20-F 1 d40784d20f.htm FORM 20-F Form 20-F
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

(Mark One)

¨ 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, 2015

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)

Level 1, 16-20 Edgeworth David Avenue, Hornsby, New South Wales 2077, Australia

(Address of principal executive offices)

Mr Lionel Mateo

(e) Lionel.Mateo@novogen.com (t) +61-2-9472-4104

Level 1, 16-20 Edgeworth David Avenue, Hornsby, New South Wales 2077, Australia

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

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

 

Title of each class

 

Name of each exchange on which registered

American Depositary Shares, each representing twenty-five

Ordinary Shares*

  The NASDAQ Stock Market

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

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

The number of outstanding Ordinary Shares of the issuer as at June 30, 2015 was 423,116,465.

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

Note – Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.

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 a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

 

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

 

 

 


Table of Contents

TABLE OF CONTENTS

 

FORWARD-LOOKING STATEMENTS

     1   

PART I

     2   

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

     10   

Item 4A.

  

Unresolved Staff Comments

     23   

Item 5.

  

Operating and Financial Review and Prospects

     23   

Item 6.

  

Directors, Senior Management and Employees

     31   

Item 7.

  

Major Shareholders and Related Party Transactions

     44   

Item 8.

  

Financial Information

     45   

Item 9.

  

The Offer and Listing

     47   

Item 10.

  

Additional Information

     49   

Item 11.

  

Quantitative and Qualitative Disclosures about Market Risk

     58   

Item 12.

  

Description of Securities Other than Equity Securities

     59   

PART II

     60   

Item 13.

  

Defaults, Dividend Arrearages and Delinquencies

     60   

Item 14.

  

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

     60   

Item 15.

  

Controls and Procedures

     60   

Item 16.

  

[Reserved]

     60   

Item 16A.

  

Audit Committee Financial Expert

     61   

Item 16B.

  

Code of Ethics

     61   

Item 16C.

  

Principal Accounting Fees and Services

     61   

Item 16D.

  

Exemptions from the Listing Standards for Audit Committees

     62   

Item 16E.

  

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

     62   

Item 16F.

  

Changes in registrant’s Certifying Accountant

     62   

Item 16G.

  

Corporate Governance

     62   

Item 16H.

  

Mine Safety Disclosure

     63   

PART III

     64   

Item 17.

  

Financial Statements – Not Applicable

     64   

Item 18.

  

Financial Statements

     64   

Item 19.

  

Exhibits

     64   

Report of Independent Registered Public Accounting Firm

     110   


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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 and section 27A of the Securities Act and Section 21E of the Exchange Act. 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, “Consolidated entity”, “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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Table of Contents

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, 2015 and 2014 and for the years ended June 30, 2015, 2014 and 2013 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 Public Company Accounting Oversight Board (‘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 ended on June 30 of that year. For example, the term “fiscal 2015” refers to the 12 months ended June 30, 2015. 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 profit or loss and other
comprehensive income (IFRS)
   2011
A$‘000
    2012
A$‘000
    2013
A$‘000
    2014
A$‘000
    2015
A$‘000
    2015
US$‘000
 

Revenue from continuing operations

     2,025        1,447        1,112        87        89        69   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income tax expense from continuing operations

     (5,339     (1,471     (1,508     (7,569     (7,306     (5,629

Profit/(loss) after income tax expense from discontinued operations

     (4,140     121        723        —          —          —     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss after income tax expense for the year

     (9,479     (1,350     (785     (7,569     (7,306     (5,629
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

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

     (6,498     1,309        (1,031     (7,468     (7,139     (5,500
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Earnings per share for loss from continuing operations attributable to the owners of Novogen Limited

            

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

     (5.22     (1.44     (1.32     (4.76     (2.99     (2.30

Diluted earnings/(loss) per share (cents per share)

     (5.22     (1.44     (1.32     (4.76     (2.99     (2.30

Earnings per share for profit/(loss) from discontinued operations attributable to the owners of Novogen Limited

            

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

     (1.14     2.72        0.42        —          —          —     

Diluted earnings/(loss) per share (cents per share)

     (1.14     2.72        0.42        —          —          —     

Earnings per share for profit/(loss) attributable to the owners of Novogen Limited

            

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

     (6.36     1.28        (0.90     (4.76     (2.99     (2.30

Diluted earnings/(loss) per share (cents per share)

     (6.36     1.28        (0.90     (4.76     (2.99     (2.30

Weighted average number of ordinary share shares used to calculate earnings per share

     102,125,894        102,435,227        114,690,737        156,725,363        238,418,048        238,418,048   

Number of outstanding ordinary shares at year end

     102,125,894        103,805,676        138,276,033        168,557,834        423,116,465        423,116,465   

 

Summary of consolidated financial position (IFRS)    2011
A$‘000
     2012
A$‘000
     2013
A$‘001
     2014
A$‘000
     2015
A$‘000
     2015
US$‘000
 

Cash and cash equivalents

     6,016         8,348         2,738         2,502         44,371         34,184   

Total assets

     12,727         8,985         5,749         4,660         46,140         35,546   

Net assets/Equity

     4,420         5,113         4,041         1,413         44,362         34,177   

Debt

     1,047         —           1,416         2,707         —           —     

Capital Stock

     194,295         199,026         137,663         142,586         190,404         146,687   

 

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At the Company’s Annual General Meeting on November 12, 2012, shareholders approved the demerger of Novogen Limited and MEI Pharma, Inc. (‘MEI’). On November 27, 2012, a dividend of $24,775,000 was paid via an in-specie distribution of shares in MEI representing 23.87 cents per ordinary share. 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 amounts actually represent such U.S. dollar amounts or could be converted into U.S. dollars at the rate indicated. Unless otherwise stated, the translations of Australian dollars into U.S. dollars have been made at the rate of US$0.7704 = A$1.00, the foreign exchange rate as issued weekly by the Board of Governors of the Federal Reserve System (www.federalreserve.gov/releases) on June 30, 2015. The rate on September 30, 2015 was US$0.7020 = A$1.00

Exchange rates for the six months to September 2015

A$ versus US$

 

Month    High      Low  

April

   $ 0.8065       $ 0.7566   

May

   $ 0.8118       $ 0.7631   

June

   $ 0.7831       $ 0.7613   

July

   $ 0.7664       $ 0.7278   

August

   $ 0.7419       $ 0.7087   

September

   $ 0.7222       $ 0.6917   

Exchange rates for the last five years

A$ versus US$

 

Fiscal Year ended June 30    Average
Rate
 

2011

   $ 0.9904   

2012

   $ 1.0323   

2013

   $ 1.0272   

2014

   $ 0.9186   

2015

   $ 0.8365   

As mentioned above, the Company paid an in-specie distribution of the shares of MEI held by Novogen Limited, on November 27, 2012 following shareholders’ approval at the Annual General Meeting held on November 17, 2012. This report has been prepared on the basis of the current business structure which excludes MEI and any other businesses or assets disposed of during the previous fiscal year. MEI and the Consumer Business show as discontinued operations.

 

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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 currently is exploring the development of anti-cancer drugs based on two unproven drug technology platforms. Failure of either or both of these platforms to prove suitable for drug candidate selection, may have a material adverse effect on our business and our financial condition

The Company is committed to the identification of lead candidate anti-cancer drugs from two drug technology platforms, super-benzopyrans (‘SBP’) and anti-tropomyosins. Although early pre-clinical studies have confirmed the utility of both drug technology platforms in the generation of compounds with novel and potent cytotoxicity against various human cancer cell lines in vitro and in vivo, there are significant risks and uncertainties in translating those early laboratory results into drugs that will have meaningful clinical application and meet the stringent requirements of regulatory authorities such as the United States Food and Drug Administration (‘FDA’), who review Investigational New Drug (‘IND’) Applications to enable the conduct of first in man clinical trials. The Company plans to obtain the appropriate approvals to enable the trials.

Factors that have a negative impact on early drug candidate selection may include:

 

   

unacceptably high toxicity;

 

   

poor bio-availability;

 

   

unacceptably short drug half-life;

 

   

inability to deliver the drug in a practical manner; and

 

   

insurmountable difficulties in large-scale manufacture.

The Company’s ability to continue as a going concern is dependent on a continuing positive news flow from its pre-clinical Research & Development (‘R&D’) programs, and its ability to raise capital to support those programs

The Company has limited cash resources and will need substantial additional funds to maintain the planned level of R&D.

The factors that will determine the actual amount of additional capital required may include the following:

 

   

the rate of success and the length of time it takes to identify lead candidate compounds in both the super-benzopyran and anti-tropomyosin drug technologies;

 

   

the length of time and amount of work required to bring any lead candidate compounds through their pre-clinical programs; and

 

   

the need to employ additional staff or contractors to meet the needs of the R&D programs.

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

The Company is at an early stage of drug development and is in the process of applying for patents over composition and matter and use for both of its drug technology platforms. There is no certainty that patent protection will be granted

The Company’s patent portfolio is in a development stage. It comprises a certain number of provisional patents that have been lodged and others that are in the process of being lodged. The patents usually have worldwide coverage, with a particular focus on U.S., European Union (‘EU’), Asia and Australia. While the Company’s patent strategy is closely supervised by experienced patent attorneys and every effort made to ensure the likely success of achieving approval of patent claims in all major territories, there is no guarantee that any or all territories will grant such claims.

 

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Negative global economic conditions may pose challenges to the Company’s business strategy, which relies on access to capital from the markets or collaborators. Failure to obtain sufficient funding on acceptable terms could have a material adverse effect on our business, results of operations and financial condition

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 the Company’s ability to complete financing transactions. The duration and severity of these conditions is uncertain, as is the extent to which they may adversely affect the Company’s business and the business of current and prospective vendors and collaborators. If negative global economic conditions persist or worsen, the Company may be unable to secure additional funding to sustain its operations or to find suitable collaborators to advance its internal programs, even if positive results are achieved from research and development efforts.

If we are unable to raise sufficient funding on acceptable terms, we may be unable to continue to operate. There is no assurance that we will be successful in obtaining sufficient financing on acceptable terms and conditions to fund continuing operations, if at all. Our failure to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations and financial condition.

Our Company has a history of incurring losses. The extent of any future losses, and whether or not the Company can generate profits, remains uncertain

With the acquisition of Triaxial Pharmaceuticals Pty Ltd in 2012 and ongoing research and development, the company has had a history of incurring losses and is likely to continue to incur operating losses in the near future, until such time as any possible commercial breakthrough occurs.

The company incurred net losses of A$785,000 for year ended June 30, 2013, net losses of A$7,569,000 for year ended June 30, 2014 and net losses of A$7,306,000 for the year ended June 30, 2015. As of June 30, 2015, we have accumulated losses of A$148,445,000 (USD114,360,000) and the extent of any future losses and whether or not the Company can generate profits remains uncertain.

Final approval by regulatory authorities of the Company’s 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 drug candidates are at an early stage of development, and each will need to successfully proceed through a number of steps in order to obtain regulatory approval before potential commercialization.

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:

 

   

the Company has identified three lead candidate compounds, Cantrixil, Anisina and Trilexium. All are in the early stages of development, and the Company will need to conduct significant pre-clinical and 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;

 

   

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.

 

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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.

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. Our failure to do so may adversely affect our business, results of operations and financial condition

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 R&D staff 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.

 

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The Company relies on third parties to conduct 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 (‘CROs’), and manufacturers, to perform critical services. For example, the Company relies on third parties to conduct all of its pre-clinical studies. 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 studies 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. 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 plans to outsource the manufacture of its drug product and test it to FDA requirements. 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 may 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 is in the process of identifying lead candidate compounds. When identified, and INDs are obtained they will be taken into the clinic. 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 our business, results of operations and financial condition.

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. Some of the Company’s directors and officers reside outside of the United States. In addition, a substantial portion of the directly owned assets of the Company are located outside of the United States. As a result, it may be difficult or impossible for investors to effect service of process within the United States against the Company or its directors and officers or to enforce against them any of the judgments, including those obtained in original actions or in actions to enforce judgments of the U.S. courts, predicated upon the civil liability provisions of the federal or state securities laws of the United States. 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.

 

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The trading price of the Company’s ordinary shares and American Depositary Receipts (‘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 U.S., EU, 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 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 that 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.

Because we are not necessarily required to provide you with the same information as an issuer of securities based in the United States, you may not be afforded the same protection or information you would have if you had invested in a public corporation based in the United States.

We are exempt from certain provisions of the Securities Exchange Act of 1934, as amended, commonly referred to as the Exchange Act, that are applicable to U.S. public companies, including (i) the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q or current reports on Form 8-K; (ii) the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; and (iii) the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time. The exempt provisions would be available to you if you had invested in a U.S. corporation.

 

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However, in line with the Australian Securities Exchange regulations, we disclose our financial results on a semi-annual basis which are required to have a limited review semi-annually and to be fully audited annually. The information, which may have an effect on our stock price on the Australian Securities Exchange, will also be disclosed to the Australian Securities Exchange and the Securities Exchange Commission. Other relevant information pertaining to our Company will also be disclosed in line with the Australian Securities Exchange regulations and information dissemination requirements for listed companies. We will provide our semi-annual results and other material information that we make public in Australia in the U.S. under the cover of an SEC Form 6-K. Nevertheless, you may not be afforded the same protection or information, which would be made available to you, were you investing in a United States public corporation because the requirements of a Form 10-Q and Form 8-K are not applicable to us.

In certain circumstances, holders of ADSs may have limited rights relative to holders of ordinary shares.

The rights of holders of ADSs with respect to the voting of ordinary shares and the right to receive certain distributions may be limited in certain respects by the deposit agreement entered into by us and The Bank of New York Mellon. For example, although ADS holders are entitled under the deposit agreement, subject to any applicable provisions of Australian law and of our Constitution, to instruct the depositary as to the exercise of the voting rights pertaining to the ordinary shares represented by the ADSs, and the depositary has agreed that it will try, as far as practical, to vote the ordinary shares so represented in accordance with such instructions, ADS holders may not receive notices sent by the depositary in time to ensure that the depositary will vote the ordinary shares. This means that, from a practical point of view, the holders of ADRs may not be able to exercise their right to vote. In addition, under the deposit agreement, the depositary has the right to restrict distributions to holders of the ADSs in the event that it is unlawful or impractical to make such distributions. We have no obligation to take any action to permit distributions to holders of our ADSs. As a result, holders of ADSs may not receive distributions.

There is a substantial risk that we are, or will become, a passive foreign investment company, or PFIC, which will subject our U.S. investors to adverse tax rules

Holders of our ADSs who are U.S. residents face income tax risks. There is a substantial risk that we are, or will become, a passive foreign investment company, commonly referred to as a PFIC. Our treatment as a PFIC could result in a reduction in the after-tax return to the holders of our ADSs and would likely cause a reduction in the value of such ADSs. For U.S. federal income tax purposes, we will be classified as a PFIC for any taxable year in which either (i) 75% or more of our gross income is passive income, or (ii) at least 50% of the average value of all of our assets for the taxable year produce or are held for the production of passive income. For this purpose, cash is considered to be an asset that produces passive income. We believe that there is a risk we will be classified as a PFIC for the taxable year ended June 30, 2015. If we are classified as a PFIC for U.S. federal income tax purposes, highly complex rules will apply to U.S. holders owning ADSs. Accordingly, you are urged to consult your tax advisors regarding the application of such rules.

United States residents should carefully read “Item 10.E. Additional Information – Taxation, United States

Federal Income Tax Consequences” in this Annual Report, for a more complete discussion of the U.S. federal income tax risks related to owning and disposing of our ADSs.

 

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 2001 (Cth). Novogen has its registered office at Level 1, 16-20 Edgeworth David Avenue, Hornsby, New South Wales NSW 2077, Australia. Its telephone number and other contact details are: Phone +61-2-9472 4100; Fax +61-2-9476-0388; 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 Securities 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 Depositary in the U.S. for ADRs is The Bank of New York Mellon, 101 Barclay Street 22W New York, N.Y. 10286.

 

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Business overview

Nature of the Business

Since its inception in 1994, the principal business of the Company has been pharmaceutical drug development. With the acquisition of Triaxial, on December 5, 2012, the Company continued pharmaceutical drug research and development.

Corporate developments

Novogen

Board of Directors

The Company directors as at the date of this report are as follows:

 

Bryce Carmine    Non Executive Director (appointed on 3 June 2015)  
Steven Coffey    Non Executive Director  
John O’Connor    Non Executive Director  
Peter Gunning    Non Executive Director  
Ian Phillips    Interim Chairman (appointed on 3 June 2015)   Note 1
Iain Ross    Director and Acting CEO (resigned on 20 November 2014 and re appointed on 22 July 2015)   Note 2

Note 1 – Ian Phillips was appointed Interim Chairman on 1 July 2015

Note 2 – Iain Ross was re-appointed as Director and Acting CEO on 22 July 2015

Former directors who served during the financial year ended June 30, 2015:

 

Graham Kelly    Former Chairman and CEO (resigned on 22 July 2015)   

More information on each of the current Directors is contained under item 6 “Directors, Senior Management and Employees” commencing on page 31.

Triaxial Pharmaceuticals Pty Ltd

On December 5, 2012, the Company acquired the biotechnology company Triaxial Pharmaceuticals Pty Ltd (‘Triaxial’). Triaxial developed a novel technology platform allowing the design and construction of a novel family of compounds that Triaxial refers to as super-benzopyrans. The Company acquired the outstanding shares of Triaxial Pharmaceuticals Pty Ltd, including those of its shareholders Dr Graham Kelly, Dr Andrew Heaton and Robert Birch, who became directors of Novogen as a result of this transaction. 15.4 million Novogen shares were issued at a fair value of $0.09 per share as part of the acquisition, the purchase price of which included a $1.5 million loan, payable to the Triaxial shareholders.

On December 4, 2014, the company and the convertible note holders, former shareholders of Triaxial, signed an amendment to the Convertible Note Deed Poll (‘Deed’) which superseded the precedent Loan Agreement between Triaxial shareholders and the Company.The amendment to the Deed extinguishes the liability created by the Loan Agreement, which was carried over to the original version of the Deed.

The amendment allowed the Company to convert the liability attached to the transaction into ordinary shares instead by removing the clauses allowing redemption in cash. The conditions of conversion into ordinary shares regarding the convertible notes are still dependent of the achievement of defined milestones established in the schedule of the Deed. Accordingly the convertible notes have been reclassified as an equity instrument rather than debt instrument.

 

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CanTx Inc.

On November 4, 2013, the Company entered into a joint venture arrangement with Yale University (‘Yale’) and Prof Gil Mor. Novogen owns 85% of CanTx and Prof Gil Mor and Yale own respectively 7.5%. The purpose of the joint venture company, CanTx Inc., (‘CanTx’) was to pool the resources of both parties in order to develop drugs for the treatment of ovarian cancer. A series of agreements underpin this joint venture. The first of those is a licensing agreement from the Company to CanTx that allows CanTx to access the Company patent portfolio of super-benzopyrans drugs in order to identify a lead candidate compound for its objective of developing an intra-abdominal product capable of treating any intra-abdominal cancer, but with a particular focus on ovarian cancer. A corporate sponsored research agreement between Yale and CanTx gave CanTx access to certain Yale cell culture technology and animal models and facilities and resources. This agreement between CanTx and Yale identified the appropriate research plan to be undertaken by Yale, and a shareholders’ agreement between all parties comprised a commitment from the Company to fund CanTx for up to three years for up to a maximum of $2 million. Yale and CanTx devised a construct comprising Trx-1 in a guided drug delivery system and commenced animal studies to investigate its utility both as an intra-peritoneal and intravenous product for the treatment of ovarian cancer.

Other

On October 8, 2013, the Company announced the acquisition of the anti-tropomyosin technology from Genscreen Pty Ltd.

On May 2, 2014, the Company announced a partnership with Genea Biocells Pty Ltd to investigate promising new approaches using the super-benzopyrans technology to treat neurodegenerative and musculodegenerative diseases.

On May 5, 2014, the Company joined CODA (the Children’s Oncology Drug Alliance) to facilitate the development of treatments for childhood cancers, using both the super-benzopyran and anti-tropomyosin drug technology platforms.

On May 27, 2014, the Company announced that it had a key milestone with its SBP drug program, having identified a number of SBP compounds with potent anti-cancer activity against human prostate cancer cells in vitro.

On June 17 2014, the Company announced the success of proof-of-concept pre-clinical studies confirming the potency of experimental drug TRX-1, in the treatment of primary of ovarian cancer when delivered into the peritoneal cavity.

On October 1, 2014, the Company announced that it had received guidance from the US Food and Drug Administration (FDA) on the process to bring the experimental drug product, Cantrixil, into the clinic in the US for the treatment of late-stage ovarian cancer.

On October 22, 2014, the Company announced results of two completed studies of one of its lead candidate compounds, TRX-E-009-1, confirming its ability to kill paediatric brain cancer cells – diffuse intrinsic pontine glioma (DIPG) and paediatric neuroblastoma cells – and clearing the way for the compound to come into the clinic as a potential treatment of childhood cancers.

On November 21, 2014 the Company announced that it had identified its lead anti-tropomyosin (ATM) drug candidate.

On December 16, 2014, the Company announced that it had confirmed that its lead candidate product, TRXE-009, originally developed for the treatment of brain cancers, had shown in pre-clinical studies to be highly active against melanoma.

On January 16, 2015, the Company announced an important discovery in its regenerative medicine program that had delivered a key proof-of-concept step forward in the quest to develop drugs capable of stimulating the function of brain tissue stem cells.

 

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On February 11, 2015, the Company announced the lodgement of final specifications of a patent that covers the Company’s first family of super-benzopyran compounds, which yielded leading drug candidates, TRXE-002, TRXE-009 and TRXE-0025.

On March 4, 2015, the Company announced that it had confirmed that one of its lead candidate products, TRXE-009, was showing the potential to become an important new therapy in the fight against adult and paediatric brain cancer.

On April 9, 2015, the Company announced that studies conducted at The University of Queensland Diamantina Institute revealed that Anisina killed melanoma cells irrespective of their mutational status.

On April 17, 2015, the Company announced that it had signed a Memorandum of Understanding with the Feinstein Institute for Medical Research of New York to collaborate with the objective of developing effective treatments for brain cancers.

On April 22, 2015, the Company announced that it had received notification from the U.S. Food and Drug Administration (FDA) that its chemotherapy candidate drug, Cantrixil, had been granted Orphan Drug Designation for ovarian cancer.

On May 8, 2015, the Company announced that TRXE-009 confirmed its potential to become an important new therapy against an incurable paediatric brain cancer, DIPG (diffuse intrinsic pontine glioma).

On May 15, 2015, the Company announced that it had confirmed that its drug candidate, Anisina, was an effective monotherapy against human melanoma in an animal model.

On May 28, 2015, the Company announced the lodgement with the US Patent Office of a key patent covering a novel family of compounds within the Company’s anti-tropomyosin (ATM) drug technology platform.

On June 5, 2015, the Company announced that a lipid formulation of TRXE-009 dosed intravenously to animals was able to deliver therapeutic concentrations of TRXE-009 to brain tissue, confirming that the drug was able to cross the blood brain barrier.

On June 24, 2015, the Company announced that its candidate cytotoxic chemotherapy drug, Anisina, has proved an effective anti-cancer agent in animals, the result of which it now has been fast-tracked by the Company to come into the clinic

On July 14, 2015, the Company announced details of an in vivo proof of concept study that demonstrates their lead anti-tropomyosin drug candidate, Anisina, has the potential to improve the effectiveness of chemotherapy in children and reduce life-long side-effects.

On July 22, 2015 the Company announced the resignation of CEO and the appointment of new Director and Acting CEO.

On July, 30, 2015, the Company confirmed its commitment to progressing its ground-breaking technology platforms to Phase 1 clinical trials as soon as practicable.

On October 21, 2015, the Company disclosed key pre-clinical data generated in an animal model of recurrent ovarian cancer suggesting that the experimental anti-cancer drug, Cantrixil, may have utility as an adjuvant therapy when dosed in combination with platinum-based drugs.

Capital raising

In June 2014, the Board adopted a strategy intended to provide the Company with sufficient funding for the foreseeable future and to sustain the Company as a going concern. The strategy was to raise capital in several tranches through the placement of new securities to underwrite Company plans for an active R&D program, with the goal of bringing at least two and possibly a third new drug into clinical testing by the end of 2015.

 

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During the financial year the Company raised cash amounting to approximately A$50,356,000 and issued 254,558,631 ordinary shares.

See Item 5 – Operating and Financial Review and Prospects – Fundraising campaigns.

Research and development

The Company has two drug technology platforms – Superbenzopyran (SBP) and Anti-tropomyosin (ATM) – around which the Company has established very strong patent positions, and made considerable advances over the last 12 months. The medicinal chemistry programs have identified two promising drug candidates, one from each platform (Cantrixil and Anisina), which the Company is progressing down the translational development path in concert.

The proprietary SBP technology was incorporated into Novogen after its acquisition of Triaxial Pharmaceuticals Pty Ltd in December 2012. Cantrixil, the Company’s first lead SBP drug candidate is being developed by its partially owned subsidiary CanTx (a joint venture between Yale University and Novogen). The planned route of administration for the Cantrixil drug-candidate is via injection into the peritoneal cavity. Pre-clinical studies have confirmed that Cantrixil induces cell death in both differentiated cancer cells and tumour initiating cells, those cells thought to be primarily responsible for cancer recurrence post chemotherapy. At a pre-IND meeting with the US Food and Drug Administration (FDA), the FDA agreed with our strategy on manufacturing and toxicology evaluation. Subsequent to this meeting, the Company has been able to produce both the active drug substance and drug product to a quality that conforms to Good Laboratory Practice (GLP) standards. Critically the drug has shown an excellent stability profile and all manufacturing processes have proven robust and scalable. The Company has commenced a safety evaluation program of the Cantrixil drug candidate with the aim of gaining Investigational New Drug (IND) status with the Food and Drug Administrations (FDA). This evaluation will characterize the toxicology signals associated with the experimental drug and correlate any toxicities with drug concentrations achieved in mammalian models. Results to date indicate that the drug is associated with gastrointestinal toxicity manifest as diarrhoea and some haematological toxicity (anaemia) and potential cardiovascular signals in in vitro studies. The Company anticipates completing the Cantrixil toxicology evaluation by the end of 2015. This information will enable regulators, such as the FDA and clinical investigators to assess the drug’s safety, ascribe a starting dose in humans, and establish AE/SAE monitoring criteria in humans.

The Company has assembled a Medical Study Committee for Cantrixil and commenced writing the Phase I clinical trial protocol where it will assess the safety and tolerability of Cantrixil in late stage cancer patients. The Company is also planning to conduct a second trial in women with late-stage ovarian cancer who have become unresponsive to standard of care therapy once it has received IND status for Cantrixil from the FDA. The FDA recently granted Cantrixil Orphan drug status for ovarian cancer. Progress and timing of these clinical studies will depend upon the outcome of the toxicology program and therefore it is not possible at this stage to be precise as to when clinical studies will commence. However the Company continues to aim to start the trials in 2016.

Pre-clinical studies have demonstrated that Anisina, a first-in-class ATM small molecule drug candidate, is able to target a protein component of the actin microfilaments, tropomyosin Tpm3.1, which is essential for tumor cell survival. In vitro studies confirm that inhibition of Tpm3.1 function impacts the structural integrity of the cancer cells cytoskeleton causing the cancer cell to die. In addition to having anti-cancer properties, these ATM compounds are also novel in that when administered to tumour-bearing nude mice and used in combination they enhance the anti-proliferative effect of one of the most widely used classes of chemotherapy drugs in cancer – the anti-microtubules. Preclinical studies are underway to validate the effectiveness of Anisina in animal models of adult and pediatric cancers both on its own and in combination with standard of care microtubule inhibitors. Importantly, a proof of concept study done in an animal cancer model as part of the Children’s Oncology Drug Alliance (CODA) has confirmed that Anisina is not only effective on its own in reducing neuroblastoma tumor growth but also enhances the sensitivity of cancer cells to microtubule targeting compounds. The Company has successfully optimized the Anisina manufacturing process using a process that is scalable, and meets GLP standards. The Company has identified the drug product to be used in the clinic, which enabled the initiation of an Anisina toxicology program with a view to filing an IND with the FDA. The Company has assembled a Medical Advisory Board for Anisina and, based on its pharmacology package, anticipates initially taking Anisina through to the clinic, pending successful completion if the safety assessment, as an IV delivered drug in combination with taxanes or vinca alkaloids. Further studies are ongoing to identify the adult cancer indication for Anisina. The FDA recently granted Anisina Orphan drug status for neuroblastoma. Pending the outcome of the Anisina toxicology program and discussions with the FDA, the first-in-human studies are predicted to start in 2016.

 

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Trilexium (TRXE-009), the Company’s second lead SBP drug candidate, is behind the development timeline of Anisina and Cantrixil. Pre-clinical studies have shown that Trilexium induces cell death in a panel of cancer cells via caspase-mediated apoptosis. Researchers have also demonstrated tumor growth inhibition in several other animal models of cancer. Further pre-clinical studies are current to identify the optimal formulation and target indication. Once the optimal drug product has been identified, the Company will commence the requisite toxicology program prior to the conduct of a first-in-human trial in 2016/2017.

Jacob Hope research consists of three discovery programs: Regenerative Medicine Program, Facioscapulohumeral muscular dystrophy (FSHD) program and Lysosomal Storage Disorder (LSD). Given the data achieved to date in the Regenerative Medicine and FSHD programs, the Company intends to pursue patent protection around the discrete SBP pharmacophores that are attributable to either potentiating neurogenesis in the Regenerative Medicine Program, or normalizing the myotube phenotype in the FSHD program. The Company will also endeavour to protect any SBP pharmacophore that is active in the LSD setting. This patent protection strategy will increase the intrinsic value of each program and establish a priority date from an intellectual property perspective thereby enabling the Company to re-visit each program that has promise when funds and time permits.

Patent Protection

The company has an aggressive global Intellectual Property (IP) strategy to protect its key assets. The principle mode of protection is through the patenting procedure, seeking to obtain exclusive licences for all its key inventions and drug pipeline. The company’s IP is centred around two key technology platforms; the super benzopyrans (SBP’s) and the anti tropomyosins (ATM’s). Each of these technology platforms is delivering hit and lead drug candidates; as part of the companies drug discovery/development pipeline. As the research programs reveal new discoveries these are protected through lodging patents. The company has partnered with the global patent law firm, K & L Gates, to lodge patents that offer the best possible protection of our IP assets. The patent philosophy is to protect the three key cornerstones of the invention of a drug: composition of matter (the drug itself), method of manufacture (capturing new manufacturing methods) and method of use (covering the use of the drug to treat certain diseases). Patents are submitted initially as provisional applications and after 12 months progress through to a Patent Cooperation Treaty (‘PCT’) application. The company has been successful in lodging several provisional applications covering the SBP technology platform, one of which has progressed through to PCT status and has been accepted in Australia. This patent covers the key SBP assets of Cantrixil and Trilexium and is expected to be fully granted in Australia in Feb 2016. The ATM technology platform has also been the subject of significant IP protection, with several of the key ATM provisional patent applications having moved to PCT. The key PCT covering the lead ATM Anisina being granted “pending-acceptance” status in Australia with this patent expected to be fully granted in May 2016. The Company pursues a broad patent filing strategy based on multiple jurisdictions with particular attention paid to those member countries offering the most significant market opportunities for its future products.

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.

 

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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.

 

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Regulatory requirements

Australian Regulatory Requirements

The Therapeutic Goods Act 1989 (‘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 (‘ARTG’), unless specifically exempted under the Act.

Medicines with a higher level of risk (prescription medicines, some non-prescription medicines) are evaluated for quality, safety and efficacy and are registered on the ARTG. Medicines with a lower risk (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 (for listed medicines) which 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 (‘TGA’). The application usually consists of a form accompanied by data (based on the EU 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 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 two months to examine the applications referred by the TGA and its resolutions are provided to the sponsoring company after five 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 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.

 

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U.S. Regulatory Requirements

The FDA regulates and imposes substantial requirements upon the research, development, pre-clinical and clinical testing, labelling, 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 (‘FDCA’), and other laws in the case of biologics, the Public Health Service Act and other acts that implement regulations. The Company believes that the FDA will regulate its products as drugs. 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 IND Application, 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 (‘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 (‘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 (‘NDA’) Application; 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 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 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, which are:

 

   

Phase I: The drug is initially introduced into healthy human subjects or patients and tested for safety and dosage tolerance. For oncology medicines, patients with the target disease are used rather than healthy patients. Absorption, metabolism, distribution, and excretion testing, among other tests, are generally performed at this stage. These studies may also provide early evidence of effectiveness. The maximum tolerated dose of the drug may be calculated from Phase I studies;

 

   

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; and

 

   

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.

 

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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 GMP 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 the FDA on a timely basis, if at all will approve any NDA it submits. 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.

A user fee, pursuant to the requirements of the Prescription Drug User Fee Act (‘PDUFA’), and its amendments, must accompany each NDA. According to the FDA’s fee schedule, effective on October 1, 2015, for the fiscal year 2016, the user fee for an application requiring clinical data, such as an NDA, is US$2,374,200. The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also imposes an annual product fee for prescription drugs and biologics (US$114,450), and an annual establishment fee (US$585,200) 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 GMPs, and the FDA periodically inspects facilities to assess GMP 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 non-compliance could have a material adverse impact on its business prospects.

 

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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 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. EU 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 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 the Company.

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 (‘BPCA’), signed into law on January 4, 2002, was reauthorized and amended by the FDA Amendments Act of 2007 (‘FDAAA’). The reauthorization of BPCA provides an additional six months of exclusivity to NDA applicants that conduct and file acceptable paediatric studies of new and currently marketed drug products for which paediatric information would be beneficial, as identified by FDA in a Paediatric Written Request. The Paediatric Research Equity Act (‘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 paediatric assessment (unless waived or deferred) to ensure the drugs’ and biologics’ safety and effectiveness in children. Such paediatric assessment must contain data, gathered using appropriate formulations for each age group for which the assessment is required, that are adequate to assess the safety and effectiveness of the drug or the biological product for the claimed indications in all relevant paediatric subpopulations, and to support dosing and administration for each paediatric subpopulation for which the drug or the biological product is safe and effective. The paediatric assessments can only be deferred provided there is a timeline for the completion of such studies. The FDA may partially waive or fully waive the paediatric 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.

 

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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 that 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 not requiring authorization 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 the EU 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 the EU, 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 EU 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 that face the Company or its products in the EU.

 

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Stock market listing compliance

On November 7, 2014, NASDAQ notified the Company that it did not comply with Listing Rule 5550(b) (Rule), which requires a minimum $2,500,000 stockholders’ equity, $35,000,000 market value of listed securities, or $500,000 net income from continuing operations.

The Company submitted a plan to regain compliance on December 18, 2014 and January 19, 2015 (‘Submission’).

Following the Submission, NASDAQ granted on January 26, 2015 an extension to regain compliance with the Rule.

On April 28, 2015, NASDAQ advised the Company that it had regain full compliance with the Rule.

The Company has met the compliance requirements for ASX listings and accordingly has not been in breach of those requirements.

Organizational structure

Corporate structure

Novogen Limited is a public company limited by shares and is incorporated and domiciled in Australia. Novogen Limited and its controlled entities have prepared a consolidated financial report incorporating the entities that Novogen Limited controlled as at the end of fiscal year 2015, which included the following controlled entities:

 

          Equity holding     Acquired
Name   

Country of

incorporation

  

2015

%

   

2014

%

     

Novogen Laboratories Pty Ltd

  

Australia

     100.00     100.00  

Novogen Research Pty Ltd

  

Australia

     100.00     100.00  

Novogen North America Inc.

  

United States of America

     100.00     100.00  

Triaxial Pharmaceuticals Pty Ltd

  

Australia

     100.00     100.00  

December 5, 2012

Novogen Inc.

  

United States of America

     100.00     100.00  

CanTx. Inc.

  

United States of America

     85.00     85.00  

November 5, 2013

Property, plant and equipment

The Company leases moderate office space in Hornsby, New South Wales, Australia, which is used as its corporate headquarters. The Company has entered into two short term leases on this property which expires in May 2016. On renewal, the terms of the lease are renegotiated. To accommodate its constant growth, the consolidated entity has entered into a new lease, starting in November 2015.

 

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 on Form 20-F. 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 on Form 20-F.

 

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Application of critical accounting policies

We prepare our financial statements in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). As such, we are required to make certain estimates, judgments, and assumptions that management believes are reasonable based upon the information available. These estimates, judgments and assumptions affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the periods presented. The significant accounting policies are summarized in Item 18. “Financial Statements – Note 2 – Significant Accounting Policies”.

Income taxes

The group has not recognized deferred tax assets relating to carried forward tax losses and taxable temporary differences since the group is currently in a loss making position and unable to generate taxable income to utilize the carried forward tax losses and taxable temporary differences. The utilization of the tax losses also depends on the ability of the entity to satisfy certain tests at the time the losses are recouped. Significant judgment is required in determining the worldwide provision for income taxes. There are certain transactions and calculations undertaken during the ordinary course of business for which the ultimate tax determination is uncertain. The group estimates its tax liabilities based on the group’s understanding of the tax law. Where the final tax outcome of these matters is different from the amounts that were initially recorded, such differences will impact the current and deferred income tax assets and liabilities in the period in which such determination is made.

Share-based Payment Transactions

The consolidated entity measures the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at the date at which they are granted. The fair value is determined by using the Black-Scholes model taking into account the terms and conditions upon which the instruments were granted. The accounting estimates and assumptions relating to equity-settled share-based payments would have no impact on the carrying amounts of assets and liabilities within the next Annual Reporting period but may impact profit or loss and equity.

Research and Development

We have expensed all internal research and development expenditures incurred during the year as the costs relate to the initial expenditure for research and development of biopharmaceutical products and the generation of future economic benefits is not considered probable given the stage of development. It was considered appropriate to expense the research and development costs as they did not meet the criteria to be capitalized under IAS 38.

The R&D Tax Incentive is a government run program which helps to offset some of the costs of R&D. Annually, the consolidated entity claims a refundable tax offset and has disclosed this as other income in the statement of profit or loss and other comprehensive income. The group currently accounts for R&D Tax Incentive on a cash basis due to the difficulty of making reasonable estimation as at year end.

Impairment of Assets

We assess impairment of non-financial assets at each reporting date by evaluating conditions specific to the consolidated entity and parent entity and to the particular asset that may lead to impairment. If an impairment trigger exists, the recoverable amount of the asset is determined. This involves fair value less costs to sell or value- in-use calculations, which incorporate a number of key estimates and assumptions.

 

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For additional information on significant accounting policies refer to Item 18. “Financial Statements – Note 2 – Significant Accounting Policies”.

Discontinued operations

On November 27, 2012, the Company disposed of the operations of MEI Pharma, Inc. (‘MEI’) and its subsidiary MEI Pharma Pty Limited in which it held majority ownership, via an in-specie distribution to its shareholders. MEI held the intellectual property originally developed by Novogen in the field of isoflavonoid drugs. The net gain on disposal was A$5.0 million. This has been classified as a discontinued operation for the purpose of this report.

For additional information on discontinued operations refer to Item 18. “Financial Statements – Note 10 – Discontinued operations”.

 

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Results of operations

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

Statements of profit or loss and other comprehensive income

For the year ended 30 June 2015

 

     Consolidated  
     2015
A$‘000
     2014
A$‘000
     2013
A$‘000
     2015
US$‘000
 

Revenue from continuing operations

     89         87         1,112         69   

Other income

     2,753         342         618         2,121   

Expenses

           

Research and development expense*

     (5,935      (3,328      (1,357      (4,573

General and administrative expense*

     (3,843      (3,415      (1,749      (2,961

Net fair value loss on convertible note derivative

     (301      (540      —           (232

Finance costs

     (69      (715      (132      (53
  

 

 

    

 

 

    

 

 

    

 

 

 

Loss before income tax expense from continuing operations

     (7,306      (7,569      (1,508      (5,629

Income tax expense

     —           —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Loss after income tax expense from continuing operations

     (7,306      (7,569      (1,508      (5,629

Profit after income tax expense from discontinued operations

     —           —           723         —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Loss after income tax expense for the year

     (7,306      (7,569      (785      (5,629

Other comprehensive income

           

Items that may be reclassified subsequently to profit or loss

           

Loss on the revaluation of available-for-sale financial assets, net of tax

     (32      (11      —           (24

Net exchange difference on translation of financial statements of foreign controlled entities, net of tax

     (376      29         3,968         (290
  

 

 

    

 

 

    

 

 

    

 

 

 

Other comprehensive income for the year, net of tax

     (408      18         3,968         (314
  

 

 

    

 

 

    

 

 

    

 

 

 

Total comprehensive income for the year

     (7,714      (7,551      3,183         (5,943
  

 

 

    

 

 

    

 

 

    

 

 

 

 

* Restatement of comparatives

Comparative information in the profit and loss statement has been restated to correct an immaterial error in classification of expenses. The profit and loss for Fiscal 2014 and Fiscal 2013, included salary and related general expenses of scientists totalling A$853,000 and A$1,101,000 respectively in general and administrative expenses. These expenses have been reclassified from general and administrative expenses to research and development expenses. The restatement is to reflect the nature of the expense in a more accurate manner. A third balance sheet has not been presented as the reclassification is immaterial and has no impact on the financial results for the year ended June 30, 2014, and June 30, 2013, or the closing financial position at that date.

 

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Operating results – Fiscal 2015 compared to Fiscal 2014

Revenue

The consolidated entity’s revenue, which is solely interest income derived from interest bearing bank account, has increased marginally from A$87,000 in 2014 to A$89,000 in 2015.

Net loss

The consolidated entity incurred a loss after income tax of $7,306,000 (2014: $7,569,000), was in a net current asset position of $42,871,000 (2014: net current liability position of $609,000) and had net cash outflows from operating activities of $5,760,000 (2014: $5,709,000) for fiscal 2015.

Research and development expenses from continuing operations for fiscal 2015 was A$5,935,000 representing an increase of A$2,607,000 in comparison with fiscal 2014. This increase is due to ongoing implementation of research and development programs, in line with our Corporate Developments as noted on page 11.

General and administrative costs from continuing operations for fiscal 2015 amounted to A$3,844,000 representing an increase of A$428,000 in comparison with fiscal 2014. This increase is due to increased overheads with employment of more staff as a result of the significant growth of the Company’s operations.

Finance costs from continuing operations were A$370,000 representing a decrease of A$885,000 in comparison with fiscal 2014. This decrease is due to the repayment of borrowings during the year as a result of the additional funds raised through the issue of equity securities.

Operating results – Fiscal 2014 compared to Fiscal 2013

Revenue

The consolidated entity’s revenue declined from A$1,112,000 in 2013 to $87,000 in 2014, due to change of operations.

Revenue from royalties in 2013 ceased following the changes in operations in 2012.

Net loss

The consolidated entity incurred a loss after income tax of A$7,569,000 (2013: A$785,000), was in a net current liability position of A$609,000 (2013: net asset position of A$1,439,000) and had net cash outflows from operating activities of A$5,709,000 (2013: A$8,795,000) for fiscal 2014.

Research and development expenses from continuing operations for fiscal 2014 was A$3,328,000 representing an increase of A$1,971,000 in comparison with Fiscal 2013. This increase is due to ongoing implementation of research and development programs.

General and administrative costs from continuing operations for fiscal 2014 amounted to A$3,415,000 representing an increase of A$1,666,000 in comparison with Fiscal 2013. This increase is due to amortisation of intellectual property and employment related expenses.

Finance costs from continuing operations were A$1,255,000 representing an increase of A$1,123,000 in comparison with fiscal 2013 due to costs associated with the Hudson Bay Master Fund Convertible Note transaction.

 

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Liquidity and capital resources

Cash resources

At June 30, 2015, the consolidated entity had total funds of A$44,371,000 compared to A$2,502,000 as at June 30, 2014.

During fiscal 2015, the consolidated entity had net cash outflows from operating activities of A$5,760,000 compared to cash outflows of A$5,709,000 in fiscal 2014.

The consolidated entity invests its cash and cash equivalents in interest bearing facilities with various maturity dates. At the end of fiscal 2015, term deposits amounting to A$15,000 had a weighted average interest rate of 2.4% and cash deposits of A$44,356,000 had a weighted average interest rate of 0.86%.

At June 30, 2015, the consolidated entity did not hold any derivative financial instruments for managing its foreign currency; however, the consolidated entity may from time to time enter into hedging arrangements where circumstances are deemed appropriate.

The Company believes that its future ability to fund its operations will be dependent on deriving sufficient cash from investors through successful capital raising and return from government grants as part of the Research and Development Tax Incentive Program available in Australia. The R&D Tax Incentive is an Australian government run program which helps to offset some of the costs of R&D. Annually, the consolidated entity claims a refundable tax offset and has disclosed this as other income in the statement of profit or loss and other comprehensive income. The group currently accounts for R&D Tax Incentive on a cash basis due to the difficulty of making reasonable estimation as at year end.

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

The Company continuously pursues opportunity for non-dilutive funding, such as grant applications.

The Company cannot provide assurance that it or its 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.

Fundraising campaigns

On April 24, 2013, the Company raised A$2,400,000 through the issue of 14,425,150 ordinary shares at a price of 16.5 cents per share.

On May 28, 2013, the Company raised A$790,000 through the issue of 4,645,207 ordinary shares at a price of 17.0 cents as part of a Share Purchase Plan.

On July 3, 2013 the Company entered into a Convertible Securities Agreement with HBMF pursuant to which HBMF agreed to invest, at the Company’s option, up to an aggregate amount of A$5,000,000 in return for the Company issuing HBMF up to five convertible securities having an aggregate face value of up to A$5,500,000 (the “Convertible Securities Agreement”). The Convertible Securities Agreement was amended on November 15, 2013 to among other things increase the total amount which HBMF agreed to invest to A$8,000,000. Under the Convertible Securities Agreement, the Company also issued to HBMF an option to purchase 4,000,000 ordinary shares (the “2013 HBMF Option”), at an option exercise price of A$0.237 per ordinary share and having an expiration date of July 4, 2016. On July 4, 2013, the Company also issued 822,369 ordinary shares to HBMF in satisfaction of our obligation to pay a commencement fee under the Convertible Securities Agreement. Between July 3, 2013 and February 10, 2015, we issued four convertible promissory notes to HBMF having an aggregate face value of A$6,050,000. HBMF or its nominees have converted all of these convertible promissory notes and were issued a further 47,173,141 ordinary shares. On January 16, 2015, we terminated the Convertible Securities Agreement, therefore no further Notes will be issued under the Convertible Securities Agreement.

 

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ASX Bookbuild – November 12, 2014

On November 12, 2014, the consolidated entity conducted a capital raising with sophisticated investors in Australia and some qualified U.S. investors, which gave the opportunity to these investors to purchase ordinary shares at A$0.11 per share and included an option for no consideration, exercisable at A$0.125 per share. The consolidated entity issued 16,859,988 ordinary shares and 16,859,988 unlisted options. The gross proceeds of the placement was approximately A$1,855,000.

At June 30, 2015, the consolidated entity received approximately A$1,406,000 from the proceeds of the exercise of options issued as part of the capital raise.

Private Equity Placement – December 16 & 18, 2014

On December 16 and 18, 2014, the consolidated entity issued 46,900,800 ordinary shares at a purchase price of A$0.125. Following shareholders’ approval received on March 4, 2015, the consolidated entity issued 50,652,864 options with an exercise price of A$0.15 per option exercisable by December 16 & 18, 2019, to U.S. based private investment funds (‘December PIPE’). As consideration for the issue of securities, the consolidated entity received gross proceeds of approximately A$5,850,000.

At June 30, 2015, the consolidated entity received approximately A$6,800,000 from the proceeds of the exercise of options issued as part of the December PIPE.

Private Equity Placement – April 27, 2015

On April 27, 2015, the consolidated entity issued 51,750,000 ordinary shares at a purchase price of A$0.30 and, following shareholders’ approval received on June 24, 2015:

 

 

51,750,000 options, exercisable at A$0.30 by December 30, 2015; and

 

 

25,875,000 options, exercisable at A$0.40 by June 30, 2020;

to U.S. based private investments funds (‘April PIPE’).

As consideration for the issue of securities, the consolidated entity received gross proceeds of A$15,525,000.

Rights Issue – June 4, 2015

On June 4, 2015, the consolidated entity issued 58,971,151 ordinary shares at a purchase price of A$0.30 and:

 

 

58,971,151 options, exercisable at A$0.30 by December 4, 2015; and

 

 

29,485,999 options, exercisable at A$0.40 by June 4, 2020;

to Australian and qualified U.S. shareholders as part of the rights entitlement offer announced on April 21, 2015 (‘Rights Issue’).

The consolidated entity received gross proceeds of approximately A$17,691,000 from the Rights Issue. The consolidated entity released a prospectus in support of the Rights Issue.

See Item 18. “Financial Statements – Note 28 – Financial Instruments” for disclosures about financial risk management including interest rate risk, foreign currency risk and liquidity risk.

 

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Research and Development

Research and development policy

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

The Company spent A$5,935,000, A$3,328,000 and A$3,648,000 on research and development expenditure from both continuing and discontinued operations during fiscal 2015, 2014 and 2013 respectively. All of these costs have been recognised as an expense in the statement of profit or loss in the respective periods. The profit and loss for Fiscal 2014 and Fiscal 2013 included salary and related general expenses of scientists totalling $853,000 and A$1,101,000 respectively in general and administrative expenses. These expenses have been reclassified from general and administrative expenses to research and development expenses. Please refer to Note 4 for details.

It is not possible to reasonably estimate the cost and timing of project completion due to the uncertainty of the research and development projects being undertaken by the Company and the nature of the research being early phase and the product being pre-clinical. 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.

Trend information

The Company expects to consume cash and incur operating losses for the foreseeable future. The Company 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.

Off-balance sheet arrangements

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

Tabular disclosure of contractual obligations

The following table sets forth the Company’s contractual obligations for the periods as at June 30, 2015

 

     2015
A$‘000
     Thereafter
A$‘000
     Total
A$‘000
 

Operating Leases^

     87         —           87   
  

 

 

    

 

 

    

 

 

 
     87         —           87   
  

 

 

    

 

 

    

 

 

 

 

^ Operating lease commitments includes contracted amounts for leases of premises and plant and equipment under non-cancellable operating leases expiring within three years. On renewal, the terms of the leases are renegotiated. Leases for premises include an annual review for CPI increases.

 

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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:

 

Bryce Carmine    Non Executive Director (appointed on 3 June 2015)  
Steven Coffey    Non Executive Director  
John O’Connor    Non Executive Director  
Peter Gunning    Non Executive Director  
Ian Phillips    Interim Chairman (appointed on 3 June 2015)   Note 1
Iain Ross    Director and Acting CEO (resigned on 20 November 2014 and re appointed on 22 July 2015)   Note 2

Note 1 - Ian Phillips was appointed Interim Chairman on 1 July 2015

Note 2 - Iain Ross was re-appointed as Director and Acting CEO on 22 July 2015

Former directors who served during the financial year ended June 30, 2015:

 

Graham Kelly    Former Chairman and CEO (resigned on 22 July 2015)

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

Names, qualifications, experience and special responsibilities

 

Name:    Mr Bryce Carmine (appointed on 3 June 2015)
Title:    Non-Executive Director
Qualifications:    B.Sc., Biochemistry, Microbiology & Genetics
Experience and expertise:    Bryce Carmine spent 36 years working for Eli Lilly & Co. and retired as Executive Vice President for Eli Lilly & Co, and President, Lilly Bio-Medicines. Prior to this he lead the Global Pharmaceutical Sales and Marketing and was a member of the company’s Executive Committee. He previously held a series of product development portfolio leadership roles culminating when he was named President, Global Pharmaceutical Product Development, with responsibility for the entire late-phase pipeline development across all therapeutic areas for Eli Lilly. During his career with Lilly, Bryce held several country leadership positions including President Eli Lilly Japan, Managing Dir. Australia/NZ & General Manager of a JV for Lilly in Seoul, Korea.
Other current directorships:    None

Former directorships

(last 3 years):

   None
Special responsibilities:    Chair of Scientific Committee, member of Remuneration and Nomination Committee and member of Strategic Planning Committee and member of the Audit, Risk and Governance Committee
Name:    Mr Steven Coffey
Title:    Non-Executive Director
Qualifications:    B. Comm., CA
Experience and expertise:    Steven Coffey is a chartered accountant, having spent his career in public practice since graduating from University of New South Wales, Australia in 1983. He has been a partner in the chartered accounting firm Watkins Coffey Martin since 1993. He is a registered company auditor and audits a number of large private companies as well as a number of not-for-profit entities. Steven has previously served on the board of an Australian listed public company. He is currently a board member of private family foundation.
Other current directorships:    None

 

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Former directorships   
(last 3 years):    None
Special responsibilities:    Chairman of the Remuneration and Nomination Committee
Name:    Mr John O’Connor
Title:    Non-Executive Director
Qualifications:    BEc, MAICD
Experience and expertise:    John 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, U.S. 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. John has been a consultant to several biotech businesses, including Novogen Limited and MEI Pharma, Inc. assisting with fundraising.
Other current directorships:    None

Former directorships

(last 3 years):

   NuSep Holdings Limited (appointed October 10, 2011, resigned February 19, 2012)
Special responsibilities:    Deputy Chairman, Chair of the Audit, Risk and Governance Committee
Name:    Prof Peter Gunning
Title:    Non-Executive Director
Qualifications:    B.Sc (Hons), Ph.D
Experience and expertise:    Peter Gunning is the Head of the Oncology Research Unit in the School of Medical Sciences and Associate Dean (Research) in the Faculty of Medicine at the University of New South Wales, Australia. His research is focused on the development of new therapeutic strategies for the treatment of childhood cancer. These strategies target the skeleton of the cancer cell and build on the principles of cell architecture that Professor Gunning’s group has discovered over the last 20 years. Peter has published over 100 primary research articles and has recently edited the first book devoted to his field of research. Previous appointments have included leadership roles as Chair of the Division of Research at The Children’s Hospital at Westmead, Chair of the Westmead Research Hub Executive and Chair, Board of Bio-Link, a company established by the NSW Government to support commercialisation of biomedical intellectual property.
Other current directorships:    None

Former directorships

(last 3 years):

   None
Special responsibilities:    Member of the Audit, Risk and Governance Committee and member of the Scientific Committee
Name:    Mr Ian M. Phillips, MNZM (appointed 3 June 2015)
Title:    Non-Executive Director, Interim Chairman (appointed 1 July 2015)
Experience and expertise:    Ian has been involved with International Banking, global financial markets and Corporate Finance for over 30 years having worked in New York (20 years plus), London (5 years), Singapore (6 months), Sydney (5 years) and Wellington (4 years). Ian is the President of KUMARA, Chairman of NNP, Deputy Chairman of the American Australian Association, Immediate past President of the American Friends of the NGA, Chairman of ANZA, an Advisory Board of the US-NZ Council and a Board member of the American friends of Christchurch. Ian studied at Otago University, University of Colorado and London School of economics. He holds dual citizenship USA & NZ. In 2013, Ian was awarded the NZ Order of Merit.
Other current directorships:    None

 

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Former directorships

(last 3 years):

   None
Special responsibilities:    Chair of Strategic Planning Committee
Name:    Mr Iain Ross
Title:    Director, Acting CEO
Qualifications:    B.Sc. (Hons), C.Dir
Experience and expertise:    Based in the UK, Iain Ross is an experienced director on a number of Australian company boards. He is also currently Chairman of Ark Therapeutics Group Plc and a director of a number of other European based technology companies. In his career he has held senior positions at Coms Plc, Sandoz AG, Fisons Plc, Hoffmann-La Roche AG, and Celltech Group Plc and also undertaken a number of start-ups and turnarounds on behalf of banks and private equity groups. His track record includes multiple financing transactions having raised in excess of £300 million, both publicly and privately, as well as extensive experience of divestments and strategic restructurings and has many years in cross-border management as a Chairman and CEO. Iain has led and participated in four London Stock Exchange (‘LSE’) Initial Public Offerings, and has direct experience of mergers and acquisitions transactions in Europe, U.S. and the Pacific Rim.
Other current directorships:    Benitec Biopharma Limited, Anatara Lifesciences Limited and Premier Veterinary Group Plc (LSE)

Former directorships

(last 3 years):

   Tissue therapies Limited, Coms Plc and Ark Therapeutics Group Plc(LSE)
Special responsibilities:    Member of Strategic Planning Committee and member of Scientific Committee
Executive officers’ profiles   
Name:    Dr David Brown
Title:    Chief Scientific Officer
Qualifications:    B.Sc. (Hons) Ph.D
Experience and expertise:    David Brown was in charge of preclinical testing for Novogen’s oncology drugs between 2000 and 2010. In his new role, he oversees the entire portfolio of Research and Development programs and is responsible for developing evidence of the Company’s drug technology platforms.
Name:    Dr Andrew Heaton
Title:    CEO & President of Novogen North America
Qualifications:    B.Sc (Hons) Ph.D
Experience and expertise:    Andrew Heaton has an extensive drug discovery background. He was one of the founders and former CEO of Triaxial Pharmaceuticals Pty Ltd. Based in the U.S., he oversees the formulation, patent and manufacture of the Company’s drug technology platforms.
Name:    Mr Lionel Mateo
Title:    Company Secretary
Qualifications:    BCL, MCL
Experience and expertise:    Lionel Mateo was appointed Company Secretary on 8 October 2013. He has a Bachelor’s degree in Civil Law and a Master’s Degree in Civil Law, Economics and Business from the University of Aix-en-Provence, France. Prior to specialising in corporate governance, he worked in Criminal Law. He previously worked for R.M. Williams Agricultural Holdings Pty Ltd, initially as Corporate Governance Officer and then Company Secretary. Lionel completed the Graduate Diploma of Applied Corporate Governance with the Governance Institute of Australia in 2015.

 

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Name:    Ms Cristyn Humphreys
Title:    Chief Financial Officer (appointed on 1 January 2015)
Qualifications:    B.Bus (Acc), DIPPOL, FTI, CA
Experience and expertise:    Cristyn Humphreys has 20 years commercial experience working for private industries including heading up finance, marketing and strategy departments for businesses with a global presence. Cristyn’s commercial experience is broad including founding a registered charity in Australia and working in the NSW Police Service. She is a Chartered Accountant and a Fellow of the Tax Institute in Australia.

Directors’ and KMP interests in the shares and options of the company for fiscal 2015:

Shareholding

The number of shares in the consolidated entity held during the financial year by each Director and other members of Key Management Personnel of the consolidated entity, including their personally related parties, is set out below:

 

    

Balance at

the start of

the year

     Received
as part of
remuneration
     Additions     

Disposals/

other

    

Balance at

the end of

the year

 

Ordinary shares

              

G Kelly

     5,715,204         —           —           (109,837      5,605,367   

S Coffey

     89,236         —           732,224         —           821,460   

J O’Connor

     278,601         —           46,434         —           325,035   

C Humphreys

     —           —           141,666         —           141,666   

A Heaton

     6,662,136         —           —           (413,038      6,249,098   

D Brown

     3,497,795         —           —           —           3,497,795   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 
     16,242,972         —           920,324         (522,875      16,640,421   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

* Disposals/other may represent no longer being designated as a KMP, not necessarily a disposal of holding.

Option holding

The number of options over ordinary shares in the consolidated entity held during the financial year by each Director and other members of Key Management Personnel of the consolidated entity, including their personally related parties, is set out below:

 

    

Balance at

the start of

the year

     Granted      Exercised    

Expired/

forfeited/

other

    

Balance at

the end of

the year

 

Options over ordinary shares

             

G Kelly*

     —           354,318         —          —           354,318   

J O’Connor*

     —           69,652         —          —           69,652   

S Coffey*

     —           448,968         (272,727     —           176,241   

C Humphreys*

     —           62,954         —          —           62,954   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 
     —           935,892         (272,727     —           663,165   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

 

* The above listed options were not issued as part of remuneration.

 

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     Vested and
exercisable
     Vested and
unexercisable
     Balance at
the end of
the year
 

Options over ordinary shares

        

G Kelly*

     354,318         —           354,318   

J O’Connor*

     69,652         —           69,652   

S Coffey*

     176,241         —           176,241   

C Humphreys*

     62,954         —           62,954   
  

 

 

    

 

 

    

 

 

 
     663,165         —           663,165   
  

 

 

    

 

 

    

 

 

 

 

* The above listed options were not issued as part of remuneration.

Further disclosures regarding KMPs options

 

     Opening
Balance
    

Granted 18/11/14

Exercise price $0.125

Expire 18/11/15

    

Granted 4/6/15

Exercise price $0.3

Expire 4/12/15

    

Granted 4/6/15

Exercise price $0.4

Expire 4/6/20

     Closing
Balance
 

G Kelly

     —           181,818         115,000         57,500         354,318   

J O’Connor

     —           —           46,434         23,218         69,652   

S Coffey

     —           —           117,494         58,747         176,241   

C Humphreys

     —           45,455         11,666         5,833         62,954   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

TOTAL

                 663,165   

All options were issued as part of capital raises conducted during the financial year. No options were issued as part of remuneration or under any specific share option scheme.

Compensation

A. Principles used to determine the nature and amount of remuneration

Remuneration philosophy

Remuneration for directors and senior executives is based on the overall objective of attracting and retaining people of high quality who will make a worthwhile contribution to the Company. While reference to remuneration levels of other companies of similar size, market capitalisation and standing is taken into consideration, the current Board and its Remuneration Committee believe that at this stage of the Company’s development, the financial capacity of the Company is of overriding importance in determining remunerations.

The current Board and its Remuneration Committee is of the view that its limited funds are best directed at the Company’s R&D efforts, while still providing a reasonable level of remuneration to its executives and directors.

Non-executive directors’ 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 the Company was at the Annual General Meeting held on October 28, 2005 when the shareholders approved an aggregate remuneration of A$560,000.

Non-executive directors’ fees are reviewed periodically by the Board and in due course are expected to be brought into line with those of companies of comparable market capitalization and stage of development. The remuneration of non-executive directors consists of directors’ fees and committee chairperson fees. Non-executive director fees proposed for the year ending 30 June 2015, amounting to A$240,900 in aggregate. The non-executive directors fee structure is a fixed fee model (inclusive of superannuation).

 

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Executive directors and other key management personnel (‘KMP’) remuneration

KMP are defined as those persons having authority and responsibility for planning, directing and controlling the major activities of the group, directly or indirectly.

The Remuneration Committee in consultation with the executive directors and other senior executives have agreed to continue with their current levels of fixed remuneration that are based on salary alone, which have been in place since the restructuring of the Company on December 6, 2012. Fixed remuneration is base salary and superannuation. The Board determines an appropriate level of fixed remuneration for the CEO and Group Executives. Fixed remuneration is reviewed annually on anniversary start dates.

Company performance and link to remuneration

Remuneration is not directly linked to the performance of the Company.

Use of remuneration consultants

During fiscal 2015, the Company did not engage remuneration consultants.

B. Details of remuneration

Details of the remuneration of the directors and other KMP of the consolidated entity are set out in the following tables.

The KMP of the consolidated entity consisted of the following directors of Novogen Limited:

 

Dr Graham Kelly    Former Chairman and CEO (resigned on 22 July 2015)
Steven Coffey    Non-Executive Director
John O’Connor    Non-Executive Director
Prof Peter Gunning    Non-Executive Director
Iain Ross   

Non-Executive Director (resigned on 20 November 2014)

Director, Acting CEO (Re-appointed 22 July 2015)

Bryce Carmine    Non-Executive Director (appointed on 3 June 2015)
Ian Phillips    Interim Chairman (appointed on 3 June 2015)

And the following persons:

 

Lionel Mateo    Company Secretary
Dr Andrew Heaton    CEO and President of Novogen North America
Dr David Brown    Chief Scientific Officer
Christine Bruce    Financial Controller (ceased as KMP on 29 December 2014)
Cristyn Humphreys    Chief Financial Officer (appointed on January 1, 2015)

 

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     Short-term benefits     

Post-employment
benefits

Other

    

Long-term
benefits

Equity-

settled

     Share-based
payments
 
     Cash salary
and fees
     Cash
bonus
    

Movements in

accrued leave

    Super
annuation
          
                   Non-monetary                          Total  
2015    A$      A$      A$     A$      A$      A$      A$  

Non-Executive Directors:

                   

S Coffey

     55,000         —           —          5,225         —           —           60,225   

J O’Connor

     55,000         —           —          5,225         —           —           60,225   

Prof P Gunning

     55,000         —           —          5,225         —           —           60,225   

I Ross**

     26,750         —           —          —           —           —           26,750   

B Carmine*

     4,219         —           —          —           —           —           4,219   

I Phillips*

     4,219         —           —          —           —           —           4,219   

Executive Directors:

                   

Dr G Kelly

     351,700         —           25,686        35,000         —           —           412,386   

Other Key Management Personnel:

                   

L Mateo

     90,000         —           (1,385     8,550         —           —           97,165   

D Brown

     211,252         —           (2,092     18,783         —           —           227,943   

A Heaton***

     284,837         —           18,356        8,005         —           —           311,198   

C Humphreys*

     80,000         —           7,546        7,600         —           —           95,146   

C Bruce**

     64,836         —           (2,577     6,759         38,367         —           107,385   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 
     1,282,813         —           45,534        100,372         38,367         —           1,467,086   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

 

* Remuneration from the date of appointment as KMP
** Remuneration for the period to cessation as KMP
*** Salary paid in US dollars, but disclosed in Australian dollars using a conversion rate of .8382

 

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C. Employment agreements

It is the Remuneration Committee policy that employment contracts are entered into with each of the executives who are considered to be KMP. Under the terms of the contracts, remuneration is reviewed at least annually (or more often at the discretion of the Remuneration Committee). The employment contracts of KMPs include a termination clause whereby a party can terminate the agreement on notice. Such notice may vary between 4 weeks and 6 months. Under the terms of each contract, payment in lieu can be made by the consolidated entity to substitute the notice period. In the event of the consolidated entity terminating without cause, under the terms of some contracts, the amount payable on termination is equal to six months remuneration, in addition to any amount payable in lieu of notice. The consolidated entity may terminate the contracts at any time without cause if serious misconduct has occurred. In the event that employment is terminated for cause, no severance pay or other benefits are payable by the consolidated entity.

Remuneration in current employment contracts is salary only, with no additional benefits including cash bonuses or share options. However, the consolidated entity has undertaken a review of all contracts and will implement a revised version that includes, at the discretion of the board, share options and cash bonuses as incentives for its employees.

D. Employee share option plan

The consolidated entity established an Employee Share Option Plan (‘ESOP’) that was reinstated by the Board in March 2014 and was approved by shareholders on March 4, 2015. However, considering the tax implications for the issue of options to employees during the last financial year, the Directors decided to defer issuing any options to employees until the legislation is amended. The Plan provides for the issue of options to eligible employees of the consolidated entity or related company. The number and timing of options issued under the terms of the ESOP are entirely at the discretion of the Board.

Each option issued under the ESOP entitles its holder to acquire one fully paid ordinary share and is exercisable at a price based on a formula, which includes factors such as the weighted average price of such shares at the close of trading on the Australian Securities Exchange for the five days prior to the date of issue. The number of options offered, the amount payable, the vesting period, the option period, the conditions of exercise or any other factor are at the discretion of the Board of Directors.

No options have been issued under the ESOP to any employee since the new Board assumed control on December 7, 2012.

Any change to the ESOP will need to be approved by shareholders.

Remuneration options: granted and vested during the year

There were no options over ordinary shares issued to directors and other KMP as part of compensation that were outstanding as at June 30, 2015.

There were no options over ordinary shares granted to, or vested in, directors and other KMP as part of compensation during the year ended June 30, 2015.

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.

Remuneration options: expired during the year

During year ended June 30, 2015, no options granted by Novogen Limited under the ESOP lapsed.

Further detail on the remuneration, shares and options held by directors and other KMP are provided in Item 18. “Financial Statements – Note 31 – Key management personnel disclosures”.

 

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Pension benefits

The Company has paid A$147,000 during fiscal 2015 for employee superannuation benefits and pension benefits.

Board functions

The role of the Board is as follows:

 

   

representing and serving the interests of shareholders by overseeing and appraising the strategies, policies and performance of the Company. This includes overviewing the financial and human resources the Company has in place to meet its objectives and the review of management performance;

 

   

protecting and optimising Company performance and building sustainable value for shareholders in accordance with any duties and obligations imposed on the Board by law and the Company’s Constitution and within a framework of prudent and effective controls that enable risk to be assessed and managed;

 

   

responsible for the overall Corporate Governance of Novogen Limited and its controlled entities, including monitoring the strategic direction of the Company and those entities, formulating goals for management and monitoring the achievement of those goals;

 

   

setting, reviewing and ensuring compliance with the Company’s values (including the establishment and observance of high ethical standards); and

 

   

ensuring shareholders are kept informed of the Company’s performance and major developments affecting its state of affairs.

Responsibilities/functions of the Board include:

 

   

selecting, appointing and evaluating from time to time the performance of, determining the remuneration of, and planning for the successor of, the CEO;

 

   

reviewing procedures in place for appointment of senior management and monitoring of its performance, and for succession planning. This includes ratifying the appointment and the removal of the Chief Financial Officer and the Company Secretary;

 

   

overseeing the Company, including its control and accountability systems;

 

   

input into and final approval of management development of corporate strategy, including setting performance objectives and approving operating budgets;

 

   

reviewing and guiding systems of risk management and internal control and ethical and legal compliance. This includes reviewing procedures in place to identify the main risks associated with the Company’s businesses and the implementation of appropriate systems to manage these risks;

 

   

overseeing and monitoring compliance with the Code of Conduct and other corporate governance policies;

 

   

monitoring corporate performance and implementation of strategy and policy;

 

   

approving major capital expenditure, acquisitions and divestitures, and monitoring capital management;

 

   

monitoring and reviewing management processes in place aimed at ensuring the integrity of financial and other reporting;

 

   

monitoring and reviewing policies and processes in place relating to occupational health and safety, compliance with laws, and the maintenance of high ethical standards; and

 

   

performing such other functions as are prescribed by law or are assigned to the Board.

In carrying out its responsibilities and functions, the Board may delegate any of its powers to a Board committee, a director, employee or other person subject to ultimate responsibility of the directors under the Australian Corporations Act 2001 (Cth).

Matters which are specifically reserved for the Board or its committees include the following:

 

   

appointment of a Chair;

 

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appointment and removal of the CEO;

 

   

appointment of directors to fill a vacancy or as additional directors;

 

   

establishment of Board committees, their membership and delegated authorities;

 

   

approval of dividends;

 

   

development and review of corporate governance principles and policies;

 

   

approval of major capital expenditure, acquisitions and divestitures in excess of authority levels delegated to management;

 

   

calling of meetings of shareholders; and

 

   

any other specific matters nominated by the Board from time to time.

Structure of the Board

The Company’s Constitution governs the regulation of meetings and proceedings of the Board. The Board determines its size and composition, subject to the terms of the Constitution. The Board does not believe that it should establish a limit on tenure other than stipulated in the Company Constitution (refer to ‘Term of Directors’ below).

While tenure limits can help to ensure that there are fresh ideas and viewpoints available to the Board, they hold the disadvantage of losing the contribution of directors who have been able to develop, over a period of time, increasing insight in the Company and its operation and, therefore, an increasing contribution to the Board as a whole. It is intended that the Board should comprise a majority of independent non-executive directors and comprise directors with a broad range of skills, expertise and experience from a diverse range of backgrounds, including compliance with the Diversity Policy. The Board regularly reviews the independence of each director in light of the interests disclosed to the Board. Due to the current size of the Company, it is not practical for the chair to be an independent director.

The Board only considers directors to be independent where they are independent of management and free of any business or other relationship that could materially interfere with, or could reasonably be perceived to interfere with, the exercise of their unfettered and independent judgment. The Board has adopted a definition of independence based on that set out in Principle 2.3 of the ASX Corporate Governance Principles and Recommendations (3rd edition). The Board will review the independence of each director in light of interests disclosed to the Board from time to time. 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

John O’Connor

   Non-Executive Director

Prof Peter Gunning

   Non-Executive Director

Bryce Carmine

   Non-Executive Director

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

 

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The appointment date of each director in office at the date of this report is as follows:

 

Name

   Position   

Year first

appointed

  

Current term

expires

Ian Phillips

   Interim Chairman    2015    November 2015

Iain Ross

   Director, Acting CEO   

2014

(resigned November 22, 2014

Re-appointed July 22, 2015)

   N/A (managing director exempt from election under constitution and Australian corporation law)

Bryce Carmine

   Non-Executive Director    2015    November 2015

Steven Coffey

   Non-Executive Director    2012    November 2016

John O’Connor

   Non-Executive Director    2012    November 2017

Prof Peter Gunning

   Non-Executive Director    2014    November 2017
Former directors who served during the fiscal 2015:   

Graham Kelly

   Former Chairman and CEO    2012    Resigned July 22, 2015

Further details on each director can be found in “Names, qualifications, experience and special responsibilities” above.

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 three 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.

 

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Board of Directors

The Board 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, four of whom are non-executive directors.

Committees

The Board has established an Audit Committee, a Remuneration Committee and a Risk and Governance Committee.

Audit Committee

The Board has established an Audit Committee which operates under a Charter approved by the Board, which is available on the Company’s website. It is the Board’s responsibility to ensure that an effective internal control framework exists within the entity. 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 the benchmarking of operational key performance indicators. The Board has delegated responsibility for establishing and maintaining a framework of internal control and ethical standards to the Audit Committee.

The Committee also provides the Board with additional assurance regarding the reliability of financial information for inclusion in the financial reports.

The members of the Audit Committee during the fiscal year 2015 were:

 

   

John O’Connor (Non-Executive Director and Chair) who has a long history at senior levels in Finance and Securities businesses;

 

   

Steven Coffey (Non-Executive Director) who is a Chartered Accountant;

 

   

Iain Ross (Non-Executive Director) who is an experienced director on a number of Australian company boards (until November 22, 2014); and

 

   

Peter Gunning (Non-Executive Director) who is an eminent scientist (after November 22, 2014).

Performance

The performance of the Board and key executives is reviewed regularly using both measurable and qualitative indicators.

On an annual basis, directors will provide written feedback in relation to the performance of the Board and its Committees against a set of agreed criteria:

 

   

each Committee of the Board will also be required to provide feedback in terms of a review of its own performance;

 

   

feedback will be collected by the chair of the Board, or an external facilitator, and discussed by the Board, with consideration being given as to whether any steps should be taken to improve performance of the Board or its Committees;

 

   

the Chief Executive Officer will also provide feedback from senior management in connection with any issues that may be relevant in the context of Board performance review; and

 

   

where appropriate to facilitate the review process, assistance may be obtained from third party advisers.

Remuneration

It is the Company’s objective to provide maximum shareholder benefit from the retention of a high quality Board and executive team by remunerating directors and key executives fairly and appropriately with reference to relevant employment market conditions. To assist in achieving this objective, the Board, in assuming the responsibilities of assessing remuneration to employees, links the nature and amount of executive directors’ and officers’ remuneration to the Company and consolidated entity’s financial and operational performance.

 

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The expected outcomes of the remuneration structure are:

 

   

retention and motivation of key executives;

 

   

attraction of high quality management to the Company and consolidated entity; and

 

   

performance incentives that allow executives to share in the success of Novogen Limited.

For a more comprehensive explanation of the Company’s remuneration framework and the remuneration received by directors and key executives in the current period, please refer to the section “Compensation” above.

There is no scheme to provide retirement benefits to executive or non-executive directors, except for the Australian Government Superannuation Guarantee.

The Remuneration Committee is responsible for determining and reviewing compensation arrangements for the directors themselves and the Chief Executive Officer and executive team.

Employees

The consolidated entity employed 14 people at June 30, 2015, 12 people at June 30, 2014, and 5 people at June 30, 2013 as follows:

 

Category of Activity    Number of People  
     2015      2014      2013  

Research and Development

     7         6         3   

Finance and Administration

     7         6         2   
  

 

 

    

 

 

    

 

 

 

Total

     14         12         5   
  

 

 

    

 

 

    

 

 

 

 

Geographic Location    Number of People  
     2015      2014      2013  

Australia

     13         11         5   

North America

     1         1         0   
  

 

 

    

 

 

    

 

 

 

Total

     14         12         5   
  

 

 

    

 

 

    

 

 

 

Exemptions from Certain Corporate Governance Rules of the NASDAQ Stock Market, LLC (‘NASDAQ’)

Refer to Item 16G. “Corporate Governance” for NASDAQ exemptions available to the Company.

 

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Item 7. Major Shareholders and Related Party Transactions

Major Shareholders

There is currently no shareholder with a holding balance exceeding 5% of the total outstanding ordinary shares on issue.

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

At October 23, 2015 there were 7,071,721 of the Company’s ADRs outstanding, representing 176,793,025 ordinary shares (or 41.67% of the then outstanding ordinary shares). At October 23, 2015 there were 47 registered holders of the Company’s ADRs.

Previous significant shareholders, in the last three years, include:

Josiah T. Austin and El Coronado Holdings, LLC (beneficially owned by Mr. Austin) – held 12,269,033 ordinary shares (4,531,633 of which are directly owned Ordinary Shares with the remaining 7,737,400 represented by 309,496 Sponsored ADRs), representing 7.73% as of November 25, 2013.

Massachusetts Mutual Life Insurance Company Group held 9,867,292 ordinary shares, representing 6.91% of the ordinary shares at August 27, 2013.

Dr Andrew Heaton held 7,600,400 ordinary shares, representing 5.77% of the ordinary shares at October 28, 2013.

Related party transactions

The following transactions occurred with related parties during the year ended June 30, 2015:

 

     2015  
     A$‘000  

Payment for other expenses:

  

Accounting fees paid to Watkins Coffey Martin, an entity (partnership) in which Steven Coffey is a partner

     12   

Salary paid to Prue Kelly, the partner of Graham Kelly, a director

     77   

Salary paid to Michael Kelly, the brother of Graham Kelly, a director

     6   

Salary paid to Kathryn Stoddart, the daughter of Graham Kelly, a director

     4   

Other Transactions

Convertible note (Triaxial) carrying value of A$1,500,000

The convertible note has a face value of A$1,500,000, as per a Deed Poll agreement executed in November 2013, convertible in ordinary shares. The convertible note may be exercised at the holders discretion as follows:

 

On completion of Phase 1a clinical trials    A$400,000 converted into 16,000,000 ordinary shares in the Company
On receipt of Investigational New Drug approval from the FDA    A$500,000 converted into 20,000,000 ordinary shares in the Company
On completion of Phase II clinical trials    A$600,000 converted into 24,000,000 ordinary shares in the Company

 

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Convertible note (Hudson Bay)

The convertible note was issued to Hudson Bay in four tranches, as follows:

 

   

Tranche 1 face value of A$1,100,000, issued July 4, 2013

 

   

Tranche 2 face value of A$1,100,000, issued October 21, 2013

 

   

Tranche 3 face value of A$2,200,000, issued November, 15 2013

 

   

Tranche 4 face value of A$1,650,000, issued December, 24 2013

The notes were issued at a discount of 10% on face value and are repayable between 21 days and 24 months after the date of issue, provided that the amount converted in each tranche is no less than $25,000 and no more than 50% of the face value of the most recently issued note. The convertible notes do not bear interest and are unsecured. The conversion price for the convertible securities is either 90% of the average of 3 daily volume-weighted average price (‘VWAP’) per share, during the 20 consecutive trading days immediately prior to the relevant conversion notice day, or a limited number at 130% of the average of the daily VWAP per share for the 20 consecutive trading days immediately prior to execution of the agreement.

HBMF or its nominees have converted all of these convertible promissory notes and were issued a further 47,173,141 ordinary shares. On January 16, 2015, the Company terminated the Convertible Securities Agreement, therefore no further Notes will be issued under the Convertible Securities Agreement.

Total secured liabilities

There is no secured liabilities as at June 30, 2015.

 

Item 8. Financial Information

Consolidated financial statements are included in Item 18. “Financial Statements” on pages 66 through 108.

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.

The consolidated entity is continuing to prosecute its Intellectual Property (‘IP’) rights and in June 2007 announced that the Vienna Commercial Court had upheld a provisional injunction against an Austrian company, APOtrend. The consolidated entity has provided a guarantee to the value of €250,000 (A$364,000) with the court to confirm its commitment to the ongoing enforcement process. As at the June 30, 2015, the receivable balance has been fully impaired on the basis that it is unlikely to be recovered.

Dividends

The Directors of Novogen Limited do not recommend the payment of a dividend during fiscal 2015.

There were no dividends paid, recommended or declared during fiscal 2015 and 2014.

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

Events after the reporting date

Appointment of Interim Chairman

On July 1, 2015, the consolidated entity announced the appointment of Mr Ian M. Phillips, MNZM, as Interim Chairman of the Board of Directors.

 

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Resignation of CEO

On 22 July 2015, the consolidated entity announced the resignation of Dr Graham Kelly as CEO, as well as Director of all entities within the group.

Appointment of Director and Acting CEO

On 22 July 2015, the consolidated entity announced the appointment of Mr Iain Ross as Director and Acting Chief Executive Officer of the consolidated entity. The consolidated entity is actively seeking a permanent Chief Executive Officer globally and has engaged an agency specialised in the recruitment of high profile senior executives to assist it in its search.

Office move

To accommodate its constant growth, the consolidated entity has entered into a new lease, starting in November 2015. The current lease held by the consolidated entity expires on 14 May 2016.

No other matter or circumstance has arisen since 30 June 2015 that has significantly affected, or may significantly affect the consolidated entity’s operations, the results of those operations, or the consolidated entity’s state of affairs in future financial years.

 

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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 Australian Securities Exchange (‘ASX’). The trading symbol on ASX is ‘NRT’.

American Depositary Receipts (‘ADRs’)

Novogen’s ordinary shares trade in the U.S. in the form of ADRs on the NASDAQ Capital Market. Each ADR represents 25 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 Mellon 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.

Novogen Limited share price history

 

  A. ASX

Our ordinary shares are traded on the ASX. The following table sets forth, for the periods indicated, the high and low market quotations for our ordinary shares, as quoted on the ASX.

 

     Per Ordinary Share (A$)  
     High      Low  

Fiscal Year Ended June 30,

     

2011

     0.46         0.10   

2012

     0.25         0.08   

2013

     0.47         0.06   

2014

     0.40         0.15   

2015

     0.45         0.08   

Quarter Ended:

     

September 2013

     0.21         0.16   

December 2013

     0.40         0.17   

March 2014

     0.23         0.18   

June 2014

     0.18         0.15   

September 2014

     0.16         0.12   

December 2014

     0.16         0.08   

March 2015

     0.24         0.10   

June 2015

     0.45         0.20   

September 2015

     0.30         0.14   

Month Ended:

     

April 2015

     0.45         0.21   

May 2015

     0.38         0.27   

June 2015

     0.30         0.20   

July 2015

     0.30         0.20   

August 2015

     0.21         0.14   

September 2015

     0.17         0.14   

 

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  B. NASDAQ CAPITAL MARKET

The ADSs are traded on the NASDAQ Capital Market under the symbol “NVGN.” The following table sets forth, for the periods indicated, the high ask and low bid prices of the ADSs on the NASDAQ Capital Market:

 

     Per ADS (US$)*  
     High      Low  

Fiscal Year Ended June 30

     

2011

     14.85         2.05   

2012

     8.25         1.95   

2013

     10.49         0.76   

2014

     6.84         3.42   

2015

     9.50         2.50   

Quarter Ended:

     

September 2013

     5.18         3.50   

December 2013

     6.84         3.73   

March 2014

     5.70         3.85   

June 2014

     4.16         3.42   

September 2014

     3.62         2.74   

December 2014

     5.38         1.64   

March 2015

     4.33         2.09   

June 2015

     9.50         3.41   

September 2015

     5.35         2.32   

Month Ended:

     

April 2015

     9.50         4.05   

May 2015

     7.66         5.50   

June 2015

     5.70         3.85   

July 2015

     5.35         3.41   

August 2015

     3.50         2.50   

September 2015

     3.22         2.32   

 

* 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” for any material contracts.

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 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.

 

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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.

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.

Australian Income Taxation

Distributions

Under Australian law, non-residents of Australia may be subject to withholding tax of up to 30% in respect of dividends received on shares in Australian companies.

In accordance with the Treaty, dividends derived by a non-resident of Australia who is a resident of the U.S. for the purposes of Treaty (which may not include all U.S. Holders) may be taxed on those dividends in Australia, but such withholding tax is limited to 15% of the gross amount of dividends unless the dividend is derived by a non-resident of Australia who has or is deemed to have a permanent establishment in Australia. In this case, the non-resident may be taxed at the rate applicable to them. Some U.S. resident companies may be entitled to a withholding rate of 5% if they hold at least 10% of the voting power of the Australian company.

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

Under the conduit foreign income rules, the unfranked portion of a dividend paid to a non-resident of Australia is not subject to withholding tax to the extent that the amount is declared to be conduit foreign income i.e. 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).

 

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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 shares 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 Capital Gains Tax (‘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.

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.

 

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United States Taxation

United States Federal Income Taxation

As used below, a “U.S. holder” is a beneficial owner of an ADR that is, for U.S. federal income tax purposes, (i) a citizen or resident alien individual of the United States, (ii) a corporation (or an entity treated as a corporation) created or organized under the law of the United States, any State thereof or the District of Columbia, (iii) an estate the income of which is subject to U.S. federal income tax without regard to its source or (iv) a trust if (1) a court within the United States is able to exercise primary supervision over the administration of the trust, and one or more United States persons have the authority to control all substantial decisions of the trust, or (2) the trust has a valid election in effect under applicable U.S. Treasury Regulations to be treated as a United States person. For purposes of this discussion, a “non-U.S. holder” is a beneficial owner of an ADR that is (i) a non-resident alien individual, (ii) a corporation (or an entity treated as a corporation) created or organized in or under the law of a country other than the United States or a political subdivision thereof or (iii) an estate or trust that is not a U.S. Holder. If a partnership (including for this purpose any entity treated as a partnership for U.S. federal tax purposes) is a beneficial owner of an ADR, the U.S. federal tax treatment of a partner in the partnership generally will depend on the status of the partner and the activities of the partnership. A holder of an ADR that is a partnership and partners in that partnership should consult their own tax advisers regarding the U.S. federal income tax consequences of holding and disposing of ADRs. We have not sought a ruling from the Internal Revenue Service (“IRS”) or an opinion of counsel as to any U.S. federal income tax consequence described herein. The IRS may disagree with the description herein, and its determination may be upheld by a court.

GIVEN THE COMPLEXITY OF THE TAX LAWS AND BECAUSE THE TAX CONSEQUENCES TO ANY PARTICULAR INVESTOR MAY BE AFFECTED BY MATTERS NOT DISCUSSED HEREIN, PROSPECTIVE INVESTORS ARE URGED TO CONSULT THEIR OWN TAX ADVISORS WITH RESPECT TO THE SPECIFIC TAX CONSEQUENCES OF THE ACQUISITION, OWNERSHIP AND DISPOSITION OF ADRs, INCLUDING THE APPLICABILITY AND EFFECT OF STATE, LOCAL AND NON-U.S. TAX LAWS, AS WELL AS U.S. FEDERAL TAX LAWS.

Nature of ADRs for U.S. Federal Income Tax Purposes

In general, for U.S. federal income tax purposes, a holder of an ADR will be treated as the owner of the underlying shares. Accordingly, except as specifically noted below, the tax consequences discussed below with respect to ADRs will be the same as for shares in the Company, and exchanges of shares for ADRs, and ADRs for shares, generally will not be subject to U.S. federal income tax.

Taxation of Dividends

U.S. holders

In general, subject to the passive foreign investment company rules discussed below, a distribution on an ADR will constitute a dividend for U.S. federal income tax purposes to the extent that it is made from our current or accumulated earnings and profits as determined under U.S. federal income tax principles. If a distribution exceeds our current and accumulated earnings and profits, it is generally treated as a non-taxable reduction of basis to the extent of the U.S. holder’s tax basis in the ADR on which it is paid, and to the extent it exceeds that basis it will be treated as capital gain. For purposes of this discussion, the term “dividend” means a distribution that constitutes a dividend for U.S. federal income tax purposes. The Company has not maintained and does not plan to maintain calculations of earnings and profits under U.S. federal income tax principles. Accordingly, it is unlikely that U.S. Holders will be able to establish that a distribution by the Company is in excess of its current and accumulated earnings and profits (as computed under U.S. federal income tax principles). Therefore, a U.S. Holder should expect that a distribution by the Company will generally be treated as taxable in its entirety as a dividend to U.S. Holders for U.S. federal income tax purposes even though the distribution may be treated in whole or in part as a non-taxable distribution for Australian tax purposes.

The gross amount of any dividend on an ADR (which will include the amount of any Australian taxes withheld) generally will be subject to U.S. federal income tax as foreign source dividend income, and will not be eligible for the corporate dividends received deduction. The amount of a dividend paid in Australian dollars will be its value in U.S. dollars based on the prevailing spot market exchange rate in effect on the day the U.S. holder receives the dividend or, in the case of a dividend received in respect of an ADR, on the date the Depositary receives it, whether or not the dividend is converted into U.S. dollars. A U.S. holder will have a tax basis in any distributed Australian dollars equal to its U.S. dollar amount on the date of receipt, and any gain or loss realized on a subsequent conversion or other disposition of Australian dollars generally will be treated as U.S. source ordinary income or loss. If dividends paid in Australian dollars are converted into U.S. dollars on the date they are received by a U.S. holder, the U.S. holder generally should not be required to recognize foreign currency gain or loss in respect of the dividend income.

 

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Subject to certain exceptions for short-term and hedged positions, a dividend that a non-corporate holder receives on an ADR will be subject to a maximum federal income tax rate of 20% if the dividend is a “qualified dividend”. A dividend on an ADR will be a qualified dividend if (i) either (a) the ADRs are readily tradable on an established market in the United States or (b) we are eligible for the benefits of a comprehensive income tax treaty with the United States that the Secretary of the Treasury determines is satisfactory for purposes of these rules and that includes an exchange of information program, and (ii) we were not, in the year prior to the year the dividend was paid, and are not, in the year the dividend is paid, a passive foreign investment company (“PFIC”). The ADRs are listed on the NASDAQ Capital Market, which should qualify them as readily tradable on an established securities market in the United States. In any event, the Treaty satisfies the requirements of clause (i)(b), and we are a resident of Australia entitled to the benefits of the Treaty. However, based on our audited financial statements and relevant market and shareholder data, we believe we were a PFIC for U.S. federal income tax purposes for our taxable year ended June 30, 2015, respectively, and expect to be classified as a PFIC in the current taxable year. Given that the determination of PFIC status involves the application of complex tax rules, and that it is based on the nature of our income and assets from time to time, no assurances can be provided that we will or will not be considered a PFIC for any past or future taxable years. In addition, as described in the section below entitled “Passive Foreign Investment Company Rules,” if we were a PFIC in a year while a U.S. holder held an ADR, and if the U.S. holder has not made a qualified electing fund election effective for the first year the U.S. holder held the ADR, the ordinary share underlying the ADR remains an interest in a PFIC for all future years or until such an election is made. The IRS takes the position that such rule will apply for purposes of determining whether an ADR is an interest in a PFIC in the year a dividend is paid or in the prior year, even if we do not satisfy the tests to be a PFIC in either of those years. Even if dividends on the ADRs would otherwise be eligible for qualified dividend treatment, in order to qualify for the reduced qualified dividend tax rates, a non-corporate holder must hold the ordinary share on which a dividend is paid for more than 60 days during the 120-day period beginning 60 days before the ex-dividend date, disregarding for this purpose any period during which the non-corporate holder has an option to sell, is under a contractual obligation to sell or has made (and not closed) a short sale of substantially identical stock or securities, is the grantor of an option to buy substantially identical stock or securities or, pursuant to Treasury regulations, has diminished their risk of loss by holding one or more other positions with respect to substantially similar or related property. In addition, to qualify for the reduced qualified dividend tax rates, the non-corporate holder must not be obligated to make related payments with respect to positions in substantially similar or related property. Payments in lieu of dividends from short sales or other similar transactions will not qualify for the reduced qualified dividend tax rates.

A non-corporate holder that receives an extraordinary dividend eligible for the reduced qualified dividend rates must treat any loss on the sale of the stock as a long-term capital loss to the extent of the dividend. For purposes of determining the amount of a non-corporate holder’s deductible investment interest expense, a dividend is treated as investment income only if the non-corporate holder elects to treat the dividend as not eligible for the reduced qualified dividend tax rates. Special limitations on foreign tax credits with respect to dividends subject to the reduced qualified dividend tax rates apply to reflect the reduced rates of tax.

The U.S. Treasury has announced its intention to promulgate rules pursuant to which non-corporate holders of stock of non-U.S. corporations, and intermediaries through whom the stock is held, will be permitted to rely on certifications from issuers to establish that dividends are treated as qualified dividends. Because those procedures have not yet been issued, it is not clear whether we will be able to comply with them.

 

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Non-corporate holders of ordinary shares are urged to consult their own tax advisers regarding the availability of the reduced qualified dividend tax rates with respect to dividends received on the ADRs in the light of their own particular circumstances.

Any Australian withholding tax imposed on dividends received with respect to the ADRs will be treated as a foreign income tax eligible for credit against a U.S. holder’s U.S. federal income tax liability, subject to generally applicable limitations under U.S. federal income tax law. For purposes of computing those limitations separately under current law for specific categories of income, a dividend generally will constitute foreign source “passive category income” or, in the case of certain holders, “general category income.” A U.S. holder will be denied a foreign tax credit with respect to Australian income tax withheld from dividends received with respect to the ADRs to the extent the U.S. holder has not held the ADRs for at least 16 days of the 30-day period beginning on the date which is 15 days before the ex-dividend date or to the extent the U.S. holder is under an obligation to make related payments with respect to substantially similar or related property. Any days during which a U.S. holder has substantially diminished its risk of loss on the ADRs are not counted toward meeting the 16-day holding period required by the statute. The rules relating to the determination of the foreign tax credit are complex, and U.S. holders are urged to consult with their own tax advisers to determine whether and to what extent they will be entitled to foreign tax credits as well as with respect to the determination of the foreign tax credit limitation. Alternatively, any Australian withholding tax may be taken as a deduction against taxable income, provided the U.S. holder takes a deduction and not a credit for all foreign income taxes paid or accrued in the same taxable year. In general, special rules will apply to the calculation of foreign tax credits in respect of dividend income that is subject to preferential rates of U.S. federal income tax.

Non-U.S. holders

A dividend paid to a non-U.S. holder of an ADR will not be subject to U.S. federal income tax unless the dividend is effectively connected with the conduct of trade or business by the non-U.S. holder within the United States (and is attributable to a permanent establishment or fixed base the non-U.S. holder maintains in the United States if an applicable income tax treaty so requires as a condition for the non-U.S. holder to be subject to U.S. taxation on a net income basis on income from the ADR). A non-U.S. holder generally will be subject to tax on an effectively connected dividend in the same manner as a U.S. holder. A corporate non-U.S. holder under certain circumstances may also be subject to an additional “branch profits tax,” the rate of which may be reduced pursuant to an applicable income tax treaty.

Taxation of Capital Gains

U.S. holders

Subject to the passive foreign investment company rules discussed below, on a sale or other taxable disposition of an ADR, a U.S. holder will recognize capital gain or loss in an amount equal to the difference between the U.S. holder’s adjusted basis in the ADR and the amount realized on the sale or other disposition, each determined in U.S. dollars. Such capital gain or loss will be long-term capital gain or loss if at the time of the sale or other taxable disposition the ADR has been held for more than one year. In general, any adjusted net capital gain of an individual is subject to a maximum federal income tax rate of 20%. Capital gains recognized by corporate U.S. holders generally are subject to U.S. federal income tax at the same rate as ordinary income. The deductibility of capital losses is subject to limitations.

Any gain a U.S. holder recognizes generally will be U.S. source income for U.S. foreign tax credit purposes, and, subject to certain exceptions, any loss will generally be a U.S. source loss. If an Australian tax is paid on a sale or other disposition of an ADR, the amount realized will include the gross amount of the proceeds of that sale or disposition before deduction of the Australian tax. The generally applicable limitations under U.S. federal income tax law on crediting foreign income taxes may preclude a U.S. holder from obtaining a foreign tax credit for any Australian tax paid on a sale or other disposition of an ADR. The rules relating to the determination of the foreign tax credit are complex, and U.S. holders are urged to consult with their own tax advisers regarding the application of such rules. Alternatively, any Australian tax paid on the sale or other disposition of an ADR may be taken as a deduction against taxable income, provided the U.S. holder takes a deduction and not a credit for all foreign income taxes paid or accrued in the same taxable year.

 

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Non-U.S. holders.

A non-U.S. holder will not be subject to U.S. federal income tax on gain recognized on a sale or other disposition of an ADR unless (i) the gain is effectively connected with the conduct of trade or business by the non-U.S. holder within the United States (and is attributable to a permanent establishment or fixed base the non-U.S. holder maintains in the United States if an applicable income tax treaty so requires as a condition for the non-U.S. holder to be subject to U.S. taxation on a net income basis on income from the ADR), or (ii) in the case of a non-U.S. holder who is an individual, the holder is present in the United States for 183 or more days in the taxable year of the sale or other disposition and certain other conditions apply. Any effectively connected gain of a corporate non-U.S. holder may also be subject under certain circumstances to an additional “branch profits tax,” the rate of which may be reduced pursuant to an applicable income tax treaty.

Passive Foreign Investment Company Rules

A special set of U.S. federal income tax rules applies to a foreign corporation that is a PFIC for U.S. federal income tax purposes. As noted above, based on our audited financial statements and relevant market and shareholder data, we believe that we were a PFIC for U.S. federal income tax purposes for our taxable year ended June 30, 2015, and expect to be classified as a PFIC in our current taxable year. In addition, given that the determination of PFIC status involves the application of complex tax rules, and that it is based on the nature of our income and assets from time to time, no assurances can be provided that we will or will not be considered a PFIC for any past or future taxable years.

In general, a foreign corporation is a PFIC if at least 75% of its gross income for the taxable year is passive income or if at least 50% of its assets for the taxable year produce passive income or are held for the production of passive income. In general, passive income for this purpose means, with certain designated exceptions, dividends, interest, rents, royalties (other than certain rents and royalties derived in the active conduct of trade or business), annuities, net gains from dispositions of certain assets, net foreign currency gains, income equivalent to interest, income from notional principal contracts and payments in lieu of dividends. Passive assets are those assets that are held for production of passive income or do not produce income at all. Thus cash will be a passive asset. Interest, including interest on working capital, is treated as passive income for purposes of the income test. The determination of whether a foreign corporation is a PFIC is a factual determination made annually and is therefore subject to change. Subject to exceptions pursuant to certain elections that generally require the payment of tax, once stock in a foreign corporation is stock in a PFIC in the hands of a particular shareholder that is a United States person, it remains stock in a PFIC in the hands of that shareholder.

If we are treated as a PFIC, contrary to the tax consequences described in “U.S. Federal Income Tax Considerations – Taxation of Dividends” and “U.S. Federal Income Tax Considerations – Taxation of Capital Gains” above, a U.S. holder that does not make an election described in the succeeding two paragraphs would be subject to special rules with respect to (i) any gain realized on a sale or other disposition of an ADR (for purposes of these rules, a disposition of an ADR includes many transactions on which gain or loss is not realized under general U.S. federal income tax rules) and (ii) any “excess distribution” by the Company to the U.S. holder (generally, any distribution during a taxable year in which distributions to the U.S. holder on the ADR exceed 125% of the average annual taxable distributions (whether actual or constructive and whether or not out of earnings and profits) the U.S. holder received on the ADR during the preceding three taxable years or, if shorter, the U.S. holder’s holding period for the ADR). Under those rules, (i) the gain or excess distribution would be allocated ratably over the U.S. holder’s holding period for the ADR, (ii) the amount allocated to the taxable year in which the gain or excess distribution is realized would be taxable as ordinary income in its entirety and not as capital gain, would be ineligible for the reduced qualified dividend rates, and could not be offset by any deductions or losses, and (iii) the amount allocated to each prior year, with certain exceptions, would be subject to tax at the highest tax rate in effect for that year, and the interest charge generally applicable to underpayments of tax would be imposed in respect of the tax attributable to each of those years. A U.S. holder who owns an ADR during any year we are a PFIC will generally have to file IRS Form 8621. A failure to file this return will suspend the statute of limitations with respect to any tax return, event, or period to which such report relates (potentially including with respect to items that do not relate to a U.S. Holder’s investment in the ADRs).

 

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The special PFIC rules described above will not apply to a U.S. holder if the U.S. holder makes a timely election, which remains in effect, to treat the Company as a “qualified electing fund” (“QEF”) in the first taxable year in which the U.S. holder owns an ADR and the Company is a PFIC and if the Company complies with certain reporting requirements. Instead, a shareholder of a QEF generally is currently taxable on a pro rata share of the Company’s ordinary earnings and net capital gain as ordinary income and long-term capital gain, respectively. Neither that ordinary income nor any actual dividend from the Company would qualify for the 20% maximum tax rate on dividends described above if the Company is a PFIC in the taxable year the ordinary income is realized or the dividend is paid or in the preceding taxable year. We have not yet determined whether we would make the computations necessary to supply U.S. holders with the information needed to report income and gain pursuant to a QEF election. It is, therefore, possible that U.S. holders would not be able to make or retain that election in any year we are a PFIC. Although a QEF election generally cannot be revoked, if a U.S. holder made a timely QEF election for the first taxable year it owned an ADR and the Company is a PFIC (or is treated as having done so pursuant to any of certain elections), the QEF election will not apply during any later taxable year in which the Company does not satisfy the tests to be a PFIC. If a QEF election is not made in that first taxable year, an election in a later year generally will require the payment of tax and interest.

In lieu of a QEF election, a U.S. holder of stock in a PFIC that is considered marketable stock could elect to mark the stock to market annually, recognizing as ordinary income or loss each year an amount equal to the difference as of the close of the taxable year between the fair market value of the stock and the U.S. holder’s adjusted basis in the stock. Losses would be allowed only to the extent of net mark-to-market gain previously included in income by the U.S. holder under the election for prior taxable years. A U.S. holder’s adjusted basis in the ADRs will be adjusted to reflect the amounts included or deducted with respect to the mark-to-market election. If the mark-to-market election were made, the rules set forth in the second preceding paragraph would not apply for periods covered by the election. A mark-to-market election will not apply during any later taxable year in which the Company does not satisfy the tests to be a PFIC. In general, the ADRs will be marketable stock if the ADRs are traded, other than in de minimis quantities, on at least 15 days during each calendar quarter on a national securities exchange that is registered with the SEC or on a designated national market system or on any exchange or market that the Treasury Department determines to have rules sufficient to ensure that the market price accurately represents the fair market value of the stock. Under current law, the mark-to-market election may be available to U.S. holders of ADRs because the ADRs are listed on the Nasdaq Capital Market, which constitutes a qualified exchange, although there can be no assurance that the ADRs will be “regularly traded” for purposes of the mark-to-market election or that the ADRs will continue to be listed on the Nasdaq Capital Market.

Given the complexities of the PFIC rules and their potentially adverse tax consequences, U.S. holders of ADRs are urged to consult their tax advisers about the PFIC rules, including the availability of, and consequences to them of making a QEF election or a mark-to-market election with respect to the ordinary shares in the event that the Company is classified as a PFIC for any taxable year.

Medicare surtax on net investment income

Non-corporate US Holders whose income exceeds certain thresholds generally will be subject to 3.8% Surtax on their “Net Investment Income” (which generally includes, among other things, dividends on, and capital gain from the sale or other taxable disposition of, the ADRs). Absent an election to the contrary, if a QEF election is available and made, QEF inclusions will not be included in net investment income at the time a US Holder includes such amounts in income, but rather will be included at the time distributions are received or gains are recognized. Non-corporate US Holders should consult their own tax advisors regarding the possible effect of such tax on their ownership and disposition of the Common Shares, in particular the applicability of this surtax with respect to a non-corporate US Holder that makes a QEF or mark-to-market election in respect of their Common Shares.

Information Reporting and Backup Withholding

Dividends paid on, and proceeds from the sale or other disposition of, an ADR to a U.S. holder generally may be subject to information reporting requirements and may be subject to backup withholding unless the U.S. holder provides an accurate taxpayer identification number or otherwise establishes an exemption. The amount of any backup withholding collected from a payment to a U.S. holder will be allowed as a credit against the U.S. holder’s U.S. federal income tax liability and may entitle the U.S. holder to a refund, provided certain required information is furnished to the Internal Revenue Service. A non-U.S. holder generally will be exempt from these information reporting requirements and backup withholding tax but may be required to comply with certain certification and identification procedures in order to establish its eligibility for exemption.

 

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Under U.S. federal income tax law and U.S. Treasury Regulations, certain categories of U.S. holders must file information returns with respect to their investment in, or involvement in, a foreign corporation. For example, all U.S. holders of PFIC stock are generally required to make annual return filings reporting their PFIC ownership and certain other information that the IRS may require. U.S. holders are urged to consult with their own tax advisors concerning such reporting requirements.

Reporting Obligations of Individual Owners of Foreign Financial Assets

Section 6038D of the Code generally requires U.S. individuals (and possibly certain entities that have U.S. individual owners) to file IRS Form 8938 if they hold certain “specified foreign financial assets,” the aggregate value of which exceeds $50,000. The definition of specified foreign financial assets includes not only financial accounts maintained in foreign financial institutions, but also, unless held in accounts maintained by a financial institution, any stock or security issued by a non-US. person, any financial instrument or contract held for investment that has an issuer or counterparty other than a U.S. person and any interest in a foreign entity.

THE DISCUSSION ABOVE IS NOT INTENDED TO CONSTITUTE A COMPLETE ANALYSIS OF ALL TAX CONSIDERATIONS APPLICABLE TO AN INVESTMENT IN ADRs. HOLDERS AND POTENTIAL HOLDERS ARE URGED TO CONSULT THEIR OWN TAX ADVISERS CONCERNING THE TAX CONSEQUENCES RELEVANT TO THEM IN THEIR PARTICULAR SITUATION.

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’s exposure to market interest rates relate primarily to the investments of cash balances.

The Company has cash reserves held primarily in Australian dollars 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. “Financial Statements – Note 28 – Financial Instruments”.

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. 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 at June 30, 2013, the Company 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 Australian Dollar have exposure to the local currency of these subsidiaries and any other currency these subsidiaries trade in.

As at June 30, 2014, the Company was not exposed to significant foreign currency risk.

As at June 30, 2015, the Company has minimised its foreign currency risk related to the significant portion of Research and Development transaction costs incurred in USD by maintaining funds in USD as well as AUD, in line with the Company’s treasury policy.

For additional disclosure regarding market risk see Item 18. “Financial Statements – Note 28 – Financial Instruments”.

 

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Item 12. Description of Securities Other than Equity Securities

American Depositary Shares

The depositary collects its fees for delivery and surrender of American Depositary 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

  
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

  

 

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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 Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on that evaluation, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures are effective as of June 30, 2015.

(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, 2015, based on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework. Management continue to use the 1992 framework for its assessment and will transition to the 2013 framework in due course. Based on this assessment, management concluded that the Company’s internal control over financial reporting is effective as of June 30, 2015.

(c) Changes in internal controls

During the fiscal year ended June 30, 2015, there were changes to management and board composition. These changes have not materially affected or are not reasonably likely to materially affect the Company’s internal control over financial reporting.

There were no major acquisitions or discontinuations of operations during the fiscal year ended June 30, 2015.

 

Item 16. [Reserved]

 

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Item 16A. Audit Committee Financial Expert

The Board of Directors has determined that John O’Connor, qualifies as an “audit committee financial expert” as that term is defined in Item 16A of Form 20-F. John O’Connor 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 and Business Conduct (the ‘Code’). The Code establishes a clear set of values that emphasise a culture encompassing strong corporate governance, sound business practices and good ethical conduct. The Code confirms the Company’s belief in treating all individuals with respect and recognises that different skills and diversity are essential to enrich the Company’s perspective, improve corporate performance, increase shareholder value and maximise the achievement and goals of the Company. The Code is available on the Company’s website www.novogen.com.

 

Item 16C. Principal Accounting Fees and Services

Grant Thornton Audit Pty Ltd (‘GT’) has audited the Company’s annual financial statements acting as the independent registered public accounting firm for the fiscal years ended June 30, 2015, 2014 and 2013.

The table below set forth the total fees for services performed by GT in fiscal years 2015, 2014 and 2013, and summarizes these amounts by the category of service.

 

     2015
A$’000
     2014
A$’000
     2013
A$’000
 

Audit services - Grant Thornton Audit Pty Ltd

        

Audit or review of the financial statements

     114         123         151   

F3 consent

     21         —           —     

Other services - Grant Thornton Audit Pty Ltd

        

Tax compliance services

     20         31         47   
  

 

 

    

 

 

    

 

 

 
     155         154         198   
  

 

 

    

 

 

    

 

 

 

Audit fees

The audit fees include the aggregate fees incurred in fiscal years 2015, 2014 and 2013 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).

SEC F-3 Form Consent

Fees paid in respect of filing of SEC F-3 form consent services, which relates to procedures required by the auditor to issue their consent in the document.

Other services

Tax compliance fees

Tax fees billed in each of the fiscal years 2015 and 2014 were for tax compliance services.

 

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Pre-approval policies and procedures

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

 

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

This item is not applicable.

 

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

This item is not applicable.

 

Item 16F. Changes in registrant’s Certifying Accountant

This item is not applicable.

 

Item 16G. Corporate Governance

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

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

 

 

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

 

 

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 16H. Mine Safety Disclosure

This item is not applicable.

 

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PART III

 

Item 17. Financial Statements – Not Applicable

Not Applicable

 

Item 18. Financial Statements

The financial statements filed as part of this Annual Report are included on pages 66 through 108 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)
  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    Prospectus in relation to the resale of securities (9)
  4.14    Prospectus in relation to the resale of securities (10)
  4.15    Placement Confirmation Letter in relation to the December PIPE, including signature pages and terms and conditions of Options (11)

 

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  4.16    Placement Confirmation Letter in relation to the April PIPE, including signature pages and terms and conditions of Options (12)
  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. (*)
23.1    Consent of Grant Thornton Audit Pty Ltd (*)

 

* 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).
(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).
(9) Incorporated by reference to Form 424B1 filed with the Securities and Exchange Commission under rule 424(b)(1) on March 19, 2015 (File No. 333-201767).
(10) Incorporated by reference to Form 424B1 filed with the Securities and Exchange Commission under rule 424(b)(1) on September 28, 2015 (File No. 333-205666).
(11) Incorporated by reference to Registration Statement on Form F-3 filed with the Securities and Exchange Commission on January 30, 2015, as amended on March 17, 2015 (File No. 333-201767).
(12) Incorporated by reference to Registration Statement on Form F-3 filed with the Securities and Exchange Commission on July 15, 2015, as amended on September 24, 2015 (File No. 333-205666).

 

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Statements of profit or loss and other comprehensive income

For the year ended 30 June 2015

 

     Note    2015     2014     2013     2015  
          A$‘000     A$‘000     A$‘000     US$‘000  

Revenue from continuing operations

   6      89        87        1,112        69   

Other income

   7      2,753        342        618        2,121   

Expenses

           

Research and development expense

        (5,935     (3,328     (1,357     (4,573

General and administrative expense

        (3,843     (3,415     (1,749     (2,961

Net fair value loss on convertible note derivative

        (301     (540     —          (232

Finance costs

   8      (69     (715     (132     (53
     

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income tax expense from continuing operations

        (7,306     (7,569     (1,508     (5,629

Income tax expense

   9      —          —          —          —     
     

 

 

   

 

 

   

 

 

   

 

 

 

Loss after income tax expense from continuing operations

        (7,306     (7,569     (1,508     (5,629

Profit after income tax expense from discontinued operations

        —          —          723        —     

Loss after income tax expense for the year

        (7,306     (7,569     (785     (5,629

Other comprehensive income

           

Items that may be reclassified subsequently to profit or loss

           

Loss on the revaluation of available-for-sale financial assets, net of tax

        (32     (11     —          (24

Net exchange difference on translation of financial statements of foreign controlled entities, net of tax

        (376     29        3,968        (290

Other comprehensive income for the year, net of tax

        (408     18        3,968        (314

Total comprehensive income for the year

        (7,714     (7,551     3,183        (5,943

Loss for the year is attributable to:

           

Non-controlling interest

        (167     (101     246        (129

Owners of Novogen Limited

        (7,139     (7,468     (1,031     (5,500
        (7,306     (7,569     (785     (5,629

The above statements of profit or loss or other comprehensive income should be read with the accompanying notes

 

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Statements of profit or loss and other comprehensive income (continued)

For the year ended 30 June 2015

 

     Note    2015     2014     2013     2015  
          A$‘000     A$‘000     A$‘000     US$‘000  

Total comprehensive income for the year is attributable to:

           

Continuing operations

        (205     (99     —          (158

Discontinuing operations

        —          —          1,509        —     
     

 

 

   

 

 

   

 

 

   

 

 

 

Non-controlling interest

        (205     (99     1,509        (158
     

 

 

   

 

 

   

 

 

   

 

 

 

Continuing operations

        (7,509     (7,452     (1,508     (5,785

Discontinuing operations

        —          —          3,182        —     
     

 

 

   

 

 

   

 

 

   

 

 

 

Owners of Novogen Limited

        (7,509     (7,452     1,674        (5,785
     

 

 

   

 

 

   

 

 

   

 

 

 
        (7,714     (7,551     3,183        (5,943
     

 

 

   

 

 

   

 

 

   

 

 

 
         

2015

Aus

Cents

   

2014

Aus

Cents

   

2013

Aus

Cents

   

2015

US

Cents

 

Earnings per share for loss from continuing operations attributable to the owners of Novogen Limited

           

Basic earnings per share

   37      (2.99     (4.76     (1.32     (2.30

Diluted earnings per share

   37      (2.99     (4.76     (1.32     (2.30

Earnings per share for profit from discontinued operations attributable to the owners of Novogen Limited

           

Basic earnings per share

   37      —          —          0.42        —     

Diluted earnings per share

   37      —          —          0.42        —     

Earnings per share for loss attributable to the owners of Novogen Limited

           

Basic earnings per share

   37      (2.99     (4.76     (0.90     (2.30

Diluted earnings per share

   37      (2.99     (4.76     (0.90     (2.30

The above statements of profit or loss or other comprehensive income should be read with the accompanying notes

 

67


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Statements of financial position

As at 30 June 2015

 

     Note    2015     2014     2015  
          A$‘000     A$‘000     US$‘000  

Assets

         

Current assets

         

Cash and cash equivalents

   11      44,371        2,502        34,184   

Trade and other receivables

   12      151        66        116   

Income tax refund due

   13      —          3        —     

Other

   14      127        67        97   
     

 

 

   

 

 

   

 

 

 

Total current assets

        44,649        2,638        34,397   
     

 

 

   

 

 

   

 

 

 

Non-current assets

         

Available-for-sale financial assets

   15      16        47        12   

Property, plant and equipment

   16      85        14        66   

Intangibles

   17      1,390        1,961        1,071   
     

 

 

   

 

 

   

 

 

 

Total non-current assets

        1,491        2,022        1,149   
     

 

 

   

 

 

   

 

 

 

Total assets

        46,140        4,660        35,546   
     

 

 

   

 

 

   

 

 

 

Liabilities

         

Current liabilities

         

Trade and other payables

   18      1,619        259        1,247   

Borrowings

   19      —          2,707        —     

Derivative financial instruments

   20      —          173        —     

Provisions

   21      159        108        122   
     

 

 

   

 

 

   

 

 

 

Total current liabilities

        1,778        3,247        1,369   
     

 

 

   

 

 

   

 

 

 

Total liabilities

        1,778        3,247        1,369   
     

 

 

   

 

 

   

 

 

 

Net assets

        44,362        1,413        34,177   
     

 

 

   

 

 

   

 

 

 

Equity

         

Contributed equity

   22      190,404        142,586        146,687   

Other contributed equity

   23      1,716        —          1,322   

Reserves

   24      990        231        762   

Accumulated losses

   25      (148,445     (141,306     (114,360
     

 

 

   

 

 

   

 

 

 

Equity attributable to the owners of Novogen Limited

        44,665        1,511        34,411   

Non-controlling interest

   26      (303     (98     (234
     

 

 

   

 

 

   

 

 

 

Total equity

        44,362        1,413        34,177   
     

 

 

   

 

 

   

 

 

 

The above statements of financial position should be read with the accompanying notes

 

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Statements of changes in equity

For the year ended 30 June 2015

 

     Contributed
equity
A$‘000
    Other
Contributed
equity
A$‘000
     Reserves
A$‘000
    Accumulated
Losses
A$‘000
    Non-
controlling
Interest
A$‘000
    Total
equity
A$‘000
    Total
equity
US$‘000
 

Balance at 1 July 2012

     199,026       —           (3,850     (191,700 )     1,637       5,113       4,280  

Profit/(loss) after income tax expense for the year

     —         —           —          (1,031 )     246       (785     (740

Other comprehensive income for the year, net of tax

     —         —           2,705       —          1,263       3,968       3,741  
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income for the year

     —         —           2,705       (1,031 )     1,509       3,183       3,001  

Transactions with owners in their capacity as owners:

               

Contributions of equity, net of transaction costs (note 22)

     3,013       —          —         —         —         3,013       2,840  

Issue of shares on acquisition

     1,386       —          —         —         —         1,386       1,307  

De-recognition of non-controlling interest

     —         —          —         —         (1,637     (1,637     (1,543

Recognition of equity component of compound financial instrument

     —         —          216       —         —          216       204  

Movement in disposal of subsidiary

     (65,762     —          1,145       83,668       (1,509     17,542       16,537  

Dividends paid (note 27)

     —         —          —         (24,775 )     —         (24,775     (23,356
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at 30 June 2013

     137,663       —          216       (133,838 )     —         4,041       3,809  
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
     Contributed
equity
A$‘000
    Other
Contributed
equity
A$‘000
     Reserves
A$‘000
    Accumulated
losses
A$‘000
    Non-
controlling
Interest
A$‘000
    Total
equity
A$‘000
    Total
equity
US$‘000
 

Balance at 1 July 2013

     137,663        —           216        (133,838     —         4,041       3,809  

Loss after income tax expense for the year

     —          —           —          (7,468     (101 )     (7,569     (7,135

Other comprehensive income for the year, net of tax

     —          —           15        —          3       18       17  
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income for the year

     —          —           15        (7,468     (98 )     (7,551 )     (7,118

Transactions with owners in their capacity as owners:

               

Contributions of equity, net of transaction costs (note 22)

     4,923        —          —          —         —         4,923       4,640  
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at 30 June 2014

     142,586        —          231        (141,306     (98 )     1,413       1,332  
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

The above statements of changes in equity should be read with the accompanying notes

 

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Statements of changes in equity (continued)

For the year ended 30 June 2015

 

     Contributed
equity
A$‘000
     Other
Contributed
equity
A$‘000
     Reserves
A$‘000
    Accumulated
Losses
A$‘000
    Non-
controlling
Interest
A$‘000
    Total
equity
A$‘000
    Total
equity
US$‘000
 

Balance at 1 July 2014

     142,586        —          231       (141,306 )     (98 )     1,413       1,332  

Loss after income tax expense for the year

     —          —           —          (7,139     (167     (7,306     (5,629

Other comprehensive income for the year, net of tax

     —          —           (370     —          (38     (408     (314
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income for the year

     —          —           (370     (7,139     (205     (7,714     (5,943

Transactions with owners in their capacity as owners:

                

Share-based payments (note 37)

     —           —          1,527        —         —         1,527        1,176   

Contributions of equity, net of transaction costs (note 22)

     47,636         —          —         —         —         47,636        36,699   

Recognition of equity component of compound financial instrument

     —           1,500         —          —          —          1,500        1,156   

Transfers

     —           216         (216     —          —          —       

Exercise of options

     182         —          (182     —          —          —       
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at 30 June 2015

     190,404         1,716         990        (148,445     (303     44,362        34,420   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

The above statements of changes in equity should be read with the accompanying notes

 

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Statements of cash flows

For the year ended 30 June 2015

 

     Note    2015     2014     2013     2015  
          A$‘000     A$‘000     A$‘000     US$‘000  

Cash flows from operating activities

           

Loss before income tax expense for the year

        (7,306     (7,569     (785     (5,629

Adjustments for:

           

Depreciation and amortisation

        575        572        336        443   

Write off of property, plant and equipment

        —          23        8        —     

Net loss on disposal of non-current assets

        13        —          —          10   

Share-based payments

        —          —          402        —     

Foreign exchange differences

        (508     28        62        (390

Gain on capital reduction - in specie distribution

        —          —          (4,996     —     

Net gain on disposal of business/subsidiary

        —          —          (462     —     

Net gain on disposal of Glucan Technology

        —          —          (150     —     

Net fair value loss on convertible note derivative

        301        540        —          232   

Imputed interest on convertible note

        68        223        132        52   
     

 

 

   

 

 

   

 

 

   

 

 

 
        (6,857     (6,183     (5,453     (5,282

Change in operating assets and liabilities:

           

Decrease in trade and other receivables

        (85     344        34        (65

Increase in income tax refund due

        3        (3     —          2   

Decrease/(increase) in prepayments

        (59     (67     206        (45

Decrease in trade and other payables

        1,360        (54     (3,412     1,048   

Increase in derivative liabilities

        (173     173        —          (133

Increase/(decrease) in other provisions

        51        81        (170     39   
     

 

 

   

 

 

   

 

 

   

 

 

 

Net cash used in operating activities

        (5,760     (5,709     (8,795     (4,436
     

 

 

   

 

 

   

 

 

   

 

 

 

Cash flows from investing activities

           

Payment for purchase of business, net of cash acquired

        —          —          32        —     

Payments for property, plant and equipment

   16      (97     (27     (10     (75

Proceeds from disposal of property, plant and equipment

        8            6   

Proceeds from sale of intellectual property

          —          150     
     

 

 

   

 

 

   

 

 

   

 

 

 

Net cash from/(used in) investing activities

        (89     (27     172        (69
     

 

 

   

 

 

   

 

 

   

 

 

 

The above statements of cash flow should be read with the accompanying notes

 

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Statement of cash flows (continued)

For the year ended 30 June 2015

 

     Note    2015     2014     2013     2015  
          A$‘000     A$‘000     A$‘000     US$‘000  

Cash flows from financing activities

           

Proceeds from issue of shares

   22      50,356        —          3,170        38,794   

Proceeds from borrowings

        —          5,500        —       

Share issue transaction costs

        (2,941     —          (157     (2,266
     

 

 

   

 

 

   

 

 

   

 

 

 

Net cash from financing activities

        47,415        5,500        3,013        36,528   
     

 

 

   

 

 

   

 

 

   

 

 

 
For the year ended 30 June 2015            
          2015
A$‘000
    2014
A$‘000
    2013
A$‘000
    2015
US$‘000
 

Net increase/(decrease) in cash and cash equivalents

        41,566        (236     (5,610     32,023   

Cash and cash equivalents at the beginning of the financial year

        2,502        2,738        8,348        1,928   

Effects of exchange rate changes on cash

        303        —          —          233   
     

 

 

   

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at the end of the financial year

   11      44,371        2,502        2,738        34,184   
     

 

 

   

 

 

   

 

 

   

 

 

 

The above statements of cash flow should be read with the accompanying notes

 

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Notes to the financial statements

30 June 2015

 

Note 1. General information

The financial statements cover the consolidated entity consisting of Novogen Limited and its subsidiaries controlled during the year. The financial statements are presented in Australian dollars, which is Novogen Limited’s functional and presentation currency.

Novogen Limited is a listed public company limited by shares, incorporated and domiciled in Australia. Its registered office and principal place of business is:

Level 1

16-20 Edgeworth David Avenue

Hornsby NSW 2077

The principal business of Novogen Limited is that of a pharmaceutical drug development business.

The financial statements were authorised for issue, in accordance with a resolution of directors, on 30 October 2015. The directors have the power to amend and reissue the financial statements.

 

Note 2. Significant accounting policies

The principal accounting policies adopted in the preparation of the financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated

New, revised or amending Accounting Standards and Interpretations adopted

The consolidated entity has adopted all of the new, revised or amending Accounting Standards and Interpretations issued by the International Accounting Standards Board that are mandatory in Australia for the current reporting period.

Any new, revised or amending Accounting Standards or Interpretations that are not yet mandatory have not been early adopted.

Any significant impact on the accounting policies of the consolidated entity from the adoption of these Accounting Standards and Interpretations are disclosed below. The adoption of these Accounting Standards and Interpretations did not have any significant impact on the financial performance or position of the consolidated entity.

The following Accounting Standards and Interpretations are most relevant to the consolidated entity:

Offsetting Financial Assets and Financial Liabilities (Amendments to IAS 32)

IAS 32 offsetting amendments adds application guidance to IAS 32 Financial Instruments: Presentation to address inconsistencies identified in applying some of the offsetting criteria of IAS 32 ‘Financial Instruments: Presentation’, including clarifying the meaning of “currently has a legally enforceable right of set-off” and that some gross settlement systems may be considered equivalent to net settlement.

IAS 32 offsetting amendments is applicable to annual reporting periods beginning on or after 1 January 2014.

The adoption of these amendments has not had a material impact on the Group as the amendments merely clarify the existing requirements in IAS 32.

 

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Recoverable Amount Disclosures for Non-Financial Assets (Amendments to IAS 36)

These narrow-scope amendments address disclosure of information about the recoverable amount of impaired assets if that amount is based on fair value less costs of disposal.

When developing IFRS 13 Fair Value Measurement, the IASB decided to amend IAS 36 ‘Impairment of Assets’ to require disclosures about the recoverable amount of impaired assets. The IASB noticed however that some of the amendments made in introducing those requirements resulted in the requirement being more broadly applicable than the IASB had intended. These amendments to IAS 36 therefore clarify the IASB’s original intention that the scope of those disclosures is limited to the recoverable amount of impaired assets that is based on fair value less costs of disposal.

IAS 36 – Recoverable amount disclosures for non-financial assets makes the equivalent amendments to IAS 36 Impairment of Assets and is applicable to annual reporting periods beginning on or after 1 January 2014.

The adoption of these amendments has not had a material impact on the Group as they are largely of the nature of clarification of existing requirements.

Investment Entities (Amendments to IFRS 10, IFRS 12 and IAS 27)

The amendments in Investment Entities (Amendments to IFRS 10, IFRS 12 and IAS 27) provide an exception to consolidation for investment entities and require them to measure unconsolidated subsidiaries at fair value through profit or loss in accordance with IFRS 9 Financial Instruments. The amendments also introduce new disclosure requirements for investment entities that have subsidiaries.

These amendments apply to investment entities, whose business purpose is to invest funds solely for returns from capital appreciation, investment income or both. Examples of entities which might qualify as investment entities would include Australian superannuation entities, listed investment companies, pooled investment trusts and Federal, State and Territory fund management authorities.

Investment Entities (Amendments to IFRS 10, IFRS 12 and IAS 27) is applicable to annual reporting periods beginning on or after 1 January 2014.

This Standard has not had any impact on the Group as it does not meet the definition of an ‘investment entity’ in order to apply this consolidation exception.

Annual Improvements to IFRSs 2010–2012 Cycle

Among other improvements, the amendments arising from Annual Improvements to IFRSs 2010-2012 Cycle:

 

 

clarify that the definition of a ‘related party’ includes a management entity that provides key management personnel services to the reporting entity (either directly or through a group entity)

 

 

amend IFRS 8 ‘Operating Segments’ to explicitly require the disclosure of judgements made by management in applying the aggregation criteria

Annual Improvements to IFRSs 2010–2012 Cycle are applicable to annual reporting periods beginning on or after 1 July 2014.

The adoption of these amendments has not had a material impact on the Group as they are largely of the nature of clarification of existing requirements.

Annual Improvements to IFRSs 2011–2013 Cycle

Among other improvements, the amendments arising from Annual Improvements to IFRSs 2011-2013 Cycle clarify that an entity should assess whether an acquired property is an investment property under IAS 40 ‘Investment Property’ and perform a separate assessment under IFRS 3 ‘Business Combination’ to determine whether the acquisition of the investment property constitutes a business combination.

Annual Improvements to IFRSs 2011–2013 Cycle are applicable to annual reporting periods beginning on or after 1 July 2014.

The adoption of these amendments has not had a material impact on the Group as they are largely of the nature of clarification of existing requirements.

 

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Going concern

The consolidated entity incurred a loss after income tax of A$7,306,000 (2014: A$7,569,000 and 2013: A$785,000) and had net cash outflows from operating activities of A$5,759,000 (2014: A$5,709,000 and 2013: A$8,795,000) for the year ended 30 June 2015, and was in a net current asset position of $42,871,000 (2014: net current liability position of A$609,000) as at 30 June 2015.

The financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realisation of assets and settlement of liabilities in the normal course of business. As is often the case with development companies, the ability of the consolidated entity to continue its development activities as a going concern including paying its debts as and when due, is dependent upon it deriving sufficient cash from investors and revenues. As at 30 June 2015 the consolidated entity had cash in hand and at bank including short term deposits of A$44,371,000 (2014: A$2,502,000).

The business of the consolidated entity is drug discovery based on research and development. The extent of this activity is dependent directly on the level of available funds and on the capacity to continue to raise further funds as the Research and Development (‘R&D’) activity proceeds.

In June 2014, the Board adopted a strategy intended to provide the consolidated entity with sufficient funding for the foreseeable future and to sustain the consolidated entity as a going concern. The strategy was to raise capital in several tranches through the placement of new securities to underwrite strategic plans for an active R&D program, with the goal of bringing at least 2 and possibly a third new drug into clinical testing.

To support this strategy, the consolidated entity conducted 3 different placements of equity securities, a rights entitlement offer to its shareholders and received proceeds from the exercise of options throughout the financial year.

The following list is a summary of gross proceeds received by the consolidated entity:

 

   

ASX Bookbuild private placement to sophisticated investors in Australia and the U.S., completed 12 November 2014: $1,854,599

 

   

Private placement of equity securities to U.S. based private investment funds, completed 16 &18 December 2014: $5,862,600

 

   

Private placement of equity securities to U.S. based private investment funds, completed 29 April 2015: $15,525,000

 

   

Rights entitlement offer to securities holder based in Australia, New Zealand and qualified U.S investors, completed 4 June 2015: $17,691,346

 

   

Proceeds from exercise of various options throughout the financial year: $9,422,360

The total proceeds from fundraising throughout the financial year aggregates to $50,356,000.

As at 30 June 2015, the consolidated entity had 179,925,987 unlisted options on issue, with various exercise price and maturity date.

The cash at bank available at 30 June 2015 provides enough funds to allow 3 lead drug candidates to start a phase 1 clinical trial. Notwithstanding any proceeds received from the new shares issued pursuant to the exercise of options, the consolidated entity does not anticipate the need to seek further dilutive funding over the next 2 years.

Basis of preparation

These financial statements comply with International Financial Reporting Standards as issued by the International Accounting Standards Board (‘IASB’).

Historical cost convention

The financial statements have been prepared under the historical cost convention, except for derivative financial instruments and available-for-sale financial assets, which are at fair value.

Critical accounting estimates

The preparation of the financial statements requires the use of certain critical accounting estimates. It also requires management to exercise its judgement in the process of applying the consolidated entity’s accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the financial statements, are disclosed in note 3.

 

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Principles of consolidation

The consolidated financial statements incorporate the assets and liabilities of all subsidiaries of Novogen Limited (‘Company’ or ‘parent entity’) as at 30 June 2015 and the results of all subsidiaries for the year then ended. Novogen Limited and its subsidiaries together are referred to in these financial statements as the ‘consolidated entity’.

Subsidiaries are all those entities over which the consolidated entity has control. The consolidated entity controls an entity when the consolidated entity is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power to direct the activities of the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the consolidated entity. They are de-consolidated from the date that control ceases.

Intercompany transactions, balances and unrealised gains on transactions between entities in the consolidated entity are eliminated. Unrealised losses are also eliminated unless the transaction provides evidence of the impairment of the asset transferred. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the consolidated entity.

The acquisition of subsidiaries is accounted for using the acquisition method of accounting. A change in ownership interest, without the loss of control, is accounted for as an equity transaction, where the difference between the consideration transferred and the book value of the share of the non-controlling interest acquired is recognised directly in equity attributable to the parent.

Non-controlling interest in the results and equity of subsidiaries are shown separately in the statement of profit or loss and other comprehensive income, statement of financial position and statement of changes in equity of the consolidated entity. Losses incurred by the consolidated entity are attributed to the non-controlling interest in full, even if that results in a deficit balance.

Where the consolidated entity loses control over a subsidiary, it derecognises the assets including goodwill, liabilities and non-controlling interest in the subsidiary together with any cumulative translation differences recognised in equity. The consolidated entity recognises the fair value of the consideration received and the fair value of any investment retained together with any gain or loss in profit or loss.

Interests in subsidiaries are accounted for at cost, less any impairment, in the parent entity. Dividends received from subsidiaries are recognised as other income by the parent entity and its receipt may be an indicator of an impairment of the investment.

Operating segments

Operating segments are presented using the ‘management approach’, where the information presented is on the same basis as the internal reports provided to the Chief Operating Decision Makers (‘CODM’). The CODM is responsible for the allocation of resources to operating segments and assessing their performance.

Foreign currency translation

The financial statements are presented in Australian dollars, which is Novogen Limited’s functional and presentation currency.

Foreign currency transactions

Foreign currency transactions are translated into Australian dollars using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at financial year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in profit or loss.

Foreign operations

The assets and liabilities of foreign operations are translated into Australian dollars using the exchange rates at the reporting date. The revenues and expenses of foreign operations are translated into Australian dollars using the average exchange rates, which approximate the rate at the date of the transaction, for the period. All resulting foreign exchange differences are recognised in other comprehensive income through the foreign currency reserve in equity.

The foreign currency reserve is recognised in profit or loss when the foreign operation or net investment is disposed of.

 

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Revenue recognition

Revenue is recognised when it is probable that the economic benefit will flow to the consolidated entity 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:

Interest

Interest revenue is recognised as interest accrues using the effective interest method. This is a method of calculating the amortised cost of a financial asset and allocating the interest income over the relevant period using the effective interest rate, which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset to the net carrying amount of the financial asset.

Royalties

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

Other revenue

Other revenue is recognised when it is received or when the right to receive payment is established.

Income tax

The income tax expense or benefit for the period is the tax payable on that period’s taxable income based on the applicable income tax rate for each jurisdiction, adjusted by changes in deferred tax assets and liabilities attributable to temporary differences, unused tax losses and the adjustment recognised for prior periods, where applicable.

Deferred tax assets and liabilities are recognised for temporary differences at the tax rates expected to apply when the assets are recovered or liabilities are settled, based on those tax rates that are enacted or substantively enacted, except for:

 

 

When the deferred income tax asset or liability arises from the initial recognition of goodwill or an asset or liability in a transaction that is not a business combination and that, at the time of the transaction, affects neither the accounting nor taxable profits; or

 

 

When the taxable temporary difference is associated with interests in subsidiaries, associates or joint ventures, and the timing of the reversal can be controlled and it is probable that the temporary difference will not reverse in the foreseeable future.

Deferred tax assets are recognised for deductible temporary differences and unused tax losses only if it is probable that future taxable amounts will be available to utilise those temporary differences and losses.

The carrying amount of recognised and unrecognised deferred tax assets are reviewed each reporting date. Deferred tax assets recognised are reduced to the extent that it is no longer probable that future taxable profits will be available for the carrying amount to be recovered. Previously unrecognised deferred tax assets are recognised to the extent that it is probable that there are future taxable profits available to recover the asset.

Deferred tax assets and liabilities are offset only where there is a legally enforceable right to offset current tax assets against current tax liabilities and deferred tax assets against deferred tax liabilities; and they relate to the same taxable authority on either the same taxable entity or different taxable entities which intend to settle simultaneously.

The R&D Tax Incentive is an Australian government run program which helps to offset some of the costs of R&D. Annually, the consolidated entity claims a refundable tax offset and has disclosed this as other income in the statement of profit or loss and other comprehensive income. The group currently accounts for R&D Tax Incentive on a cash basis due to the difficulty of making reasonable estimation as at year end.

Novogen Limited (the ‘head entity’) and its wholly-owned Australian controlled entities have formed an income tax consolidated group under the Australian tax consolidation regime. Novogen Limited as the head entity discloses all of the deferred tax assets of the tax consolidated group in relation to tax losses carried forward (after elimination of inter-group transactions). The tax consolidated group has applied the ‘separate taxpayer in the group’ allocation approach in determining the appropriate amount of taxes to allocate to members of the tax consolidated group.

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

 

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Discontinued operations

A discontinued operation is a component of the consolidated entity that has been disposed of or is classified as held for sale and that represents a separate major line of business or geographical area of operations, is part of a single co-ordinated plan to dispose of such a line of business or area of operations, or is a subsidiary acquired exclusively with a view to resale. The results of discontinued operations are presented separately on the face of the statement of profit or loss and other comprehensive income.

Current and non-current classification

Assets and liabilities are presented in the statement of financial position based on current and non-current classification.

An asset is current when: it is expected to be realised or intended to be sold or consumed in normal operating cycle; it is held primarily for the purpose of trading; it is expected to be realised within 12 months after the reporting period; or the asset is cash or cash equivalent unless restricted from being exchanged or used to settle a liability for at least 12 months after the reporting period. All other assets are classified as non-current.

A liability is current when: it is expected to be settled in normal operating cycle; it is held primarily for the purpose of trading; it is due to be settled within 12 months after the reporting period; or there is no unconditional right to defer the settlement of the liability for at least 12 months after the reporting period. All other liabilities are classified as non-current.

Deferred tax assets and liabilities are always classified as non-current.

Cash and cash equivalents

Cash and cash equivalents includes cash on hand, deposits held at call with financial institutions, other short-term, highly liquid investments with original maturities 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.

Trade and other receivables

Trade receivables are initially recognised at fair value and subsequently measured at amortised cost using the effective interest method, less any provision for impairment. Trade receivables are generally due for settlement within 30 to 60 days.

Collectability of trade receivables is reviewed on an ongoing basis. Debts which are known to be uncollectable are written off by reducing the carrying amount directly. A provision for impairment of trade receivables is raised when there is objective evidence that the consolidated entity will not be able to collect all amounts due according to the original terms of the receivables. Significant financial difficulties of the debtor, probability that the debtor will enter bankruptcy or financial reorganisation and default or delinquency in payments (more than 120 days overdue) are considered indicators that the trade receivable may be impaired. The amount of the impairment allowance is the difference between the asset’s carrying amount and the present value of estimated future cash flows, discounted at the original effective interest rate. Cash flows relating to short-term receivables are not discounted if the effect of discounting is immaterial.

Other receivables are recognised at amortised cost, less any provision for impairment.

Derivative financial instruments

Derivatives are initially recognised at fair value on the date a derivative contract is entered into and are subsequently remeasured to their fair value at each reporting date. The accounting for subsequent changes in fair value depends on whether the derivative is designated as a hedging instrument, and if so, the nature of the item being hedged.

Derivatives are classified as current or non-current depending on the expected period of realisation.

Hedges of a net investment

Hedges of a net investment in a foreign operation include monetary items that are considered part of the net investment. Gains or losses on the hedging instrument relating to the effective portion of the hedge are recognised directly in equity whilst gains or losses relating to the ineffective portion are recognised in profit or loss. On disposal of the foreign operation, the cumulative value of any such gains or losses recognised directly in equity is transferred to profit or loss.

 

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Investments and other financial assets

Investments and other financial assets are initially measured at fair value. Transaction costs are included as part of the initial measurement, except for financial assets at fair value through profit or loss. They are subsequently measured at either amortised cost or fair value depending on their classification. Classification is determined based on the purpose of the acquisition and subsequent reclassification to other categories is restricted.

Financial assets are derecognised when the rights to receive cash flows from the financial assets have expired or have been transferred and the consolidated entity has transferred substantially all the risks and rewards of ownership.

Loans and receivables

Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They are carried at amortised cost using the effective interest rate method. Gains and losses are recognised in profit or loss when the asset is derecognised or impaired.

Available-for-sale financial assets

Available-for-sale financial assets are non-derivative financial assets, principally equity securities, that are either designated as available-for-sale or not classified as any other category. After initial recognition, fair value movements are recognised in other comprehensive income through the available-for-sale reserve in equity. Cumulative gain or loss previously reported in the available-for-sale reserve is recognised in profit or loss when the asset is derecognised or impaired.

Impairment of financial assets

The consolidated entity assesses at the end of each reporting period whether there is any objective evidence that a financial asset or group of financial assets is impaired. Objective evidence includes significant financial difficulty of the issuer or obligor; a breach of contract such as default or delinquency in payments; the lender granting to a borrower concessions due to economic or legal reasons that the lender would not otherwise do; it becomes probable that the borrower will enter bankruptcy or other financial reorganisation; the disappearance of an active market for the financial asset; or observable data indicating that there is a measurable decrease in estimated future cash flows.

The amount of the impairment allowance for loans and receivables carried at amortised cost is the difference between the asset’s carrying amount and the present value of estimated future cash flows, discounted at the original effective interest rate. If there is a reversal of impairment, the reversal cannot exceed the amortised cost that would have been recognised had the impairment not been made and is reversed to profit or loss.

Available-for-sale financial assets are considered impaired when there has been a significant or prolonged decline in value below initial cost. Subsequent increments in value are recognised in other comprehensive income through the available-for-sale reserve.

Property, plant and equipment

Plant and equipment is stated at historical cost less accumulated depreciation and impairment. Historical cost includes expenditure that is directly attributable to the acquisition of the items.

Depreciation is calculated on a straight-line basis to write off the net cost of each item of property, plant and equipment over their expected useful lives as follows:

 

Plant and equipment    2.5 to 10 years

The residual values, useful lives and depreciation methods are reviewed, and adjusted if appropriate, at each reporting date.

An item of property, plant and equipment is derecognised upon disposal or when there is no future economic benefit to the consolidated entity. Gains and losses between the carrying amount and the disposal proceeds are taken to profit or loss.

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.

 

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Leases

The determination of whether an arrangement is or contains a lease is based on the substance of the arrangement and requires an 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.

A distinction is made between finance leases, which effectively transfer from the lessor to the lessee substantially all the risks and benefits incidental to ownership of leased assets, and operating leases, under which the lessor effectively retains substantially all such risks and benefits.

Finance leases are capitalised. A lease asset and liability are established at the fair value of the leased assets, or if lower, the present value of minimum lease payments. Lease payments are allocated between the principal component of the lease liability and the finance costs, so as to achieve a constant rate of interest on the remaining balance of the liability.

Leased assets acquired under a finance lease are depreciated over the asset’s useful life or over the shorter of the asset’s useful life and the lease term if there is no reasonable certainty that the consolidated entity will obtain ownership at the end of the lease term.

Operating lease payments, net of any incentives received from the lessor, are charged to profit or loss on a straight-line basis over the term of the lease.

Intangible assets

Intangible assets acquired as part of a business combination, other than goodwill, are initially measured at their fair value at the date of the acquisition. Intangible assets acquired separately are initially recognised at cost. Indefinite life intangible assets are not amortised and are subsequently measured at cost less any impairment. Finite life intangible assets are subsequently measured at cost less amortisation and any impairment. The gains or losses recognised in profit or loss arising from the derecognition of intangible assets are measured as the difference between net disposal proceeds and the carrying amount of the intangible asset. The method and useful lives of finite life intangible assets are reviewed annually. Changes in the expected pattern of consumption or useful life are accounted for prospectively by changing the amortisation method or period.

Patents and intellectual property

Significant costs associated with patents and intellectual property are deferred and amortised on a straight-line basis over the period of their expected benefit, being their finite useful life of five years.

Impairment of non-financial assets

Non-financial assets with finite useful lives are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is recognised for the amount by which the asset’s carrying amount exceeds its recoverable amount.

Recoverable amount is the higher of an asset’s fair value less costs of disposal and value-in-use. The value-in-use is the present value of the estimated future cash flows relating to the asset using a pre-tax discount rate specific to the asset or cash-generating unit to which the asset belongs. Assets that do not have independent cash flows are grouped together to form a cash-generating unit.

Trade and other payables

These amounts represent liabilities for goods and services provided to the consolidated entity prior to the end of the financial year and which are unpaid. Due to their short-term nature they are measured at amortised cost and are not discounted. The amounts are unsecured and are usually paid within 30 days of recognition.

Borrowings

Loans and borrowings are initially recognised at the fair value of the consideration received, net of transaction costs. They are subsequently measured at amortised cost using the effective interest method.

 

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Compound financial instruments

Compound financial instruments issued by the consolidated entity comprise convertible notes that can be converted to share capital at the option of the holder, and the number of shares does not vary with changes in fair value. The liability component of a financial liability is recognised at the fair value of a similar liability that does not have an equity conversion option. The equity component is recognised initially at the difference between the fair value of the compound financial instrument as a whole and the fair value of the liability component. Any directly attributable transaction costs are allocated to the liability and equity components in proportion to their initial carrying amounts.

Subsequent to initial recognition, the liability component of a compound financial instrument is measured at amortised cost using the effective interest rate method, whereas the equity component is not remeasured. Interest, gains and losses relating to the financial liability are recognised in profit or loss. On conversion, the financial liability is reclassified to equity; no gain or loss is recognised on conversion.

Finance costs

Finance costs attributable to qualifying assets are capitalised as part of the asset. All other finance costs are expensed in the period in which they are incurred, including interest on short-term and long-term borrowings.

Provisions

Provisions are recognised when the consolidated entity has a present (legal or constructive) obligation as a result of a past event, it is probable the consolidated entity will be required to settle the obligation, and a reliable estimate can be made of the amount of the obligation. The amount recognised as a provision is the best estimate of the consideration required to settle the present obligation at the reporting date, taking into account the risks and uncertainties surrounding the obligation. If the time value of money is material, provisions are discounted using a current pre-tax rate specific to the liability. The increase in the provision resulting from the passage of time is recognised as a finance cost.

Employee benefits

Short-term employee benefits

Liabilities for wages and salaries, including non-monetary benefits, annual leave and long service leave expected to be settled within 12 months of the reporting date are measured at the amounts expected to be paid when the liabilities are settled.

Other long-term employee benefits

The liability for annual leave and long service leave not expected to be settled within 12 months of the reporting date is measured as the present value of expected future payments to be made in respect of services provided by employees up to the reporting date using the projected unit credit method. Consideration is given to expected future wage and salary levels, experience of employee departures and periods of service. Expected future payments are discounted using market yields at the reporting date on national government bonds with terms to maturity and currency that match, as closely as possible, the estimated future cash outflows.

Defined contribution superannuation expense

Contributions to defined contribution superannuation plans are expensed in the period in which they are incurred.

Share-based payments

Equity-settled share-based compensation benefits are provided to employees under the terms of the Employee Share Option Plan (‘ESOP’) and consultants as compensation for services performed.

Equity-settled transactions are awards of shares, or options over shares, that are provided to employees in exchange for the rendering of services.

 

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The cost of equity-settled transactions are measured at fair value on grant date. Fair value is independently determined using the Binomial option pricing model that takes into account the exercise price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option, together with non-vesting conditions that do not determine whether the consolidated entity receives the services that entitle the employees to receive payment. No account is taken of any other vesting conditions.

The cost of equity-settled transactions are recognised as an expense with a corresponding increase in equity over the vesting period. The cumulative charge to profit or loss is calculated based on the grant date fair value of the award, the best estimate of the number of awards that are likely to vest and the expired portion of the vesting period. The amount recognised in profit or loss for the period is the cumulative amount calculated at each reporting date less amounts already recognised in previous periods.

 

   

during the vesting period, the liability at each reporting date is the fair value of the award at that date multiplied by the expired portion of the vesting period.

 

   

from the end of the vesting period until settlement of the award, the liability is the full fair value of the liability at the reporting date.

Market conditions are taken into consideration in determining fair value. Therefore any awards subject to market conditions are considered to vest irrespective of whether or not that market condition has been met, provided all other conditions are satisfied.

If equity-settled awards are modified, as a minimum an expense is recognised as if the modification has not been made. An additional expense is recognised, over the remaining vesting period, for any modification that increases the total fair value of the share-based compensation benefit as at the date of modification.

If the non-vesting condition is within the control of the consolidated entity or employee, the failure to satisfy the condition is treated as a cancellation. If the condition is not within the control of the consolidated entity or employee and is not satisfied during the vesting period, any remaining expense for the award is recognised over the remaining vesting period, unless the award is forfeited.

If equity-settled awards are cancelled, it is treated as if it has vested on the date of cancellation, and any remaining expense is recognised immediately. If a new replacement award is substituted for the cancelled award, the cancelled and new award is treated as if they were a modification.

Fair value measurement

When an asset or liability, financial or non-financial, is measured at fair value for recognition or disclosure purposes, the fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date; and assumes that the transaction will take place either: in the principal market; or in the absence of a principal market, in the most advantageous market.

Fair value is measured using the assumptions that market participants would use when pricing the asset or liability, assuming they act in their economic best interest. For non-financial assets, the fair value measurement is based on its highest and best use. Valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, are used, maximising the use of relevant observable inputs and minimising the use of unobservable inputs.

Assets and liabilities measured at fair value are classified, into three levels, using a fair value hierarchy that reflects the significance of the inputs used in making the measurements. Classifications are reviewed each reporting date and transfers between levels are determined based on a reassessment of the lowest level input that is significant to the fair value measurement.

For recurring and non-recurring fair value measurements, external valuers may be used when internal expertise is either not available or when the valuation is deemed to be significant. External valuers are selected based on market knowledge and reputation. Where there is a significant change in fair value of an asset or liability from one period to another, an analysis is undertaken, which includes a verification of the major inputs applied in the latest valuation and a comparison, where applicable, with external sources of data.

 

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Issued capital

Ordinary shares are classified as equity.

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

Business combinations

The acquisition method of accounting is used to account for business combinations regardless of whether equity instruments or other assets are acquired.

The consideration transferred is the sum of the acquisition-date fair values of the assets transferred, equity instruments issued or liabilities incurred by the acquirer to former owners of the acquiree and the amount of any non-controlling interest in the acquiree. For each business combination, the non-controlling interest in the acquiree is measured at either fair value or at the proportionate share of the acquiree’s identifiable net assets. All acquisition costs are expensed as incurred to profit or loss.

On the acquisition of a business, the consolidated entity assesses the financial assets acquired and liabilities assumed for appropriate classification and designation in accordance with the contractual terms, economic conditions, the consolidated entity’s operating or accounting policies and other pertinent conditions in existence at the acquisition-date.

Where the business combination is achieved in stages, the consolidated entity remeasures its previously held equity interest in the acquiree at the acquisition-date fair value and the difference between the fair value and the previous carrying amount is recognised in profit or loss.

Contingent consideration to be transferred by the acquirer is recognised at the acquisition-date fair value. Subsequent changes in the fair value of contingent consideration classified as an asset or liability is recognised in profit or loss. Contingent consideration classified as equity is not remeasured and its subsequent settlement is accounted for within equity.

The difference between the acquisition-date fair value of assets acquired, liabilities assumed and any non-controlling interest in the acquiree and the fair value of the consideration transferred and the fair value of any pre-existing investment in the acquiree is recognised as goodwill. If the consideration transferred and the pre-existing fair value is less than the fair value of the identifiable net assets acquired, being a bargain purchase to the acquirer, the difference is recognised as a gain directly in profit or loss by the acquirer on the acquisition-date, but only after a reassessment of the identification and measurement of the net assets acquired, the non-controlling interest in the acquiree, if any, the consideration transferred and the acquirer’s previously held equity interest in the acquirer.

Business combinations are initially accounted for on a provisional basis. The acquirer retrospectively adjusts the provisional amounts recognised and also recognises additional assets or liabilities during the measurement period, based on new information obtained about the facts and circumstances that existed at the acquisition-date. The measurement period ends on either the earlier of (i) 12 months from the date of the acquisition or (ii) when the acquirer receives all the information possible to determine fair value.

Earnings per share

Basic earnings per share

Basic earnings per share is calculated by dividing the profit attributable to the owners of Novogen Limited, excluding any costs of servicing equity other than ordinary shares, by the weighted average number of ordinary shares outstanding during the financial year, adjusted for bonus elements in ordinary shares issued during the financial year.

Diluted earnings per share

Diluted earnings per share adjusts the figures used in the determination of basic earnings per share to take into account the after income tax effect of interest and other financing costs associated with dilutive potential ordinary shares and the weighted average number of shares assumed to have been issued for no consideration in relation to dilutive potential ordinary shares.

 

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Goods and Services Tax (‘GST’) and other similar taxes

Revenues, expenses and assets are recognised net of the amount of associated GST, unless the GST incurred is not recoverable from the tax authority. In this case it is recognised as part of the cost of the acquisition of the asset or as part of the expense.

Receivables and payables are stated inclusive of the amount of GST receivable or payable. The net amount of GST recoverable from, or payable to, the tax authority is included in other receivables or other payables in the statement of financial position.

Cash flows are presented on a gross basis. The GST components of cash flows arising from investing or financing activities which are recoverable from, or payable to the tax authority, are presented as operating cash flows.

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

Rounding of amounts

Amounts in these financial statements have been rounded to the nearest thousand dollars, or in certain cases, the nearest dollar.

New Accounting Standards and Interpretations not yet mandatory or early adopted

Accounting Standards and Interpretations that have recently been issued or amended but are not yet mandatory, have not been early adopted by the consolidated entity for the annual reporting period ended 30 June 2015. The consolidated entity’s assessment of the impact of these new or amended Accounting Standards and Interpretations, most relevant to the consolidated entity, are set out below.

IFRS 15 Revenue from Contracts with Customers

This standard is expected to be applicable to annual reporting periods beginning on or after 1 January 2018. The standard provides a single standard for revenue recognition. The core principle of the standard is that an entity will recognise revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The standard will require: contracts (either written, verbal or implied) to be identified, together with the separate performance obligations within the contract; determine the transaction price, adjusted for the time value of money excluding credit risk; allocation of the transaction price to the separate performance obligations on a basis of relative stand-alone selling price of each distinct good or service, or estimation approach if no distinct observable prices exist; and recognition of revenue when each performance obligation is satisfied. Credit risk will be presented separately as an expense rather than adjusted to revenue. For goods, the performance obligation would be satisfied when the customer obtains control of the goods. For services, the performance obligation is satisfied when the service has been provided, typically for promises to transfer services to customers. For performance obligations satisfied over time, an entity would select an appropriate measure of progress to determine how much revenue should be recognised as the performance obligation is satisfied. Contracts with customers will be presented in an entity’s statement of financial position as a contract liability, a contract asset, or a receivable, depending on the relationship between the entity’s performance and the customer’s payment. Sufficient quantitative and qualitative disclosure is required to enable users to understand the contracts with customers; the significant judgments made in applying the guidance to those contracts; and any assets recognised from the costs to obtain or fulfil a contract with a customer.

The consolidated entity will adopt this standard and the amendments from 1 July 2018 but the impact of its adoption is yet to be assessed by the consolidated entity.

 

Note 3. Critical accounting judgements, estimates and assumptions

The preparation of the financial statements requires management to make judgements, estimates and assumptions that affect the reported amounts in the financial statements. Management continually evaluates its judgements and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgements, estimates and assumptions on historical experience and on other various factors, including expectations of future events, management believes to be reasonable under the circumstances. The resulting accounting judgements and estimates will seldom equal the related actual results. The judgements, estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities (refer to the respective notes) within the next financial year are discussed below.

 

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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. 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

Estimates have been used in determining the expense liability under certain clinical trial contracts performed but not yet invoiced.

Share-based payment transactions

The consolidated entity measures the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at the date at which they are granted. The fair value is determined by using the Binomial model taking into account the terms and conditions upon which the instruments were granted. The accounting estimates and assumptions relating to equity-settled share-based payments would have no impact on the carrying amounts of assets and liabilities within the next annual reporting period but may impact profit or loss and equity.

Fair value measurement hierarchy

The consolidated entity is required to classify all assets and liabilities, measured at fair value, using a three level hierarchy, based on the lowest level of input that is significant to the entire fair value measurement, being: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the measurement date; Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly; and Level 3: Unobservable inputs for the asset or liability. Considerable judgement is required to determine what is significant to fair value and therefore which category the asset or liability is placed in can be subjective.

Research and development tax rebate

No accrual estimate has been made in relation to the R&D tax rebate as there is uncertainty around the value that will be received and as such the amount cannot be quantified reliably.

Recovery of deferred tax assets

Deferred tax assets are recognised for deductible temporary differences only if the consolidated entity considers it is probable that future taxable amounts will be available to utilise those temporary differences and losses.

Borrowing costs

Borrowing costs incurred for the construction of any qualifying asset are capitalised during the period of time that is required to complete and prepare the asset for its intended use or sale. Other borrowing costs are expensed.

 

Note 4. Restatement of comparatives

Reclassification

Comparative information in the profit and loss statement has been restated to correct an immaterial error in classification of expenses. The profit and loss for Fiscal 2014 and Fiscal 2013, included salary and related general expenses of scientists totalling A$853,000 and A$1,101,000 respectively in general and administrative expenses. These expenses have been reclassified from general and administrative expenses to research and development expenses. The restatement is to reflect the nature of the expense in a more accurate manner. A third balance sheet has not been presented as the reclassification is immaterial and has no impact on the financial results for the year ended June 30, 2014, and June 30, 2013, or the closing financial position at that date.

 

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Note 5. Operating segments

Identification of reportable operating segments

The consolidated entity’s operating segment is based on the internal reports that are reviewed and used by the Board of Directors (being the Chief Operating Decision Makers (‘CODM’)) in assessing performance and in determining the allocation of resources.

The consolidated entity operates in the pharmaceutical research and development business. There are no operating segments for which discrete financial information exists.

The information reported to the CODM, on at least a monthly basis, is the consolidated results as shown in the statement of profit or loss and other comprehensive income and statement of financial position.

Major customers

During the years ended 30 June 2015, 30 June 2014 and 30 June 2013 there were no major customers.

 

     Sales to external customers     

Geographical

non-current assets

 
     2015      2014      2013      2015      2014      2013  
     A$‘000      A$‘000      A$‘000      A$‘000      A$‘000      A$‘000  

Australia

     —           —           —           1,475         1,975         2,543   

Other

     —           —           —           —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 
     —           —           —           1,475         1,975         2,543   

The geographical non-current assets above are exclusive of, where applicable, financial instruments, deferred tax assets, post-employment benefits assets and rights under insurance contracts.

 

Note 6. Revenue

 

     2015      2014      2013  
     A$‘000      A$‘000      A$‘000  

From continuing operations

        

Sales revenue

        

Bank interest

     89         87         45   

Royalties

     —           —           1,067   
  

 

 

    

 

 

    

 

 

 
     89         87         1,112   
  

 

 

    

 

 

    

 

 

 

Revenue from continuing operations

     89         87         1,112   
  

 

 

    

 

 

    

 

 

 

 

Note 7. Other income

 

     2015      2014      2013  
     A$‘000      A$‘000      A$‘000  

Net foreign exchange gain

     1,116         —           —     

Payroll tax rebate

     8         —           —     

Research and development rebate

     1,538         342         —     

Gain on disposal of Glycotex

     —           —           462   

Glycotex sale of asset - Glucan Technology

     —           —           150   

Subsidies and grants

     91         —           —     

Other income

     —           —           6   
  

 

 

    

 

 

    

 

 

 

Other income

     2,753         342         618   
  

 

 

    

 

 

    

 

 

 

 

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Note 8. Expenses

 

     2015      2014      2013  
     A$‘000      A$‘000      A$‘000  

Loss before income tax from continuing operations includes the following specific expenses:

        

Depreciation

        

Property, plant and equipment

     5         2         2   
  

 

 

    

 

 

    

 

 

 

Amortisation

        

Patents and intellectual property

     570         570         320   
  

 

 

    

 

 

    

 

 

 

Total depreciation and amortisation

     575         572         322   
  

 

 

    

 

 

    

 

 

 

Finance costs

        

Interest and finance charges paid/payable

     1         492         —     

Imputed interest on convertible note

     68         223         132   
  

 

 

    

 

 

    

 

 

 

Finance costs expensed

     69         715         132   
  

 

 

    

 

 

    

 

 

 

Rental expense relating to operating leases

        

Minimum lease payments

     98         64         40   
  

 

 

    

 

 

    

 

 

 

Superannuation expense

        

Defined contribution superannuation expense

     147         88         64   
  

 

 

    

 

 

    

 

 

 

Employee benefits expense excluding superannuation

        

Employee benefits expense excluding superannuation

     2,105         1,437         1,185   

Refer to note 10 for specific expenses related to discontinued operations.

 

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Note 9. Income tax expense

 

     2015      2014      2013  
     A$‘000      A$‘000      A$‘000  

Numerical reconciliation of income tax expense and tax at the statutory rate

        

Loss before income tax expense from continuing operations

     (7,306      (7,569      (1,508

Profit before income tax expense from discontinued operations

        —           723   
  

 

 

    

 

 

    

 

 

 
     (7,306      (7,569      (785
  

 

 

    

 

 

    

 

 

 

Tax at the statutory tax rate of 30%

     (2,192      (2,271      (236

Tax effect amounts which are not deductible/(taxable) in calculating taxable income:

        

Non-deductible expenses

     772         1,205         55   

Derecognition of foreign currency reserve

     —           —           (3,754

Other

     60         (178      —     
  

 

 

    

 

 

    

 

 

 
     (1,360      (1,244      (3,935

Difference in overseas tax rates

     —           —           148   

Tax losses and timing differences not recognised

     1,360         1,244         3,787   
  

 

 

    

 

 

    

 

 

 

Income tax expense

     —           —           —     
  

 

 

    

 

 

    

 

 

 

 

     2015      2014      2013  
     A$‘000      A$‘000      A$‘000  

Tax losses not recognised

        

Unused tax losses for which no deferred tax asset has been recognised

     57,741         54,872         51,804   
  

 

 

    

 

 

    

 

 

 

Potential tax benefit @ 30%

     17,322         16,462         15,541   

The above potential tax benefit for tax losses has not been recognised in the statement of financial position. These tax losses can only be utilised in the future if the continuity of ownership test is passed, or failing that, the same business test is passed.

There was a prior period adjustment to tax losses of A$2,240,000 for the consolidated group due to adjustments not previously recognised. The effect was to reduce the carried forward tax losses of the consolidated group from A$54,872,000 to A$52,632,000 for the year ending June 30, 2014.

 

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Note 10. Discontinued operations

Description

During the financial year ended June 30, 2013, the consolidated entity disposed of the operations of MEI Pharma, Inc. (‘MEI’) and its subsidiary MEI Pharma Pty Limited in which it held majority ownership, via an in-specie distribution to its shareholders. MEI held the intellectual property originally developed by Novogen in the field of isoflavonoid drugs.

Financial information for the discontinued operations are set out as follows:

Financial performance information

 

     2015      2014      2013  
     A$‘000      A$‘000      A$‘000  

Revenue - MEI

           3   
  

 

 

    

 

 

    

 

 

 

Total revenue

     —           —           3   
  

 

 

    

 

 

    

 

 

 

Research and development expense - MEI

     —           —           (2,291

General and administrative expense - MEI

     —           —           (1,524

Depreciation and amortisation expense - MEI

     —           —           (14

Share-based payments - MEI

     —           —           (402
  

 

 

    

 

 

    

 

 

 

Total expenses

     —           —           (4,231
  

 

 

    

 

 

    

 

 

 

Loss before income tax expense

     —           —           (4,228

Income tax expense

     —           —           —     
  

 

 

    

 

 

    

 

 

 

Loss after income tax expense

     —           —           (4,228
  

 

 

    

 

 

    

 

 

 

Net gain on disposal before income tax - MEI

     —           —           4,951   

Income tax expense

     —           —           —     
  

 

 

    

 

 

    

 

 

 

Gain on disposal after income tax expense

     —           —           4,951   
  

 

 

    

 

 

    

 

 

 

Profit after income tax expense from discontinued operations

     —           —           723   
  

 

 

    

 

 

    

 

 

 

Cash flow information

 

     2015      2014      2013  
     A$‘000      A$‘000      A$‘000  

Net cash used in operating activities

     —           —           (4,179

Net cash used in investing activities

     —           —           (2

Net decrease in cash and cash equivalents from discontinued operations

     —           —           (4,181
  

 

 

    

 

 

    

 

 

 

Details of the disposal

 

     2015      2014      2013  
     A$‘000      A$‘000      A$‘000  

Total sale consideration

     —           —           6,386   

Derecognition of foreign currency reserve

     —           —           (12,514

Derecognition of impairment provision

     —           —           11,079   
  

 

 

    

 

 

    

 

 

 

Gain on disposal before tax income

     —           —           4,951   

Income tax expense

     —           —           —     

Gain on disposal after income tax

     —           —           4,951   
  

 

 

    

 

 

    

 

 

 

 

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Note 11. Current assets - cash and cash equivalents

 

     2015      2014  
     A$‘000      A$‘000  

Cash at bank and on hand

     44,356         2,486   

Short-term deposits

     15         16   
  

 

 

    

 

 

 
     44,371         2,502   
  

 

 

    

 

 

 

 

Note 12. Current assets - trade and other receivables

 

     2015      2014  
     A$‘000      A$‘000  

Trade receivables

     228         226   

Less: Provision for impairment of receivables

     (226      (226
  

 

 

    

 

 

 
     2         —     
  

 

 

    

 

 

 

Other receivables

     99         62   

Deposits held

     414         366   

Less: Provision for impairment of deposits held

     (364      (362
  

 

 

    

 

 

 
     151         66   
  

 

 

    

 

 

 

Refer to note 32 for further information on ‘deposits held’.

Impairment of receivables

The consolidated entity has recognised a loss of A$2,000 (2014: loss of A$45,000) in profit or loss in respect of impairment of receivables (excluding ‘deposits held’) for the year ended 30 June 2015.

The ageing of the impaired receivables provided for above are as follows:

 

     2015      2014  
     A$‘000      A$‘000  

Over 90 days overdue

     —           226   

Over 6 months overdue

     226         —     
  

 

 

    

 

 

 
     226         226   
  

 

 

    

 

 

 

Movements in the provision for impairment of receivables are as follows:

 

     2015      2014  
     A$‘000      A$‘000  

Opening balance

     226         181   

Additional provisions recognised

     —           45   
  

 

 

    

 

 

 

Closing balance

     226         226   
  

 

 

    

 

 

 

 

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Note 13. Current assets - income tax refund due

 

     2015      2014  
     A$‘000      A$‘000  

Income tax refund due

     —           3   
  

 

 

    

 

 

 

 

Note 14. Current assets - other

 

     2015      2014  
     A$‘000      A$‘000  

Prepayments

     127         67   
  

 

 

    

 

 

 

 

Note 15. Non-current assets - available-for-sale financial assets

 

     2015      2014  
     A$‘000      A$‘000  

Listed ordinary shares

     16         47   
  

 

 

    

 

 

 

Refer to note 29 for further information on fair value measurement.

 

Note 16. Non-current assets - property, plant and equipment

 

     2015      2014  
     A$‘000      A$‘000  

Plant and equipment - at cost

     153         77   

Less: Accumulated depreciation

     (68      (63
  

 

 

    

 

 

 
     85         14   
  

 

 

    

 

 

 

 

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Reconciliations

Reconciliations of the written down values at the beginning and end of the current and previous financial year are set out below:

 

     Plant and
equipment
A$‘000
     Total
A$‘000
 

Balance at 30 June 2013

     12         12   

Additions

     27         27   

Write off of assets

     (23      (23

Depreciation expense

     (2      (2
  

 

 

    

 

 

 

Balance at 30 June 2014

     14         14   

Additions

     97         97   

Write off of assets

     (21      (21

Depreciation expense

     (5      (5
  

 

 

    

 

 

 

Balance at 30 June 2015

     85         14   
  

 

 

    

 

 

 

 

Note 17. Non-current assets - intangibles

 

     2015      2014  
     A$‘000      A$‘000  

Patents and intellectual property - at cost

     2,851         2,851   

Less: Accumulated amortisation

     (1,461      (890
  

 

 

    

 

 

 
     1,390         1,961   
  

 

 

    

 

 

 

Reconciliations

Reconciliations of the written down values at the beginning and end of the current and previous financial year are set out below:

 

     Patents and
intellectual
property
A$‘000
     Total
A$‘000
 

Balance at 1 July 2013

     2,531         2,531   

Amortisation expense

     (570      (570
  

 

 

    

 

 

 

Balance at 30 June 2014

     1,961         1,961   

Amortisation expense

     (571      (571
  

 

 

    

 

 

 

Balance at 30 June 2015

     1,390         1,390   
  

 

 

    

 

 

 

 

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Note 18. Current liabilities - trade and other payables

 

     2015      2014  
     A$‘000      A$‘000  

Trade payables

     766         81   

Accrued payables

     853         178   
  

 

 

    

 

 

 
     1,619         259   
  

 

 

    

 

 

 

Refer to note 28 for further information on financial instruments.

 

Note 19. Current liabilities - borrowings

 

     2015      2014  
     A$‘000      A$‘000  

Convertible notes payable

     —           2,707   
  

 

 

    

 

 

 

Refer to note 28 for further information on financial instruments.

 

Note 20. Current liabilities - derivative financial instruments

 

     2015      2014  
     A$‘000      A$‘000  

Convertible note derivative

     —           173   
  

 

 

    

 

 

 

Refer to note 28 for further information on financial instruments.

Refer to note 29 for further information on fair value measurement.

 

Note 21. Current liabilities - provisions

 

     2015      2014  
     A$‘000      A$‘000  

Employee benefits

     159         108   
  

 

 

    

 

 

 

 

Note 22. Equity - contributed equity

 

     2015      2014      2015      2014  
     Shares      Shares      A$‘000      A$‘000  

Ordinary shares - fully paid

     423,116,465         168,557,834         190,404         142,586   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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Note 22. Equity - contributed equity (continued)

 

Movements in ordinary share capital

 

Details    Date    Shares     

Issue price

A$

     A$‘000  

Balance

   1 July 2013      138,276,033            137,663   

Share based payment expense

   4 July 2013      822,369       $ 0.15         125   

Part conversion of convertible note tranche 1

   26 July 2013      1,315,790       $ 0.13         175   

Part conversion of convertible note tranche 1

   8 August 2013      1,013,514       $ 0.13         130   

Part conversion of convertible note tranche 1

   14 August 2013      675,676       $ 0.13         87   

Part conversion of convertible note tranche 1

   22 August 2013      405,406       $ 0.13         52   

Part conversion of convertible note tranche 1

   27 August 2013      337,838       $ 0.13         43   

Part conversion of convertible note tranche 1

   2 September 2013      337,838       $ 0.13         45   

Part conversion of convertible note tranche 1

   5 September 2013      506,757       $ 0.13         67   

Part conversion of convertible note tranche 1

   16 September 2013      517,242       $ 0.13         67   

Part conversion of convertible note tranche 1

   8 October 3013      413,794       $ 0.14         59   

Part conversion of convertible note tranche 2

   1 November 2013      337,838       $ 0.15         52   

Part conversion of convertible note tranche 2

   5 November 2013      506,757       $ 0.18         92   

Part conversion of convertible note tranche 1

   7 November 2013      1,891,892       $ 0.21         391   

Part conversion of convertible note tranche 2

   7 November 2013      5,202,703       $ 0.19         966   

Part conversion of convertible note tranche 2

   11 November 2013      974,026       $ 0.22         218   

Part conversion of convertible note tranche 3

   19 November 2013      5,089,821       $ 0.16         807   

Part conversion of convertible note tranche 3

   23 November 2013      2,873,564       $ 0.15         439   

Part conversion of convertible note tranche 3

   23 January 2014      2,312,139       $ 0.15         356   

Part conversion of convertible note tranche 3

   19 March 2014      949,368       $ 0.16         153   

Part conversion of convertible note tranche 4

   20 March 2014      3,797,469       $ 0.16         599   

Balance

   30 June 2014      168,557,834            142,586   
     

 

 

       

 

 

 

Part conversion of convertible note tranche 2

   18 November 2014      242,719       $ 0.091         22   

Issue of shares

   18 November 2014      16,859,988       $ 0.110         1,855   

Part conversion of convertible note tranche 4

   20 November 2014      963,856       $ 0.076         73   

Part conversion of convertible note tranche 4

   5 December 2014      986,843       $ 0.072         71   

Issue of shares

   18 December 2014      46,900,800       $ 0.125         5,863   

Issue of shares on exercise of options

   18 December 2014      45,455       $ 0.125         6   

Part conversion of convertible note tranche 4

   22 December 2014      2,666,667       $ 0.094         250   

Issue of shares on exercise of options

   7 January 2015      100,000       $ 0.125         12   

Final conversion of convertible note tranche 4

   9 January 2015      9,266,667       $ 0.096         888   

Final conversion of convertible note tranche 2

   10 February 2015      326,087       $ 0.127         41   

Final conversion of convertible note tranche 3

   10 February 2015      3,260,870       $ 0.124         403   

Issue of shares on exercise of options

   23 April 2015      4,000,000       $ 0.237         948   

Issue of Shares to US investors under PIPE

   24 April 2015      51,750,000       $ 0.300         15,525   

Issue of shares on exercise of options

   13 Mar - 29 May 2015      47,110,841       $ 0.150         7,067   

Issue of shares on exercise of options

   25 Feb - 3 June 2015      11,100,309       $ 0.125         1,388   

Issue of shares

   4 June - 5 June 2015      58,971,151       $ 0.300         17,691   

Issue of shares on exercise of options

   30 June 2015      5,378       $ 0.300         2   

Issue of shares on exercise of options*

   30 June 2015      1,000       $ 0.400         —     

Share issue transaction costs (including share-based payments)

   30 June 2015      —           0.000         (4,287
     

 

 

       

 

 

 

Balance

   30 June 2015      423,116,465            190,404   
     

 

 

       

 

 

 

 

* The actual amount paid is A$400, which has been rounded to nil inMovements in ordinary share capital”.

 

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Ordinary shares

Ordinary shares entitle the holder to participate in dividends and the proceeds on the winding up of the Company in proportion to the number of and amounts paid on the shares held. The fully paid ordinary shares have no par value and the Company does not have a limited amount of authorised capital.

On a show of hands every member present at a meeting in person or by proxy shall have one vote and upon a poll each share shall have one vote.

Share buy-back

There is no current on-market share buy-back.

Capital risk management

The consolidated entity’s objectives when managing capital are to safeguard its ability to continue as a going concern, so that it can provide returns for shareholders and benefits for other stakeholders and to maintain an optimum capital structure to reduce the cost of capital.

The capital structure of the consolidated entity consists of cash and cash equivalents and equity attributable to equity holders. Operating globally, the consolidated entity develops specialty pharmaceutical products. The overall strategy of the consolidated entity is to continue its drug development programs, which depends on raising additional equity.

The capital risk management policy remains unchanged from the prior year.

 

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Note 23. Equity - Other contributed equity

 

     2015      2014  
     A$‘000      A$‘000  

Convertible loan note - Triaxial

     1,716         —     
  

 

 

    

 

 

 

On 4 December 2014, the consolidated entity and the convertible note holder (‘Triaxial’) signed a Convertible Note Deed Poll (‘Deed’) which superseded the precedent Loan Agreement between Triaxial shareholders and the consolidated entity. The Deed extinguishes the liability created by the Loan Agreement, which previously allowed for a cash settlement and now allows Triaxial to convert their debt into ordinary shares during the current financial year, providing that the consolidated entity achieves defined milestones established in the schedule of the Deed. Accordingly the convertible note has been reclassified as an equity instrument rather than debt instrument.

The convertible note may be exercised at the holders discretion as follows:

 

 

on completion of Phase 1a clinical trials: $400,000 converted into 16,000,000 ordinary shares in the Company;

 

 

on receipt of Investigational New Drug approval from the US Food and Drug Administration $500,000 converted into 20,000,000 ordinary shares in the Company; and

 

 

on completion of Phase II clinical trials: $600,000 converted into 24,000,000 ordinary shares in the Company.

The milestones listed above refer to any drug developed based on the super-benzopyran technology.

 

Note 24. Equity - reserves

 

     2015      2014  
     A$‘000      A$‘000  

Available-for-sale reserve

     (43      (11

Foreign currency reserve

     (312      26   

Convertible note reserve

     1,345         216   
  

 

 

    

 

 

 
     990         231   
  

 

 

    

 

 

 

Available-for-sale reserve

The reserve is used to recognise increments and decrements in the fair value of available-for-sale financial assets.

Foreign currency reserve

The reserve is used to recognise exchange differences arising from translation of the financial statements of foreign operations to Australian dollars.

Convertible note reserve

The reserve is used to recognise the equity component of the compound financial instrument.

Share-based payments reserve

The reserve is used to recognise the value of equity benefits provided to employees and Directors as part of their remuneration, and other parties as part of their compensation for services.

 

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Movements in reserves

Movements in each class of reserve during the current and previous financial year are set out below:

 

    

Share-based

payment
reserve

    Available-
for-sale
    Foreign
currency
    Convertible
note
    Total  
     A$‘000     A$‘000     A$‘000     A$‘000     A$‘000  

Balance at 30 June 2013

     —          —          —          216        216   

Foreign currency translation

     —          —          26        —          26   

Loss on the revaluation of available-for-sale financial assets

     —          (11     —          —          (11

Balance at 30 June 2014

     —          (11     26        216        231   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Revaluation - gross

     1,528        —          —          —          1,528   

Transfer to equity on exercise of options

     (183     —          —          —          (183

Other comprehensive income

             —     

Foreign currency translation

     —          —          (338     —          (338

Loss on the revaluation of available for-sale financial assets

     —          (32     —          —          (32
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total other comprehensive income

     —          (32     (338     —          (370

Reclass of Triaxial note to other contributed equity

     —          —          —          (216     (216
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at 30 June 2015

     1,345        (43     (312     —          990   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

Note 25. Equity - accumulated losses

 

     2015      2014      2013  
     A$‘000      A$‘000      A$‘000  

Accumulated losses at the beginning of the financial year

     (141,306      (133,838      (191,700

Loss after income tax expense for the year

     (7,139      (7,468      (1,031

Dividends paid (note 27)

     —           —           (24,775

Transfer from issued capital

     —           —           65,762   

Transfer from foreign currency reserve

     —           —           (1,144

Other adjustments attributable to minority interest and disposals

     —           —           19,050   
  

 

 

    

 

 

    

 

 

 

Accumulated losses at the end of the financial year

     (148,445      (141,306      (133,838
  

 

 

    

 

 

    

 

 

 

 

Note 26. Equity - non-controlling interest

 

     2015      2014  
     A$‘000      A$‘000  

Issued capital

     —           —     

Reserves

     (35      3   

Accumulated losses

     (268      (101
  

 

 

    

 

 

 
     (303      (98
  

 

 

    

 

 

 

 

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Note 27. Equity - dividends

Financial year ended 30 June 2015 and 30 June 2014

There were no dividends paid, recommended or declared during the current or previous financial year.

Financial year ended 30 June 2013

On 27 November 2012, a dividend of A$24,775,000 was paid via an in-specie distribution of shares in MEI Pharma, Inc. representing 23.87 cents per ordinary share.

 

Note 28. Financial instruments

Financial risk management objectives

The consolidated entity’s activities expose it to a variety of financial risks: market risk, credit risk and liquidity risk. The consolidated entity uses different methods to measure and manage the different types of risks to which it is exposed. These methods include monitoring the levels of exposure to interest rates and foreign exchange, ageing analysis and monitoring of specific credit allowances to manage credit risk, and, rolling cash flow forecasts to manage liquidity risk.

Market risk

Foreign currency risk

The consolidated entity operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the US 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 30 June 2015, the consolidated entity did not hold derivative financial instruments in managing its foreign currency, however, the consolidated entity may from time to time enter into hedging arrangements where circumstances are deemed appropriate. Foreign subsidiaries with a functional currency of Australian Dollar (‘AUD’) have exposure to the local currency of these subsidiaries and any other currency these subsidiaries trade in.

The carrying amount of the consolidated entity’s foreign currency denominated financial assets and financial liabilities at the reporting date was as follows:

 

     Assets      Liabilities  
     2015      2014      2015      2014  
     A$‘000      A$‘000      A$‘000      A$‘000  

US dollars

     20,006         —           521         26   

Euros

     1         28         1         —     

Pound Sterling

     —           —           —           3   
  

 

 

    

 

 

    

 

 

    

 

 

 
     20,007         28         522         29   
  

 

 

    

 

 

    

 

 

    

 

 

 

The consolidated entity had net assets denominated in foreign currencies of A$19,485,000 as at 30 June 2015 (2014: net liabilities A$1,000).

Price risk

The consolidated entity is not exposed to any significant price risk.

Interest rate risk

The consolidated entity’s exposure to market interest rates relate primarily to the investments of cash balances.

The consolidated entity has cash reserves held primarily in Australian dollars and United States dollars and places funds on deposit with financial institutions for periods generally not exceeding three months.

 

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As at the reporting date, the consolidated entity had the following variable interest rate balances:

 

     2015      2014  
     Weighted
average
interest rate
    Balance      Weighted
average
interest rate
    Balance  
     %     A$‘000      %     A$‘000  

Cash at bank and in hand

     0.86     44,356         0.25     2,486   

Short term deposits

     2.40     15         2.60     16   
    

 

 

      

 

 

 

Net exposure to cash flow interest rate risk

       44,371           2,502   
    

 

 

      

 

 

 

The consolidated entity has cash and cash equivalents totalling A$44,371,000 (2014: A$2,502,000). An official increase/decrease in interest rates of 100 basis points (2014: 100 basis points) would have an favourable/adverse effect on profit before tax and equity of A$444,000 (2013: A$25,000) per annum. The percentage change is based on the expected volatility of interest rates using market data and analysts forecasts.

Credit risk

Credit risk refers to the risk that a counterparty will default on its contractual obligations resulting in financial loss to the consolidated entity. The entity is not exposed to significant credit risk on receivables.

The consolidated entity places its cash deposits with high credit quality financial institutions and by policy, limits the amount of credit exposure to any single counter-party. The consolidated entity 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 consolidated entity mitigates default risk by constantly positioning its portfolio to respond appropriately to a significant reduction in a credit rating of any financial institution.

The consolidated entity’s maximum exposures to credit risk at the end of the reporting period in relation to each class of recognised financial assets is the carrying amount of those assets as indicated in the statement of financial position, the significant majority in Australia.

There are no significant concentrations of credit risk within the consolidated entity. The credit risk on liquid funds is limited as the counter parties are banks with high credit ratings.

Credit risk is managed by limiting the amount of credit exposure to any single counter-party for cash deposits.

Liquidity risk

The consolidated entity manages liquidity risk by maintaining adequate cash reserves and available borrowing facilities by continuously monitoring actual and forecast cash flows and matching the maturity profiles of financial assets and liabilities.

 

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Remaining contractual maturities

The following tables detail the consolidated entity’s remaining contractual maturity for its financial instrument liabilities. The tables have been drawn up based on the undiscounted cash flows of financial liabilities based on the earliest date on which the financial liabilities are required to be paid. The tables include both interest and principal cash flows disclosed as remaining contractual maturities and therefore these totals may differ from their carrying amount in the statement of financial position.

 

     Weighted
average
interest rate
    1 year or less      Between 1
and 2 years
     Between 2
and 5 years
     Over 5 years      Remaining
contractual
maturities
 
2015    %     A$‘000      A$‘000      A$‘000      A$‘000      A$‘000  

Non-derivatives

                

Non-interest bearing

                

Trade payables

     —       765         —           —           —           765   
    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total non-derivatives

       765         —           —           —           765   
    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 
     Weighted
average
interest rate
    1 year or less      Between 1
and 2 years
     Between 2
and 5 years
     Over 5 years      Remaining
contractual
maturities
 
2014    %     A$‘000      A$‘000      A$‘000      A$‘000      A$‘000  

Non-derivatives

                

Non-interest bearing

                

Trade payables

     —       81         —           —           —           81   

Convertible note 1

     —       1,500         —           —           —           1,500   

Interest-bearing - fixed rate

                

Convertible note 2

     11.36     160         1,445         —           —           1,605   
    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total non-derivatives

       1,741         1,445         —           —           3,186   
    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

The cash flows in the maturity analysis above are not expected to occur significantly earlier than contractually disclosed above.

 

Note 29. Fair value measurement

Fair value hierarchy

The following tables detail the consolidated entity’s assets and liabilities, measured or disclosed at fair value, using a three level hierarchy, based on the lowest level of input that is significant to the entire fair value measurement, being:

Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the measurement date

Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly

Level 3: Unobservable inputs for the asset or liability

 

     Level 1      Level 2      Level 3      Total  
2015    A$‘000      A$‘000      A$‘000      A$‘000  

Assets

           

Ordinary shares

     16         —           —           16   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets

     16         —           —           16   
  

 

 

    

 

 

    

 

 

    

 

 

 

Liabilities

           

Derivative financial instrument

     —           —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Total liabilities

     —           —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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     Level 1      Level 2      Level 3      Total  
2014    A$‘000      A$‘000      A$‘000      A$‘000  

Assets

           

Ordinary shares

     47         —           —           47   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets

     47         —           —           47   
  

 

 

    

 

 

    

 

 

    

 

 

 

Liabilities

           

Derivative financial instrument

     —           —           173         173   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total liabilities

     —           —           173         173   
  

 

 

    

 

 

    

 

 

    

 

 

 

There were no transfers between levels during the financial year.

Valuation techniques for fair value measurements categorised within level 2 and level 3

Derivative financial instrument was valued using the Monte Carlo simulation model, based on the following inputs:

 

 

Effective life: life of convertible note

 

 

Conversion price: based on terms of convertible note

 

 

Dividend yield: 0%

 

 

Risk free rate: 2.5%

 

 

Volatility: 90% to 110%

 

Note 30. Remuneration of auditors

During the financial year the following fees were paid or payable for services provided by Grant Thornton Audit Pty Ltd, the auditor of the consolidated entity:

 

     Consolidated  
     2015      2014      2013  
     A$‘000      A$‘000      A$‘000  

Audit services - Grant Thornton Audit Pty Ltd

        

Audit or review of the financial statements

     114         123         151   

F3 consent

     21         

Other services - Grant Thornton Audit Pty Ltd

        

Tax compliance services

     20         31         47   
  

 

 

    

 

 

    

 

 

 
     155         154         198   
  

 

 

    

 

 

    

 

 

 

 

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Note 31. Key management personnel disclosures

Compensation

The aggregate compensation made to directors and other members of key management personnel (‘KMP’) of the consolidated entity is set out below:

 

     2015      2014      2013  
     A$’000      A$’000      A$’000  

Short-term employee benefits

     1,328         1,133         1,587   

Post-employment benefits

     101         109         91   

Long-term benefits

     38         —           242   

Termination benefits

     —           —           66   

Share-based payments

     —           —           438   
  

 

 

    

 

 

    

 

 

 
     1,467         1,242         2,424   
  

 

 

    

 

 

    

 

 

 

Please refer to Note 34 for other transactions with key management personnel and their related parties.

Shareholding

The number of shares in the Company held during the financial year by each director and other members of key management personnel of the consolidated entity, including their personally related parties, is set out below:

 

     Balance at
the start of
the year
    

Received

as part of
remuneration

     Additions      Disposals/
other*
   

Balance at
the end of

the year

 

Ordinary shares

             

G Kelly

     5,715,204         —           —           (109,837     5,605,367   

S Coffey

     89,236         —           732,224         —          821,460   

J O’Connor

     278,601         —           46,434         —          325,035   

C Humphreys

     —           —           141,666         —          141,666   

A Heaton

     6,662,136         —           —           (413,038     6,249,098   

D Brown

     3,497,795         —           —           —          3,497,795   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 
     16,242,972         —           920,324         (522,875     16,640,421   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

 

* Disposals/other may represent no longer being designated as a KMP, not necessarily a disposal of holding.

Option holding

The number of options over ordinary shares in the Company held during the financial year by each director and other members of key management personnel of the consolidated entity, including their personally related parties, is set out below:

 

    

Balance at

the start of
the year

     Granted      Exercised     Expired/
forfeited/
other
     Balance at
the end of
the year
 

Options over ordinary shares

             

G Kelly*

     —           354,318         —          —           354,318   

J O’Connor*

     —           69,652         —          —           69,652   

S Coffey*

     —           448,968         (272,727     —           176,241   

C Humphreys*

     —           62,954         —          —           62,954   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 
     —           935,892         (272,727     —           663,165   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

 

* The above listed options were not issued as part of remuneration.

 

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Note 32. Contingent liabilities

The consolidated entity is continuing to prosecute its Intellectual Property (‘IP’) rights and in June 2007 announced that the Vienna Commercial Court had upheld a provisional injunction against an Austrian company, APOtrend. The consolidated entity has provided a guarantee to the value of €250,000 ($364,000) with the court to confirm its commitment to the ongoing enforcement process. As at the 30 June 2015, the receivable balance has been fully impaired on the basis that it is unlikely to be recovered. The receivable balance and the corresponding provision for impairment is classified as ‘deposits held’. Refer to note 12.

 

Note 33. Commitments

 

     2015      2014  
     A$‘000      A$‘000  

Lease commitments - operating

     

Committed at the reporting date but not recognised as liabilities, payable:

     

Within one year

     87         80   

One to five years

     —           72   
  

 

 

    

 

 

 
     87         152   
  

 

 

    

 

 

 

Operating lease commitments includes contracted amounts for leases of premises and plant and equipment under non-cancellable operating leases expiring within three years. On renewal, the terms of the leases are renegotiated. Leases for premises include an annual review for CPI increases.

 

Note 34. Related party transactions

Parent entity

Novogen Limited is the parent entity.

Subsidiaries

Interests in subsidiaries are set out in note 35.

Key management personnel

Disclosures relating to key management personnel are set out in note 31.

Transactions with related parties

The following transactions occurred with related parties:

 

     2015      2014      2013  
     A$’000      A$’000      A$’000  

Sale of goods and services:

        

Sale of goods to Glycotex, Inc. an associated company through William Rueckert a former director

     —           —           462   

Payment for other expenses:

        

Accounting fees paid to Watkins Coffey Martin, an entity (partnership) in which Steven Coffey is a partner

     12         79         45   

Salary paid to Prue Kelly, the partner of Graham Kelly, a former director

     77         76         7   

Salary paid to Michael Kelly, the brother of Graham Kelly, a former director

     6         24         —     

Salary paid to Kathryn Stoddart, the daughter of Graham Kelly, former director

     4         —           —     

 

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Note 34. Related party transactions (continued)

 

Other transactions:

There were no other transactions with KMP and their related parties.

Receivable from and payable to related parties

There were no trade receivables from or trade payables to related parties at the current and previous reporting date.

Loans to/from related parties

There were no loans to or from related parties at the current and previous reporting date.

Terms and conditions

All transactions were made on normal commercial terms and conditions and at market rates.

 

Note 35. Interests in subsidiaries

The consolidated financial statements incorporate the assets, liabilities and results of the following subsidiaries in accordance with the accounting policy described in note 2:

 

          Ownership interest  
     Principal place of business /    2015     2014  
Name    Country of incorporation    %     %  

Novogen Laboratories Pty Ltd

   Australia      100.00     100.00

Novogen Research Pty Ltd

   Australia      100.00     100.00

Novogen North America Inc.

   United States of America      100.00     100.00

Triaxial Pharmaceuticals Pty Ltd

   Australia      100.00     100.00

Novogen Inc.

   United States of America      100.00     100.00

CanTx. Inc.

   United States of America      85.00     85.00

In November 2013 the Company entered into a joint venture arrangement with Yale University (‘Yale’), in which the Company owns 85% of the joint venture company. The purpose of the joint venture company, CanTx. Inc, (‘CanTx’) was to pool the resources of both parties in order to develop drugs for the treatment of ovarian cancer. A series of agreements underpin this joint venture. The first of those is a licensing agreement from the consolidated entity to CanTx that allows CanTx to access the Company patent portfolio of SBP drugs in order to identify a lead candidate compound for its objective of developing an intra-abdominal product capable of treating any intra-abdominal cancer, but with a particular focus on ovarian cancer. A licensing agreement between Yale and CanTx gave CanTx access to certain Yale cell culture technology and animal models and facilities and resources. A sponsored research agreement between CanTx and Yale identified the appropriate research plan to be undertaken by Yale, and a shareholders’ agreement between all parties comprised a commitment from the consolidated entity to fund CanTx for up to 3 years for up to a maximum of US$2 million. Yale and CanTx devised a construct comprising Trx-1 in a guided drug delivery system and commenced animal studies to investigate its utility both as an intra-peritoneal and intravenous product for the treatment of ovarian cancer.

 

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Note 36. Events after the reporting period

Appointment of Interim Chairman

On 1 July 2015, the consolidated entity announced the appointment of Mr Ian M. Phillips, MNZM, as Interim Chairman of the Board of Directors.

Resignation of CEO

On 22 July 2015, the consolidated entity announced the resignation of Dr Graham Kelly as CEO, as well as Director of all entities within the group.

Appointment of Director and Acting CEO

On 22 July 2015, the consolidated entity announced the appointment of Mr Iain Ross as Director and Acting Chief Executive Officer of the consolidated entity. The consolidated entity is actively seeking a permanent Chief Executive Officer globally and has engaged an agency specialised in the recruitment of high profile senior executives to assist in its search.

Office move

To accommodate its constant growth, the consolidated entity has entered into a new lease, starting in November 2015.The current lease held by the consolidated entity expires on 14 May 2016.

No other matter or circumstance has arisen since 30 June 2015 that has significantly affected, or may significantly affect the consolidated entity’s operations, the results of those operations, or the consolidated entity’s state of affairs in future financial years.

 

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Note 37. Earnings per share

 

     2015      2014      2013  
     A$‘000      A$‘000      A$‘000  

Earnings per share for loss from continuing operations

        

Loss after income tax

     (7,306      (7,569      (1,508

Non-controlling interest

     167         101         —     
  

 

 

    

 

 

    

 

 

 

Loss after income tax attributable to the owners of Novogen Limited

     (7,139      (7,468      (1,508
  

 

 

    

 

 

    

 

 

 
     Number      Number      Number  

Weighted average number of ordinary shares used in calculating basic earnings per share

     238,418,048         156,725,363         114,690,737   
  

 

 

    

 

 

    

 

 

 

Weighted average number of ordinary shares used in calculating diluted earnings per share

     238,418,048         156,725,363         114,690,737   
  

 

 

    

 

 

    

 

 

 
     Cents      Cents      Cents  

Basic earnings per share

     (2.99      (4.76      (1.32

Diluted earnings per share

     (2.99      (4.76      (1.32
     2015      2014      2013  
     A$‘000      A$‘000      A$‘000  

Earnings per share for profit from discontinued operations

        

Profit after income tax

     —           —           723   

Non-controlling interest

     —           —           (246
  

 

 

    

 

 

    

 

 

 

Profit after income tax attributable to the owners of Novogen Limited

     —           —           477   
  

 

 

    

 

 

    

 

 

 
     Number      Number      Number  

Weighted average number of ordinary shares used in calculating basic earnings per share

     238,418,048         156,725,363         114,690,737   
  

 

 

    

 

 

    

 

 

 

Weighted average number of ordinary shares used in calculating diluted earnings per share

     238,418,048         156,725,363         114,690,737   
  

 

 

    

 

 

    

 

 

 
     Cents      Cents      Cents  

Basic earnings per share

     —           —           0.42   

Diluted earnings per share

     —           —           0.42   
     2015      2014      2013  
     A$‘000      A$‘000      A$‘000  

Earnings per share for loss

        

Loss after income tax

     (7,306      (7,569      (785

Non-controlling interest

     167         101         (246
  

 

 

    

 

 

    

 

 

 

Loss after income tax attributable to the owners of Novogen Limited

     (7,139      (7,468      (1,031
  

 

 

    

 

 

    

 

 

 

 

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Note 37. Earnings per share (continued)

 

     Number      Number      Number  

Weighted average number of ordinary shares used in calculating basic earnings per share

     238,418,048         156,725,363         114,690,737   
  

 

 

    

 

 

    

 

 

 

Weighted average number of ordinary shares used in calculating diluted earnings per share

     238,418,048         156,725,363         114,691,737   
  

 

 

    

 

 

    

 

 

 
     Cents      Cents      Cents  

Basic earnings per share

     (2.99      (4.76      (0.90

Diluted earnings per share

     (2.99      (4.76      (0.90

60,000,000 unlisted convertible notes with a face value of A$1,500,000 and 179,925,987 unlisted options have been excluded from the above calculations as they were antidilutive.

 

Note 38. Share-based payments

The options in the table below have been issued as consideration for services rendered in relation to capital raising conducted during the year by the consolidated entity.

 

2015                                                
Grant date    Expiry date     

Exercise

price

     Balance at
the start of
the year
     Granted      Exercised     Expired/
forfeited/
other
     Balance at
the end of
the year
 

04/03/2015(1)

     16/12/2019       A$ 0.150         —           1,314,000         (847,530     —           466,470   

04/03/2015(2)

     18/12/2019       A$ 0.150         —           562,032         (362,511     —           199,521   

24/06/2015(3)

     30/12/2015       A$ 0.300         —           1,380,000         —          —           1,380,000   

24/06/2015(4)

     30/06/2020       A$ 0.400         —           5,190,000         —          —           5,190,000   
        

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 
           —           8,446,032         (1,210,041     —           7,235,991   
        

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

 

     A$      A$      A$      A$      A$  

Weighted average exercise price

   $ 0.000       $ 0.328       $ 0.150       $ 0.000       $ 0.358   

 

* All the options listed above were vested and exercisable at the end of the period.

(1) Tranche 1 – (2) Tranche 2 – (3) Tranche 3 – (4) Tranche 4

The weighted average remaining contractual life of options outstanding at the end of the period is 4.1 years.

Options Valuation

In order to obtain a fair valuation of these options, the following assumptions have been made:

The Black and Scholes option valuation methodology has been used. This Option Valuation methodology has been used with the expectation that the majority of these options would be exercised towards the end of the term of these options.

The exercise prices and expiry dates of these options are disclosed in the table above.

 

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The closing price of an ordinary share as at the close of 4 March 2015 (for Tranches 1 and 2) and 24 June 2015 (for Tranches 3 and 4) was 18.0 cents and 24.50 cents respectively. These dates were used as deemed dates of grant and this price as deemed spot price on the date of grant for the valuation purposes.

The risk-free rate of a five year Australian Government bond as being 2.07% (on 4 March 2015) was used. Similarly, the risk-free rate of a two year and a five year Australian Government bond as being 2.02% (on 4 March 2015) and 2.34% (on 24 June 2015) were applied respectively.

The Tranches 1, 2, 3 and 4 options do not have any vesting conditions and vest immediately on the grant date. These options are unlisted. To reflect the unlisted status of the options, a discount rate of 20% to 30% may be applicable. No discount rate was applied in this instance.

No dividends are expected to be declared or paid by the consolidated entity during the terms of the options.

The underlying expected volatility was determined by reference to historical data of the Company’s shares over a period of time. No special features inherent to the options granted were incorporated into measurement of fair value.

Based on the above assumptions, the table below sets out the valuation for each tranche of options:

 

Grant date    Expiry date      Share price at
Grant Date
     Exercise
price
     Volatility
(%)
    Option
Life
     Grant Date Fair
value per option
 

04/03/2015

     16/12/2019       A$ 0.180       A$ 0.150         120.00     4.79       A$ 0.150   

04/03/2015

     18/12/2019       A$ 0.180       A$ 0.150         120.00     4.79       A$ 0.150   

24/06/2015

     30/12/2015       A$ 0.245       A$ 0.300         150.00     0.52       A$ 0.083   

24/06/2015

     30/06/2020       A$ 0.245       A$ 0.400         150.00     5.02       A$ 0.217   

 

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Directors’ declaration

In the directors’ opinion:

 

 

the attached financial statements and notes thereto comply with International Financial Reporting Standards as issued by the International Accounting Standards Board as described in note 2 to the financial statements;

 

 

the attached financial statements and notes thereto give a true and fair view of the consolidated entity’s financial position as at June 30, 2015 and June 30, 2014 and of its performance for the financial years ended June 30, 2015, June 30, 2014 and June 30, 2013; and

 

 

there are reasonable grounds to believe that the Company will be able to pay its debts as and when they become due and payable.

Signed in accordance with a resolution of the directors.

On behalf of the directors

 

/s/ Ian Phillips

Ian Phillips, MNZM
Chairman

October 30, 2015

Sydney

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

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, 2015 and 2014, and the related consolidated statements of profit or loss and other comprehensive income, changes in shareholders’ equity, and cash flows for each of the three years in the period ended June 30, 2015. 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. We were not engaged to perform an audit of the Company’s 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, 2015 and 2014, and the results of their operations and their cash flows for each of the three years in the period ended June 30, 2015 in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.

/s/ Grant Thornton

GRANT THORNTON AUDIT PTY LTD

Chartered Accountants

Sydney, NSW, Australia

October 30, 2015

 

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SIGNATURES

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

 

NOVOGEN LIMITED

/s/ Iain Ross

Iain Ross
Chief Executive Officer

Date: October 30, 2015

 

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Exhibit Index

 

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)
  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    Prospectus in relation to the resale of securities (9)
  4.14    Prospectus in relation to the resale of securities (10)
  4.15    Placement Confirmation Letter in relation to the December PIPE, including signature pages and terms and conditions of Options (11)
  4.16    Placement Confirmation Letter in relation to the April PIPE, including signature pages and terms and conditions of Options (12)
  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. (*)
23.1    Consent of Grant Thornton Audit Pty Ltd (*)

 

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* 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).
(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).
(9) Incorporated by reference to Form 424B1 filed with the Securities and Exchange Commission under rule 424(b)(1) on March 19, 2015 (File No. 333-201767).
(10) Incorporated by reference to Form 424B1 filed with the Securities and Exchange Commission under rule 424(b)(1) on September 28, 2015 (File No. 333-205666).
(11) Incorporated by reference to Registration Statement on Form F-3 filed with the Securities and Exchange Commission on January 30, 2015, as amended on March 17, 2015 (File No. 333-201767).
(12) Incorporated by reference to Registration Statement on Form F-3 filed with the Securities and Exchange Commission on July 15, 2015, as amended on September 24, 2015 (File No. 333-205666).

 

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