TruScreen Half Year Report and Interim Financial Statements
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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