20-F 1 d272985d20f.htm FORM 20-F FORM 20-F
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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, 2016

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 5, 20 George Street, Hornsby, New South Wales 2077, Australia

(Address of principal executive offices)

Ms Cristyn Humphreys

(e)Cristyn.Humphreys@novogen.com (t) +61-2-9472-4101

Level 5, 20 George Street, 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, 2016 was 429,733,982.

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      12   

Item 4A.

   Unresolved Staff Comments      21   

Item 5.

   Operating and Financial Review and Prospects      21   

Item 6.

   Directors, Senior Management and Employees      29   

Item 7.

   Major Shareholders and Related Party Transactions      45   

Item 8.

   Financial Information      46   

Item 9.

   The Offer and Listing      46   

Item 10.

   Additional Information      48   

Item 11.

   Quantitative and Qualitative Disclosures about Market Risk      59   

Item 12.

   Description of Securities Other than Equity Securities      59   

PART II

     61   

Item 13.

   Defaults, Dividend Arrearages and Delinquencies      61   

Item 14.

   Material Modifications to the Rights of Security Holders and the Use of Proceeds      61   

Item 15.

   Controls and Procedures      61   

Item 16.

   [Reserved]      62   

Item 16A.

   Audit Committee Financial Expert      62   

Item 16B.

   Code of Ethics      62   

Item 16C.

   Principal Accounting Fees and Services      62   

Item 16D.

   Exemptions from the Listing Standards for Audit Committees      63   

Item 16E.

   Purchases of Equity Securities by the Issuer and Affiliated Purchasers      63   

Item 16F.

   Changes in registrant’s Certifying Accountant      63   

Item 16G.

   Corporate Governance      63   

Item 16H.

   Mine Safety Disclosure      64   

PART III

     64   

Item 17.

   Financial Statements – Not Applicable      64   

Item 18.

   Financial Statements      64   

Item 19.

   Exhibits      64   


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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, “Novogen,” “Company,” “we,” “us” and “our” refer to Novogen Limited and its wholly owned subsidiaries on a consolidated basis, unless the context otherwise provides.

 

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PART I

 

Item 1. Identity of Directors, Senior Management and Advisors

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

 

Item 2. Offer Statistics and Expected Timetable

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

 

Item 3. Key Information

Selected financial data

The selected financial data at June 30, 2016 and 2015 and for the years ended June 30, 2016, 2015 and 2014 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 2016” refers to the 12 months ended June 30, 2016. 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)
   2012
A$’000
    2013
A$’000
    2014
A$’000
    2015
A$’000
    2016
A$’000
    2016
US$’000
 

Revenue and other income

     2,373        1,730        429        2,842        4,071        3,026   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income tax expense from continuing operations

     (1,471     (1,508     (7,569     (7,306     (12,155     (9,033

Profit after income tax expense from discontinued operations

     121        723        —          —          —          —     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss after income tax expense for the year

     (1,350     (785     (7,569     (7,306     (12,155     (9,033
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

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

     1,309        (1,031     (7,468     (7,139     (12,062     (8,965
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

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

            

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

     (1.44     (1.32     (4.76     (2.99     (2.82     (2.10

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

     (1.44     (1.32     (4.76     (2.99     (2.82     (2.10

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

            

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

     2.72        0.42        —          —          —          —     

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

     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)

     1.28        (0.90     (4.76     (2.99     (2.82     (2.10

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

     1.28        (0.90     (4.76     (2.99     (2.82     (2.10

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

     102,435,227        114,690,737        156,725,363        238,418,048        427,431,910        427,431,910   

Number of outstanding ordinary shares at year end

     103,805,676        138,276,033        168,557,834        423,116,465        429,733,982        429,733,982   

 

Summary of consolidated financial position (IFRS)    2012
A$’000
     2013
A$’000
     2014
A$’000
     2015
A$’000
     2016
A$’000
     2016
US$’000
 

Cash and cash equivalents

     8,348         2,738         2,502         44,371         33,453         24,862   

Total assets

     8,985         5,749         4,660         46,140         35,517         26,396   

Net assets/Equity

     5,113         4,041         1,413         44,362         33,931         25,217   

Debt

     —           1,416         2,707         —           —           —     

Capital Stock

     199,026         137,663         142,586         190,404         191,301         142,175   

 

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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$0.7432 = 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, 2016. The rate on September 30, 2016 was US$0.7667 = A$1.00.

Exchange rates for the six months to September 2016 A$1.00 per US$

 

Month    High      Low  

April

   $ 0.7817       $ 0.7504   

May

   $ 0.7641       $ 0.7184   

June

   $ 0.7598       $ 0.7225   

July

   $ 0.7632       $ 0.7453   

August

   $ 0.7717       $ 0.7516   

September

   $ 0.7676       $ 0.7470   

Exchange rates for the last five fiscal years A$1.00 per US$

 

Fiscal year ended June 30    Average Rate*  

2012

   $ 1.0323   

2013

   $ 1.0272   

2014

   $ 0.9186   

2015

   $ 0.8365   

2016

   $ 0.7289   

 

* Determined by calculating the average rate of the exchange rates on the last trading day of each month during the period.

 

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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 developing lead candidate anti-cancer drugs from two drug technology platforms, super-benzopyrans (“SBP”) and anti-tropomyosins (“ATM”). 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. The Company was successful in gaining Investigational New Drug (“IND”) status from the U.S. Food and Drug Administration (“FDA”) for our lead SBP. While we have addressed early stage risk associated with toxicity, significant risks and uncertainties remain in translating those early laboratory results into drugs that will have meaningful clinical application in the market place given the stringent clinical trial process that is required to achieve market approval. We are in the process of our IND-enabling safety evaluation of our lead ATM drug candidate so significant safety risk remains with this technology platform. The Company plans to submit an IND to the FDA to obtain the appropriate approval to enable a Phase I trial of our lead ATM drug candidate.

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

 

   

poor formulation;

 

   

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. We expect to consume cash and incur operating losses for the foreseeable future as the Company continues developing 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. While it is not possible to make accurate predictions of future operating results, we expect existing cash and cash equivalents will be sufficient to enable us to continue our research and development activities until approximately second quarter 2018.

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

 

   

the recruitment rate, duration and of the Cantrixil Phase I clinical trial and observed efficacy signals in cancer patients;

 

   

the length of time and amount of work required for the lead ATM to complete its safety evaluation program to bring any lead candidate compounds through their pre-clinical programs;

 

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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; 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 favorable 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.

We receive Australian government research and development grants. If we lose funding from these research and development grants, we may encounter difficulties in the funding of future research and development projects, which could harm our operating results.

We have historically received, and expect to continue to receive, grants through the Australian federal government’s Research and Development Tax Incentive program, under which the government provides a cash refund for the 45% of eligible research and development expenditures by small Australian entities, which are defined as Australian entities with less than A$20 million in revenue, having a tax loss. The Australian federal government’s Research and Development Tax incentive program cash refund changes from 45% to 43.5% from July 2016. The Research and Development Tax Incentive grant is made by the Australian federal government for eligible research and development purposes based on the filing of an annual application. We received Research and Development Tax Incentive grants in fiscal 2015 and 2016 of A$1.5 million and A$2.9 million, respectively. This grant is available for our research and development activities in Australia, as well as activities in the United States to the extent such U.S. based expenses relate to our activities in Australia, do not exceed half the expenses for the relevant activities and are approved by the Australian government. To the extent our research and development expenditures are deemed to be “ineligible,” then our grants would decrease. In addition, the Australian government may in the future decide to modify the requirements of, reduce the amounts of the grants available under, or discontinue the Research and Development Tax Incentive program. For instance, the Australian government recently received a recommendation from a review panel recommending a reduction of the amount of the grants available to small entities such as Novogen to a maximum of A$2 million per annum. Any such change in the Research and Development Tax Incentive program could have a material adverse effect on our future cash flows and financial position.

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 has an extensive patent portfolio to protect its key assets. The patent strategy is adapted for each technology platform and the sub-sections of each platform. The over-arching strategy in the IP portfolio is to cover the three critical corner stones of pharmaceutical patent: composition of matter (the breadth structures covered in the patent), method of manufacture (the chemical processes used to manufacture the compounds disclosed in the patent) and method of use. Our key patents covering lead assets have been granted in Australia and are at different stages of entering national phase in jurisdictions covering ~95% of the global market as measured by sales. Consequently, the risk to our patent coverage for our lead assets has been substantially reduced. 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.

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.

 

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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.

The Company is involved in early stage research and development and has a history of incurring losses. The Company is likely to continue to incur losses in the near future, until such time as any possible commercial breakthrough occurs.

The Company incurred net losses of A$7.6 million for year ended June 30, 2014, net losses of A$7.3 million for the year ended June 30, 2015 and net losses of A$12.2 million for year ended June 30, 2016. As of June 30, 2016, we have accumulated losses of A$160.5 million (US$119.3 million) 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 via Royalty and license agreements. 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. Cantrixil has received IND status and will commence clinical trials later in 2016. The company and/or licensees of the technology will need to demonstrate safety and efficacy through standard clinical development methodologies before an application to market can be made to begin generating revenue. Anisina and Trilexium are at early stages of development, and the Company will need to conduct significant pre-clinical safety and efficacy studies of these drug candidates before clinical trials can begin with these compounds;

 

   

data obtained from pre-clinical and clinical studies will impact “go”/“no-go” decision points that may impact further development;

 

   

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

 

   

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.

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.

 

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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.

Regardless of regulatory approval, products arising from the development process 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:

 

   

advancements in the treatment of cancer that make our treatments obsolete;

 

   

market exclusivity and competitor products;

 

   

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.

The Company has been successful in executing contractual agreements with strategic partners. This remains a key part of the Company’s business plan and the Company must continue to partner with third parties to manufacture clinical grade drug product, and conduct key pre-clinical and clinical investigations. Strategic agreements around packaging, branding, market access and distribution for its drug products will also eventually be required.

Potential partners could 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, the Company 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 and is high risk. 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.

 

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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.

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 outsources the manufacture of its drug product and testing of it to FDA requirements. The Company uses 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.

 

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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.

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:

 

   

unacceptable toxicity findings in animals and humans;

 

   

lack of efficacy in human trials at Phase II stage or beyond;

 

   

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.

 

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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.

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. An ADS refers to the individual share represented by the ADR program. 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, 2016. 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. See Item 10 - Additional Information - Taxation, United States Federal Income Tax Consequences” for a more complete discussion of the U.S. federal income tax risks related to owning and disposing of our ADSs.

 

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Item 4. Information on the Company

History and development of the Company

Novogen Limited, a public company limited by shares, was incorporated in March 1994 under the laws of New South Wales, Australia. Novogen is registered and operates under the Australian Corporations Act 2001. Novogen has its registered office at Level 5, 20 George Street, 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 Depositary for the Company’s ADRs is The Bank of New York Mellon, 101 Barclay Street 22W New York, N.Y. 10286.

Business overview

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

Corporate developments

Triaxial Pharmaceuticals Pty Ltd

In December 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 A$0.09 per share as part of the acquisition, the purchase price of which included a A$1.5 million loan, payable to the Triaxial shareholders.

In December 2014, the Company and 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.

In August 2016, the Company announced the submission of an IND application with the FDA and, in September 2016, the Company received a letter from the FDA advising that the study may proceed. Accordingly, the Company advised the note holders of this conversion event and 20,000,000 ordinary shares were issued to the noteholders in September 2016.

 

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CanTx Inc.

CanTx, Inc., a subsidiary in which a wholly-owned subsidiary of the Company held an 85% interest, was dissolved in May 2016. The dissolution was completed following a decision to stop funding the operations of CanTx, Inc.

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 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 July 16, 2015, the Company announced that it has received orphan drug status designation from the FDA for Anisina.

On February 19, 2016, the Company announced the patent covering Cantrixil and Trilexium has proceeded to grant.

On June 14, 2016, the Company announced the patent covering Anisina has proceeded to grant.

On September 12, 2016, the Company announced the FDA approved the IND application for Cantrixil.

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 in fiscal 2016.

Cantrixil: From an operational perspective we successfully prepared and lodged our IND Application for our lead drug candidate Cantrixil (TRXE-002-1) with the FDA. This application consisted of the pharmacology, toxicology, Chemistry, Manufacturing Controls and Clinical protocol documentation considered requisite for an IND submission. The TRXE-002-1 pharmacology data was published in the prestigious American Association for Cancer Research (“AACR”) journal “Molecular Cancer Therapeutics” and the Toxicology data was presented at the 2016 Annual Conference of the American Association for Cancer Research. The Company successfully gained IND status from the FDA for TRXE-002-1 enabling us to execute our Phase I trial, and finalised agreements with Quintiles, the Clinical Research Organisation contracted to oversee the TRXE-002-1 Phase I clinical trial and identify hospital trial sites to conduct the Phase I trial.

Anisina: The Company is currently preparing Anisina (ATM-3507) pharmacology proof-of-concept reports and identifying target cancer indication(s) and completing scale up manufacture of ATM-3507 drug substance and drug product to GLP standards for formal safety pharmacology and toxicity studies. The Company has initiated the requisite IND-enabling safety studies and commenced document preparation for the ATM-3507 IND submission to the FDA ahead of commencing our Phase I clinical trial on this drug candidate. The Company has also completed manufacture of cGMP drug substance to be used in the ATM-3507 Phase I trial.

 

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Trilexium: The Company has identified the Trilexium (TRXE-009-1) drug target, mechanism of action and target cancer indication(s); generated proof-of-concept data in animal models of cancer, and are currently in the process of optimising drug product formulation to take forward into safety-pharmacology and toxicity studies ahead of progressing into the clinic with this molecule.

Discovery: The Company has identified a series of pipeline molecules from the second-generation super-benzopyran technology platform (AD-HET system) and a series of pipeline molecules from the next generation N-terminal targeting anti-tropomyosin family (termed 6500).

Intellectual Property: The Company has substantially strengthened the IP estate around the SBP and ATM technology platforms and has begun national phase roll out into international jurisdictions for current granted patents.

Other technologies: Results from the Regenerative Medicine, and Lysosomal storage disorder research programs did not justify further R&D expenditure. However, we did observe some positive data from the Facioscapulohumeral muscular dystrophy (“FSHD”) program and we are currently pursuing several development opportunities. Our decision to focus on Oncology drug development has allowed us to meet key development, intellectual and regulatory milestones for our lead oncology assets.

Patent Protection

The Company has an aggressive global Intellectual Property (“IP”) strategy to protect its key assets and we have partnered with a global patent law firm to lodge patents that offer the best possible protection for our assets. The patent strategy is adapted for each technology platform and the principle mode of protection is through the patenting procedure, seeking to obtain exclusive licences for all its key inventions and drug pipeline. The over-arching strategy in the IP portfolio is to cover the three critical corner stones of pharmaceutical patent: composition of matter (the breadth structures covered in the patent), method of manufacture (the chemical processes used to manufacture the compounds disclosed in the patent) and method of use. The Company’s IP is centered around two key technology platforms; the super-benzopyrans (SBPs) and the anti-tropomyosins (ATMs). Patents are submitted initially as provisional applications and after 12 months’ progress through to a Patent Cooperation Treaty (“PCT”) application. Our key patents covering lead assets, Cantrixil, Trilexium (both SBP assets) and Anisina (ATM asset) have been granted in Australia and are at different stages of entering national phase in jurisdictions covering approximately 95% of the global market as measured by sales.

Drug discovery/development efforts are contributing to our pipeline with our other technology platforms also delivering hit and lead drug candidates. As the research programs reveal new hit molecules, these are protected through lodging patents. The Company will continue to pursue a broad patent filing strategy based on multiple jurisdictions with a focus on those member countries offering the most significant market opportunities for future development.

Key developments during fiscal 2016 include:

 

   

The Tri Series patent, which covers clinical candidates TRXE-002-1 and TRXE-009-1, was granted in Australia on February 18, 2016. The 30 month national phase entry deadline on this patent (priority date February 7, 2014) occurred on August 7, 2016. All documents are in place and national phase has been entered in jurisdictions that cover approximately 95% of the global pharmaceutical market, as measured by sales.

 

   

The 3500 Series patent, which covers the clinical candidate ATM-3507 was granted in Australia on June 9, 2016. The national phase deadline for this patent (priority date July 16, 2014) is January 17, 2017. The patent will enter national phase in jurisdictions covering 95% of the global pharmaceutical market (as measured by sales).

 

   

The Company’s other patent families have either reached the PCT stage, have begun to enter national phase in selected jurisdictions or are currently in preparation for filing.

 

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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.

 

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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.

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;

 

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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.

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 2017, the user fee for an application requiring clinical data, such as an NDA, is US$2,038,100. The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also imposes an annual product fee for prescription drugs and biologics (US$97,750), and an annual establishment fee (US$512,200) 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.

 

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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.

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.

 

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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.

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.

 

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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.

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.

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 regained 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

Novogen Limited is incorporated in Australia and has the following wholly-owned subsidiaries:

 

Name

  

Country of incorporation

Novogen Laboratories Pty Ltd    Australia
Novogen Research Pty Ltd    Australia
Novogen North America Inc.    United States (Delaware)
Triaxial Pharmaceuticals Pty Ltd    Australia

 

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On 31 May 2016, the Company merged its U.S. fully owned subsidiary Novogen, Inc. with Novogen North America, Inc. The merger was completed to simplify the group’s structure. The Company also approved the dissolution of Cantx, Inc., a subsidiary in which Novogen North America, Inc. held an 85% interest. The dissolution of Cantx, Inc. was completed on 31 May 2016.

Property, plant and equipment

To accommodate its growth, the Company has entered into a new 3-year lease, starting November 2015. The office lease contains two renewal options, each for a three-year period. These renewal options may be cancelled by the Company. The Company at this stage intends to exercise the two remaining options. In order to exercise an option, the Company must inform the lessor no later than 6 months prior to the end of the lease, by which time it must commit to the term of the option.

 

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.

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 Company has not recognized deferred tax assets relating to carried forward tax losses and taxable temporary differences since the Company 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 Company estimates its tax liabilities based on the Company’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.

 

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Share-based Payment Transactions

The Company 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 expense all internal research and development expenditures 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 Australian Research and Development Tax Incentive is a government run program which helps to offset some of the costs of R&D. Annually, the Company claims a refundable tax offset and has disclosed this as other income in the statement of profit or loss and other comprehensive income. The Company 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 Company 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 such as cash flow projections and discount rate.

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

Operating results

The following table provides a summary of revenues and income for the past three fiscal years:

 

(in thousands)    For the fiscal year ended June 30,  
     2016      2015      2014  

Revenue:

        

Interest income

     406         89         87   

Other income:

        

Net foreign exchange gain

     781         1,116         —     

Payroll tax rebate

     18         8         —     

Research and development rebate

     2,866         1,538         342   

Subsidies and grants

     —           91         —     
  

 

 

    

 

 

    

 

 

 

Total revenue and other income

   A$ 4,071       A$ 2,842       A$ 429   
  

 

 

    

 

 

    

 

 

 

 

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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.

Fiscal 2016 compared to fiscal 2015

Revenue and other income

The Company’s revenue, which is solely interest income derived from interest bearing bank account, increased from A$89,000 in 2015 to A$406,000 in 2016 as a result of capital raisings in April and June 2015 that raised aggregate gross proceeds of A$33.2 million, thus providing for higher interest returns on increased bank account cash balances in fiscal 2016.

Net foreign exchange gain decreased 30% from A$1.1 million in fiscal 2015 to A$0.8 million in fiscal 2016 due to less volatility in the exchange rate.

Research and development grant (rebate) increased 86% from A$1.5 million in fiscal 2015 to A$2.9 million in fiscal 2016 due to higher level of eligible research and development expense in fiscal 2016. The Australian federal government’s Research and Development Tax incentive program cash refund changes from 45% to 43.5% from July 2016. We note that the Australian government recently received a recommendation from a review panel recommending a reduction of the amount of the grants available to small entities such as Novogen to a maximum of A$2 million per annum commencing fiscal year 2018. Any such change in the Research and Development Tax Incentive program could have a material adverse affect on the Company’s research and development grant (rebate) as well as on our future cash flows and financial position.

Expenses

Research and development expenses increased A$4.0 million from A$5.9 million in fiscal 2015 to A$9.9 million in fiscal 2016 due to higher research and development activity in fiscal 2016, including the completion of necessary Chemistry, Manufacturing and Controls activity in relation to the Cantrixil program, as required by the FDA and finalization of the first-in-human Phase I clinical protocol. In relation to Anisina, the Company has manufactured both the active candidate drug substance and candidate drug product. The Company has also manufactured the candidate drug substance to cGMP in preparation for first-in-human clinical trials.

General and administrative costs increased A$2.0 million (53%) from A$3.8 million in fiscal 2015 to A$5.8 million in fiscal 2016 due, in large part, to a rental increase arising from a relocation of our headquarters in November 2015 as well as higher legal and consultancy fees.

There were no finance costs in fiscal 2016, representing a decrease of A$370,000 in comparison with fiscal 2015, with the A$370,000 consisting of A$69,000 finance costs and A$301,000 loss in fair value of convertible notes. There was no borrowing during fiscal 2016 as a result of the additional funds raised through the issue of equity securities in fiscal 2015.

 

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Net loss

As a result of the above and particularly the higher research and development expenses, the Company’s loss after income tax increased A$4.9 million (67%) from A$7.3 million in fiscal 2015 to A$12.2 million in fiscal 2016.

Fiscal 2015 compared to fiscal 2014

Revenue and other income

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

Net foreign exchange gain increased from none in fiscal 2014 to A$1.1 million in fiscal 2015 due to an increase in the foreign currency balances and transactions.

Research and development grant increased from A$342,000 in fiscal 2014 to A$1.5 million in fiscal 2015 due to higher level of eligible research and development expense in fiscal 2015.

Expenses

Research and development expenses increased A$2.6 million (79%) from A$3.3 million in fiscal 2014 to A$5.9 million in fiscal 2015 due to ongoing implementation of research and development programs.

General and administrative costs for fiscal 2015 were A$3.8 million, 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 were A$370,000 in fiscal 2015, representing a decrease of A$885,000 in comparison with fiscal 2014. This decrease is due to the repayment of borrowings during fiscal as a result of the additional funds raised through the issue of equity securities.

Net loss

As a result of the above, the Company’s loss after income tax decreased 4% from A$7.6 million in fiscal 2014 to A$7.3 million in fiscal 2015.

Liquidity and capital resources

We have incurred cumulative losses and negative cash flows from operations since our inception and, as of June 30, 2016, we had accumulated losses of A$161.5 million. We anticipate that we will continue to incur losses for at least the next several years. We expect that our research and development and general and administrative expenses will continue to increase and, as a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, debt financings, other third-party funding and other collaborations, strategic alliances and licensing arrangements.

We had no borrowings in fiscal 2016 and do not currently have a credit facility.

As of June 30, 2016, we had cash and cash equivalents of A$33.5 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our cash and cash equivalents are held in bank accounts. Our short-term investments consist of term deposits with maturity within 90 days. At June 30, 2016, term deposits amounting to A$13.0 million had a weighted average interest rate of 2.60% and cash deposits of A$20.4 million had a weighted average interest rate of 0.31%.

 

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We expect to consume cash and incur operating losses for the foreseeable future as the Company continues developing 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. While it is not possible to make accurate predictions of future operating results, we expect existing cash and cash equivalents will be sufficient to enable us to continue or research and development activities until approximately second quarter fiscal 2018.

Cash flows

The following table set forth the sources and uses of cash for the past three fiscal years:

 

     For the fiscal year ended June 30,  
(in thousands)    2016      2015      2014  

Net cash used in operating activities

   A$ (11,978    A$ (5,759    A$ (5,709

Net cash used in investing activities

     (522      (89      (27

Net cash provided by financing activities

     782         47,415         5,500   

Operating activities. Net cash used in operating activities for fiscal 2016, fiscal 2015 and fiscal 2014 was A$12.0 million, A$5.8 million and A$5.7 million, respectively. The use of net cash in all periods resulted primarily from our net losses.

Investing activities. Net cash used in investing activities in fiscal 2016, 2015 and 2014 was A$522,000, A$89,000 and A$27,000, respectively, and mostly related to purchases of equipment.

Financing activities. Net cash provided by financing activities of A$782,000 in fiscal 2016 related to the exercise of options, A$47.4 million in fiscal 2015 related to the issuance of ordinary shares in private placements and a rights issue and A$5.5 million in fiscal 2014 related to the issuance of convertible notes.

At June 30, 2016, the Company entity did not hold any derivative financial instruments for managing its foreign currency; however, the Company may from time to time enter into hedging arrangements where circumstances are deemed appropriate.

The Company believes that 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 Company claims a refundable tax offset and has disclosed this as other income in the statement of profit or loss and other comprehensive income. The Company currently accounts for R&D Tax Incentive on a cash basis due to the difficulty of making a reasonable estimation as at year end.

The Company had no commitments for capital expenditure at the end of fiscal 2016.

The Company continuously pursues opportunities 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.

Financing activities

The Company has historically financed its operations primarily from issuing equity capital and, to a lesser extent, convertible notes.

 

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Private Equity Placement – November 2014

On November 12, 2014, the Company issued ordinary shares in a private placement to institutional and professional investors at A$0.11 per share along with an option (for no consideration), exercisable at A$0.125 per share. In the aggregate, the Company issued 16,859,988 ordinary shares and 16,859,988 unlisted options. The gross proceeds of the private placement were approximately A$1.9 million. In addition, during fiscal 2015, the Company received approximately A$1.4 million from the proceeds of the exercise of options issued as part of the private placement.

Private Equity Placement – December 2014

In December 2014, the Company issued to institutional and professional investors an aggregate of 46,900,800 ordinary shares at a purchase price of A$0.125 per share. Following the approval of shareholders in March 2015, the Company issued 50,652,864 options with an exercise price of A$0.15 per option exercisable by December 2019. As consideration for the issue of ordinary shares, the Company received gross proceeds of approximately A$5.9 million. In addition, the Company received approximately A$6.8 million from the proceeds of the exercise of options issued as part of this private placement.

Private Equity Placement – April 2015

In April 2015, the Company issued to institutional investors in a private placement 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.

Rights Issue – June 2015

On June 4, 2015, the Company issued as part of a rights offer to eligible shareholders 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.

The Company received gross proceeds of approximately A$17.7 million from the rights offer.

During fiscal 2016, the Company issued 6,617,517 ordinary shares, all following the exercise of options. The details of these options is as follows:

 

 

1,000 options expiring June 4, 2020, at an exercise price of A$0.40 per option;

 

 

1,000,000 options expiring on December 18, 2019, at an exercise price of A$0.15 per option;

 

 

5,614,224 options expiring on November 18, 2015, at an exercise price of A$0.125 per option; and

 

 

2,293 options expiring December 4, 2015, at an exercise price of A$0.30 per option.

Foreign currency fluctuations were not material for the Company in fiscal 2016. See Item 18. “Financial Statements - Note 27 – Financial Instruments” for disclosures about financial risk management including interest rate risk, foreign currency risk and liquidity risk.

Convertible notes

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

A convertible note was issued in November 2013 with a face value of A$1,500,000. The convertible note was exercisable at the holder’s discretion as follows:

 

•    On completion of Phase 1a clinical trials

   A$400,000 converted into 16,000,000 ordinary shares

•    On receipt of Investigational New Drug approval from the FDA*

   A$500,000 converted into 20,000,000 ordinary shares

•    On completion of Phase II clinical trials

   A$600,000 converted into 24,000,000 ordinary shares

 

* On September 12, 2016, the FDA approved the IND application for Cantrixil. Accordingly, 20,000,000 ordinary shares in the Company were issued to noteholders on September 14, 2016.

 

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Convertible note (Hudson Bay)

In July 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 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.

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$9.9 million, A$5.9 million and A$3.3 million on research and development expenditure from both continuing and discontinued operations during fiscal 2016, 2015 and 2014 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 included salary and related general expenses of scientists totalling $853,000 in general and administrative expenses. These expenses have been reclassified from general and administrative expenses to research and development expenses.

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.

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, 2016:

 

     Total      less than 1
year
     1 - 3 years      3 - 5 years      more than
5 years
 
     A$’000      A$’000      A$’000      A$’000      A$’000  

Operating Leases

     494         204         287         3         —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 
     494         204         287         3         —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

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Operating lease commitments include contracted amounts for leases of premises and plant and equipment under non-cancellable operating leases expiring within three years. Leases for premises include an annual review for CPI increases.

The office lease contains two renewal options, each for a three-year period. These renewal options are not included in the commitments as they may be cancelled by the Company. The Company at this stage intends to exercise the two remaining options. In order to exercise an option, the Company must inform the lessor no later than 6 months prior to the end of the lease, by which time it must commit to the term of the option.

 

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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, Deputy Chairman
Steven Coffey   Non-Executive Director
James Garner   Managing Director, CEO
John O’Connor   Non-Executive Director, Chairman
Ian Phillips   Non-Executive Director
Iain Ross   Non-Executive Director

Former directors who served during fiscal 2016:

 

 

Graham Kelly, former Chairman and CEO (resigned in July 2015)

 

 

Peter Gunning, former Non-Executive Director (resigned on September 5, 2016)

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

Names, qualifications, experience and special responsibilities

 

Name:   John O’Connor
Title:   Non-Executive Director, Chairman
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 MEI Pharma, Inc. assisting with fundraising.
Other current directorships:   None
Special responsibilities:   None
Name:   Bryce Carmine
Title:   Non-Executive Director, Deputy Chairman
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 led the Global Pharmaceutical Sales and Marketing and was a member of the company’s Executive Committee. Mr Carmine 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
Special responsibilities:   Chair of Audit, Risk and Governance Committee, Chair of Scientific Committee, Member of Strategy and Innovation Committee

 

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Name:   Steven Coffey
Title:   Non-Executive Director
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
Special responsibilities:   Chairman of the Remuneration and Nomination Committee
Name:   Dr James Garner
Title:   Executive Director and Chief Executive Officer
Experience and expertise:   Dr Garner is an internationally experienced life sciences executive who has previously worked with companies ranging from small biotechs to multinational pharmaceutical companies such as Biogen and Takeda. His career has focused on regional and global development of new medicines from preclinical to commercialisation.
  Dr Garner is a physician by training and holds an MBA from the University of Queensland. He began his career in hospital medicine and worked for a number of years as a corporate strategy consultant with Bain & Company before entering the pharmaceutical industry. From 2013 to 2016, he led R&D strategy for Sanofi in Asia-Pacific and was based in Singapore. Prior to that, he was regional Vice President of R&D for Takeda, from 2009-2013, where he had responsibility for a multinational team of approximately 60 people, and oversight of all development activities in the Asia-Pacific region.
Other current directorships:   None
Special responsibilities:   Member of Scientific Committee and Member of the Strategy and Innovation Committee
Name:   Ian M. Phillips MNZM
Title:   Non-Executive Director
Experience and expertise:   Ian M. Phillips has been involved with International Banking, global financial markets and Corporate Finance for over 30 years having worked in New York, London, Singapore, Sydney and Wellington. 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. As Regional Head of Commonwealth Bank North and South America between 1996 and 2002 and then 2006 to 2013, Ian was responsible to the US regulators, the OCC, as well as taking overall responsibility for compliance with accounting standards. He also chaired the New York based Broker Dealer of CBA Americas during this period. Ian studied at Otago University, University of Colorado and London School of economics. He holds dual citizenship in the USA & New Zealand. In 2013, Ian was awarded the New Zealand Order of Merit.
Other current directorships:   None
Special responsibilities:   Chair of Strategy and Innovation Committee, Member of Remuneration and Nomination Committee and Member of the Audit, Risk and Governance Committee.

 

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Name:   Iain Ross
Title:   Director, Acting CEO (appointed July 2015 - retired January 2016)
  Non-Executive Director (from February 2016)
Experience and expertise:   Iain is an experienced Director on a number of Australian company boards. He is also currently Executive Chairman of e-Therapeutics plc. In his career he has held senior positions in 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 over 20 years in cross-border management as a Chairman and CEO. He has led and participated in four London Stock Exchange (“LSE”) Initial Public Offerings, and has direct experience of mergers and acquisitions transactions in Europe, USA and the Pacific Rim.
Other current directorships:   Anatara Lifesciences Limited, Premier Veterinary Group Plc (LSE: PVG), e-Therapeutics plc (LSE: ETX) and Biomer Technology Limited
Former directorships  
(last 3 years):   Coms Plc, Tissue Therapies Limited, Benitec Biopharma Limited
Special responsibilities:   Member of Remuneration and Nomination Committee, Member of Scientific Committee and Member of the Audit, Risk and Governance Committee.
Executive officers’ profiles  
Name:   Dr David Brown
Title:   Chief Scientific Officer
Experience and expertise:   David Brown was in charge of preclinical testing for Novogen’s oncology drugs between 2000 and 2010 and was appointed CSO in 2009. David left Novogen in 2010 and re-joined the company in May 2013 as Chief Science Officer, overseeing 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
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. Andrew re-joined Novogen in 2013 as CEO & President of Novogen North America and oversees the formulation, patent and manufacture of the Company’s drug technology platforms.
Name:   Cristyn Humphreys
Title:   Chief Financial Officer
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. Cristyn commenced as Novogen CFO on January 1, 2015. Between 2012 and 2014, Cristyn was Head of Finance and Chief Strategic Officer of a privately held global manufacturing and design company.

 

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Table of Contents

Directors’ and Key Management Personnel (“KMP”) interests in the shares and options of the company for fiscal 2016:

Shareholding

The number of shares in the Company held during fiscal 2016 by each Director and other members of Key Management Personnel of the Company, 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              

B Carmine

           318,181           318,181   

S Coffey

     822,460                 822,460   

J O’Connor

     325,035                 325,035   

J Garner (appointed Feb 2016)

           150,000           150,000   

I Ross (appointed July 2016)

           750,000           750,000   

I Phillips

           70,000           70,000   

C Humphreys

     145,283            38,400           183,683   

A Heaton

     6.037,098               (872,000     5,165,098   

D Brown

     3,497,795                 3,497,795   

G Kelly* (resigned July 2015)

     5,606,534                 5,606,534   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 
     16,434,205            1,326,581         (872,000     16,886,786   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

 

* 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 fiscal 2016 by each Director and other members of Key Management Personnel of the Company, 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             

J O’Connor*

     69,654         —           —          (46,436     23,218   

S Coffey*

     176,241         —           —          (117,494     58,747   

J Garner**

     —           7,500,000         —          —          7,500,000   

C Humphreys*

     68,231         —           (38,400     (22,239     7,592   

C Humphreys**

     —           800,000         —          —          800,000   

L Mateo**(resigned September 2016)

     —           500,000         —          —          500,000   

G Kelly*,*** (resigned July 2015)

     356,069         —           —          —          356,069   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 
     670,195         8,800,000         (38,400     (186,169     9,245,626   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

 

* The above listed options were not issued as part of remuneration.
** Options issued under the Employee Share Option Plan, approved by shareholders on March 4, 2014
*** Number of options as at July 22, 2015.

 

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Table of Contents
     Vested and
exercisable
     Vested and
unexercisable
     Balance at
the end of
the year
 
Options over ordinary shares         

J O’Connor*

     23,218         —           23,218   

S Coffey*

     58,747         —           58,747   

C Humphreys*

     7,592         —           7,592   

G Kelly* (as at July 22, 2015)

     356,069         —           356,069   
  

 

 

    

 

 

    

 

 

 
     445,626         —           445,626   
  

 

 

    

 

 

    

 

 

 

 

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

For all other KMPs, no options were vested at year end.

In addition to Director’s fees, one-off consultancy fees of A$266,000 for interim executive duties while Mr Iain Ross was Acting CEO were paid in fiscal 2016 to Gladstone Consultancy Partnership, a UK based consulting partnership in which he has a beneficial interest. These fees were paid between July 2015 and February 2016. No such consultancy fees will be paid in fiscal 2017.

In addition to Director’s fees, one-off consultancy fees of A$120,000 for interim duties were paid in fiscal 2016 to Kumara Inc, a corporation in which Mr Ian Phillips is a Director and has a beneficial interest. These fees were paid between July 2015 and March 2016. No such consultancy fees will be paid in fiscal 2017.

In addition to Director’s fees, consultancy fees of A$7,000 were paid to Watkins Coffey Martin, a partnership in which Steven Coffey is a partner.

Share-based compensation

There were no shares issued to Directors or other KMP as part of compensation during fiscal 2016

Options

The terms and conditions of each grant of options over ordinary shares affecting remuneration of Directors and other Key Management Personnel in fiscal 2016 or future reporting years are as follows;

Further disclosures regarding KMPs options

 

     Opening
Balance
     Expired     Grant*      Grant**      Grant***      Closing
balance
 

J Garner

     —           —          —           5,000,000         2,500,000         7,500,000   

C Humphreys

     64,713         (57,121     800,000         —           —           807,592   

L Mateo****

     —           —          500,000         —           —           500,000   

 

* Granted October 15, 2015 with an exercise price of A$0.22 and an expiry date of November 16, 2020
** Granted March 18, 2016 with an exercise price of A$0.1988 and an expiry date of February 1, 2021
*** Granted March 18, 2016 with an exercise price of A$0.2605 and an expiry date of February 1, 2021
**** No longer Company Secretary as of September 9, 2016

 

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Table of Contents

Remuneration (Compensation)

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 and Nomination Committee believe that at this stage of the Company’s development, the financial capacity of the Company is of overriding importance in determining remuneration.

The Board and the Remuneration and Nomination Committee have instigated a performance based short-term incentive (cash bonus), provided that certain Key Performance Indicators, as determined during periodic appraisal of employees, are met.

The Board and the Remuneration and Nomination Committee have instigated a long term incentive (share options). Employees have been issued share options, under the Employee Share Options Plan (ESOP), which was approved by the shareholders at a general meeting on March 4, 2015.

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. The non-executive directors fee structure is a fixed fee model (inclusive of superannuation).

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 Company, directly or indirectly.

Use of remuneration consultants

During fiscal 2016, the Company did not engage remuneration consultants.

Details of remuneration

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

The KMP of the Company consisted of the following directors of Novogen Limited:

 

John O’Connor   Non-Executive Director, Chairman
Bryce Carmine   Non-Executive Director, Deputy Chairman
Steven Coffey   Non-Executive Director
Prof Peter Gunning   Non-Executive Director (resigned September 2016)
Ian Phillips   Non-Executive Director
Iain Ross   Non-Executive Director (appointed July 22, 2015)
Dr James Garner   Managing Director, CEO (appointed February 5, 2016)
Dr Graham Kelly   Chairman (resigned July 2015)
And the following persons:  
Dr Andrew Heaton   CEO and President of Novogen North America
Dr David Brown   Chief Scientific Officer
Cristyn Humphreys   Chief Financial Officer
Lionel Mateo   Company Secretary (resigned September 2016)

 

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     Short-term benefits     Post-
employment
benefits
     Long-term
benefits
    

Share-

based
payments

        
                   Movements
in accrued
leave
                            
     Cash salary      Cash      Non-     Super-             Equity-         
     and fees      bonus      monetary     annuation      Other      settled      Total  
2016    A$      A$      A$     A$      A$      A$      A$  

Non-Executive Directors:

                   

S Coffey

     30,700         —           —          35,000         —           —           65,700   

J O’Connor**

     97,084         —           —          9,223         —           —           106,307   

P Gunning

     60,000         —           —          5,700         —           —           65,700   

I Ross*,**

     65,700         —           —          —           —           —           65,700   

B Carmine**

     73,483         —           —          3,167         —           —           76,650   

I Phillips**

     133,861         —           —          —           —           —           133,861   

Executive Directors:

                   

G Kelly *

     72,795         —           (63,178     9,891         199,875         —           219,383   

J Garner *

     166,663         —           10,752        15,833         —           120,543         313,791   

Other Key Management Personnel:

                   

L Mateo****

     120,416         4,824         (4,548     11,898         —           24,199         156,789   

D Brown

     279,574         11,876         9,733        19,308         —           —           320,491   

A Heaton***

     348,414         14,961         (13,641     3,902         —           —           353,636   

C Humphreys

     162,399         7,306         (3,451     16,122         —           38,718         221,094   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 
     1,611,089         38,967         (64,333     130,044         199,875         183,460         2,099,102   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

 

* Remuneration for the duration of appointment if KMP was appointed or resigned during the period
** Remuneration includes:

 

   

Appointment of I Phillips as Interim Chairman, from July 1, 2015 to February 5, 2016

 

   

Appointment of I Ross as Acting CEO, from July 22, 2015 to January 31, 2106

 

   

Appointment of J O’Connor as Chairman, from February 5, 2016

 

   

Appointment of B Carmine as Deputy Chairman, from February 5, 2016

 

*** Salary paid in U.S. dollars, but disclosed in Australian dollars using a conversion rate of .7283
**** No longer Company Secretary as of September 9, 2016

 

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Table of Contents

The relative proportions of remuneration that are linked to performance and those that are at risk:

 

     Fixed remuneration     At risk - STI      At risk - LTI  
Name    2016     2015     2016     2015      2016     2015  

Executive Directors:

             

James Garner

     62     —          —          —           38     —     

Other Key Management Personnel:

             

Lionel Mateo****

     81     100     3     —           16     —     

David Brown

     96     100     4     —           —          —     

Andrew Heaton

     96     100     4     —           —          —     

Cristyn Humphreys

     79     100     3     —           18     —     

 

**** No longer Company Secretary as of September 9, 2016

Consequences of performance on shareholder wealth

The earnings of the Company for the past five fiscal years are summarised below:

 

    

2012

A$’000

   

2013

A$’000

   

2014

A$’000

   

2015

A$’000

   

2016

A$’000

 

Loss after income tax attributable to owners

     (1,309     (1,031     (7,467     (7,139     (12,063

The factors that are considered to affect total shareholders return (“TSR”) are summarised below:

 

     2012      2013     2014     2015     2016  

Share price at financial year end (A$)

     0.07         0.19        0.14        0.22        0.10   

Basic earnings per share (cents per share A$)

     1.28         (0.90     (4.76     (2.99     (2.82

Bonuses included in remuneration

Details of the short-term incentive cash bonuses awarded as remuneration to each key management personnel, the percentage of the available bonus that was paid in the financial year, and the percentage that was forfeited because the person did not meet the service and performance criteria is set out below. No part of the bonus is payable in future years.

Bonuses included in remuneration

 

     Included in
Remuneration (A$)
     Percentage vested
during the year
    Percentage forfeited
during the year
 

Key Management Personnel

  

David Brown

   $ 11,876         100     —     

Andrew Heaton

   $ 14,961         100     —     

Cristyn Humphreys

   $ 7,306         100     —     

Lionel Mateo****

   $ 4,824         100     —     

 

**** No longer Company Secretary as of September 9, 2016

 

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Table of Contents

Employment agreements

It is the Remuneration and Nomination 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 and Nomination 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 Company to substitute the notice period. In the event of the Company 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 Company 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 Company.

Remuneration and other terms of employment for key management personnel are formalised in service agreements. Details of these agreements are as follows:

 

Name:    James Garner
Title:    Chief Executive Officer, Managing Director
Agreement commenced:    February 1, 2016
Term of agreement:    Full-time employment
Details:    Base salary for fiscal 2016 of A$400,000, to be reviewed annually by the Remuneration and Nomination Committee. James’s appointment with the Company may be terminated with the Company giving 6 months’ notice or by James giving 6 months’ notice. The Company may elect to pay James equal amount to that proportion of his salary equivalent 6 months’ pay in lieu of notice, together with any outstanding entitlements due to him.
Name:    David Brown
Title:    Chief Scientific Officer
Agreement commenced:    April 29, 2013
Term of agreement:    Full time employment
Details:    Base salary for fiscal 2016 of A$226,600, to be reviewed annually by the Remuneration and Nomination Committee. David’s appointment with the Company may be terminated with the Company giving 6 months’ notice or by David giving 6 months’ notice. The Company may elect to pay David equal amount to that proportion of his salary equivalent 3 months’ pay in lieu of notice, together with any outstanding entitlements due to him. Additionally, if notice of termination is given by the Company, the Company must pay David an amount equal to 6 months’ salary.
Name:    Andrew Heaton
Title:    CEO and President of Novogen North America, Inc.
Agreement commenced:    April 29, 2013
Term of agreement:    Full-time employment
Details:    Base salary for fiscal 2016 of US$257,500 to be reviewed annually by the Remuneration and Nomination Committee. Andrew’s appointment with the Company may be terminated with the Company giving 6 months’ notice or by Andrew giving 6 months’ notice. The Company may elect to pay Andrew equal amount to that proportion of his salary equivalent 3 months’ pay in lieu of notice, together with any outstanding entitlements due to him. Additionally, if notice of termination is given by the Company, the Company must pay Andrew an amount equal to 6 months’ salary.

 

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Table of Contents

Name:

  

Cristyn Humphreys

Title:    Chief Financial Officer
Agreement commenced:    January 1, 2015
Term of agreement:    Full-time employment
Details:    Base salary for fiscal 2016 of A$164,800, to be reviewed annually by the Remuneration and Nomination Committee. Cristyn’s appointment with the Company may be terminated with the Company giving 4 weeks’ notice or by Cristyn giving 4 weeks’ notice. The Company may elect to pay Cristyn equal amount to that proportion of her salary equivalent 4 weeks’ pay in lieu of notice, together with any outstanding entitlements due to her.

Key management personnel have no entitlement to termination payments in the event of removal for misconduct.

Employee share option plan

The Company established an Employee Share Option Plan (“ESOP”) that was approved by shareholders on March 4, 2015.

Share-based compensation

Issue of shares

There were no shares issued to Directors and other KMP as part of remuneration during the fiscal 2016.

 

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Table of Contents

Options

The terms and conditions of each grant of options over ordinary shares affecting remuneration of Directors and other Key Management Personnel in this financial year or future reporting years are as follows:

 

Grant date   

Vesting date and

exercisable date

   Expiry date    Exercise price     

Fair value per option

at grant date

 

October 15, 2015

   433,334 options vest on November 16, 2016    November 16, 2020    A$ 0.220       A$ 0.128   
   433,333 options vest on November 16, 2017         
   433,333 options vest on November 16, 2018         

February 1, 2016

   750,000 options vest on August 1, 2016    February 1, 2021    A$ 0.198       A$ 0.081   
   750,000 options vest on February 1, 2017         
  

750,000 options vest on August 1, 2017

        
   750,000 options vest on February 1, 2018         

February 1, 2016

   2,000,000 options vest on February 1, 2019    February 1, 2021    A$ 0.198       A$ 0.086   

February 1, 2016

   2,500,000 options vest on February 1, 2020    February 1, 2021    A$ 0.260       A$ 0.087   

None of the options issued as part of remuneration, which are listed in the table above, were exercised during the period.

Options granted carry no dividend or voting rights. Each option is convertible to one ordinary share upon exercise.

 

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Table of Contents
Name of KMP    Number
Options
Granted
     Grant Date    Value per
Option at
Grant date
    

Total Value
at Grant

Date

     Number
Vested
     Exercise
Price
    

First

Exercise

Date

  

Last

Exercise

Date

J Garner

     3,000,000       Mar 18, 2016    A$ 0.0814       A$ 244,200         —         A$ 0.1988       Aug 1, 2016    Feb 1, 2021

J Garner

     2,000,000       Mar 18, 2016    A$ 0.0861       A$ 172,200         —         A$ 0.1988       Feb 1, 2019    Feb 1, 2021

J Garner

     2,500,000       Mar 18, 2016    A$ 0.0868       A$ 217,000         —         A$ 0.2605       Feb 1, 2020    Feb 1, 2021

L Mateo****

     500,000       Oct 15, 2015    A$ 0.1276       A$ 63,800         —         A$ 0.2200       Nov 16, 2017    Nov 16, 2020

C Humphreys

     800,000       Oct 15, 2015    A$ 0.1276       A$ 102,080         —         A$ 0.2200       Nov 16, 2017    Nov 16, 2020

 

**** No longer Company Secretary as of September 9, 2016

During the fiscal 2016, 5,500,008 options have been issued to the employees by the Company under the ESOP. Any change to the ESOP will need to be approved by shareholders.

Remuneration options: granted and vested during the year

There were 8,800,000 options over ordinary shares issued to directors and other KMP as part of remuneration that were outstanding as at June 30, 2016.

There were no options over ordinary shares vested in fiscal 2016.

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 fiscal 2016, no options had lapsed.

Pension benefits

The Company paid A$209,000 during fiscal 2016 for employee superannuation benefits and pension benefits.

Board of Directors

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 subsidiaries, including monitoring the strategic direction of the Company and those entities, formulating goals for management and monitoring the achievement of those goals;

 

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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 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.

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

 

   

appointment of a Chair;

 

   

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).

 

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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 Board considers John O’Connor, Bryce Carmine, Iain Ross and Ian Phillips to be independent directors.

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.

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

 

Name    Position    Year first appointed    Current term expires
John O’Connor    Non-Executive Chairman    2012    November 2016
Bryce Carmine    Non-Executive Deputy Chairman    2015    November 2017
Ian Phillips    Non-Executive Director    2015    November 2017
Iain Ross    Non-Executive Director   

2014

(resigned November 22, 2014

Re-appointed July 22, 2015)

   November 2018
Steven Coffey    Non-Executive Director    2012    November 2016
James Garner    Managing Director, CEO    2016    N/A (managing director exempt from election under constitution and Australian corporation law)

 

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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.

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. As at June 30, 2016, the Board comprised of seven directors, four of whom were non-executive directors.

Committees

The Board has established an Audit, Risk and Governance Committee, a Remuneration and Nomination Committee, a Strategy and Innovation Committee and a Scientific Committee.

Audit, Risk and Governance Committee

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

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

Members of the Audit, Risk and Governance Committee are Bryce Carmine (Chairman), Ian Phillips and Iain Ross, each of whom is an independent director.

Remuneration and Nomination Committee

The purpose of the Remuneration and Nomination Committee is to assist and advise the Board to develop, implement and, from time to time, update policies in relation to:

 

   

the selection, nomination and appointment processes for directors; and

 

   

the remuneration of key management personnel and directors.

This committee is accountable to the Board for its performance and is subject to an annual review by the Board. Members of the Remuneration and Nomination Committee are Steven Coffey (Chairman), Ian Phillips and Iain Ross.

 

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Strategy and Innovation Committee

The purpose of the Committee is to assist and advise the Board in overseeing the development and implementation of strategies and strategic plans for Novogen Limited and its subsidiaries.

The Committee is empowered by the Board to review and recommend to the Board in relation to strategic planning and innovation opportunities.

Scientific Committee

The purpose of the Committee is to assist and advise the Board in overseeing the strategic direction and investment in research and development and other scientific initiatives of Novogen Limited and its subsidiaries.

The Committee is empowered by the Board to review and recommend scientific strategies to the Board.

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 Company’s financial and operational performance.

The expected outcomes of the remuneration structure are:

 

   

retention and motivation of key executives;

 

   

attraction of high quality management to the Company and Company; 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 plan to provide retirement benefits to executive or non-executive directors, except for the Australian Government Superannuation Guarantee.

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

 

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Employees

As of the end of each of the last three fiscal years, the Company employed the following number of people:

 

Category of Activity    Number of People  
   2016      2015      2014  

Research and Development

     9         7         6   

Finance and Administration

     7         7         6   
  

 

 

    

 

 

    

 

 

 

Total

     16         14         12   
  

 

 

    

 

 

    

 

 

 
Geographic Location    Number of People  
   2016      2015      2014  

Australia

     15         13         11   

United States

     1         1         1   
  

 

 

    

 

 

    

 

 

 

Total

     16         14         12   
  

 

 

    

 

 

    

 

 

 

 

Item 7. Major Shareholders and Related Party Transactions

Major shareholders

As of June 30, 2016, no shareholder beneficially owned more than 5% of the total outstanding ordinary shares on issue.

At October 21, 2016 there were 7,144,692 of the Company’s ADRs outstanding, representing 178,617,300 ordinary shares (or 39.68% of the then outstanding ordinary shares). At October 21, 2016 there were 52 registered holders of the Company’s ADRs.

Previous significant shareholders, in the last three fiscal 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.

 

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Related party transactions

Other than as disclosed below, during fiscal 2016, we did not enter into any transactions or loans with any: (i) enterprises that directly or indirectly, through one or more intermediaries, control, are controlled by or are under common control with us; (ii) associates; (iii) individuals owning, directly or indirectly, an interest in our voting power that gives them significant influence over us, and close members of any such individual’s family; (iv) executive officers and close members of such individuals’ families; or (v) enterprises in which a substantial interest in our voting power is owned, directly or indirectly, by any person described in (iii) or (iv) or over which such person is able to exercise significant influence.

A one-off consultancy fee of A$266,000 was paid to Gladstone Consultancy Partnership, a partnership in which our Director Iain Ross has an interest, for interim executive duties he performed while he was Acting CEO between July 2015 and February 2016 following the resignation of then CEO Graham Kelly in July 2015. No such consultancy fees have been, or will be, paid in fiscal 2017.

A one-off consultancy fee of A$120,000 was paid to Kumara Inc, a corporation in which our Director Ian Phillips is a director and has a beneficial interest, for interim duties he performed between July 2015 and March 2016 following the resignation of then CEO Graham Kelly in July 2015. No such consultancy fees have been, or will be, paid in fiscal 2017.

Consultancy fees of A$7,000 were paid to Watkins Coffey Martin, a partnership in which our Director Steven Coffey is a partner.

A salary of A$47,000 was paid to Prue Kelly, the partner of Graham Kelly, a former CEO.

Transactions between related parties are on normal commercial terms and the conditions no more favorable than those available to other non-related parties.

 

Item 8. Financial Information

Consolidated financial statements are included in Item 18. “Financial Statements” commencing on page F-1. No significant change has occurred since the date of the annual financial statements included in this Annual Report on Form 20-F.

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 Company 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 Company has provided a guarantee to the value of €250,000 (A$373,000) with the court to confirm its commitment to the ongoing enforcement process. As at the June 30, 2016, the receivable balance has been fully impaired on the basis that it is unlikely to be recovered.

Dividends

There were no dividends paid, recommended or declared during fiscal years 2016 and 2015.

 

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’. Novogen Limited options are listed on the ASX. The trading symbol is ‘NRTO’.

 

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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

The Company’s 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,

     

2012

     0.25         0.08   

2013

     0.47         0.06   

2014

     0.40         0.15   

2015

     0.45         0.08   

2016

     0.30         0.10   

Quarter Ended:

     

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   

December 2015

     0.18         0.11   

March 2016

     0.15         0.10   

June 2016

     0.14         0.10   

September 2016

     0.12         0.09   

Month Ended:

     

April 2016

     0.14         0.12   

May 2016

     0.12         0.11   

June 2016

     0.12         0.10   

July 2016

     0.11         0.10   

August 2016

     0.12         0.09   

September 2016

     0.12         0.10   

 

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  B. NASDAQ CAPITAL MARKET

The ADRs 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 ADRs on the NASDAQ Capital Market:

 

     Per ADR (US$)*  
     High      Low  

Fiscal Year Ended June 30

     

2012

     8.25         1.95   

2013

     10.49         0.76   

2014

     6.84         3.42   

2015

     9.50         1.51   

2016

     5.35         1.79   

Quarter Ended:

     

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   

December 2015

     3.09         1.98   

March 2016

     2.85         1.79   

June 2016

     2.67         1.81   

September 2016

     2.44         1.72   

Month Ended:

     

April 2016

     2.67         2.17   

May 2016

     2.23         1.96   

June 2016

     2.19         1.81   

July 2016

     2.01         1.79   

August 2016

     2.15         1.72   

September 2016

     2.44         1.81   

 

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

 

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).

 

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Material contracts

Development and IP Assignment Deed with Genscreen Pty. Ltd.

In October 2013, we acquired all rights, title and interest in Genscreen Pty. Ltd.‘s (“Genscreen”) anti-tropomyosin (ATM). Under the terms of the Development and IP Assignment Deed between Novogen Limited, Genscreen and Mr. Ian Dixon, Novogen acquired the intellectual property rights to Genscreen’s ATM technology to develop anti-cancer drugs, and in return Genscreen receives an annual fee of A$10,000 per year and would receive royalty fees in the event of future product sales and a percentage of any future licensing revenue received from unaffiliated third party licensees. Novogen’s objective is to commence Phase 1A clinical trial in respect of at least one lead candidate product within 4 years after the commencement date.

Clinical Trial Funding Agreement with The Kids’ Cancer Project

In October 2015, Novogen and The Kids’ Cancer Project (“TKCP”) entered into an agreement (the “Funding Agreement”) to fund a future Phase I clinical trial for Anisina (or other ATM candidate as agreed by the parties) in the event Novogen’s ATM technology advances to that stage. Under the Funding Agreement, Novogen and TKCP agree to enter into a future Clinical Trial Research Agreement detailing and finalising the relevant information, obligations and budget for a Phase I clinical trial for Anisina (or other ATM candidate as agreed by the parties). The budget under the Funding Agreement is up to, but not to exceed, funds of US$1.5 million in an amount to be finalised under the Clinical Trial Research Agreement. The Funding Agreement is predicated on the agreement that Novogen will expand its focus on developing Anisina (or other ATM candidate as agreed) for adult cancer indications to include paediatric indications in any future clinical trials.

Convertible Note Deed Poll and Amendment

On 4 December 2014, the consolidated entity and the convertible note holder, former shareholders of Triaxial Pharmaceuticals Pty Ltd (‘Triaxial’) signed an amendment to the Convertible Note Deed Poll (‘Deed’), signed on 4 November 2013. The Deed previously superseded a loan agreement between the consolidated entity and Triaxial.

The amendment to the Deed extinguished the liability that originally arose from the provisions that allowed the redemption in cash of the value of the convertible note, under some specific circumstances. The liability originated in the loan agreement and was carried over to the original version of the Deed. The amendment allowed the consolidated entity to convert the liability attached to the transaction into equity. The convertible note may be exercised at the holders’ discretion as follows:

 

 

on completion of Phase 1a clinical trial, which will occur upon the receipt by the consolidated entity of a signed study report: $400,000 converted into 16,000,000 ordinary shares in the consolidated entity;

 

 

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 consolidated entity; and

 

 

on completion of Phase II clinical trial or achieving Breakthrough Designation. Completion will be deemed to occur upon the receipt by the consolidated entity of a signed study report or notification of the designation: $600,000 converted into 24,000,000 ordinary shares in the consolidated entity.

There is a possibility for an early conversion of the convertibles notes if a third party acquires more than 50% of the issued capital of the consolidated entity.

 

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The Company submitted its first Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) on 11 August 2016 which triggered a conversion event for the issue of 20,000,000 ordinary shares.

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.

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.

 

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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.

 

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Estate and Gift Tax

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

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.

 

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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.

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.

 

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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.

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.

 

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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.

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.

 

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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.

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 27 – 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 of June 30, 2016, 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. The Company used natural hedging to reduce the foreign currency risk, which involved processing USD payments from cash held in USD. 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.

For additional disclosure regarding market risk see Item 18. “Financial Statements – Note 27 – Financial Instruments”.

 

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. The depositary may collect any of its fees by deduction from any cash distribution payable to you that are obligated to pay those fees.

 

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From time to time, the depositary may make payments to us to reimburse or share revenue from the fees collected from you, or waive fees and expenses for services provided, generally relating to costs and expenses arising out of establishment and maintenance of the ADS program. In performing its duties under the deposit agreement, the depositary may use brokers, dealers or other service providers that are affiliates of the depositary and that may earn or share fees or commissions.

 

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, 2016.

(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. Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of June 30, 2016 based on the criteria set forth in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO 2013). Based on our evaluation under the criteria set forth in Internal Control — Integrated Framework, our management concluded that our internal control over financial reporting was effective as of June 30, 2016.

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, 2016. Based on this assessment, management concluded that the Company’s internal control over financial reporting is effective as of June 30, 2016.

There were no major acquisitions or discontinuations of operations during the fiscal 2016.

 

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Item 16. [Reserved]

 

Item 16A. Audit Committee Financial Expert

The Board of Directors has determined that Ian Phillips, qualifies as an “audit committee financial expert” as that term is defined in Item 16A of Form 20-F. Ian Phillips meets the independence requirements of the NASDAQ Capital Market and SEC’s rules and regulations as he has been involved with banking, global financial markets and corporate finance for over 30 years, including in various roles in New York, London, Singapore, Sydney and Wellington.

 

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 applies to all Company employees, including management and Directors. 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, 2016, 2015 and 2014.

The table below set forth the total fees for services performed by GT in fiscal years 2016, 2015 and 2014, and summarizes these amounts by the category of service.

 

     2016
A$’000
     2015
A$’000
     2014
A$’000
 

Audit services - Grant Thornton Audit Pty Ltd

        

Audit or review of the financial statements

     140         114         123   

SEC Form F-3 consent

     1         21         —     

Other services - Grant Thornton Audit Pty Ltd

        

Tax compliance services

     12         20         31   
  

 

 

    

 

 

    

 

 

 
     153         155         154   
  

 

 

    

 

 

    

 

 

 

Audit fees

The audit fees include the aggregate fees incurred in fiscal years 2016, 2015 and 2014 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 Form F-3 Consent

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

 

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Other services

Tax compliance fees

Tax fees billed in fiscal year 2016 were for tax compliance advisory services. Tax fees billed in each of the fiscal years 2015 and 2014 were for tax compliance services.

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”.

 

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Novogen will rely an exemption from the requirement that at least two members of a compensation committee be “independent” as defined in NASDAQ Rule 5605(a)(2). The ASX Listing Rules and Australian law do not require an Australian company to establish a compensation committee, known in Australia as a remuneration committee, which is comprised solely of non-executive directors if the company is not included in the S&P/ASX300 Index at the beginning of its financial year. Novogen was not included on the S&P/ASX300 Index at the beginning of its its last financial year and, hence, is not required under ASX Listing Rules to have a remuneration (compensation) committee. The ASX Corporate Governance Principles and Recommendations contain a non-binding recommendation that all ASX-listed companies should have a remuneration committee comprised of at least three members, a majority of whom (including the chair) are “independent”. While these recommendations contain guidelines for assessing independence, ASX-listed entities are able to adopt their own definitions of an independent director for this purpose and is different from the definition in NASDAQ Rule 5605(a)(2). That being said, Novogen has, and expects to continue to have, a Remuneration and Nomination Committee consisting of three non-executive directors.

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

 

Item 16H. Mine Safety Disclosure

This item is not applicable.

PART III

 

Item 17. Financial Statements – Not Applicable

Not Applicable

 

Item 18. Financial Statements

The financial statements filed as part of this Annual Report commencing on page F-1.

 

Item 19. Exhibits

 

(a) Exhibits

 

Exhibit
No.
   Exhibit Description

  1.1

   Constitution of Novogen Limited (1).

  2.1

   Deposit Agreement, dated as of June 6, 2016 among Novogen Limited, The Bank of New York, as Depositary, and owners and holders from time to time of ADRs issued thereunder.

  4.1

   Lease Agreement, dated November 1, 2015 between Coal Services Pty Limited and Novogen.

  4.2

   Employment Agreement for Chief Executive Officer of Novogen Limited, dated December 10, 2015.

  4.3

   Employment Agreement for Chief Financial Officer of Novogen Limited, dated July 23, 2014.

 

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  4.4

   Employment Agreement for Chief Scientific Officer of Novogen Laboratories Pty Ltd, dated April 29, 2013.

  4.5

   Employment Agreement for Chief Executive Officer of Novogen (North America) LLC, dated April 29, 2013.

  4.6

   Convertible Note Deed Poll with Triaxial Pty Ltd Noteholders dated December 6, 2012

  4.7

   Amendment to Convertible Note Deed Poll with Triaxial Pty Ltd Noteholders dated December 4, 2014

  4.8

   Development and IP Assignment Deed with Genscreen Pty. Ltd. and Ian Dixon, dated October 8, 2013.

  4.9

   Heads of Agreement Clinical Trial Funding with The Kids’ Cancer Project, dated October 29, 2015

  4.10

   Novogen Officers’ and Employees’ Share Option Plan

  8.1

   Company Subsidiaries.

12.1

   Certification of the 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 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

 

(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).

 

65


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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/ James Garner

Dr James Garner
Chief Executive Officer
Date: October 27, 2016

 

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Index to Financial Statements

 

     Page  

Consolidated Financial Statements for June 30, 2016, 2015 and 2014 and the years then ended:

  

Report of Independent Registered Public Accounting Firm

     F- 2   

Consolidated Statement of Profit or Loss and Other Comprehensive Income

     F- 3   

Consolidated Statement of Financial Position

     F- 5   

Consolidated Statement of Changes in Equity

     F- 6   

Consolidated Statement of Cash Flows

     F- 8   

Notes to Consolidated Financial Statements

     F-10   

 

F-1


Table of Contents

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, 2016 and 2015, 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, 2016. 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, 2016 and 2015, and the results of their operations and their cash flows for each of the three years in the period ended June 30, 2016 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 27, 2016

 

F-2


Table of Contents

Statement of profit or loss and other comprehensive income

For the year ended 30 June 2016

 

     Note    2016
A$’000
    2015
A$’000
    2014
A$’000
 

Revenue from continuing operations

   6      406        89        87   

Other income

   7      3,665        2,753        342   

Expenses

         

Research and development expense

        (9,894     (5,935     (3,328

General and administrative expense

        (5,761     (3,843     (3,415

Loss on disposal of fixed assets

        (2     —          —     

Net fair value loss on convertible note derivative

        —          (301     (540

Loss on disposal of CanTx, Inc. after income tax expense

        (569     —          —     

Finance costs

   8      —          (69     (715
     

 

 

   

 

 

   

 

 

 

Loss before income tax expense from continuing operations

        (12,155     (7,306     (7,569

Income tax expense

   9      —          —          —     
     

 

 

   

 

 

   

 

 

 

Loss after income tax expense from continuing operations

        (12,155     (7,306     (7,569

Profit after income tax expense from discontinued operations

        —          —          —     

Loss after income tax expense for the year

        (12,155     (7,306     (7,569

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

        (3     (32     (11

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

        (1     (376     29   

Derecognition of foreign currency reserve relating to CanTx, Inc.

        178       

Other comprehensive income for the year, net of tax

        174        (408     18   

Total comprehensive income for the year

        (11,981     (7,714     (7,551

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

 

F-3


Table of Contents

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

For the year ended 30 June 2016

 

     Note      2016
A$’000
    2015
A$’000
    2014
A$’000
 

Loss for the year is attributable to:

         

Non-controlling interest

        (93     (167     (101

Owners of Novogen Limited

        (12,062     (7,139     (7,468
        (12,155     (7,306     (7,569

Total comprehensive income for the year is attributable to:

         

Non-controlling interest

        (96     (205     (99

Owners of Novogen Limited

        (11,885     (7,509     (7,452
     

 

 

   

 

 

   

 

 

 
        (11,981     (7,714     (7,551
     

 

 

   

 

 

   

 

 

 
            2016
Aus
Cents
    2015
Aus
Cents
    2014
Aus
Cents
 

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

         

Basic earnings per share

     37         (2.82     (2.99     (4.76

Diluted earnings per share

     37         (2.82     (2.99     (4.76

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

 

F-4


Table of Contents

Statements of financial position

As at 30 June 2016

 

     Note      2016
A$’000
    2015
A$’000
 

Assets

       

Current assets

       

Cash and cash equivalents

     11         33,453        44,371   

Trade and other receivables

     12         199        151   

Income tax refund due

     13         4        —     

Other

     14         434        127   
     

 

 

   

 

 

 

Total current assets

        34,090        44,649   
     

 

 

   

 

 

 

Non-current assets

       

Available-for-sale financial assets

     15         13        16   

Property, plant and equipment

     16         592        85   

Intangibles

     17         822        1,390   
     

 

 

   

 

 

 

Total non-current assets

        1,427        1,491   
     

 

 

   

 

 

 

Total assets

        35,517        46,140   
     

 

 

   

 

 

 

Liabilities

       

Current liabilities

       

Trade and other payables

     18         1,300        1,619   

Provisions

     19         132        159   
     

 

 

   

 

 

 

Total current liabilities

        1,432        1,778   
     

 

 

   

 

 

 

Non-current liabilities

       

Provisions

     20         62        —     

Trade and other payables

     21         92        —     
     

 

 

   

 

 

 

Total Non-current liabilities

        154     
     

 

 

   

 

 

 

Total liabilities

        1,586        1,778   
     

 

 

   

 

 

 

Net assets

        33,931        44,362   
     

 

 

   

 

 

 

Equity

       

Contributed equity

     22         191,301        190,404   

Other contributed equity

     23         1,716        1,716   

Reserves

     24         1,421        990   

Accumulated losses

     25         (160,507     (148,445
     

 

 

   

 

 

 

Equity attributable to the owners of Novogen Limited

        33,931        44,665   

Non-controlling interest

     26         —          (303
     

 

 

   

 

 

 

Total equity

        33,931        44,362   
     

 

 

   

 

 

 

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

 

F-5


Table of Contents

Statements of changes in equity

For the year ended 30 June 2016

 

    

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
 

Balance at 1 July 2013

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

Loss after income tax expense for the year

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

Other comprehensive income for the year, net of tax

     —           —           15        —          3       18  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income for the year

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

Transactions with owners in their capacity as owners:

              

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

     4,923         —          —          —         —         4,923  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Balance at 30 June 2014

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

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 
     Contributed
equity
     Other
Contributed
equity
     Reserves     Accumulated
Losses
   

Non-

controlling
Interest

    Total equity  
     A$’000      A$’000      A$’000     A$’000     A$’000     A$’000  

Balance at 1 July 2014

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

Loss after income tax expense for the year

     —          —           —          (7,139     (167     (7,306

Other comprehensive income for the year, net of tax

     —          —           (370     —          (38     (408
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income for the year

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

Transactions with owners in their capacity as owners:

              

Share-based payments (note 37)

     —           —          1,527        —         —         1,527   

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

     47,636         —          —         —         —         47,636   

Recognition of equity component of compound financial instrument

     —           1,500         —          —          —          1,500   

Transfers

     —           216         (216     —          —          —     

Exercise of options

     182         —          (182     —          —          —     
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Balance at 30 June 2015

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

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

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

 

F-6


Table of Contents

Statements of changes in equity (continued)

For the year ended 30 June 2016

 

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

Balance at 1 July 2015

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

Loss after income tax expense for the year

     —           —           —          (12,062     (93     (12,155

Other comprehensive income for the year, net of tax

     —           —           174        —          —          174   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income for the year

     —           —           174        (12,062     (93     (11,981

Transactions with owners in their capacity as owners:

              

Share-based payments (note 38)

     —           —           372        —          —          372   

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

     782         —           —          —          —          782   

Derecognition of non-controlling interest

     —           —           —          —          392        392   

Derecognition of foreign currency reserve

     —           —           —          —          4        4   

Exercise of options

     115         —           (115     —          —          —     
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Balance at 30 June 2016

     191,301         1,716         1,421        (160,507     —          33,931   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

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

 

F-7


Table of Contents

Statements of cash flows

For the year ended 30 June 2016

 

     Note      2016
A$’000
    2015
A$’000
    2014
A$’000
 

Cash flows from operating activities

         

Loss before income tax expense for the year

        (12,155     (7,306     (7,569

Adjustments for:

         

Depreciation and amortisation

        643        575        572   

Write off of property, plant and equipment

        2        —          23   

Net loss on disposal of non-current assets

        —          13        —     

Share-based payments

        372        —          —     

Foreign exchange differences

        (796     (508     28   

Gain on capital reduction - in specie distribution

          —          —     

Make good credit and rental adjustment

        101        —          —     

Net gain on disposal of CanTx, Inc.

        569        —          —     

Net fair value loss on convertible note derivative

        —          301        540   

Interest income accrued

        (1     —          —     

Imputed interest on convertible note

        —          68        223   
     

 

 

   

 

 

   

 

 

 
        (11,265     (6,857     (6,183

Change in operating assets and liabilities:

         

Decrease/(increase) in trade and other receivables

        15        (85     344   

Decrease/(increase) in income tax refund due

        (4     3        (3

(Increase) in prepayments

        (307     (59     (67

(Decrease)/increase in trade and other payables

        (328     1,360        (54

(Decrease)/increase in derivative liabilities

        —          (173     173   

(Decrease) in deposit paid

        (62     —          —     

(Decrease)/increase in other provisions

        (29     51        81   
     

 

 

   

 

 

   

 

 

 

Net cash used in operating activities

        (11,980     (5,760     (5,709
     

 

 

   

 

 

   

 

 

 

Cash flows from investing activities

         

Payments for property, plant and equipment

     16         (522     (97     (27

Payments for intangibles

     17         (3     —          —     

Proceeds from disposal of property, plant and equipment

        3        8        —     
     

 

 

   

 

 

   

 

 

 

Net cash used in investing activities

        (522     (89     (27
     

 

 

   

 

 

   

 

 

 

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

 

F-8


Table of Contents

Statement of cash flows (continued)

For the year ended 30 June 2016

 

     Note      2016
A$’000
    2015
A$’000
    2014
A$’000
 

Cash flows from financing activities

         

Proceeds from issue of shares

     22         853        50,356        —     

Proceeds from borrowings

        —          —          5,500   

Share issue transaction costs

        (71     (2,941     —     
     

 

 

   

 

 

   

 

 

 

Net cash from financing activities

        782        47,415        5,500   
     

 

 

   

 

 

   

 

 

 

Net (decrease)/increase in cash and cash equivalents

        (11,720     41,566        (236

Cash and cash equivalents at the beginning of the financial year

        44,371        2,502        2,738   

Effects of exchange rate changes on cash

        802        303        —     
     

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at the end of the financial year

     11         33,453        44,371        2,502   
     

 

 

   

 

 

   

 

 

 

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

 

F-9


Table of Contents

Notes to the financial statements

For the year ended 30 June 2016

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 5

20 George Street

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 2016. 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.

Going concern

The consolidated entity incurred a loss after income tax of A$12,155,000 (2015: A$7,306,000 and 2014: A$7,569,000) and had net cash outflows from operating activities of A$11,980,000 (2015: A$5,760,000 and 2014: A$5,709,000) for the year ended 30 June 2016, and was in a net current asset position of $32,658,000 (2015: net current asset position of $42,871,000) as at 30 June 2016.

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 2016 the consolidated entity had cash in hand and at bank including short term deposits of A$33,453,000 (2015: A$44,371,000).

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.

 

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Note 2. Significant accounting policies (continued)

 

As at 30 June 2016, the consolidated entity had 73,915,001 options on issue, with various exercise prices and maturity dates.

The cash at bank available at 30 June 2016 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 is well funded to advance the current platforms 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.

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 2016 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.

 

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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.

 

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Note 2. Significant accounting policies (continued)

 

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.

Exchange differences arising on a monetary item that forms part of a reporting entity’s net investment in a foreign operationshall be recognised initially in other comprehensive income and reclassified from equity to profit or loss on disposal of the net investment.

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.

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.

 

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Note 2. Significant accounting policies (continued)

 

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.

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.

 

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Note 2. Significant accounting policies (continued)

 

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 plant and equipment over their expected useful lives from 2.5 to 10 years.

Leasehold improvements and plant and equipment under lease are depreciated over the 9-year period of the lease (including options to extend) or the estimated useful life of the assets, whichever is shorter.

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.

 

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Note 2. Significant accounting policies (continued)

 

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.

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.

Software

Amortisation is calculated on a straight-line basis to write off the net cost of each item of software over their expected useful lives from 2.5 to 10 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.

 

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Note 2. Significant accounting policies (continued)

 

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.

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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Note 2. Significant accounting policies (continued)

 

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.

 

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Note 2. Significant accounting policies (continued)

 

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.

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.

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.

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.

 

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Note 2. Significant accounting policies (continued)

 

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 2016. 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 9 Financial Instruments and its consequential amendments

This standard and its consequential amendments are applicable to annual reporting periods beginning on or after 1 January 2018 and completes phases I and III of the IASB’s project to replace IAS 39 ‘Financial Instruments:Recognition and Measurement’. This standard introduces new classification and measurement models for financial assets, using a single approach to determine whether a financial asset is measured at amortised cost or fair value. The accounting for financial liabilities continues to be classified and measured in accordance with IAS 139, with one exception, being that the portion of a change of fair value relating to the entity’s own credit risk is to be presented in other comprehensive income unless it would create an accounting mismatch. Chapter 6 ‘Hedge Accounting’ supersedes the general hedge accounting requirements in IAS 139 and provides a new simpler approach to hedge accounting that is intended to more closely align with risk management activities undertaken by entities when hedging financial and non-financial risks.

The consolidated entity will adopt this standard and the amendments from 1 July 2018. The entity is yet to undertake a detailed assessment of the impact of IFRS 9. However, based on the entity’s preliminary assessment, the Standard is not expected to have a material impact on the transactions and balances recognised in the financial statements when it is first adopted for the year ending 30 June 2019.

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.

 

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Note 2. Significant accounting policies (continued)

 

IFRS 16 Leases

This standard is applicable to annual reporting periods beginning on or after 1 January 2019. The standard replaces IAS 17 ‘Leases’ and for lessees will eliminate the classifications of operating leases and finance leases. Subject to exceptions, a ‘right-of-use’ asset will be capitalised in the statement of financial position, measured as the present value of the unavoidable future lease payments to be made over the lease term. The exceptions relate to short-term leases of 12 months or less and leases of low-value assets (such as personal computers and small office furniture) where an accounting policy choice exists whereby either a ‘right-of-use’ asset is recognised or lease payments are expensed to profit or loss as incurred. A liability corresponding to the capitalised lease will also be recognised, adjusted for lease prepayments, lease incentives received, initial direct costs incurred and an estimate of any future restoration, removal or dismantling costs. Straight-line operating lease expense recognition will be replaced with a depreciation charge for the leased asset (included in operating costs) and an interest expense on the recognised lease liability (included in finance costs). In the earlier periods of the lease, the expenses associated with the lease under IFRS 16 will be higher when compared to lease expenses under IAS 17. However, EBITDA (Earnings Before Interest, Tax, Depreciation and Amortisation) results will be improved as the operating expense is replaced by interest expense and depreciation in profit or loss under IFRS 16. For classification within the statement of cash flows, the lease payments will be separated into both a principal (financing activities) and interest (either operating or financing activities) component. For lessor accounting, the standard does not substantially change how a lessor accounts for leases. The entity is yet to undertake a detailed assessment of the impact of IFRS 16. However, based on the entity’s preliminary assessment, the Standard is not expected to have a material impact on the transactions and balances recognised in the financial statements when it is first adopted for the year ending 30 June 2020.

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.

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.

 

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Table of Contents

Note 3. Critical accounting judgements, estimates and assumptions (continued)

 

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.

Net investment in foreign operations

In management’s view, repayment of the Novogen, Inc. intercompany loan, which has been merged into Novogen North America, Inc., is neither planned nor likely to occur in the foreseeable future, thus it has been treated as a net investment in foreign operations. Exchange differences arising on a monetary item that forms part of the net investment in a foreign operation is recognised initially in other comprehensive income and reclassified from equity to profit or loss on disposal of the net investment.

Note 4. Restatement of comparatives

Reclassification

Comparative information in the profit of loss statement has been restated to correct an error in classification of expenses. The profit and loss for the year ended 30 June 2014 included salary and related general expenses of scientists totalling $852,621 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 expense in a more accurate manner. A third balance sheet has not been presented as the reclassification has no impact on the financial results for the year ended 30 June 2014 or the closing financial position at that date.

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 2016, 30 June 2015 and 30 June 2014 there were no major customers.

 

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Note 6. Revenue

 

     2016      2015      2014  
     A$’000      A$’000      A$’000  

From continuing operations

        
Sales revenue         

Bank interest

     406         89         87   
  

 

 

    

 

 

    

 

 

 
     406         89         87   
  

 

 

    

 

 

    

 

 

 

Revenue from continuing operations

     406         89         87   
  

 

 

    

 

 

    

 

 

 

Note 7. Other income

 

     2016      2015      2014  
     A$’000      A$’000      A$’000  

Net foreign exchange gain

     781         1,116         —     

Payroll tax rebate

     18         8         —     

Research and development rebate

     2,866         1,538         342   

Subsidies and grants

     —           91         —     
  

 

 

    

 

 

    

 

 

 

Other income

     3,665         2,753         342   
  

 

 

    

 

 

    

 

 

 

Note 8. Expenses

 

     2016      2015      2014  
     A$’000      A$’000      A$’000  

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

        
Depreciation         

Leasehold improvements

     30         —           —     

Property, plant and equipment

     43         5         2   

Total depreciation

     73         5         2   
  

 

 

    

 

 

    

 

 

 
Amortisation         

Patents and intellectual property

     570         571         570   
  

 

 

    

 

 

    

 

 

 

Total depreciation and amortisation

     643         575         572   
  

 

 

    

 

 

    

 

 

 
Finance costs         

Interest and finance charges paid/payable

     —           1         492   

Imputed interest on convertible note

     —           68         223   
  

 

 

    

 

 

    

 

 

 

Finance costs expensed

     —           69         715   
  

 

 

    

 

 

    

 

 

 
Rental expense relating to operating leases         

Minimum lease payments

     280         98         64   
  

 

 

    

 

 

    

 

 

 

Superannuation expense

        

Defined contribution superannuation expense

     209         147         88   
  

 

 

    

 

 

    

 

 

 
Employee benefits expense excluding superannuation         

Employee benefits expense excluding superannuation

     2,828         2,105         1,437   

 

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Note 9. Income tax expense

 

     2016      2015      2014  
     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

     (12,155      (7,306      (7,569

Profit before income tax expense from discontinued operations

     —           —           —     
  

 

 

    

 

 

    

 

 

 
     (12,155      (7,306      (7,569
  

 

 

    

 

 

    

 

 

 

Tax at the statutory tax rate of 30%

     (3,646      (2,192      (2,271

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

        

Non-deductible expenses

     1,353         772         1,205   

Derecognition of foreign currency reserve

     —           —           —     

Other

     44         60         (178
  

 

 

    

 

 

    

 

 

 
     (2,249      (1,360      (1,244

Difference in overseas tax rates

        —           —     

Tax losses and timing differences not recognised

     2,249         1,360         1,244   
  

 

 

    

 

 

    

 

 

 

Income tax expense

     —           —           —     
  

 

 

    

 

 

    

 

 

 
     2016      2015      2014  
     A$’000      A$’000      A$’000  

Tax losses not recognised

        

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

     59,909         53,995         52,632   
  

 

 

    

 

 

    

 

 

 

Potential tax benefit @ 30%-Australia

     17,973         16,199         15,790   
  

 

 

    

 

 

    

 

 

 

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

     2,100         1,401         990   
  

 

 

    

 

 

    

 

 

 

Potential tax benefit @ 34%-US

     714         476         337   
  

 

 

    

 

 

    

 

 

 

 

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Table of Contents

Prior period tax adjustment disclosure due to adjustments not previously recognised

Prior period adjustments were made for the consolidated group as follows:

 

   

A$3,746,000 to the Australian tax losses

 

   

A$1,401,000 to the US tax losses

The effect reduces the Australian tax losses of the consolidated group from A$57,740,000 reported in the prior year to A$53,995,000 for the year ending 30 June 2015 and reduce the Australian tax losses of the consolidated group from A$54,872,000 to A$52,632,000. The effect also increases the US tax losses of the consolidated group from A$nil to A$1,401,000 for the year ending 30 June 2015 and increase from A$nil to $A990,000 for the year ending 30 June 2014.

Note 10. Losing control over a subsidiary during the reporting period

Description

In May, 2016, the Board of Directors and Senior Management of the consolidated entity decided to conclude its funding of CanTx, Inc., the joint venture with Yale University. The decision was to wind up CanTx, Inc., and return all intellectual property licensed from Novogen Ltd to CanTx, Inc. back to Novogen, in accordance with the terms of the agreement between the companies. Consequently, the assets and liabilities allocatable to CanTx, Inc., were classified as a disposal group. Expenses, gains and losses relating to the loss of control of the subsidiary held during the period have been eliminated from profit and loss from the consolidated entity’s continuing operations and are shown in a single line item on the face of the statement of profit and loss and other comprehensive income (see loss for the year from loss of control of the subsidiary held during the period). On 31st May, 2016, CanTx, Inc. was wound up.

Financial information for CanTx, Inc., are set out as follows:

Carrying amounts of assets and liabilities disposed

 

     2016      2015      2014  
     A$’000      A$’000      A$’000  

Cash and cash equivalents

     —           —           —     
  

 

 

    

 

 

    

 

 

 

Total assets

     —           —           —     
  

 

 

    

 

 

    

 

 

 

Trade and other payables

     1         —           —     
  

 

 

    

 

 

    

 

 

 

Total liabilities

     1         —           —     
  

 

 

    

 

 

    

 

 

 

Net liabilities

     (1      —           —     
  

 

 

    

 

 

    

 

 

 

Details of the disposal

 

     2016      2015      2014  
     A$’000      A$’000      A$’000  

Carrying amount of net liabilities dispose

     1         —           —     

Derecognition of foreign currency reserve

     (178      —           —     

Derecognition of non-controlling interest

     (392      —           —     
  

 

 

    

 

 

    

 

 

 

Loss on disposal before income tax

     (569      —           —     

Income tax expense

     —           —           —     

Loss on disposal after income tax

     (569      —           —     
  

 

 

    

 

 

    

 

 

 

 

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Note 11. Current assets - cash and cash equivalents

 

     2016      2015  
     A$’000      A$’000  

Cash at bank and on hand

     20,437         44,356   

Short-term deposits

     13,016         15   
  

 

 

    

 

 

 
     33,453         44,371   
  

 

 

    

 

 

 

Note 12. Current assets - trade and other receivables

 

     2016      2015  
     A$’000      A$’000  

Trade receivables

     235         228   

Less: Provision for impairment of receivables

     (226      (226
  

 

 

    

 

 

 
     9         2   
  

 

 

    

 

 

 

Other receivables

     78         99   

Deposits held

     485         414   

Less: Provision for impairment of deposits held

     (373      (364
  

 

 

    

 

 

 
     199         151   
  

 

 

    

 

 

 

Deposit held included a guarantee to the value of €250,000 (A$373,000) for the “APO Trend” case. Please refer to Note 31 for further information on ‘deposits held’.

Impairment of receivables

The consolidated entity has recognised a loss of nil (2015: loss of A$2,000) in profit or loss in respect of impairment of receivables (excluding ‘deposits held’) for the year ended 30 June 2016.

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

 

     2016      2015  
     A$’000      A$’000  

Over 6 months overdue

     226         226   
  

 

 

    

 

 

 
     226         226   
  

 

 

    

 

 

 

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

 

     2016      2015  
     A$’000      A$’000  

Opening balance

     226         226   

Additional provisions recognised

     —           —     
  

 

 

    

 

 

 

Closing balance

     226         226   
  

 

 

    

 

 

 

 

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Note 13. Current assets - income tax refund due

 

     2016      2015  
     A$’000      A$’000  

Income tax refund due

     4         —     
  

 

 

    

 

 

 

Note 14. Current assets - other

 

     2016      2015  
     A$’000      A$’000  

Prepayments

     434         127   
  

 

 

    

 

 

 

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

 

     2016      2015  
     A$’000      A$’000  

Listed ordinary shares

     13         16   
  

 

 

    

 

 

 

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

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

 

     2016      2015  
     A$’000      A$’000  

Leasehold improvements - at cost

     464         —     

Less: Accumulated depreciation

     (30      —     
  

 

 

    

 

 

 
     434         —     
  

 

 

    

 

 

 

Plant and equipment - at cost

     217         153   

Less: Accumulated depreciation

     (59      (68
  

 

 

    

 

 

 
     158         85   
  

 

 

    

 

 

 
     592         85   
  

 

 

    

 

 

 

 

F-27


Table of Contents

Reconciliations

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

 

     Leasehold
improvement
A$’000
     Plant and
Equipment
A$’000
     Total
A$’000
 

Balance at 30 June 2014

     —           14         14   

Additions

     —           97         97   

Disposals

     —           (21      (21

Depreciation expense

     —           (5      (5
  

 

 

    

 

 

    

 

 

 

Balance at 30 June 2015

     —           85         85   

Additions

     465         120         585   

Disposals

     —           (5      (5

Depreciation expense

     (30      (43      (73
  

 

 

    

 

 

    

 

 

 

Balance at 30 June 2016

     435         157         592   
  

 

 

    

 

 

    

 

 

 

Note 17. Non-current assets – intangibles

 

     2016
A$’000
     2015
A$’000
 

Patents and intellectual property - at cost

     2,851         2,851   

Less: Accumulated amortisation

     (2,031      (1,461
  

 

 

    

 

 

 
     820         1,390   
  

 

 

    

 

 

 

Software – at cost

     2         —     

Less: Accumulated amortisation

     —           —     
  

 

 

    

 

 

 
     2         —     
  

 

 

    

 

 

 
     822         1,390   
  

 

 

    

 

 

 

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

Balance at 1 July 2014

     —           1,961         1,961   

Amortisation expense

     —           (571      (571
  

 

 

    

 

 

    

 

 

 

Balance at 30 June 2015

     —           1,390         1,390   

Additions

     2         —           2   

Amortisation expense

     —           (570      (570
  

 

 

    

 

 

    

 

 

 

Balance at 30 June 2016

     2         820         822   
  

 

 

    

 

 

    

 

 

 

 

F-28


Table of Contents

Note 18. Current liabilities - trade and other payables

 

     2016
A$’000
     2015
A$’000
 

Trade payables

     512         766   

Accrued payables

     778         853   

Lease incentive liability

     10      
  

 

 

    

 

 

 
     1,300         1,619   
  

 

 

    

 

 

 

Refer to Note 28 for further information on financial instruments.

Note 19. Current liabilities - provisions

 

     2016
A$’000
     2015
A$’000
 

Employee benefits

     132         159   
  

 

 

    

 

 

 

Note 20. Non-current liabilities - provisions

 

     2016
A$’000
     2015
A$’000
 

Lease make good

     62         —     
  

 

 

    

 

 

 

Note 21. Non-current liabilities - Trade and other payables

 

     2016
A$’000
     2015
A$’000
 

Liability for straight-lining

     19         —     

Lease incentive liability

     73         —     
  

 

 

    

 

 

 
     92         —     
  

 

 

    

 

 

 

Note 22. Equity - contributed equity

 

    

2016

Shares

    

2015

Shares

     2016
A$’000
     2015
A$’000
 

Ordinary shares - fully paid

     429,733,982         423,116,465         191,301         190,404   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

F-29


Table of Contents

Note 22. Equity - contributed equity (continued)

 

Movements in ordinary share capital

 

Details    Date    Shares     

Issue price

A$

     A$’000  

Balance

   1 July 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   

Issue of shares on exercise of options*

   24 July 2015      1,000         0.400         —     

Issue of shares on exercise of options

   24 July 2015      1,000,000         0.150         150   

Issue of shares on exercise of options

   8 October 2015      109,309         0.125         14   

Issue of shares on exercise of options

   23 November 2015      1,990,545         0.125         249   

Issue of shares on exercise of options

   24 November 2015      3,514,370         0.125         439   

Issue of shares on exercise of options

   09 December 2015      2,293         0.300         1   

Share issue transaction costs (including share-based payments)

        —           0.000         (71

Share based payment fair value movement

        —           0.000         115   
     

 

 

       

 

 

 

Balance

   30 June 2016      429,733,982            191,301   
     

 

 

       

 

 

 

 

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

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.

 

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Table of Contents

Note 22. Equity - contributed equity (continued)

 

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.

Note 23. Equity - Other contributed equity

 

     2016
A$’000
     2015
A$’000
 

Convertible loan note - Triaxial

     1,716         1,716   
  

 

 

    

 

 

 

On 4 December 2014, the consolidated entity and the convertible note holder, former shareholders of Triaxial Pharmaceuticals Pty Ltd (‘Triaxial’) signed an amendment to the Convertible Note Deed Poll (‘Deed’), signed on 4 November 2013. The Deed previously superseded a loan agreement between the consolidated entity and Triaxial. The amendment to the Deed extinguished the liability that originally arose from the provisions that allowed the redemption in cash of the value of the convertible note, under some specific circumstances. The liability originated in the loan agreement and was carried over to the original version of the Deed. The amendment allowed the consolidated entity to convert the liability attached to the transaction into equity.

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

 

   

on completion of Phase 1a clinical trial, which will occur upon the receipt by the consolidated entity of a signed study report: $400,000 converted into 16,000,000 ordinary shares in the consolidated entity;

 

   

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 consolidated entity; and

 

   

on completion of Phase II clinical trial or achieving Breakthrough Designation. Completion will be deemed to occur upon the receipt by the consolidated entity of a signed study report or notification of the designation: $600,000 converted into 24,000,000 ordinary shares in the consolidated entity.

There is a possibility for an early conversion of the convertibles notes if a third party acquires more than 50% of the issued capital of the consolidated entity.

The previous annual report incorrectly stated that “The milestones listed above refer to any drug developed based on the super-benzopyran technology”. However, any drug developed by Novogen can trigger the milestones listed above. Moreover, the previous report referred to “trials” in relation to the milestone listed above, when in fact a single study can serve as a trigger for the relevant milestone.

On 14 September, 2016, the Company announced that it had reached a milestone which triggered the conversion of a portion of its convertible notes. 20,000,000 shares were issued to the convertible note holders.

 

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Table of Contents

Note 24. Equity - reserves

 

     2016
A$’000
     2015
A$’000
 

Available-for-sale reserve

     (45      (43

Foreign currency reserve

     (136      (312

Convertible note reserve

     1,602         1,345   
  

 

 

    

 

 

 
     1,421         990   
  

 

 

    

 

 

 

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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Table of Contents

Movements in reserves

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

 

    

Share-based

payment
reserve
A$’000

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

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   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Revaluation - gross

          

Transfer to equity on exercise of options

     (115     —          —          —          (115

Other comprehensive income

          

Foreign currency translation

     —          —          (1     —          (1

Loss on the revaluation of available for-sale financial assets

     —          (3     —          —          (3
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total other comprehensive income

     —          (3     (1     —          (4
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Share based payment expense

     372        —          —          —          372   

Derecognition of FCTR of CanTx, Inc.

     —          —          178        —          178   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
          
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at 30 June 2016

     1,602        (46     (135     —          1,421   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Note 25. Equity - accumulated losses

 

     2016
A$’000
     2015
A$’000
     2014
A$’000
 

Accumulated losses at the beginning of the financial year

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

Loss after income tax expense for the year

     (12,062      (7,139      (7,468
  

 

 

    

 

 

    

 

 

 

Accumulated losses at the end of the financial year

     (160,507      (148,445      (141,306
  

 

 

    

 

 

    

 

 

 

Note 26. Equity - non-controlling interest

 

     2016
A$’000
     2015
A$’000
 

Issued capital

     —           —     

Reserves

     —           (35

Accumulated losses

     —           (268
  

 

 

    

 

 

 
     —           (303
  

 

 

    

 

 

 

 

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Note 27. Equity - dividends

There were no dividends paid, recommended or declared during the financial year ended 30 June 2016, 30 June 2015 and 30 June 2014.

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 2016, 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  
     2016      2015      2016      2015  
     A$’000      A$’000      A$’000      A$’000  

US dollars

     15,314         20,006         702         521   

Euros

     —           1         5         1   

Pound Sterling

     20         —           59         —     
  

 

 

    

 

 

    

 

 

    

 

 

 
     15,334         20,007         766         522   
  

 

 

    

 

 

    

 

 

    

 

 

 

The consolidated entity had net assets denominated in foreign currencies of A$14,568,000 as at 30 June 2016 (2015: net assets A$19,485,000).

Price risk

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

 

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Note 28. Financial instruments (continued)

 

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.

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

 

     2016      2015  
     Weighted
average
interest rate
    Balance      Weighted
average
interest rate
    Balance  
     %     A$’000      %     A$’000  

Cash at bank and in hand

     0.31     20,437         0.86     44,356   

Short term deposits

     2.60     13,016         2.40     15   
    

 

 

      

 

 

 

Net exposure to cash flow interest rate risk

       33,453           44,371   
    

 

 

      

 

 

 

The consolidated entity has cash and cash equivalents totalling A$33,453,000 (2015: A$44,371,000). An official increase/decrease in interest rates of 100 basis points (2015: 100 basis points) would have a favourable/adverse effect on profit before tax and equity of A$335,000 (2015: A$444,000) 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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Note 28. Financial instruments (continued)

 

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.

 

2016   

Weighted average
interest rate

%

     1 year or less
A$’000
     Between 1
and 2 years
A$’000
    

Between 2 and
5 years

A$’000

     Over 5
years
A$’000
     Remaining
contractual
maturities
A$’000
 

Non-derivatives

                 

Non-interest bearing

                 

Trade payables

     —           513         —           —           —           513   

Accrued payables

     —           778         —           —           —           778   
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total non-derivatives

        1,291         —           —           —           1,291   
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 
2015   

Weighted average
interest rate

%

     1 year or less
A$’000
     Between 1
and 2 years
A$’000
    

Between 2 and
5 years

A$’000

     Over 5
years
A$’000
     Remaining
contractual
maturities
A$’000
 

Non-derivatives

                 

Non-interest bearing

                 

Trade payables

     —           765         —           —           —           765   
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total non-derivatives

        765         —           —           —           765   
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

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

 

2016    Level 1
A$’000
     Level 2
A$’000
     Level 3
A$’000
     Total
A$’000
 

Assets

           

Ordinary shares

     13         —           —           13   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets

     13         —           —           13   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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Table of Contents

Note 29. Fair value measurement (continued)

 

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

Assets

           

Ordinary shares

     16         —           —           16   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets

     16         —           —           16   
  

 

 

    

 

 

    

 

 

    

 

 

 

There were no transfers between levels during the financial year.

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  
     2016
A$’000
     2015
A$’000
     2014
A$’000
 

Audit services - Grant Thornton Audit Pty Ltd

        

Audit or review of the financial statements

     140         114         123   

F3 consent

     1         21      

Other services - Grant Thornton Audit Pty Ltd

        

Tax compliance services

     12         20         31   
  

 

 

    

 

 

    

 

 

 
     153         155         154   
  

 

 

    

 

 

    

 

 

 

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:

 

     2016      2015      2014  
     A$’000      A$’000      A$’000  

Short-term employee benefits

     1,586         1,328         1,133   

Post-employment benefits

     130         101         109   

Long-term benefits

     200         38         —     

Termination benefits

        —           —     

Share-based payments

     183         —           —     
  

 

 

    

 

 

    

 

 

 
     2,099         1,467         1,242   
  

 

 

    

 

 

    

 

 

 

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

 

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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 ($373,000) with the court to confirm its commitment to the ongoing enforcement process. As at 30 June 2016, the receivable balance continues to be 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 11. Due to the lengthy procedure, further delayed by the appointment of technical experts, the case did not progress and the status remained unchanged during the period.

Note 33. Commitments

 

     2016
A$’000
     2015
A$’000
 

Lease commitments - operating

     

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

     

Within one year

     204         87   

One to five years

     290         —     
  

 

 

    

 

 

 
     494         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.

The office lease contains two renewal options, each for a three-year period. These renewal options are not included in the commitments as they may be cancelled by the consolidated entity. The consolidated entity at this stage intends to exercise the two remaining options. In order to exercise an option, the consolidated entity must inform the lessor no later than 6 months prior to the end of the lease, by which time it must commit to the term of the option.

 

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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:

 

     2016
A$’000
     2015
A$’000
     2014
A$’000
 

Payment for other expenses:

        

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

     7         12         79   

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

     47         77         76   

In addition to Director’s fees, Consultancy fees for executive duties while Mr Iain Ross was Acting CEO were paid to Gladstone Consultancy Partnership, a UK based consulting partnership in which he has a beneficial interest.

     266         —           —     

In addition to Director’s fees, Consultancy fees for executive duties were paid to Kumara Inc, a corporation in which Mr Ian Phillips is a Director and has a beneficial interest.

     120         —           —     

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         —     

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.

 

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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  
Name    Principal place of business /
Country of incorporation
  

2016

%

   

2015

%

 

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

CanTx. Inc.

   United States of America      —          85.00

On 31 May 2016, the consolidated entity merged its U.S. fully owned subsidiary Novogen, Inc. with another U.S. fully owned subsidiary, Novogen North America, Inc. The merger was completed to simplify the group’s structure.

A predecessor value method has been used for the merger, which involved accounting for the assets and liabilities of the acquired business using existing carrying values.

The consolidated entity approved the dissolution of CanTx, Inc., a subsidiary in which U.S. based Novogen North America, Inc. held an 85% interest. The dissolution of CanTx, Inc. was completed on 31 May 2016. The dissolution was completed following the decision to stop funding the operations of CanTx, Inc., and to bring Cantrixil, one of the consolidated entity’s assets back into the consolidated entity’s portfolio.

Please refer to Note 9 for more details.

 

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Note 36. Events after the reporting period

Filing of Investigational New Drug Application with FDA

The consolidated entity submitted its first Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) on 11 August 2016. This is a major step that must be undertaken in order to proceed with a phase 1 clinical trial in the U.S.

Liquidation of Triaxial Pharmaceuticals Pty Ltd

On 21 April 2016, the consolidated entity lodged a request with ASIC for the voluntary liquidation of its fully owned subsidiary Triaxial Pharmaceuticals Pty Ltd. The subsidiary will be dissolved and withdrawn from the Register of Companies maintained by ASIC.

Appointment and resignation of KMPs

On 29 August 2016, the consolidated entity appointed Dr Gordon Hirsch as Chief Medical Officer. Dr Hirsch will be taking charge of overseeing the development of the clinical studies for the consolidated entity’s assets.

On 29 August 2016, the consolidated entity appointed Dr Peng Leong as Chief Business Officer. Dr Leong will be taking charge of overseeing the business development of the consolidated entity and will be based in the U.S.

On 5 September 2016, Professor Peter Gunning resigned from the Board of Novogen.

On 9 September 2016, Mr Lionel Mateo resigned as Company Secretary and Ms Kate Hill is appointed as Interim Company Secretary.

Approval of Investigational New Drug Application with FDA

On 12 September, 2016, the Company announced the IND application for Cantrixil had been approved by the FDA

No other matter or circumstance has arisen since 30 June 2016 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

 

    

2016

A$’000

    

2015

A$’000

    

2014

A$’000

 

Earnings per share for loss from continuing operations

        

Loss after income tax

     (12,155      (7,306      (7,569

Non-controlling interest

     93         167         101   
  

 

 

    

 

 

    

 

 

 

Loss after income tax attributable to the owners of Novogen Limited

     (12,062      (7,139      (7,468
  

 

 

    

 

 

    

 

 

 
     Number      Number      Number  

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

     427,431,910         238,418,048         156,725,363   
  

 

 

    

 

 

    

 

 

 

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

     427,431,910         238,418,048         156,725,363   
  

 

 

    

 

 

    

 

 

 
     Cents      Cents      Cents  

Basic earnings per share

     (2.82      (2.99      (4.76

Diluted earnings per share

     (2.82      (2.99      (4.76

Basic earnings per share

     (2.82      (2.99      (4.76

Diluted earnings per share

     (2.82      (2.99      (4.76

60,000,000 unlisted convertible notes with a face value of $1,500,000 and 73,915,001 options have been excluded from the above calculations as they were antidilutive.

Note 38. Share-based payments

The options in tranches 1,2,3 and 4 in the table below have been issued as consideration for services rendered in relation to capital raising conducted during the previous year by the consolidated entity.

The options in tranches 5,6,7 and 8 in the table below have been issued to employees under the ESOP.

2016

 

Tranche    Grant date    Expiry date    Exercise
price
    

Balance at

the start of

the year

     Granted     

Expired/

forfeited/

other

   

Balance at

the end of

the year

     Vested and
Exercisable
 

1

   04/03/2015    16/12/2019    $ 0.150         466,470         —           —          466,470         466,470   

2

   04/03/2015    18/12/2019    $ 0.150         199,521         —           —          199,521         199,521   

3

   24/06/2015    30/12/2015    $ 0.300         1,380,000         —           (1,380,000     —           —     

4

   24/06/2015    30/06/2020    $ 0.400         5,190,000         —           —          5,190,000         —     

5*

   15/10/2015    16/11/2020    $ 0.220         —           5,500,008         (300,000     5,200,008         —     

6**

   18/03/2016    01/02/2021    $ 0.199         —           3,000,000         —          3,000,000         750,000   

7**

   18/03/2016    01/02/2021    $ 0.199         —           2,000,000         —          2,000,000         —     

8**

   18/03/2016    01/02/2021    $ 0.261         —           2,500,000         —          2,500,000         —     
           

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 
              7,235,991         13,000,008         (1,680,000     18,555,999         1,415,991   
           

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

Weighted average exercise price

  

   $ 0.358       $ 0.220       $ 0.286      $ 0.268       $ 0.176   

 

* Employee share options. Please refer to “Employee share options” section below for more details.
** Share options issued to CEO. Please refer to “Share options issued to CEO” section below for more details.

None of the options listed above have been exercised during the year.

 

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Note 38. Share-based payments (continued)

 

The weighted average remaining contractual life of options outstanding at the 30 Jun 2016 is 4.33 years.

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

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

04/03/2015

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

24/06/2015

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

24/06/2015

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

 

 

    

 

 

    

 

 

   

 

 

    

 

 

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

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

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.

The weighted average remaining contractual life of options outstanding at the 30 Jun 2015 is 4.10 years.

Employee share options

During the year ended 30 June 2016, 5,500,008 options (tranche 5) have been issued to the employees by the consolidated entity, pursuant to the approved ESOP.

Tranche 5 of 5,500,008 options

The options vest over 3 years. The vesting periods applying to options issued under this tranche are:

 

(i) 16/11/2016 (1,833,336 options)

 

(ii) 16/11/2017 (1,833,336 options), and

 

(iii) 16/11/2018 (1,833,336 options).

An option will only vest if the option holder continues to be a full time employee with the consolidated entity during the vesting period relating to the option.

Conditions for an option to be exercised:

 

 

The option must have vested and a period of 2 years from the date the option was issued must have passed;

 

 

Option holder must have provided the consolidated entity with an exercise notice and have paid the exercise price for the option;

 

 

The exercise notice must be for the exercise of at least the minimum number of options; and

 

 

The exercise notice must have been provided to the consolidated entity and exercise price paid before the expiry of 5 years from the date the option is issued.

Share options issued to CEO

During the year ended 30 June 2016, 7,500,000 options (tranche 6,7 and 8) have been issued to CEO Dr James Garner during the year by the consolidated entity pursuant to the approved Employee Share Option Plan.

Tranche 6 of 3,000,000 options

The options vest over 2 years. The vesting periods applying to options issued under this tranche are:

 

(i) 01/08/2016 (750,000 options),

 

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Note 38. Share-based payments (continued)

 

(ii) 01/02/2017 (750,000 options),

 

(iii) 01/08/2017 (750,000 options), and

 

(iv) 01/02/2018 (750,000 options).

Tranche 7 of 2,000,000 options

The options vest on 01/02/2019.

Tranche 8 of 2,500,000 options

The options vest on 01/02/2020.

An option will only vest if the option holder continues to be a full time employee with the consolidated entity during the vesting period relating to the option.

Conditions for an option to be exercised:

 

 

The option must have vested;

 

 

Option holder must have provided the consolidated entity with an exercise notice and have paid the exercise price for the option;

 

 

The exercise notice must be for the exercise of at least the minimum number of options; and

 

 

The exercise notice must have been provided to the consolidated entity and exercise price paid before the expiry of 5 years from the date the option is issued.

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 for Tranche 1 to Tranche 5. For Tranche 6 to Tranche 8, this Option Valuation methodology has been used with the expectation that the majority of these options would be exercised halfway through exercise period of these options.

The exercise prices and expiry dates of these options are disclosed in the table above.

The closing price of an ordinary share is as follows:

 

 

On 4 March 2015 (Tranche 1 and 2), $0.180 per ordinary share,

 

 

On 24 June 2015 (Tranche 3 and 4), $0.245 per ordinary share,

 

 

On 15 October 2015 (Tranche 5), $0.140 per ordinary share, and

 

 

On 18 March 2016 (Tranche 6, 7 and 8), $0.115 per ordinary share.

Risk-free rate and grant date

For Tranches 1 and 2, the risk-free rate of a five-year Australian Government bond was 2.07% on grant date, being 4 March 2015,

For Tranche 3, the risk-free rate of a two-year Australian Government bond was 2.02% on grant date, being 4 March 2015,

For Tranche 4, the risk-free rate of a five-year Australian Government bond was 2.34% on grant date, being 24 June 2015,

For Tranche 5, the risk-free rate of a five year Australian Government bond was 2.04% on grant date, being 15 October 2015, and;

For Tranche 6, 7 and 8, the risk-free rate of a five-year Australian Government bond was 2% on grant date, being 18 March 2016.

For Tranches 1, 2, 3 and 4, options do not have any vesting conditions and vest immediately on the grant date. These options are unlisted as at 30/06/2016. 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.

The Tranches 5, 6, 7 and 8 options have various vesting periods and exercising conditions. These options are unlisted as at 30/06/2016.

 

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Table of Contents

Note 38. Share-based payments (continued)

 

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:

 

Tranche    Grant date      Expiry date      Share price at
Grant Date
     Exercise
price
     Volatility
(%)
    Option
Life
     Fair value
per option
 

1

     04/03/2015         16/12/2019       $ 0.180       $ 0.150         120.00     3.46       $ 0.150   

2

     04/03/2015         18/12/2019       $ 0.180       $ 0.150         120.00     3.47       $ 0.150   

3

     24/06/2015         30/06/2020       $ 0.245       $ 0.400         150.00     4.00       $ 0.217   

4

     15/10/2015         16/11/2020       $ 0.140       $ 0.220         158.11     4.38       $ 0.128   

5

     18/03/2016         18/03/2021       $ 0.115       $ 0.199         130.00     4.59       $ 0.081   

6

     18/03/2016         18/03/2021       $ 0.115       $ 0.199         130.00     4.59       $ 0.086   

7

     18/03/2016         18/03/2021       $ 0.115       $ 0.261         130.00     4.59       $ 0.087   

 

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