TruScreen Half Year Results
28/11/2025 08:30 NZDT, HALFYRP
28 November 2025
NZX/ASX Announcement
TruScreen Unaudited Interim Results for the Half Year Ended 30 September 2025
Highlights for TruScreen in 1H FY2026:
• First half year product sales at NZ$860k, FY2026 revenue guidance is affirmed at NZ$2.8m
• China continued to perform strongly, with public screening programs in Zimbabwe and Vietnam to commence 2H FY2026. Deferred revenue impact of NZ$200k
• Further progress in Indonesia and Uzbekistan with significant market opportunity
• New distributors appointed in India and South Africa
• Strategic alliance with Hangzhou Dalton Biosciences Ltd (DaltonBio) expanding HPV product range and market access
• Successful capital raise of NZ$4m, before costs, to see Company through to monthly cash flow positive
• Ms Christine Pears elected to the Board on retirement of Ms Juliet Hull
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 2025 (1H FY2026), together with the following Review of Operations. TruScreen reports according to the New Zealand financial year, which runs from 1 April to 31 March.
In FY2026 TruScreen made a strategic move into public screening programs which are expected to account for 20% of revenue in this financial year. In July 2025 Vietnam launched a five-year program to screen 260,000 women. Following receipt of regulatory approval in Uzbekistan a Memorandum of Understanding was signed, and medical experts were selected to conduct a 500 patient pilot project in Karakalpakstan province. This program is a pre-requisite to government consideration of the inclusion of TruScreen as a screening option for Uzbekistan’s 11 million women of screening age. Zimbabwe’s screening program, following the completion of the product re-validation will recommence in 2H FY2026 with 20,000 women expected to be screened in this financial year.
Sales revenue of products decreased by 17% over the prior period year on year to NZ$0.86 million as programs with revenue of NZ$200k were deferred from 1H to 2H. As a consequence, the Company reported an increased operating loss of NZ$1.36 million (1H FY2025: NZ$1.13 million), which includes costs associated with the June 2025 capital raise.
China continues to perform strongly and will be enhanced as we develop the relationship with DaltonBio.
Net operating cash outflow increased to NZ$1.7 million (1H FY2025: NZ$0.9 million), with lower receipts from customers and higher prepayment to our SUS contract manufacturer from higher forward demand production. There was also a timing delay in the receipt of the Australian research and development tax offset refund of NZ$460,000 expected in 2H FY2026.
As at 30 September 2025, the Company had cash and cash equivalents of NZ$2.2 million.
Half-Year Commentary
Market Development and Outlook
China
Consumable sales of Single Use Sensor (SUS) to China was 80,000 units in 1H FY2026,11% lower that FY2025 attributable to a production delay of our contract manufacturer in the current period. Full year SUS sales are expected to be in line with the prior year. This will continue to underpin TruScreen’s revenue, with overall revenue expected to increase by 13% from additional devices to be installed.
Our distributor in China, Beijing Siweixiangtai Tech Ltd. Co (SWXT) continues to focus its sales activities on the existing key provinces, including Beijing and four other key expansion markets – Jiangsu, Guangdong, Shanghai and Zhejiang.
In addition to major public hospitals SWXT has expanded its channels to include Traditional Chinese Medicine Hospitals, the private Luxury Hospital market and the Health Check Clinic market.
To support the marketing activity the investigators of the Chinese Obstetricians and Gynecologists Association (COGA) 15,000 patient clinical trial have submitted their clinical trial report for publication in a major international journal. Adding to the existing COGA blue paper and Chinese Society for Colposcopy and Cervical Pathology (CSCCP) endorsements, the publication will significantly enhance TruScreen’s clinical efficacy reputation in both China and internationally.
Vietnam
In April 2025 the Vietnamese government amalgamated and enlarged its provincial administration structure with the Ho Chi Minh City precinct and the HPHA doubling in size. These administrative changes have delayed the five year program to screen 260,000 women, however training of community health workers and a pilot screening program has commenced. The Ho Chi Minh City Centre for Diseases Control (CDC) is to manage the core program, starting in 2H FY2026.
TruScreen is listed in the Vietnam Ministry of Health National Technical List and agreements were signed with six major public hospitals to install TruScreen devices in 2H FY2026 for their cervical cancer screening programs.
India
The Company re-entered India with the appointment of Renovate Biologicals Pvt Ltd (RBL) to distribute our AI enabled TruScreen cervical cancer screening system.
India is the most populous country in the world, with one-sixth of the world's population – a total of 1.4 billion people – and an estimated screening population of 468 million women*.
RBL’s leadership team has combined relevant experience of over 50 years and is supported by a sales team of 22 and 130 sub-distributors and/or partners. First sales were made and RBL is well placed to achieve their target of gaining a 70-80% share of the cervical cancer screening market within 5 years.
RBL have also commenced registration of the DaltonBio HPV DNA system for which TruScreen has the distribution rights in India.
TruScreen was also selected for a public screening program in Leh Town, Ladakh, Jammu Kashmir. The program was organised by a Singapore volunteer gynecological team led by Dr Quek Swee Cheong. Dr Quek is a board member of the International Federation of Colposcopy and Cervical Pathology, and past President and a current council member of the Society of Colposcopy and Cervical Pathology of Singapore.
Mexico
Sunbird S.A de C.V, TruScreen’s distributor in Mexico, continues its focus on private and public health sector sales in Mexico City.
We expect modest growth in 2H FY2026 over FY2025, building on the inclusion of TruScreen in the Mexico COFEPRIS approval for use in the public health system.
Sunbird continues to engage with government officials to introduce TruScreen to the public health sector and are in advanced discussions with IMSS (Mexico’s largest public health insurer covering 38% of the population) for TruScreen’s inclusion in their planned cervical cancer screening program.
*CIA World Factbook women aged 15-64 = 467,593,7814
Uzbekistan
Since the registration of the TruScreen device with the Ministry of Health and the President’s Office, TruScreen signed a memorandum of understanding to conduct a 500-patient pilot program in Karakalpakstan province in August 2025.
The objectives of the program are to assess cervical screening options for the women of Uzbekistan and the implementation of TruScreen in the most effective way to prevent cervical cancer. The program will compare the efficacy and operational requirements of TruScreen compared to Pap tests in detecting early cancerous changes in the cervix; and to develop a framework for a National Cervical Cancer Screening program for Uzbekistan. First revenues are expected in 2H FY2026.
Indonesia
The completion of product registration saw TruScreen making its first sale to distributor PT Mawar Mitra Medika for Indonesia in early 2H FY2026.
Indonesia, with a population of 283 million, the world’s most populous Islamic nation, has an addressable screening market of 95 million women, with only 11% of women having ever been screened for cervical cancer**.
In November 2025 CEO Marty Dillon with Mawar Mitra Medika met with the Director of Non-Communicable Diseases in the Indonesian Ministry of Health to discuss TruScreen’s value proposition as a screening method of choice for Indonesia.
With over 17,000 islands in the Indonesian archipelago, TruScreen, being totally portable and not requiring major health infrastructure, is the ideal technology for screening women who have no access to traditional laboratory-based methods.
Zimbabwe
Re-validation of TruScreen, as requested by the Ministry of Health, was completed in October. Following the release of the final validation report, and completion of the tender process, screening will recommence in Harare and regional Zimbabwe.
Zimbabwe is an important market for TruScreen with a significant contribution to sales with over 20,000 women to be screened in Zimbabwe in 2H FY2026.
South Africa
Zimbabwe is an important springboard to South Africa where TruScreen has appointed a new distributor trading as AIR.
Product registration is expected shortly, and first revenue is expected in Q4 FY2026. South Africa has an addressable market of 19 million women and the 10th highest global cervical cancer incidence***.
Thailand, Malaysia and Singapore
TruScreen is working with its distributor INTEGA Pte Ltd to introduce TruScreen into this region.
TruScreen has received Singapore HAS regulatory approval and a key opinion leader, Dr Quek Swee Cheong, a board member of the International Federation of Colposcopy and Cervical Pathology, and past President and a current council member of the Society of Colposcopy and Cervical Pathology of Singapore, will be using TruScreen in his private clinic at Gleneagles hospital in Singapore and for the trial being undertaken in India with his sponsorship.
The submission of documents for regulatory approvals in Thailand and Malaysia have also commenced.
Regulatory compliance
TruScreen’s annual quality management system audit by TUV Germany will commence in December 2025 in Sydney.
*** ICO/IARC HPV Information Centre (*ICO = Catalan Institute of Oncology and IARC = International Agency for Research on Cancer)
Corporate
With the support of existing and new shareholders the Company raised NZ$4 million in June/July 2025 with the issue of 83,681,940 shares under the Share Purchase Plan at NZ$0.02 per share and a Share Placement of a further 107,034,091 shares to new professional and institutional investors at NZ$0.022 per share.
The Company also issued 190,716,031 share options on the basis of one option for every new share issued, with an exercise price of NZ$0.022 and an expiry date of 17 July 2026, and a further 14,025,000 options to a broker on the same terms.
The Company’s forward projections indicate that these funds should allow the Company to move to a monthly positive cash flow position by late FY2026.
The Company was pleased to welcome Ms Christine Pears to the Board in September on the retirement of Ms Juliet Hull. Christine is an experienced non-executive independent director and has held numerous roles as Chairs of boards, Audit & Risk Committee, Remuneration & Nomination Committee, across a range of New Zealand public and private companies with a focus on sales by indirect channel distribution.
On behalf of the Board, I take the opportunity to thank Juliet Hull for her contribution to Truscreen as Non-Executive Director and Interim CEO during the COVID years.
Looking Ahead
TruScreen’s new growing sales channel with three Public Screening Programs have significant growth potential. Our investment in building the strategic alliance with DaltonBio to extend our HPV product range and market access, gaining regulatory approval and distribution capability in a further two of the world’s most populous countries, India and Indonesia, will strengthen TruScreen’s foundations for growth in the years ahead.
Our 1H FY2026 performance is below expectations from timing of sales programs. However, we are confident that revenue in 2H FY2026 will reflect the progress we have made and reward investors for the commitment they have made to TruScreen.
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