TruScreen Half Year Results

Template
Results announcement
(for Equity Security issuer/Equity and Debt Security issuer)
Updated as at 17 October 2019


Results for announcement to the market
Name of issuer Truscreen Group Limited
Reporting Period 6 months to 30 September 2021
Previous Reporting Period 6 months to 30 September 2020
Currency
Amount (000s) Percentage change
Revenue from continuing
operations
$745 +25%
Total Revenue $1,419 +43%
Net profit/(loss) from
continuing operations
($1,259) +17%
Total net profit/(loss) ($1,259) +17%
Interim/Final Dividend
Amount per Quoted Equity
Security
The Company does not propose to pay a dividend
Imputed amount per Quoted
Equity Security
N/A
Record Date N/A
Dividend Payment Date N/A
Current period Prior comparable period
Net tangible assets per
Quoted Equity Security
$0.0141 $0.0176
A brief explanation of any of
the figures above necessary
to enable the figures to be
understood
For commentary on the results please refer to the commentary
on the related NZX Release.
Authority for this announcement
Name of person

authorised
to make this announcement
Guy Robertson (Chief Financial Officer)
Contact person for this
announcement
Guy Robertson (Chief Financial Officer)
Contact phone number +61 407 983 270
Contact email address guyrobertson@truscreen.com
Date of release through MAP

29 November 2021

Unaudited financial statements accompany this announcement.

---

TRUSCREEN GROUP LIMITED








TRUSCREEN GROUP LIMITED

Interim Unaudited Financial Statements

For the Six Months Ended 30 September 2021

TRUSCREEN GROUP LIMITED


Table of contents


Page


Review of Operations 1
Consolidated statement of profit or loss and other comprehensive income 6
Consolidated statement of financial position 7
Consolidated statement of changes in equity 8
Consolidated statement of cash flows 9
Notes to the interim unaudited condensed financial statements 10

TRUSCREEN GROUP LIMITED

3
REVIEW OF OPERATIONS

Highlights for Half Year ended 30 September 2021
• Strong revenue and Single Use Sensor (SUS) sales growth of 25% and 35% year on year
(YOY) respectively
• Launch of TruScreen Made in China device for the Chinese market
• Firmware upgrade and cervical cancer screening device enhancements
• Continuous expansion and first sales in Eastern Europe
• Ongoing excellent trial results confirm efficacy of TruScreen cervical cancer screening
device
Cervical cancer screening technology company, TruScreen Group Limited (NZX/ASX: TRU) (‘TruScreen’
or ‘the Company), is pleased to provide its unaudited financial results for the six months to 30 September
2021 (1H FY22), along with the following operational update. TruScreen reports according to the New
Zealand financial year, which runs from 1 April to 31 March.
The Company reported an operating loss of $1.26m (1H FY21: $1.51m), a 20% reduction over the prior
year. Despite the negative impacts of COVID-19 in some of our markets, notably Russia and Vietnam,
product revenue increased by 25% YOY.
Pleasingly, SUS unit sales were 35% higher YOY although getting new cervical cancer screening devices
installed in hospitals was hampered by ongoing COVID-19 restrictions.
Net operating cash outflow was $1.7m (1H FY21: $1.6m). An Australian research and development tax
offset was received just after quarter-end in the amount of $0.6m. Cash operating costs were 22% higher
in 1H FY22, at $2.5m (1H FY21: $2.1m), reflecting the Company’s increased investment in research and
development which resulted in re-engineered firmware that enhanced cybersecurity and facilitated self-
calibration which will reduce future operating costs. The Australian tax offset for the related research will
be received in the next financial year.
The loss for the six months included a non-cash amortisation and depreciation charge of $0.30m (1H
FY21: $0.35m).
As at 30 September 2021, the Company had cash and cash equivalents of $3.67m, which was
supplemented by a research and development tax offset receipt of $0.6m from the Australian Tax Office
on 1 October 2021.

Half-Year Commentary
TruScreen continued to make good market and technical progress in 1H 22 and, going forward, is well
placed to build upon this success as the COVID-19 pandemic wanes.
Market development - China
TruScreen has continued to successfully expand in China, its most established market and the world’s
largest addressable cervical cancer screening market.
With the launch of the TruScreen Made in China device, developed specifically for the Chinese market,
the Company’s China distributor Beijing Siweixiangtai (SWXT) has expanded its addressable distribution
market. It is now marketing this TruScreen device to the growing Health Check sector. SWXT anticipates
the first major placement of TruScreen devices in the private Health Check sector to commence before
the end of the 2021 calendar year.

TRUSCREEN GROUP LIMITED

4
This development provides TruScreen with revenue upside, as China’s Health Check sector is rapidly
growing, aided by support from provincial governments, private organisations, and non-government
organisations (NGOs). Major public hospitals will have separate Health Check clinics offering a wide range
of women’s health medical checks, including cervical cancer screening.
Market development - Europe
TruScreen has, at the same time, continued to broaden its market access throughout Central and Eastern
Europe, with the Company’s current focus on Serbia and Poland. The market access strategies in these
two countries are now being actively supported by key opinion leader engagement, clinical trials, and local
clinical evaluation initiatives.
TruScreen is currently in the final planning stages for a clinical trial in Poland, led by a well-known medical
opinion leader in that country. The pilot phase of this trial will screen women in five centres across Poland
to evaluate the clinical performance of the TruScreen device. TruScreen anticipates the results of the trial
will facilitate market access throughout Poland as well as neighbouring countries.
TruScreen has recently concluded training in Serbia targeting new key opinion leaders and clinicians. The
training has enabled the commencement of planned local clinical evaluations and facilitated the
commencement of early market activities with the first sales being concluded in September.
The World Health Organisation (WHO) has highlighted that innovative technologies such as TruScreen’s
portable and real time device are applicable for use in low-and-middle-income countries (LMIC).
Leveraging our success in Zimbabwe and partnership with its National Aids Council, we are having
dialogues with potential distributors in markets where TruScreen is not currently represented, and where
TruScreen as a primary cervical cancer screening device can make a positive difference to women’s
health.
Upgraded firmware
After twelve months of development work, TruScreen has completed verification and validation of a key
firmware update that is now being progressively released to TruScreen devices already in the market. The
firmware update enhances the device’s cyber security framework and allows TruScreen devices to more
effectively interface with compatible hospitals’ systems. By incorporating a state-of-the-art optical
calibration feature, the firmware has reduced the need for the device to return to service centres for
scheduled re-calibration. This reduced service-related downtime means clients have their devices online
for longer time periods, boosting operational efficiencies.
The new firmware update also includes enhancements to the user interface and battery management
features. These were developed in collaboration with the Company’s distributors and in response to market
feedback, a demonstration of the collaborative nature of the relationship TruScreen has with these crucially
important groups.
Clinical trials continue to show promising results
A new study, published in the European Journal of Obstetrics and Gynaecology and Reproductive
Biology
1
, concludes that TruScreen’s cervical cancer screening technology meets or exceeds the
effectiveness of alternative cervical cancer screening methods. The study evaluated the efficacy of
TruScreen in screening for cervical abnormalities, in a real-world, primary cervical cancer screening setting
in China.


1

1
Yingting Wei, Wenjing Wang, Mengxing Cheng, Zubei Hong, Liying Gu, Jiaxin Niu, Wen Di, Lihua Qiu,
Clinical evaluation of a real-time optoelectronic device in cervical cancer screening, Yingting We et al., European
Journal of Obstetrics & Gynecology and Reproductive Biology, 2021, ISSN 0301-2115,
https://doi.org/10.1016/j.ejogrb.2021.09.027. (https://www.sciencedirect.com/science/article/pii/S0301211521004826)

TRUSCREEN GROUP LIMITED

5
The TruScreen screening device was found to be very effective at detecting cervical intraepithelial
neoplasia grade 2 or worse (CIN2+ or CIN3+).
The Chinese Obstetrics and Gynaecology Association (COGA) national clinical trial which has screened
~15,000 women in 64 top-tier public hospitals across 9 provinces in China, has concluded. The COGA
evaluation compares the TruScreen technology to Liquid Based Cytology (LBC) and human papillomavirus
(HPV) DNA testing, targeting a nationwide consensus on Truscreen technology applications in China as
the main outcome of this large-scale trial.
The final report from this trial is still awaited, however preliminary results from two major provincial trials
(See NZX announcements 2 September 2019 and 19 October 2020) showed TruScreen to be better or on
parity than tests for HPV and LBC.
Outlook
TruScreen’s Strategic Plan for FY22 and beyond will see the Company focus on three key areas:
continuous product improvement, rapid expansion in China, and growth into other key markets.
I would like to take the opportunity to thank shareholders for your ongoing support and encourage you to
stay up to date with TruScreen news via the NZX/ASX announcements platforms as well as our website
and social media accounts.


Anthony Ho
Chairman
29 November 2021

TRUSCREEN GROUP LIMITED

6

CONSOLIDATED STATEMENT OF PROFIT OR LOSS
AND OTHER COMPREHENSIVE INCOME
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2021


Unaudited
for the six
months
ended 30
September
2021


Unaudited
for the six
months
ended 30
September
2020




Audited
for the year
ended 31
March 2021
Note $

$ $
Revenue from the sale of goods 745,146

596,824 1,132,641
Other income 4 673,688

398,169 843,274
Cost of product sales (519,378)

(351,272)

(732,603)
Employee benefit expenses and directors’
fees (507,112)

(644,236)

(1,180,425)
Administration (170,971)

(227,859)

(403,638)
Research and development expenses (796,339)

(524,718)

(1,288,197)
Rent (27,263)

(17,068)

(40,876)
Travel (3,376)

(1,598)

(4,192)
Marketing & product approvals (197,479)

(284,811)

(618,281)
Insurance (57,146)

(39,840)

(85,196)
Shareholder relations & services (97,838)

(35,362)

(295,163)
Foreign exchange gain/(loss) -

-

(136,200)
Amortisation & depreciation (300,850)

(346,192)

(646,598)
Finance costs -

(32,202)

(34,556)
Loss before income tax (1,258,918)

(1,510,165)

(3,490,010)
Income tax expense -

-

-
Loss for the period after income tax (1,258,918)

(1,510,165)

(3,490,010)
Other comprehensive income




Item that may be reclassified subsequently to
profit or loss




Exchange (loss)/gain on translating foreign
subsidiary operations (394,945)

448,242

500,136
Other comprehensive (loss)/income for the
period

(394,945)

448,242

500,136
Total comprehensive loss for the period

(1,653,863) (1,061,923) (2,989,874)
Basic and diluted losses (cents per share) (0.35)

(0.48)

(1.08)
The accompanying notes form part of these financial statements.

TRUSCREEN GROUP LIMITED

7
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 SEPTEMBER 2021


Unaudited
30
September
2021

Unaudited
30
September
2020

Audited
31 March
2021

Note $ $ $
CURRENT ASSETS


Cash and cash equivalents 3,673,500 4,467,663 5,255,074
Trade receivables 6,672 156,924 -
Other receivables 961,466 923,419 558,485
Loan receivable - 75,000 -
Goods and services taxes recoverable 33,902 37,249 44,233
Inventories 691,607 610,774 732,574
Other assets – prepayments 160,588 293,620 105,931
TOTAL CURRENT ASSETS 5,527,735 6,564,649 6,696,297

NON-CURRENT ASSETS
Plant and equipment 266,078 314,042 307,092
Intangible assets 4,546,722 5,292,643 5,001,302
TOTAL NON-CURRENT ASSETS 4,812,800 5,606,685 5,308,394

TOTAL ASSETS 10,340,535 12,171,334 12,004,691

CURRENT LIABILITIES
Trade and other payables 556,238 447,951 454,494
Borrowings - 436,840 -
Employee benefits 92,743 88,531 205,373
TOTAL CURRENT LIABILITIES 648,981 973,322
657,867

NON-CURRENT LIABILITIES

Employee benefits 36,226 49,375
37,633
TOTAL NON-CURRENT LIABILITIES 36,226 49,375
37,633

TOTAL LIABILITIES 685,207 1,022,697 695,500

NET ASSETS 9,655,328 11,148,637 11,309,191

EQUITY
Issued capital 7 34,550,048 32,461,543 34,550,048
Share option reserve 306,000 306,000 306,000
Foreign currency translation reserve (609,508) (266,457) (214,563)
Accumulated losses (24,591,212) (21,352,449) (23,332,294)
Total Equity 9,655,328 11,148,637 11,309,191
The accompanying notes form part of these financial statements.

TRUSCREEN GROUP LIMITED

8

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2021

Share
Capital
Accumulated
Losses
Foreign
Currency
Translation
Reserve
Option
Reserve Total
Note $ $ $ $ $
Balance at 31 March
2021 (Audited)

34,550,048 (23,332,294)
(214,563)
306,000 11,309,191
Comprehensive income




Loss for the period ended
30 September 2021

- (1,258,918) - - (1,258,917)
Exchange differences on
translation of foreign
subsidiary operations

- - (394,945) - (394,945)
Total comprehensive
loss for the period
(unaudited)

- (1,258,918) (394,945) - (1,653,862)
Balance at 30
September 2021
(Unaudited)

34,550,048

(24,591,212)

(609,508)

306,000

9,655,328
Balance at 31 March
2020 (Audited)

27,492,050 (19,842,284)
(714,699)
306,000 7,241,067
Comprehensive income




Loss for the period ended
30 September 2020

- (1,510,165) - - (1,510,165)
Exchange differences on
translation of foreign
subsidiary operations
- - 448,242 - 448,242
Total comprehensive
loss for the period
(unaudited)

- (1,510,165) 448,242 - (1,061,923)

Transactions with
owners







Issue of shares 7
5,243,001 - - - 5,243,001
Share issue costs 7
(273,508) - - - (273,508)
Total transactions with
owners

4,969,493 - - - 4,969,493
Balance at 30
September 2020
(Unaudited)

32,461,543

(21,352,449)

(266,457)

306,000

11,148,637

The accompanying notes form part of these financial statements.

TRUSCREEN GROUP LIMITED

9
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2021

Unaudited
for the six
months
ended 30
September
2021

Unaudited
for the six
months
ended 30
September
2020


Audited for
the year
ended 31
March 2021
Note $

$ $
CASH FLOW FROM OPERATING
ACTIVITIES




Cash receipts from customers 763,087 561,141 1,242,595
Cash paid to suppliers and employees (2,517,329) (2,067,640) (4,282,506)
Cash received from research and
development tax offset

-

-

689,167
Government subsidies 99,114 -
268,717
Short-term lease payments not included in
lease liability (64,933) (34,136)

(73,978)
Interest paid - (32,202) (35,146)
Interest received 196 - 1,820
Net cash used in operating activities 8
(1,719,865) (1,572,837) (2,189,331)

CASH FLOW FROM INVESTING
ACTIVITIES






Purchase of plant and equipment - (74,064) (97,524)
Net cash used in investing activities - (74,064) (97,524)

CASH FLOW FROM FINANCING
ACTIVITIES





Proceeds from issue of shares - 5,243,001 7,489,968
Share issue costs - (273,508) (431,970)
Repayment of borrowings - - (410,280)

Net cash provided by financing activities

- 4,969,493 6,647,718

Net (decrease)/increase in cash and cash
equivalents

(1,719,865) 3,322,592 4,360,863
Cash and cash equivalents at beginning of
period

5,255,074 1,024,153
1,024,153
Effect of foreign exchange adjustment on
cash balances

138,291 120,918

(129,942)
Cash and cash equivalents at end of
period 3,673,500 4,467,663 5,255,074
The accompanying notes form part of these financial statements.

TRUSCREEN GROUP LIMITED

10

1. REPORTING ENTITY
These consolidated unaudited interim condensed financial statements presented for the six
months ended 30 September 2021 are those of TruScreen Group Limited and its subsidiaries
(the “Group”). References to “TruScreen” are used to refer both to the Group and TruScreen
Group Limited (the “Company”).
The parent company, Truscreen Group Limited, is the ultimate legal parent company of the Group
and is a limited liability company incorporated and domiciled in New Zealand. It is registered under
the Companies Act 1993. Truscreen is listed on the NZX and on the ASX as an ASX Foreign
Exempt Listing.
Truscreen is a FMC reporting entity under Part 7 of the Financial Markets Conduct
Act 2013.
The Group’s principal activity relates to the research & development and manufacture of cancer
detection devices and systems.
These consolidated unaudited interim financial statements were authorised for issue by the Board
of Directors on 29 November 2021.
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 part 7 of the Financial Markets
Conduct Act 2013. The financial statements comply with NZ IAS 34: Interim Financial Reporting
and International Accounting Standards IAS 34: Interim Financial Reporting.
The consolidated unaudited interim financial statements have been prepared in New Zealand
dollars, which is the presentation currency, with the New Zealand dollar and the Australian dollar
being the functional currency of the New Zealand parent company and the Australian subsidiary
respectively. 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 2021.
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 2021.
The consolidated unaudited interim financial statements are prepared on the basis of historical
cost, except where otherwise identified.
3. 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 GROUP LIMITED

11

4. 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
2021

Unaudited for
the six months
ended 30
September 2020
Audited for
the year ended
31 March
2021

$ $ $
Other income

Research and development tax
offset¹

- Current year
361,032 185,506 549,109
- Prior year adjustment
48,898 53,663 23,628

409,930 239,169 572,737
Interest
216 919 1,820
Government subsidies
99,114 154,111 268,717
Foreign exchange gains - realised
164,428 3,970 -
Total other income
673,688 398,169 843,274
¹Ongoing Research & development is being conducted in the following areas:
• Clinical trials;
• Software & firmware improvements incorporated from feedback on prototypes to improve
usability;
• Manufacturing processes of the electrical and optical assembly;
• Changes and improvements to the electrical and optical assembly; and
• Further work on developing and testing the algorithm.
²The Directors undertook a comprehensive Impairment Review (“Review”) of the intangible assets
of the Company as at the 31 March 2021 year end. This Review was undertaken in compliance
with NZ IAS 36 Impairment (‘IAS 36’) and its detailed specifications with the assistance of an
independent consultant.
In particular, the Directors assessed the risk of not meeting the projected device sales and rollout
in China and other countries as a result of COVID-19 pandemic. These risks were taken into
account in determining the budget for 2022 and the impact on sales revenue in subsequent years.
A further limited review was undertaken at the 30 September 2021 half year. The current 2022
forecast is tracking close to the 2022 budget, which was used in the March 2021 impairment
review. A further full review will be undertaken for the March 2022 financial year. The Company’s
business in the key market of China, impacted early in calendar 2020 by COVID-19 and the first
country to lift COVID-19 restrictions, has made a strong recovery.

TRUSCREEN GROUP LIMITED

12
5. ADMINSTRATION AND OTHER OPERATING EXPENSES
The following commentary explains the improvement in administration and operating expenses
over the previous half year:
Employee benefits expense: The reduction in costs is attributable to the business is currently
operating with a Director, Juliet Hull, as CEO on an interim basis.
Research and development costs: The increase in these costs reflect research and development
work to improve cybersecurity, facilitate self-calibration of the TruScreen cervical cancer
screening device, and other enhancements to meet market requirements.
Marketing and product approvals: The reduction in marketing costs reflects a decision in the face
of COVID-19, and limited access in a number of markets, to focus on research and development.
The firmware upgrade now complete, marketing efforts will accelerate as more markets emerge
from COVID-19 lockdowns.
Shareholder relations and services: The increase in these costs reflect the dual listing costs of
the NZX and ASX, following the listing on the ASX in January 2021.

6. OPERATING SEGMENTS
The Group operates in one operating segment. It owns the intellectual property and 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 earns revenue largely from China, with developing markets in South East Asia, Russia,
Mexico, India, Africa and Eastern Europe. Revenues are from sales to the Company’s distributors
(indirect channel of distribution).
One major customer contributed more than 10% of the Group’s revenue in the six months to 30
September 2021 (2020: two customers):
• One customer provided revenue of $647,839 (87%) (2020: $508,712 (85%)); and
• In 2020 a further customer provided revenue of $88,154 (15%).
No additional disclosure is required in the interim financial statements as the Group has one
reportable segment.

7. SHARE CAPITAL

No. $
Balance at 30 September 2020
332,394,825 32,461,543
Balance at 31 March 2021
362,866,253 34,550,048
Balance at 30 September 2021
362,866,253 34,550,048

TRUSCREEN GROUP LIMITED

13

8. RECONCILIATION OF CASH FLOW FROM OPERATING ACTIVITIES


Unaudited
for the six
months
ended 30
September
2021
Unaudited
for the six
months
ended 30
September
2020
Audited for
the year
ended 31
March 2021

$

$ $
Reconciliation of cash flow from operations
with loss after income tax





Loss for the period
(1,258,918)

(1,510,165)

(3,490,010)
Adjusted for:



Amortisation and depreciation
300,850 346,192

646,597
Exchange difference arising from translating
loss items at the date of transaction and
translating cash balances at period end rates
(338,487) 943

298,477
Operating cash flows before working capital
changes
(1,296,555) (1,163,030)
(2,544,936)
(Increase)/decrease in trade receivables
(6,672) (49,906) 182,018
(Increase)/decrease in goods and services
taxes recoverable
10,325

(19,739)

(26,718)
(Increase)/decrease in prepayments
(54,658)

(157,178)
30,511
(Increase)/decrease in inventory
40,967

(107,006)
(228,806)
Increase/(decrease) in research and
development refundable tax offset
(402,981)

(239,169)

125,765
Increase in trade and other payables
103,745

154,806
159,451
(Decrease)/increase in employee liabilities
(114,036)

8,385
113,384
Net cash outflow from operating activities
(1,719,865)

(1,572,837)

(2,189,331)

TRUSCREEN GROUP LIMITED

14

9. NET TANGIBLE ASSETS PER SHARE



Unaudited
as at
30 September
2021
Unaudited
as at
30 September
2020
Audited
as at
31 March
2021
Net tangible assets ($)

5,108,606 5,855,994 6,307,889
Shares on issue at the end of period

362,866,253

332,394,825

362,866,253
Net tangible assets per share (cents
per share)

1.41

1.76

1.74

10. CONTINGENT LIABILITIES
There are no contingent liabilities in this or the previous reporting period.

11. EVENTS SUBSEQUENT TO END OF THE INTERIM PERIOD
The Company received $605,104 on 1 October 2021, being the Australian research and
development tax offset refund for the year ended 31 March 2021.
On 11 October, COVID-19 lockdown restrictions were lifted in Sydney where the Company’s
operation is located. Staff are now working back in the office. International travel is allowed with
limited international destinations for fully vaccinated travellers. It is anticipated that full
international travel for fully vaccinated travellers could recommence by mid-2022.
The Company’s business is not materially impacted by the New Zealand and Australian
governments commitments to their respective emission reductions target announced at the recent
October 2021 United Nation Climate Change Cop 26 conference at Glasgow UK. As part of its
ongoing product development and operations review the Company will take steps to reduce its
carbon footprint.
Other than outlined above and as outlined in the Corporate section of the Half-Yearly Review of
Operations, there are no other events since 30 September 2021 which would have a material
effect on the Group’s unaudited interim financial statements for the six months ended 30
September 2021.

---

NZX/ASX Announcement
29 November 2021
TruScreen unaudited interim results for the half-year ended 30 September 2021
Highlights for Half Year ended 30 September 2021
• Strong revenue and Single Use Sensor sales growth of 25% and 35% year on year
respectively
• Launch of TruScreen Made in China device for the Chinese market
• Firmware upgrade and cervical cancer screening device enhancements
• Continuous expansion and first sales in Eastern Europe
• Ongoing excellent trial results confirm efficacy of TruScreen cervical cancer
screening device
TruScreen Group Limited (NZX/ASX: TRU) (‘TruScreen’ or ‘the Company’) is pleased to announce
its unaudited half year financial results for the period ended 30 September 2021. TruScreen reports
according to the New Zealand financial year, which runs from 1 April to 31 March.
Strong revenue growth of 25%
The Company reported an operating loss of $1.26m (1H FY21: $1.51m), a 20% reduction over the
prior year. Despite the negative impacts of COVID-19 in some of our markets, notably Russia and
Vietnam, product revenue increased by 25% year on year (YOY).
Pleasingly, Single Use Sensor (SUS) unit sales were 35% higher YOY, although getting new cervical
cancer screening devices installed in hospitals was hampered by ongoing COVID-19 restrictions.
Net operating cash outflow was $1.7m (1H FY21: $1.6m). An Australian research and development
tax offset was received just after quarter-end in the amount of $0.6m. Cash operating costs were 22%
higher in 1H FY22, at $2.5m (1H FY21: $2.1m), reflecting the Company’s increased investment in
research and development which resulted in re-engineered firmware that enhanced cybersecurity and
facilitated self-calibration which will reduce future operating costs. The Australian tax offset for the
related research will be received in the next financial year.
The loss for the six months included a non-cash amortisation and depreciation charge of $0.30m (1H
FY21: $0.35m).
As at 30 September 2021, the Company had cash and cash equivalents of $3.67m, which was
supplemented by a research and development tax offset receipt of $0.6m from the Australian Tax
Office on 1 October 2021.
Operational Update
TruScreen continued to make good market and technical progress in 1H 22 and, going forward, is
well placed to build upon this success as the COVID-19 pandemic wanes throughout our markets.

Market development - China
TruScreen has continued to successfully expand in China, its most established market and the world’s
largest addressable cervical cancer screening market.
With the launch of the TruScreen Made in China device, developed specifically for the Chinese
market, the Company’s China distributor Beijing Siweixiangtai (SWXT) has expanded its addressable
distribution market. It is now marketing this TruScreen device to the growing Health Check sector.
SWXT anticipates the first major placement of TruScreen devices in the private Health Check sector
to commence before the end of the 2021 calendar year.
This development provides TruScreen with revenue upside, as China’s Health Check sector is rapidly
growing, aided by support from provincial governments, private organisations, and non-government
organisations (NGOs). Major public hospitals will have separate Health Check clinics offering a wide
range of women’s health medical checks, including cervical cancer screening.
In July 2021, TruScreen’s largest clinical evaluation, with the Chinese Obstetrics and Gynaecology
Association (COGA), came to a close after screening over 15,000 women in 64 hospitals and 9
provinces around the country. The final results are expected to be presented to the COGA panel for
review and consensus in the coming months.
Market development – Rest of world
TruScreen has continued to broaden its market access throughout Central and Eastern Europe, with
the Company’s current focus on Serbia and Poland. The market access strategies in these two
countries are now being actively supported by key opinion leader engagement, clinical trials, and local
clinical evaluation initiatives.
TruScreen is currently in the final planning stages for a clinical trial in Poland, led by a well-known
medical opinion leader in that country. The pilot phase of this trial will screen women in five centres
across Poland to evaluate the clinical performance of the TruScreen cervical cancer screening device.
TruScreen anticipates the results of the trial will facilitate accelerated market access throughout
Poland as well as neighbouring countries.
TruScreen has recently concluded training in Serbia targeting new key opinion leaders and clinicians.
The training has enabled the commencement of planned local clinical evaluations and facilitated the
commencement of early market activities with the first sales to the region completed in September.
The World Health Organisation (WHO) has highlighted that low-and-middle income countries will
require innovative technologies, like TruScreen’s portable and real time device, if they are to make
progress in achieving the goal of eliminating cervical cancer. Leveraging our success in Zimbabwe
and in partnership with its National Aids Council, we are in discussion with potential distributors in
markets where TruScreen is not currently represented, and where TruScreen, as a primary cervical
cancer screening device, can make a positive difference to women’s health.

Upgraded firmware
After twelve months of development work, TruScreen has completed verification and validation of a
key firmware update that is now being progressively released to TruScreen devices already in the
market. The firmware update enhances the device’s cyber security framework and allows TruScreen
devices to more effectively interface with compatible hospitals’ systems. By incorporating a state-of-
the-art optical calibration feature, the firmware has reduced the need for the device to return to service
centres for scheduled re-calibration. This reduced service-related downtime means clients have their
devices online for longer time periods, boosting operational efficiencies.
The new firmware update also includes enhancements to the user interface and battery management
features. These were developed in collaboration with the Company’s distributors and in response to
market feedback, a demonstration of the collaborative nature of the relationship TruScreen has with
these crucially important groups.
Clinical trials continue to show promising results
A new study, published in the European Journal of Obstetrics and Gynaecology and Reproductive
Biology
1
, concludes that TruScreen’s cervical cancer screening technology meets or exceeds the
effectiveness of alternative cervical cancer screening methods. The study evaluated the efficacy of
TruScreen in screening for cervical abnormalities, in a real-world primary cervical cancer screening
setting in China.

The TruScreen screening device was found to be very effective at detecting cervical intraepithelial
neoplasia grade 2 or worse (CIN2+ or CIN3+).
The Chinese Obstetrics and Gynaecology Association (COGA) national clinical trial which has
screened ~15,000 women in 64 top-tier public hospitals across 9 provinces in China, has concluded.
The COGA evaluation compares the TruScreen technology to Liquid Based Cytology (LBC) and
human papillomavirus (HPV) DNA testing, targeting a nationwide consensus on Truscreen technology
applications in China as the main outcome of this large-scale trial.
The final report from this trial is still awaited, however preliminary results from two major provincial
trials (See NZX announcements 2 September 2019 and 19 October 2020) showed TruScreen to be
better or on parity than tests for HPV and LBC.




1

1
Yingting Wei, Wenjing Wang, Mengxing Cheng, Zubei Hong, Liying Gu, Jiaxin Niu, Wen Di, Lihua Qiu,
Clinical evaluation of a real-time optoelectronic device in cervical cancer screening, Yingting We et al.,
European Journal of Obstetrics & Gynecology and Reproductive Biology, 2021, ISSN 0301-2115,
https://doi.org/10.1016/j.ejogrb.2021.09.027. (https://www.sciencedirect.com/science/article/pii/S0301211521004826)

Corporate
TruScreen’s operations are based in Sydney Australia, which for much of the six months to 30
September 2021 was under COVID-19 lockdown restrictions. Throughout the lockdown the company
functioned while following the health orders with limited impact on operations. The lockdown was lifted
in early October and TruScreen’s offices and manufacturing sites have since reopened.
Outlook
TruScreen’s Strategic Plan for FY22 and beyond will see the Company focus on three key areas:
continuous product improvement, rapid expansion in China, and growth into other key markets.
Juliet Hull, TruScreen’s CEO said “Our half year results reflect the significant efforts of the team,
despite COVID-19’s ongoing impacts. The strong revenue growth, attributed largely to SUS sales, is
pleasing to see at this point in the year.
It is great to see the efforts of the last year start to materialise, with key projects in China and Europe
moving ahead with pace. In addition to the strong revenue growth year on year, we have seen a 20%
growth in commercial users around the world since the start of FY22. As our markets continue to
recover from COVID-19 we expect to see commercial and clinical activities start to ramp up
significantly.”

-ENDS-
For more information, visit

www.truscreen.com or contact:
Juliet Hull
Chief Executive Officer
juliethull@truscreen.com

Guy Robertson
Chief Financial Officer
guyrobertson@truscreen.com

Julia Maguire
Investor Relations
julia@thecapitalnetwork.com.au

About TruScreen:

TruScreen Group Limited (NZX/ASX: TRU) is a New Zealand-based medical device company that
has developed an AI-enabled device that can detect precancerous and cancerous cervical changes
in real-time via optical and electrical measurements of cervical tissue. Unlike many cervical screening
technologies that have only triage/adjunct functionality, the TruScreen device is registered as a
primary screening tool.
TruScreen’s cervical screening technology effectively resolves many of the ongoing issues with
conventional cytology, including failed samples, poor patient follow-up, patient discomfort, and the
need for supporting laboratory infrastructure.
The device is CE-marked, meaning it meets EU safety, health and environmental protection standards
required for sale and use throughout Europe. It is also National Medical Products Administration
approved for sale in China.
TruScreen is currently targeting product sales to a range of low and middle-income countries,
including China, Mexico, Vietnam, Russia, and Saudi Arabia, where no large-scale cervical cancer
screening programs and infrastructure are currently in place. By doing so, the Company hopes to help
improve the health and wellbeing of women worldwide.

To learn more, please visit: www.truscreen.com/