20-F/A 1 d563116d20fa.htm FORM 20-F/A FORM 20-F/A
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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, 2012

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)

16-20 Edgeworth David Ave Hornsby NSW 2077 AUSTRALIA

(Address of principal executive offices)

Securities registered or to be registered pursuant to Section 12(b) of the Act.

Ordinary Shares*

American Depositary Shares, each representing twenty-five Ordinary Shares

Securities registered or to be registered pursuant to Section 12(g) of the Act.

None

 

 

 

* 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, 2012 was 103,805,676.

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  ¨    Non-accelerated filer  x

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

 

 

 


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EXPLANATORY NOTE

This form 20-F/A hereby amends the Audit Report of Independent Registered Public Accounting Firm Grant Thornton Audit Pty Limited for the fiscal year ended June 30, 2012 which was filed with the Securities and Exchange Commission on October 29, 2012; the Audit Report has been updated to amend the first paragraph and to add an explanatory paragraph at the end of the Audit Report. These amendments arose from communications the company has received from the Securities and Exchange Commission. 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 October 29, 2012.


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TABLE OF CONTENTS

 

Forward Looking Statements      1   
PART I   
ITEM 1.  

Identity of Directors, Senior Management and Advisors

     2   
ITEM 2.  

Offer Statistics and Expected Timetable

     2   
ITEM 3.  

Key Information

     2   
ITEM 4.  

Information on the Company

     13   
ITEM 4A.  

Unresolved Staff Comments

     33   
ITEM 5.  

Operating and Financial Review and Prospects

     33   
ITEM 6.  

Directors, Senior Management and Employees

     41   
ITEM 7.  

Major Shareholders and Related Party Transactions

     54   
ITEM 8.  

Financial Information

     56   
ITEM 9.  

The Offer and Listing

     58   
ITEM 10.  

Additional Information

     60   
ITEM 11.  

Quantitative and Qualitative Disclosures about Market Risk

     64   
ITEM 12.  

Description of Securities other than Equity Securities

     65   
PART II   
ITEM 13.  

Defaults, Dividend Arrearages and Delinquencies

     67   
ITEM 14.  

Material Modifications to the Rights of Security Holders and Use of Proceeds

     67   
ITEM 15.  

Controls and Procedures

     67   
ITEM 16.  

Reserved

     68   
ITEM 16A.  

Audit Committee Financial Expert

     68   
ITEM 16B.  

Code of Ethics

     68   
ITEM 16C.  

Principal Accountant Fees and Services

     69   
ITEM 16D.  

Exemptions from the Listing Standards for Audit Committees

     69   
ITEM 16E.  

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

     70   
ITEM 16F.  

Change in Registrant’s Certifying Accountant

     70   
ITEM 16G.  

Corporate Governance

     71   
ITEM 16H.  

Mine Safety Disclosure

     71   
PART III   
ITEM 17.  

Financial Statements – Not Applicable

     72   
ITEM 18.  

Financial Statements

     72   
ITEM 19.  

Exhibits

     72   


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FORWARD-LOOKING STATEMENTS

This Annual Report on Form 20-F includes forward-looking statements, which involve a number of risks and uncertainties. These forward-looking statements can generally be identified as such because the context of the statement will include words such as “may,” “will,” “intend,” “plan,” “believe,” “anticipate,” “expect,” “estimate,” “predict,” “potential,” “continue,” “likely,” or “opportunity,” the negative of these words or other similar words. Similarly, statements that describe our future plans, strategies, intentions, expectations, objectives, goals or prospects and other statements that are not historical facts are also forward-looking statements. Discussions containing these forward-looking statements may be found, among other places, in “Business Overview” and “Operating and Financial Review and Prospects” in this Annual Report on Form 20-F. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Readers of this Annual Report on Form 20-F are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the time this Annual Report on Form 20-F was filed with the Securities and Exchange Commission, or SEC. These forward-looking statements are based largely on our expectations and projections about future events and future trends affecting our business, and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. These risks and uncertainties include, without limitation, those discussed in “Risk Factors” and in “Operating and Financial Review and Prospects” of this Annual Report on Form 20-F. In addition, past financial or operating performance is not necessarily a reliable indicator of future performance, and you should not use our historical performance to anticipate results or future period trends. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Except as required by law, we undertake no obligation to update publicly or revise our forward-looking statements to reflect events or circumstances that arise after the filing of this Annual Report on Form 20-F.

In this Annual Report on Form 20-F, “Novogen,” “Company,” “we,” “us” and “our” refer to Novogen Limited and its wholly owned subsidiaries on a consolidated basis, unless the context otherwise provides.

 

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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, 2012 and 2011 and for the years ended June 30, 2012, 2011 and 2010 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 the PCAOB auditing standards in the United States by the Company’s independent registered public accounting firm.

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 2012” refers to the 12 months ended June 30, 2012. 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 Statements of Comprehensive Income

(IFRS)

 

     2008
(A$‘000)
    2009
(A$‘000)
    2010
(A$‘000)
    2011
(A$‘000)
    2012
(A$‘000)
    2012
(US$‘000)
 

Revenue from continuing operations

     —       2,504        1,784        2,025        1,513        1,549   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss after tax from continuing operations

     —       (21,932     (15,814     (10,946     (8,742     (8,948

Profit/(loss) after tax from discontinuing operations

     —       (1,855     568        1,467        7,392        7,566   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

     (24,777     (23,787     (15,246     (9,479     (1,350     (1,382
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net profit/(loss) attributable to members of Novogen Limited

     (20,264     (18,928     (12,345     (6,498     1,309        1,340   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted earnings/(loss) per share from continuing operations (cents per share)

     —       (16.8     (12.6     (7.8     (5.9     (6.0

Basic and diluted earnings/(loss) per share from discontinuing operations (cents per share)

     —       (1.8     0.6        1.4        7.2        7.4   

Basic and diluted earnings/(loss) per share (cents per share)

     (20.8     (18.6     (12.1     (6.4     1.3        1.3   

Weighted average number of Ordinary Shares used to calculate earnings per share

     97,594,261        101,741,016        102,125,894        102,125,894        102,430,637        102,430,637   

Number of outstanding Ordinary Shares at year end

     97,594,261        102,125,894        102,125,894        102,125,894        103,805,676        103,805,676   

 

* Comparative information for these periods cannot be provided without unreasonable effort or expense.

Summary of Consolidated Statements of Financial Position

(IFRS)

 

     2008
(A$‘000)
     2009
(A$‘000)
     2010
(A$‘000)
     2011
(A$‘000)
     2012
(A$‘000)
     2012
(US$‘000)
 

Cash and Cash Equivalents

     35,386         33,338         15,131         6,016         8,348         8,545   

Total Assets

     43,401         37,842         19,290         12,727         8,985         9,197   

Net Assets

     35,637         28,773         13,176         4,420         5,113         5,234   

Capital Stock

     200,432         206,419         206,419         194,295         199,026         203,723   

The Directors of Novogen Limited do not recommend the payment of a dividend at year end. During the year ended June 30, 2012, Novogen Limited distributed to its shareholders, by way of a dividend, 90% of the rights it received from its majority owned subsidiary, MEI Pharma, Inc. (“MEI”), under MEI’s rights offering which concluded in May, 2012. More information on the rights issue is included below under “corporate developments” contained in Item 4. No other dividends have been declared by the Company in the fiscal years included in this 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

 

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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$1.0236 = 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 29, 2012. The noon buying rate on September 28, 2012 was US$1.0388 = A$1.00

Exchange Rates for the six months to September 2012

A$ versus US$

 

Month    High      Low  

April

   $ 1.0447       $ 1.0255   

May

   $ 1.0345       $ 0.9709   

June

   $ 1.0236       $ 0.9688   

July

   $ 1.0522       $ 1.0131   

August

   $ 1.0591       $ 1.0301   

September

   $ 1.0561       $ 1.0195   

Exchange Rates for the Last Five Years A$ versus US$

 

Fiscal Year Ended June 30    Average
Rate
 

2008

   $ 0.8968   

2009

   $ 0.7455   

2010

   $ 0.8820   

2011

   $ 0.9904   

2012

   $ 1.0323   

The Company is currently proposing an in specie distribution of the shares of MEI Pharma, Inc. (“MEI”) held by Novogen limited, which is subject to shareholder approval at an the Annual General Meeting of shareholders to be held on November 12, 2012. Separate explanatory materials have been distributed to shareholders for them to make an informed decision on the proposed transaction. This report has been prepared on the basis of the current business structure which includes the business and consolidated accounts of the Company’s majority owned subsidiary MEI. The MEI shares held by Novogen Limited are subject to the proposed in specie distribution to Novogen shareholders.

 

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Risk Factors

Investment in our securities involves a high degree of risk. You should consider carefully the risks described below, together with other information in this Annual Report on Form 20-F and our other public filings, before making investment decisions regarding our securities. If any of the following events actually occur, our business, operating results, prospects or financial condition could be materially and adversely affected. This could cause the trading price of our common stock to decline and you may lose all or part of your investment. Moreover, the risks described below are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business, operating results, prospects or financial condition.

The Company is currently proposing, subject to shareholder approval, an in specie distribution of its holdings of securities of MEI Pharma, Inc. (“MEI”), its majority-owned subsidiary, which comprise the Company’s principal assets.

The Company is currently proposing an in specie distribution of the shares of its majority-owned subsidiary, MEI, that the Company holds, which is subject to shareholder approval at the Annual General Meeting of shareholders to be held on November 12, 2012. Separate explanatory materials have been distributed to shareholders for them to make an informed decision on the proposed transaction. Following the sale of the glucan assets in August 2012 of the Company’s majority owned subsidiary, Glycotex, Inc., the securities of MEI are the Company’s principal remaining asset.

This annual report has been prepared on the basis of the current business structure which includes the business and consolidated accounts of the Company’s majority owned subsidiary MEI. If, however, the Company effects the in specie distribution of MEI shares currently contemplated, after obtaining the required shareholder approval, the Company would have no active operations and limited financial resources. As such, the Company may cease operations and depending on the applicable circumstances, including any merger transaction with an operating company, may constitute a “shell company”, which are subject to certain unfavorable requirements, under SEC and stock exchange rules.

There can be no assurance that the in specie distribution of MEI shares will be consummated, or the specific terms and conditions of any distribution that is consummated, whether or not shareholders approve such transaction. There are risks and uncertainties associated with any such potential transaction, or any other transactions the Company may consider, including a transaction such as that initially agreed and subsequently terminated with Kai Medical, any of which could result in a substantial decline in the trading price of the Company’s shares, which may result from the consummation, or the failure to consummate, any such transaction.

The Company is currently exploring various strategic alternatives involving assets comprising substantially all of its business.

The Company continues to explore opportunities to maximize value to its stakeholders, including, among other things, through reorganizations, recapitalizations, private placements, strategic alliances, joint ventures, acquisitions and dispositions potentially involving all types and combinations of equity, debt and other alternatives. In this regard, the Company is currently contemplating possible transactions which may involve the spin-off or sale of one or more businesses, transfers of various assets, possible distributions of MEI securities held by the Company, or other features. The assets involved in these transactions may include substantially all of the Company’s assets.

 

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There are risks and uncertainties associated with any such potential transaction, including the risk that, due to business considerations, regulatory constraints or other reasons, the Company may be unable or unwilling to pursue or consummate any such transaction and that as a result of the consummation, or failure to consummate, such transactions the trading price of the Company’s shares may decline.

The Company’s ability to continue as a going concern is uncertain as a result of the strategic options that are currently being explored and the potential that any new business the Company may choose to pursue may require additional future funding.

Following the planned in specie distribution of shares of MEI held by Novogen limited, which is subject to shareholder approval at an the Annual General Meeting of shareholders to be held on November 12, 2012, the Company will have no active operations and limited financial resources. Although the Company believes it will have sufficient cash resources to fund operations over the next twelve months, its future will be dependant on the result of the current options that are being explored for the future of the Company, as described above. If such a transaction is completed, the going concern of the Company will be dependent on the operations of the new business and we can not provide assurance that additional funding will not be required for the Company to continue as a going concern.

If the Company’s subsidiary MEI, cannot obtain additional funding, its product development and commercialization efforts may be reduced or discontinued and it may not be able to continue its operations.

MEI’s audited financial statements for the year ended June 30, 2012 were prepared under the assumption that it would continue its operations as a going concern. Their independent registered public accounting firm has included a “going concern” explanatory paragraph in its report on MEI’s financial statements for the years ended June 30, 2012 and 2011 indicating that it had incurred recurring losses from operations and has no current source of revenues and limited sources of financing, and that these factors raise substantial doubt about its ability to continue as a going concern. While MEI believe that its existing cash balances, which were approximately US$6.2 million as of June 30, 2012 will be sufficient to fund its operations until early calendar year 2013, it will need substantial additional funds to progress the clinical trial program for its drug candidates and to develop any additional compounds. MEI’s ability to raise additional funds is uncertain; such funds may not be available on acceptable terms, or at all. In the event that MEI do not obtain additional capital, there is a substantial doubt of it being able to continue its operations as a going concern. If MEI cannot continue its operations as a going concern, stockholders would likely lose most or all of their investment in MEI and Novogen’s share price, as the current majority owner of MEI would be significantly impacted.

The Company has limited existing financial resources and will need substantial additional funds to progress the clinical trial program for MEI’s drug candidates ME-143, ME-344 and Pracinostat and to develop new compounds. The actual amount of funds MEI will need will be determined by a number of factors, some of which are beyond its control.

The Company has limited cash resources and liquidity. MEI will need substantial additional funds to progress the clinical trial program for its drug candidates ME-143, ME-344 and Pracinostat and to develop any additional compounds. The factors which will determine the actual amount of funds that MEI will need to progress the clinical trial programs for ME-143, ME-344 and Pracinostat may include the following:

 

   

the number of trials;

 

   

the number of sites included in the trials;

 

   

the length of time required to enroll suitable patients;

 

   

the number of patients who participate in the trials and the rate that they are recruited;

 

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the number of treatment cycles patients complete while they are enrolled in the trials; and

 

   

the efficacy and safety profile of the product.

If MEI is unable to obtain additional funds on favorable terms or at all, it may be required to cease or reduce its operations. Also, if MEI raises more funds by selling additional securities, the ownership interests of holders of its securities, including Novogen, will be diluted.

Negative global economic conditions may pose challenges to our business strategy, which relies on access to capital from the markets or collaborators.

Negative conditions in the global economy, including credit markets and the financial services industry, have generally made equity and debt financing more difficult to obtain, and may negatively impact our ability to complete financing transactions. The duration and severity of these conditions is uncertain, as is the extent to which they may adversely affect our business and the business of current and prospective vendors and collaborators. If negative global economic conditions persist or worsen, we may be unable to secure additional funding to sustain our operations or to find suitable collaborators to advance our internal programs, even if we achieve positive results from our research and development efforts.

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$228,673,000 since its inception, including net losses of A$1,350,000, A$9,479,000 and A$15,246,000 for the years ended June 30, 2012, 2011, and 2010, respectively. The Company anticipates that it will incur operating losses and negative cash flow for the foreseeable future.

The results of pre-clinical studies and completed clinical trials are not necessarily predictive of future results, and the Company’s subsidiaries’ current drug candidates may not have favorable results in later studies or trials.

Pre-clinical studies and Phase I and Phase II clinical trials are not primarily designed to test the efficacy of a drug candidate, but rather to test safety, to study pharmacokinetics and pharmacodynamics, and to understand the drug candidate’s side effects at various doses and schedules. Favorable results in early studies or trials may not be repeated in later studies or trials, including continuing pre-clinical studies and clinical trials, and the Company’s drug candidates in later-stage trials may fail to show desired safety and efficacy despite having progressed through earlier-stage trials. Unfavourable results from ongoing pre- clinical studies or clinical trials could result in delays, modifications or abandonment of ongoing or future clinical trials, or abandonment of a clinical program. Pre-clinical and clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals or commercialization. Negative or inconclusive results or adverse medical events during a clinical trial could cause a clinical trial to be delayed, repeated or terminated, or a clinical program to be abandoned.

Final approval by regulatory authorities of the Company’s or its subsidiaries’ drug candidates for commercial use may be delayed, limited or prevented, any of which would adversely affect its ability to generate operating revenues.

The Company will not generate any operating revenue until it, or its subsidiaries, successfully commercializes one of its drug candidates. Currently, the Company’s subsidiaries drug candidates are at different stages of development, and each will need to successfully complete a number of studies and obtain regulatory approval before potential commercialization.

 

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For example, any of the following factors may serve to delay, limit or prevent the final approval by regulatory authorities of the Company’s drug candidates for commercial use:

 

   

ME-143, ME-344 and Pracinostat are in the early stages of development, and the Company will need to conduct significant clinical testing to demonstrate safety and efficacy of these drug candidates before applications for marketing can be filed with the FDA, or with the regulatory authorities of other countries;

 

   

data obtained from pre-clinical and clinical studies can be interpreted in different ways, which could delay, limit or prevent regulatory approval;

 

   

development and testing of product formulation, including identification of suitable excipients, or chemical additives intended to facilitate delivery of the Company’s drug candidates;

 

   

it may take the Company many years to complete the testing of its drug candidates, and failure can occur at any stage of this process; and

 

   

negative or inconclusive results or adverse medical events during a clinical trial could cause the Company to delay or terminate its development efforts.

The successful development of any of these drug candidates is uncertain and, accordingly, the Company may never commercialise any of these drug candidates or generate revenue.

Even if the Company receives regulatory approval to commercialize its drug candidates, the ability to generate revenues from any resulting products will be subject to a variety of risks, many of which are out of the Company’s control.

Even if the drug candidates obtain regulatory approval, resulting products may not gain market acceptance among physicians, patients, healthcare payers or the medical community. The Company believes that the degree of market acceptance and its ability to generate revenues from such products will depend on a number of factors, including, but not limited to:

 

   

timing of market introduction of the Company’s drugs and competitive drugs;

 

   

actual and perceived efficacy and safety of the Company’s drug candidates;

 

   

prevalence and severity of any side effects;

 

   

potential or perceived advantages or disadvantages over alternative treatments;

 

   

strength of sales, marketing and distribution support;

 

   

price of future products, both in absolute terms and relative to alternative treatments;

 

   

the effect of current and future healthcare laws on the Company’s drug candidates; and

 

   

availability of coverage and reimbursement from government and other third-party payers.

 

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If any of the Company’s drugs are approved and fail to achieve market acceptance, the Company may not be able to generate significant revenue to achieve or sustain profitability.

The Company may not be able to establish the contractual arrangements necessary to develop, market and distribute the product candidates.

A key part of the Company’s business plan is to establish contractual relationships with strategic partners. The Company must successfully contract with third parties to package, market and distribute its product candidates.

Potential partners may be discouraged by the Company’s limited operating history.

There is no assurance that the Company will be able to negotiate commercially acceptable licensing or other agreements for the future exploitation of its drug product candidates including continued clinical development, manufacture or marketing. If the Company is unable to successfully contract for these services, or if arrangements for these services are terminated, it may have to delay the commercialization program which will adversely affect its ability to generate operating revenues.

The Company’s commercial opportunity will be reduced or eliminated if competitors develop and market products that are more effective, have fewer side effects or are less expensive than its drug candidates.

The development of drug candidates is highly competitive. A number of other companies have products or drug candidates in various stages of pre-clinical or clinical development that are intended for the same therapeutic indications for which the Company’s drug candidates are being developed. Some of these potential competing drugs are further advanced in development than the Company’s drug candidates and may be commercialized sooner. Even if the Company is successful in developing effective drugs, its compounds may not compete successfully with products produced by its competitors.

The Company’s competitors include pharmaceutical companies and biotechnology companies, as well as universities and public and private research institutions. In addition, companies active in different but related fields represent substantial competition. Many of the Company’s competitors developing oncology drugs have significantly greater capital resources, larger research and development staffs and facilities and greater experience in drug development, regulation, manufacturing and marketing. These organizations also compete with the Company and its service providers, to recruit qualified personnel, and to attract partners for joint ventures and to license technologies. As a result, the Company’s competitors may be able to more easily develop technologies and products that would render the Company’s technologies or its drug candidates obsolete or non-competitive.

The Company relies on third parties to conduct its clinical trials and many of its pre-clinical studies. If those parties do not successfully carry out their contractual duties or meet expected deadlines, the Company’s drug candidates may not advance in a timely manner or at all.

In the course of discovery, pre-clinical testing and clinical trials, the Company relies on third parties, including laboratories, investigators, clinical contract research organizations, or CROs, and manufacturers, to perform critical services. For example, the Company relies on third parties to conduct its clinical trials and many of its pre-clinical studies. CROs are responsible for many aspects of the trials, including finding and enrolling subjects for testing and administering the trials. Although the Company relies on these third parties to conduct its clinical trials, it is responsible for ensuring that each of the clinical trials is conducted in

 

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accordance with its investigational plan and protocol. Moreover, the FDA and foreign regulatory authorities require the Company to comply with regulations and standards, commonly referred to as good clinical practices, or GCPs, for conducting, monitoring, recording, and reporting the results of clinical trials to ensure that the data and results are scientifically credible and accurate, and that the trial subjects are adequately informed of the potential risks of participating in clinical trials. The Company’s reliance on third parties does not relieve it of these responsibilities and requirements. These third parties may not be available when the Company needs them or, if they are available, may not comply with all regulatory and contractual requirements or may not otherwise perform their services in a timely or acceptable manner, and the Company may need to enter into new arrangements with alternative third parties and the clinical trials may be extended, delayed or terminated. These independent third parties may also have relationships with other commercial entities, some of which may compete with the Company. In addition, if such third parties fail to perform their obligations in compliance with the Company’s clinical trial protocols or GCPs, the clinical trials may not meet regulatory requirements or may need to be repeated. As a result of the Company’s dependence on third parties, it may face delays or failures outside of its direct control. These risks also apply to the development activities of collaborators, and the Company does not control their research and development, clinical trial or regulatory activities.

The Company has no direct control over the cost of manufacturing its drug candidates. Increases in the cost of manufacturing the Company’s drug candidates would increase the costs of conducting clinical trials and could adversely affect future profitability.

The Company does not intend to manufacture the drug product candidates in-house, and it will rely on third parties for drug supplies both for clinical trials and for commercial quantities in the future. The Company has taken the strategic decision not to manufacture active pharmaceutical ingredients (“API”) for the drug candidates, as these can be more economically supplied by third parties with particular expertise in this area. The Company has identified contract facilities that are registered with the FDA, have a track record of large scale API manufacture, and have already invested in capital and equipment. The Company has no direct control over the cost of manufacturing its product candidates. If the cost of manufacturing increases, or if the cost of the materials used increases, these costs will be passed on, making the cost of conducting clinical trials more expensive. Increases in manufacturing costs could adversely affect the Company’s future profitability if it was unable to pass all of the increased costs along to its customers.

The Company may face a 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 therapeutic products. The Company has product liability insurance. The coverage is subject to deductibles and coverage limitations. The Company may not be able to obtain or maintain adequate protection against potential liabilities, or claims may exceed the insurance limits. If the Company cannot or does not sufficiently insure against potential product liability claims, it may 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 or 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. Two out of the Company’s five directors and many of the officers named in this Annual Report reside outside the U.S. Substantially all of the assets of those persons are located outside

 

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the U.S. As a result, it may not be possible to affect service on the Company or 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. 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, MEI, declines.

Novogen currently owns 67.3% (if the preference shares held were converted) of its subsidiary MEI, whose shares are currently traded on the Nasdaq Capital 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 and its securities may be delisted from Nasdaq.

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:

 

   

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 US$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

 

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restricted from investing in securities priced below US$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 Nasdaq rules, companies listed on the Nasdaq Capital Market are required to maintain a share price of at least US$1.00 per share and if the share price declines below US$1.00 for a period of 30 consecutive business days, then the listed company would have 180 days to regain compliance with the US$1.00 per share minimum. In the event that the Company’s share price declines below US$1.00, it may be required to take action, such as a reverse stock split, in order to comply with the Nasdaq rules that may be in effect at the time.

The MEI common stock held by the Company, in respect of which the Company is currently proposing, subject to shareholder approval, to make an in specie distribution, has experienced highly volatile trading prices in response to various factors, and is currently trading at low levels, and may be delisted from Nasdaq.

The MEI common stock held by the Company in respect of which the Company is currently proposing, subject to shareholder approval, to make an in specie distribution, has experienced highly volatile trading prices in response to various factors and may continue to do so. MEI common stock is currently trading at low share price levels.

MEI has not been in compliance with Nasdaq’s US$1.00 per share minimum bid price requirement and intends to effect a one-for-ten reverse stock split in order to regain compliance with the minimum closing bid price requirements. On September 25, 2012, MEI’s board of directors approved, subject to stockholder approval, an amendment to MEI’s Restated Certificate of Incorporation to effect a one-for-ten reverse stock split (the “Reverse Stock Split”). On September 27, 2012, the Company, as the holder of a majority of MEI’s outstanding common stock, executed a written consent approving the amendment, which approval will become effective 20 days after MEI has mailed a definitive information statement to its stockholders; however, there can be no assurance that the Reverse Stock Split will be consummated or that it will achieve its intended effects. MEI has reserved the right, in its discretion, to abandon the Reverse Stock Split at any time prior to filing the amendment with the Delaware Secretary of State.

In addition, under Nasdaq rules, MEI is required to maintain minimum stockholders’ equity of US$2.5 million. If MEI’s stockholders’ equity falls below US$2.5 million, MEI would have 45 calendar days from the date of notification by Nasdaq to submit a plan to regain compliance. If the plan is accepted, Nasdaq can grant an extension of up to 180 calendar days from the date of the original notification for MEI to evidence compliance with this requirement.

If MEI is not able to comply with the listing standards of the Nasdaq Capital Market, MEI’s common stock will be delisted from Nasdaq and an associated decrease in liquidity in the market for MEI’s common stock will occur.

 

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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 Level 1, 1-7 Waterloo 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 twenty-five ordinary shares, trade on the Nasdaq Capital 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 2012, 2011 or 2010.

Business overview

Nature of the Business

The Company is a pharmaceutical company which has been involved in the discovery, development, manufacture and marketing of products based on the emerging field of isoflavonoid technology. The Company’s product development program, which it conducts through its subsidiary MEI Pharma, Inc. (“MEI”), embraces a novel range of pharmaceuticals based on the field of isoflavonoid technology and on compounds known as isoflavones. Pending the current proposed transactions detailed below, the Company’s strategy is to continue to advance its research and development, through its subsidiary MEI, in more advanced pharmaceuticals in the area of human phenolic compound technology with a focus on progressing the development of drug candidates in the field of oncology.

The Company is currently proposing an in specie distribution of the shares of MEI held by Novogen limited, which is subject to shareholder approval at an the Annual General Meeting of shareholders to be held on November 12, 2012. Separate explanatory materials have been distributed to shareholders for them to make an informed decision on the proposed transaction. This report has been prepared on the basis of the current business structure which includes the business and consolidated accounts of the Company’s majority owned subsidiary MEI. The MEI shares held by Novogen Limited are subject to the proposed in specie distribution to Novogen shareholders.

Following the planned in specie distribution of shares of MEI held by Novogen limited the Company will have no active operations and limited financial resources. The Company is currently exploring various strategic alternatives involving assets comprising substantially all of its business.

 

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Corporate developments

Novogen

Board of Directors

On May 25, 2012, Mr John O’Connor was appointed to the Board following the resignation of Mr Peter Scutt. Mr O’Connor brings broad financial experience and expertise to the Board. More information on each of the Directors is contained under the item “Directors” commencing on page 41.

Investment in MEI Pharma, Inc.

During the year ended June 30, 2012, Novogen continued its support of its majority owned subsidiary MEI through a number of cash investments to support the continued development of MEI’s drug development programs.

In September 2011, Novogen Limited purchased common stock of MEI in a private placement for a total investment of US$2 million through the purchase of 1,333,333 common shares.

In December 2011 Novogen Limited made an additional investment of US$2 million in MEI with the purchase of 1,941,747 common shares.

Following approval by its shareholders at an Extraordinary General Meeting held on May 7, 2012, Novogen Limited invested a further US$4 million in MEI under the MEI rights offering (described in more detail below) with the purchase of 8,988,674 units, amounting to 4,494,337 common shares and warrants to purchase 2,247,168 common shares at a price of US$1.19 per share. These warrants will expire in May 2017. Novogen owned 63.5% of MEI at June 30, 2012.

Sale of OTC business

On August 1, 2011 Novogen completed the sale of its consumer products business to Pharm-a-Care Laboratories Pty Limited for a total sale price of A$10.1 million. The sale of the consumer business follows the review by the Board of the Company of the strategic alternatives for its consumer products business. While this business had grown over the preceding 12 months and was profitable, it did not fit with the Company’s longer term focus on therapeutic drug development programs primarily, through the Company’s majority owned subsidiaries MEI and Glycotex.

Building Lease Assignment

Following the transition of the research and development function of MEI to the US and the sale of the consumer business, the Company sought alternative arrangements to utilise the excess space in the building it had leased in North Ryde. In June 2012 the Company assigned its lease obligations for the North Ryde premises and relocated to a smaller office in North Ryde.

Nox Technology Investment Disposal

During the year ended June 30, 2012 the Company disposed of its investment in Nox Technology, Inc for total profit of A$0.2 million.

Glycotex, Inc.

On January 25, 2012, Novogen offered to purchase the shares held by the minority shareholders in Glycotex, Inc. (“Glycotex”) in exchange for issuing Novogen Limited shares. The offer was based on issuing three Novogen shares for every share held in Glycotex. Novogen issued 1,429,782 shares as a result of this offer and currently owns 99.7% of Glycotex following this transaction.

 

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The glucan technology assets, previously being developed by Glycotex, Inc., were sold to TR Therapeutics, Inc., a privately held US corporation, on August 16, 2012.

MEI Pharma, Inc.

Capital Raising

May 2011 Private Placement

On May 16, 2011, MEI entered into an Amended and Restated Securities Purchase Agreement (the “Amended Securities Purchase Agreement”) with certain accredited investors pursuant to which MEI agreed to issue and sell to the investors certain shares of MEI’s common stock, and warrants to purchase additional shares of common stock. Pursuant to the Amended Securities Purchase Agreement, in May 2011 MEI issued to the investors: (i) 835,217 shares (the “Initial Shares”) of common stock, at a purchase price of US$1.333 per share; (ii) series A warrants (the “Series A warrants”) which initially represented the right to purchase up to 626,413 shares of common stock, up to a maximum of 2,250,564 shares; and (iii) series B warrants (the “Series B warrants”) which initially represented the right to purchase up to 2,165,534 shares of common stock in MEI. In addition, MEI agreed to issue certain additional shares of common stock (the “Adjustment Shares”) to the extent the price of the common stock was below US$1.333 per share, but greater than or equal to US$0.75 per share, on certain dates (“Adjustment Dates”) during the period ending June 26, 2012, including as a result of a subsequent offering by MEI of its securities at a price below the purchase price of the Initial Shares. The number of Adjustment Shares issuable was initially limited to 649,242, subject to proportionate increases to the extent the Series B warrants have been exercised prior to the applicable Adjustment Date, up to a maximum of 2,332,583 shares. If the trading price of MEI’s common stock was below US$0.75 per share on any Adjustment Date, MEI would, in addition to issuing the applicable number of Adjustment Shares, refund to the investors an amount per share of its common stock received by the investors in the transaction equal to the difference between US$0.75 and the price of the common stock on such Adjustment Date. The transactions contemplated by the Amended Securities Purchase Agreement are referred to as the May 2011 private placement. Upon the closing of the May 2011 private placement, MEI also issued warrants to the placement agent for the purchase of up to 210,053 shares of MEI common stock, which warrants were exercisable on the same terms as the Series A warrants.

On December 29, 2011, MEI issued an aggregate of 667,272 Adjustment Shares to the investors in accordance with the calculation of the applicable price, based on the trading price of MEI’s common stock, with respect to the first Adjustment Date. Additionally, on December 29, 2011, MEI issued an aggregate of 245,700 Adjustment Shares to the investors in connection with the private placement of common stock to Novogen that closed on December 29, 2011.

Terms of Series A and Series B Warrants

The Series A warrants became exercisable on the six month anniversary of the May 18, 2011 closing of the May 2011 private placement. The Series A warrants will expire on the fifth anniversary of the date on which the Series A warrants first became exercisable. Prior to the amendment of the warrant terms in September 2011 in conjunction with the Supplemental Agreement, as defined and described below, the Series A warrants were initially exercisable at an exercise price of US$1.57 per share, subject to adjustment as provided in the Series A warrant agreements. Under the terms of the warrant agreements, the number of shares of common stock issuable upon exercise of the Series A warrants would be increased by an amount equal to 75% of the number of shares of common stock issued upon each exercise of the Series B warrants.

 

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Prior to the amendment of the warrant terms in September 2011 in conjunction with the Supplemental Agreement, as described below, the initial exercise price per share of the Series B warrants was equal to the lower of (i) US$1.333, and (ii) 85% of the arithmetic average of the lowest eight weighted average prices of MEI’s common stock during the 20 consecutive trading day period in the case of a voluntary exercise by the holders, ending on the trading day immediately preceding the date of delivery of a notice of exercise.

In July and August 2011, the investors exercised an aggregate of 1,294,000 Series B warrants for 1,294,000 shares of MEI’s common stock. MEI received net proceeds of US$1,094,000 in conjunction with the exercise of the Series B warrants. Pursuant to the terms of the Amended Securities Purchase Agreement, an additional 970,500 Series A warrants became exercisable as a result of these Series B warrant exercises.

Supplemental Agreement

On September 28, 2011, MEI entered into a Supplemental Agreement (the “Supplemental Agreement”) with each of the investors party to the Amended Securities Purchase Agreement.

Pursuant to the Supplemental Agreement, each of the Series A warrants and the Series B warrants issued pursuant to the Amended Securities Purchase Agreement were amended and restated (the “Amended Series A Warrants” and “Amended Series B Warrants”, respectively). The exercise price of each of the Series A warrants and Series B warrants was reduced to US$1.00 per share. As amended, the exercise price of the Amended Series A Warrants is no longer subject to further adjustment upon the occurrence of certain events, including the subsequent sale or deemed sale by MEI of shares of its common stock at a price per share below the exercise price of the Amended Series A Warrants; however, the Amended Series A Warrants continue to provide for certain customary anti-dilution adjustments.

The Series B warrants were amended to permit the exercise of such warrants on a cashless basis. Pursuant to the terms of the Supplemental Agreement, on September 28, 2011, the investors exercised, on a cashless basis, the Amended Series B Warrants for all of the remaining shares of common stock for which such Amended Series B Warrants were exercisable, resulting in the issuance by MEI of an aggregate of 305,603 shares of its common stock. As of September 28, 2011, there were no remaining outstanding Series B warrants.

The Supplemental Agreement also effected certain amendments to the Amended Securities Purchase Agreement, including the extension, through September 28, 2013, of the period during which the investors have the right to participate in subsequent equity offerings of MEI. In connection with the amendments described above, MEI made cash payments to the investors in an aggregate amount of US$365,000.

Derivative Liabilities

The Company accounted for the Series A and B warrants and the Adjustment Shares feature pursuant to the Amended Securities Purchase Agreement in accordance with accounting guidance for derivatives. Additionally, the Company determined that the Adjustment Shares feature, as specified in the Amended Securities Purchase Agreement, resulted in an embedded derivative. As a result of amending the Series A and Series B warrant terms pursuant to the Supplemental Agreement, and the exercise of the Amended Series B Warrants, as described above, the Series A and Series B warrants are no longer considered to be derivatives as of September 30, 2011. As a result of MEI’s completion of its contractual obligations under the Amended Securities Purchase Agreement related to the issuance of Adjustment Shares, the Company had no remaining derivative liabilities as of June 30, 2012.

 

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Rights Offering

On March 26, 2012, MEI’s registration statement on Form S-1, filed with the Securities and Exchange Commission, became effective. The Form S-1 was filed in connection with MEI’s rights offering (“Rights Offering”) to its existing stockholders and to holders of MEI’s Series A warrants issued in connection with the May 2011 private placement. Pursuant to the Rights Offering, MEI distributed one subscription right for each share of its common stock and each Series A warrant exercisable for a share of its common stock to holders of record as of March 30, 2012. Each subscription right entitled the holder to purchase one Unit, which consisted of 0.5 shares of MEI’s common stock and a warrant to purchase 0.25 shares of MEI’s common stock.

For every two Units purchased in the Rights Offering, stockholders received one share of common stock in MEI for a purchase price of US$0.89 per share, which represented a 10 percent discount to the volume- weighted average price of MEI’s common stock for the 30 consecutive trading days ending on, and inclusive of, March 13, 2012, and warrants to purchase one-half of one share of MEI’s common stock with an exercise price of US$1.19 per share, which represented a 20 percent premium to the volume-weighted average price of MEI’s common stock during the same period. The warrants are exercisable for a five-year period beginning on May 11, 2012.

The Rights Offering also included an over-subscription privilege, which entitled stockholders to purchase additional Units that remained unsubscribed at the expiration of the Rights Offering.

The subscription period expired on May 11, 2012. Eligible participants exercised subscription rights to purchase 11,660,606 Units under the offering, including 8,988,675 Units purchased by Novogen Limited (described above). Based on the irrevocable exercise of the subscription rights, MEI issued 5,830,202 shares of its common stock and warrants to purchase 2,915,152 shares upon exercise of the warrants (subject to adjustment for fractional shares). Gross proceeds of US$5.2 million were received by MEI in connection with the Rights Offering.

Clinical development or product candidates

The Company’s clinical development program was conducted through Novogen’s subsidiaries MEI and Glycotex. MEI runs the Company’s oncology drug development program and Glycotex had been developing the Glucan based wound healing technology.

MEI Clinical Product Development Programs

MEI’s pipeline of drug candidates is derived from an isoflavone technology platform that has generated a number of compounds with potential anti-tumor activity. Through laboratory studies these compounds have been shown to interact with specific targets resulting in the inhibition of tumor metabolism, a function critical for cancer cell survival. MEI’s lead programs focus on two families of compounds with related but distinct mechanisms of action: NADH oxidase inhibitors and mitochondrial inhibitors.

NADH Oxidase Inhibitors

MEI’s most advanced program is a family of isoflavone compounds that includes Phenoxodiol, a first- generation compound that has been investigated in multiple human clinical studies, and a next-generation compound and lead drug candidate ME-143. ME-143 in particular has demonstrated robust anti-tumor activity in pre-clinical laboratory studies and is currently under evaluation in human clinical studies.

 

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First Generation: Phenoxodiol

Phenoxodiol has been administered to more than 400 patients in clinical studies via oral or intravenous routes and appears to be well tolerated with an acceptable toxicity profile. In a Phase II clinical trial of intravenously administered Phenoxodiol in combination with platinum-based chemotherapy in women with recurrent ovarian cancer, a clinical response was observed in 19% of patients (three out of 16). These results were published in the May 2011 issue of International Journal of Gynecological Cancer. However, in a Phase III clinical trial of orally administered Phenoxodiol in combination with platinum-based chemotherapy in women with advanced ovarian cancer resistant or refractory to platinum-based drugs, a clinical response was observed in less than 1% of patients (one out of 142).

Pharmacokinetic studies suggest that significantly higher blood plasma levels of active drug are measured when isoflavone compounds are administered intravenously versus orally. As a result of these findings and the clinical experience to date, MEI is actively pursuing the clinical development of its next-generation compounds using an intravenous formulation.

Lead Drug Candidate: ME-143

ME-143 is a next-generation analogue of Phenoxodiol. Pre-clinical laboratory studies show that ME-143 demonstrates enhanced anti-tumor activity against a broad range of tumor cell lines when used alone or in combination with platinum-based chemotherapy when compared to Phenoxodiol. As a result, ME-143 was selected as MEI’s lead drug candidate for the NADH oxidase inhibitor program.

In September 2011, MEI initiated a Phase I open label, multi-center, dose escalation trial of ME-143 in patients with refractory solid tumors following the approval of an Investigational New Drug (“IND”) application by the US Food and Drug Administration (“FDA”). This clinical trial, conducted in collaboration with the Sarah Cannon Research Institute, was designed to evaluate the safety and tolerability of intravenous ME-143 and characterize its pharmacokinetic profile.

Results from a Phase I clinical trial of intravenous ME-143 were presented at the American Society of Clinical Oncology Annual Meeting in June 2012. A total of 15 patients were enrolled in escalating dose cohorts of 2.5 mg/kg, 5 mg/kg, 10 mg/kg and 20 mg/kg. With the exception of a serious infusion reaction in one patient at the highest dose level, ME-143 was generally well tolerated with minimal toxicity in heavily treated patients. The maximum tolerated dose was defined as 20 mg/kg. In addition, the pharmacokinetic profile of intravenous ME-143 resulted in drug levels that were approximately 30 times higher than the expected exposure achieved in a Phase II trial of intravenous Phenoxodiol in combination with platinum- based chemotherapy in women with platinum-resistant ovarian cancer.

MEI is now preparing for a randomized, placebo-controlled Phase II clinical trial of intravenous ME-143 in combination with gemcitabine and carboplatin, a platinum-base chemotherapy, in women with triple- negative breast cancer. Triple-negative accounts for 10-20% of all breast cancers and refers to a subgroup of breast cancers that do not express estrogen receptors, progesterone receptors or human epidermal growth factor receptor 2 (HER2). Therefore, women with triple-negative breast cancer generally do not respond to targeted therapies, leaving chemotherapy as a standard treatment option. MEI expects to begin enrolling patients in this trial during the first quarter of calendar year 2013.

Program 2: Mitochondrial Inhibitors

MEI’s mitochondrial inhibitor program consists of a family of compounds that includes NV-128, a first- generation compound that has shown activity against a broad range of cancers in laboratory research

 

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studies, including chemotherapy-resistant ovarian cancer cell lines, and a next-generation compound and lead drug candidate ME-344. ME-344 appears to be significantly more active than NV-128 in pre-clinical studies and is currently being investigated in human clinical studies.

First Generation: NV-128

NV-128 is a novel mitochondrial inhibitor which has been shown in pre-clinical laboratory studies to disrupt mitochondrial function and induce cancer cell death by two distinct mechanisms; 1) through the induction of DNA fragmentation, and 2) through the process of destructive autophagy, wherein a cell consumes itself. Structurally, NV-128 is an analogue of Phenoxodiol, but, in contrast, uses different molecular mechanisms to promote the death of cancer cells.

NV-128 has shown activity in pre-clinical models against a broad range of cancers. Administration of NV-128 to cancer cells has been shown to induce a rapid loss of cellular energy resulting in the inhibition of both mammalian target of rapamycin (mTOR1 and mTOR2) pathways, which are suggested to be central to the aberrant proliferative capacity of both mature cancer cells and cancer stem cells. Results from an ongoing collaboration with Dr. Gil Mor at the Yale University School of Medicine’s Department of Obstetrics, Gynecology and Reproductive Sciences, have demonstrated that NV-128 is active against chemotherapy- resistant ovarian tumor cells in laboratory studies. In April 2011, his colleague Dr. Ayesha Alvero presented data at the American Association for Cancer Research Annual Meeting from a pre-clinical study of NV-128 demonstrating its ability to induce mitochondrial instability, ultimately leading to cell death in otherwise chemotherapy-resistant ovarian cancer stem cells. These results were later published in the August 2011 issue of Molecular Cancer Therapeutics.

Lead Drug Candidate: ME-344

ME-344 is a next-generation analogue and active metabolite of NV-128. In pre-clinical laboratory studies, ME-344 has demonstrated superior anti-tumor activity against a broad panel of human cancer cell lines compared to NV-128. MEI received FDA approval of an IND application for ME-344 in April 2012 and initiated a Phase I clinical trial of intravenous ME-344 in patients with solid refractory tumors shortly thereafter.

The Phase I clinical trial is evaluating the safety and tolerability of intravenous ME-344 in escalating dose cohorts of 1.2 mg/kg, 2.5 mg/kg, 5 mg/kg, 10 mg/kg and 20 mg/kg. In addition, the trial is designed to characterize the pharmacokinetic profile of ME-344 and describe any preliminary clinical anti-tumor activity observed. Patients in the trial are administered intravenous infusions of ME-344 once weekly for three weeks and, after safety assessment, may continue weekly dosing if a clinical benefit is determined. The trial is expected to enroll up to 24 patients with final safety and pharmacokinetic data expected in the second quarter of calendar year 2013.

Glycotex Clinical Product Development Programs

The investigational product candidate GLYC-101 Gel, being developed by the Company’s US subsidiary Glycotex, Inc. (“Glycotex”), is intended to stimulate and modulate the natural cascade of wound healing activities in several cell populations. The product candidate is a topical glucan 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.

The Company has made the strategic decision this year to focus its resources on the oncology drug development program conducted by its subsidiary MEI. Therefore there have not been any advancements in the glucan development during the last 12 months. The Company reached an agreement to terminate

 

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Glycotex’s Chief Executive Officer’s employment effective May 31, 2012 and has been evaluating a number of strategic options to best utilise the glucan technology. The Company signed an agreement to dispose of the glucan assets on July 27, 2012 for total cash proceeds of A$0.15 million.

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 introduced dietary supplement line extensions including Promensil Vitality and Promensil Double Strength.

The Company established 100% owned subsidiary companies in Canada and the U.K. to market and distribute its range of dietary supplements. The Company 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.

On August 1, 2011 Novogen completed the sale of its consumer products business to Pharm-a-Care Laboratories Pty Limited for a total sale price of A$10.1 million.

 

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The following table is an analysis of revenue from sales and other sources during the past three fiscal years, up to the date the consumer business was sold, by categories of activity and by geographical market. Other revenue consists principally of interest income and royalty receipts.

Category of Activity

 

     2010
(A$‘000)
     2011
(A$‘000)
     2012
(A$‘000)
 

Revenue from sale of goods

     7,983         10,843         988   

Other revenue

     1,925         2,535         1,556   
  

 

 

    

 

 

    

 

 

 

Total Revenue

     9,908         13,378         2,544   
  

 

 

    

 

 

    

 

 

 

Geographical Markets

 

     2010
(A$‘000)
     2011
(A$‘000)
     2012
(A$‘000)
 

Revenue from sale of goods

        

Australasia

     3,955         3,793         730   

Europe

     2,240         2,367         87   

North America

     1,788         1,778         171   

South America

     —           2,905         0   
  

 

 

    

 

 

    

 

 

 
     7,983         10,843         988   
  

 

 

    

 

 

    

 

 

 

Other revenue

        

Australasia

     1,824         2,404         1,421   

Europe

     2         —           —     

North America

     99         131         135   
  

 

 

    

 

 

    

 

 

 
     1,925         2,535         1,556   
  

 

 

    

 

 

    

 

 

 

Total Revenue

     9,908         13,378         2,544   
  

 

 

    

 

 

    

 

 

 

Source and Availability of Raw Materials

Phenolic Pharmaceutical Compounds

The Company has taken the strategic decision not to manufacture compounds for clinical trials or commercial scale Active Pharmaceutical Ingredients (API) for its drug candidates, including ME-143, ME-344 and Pracinostat as these can be more economically supplied by third parties with particular expertise in this area.

Raw Material License

On September 28, 2012, MEI entered into a License Agreement (the “License Agreement”) with CyDex Pharmaceuticals, Inc. (“CyDex”). Under the License Agreement, CyDex granted to the MEI an exclusive,

 

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non-transferable license to intellectual property rights relating to Captisol® for use with the MEI’s two lead isoflavone-based drug compounds. Captisol has been shown to enhance the solubility, stability and bioavailability of drug formulations and is currently used in FDA approved drugs by several other pharmaceutical companies.

The License Agreement will continue in effect on a country-by-country basis until the later of (a) the fifth anniversary of the first commercial sale of a Licensed Product (anywhere in the world) or (b) the date as of which a license for the use of Captisol, as contemplated by the License Agreement, is no longer required in such country in order to avoid infringing applicable intellectual property rights. MEI may terminate the License Agreement for convenience at any time upon 90 days’ prior written notice to CyDex. Either party may also terminate the License Agreement upon the breach by the other party of any material term of the License Agreement which is not cured, upon notice, within 60 days (or 10 days with respect to any payment obligation).

Contemporaneously with the License Agreement, MEI and CyDex entered into a commercial supply agreement (the “Supply Agreement”) pursuant to which MEI agreed to purchase 100% of its requirements for Captisol from CyDex. The Supply Agreement will terminate on the earlier of the termination of the License Agreement in its entirety or 90 days after MEI provides CyDex with written notice of its intent to terminate the Supply Agreement. Either party may also terminate the Supply Agreement upon any breach by the other party of the Supply Agreement which is not cured, upon notice, within 60 days (or 10 days with respect to any payment obligation).

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 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. In May 2011, Novogen sold to its subsidiary, MEI, its isoflavone-based intellectual property portfolio, following approval by Novogen and MEI shareholders in respective Extraordinary General Meetings.

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

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

 

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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.

In 2011 the Company renegotiated the licence agreement in place with ADM. The result was that in July 2011 the Company received an upfront cash payment of US$2.9 million (less any withholding tax payable) as the full consideration for all unpaid amounts otherwise payable by ADM for the period to May 31, 2013. This upfront payment is being recognised as income over the period to which it relates.

In connection with agreement, the Company recognized royalty income from ADM of A$1.2 million and A$1.7 million in fiscal years 2012 and 2011, 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.

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.

 

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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 (many 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.

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 first phase of evaluation, known as the Application Entry Process, is usually a short period during which an application is assessed at 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, quality control bioavailability and pharmacokinetics 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 Advisory Committee on Prescriptive Medicines (ACPM) to review the relevant clinical evaluation reports.

The clinical evaluation reports (along with any resolutions of the ACPM 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 either the ACPM (for new medicines) or from the Peer Review Committee (PRC) for extensions to products which are already registered. This summary is sent to the sponsoring company which is able to submit a response to the ACPM or PRC dealing with issues raised in the summary and those not previously addressed in the evaluation report. The ACPM/PRC provide independent advice on the quality, risk-benefit, effectiveness and access of the product and conduct medical and scientific evaluations of the application. The ACPM 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 ACPM meeting.

The TGA takes into account the advice of the ACPM 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

 

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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 regulates and impose substantial requirements upon the research, development, pre-clinical and clinical testing, labeling, manufacture, quality control, storage, approval, advertising, promotion, marketing, distribution, import and export of pharmaceutical products including drugs and 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, other laws including in the case of biologics, the Public Health Service Act and the acts’ implementing regulations. 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 pharmacological activity and toxicity potential;

 

   

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

 

   

obtaining approval of Institutional Review Boards, or IRBs, to administer the products to human subjects in clinical trials;

 

   

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 results for pre-clinical and clinical studies, and chemistry, manufacture and control information on the product to the FDA in a New Drug Approval Application, or NDA; and

 

   

FDA review and approval of an NDA, prior to any commercial sale, promotion 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.

The results of the pre-clinical studies, clinical experience together with initial specified manufacturing information, the proposed clinical trial protocol, and information about the participating investigators are

 

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submitted to the FDA as part of an IND, which must become effective before the Company may begin human clinical trials in the U.S. Additionally, an independent Institutional Review Board (“IRB”) must review and approve each study protocol and oversee conduct of the trial. An IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises concerns or questions about the conduct of the trials as outlined in the IND and imposes a clinical hold. If the FDA imposes a clinical hold, the IND sponsor must resolve the FDA’s concerns before clinical trials can begin. Pre-clinical tests and studies can take several years to complete, and there is no guarantee that an IND submitted, 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, among other tests, are generally performed at this stage. These studies may also provide early evidence of effectiveness.

 

   

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. These studies are used to evaluate the overall benefit – risk relationship of the drug and provide a basis for physician labelling.

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.

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 an 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 an 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 an NDA is approved, the FDA may impose additional obligations or restrictions (such as labelling 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 it submits 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.

 

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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, 2012 for the fiscal year 2013, the user fee for an application requiring clinical data, such as an NDA, is US$1,958,800. The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also imposes an annual product fee for prescription drugs and biologics (US$98,380), and an annual establishment fee (US$526,500) on facilities used to manufacture prescription drugs and biologics. A written request can be submitted for a waiver under certain circumstances. Waivers may be possible for the application fee for the first human drug application that is filed by a small business, as defined by the FDCA, but there are no small business waivers for product or establishment fees. Waivers may also be possible for one or more fees, upon written request, when a waiver or reduction is necessary to protect the public health, the user fees would present a significant barrier to innovation, or the fees are anticipated to exceed the present or future costs incurred by FDA. The Company is not at the stage of development with its products where it 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.

After product approval, there are continuing significant regulatory requirements imposed by the FDA, including record-keeping requirements, obligations to report adverse events 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 labelling, 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 it, 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 it’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 its 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 business. The Company’s failure to obtain coverage, an adequate level of reimbursement, or acceptable prices for 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

 

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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 may also be subject to state laws and regulations that affect the its ability to develop and sell 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 business prospects.

The FDCA includes provisions designed to facilitate the development and expedite the 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 if they meet the necessary requirements. 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 post-marketing 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 reductions taken for any time an applicant did not act with due diligence. There is a five year maximum patent extension and a maximum of 14 years protection from product approval. 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 exclusivity to NDA applicants that conduct and file 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

 

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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 necessary studies are impossible or highly impracticable. The FDA Safety and Innovation Act permanently renewed and strengthened BPCA and PREA.

European Union Regulatory Requirements

Outside the U.S., the Company’s ability to market its 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 (EMA) 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 EMA. 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.

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.

 

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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 or its products in Europe.

Nasdaq compliance

Novogen

Nasdaq

On July 21, 2011 the Company received a notice from Nasdaq notifying it that for the last 30 consecutive business days the bid price of the Company’s American Depository Receipts (“ADR’s”) closed below the minimum US$1.00 per share requirement for continued inclusion on the Nasdaq Capital Market under Nasdaq Rule 5450(a)(1). The Company was afforded a grace period of 180 calendar days, or until January 17, 2012, to regain compliance in accordance with Nasdaq Rule 5810(c)(3)(A).

The Company announced on December 30, 2011, that it had modified the provisions of its ADR program. The previous conversion ratio of 5 Novogen Limited ordinary shares for each ADR share has become 25 Novogen Limited ordinary shares for each ADR share. The change was effective from January 3, 2012. The change in the ADR ratio had no effect on the number of outstanding common shares the Company has on issue or the listing of its common shares on the ASX.

Following the ADR ratio change the Company received confirmation from Nasdaq on January 18, 2012 confirming that for the ten consecutive business days, from January 3, 2012 to January 17, 2012, the closing bid price of the Company’s American Depository Receipts (“ADR’s”) had been at US$1.00 per ADR or greater. Accordingly, the Company regained compliance with Listing Rule 5550(a)(2).

Notification from the Nasdaq Stock Market has no bearing on the ASX listing.

MEI Pharma, Inc.

Nasdaq

During fiscal year 2011, MEI received deficiency notices from The Nasdaq Stock Market (“Nasdaq”) regarding non-compliance with the minimum stockholders’ equity and the minimum Market Value of Publicly Held Shares in accordance with Nasdaq Listing Standards for the Nasdaq Global Market. In March 2011 MEI received a positive response from the Nasdaq Listing Qualifications Staff indicating that its request for a transfer and continued listing on the Nasdaq Capital Market had been granted. MEI’s common stock began trading on the Nasdaq Capital Market effective with the open of business on March 16, 2011.

Under Nasdaq rules, failure to maintain minimum stockholders’ equity of US$2.5 million may result in the delisting of MEI’s common stock from the Nasdaq Capital Market, in which case MEI would have 45 calendar days from the date of notification by Nasdaq to submit a plan to regain compliance. If the plan is accepted, Nasdaq can grant an extension of up to 180 calendar days from the date of the original notification for MEI to evidence compliance with this requirement. As a result of continuing losses from operations, MEI’s stockholders’ equity fell below US$2.5 million as of March 31, 2012. The gross proceeds of US$5.2 million received in connection with the Rights Offering increased MEI’s stockholders’ equity above US$2.5 million as of May 15, 2012.

 

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On March 27, 2012, MEI received notice from Nasdaq stating that, based on the closing bid price for MEI’s common stock for the last 30 consecutive business days, MEI no longer met the US$1.00 per share minimum bid price requirement for continued inclusion on the Nasdaq Capital Market under Nasdaq Rule 5550(a)(2). The notification letter states that MEI will be afforded a grace period of 180 calendar days, or until September 24, 2012, to regain compliance with the minimum bid price requirement in accordance with Nasdaq Rule 5810(c)(3)(A). In order to regain compliance, shares of MEI’s common stock must maintain a minimum closing bid price of at least US$1.00 per share for a minimum of ten consecutive business days during the grace period.

On September 25, 2012, MEI received a determination letter from NASDAQ notifying MEI that it had not regained compliance with the bid price requirement during the 180 calendar day period and that MEI’s common stock is therefore subject to delisting from The NASDAQ Capital Market, unless the Company requests a hearing before the NASDAQ Listing Qualifications Panel. MEI has timely requested a hearing before the panel to present its plan to regain compliance, which request will automatically stay the delisting of MEI’s securities pending at least the issuance of the panel’s decision following the hearing. Under NASDAQ’s Listing Rules, the panel may, in its discretion, determine to continue MEI’s listing pursuant to an exception to the rule for a maximum of 180 calendar days from the date of the NASDAQ Staff’s delisting notification, or through March 24, 2013. However, there can be no assurance that the panel will do so.

MEI intends to effect a one-for-ten reverse stock split in order to regain compliance with the minimum closing bid price requirements and, on September 25, 2012, MEI’s board of directors approved, subject to stockholder approval, an amendment to MEI’s Restated Certificate of Incorporation to effect a one-for-ten reverse stock split (the “Reverse Stock Split”). On September 27, 2012, the Company, as the holder of a majority of MEI’s outstanding common stock, executed a written consent approving the amendment, which approval will become effective 20 days after MEI has mailed a definitive information statement to its stockholders; however, there can be no assurance that the Reverse Stock Split will be consummated or that it will achieve its intended effects. MEI has reserved the right, in its discretion, to abandon the Reverse Stock Split at any time prior to filing the amendment with the Delaware Secretary of State.

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 2012, 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.      100   

Glycotex, Inc.

   U.S.      99.7   

MEI Pharma, Inc.#

   U.S.      63.5   

 

+ 

Ownership % at June 30, 2012.

# The proportion of ownership interest is equal to the proportion of voting power held and excludes convertible preference shares which do not hold any voting rights until converted.

 

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Property, Plant and Equipment

The Company leases office space in North Ryde, Sydney which occupies approximately 300 square meters. These premises are used as Novogen’s corporate headquarters. The Company has entered into a short term lease on this property which expires in July 2012 and then continues on a month to month basis. The Company believes these facilities will adequately meet the Company’s needs for the foreseeable future.

The Company’s subsidiary MEI has leased office space, of approximately 345 square meters, located at 11975 El Camino Real, San Diego, California. The location houses MEI’s executive and administrative offices. The lease commenced in July 2010 and expires in April 2013. In addition, MEI has two options to extend the lease for one year each at the market rate in effect at the time of renewal. The Company believes these facilities will adequately meet MEI’s office needs for the foreseeable future.

 

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Item 4A. Unresolved Staff Comments

None

 

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

A$‘000

    

Charged to

Cost and
Expense
A$‘000

    

Actual

Returns
A$‘000

    

Balance at

End of Year

A$‘000

 

Allowance for Sales returns:

           

Year ended June 30, 2010

     36         75         110         1   

Year ended June 30, 2011

     1         126         127         0   

Year ended June 30, 2012

     0         16         16         0   

 

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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

A$‘000

    

Charged to

Cost and
Expense
A$‘000

    

Actual

Discounts
A$‘000

    

Balance at

End of Year
A$‘000

 

Allowance for Sales discounts:

           

Year ended June 30, 2010

     142         492         557         77   

Year ended June 30, 2011

     77         490         497         70   

Year ended June 30, 2012

     70         26         96         0   

Inventory Adjustments

Inventories are measured at the lower of cost or net realizable value. The Company reviewed the components of inventory on a regular basis for excess, obsolete and impaired inventory based on estimated future usage and sales. Following the sale of the consumer business in August 2011, the Company no longer owns any inventory.

For additional information on significant accounting policies refer to Item 18 “Financial Statements” – Note 1 – “Summary of Significant Accounting Policies”.

Discontinued operations

During fiscal 2011, the Company evaluated strategic alternatives for its consumer products business. The consumer products business was not part of the Company’s longer term focus of therapeutic drug development, which the Company was undertaking through its majority owned subsidiaries MEI and Glycotex. The Company commenced a planned process to dispose of this business and in April 2011 appointed a financial advisor to actively search for a buyer and complete the plan. On August 1, 2011 Novogen completed the sale of its consumer products business to Pharm-a-Care Laboratories Pty Limited for a total sale price of A$10.1 million in cash.

This business has been classified as a discontinuing operation for the purposes of this report.

Subsequent to year end, on August 16, 2012, the Company completed the sale of the glucan technology assets, previously being developed by Glycotex, Inc. Therefore following the planned in specie distribution of shares of MEI held by Novogen limited the Company will have no active operations and limited financial resources. The Company is currently exploring various strategic alternatives involving assets comprising substantially all of its business. This has not been treated as a discontinuing operation for the purposes of this report as the transaction occurred after the end of the fiscal year.

 

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Results of Operations

The following table provides a summary of revenues and expenses to supplement the more detailed discussions below:

STATEMENT OF COMPREHENSIVE INCOME

for the year ended 30 June, 2012

 

     Consolidated  
     2012
A$‘000
    2011
A$‘000
    2010
A$‘000
    2012
US$‘000
 

Continuing Operations

        

Revenue

     1,513        2,025        1,784        1,549   

Other income

     937        512        7        959   

Research & development expenses

     (5,403     (3,902     (7,550     (5,531

General and administrative expenses

     (5,789     (9,562     (10,039     (5,926

Finance costs

     —          (18     (15     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income tax

     (8,742     (10,945     (15,813     (8,949

Income tax expense

     —          (1     (1     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss after tax from continuing operations

     (8,742     (10,946     (15,814     (8,949
  

 

 

   

 

 

   

 

 

   

 

 

 

Profit after tax from discontinuing operations

     7,392        1,467        568        7,566   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss for the period

     (1,350     (9,479     (15,246     (1,383
  

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income

        

Net exchange difference on translation of financial statements of foreign controlled entities (net of tax 2012: Nil, 2011:Nil)

     (278     (690     (1,079     (285
  

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income

     (278     (690     (1,079     (285
  

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income

     (1,628     (10,169     (16,325     (1,668
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating Results – Fiscal 2012 compared to Fiscal 2011

Revenue

The Group earned revenues from continuing operations for the year ended June 30, 2012 of A$1.5 million versus A$2.0 million in the previous corresponding period. The decrease relates to additional royalty revenue recognised in the prior period as a result of a renegotiation of the terms of the licence agreement, not repeated this period. The Company also experienced a decrease in the dividend income received from a small investment the Company held in Nox Technology, which was partially offset by an increase in interest earned due to higher cash balances held following the sale of the consumer products business.

The Company had been looking at strategic alternatives for its consumer products business. The consumer products business was not part of the Company’s longer term focus of therapeutic drug development, which the Company was undertaking through its majority owned subsidiaries MEI and Glycotex. The Company commenced a planned process to dispose of this business and in April 2011 appointed a financial advisor to actively search for a buyer. This process concluded with the sale of the consumer products business in August 2011. This business has been classified as a discontinuing operation for the purposes of this report.

 

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The group earned revenue from discontinuing operations for the year ended June 30, 2012 of A$1.0 million versus A$11.4 million for the year ended June 30, 2011.

Consumer product sales

Sales of consumer health care products for the year ended June 30, 2012 were A$1.0 million, a decrease of A$9.8 million from A$10.8 million for the twelve months ended June 30, 2011. The decrease was as a result of the consumer products business only operating for one month of the year before it was sold in August 2011.

Other revenue from discontinuing operations for the year ended June 30, 2012 was nil compared to A$0.5 million for the twelve months ended June 30, 2011. The decrease was due to up-front licence fees received in the prior period, not repeated in the current year, as a result of the sale of the consumer products business in August 2011.

Net profit

The operating profit attributable to Novogen shareholders for the financial year, after allowing for losses attributable to non-controlling interests of A$2.6 million, increased by A$7.8 million or 121% to A$1.3 million from a loss of A$6.5 million for the previous year.

The net loss from continuing operations after income tax for the consolidated Group for the year ended June 30, 2012 reduced by A$2.2 million to A$8.7 million from A$10.9 million for the previous year. The reduction in the Group’s net loss for the year ended June 30, 2012 was primarily due to reduced general and administrative expenses partly offset by increased research and development costs.

Research and development expenses have increased by A$1.5 million to A$5.4 million for the year ended June 30, 2012, as a result of MEI conducting new Phase I clinical trials for ME-143 and ME-344 combined with the cost for drug manufacture and development for these two drug compounds. These additional costs were partly offset by savings in onerous lease costs incurred in the prior period, not repeated this period.

General and administrative costs have decreased by A$3.8 million due to a number of factors including a net gain of A$1.2 million from the movement of the derivative liability recognised by MEI in the prior period. Additional savings of A$0.8 million for salary, wages and associated costs were achieved following the company restructuring of the Australian business that occurred in December 2010 and further changes that were implemented following the sale of the consumer business in August 2011. Additional savings of A$0.6 million relate to termination payments incurred during the year of A$0.1 million compared to A$0.7 million in the prior year. Further savings of A$1.0 million have been experienced with currency gains of A$0.2 million for the period ended June 30, 2012 compared to currency losses of A$0.8 million for the prior period.

The net profit after tax from discontinuing operations was A$7.4 million for the year ended June 30, 2012 compared to A$1.5 million for the previous year ended June 30, 2011. The discontinued operations represents the Company’s consumer products business which was sold in August 2011 for A$10.1 million. As a result, sales revenue represents only one months operations during the year ended June 30, 2012. Costs associated with the sale of this business include commission and legal fees of A$0.5 million, termination payments of A$1.0 million and cost of goods sold of A$0.7 million.

 

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Operating Results – Fiscal 2011 compared to Fiscal 2010

Revenue

The Group earned revenues from continuing operations for the year ended June 30, 2011 of A$2.0 million versus A$1.8 million in the previous corresponding period. The increase relates to additional royalty revenue recognised and dividend income received from a small investment the Company holds in Nox Technology, which was partially offset by a decrease in interest earned due to a reduction in cash balances held.

The Company looked at strategic alternatives for its consumer products business. The consumer products business was not part of the Company’s longer term focus of therapeutic drug development, which the Company is undertaking through its majority owned subsidiaries MEI and Glycotex. The Company commenced a planned process to dispose of this business and in April 2011 appointed a financial advisor to actively search for a buyer and complete the plan. This business has been classified as a discontinuing operation for the purposes of this report.

The group earned revenue from discontinuing operations for the year ended June 30, 2011 of A$11.4 million versus A$8.1 million for the year ended June 30, 2010.

Consumer product sales

Sales of consumer health care products for the year ended June 30, 2011 were A$10.8 million, an increase of A$2.8 million from A$8.0 million for the twelve months ended June 30, 2010. The increase was primarily related to new distribution in Brazil and increased volume sold to the Company’s distributor in Italy.

Other revenue from discontinuing operations for the year ended June 30, 2011 was A$0.5 million, an increase of A$0.4 million from A$0.1 million for the twelve months ended June 30, 2010. The increase was as a result of signing an amended licence agreement with a European distributor to sell an alternate red clover product. This agreement replaces a previous licence agreement and included an upfront licence fee and an ongoing minimum royalty fee.

Net loss

The operating loss attributable to Novogen shareholders for the financial year, after allowing for losses attributable to non-controlling interests of A$3.0 million, reduced by A$5.8 million or 47% to A$6.5 million from a loss of A$12.3 million for the previous year.

The net loss from continuing operations after income tax for the consolidated Group for the year ended June 30, 2011 reduced by A$4.9 million to A$10.9 million from A$15.8 million for the previous year. The reduction in the Group’s net loss for the year ended June 30, 2011 was primarily due to reduced research and development costs as the Company is refocusing on smaller clinical studies of its next generation drug candidates, representing savings from the large Phase III OVATURE study conducted in previous years. These savings have been partially offset by termination payments made in relation to the restructuring of the Australian business and the increased costs of developing the U.S. management team in MEI, to progress the Company’s oncology drug development program.

The net profit from discontinuing operations was A$1.5 million for the year ended June 30, 2011 compared to A$0.6 million for the previous year ended June 30, 2010. The increased profit was primarily as a result of the increased revenue earned from Brazil and Italy, combined with currency gains by this business segment, which are partially offset by corresponding currency movements in the Company’s other business segments.

 

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Liquidity and capital resources

Cash resources

At June 30, 2012, the Group had total funds of A$8.3 million compared to A$6.0 million at June 30, 2011.

During fiscal 2012, the Company had net cash inflows from operating activities of A$0.6 million compared to cash outflows of A$8.7 million in fiscal 2011. The Company received cash of A$10.1 from the sale of its consumer products business in August, 2011. Cash was used to fund the Group’s operations including the drug development program undertaken by Novogen’s US subsidiaries MEI Pharma, Inc. (“MEI”), Glycotex, Inc. (“Glycotex”) and in connection with the restructuring undertaken following the sale of the consumer products business.

The Company invests its cash and cash equivalents in interest bearing facilities with various maturity dates. At the end of fiscal 2012, term deposits amounting to A$2.0 million had a weighted average interest rate of 4.25% and cash deposits at call of A$6.3 million had a weighted average interest rate of 0.25%.

The Company has a multi option facility with St George Bank Limited, an Australian commercial bank, of A$0.25 million, which was fully utilised to support the security deposit in place covering the bank guarantee required under the lease for the premises previously occupied in North Ryde. This lease was assigned in May, 2012 and the associated bank guarantee will be returned upon provision of satisfactory documentation required to be provided to the former landlord by the new lease assignee.

As of June 30, 2012, 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.

Following the planned in specie distribution of shares of MEI held by Novogen limited, which is subject to shareholder approval at the Annual General Meeting of shareholders to be held on November 12, 2012, the Company will have no active operations and limited financial resources. Although the Company believes it will have sufficient cash resources to fund operations of the next twelve months, its future will be dependant on the result of the current options that are being explored for the future of the Company. If such a transaction is completed, the liquidity of the Company will be dependent on the operations of the new business which may require additional funding to finance future operations.

MEI will require additional funds in order to complete the planned clinical development programs. In order to obtain additional funding the Company’s subsidiaries may need to rely on collaboration and /or licensing opportunities.

The Company cannot assure you that it’s subsidiaries will be able to raise the funds necessary to complete the planned clinical trial programs, or find appropriate collaboration or licensing opportunities. For more information on future funding requirements of the subsidiaries please refer to the disclosure contained in the Risk Factors section of this report.

The Company has historically financed its operations primarily from equity capital.

 

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On August 1, 2011 the Company completed the sale of its consumer products business to Pharm -a-Care Laboratories Pty Limited for a total sale price of A$10.1 million in cash.

On September 30, 2011, the Company purchased 1,333,333 shares of common stock of MEI for an aggregate cash purchase price of US$2 million.

In December 2011 Novogen Limited made an additional investment of US$2 million in MEI with the purchase 1,941,747 common shares.

On March 26, 2012, MEI’s registration statement on Form S-1, filed with the Securities and Exchange Commission, became effective. The Form S-1 was filed in connection with MEI’s rights offering (“Rights Offering”) to its existing stockholders and to holders of MEI’s Series A warrants issued in connection with the May 2011 private placement.

Following approval by its shareholders at an Extraordinary General Meeting held on May 7, 2012, Novogen Limited invested US$4 million in MEI under the MEI rights offering with the purchase of 8,988,674 units, amounting to 4,494,337 common shares and warrants to purchase 2,247,168 common shares at a unit price of US$1.19 per share. These warrants will expire in May 2017. Novogen owned 63.5% of MEI at June 30, 2012.

The subscription period for the Rights Offering expired on May 11, 2012. Eligible participants exercised subscription rights to purchase 11,660,606 Units under the offering, including 8,988,675 Units purchased by Novogen Limited (described above). Based on the irrevocable exercise of the subscription rights, MEI issued 5,830,202 shares of its common stock and warrants to purchase 2,915,152 shares upon exercise of the warrants (subject to adjustment for fractional shares). Gross proceeds of US$5.2 million were received in connection with the Rights Offering.

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

See Note 15 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$5.4 million, A$4.4 million and A$8.1 million on gross research and development expenditure during fiscal 2012, 2011 and 2010 respectively. All of these costs have been recognised as an expense in the statement of comprehensive income in the respective periods.

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.

 

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Trend Information

The Company expects to consume cash and incur operating losses for the foreseeable future. The Company’s subsidiary MEI intends to continue its expenditure on the development of its oncology drug candidates.

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 particularly in light of the potential capital reduction and in specie distribution, currently awaiting shareholder approval.

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, 2012.

 

            Payments due by period  

In A$000’s

   Total      Less than 1 year      1-3 years      3-5 years      After 5 years  

Operating Leases

     105         102         3         —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total Contractual Cash Obligations

     105         102         3         —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

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Item 6. Directors, Senior Management and Employees.

DIRECTORS

The names and details of the Company’s Directors at the date of this report are as follows:

Mr WD Rueckert – Chairman

Mr JT Austin

Mr JP O’Connor – appointed May 25, 2012

Mr PR White

Mr RC Youngman

Former directors who served during the twelve months ended June 30, 2012:

Mr PDA Scutt – resigned May 25, 2012

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

Names, qualifications, experience and special responsibilities

William D Rueckert Non-executive Chairman

Mr Rueckert has been director of the Company since March 2009 and was elected Chairman of Novogen Limited effective October 18, 2010. Mr Rueckert was a Director of MEI Pharma (“MEI”) (formerly Marshall Edwards, Inc.) between March 2007 and March 2009 and was reappointed as a Director in March 2011. Mr Rueckert is the Managing Member of Oyster Management Group LLC an investment fund specialising in community banks. From 1991 to 2006 he was President and Director of Rosow & Company, a private investment firm based in Connecticut with interests in the petroleum and resort development industries. From 1981 until 1988 he was President of United States Oil Company, a publicly traded oil exploration business. 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

Mr Rueckert is currently a Director of Chelsea Therapeutics, Inc. a Nasdaq listed drug development company and Fairfield County Bank, a community bank in Ridgefield, Connecticut. Mr Rueckert is currently a Director of NASDAQ listed, Novogen subsidiary, MEI.

During the last three years Mr Rueckert has served as a Director for the Emergency Filtration Products, Inc. and Rapid Pathogen Screening, Inc.

Special responsibilities

Chairman of the Board

Chairman of the Remuneration Committee

Member of the Audit Committee

 

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Josiah T Austin Non-executive Director

Mr Austin is a United States resident and the largest shareholder in Novogen. He is managing member of El Coronado Holdings, LLC, a privately owned investment holding company, which invests in public and private companies. He and his family own and operate agricultural properties in the states of Arizona, Montana, and Northern Sonora, Mexico through El Coronado Ranch & Cattle Company, LLC and other entities. Mr Austin previously served on the Board of Directors of Monterey Bay Bancorp of Watsonville, California, and was a prior board member of New York Bancorp, Inc., and North Fork Bancorporation.

Other current and former directorships held in the last three years

During the last three years Mr Austin has served as Director of Goodrich Petroleum, Inc., a position he has held since 2002.

Special responsibilities

Member of the Audit Committee

Member of the Remuneration Committee

John P O’Connor Non-executive Director (appointed 25 May, 2012)

BEc., MAICD

Mr O’Connor has spent his working life in the financial industry. In this time he has worked both in funds management and as a stockbroker. He has worked in the UK, US and in Australia. He has held management roles and been a Partner in securities businesses. He served on the Board of Lonsec Securities, a Zurich Insurance owned business, for several years.

He has been a consultant to several biotech businesses, including Novogen Limited and MEI, assisting with fundraising.

Other current and former directorships held in the last three years

Mr O’Connor is currently on the Board of the Fragile X Association of Australia, a not for profit organisation.

Peter DA Scutt Non-executive Director (resigned 25 May, 2012)

B Com

Mr Scutt is an Australian based corporate advisor who is currently a consultant to specialist corporate advisory house, Spark Capital. Mr Scutt has broad investment and corporate finance experience through his past positions as co-founder and CEO of Texel Capital and managing partner of BT Venture Partners. His early career was highlighted by senior positions, over a 12 year period, at Bankers Trust Company both in Australia and New York where he was a partner and senior managing director. Mr Scutt has a Bachelor of Commerce from the University of NSW.

Other current and former directorships held in the last three years

During the last three years Mr Scutt has served as an alternate Director of Print and Digital Publishing Pty Ltd.

 

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Ross C Youngman Non-executive Director

B Com, MBA

Based in Australia, Mr Youngman is co-founder and Chief Executive Officer of Five Oceans Asset Management and has over 25 years’ international experience in the finance industry covering stockbroking, financial planning and asset management. He spent 12 years with Bankers Trust and Deutsche Bank in both Sydney and New York and was most recently Chief Executive Officer of Deutsche Asset Management in Australia. Prior positions included Head of Deutsche Asset Management’s US mutual fund business and Head of BT Funds Management’s US asset management business. Mr Youngman has a Bachelor of Commerce from the University of Tasmania and an MBA from Columbia Business School, New York.

Peter R White Non-executive Director

AB, MBA

Mr White is a United States resident and is a corporate finance professional with over 30 years’ experience in financing and advising companies in the US. He has broad industry experience including technology, media and communications, business services and energy distribution. Among current responsibilities, Mr White is building a leveraged finance business servicing private equity firms in the US for RBS Citizens Bank. Mr White has previously worked in senior positions for several large North American financial services leaders, including BankBoston, Fleet Securities, GE Capital, CIT Group and TD Bank. Mr White was educated at Dartmouth College, AB Cum Laude 1977 and has an MBA from The Wharton School – University of Pennsylvania.

Special responsibilities

Chairman of the Audit Committee

Member of the Remuneration Committee

Executive Officers’ profiles

Mark G. Hinze – Chief Financial Officer

BEc, CPA

Mr. Hinze joined the Novogen Group in 1999 and previously held the position of the Group’s Financial Controller. Mr. Hinze holds a Bachelors Degree in Economics from Macquarie University and is a CPA. Mr. Hinze has over 19 years experience in accounting and finance. Prior to joining Novogen Mr. Hinze worked as the Finance and Administration Manager of Alpha Healthcare’s Pathology division. Mr. Hinze was also the Finance Manager for Diagnostic Pathology prior to its sale to Alpha Healthcare.

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 19 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.

 

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Mr. Kearney‘s employment with the Company ceased following the sale of the consumer products business in August 2011.

Ronald L Erratt – Company Secretary

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.

Mr Erratt’s employment was terminated on December 31, 2010. However he continues to provide consulting services to the Company and has remained as the Company Secretary following the termination of his employment.

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. The financial and non-financial objectives of the Company are also considered when assessing the remuneration of Directors and other key management personnel.

The Board has a Remuneration Committee which is responsible for determining and reviewing compensation arrangements for the 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 last 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, including share based payments, for the year ended June 30, 2012 utilised A$345,000, (2011: A$415,000) 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.

 

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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, this reduction was maintained for the year ended June 30, 2012.

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 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.

Employment Agreements

Novogen Executive Directors and key management executives (standard contracts)

It is the Remuneration Committee policy that employment contracts are entered into with each of the executives who are considered key management personnel. Under the terms of the agreement remuneration is reviewed annually and any increases may be made 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.

The employment agreement with the Chief Financial Officer continues until terminated by either party by giving six months notice in accordance with the terms of their contract or in the case of the Company by making a payment in lieu of six months notice to the employee. In the event of the Company terminating without cause, under the terms of the contract the amount payable on termination is equal to 6 months remuneration, in addition to any amount payable in lieu of notice.

The Company may terminate the contracts at any time without cause if serious misconduct has occurred.

MEI Pharma, Inc. – Chief Executive Officer and Chief Financial Officer Contracts

MEI Pharma, Inc. (“MEI”) has entered into employment contracts with its Chief Executive Officer and Chief Financial Officer. These contracts have no set term and detail the amount of remuneration and other benefits applicable on their initial appointment. These contracts do not fix the amount of remuneration increases from year to year.

The Chief Executive Officer of MEI commenced in April, 2010 and is employed under an employment agreement. The current base salary under this agreement is US$440,000 per annum. An additional cash bonus up to a maximum of 40% of the base salary per fiscal year may be payable upon attainment of milestone goals established by the Board. Share options were also granted as part of the employment terms – details of these options is described further under Note 13. In the event that employment is terminated by MEI without cause, payment in lieu of notice equivalent to 12 months base salary is payable. Voluntary termination by the CEO can take place at any time by giving three months notice to MEI. In the event that employment is terminated for cause no severance pay or other benefits are payable by MEI.

 

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The Chief Financial Officer of MEI commenced in June, 2010 and is employed under an employment agreement. The current base salary under this agreement is US$265,000 per annum. An additional cash bonus up to a maximum of 20% of the base salary per fiscal year may be payable upon attainment of milestone goals established by the Board. Share options were also granted as part of the employment terms – details of these options is described further under Note 13. In the event that employment is terminated by MEI without cause, payment in lieu of notice equivalent to 12 months base salary is payable. Voluntary termination by the CFO can take place at any time by giving two months notice to MEI. In the event that employment is terminated for cause no severance pay or other benefits are payable by MEI.

The Chief Medical Officer (“CMO”) of MEI commenced employment with MEI in June, 2011, and is employed under an employment agreement. The base salary under this agreement is US$350,000 per annum. An additional cash bonus up to a maximum of 20% of the base salary per fiscal year may be payable upon attainment of milestone goals established by the Board. The CMO works a reduced hours schedule and is currently paid at a rate of 25% of their annual base salary. Share options were also granted as part of the employment terms – details of these options are described further under Note 13. In the event that employment is terminated by MEI without cause, payment in lieu of notice equivalent to 12 months base salary is payable. Voluntary termination by the CMO can take place at any time by giving three months notice to MEI. In the event that employment is terminated for cause no severance pay or other benefits are payable by MEI.

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.

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
    Termination
payments
     Share based
payments
    Total  
2012    Salary &
fees
     Cash
bonus
     Non-
monetary
benefits
     Superan-
nuation
     Long Service
Leave
           Options              
     $      $      $      $      $     $      $     %     $  

Key management personnel

                       

Non-executive Directors

                       

W D Rueckert (i)

     131,328         —           —           —           —          —           30,704        18.9     162,032   

JT Austin

     46,400         —           —           —           —          —           —          —          46,400   

JP O’Connor ^

     3,303         —           —           297         —          —           —          —          3,600   

P Scutt ^

     36,330         —           —           3,270         —          —           (3,901     -10.9     35,699   

PR White

     47,200         —           —           —           —          —           30,704        39.4     77,904   

R Youngman

     39,632         —           —           3,568         —          —           30,704        41.5     73,904   

Executives

                       

CD Kearney ^ (ii)

     26,832         25,000         9,032         7,927         (3,038     436,158         (20,934     -4.4     480,977   

DP Gold ** (iii)

     449,397         116,290         20,887         —           —          —           228,043        28.0     814,617   

TM Zech ** (iv)

     265,464         48,454         23,418         —           —          —           47,106        12.3     384,442   

MG Hinze (v)

     170,873         100,000         15,406         15,689         (296     —           24,231        7.4     325,903   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

   

 

 

 
     1,216,759         289,744         68,743         30,751         (3,334     436,158         366,657        15.2     2,405,478   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

   

 

 

 

 

(i) Remuneration includes MEI and Glycotex Director’s fees of A$54,528 (Glycotex Director’s fees have been earned but not paid as at the date of this report. The amounts owed from Glycotex are not expected to be received in cash.)
(ii) Cash bonus paid August 2011 – no performance conditions attached.
(iii) Cash bonus paid August 2011, represents 75% of the possible amount payable (25% forfeited) based on achieving milestone goals.
(iv) Cash bonus paid August 2011, represents 100% of the possible amount payable based on achieving milestone goals.
(v) Cash bonus paid September 2011 – no performance conditions attached.
** US based employee.
^ Remuneration and benefits covered period of appointment which was only part of the financial year.

 

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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

The Company established an Employee Share Option Plan which was approved by shareholders in October, 2007. 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. The number and timing of options issued under the terms of the Employee Share Option Plan is entirely at the discretion of the Board.

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 generally 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 generally vest equally over a four year period from the 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.

Remuneration options: granted and vested during the year

During the financial year no options were granted, by Novogen Limited, under the Employee Share Option Plan.

There were no alterations to the terms and conditions of options granted as remuneration since their grant date.

There is no Board policy in relation to staff members limiting their exposure to risk as options vest subject to service criteria, not performance criteria.

The following table sets out options issued by MEI to Directors and key management personnel during the year:

 

     Granted
number
     Terms and conditions for each grant  
         Grant date      Value per
option at
grant date
(US$)
     Exercise
price per
share
(US$)
     First
exercise
date
     Last
exercise
date
 

Non-executive Directors

                 

W D Rueckert

     25,169         20/10/2011         1.18         1.34         20/10/2012         20/10/2016   

Executives

                 

DP Gold

     100,000         1/08/2011         1.66         1.90         1/08/2012         1/08/2016   

TM Zech

     26,537         1/08/2011         1.66         1.90         1/08/2012         1/08/2016   
  

 

 

                

Total

     151,706                  
  

 

 

                

 

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Under the terms of the options issued by MEI, 25% will vest one year from grant date and, thereafter, the remaining 75% of options will vest in equal monthly instalments over the following thirty-six (36) months. The options do not have any performance conditions. There were no options forfeited and all options granted are available for future years.

Shares issued on exercise of remuneration options

No key management personnel or executives exercised options during the year ended June 30, 2012.

Shares lapsed

The value of options for key management personnel, which lapsed during the year ended June 30, 2012, was nil.

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:

Novogen

 

     6 May,
2011
 

Exercise price

   A$ 0.297   

Share price at grant date

   A$ 0.24   

Dividend yield

     0

Expected volatility

     125

Historical volatility

     125

Risk-free interest rate

     5.20

Expected life of option

     3.7 years   

Option fair value

   A$ 0.19   

MEI Pharma, Inc.

 

     1 June,
2012
    20 October,
2011
    1 September,
2011
    1 August,
2011
    1 June,
2011
    1 November,
2010
    1 September,
2010
 

Exercise price

   US$ 0.61      US$ 1.34      US$ 1.53      US$ 1.90      US$ 1.28      US$ 1.15      US$ 0.77   

Share price at grant date

   US$ 0.61      US$ 1.34      US$ 1.53      US$ 1.90      US$ 1.28      US$ 1.15      US$ 0.77   

Dividend yield

     0     0     0     0     0     0     0

Expected volatility

     152     148     147     145     144     137     136

Historical volatility

     152     148     147     145     144     137     136

Risk-free interest rate

     0.62     1.05     0.90     1.32     1.60     1.17     1.41

Expected life of warrant/option

     5 years        5 years        5 years        5 years        5 years        5 years        5 years   

Warrant/option fair value

   US$ 0.54      US$ 1.18      US$ 1.34      US$ 1.66      US$ 0.67      US$ 1.01      US$ 1.11   

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 20 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.

 

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No Director has received or has become entitled to receive, during or since the end of the fiscal year ended 2012, 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$90,000 during fiscal 2012 for employee superannuation benefits and pension benefits.

Board Practices

Novogen Board of Directors

 

Name

   Position Held    Year First
Appointed
   Current Term
Expires

Current Directors:

        

W.D. Rueckert

   Chairman    2009    October-2013

J.T. Austin

   Director    2010    October-2014

P.R. White

   Director    2010    October-2013

R. Youngman

   Director    2010    October-2013

J.P. O’Connor

   Director    2012    November-2012
Former Directors who served during the fiscal year 2012:
P. Scutt    Director    2010    Resigned May 25, 2012

Term of Directors

The Company’s Constitution requires that at each Annual General Meeting of the Company, one third (or the number nearest to but not exceeding one third) of the Directors, (excluding a Director who is the Managing Director, and a director appointed to fill a casual vacancy) must retire from office provided that no Director may retain office for more than 3 years without offering himself/herself for re-election even though such submission results in more than one third of the Directors retiring from office.

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

 

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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 41. 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.

Also, the following qualitative factors, among others, are considered:

 

   

whether the director has been employed as an Executive of the Company within the last three years;

 

   

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

William D. Rueckert

   Non-Executive Director

John P. O’Connor

   Non-Executive Director

Peter R. White

   Non-Executive Director

Ross Youngman

   Non-Executive Director

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 has an Audit Committee which comprises a majority of independent Non-executive Directors and 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 has delegated the responsibility for the establishment and maintenance of a framework of internal control and ethical standards for the management of the Company to the Audit Committee.

 

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The Audit Committee is responsible for the selection and appointment of the external auditor.

The Audit Committee reviews the performance of the external auditor on an annual basis and meets with it to discuss audit planning matters and statutory reporting requirements. The Audit Committee also assesses whether non-audit services provided by the external auditor are consistent with maintaining auditor independence. The Audit Committee also meets periodically with the auditor without management being present.

The current external auditor, Grant Thornton Audit Pty Limited (“GT”) (previous auditors BDO Audit (NSW-VIC) Pty Ltd), attends the Annual General Meeting.

The Audit Committee also provides the Board with additional assurance regarding the reliability of financial information for inclusion in the financial reports. The Board is of the view that the skill and experience of its members are sufficient to enable the Committee to discharge its responsibilities within its charter. The members of the Audit Committee during the year were Peter White (appointed Chairman January 18, 2012), Josiah Austin and William Rueckert (resigned as Chairman January 18, 2012).

Performance

The performance of the Board of Directors and the key Executives is reviewed regularly against both measurable and qualitative indicators. The performance criteria against which Directors and Executives are assessed have regard to the financial and non-financial objectives of Novogen Limited.

Remuneration Committee

Remuneration Committee.

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

The Remuneration Committee operates in accordance with its charter which is available on the Company’s website. The Remuneration Committee comprises a majority of independent Non-executive Directors and has responsibility for reviewing and setting the remuneration of any Executive Directors and key management personnel by reference to independent data, external professional advice (as required) and the requirement to retain high quality management.

Remuneration policies are established to attract and retain highly qualified Directors and senior management. The Remuneration Committee obtains independent advice on the appropriateness of remuneration levels.

The members of the Remuneration Committee during the year were William Rueckert (Chairman), Josiah Austin and Peter White.

During the year the impact of the global financial crisis continued which delayed our ability to raise significant new funds into the Group. In response to this situation the remuneration committee resolved to continue the Director fee reduction of 20% made in February 2009.

 

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Employees

The Group employed 13 people at June 30, 2012, 21 people at June 30, 2011 and 37 people at June 30, 2010 as follows:

 

Category of Activity    Number of People  
     2012      2011      2010  

Research and development

     4         3         14   

Production

     0         1         3   

Sales and marketing

     0         7         8   

Finance and administration

     9         10         12   
  

 

 

    

 

 

    

 

 

 

Total

     13         21         37   
  

 

 

    

 

 

    

 

 

 

 

Geographic Location    Number of People  
     2012      2011      2010  

Australasia

     3         10         31   

North America

     10         10         5   

Europe

     0         1         1   
  

 

 

    

 

 

    

 

 

 

Total

     13         21         37   
  

 

 

    

 

 

    

 

 

 

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 September 30, 2012. 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

JT Austin

     20,288,053         —           

WD Rueckert

     5,000         375,000         0.2970      

26 January, 2015

JP O’Connor

     253,551         35,460         1.0600      

1 March, 2013

        45,644         0.5256      

6 May, 2014

PR White

     —           375,000         0.2970      

26 January, 2015

RC Youngman

     —           375,000         0.2970      

26 January, 2015

  

 

 

    

 

 

       
     20,546,604         831,104         

 

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The table 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 September 30, 2012. The ordinary shares held by the named Executive does 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

MG Hinze

     14,728         44,324         1.06       1 March 2013
        71,352         0.5256       6 March 2014
        250,000         0.2970       26 January 2015
  

 

 

    

 

 

       
     14,728         365,676         

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.

 

 

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 20,288,053 Ordinary Shares representing 19.5% of the outstanding Ordinary Shares.

Oppenheimer holds 11,552,712 ordinary shares representing 11.1% of the outstanding ordinary shares.

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

At September 28, 2012 there were 1,917,223 of the Company’s ADRs outstanding, representing 47,930,575 Ordinary Shares (or 46.1% of the then outstanding Ordinary Shares). At September 28, 2012 there were 26 registered holders of the Company’s ADRs.

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

Related Party Transactions

On May 10, 2011 the asset purchase agreement entered into between Novogen Limited, Novogen Research Pty Limited and MEI on December 21, 2010 was completed. The closing of the transaction followed approval at a meeting of Novogen shareholders on May 6, 2011. The agreement was previously approved at MEI’s Annual Meeting of Stockholders on April 13, 2011. Under the agreement, MEI acquired Novogen’s isoflavone-based intellectual property portfolio in exchange for issuing Novogen 1,000 shares of Class A Preferred Stock. Each share of Preferred Stock is convertible into 4,827 shares of MEI common stock for an aggregate of 4,827,000 shares, valued in total at US$4 million based on the volume weighted average price over the 20 trading days prior to the date of the execution of the asset purchase agreement. Should any of the acquired assets achieve a statistically significant result in a Phase II clinical trial or the first patient is enrolled in a Phase III clinical trial, each share of Class A Preferred Stock not already converted will become convertible into 9,654 of MEI’s common stock. MEI can buy back the Preferred Stock at any time within five years at a total price of US$12 million. In connection with the asset purchase agreement, the Company’s license and services agreements with MEI were terminated, and the Company will not receive any further payments under these agreements.

On September 30, 2011, the Company purchased 1,333,333 shares of common stock of MEI for an aggregate cash purchase price of US$2 million. The Company also committed to make an additional equity investment in MEI of US$2 million on or before June 30, 2012.

In December 2011 Novogen Limited made an additional investment of US$2 million in MEI with the purchase 1,941,747 common shares.

Following approval by its shareholders at an Extraordinary General Meeting held on May 7, 2012, Novogen Limited invested a further US$4 million in MEI under the MEI rights offering with the purchase of 8,988,674 units, amounting to 4,494,337 common shares and warrants to purchase 2,247,168 common shares at a unit price of US$1.19 per share. These warrants will expire in May 2017.

 

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During the year the Company incurred A$374,000 (2011: A$30,000) in fees from Spark Capital, to which Mr Peter Scutt, a former director of Novogen, consulted as a corporate advisor. The fees were in association with the process of selling which resulted in the successful sale of the consumer business Mr Scutt did not act as a consultant to Spark Capital in this matter. The transaction was entered into on an arms length basis on both normal market prices and normal commercial terms.

 

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Table of Contents
Item 8. Financial Information

Consolidated financial statements are included in “Item 18 – Financial Statements” on pages 77 through 129.

Export Sales

Due to the sale in August 2011 of the consumer products business, now classified as discontinued operations, fiscal 2012 only represents one months sales during which there were no significant export 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 Directors of Novogen Limited do not recommend the payment of a dividend at year end.

During the year Novogen Limited distributed to its shareholders, by way of a dividend, 90% of the rights it received from its majority owned subsidiary, MEI Pharma, Inc. (“MEI”), under MEI’s rights offering which concluded in May, 2012.

Any dividends declared in the future will be paid in Australian dollars.

Significant Changes After Balance Sheet Date

Novogen Limited

On July 27, 2012, Novogen announced that it had entered into a merger agreement with Kai Medical, a United States based company, incorporated in Delaware, whose business is focused on sleep apnea therapy devices and wireless respiration monitoring technology. The agreement was subject to a number of conditions including completion of due diligence and shareholder approval. On September 24, 2012 Novogen announced the termination of the merger agreement with Kai Medical following confirmation that the merged entity would not be able to maintain continued listing on the ASX (and Nasdaq markets). Under the terms of the merger agreement entered into by the companies, the merger agreement shall forthwith become void and have no effect without any liability or obligation on the part of Novogen or Kai.

Novogen plans to undertake a capital reduction and in specie distribution to the Novogen shareholders of the shares of MEI Pharma, Inc. (“MEI”) that it owns. This transaction is subject to shareholder approval. On 11 October 2012, Novogen announced that this transaction would be included in the items for shareholders to vote on at the Annual General Meeting to be held on 12 November, 2012. This distribution will allow Novogen shareholders to directly own their proportionate share of the MEI’s shares now held by Novogen.

 

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The glucan technology assets, previously being developed by Glycotex, Inc., were not going to be acquired by Kai Medical in the proposed merger and Novogen completed a sale of those assets to TR Therapeutics, Inc., a privately held US corporation, on August 16, 2012.

Following the planned in specie distribution of shares of MEI held by Novogen Limited the Company will have no active operations and limited financial resources. The Company is currently exploring various strategic alternatives involving assets comprising substantially all of its business.

MEI Pharma, Inc.

On August 9, 2012, MEI announced that it had entered into a definitive asset purchase agreement with S*BIO Pte Ltd, pursuant to which MEI will acquire S*BIO’s exclusive worldwide rights to Pracinostat, an investigational, potential best-in-class, based on improved physicochemical, pharmaceutical and pharmacokinetic properties when compared to other compounds in its class of oral histone deacetylase (HDAC) inhibitors. Pracinostat is an orally available, selective HDAC inhibitor that has demonstrated clinical study evidence of single-agent activity, including studies in patients with advanced hematologic disorders such as acute myeloid leukemia and myelofibrosis. In addition, Pracinostat has demonstrated pharmacokinetic properties in the clinic, including increased bioavailability and increased half-life that compare favorably to other compounds of this class. Pursuant to the terms of the agreement, MEI will issue US$500,000 of common stock to S*BIO. The agreement also includes potential success-based clinical, regulatory and sales milestone payments of up to US$75.2 million, as well as low single-digit contingent earn-out payments based on net sales. On August 22, 2012, MEI completed the asset purchase and issued 1,174,536 shares of common stock to S*Bio Pte Ltd.

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

 

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Item 9. The Offer and Listing

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 Capital Market. Each ADR represents tweny-five Ordinary Shares of Novogen. The trading symbol on the Nasdaq Capital 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 Capital 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 2008

     2.14         0.83         50.65         19.45   

June 2009

     1.70         0.37         37.25         6.15   

June 2010

     0.89         0.17         26.20         2.85   

June 2011

     0.46         0.10         14.85         2.05   

June 2012

     0.25         0.08         8.25         1.95   

Quarter Ended

           

December 2010

     0.15         0.10         3.50         2.05   

March 2011

     0.46         0.12         14.85         2.45   

June 2011

     0.34         0.14         10.70         3.90   

September 2011

     0.25         0.12         8.25         2.50   

December 2011

     0.14         0.09         3.60         2.00   

March 2012

     0.10         0.09         3.00         2.03   

June 2012

     0.12         0.08         2.55         1.95   

September 2012

     0.10         0.07         2.44         1.81   

Month Ended

           

April 2012

     0.12         0.09         2.55         2.30   

May 2012

     0.10         0.09         2.44         2.00   

June 2012

     0.10         0.08         2.19         1.95   

July 2012

     0.09         0.08         2.44         1.95   

August 2012

     0.10         0.07         2.20         1.85   

September 2012

     0.09         0.07         2.16         1.81   

 

* Note the Company effected a change to the ADR ratio on January 3, 2012. The ratio changed from each ADR representing 5 ordinary shares to now representing 25 ordinary shares. All of the ADR prices presented above have been adjusted to be comparative to the current ratio.

 

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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

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 (whichever is higher) exceed A$231 million. If the person is a U.S. investor, the A$231 million threshold applies only for investments in prescribed sensitive sectors, otherwise a threshold of A$1,004 million rather than A$231 million applies. All direct investment by foreign governments and their related entities regardless of the value of the investment, including proposals to establish new businesses, must be notified to the Australian Treasurer. 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 period of time. 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

 

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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 (whichever is higher) totaling over A$231 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$1,004 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.

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

 

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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, where the disposal proceeds exceeds the cost base. 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 regarding the capital gains tax consequences of a disposal of shares or ADR’s in the Company.

Shares or ADRs will also 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 by 50% if they have held their shares or ADRs for at least 12 months. 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 for the shares or ADRs 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.

 

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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.

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.

 

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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 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). 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, 2012, 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 MEI Pharma, Inc. and Glycotex, Inc. is USD and these subsidiaries have exposure to AUD and any other currency these subsidiaries trade in.

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

 

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Item 12. Description of Securities Other than Equity Securities

American Depository Shares

The depositary collects its fees for delivery and surrender of American Depository Shares (ADSs) directly from investors depositing shares or surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deductions from cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them. The depositary may generally refuse to provide fee-attracting services until its fees for those services are paid.

 

Persons depositing or withdrawing shares must pay:

    

For:

     
US$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)     

•          Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property

 

•          Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates

  
US$.02 (or less) per ADS     

•          Any cash distribution to ADS registered holders

  
A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs     

•          Distribution of securities distributed to holders of deposited securities which are distributed by the depositary to ADS registered holders

  
US$.02 (or less) per ADSs per calendar year     

•          Depositary services

  
Registration or transfer fees     

•          Transfer and registration of shares on the Company’s share register to or from the name of the depositary or its agent when you deposit or withdraw shares

  

 

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Expenses of the depositary     

•          Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement)

 

•          Converting foreign currency to U.S. dollars

  
Taxes and other governmental charges the depositary or the custodian have to pay on any ADS or share underlying an ADS, for example, stock transfer taxes, stamp duty or withholding taxes     

•          As necessary

  
Any charges incurred by the depositary or its agents for servicing the deposited securities     

•          As necessary

  

As part of its service to the Company, The Bank of New York Mellon as depositor, has agreed to waive fees for the standard costs associated with the administration and maintenance of the ADR program. The estimated cost for this service is approximately US$55,000 per annum. For the period July 1, 2011 to June 30, 2012 the Company has paid The Bank of New York approximately US$26,000 for other services including AGM/EGM services and mailing of Company Notices.

 

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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 Principal 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 Principal Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures are effective as of June 30, 2012.

(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.

Management assessed the effectiveness of the Company’s internal control over financial reporting as of June 30, 2012 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 concluded that the Company’s internal control over financial reporting is effective as of June 30, 2012.

 

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(c) Changes in Internal Controls

During the fiscal year ended June 30, 2012, 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. Peter White, qualifies as an “audit committee financial expert” as that term is defined in Item 16A of Form 20-F. Mr. White meets the independence requirements of the Nasdaq Capital 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 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.

 

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Item 16C. Principal Accounting Fees and Services

Grant Thornton Audit Pty Ltd (“GT”) (previous auditors BDO Audit (NSW-VIC) Pty Ltd) has audited the Company’s annual financial statements acting as the independent registered public accounting firm for the fiscal years ended June 30, 2012 and 2011.

The charts below set forth the total fees for services performed by GT in 2012 and 2011 and summarizes these amounts by the category of service.

 

     2012
A$‘000
     2011
A$‘000
 

Audit fees

     106         270   

Audit related fees

     13         83   

Tax fees

     29         31   
  

 

 

    

 

 

 

Total fees

     148         384   
  

 

 

    

 

 

 

Audit fees

The audit fees include the aggregate fees incurred in fiscal years 2012 and 2011 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 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 Fees

Fees for audit related services billed in fiscal years 2012 and 2011 include audit related services provided in connection with the filing of registration statements for MEI.

Tax Fees

Tax fees billed in each of the fiscal years 2012 and 2011 were for the preparation of tax returns and related advice.

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.

 

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

This item is not applicable.

 

Item 16F. Change in Registrant’s Certifying Accountant.

On May 8, 2012 the Audit Committee approved the appointment of Grant Thornton Audit Pty Limited (“Grant Thornton”) as the Company’s new independent registered public accounting firm. BDO Audit (NSW-VIC) Pty Limited (“BDO”) the Company’s former independent registered public accounting firm resigned as the Company’s independent registered public accounting firm simultaneous with the engagement of Grant Thornton by the Company. This change was a result of BDO’s practices in Melbourne and Sydney merging with Grant Thornton in May 2012.

BDO’s reports on the Company’s consolidated financial statements for the years ended June 30, 2011 and

2010 did not contain any adverse opinion or disclaimer of opinion and were not qualified or modified as to uncertainty, audit scope or accounting principles.

During the Company’s fiscal years ended June 30, 2011 and 2010, and through May 8, 2012, there were no disagreements between the Company and BDO on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedure, which, if not resolved to the satisfaction of BDO, would have caused BDO to make reference to the subject matter of such disagreement in connection with their report. None of the “reportable events” described in Item 304(a)(1)(v) of Regulation S-K of the SEC’s rules and regulations have occurred during the fiscal years ended June 30, 2011 and 2010 or through May 8, 2012.

During the Company’s fiscal years ended June 30, 2011, and 2010 and through May 8, 2012, neither the Company nor anyone acting on its behalf consulted Grant Thornton regarding (1) the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on the Company’s consolidated financial statements, and Grant Thornton did not provide either a written report or oral advice to the Company that was an important factor considered by the Company in reaching a decision as to any accounting, auditing, or financial reporting issue, or (2) any matter that was either the subject of a disagreement with BDO, which, if not resolved to the satisfaction of BDO, would have caused BDO to make reference to the subject matter of such disagreement in connection with their report, or any “reportable events” as described in Item 304(a)(1)(v) of Regulation S-K of the SEC’s rules and regulations.

 

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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.

 

 

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.

 

Item 16H. Mine Safety Disclosure

This item is not applicable.

 

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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 77 through 129 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    Lease between Hyperion Property Syndicates Limited (Lessor) and Novogen Laboratories Pty Ltd for the Company’s corporate headquarters at 140 Wicks Road, North Ryde, New South Wales. (5)
  4.2    Employment Contract between the Company and Professor Alan Husband dated March 10, 2010. (5)
  4.3    Employment Contract between the Company and Bryan Palmer dated March 10, 2010. (5)
  4.4    Employment Contract between the Company and Craig Kearney dated March 10, 2010. (5)
  4.5    Employment Contract between the Company and Ronald Erratt dated March 10, 2010. (5)
  4.6    Employment Contract between the Company and Mark Hinze dated September 23, 2010. (5)
  4.7    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.** (3)
  4.8    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.)** (4)

 

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  4.9    Asset Purchase Agreement, dated as of December 21, 2010, between MEI, the Company and Novogen Pty Limited (6).
  4.10    Amendment Agreement with Archer Daniels Midland Company, dated June 30, 2011 (6)
  4.11    Securities Subscription Agreement, dated as of September 27, 2011, between Marshall Edwards, Inc. and Novogen Limited. (7)
  4.12    Securities Subscription Agreement, dated as of December 28, 2011, between Marshall Edwards, Inc. and Novogen Limited. (8)
  4.13    Letter from BMS Audit (NSW-VIC) Pty Ltd (formerly named BDO Audit (NSW-VIC) Pty Ltd),, dated October 26, 2012, confirming the disclosure in Item 16F. (*)
  8.1    Company Subsidiaries. (*)
12.1    Certification of the Acting Principal Executive Officer 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 Principal 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/A filed with the Securities and Exchange Commission on March 20, 2009 (File No. 0-29962).
(4) 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).
(5) Incorporated by reference to the Annual Report on Form 20-F filed with the Securities and Exchange Commission on December 13, 2010 (File No. 0-29962).

 

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(6) Incorporated by reference to the Annual Report on Form 20-F filed with the Securities and Exchange Commission on December 13, 2011 (File No. 0-29962).
(7) Incorporated by reference to Exhibit 10.1 to the Registrant’s Subsidiary’s (MEI Pharma, Inc.) filing on Form 8-K filed on September 29, 2011 (File No. 000-50484).
(8) Incorporated by reference to Exhibit 10.1 to the Registrant’s Subsidiary’s (MEI Pharma, Inc.) filing on Form 8-K filed on December 28, 2011 (File No. 000-50484).

 

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LOGO    Grant Thornton Audit Pty Ltd
   ACN 130 913 594
  

 

Level 17, 383 Kent Street

   Sydney NSW 2000
   Locked Bag Q800
   QVB Post Office
   Sydney NSW 1230
   T +61 2 8297 2400
Report of Independent Registered Public Accounting Firm    F +61 2 9299 4445
   E info.nsw@au.gt.com
   W www.grantthornton.com.au
Board of Directors and Shareholders of Novogen Limited   

We have audited the accompanying consolidated statement of financial position of Novogen Limited and subsidiaries (the “Company”) as of June 30, 2012 and 2011, and the related consolidated statements of comprehensive income, shareholders’ equity, and cash flows for each of the three years in the period ended June 30, 2012. 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. The Company is not required to have, nor were we engaged to perform an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. 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 and subsidiaries as of June 30, 2012 and 2011, and the results of their operations and their cash flows for each of the three years in the period ended June 30, 2012, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.

The accompanying financial statements have been prepared assuming that Novogen Limited will continue as a going concern. As more fully described in Note 1, the Company intends to undertake, subject to shareholder approval, an in specie distribution of the MEI Pharma, Inc. shares, following the distribution the Company will have no active operations and limited financial resources. These conditions, among others, as discussed in Note 1 to the consolidated financial statements, raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters also are described in Note 1. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of this uncertainty.

Grant Thornton Audit Pty Ltd acquired the partners and staff of BMS Audit (NSW-VIC) Pty Limited formerly BDO Audit (NSW- VIC) Pty Limited, the auditors of the Company’s consolidated financial statements as of June 30, 2011 and for each of the two years in the period ended June 30, 2011, and thus succeeded to the practice and accepts responsibility for expressing an opinion on the consolidated financial statements as of June 30, 2011 and for each of the two years in the period ended June 30, 2011.

 

 

GRANT THORNTON AUDIT PTY LTD

Chartered Accountants

Sydney, NSW, Australia

October 26, 2012

 

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Directors’ Declaration

The Directors of the Company declare that:

 

1. The financial statements, comprising the Statement of Comprehensive Income, Statement of Financial Position, Statement of Cash Flows, Statement of Changes in Equity and accompanying notes, are in accordance with the Corporations Act 2001 and:

 

  (a) comply with Accounting Standards and the Corporations Regulations2001; and

 

  (b) give a true and fair view of the consolidated entity’s financial position as at June 30, 2012 and of its performance for the year ended on that date.

 

2. The Company has included in the notes to the financial statements an explicit and unreserved statement of compliance with International Financial Reporting Standards.

 

3. In the Directors’ opinion, there are reasonable grounds to believe that the Company will be able to pay its debts as and when they become due and payable.

 

4. The Directors have been given the declaration by Chief Financial Officer required by section 295A.

Novogen Limited and its subsidiaries identified in Note 17 are parties to the deed of cross guarantee under which each company guarantees the debts of the others. At the date of this declaration there are reasonable grounds to believe that the companies which are parties to this deed of cross guarantee will as a consolidated entity be able to meet any obligations and liabilities to which they are, or may become, subject to, by virtue of the deed.

This declaration is made in accordance with a resolution of the Board of Directors and is signed for and on behalf of the Directors by:

William Rueckert

Non-executive Chairman

Sydney, October 26, 2012


Table of Contents

STATEMENT OF COMPREHENSIVE INCOME

for the year ended 30 June, 2012

 

     Notes   Consolidated  
         2012     2011     2010     2012  
         A$‘000     A$‘000     A$‘000     US$‘000  

Continuing Operations

          

Revenue

   2     1,513        2,025        1,784        1,549   

Other income

   2     937        512        7        959   

Research & development expenses

       (5,403     (3,902     (7,550     (5,531

General and administrative expenses

       (5,789     (9,562     (10,039     (5,926

Finance costs

       —          (18     (15     —     
    

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income tax

   2     (8,742     (10,945     (15,813     (8,949

Income tax expense

   3     —          (1     (1     —     
    

 

 

   

 

 

   

 

 

   

 

 

 

Loss after tax from continuing operations

       (8,742     (10,946     (15,814     (8,949

Profit after tax from discontinuing operations

   21     7,392        1,467        568        7,566   

Loss for the period

       (1,350     (9,479     (15,246     (1,383

Other comprehensive income

          

Net exchange difference on translation of financial statements of foreign controlled entities (net of tax 2012: Nil, 2011:Nil)

       (278     (690     (1,079     (285
    

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income

       (278     (690     (1,079     (285

Total comprehensive income

       (1,628     (10,169     (16,325     (1,668

Profit/(loss) attributable to:

          

Non-controlling interest

       (2,659     (2,981     (2,901     (2,722

Novogen Limited

   12(c)     1,309        (6,498     (12,345     1,340   
    

 

 

   

 

 

   

 

 

   

 

 

 
       (1,350     (9,479     (15,246     (1,382

Total comprehensive income attributable to:

          

Non-controlling interest

       (2,707     (3,388     (3,212     (2,772

Novogen Limited

       1,079        (6,781     (13,113     1,104   
    

 

 

   

 

 

   

 

 

   

 

 

 
       (1,628     (10,169     (16,325     (1,668

Basic and diluted earnings/(loss) per share (cents) from continuing operations

   4     (5.9     (7.8     (12.6     (6.0

Basic and diluted earnings/(loss) per share (cents) from discontinuing operations

   4     7.2        1.4        0.6        7.4   

Basic and diluted earnings/(loss) per share (cents)

   4     1.3        (6.4     (12.1     1.3   

The above Statement of Comprehensive income should be read in conjunction with the accompanying notes.

 

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STATEMENT OF FINANCIAL POSITION

as at 30 June, 2012

 

     Notes         Consolidated        
         2012     2011     2012  
         A$‘000     A$‘000     US$‘000  

CURRENT ASSETS

        

Cash and cash equivalents

   5     8,348        6,016        8,545   

Trade and other receivables

   6     404        5,469        414   

Assets held for sale - inventories

   7     —          654        —     

Other current assets

   8     206        521        211   
    

 

 

     

 

 

 

Total current assets

       8,958        12,660        9,170   
    

 

 

     

 

 

 

NON-CURRENT ASSETS

        

Property, plant and equipment

   9     27        67        28   
    

 

 

     

 

 

 

Total non-current assets

       27        67        28   
    

 

 

     

 

 

 

TOTAL ASSETS

       8,985        12,727        9,198   
    

 

 

     

 

 

 

CURRENT LIABILITIES

        

Trade and other payables

   10     3,675        6,386        3,762   

Provisions

   11     190        770        194   

Derivative liability

   15     —          1,047        —     
    

 

 

     

 

 

 

Total current liabilities

       3,865        8,203        3,956   
    

 

 

     

 

 

 

NON-CURRENT LIABILITIES

        

Provisions

   11     7        104        7   
    

 

 

     

 

 

 

Total non-current liabilities

       7        104        7   
    

 

 

     

 

 

 

TOTAL LIABILITIES

       3,872        8,307        3,963   
    

 

 

     

 

 

 

NET ASSETS

       5,113        4,420        5,235   
    

 

 

     

 

 

 

EQUITY

        

Contributed equity

   12(a)     199,026        194,295        203,723   

Reserves

   12(b)     (3,850     (3,422     (3,940

Accumulated losses

   12(c)     (191,701     (186,644     (196,225
    

 

 

     

 

 

 

Capital and reserves attributable to owners of Novogen Limited

       3,475        4,229        3,558   

Non-controlling interest

   12(d)     1,638        191        1,677   
    

 

 

     

 

 

 

TOTAL EQUITY

       5,113        4,420        5,235   
    

 

 

   

 

 

   

 

 

 

The above Statement of Financial Position should be read in conjunction with the accompanying notes.

 

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STATEMENT OF CHANGES IN EQUITY

for the year ended 30 June, 2012

 

Consolidated   Contributed
equity
A$‘000
    Accumulated
losses
A$‘000
    Reserves
A$‘000
    Total
A$‘000
    Non-
controlling
interest
A$‘000
    Total
equity
A$‘000
    Total
equity
US$‘000
 

At 1 July, 2009

    206,419        (179,730     (3,010     23,679        5,094        28,773        29,453   

Loss for the period

    —          (12,345     —          (12,345     (2,901     (15,246     (15,606

Exchange differences on translation of foreign operations

    —          —          (768     (768     (311     (1,079     (1,104
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income

    —          (12,345     (768     (13,113     (3,212     (16,325     (16,710

Share-based payments

    —          623        —          623        105        728        745   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total transactions with owners in their capacity as owners

    —          623        —          623        105        728        745   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

At 30 June, 2010

    206,419        (191,452     (3,778     11,189        1,987        13,176        13,488   
             

 

 

 

At 1 July, 2010

    206,419        (191,452     (3,778     11,189        1,987        13,176        13,488   

Loss for the period

    —          (6,498     —          (6,498     (2,981     (9,479     (9,703

Exchange differences on translation of foreign operations

    —          —          (283     (283     (407     (690     (706
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income

    —          (6,498     (283     (6,781     (3,388     (10,169     (10,409

Issue of share capital by subsidiary

    706        —          —          706        —          706        723   

less non-controlling interest

    (289     —          —          (289     289        —          —     

Share-based payments

    —          116        —          116        591        707        724   

Share of opening equity transferred to non-controlling interest due to issuance of shares by subsidiary

    (12,541     11,190        639        (712     712        —          —     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total transactions with owners in their capacity as owners

    (12,124     11,306        639        (179     1,592        1,413        1,447   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

At 30 June, 2011

    194,295        (186,644     (3,422     4,229        191        4,420        4,526   
             

 

 

 

At 1 July, 2011

    194,295        (186,644     (3,422     4,229        191        4,420        4,526   

Profit/(loss) for the period

    —          1,309        —          1,309        (2,659     (1,350     (1,382

Exchange differences on translation of foreign operations

    —          —          (230     (230     (48     (278     (285
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income

    —          1,309        (230     1,079        (2,707     (1,628     (1,667

Issue of share capital

    164        —          —          164        —          164        168   

Issue of share capital by subsidiary

    1,606        —          —          1,606        —          1,606        1,644   

less non-controlling interest

    (3,560     —          —          (3,560     3,560        —          —     

Share-based payments

    —          730        —          730        (179     551        564   

Share of opening equity transferred to non-controlling interest due to issuance of shares by subsidiary

    6,521        (7,096     (198     (773     773        —          —     
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total transactions with owners in their capacity as owners

    4,731        (6,366     (198     (1,833     4,154        2,321        2,376   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

At 30 June, 2012

    199,026        (191,701     (3,850     3,475        1,638        5,113        5,235   
             

 

 

 

The above Statements of Changes in Equity should be read in conjunction with the accompanying notes.

 

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STATEMENT OF CASH FLOWS

for the year ended 30 June, 2012

 

     Notes          Consolidated  
          2012
A$‘000
    2011
A$‘000
    2010
A$‘000
    2012
US$‘000
 

Cash flows from operating activities

           

Net loss before tax

        (1,343     (9,474     (15,236     (1,375

Income tax paid

        (7     (5     (10     (7

Adjustments to reconcile net loss to net cash used in operating activities:

           

Depreciation and amortisation

        25        83        198        26   

Net (gain)/loss on disposal of property, plant and equipment

        9        (265     (7     9   

Share-based payments

        574        651        728        588   

Sale of business - gain on disposal

        (7,992     —          —          (8,180

Changes in operating assets and liabilities:

           

(increase)/decrease in trade receivables

        2,408        (1,172     252        2,465   

(increase)/decrease in other receivables

        2,657        (2,313     16        2,720   

(increase)/decrease in inventories

        654        907        (227     669   

(increase)/decrease in prepayments

        315        (79     123        322   

increase/(decrease) in trade and other payables

        (2,711     1,021        (2,694     (2,775

increase/(decrease) in provisions

        (677     125        (261     (693

increase/(decrease) in derivative liability

        (1,047     1,047        —          (1,072

exchange rate change on opening cash

        (214     771        512        (219
       

 

 

   

 

 

   

 

 

 

Net cash flows from/(used in) operating activities

        (7,349     (8,703     (16,606     (7,522
       

 

 

   

 

 

   

 

 

 

Cash flows from investing activities

           

Acquisition of property, plant and equipment

        (1     (56     (22     (1

Proceeds from sale of plant and equipment

        7        343        12        7   

Sale of business - net proceeds

        9,500        —          —          9,724   

Sale of business - related costs

        (1,508     —          —          (1,544
       

 

 

   

 

 

   

 

 

 

Net cash flows from/(used in) investing activities

        7,998        287        (10     8,186   
       

 

 

   

 

 

   

 

 

 

Financing Activities

           

Proceeds from the issue of shares by subsidiary

        1,747        763        —          1,788   
       

 

 

   

 

 

   

 

 

 

Net cash flows from/(used in) financing activities

        1,747        763        —          1,788   
       

 

 

   

 

 

   

 

 

 

Net (decrease)/increase in cash and cash equivalents

        2,396        (7,653     (16,616     2,452   

Cash and cash equivalents at beginning of period

        5,766        14,131        32,338        5,902   

Effect of exchange rates on cash holdings in foreign currencies

        (64     (1,462     (1,591     (66

Movements in secured facility

        —          750        —          —     
       

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at end of period

   5      8,098        5,766        14,131        8,288   
       

 

 

   

 

 

   

 

 

 

The above Statements of Cash Flows should be read in conjunction with the accompanying notes.

 

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NOTES TO THE FINANCIAL STATEMENTS

The financial statements of Novogen Limited for the year ended 30 June, 2012 were authorised for issue in accordance with a resolution of the Board of Directors on 26 October, 2012.

 

Note 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

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

Basis of preparation

The financial statements are general-purpose financial statements, which have been prepared in accordance with the requirements of the Corporations Act 2001, Australian Accounting Standards and other authoritative pronouncements of the Australian Accounting Standards Board (“AASB”). Novogen Limited is a for-profit entity for the purpose of preparing the financial statements. The financial statements have been prepared on a historical cost basis with all amounts presented in Australian dollars, rounded to the nearest thousand dollars ($’000), unless otherwise stated.

Going Concern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

While the basis of presentation remains that of a going concern, the Group’s ability to continue as a going concern is dependent on the in specie distribution of the MEI shares proceeding as described in Note 23, which is subject to shareholder approval.

Following the planned in specie distribution of shares of MEI held by Novogen Limited the Company will have no active operations and limited financial resources. The Directors will continue to explore a number of acquisition or merger options for the company so as to achieve the best outcome for shareholders. Although the Directors believe the company will have sufficient cash resources to fund operations for the next twelve months, its future will be dependent on the result of the current options that are being explored for the future of the Company. If such a transaction is completed, the going concern of the Company will be dependent on the operations of the new business and no assurance can be provided that additional funding will not be required for the Company to continue as a going concern.

If the in specie distribution does not occur Novogen Limited’s future performance will continue to be dependent upon the performance of its subsidiary MEI and MEI’s ability to continue to raise capital to continue its operations. Should the Company not participate in any of MEI’s capital raises, the Company’s investment in MEI could be further diluted. Any participation by the Company in MEI’s capital raising efforts would be dependent on the Company’s ability to raise funds on market.

If the Company does not undertake the in specie distribution and its subsidiary MEI is unable to obtain funds on favourable terms or at all and/or the Directors are unable to identify future options for the Company, the Company may be required to cease or reduce its operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

 

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Statement of compliance

The financial statements comply with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board.

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.

Non-controlling interests represent the portion of profit or loss and net assets in MEI and Glycotex not held by the Group and are presented separately in the Statement of Comprehensive Income and within equity in the consolidated Statement of Financial Position.

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 A$152,000 have been accrued at June 30, 2012. These estimates are based on the number of patients in each trial and the drug administration cycle.

 

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(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.

Impairments

The Group assesses impairment at the end of each reporting period 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 profit or loss over the periods necessary to match the grant on a systematic basis to the costs that it is intended to compensate.

Royalties

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

 

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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 profit or loss on a straight-line basis over the lease term. Lease incentives are recognised in the profit or loss 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 Statement of Financial Position 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.

For the purposes of the Statement 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.

 

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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. Costs are assigned using a standard costing system on the basis of weighted average costs.

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 MEI, Marshall Edwards Pty Limited and Glycotex, where the functional currency is US 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 as at the end of the reporting period.

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.

Translation of financial statements of overseas operations

As at the end of the reporting period the assets and liabilities of overseas subsidiaries are translated into the presentation currency of the Group at the rate of exchange ruling as at the end of the reporting period and the income and expenses are translated at the weighted average exchange rates for the period.

The exchange differences arising on the retranslation of overseas operations which have a functional currency of A$ are taken directly to the profit or loss. 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 end of the reporting period.

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

 

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The carrying amount of deferred income tax assets is reviewed at the end of each reporting period 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 as at the end of the reporting period.

Unrecognised deferred income tax assets are reassessed at the end of each reporting period 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 Statement of Comprehensive Income.

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.

The net amount of GST recoverable from, or payable to, the taxation authority is included as part of receivables or payables in the Statement of Financial Position.

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 the end of each reporting period, 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.

 

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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.

Non-current assets held for sale and discontinued operations

Non-current assets and disposal groups classified as held for sale are measured at the lower of their carrying amount and fair value less costs to sell. Non-current assets and disposal groups are classified as held for sale if their carrying amounts will be recovered principally through a sale transaction rather than through continuing use. This condition is regarded as met only when the sale is highly probable and the asset or disposal group is available for immediate sale in its present condition. Management must be committed to the sale, which should be expected to qualify for recognition as a completed sale within one year from the date of classification.

In the statement of comprehensive income, income and expenses from discontinued operations are reported separately from income and expenses from continuing operations. The resulting profit or loss (after taxes) is reported separately in the statement of comprehensive income.

Property, plant and equipment, once classified as held for sale, are not depreciated or amortised.

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.

 

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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 end of the reporting period. Liabilities for annual leave are recognised in current provisions in respect of employees’ services up to the end of the reporting period. 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 end of the reporting period 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 end of the reporting period 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.

Onerous lease provision

When a lease contract is considered to be onerous, the present obligation under the lease is recognised as a provision. A contract is considered to be onerous when the unavoidable costs of meeting the obligations under the contract exceed the economic benefits expected to be received under it. The unavoidable costs under a contract reflect the least net costs of exiting from the contract, which is the lower of the cost of fulfilling it and any compensation or penalties arising from failure to fulfil it.

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 end of the reporting period 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 Statement of Comprehensive Income 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.

 

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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 non-controlling interests, the parent company may make a gain or loss due to dilution of non-controlling interests. These gains or losses are recognised in equity attributable to the parent company.

Earnings per share (EPS)

Basic earnings per share amounts are calculated by dividing net loss for the year attributable to owners 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 owners 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.

Deferred offering costs

Where costs associated with a capital raising have been incurred at the end of the reporting period and it is probable that the capital raising will be successfully completed after the end of the reporting period, 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.

Derivative liabilities are initially recognised at fair value. Changes in the fair value of the derivative liabilities are recognised in profit or loss.

 

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New accounting standards and interpretations

Certain new accounting standards and interpretations have been published that are not mandatory for 30 June, 2012 reporting periods. The Group’s assessment of the impact of these new standards and interpretations is set out below.

(i) AASB 9 Financial Instruments (effective from 1 January, 2015)

In September 2009 the AASB issued AASB 9, Financial Instruments, which amends the requirements for classification and measurement of financial assets. This standard was subsequently amended in December, 2010. AASB 9 requires that gains or losses on financial liabilities measured at fair value are recognised in profit or loss, except that the effects of changes in the liability’s credit risk are recognised in other comprehensive income. At 30 June 2012, the Company currently has no financial liabilities measured at fair value through profit or loss (2011: A$1,047,000). The amendments require that any changes in fair value attributable to the liability’s credit risk be recognised in other comprehensive income instead of profit or loss. The amendments apply retrospectively from date of initial application, which will be 1 July 2015. Therefore, at this stage, it is not yet possible for the Company to quantify the impact on the financial statements of first time application of these amendments.

(ii) AASB 10 Consolidated Financial Statements (effective from 1 January, 2013)

AASB 10 establishes a revised control model which broadens the situations when an entity is considered to be controlled by another entity. The effect of this change may lead to more entities being consolidated into the Group.

The Company does not expect that this change with have any impact on the financial statements due to there currently not being any entities or investment with in the group that are not currently consolidated. However, should the investment that the Company currently has in MEI Pharma, Inc become diluted to less than 50% ownership interest, due to further share issuances by the subsidiary, the Company will need to review the new standard.

(iii) AASB 12 Disclosure of Interests in Other Entities (effective from 1 January, 2013)

AASB 12 combines the disclosure requirements for subsidiaries, joint arrangements, associates and structured entities within a comprehensive disclosure standard. Its aim is to provide more transparency on ‘borderline’ consolidations decisions and includes enhanced disclosures centred on significant judgements and assumptions made around determining control, joint control and significant influence.

The Company does not expect that this change with have any impact on the financial statements other than to add additional disclosure.

(iv) AASB 13 Fair Value Measurement (effective from 1 January, 2013)

Currently, fair value measurement requirements are included in several Accounting Standards. AASB 13 establishes a single framework for measuring fair value of financial and non-financial items recognized at fair value in the statement of financial position or disclosed in the notes in the financial statements.

The Company has not yet conducted a detailed analysis of the differences between the current fair calculation methodologies used and those required by AASB 13. However, when this standard is adopted for the first time for the year ended 30 June 2014, there will be no impact on the financial statements because the revised fair value measurement requirements apply prospectively from 1 July 2013.

 

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(v) AASB 2011-9 Amendments to Australian Accounting Standards – Presentation of Other Comprehensive Income (effective 1 July, 2013).

These amendments align the presentation of items of other comprehensive income (OCI) with US GAAP. When this standard is first adopted for the year ended 30 June 2014, there will be no impact on amounts recognised for transactions and balances for 30 June 2014 (and comparatives). However, the statement of comprehensive income will include name changes and include subtotals for items of OCI that can subsequently be reclassified to profit or loss in future (e.g. foreign currency translation reserves) and those that cannot subsequently be reclassified (e.g. fixed asset revaluation surpluses).

(vi) AASB 119 Employee Benefits (effective 1 January, 2013).

The Company currently calculates its liability for annual leave employee benefits on the basis that it is due to be settled within 12 months of the end of the reporting period because employees are entitled to use this leave at any time. The amendments to IAS 19 require that such liabilities be calculated on the basis of when the leave is expected to be taken, i.e. expected settlement.

When this standard is first adopted for the 30 June, 2014 year end, annual leave liabilities will be recalculated on 1 July 2012. Leave liabilities for any employees with significant balances of leave outstanding who are not expected to take their leave within 12 months will be discounted, which may result in a reduction of the annual leave liabilities recognised on 1 July 2012, and a corresponding increase in retained earnings at that date.

 

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Note 2 (LOSS)/PROFIT BEFORE INCOME TAX

 

     Consolidated  
     2012
A$‘000
    2011
A$‘000
     2010
A$‘000
 

Revenue and other income from continuing operations

       

(a) Revenue

       

Bank interest

     285        144         290   

Royalties

     1,162        1,714         1,492   

Dividends

     66        165         —     

Other