TRUSCREEN INTERIM RESULTS TO 30 SEPTEMBER 2017
NZX and Media Release 14 December 2017
TRUSCREEN INTERIM RESULTS TO 30 SEPTEMBER 2017
Cervical cancer technology company, TruScreen Limited (NZAX:TRU) has released its 2018 interim results
for the six months to 30 September 2017.
The company has continued to build its global footprint with a number of new distribution
agreements signed in the first half of the year and positive progress being made in discussions to
utilise TruScreen2 in public screening programmes.
Commercial performance was hampered in the first half due to delays in gaining CFDA approval for
the TruScreen2 device in China. This has now been received and benefits are expected in the final
quarter of FY18 and onwards as initial orders for the TruScreen2 device are exported to China and
commercialisation moves ahead in other new markets. A corresponding increase in sales of the
Single Use Sensors is expected as more devices enter the market.
Total revenue was $572,101 made up of sales of $225,896 (HY17: $361,443) and other income of
$346,205, primarily from grants for Research & Development. Sales were down on the previous first
half year (although in line with the second half of FY17) due to ongoing product improvements and
validation thereof and the delays in obtaining Chinese CFDA approval. In line with this, net operating
cashflow decreased slightly to $(1.77) million (HY17: $(747,100)).
Inventory costs rose as expected, due to increased production of TruScreen2 in advance of receiving
CFDA approval and in anticipation of growing demand from new markets.
In May 2017 the company successfully completed an $897,000 Share Purchase Plan as part of a
larger capital raising which included a private placement of $4.09m in March 2018. This contributed
to cash and cash equivalents of $2.63 million as at 30 September 2017, and was the primary driver
for the increased foreign exchange impact, following translation from New Zealand into Australian
dollars.
TruScreen reported a Net Loss of $1.76 million for the six months, slightly up on the previous first
half year of $1.68 million.
Operational Review
In the past two years, TruScreen has made significant progress with a number of major
achievements including an expanded global market presence, development and CE mark certification of
the new TruScreen2 device and, most recently, CFDA approval for TruScreen2 in China.
TruScreen has signed distribution agreements covering 24 countries, with a combined screening
population of approximately 1 billion women and is continuing to negotiate new agreements. The focus
remains firmly on the larger of these markets - China, India, Russia and Mexico - and capitalising on the
work done over the past two years to gain acceptance of TruScreen in these countries.
Acceptance and adoption can take time and is often dependent on the decisions and speed of
progress of third parties, such as regulatory bodies or government departments, and this timing can
be hard to predict. In particular, evaluations of the TruScreen product for use in public screening
programmes can take many years and involve multiple in-market trials, however, each could
produce significant revenue in the future.
China remains the primary opportunity for the company and the current focus is on encouraging the
selection of TruScreen technology for large screening programs, as well as increasing adoption in large
provincial hospitals.
A major new sub-distribution agreement was signed in the first half to manage government sales
channels in China. The goal is to have TruScreen recommended for use in major central government
screening programs and to be included in the list of basic medical equipment for the over 30,000
community healthcare centres throughout rural China.
After China, India is potentially the world’s largest screening market with close to 300 million women
of screening age and the Indian government is looking to set up public screening programmes.
TruScreen is currently going through the validation process for inclusion in these programmes.
In Mexico, the evaluation of TruScreen by the Ministry of Health as a screening protocol has
commenced and subsequent approval will allow government hospital purchases. In addition, the
company is tendering for a major national health secretariat program to supply primary screening to
the Central Government in Mexico and has also commenced sales to hospitals controlled by the
largest public health insurer in Mexico, ISSSTE.
TruScreen has been approved for reimbursement by a major health insurer in Jordan. Whilst Jordan
is not a major market, the attaining of this insurance rebate is noteworthy in that it is the first of its
kind globally for TruScreen. This is an important step in breaking down the pricing barriers that
traditional cytology tests enjoy in larger markets.
The clinical performance evaluation of TruScreen2 at the Royal Hospital for Women in Sydney is
progressing well. Initial results have confirmed TruScreen’s advantages over the Pap smear in
developing countries and indicate that TruScreen2 will be a substantially more accurate screening
method than cytology in those target markets.
The Board was refreshed during the half year period, with world renowned Professor Ron Jones
replacing director Tim Preston as an independent director.
Outlook
There is growing awareness and demand from low resource countries for screening programmes
and the global market for cervical cancer screening is forecast to exceed US$22 billion per year in the
next three years
i
.
The opportunities for TruScreen look promising and the company is well positioned to continue to
advance the commercial agenda for its product.
With the outlook of increasing sales following the receipt of the CFDA approval the company is
looking to increase its manufacturing capabilities both locally and overseas in certain key markets.
-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.
i
http://www.marketsandmarkets.com/Market-Reports/cervicalcancer-screening-market-%2010110147.html
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TRUSCREEN LIMITED
Interim Unaudited Financial Statements
For the six months ended 30 September 2017
TRUSCREEN LIMITED
Table of contents
Page
Consolidated statement of profit or loss and other comprehensive income 1
Consolidated statement of financial position 2
Consolidated statement of changes in equity 3
Consolidated statement of cash flows 4
Notes to the interim unaudited financial statements 5
TRUSCREEN LIMITED
The accompanying notes form part of these interim financial statements.
1
CONSOLIDATED STATEMENT OF PROFIT OR LOSS
AND OTHER COMPREHENSIVE INCOME
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2017
Unaudited
for the six
months
ended 30
September
2017
Unaudited
for the six
months
ended 30
September
2016
Audited
for the year
ended 31 March
2017
Note $
$ $
Revenue from the sale of goods
225,896
361,443
585,388
Other income 3 346,205
461,707
810,202
Changes in inventories 288,587
209,121
408,944
Purchases of inventory (464,115)
(459,448)
(881,746)
Employee benefit expenses and directors’ fees (670,864)
(576,427)
(1,174,222)
Administration (185,739)
(152,739)
(470,394)
Research expenses 3 (649,171)
(564,377)
(1,190,910)
Rent (48,444)
(47,907)
(95,625)
Travel (28,107)
(75,931)
(156,900)
Marketing & product approvals (159,801)
(146,092)
(561,811)
Insurance (50,999)
(37,724)
(87,424)
Shareholder relations & services (3,710)
(11,196)
(91,999)
Foreign exchange loss 3 (98,679)
(381,432)
(68,502)
Amortisation & depreciation 3 (266,296)
(263,131)
(528,134)
Finance costs -
-
(37,477)
Loss before income tax
(1,765,237)
(1,684,133)
(3,540,610)
Income tax expense -
-
-
Loss for the period after income tax
(1,765,237)
(1,684,133)
(3,540,610)
Other comprehensive income
Item that may be reclassified subsequently
to profit or loss
Exchange differences on translating foreign
subsidiary operations (42,673)
(369,400)
(241,728)
Other comprehensive loss for the period
(42,673) (369,400)
(241,728)
Total comprehensive loss for the period
(1,807,910) (2,053,533) (3,782,338)
Basic and Diluted losses (cents per share)
(0.9)
(1.0)
(2.1)
TRUSCREEN LIMITED
The accompanying notes form part of these interim financial statements.
2
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 SEPTEMBER 2017
Unaudited
30 September
2017
Unaudited
30 September
2016
Audited
31 March
2017
Note $
$ $
CURRENT ASSETS
Cash and cash equivalents 2,630,624 1,410,327 3,671,571
Trade receivables 226,495 372,879 217,397
Other receivables 326,769 448,246 791,791
Goods and services taxes recoverable 97,090 72,059 69,395
Inventories 756,114 267,704 467,527
Other assets – prepayments 75,268 220,701 77,100
TOTAL CURRENT ASSETS
4,112,360 2,791,916 5,294,781
NON-CURRENT ASSETS
Plant and equipment 7,259 10,510 8,275
Intangible assets 9,401,709 9,583,430 9,738,424
TOTAL NON-CURRENT ASSETS
9,408,968 9,593,940 9,746,699
TOTAL ASSETS
13,521,328 12,385,856 15,041,480
CURRENT LIABILITIES
Trade and other payables 36,556 198,440 644,587
Employee benefits 111,743 80,142 72,605
TOTAL CURRENT LIABILITIES
148,299 278,582
717,192
NET ASSETS
13,373,029 12,107,274
14,324,288
EQUITY
Issued capital 6 22,657,236 17,840,460
21,800,585
Share Option Reserve 172,800 187,106 172,800
Foreign currency translation reserve (581,977) (666,976) (539,304)
Accumulated losses (8,875,030) (5,253,316) (7,109,793)
Total Equity
13,373,029 12,107,274
14,324,288
TRUSCREEN LIMITED
The accompanying notes form part of these interim financial statements.
3
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2017
Share
Capital
Accumulated
Losses
Foreign
Currency
Translation
Reserve
Option
Reserve
Total
Note $
$ $ $
$
Balance at 31 March 2016
(Audited)
17,840,460 (3,569,183)
(297,576)
172,712
14,146,413
Loss for the period to 30
September 2016
-
(1,684,133) - (1,684,133)
Other comprehensive income
for the period
- - (369,400) - (369,400)
Total comprehensive loss
for the period (unaudited)
-
(1,684,133) (369,400) - (2,053,533)
Transactions with owners
Share based payment
-
-
-
14,394
14,394
Total transactions with
owners
-
-
-
14,394
14,394
Balance at 30 September
2016 (Unaudited)
17,840,460
(5,253,316)
(666,976)
187,106
12,107,274
Balance at 31 March 2017
(Audited)
21,800,585 (7,109,793)
(539,304)
172,800
14,324,288
Loss for the period ended 30
September 2017
-
(1,765,237) - (1,765,237)
Other comprehensive loss
for the period
- - (42,673) - (42,673)
Total comprehensive loss
for the period (unaudited)
-
(1,765,237) (42,673) - (1,807,910)
Transactions with owners
Issue of Ordinary Shares
856,651
-
-
-
856,651
Balance at 30 September
2017 (Unaudited)
22,657,236
(8,875,030)
(581,977)
172,800
13,373,029
TRUSCREEN LIMITED
The accompanying notes form part of these interim financial statements.
4
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2017
Unaudited
for the six
months
ended 30
September
2017
Unaudited
for the six
months
ended 30
September
2016
Audited for
the year
ended 31
March 2017
Note $
$ $
CASH FLOW FROM OPERATING
ACTIVITIES
Cash receipts from customers 182,029 374,616 754,043
Cash paid to suppliers and employees (2,794,335) (2,305,914) (4,436,358)
Cash received from 45% refundable tax offset 833,228 1,172,039 1,126,610
Interest paid - - (37,477)
Interest received 12,768 12,159 17,598
Net cash used in operating activities
7
(1,766,310) (747,100) (2,575,584)
CASH FLOW FROM INVESTING
ACTIVITIES
Development of intangible asset – development
costs of upgraded cervical cancer console
-
(141,188)
(141,188)
Purchase of plant and equipment
(1,411) (6,083) (6,355)
Net cash used in investing activities
(1,411) (147,271) (147,543)
CASH FLOW FROM FINANCING
ACTIVITIES
Proceeds from issue of shares 6 897,350 - 4,090,000
Share issue costs (170,576) - -
Net cash provided by financing activities
726,774 - 4,090,000
Net (decrease) / increase in cash and cash
equivalents
(1,040,947) (894,371)
1,366,873
Cash and cash equivalents at beginning of period 3,671,571 2,304,698 2,304,698
Cash and cash equivalents at end of period
2,630,624 1,410,327 3,671,571
TRUSCREEN LIMITED
NOTES TO THE UNAUDITED INTERIM FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2017
5
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 unaudited interim financial statements presented for the six months ended 30 September
2017 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
2017.
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 NZ IAS 34: Interim
Financial Reporting.
The consolidated unaudited 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 2017.
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 2017.
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.
TRUSCREEN LIMITED
NOTES TO THE UNAUDITED INTERIM FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2017
6
3. SIGNIFICANT TRANSACTIONS AFFECTING NET LOSS
Significant transactions affecting net loss
The following significant items affecting the unaudited loss for the period are highlighted below because
of their size:
Unaudited
for the six
months
ended 30
September
2017
Unaudited
for the six
months
ended 30
September
2016
Audited for
the year
ended 31
March
2017
$ $
$
Other income
Research and development grant 333,437 449,548 792,604
Interest 12,768 12,159 17,598
Total other income
346,205
461,707
810,202
Expense
Amortisation of intangible assets (263,868) (260,961) (523,346)
Foreign exchange loss / unrealized (98,679) (381,432) (68,502)
Research & development costs (649,171) (564,377) (1,190,910)
Ongoing Research & development is being conducted in the following areas:
Software & firmware improvements incorporated from feedback on prototypes to improve usability;
Ongoing regulatory and verification processes;
Changes and improvements to the Electrical Optical Assembly; and
Further work on developing and testing the algorithm
4. ADMINSTRATIVE AND OTHER OPERATING EXPENSES
Administrative expenses increased in the six months ended 30 September 2017 compared to the six months
ended 30 September 2016 largely due to costs associated with compliance, marketing and travel necessary
for expansion and ongoing operations in various regions including China, Mexico and Europe.
TRUSCREEN LIMITED
NOTES TO THE UNAUDITED INTERIM FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2017
7
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.
Three major customers each contributed more than 10% of the Group’s revenue in the six months to 30
September 2017 (2016: two customers):
One customer provided revenue of $71,170 (34%);
One customer provided revenue of $69,095 (33%); and
Once customer provided revenue of $50,278 (24%)
No additional disclosure is required in the interim financial statements as the Group has one reportable
segment.
6. SHARE CAPITAL
No. $
Balance as at 31 March 2016 & 30 September 2016 164,766,666
17,840,460
Balance as at 31 March 2017
190,329,166 21,800,585
Share purchase plan 5,609,375 897,350
Share issue costs - (40,699)
Balance as at 30 September 2017
195,938,541 22,657,236
TRUSCREEN LIMITED
NOTES TO THE UNAUDITED INTERIM FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2017
8
7. RECONCILIATION OF CASH FLOW FROM OPERATING ACTIVITIES
Unaudited
for the six
months
ended 30
September
2017
Unaudited
for the six
months
ended 30
September
2016
Audited for
the year
ended 31
March 2017
$ $ $
Reconciliation of cash flow from operations with
loss after income tax
Loss for the period (1,765,237)
(1,684,133)
(3,540,610)
Adjusted for:
Share based expense payment – employment
expenses - 14,394
88
Amortisation and depreciation 266,295 263,131 528,134
Exchange difference arising from translating loss
items at the date of transaction and translating cash
balances at year end rates 30,174 206,227
(83,591)
Operating cash flows before working capital changes (1,468,768) (1,200,381) (3,095,979)
(Increase) / Decrease in trade receivables (9,098) 13,173 547,601
(Increase) / Decrease in other receivables 465,022 722,491 -
(Increase) / Decrease in goods and services taxes
recoverable (27,695)
(9,453)
(6,789)
(Increase) / Decrease in prepayments 1,832 (54,144) 89,457
(Increase) / Decrease in inventory (288,587) (209,122) (408,945)
Increase / (Decrease) in trade and other payables (608,029) (12,819) 292,140
(Increase) / Decrease in trade and other payables
relating to investing activities -
-
141,188
(Increase) / Decrease in trade and other payables
relating to financing activities 129,875
-
(129,875)
Increase / (Decrease) in employee liabilities 39,138 3,155 (4,382)
Net cash from operating activities
(1,766,310)
(747,100)
(2,575,584)
TRUSCREEN LIMITED
NOTES TO THE UNAUDITED INTERIM FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2017
9
8. NET TANGIBLE ASSETS PER SHARE
Unaudited
30 September
2017
Unaudited
30 September
2016
Audited
31 March
2017
Net tangible assets 3,971,320 2,523,844 4,964,164
Shares on issue at the end of period 195,938,541 164,766,666 190,329,166
Net tangible assets per share (cents per
share)
2.03
1.53
2.41
9. EVENTS SUBSEQUENT TO END OF THE INTERIM PERIOD
There have been no events since 30 September 2017 which would have a material effect on the Group’s
interim financial statements for the 6 months ended 30 September 2017.
---
1
TRUSCREEN LIMITED
NZX APPENDIX 1 RELEASE
This document covers TruScreen Limited’s unaudited financial results for the 6 months ended 30 September
2017, released to NZX on 14 December 2017. These results are unaudited.
(TRU): TruScreen Limited
Results for announcement to the market
Reporting Period 6 months to 30 September 2017
Previous Reporting Period 6 months to 30 September 2016
Amount ($NZ’000s) Percentage change
Revenue from ordinary
activities
572 Down 30%
Profit (loss) from ordinary
activities after tax attributable
to security holder
(1,765) Loss increased 5%
Net profit (loss) attributable to
security holders
(1,765) Loss increased 5%
Interim/ Final Dividend Amount per security
$NZ
Imputed amount per security
Nil Nil n/a
Record Date Not Applicable
Dividend Payment Date Not Applicable
Comment: As per attached report
Commentary on results
For commentary on the results please refer to the commentary on the related NZX release.
Financial Information
The Appendix 1 Release should be read in conjunction with the Interim Unaudited Financial Statements for
the six-month period ended 30 September 2017 which have been released together with this NZAX
Appendix 1 Release.
2
TRUSCREEN LIMITED
PRELIMINARY HALF-YEAR ANNOUNCEMENT
For the six-month period ended 30 September 2017
The information below is required by Appendix 1 of the NZAX Listing Rules:
2.1 Details of the reporting period and the previous reporting period
The reporting period is for the six-month period ended 30 September 2017 (“current period”) with the
comparative period being for the period from 1 April 2016 to 30 September 2016. (“previous period”}.
2.2 Information prescribed by NZX
Refer to “Results for Announcement to the Market”.
2.3 The following information:
(a) A statement of financial performance
Refer to the Interim Unaudited Financial Statements for the six-month period ended 30 September 2017.
(b) A statement of financial position
Refer to the Interim Unaudited Financial Statements for the six-month period ended 30 September 2017.
(c) A statement of cash flows
Refer to the Interim Unaudited Financial Statements for the six-month period ended 30 September 2017.
(d) Details of dividends or distributions
No dividends to shareholders have been declared for this six-month period.
(e) Details of any dividend or distribution reinvestment plans in operation and the last date for the
receipt of an election notice for participation in any dividend or distribution reinvestment plan
The Company has no dividend reinvestment plan.
(f) Net tangible assets per security
NZ CENTS PER SHARE CURRENT PERIOD PREVIOUS PERIOD
Net tangible assets per share 2.03 1.53
(g) Details of entities over which control has been gained or lost during the period
A wholly owned Mexican subsidiary, TruScreen S. de R.L. de C.V. was incorporated in August, 2017.
Paid up capital is 100 Mexican Pesos. The subsidiary has not traded.
Except for the above entity there are no other entities over which control has been gained or lost during
the period.
3
PRELIMINARY HALF-YEAR ANNOUNCEMENT
For the six-month period ended 30 September 2017
(h) Details of associates and joint ventures
Nil.
3.1 Basis of preparation
These financial statements have been prepared in accordance with New Zealand Generally Accepted
Accounting Practice (NZ GAAP). They comply with New Zealand equivalents to International Financial
Reporting Standards (NZ IFRS), and other applicable New Zealand Financial Reporting Standards, as
appropriate for profit-oriented entities. They also comply with International Financial Reporting Standards.
3.2 Accounting
Refer to Statement of Accounting Policies in the Interim Unaudited Financial Statements for the six-month
period ended 30 September 2017.
3.3 Changes in condensed accounting policies
The accounting policies used are consistent with those used to prepare the Consolidated Financial Statements
for the year ended 31 March 2017.
3.4 Audit Report
The Interim Unaudited Financial Statements for the six-month period ended 30 September 2017 have not been
audited.
3.5 Additional information
Not applicable.
The Interim Unaudited Financial Statements were approved by the Board of Directors on 12 December 2017.
Robert Hunter
Chairman
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