FORM 6-K

U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE

SECURITIES EXCHANGE ACT OF 1934

 

dated February 25, 2016

 

Commission File Number 0-51504

 

GENETIC TECHNOLOGIES LIMITED

(Exact Name as Specified in its Charter)

 

N/A

(Translation of Registrant’s Name)

 

60-66 Hanover Street

Fitzroy

Victoria 3065 Australia

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F    x

Form 40-F    o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):   o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):   o

 

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

 

Yes    o

No    x

 

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):  Not applicable.

 

 

 



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused the Report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

Date:  February 25, 2016

 

 

 

GENETIC TECHNOLOGIES LIMITED

 

 

 

 

 

By:

/s/ Kevin Fischer

 

 

Name:

Kevin Fischer

 

 

Title:

Company Secretary

 

2



 

EXHIBIT INDEX

 

Exhibit

 

Description of Exhibit

 

 

 

99.1

 

Half-Year Financial Report for the period ended 31 December 2015

 

3


Exhibit 99.1

 

 

G ENETIC T ECHNOLOGIES L IMITED

A.B.N. 17 009 212 328

 

Half-Year Financial Report

for the period ended

31 DECEMBER 2015

 



 

G ENETIC T ECHNOLOGIES L IMITED

Half-Year Financial Report

 

DIRECTORS’ REPORT

 

The Directors submit the financial report of Genetic Technologies Limited (“GTG” and the “Company”) and the entities it controlled for the half-year ended 31 December 2015.

 

Directors

 

The names of the Directors of the Company in office at the date of this Report are stated below.  All Directors were in office for the entire period, except as noted below.

 

Dr. Malcolm R. Brandon (Non-Executive Chairman)

Mr. Grahame J. Leonard AM (Non-Executive Director)

Dr. Paul A. Kasian (Non-Executive Director)

Dr. Lindsay Wakefield (Non-Executive Director)

Mr. Eutillio Buccilli (Executive Director)

 

Review and results of operations

 

Financial overview

 

During the period under review, the consolidated entity continued to operate in the molecular diagnostics sector, focussing its energies and resources on the further expansion of its U.S.-based business and the distribution of its proprietary breast cancer risk assessment test BREVAGen plus ® . The total comprehensive loss of the consolidated entity for the financial half-year ended 31 December 2015 was $3,019,678 (2014: $4,774,751).  The net cash flows used in operations during the half-year were 23.6% lower than the previous corresponding period ($4,444,201 as compared to $5,820,310).  Overall, total cash and cash equivalents for the half-year ended 31 December 2015 decreased by $3,821,816 to $14,519,541 at balance date.

 

BREVAGen plus ®  breast cancer risk test

 

The Company’s lead product, BREVAGen plus, is a clinically validated, easy-to-use, predictive risk assessment test for women at risk of developing sporadic, or non-hereditary, breast cancer.  BREVAGen plus improves upon the predictive power of the first generation BREVAGen test and is designed to facilitate better informed decisions about breast cancer screening and preventive treatment plans. BREVAGen plus expands the application of BREVAGen from Caucasian women to include African-Americans and Hispanics, and is directed towards women aged 35 years or above, who have not had breast cancer and have one or more risk factors for developing breast cancer. The Company markets BREVAGen plus to healthcare professionals in comprehensive breast health care and imaging centres, as well as to obstetricians/gynaecologists (OBGYNs) and breast cancer risk assessment specialists (such as breast surgeons). Results from BREVAGen plus provide physicians with valuable information to assist in developing a patient-specific Breast Cancer Risk Reduction and Screening Plan based on professional medical society guidelines, such as the American Cancer Society (ACS) (www.cancer.org) and The National Comprehensive Cancer Network (NCCN) (www.nccn.org). BREVAGen plus combines genetic information with a common, questionnaire-based, method of breast cancer risk-assessment (termed the Breast Cancer Risk Assessment Tool (BRCAT) or Gail Score) to provide a more accurate estimate of a woman’s risk of developing breast cancer. The genetic information used in BREVAGen plus is based on the presence/absence of 77 different single nucleotide polymorphisms (SNPs) in a woman’s DNA, with each particular SNP being associated with breast cancer risk. While the presence or absence of each SNP has a small impact on breast cancer risk, collectively, the 77 SNPs can have a significant impact. The impact of the SNPs can move a patient up or down in terms of breast cancer risk classification, which as result, enables the most appropriate type/form of breast cancer screening available and may provide eligibility for prophylactic medications.

 

Key accomplishments during the half year under review include;

 

·                   Issuance of U.S. Patent Nos: 9,051,617 and 9,068,229 covering three of the core genetic markers referred to as single nucleotide polymorphisms (“SNPs”) in the Company’s BREVAGen plus risk assessment test. The particular SNPs in question were amongst the first of the breast cancer susceptibility loci to be consistently and robustly confirmed across multiple genome-wide association

 

1



 

studies, such that their inclusion in BREVAGen plus provides the test with an additional significant proprietary competitive advantage over other SNP-based tests that might be developed. This patent family is assigned to Cambridge University, England and licensed exclusively to Genetic Technologies Limited. The patents comprise an important part of the commercialisation strategy for our breast cancer risk assessment test.

 

·                   Publication of the validation study paper entitled “Breast cancer risk prediction based on clinical models and 77 independent risk-associated SNPs in women aged under 50 years: Australian Breast Cancer Family Registry” in the peer-reviewed journal, Cancer, Epidemiology, Biomarkers and Prevention on December 16, 2015. The study was designed to examine the predictive accuracy of BREVAGen plus when using a variety of other breast cancer risk assessment methods and was conducted under the supervision of Professor John Hopper and first authored by Dr. Gillian Dite from the Centre for Molecular Epidemiology at The University of Melbourne. The authors utilised the Australian Breast Cancer Family Registry to conduct a case-control study of 1,155 women aged between 35 and 50 years. The authors concluded: “By combining a 77 SNP-based score with clinical models, the AUC (accuracy) for predicting breast cancer before age 50 years improved by >20%”. The new risk prediction scores presented in the study, represent the strongest known means available for physicians to assess the risk of a woman developing breast cancer. The article can be viewed at:

http://cebp.aacrjournals.org/content/early/2015/12/16/1055-9965.EPI-15-0838.abstract.

 

·                   Publication of the validation study paper entitled entitled “SNPs and Breast Cancer Risk Prediction for African-American and Hispanic Women” was published in the peer-reviewed journal, Breast Cancer Research and Treatment on 20 November, 2015. The authors studied 7,539 African-American and 3,363 Hispanic women from the Women’s Health Initiative. The results from this study demonstrates that including information from the SNPs associated with breast cancer risk improves the discriminatory accuracy of BCRAT and IBIS for both African-American and Hispanic women. These groups of women comprise increasing proportions of the U.S. population and are both under-represented in scientific literature and the U.S. healthcare system. The results from this study are important to physicians in that it allows them to better target and develop individualised breast cancer prevention and screening strategies for more of their patients. This publication is not only important because it increases the potential market for BREVAGen plus by about a third, but because it makes selling the test easier. The physician doesn’t need to screen for race when deciding to offer a woman BREVAGen plus and advertising materials do not need to comment on the uncomfortable subject of racial applicability. BREVAGen plus is un-validated in Asians at this time. The article can be viewed at:

http://link.springer.com/article/10.1007/s10549-015-3641-7 .

 

The Company had previously conducted multiple scientific studies to develop and validate the first generation BREVAGen test as well as created two health economic models to demonstrate potential cost savings and health benefits associated with the BREVAGen test. Importantly, due to the nature of the technology and the specific improvements incorporated in BREVAGen plus , the research undertaken and published based on the original version of the test remains applicable to the new and improved BREVAGen plus test.

 

The Company continues to amass scientific validation for the important role BREVAGen plus plays in women’s health and is making meaningful strides in the commercial development of this next generation predictive breast cancer test. The publication of the above two new validation studies, serve as a testament to the continued momentum for the Company’s BREVAGen plus breast cancer risk assessment test in the scientific community. In addition, attaining such publications in medical journals will help to further strengthen the Company’s commercial position and accelerate reimbursement discussions with private payers.

 

Licensing and IP

 

The Company continued to bolster its intellectual property portfolio with the issuance of U.S. Patent Nos: 9,051,617 and 9,068,229. These patents cover three core genetic markers referred to as SNPs in

 

2



 

Review and results of operations (cont.)

 

Licensing and IP (cont.)

 

BREVAGen plus , and comprise an important part of the commercialisation strategy for the test. This patent family is assigned to Cambridge University, England and licensed exclusively to Genetic Technologies Limited.

 

Non-Coding Assertion Program

 

On 30 October 2014, Judge Stark issued a Memorandum Opinion finding Claim 1 of the GTG’s foundation ‘179 patent ineligible and granted that Motion to Dismiss. The Company’s Legal Counsel prepared an appeal to the decision in the Federal Circuit. Counsel sought and achieved a stay of all non-appealed actions pending resolution of the Appeal.

 

On 7 December 2015, the Company argued before the Federal Circuit Court of Appeals in Washington DC that Claim 1 of the GTG’s foundation ‘179 patent is patent eligible under the standards set forth in the Mayo/Alice line of Supreme Court cases, and that Judge Stark’s decision to grant motions to dismiss finding Claim 1 patent ineligible should be reversed. It is anticipated that the Federal Circuit will issue its decision on the appeal between June and September 2016. If the appeal is successful in overturning Judge Stark’s decision, the pending cases may be immediately resumed and if the appeal is not completed or is lost, then these cases will be dismissed and over.

 

There are five cases pending, several of those cases are asserted against major pharmaceutical companies.

 

Other commercial assets

 

As part of the Company’s strategy to focus on the expansion of its cancer diagnostic franchise, work continues to sell, out-license or co-develop other assets and technologies in which the Group has an interest.

 

Significant changes in the state of affairs

 

In addition to the matters discussed above in the Review and results of operations , the following events occurred during the half-year ended 31 December 2015.

 

Key Managerial Changes

 

As announced on 6 October 2015, Mr. Kevin Fischer was appointed Chief Financial Officer and joint Company Secretary, effective 2 November 2015. Mr. Fischer has subsequently been appointed as sole Company Secretary effective 13 January 2016.

 

On 2 November 2015, Mr. Chris Saunders was appointed Senior VP Sales and Marketing, Phenogen Sciences Inc., replacing Mr. Mark Ostrowski.

 

Options

 

On 25 November 2015, the Company granted the following options over ordinary shares in the Company;

 

·                   As approved by shareholders at the Company’s Annual General Meeting held on 25 November 2015, 14,236,111 options to the CEO, Mr. Eutillio Buccilli. The options, which were granted at nil consideration, entitle Mr. Buccilli to acquire one ordinary share, at a strike price of $0.02 at any time up to, and including 24 November 2020, subject to certain vesting conditions.

 

·                   10,000,000 options to Key Management Personnel.  The options, which were granted at nil consideration, entitle the holders to acquire one ordinary share, at a strike price of $0.02 at any time up to, and including 24 November 2020, subject to certain vesting conditions.

 

·                   1,500,000 options to US based employees. The options, which were granted at nil consideration, entitle the holders to acquire one ordinary share, at a strike price of $0.058 at any time up to, and including 24 September 2020, subject to certain vesting conditions.

 

There were no other significant changes in the state of affairs that are not described elsewhere in this Report.

 

3



 

Review and results of operations (cont.)

 

Significant events after balance date

 

There have been no significant events which have occurred after balance date.

 

Further information

 

Further information concerning the operations and financial condition of the consolidated entity can be found in the reports and releases made by the Company to the Australian Securities Exchange during the half-year.

 

Auditor’s independence declaration

 

The Company has obtained an independence declaration from its auditor, PricewaterhouseCoopers, which has been reproduced on page 5 of this Report.

 

Signed in accordance with a resolution of the Directors.

 

 

DR. MALCOLM R. BRANDON

 

Non-Executive Chairman

 

 

 

Melbourne, 24 February 2016

 

 

4



 

CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

 

 

 

 

 

Half-year ended

 

Half-year ended

 

 

 

 

 

31 December 2015

 

31 December 2014

 

 

 

Notes

 

$

 

$

 

 

 

 

 

 

 

 

 

Revenue from continuing operations - genetic testing services

 

 

 

393,054

 

1,252,170

 

Less: cost of sales

 

3

 

(289,038

)

(650,360

)

Gross profit from continuing operations - genetic testing services

 

 

 

104,016

 

601,810

 

Other revenue

 

4

 

263,168

 

365,438

 

Other income and expenses

 

5

 

123,498

 

190,466

 

Selling and marketing expenses

 

 

 

(1,693,071

)

(2,824,183

)

General and administrative expenses

 

 

 

(1,915,373

)

(1,768,407

)

Licensing, patent and legal costs

 

 

 

(67,988

)

(318,036

)

Laboratory and research and development costs

 

 

 

(1,160,797

)

(1,724,767

)

Finance costs

 

 

 

 

(232,985

)

Gain on disposal of business

 

6

 

 

1,480,811

 

Fair value gain on financial liabilities at fair value through profit or loss

 

 

 

 

193,893

 

Fair value loss on financial assets at fair value through profit or loss

 

9

 

 

(795,533

)

Loss from continuing operations before income tax expense

 

 

 

(4,346,547

)

(4,831,493

)

Income tax expense

 

 

 

 

 

Loss for the half-year

 

 

 

(4,346,547

)

(4,831,493

)

 

 

 

 

 

 

 

 

Other comprehensive income / (loss)

 

 

 

 

 

 

 

Items that may be reclassified to profit or loss

 

 

 

 

 

 

 

Exchange gains / (losses) on translation of controlled foreign operations

 

 

 

1,326,869

 

56,742

 

Other comprehensive income / (loss) for the half-year, net of tax

 

 

 

1,326,869

 

56,742

 

Total comprehensive loss for the half-year

 

 

 

(3,019,678

)

(4,774,751

)

 

 

 

 

 

 

 

 

Loss for the half-year is attributable to:

 

 

 

 

 

 

 

Owners of Genetic Technologies Limited

 

 

 

(4,346,547

)

(4,831,493

)

Non-controlling interests

 

 

 

 

 

Loss for the half-year

 

 

 

(4,346,547

)

(4,831,493

)

 

 

 

 

 

 

 

 

Total comprehensive loss for the half-year is attributable to:

 

 

 

 

 

 

 

Owners of Genetic Technologies Limited

 

 

 

(3,019,678

)

(4,774,751

)

Non-controlling interests

 

 

 

 

 

Total comprehensive loss for the half-year

 

 

 

(3,019,678

)

(4,774,751

)

 

 

 

 

 

 

 

 

Earnings per share attributable to owners of the Company and from continuing operations:

 

 

 

 

 

 

 

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

 

8

 

(0.25

)

(0.68

)

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

 

8

 

(0.25

)

(0.68

)

 

The above condensed consolidated statement of comprehensive income should be read in conjunction with the accompanying notes.

 

5



 

CONDENSED CONSOLIDATED BALANCE SHEET

 

 

 

 

 

As at

 

As at

 

 

 

 

 

31 December 2015

 

30 June 2015

 

 

 

Notes

 

$

 

$

 

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

 

14,519,541

 

18,341,357

 

Trade and other receivables

 

 

 

681,057

 

714,951

 

Prepayments and other assets

 

 

 

682,457

 

509,788

 

Total current assets

 

 

 

15,883,055

 

19,566,096

 

 

 

 

 

 

 

 

 

Non-current assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Property, plant and equipment

 

 

 

655,712

 

417,595

 

Intangible assets

 

 

 

672,259

 

736,041

 

Total non-current assets

 

 

 

1,327,971

 

1,153,636

 

Total assets

 

 

 

17,211,026

 

20,719,732

 

 

 

 

 

 

 

 

 

LIABILITIES

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

Trade and other payables

 

 

 

621,921

 

1,102,974

 

Financial liabilities at fair value through profit or loss

 

10

 

 

25,000

 

Deferred revenue

 

 

 

25,149

 

77,282

 

Provisions

 

 

 

506,496

 

529,907

 

Total current liabilities

 

 

 

1,153,566

 

1,735,163

 

 

 

 

 

 

 

 

 

Non-current liabilities

 

 

 

 

 

 

 

Provisions

 

 

 

81,104

 

25,321

 

Total non-current liabilities

 

 

 

81,104

 

25,321

 

Total liabilities

 

 

 

1,234,670

 

1,760,484

 

Net assets

 

 

 

15,976,356

 

18,959,248

 

 

 

 

 

 

 

 

 

EQUITY

 

 

 

 

 

 

 

Contributed equity

 

12

 

115,272,576

 

115,247,128

 

Reserves

 

 

 

6,035,610

 

4,697,403

 

Accumulated losses

 

 

 

(105,331,830

)

(100,985,283

)

Total equity

 

 

 

15,976,356

 

18,959,248

 

 

The above condensed consolidated balance sheet should be read in conjunction with the accompanying notes.

 

6



 

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

 

 

 

 

 

Half-year ended

 

Half-year ended

 

 

 

 

 

31 December 2015

 

31 December 2014

 

 

 

Notes

 

$

 

$

 

 

 

 

 

 

 

 

 

Cash flows from / (used in) operating activities

 

 

 

 

 

 

 

Receipts from customers

 

 

 

608,160

 

1,719,718

 

Payments to suppliers and employees

 

 

 

(5,069,856

)

(7,532,962

)

Interest received

 

 

 

17,495

 

15,898

 

Interest and finance charges paid

 

 

 

 

(22,964

)

Net cash flows from / (used in) operating activities

 

 

 

(4,444,201

)

(5,820,310

)

 

 

 

 

 

 

 

 

Cash flows from / (used in) investing activities

 

 

 

 

 

 

 

Purchase of property, plant and equipment

 

 

 

(263,698

)

(152,267

)

Proceeds from the sale of plant and equipment

 

 

 

 

53,276

 

Cash received on disposal of Heritage Business

 

6

 

 

2,100,894

 

Net cash flows from / (used in) investing activities

 

 

 

(263,698

)

2,001,903

 

 

 

 

 

 

 

 

 

Cash flows from / (used in) financing activities

 

 

 

 

 

 

 

Proceeds from the issue of shares

 

 

 

 

257,500

 

Equity transaction costs

 

 

 

(1,654

)

(42,086

)

Net proceeds from borrowings

 

 

 

 

1,999,500

 

Net cash flows from / (used in) financing activities

 

 

 

(1,654

)

2,214,914

 

Net increase / (decrease) in cash and cash equivalents

 

 

 

(4,709,553

)

(1,603,493

)

Cash and cash equivalents at the beginning of the period

 

 

 

18,341,357

 

2,831,085

 

Net foreign exchange difference

 

 

 

887,737

 

47,216

 

Cash and cash equivalents at the end of the period

 

 

 

14,519,541

 

1,274,808

 

 

The above condensed consolidated statement of cash flows should be read in conjunction with the accompanying notes.

 

7



 

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

 

 

 

Contributed
equity

 

Reserves

 

Accumulated
losses

 

Total
equity

 

 

 

$

 

$

 

$

 

$

 

 

 

 

 

 

 

 

 

 

 

Balance at 1 July 2014

 

90,080,492

 

3,922,140

 

(92,175,113

)

1,827,519

 

Loss for the half-year

 

 

 

(4,831,493

)

(4,831,493

)

Other comprehensive income

 

 

56,742

 

 

56,742

 

Total comprehensive loss

 

 

56,742

 

(4,831,493

)

(4,774,751

)

Transactions with owners in their capacity as owners

 

 

 

 

 

 

 

 

 

Contributions of equity net of transaction costs

 

3,189,795

 

 

 

3,189,795

 

Share-based payments

 

 

60,020

 

 

60,020

 

 

 

3,189,795

 

60,020

 

 

3,249,815

 

Balance at 31 December 2014

 

93,270,287

 

4,038,902

 

(97,006,606

)

302,583

 

 

 

 

 

 

 

 

 

 

 

Balance at 1 July 2015

 

115,247,128

 

4,697,403

 

(100,985,283

)

18,959,248

 

Loss for the half-year

 

 

 

(4,346,547

)

(4,346,547

)

Other comprehensive income

 

 

1,326,869

 

 

1,326,869

 

Total comprehensive loss

 

 

1,326,869

 

(4,346,547

)

(3,019,678

)

Transactions with owners in their capacity as owners

 

 

 

 

 

 

 

 

 

Contributions of equity net of transaction costs

 

25,448

 

 

 

25,448

 

Share-based payments

 

 

11,338

 

 

11,338

 

 

 

25,448

 

11,338

 

 

36,786

 

Balance at 31 December 2015

 

115,272,576

 

6,035,610

 

(105,331,830

)

15,976,356

 

 

The above condensed consolidated statement of changes in equity should be read in conjunction with the accompanying notes.

 

8



 

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

Half-year ended 31 December 2015

 

1.                   BASIS OF PREPARATION OF HALF-YEAR REPORT

 

This condensed consolidated interim financial report for the half-year reporting period ended 31 December 2015 has been prepared in accordance with AASB 134 Interim Financial Reporting and the Corporations Act 2001. This condensed consolidated interim financial report also complies with IAS 34 Interim Financial Reporting as issued by the International Accounting Standards Board. The condensed consolidated interim financial report was authorised for issue in accordance with a resolution of the Directors dated 24 February 2016.

 

This condensed consolidated interim financial report does not include all the notes of the type normally included in an annual financial report.  Accordingly, this Report is to be read in conjunction with the annual report for the year ended 30 June 2015 and any public announcements made by Genetic Technologies Limited during the interim reporting period in accordance with the continuous disclosure requirements of the Corporations Act 2001.

 

The accounting policies adopted are consistent with those of the previous financial year and corresponding interim reporting period.

 

2.                   CRITICAL ACCOUNTING ESTIMATES AND JUDGEMENTS

 

Estimates and judgements are evaluated and based on historical experience and other factors, including expectations of future events that may have a financial impact on the Company and that are believed to be reasonable under the circumstances.

 

Going concern

 

During the financial half-year, the consolidated entity incurred a total comprehensive loss after income tax of $3,019,678 (2014: $4,774,751) and net cash outflows from operations of $4,444,201 (2014: $5,820,310).  As at 31 December 2015, the consolidated entity held cash reserves of $14,519,541.

 

The cash generated from revenue combined with its existing cash reserves will enable the Company to fund its operations in the next twelve months from the date of this report.

 

However, the Company is aware that the long term viability of the Company is directly dependent on the ability to grow revenue, control costs and raise additional funds via the issuance of new equity should the need arise.   Any issuance of new equity will be subject to normal risks and therefore could impact the ability of the Company to continue as a going concern. However, the Directors believe that the Company would be successful in raising new funds if the need arises and have prepared the financial report on a going concern basis.

 

Critical accounting estimates and assumptions

 

The carrying amounts of certain assets and liabilities are often determined based on estimates and assumptions of future events.  The key estimates and assumptions that have a significant risk of causing a material adjustment to the carrying value of certain assets and liabilities within the next annual reporting period are set out below.

 

Impairment of intangible assets

 

The Group determines whether intangible assets, are impaired on at least an annual basis , in accordance with the Group’s accounting policies.  This process requires an estimation to be made of the recoverable amount of the cash-generating units to which the respective assets are allocated.

 

Useful lives of assets

 

The estimation of the useful lives of assets has been based on historical experience as well as lease terms (for leased equipment) and patent terms (for patents).  In addition, the condition of the assets is assessed at least annually and considered against the remaining useful life and adjustments to useful lives are made when considered necessary.

 

9



 

2.                   CRITICAL ACCOUNTING ESTIMATES AND JUDGEMENTS (cont.)

 

Revenue from the sale of BREVAGen tests

 

In accordance with revenue recognition principles, the Group recognises the revenue from the sale of BREVAGen TM  and BREVAGen plus ® test on an accruals basis. This requires the Group to estimate the amount of revenue expected to be received based on the historical data of amounts received from tests sold since the launch of BREVAGen TM  and BREVAGen plus ®. The accrual estimate may be impacted by the recoverability of the amounts via the U.S. healthcare reimbursement system.

 

 

 

Consolidated

 

 

 

Half-year ended

 

Half-year ended

 

 

 

31 December 2015

 

31 December 2014

 

 

 

$

 

$

 

3.                    COST OF SALES

 

 

 

 

 

 

 

 

 

 

 

Inventories used

 

96,504

 

333,667

 

Direct labour costs

 

116,743

 

261,604

 

Depreciation expense

 

71,041

 

30,368

 

Inventories written off

 

4,750

 

24,721

 

Total cost of sales

 

289,038

 

650,360

 

 

 

 

 

 

 

4.                    OTHER REVENUE

 

 

 

 

 

 

 

 

 

 

 

License fees received

 

215,326

 

323,193

 

Royalties and annuities received

 

47,842

 

42,245

 

Total other revenue

 

263,168

 

365,438

 

 

 

 

 

 

 

5.                    OTHER INCOME AND EXPENSES

 

 

 

 

 

 

 

 

 

 

 

Research and development tax incentive

 

48,000

 

133,000

 

Rental income

 

58,003

 

41,568

 

Interest Revenue

 

17,495

 

15,898

 

Total other income and expenses

 

123,498

 

190,466

 

 

6.                    GAIN ON DISPOSAL OF BUSINESS

 

On 19 November 2014, the Company announced that it had completed the sale of its heritage Australian Genetics business to Specialist Diagnostics Services Ltd (“SDS”), the wholly owned pathology subsidiary of Primary Health Care Ltd. Under the terms of sale, SDS acquired the Australian Genetics business for $2,100,894 (net of employee entitlements and inclusive of GST), in cash. The gain on disposal as recognised in the Consolidated Statement of Comprehensive Income for the half-year ended 31 December 2014 was $1,480,811. Goodwill of $315,388 attributable to the heritage business disposed of has been included in the net assets disposed.

 

7.                   EXPENSES

 

Amortisation of intangible assets

 

63,783

 

64,306

 

Depreciation of fixed assets

 

109,539

 

25,738

 

Employee benefits expenses

 

2,012,986

 

3,220,846

 

Net foreign exchange losses

 

415,320

 

9,526

 

 

10



 

 

 

Consolidated

 

 

 

As at

 

As at

 

 

 

31 December 2015

 

31 December 2014

 

 

 

$

 

$

 

 

 

 

 

 

 

8.                    LOSS PER SHARE

 

 

 

 

 

 

 

 

 

 

 

The following reflects the income and share data used in the calculations of basic and diluted loss per share:

 

 

 

 

 

 

 

 

 

 

 

Loss for the half-year attributable to the owners of Genetic Technologies Limited

 

(4,346,547

)

(4,831,493

)

 

 

 

 

 

 

Weighted average number of ordinary shares used in calculating loss per share (as at 31 December 2015 and 31 December 2014)

 

1,715,146,337

 

702,201,933

 

 

Note:         None of the 49,977,778 (31 December 2014: 14,025,000) options outstanding as at the reporting date are considered to be dilutive for the purposes of calculating diluted earnings per share and have therefore been excluded from the weighted average number of shares.

 

9.                                       FAIR VALUE MEASUREMENT OF FINANCIAL INSTRUMENTS

 

Fair value hierarchy

 

AASB requires disclosure of fair value measurements by level of the following fair value measurement hierarchy:

 

(a)              quoted prices (unadjusted) in active markets for identical assets or liabilities (level 1);

 

(b)              inputs other than prices included within level 1 that are observable for the asset or liability, either directly or indirectly (level 2); and

 

(c)               inputs for the asset or liability that are not based on observable market data (unobservable inputs) (level 3).

 

The following table presents the Group’s financial assets and financial liabilities measured and recognised at fair value as at 31 December 2015 and 30 June 2015. No level 1 or level 2 financial assets or liabilities were held by the Group as at 31 December 2015 and 30 June 2015.

 

 

 

ImmunAid option
financial asset
$

 

Convertible note
(financial liabilities)
$

 

Opening balance 1 July 2014

 

795,533

 

(2,502,384

)

Additions

 

 

(2,150,000

)

Conversions to equity

 

 

4,433,491

 

Exchange differences

 

 

(155,353

)

Fair value gain/ (loss) recognized through profit and loss

 

(795,533

)

349,246

 

Closing balance 30 June 2015

 

(1)

(25,000

)

Additions

 

 

 

Conversions to equity

 

 

25,000

 

Exchange differences

 

 

 

Fair value gain/ (loss) recognized through profit and loss

 

 

 

Closing balance 31 December 2015

 

 

 

 

11



 


(1)Management recognised a fair value of $NIL for the ImmunAid financial asset as at 30 June 2015, resulting in a fair value loss on financial assets at fair value through profit or loss of $(795,533).

 

9.              FAIR VALUE MEASUREMENT OF FINANCIAL INSTRUMENTS (cont.)

 

Valuation techniques used to derive level 2 and level 3 fair values

 

The fair value of financial instruments that are not traded in an active market is determined using valuation techniques.  These valuation techniques maximise the use of observable market data where it is available and rely as little as possible on entity specific estimates.  If all significant inputs required to fair value an instrument are observable, the instrument is included in level 2.  If one or more of the significant inputs is not based on observable market data, the instrument is included in level 3.

 

Valuation process

 

The value of the convertible note outstanding at 30 June 2015 was calculated with reference to its face value, which approximated to its fair value.

 

10.           BORROWINGS (CURRENT)

 

 

 

Consolidated

 

 

 

As at

 

As at

 

 

 

31 December 2015

 

30 June 2015

 

 

 

$

 

$

 

 

 

 

 

 

 

Debt convertible notes at fair value

 

 

25,000

 

Total borrowings

 

 

25,000

 

 

On 23 July 2015 the convertible notes plus capitalised interest were converted into 1,091,093 ordinary shares in the Company.

 

11.            SEGMENT REPORTING

 

Identification of reportable segments

 

The Group has identified a sole operating segment as reported that is consistent with the internal reporting provided to the chief operating decision maker and is aligned to the one major revenue stream.

 

The Groups operating segment is summarised as follows:

 

Business segments

 

 

 

 

 

Revenues and income

 

Profit / (loss)

 

 

 

 

 

Sales

 

Other

 

Totals

 

after tax

 

Segment

 

 

 

$

 

$

 

$

 

$

 

Operations

 

2015

 

393,054

 

386,666

 

779,720

 

(4,346,547

)

 

 

2014

 

1,252,170

 

2,221,082

 

3,473,252

 

(4,831,493

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortisation

 

Purchases of

 

 

 

 

 

Assets

 

Liabilities

 

/depreciation

 

equipment

 

Segment

 

 

 

$

 

$

 

$

 

$

 

Operations

 

2015

 

17,211,026

 

(1,234,670

)

(173,322

)

263,698

 

 

 

2014

 

20,719,732

 

(1,760,484

)

(232,203

)

304,135

 

 

Notes:             In the above tables, all income statement figures relate to the periods ended 31 December 2015 and 2014, respectively whilst all balance sheet figures are as at 31 December 2015 and 30 June 2015, respectively.

 

Other revenues and income includes interest revenue of $17,495 (2014: $15,898).

 

Profit / (loss) after tax includes employee benefits expenses of $2,012,986 (2014: $3,220,846).

 

12



 

Assets includes cash of $14,519,541 (30 June 2015: $18,341,357).

 

Liabilities includes trade and other payables of $621,921 (30 June 2015: $1,102,974) and provisions of $587,600 (30 June 2015: $555,228).

 

There were no intersegment sales.

 

11.            SEGMENT REPORTING (cont.)

 

Geographic information

 

Australia — is the home of the parent entity and the location of the Company’s genetic testing and licensing operations.

USA — is the home of Phenogen Sciences Inc. and GeneType Corporation.

Switzerland — is the home of GeneType AG.

 

Geographic segments

 

 

 

 

 

Revenues and income

 

Profit / (loss)

 

 

 

 

 

Sales

 

Other

 

Totals

 

after tax

 

Segment

 

 

 

$

 

$

 

$

 

$

 

Australia

 

2015

 

220

 

386,666

 

386,886

 

(710,657

)

 

 

2014

 

757,428

 

4,514,628

 

5,272,056

 

(232,884

)

USA

 

2015

 

392,834

 

 

392,834

 

(3,624,954

)

 

 

2014

 

494,742

 

(2,293,547

)

(1,798,805

)

(4,591,282

)

Switzerland

 

2015

 

 

 

 

(10,936

)

 

 

2014

 

 

 

 

(7,327

)

Totals

 

2015

 

393,054

 

386,666

 

779,720

 

(4,346,547

)

 

 

2014

 

1,252,170

 

2,221,081

 

3,473,251

 

(4,831,493

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortisation

 

Purchases of

 

 

 

 

 

Assets

 

Liabilities

 

/depreciation

 

equipment

 

Segment

 

 

 

$

 

$

 

$

 

$

 

Australia

 

2015

 

16,316,921

 

(1,034,876

)

(167,698

)

261,468

 

 

 

2014

 

3,139,778

 

(1,532,911

)

(219,784

)

304,135

 

USA

 

2015

 

891,129

 

(197,807

)

(5,624

)

2,230

 

 

 

2014

 

17,576,978

 

(224,917

)

(12,419

)

 

Switzerland

 

2015

 

2,976

 

(1,987

)

 

 

 

 

2014

 

2,976

 

(2,656

)

 

 

Totals

 

2015

 

17,211,026

 

(1,234,670

)

(173,322

)

263,698

 

 

 

2014

 

20,719,732

 

(1,760,484

)

(232,203

)

304,135

 

 

Note:         In the above tables, all income statement figures relate to the periods ended 31 December 2015 and 2014, respectively whilst all balance sheet figures are as at 31 December 2015 and 30 June 2015, respectively.

 

Included in the above figures are the following intersegment balances and transactions:

 

 

 

Consolidated

 

 

 

As at

 

As at

 

 

 

31 December 2015

 

30 June 2015

 

 

 

$

 

$

 

Loan payable (USA) and loan receivable (Australia)

 

3,419,479

 

16,792,051

 

Loan payable (Switzerland) and loan receivable (Australia)

 

168,155

 

156,550

 

Foreign exchange loss (USA) and foreign exchange gain (Australia)

 

2,203,232

 

3,823,791

 

Cost of sales (USA) and sales (Australia)

 

48,696

 

153,581

 

 

13



 

Segment products and locations

 

The principal geographic segment is Australia, with the Company’s headquarters being located in Melbourne in the State of Victoria however key sales activities take place in the USA.

 

11.            SEGMENT REPORTING (cont.)

 

Major customers

 

During the half-year ended 31 December 2014, there was one customer from whom the Group generated revenues representing more than 10% ($184,906) of the total consolidated revenue from operations.  During the half-year ended 31 December 2015, there were no such customers.

 

12.  CONTRIBUTED EQUITY

 

 

 

Consolidated

 

 

 

As at

 

As at

 

 

 

31 December 2015

 

30 June 2015

 

 

 

$

 

$

 

Issued and paid-up capital

 

 

 

 

 

Fully paid ordinary shares

 

115,272,577

 

115,247,128

 

Total contributed equity

 

115,272,577

 

115,247,128

 

 

Movements in shares on issue

 

 

 

 

 

 

Period ended 31 December 2015

 

Shares

 

$

 

Balance at the beginning of the half-year

 

1,714,191,631

 

115,247,128

 

Add: shares issued as part of the conversion of debt notes

 

1,091,093

 

27,103

 

Less: transaction costs arising on share issue

 

 

(1,654

)

Balance at the end of the half-year

 

1,715,282,724

 

115,272,577

 

 

Year ended 30 June 2015

 

Shares

 

$

 

Balance at the beginning of the financial year

 

613,918,492

 

90,080,492

 

Add: shares issued as part of private placements

 

621,574,062

 

21,445,427

 

Add: shares issued as part of the conversion of convertible notes

 

315,732,411

 

4,507,109

 

Add: shares issued on exercise of options

 

122,966,666

 

1,844,500

 

Less: transaction costs arising on share issue

 

 

(2,572,664

)

Add: shares issued in relation to share-based payment

 

35,876,392

 

 

Add/ (less): transaction costs on placement of shares

 

4,123,608

 

(57,736

)

Balance at the end of the financial year

 

1,714,191,631

 

115,247,128

 

 

Terms and conditions of contributed equity

 

Ordinary shares have the right to receive dividends as declared and, in the event of winding up the Company, to participate in the proceeds from the sale of all surplus assets in proportion to the number of and amounts paid up on shares held.  Ordinary shares, which have no par value, entitle their holder to one vote, either in person or by proxy, at a meeting of the Company.

 

Capital management

 

When managing capital, Management’s objective is to ensure that the Group continues as a going concern as well as to provide returns for shareholders and benefits for other stakeholders.  Management also aims to maintain a capital structure to reduce the entity’s cost of capital.

 

14



 

13.            RELATED PARTY DISCLOSURES

 

Ultimate parent

 

Genetic Technologies Limited is the ultimate Australian parent company.  As at the date of this Report, no shareholder controls more than 50% of the issued capital of the Company.

 

13.            RELATED PARTY DISCLOSURES (cont.)

 

Transactions within the Group and with other related parties

 

During the half-year ended 31 December 2015 various transactions between entities within the Group and other related parties occurred, as listed below.  Except where noted, all amounts were charged on commercial, similar to market terms and at commercial rates.

 

Phenogen Sciences Inc.

 

During the half year ended 31 December  2015 Phenogen Sciences Inc., a subsidiary, purchased testing services from Genetic Technologies Corporation Pty. Ltd., another subsidiary at a cost of $48,696 (2014: $69,509).

 

14.            DIVIDENDS PAID AND PROPOSED

 

No dividends were paid during the half-year ended 31 December 2015 and no dividends were proposed.

 

15.  EVENTS AFTER THE BALANCE SHEET DATE

 

There have been no events which have occurred after balance sheet date.

 

15



 

DIRECTORS’ DECLARATION

 

In the opinion of the Directors:

 

(a)              the financial statements and notes, as set out on pages 5 to 15 are in accordance with the Corporations Act 2001 , including:

 

(i)                  complying with Accounting Standards, the Corporations Regulations 2001 and other mandatory professional reporting requirements; and

 

(ii)               giving a true and fair view of the consolidated entity’s financial position as at 31 December 2015 and of its performance for the half-year ended on that date; and

 

(b)              there are reasonable grounds to believe that the Company will be able to pay its debts as and when they become due and payable.

 

This declaration is made in accordance with a resolution of the Directors.

 

 

DR. MALCOLM R. BRANDON

 

Non-Executive Chairman

 

 

 

Melbourne, 24 February 2016

 

 

16