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TruScreen Results Half Year Ended 30 September 2020

Half Year Results3 November 2020TRUIndustrials

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 2020

Previous Reporting Period 6 months to 30 September 2019

Currency

Amount (000s) Percentage change

Revenue from continuing

operations

$597 (22%)

Total Revenue $991 (47%)

Net profit/(loss) from

continuing operations

($1,510) (48%)

Total net profit/(loss) ($1,510) (48%)

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

$0.0176 $0.0151

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


4 November 2020


Unaudited financial statements accompany this announcement.

---

TRUSCREEN GROUP LIMITED
(formerly Truscreen Limited)


Interim Unaudited Financial Statements


For the Six Months Ended 30 September 2020


TRUSCREEN GROUP LIMITED





Table of contents



Page



Operations report 1

Consolidated statement of profit or loss and other comprehensive income 3

Consolidated statement of financial position 4

Consolidated statement of changes in equity 5

Consolidated statement of cash flows 6

Notes to the interim unaudited condensed financial statements 7

TRUSCREEN GROUP LIMITED
1


OPERATIONS REPORT

Cervical cancer screening technology company, TruScreen Group Limited (NZX: TRU) (Company), is pleased to

provide the unaudited financial results for the six months to 30 September 2020 (1H 2021).

The Company reported a bottom-line loss of $1.5m (2019: $1.0m). The major contributor to that loss was a reduction

of $0.7m in the Australian research and development tax offset refund. The 2019 result included the impact of share-

based payments of $0.3m attributable to that half-year (1H) period.

Product revenue at $0.6m (2019: $0.76m) is down 22% on the prior year. Note that the 2019 period benefitted from

sales to Zimbabwe of $0.28m billed and shipped in Financial Year (FY) 2018. However, the application of NZ IFRS

15 required that this be recognised as sales on receipt of cash early in FY 2019. On a shipped and billed basis, sales

are up 24%, and Single Use Sensor (SUS) revenues grew 85% on the prior period. SUS sales by volume shipped

increased by 80% year on year (YOY), largely attributable to China.

Net operating cash outflow was $1.6m (1H 2019: $1.7m). Cash operating costs were 5% lower in the six months, at

$1.8m (1H 2019: $1.9m). The loss for the six months included a non-cash amortisation and depreciation charge of

$0.35m (1H 2019: $0.30m).

At 30 September 2020, the Company had cash and cash equivalents of $4.47m. A capital raise of $4.97m (net of

costs) was completed in April/May 2020. The capital raising was undertaken via a successful Share Purchase Plan

and a private placement.

Half-Year Commentary

TruScreen continued to make significant commercial progress in the six months to 30 September 2020,

notwithstanding the challenges presented by COVID-19.

The Company continues to apply appropriate Occupational Health and Safety protocols to protect staff, our suppliers,

and consultants. The TruScreen team continue to work effectively between home and the office at the Commonwealth

Scientific and Industrial Research Organisation (CSIRO), Lindfield. NSW.

Market development

China, our largest market, after an early lockdown was the first country to lift COVID-19 restrictions and has

recovered well. Our distributor has added installed devices to new hospitals in the Municipality of Shanghai,

Provinces of Sichuan, Hunan, Guangdong, Shandong, Jiangsu, Guangxi, Shan’xi, and Guizhou, increasing the

number of in-use TruScreen cervical cancer screening devices from 49 to 69 over the course of the half-year. SUS

sales to China have increased by 80% YOY. Unfortunately, this positive improvement has been offset by the negative

impact of COVID-19 restrictions in Russia and Zimbabwe, and a hiatus in Mexico prior to the appointment of a

replacement distributor.

After four years of market development, in April 2020 TruScreen received approval from the Ministry of Health

(MOH) of the Vietnam Government for the commercial rollout of the TruScreen cervical cancer screening device.

This followed a MOH-managed clinical trial which compared TruScreen to a Pap test and covered 989 patients. The

trial was concluded successfully, with a positive clinical outcome at the Hanoi Obstetrics & Gynaecology Hospital.

The positive trial results in Vietnam were further confirmed by preliminary trial results in Sichuan Province, China,

covering 1,243 patients in 14 hospitals. The Sichuan trial results were better than, or at least on parity with, tests for

HPV (Human Papillomavirus DNA Test) and LBC (Liquid-based Cytology). The Sichuan trial results were

presented by the lead investigator of the China Obstetrics and Gynaecology Association (COGA) project in Sichuan

Province, at COGA’s annual congress in September 2020.



TRUSCREEN GROUP LIMITED
2

Operations

The Company has strengthened its executive team with the following appointments:

- Edmond Capcelea as Chief Technology Officer. Edmond has more than 20 years’ experience in medical design

and development. Edmond holds a Master’s Degree in Engineering Physics, and his previous roles include

Divisional Director Head of Implants and Design Development at Cochlear Limited, and Senior Vice President

of Research and Development at Saluda Medical.

- Dr Beata Edling MD, Phd, MBA as Medical Affairs Lead. Beata’s previous roles include Executive Medical

Director Amgen, Eli Lily, and Sanofi.

- Jerome Villalon as Senior Software Engineer. Jerome holds a Bachelor’s Degree in Information

Communications Technology from UTS.

Further product research and development is continuing to be undertaken, with particular focus on reducing the cost

of manufacture of both the TruScreen cervical cancer screening device and SUS. These projects, should they prove

successful, should result in improved gross margins in calendar 2021 and beyond.

As announced in early 2020, the Company proposes to relocate its device manufacturing for the China market to

Shenzhen, China. Planning for the project has commenced. This will provide TruScreen greater access to the China

market where the public health system gives preference to locally manufactured product. Subject to COVID-19

restrictions, this is scheduled to be operational by 30 June 2021.

During 1H, we have improved our commercial support to our distribution network. Several key projects were initiated

in these areas to improve our capabilities to support product rollout and a higher number of installed devices active

in the field across the globe.

We have completed development of an online training platform available to end-users. The platform hosts our

recently developed training video and theory exam and will accompany on-patient training provided by our

distributors. We have also expanded our cloud-based Jira service system to enable distributors to use the portal to

provide feedback on device performance, update service records, and track location of the devices.

Highlights for HY2020:

• Operational SUS sales volume growth of +80% over 1H 2019;

• Expansion in China, with installed devices in new hospitals increased by 40% YOY;

• Expansion into Vietnam with MOH approval, and first shipment of product;

• Appointment of distributors in Eastern Europe, Aspironix s.r.o and MPG d.o.o Beograd for the Balkans;

• Appointment of replacement distributor in Mexico, Sunbird S.A. de C.V.; and

• Successful $5.243m (before costs) capital raising completed in May/June 2020.

Corporate

The Company appointed Victoria Potarina, an executive with more than 18 years’ experience at Johnson & Johnson

(J & J) and other blue-chip multinational companies in FMCG, OTC, medical devices and healthcare, as CEO on 2

March 2020.

Prof Ron Jones and Mr Con Hickey retired as Directors on 31 March 2020 and 10 September 2020, respectively. Ms

Juliet Hull was elected a Director on 10 September 2020. Ms Hull is the NZ General Manager/Country Director of

Johnson & Johnson Medical, a Director of the ANZ Johnson & Johnson Medical Executive Board, a Director of

MTANZ (Medical Technology Association of NZ) and a member of both the APAC Regional Leadership team for

J & J’s Orthopaedics and Ethicon Divisions.


Thanks to the strong support of shareholders, the Company raised $5.243m before costs in April/May 2020. A Share

Purchase Plan raised $3m through the issue of 74,860,021 shares at 5 cents each, and a further $2.243m was raised

through an over-subscribed placement of 30,000,000 shares at 5 cents each.


Anthony Ho

Chairman

4 November 2020

TRUSCREEN GROUP LIMITED
3


CONSOLIDATED STATEMENT OF PROFIT OR LOSS

AND OTHER COMPREHENSIVE INCOME

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2020




Unaudited

for the six

months

ended 30

September

2020


Restated

Unaudited

for the six

months

ended 30

September

2019





Audited

for the year

ended 31 March

2020

Note $


$ $

Revenue from the sale of goods 596,824


762,110 1,288,242

Other income 4 394,199


1,110,993 1,266,040

Changes in inventories -


3,011


960

Purchases of inventory (351,272)


(366,424)


(772,980)

Employee benefit expenses and directors’ fees (644,236)


(715,432)


(1,308,222)

Administration (244,927)


(222,223)


(541,663)

Research and development expenses (524,718)


(524,823)


(1,137,389)

Travel (1,598)


(72,047)


(77,777)

Marketing & product approvals (284,811)


(134,119)


(430,656)

Insurance (39,840)


(48,445)


(87,410)

Shareholder relations & services (35,362)


(136,570)


(148,115)

Foreign exchange gain/(loss) 3,970


-


108,038

Amortisation & depreciation (346,192)


(304,886)


(597,830)

Impairment of non-current assets 4 -


-


(2,380,000)

Finance costs (32,202)


(60,319)


(71,959)

Share based payments -


(306,000)


(306,000)

Loss before income tax (1,510,165)


(1,015,174)


(5,196,721)

Income tax expense -


-


-

Loss for the period after income tax (1,510,165)


(1,015,174)


(5,196,721)

Other comprehensive income





Item that may be reclassified subsequently to

profit or loss





Exchange gain/(loss) on translating foreign

subsidiary operations 448,242


(145,940)


(259,903)

Other comprehensive income/(loss) for the period


448,242 (145,940) (259,903)

Total comprehensive loss for the period


(1,061,923) (1,161,114) (5,456,624)

Basic and diluted losses (cents per share) (0.48)


(0.46)


(2.32)

The accompanying notes form part of these financial statements.

TRUSCREEN GROUP LIMITED
4

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 SEPTEMBER 2020



Unaudited

30 September

2020


Unaudited

30 September

2019


Audited

31 March

2020


Note $ $ $

CURRENT ASSETS



Cash and cash equivalents 4,467,663 990,821 1,024,153

Trade receivables 156,924 480,947 107,018

Other receivables 923,419 1,987,743 684,250

Loan receivable 75,000 75,000 75,000

Goods and services taxes recoverable 37,249 34,224 17,510

Inventories 610,774 797,985 503,768

Other assets – prepayments 293,620 181,395 136,442

TOTAL CURRENT ASSETS 6,564,649 4,548,115 2,548,141


NON-CURRENT ASSETS

Plant and equipment 314,042 345,314 295,048

Intangible assets 5,292,643 8,102,857 5,230,821

TOTAL NON-CURRENT ASSETS 5,606,685 8,448,171 5,525,869


TOTAL ASSETS 12,171,334 12,996,286 8,074,010


CURRENT LIABILITIES

Trade and other payables 447,951 636,798 293,141

Borrowings 436,840 626,501 410,280

Employee benefits 88,531 138,895 83,149

TOTAL CURRENT LIABILITIES 973,322 1,402,194

786,570


NON-CURRENT LIABILITIES


Employee benefits 49,375 57,515

46,373

TOTAL NON-CURRENT LIABILITIES 49,375 57,515

46,373


TOTAL LIABILITIES 1,022,697 1,459,709 832,943


NET ASSETS 11,148,637 11,536,577 7,241,067


EQUITY

Issued capital 8 32,461,543 27,492,050 27,492,050

Share option reserve 306,000 306,000 306,000

Foreign currency translation reserve (266,457) (600,736) (714,699)

Accumulated losses (21,352,449) (15,660,737) (19,842,284)

Total Equity 11,148,637 11,536,577 7,241,067

The accompanying notes form part of these financial statements.

TRUSCREEN GROUP LIMITED
5

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2020



Share

Capital

Accumulated

Losses

Foreign

Currency

Translation

Reserve

Option

Reserve Total


Note $


$


$


$


$

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)

Other comprehensive loss

for the period

- - 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 8

5,243,001 - - - 5,243,001

Share issue costs 8

(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

Balance at 31 March 2019

(Audited)


26,421,168 (14,645,563)

(454,796)

- 11,320,809

Comprehensive income





Loss for the period ended 30

September 2019 - restated


- (1,015,174) - - (1,015,174)

Other comprehensive loss

for the period

- - (145,940) - (145,940)

Total comprehensive loss

for the period (unaudited) -

restated


- (1,015,174) (145,940) - (1,161,114)

Transactions with owners







Issue of shares 8

1,131,800 - - - 1,131,800

Share issue costs 8

(60,918) - - - (60,918)

Share based payments -

restated


- - - 306,000 306,000

Total transactions with

owners

1,070,882 - - 306,000 1,376,882

Balance at 30 September

2019 (Unaudited) - restated


27,492,050


(15,660,737)


(600,736)


306,000


11,536,577

The accompanying notes form part of these financial statements.


TRUSCREEN GROUP LIMITED
6

CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2020



Unaudited

for the six

months

ended 30

September

2020


Unaudited

for the six

months

ended 30

September

2019


Audited for

the year

ended 31

March 2020


Note $


$


$

CASH FLOW FROM OPERATING

ACTIVITIES





Cash receipts from customers 561,141 506,468

1,309,080

Cash paid to suppliers and employees (2,067,640) (2,179,539)

(4,415,470)

Cash received from research and development tax

offset


-


-



1,645,985

Short-term lease payments not included in lease

liability


(34,136)


-



(111,002)

Interest paid (32,202) (60,317)

(71,959)

Interest received - 3,272

8,867

Net cash used in operating activities 9

(1,572,837) (1,730,116) (1,634,499)


CASH FLOW FROM INVESTING

ACTIVITIES







Purchase of plant and equipment (74,064) - -

Net cash used in investing activities (74,064) - -


CASH FLOW FROM FINANCING

ACTIVITIES






Proceeds from issue of shares 5,243,001 1,131,800 1,131,800

Share issue costs (273,508) (60,918) (60,918)

Proceeds from borrowings - - 410,280

Repayment of borrowings - - (626,501)


Net cash provided by financing activities


4,969,493 1,070,882 854,661


Net increase/(decrease) in cash and cash

equivalents


3,322,592 (659,234) (779,838)

Cash and cash equivalents at beginning of period 1,024,153 1,737,775

1,737,775

Effect of foreign exchange adjustment on cash

balances


120,918 (87,720)


66,216

Cash and cash equivalents at end of period 4,467,663 990,821 1,024,153

The accompanying notes form part of these financial statements.

TRUSCREEN GROUP LIMITED
7

1. REPORTING ENTITY

TruScreen Group Limited (the “Company”) is a Tier 1 for-profit listed incorporated public company and is

an issuer on the New Zealand Stock Exchange (“NZX”). The Company is a limited liability company

incorporated and domiciled in New Zealand and registered under the Companies Act 1993. The NZX

ticker code for TruScreen is TRU. TruScreen is an 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 research & development and manufacture of cancer detection

devices and systems.

The consolidated unaudited interim condensed financial statements presented for the six months ended 30

September 2020 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 Company changed its name to TruScreen Group Limited (formerly TruScreen Limited) on 21 August

2020.

These consolidated unaudited interim financial statements were authorised for issue by the Board of

Directors on 4 November 2020.

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 2020.

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 2020.

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
8



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

2020

Unaudited for

the six months

ended 30

September

2019

Audited for

the year

ended 31

March 2020

$ $ $

Other income

Research and development tax offset¹


- Current year

185,506 365,085 684,250

- Prior year adjustment

53,663 572,923 572,923


239,169 938,008 1,257,173

Interest

919 3,204 8,867

Government subsidies

154,111 - -

Foreign exchange gains - unrealised

- 169,781 -

Total other income

394,199 1,110,993 1,266,040

Expense


Impairment²

- - 2,380,000

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 2020 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 2021 and the impact on sales revenue in subsequent years.

A further limited review was undertaken at the 30 September 2020 half year. The current 2021 forecast is

under the budget projected in March 2020 due to COVID-19 impact. However, this may not have a material

impact on the carrying value of intangible assets at 31 March 2021, and a full determination will be made

as at this date. 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
9

5. ADMINSTRATION AND OTHER OPERATING EXPENSES

The following commentary explains the improvement in cash administration and operating expenses over

the previous half year:

Clinical trials – lower level of support activity in 1H 2020 partly attributable to COVID-19;

Research and development – 1H 2019 includes support expenditure relating to a pilot plant;

Travel – no travel in 1H 2020 attributable to COVID-19. This inability to meet with distributors is a limiting

factor in the short term; and

Share-based payments – the prior period contains a share-based payment charge of $306,000 relating to

Director and Officer options issued on 24 September 2019. As the options had vested, they were fully

expensed in that period.


6. 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 earns revenue largely from China, with developing markets in South East Asia, Russia, Mexico,

India, and Eastern Europe. Revenues are from sales to the Company’s distributors (indirect channel of

distribution).

Two major customers each contributed more than 10% of the Group’s revenue in the six months to 30

September 2020 (2019: two customers):

• One customer provided revenue of $508,712 (85%); and

• One 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. RESTATEMENT OF PRIOR PERIOD

The results for the half year ended 30 September 2019 have been restated to include a one-off charge of

$306,000 being 9,000,000 unlisted options issued to Directors and Officers on 24 September 2019. The

options which were fully vested have an exercise price of 15 cents per share with an expiry date of 27

August 2022.


8. SHARE CAPITAL

No. $

Balance at 30 September 2019 227,535,804 27,492,050

Balance at 31 March 2020 227,534,804 27,492,050

Share Purchase Plan, 21 May 2020 74,860,021 3,743,001

Share placement, 29 May and 5 June 2020 30,000,000 1,500,000

Share issue costs - (273,508)

Balance at 30 September 2020 332,394,825 32,461,543

TRUSCREEN GROUP LIMITED
10


9. RECONCILIATION OF CASH FLOW FROM OPERATING ACTIVITIES



Unaudited

for the six

months

ended 30

September

2020

Restated

Unaudited

for the six

months

ended 30

September

2019

Audited for

the year

ended 31

March 2020

$ $ $

Reconciliation of cash flow from operations with

loss after income tax






Loss for the period (1,510,165)


(1,015,174)


(5,196,721)

Adjusted for:

Amortisation and depreciation 346,192 304,886 597,830

Impairment of non-current assets - - 2,380,000

Share based payment expense - 306,000 306,000

Exchange difference arising from translating loss

items at the date of transaction and translating cash

balances at period end rates 943 (170,220)


(188,764)

Operating cash flows before working capital changes (1,163,030) (574,508) (2,101,655)

(Increase)/decrease in trade receivables (49,906) (293,443) 80,486

(Increase)/decrease in goods and services taxes

recoverable (19,739)


(3,889)


12,826

Increase in prepayments (157,178) (159,843) (114,890)

(Increase)/decrease in inventory (107,006) (15,959) 278,258

Increase/(decrease) in research and development

refundable tax offset (239,169)


(917,226)


386,267

Increase/(decrease) in trade and other payables 154,806 199,766 (143,889)

Increase in employee liabilities 8,385 34,986 (31,902)

Net cash outflow from operating activities

(1,572,837)


(1,730,116)


(1,634,499)


TRUSCREEN GROUP LIMITED
11


10. NET TANGIBLE ASSETS PER SHARE



Unaudited

as at

30 September

2020

Unaudited

as at

30 September

2019

Audited

as at

31 March

2020

Net tangible assets ($) 5,855,994 3,433,720 2,010,246

Shares on issue at the end of period 332,394,825 227,534,804 227,534,804

Net tangible assets per share (cents per

share)


1.76


1.51


1.13


11. CONTINGENT LIABILITIES

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


12. EVENTS SUBSEQUENT TO END OF THE INTERIM PERIOD

The Company repaid a loan of $436,840 in October 2020.

Except for the above and as outlined in the Corporate section of the Half-Yearly Operations Report, there

have been no other events since 30 September 2020 which would have a material effect on the Group’s

unaudited interim financial statements for the six months ended 30 September 2020.

---

NZX Announcement

4 November 2020


TruScreen Unaudited Preliminary Results for the Half-Year ended 30 September 2020

Highlights for HY2020:

✓ Operational SUS sales volume growth of +80% over 1H 2019;

✓ Expansion in China, with installed devices in new hospitals up 40% YOY;

✓ Expansion into Vietnam with MOH approval, and first shipment of product;

✓ Appointment of distributors in Eastern Europe, Aspironix s.r.o and MPG d.o.o Beograd for

the Balkans;

✓ Appointment of replacement distributor in Mexico, Sunbird S.A. de C.V.; and

✓ Successful $5.243m (before costs) capital raising completed in May/June 2020.


Cervical cancer technology company TruScreen Group Limited (NZX: TRU) (the Company,

TruScreen) announces its preliminary unaudited half-yearly results for the period ended 30

September 2020. TruScreen continued to make commercial progress throughout the period.

Unaudited Preliminary Half-Yearly Financial Results for the period ended 30 September 2020

(1H 2021)

The Company reported a bottom-line loss of $1.5m (2019: $1.0m). The major contributor to that

loss was a reduction of $0.7m in the Australian research and development tax offset refund. The

2019 result included the impact of share-based payments of $0.3m attributable to that half-year

(1H) period.

Product revenue at $0.6m (2019: $0.76m) was down 22% on the prior year. Note that the 2019

period benefitted from sales to Zimbabwe of $0.28m billed and shipped in Financial Year (FY)

2018. However, the application of NZ IFRS 15 required that this be recognised as sales on receipt

of cash early in FY 2019. On a shipped and billed basis, sales were up 24%, and Single Use Sensor

(SUS) revenues grew 85% on the prior period. SUS sales by volume shipped increased by 80%

year on year (YOY), largely attributable to China.

Net operating cash outflow was $1.6m (1H 2019: $1.7m). Cash operating costs were 5% lower

in the six months, at $1.8m (1H 2019: $1.9m). The loss for the six months included a non-cash


amortisation and depreciation charge of $0.35m (1H 2019: $0.30m).

At 30 September 2020, the Company had cash and cash equivalents of $4.47m. A capital raise of

$4.97m (net of costs) was completed in April/May 2020. The capital raising was undertaken via a

successful over-subscribed Share Purchase Plan and a private placement.

Operational update

TruScreen continued to make significant commercial progress in the six months to 30 September

2020, notwithstanding the challenges presented by COVID-19.

• China screening continues to produce outstanding results

The China Obstetrics and Gynaecology Association’s (COGA) ongoing national clinical trial that

originally planned to screen over 20,000 women has been reduced to 10,000 patients due to

interruptions from COVID-19 lockdowns. The COGA trial is being conducted in 100 top-tier public

hospitals across 10 provinces in China. The trial is comparing the TruScreen’s technology to Liquid

Based Cytology (LBC), and HPV DNA testing (HPV). This large-scale trial is targeting as the main

outcome a nationwide consensus on the application of TruScreen’s technology in China.

Preliminary trial results from Sichuan Province were presented by the lead investigator of the

COGA project in Sichuan Province, at COGA’s annual congress in September 2020. The Sichuan

trial covered 14 hospitals and 1,243 patients in the data analysis.

The preliminary results from the Sichuan Province trial were better than, or at least on parity

with, tests for HPV (Human Papillomavirus DNA Test) and LBC (Liquid-based Cytology). These

results confirm trial results from Hunan Province that were announced in 2019.

TruScreen’s China distributor has increased the number of in-use TruScreen cervical cancer

screening devices from 49 to 69 over the course of the half-year, adding new hospitals in the

Municipality of Shanghai and the Provinces of Sichuan, Hunan, Guangdong, Shandong, Jiangsu,

Guangxi, Shan’xi, and Guizhou.

• Vietnam – Approval from Vietnam Government’s Ministry of Health (MOH)

After a successful clinical trial covering 989 patients, the Company received approval from the Ministry

of Health (MOH) of the Vietnam Government for the commercial rollout of the TruScreen cervical cancer

screening device.



This landmark approval is granted initially for the Hanoi Obstetrics and Gynaecology Hospital

(HOGH). It is anticipated that further rollouts across other public and private hospitals in Vietnam

will occur this financial year.

• Distributor development

Prominent medical device distributor Aspironix s.r.o (Aspironix) was appointed exclusive

distributor for the Czech Republic, Slovakia, and Poland. These countries have a combined

cervical cancer addressable screening population of over 17.91 million women, presenting a

significant market opportunity for the Company.

A further distributor, MPG d.o.o Beograd, was appointed with responsibility for Serbia,

Montenegro, Bosnia, and Macedonia.

• Corporate

Capital Raise

With the strong support of shareholders, the Company raised $5.243m before costs in April/May

2020, with a Share Purchase Plan raising $3m through the issue of 74,860,021 shares at 5 cents

each and a further $2.243m through an over-subscribed placement of 30,000,000 shares at 5

cents each.


Enhanced Team Capability


The Company appointed Victoria Potarina, an executive with more than 18 years’ experience at

Johnson & Johnson (J & J) and other blue-chip multinational companies in FMCG, OTC, medical

devices and healthcare, as CEO on 2 March 2020.


The team was further strengthened during 1H 2021 with the appointment of;

Edmond Capcelea as Chief Technology Officer. Edmond holds a Master’s Degree in Engineering

Physics, and his previous roles include Divisional Director Head of Implants and Design

Development at Cochlear Limited, and Senior Vice President of Research and Development at

Saluda Medical. TruScreen also appointed


Dr Beata Edling MD, PhD, MBA as Medical Affairs Lead. Beata’s previous roles include Executive

Medical Director Amgen, Eli Lily, Sanofi.

Jerome Villalon as Senior Software Engineer. Jerome holds a Bachelor’s Degree in Information

Communications Technology from UTS.


Outlook

TruScreen’s goals for FY 2021 and beyond:

• Achieve >160 commercially installed devices across key markets by March 2021 (+100%

on 2020)

• Target COGA consensus in China on TruScreen as a primary cervical cancer screening tool

• Increase commercial coverage in Russia, following COVID-19 recovery

• Achieve China manufacture for China TruScreen device requirements

• Through research and development and process optimisation reduce cost of production

of both the TruScreen device and SUS

• Expand market presence in Eastern Europe

Commenting on the outlook, TruScreen CEO Victoria Potarina said,

“In the last 6 months Truscreen has advanced substantially in it’s transformational phase. The

reinforced team has identified a number of key projects which will give us greater access to the

China market, improve the Company’s gross margin and optimise our go to market capabilities.


Our results this half year have been impacted by COVID-19, nonetheless Truscreen has a solid

growth plan which is expected to build sustainable SUS revenue streams from diverse markets

over the medium term once the COVID-19 effect subsides”.


- ENDS -


For more information, visit www.TruScreen.com or contact:


TruScreen

Victoria Potarina

CEO

victorinapotarina@truscreen.com

TruScreen

Guy Robertson

CFO

guyrobertson@truscreen.com

Investors

Investor Relations

Phone: +61 2 9237 2801

TruScreen@we-buchan.com




About TruScreen:

TruScreen’s cervical cancer screening device offers the latest technology in cervical screening,

providing real-time, accurate detection of pre-cancerous and cancerous cervical cells to help

improve the health and well-being of women around the world.

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 tissues. A

sophisticated proprietary algorithm framework is utilised to detect pre-cancerous change, or

cervical intra-epithelial neoplasia (CIN), by optical and electrical measurement of cervical tissue.

TruScreen offers an alternative approach to cervical screening, resolving many of the ongoing

issues with conventional Pap tests, including failed samples, poor patient follow-up, patient

discomfort and the need for supporting laboratory infrastructure. As such, TruScreen’s target

market is low- and middle-income countries where no large-scale cervical cancer screening

programs and infrastructure are in place, such as China, Mexico, Africa, Russia, and India.

TruScreen’s cervical cancer screening device is CE-marked and certified for use throughout

Europe and NMPA (previously CFDA) approved for sale in China. The global market potential for

TruScreen is significant.

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.