Truscreen Half Year Results
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.