares or ADRs. Broadly, the cost base is the total of the amount paid for the shares or ADRs plus acquisition and/or disposal costs (such as brokerage or stamp duty).

Capital gains made by non-residents of Australia are only subject to Australian tax if they are in respect of the disposal of assets which are taxable Australian property.  Very broadly, a share or ADR will be taxable Australian property if the share or ADR is in a company that principally owns (directly or indirectly) Australian real property and the share is part of a shareholding that represents at least 10% of all of the shares or ADRs in the company (when taking into account shares or ADRs owned by the participant or associates).  Any non-resident shareholder who held at least 10% of shares or ADRs (when taking into account shares or ADRs owned by the participant or associates) at any time during the 2 years prior to disposing of the shares or ADRs in the company should consult their own tax advisers.
 
 
65
 
 
However, shares or ADRs will be taxable Australian property and any capital gain made on the disposal of such shares or ADRs will be subject to Australian tax if the share or ADRs have at any time been held by a taxpayer in carrying on a business through a permanent establishment in Australia.
 
If the shares or ADRs were acquired before 11:45 am on September 21, 1999 the cost base may be indexed for inflation up to September 30, 1999. For a Holder to whom the CGT discount applies (see below), indexation will only apply if the Holder elects to use indexation instead of the discount. Indexation will not be available if the shares or ADRs were acquired after 11:45 am on September 21, 1999 and will effectively only be relevant if the shares were acquired before July 1, 1999.
 
Holders who are individuals or who hold shares or ADRs directly through trusts and are subject to Australian tax may be eligible to have their capital gain (after applying any capital losses against it) discounted if they have held their shares or ADRs for at least 12 months. The CGT discount is 50%. If the shares or ADRs were acquired before 11:45 am on September 21, 1999, such Holders may choose whether to calculate their capital gain using indexation frozen at September 21, 1999 or by applying the CGT discount without indexation. If the shares or ADRs were acquired after 11:45 am on September 21, 1999, it will not be possible to elect to apply indexation and such Holders will be entitled to the CGT discount if they have held the shares or ADRs for at least 12 months. Companies are not entitled to the CGT discount.
 
A capital loss will be made if the disposal proceeds are less than the reduced cost base. Broadly, the reduced cost base will be calculated in a similar way to the cost base, however, the reduced cost base is calculated without indexation. Capital losses can only be offset against capital gains realised in the same year or in later years.

Non-residents of Australia who are subject to Australian tax on capital gains made on the disposal of shares or ADRs are required to file an Australian income tax return for the year in which the disposal occurs.

Non-residents of Australia who are securities dealers or in whose hands a profit on disposal of ADRs or shares is regarded as ordinary income and not as a capital gain (such shares and ADRs are referred to as "revenue assets") will be subject to Australian income tax on Australian source profits arising on the disposal of the ADRs or shares, without indexation or discount, unless such profits are exempt from Australian tax under the Treaty. Under the Business Profits Article of the Treaty, the profits of a person that is a resident of the U.S. for the purposes of the Treaty (which may not include all U.S. Holders) will not be subject to tax in Australia unless the profits are attributable to the carrying on of a business by that person through a permanent establishment of that person in Australia. Prospective investors should consult their own tax advisers as to whether the shares or ADRs are revenue assets as such a conclusion depends on the particular facts and circumstances of the individual investor concerned.

Non-residents of Australia with no taxable capital gains or income from sources in Australia other than dividends with respect to the shares or ADRs are not required to file an Australian income tax return.

 
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Estate and Gift Tax

Australia does not impose any estate, inheritance or gift taxes. Therefore, no Australian estate tax, inheritance tax or gift tax will be imposed on the death of, or upon a lifetime gift by, a U.S. Holder. However, the transfer by a U.S. Holder of ordinary shares or ADRs by way of gift or upon death may have Australian income tax and stamp duty implications.


Documents on Display
 
The Company is subject to the reporting requirements of the Exchange Act that are applicable to a foreign private issuer. Under the Exchange Act, the Company is required to file periodic reports and other information with the SEC. These materials, including this Annual Report and the exhibits hereto, may be inspected without charge and copied at established rates at the public reference facilities maintained by the SEC at 100 F Street, N.E., Washington, D.C., 20549.   Please call the SEC at 1-800-SEC-0330 to obtain information on the operation of the public reference room.  Such materials can also be obtained at the SEC’s website at www.sec.gov.
 
 
67
 
 
Item 11.                 Quantitative and Qualitative Disclosures about Market Risk.
 
Interest Rate Risk

The Company has cash reserves and places funds on deposit with financial institutions for periods generally not exceeding three months.

The Company does not use derivative financial instruments. The Company places its deposits with high credit quality financial institutions, and, by policy, limits the amount of credit exposure to any single counter-party. The Company is averse to principal loss and ensures the safety and preservation of its invested funds by limiting default risk, market risk and reinvestment risk.

The Company mitigates default risk by depositing funds with only the safest and highest credit quality financial institutions and by constantly positioning its portfolio to respond appropriately to a significant reduction in a credit rating of any financial institution.

The Company has no interest rate exposure due to rate changes for long-term debt obligations. The Company primarily enters into debt obligations to support general corporate purposes, including capital expenditures and working capital needs.

The Company does not consider the effects of interest rate movements to be a material risk to its financial condition.

For additional disclosure regarding interest rate risk see Item 18 – Note 15.

Foreign Currency Risk
The Company operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the U.S. dollar (USD), the British pound (GBP), the Euro, the Swiss Franc (CHF) and the Canadian dollar (CAD). Foreign exchange risk arises from future transactions and recognised assets and liabilities denominated in a currency that is not the entity’s functional currency and net investments in foreign operations.

As of June 30, 2009, the Group did not hold derivative financial instruments in managing its foreign currency, however, the Company may from time to time enter into hedging arrangements where circumstances are deemed appropriate. Foreign subsidiaries with a functional currency of AUD have exposure to the local currency of these subsidiaries and any other currency these subsidiaries trade in. The functional currency of Marshall Edwards, Inc. and Glycotex, Inc. is USD and these subsidiaries have exposure to AUD and any other currency these subsidiaries trade in.


 
68
 
 
The Company has mitigated and will continue to mitigate a portion of its currency exposure through international sales, marketing and support operations in which all costs are local currency based. Net foreign currency gain in fiscal year 2009 was A$920,000 compared with net foreign currency loss of A$937,000 in fiscal year 2008.

For additional disclosure regarding market risk see Item 18 – Note 15.

 
Item 12.                 Description of Securities Other than Equity Securities
 
Item 12 details are not required to be disclosed as part of the Annual Report.
 

 
 
69
 
 
PART II
 

 
Item 13.                 Defaults, Dividend Arrearages and Delinquencies
 
This item is not applicable.
 

 
Item 14.
Material Modifications to the Rights of Security Holders and the Use of Proceeds
 
This item is not applicable.
 

 
Item 15.                 Controls and Procedures
 

(a) Disclosure Controls and Procedures

At the end of the period covered by this Annual Report, the Company’s management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on that evaluation, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures are effective to ensure that the information required to be disclosed by the Company in reports that it files or submits under the Exchange Act were recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.
 
(b) Management’s Annual Report on Internal Controls Over Financial Reporting
 
The management of Novogen Limited is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a - 15(f) under the Exchange Act. Novogen Limited’s internal control was designed to provide reasonable assurance to the Company’s management and Board of Directors regarding the preparation and fair presentation of published financial statements.  All internal control systems, no matter how well designed, have inherent limitations.  Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
 
Management maintains a comprehensive system of controls intended to ensure that transactions are executed in accordance with management’s authorization, assets are safeguarded, and financial records are reliable.  Management also takes steps to ensure that information and communication flows are effective and monitor performance, including performance of internal control procedures.
 
 
70
 
 
Management assessed the effectiveness of the Company’s internal control over financial reporting as of June 30, 2009 based on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework. Based on this assessment, management believes that the Company’s internal control over financial reporting is effective as of June 30, 2009.

(c) Attestation Report

The attestation report of the Company’s independent registered public accounting firm regarding the Company’s internal control over financial reporting appears in the independent public account firm’s report on page 79.

(d) Changes in Internal Controls

During the fiscal year ended June 30, 2009, there has been no change in internal control over reporting that has materially affected or is reasonably likely to materially affect the Company’s internal control over financial reporting.


Item 16.                 Reserved


Item 16A.                      Audit Committee Financial Expert

The Board of Directors has determined that Mr. Geoffrey Leppinus, qualifies as an “audit committee financial expert” as that term is defined in Item 16A of Form 20-F. Mr. Leppinus meets the independence requirements of the Nasdaq Global Market and SEC’s rules and regulations.


Item 16B.                      Code of Ethics

The Company has adopted a Code of Ethics that applies to all its employees, Executive Officers and Directors, including its Chief Executive Officer, Chief Financial Officer and persons performing similar functions. A copy of the Code of Ethics is posted in the “About Novogen – Corporate Governance” section of Novogen Limited’s website, and may be viewed at http://www.novogen.com. If the Company makes any substantive amendment, to the Code of Ethics or grants any waiver, including an implicit waiver, from a provision of the Code of Ethics to Directors or Executive Officers, it will disclose the nature of such amendment or waiver on the Company’s website.


 
71
 
 
Item 16C.                      Principal Accounting Fees and Services

BDO Kendalls Audit Assurance (NSW-VIC) Pty Ltd (“BDO”) has audited the Company’s annual financial statements acting as the independent registered public accountant for the fiscal years ended June 30, 2009 and 2008.
 
The charts below set forth the total fees for services performed by BDO in 2009 and 2008 and summarizes these amounts by the category of service.
 

 
2009
2008
 
 
A$’000
A$’000
 
       
       
Audit fees
        329
          334
 
Audit related fees
            3
            29
 
Tax fees
          51
            26
 
Other Fees
            6
              8
 
Total fees
        389
          397
 
Audit fees

The audit fees include the aggregate fees incurred in fiscal years 2009 and 2008 for professional services rendered in connection with the audit of the Company’s annual financial statements and for related services that are reasonably related to the performance of the audit (including audit in respect of the Sarbanes-Oxley Section 404) or services that are normally provided by the auditor in connection with regulatory filings of engagements for those financial years (including review of the Company’s Annual Report on Form 20-F, consents and other services related to SEC matters).

Audit Related Services

Fees for audit related services billed in each of the fiscal years 2009 and 2008 include audit related services provided in connection with the filing of a registration statement for Marshall Edwards and the requirements of the provisions of government grant agreements pursuant to which the Company receives reimbursement of certain expenses incurred in research and development including START grants and Pharmaceutical Partnership Program.

Tax Fees

Tax fees billed in each of the fiscal years 2009 and 2008 were for the preparation of tax returns and related advice.

All Other Fees

Other fees incurred by the Company in fiscal years 2009 and 2008 relate to the costs associated with regulatory compliance and other general matters.

 
72
 
 
Pre-approval Policies and Procedures

The Audit Committee Charter sets forth the Company’s policy regarding the appointment of independent auditors. The Audit Committee Charter also requires the Audit Committee to review and approve in advance the appointment of the independent auditors for the performance of 100% of all audit services and, after taking into account the opinion of management, 100% of lawfully permitted non audit services. The Audit Committee may delegate authority to one or more members of the Audit Committee where appropriate, but no such delegation is permitted if the authority is required by law, regulation or listing standard to be exercised by the Audit Committee as a whole.


Item 16D.                      Exemptions from the Listing Standards for Audit Committees.

This item is not applicable.


Item 16E.                      Purchases of Equity Securities by the Issuer and Affiliated Purchasers.

This item is not applicable.

Item 16G.                      Corporate Governance

Exemptions from Certain Corporate Governance Rules of the NASDAQ Stock Market, LLC

Exemptions from the corporate governance standards of the NASDAQ Stock Market, LLC (“Nasdaq”) are available to foreign private issuers such as Novogen when those standards are contrary to a law, rule or regulation of any public authority exercising jurisdiction over such issuer or contrary to generally accepted business practices in the issuer's country of domicile. In connection with Novogen's National Market Listing Application, Nasdaq granted Novogen exemptions from certain corporate governance standards that were contrary to the laws, rules, regulations or generally accepted business practices of Australia. These exemptions and the practices followed by Novogen are described below:

·  
Novogen is exempt from Nasdaq's quorum requirements applicable to meetings of ordinary shareholders. In keeping with the law of Australia and generally accepted business practices in Australia, Novogen's Constitution requires a quorum of three shareholders for a shareholders' meeting.

 
73
 
 
·  
Novogen is exempt from Nasdaq's requirement that each Nasdaq issuer shall require shareholder approval of a plan or arrangement in connection with the acquisition of the stock or assets of another company if "any director, officer or substantial shareholder of the issuer has a 5 percent or greater interest (or such persons collectively have a 10 percent or greater interest), directly or indirectly, in the Company or assets to be acquired or in the consideration to be paid in the transaction or series of related transactions and the present or potential issuance of common stock, or securities convertible into or exercisable for common stock, could result in an increase in outstanding common shares or voting power of 5 percent or more".

Novogen is listed on the ASX and subject to Chapter 10 of the ASX listing rules which requires shareholder approval for an acquisition from or disposal to a "related party" (including a director) or "substantial shareholder" (who is entitled to at least 10% of the voting securities) of "substantial assets". The Australian Corporations Act to which Novogen is also subject generally requires shareholder approval for a transaction with a director or director-controlled entity unless on arm's length terms.

 
74
 
 
PART III

Item 17.                 Financial Statements

Not Applicable


Item 18.                 Financial Statements

The financial statements filed as part of this Annual Report are included on pages 81 through 132 hereof.

Item 19.                 Exhibits

(a)                        
Exhibits
 

Exhibit No.
Exhibit Description
 
1.1
Constitution of Novogen Limited (formerly known as the Memorandum of Association and Articles of Association). (1)
 
2.1
Deposit Agreement as further amended and restated, dated as of September 29, 2005, among Novogen Limited, the Bank of New York, as Depositary, and owners and holders from time to time of ADRs issued thereunder. (2)
 
4.1
Employment Contract between the Company and Mr. C. Naughton dated June 21, 2006. (4)
 
4.2
Employment Contract between the Company and Professor Alan Husband dated June 21, 2006. (4)
 
4.4
Lease between Kendall Glen Pty Limited (Lessor) and Novogen Laboratories Pty Ltd for the Company's corporate headquarters at 140 Wicks Road, North Ryde, New South Wales. (3)
 
4.5
Employment Contract between the Company and Bryan Palmer dated June 21, 2006. (4)
 
4.6
Employment Contract between the Company and Craig Kearney dated June 21, 2006. (4)
 
4.7
Employment Contract between the Company and David Seaton dated June 21, 2006. (4)
 
4.8
Employment Contract between the Company and Ronald Erratt dated June 21, 2006. (4)
 
4.9
Employment Contract between the Company and Warren Lancaster dated June 21, 2006. (5)
 
 
 
 
75
 
 

4.10
Patent License Agreement, dated as of November 13, 1997, by and among Novogen Limited, Novogen Research Pty Limited, Novogen Inc. and Protein Technologies International Inc.** (6)
 
4.11
Amendment to the Patent License Agreement, dated as of June 21, 2004 by and among Novogen Limited, Novogen Research Pty Limited, Novogen Inc. and Solae LLC (formerly known as Protein Technologies International Inc.)** (7)
 
8.1
Company Subsidiaries. (*)
 
12.1
Certification of the Acting Chief Executive Office pursuant to Rule 13a – 14(a) of the Securities Exchange Act of 1934, as amended. (*)
 
12.2
Certification of Chief Financial Officer pursuant to Rule 13a – 14(a) of the Securities Exchange Act of 1934, as amended. (*)
 
13.1
Certification by the Acting Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as added by Section 906 of the Sarbanes – Oxley Act of 2002. (*)

 
*
Filed herewith.
 
**
Portions of these documents have been omitted pursuant to a request for confidential treatment. Such omitted portions have been filed separately with the SEC.

 
(1)
Incorporated by reference to the Registration Statement on Form 20-F filed with the Securities and Exchange Commission on December 24, 1998 (File No. 0-29962)

(2)  
Incorporated by reference to the Registration Statement on Form F-6 filed with the Securities and Exchange Commission on September 29, 2005 (File No. 333-128681)

(3)  
Incorporated by reference to the Annual Report on Form 20-F filed with the Securities and Exchange Commission on November 27, 2000 (File No. 0-29962)

(4)  
Incorporated by reference to the Annual Report on Form 20-F filed with the Securities and Exchange Commission on November 29, 2006 (File No. 0-29962)
 
 
 
76
 
 
 
 
(5)  
Incorporated by reference to the Annual Report on Form 20-F filed with the Securities and Exchange Commission on December 14, 2007 (File No. 0-29962)

 
(6)
Incorporated by reference to the Annual Report on Form 20-F/A filed with the Securities and Exchange Commission on March 20, 2009 (File No. 0-29962).

 
(7)
Incorporated by reference to the Annual Report on Form 20-F/A filed with the Securities and Exchange Commission on May 5, 2009 (File No. 0-29962).
 
 
 
 
77
 
 
Report of Independent Registered Public Accounting Firm
 
Board of Directors
Novogen Limited
 
We have audited the accompanying consolidated balance sheets of Novogen Limited as of June 30, 2009 and 2008 and the related consolidated statements of income, consolidated statements of changes in equity, and consolidated statements of cash flows for each of the three years in the period ended June 30, 2009.  These financial statements are the responsibility of the Company’s management.  Our responsibility is to express an opinion on these financial statements based on our audits.
 
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States).  Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation.
 
We believe that our audits provide a reasonable basis for our opinion.
 
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Novogen Limited at June 30, 2009 and 2008, and the results of its operations and its cash flows for each of the three years in the period ended June 30, 2009, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.
 
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Novogen Limited’s internal control over financial reporting as of June 30, 2009, based on criteria established in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) and our report dated December 9, 2009 expressed an unqualified opinion thereon.
 
 
 
BDO Kendalls Audit & Assurance (NSW-VIC) Pty Ltd
 
Sydney, NSW Australia
 
December 9, 2009
 
 
78
 
 
Report of Independent Registered Public Accounting Firm
 
Board of Directors
Novogen Limited
 
We have audited Novogen Limited’s internal control over financial reporting as of June 30, 2009, based on criteria established in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). Novogen Limited’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Item 15(b), Management’s Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the company’s internal control over financial reporting based on our audit.
 
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
 
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board.
 
A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
 
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
 
In our opinion, Novogen Limited maintained, in all material respects, effective internal control over financial reporting as of June 30, 2009, based on the COSO criteria.
 
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the accompanying consolidated balance sheets of Novogen Limited as of June 30, 2009 and June 30, 2008, and the related consolidated income statements, consolidated statements of changes in equity and consolidated statements of cash flows for each of the three years in the period ended June 30, 2009 and our report dated December 9, 2009 expressed an unqualified opinion.
 
 
BDO Kendalls Audit & Assurance (NSW-VIC) Pty Ltd
 
Sydney, NSW, Australia
December 9, 2009
 
 
79
 
 
Directors’ Declaration

In accordance with a resolution of the Directors of Novogen Limited, I state that:

1.  
In the opinion of the Directors:

a)  
the financial statements and notes of the Company are in accordance with the Corporations Act 2001, including:

i)  
giving a true and fair view of the Company’s financial position as at June 30, 2009 and of their performance for the year ended on that date; and

ii)  
complying with Accounting Standards and 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.

2.  
This declaration has been made after receiving the declarations required to be made to the directors in accordance with section 295A of the Corporations Act 2001 for the financial period ending June 30, 2009.

3.  
In the opinion of the Directors, as at the date of this declaration, there are reasonable grounds to believe that the members of the Closed Group identified in Note 17, will be able to meet any obligations or liabilities to which they are or may become subject to, by virtue of the Deed of Cross Guarantee.


On behalf of the Board,





/s/ Philip Johnston

Philip Johnston
Non-executive Chairman


Sydney, December 9, 2009


 
80
 
 
 
 
INCOME STATEMENTS
                             
for the year ended 30 June, 2009
                             
   
Notes
   
Consolidated
 
         
2009
   
2008
   
2007
   
2009
 
         
A$'000
   
A$'000
   
A$'000
   
US$'000
 
Continuing Operations
                             
Revenue
    2       11,147       13,283       17,295       8,979  
Cost of sales
            (2,523 )     (4,090 )     (6,945 )     (2,032 )
                                         
Gross profit
            8,624       9,193       10,350       6,947  
                                         
Other income
    2       -       1,623       2,710       -  
                                         
Research & development expenses
            (18,788 )     (18,811 )     (16,134 )     (15,134 )
Selling & promotional expenses
            (6,572 )     (6,134 )     (7,908 )     (5,294 )
Shipping and handling expenses
            (341 )     (300 )     (392 )     (275 )
General and administrative expenses
            (6,671 )     (9,792 )     (12,902 )     (5,373 )
Other expenses
            (27 )     (528 )     (17 )     (21 )
Finance costs
            (11 )     (24 )     (2 )     (9 )
                                         
Loss before income tax
    2       (23,786 )     (24,773 )     (24,295 )     (19,159 )
                                         
Income tax expense
    3       (1 )     (4 )     (1 )     (1 )
                                         
                                         
Loss for the period
            (23,787 )     (24,777 )     (24,296 )     (19,160 )
                                         
Loss attributable to minority interest
            4,859       4,513       4,315       3,914  
                                         
Loss attributable to members of Novogen Limited
    12 (c)     (18,928 )     (20,264 )     (19,981 )     (15,246 )
                                         
Basic and diluted earnings/(loss) per share (cents)
    4       (18.6 )     (20.8 )     (20.5 )     (15.0 )
 
The above Income Statements should be read in conjunction with the accompanying notes.
 
 
81
 
 
 
BALANCE SHEETS
                       
as at 30 June, 2009
                       
   
Notes
   
Consolidated
 
         
2009
   
2008
   
2009
 
         
A$'000
   
A$'000
   
US$'000
 
CURRENT ASSETS
                       
Cash and cash equivalents
    5       33,338       35,386       26,854  
Trade and other receivables
    6       2,252       4,969       1,814  
Inventories
    7       1,334       1,929       1,075  
Other current assets
    8       565       542       455  
Total current assets
            37,489       42,826       30,198  
                                 
NON-CURRENT ASSETS
                               
Property, plant and equipment
    9       353       575       284  
Total non-current assets
            353       575       284  
                                 
TOTAL ASSETS
            37,842       43,401       30,482  
                                 
CURRENT LIABILITIES
                               
Trade and other payables
    10       8,059       6,671       6,492  
Provisions
    11       774       708       623  
Total current liabilities
            8,833       7,379       7,115  
                                 
NON-CURRENT LIABILITIES
                               
Provisions
    11       236       385       190  
Total non-current liabilities
            236       385       190  
                                 
TOTAL LIABILITIES
            9,069       7,764       7,305  
NET ASSETS
            28,773       35,637       23,177  
                                 
EQUITY
                               
Contributed equity
    12(a)       206,419       200,432       166,271  
Reserves
    12(b)       (3,010 )     (7,491 )     (2,425 )
Accumulated losses
    12(c)       (179,730 )     (162,251 )     (144,772 )
Parent interest
            23,679       30,690       19,074  
                                 
Minority Interest
    12(d)       5,094       4,947       4,103  
                                 
TOTAL EQUITY
            28,773       35,637       23,177  
 
 
The above Balance Sheets should be read in conjunction with the accompanying notes.
 
 
 
82
 
 
 
STATEMENTS OF CHANGES IN EQUITY
 
for the year ended 30 June, 2009
                                     
                                           
    Consolidated
   
Contributed equity
   
Accumulated losses
   
Reserves
   
Total
   
Minority interest
   
Total equity
   
Total equity
 
   
A$'000
   
A$'000
   
A$'000
   
A$'000
   
A$'000
   
A$'000
   
US$'000
 
                                           
At 1 July, 2006
    176,989       (131,700 )     (2,847 )     42,442       2,136       44,578       35,908  
Exchange differences on translation of foreign operations
    -       -       (2,607 )     (2,607 )     (1,312 )     (3,919 )     (3,157 )
Share-based payments
    -       2,303       -       2,303       478       2,781       2,240  
Net income recognised directly in equity
    176,989       (129,397 )     (5,454 )     42,138       1,302       43,440       34,991  
Issue of share capital by subsidiary
    24,371       -       -       24,371       -       24,371       19,631  
less minority interest
    (5,277 )     -       -       (5,277 )     5,277       -       -  
Options exercised (1)
    513       -       -       513       -       513       413  
Loss for the period
    -       (19,981 )     -       (19,981 )     (4,315 )     (24,296 )     (19,570 )
Share of opening equity transferred to minority interest due to issuance of shares by subsidiary
    (4,720 )     3,231       299       (1,190 )     1,788       598       482  
At 30 June, 2007
    191,876       (146,147 )     (5,155 )     40,574       4,052       44,626       35,947  
                                                         
At 1 July, 2007
    191,876       (146,147 )     (5,155 )     40,574       4,052       44,626       35,947  
Exchange differences on translation of foreign operations
    -       -       (2,729 )     (2,729 )     (1,046 )     (3,775 )     (3,041 )
Share-based payments
    -       850       -       850       284       1,134       913  
Net income recognised directly in equity
    191,876       (145,297 )     (7,884 )     38,695       3,290       41,985       33,819  
Issue of share capital by subsidiary
    18,429       -       -       18,429       -       18,429       14,845  
less minority interest
    (5,334 )     -       -       (5,334 )     5,334       -       -  
Loss for the period
    -       (20,264 )     -       (20,264 )     (4,513 )     (24,777 )     (19,958 )
Share of opening equity transferred to minority interest due to issuance of shares by subsidiary
    (4,539 )     3,310       393       (836 )     836       -       -  
At 30 June, 2008
    200,432       (162,251 )     (7,491 )     30,690       4,947       35,637       28,706  
                                                         
At 1 July, 2008
    200,432       (162,251 )     (7,491 )     30,690       4,947       35,637       28,706  
Exchange differences on translation of foreign operations
    -       -       4,425       4,425       1,738       6,163       4,964  
Share-based payments
    -       1,060       -       1,060       140       1,200       967  
Net income recognised directly in equity
    200,432       (161,191 )     (3,066 )     36,175       6,825       43,000       34,637  
Issue of share capital by subsidiary
    4,033       -       -       4,033       -       4,033       3,248  
less minority interest
    (3,047 )     -       -       (3,047 )     3,047       -       -  
New shares issued
    5,527       -       -       5,527       -       5,527       4,452  
Loss for the period
    -       (18,928 )     -       (18,928 )     (4,859 )     (23,787 )     (19,160 )
Share of opening equity transferred to minority interest due to issuance of shares by subsidiary
    (526 )     389       56       (81 )     81       -       -  
At 30 June, 2009
    206,419       (179,730 )     (3,010 )     23,679       5,094       28,773       23,177  
 
 
(1)  
During the period 300,207 Novogen Limited shares were issued following the exercise of options.

The above Statements of Changes in Equity should be read in conjunction with the accompanying notes.
 
 
83
 
 
 
STATEMENTS OF CASH FLOWS
                         
for the year ended 30 June, 2009
                         
                           
 
Notes
 
Consolidated
 
     
2009
   
2008
   
2007
   
2009
 
     
A$'000
   
A$'000
   
A$'000
   
US$'000
 
                           
Cash flows from operating activities
                         
Net loss before tax
      (23,786 )     (24,773 )     (24,295 )     (19,160 )
Income tax paid
      (1 )     (4 )     (1 )     (1 )
                                   
Adjustments to reconcile net loss to net cash used in operating activities:
                         
Depreciation and amortisation
      282       353       976       227  
Net (gain)/loss on disposal of property, plant and equipment
    29       (1,623 )     17       23  
Share-based payments
      1,200       602       2,686       967  
                                   
Changes in operating assets and liabilities:
                                 
(increase)/decrease in trade receivables
      527       300       388       424  
(increase)/decrease in other receivables
      190       1,007       (128 )     153  
(increase)/decrease in inventories
      595       1,970       4,487       479  
(increase)/decrease in prepayments
      (23 )     88       55       (19 )
increase/(decrease) in trade and other payables
      1,388       751       274       1,118  
increase/(decrease) in provisions
      (83 )     282       (48 )     (67 )
exchange rate change on opening cash
      (920 )     937       981       (741 )
                                   
Net cash flows used in operating activities
      (20,602 )     (20,110 )     (14,608 )     (16,597 )
                                   
Cash flows from investing activities
                                 
Acquisition of property, plant and equipment
      (94 )     (95 )     (299 )     (76 )
Proceeds from sale of plant and equipment
      5       3,831       262       4  
                                   
Net cash flows from/(used in) investing activities
      (89 )     3,736       (37 )     (72 )
                                   
Financing Activities
                                 
Proceeds from the issue of ordinary shares
      5,527       -       513       4,452  
Proceeds from the issue of shares by subsidiary
      4,033       18,961       24,371       3,249  
Repayment of borrowings
      -       -       (15 )     -  
Withdrawal of/(investment in) short-term deposits
      2,000       (2,000 )     -       1,611  
                                   
Net cash flows from/(used in) financing activities
      11,560       16,961       24,869       9,312  
                                   
Net (decrease)/increase in cash and cash equivalents
      (9,131 )     587       10,224       (7,357 )
Cash and cash equivalents at beginning of period
      34,386       38,511       30,513       27,698  
Effect of exchange rates on cash holdings in foreign currencies
    7,083       (4,712 )     (4,226 )     5,705  
Movements in secured facility
      -       -       2,000       -  
                                   
Cash and cash equivalents at end of period
5
    32,338       34,386       38,511       26,046  
 
The above Statements of Cash Flows should be read in conjunction with the accompanying notes.
 
 
 
84
 
 
NOTES TO THE FINANCIAL STATEMENTS


The financial report of Novogen Limited for the year ended 30 June, 2009 was authorised for issue in accordance with a resolution of the Board of Directors on 26 August, 2009.

Note 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

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

Basis of preparation

The financial report is a general-purpose financial report, which has been prepared in accordance with the requirements of the Corporations Act 2001, Australian Accounting Standards and other authorative pronouncements of the AASB. The financial report has also been prepared on a historical cost basis with all amounts presented in Australian dollars, rounded to the nearest thousand dollars ($’000), unless otherwise stated.

Statement of compliance

This financial report complies with International Financial Reporting Standards (IFRS) as adopted by the International Accounting Standards Board (IASB).

Basis of consolidation

The consolidated financial statements comprise the financial statements of Novogen Limited and its subsidiaries (the “Group”) as at 30 June each year.

The financial statements of the subsidiaries are prepared for the same reporting period as the parent company, using consistent accounting policies.

In preparing the consolidated financial statements, all inter-company balances and transactions, income and expenses and profit and losses resulting from intra-group transactions have been eliminated in full.

Subsidiaries are fully consolidated from the date on which control is transferred to the Group and cease to be consolidated from the date on which control is transferred out of the Group.

Minority interests represent the portion of profit or loss and net assets in Marshall Edwards, Inc. and Glycotex, Inc. not held by the Group and are presented separately in the Income Statement and within equity in the consolidated Balance Sheet.

Interest in controlled entities are recorded at cost less impairment write downs, in the parent entity’s financial statements.

 
85
 
 
Significant accounting judgements, estimates and assumptions

(i) Significant accounting judgements
In the process of applying the Group’s accounting policies, management has made the following judgement, apart from those involving estimations.

Research and development expenses
The Directors do not consider the development programs to be sufficiently advanced to reliably determine the economic benefits and technical feasibility to justify capitalisation of development costs. These costs have been recognised as an expense when incurred.

Research and development expenses relate primarily to the cost of conducting human clinical and pre-clinical trials. Clinical development costs are a significant component of research and development expenses. Estimates have been used in determining the expense liability under certain clinical trial contracts where services have been performed but not yet invoiced. The actual costs of those services could differ in amount and timing from the estimates used in completing the financial statements.

Generally the costs, and therefore estimates, associated with clinical trial contracts are based on the number of patients, drug administration cycles, the type of treatment and the outcome being measured. The length of time before actual amounts can be determined will vary depending on length of the patient cycles and the timing of the invoices by the clinical trial partners.

Clinical trial expenses of $3,912,000 has been accrued at June 30, 2009. These estimates are based on the number of patients in each trial and the drug administration cycle.

Following the termination of enrollment into the OVATURE Phase III clinical trial, claims for clinical trial expenses were received totaling $2,741,000. Approximately $1,456,000 was accrued and was subject to continued negotiation and represented management’s best estimate of amounts that may be payable. The remaining balance of $1,285,000 was disputed as management believed the costs were outside the scope of the contracts and did not believe that these amounts were due and owing. In November 2009, MEI finalized negotiations and signed a Deed of Release in relation to these claims. As a result of receiving the of Deed of Release, the final amount agreed to be paid in connection with the claims was $477,000 less than management’s estimates which were accrued in the accounts at June 30, 2009. Management does not believe this amount has a material impact on the financial statements. The disputed claim amount of $1,285,000 has been withdrawn.

(ii) Significant accounting estimates and assumptions
The carrying amounts of certain assets and liabilities are often determined based on estimates and assumptions of future events. The key estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of certain assets and liabilities within the next annual reporting period are:

Share-based payment transactions
The Group measures the cost of equity-settled transactions with employees by reference to the fair value of equity instruments at the date at which they are granted. The fair value is determined using a binomial model, using the assumptions detailed in Note 13.

 
86
 
 
Impairments
The Group assesses impairment at each reporting date by evaluating conditions specific to the Group that may lead to impairment of assets. Where an impairment trigger exists, the recoverable amount of the asset is determined. Value-in-use calculations performed in assessing recoverable amounts incorporate a number of key estimates.

Clinical Trial Expenses
Estimates have been used in determining the expense liability under certain clinical trial contracts where services have been performed but not yet invoiced. The actual costs of those services could differ in amount and timing from the estimates used in completing the financial results.

Revenue recognition

Revenue is recognised to the extent that it is probable that the economic benefits will flow to the Group and the revenue can be reliably measured. In determining the economic benefits, provisions are made for certain trade discounts and returned goods. The following specific recognition criteria must also be met:

Sale of goods
Revenue from sale of goods is recognised when the significant risks and rewards of ownership of the goods have passed to the buyer and can be measured reliably. Risks and rewards are considered passed to the buyer when the goods have been dispatched to a customer pursuant to a sales order and invoice. Net sales represent product shipped less actual and estimated future returns, and slotting fees, rebates and other trade discounts accounted for as reductions of revenue.

Estimates and allowances are based upon known claims and an estimate of additional returns. In order to calculate estimates, management regularly monitor historical patterns of returns from, and discounts to, individual customers.

Interest
Interest revenue is recognised as interest accrues using the effective interest method. The effective interest method uses the effective interest rate which is the rate that exactly discounts the estimated future cash receipts over the expected life of the financial asset.

Dividends
Dividend revenue is recognised when the right to receive the payment is established.

Government grants
Grant income is recognised when there is reasonable assurance that the grant will be received and all attaching conditions will be complied with. Grant income is recognised in the Income Statement over the periods necessary to match the grant on a systematic basis to the costs that it is intended to compensate.

 
87
 
 
Royalties
Royalty revenue is recognised on an accruals basis in accordance with the substance of the relevant agreements.

Litigation Settlement
Revenue is recognised when the risks and rewards have been transferred, which is considered to occur on settlement.

Borrowing costs

Borrowing costs are recognised as an expense when incurred. Novogen Limited does not currently hold any qualifying assets but if it did, the borrowing costs directly associated with this asset would be capitalised (including any other costs directly attributable to the borrowing and temporary investment income earned on the borrowing).

Leases

The determination of whether an arrangement is or contains a lease is based on the substance of the arrangement and requires assessment of whether the fulfilment of the arrangement is dependent on the use of a specific asset or assets and the arrangement conveys a right to use the asset.

Finance leases, which transfer to the Group substantially all the risks and benefits incidental to ownership of the leased item, are capitalised at the inception of the lease at the fair value of the leased property or, if lower, at the present value of the minimum lease payments. Lease payments are apportioned between the finance charges and reduction of the lease liability so as to achieve a constant rate of interest on the remaining balance of the liability. Finance charges are recognised as an expense in profit or loss.

Capitalised leased assets are depreciated over the shorter of the estimated useful life of the asset and the lease term if there is no reasonable certainty that the Group will obtain ownership by the end of the lease term.

Operating lease payments are recognised as an expense in the Income Statement on a straight-line basis over the lease term. Lease incentives are recognised in the Income Statement as an integral part of the total lease expense.

The cost of improvements to or on leasehold property is capitalised, disclosed as leasehold improvements, and amortised over the unexpired period of the lease or the estimated useful lives of the improvements, whichever is the shorter.

Cash and cash equivalents

Cash and short term deposits in the Balance Sheet comprise cash at bank and in hand and short-term deposits with an original maturity of three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value.

 
88
 
 
For the purposes of the Statements of Cash Flows, cash and cash equivalents consist of cash and cash equivalents as defined above, net of outstanding bank overdrafts and secured cash.

Trade and other receivables

Trade receivables, which generally have 30-60 day terms, are recognised initially at fair value and subsequently measured at amortised cost using the effective interest method less an allowance for any uncollectible amounts.

An allowance for doubtful debts is made when there is objective evidence that the Group will not be able to collect the debts. Objective evidence of impairment includes: financial difficulties of debtors; default payments; or debts more than 120 days overdue. Bad debts are written off when identified.

Cash flows relating to short term receivables are not discounted if the effect of discounting is immaterial.

Inventories

Inventories are measured at the lower of cost and net realisable value.

Costs incurred for finished goods and work-in-progress in bringing each product to its present location and condition are accounted for as cost of direct material, direct labour and a proportion of manufacturing overheads based on normal operating capacity but excluding borrowing costs and assigned on a standard costing basis.

Net realisable value is the estimated selling price in the ordinary course of business, less estimated costs of completion and the estimated costs necessary to make the sale.

Foreign currency translation

Functional currency

Both the functional and presentation currency of Novogen Limited and its subsidiaries is Australian dollars ($A) except for Marshall Edwards, Inc., Marshall Edwards Pty Limited and Glycotex, Inc., where the functional currency is U.S. dollars.

Translation of foreign currency transactions

Transactions in foreign currencies are initially recorded in the functional currency at the exchange rates ruling at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies are translated at the rate of the exchange ruling at the balance sheet date.

Non-monetary items that are measured in terms of historical cost in a foreign currency are translated using the exchange rate as at the date of the initial transaction.

 
89
 
 
Translation of financial reports of overseas operations

As at the reporting date the assets and liabilities of overseas subsidiaries are translated into the presentation currency of the Group at the rate of exchange ruling at the balance sheet date and the Income Statements are translated at the weighted average exchange rates for the period.

The exchange differences arising on the translation of overseas operations which have a functional currency of $A are taken directly to the Income Statement. The exchange differences arising on the retranslation of overseas operations which have a functional currency that is not $A are taken directly to a separate component of equity (foreign currency translation reserve).

Taxes

Income tax

Current tax assets and liabilities for the current and prior periods are measured at the amount expected to be recovered from or paid to the taxation authorities. The tax rates and tax laws used to compute the amount are those that are enacted or substantially enacted by the balance sheet date.

Deferred income tax is provided on all temporary differences at the balance sheet date between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes.

The carrying amount of deferred income tax assets is reviewed at each balance sheet date and reduced to the extent that it is no longer probable that sufficient taxable profit will be available to allow all or part of the deferred income tax asset to be utilised.

Deferred income tax assets and liabilities are measured at the tax rates that are expected to apply to the year when the asset is realised or the liability is settled, based on the tax rates (and tax laws) that have been enacted or substantively enacted at the balance sheet date.

Unrecognised deferred income tax assets are reassessed at each balance sheet date and recognised to the extent that it has become probable that future taxable profit will allow the deferred tax asset to be recovered.

Income taxes relating to items recognised directly in equity are recognised in equity and not in the Income Statement.

Other taxes

 
Revenues, expenses and assets are recognised net of the amount of GST receipt except:
 
·  
when the GST incurred on a purchase of goods or services is not recoverable from the taxation authority, in which case the GST is recognised as part of the cost of acquisition of the asset or as part of the expense item as applicable; and
·  
receivables and payables, which are stated with the amounts of GST included.
 

 
 
90
 
 
The net amount of GST recoverable from, or payable to, the taxation authority is included as part of receivables or payables in the Balance Sheet.

Commitments and contingencies are disclosed net of the amount of GST recoverable from, or payable to, the taxation authority.

Property, plant and equipment

Cost and valuation
Each class of property, plant and equipment is carried at cost or fair value less, where applicable, any accumulated depreciation and impairment losses.

Depreciation
Depreciation is calculated on a straight-line basis to write off the depreciable amount of each item of property, plant and equipment over its expected useful life to the Group.

Major depreciation periods are:
Plant and equipment                                                                          2.5-10 years
Leasehold improvements                                                                   the lease term

Impairment of assets

At each reporting date, the Group assesses whether there is any indication that an asset may be impaired. Where an indicator of impairment exists, the Group makes a formal estimate of recoverable amount. Where the carrying amount of an asset exceeds its recoverable amount the asset is considered impaired and is written down to its recoverable amount.

Recoverable amount is the greater of fair value less costs to sell and value in use. It is determined for an individual asset, unless the asset’s value in use cannot be estimated to be close to its fair value less costs to sell and it does not generate cash inflows that are largely independent of those from other assets or groups of assets, in which case, the recoverable amount is determined for the cash-generating unit to which the asset belongs.

In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset.

Derecognition and disposal
An item of property, plant and equipment is derecognised upon disposal or when no further future economic benefits are expected from its use or disposal.

Any gain or loss arising on derecognition of the asset (calculated as the difference between the net disposal proceeds and the carrying amount of the asset) is included in profit or loss in the year the asset is derecognised.

 
91
 
 
Research and development

Expenditure during the research phase of a project is recognised as an expense when incurred. Development costs are capitalised only when technical feasibility studies identify that the project will deliver future economic benefits and these benefits can be measured reliably.

Capitalised development costs have a finite life and are amortised on a systematic basis matched to the future economic benefits over the useful life of the project.

Trade and other payables

Trade and other payables are carried at amortised cost and represent liabilities for goods and services provided to the Group prior to the end of the financial year that are unpaid and arise when the Group becomes obliged to make future payments in respect of the purchases of these goods and services.

Interest bearing loans and borrowings

All loans and borrowings are initially recognised at the fair value of the consideration received less directly attributable transaction costs.

Gains and losses are recognised in profit or loss when the liabilities are derecognised.

Provisions

Provisions are recognised when the Group has a present obligation (legal or constructive) as a result of a past event, it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation and a reliable estimate can be made of the amount of the obligation.

Employee benefits

Wages, salaries, annual leave
Liabilities for wages and salaries, including non-monetary benefits, are recognised in other payables in respect of employees’ services up to the reporting date. Liabilities for annual leave are recognised in current provisions in respect of employees’ services up to the reporting date. They are measured at the amounts expected to be paid when the liabilities are settled.

Long service leave
The liability for long service leave is recognised in the provision for employee benefits and measured as the present value of expected future payments to be made in respect of services provided by employees up to the reporting date using the projected unit credit method. Consideration is given to expected future wage and salary levels, experience of employee departures, and periods of service. Expected future payments are discounted using market yields at the reporting date on national government bonds with terms to maturity and currencies that match, as closely as possible, the estimated future cash outflows.

Defined contribution plan
Defined superannuation contributions are recognised as an expense in the period they are incurred.

 
92
 
 
Share-based payment transactions

The Group provides benefits to employees of the Group in the form of share-based payments, whereby employees render services in exchange for shares or rights over shares (equity-settled transactions) under the terms of the Employee Share Option Plan (ESOP).

The cost of these equity-settled transactions with employees is measured by reference to the fair value of the equity instruments at the date at which they are granted. The fair value is determined using a binomial model. Further details are given in Note 13.

In valuing equity-settled transactions, no account is taken of any performance conditions.

The cost of equity-settled transactions is recognised, together with a corresponding increase in equity, over the vesting period of the instrument. The cumulative expense recognised for equity-settled transactions at each reporting date until vesting date reflects (i) the extent to which the vesting period has expired and (ii) the Group’s best estimate of the number of equity instruments that will ultimately vest. The income statement charge or credit for a period represents the movement in cumulative expense recognised as at the beginning and end of that period.

Termination benefits

Termination benefits are payable when employment is terminated before the normal retirement date, or when an employee accepts voluntary redundancy in exchange for these benefits. The Group recognises termination benefits when they are demonstrably committed to either terminating the employment of current employees according to a detailed formal plan without the possibility of withdrawing or providing termination benefits as a result of an offer made to encourage voluntary redundancy.

Contributed equity

Ordinary shares are classified as equity. Incremental costs directly attributable to the issue of new shares or options are shown as a deduction, net of tax, from the proceeds.

Subsidiary equity issues

Where a subsidiary makes a new issue of capital subscribed by minority interests, the parent company may make a gain or loss due to dilution of minority interests. These gains or losses are recognised in equity attributable to the parent company.

Earnings per share (EPS)

Basic EPS is calculated as net profit/(loss) attributable to members of the parent, adjusted to exclude costs of servicing equity (other than dividends) and preference share dividends, divided by the weighted average number of ordinary shares, adjusted for any bonus element.

 
93
 
 
Diluted EPS is calculated as net profit/(loss) attributable to members of the parent, adjusted for:
 
·  
costs of servicing equity (other than dividends) and preference share dividends;
·  
the after tax effect of dividends and interest associated with dilutive potential ordinary shares that have been recognised as expenses; and
·  
other non-discretionary changes in revenues or expenses during the period that would result from the dilution of potential ordinary shares,
divided by the weighted average number of ordinary shares and dilutive potential ordinary shares adjusted for any bonus element.

Deferred offering costs

Where costs associated with a capital raising have been incurred at balance date and it is probable that the capital raising will be successfully completed after balance date, such costs are deferred and offset against the proceeds subsequently received from the capital raising.

Financial instruments

Recognition
Financial instruments are initially measured at cost on trade date, which includes transaction costs, when the related contractual rights or obligations exist. Subsequent to initial recognition these instruments are measured as set out below.

Loans and receivables
Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market and are stated at amortised cost using the effective interest rate method.

Financial liabilities
Non-derivative financial liabilities are recognised at amortised cost, comprising original debt less principal payments and amortisation.

New accounting standards and interpretations

Certain new accounting standards and interpretations have been published that are not mandatory for 30 June, 2009 reporting periods. The Group’s and the parent entity’s assessment of the impact of these new standards and interpretations is set out below.

(i) AASB 8 Operating Segments and AASB 2007-3 Amendments to Australian Accounting Standards arising from AASB 8 (effective from 1 January, 2009)

AASB 8 will result in a significant change in the approach to segment reporting, as it requires adoption of a 'management approach' to reporting on financial performance. The information being reported will be based on what the key decision makers use internally for evaluating segment performance and deciding how to allocate resources to operating segments. The Group will adopt AASB 8 from 1 July, 2009. It is likely to result in an increase in the number of reportable segments presented. In addition, the segments will be reported in a manner that is more consistent with the internal reporting provided to the chief operating decision-maker.

 
94
 
 
(ii) Revised AASB 123 Borrowing Costs and AASB 2007-6 Amendments to Australian Accounting Standards arising from AASB 123 (effective from 1 January, 2009)

The revised AASB 123 has removed the option to expense all borrowing costs and - when adopted – will require the capitalisation of all borrowing costs directly attributable to the acquisition, construction or production of a qualifying asset. There will be no impact on the financial report of the Group.

(iii) Revised AASB 101 Presentation of Financial Statements and AASB 2007-8 Amendments to Australian Accounting Standards arising from AASB 101 (effective from 1 January, 2009)

The September 2007 revised AASB 101 requires the presentation of a statement of comprehensive income and makes changes to the statement of changes in equity, but will not affect any of the amounts recognised in the financial statements. If an entity has made a prior period adjustment or has reclassified items in the financial statements, it will need to disclose a third Balance Sheet (Statement of Financial Position), this one being as at the beginning of the comparative period. The Group will apply the revised standard from 1 July, 2009.

(iv) AASB 2008-1 Amendments to Australian Accounting Standard – Share-based Payments: Vesting Conditions and Cancellations (effective from 1 January, 2009)

AASB 2008-1 clarifies that vesting conditions are service conditions and performance conditions only and that other features of a share-based payment are not vesting conditions. It also specifies that all cancellations, whether by the entity or by other parties, should receive the same accounting treatment. The Group will apply the revised standard from 1 July, 2009, but it is not expected to affect the accounting for the Group's share-based payments.

(v) Revised AASB 3 Business Combinations, AASB 127 Consolidated and Separate Financial Statements and AASB 2008-3 Amendments to Australian Accounting Standards arising from AASB 3 and AASB 127 (effective 1 July, 2009)

The revised AASB 3 continues to apply the acquisition method to business combinations, but with some significant changes. For example, all payments to purchase a business are to be recorded at fair value at the acquisition date, with contingent payments classified as debt subsequently remeasured through the Income Statement. There is a choice on an acquisition-by-acquisition basis to measure the non-controlling interest in the acquiree either at fair value or at the non-controlling interest’s proportionate share of the acquiree’s net assets. All acquisition-related costs must be expensed.

 
95
 
 
The revised AASB 127 requires the effects of all transactions with non-controlling interests to be recorded in equity if there is no change in control and these transactions will no longer result in goodwill or gains and losses. The standard also specifies the accounting when control is lost. Any remaining interest in the entity is remeasured to fair value, and a gain or loss is recognised in profit or loss. The Group will apply the revised standards prospectively to all business combinations and transactions with non-controlling interests from 1 July, 2009

 (vi) AASB 2008-7 Amendments to Australian Accounting Standards - Cost of an Investment in a Subsidiary, Jointly Controlled Entity or Associate (effective 1 July, 2009)

In July 2008, the AASB approved amendments to AASB 1 First-time Adoption of International Financial Reporting Standards and AABS 127 Consolidated and Separate Financial Statements. The Group will apply the revised rules prospectively from 1 July, 2009. After that date, all dividends received from investments in subsidiaries, jointly controlled entities or associates will be recognised as revenue, even if they are paid out of pre-acquisition profits, but the investments may need to be tested for impairment as a result of the dividend payment.

(vii) AASB Interpretation 16 Hedges of a Net Investment in a Foreign Operation (effective 1 October, 2008)

AASB-I 16 clarifies which foreign currency risks qualify as hedged risk in the hedge of a net investment in a foreign operation and that hedging instruments may be held by any entity or entities within the group. It also provides guidance on how an entity should determine the amounts to be reclassified from equity to profit or loss for both the hedging instrument and the hedged item. The Group will apply the interpretation prospectively from 1 July, 2009. It is not expected to have a material impact on the Group’s financial statements.

(viii) AASB 2008-8 Amendment to IAS 39 Financial Instruments: Recognition and Measurement (effective 1 July, 2009)

AASB 2008-8 amends AASB 139 Financial Instruments: Recognition and Measurement and must be applied retrospectively in accordance with AASB 108 Accounting Policies, Changes in Accounting Estimates and Errors. The amendment makes two significant changes. It prohibits designating inflation as a hedgeable component of a fixed rate debt. It also prohibits including time value in the one-sided hedged risk when designating options as hedges. The Group will apply the amended standard from 1 July, 2009. It is not expected to have a material impact on the Group’s financial statements.

(ix) AASB Interpretation 17 Distribution of Non-cash Assets to Owners and AASB 2008-13 Amendments to Australian Accounting Standards arising from AASB Interpretation 17

AASB-I 17 applies to situations where an entity pays dividends by distributing non-cash assets to its shareholders. These distributions will need to be measured at fair value and the entity will need to recognise the difference between the fair value and the carrying amount of the distributed assets in the Income Statement on distribution.
 
 
96
 
 
The interpretation further clarifies when a liability for the dividend must be recognised and that it is also measured at fair value. The Group will apply the interpretation prospectively from 1 July, 2009. It is not expected to have a material impact on the Group’s financial statements.





 
97
 
 
Note 2                      (LOSS) BEFORE INCOME TAX
 
   
Consolidated
 
   
2009
   
2008
   
2007
 
   
A$'000
   
A$'000
   
A$'000
 
                   
Revenue and expenses from continuing operations
                 
                   
(a) Revenue
                 
Sale of goods
    8,333       9,400       10,709  
      8,333       9,400       10,709  
                         
Bank interest
    888       1,773       1,912  
Royalties
    1,923       1,749       1,746  
Licence fees
    -       224       1,122  
Dividends
    -       -       1,026  
Other
    3       137       780  
      2,814       3,883       6,586  
                         
Total revenue
    11,147       13,283       17,295  
                         
(b) Other income
                       
                         
Government grants - research and development
    -       -       2,710  
Net gains on disposal of property, plant and         .   equipment
    -       1,623       -  
      -       1,623       2,710  
 
(c) Other expenses
                 
Loss on disposal of plant and equipment
    29       -       17  
Reassessment of expected grant income
    -       915       -  
Inventory impairment provision
    1,087       (387 )     933  
Impairment loss - financial assets
                    -  
Trade receivables
    23       (29 )     29  
Other debtors
    -       62       -  
      1,139       561       979  
                         
(d) Depreciation included in the income statement
                       
Depreciation :
                       
Included in cost of sales
    -       2       367  
Included in administrative expenses
    282       351       609  
 
 
 
98
 
 
 
 
 
   
Consolidated
 
   
2009
   
2008
   
2007
 
   
A$'000
   
A$'000
   
A$'000
 
(e) Lease payments and other expenses included in the income statement
       
Included in administrative expenses:
                 
Minimum lease payments - operating leases
    775       663       668  
Net foreign exchange differences
    (920 )     937       893  
                         
(f) Employee benefit expense
                       
Wages and salaries
    6,884       7,248       8,163  
Workers' compensation costs
    51       61       67  
Defined contribution plan expense
    1,139       1,147       1,022  
Share-based payments expense
    1,065       576       549  
      9,139       9,032       9,801  


 
99
 
Note 3                 INCOME TAX
 
   
Consolidated
 
   
2009
   
2008
   
2007
 
   
A$'000
   
A$'000
   
A$'000
 
A reconciliation between tax expense and the product of accounting
(loss)/profit before income tax multiplied by the Group's applicable
tax rate is as follows:
 
                   
Accounting (loss)/profit before tax from operations
    (23,786 )     (24,773 )     (24,295 )
                         
At the Group's statutory income tax rate of 30% (2008 and 2007: 30%)
    (7,136 )     (7,432 )     (7,289 )
                         
Foreign tax rate differentials
    (727 )     619       (250 )
Non deductible expenses
    310       307       975  
Deductible balancing adjustments
    -       3       -  
Research and development allowance
    (1,403 )     (1,165 )     (143 )
Sub-total
    (8,956 )     (7,668 )     (6,707 )
Tax losses and timing differences not recognised
    8,957       7,672       6,708  
Previously unrecognised tax losses used to reduce tax expense
    -       -       -  
Tax expense
    1       4       1  
                         
Components of income tax expense/(benefit)
                       
Current tax
    (8,956 )     (7,668 )     (6,707 )
Deferred tax
    8,957       7,672       6,708  
Income tax expense
    1       4       1  
 
Deferred income tax
                 
                   
Deferred income tax at 30 June relates to the following:
             
Deferred tax assets
                 
   Depreciation
    340       761       733  
   Provisions and accruals
    1,875       1,025       1,042  
   Exchange losses
    121       78       549  
   Share based payments by USA subsidiaries
    203       -       -  
   Other
    60       6       113  
   Losses carried forward
                       
                                    - Australia
    35,177       33,238       24,157  
                                    - US
    16,990       11,876       14,729  
                                    - Other countries
    2,368       3,653       5,139  
Total deferred tax assets not recognised
    57,134       50,637       46,462  
                         
Deferred tax liability
                       
   Exchange gains
    -       -       -  
   Other
    (76 )     (117 )     (304 )
                         
Total deferred tax liability not recognised
    (76 )     (117 )     (304 )
                         
Net deferred tax asset not recognised
    57,058       50,520       46,158  
 
 
 
100
 
 
Tax consolidation

Novogen Limited and its 100% owned Australian subsidiaries elected to form a tax consolidation group for income tax purposes with effect from July 1, 2003. The Australian Tax Office has been formally notified of this decision. Novogen Limited as the head entity discloses all of the deferred tax assets of the tax consolidated group in relation to tax losses carried forward (after elimination of inter-group transactions).

As the tax consolidation group continues to generate tax losses there has been no reason for the Company to enter a tax funding agreement with members of the tax consolidation group.


Note 4                 EARNINGS PER SHARE

Basic earnings per share amounts are calculated by dividing net loss for the year attributable to ordinary equity holders of the parent by the weighted average number of ordinary shares outstanding during the year.

Diluted earnings per share amounts are calculated by dividing the net loss attributable to ordinary equity holders of the parent by the weighted average number of ordinary shares outstanding during the year plus the weighted average number of ordinary shares that would be issued on the conversion of all the dilutive potential ordinary shares into ordinary shares. The notional issue of potential ordinary shares resulting from the exercise of options detailed in Note 13 does not result in diluted earnings per share that shows a different view of the earnings performance of the Company, therefore the information has not been disclosed.

Potential ordinary shares (non-dilutive) and not included in determining earnings per share: 4,213,416 options (refer Note 13).

There have been no conversions to, calls of, or subscriptions for ordinary shares or issues of potential ordinary shares since the reporting date and before the completion of this financial report.

 
101
 
 
The following reflects the income and share data used in the basic and diluted earnings per share computations:

   
Consolidated
 
   
2009
   
2008
   
2007
 
   
$'000
   
$'000
   
$'000
 
                   
Net loss attributable to ordinary equity holders of the parent
    (18,928 )     (20,264 )     (19,981 )
                         
                         
   
2009 Thousands
   
2008 Thousands
   
2007 Thousands
 
                         
Weighted average number of ordinary shares used in calculating basic and diluted earnings per share
    101,741       97,594       97,567  
 
 
Note 5                  CASH AND CASH EQUIVALENTS

   
Consolidated
 
   
2009
   
2008
   
2007
 
   
$'000
   
$'000
   
$'000
 
                   
Cash at bank and in hand
    27,848       27,930       30,059  
Short-term deposits
    4,490       6,456       8,452  
      32,338       34,386       38,511  
                         
Secured cash (Refer Note 15)
    1,000       1,000       1,000  
      33,338       35,386       39,511  

 
Cash at bank earns interest at floating rates based on daily bank deposit rates.

Short-term deposits are made for varying periods of between one day and three months, depending on the immediate cash requirements of the Group, and earn interest at the respective short-term deposit rates.


 
102
 
 
Note 6                 TRADE AND OTHER RECEIVABLES

   
Consolidated
 
   
2009
   
2008
 
   
$'000
   
$'000
 
             
Current
           
             
Trade receivables
    1,531       2,042  
Allowance for doubtful debts
    (36 )     (20 )
      1,495       2,022  
                 
Deposits held
    454       427  
Term deposits with greater than three months to maturity
    -       2,000  
Deferred offering costs
    -       114  
Other debtors
    303       468  
Allowance for doubtful debts - other
    -       (62 )
      2,252       4,969  

Provision for doubtful debts

Trade receivables are non-interest bearing and are generally on 30-60 day terms. An allowance for doubtful debts is made when there is objective evidence that the Group will not be able to collect the debts.

At 30 June, 2009 trade receivables of $36,000 (2008: $20,000) were considered doubtful. These amounts have been included in selling and promotional expenses.

Movements in the allowance for doubtful debts were as follows:

   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
             
Balance at 1 July
    (20 )     (46 )
                 
Change in allowance for the year
    (23 )     29  
Amounts (recovered)/written off during the year
    7       (3 )
                 
Balance at 30 June
    (36 )     (20 )


Past due but not considered doubtful

At 30 June, 2009 trade receivables of $280,000 (2008: $645,000) were past due but were not considered to be doubtful. These relate to a number of independent customers for whom there is no recent history of default. The ageing analysis of these trade receivables is as follows:

 
103
 
 
 
   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
             
1 - 30 days overdue
    250       447  
31 - 60 days overdue
    15       196  
61 - 90 days overdue
    3       2  
91 + days overdue
    12       -  
                 
      280       645  

Receivable balances which are neither overdue nor impaired are expected to be received when due.

Other receivables

Other debtors, generally arising from transactions outside usual operating activities of the Group, are non-interest bearing and have repayment terms between 7 and 30 days.

At 30 June, 2009  no other receivables (2008: $86,000) were past due but were not considered to be doubtful.
 
   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
             
1 - 30 days overdue
    -       9  
31 - 60 days overdue
    -       28  
61 - 90 days overdue
    -       -  
91 + days overdue
    -       49  
                 
      -       86  

Other receivable balances which are neither overdue nor impaired are expected to be received when due.

Related party receivables

Related party receivables – see Note 17 for terms and conditions.

Fair value and credit risk
Due to the short term nature of these receivables, their carrying value is assumed to approximate their fair value.

The maximum exposure to credit risk is the fair value of receivables. Collateral is not held against these receivables.

 
104
 
 
Foreign exchange and interest rate risk

Details regarding foreign exchange and interest rate risk exposure are disclosed in Note 15.


Note 7                 INVENTORIES

   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
             
Current
           
             
Work in progress (at cost)
    573       536  
Finished goods (at cost)
    761       1,393  
      1,334       1,929  
                 

Note 8                 OTHER CURRENT ASSETS

   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
             
Prepayments
    565       542  

 

 
 
105
 
 
Note 9                 PROPERTY, PLANT AND EQUIPMENT
 
   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
             
Plant and equipment - at cost
    2,697       2,753  
Accumulated depreciation
    (2,395 )     (2,236 )
      302       517  
                 
                 
Leasehold improvements - at cost
    107       112  
Accumulated depreciation
    (56 )     (54 )
      51       58  
                 
Total property, plant and equipment - at cost
    2,804       2,865  
Accumulated amortisation and depreciation
    (2,451 )     (2,290 )
                 
Total property, plant and equipment
    353       575  
 


Reconciliations
Reconciliations of the carrying amount of plant, property and equipment at the beginning and at the end of the current financial year:

   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
Plant and equipment
           
Carrying amount at beginning of financial year
    517       758  
Additions
    63       95  
Disposals
    (21 )     (5 )
Depreciation expense
    (257 )     (331 )
Carrying amount at end of financial year
    302       517  
                 
Leasehold improvements
               
Carrying amount at beginning of financial year
    58       80  
Additions
    32       -  
Disposals
    (14 )     -  
Depreciation expense
    (25 )     (22 )
Carrying amount at end of financial year
    51       58  


 
 
 
106
 
 
Note 10                 TRADE AND OTHER PAYABLES
   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
             
Current
           
             
Trade payables
    2,837       3,427  
Accrued trade payables
    1,261       1,239  
Accrued clinical trial payments
    3,961       2,005  
Intercompany payable
    -       -  
      8,059       6,671  
 
Terms and conditions relating to the above payables:
 
· trade payables are non-interest bearing and normally settled on 30 day terms; and
· clinical trial payables are non-interest bearing and normally settled on 30 day terms.

Risk exposure
Information about the Group’s and the parent entity’s exposure to foreign exchange risk and liquidity risk is provided in Note 15.

Fair value
Due to the short term nature of these payables, their carrying value is assumed to approximate their fair value.

 
Note 11                 PROVISIONS
 
   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
Employee benefit provision
           
Current
    774       708  
Non-current
    190       339  
      964       1,047  
                 
Make good provision
               
Opening balance at beginning of the year
    46       46  
Additional provision made in the period
    -       -  
Closing balance at the end of the year
    46       46  
                 
Current
    -       -  
Non-current
    46       46  
      46       46  

In accordance with its Sydney premises lease, the Group must restore the leased premises to agreed condition at the end of the lease term. A provision of A$46,000 was made in respect of the Group’s expected obligation.


 
107
 
 
Note 12                 CONTRIBUTED EQUITY AND RESERVES

(a) Issued and paid up capital
           
   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
Fully Paid Ordinary Shares
           
Novogen Limited
           
102,125,894 (2008: 97,594,261) ordinary shares
    133,100       127,573  
      133,100       127,573  
                 
Other
               
Gain arising on issue of shares by subsidiaries to outside shareholders:
         
Marshall Edwards, Inc.
    65,855       65,654  
Glycotex, Inc.
    7,464       7,205  
      73,319       72,859  
                 
Contributed Equity
    206,419       200,432  

Ordinary shares have the right to receive dividends as declared and, in the event of winding up the Company, to participate in the proceeds from the sale of all surplus assets in proportion to the number of and amounts paid up on shares held.

Ordinary shares entitle their holder to one vote, either in person or by proxy, at a meeting of the Company.

Movements in issued and paid up ordinary share capital of Novogen Limited are as follows:

   
Number of
shares
   
Issue
price
   
A$'000
 
            $A        
On issue 1 July, 2007
    97,594,261               127,573  
                         
On issue 30 June, 2008
    97,594,261               127,573  
                         
On issue 1 July, 2008
    97,594,261               127,573  
                         
New Share Issue
    4,531,633       1.22       5,527  
Total shares issued during the period
    4,531,633               5,527  
                         
On issue 30 June, 2009
    102,125,894               133,100  

Share options
The Company has an employee share option plan under which options to subscribe for the Company’s shares have been granted to certain executive and other employees (refer Note 13).

 
108
 
 
(b) Reserves

The foreign currency translation reserve is used to record exchange differences arising from the translation of the financial statements of foreign subsidiaries.

Movements in the currency translation reserve were as follows:

   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
             
Balance at the beginning of the year
    (7,491 )     (5,155 )
Share of opening reserve transferred to minority interest due to issuance of shares by subsidiary
    56       393  
Exchange differences on translation of foreign operations
    4,425       (2,729 )
Balance at the end of the year
    (3,010 )     (7,491 )


(c) Accumulated losses
Movements in accumulated losses were as follows:

   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
             
Balance at the beginning of the year
    (162,251 )     (146,147 )
                 
Adjustment to opening retained earnings attributed to minority interest holders
    389       3,310  
Equity attributable to share based payments
    1,060       850  
Current year (loss)/profit
    (18,928 )     (20,264 )
                 
Balance at the end of the year
    (179,730 )     (162,251 )

(d) Minority interests
The minority interests are detailed as follows:

   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
             
Ordinary shares
    31,141       27,567  
Foreign currency translation reserve
    (1,193 )     (2,875 )
Accumulated losses
    (24,854 )     (19,745 )
      5,094       4,947  
 
 
 
109
 
 
Note 13                      SHARE BASED PAYMENT PLANS
 
Employee Share Option Plan
The Employee Share Option Plan provides for the issue of options to eligible employees being an employee or Director of the Company or related company. Each option entitles its holder to acquire one fully paid ordinary share and is exercisable at a price equal to the weighted average price of such shares at the close of trading on the Australian Stock Exchange Limited for the five days prior to the date of issue. Options issued under the Employee Share Option Plan vest in four equal annual instalments over the vesting period. Options are not transferable and cannot be settled by the Company in cash. The option lapses if the employee ceases to be an employee during the vesting period. There are currently 38 employees eligible to receive option grants under the Employee Share Option Plan. (2008: 45)

The expense recognised in the income statement in relation to employee share-based payments is disclosed in Note 2(f).

Consultant options
The Company has also granted options by way of compensation to consultants who perform services for Novogen and its controlled entities. Options issued to consultants generally vest in four equal annual instalments over the vesting period. The expense recognised in the income statement relation to consultant options is $134,901 (2008:$26,216).

The contractual life of all options granted is five years. There are no cash settlement alternatives.

The following table illustrates the number (No.) and weighted average exercise price (WAEP) of, and movements in, share options issued to employees during the year:
 
   
2009
   
2008
 
   
No.
   
WAEP
   
No.
   
WAEP
 
Outstanding at the beginning of the year
    2,327,976     $ 2.28       1,446,054     $ 3.37  
  Granted
    2,441,712     $ 0.60       1,326,552     $ 1.20  
  Forfeited
    (586,996 )   $ 1.53       (184,114 )   $ 3.27  
  Exercised (i)
    -       N/A       -       N/A  
  Expired
    (111,280 )   $ 6.76       (260,516 )   $ 2.10  
Outstanding at the end of the year
    4,071,412     $ 1.26       2,327,976     $ 2.28  
Exercisable at the end of the year
    886,110     $ 2.63       534,192     $ 4.33  
 
(i) There were no options exercised during the year ended 30 June, 2009 and 30 June, 2008.

 
 
110
 
 
The following table details the exercise price, expiry date and number of options issued to employees that were outstanding as at the end of the year:
 
 
Exercise Price
Expiry Date
No. outstanding
30 June, 2009
No. outstanding
30 June, 2008
 
 
$6.76
27/02/09
                    -
           118,468
 
 
$4.90
16/03/10
           160,340
           182,868
 
 
$3.64
16/04/11
           228,964
           272,536
 
 
$2.41
30/03/12
           346,172
           427,552
 
 
$2.41
30/03/12
           141,668
           141,668
 
 
$1.06
1/03/13
           894,916
        1,184,884
 
 
$1.06
1/03/13
           345,592
                    -
 
 
$0.53
6/03/14
        1,953,760
                    -
 
           
     
4,071,412
2,327,976
 
 
The following table illustrates the number (No.) and weighted average exercise price (WAEP) of, and movements in, share options issued to consultants during the year;

   
2009
   
2008
 
   
No.
   
WAEP
   
No.
   
WAEP
 
Outstanding at the beginning of the year
    103,020     $ 2.69       130,012     $ 3.08  
  Granted
    45,644     $ 0.53       35,460     $ 1.06  
  Forfeited
    -       N/A       (25,252 )   $ 3.24  
  Expired
    (6,660 )   $ 6.76       (37,200 )   $ 2.10  
Outstanding at the end of the year
    142,004     $ 1.81       103,020     $ 2.69  
Exercisable at the end of the year
    49,063     $ 3.02       31,633     $ 4.27  

 
 
111
 
 
The following table details the exercise price, expiry date and number of options issued to consultants that were outstanding as at the end of the year:

 
Exercise Price
Expiry Date
No. outstanding
30 June, 2009
No. outstanding
30 June, 2008
 
 
$6.76
27/02/09
                    -
              6,660
 
 
$4.90
16/03/10
              9,184
              9,184
 
 
$3.64
16/04/11
            20,624
            20,624
 
 
$2.41
30/03/12
            31,092
            31,092
 
 
$1.06
1/03/13
            35,460
            35,460
 
 
$0.53
6/03/14
            45,644
                    -
 
           
     
142,004
103,020
 

The weighted average remaining contractual life for the share options outstanding as at 30 June, 2009 is between 1 and 5 years. (2008: 1 and 5 years)

The weighted average fair value of options granted during the year was A$0.34. (2008: A$0.61)

The fair value of the equity-settled share options granted to both employees and consultants is estimated as at the date of grant using a binomial model taking into account the terms and conditions upon which the options were granted.

The following table lists the inputs to the model used to calculate the fair value of the options.
 
   
6 March,
   
31 October,
   
1 March,
   
26 October,
 
   
2009
   
2008
   
2008
   
2007
 
Exercise price
    0.5256       1.06       1.06       2.41  
Share price at grant date
    0.51       0.95       1.07       1.62  
Dividend yield
    0 %     0 %     0 %     0 %
Expected volatility
    73 %     66 %     57 %     55 %
Historical volatility
    73 %     66 %     57 %     55 %
Risk-free interest rate
    3.61 %     4.76 %     6.35 %     6.41 %
Expected life of option
 
5 years
   
4.3 years
   
5 years
   
4.4 years
 
Option fair value
    0.31       0.51       0.60       0.66  
 
The dividend yield reflects the assumption that the current dividend payout, which is zero, will continue with no anticipated increases. The expected life of the options is based on historical data and is not necessarily indicative of exercise patterns that may occur. The expected volatility reflects the assumption that the historical volatility is indicative of future trends, which may also not necessarily be the actual outcome.

 
112
 
 
Marshall Edwards, Inc.

Share based payment plans

On December 9, 2008, MEI adopted the Marshall Edwards, Inc. 2008 Stock Omnibus Equity Compensation Plan (the “Equity Compensation Plan”) and cancelled the Marshall Edwards, Inc. Share Option Plan (the “Share Option Plan”).  No options were issued under the Share Option Plan. The Equity Compensation Plan provides for the issuance of a maximum of 7,000,000 shares of common stock in connection with the grant of options and/or other stock-based or stock-denominated awards to non-employee directors, officers, employees and advisors. On 28 January, 2009, options exercisable for 50,000 shares of common stock were granted to a consultant for services to the company under the Equity Compensation Plan.

The options have an exercise price of US$0.63 and are fully exercisable at date of grant. The options have a term of 5 years and expire on 28 January, 2014. At 30 June, 2009 no options had expired, been forfeited or exercised and all 50,000 were outstanding at that date.

Other share based payments.

On 30 July, 2008 MEI granted a warrant to a consultant, to purchase up to 46,083 shares of common stock at an exercise price of US$2.17 per share for services provided to the company. The shares are fully vested from grant date and expire five years from grant date on 30 July, 2013. At 30 June, 2009 no shares had been issued as a result of exercise of the warrant.

The fair value of the equity settled transactions with consultants are estimated as at the date of grant using a binomial model taking into account the terms and conditions upon which the options and warrant were granted.

The following table lists the inputs to the model used to calculate fair value:

 
   
28 January, 2009
30 July, 2008
 
Exercise price
 
 0.63
 2.17
 
Share price at grant date
 
 0.63
 2.13
 
Dividend yield
 
0%
0%
 
Expected volatility
 
111%
81%
 
Historical volatility
 
111%
81%
 
Risk-free interest rate
 
1.70%
3.36%
 
Expected life of warrant
 
5 years
5 years
 
Warrant fair value
 
US$0.50
US$1.41
 


 
113
 
 
Glycotex, Inc. Share based payment plans

The Glycotex, Inc, 2007 stock option plan provides for the issuance of a maximum of 357,000 shares of common stock in connection with the grant of options and/or other stock-based or stock-denominated awards to non-employee directors, officers, employees and advisors. On 29 May, 2009, options exercisable for 125,573 shares of common stock were granted under the Stock Option Plan.

A total of 50,229 options vest and become exercisable on the grant date, 37,672 options vest on 29 May, 2010 and 37,672 options vest on 29 May, 2011. The options have an exercise price of US$15.13. The options have a term of 5 years and expire on 29 May, 2014. At 30 June, 2009, 50,229 options were exercisable, no options had expired, been forfeited or exercised and all 125,573 were outstanding at that date.

The fair value of the equity settled transactions with consultants are estimated as at the date of grant using a binomial model taking into account the terms and conditions upon which the options and warrant were granted.

The following table lists the inputs to the model used to calculate fair value:

   
29 May, 2009
 
Exercise price
 
 15.13
 
Share price at grant date
 
 15.13
 
Dividend yield
 
0%
 
Expected volatility
 
52%
 
Historical volatility
 
52%
 
Risk-free interest rate
 
2.34%
 
Expected life of warrant
 
5 years
 
Warrant fair value
 
US$7.13
 

 
 
114
 
 
Note 14                 SEGMENT INFORMATION

The Group generally accounts for intercompany sales and transfers as if the sales or transfers were to third parties. Revenues are attributed to geographic areas based on the location of the assets producing the revenues.

The Novogen Group operates subsidiary companies in 3 major geographical areas being Australia, North America and Europe. The subsidiaries are involved in the selling and marketing of Novogen's consumer healthcare products.

Segment accounting policies are the same as the Group’s policies described in Note 1. During the financial year there were no changes in the segment accounting policies that had a material effect on the segment information.

 
115
 
 
Geographic Segments

The following table presents revenue and profit information and certain asset and liability information regarding business segments for the years ended June 30, 2009, June 30, 2008, and June 30, 2007.
 
Australia
North America
Europe
Elimination
Consolidated
 
 
2009
2008
2007
2009
2008
2007
2009
2008
2007
2009
2008
2007
2009
2008
2007
 
 
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
 
Revenue
                               
Sales to external customers
       4,902
       4,755
       4,453
       2,068
       2,428
       3,152
       1,363
       2,217
       3,104
             -
             -
             -
        8,333
        9,400
      10,709
 
Other revenues from external . customers
       2,059
       2,171
       4,691
             -
              5
            54
             -
            13
             -
        (133)
          (79)
          (71)
        1,926
        2,110
        4,674
 
Inter-segment revenues
       1,077
       1,206
       3,543
             -
             -
             -
       4,050
             -
             -
     (5,127)
     (1,206)
     (3,543)
             -
             -
             -
 
Total segment revenue
       8,038
       8,132
     12,687
       2,068
       2,433
       3,206
       5,413
       2,230
       3,104
     (5,260)
     (1,285)
     (3,614)
      10,259
      11,510
      15,383
 
Unallocated revenue
                       
           888
        1,773
        1,912
 
Total consolidated revenue
                       
      11,147
      13,283
      17,295
 
                                 
                                 
Result (from continuing operations)
                             
Segment result (loss)/profit
   (25,340)
   (27,435)
   (18,684)
   (10,055)
          997
     (1,493)
       3,786
          139
          105
       7,834
       1,550
     (4,221)
    (23,775)
    (24,749)
    (24,293)
 
Unallocated expenses
                       
           (11)
           (24)
             (2)
 
Consolidated entity (loss) before income tax
                   
    (23,786)
    (24,773)
    (24,295)
 
Income tax expense
                       
             (1)
             (4)
             (1)
 
Net (loss) from continuing operations
                     
    (23,787)
    (24,777)
    (24,296)
 
                                 
                                 
Assets and liabilities
                               
Segment assets
     62,344
     61,667
     71,533
     98,248
     82,874
     70,414
          811
       1,026
       1,722
 (123,561)
 (102,166)
   (92,312)
      37,842
      43,401
      51,357
 
Segment liabilities
       8,609
       7,272
       6,471
     47,105
     39,572
     44,107
       6,495
     10,495
     11,331
   (53,140)
   (49,575)
   (55,178)
        9,069
        7,764
        6,731
 
                                 
                                 
Other segment information
                               
Capital expenditure
            81
            88
          269
            13
              4
            27
             -
              3
              3
             -
             -
             -
             94
             95
           299
 
Depreciation
          270
          341
          954
            11
              7
            15
              1
              5
              7
             -
             -
             -
           282
           353
           976
 
Other non-cash expenses
       5,409
          514
       1,395
          799
            31
       2,208
            66
          (18)
            35
     (4,029)
             -
             -
        2,245
           527
        3,638
 
Segment net gain/(loss) on foreign currency
       6,990
     (6,466)
     (7,031)
     (5,782)
       4,767
       5,573
        (289)
          764
          581
              1
            (2)
          (16)
           920
         (937)
         (893)
 
Inventory impairment provision
          894
        (364)
          845
          123
             -
            89
            70
              6
            (1)
             -
             -
             -
        1,087
         (358)
           933
 
 
116
 
 
 
Business Segments
 
The following table presents revenue, expenditure and certain asset information regarding business segments for the years ended June 30, 2009, June 30, 2008 and June 30, 2007.
 
 
Consumer healthcare
Pharmaceutical research and development
Elimination
Consolidated
 
2009
2008
2007
2009
2008
2007
2009
2008
2007
2009
2008
2007
 
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
                         
Segment revenue
       8,907
     10,507
     12,450
       2,240
       2,776
       4,845
             -
             -
             -
     11,147
     13,283
     17,295
Segment assets
     20,707
     21,469
     28,461
     24,787
     22,717
     23,790
     (7,652)
        (785)
        (894)
     37,842
     43,401
     51,357
 

Note 15                 FINANCIAL INSTRUMENTS

Capital Risk Management

The Group manages its capital to ensure that the entities in the Group will be able to continue as a going concern while maximising shareholder value.

The capital structure of the Group consists of cash and cash equivalents and equity attributable to equity holders. The Group operates globally, primarily through subsidiary companies established in the markets in which the Group trades, or through subsidiary companies established to facilitate the development of specialty pharmaceutical products including oncology drug development through Marshall Edwards, Inc. and wound healing through Glycotex, Inc.

The Group’s overall strategy remains unchanged from 2008, whereby future operating cash flows generated by a profitable Consumer Health business will supplement the funds raised in equity markets by the Group’s listed subsidiary companies. Also the Group intends to fund its operations through licence opportunities for its pharmaceutical product candidates.

Financial Risk Management

The Group’s principal financial instruments comprise cash and short term deposits, receivables and payables. The Group is not exposed to significant debt or borrowings.

The Group’s activities expose it to a variety of financial risks. The main risks arising from the Group’s financial instruments are market risk (including currency risk and interest rate risk), credit risk and liquidity risk. The Group uses different methods to measure and manage the different types of risks to which it is exposed. These methods include monitoring the levels of exposure to interest rates and foreign exchange, ageing analysis and monitoring of specific credit allowances to manage credit risk, and, rolling cash flow forecasts to manage liquidity risk.

 
117
 
 
Market Risk

Interest rate risk

The Group’s exposure to market interest rates relate primarily to the investments of cash balances.
The Group has cash reserves held primarily in US$ and A$ and places funds on deposit with financial institutions for periods generally not exceeding three months.

At balance date the Group had the following exposure to variable interest rate risk:

   
Consolidated
 
   
2009
2008
 
   
A$'000
A$'000
 
Financial assets
       
         
Cash at bank and in hand
 
     27,848
      27,930
 
Short term deposits
 
       4,490
       6,456
 
   
     32,338
      34,386
 
         
Secured cash
 
       1,000
       1,000
 
         
Net exposure
 
     33,338
      35,386
 

At 30 June, 2009, if interest rates had moved as illustrated in the table below, with all other variables held constant, post tax profit would have been affected as follows:

Judgements of reasonably possible
movements:
Post tax profit
 
   
Higher/(Lower)
 
   
2009
2008
 
   
A$'000
A$'000
 
Consolidated
       
+1% (100 basis points)
 
         333 
          354 
 
-1% (100 basis points)
 
        (333)
         (354)
 

 
 
118
 
 
The Group's exposure to interest rate risk and the effective weighted average interest rate for each class of financial assets and liabilities is set out below.

Consolidated
 
Consolidated
                         
   
Floating Interest
Rate
Fixed 
1 year or less
Fixed 
Over 1 to 5 years
Non-interest     
bearing
Total
 
Weighted average rate of interest
 
Note
2009
2008
2009
2008
2009
2008
2009
2008
2009
2008
2009
2008
   
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
A$'000
   
Financial assets
                         
Cash
5
 18,835
 25,049
       -
       -
         -
         -
  9,013
  2,881
    27,848
    27,930
0.58%
2.02%
Deposits
5
       -
       -
  5,490
  7,456
         -
         -
       -
       -
      5,490
     7,456
3.62%
7.75%
Trade and other receivables
6
       -
       -
       -
  2,000
         -
         -
  2,252
  2,969
      2,252
     4,969
N/A
8.50%
Loans and receivables
 
       -
       -
  5,490
  9,456
         -
         -
  2,252
  2,969
      7,742
    12,425
   
                           
   
 18,835
 25,049
  5,490
  9,456
         -
         -
 11,265
  5,850
    35,590
    40,355
   
                           
Financial liabilities
                         
Trade and other payables
10
       -
       -
       -
       -
         -
         -
  8,059
  6,671
      8,059
     6,671
N/A
N/A
Financial liabilities at amortised cost
       -
       -
       -
       -
         -
         -
  8,059
  6,671
      8,059
     6,671
   
                           
Net financial assets/(liabilities)
 18,835
 25,049
  5,490
  9,456
         -
         -
  3,206
    (821)
    27,531
    33,684
   

Foreign currency risk

The Group operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the U.S. dollar (USD), the British pound (GBP), the Euro, the Swiss Franc (CHF) and the Canadian dollar (CAD). Foreign exchange risk arises from future transactions and recognised assets and liabilities denominated in a currency that is not the entity’s functional currency and net investments in foreign operations.

As of 30 June, 2009, the Group did not hold derivative financial instruments in managing its foreign currency, however, the Company may from time to time enter into hedging arrangements where circumstances are deemed appropriate. Foreign subsidiaries with a functional currency of AUD have exposure to the local currency of these subsidiaries and any other currency these subsidiaries trade in. The functional currency of Marshall Edwards, Inc. and Glycotex, Inc. is USD and these subsidiaries have exposure to AUD and any other currency these subsidiaries trade in.

 
119
 
 
The Group’s exposure to foreign currency risk at 30 June, 2009 was as follows:

 
Consolidated
 
 
2009
2008
 
 
A$'000
A$'000
 
USD denominated
     
       
Financial assets
     
Cash and cash equivalents
        467
     3,524
 
Trade and other receivables
        243
        268
 
 
        710
     3,792
 
Financial liablities
     
Trade and other payables
        155
        110
 
Net exposure
        555
     3,682
 
       
GBP denominated
     
       
Financial assets
     
Cash and cash equivalents
        126
          18
 
Trade and other receivables
        340
        474
 
 
        466
        492
 
Financial liablities
     
Trade and other payables
        337
        319
 
Net exposure
        129
        173
 
       
CAD denominated
     
       
Financial assets
     
Cash and cash equivalents
        150
        138
 
Trade and other receivables
        121
        200
 
 
        271
        338
 
Financial liablities
     
Trade and other payables
        145
          79
 
Net exposure
        126
        259
 
       
EURO denominated
     
       
Financial assets
     
Cash and cash equivalents
          12
          49
 
Trade and other receivables
        491
        660
 
 
        503
        709
 
Financial liablities
     
Trade and other payables
        339
        779
 
Net exposure
        164
         (70)
 
 
 
 
120
 
 
 
CHF denominated
     
       
Financial assets
     
Cash and cash equivalents
          -
          -
 
Trade and other receivables
          -
          -
 
 
          -
          -
 
Financial liablities
     
Trade and other payables
        218
          -
 
Net exposure
       (218)
          -
 
       
AUD denominated
     
       
Financial assets
     
Cash and cash equivalents
        738
        441
 
Trade and other receivables
        293
          -
 
 
     1,031
        441
 
Financial liablities
     
Trade and other payables
     4,085
     1,695
 
Net exposure
    (3,054)
    (1,254)
 
 
 
 
121
 
 
The following sensitivity is based on the foreign currency risk exposures in existence at the balance sheet date:

Judgements of reasonably possible movements:
Post tax profit
 
 
Higher/(Lower)
 
 
2009
2008
 
 
A$'000
A$'000
 
USD denominated
     
       
Consolidated
     
AUD/USD +10%
         (50)
       (335)
 
AUD/USD -10%
          62 
        409 
 
       
GBP denominated
     
       
Consolidated
     
AUD/GBP +10%
         (12)
         (16)
 
AUD/GBP -10%
          14 
            9 
 
       
CAD denominated
     
       
Consolidated
     
AUD/CAD +10%
         (11)
         (24)
 
AUD/CAD -10%
          14 
          29 
 
       
EURO denominated
     
       
Consolidated
     
AUD/EURO +10%
         (15)
            6 
 
AUD/EURO -10%
          18 
           (8)
 
       
CHF denominated
     
       
Consolidated
     
AUD/EURO +10%
          20 
          -
 
AUD/EURO -10%
         (24)
          -
 
       
AUD denominated
     
       
Consolidated
     
AUD/USD +10%
        278 
        114 
 
AUD/USD -10%
       (339)
       (139)
 
       
 
 
 
122
 
 
Credit risk

The Group trades only with recognised, creditworthy third parties.

It is the Group’s policy that all customers who wish to trade on credit terms are subject to credit application procedures. In addition, receivable balances are monitored on an ongoing basis with the result that the Group’s exposure to bad debts is not significant.

As of 30 June, 2009 the Group did not hold derivative financial instruments. The Group places its cash deposits with high credit quality financial institutions and by policy, limits the amount of credit exposure to any single counter-party. The Group is averse to principal loss and ensures the safety and preservation of its invested funds by limiting default risk, market risk, and reinvestment risk.

The Group mitigates default risk by depositing funds with high credit quality financial institutions and by constantly positioning its portfolio to respond appropriately to a significant reduction in a credit rating of any financial institution.

The Group’s maximum exposures to credit risk at balance date in relation to each class of recognised financial assets is the carrying amount of those assets as indicated in the Balance Sheet. Trade and other receivables by geographical segment are as follows:


 
Consolidated
 
 
2009
2008
 
 
A$'000
A$'000
 
Australia
     1,724
     4,089
 
North America
        182
        338
 
Europe
        346
        542
 
 
     2,252
     4,969
 

Concentration of credit risk
There are no significant concentrations of credit risk within the Group. The Group minimises concentration of credit risk in relation to trade receivables by undertaking transactions with a large number of customers. The credit risk on liquid funds is limited as the counterparties are banks with high credit ratings.

Credit risk is managed in the following way:
   (i)
customer payment terms are 30 days except for some customers who have 60 day terms;
 (ii)     
credit limits are applied to customers to limit the credit risk exposure; and
(iii)     
by limiting the amount of credit exposure to any single counter-party for cash deposits.

 
 
123
 
 
Liquidity risk

The Group manages liquidity risks by maintaining adequate cash reserves and by continuously monitoring cash forecasts and actual cash flows.

Maturity analysis of financial liabilities based on management’s expectation
Trade payables and other financial liabilities mainly arise from the financing of assets used in the Company’s ongoing operations such as plant and equipment and investments in working capital. These assets are considered in the Group’s overall liquidity risk.

Consolidated
                             
Year ended 30 June, 2009
 
< 6 months
   
6-12 months
   
1-5 Years
   
> 5 years
   
Total
 
   
$'000
   
$'000
   
$'000
   
$'000
   
$'000
 
                               
Financial Liabilities
                             
Trade and other payables
    8,059       -       -       -       8,059  
                                         
Total
    8,059       -       -       -       8,059  
                                         
                                         
                                         
Consolidated
                                       
Year ended 30 June, 2008
 
< 6 months
   
6-12 months
   
1-5 Years
   
> 5 years
   
Total
 
   
$'000
   
$'000
   
$'000
   
$'000
   
$'000
 
                                         
Financial Liabilities
                                       
Trade and other payables
    6,671       -       -       -       6,671  
                                         
Total
    6,671       -       -       -       6,671  
 
Financing facilities available
At reporting date, the following financing facilities had been negotiated and were available:

   
Consolidated
 
   
2009
2008
 
   
A$'000
A$'000
 
         
Multi option facility
 
      1,000
      1,000
 
   
      1,000
      1,000
 
         
Used at balance date
 
        526
        526
 
Unused at balance date
 
        474
        474
 
   
      1,000
      1,000
 
 
Novogen Limited has entered into a Deed of Set-off where it has agreed to hold a deposited sum with the bank of at least $1 million at all times as additional security for the multi-option facility.
 
 
 
124
 
 
Note 16                 COMMITMENTS

   
Consolidated
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
             
(a) Lease commitments *
           
             
Commitments in relation to operating leases
           
contracted for at the reporting date but not
           
recognised as liabilities payable:
           
Not later than 1 year
    490       466  
Later than 1 year but not later than 2 years
    84       431  
Later than 2 years but not later than 3 years
    -       58  
      574       955  
                 
(b) Other expenditure commitments
               
                 
Research and development contracts for
               
service to be rendered:
               
Not later than 1 year
    1,797       10,493  
Later than 1 year but not later than 2 years
    518       6,328  
Later than 2 years but not later than 3 years
    324       2,225  
      2,639       19,046  

* Operating leases represent payments for property and equipment rental. Leases for property include an annual review for Consumer Price Index increases.

There are no commitments for capital expenditure outstanding at the end of the financial year.


 
125
 
 
Note 17                 RELATED PARTY DISCLOSURES

Interests in controlled entities
The consolidated financial statements include the financial statements of Novogen Limited and the subsidiaries listed in the following table.
 
Name of Entity
Country of Incorporation
 
% Equity interest *
   
Investment (A$'000)
 
     
2009
   
2008
   
2009
   
2008
 
Novogen Laboratories Pty Ltd ^
Australia
    100       100       2,154       1,551  
Novogen Research Pty Ltd ^
Australia
    100       100       7,000       7,000  
Phytosearch Pty Ltd #
Australia
    -       100       -       -  
Phytogen Pty Ltd #
Australia
    -       100       -       20  
Glycotex Pty Ltd #
Australia
    -       100       -       -  
Norvogen Pty Ltd #
Australia
    -       100       -       -  
Central Coast Properties Pty Ltd #
Australia
    -       100       -       -  
Novogen Inc
US
    100       100       -       -  
  Glycotex, Inc.
US
    80.7       81.0       857       857  
Novogen Limited (UK)
UK
    100       100       -       -  
  Promensil Limited
UK
    100       100       -       -  
  Novogen BV
Netherlands
    100       100       -       -  
Novogen Canada Limited
Canada
    100       100       -       -  
Marshall Edwards, Inc.
US
    71.3       71.9       6,712       -  
  Marshall Edwards Pty Limited #
Australia
    71.3       71.9       -       -  
                        16,723       9,428  
 
Novogen Limited, a company incorporated in Australia, is the ultimate parent entity.

^ Entities subject to class order relief
Pursuant to Class Order 98/1418 (as amended) issued by the Australian Securities and Investment Commission, relief has been granted to these companies from the Corporations Act 2001 requirements for preparation, audit and lodgement of their financial reports.

As a condition of the Class Order, Novogen Limited and the controlled entities subject to the Class Order (the “Closed Group”), entered into a Deed of Cross Guarantee on 28 May, 1999. The effect of the deed is that Novogen Limited has guaranteed to pay any deficiency in the event of winding up of the controlled entities. The controlled entities have also given a similar guarantee in the event that Novogen Limited is wound up.

# Entities that meet the requirements of small proprietary limited corporations.

* The proportion of ownership interest is equal to the proportion of voting power held.
 
 
 
126
 
 
The consolidated income statement and balance sheet of the entities that are members of the “Closed Group” are as follows:
Consolidated Income Statement
 
CLOSED GROUP
 
   
2009
   
2008
 
   
A$'000
   
A$'000
 
             
Loss from continuing operations before income tax
    (6,395 )     (8,143 )
Income tax expense
    -       -  
Loss after tax from continuing operations
    (6,395 )     (8,143 )
Accumulated losses at the beginning of the period
    (111,224 )     (103,683 )
Net income recognised directly in equity
    604       602  
Accumulated losses at the end of the period
    (117,015 )     (111,224 )
                 
                 
Consolidated Balance Sheet
 
CLOSED GROUP
 
      2009       2008  
   
A$'000
   
A$'000
 
CURRENT ASSETS
               
Cash and cash equivalents
    9,164       13,718  
Trade and other receivables
    2,161       4,506  
Inventories
    827       1,162  
Other current assets
    489       433  
Total current assets
    12,641       19,819  
                 
NON-CURRENT ASSETS
               
Property, plant and equipment
    329       549  
Other financial assets
    6,712       -  
Total non-current assets
    7,041       549  
                 
TOTAL ASSETS
    19,682       20,368  
                 
CURRENT LIABILITIES
               
Trade and other payables
    2,653       2,958  
Provisions
    708       676  
Total current liabilities
    3,361       3,634  
                 
NON-CURRENT LIABILITIES
               
Provisions
    236       385  
Total non-current liabilities
    236       385  
                 
TOTAL LIABILITIES
    3,597       4,019  
                 
NET ASSETS
    16,085       16,349  
                 
EQUITY
               
Contributed equity
    133,100       127,573  
Accumulated losses
    (117,015 )     (111,224 )
TOTAL EQUITY
    16,085       16,349  


 
127
 
 
Note 18                 REMUNERATION OF AUDITORS

   
Consolidated
 
   
2009
   
2008
 
      A$       A$  
                 
Amounts received or due and receivable by BDO for:
               
(a) an audit or review of the financial report of the entity and any other entity in the consolidated group;
    328,726       333,718  
(b) other services in relation to the entity and any other entity in the consolidated entity.
 
 - Tax compliance services
    50,650       26,109  
 - MEI S3/S8 audit and review services
    3,381       25,726  
 - Review of government grants
    -       2,980  
 - Other
    6,240       8,007  
      388,997       396,540  
                 
Amounts received or due and receivable by other entities in the BDO network for other services
in relation to the entity and any other entity in the consolidated entity.
 
 - Tax compliance services
    4,359       -  
 - Administrative matters
    30,456       -  
      34,816       -  
                 
Amounts received or due and receivable by non BDO audit firms for:
         
 - an audit or review of the financial report of the entity and any other entity in the consolidated group, for local statutory purposes
    22,229       21,600  
 - other non-audit services - local statutory auditors
    46,705       33,662  
      68,934       55,262  
                 
      492,746       451,802  


 
128
 
 
Note 19                      DIRECTOR AND EXECUTIVE DISCLOSURES


a) Compensation of key management personnel


 
Consolidated
 
 
2009
2008
 
 
A$
A$
 
       
Short term employee benefits
  2,705,031
 2,686,531
 
Post employment benefits
     532,290
    570,947
 
Long term employee benefits
     (52,228)
    103,008
 
Share-based payment
     347,921
    290,682
 
Total Compensation
  3,533,014
 3,651,168
 
 
Further information regarding key management personnel and their compensation can be found in Item 6 Directors, Senior Management and Employees commencing on page 42.
 

 
129
 
 
 
b) Option holding of key management personnel
 
   
Balance at beginning of period
   
Granted as remuneration
   
Options exercised
   
Net change other
   
Balance at end of period
   
Vested and exercisable
   
Not exercisable
 
   
 
     1 July, 2008
         
30 June, 2009
   
30 June, 2009
   
30 June, 2009
 
   
Number
   
Number
   
Number
   
Number
   
Number
   
Number
   
Number
 
Executive Directors
                               
C Naughton
    91,196       218,664       -       -       309,860       100,264       209,596  
AJ Husband
    118,392       126,928       -       (14,892 )     230,428       102,387       128,041  
                                                         
                                                         
Executives
                                                       
DR Seaton
    243,884       212,108       -       (14,892 )     441,100       102,028       339,072  
WJ Lancaster (US)
    107,736       109,400       -       (7,848 )     209,288       44,859       164,429  
BM Palmer
    132,868       114,160       -       (8,244 )     238,784       55,715       183,069  
CD Kearney
    136,360       117,004       -       (8,192 )     245,172       57,176       187,996  
RL Erratt
    127,176       106,880       -       (8,156 )     225,900       53,813       172,087  
                                                         
Total
    957,612       1,005,144       -       (62,224 )     1,900,532       516,242       1,384,290  
 
 
   
Balance at beginning of period
   
Granted as remuneration
   
Options exercised
   
Net change other
   
Balance at end of period
   
Vested and exercisable
   
Not exercisable
 
   
 
1 July, 2007
                     
30 June, 2008
   
30 June, 2008
   
30 June, 2008
 
   
Number
   
Number
   
Number
   
Number
   
Number
   
Number
   
Number
 
Executive Directors
                                         
C Naughton
    -       91,196       -       -       91,196       -       91,196  
AJ Husband
    106,176       50,472       -       (38,256 )     118,392       59,672       58,720  
                                                         
                                                         
Executives
                                                       
DR Seaton
    156,860       125,492       -       (38,468 )     243,884       59,672       184,212  
WJ Lancaster (US)
    60,090       53,020       -       (5,374 )     107,736       27,735       80,001  
BM Palmer
    89,112       67,864       -       (24,108 )     132,868       32,803       100,065  
CD Kearney
    90,612       69,560       -       (23,812 )     136,360       33,326       103,034  
RL Erratt
    87,864       63,836       -       (24,524 )     127,176       32,214       94,962  
                                                         
Total
    590,714       521,440       -       (154,542 )     957,612       245,422       712,190  
 
 

 
 
130
 
 
c) Shareholdings of key management personnel and their related parties

   
Balance 
1 July, 2008
   
Granted as remuneration
   
On exercise of options
   
Net change other
   
Balance 
30 June, 2009
 
   
Number Ord
   
Number Ord
   
Number Ord
   
Number Ord
   
Number Ord
 
Executive Directors
                             
PA Johnston
    73,594       -       -       -       73,594  
C Naughton
    633,511       -       -       -       633,511  
AJ Husband
    102,920       -       -       -       102,920  
GM Leppinus
    3,000       -       -       8,883       11,883  
PJ Nestel AO
    32,000       -       -       -       32,000  
WD Rueckert *
    -       -       -       5,000       5,000  
PB Simpson
    5,500       -       -       -       5,500  
                                         
Executives
                                       
DR Seaton
    37,378       -       -       -       37,378  
BM Palmer
    205,636       -       -       -       205,636  
CD Kearney
    8,850       -       -       -       8,850  
RL Erratt
    231,368       -       -       40,000       271,368  
                                         
Total
    1,333,757       -       -       53,883       1,387,640  
* Shares held as sponsored ADR’s

   
Balance 
1 July, 2007
   
Granted as remuneration
   
On exercise of options
   
Net change other
   
Balance 
30 June, 2008
 
   
Number Ord
   
Number Ord
   
Number Ord
   
Number Ord
   
Number Ord
 
Executive Directors
                             
PA Johnston
    58,594       -       -       15,000       73,594  
C Naughton
    633,511       -       -       -       633,511  
AJ Husband
    102,920       -       -       -       102,920  
GM Leppinus
    3,000       -       -       -       3,000  
PJ Nestel AO
    32,000       -       -       -       32,000  
PB Simpson
    500       -       -       5,000       5,500  
                                         
Executives
                                       
DR Seaton
    37,378       -       -       -       37,378  
BM Palmer
    134,023       -       -       71,613       205,636  
CD Kearney
    8,850       -       -       -       8,850  
RL Erratt
    232,368       -       -       (1,000 )     231,368  
                                         
Total
    1,243,144       -       -       90,613       1,333,757  
 
 
All equity transactions with Executive Directors and executives, other than those arising from the exercise of remuneration options, have been entered into under terms and conditions no more favourable than those the entity would have adopted if dealing at arm’s length.
 
 
 
131
 
 
Note 20                      EVENTS AFTER THE BALANCE SHEET DATE

In August 2009 the Company entered into a licence agreement with MEPL granting an exclusive world-wide, non-transferable licence, under the Novogen patent rights, to conduct clinical trials and commercialise and distribute all forms of administering NV-128, except topical applications. The agreement covers uses of NV-128 in the field of prevention, treatment or cure of cancer in humans. NV-128 is currently in pre-clinical development stage.

In consideration of the license granted MEPL paid Novogen a licence fee of US$1,500,000 on 7 August, 2009.

In November 2009, MEPL finalised negotiations and signed a Deed of Release in relation to claims received in connection with the termination of enrolment into the OVATURE Phase III clinical trial. As a result of receiving the Deed of Release, the final amount agreed to be paid in connection with the claims was $477,000 less than management’s estimates which were accrued in the accounts at June 30, 2009. Management does not believe this amount has a material impact on the financial statements.

On December 1, 2009, Novogen’s Managing Director Christopher Naughton ceased his employment with the Company. The termination payment of approximately $1.7 million was made in accordance with Mr. Naughton’s employment contract.

There have been no other significant events occurring after balance date which have had a material impact on the business.

Note 21                 DIVIDENDS

The Company has incurred losses since its inception and, as a result, has not declared any dividends. Any dividends in future periods will be declared in Australian dollars.

Note 22                 CONTINGENT ASSETS AND CONTINGENT LIABILITIES

The Company is continuing to prosecute its IP rights and in June 2007 announced that the Vienna Commercial Court had upheld a provisional injunction against an Austrian company, APOtrend. The Company has provided a guarantee to the value of €250,000 with the court to confirm its commitment to the ongoing enforcement process.

 

 




 
132
 
 
SIGNATURES

The registrant hereby certifies that it meets all the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this Annual Report on its behalf.




NOVOGEN LIMITED




/s/ David Seaton


Mr. David Seaton
Acting Chief Executive Officer and Chief Financial Officer

Date: May 17, 2010

 
133
 
 
 Exhibit Index
 
Exhibit No.
Exhibit Description
 
1.1
Constitution of Novogen Limited (formerly known as the Memorandum of Association and Articles of Association). (1)
 
2.1
Deposit Agreement as further amended and restated, dated as of September 29, 2005, among Novogen Limited, the Bank of New York, as Depositary, and owners and holders from time to time of ADRs issued thereunder. (2)
 
4.1
Employment Contract between the Company and Mr. C. Naughton dated June 21, 2006. (4)
 
4.2
Employment Contract between the Company and Professor Alan Husband dated June 21, 2006. (4)
 
4.4
Lease between Kendall Glen Pty Limited (Lessor) and Novogen Laboratories Pty Ltd for the Company's corporate headquarters at 140 Wicks Road, North Ryde, New South Wales. (3)
 
4.5
Employment Contract between the Company and Bryan Palmer dated June 21, 2006. (4)
 
4.6
Employment Contract between the Company and Craig Kearney dated June 21, 2006. (4)
 
4.7
Employment Contract between the Company and David Seaton dated June 21, 2006. (4)
 
4.8
Employment Contract between the Company and Ronald Erratt dated June 21 30, 2006. (4)
 
4.9
Employment Contract between the Company and Warren Lancaster dated June 21, 2006. (*)
 
4.10
Patent License Agreement, dated as of November 13, 1997, by and among Novogen Limited, Novogen Research Pty Limited, Novogen Inc. and Protein Technologies International Inc.** (6)
 
 
 
 
 
134
 
 
 
4.11
Amendment to the Patent License Agreement, dated as of June 21, 2004 by and among Novogen Limited, Novogen Research Pty Limited, Novogen Inc. and Solae LLC (formerly known as Protein Technologies International Inc.)** (7)
 
8.1
Company Subsidiaries. (*)
 
12.1
Certification of Acting Chief Executive Officer pursuant to Rule 13a – 14(a) of the Securities Exchange Act of 1934, as amended. (*)
 
12.2
Certification of Chief Financial Officer a pursuant to Rule 13a – 14(a) of the Securities Exchange Act of 1934, as amended. (*)
 
13.1
 
Certification by the Acting Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as added by Section 906 of the Sarbanes – Oxley Act of 2002. (*)

 
*
Filed herewith.
 
**
Portions of these documents have been omitted pursuant to a request for confidential treatment. Such omitted portions have been filed separately with the SEC.


 
(1)
Incorporated by reference to the Registration Statement on Form 20-F filed with the Securities and Exchange Commission on December 24, 1998 (File No. 0-29962)

(2)  
Incorporated by reference to the Registration Statement on Form F-6 filed with the Securities and Exchange Commission on September 29, 2005 (File No. 333-128681)

(3)  
Incorporated by reference to the Annual Report on Form 20-F filed with the Securities and Exchange Commission on November 27, 2000 (File No. 0-29962)

 
135
 
 
 
 
(4)  
Incorporated by reference to the Annual Report on Form 20-F filed with the Securities and Exchange Commission on November 29, 2006 (File No. 0-29962)

(5)  
Incorporated by reference to the Annual Report on Form 20-F filed with the Securities and Exchange Commission on December 14, 2007 (File No. 0-29962)

 
(6)
Incorporated by reference to the Annual Report on Form 20-F/A filed with the Securities and Exchange Commission on March 20, 2009 (File No. 0-29962).

 
(7)
Incorporated by reference to the Annual Report on Form 20-F/A filed with the Securities and Exchange Commission on May 5, 2009 (File No. 0-29962).


 
136
 
 
 



 
 
 Exhibit 8.1
 
Company Subsidiaries
 
Novogen Limited is a company limited by shares and is incorporated and domiciled in Australia. Novogen Limited has prepared a consolidated financial report incorporating the entities that it controlled during the financial year ended June 30, 2009, which included the following:
 

Name of Entity
Country of Incorporation
Ownership %
Novogen Laboratories Pty Ltd
Australia
100
Novogen Research Pty Ltd
Australia
100
Novogen Inc
U.S.A.
100
Glycotex, Inc
U.S.A.
80.7
Novogen Limited(U.K.)
U.K.
100
Promensil Limited
U.K.
100
Novogen BV
Netherlands
100
Novogen New Zealand Limited
New Zealand
100
Novogen Canada Limited
Canada
100
Marshall Edwards, Inc.
U.S.A.
71.3
Marshall Edwards Pty Limited
Australia
71.3
 
* Owned indirectly through Marshall Edwards, Inc.


 
137
 
 
Exhibit 12.1
Certification
Pursuant to Section 302
The Sarbanes-Oxley Act of 2002


I, David Ross Seaton, certify that:

1.
I have reviewed this Annual Report on Form 20-F for the fiscal year ended June 30, 2009 (“Annual Report”) of Novogen Limited (the “Company”);

2.
Based on my knowledge, this Annual Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Annual Report;

3.
Based on my knowledge, the financial statements, and other financial information included in this Annual Report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this Annual Report.

4.
The Company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) ) and internal control over financial reporting (as defined in the Exchange Act Rules 13a-15(f) and 15d-15(f)  for the Company and have:

 
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared:

 
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 
c.
Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 
d.
Disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect the Company’s internal control over financial reporting; and
 
 

 
 
138
 
 
5.
The Company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s board of directors (or persons performing the equivalent functions).

 
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and

 
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting.



 
 
/s/ David Seaton
 

David Seaton
Acting Chief Executive Officer

Date: May 17, 2010
 
 
139
 
 
Exhibit 12.2
Certification
Pursuant to Section 302
The Sarbanes-Oxley Act of 2002


I, David Ross Seaton, certify that:

 
1.   I have reviewed this Annual Report on Form 20-F (“Annual Report”) of Novogen Limited (the”Company”);

 
2.   Based on my knowledge, this Annual Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Annual Report;

 
3.  Based on my knowledge, the financial statements, and other financial information included in this Annual Report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this Annual Report;

 
4.  The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) ) and internal control over financial reporting (as defined in the Exchange Act Rules 13a-15(f) and 15d-15(f))  for the Company and have:

(a)  
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared:

(b)  
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 
 
(c)  
Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)  
Disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect the Company’s internal control over financial reporting; and

 
 
140
 
 
5.  The Company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s board of directors (or persons performing the equivalent functions).

(a)  
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and

(b)  
Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting.

 
 


/s/ David Seaton
 

David Seaton
Chief Financial Officer

Date: May 17, 2010
 
 
141
 
 

Exhibit 13.1

Certification
Pursuant to Section 302
The Sarbanes-Oxley Act of 2002


David Ross Seaton, Acting Chief Executive Officer and Chief Financial Officer of Novogen Limited, a New South Wales corporation (the “Company”), hereby certifies that:

(1)  
The Company’s periodic report on form 20-F for the period ended June 30, 2009 (the “Form 20-F”) fully complies with the requirements of section 13(a) of the Securities Exchange Act of 1934 as amended; and
(2)  
The information contained in the Form 20-F fairly presents, in all material respects, the financial condition and results of operations of the Company.


*           *           *


Acting Chief Executive Officer and Chief Financial Officer




/s/ David Seaton
 
David Seaton

Date: May 17, 2010
 
 
142