TRUSCREEN GROUP LIMITED logo

Truscreen Half Year Results

Half Year Results28 November 2024TRUIndustrials

29 November 2024
NZX/ASX Announcement

TruScreen Unaudited Interim Results for the Half Year Ended 30 September 2024


Highlights for TruScreen in FY25 to date:

• First half year product sales up 5% on same period over prior year

• China continues to perform strongly

• Market entry to Indonesia underway with completion of registration

• Major validation screening program for Tashkent, Uzbekistan subject to completion of

product registration

• Increasing publications of trial results by global professional journals

• Post 30 September 2024, announcement of MOU to launch 5-year cervical cancer

screening program in Ho Chi Minh City (See NZX/ASX announcement 25 November

2024)


Cervical cancer screening technology company, TruScreen Group Limited (NZX/ASX: TRU)

(‘TruScreen’ or ‘the Company), is pleased to provide its unaudited interim financial results for the six

months to 30 September 2024 (1H FY25), along with the following Review of Operations. TruScreen

reports according to the New Zealand financial year, which runs from 1 April to 31 March.

After 3 years of COVID19 interruptions from 2020 to 2022, the Company resumed its

commercialisation of its TruScreen AI-enabled, non-invasive cervical cancer screening technology.

The low- and middle-income markets that the Company are in, have also resumed their public health

programs with a focus on women’s health. World Health Organisation (WHO) is pushing ahead with

its global strategy (approved by its member nations) of eliminating cervical cancer by the end of the

century and achieving milestone targets of 70% coverage of screening and 90% treatment of

precancerous lesions by the end of 2030. This is TruScreen’s target market.

Sales revenue of products increased by 5% over the prior period year on year to $1.03 million. The

Company reported a reduced operating loss of $1.13 million (1H FY24: $1.35 million).

Ongoing strong results from China offset timing delays of orders in other markets from product

registrations.

Net operating cash outflow was reduced to $0.9 million (1H FY24: $1.4 million).

As at 30 September 2024, the Company had cash and cash equivalents of $1.7 million.








Half-Year Commentary

TruScreen has improved its sales over the corresponding period in FY 2024 and expects revenue

growth to accelerate as market entry activities are converted to sales.

Market Development and Outlook

Global recognition by national Governments and NGOs

TruScreen is now included in screening guidelines published by WHO, UNITAID (including the

Clinton Health Access Initiative and Australia’s Daffodil Foundation), The Chinese Obstetricians and

Gynaecologists Association (COGA), the China Society for Colposcopy and Cervical Pathology

(CSCCP), Cofepris public health approval in Mexico, the Vietnam Hospital national Technical List

and the Russian Cervical Cancer Screening Guideline.

As well as including TruScreen in its cervical cancer screening guideline WHO invited TruScreen to

present at its November 2024 global meeting in Edinburgh to further the use of Artificial Intelligence

(AI) tools for visualisation of the cervix for cervical screening and treatment.

In Vietnam the Ho Chi Minh City Public Health Association has signed a tripartite 5-year

memorandum of understanding (MOU) with TruScreen to screen 260,000 women. This is the largest

public screening program outside of China for which TruScreen has been selected as the exclusive

screening technology.

China

Consumable sales (SUS) in China exceeded 90,000 units in the first half of FY2025, and these sales

continue to underpin TruScreen’s revenue. Following the submission of documents for the NMPA’s

registration variation, devices in China will be upgraded with new software, improving the user

experience for doctors and clinicians and leading to an increase in hospitals installing TruScreen with

increases in hospitals usage of consumable SUS (Single Use Sensors).

Our distributor in China, Beijing Siweixiangtai Tech Ltd. Co (SWXT) is focusing its sales activities

on the existing key province of Beijing and four other key expansion markets – Jiangsu, Guangdong,

Shanghai and Zhejiang.

This focus has resulted in Jiangsu province, after the initial installation of TruScreen in the Affiliated

hospital of Nantong University, having eight private hospitals confirming the adoption of the

TruScreen technology, with an estimated monthly SUS usage of 300-500 units per device per month

(> than twice the current average SUS usage per device per month).

Vietnam

TruScreen, with its distributor Gorton Health Services (GHS) and the Ho Chi Minh City Public Health

Association (HPHA) have signed an MOU to launch a public cervical cancer screening program in Ho

Chi Minh City. The program targets cervical cancer screening of 260,000 women over the next five

years. This program is in addition to TruScreen’s planned installations in major District Hospitals,

targeted by GHS following the inclusion of TruScreen in the Vietnam Ministry of Health national

Technical List and the ensuing simplification of the public hospital procurement process.

Purchases of TruScreen in these hospitals were delayed as the hospitals waited for the Ministry of

Health new approval guidelines following the Technical List inclusion. This has now been finalised

and four major public hospitals in Vietnam have obtained procurement approval and are installing





TruScreen for their cervical cancer screening programs. Two key hospitals are expected to follow

shortly.

To support our activities in Vietnam Professor Michael Campion, chair of TruScreen’s Medical

Advisory Committee will be conducting a training seminar in Tu Du hospital in early January 2025.

Key opinion leaders and screening clinicians will be updated on the use of TruScreen for the primary

screening of women for cervical cancer.

Mrs Nguyen Thi Tuyet Hanh, Director Gorton Health Services, Professor Le Truong Giang, Chair, Ho Chi

Minh Public Health Association, Martin Dillon, CEO TruScreen, signing MOU for Vietnam Screening program

Mexico

Sunbird S.A de C.V, TruScreen’s distributor in Mexico, is focusing on private and public health sector

sales in Mexico City.

Their key target is to have TruScreen selected as the technology for health checkup clinics in Mexico

City. The program has a potential for up to 20 devices to be installed with strong SUS pull through

over a two-year period.

In addition, Sunbird is leveraging the government's focus on AI in medicine to highlight TruScreen's

AI capabilities. Sunbird has commenced a series of cervical cancer screening webinars to increase

sales to gynaecologists in the private health sector in Mexico.

Uzbekistan

The National Pharmaceutical Safety Committee of Uzbekistan has submitted documents for the

registration of TruScreen. On completion of the registration, the Ministry of Health and the President’s

Office will begin validation of TruScreen for a major public screening program.

The validation is expected to commence in Q1 CY2025 in Tashkent and is a precursor for a larger

national program, starting with fourteen primary healthcare clinics in Tashkent and rolling out to

provinces in Uzbekistan.

Indonesia

Following product registration in Indonesia TruScreen has advanced discussion with a health clinic

group in Java and a major medical products distributor to commence commercialisation of TruScreen

in the world’s largest Islamic nation. Training with key medical heads of the clinics is scheduled for

December 2024, with commercial sales expected to begin in Q1 CY2025.

Zimbabwe

The Ministry of Health has requested a periodic re-validation of TruScreen for January 2025. Once

completed, tenders will be called for the next round of TruScreen enabled cervical cancer screening in

Harare and regional Zimbabwe.







Thailand, Malaysia and Singapore

Intega Pte Ltd- a Singapore based medical technology distributor, was appointed TruScreen’s

distributor for Singapore, Malaysia, and Thailand. Meetings were held with key hospitals in

Singapore to scope out the steps required for TruScreen to access the pubic hospital system in

Singapore.

This is a first step in TruScreen’s expansion in the ASEAN region and completes a continuous vertical

East Asian market, from Indonesia in the south, north through ASEAN (Association of South-East

Asian Nations) region, then Vietnam and China in the north. ASEAN is the fastest growing economic

regional bloc in Asia. Note that Vietnam is a member of ASEAN and the territory is not included with

Intega.

Jordan, Palestine and Rwanda

TruScreen was featured in expos and symposia in Jordan, Palestine and Rwanda by its distributor,

Sadaf Medical. D evices and SUS were ordered for installation in Rwanda and Jordan in Q1 CY2025.

Poland

In mid-December 2024 TruScreen will submit to the Institute of Mother and Child hospitals in Warsaw

and Lodz a plan and protocol for the evaluation of TruScreen for use in the Polish public health system.

The 3-month evaluation is planned for 200 women in public hospitals.

Recent global publications

During the first 6 months of FY 2025, recognition of TruScreen in several international publications

have strengthened our global position in the cervical cancer screening world.

• In August (See NZX/ASX announcement 5 August 2024) TruScreen was shown to outperform

Pap in a Saudi Arabian study involving 507 women. In the study, titled “Beyond Tradition:

Investigating TruScreen’s Performance Versus Pap Smear in Cervical Cancer Detection”,

TruScreen was shown to have a sensitivity 83.3% (Pap 66.7%) and a specificity 95% (Pap

98.2%). The authors concluded that TruScreen “represents a reliable, practical screening tool

for cervical neoplasms” and that their results “provide an evidence-based approach for

policymakers when selecting the optimal cervical cancer screening strategy in countries

without an established national screening program.”


• In November (See NZX/ASX announcement 11 November 2024) trial results were reinforced

by a study titled “Evaluation of a real-time optoelectronic method for the detection of cervical

intraepithelial neoplasia and cervical cancer in patients with different transformation zone types”

conducted by Dr Fengyi Xiao & Professor Long Sui from The Cervical Diseases Centre,

Obstetrics and Gynaecology Hospital of Fudan University, Shanghai, China. Published in the

leading research journal, Germany’s Springer Nature, the authors concluded that TruScreen

cervical cancer screening results were comparable and even better (for patients with type 3 TZ)

than conventional LBC (Liquid based Cytology).






• This study also reinforces for our key China market the COGA (Chinese Obstetricians and

Gynaecologists Association) large scale clinical trial of 15,661 patients conducted across 9

China Provinces over 3 years, that determined TruScreen to be a simple, effective and rapid

real-time method to screen for cervical cancer.

• In October 2024 TruScreen was selected by UNITAID, an agency of the Worlds Health

Organisation (WHO) and included in its Technology Landscape Report to its member nations.

(see NZX/ASX announcement 3 October 2024).

• TruScreen was also selected as one of six global companies, from a cohort of 580 companies,

that will have an impact on global women’s health. The evaluation was conducted by Austrian

based StartUs Insights. (See NZX/ASX announcement 29 October 2024)


Regulatory compliance

TruScreen successfully completed a compliance audit of its CE Mark with the European Medica

Device Directive and with International Standard ISO13485 during the half year, with the auditor,

Germany’s based TUV.

Looking Ahead

TruScreen is at the turning point of its commercialisation phase. Sales have been increasing as markets

and medical key opinion leaders become more aware of the advantages that TruScreen brings to

cervical cancer screening. Recent developments, with the increased recognition by WHO, NGO’s,

government guidelines, and the invitations to develop public screening programs in Ho Chi Minh City

and Uzbekistan indicate that TruScreen technology is now at a point where adoption of our unique

technology will accelerate, improving our financial performance and improving global women’s health.

This announcement was approved for release by the Board.

-ENDS-


For more information, visit www.truscreen.com

or contact:

Marty Dillion

Chief Executive Officer

martindillon@truscreen.com

Guy Robertson

Chief Financial Officer

guyrobertson@truscreen.com









About TruScreen:


TruScreen Group Limited (NZX/ASX: TRU) is a medical device company that has developed and

manufactures an AI-enabled device for detecting abnormalities in the cervical tissue in real-time via

measurements of the low level of optical and electrical stimuli.

TruScreen’s cervical screening technology enables cervical screening, negating sampling and

processing of biological tissues, failed samples, missed follow-up, discomfort, and the need for costly,

specialised personnel and supporting laboratory infrastructure.

The TruScreen device, TruScreen Ultra

®

, is registered as a primary screening device for cervical

cancer screening.

The device is CE Marked/EC certified, ISO 13485 compliant and is registered for clinical use with the

TGA (Australia), MHRA (UK), NMPA (China), SFDA (Saudi Arabia), Roszdravnadzor (Russia), and

COFEPRIS (Mexico). It has Ministry of Health approval for use in Vietnam, Israel, Ukraine, and the

Philippines, among others and has distributors in 23 countries. In 2021, TruScreen established a

manufacturing facility in China for devices marketed and sold in China, with the “Made in China”

registration.

TruScreen technology has been recognised in CSCCP’s (Chinese Society for Colposcopy and Cervical

Pathology) China Cervical Cancer Screening Management Guideline.

TruScreen has been recognised in a China Blue Paper “Cervical Cancer Three Stage Standardized

Prevent and Treatment” published on 28 April 2023, by COGA (Chinese Obstetricians and

Gynaecologists Association).

In financial year 2023 alone, over 140000

1

examinations have been performed with TruScreen device.

To date, over 200 devices have been installed and used in China, Vietnam, Mexico, Zimbabwe, Russia,

and Saudi Arabia. TruScreen’s vision is “A world without the cervical cancer”

©

.

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

1

Based on Single Use Sensor sales.











Glossary:

Pap smear (the Papanicolaou smear) test involves gathering a sample of cells from the cervix, with a special

brush. The sample is placed on a glass slide or in a bottle containing a solution to preserve the cells. Then it is

sent to a laboratory for a pathologist to examine under a microscope. https://www.cancer.net/navigating-

cancer-care/diagnosing-cancer/tests-and-procedures/pap-test

LBC (the liquid-based cytology) test, transfers a thin layer of cells, collected with a brush from the cervix, onto

a slide after removing blood or mucus from the sample. The sample is preserved so other tests can be done at

the same time, such as the human papillomavirus (HPV) test https://www.cancer.net/cancer-types/cervical-

cancer/diagnosis


HPV (human papilloma virus) test is done on a sample of cells removed from the cervix, the same sample

used for the Pap test or LBC. This sample is tested for the strains of HPV most commonly linked to cervical

cancer. HPV testing may be done by itself or combined with a Pap test and/or LBC. This test may also be done

on a sample of cells which a person can collect on their own.

https://www.cancer.net/cancer-types/cervical-

cancer/screening-and-prevention


Sensitivity and specificity mathematically describe the accuracy of a test which reports the presence or

absence of a condition. If individuals who have the condition are considered "positive" and those who don't

are considered "negative", then sensitivity is a measure of how well a test can identify true positives and

specificity is a measure of how well a test can identify true negatives:

• Sensitivity (true positive rate) is the probability of a positive test result, conditioned on the

individual truly being positive.

• Specificity (true negative rate) is the probability of a negative test result, conditioned on the

individual truly being negative (Sensitivity and specificity – Wikipedia).

For more information about the cervical cancer and cervical cancer screening in New Zealand and Australia,

please see useful links:

New Zealand: National Cervical Screening Programme | National Screening Unit (nsu.govt.nz)


Australia: Cervical cancer | Causes, Symptoms & Treatments | Cancer Council

---

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 2024

Previous Reporting Period 6 months to 30 September 2023

Currency NZ$

Amount (000s) Percentage change

Revenue from continuing

operations

1,034 +5.1%

Total Revenue 1,246 +7.0%

Net profit/(loss) from

continuing operations

(1,133) +16.4%

Total net profit/(loss) (1,133) +16.4%

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

$0.0037 $0.0029

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 2024


Unaudited financial statements accompany this announcement.

---

TRUSCREEN GROUP LIMITED








TRUSCREEN GROUP LIMITED


Interim Unaudited Financial Statements


For the Six Months Ended 30 September 2024






TRUSCREEN GROUP LIMITED


Table of contents



Page



Review of Operations 1

Consolidated statement of profit or loss and other comprehensive income 9

Consolidated statement of financial position 10

Consolidated statement of changes in equity 11

Consolidated statement of cash flows 12

Notes to the interim unaudited condensed financial statements 13

TRUSCREEN GROUP LIMITED

3

REVIEW OF OPERATIONS


Highlights for TruScreen in FY25 to date:

• First half year product sales up 5% on same period over prior year

• China continues to perform strongly

• Market entry to Indonesia underway with completion of registration

• Major validation screening program for Tashkent, Uzbekistan subject to completion of

product registration

• Increasing publications of trial results by global professional journals

• Post 30 September 2024, announcement of MOU to launch 5-year cervical cancer screening

program in Ho Chi Minh City (See NZX/ASX announcement 25 November 2024)


Cervical cancer screening technology company, TruScreen Group Limited (NZX/ASX: TRU) (‘TruScreen’

or ‘the Company), is pleased to provide its unaudited interim financial results for the six months to 30

September 2024 (1H FY25), along with the following Review of Operations. TruScreen reports according

to the New Zealand financial year, which runs from 1 April to 31 March.

After 3 years of COVID19 interruptions from 2020 to 2022, the Company resumed its commercialisation

of its TruScreen AI-enabled, non-invasive cervical cancer screening technology. The low- and middle-

income markets that the Company are in, have also resumed their public health programs with a focus on

women’s health. World Health Organisation (WHO) is pushing ahead with its global strategy (approved by

its member nations) of eliminating cervical cancer by the end of the century and achieving milestone targets

of 70% coverage of screening and 90% treatment of precancerous lesions by the end of 2030. This is

TruScreen’s target market.

Sales r evenue of products increased by 5% over the prior period year on year to $1.03 million. The

Company reported a reduced operating loss of $1.13 million (1H FY24: $1.35 million).

Ongoing strong results from China offset timing delays of orders in other markets from product

registrations.

Net operating cash outflow was reduced to $0.9 million (1H FY24: $1.4 million).

As at 30 September 2024, the Company had cash and cash equivalents of $1.7 million.

Half-Year Commentary

TruScreen has improved its sales over the corresponding period in FY 2024 and expects revenue growth to

accelerate as market entry activities are converted to sales.

Market Development and Outlook

Global recognition by national Governments and NGOs

TruScreen is now included in screening guidelines published by WHO, UNITAID (including the Clinton

Health Access Initiative and Australia’s Daffodil Foundation), The Chinese Obstetricians and

Gynaecologists Association (COGA), the China Society for Colposcopy and Cervical Pathology (CSCCP),

Cofepris public health approval in Mexico, the Vietnam Hospital national Technical List and the Russian

Cervical Cancer Screening Guideline.

TRUSCREEN GROUP LIMITED

4

As well as including TruScreen in its cervical cancer screening guideline WHO invited TruScreen to present

at its November 2024 global meeting in Edinburgh to further the use of Artificial Intelligence (AI) tools for

visualisation of the cervix for cervical screening and treatment.

In Vietnam the Ho Chi Minh City Public Health Association has signed a tripartite 5-year memorandum of

understanding (MOU) with TruScreen to screen 260,000 women. This is the largest public screening

program outside of China for which TruScreen has been selected as the exclusive screening technology.

China

Consumable sales (SUS) in China exceeded 90,000 units in the first half of FY2025, and these sales

continue to underpin TruScreen’s revenue. Following the submission of documents for the NMPA’s

registration variation, devices in China will be upgraded with new software, improving the user experience

for doctors and clinicians and leading to an increase in hospitals installing TruScreen with increases in

hospitals usage of consumable SUS (Single Use Sensors).

Our distributor in China, Beijing Siweixiangtai Tech Ltd. Co (SWXT) is focusing its sales activities on the

existing key province of Beijing and four other key expansion markets – Jiangsu, Guangdong, Shanghai

and Zhejiang.

This focus has resulted in Jiangsu province, after the initial installation of TruScreen in the Affiliated

hospital of Nantong University, having eight private hospitals confirming the adoption of the TruScreen

technology, with an estimated monthly SUS usage of 300-500 units per device per month (> than twice the

current average SUS usage per device per month).

Vietnam

TruScreen, with its distributor Gorton Health Services (GHS) and the Ho Chi Minh City Public Health

Association (HPHA) have signed an MOU to launch a public cervical cancer screening program in Ho Chi

Minh City. The program targets cervical cancer screening of 260,000 women over the next five years. This

program is in addition to TruScreen’s planned installations in major District Hospitals, targeted by GHS

following the inclusion of TruScreen in the Vietnam Ministry of Health national Technical List and the

ensuing simplification of the public hospital procurement process.

Purchases of TruScreen in these hospitals were delayed as the hospitals waited for the Ministry of Health

new approval guidelines following the Technical List inclusion. This has now been finalised and four major

public hospitals in Vietnam have obtained procurement approval and are installing TruScreen for their

cervical cancer screening programs. Two key hospitals are expected to follow shortly.

To support our activities in Vietnam Professor Michael Campion, chair of TruScreen’s Medical Advisory

Committee will be conducting a training seminar in Tu Du hospital in early January 2025. Key opinion

leaders and screening clinicians will be updated on the use of TruScreen for the primary screening of women

for cervical cancer.

TRUSCREEN GROUP LIMITED

5


Mrs Nguyen Thi Tuyet Hanh, Director Gorton Health Services, Professor Le Truong Giang, Chair, Ho Chi Minh

Public Health Association, Martin Dillon, CEO TruScreen, signing MOU for Vietnam Screening program


Mexico

Sunbird S.A de C.V, TruScreen’s distributor in Mexico, is focusing on private and public health sector sales

in Mexico City.

Their key target is to have TruScreen selected as the technology for health checkup clinics in Mexico City.

The program has a potential for up to 20 devices to be installed with strong SUS pull through over a two-

year period.

In addition, Sunbird is leveraging the government's focus on AI in medicine to highlight TruScreen's AI

capabilities. Sunbird has commenced a series of cervical cancer screening webinars to increase sales to

gynaecologists in the private health sector in Mexico.

Uzbekistan

The National Pharmaceutical Safety Committee of Uzbekistan has submitted documents for the registration

of TruScreen. On completion of the registration, the Ministry of Health and the President’s Office will

begin validation of TruScreen for a major public screening program.

The validation is expected to commence in Q1 CY2025 in Tashkent and is a precursor for a larger national

program, starting with fourteen primary healthcare clinics in Tashkent and rolling out to provinces in

Uzbekistan.

TRUSCREEN GROUP LIMITED

6

Indonesia

Following product registration in Indonesia TruScreen has advanced discussion with a health clinic group

in Java and a major medical products distributor to commence commercialisation of TruScreen in the

world’s largest Islamic nation. Training with key medical heads of the clinics is scheduled for December

2024, with commercial sales expected to begin in Q1 CY2025.

Zimbabwe

The Ministry of Health has requested a periodic re-validation of TruScreen for January 2025. Once

completed, tenders will be called for the next round of TruScreen enabled cervical cancer screening in

Harare and regional Zimbabwe.

Thailand, Malaysia and Singapore

Intega Pte Ltd- a Singapore based medical technology distributor, was appointed TruScreen’s distributor

for Singapore, Malaysia, and Thailand. Meetings were held with key hospitals in Singapore to scope out

the steps required for TruScreen to access the pubic hospital system in Singapore.

This is a first step in TruScreen’s expansion in the ASEAN region and completes a continuous vertical East

Asian market, from Indonesia in the south, north through ASEAN (Association of South-East Asian

Nations) region, then Vietnam and China in the north. ASEAN is the fastest growing economic regional

bloc in Asia. Note that Vietnam is a member of ASEAN and the territory is not included with Intega.

Jordan, Palestine and Rwanda

TruScreen was featured in expos and symposia in Jordan, Palestine and Rwanda by its distributor, Sadaf

Medical. Devices and SUS were ordered for installation in Rwanda and Jordan in Q1 CY2025.


TruScreen in Jordan

TRUSCREEN GROUP LIMITED

7


TruScreen in Rwanda

Poland

In mid-December 2024 TruScreen will submit to the Institute of Mother and Child hospitals in Warsaw and

Lodz a plan and protocol for the evaluation of TruScreen for use in the Polish public health system. The 3-

month evaluation is planned for 200 women in public hospitals.

Recent global publications

During the first 6 months of FY 2025, recognition of TruScreen in several international publications have

strengthened our global position in the cervical cancer screening world.

• In August (See NZX/ASX announcement 5 August 2024) TruScreen was shown to outperform Pap

in a Saudi Arabian study involving 507 women. In the study, titled “Beyond Tradition:

Investigating TruScreen’s Performance Versus Pap Smear in Cervical Cancer Detection”,

TruScreen was shown to have a sensitivity 83.3% (Pap 66.7%) and a specificity 95% (Pap 98.2%).

The authors concluded that TruScreen “represents a reliable, practical screening tool for cervical

neoplasms” and that their results “provide an evidence-based approach for policymakers when

selecting the optimal cervical cancer screening strategy in countries without an established national

screening program.”


• In November (See NZX/ASX announcement 11 November 2024) trial results were reinforced by a

study titled “Evaluation of a real-time optoelectronic method for the detection of cervical

intraepithelial neoplasia and cervical cancer in patients with different transformation zone types”

conducted by Dr Fengyi Xiao & Professor Long Sui from The Cervical Diseases Centre, Obstetrics

and Gynaecology Hospital of Fudan University, Shanghai, China. Published in the leading research

journal, Germany’s Springer Nature, the authors concluded that TruScreen cervical cancer

screening results were comparable and even better (for patients with type 3 TZ) than conventional

LBC (Liquid based Cytology).



TRUSCREEN GROUP LIMITED

8


• This study also reinforces for our key China market the COGA (Chinese Obstetricians and

Gynaecologists Association) large scale clinical trial of 15,661 patients conducted across 9 China

Provinces over 3 years, that determined TruScreen to be a simple, effective and rapid real-time

method to screen for cervical cancer.

• In October 2024 TruScreen was selected by UNITAID, an agency of the Worlds Health

Organisation (WHO) and included in its Technology Landscape Report to its member nations. (see

NZX/ASX announcement 3 October 2024).

• TruScreen was also selected as one of six global companies, from a cohort of 580 companies, that

will have an impact on global women’s health. The evaluation was conducted by Austrian based

StartUs Insights. (See NZX/ASX announcement 29 October 2024)

Regulatory compliance

TruScreen successfully completed a compliance audit of its CE Mark with the European Medica Device

Directive and with International Standard ISO13485 during the half year, with the auditor, Germany’s based

TUV.

Looking Ahead

TruScreen is at the turning point of its commercialisation phase. Sales have been increasing as markets and

medical key opinion leaders become more aware of the advantages that TruScreen brings to cervical cancer

screening. Recent developments, with the increased recognition by WHO, NGO’s, government guidelines,

and the invitations to develop public screening programs in Ho Chi Minh City and Uzbekistan indicate that

TruScreen technology is now at a point where adoption of our unique technology will accelerate, improving

our financial performance and improving global women’s health.


Thank you for your continued support.



Anthony Ho

Chairman

29 November 2024

TRUSCREEN GROUP LIMITED

9

CONSOLIDATED STATEMENT OF PROFIT OR LOSS

AND OTHER COMPREHENSIVE INCOME

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2024



Unaudited

for the six

months

ended 30

September

2024

Unaudited

for the six

months

ended 30

September

2023


Audited

for the year

ended 31

March 2024

Note $ $ $

Revenue from the sale of goods 1,034,128 984,512

2,107,839

Other income 4 211,870 179,422

497,045

Product cost of goods sold (736,232) (806,871) (1,416,070)

Employee benefit expenses and directors’

fees (314,174) (455,697) (792,513)

Other administration costs (338,886) (182,853)

(366,222)

Research and development expenses (393,058) (540,622)

(877,303)

Rent (12,487) (20,384)

(44,403)

Travel (28,032) (22,885)

(30,258)

Marketing and product approvals (398,172) (331,848)

(676,077)

Insurance (69,952) (69,841)

(139,414)

Shareholder relations & services (88,483) (89,300)

(201,937)

Provision for inventory obsolescence - - (21,577)

Share based payments - - (89,643)

Loss before income tax (1,133,478) (1,356,367) (2,050,533)

Income tax expense - - -

Loss for the period after income tax (1,133,478) (1,356,367) (2,050,533)

Other comprehensive income

Item that may be reclassified subsequently to

profit or loss

Exchange gain/(loss) on translating foreign

subsidiary operations (39,924) 13,864 41,980

Total comprehensive loss for the period


(1,173,402) (1,342,503) (2,008,553)

Basic and diluted losses (cents per share) (0.21) (0.32) (0.49)


The accompanying notes form part of these financial statements.





TRUSCREEN GROUP LIMITED

10

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 SEPTEMBER 2024



Unaudited

30

September

2024


Unaudited

30

September

2023


Audited

31

March

2024


Note $ $ $

CURRENT ASSETS



Cash and cash equivalents 1,742,167 807,228 2,728,036

Trade receivables 70,426 122,846 48,152

Other receivables 285,155 187,535 489,336

Inventories 934,983 640,998 491,254

Other assets – prepayments 120,475 326,871 273,603

TOTAL CURRENT ASSETS 3,153,206 2,085,478 4,030,381


NON-CURRENT ASSETS

Right-of-use assets 7 372,057 - -

Intangible assets - - -

TOTAL NON-CURRENT ASSETS 372,057 - -


TOTAL ASSETS 3,525,263 2,085,478 4,030,381


CURRENT LIABILITIES

Trade and other payables 946,567 718,470

653,732

Current lease liabilities 7 115,606 -

-

Employee benefits 115,487 127,834

115,635

TOTAL CURRENT LIABILITIES 1,177,660 846,304

769,367


NON-CURRENT LIABILITIES

Lease liabilities 7 260,028 - -

Employee benefits 29,043 39,653 29,080

TOTAL NON-CURRENT LIABILITIES 289,071 39,653 29,080


TOTAL LIABILITIES 1,466,731 885,957 798,447


NET ASSETS 2,058,532 1,199,521 3,231,934


EQUITY

Issued capital 8 38,705,945 36,097,125

38,705,945

Share option reserve 234,456 144,813

234,456

Foreign currency translation reserve (377,052) (365,244)

(337,128)

Accumulated losses (36,504,817) (34,677,173)

(35,371,339)

Total Equity 2,058,532 1,199,521

3,231,934

The accompanying notes form part of these financial statements.

TRUSCREEN GROUP LIMITED

11





CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023


Share

Capital

Accumulated

Losses

Foreign

Currency

Translation

Reserve

Option

Reserve Total

Note $ $ $ $ $

Balance at 31 March

2023 (Audited)


36,097,125 (33,320,806)

(379,108)

144,813 2,542,024

Comprehensive income





Loss for the period ended

30 September 2023


- (1,356,367) - - (1,356,367)

Exchange differences on

translation of foreign

subsidiary operations

- - 13,864 - 13,864

Total comprehensive

loss for the period

(unaudited)


- (1,356,367) 13,864 - (1,342,503)

Balance at 30

September 2023

(Unaudited)


36,097,125


(34,677,173)


(365,244)


144,813


1,199,521












Balance at 31 March

2024 (Audited)


38,705,945 (35,371,339)

(337,128)

234,456 3,231,934

Comprehensive income





Loss for the period ended

30 September 2024


- (1,133,478) - - (1,133,478)

Exchange differences on

translation of foreign

subsidiary operations

- - (39,924) - (39,924)

Total comprehensive

loss for the period

(unaudited)


- (1,133,478) (39,924) - (1,173,402)

Balance at 30

September

2024(Unaudited)


38,705,945


(36,504,817)


(377,052)


234,456


2,058,532



The accompanying notes form part of these financial statements.


TRUSCREEN GROUP LIMITED

12

CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2024


Unaudited

for the six

months

ended 30

September

2024


Unaudited

for the six

months

ended 30

September

2023



Audited for

the year

ended 31

March 2024

Note $


$ $

CASH FLOW FROM OPERATING

ACTIVITIES





Cash receipts from customers 954,731 1,044,974

2,273,035

Cash paid to suppliers and employees (2,282,908) (2,748,101)

(4,521,699)

Cash received from research and

development tax offset

439,080 372,223

371,240

Short-term lease payments not included in

lease liability

(29,428) (72,922)

(159,849)

Finance costs paid (4,758) -

-

Interest received 3,444 2,957

4,099

Net cash used in operating activities

9

(919,839) (1,400,869) (2,033,174)

CASH FLOW FROM INVESTING

ACTIVITIES







Purchase of plant and equipment - - -

Net cash used in investing activities


-


-


-


CASH FLOW FROM FINANCING

ACTIVITIES






Proceeds from issue of shares - - 2,651,316

Share issue costs - (21,100) (67,200)

Proceeds from borrowings - - 215,760

Repayment of borrowings - - (215,760)

Repayment of lease liabilities (34,730) - -


Net cash provided by financing activities


(34,730) (21,100) 2,584,116


Net (decrease)/increase in cash and cash

equivalents


(954,569) (1,421,969) 550,942

Cash and cash equivalents at beginning of

period


2,728,036 2,160,468

2,160,468

Effect of foreign exchange adjustment on

cash balances (31,300) 68,729

16,626

Cash and cash equivalents at end of

period 1,742,167 807,228 2,728,036

The accompanying notes form part of these financial statements.

TRUSCREEN GROUP LIMITED

13


1. REPORTING ENTITY

These consolidated unaudited interim condensed financial statements presented for the six

months ended 30 September 2024 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 2024.


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 2024.

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 2024.


The Company entered into a premises lease during the period and the accounting policy for the

treatment of leases is outlined below:


Leases

Assets and liabilities arising from a lease are initially measured on a present value basis. Lease

liabilities include the net present value of the fixed payments less lease incentives receivable.

There is no option to release.

Lease payments are allocated between principal and finance cost. The finance cost is charged to

profit or loss over the lease period so as to produce a constant periodic rate of interest on the

remaining balance of the liability for each period.



TRUSCREEN GROUP LIMITED

14


Right-of-use assets are measured at cost comprising the following:

• The amount of the initial measurement of lease liability;

• Any lease payments made at or before the commencement date less any lease incentives

received;

• Any initial direct costs; and

• Restoration costs.


The consolidated unaudited interim financial statements are prepared on the basis of historical

cost, except where otherwise identified.


Going Concern

The Group interim financial statements have been prepared on a going concern basis, which

contemplates the continuity of normal business activity and the realisation of assets and the

settlement of liabilities in the normal course of business.

As disclosed in the interim financial statements, the Group reported;

• a loss of $1,133,478 (2023: $1,356,367).

• net cash outflows from operating and investing activities of $922,376 (2023: $1,400,869)

• cash as at half year end of $1,742,167 (2023: $807,228)

The Directors have undertaken a detailed cash flow forecast for the twelve months following the

date of approval of report.

The Directors have determined that the Company will need to raise capital to support the further

development of its target markets to move the Company to profitability. The Directors are

confident that it will be able to raise sufficient funds to support the Company in the twelve months

following the date of this report.

The Board considers that supported by a capital raise, the projected twelve month cash flow

forecasts will be achievable and sufficient to provide cash to cover any operating deficit. The

Board considers managing cash flow and working capital as critical in executing the strategies of

the Group.

If the Group is unable to meet forecasts due to market uncertainties and is also unable to raise

additional capital when required, it can cast doubt on the entities ability to continue as a going

concern, and trade in the normal course of business.


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.

TRUSCREEN GROUP LIMITED

15


IMPAIRMENT OF NON-CURRENT ASSETS

The Directors undertook a comprehensive Impairment Review (“Review”) of the intangible assets

of the Company as at the 31 March 2022 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 and SUS sales

and rollout in China and other countries as a result of the Russia/Ukraine conflict and the COVID-

19 pandemic. As a consequence the directors resolved as at 31 March 2022 to create a provision

for the carrying cost of the remaining non-current assets in the amount of $4.6 million.

Global uncertainties from ongoing geopolitical tensions continue to impact the markets that the

Group are in. As at 30 September 2024, the Directors have determined that there are no indicators

which would warrant reversal of the Provision for impairment made as at 31 March 2022.

The Directors will continue to review available indicators as at each future reporting balance date.


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

2024


Unaudited for

the six months

ended 30

September 2023

Audited for

the year ended

31 March

2024


$ $ $

Other income


Research and development tax

refund/offset¹


- Current year

230,758 177,154 463,192

- Prior year adjustment

(22,332) - 31,203


208,426 177,154 494,395

Interest

3,444 2,268 2,650

Total other income

211,870 179,422 497,045


¹Ongoing Research & development is being conducted in the following areas:

• Software & firmware improvements incorporated from feedback on devices to improve

usability;

• Manufacturing processes of the electrical and optical assembly;

• Changes and improvements to the electrical and optical assembly; and

• Work on reducing the cost of production for both the device and SUS.




TRUSCREEN GROUP LIMITED

16


5. ADMINSTRATION AND OTHER OPERATING EXPENSES

Administration and other operating expenses were 4% down on the same period for the prior

year, with some small variations between categories.


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 2024 of $887,608 (86%) (2023: one customer of $973,208 (84%).

No additional disclosure is required in the interim financial statements as the Group has one

reportable segment.


7. LEASES


Amounts recognised in the balance sheet:

Consolidated

30

September

2024


31 March

2024

$ $

Right-of-use assets


Offices

372,057 -

Total right-of-use assets

372,057 -


Lease liabilities


Current

115,606 -

Non-current

260,028 -

Total right-of-use liabilities

375,634 -


Movement in right-of-use assets

Right-of-use assets opening balance

Add: New leases 405,881 -

Less: Amortisation (33,824) -

Right-of-use assets closing balance 372,057 -


Movement in lease liabilities

Lease liability recognised at start of year

- -

New lease

405,881 -

Add: Interest Expense

4,758 -

Less: Principal repayment

(35,005) -

Closing balance

375,634 -

TRUSCREEN GROUP LIMITED

17


LEASES (Continued)

a)

Amounts recognised in the statement of profit or loss:


30

September

2024


31 March

2024


$ $

Interest expense (included in finance cost)

4,758 -

Expenses relating to short-term leases

(included in administrative expenses)


29,428 -


The total cash outflow for leases during the year ended 30 June 2024 was

$35,005 (2023: $Nil).


8. SHARE CAPITAL


No. $

Balance at 30 September 2023

416,642,008 36,097,125

Ordinary shares issued


Share issue – placement

70,748,386 1,414,968

Share issue – rights issue

61,817,391 1,236,348

Share issue costs

- (127,079)

Shares issued in lieu of fees to directors

1,383,331 34,583

Share issue – employee benefit

2,000,000 50,000

Balance at 31 March 2024

552,591,116 38,705,945

Balance at 30 September 2024

552,591,116 38,705,945

TRUSCREEN GROUP LIMITED

18


9. RECONCILIATION OF CASH FLOW FROM OPERATING ACTIVITIES



Unaudited

for the six

months

ended 30

September

2024

Unaudited

for the six

months

ended 30

September

2023

Audited for

the year

ended 31

March 2024


$


$ $

Reconciliation of cash flow from operations

with loss after income tax






Loss for the period

(1,133,478)


(1,356,367)


(2,050,533)

Adjusted for:




Depreciation on right-of-use asset

33,959 -


-

Provision for inventory obsolescence

- -


21,577

Share based payment expense

- -


89,643

Exchange difference arising from translating

loss items at the date of transaction and

translating cash balances at period end rates

(4,276) (33,768)


(6,104)

Operating cash outflows before working capital


(1,103,795) (1,390,135)

(1,945,417)

(Increase)/decrease in trade receivables

(22,273) 47,465 122,159

(Increase)/decrease in goods and services

taxes recoverable

(28,506)


(8,494)


12,590

Decrease/(increase) in prepayments

153,129


(121,509)

(68,242)

(Increase)/decrease in inventory

(443,729)


(77,558)

72,187

Decrease/(increase) in research and

development refundable tax offset

232,686


191,561


(131,323)

Increase/(decrease) in trade and other

payables

292,835 (81,783) (111,939)

(Decrease)/increase in employee liabilities

(186)


39,583

16,811

Net cash outflow from operating activities

(919,838)


(1,400,869)


(2,033,174)


TRUSCREEN GROUP LIMITED

19


10. NET TANGIBLE ASSETS PER SHARE




Unaudited

as at

30 September

2024

Unaudited

as at

30 September

2023

Audited

as at

31 March

2024

Net tangible assets ($)


2,058,532 1,199,521 3,231,934

Shares on issue at the end of period


552,591,116


416,642,008


552,591,116

Net tangible assets per share (cents

per share)


0.37


0.29


0.58


11. CONTINGENT LIABILITIES

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


12. EVENTS SUBSEQUENT TO END OF THE INTERIM PERIOD

Other than as outlined in the Half-Yearly Review of Operations on matters reported post 30

September 2024, there are no other events since 30 September 2024 which would have a

material effect on the Group’s unaudited interim financial statements for the six months ended 30

September 2024.

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.