TRUSCREEN GROUP LIMITED logo

TruScreen Half Year Report and Interim Financial Statements

Half Year Results30 January 2017TRUIndustrials

Interim Report 2017

CONTENTS
TruScreen Key Events 04 Financial Results Snapshot 05

Introducing TruScreen

2

06 Chairman and CEO’s Report 07

Interim Unaudited Financial Statements

09

TruScreen offers an
alternative approach

to cervical screening,

providing real-time,

accurate detection of

pre-cancerous and

cancerous cervical cells

to help improve the

health and wellbeing

of women around

the world.

Our low cost, portable TruScreen

diagnostic system resolves many

of the ongoing issues associated

with Pap smears, and is particularly

relevant in developing countries.

TruScreen manufactures and owns

all rights in the TruScreen

®

Cervical

Cancer Screening System which

comprises of a unique medical device

(TruScreen

1

and TruScreen

2

now in

market), algorithm technology and

processes designed to detect the

presence, at the time of screening, of

pre-cancerous and cancerous tissue

on the cervix.

TruScreen (TRU) is listed on the

New Zealand Stock Exchange’s NZAX

Market, providing investors with an

opportunity to invest in this leading

edge health technology.

TruScreen

1

TruScreen’s first generation cervical cancer screening device

TruScreen

2

TruScreen’s second generation cervical cancer screening device

Algorithm

1

TruScreen’s original tissue differentiating algorithm

Algorithm

2

TruScreen’s refined tissue differentiating algorithm

4
TruScreen Interim Report 2017

Half Year Key Events

• TruScreen² gained certification in Europe (CE),

Australia (TGA), New Zealand (WAND) and

United Kingdom (MHRA).

• Commercial sales of TruScreen² commenced.

• TruScreen

1

selected for major screening programmes

in North China.

• Commenced liaising with Governments for adoption

of TruScreen technology in Mexico.

• Establishment of European business base.

Key Events Since Half Year End

• Clinical Trial completed in Mexico indicating excellent

results with TruScreen

1

being twice as sensitive as Pap

in detecting high grade cervical lesions.

• Mexican National Cancer Institute completed stage 1

of TruScreen² evaluation.

• Commenced liaison with Government of India

to adopt TruScreen technology.

• Improved, finalised and released TruScreen

Algorithm

2

for clinical evaluation.

TruScreen Key Events

5
TruScreen Interim Report 2017

Financial Results Snapshot

HY17HY16

Revenue From Ordinary Activities$810,911$901,144

Sales$361,443$305,882

Other Income$461,707$861,358

Net Loss$1,684,133$352,068

Net Assets$12,107,274$15,018,525

Cash and Cash Equivalents$1,410,327$3,704,736

• Total revenue for the six months ended September 30, 2016, was $823,150 compared to $901,144 for the previous

comparative first period.

• Sales of $361,443 were up 18% on the prior comparative first half period and up 177% on the FY16 second half period.

• Net Loss of $1.68m for the half year included increased expenses in line with TruScreen’s growth strategy.

• Net cash flow for the period was $(894,371).

6
TruScreen Interim Report 2017

INTRODUCING

TRUSCREEN

2

KEY

IMPROVEMENTS

Massively increased processing

capacity and faster processing

Significantly improved

performance

Wireless handpiece with

increased portability

Rechargeable battery freeing

the device from reliance upon

continuous connection to

mains power

Wi-Fi connectivity to PCs,

Laptops and Smart Devices

Internet browser compatibility

Graphic User Interface with

LCD touch screen

TruScreen

2

7
TruScreen Interim Report 2017

In the six months to

September 30, 2016,

TruScreen focused on four

key pillars of activity.

• Further development of the company’s innovative

technology, TruScreen

2

and Algorithm

2

.

• Clinical validation, cerification and registration

of TruScreen

2

.

• Review and improve our manufacturing costs

and capacity.

• Further enhance our distribution network

and servicing capacity

TruScreen² is in the early stages of commercialisation.

Convincing governments and large private institutions to

adopt an innovative medical technology is neither simple

nor instant and regulatory approval processes can

take time.

As previously advised to the market, initial stocks of the

original TruScreen

1

device sold out quickly in 2015 and

the company chose to discontinue with the sale and

supply of the original device and instead focus on further

development and product improvements to our second-

generation device known as TruScreen². This has involved

significant R & D cost to refine the device and Single Use

Sensors (SUS) together with associated clinical trials and

regulatory certifications.

The company continued to refine its diagnostic capacity

through its Algorithm Improvement Programme with a

significant improvement in accuracy expected. Algorithm

2


has been released for clinical evaluation at a number

of leading hospitals in Australia, Mexico and China. The

company has also made significant product improvements

to improve the device in both clinical and practical use.

TruScreen received European certification (CE Mark)

and commenced production of the TruScreen² device in

April 2016, with several other country-specific regulatory

approvals received in subsequent months. Our application

for Chinese Certification of Truscreen

2

(CFDA) is

progressing to plan and is expected to be finalised

mid-2017.

CHAIRMAN

AND CEO’S REPORT

The company’s

objectives for the

next 12 months are:

• Finalise the clinical validation of the new

TruScreen Algorithm

2

and release that

to the commercial market.

• Submit Truscreen

2

for adoption in various

selected international Government

Screening programs.

• Obtain Chinese model upgrade

certification for TruScreen².

• Complete and expand the current screening

programs in China and military hospitals.

• Further establish our global

distribution networks.

• Enhance sales of TruScreen

2

.

8
TruScreen Interim Report 2017

The company has initiated small sales of TruScreen² to new

markets including Mexico, Hong Kong, Vietnam, Turkey,

Kazakhstan and Poland during the six-month period, with

subsequent sales to Jordan, Philippines and Russia since

September. We have also progressed our plans to enter the

European market and have identified several suitable and

interested distributors in various countries including the

European Union, Middle East and Latin America.

The company’s strategy is to gain early adoption in all

markets and then after a period of evaluation, gain key

opinion leader endorsement which is essential for adoption

for recurring sales in both the private and government

sectors. TruScreen is still the world’s only real time, certified

primary screening device for cervical cancer and is an

innovative technology which takes time for adoption by

governments and major medical institutions.

China remains an important long term opportunity for the

company and the current focus is on building a customer

and reference base, and in particular, encouraging the

selection of TruScreen technology for large screening

programs, as well as increasing adoption in large provincial

hospitals. The CFDA model upgrade approval process

for TruScreen² is progressing to plan and, the company

is continuing to promote TruScreen

1

which is being used

in several large-scale screening programs in China. Over

40,000 women have been screened so far in the three

main programs underway conducted by the All-China

Federation of Trade Unions, the China Doctors Association

and the Shengli Oilfields programs. Continuation of all

three of these programs has been confirmed for 2017

where the speed of women being screened is expected

to increase once TruScreen² is introduced. In total, 86

hospitals in China are in the process of procuring

TruScreen devices and another 57 hospitals have TruScreen

installed either for trial or acting as reference centres.

Twenty-four hospitals are now commercially using

TruScreen’s technology.

In Mexico, we continue to gain momentum. TruScreen² has

been undergoing evaluation for inclusion by the Federal

Health Secretariat in the National Standard for the Primary

Screening of Cervical Cancer. The initial pilot evaluation

at the National Cancer Institute (INCAN) in Mexico City

has been completed and TruScreen² is now undergoing a

300 patient evaluation at the same centre of excellence.

TruScreen² has also started the official evaluation process

for acceptance as a replacement for HPV DNA testing

for the primary screening of women for cervical cancer

by the Ministry of Health in the State of Nuevo Leon in

Mexico, and commenced preparatory steps for similar state

Ministry of Health adoption in other states

– Jalisco, Guanajuato and Queretaro.

In the Philippines, TruScreen² has recently been selected

for inclusion in a screening program in the province of

Pampanga, which started in December 2016. This pilot

project is designed to evaluate TruScreen for use in

government funded screening programs with the aim

that, if successful, TruScreen will be gradually adopted as

the preferred device for additional Provincial Government

screening programs in the Philippines.

India represents perhaps the largest government program

opportunity for TruScreen² with a population of 1.3 billion

and approximately 300 million women of screening age.

With a shortage of expert colposcopists and cytologists,

the Indian government has identified a need for innovative

technology including an economical real time solution

for adoption in their country. TruScreen’s technology

potentially meets India’s requirements and we have started

liaising with the Indian government on this opportunity.

Outlook

TruScreen has made significant progress in the further

development of its products and market opportunities

during 2017 and we look forward to experiencing the

commercial benefits of these in the near term.

We wish to thank shareholders for their patience

and continued support.

Robert Hunter

Chairman

Martin Dillon

Chief Executive Officer

9
TruScreen Interim Report 2017

Interim Unaudited

Financial Statements

FOR THE SIX MONTHS ENDED

30 SEPTEMBER 2016

Consolidated Statement of Profit

or Loss and Other Comprehensive Income ..................................10

Consolidated Statement of Financial Position

.........................11

Consolidated Statement of Changes In Equity

.......................12

Consolidated Statement of Cash Flows

..........................................13

Notes to the Financial Statements

.......................................................14

10
TruScreen Interim Report 2017

Unaudited for

the six months

ended 30

September 2016

Unaudited for

the six months

ended 30

September 2015

Audited for the

year ended 31

March 2016

Note$$$

Revenue from the sale of goods361,443305,882472,104

Other income 3461,707861,3581,370,317

Changes in inventories209,121(26,622)(48,405)

Purchases of inventory(459,448)(102,973)(204,530)

Employee benefit expenses and directors’ fees(576,427)(444,839)(946,914)

Administration(152,739)(169,687)(365,721)

Research expenses3(564,377)(131,104)(171,959)

Stock for demonstration--(292,493)

Rent(47,907)(49,029)(97,826)

Travel(75,931)(71,363)(127,883)

Marketing & product approvals(146,092)(174,250)(291,164)

Insurance(37,724)(41,706)(74,106)

Shareholder relations & services(11,196)(65,967)(93,309)

Foreign exchange loss3(381,432)--

Amortisation & depreciation3(263,131)(216,620)(400,800)

Finance costs -(25,148)(24,240)

Loss before income tax(1,684,133)(352,068)(1,296,929)

Income tax expense---

Loss for the period(1,684,133)(352,068)(1,296,929)

Other comprehensive income

Item that may be reclassified subsequently

to profit or loss

Exchange differences on translating foreign

subsidiary operations

(369,400)566,734640,217

Other comprehensive (loss) / income for the period(369,400)566,734640,217

Total comprehensive (loss) / income for the period (2,053,533)214,666(656,712)

Basic (losses) / earnings (cents per share)(1.0)(0.2)(0.8)

Diluted (losses) / earnings (cents per share)(1.0)(0.2)(0.8)

Consolidated Statement of Profit or Loss

and other Comprehensive Income

For the six months ended 30 September 2016

The accompanying notes form part of these financial statements.

11
TruScreen Interim Report 2017

The accompanying notes form part of these financial statements.

Unaudited

30 September 2016

Unaudited

30 September 2015

Audited

31 March 2016

Note$$$

CURRENT ASSETS

Cash and cash equivalents1,410,3273,704,7362,304,698

Trade receivables372,879 1,114,119386,052

Other receivables448,246588,1641,170,737

Goods and services taxes recoverable72,05998,94762,606

Inventories267,70480,36658,582

Other assets – prepayments220,701143,023166,557

TOTAL CURRENT ASSETS2,791,9165,729,3554,149,232

NON-CURRENT ASSETS

Plant and equipment10,51011,3276,951

Intangible assets9,583,4309,802,30210,419,664

TOTAL NON-CURRENT ASSETS9,593,9409,813,62910,426,615

TOTAL ASSETS12,385,85615,542,98414,575,847

CURRENT LIABILITIES

Trade and other payables198,440472,282352,447

Employee benefits80,14252,17776,987

TOTAL CURRENT LIABILITIES278,582524,459429,434

NET ASSETS12,107,27415,018,52514,146,413

EQUITY

Issued capital617,840,46017,853,55717,840,460

Share Option Reserve187,106160,349172,712

Foreign currency translation reserve(666,976)(371,059)(297,576)

Accumulated losses(5,253,316)(2,624,322)(3,569,183)

Total Equity12,107,27415,018,52514,146,413

Consolidated Statement of Financial Position

As at 30 September 2016

12
TruScreen Interim Report 2017

The accompanying notes form part of these financial statements.

Share Capital

Accumulated

Losses

Foreign

Currency

Translation

Reserve

Option

ReserveTotal

Note$$$$$

Balance at 31 March 2015 12,921,275(2,272,254)(937,793)145,9559,857,183

Loss for the period to

30 September 2015

-(352,068)--(352,068)

Other comprehensive income

for the period

--566,734-566,734

Total comprehensive income /

(loss) for the period

-(352,068)566,734-214,666

Transactions with owners

Issue of ordinary shares64,932,282---4,932,282

Share based payment---14,39414,394

Total transactions with owners4,932,282--14,3944,946,676

Balance at 30 September 2015

(Unaudited)

17,853,557(2,624,322)(371,059)160,34915,018,525

Balance at 31 March 2016 (Audited)17,840,460(3,569,183)(297,576)172,71214,146,413

Loss for the period ended

30 September 2016

-(1,684,133)-(1,684,133)

Other comprehensive (loss) /

income for the period

--(369,400)-(369,400)

Total comprehensive income / (loss)

for the period

-(1,684,133)(369,400)-(2,053,533)

Transactions with owners

Share based payment---14,39414,394

Total transactions with owners---14,39414,394

Balance at 30 September 2016

(Unaudited)

17,840,460(5,253,316)(666,976)187,10612,107,274

Consolidated Statement of Changes in Equity

For the six months ended 30 September 2016

13
TruScreen Interim Report 2017

The accompanying notes form part of these financial statements.

Unaudited

for the six

months ended

30 September

2016

Unaudited

for the six

months ended

30 September

2015

Audited for the

year ended 31

March 2016

Note$$$

CASH FLOW FROM OPERATING ACTIVITIES

Cash receipts from customers374,6161,324,1421,050,083

Cash paid to suppliers and employees(2,305,914)(1,697,866)(2,386,515)

Cash received from 45% refundable tax offset1,172,039-679,855

Interest paid-(25,148)(24,240)

Interest received12,15910,34818,713

Net cash provided by / (used in) operating activities7(747,100)(388,524)(662,104)

CASH FLOW FROM INVESTING ACTIVITIES

Development of intangible asset – development costs

of upgraded cervical cancer console

(141,188)(957,080)(2,071,893)

Purchase of plant and equipment(6,083)-(6,975)

Net cash used in investing activities(147,271)(957,080)(2,078,868)

CASH FLOW FROM FINANCING ACTIVITIES

Proceeds from issue of shares6-5,080,0005,080,000

(Repayment) / Proceeds of borrowing-(439,920)(407,800)

Share issue costs-(147,718)(160,815)

Net cash provided by / (used in) financing activities-4,492,3624,511,385

Net (decrease) / increase in cash and cash equivalents(894,371)3,146,7581,770,413

Cash and cash equivalents at beginning of period2,304,698534,285534,285

Effects of exchange rate changes on cash and cash

equivalents

-23,693-

Cash and cash equivalents at end of period1,410,3273,704,7362,304,698

Consolidated Statement of Cash Flows

For the six months ended 30 September 2016

14
TruScreen Interim Report 2017

Notes to the Financial Statements

For the six months ended 30 September 2016

1. REPORTING ENTITY

Truscreen Limited (the “Company”) is a Tier 1 for-profit

listed incorporated public company and is an issuer on the

New Zealand Stock Exchange Alternative Market (“NZAX”).

The Company is a limited liability company incorporated

and domiciled in New Zealand and registered under the

Companies Act 1993.

Truscreen is a FMC reporting entity for the purposes of the

Financial Reporting Act 2013 and the Financial Markets

Conduct Act 2013.

The Group’s principal activity relates to the development

and manufacture of cancer detection devices and systems.

The consolidated interim financial statements presented

for the six months ended 30 September 2016 are those

of Truscreen Limited and its subsidiaries (the “Group”).

References to “Truscreen” are used to refer both to the

Group and Truscreen Limited (the “Company”).

These interim financial statements were authorised for

issue by the Board of Directors on the 12 December 2016.

2. SUMMARY OF SIGNIFICANT

ACCOUNTING POLICIES

Basis of Preparation

These financial statements are unaudited and have been

prepared in accordance with New Zealand Generally

Accepted Accounting Practice (“NZ GAAP”) and are in

compliance with NZIAS 34: Interim Financial Reporting.

The consolidated interim financial statements have been

prepared in New Zealand dollars, which is the functional

currency. These financial statements do not include all

the information required for full financial statements

and consequently should be read in conjunction with the

Group’s financial statements for the year ended 31 March

2016.

The same accounting policies have been followed in these

financial statements as were applied in the preparation

of the Group’s audited financial statements for the year

ended 31 March 2016.

Critical Accounting Estimates and Judgements

When preparing the interim financial statements,

management is required to make judgements, estimates

and assumptions about carrying values of assets and

liabilities that are not readily apparent from other sources.

The estimates and associated assumptions are based

on experience and other factors that are believed to be

reasonable under the circumstances. Actual results may

differ from the estimates, judgements and assumptions

made by management. Estimates and underlying

assumptions are reviewed on an on-going basis. Revisions

to accounting estimates are recognised in the period in

which the estimate is revised and in any future periods

affected. Information about significant areas of estimation

uncertainty and critical judgements in applying accounting

policies that have the most significant effect on the

amounts recognised in the financial statements can be

found in the previous annual report.

Seasonality

Operations are not subject to seasonal influences.

15
TruScreen Interim Report 2017

3. SIGNIFICANT TRANSACTIONS AFFECTING NET PROFIT / (LOSS)

Significant transactions affecting net profit / loss

The following significant items affecting the loss for the period are highlighted below because of their size:

Unaudited for

the six months

ended 30

September 2016

Unaudited for

the six months

ended 30

September 2015

Audited for the

year ended 31

March 2016

$$$

Other income

Research and development grant449,548595,2621,170,737

Foreign exchange gain / unrealised-255,748180,867

Expense

Amortisation of intangible assets260,961212,868392,176

Foreign exchange loss / unrealised381,432--

Research & development costs 564,377131,104171,959

Research & development costs increased in the six months

ended 30 September 2016 compared to the six months

ended 30 September 2015 largely due to:

• Further work on developing and testing the algorithm;

• Software & firmware improvements incorporated from

feedback on prototypes;

• Ongoing regulatory and verification processes; and

• Changes and improvements to the Ultra console

following beta testing.

Amortisation of intangibles commenced on 1 February

2015 and 1 April 2016 as the product to which the

particular intangibles related to became available for use.

Accordingly, amortisation expense was more significant in

the current period than in prior periods.

4. ADMINSTRATIVE AND OTHER

OPERATING EXPENSES

Administrative expenses increased in the six months

ended 30 September 2016 compared to the six months

ended 30 September 2015 largely due to costs associated

with compliance, marketing and travel necessary for

expansion and ongoing operations in various regions

including China, Mexico and Europe.

5. OPERATING SEGMENTS

The Group operates in one operating segment. It owns

the rights to the Truscreen Cervical Cancer Screening

System. The system comprises a medical device and

process designed to detect the presence in real time of

precancerous and cancerous tissue on the cervix.

The Group is in the process of obtaining further regulatory

approvals. On the granting of these approvals the Group

anticipates the ability to increase distribution and revenue.

It is anticipated revenues will be obtained largely from

Asia, Europe, Central and South America. The limited

revenues to date have been obtained in anticipation of

these approvals. These revenues have been obtained from

distributors.

Two major customers each contributed more than 10% of

the Group’s revenue in the six months to 30 September

2016 (2015: three customers):

• One customer provided revenue of $147,111 (41%);

• One customer provided revenue of $75,886 (21%);

No additional disclosure is required in the interim financial

statements as the Group has one reportable segment.

Notes to the Financial Statements for the six months ended 30 September 2016 Cont.

16
TruScreen Interim Report 2017

6. SHARE CAPITAL

Significant transactions affecting net profit / loss

The following significant items affecting the loss for the period are highlighted below because of their size:

No.$

Balance as at 31 March 2015144,446,66612,921,275

Private share placement 13,080,0003,270,000

Share purchase plan 7,240,0001,810,000

Share issue costs-(147,718)

Balance as at 30 September 2015164,766,66617,853,557

Balance as at 31 March 2016164,766,66617,840,460

Private share placement --

Share purchase plan --

Share issue costs--

Balance as at 30 September 2016164,766,66617,840,460

Notes to the Financial Statements for the six months ended 30 September 2016 Cont.

17
TruScreen Interim Report 2017

Notes to the Financial Statements for the six months ended 30 September 2016 Cont.

7. RECONCILIATION OF CASH FLOW FROM OPERATING ACTIVITIES

Unaudited for

the six months

ended 30

September 2016

Unaudited for

the six months

ended 30

September 2015

Audited for the

year ended 31

March 2016

$$$

Reconciliation of cash flow from operations

with loss after income tax

(Loss) for the period(1,684,133)(352,068)(1,296,929)

Adjusted for:

Share based expense payment – employment expenses14,39414,39426,757

Amortisation and depreciation263,131216,620400,800

Assets written off--6,339

Exchange difference arising from translating loss items at

the date of transaction and translating cash balances at

year end rates

206,227(47,694)(72,152)

Operating cash flows before working capital changes(1,200,381)(168,748)(935,185)

(Increase) / Decrease in trade receivables13,173405,251870,470

(Increase) / Decrease in other receivables722,491(206,471)(526,196)

(Increase) / Decrease in goods and services taxes

recoverable

(9,453)(64,971)(28,630)

(Increase) / Decrease in prepayments(54,144)(143,023)(166,557)

(Increase) / Decrease in inventory(209,122)14,49235,465

Increase / (Decrease) in trade and other payables(12,819)(248,827)39,946

Increase / (Decrease) in provisions3,15523,77348,583

Net cash from operating activities(747,100)(388,524)(662,104)

18
TruScreen Interim Report 2017

Notes to the Financial Statements for the six months ended 30 September 2016 Cont.

8. NET TANGIBLE ASSETS PER SHARE

Unaudited

30 September

2016

Unaudited

30 September

2015

Audited

31 March 2016

Net tangible assets 2,523,8445,216,2233,726,749

Shares on issue at the end of period164,766,666164,766,666164,766,666

Net tangible assets per share (cents per share)1.533.172.26

9. EVENTS SUBSEQUENT TO

END OF THE INTERIM PERIOD

There have been no events since the end of the interim

period which would have a material effect on the Group’s

interim financial statements for the 6 months ended 30

September 2016.

19
TruScreen Interim Report 2017

Corporate Directory

Directors

Robert Hunter

Sydney, New South Wales

Australia

Sean Joyce

Parnell, Auckland

New Zealand

Christopher Horn

Sydney, New South Wales

Australia

Tim Preston

Murrays Bay, Auckland

New Zealand

Registered Office

Suite 107

Geyser Building

100 Parnell Road

Parnell

Auckland 1052

Auditor

BDO Auckland

120 Albert Street

Auckland

Share Registrar

Link Market Services

PO Box 91976,

Auckland 1142

Level 7, Zurich House,

21 Queen Street,

Auckland 1010

Investor enquiries: 09 375 5998

Investor email: enquiries@linkmarketservices.co.nz

Website: www.linkmarketservices.co.nz

Suite 107,
Geyser Building,

100 Parnell Road,

Parnell, Auckland 1052,

New Zealand

e: info@TruScreen.com

t: +61 2 9262 4644

www.TruScreen.com

---

NZX and Media Release 31 January 2017

TruScreen Half Year Report and Interim Financial Statements


TruScreen Limited has provided a copy of its 2017 Interim Report for the six months ended 30

September 2016. The report is available for viewing on the company website

http://truscreen.com/investor-centre/reports-presentations/.



-ENDS-


For more information visit www.truscreen.com or contact Martin Dillon, TruScreen Chief Executive Officer,

eMail: martindillon@truscreen.com


About TruScreen:

TruScreen’s real time cervical cancer

technology utilises a digital wand which is

placed on the surface of the cervix to measure

electrical and optical signals from the

surrounding tissue. A sophisticated proprietary

algorithm framework distinguishes between

normal and abnormal (cancerous and

precancerous) tissue to identify precancerous

change, or cervical intraepithelial neoplasia

(CIN). A Single Use Sensor (SUS) is used for

each patient to protect against cross-infection.

Data sourced from publicly available filings. Our datasets may not be complete. Automated analysis can produce errors. If you believe any data on this page is incorrect, please contact us at hello@nzxplorer.co.nz. For informational purposes only. Not investment advice.

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