TRU - TruScreen Preliminary Final Results

Monday 26th May 2025

Highlights

 Key market China, accounted for more than 85% of global sales exceeded budget and is poised for further expansion in 6 key provinces

 Memorandum of Understanding signed with Hangzhou Dalton Bioscience (DaltonBio) in February 2025 to form a strategic alliance for expanding product portfolio and distribution channels

 TruScreen re-enters India with appointment of Renovate Biologicals Pvt Ltd in April 2025

 5-year program to screen 260,000 women for cervical cancer in Ho Chi Minh City, Vietnam launched April, 2025

 Indonesia product registration completed and distributor appointed, with commercial activity commenced in May 2025

 TruScreen clinical trial results confirm suitability for large scale screening in emerging markets

 TruScreen continues to be validated by independent studies and the World Health Organization

Cervical cancer technology company Truscreen Group Limited (NZX/ASX: TRU) (the Company) has released its preliminary unaudited financial results for the year ended 31 March 2025.

TruScreen generated product sales of $1.7m (2024: $2.1m) for the year. This lower result was largely due to delays in roll-out programs in Vietnam (launched April 2025), and Zimbabwe (delayed until FY2026) and delayed product registrations in Indonesia and Uzbekistan. Revenues from these delayed commercial activities are expected to be realised in FY2026.

TruScreen Group Ltd expects FY2026 sales to exceed NZ$ 2.8m.

Gross margin in FY2025 was 30.1% (2024: 32.7%) with the lower margin attributable to variances in the country sales mix due to delays in programs and product registrations. Other income was lower than the prior year at $0.4m (2024: $0.5m) attributable to a lower research and development Australian tax offset refund.

Total overhead expenses were $3.1m (2024: $3.24m) and have reduced in the latter part of the year with further cost saving measures. The result for the year was a loss of $2.2m (2024: $2.0m) being adversely impacted by the shortfall in margin as a result of deferred product sales and a lower research and development Australian tax offset refund, foreign exchange translation loss and increased costs in: regulatory product registrations; facility relocation costs; and increased travel to support existing markets and open new markets.

Operating cash outflow for the year $2.3 million (2024: $2.0 million) was in line with the profit and loss result for the year. Cash at the end of the year was $0.4 million (2024: 2.7 million). The cash balance reflected completion of a 2024 capital raise prior to 31 March 2024.

Operational Key Performance and Update

Key market China, accounting for over 85% of global sales, goes from strength to strength

Number of Women of Screening Age: 476,599,793*

• Key provinces for growth: TruScreen’s China distributor Beijing Siweixiangtai Technology Ltd. Co (SWXT) is targeting 6 key provinces for growth in 2025 - Guangxi, Jiangsu, Hunan, Zhejiang, Shanghai and Guangdong. These provinces have a combined population of 496 million, and an addressable screening market of approximately 124 million women.

• SUS Pull Through: Consumable Single Use Sensor (SUS) pull through per month per device has reached peak of 142 SUS per month per device, an increase of 30 % over 12 months.

• Software Upgrade: China’s NMPA registration variations have been approved and the software upgrade on Chinese devices has commenced. The upgrade will improve user experience for clinicians and extend the device’s in-use service interval.

• Private Sector Expansion: SWXT is targeting the growing China private health sector including private clinics and Health Check Centre approvals in Jiangsu and Shenzhen, and entry into the Luxury Hospital and Traditional Chinese Medicine Hospital sectors.

• Public Health Insurance: In addition to having 11 provinces with approved pricing for TruScreen, Beijing has awarded public health insurance reimbursement for eligible TruScreen patients. Shanghai has completed the final round of evaluation for public health insurance reimbursement and once administrative processes for this are formalised sales are expected to grow rapidly in this province.

Memorandum of Understanding signed with Hangzhou Dalton Bioscience (DaltonBio) in February 2025

• Strategic alliance: TruScreen signed a non-binding MOU with DaltonBio, a leading China based manufacturer of high-performance HPV DNA tests and laboratory equipment for cervical cancer screening, for a strategic alliance to expand global commercial opportunities for a suite of DaltonBio’s HPV related IVD products to be marketed under the TruScreen brand.

• Product portfolio expansion: Following due diligence TruScreen would be appointed a global distributor of DaltonBio HPV related IVD products (excluding U.S.A. and Canada).

• Opportunities with Dalton’s distribution channels: DaltonBio will explore opportunities to assist TruScreen’s AI enabled real time cervical screening device within its distribution network, notably in its selected distributors in China and South America.

DaltonBio have 200 sub distributors in China which may augment TruScreen’s current distribution network in it’s largest market (>85% of sales)

TruScreen selected to screen 260,000 women in Ho Chi Minh City and adoption in Vietnam picks up pace

Number of Women of Screening Age: 35,887,201*

• The formal agreement to conduct a 5-year program to screen 260,000 women for cervical cancer in Ho Chi Minh City was signed in April 2025

Following the signing of a Memorandum of Understanding with the Ho Chi Minh City Public Health Association and Gorton Health Services (Truscreen’s Vietnam distributor) in November, TruScreen has been selected as the primary screening methodology for the capability of its unique, AI-enabled real time cervical cancer screening technology to assist the Government of Vietnam achieve its goal of screening 60% of women aged 30 to 54 for cervical cancer (currently only 25% screened).

• Public Hospital Adoption: In January 2025 Professor Michael Campion presented at Tu Duc Hospital in Ho Chi Minh City, leading to 6 major Ho Chi Minh City hospitals agreeing to adopt and install TruScreen.

TruScreen re-enters India with appointment of Renovate Biologicals Pvt Ltd in April 2025

Number of Women of Screening Age: 468,000,000*

• New distributor: India holds one-sixth of the world's population and one woman dies from cervical cancer every eight minutes in the country. The cervical cancer screening rate is only 2%, and India’s National Academy of Medical Sciences (NAMS) has recently set a target of 70% by 2030.

The appointment of Renovate Biologicals now gives TruScreen distribution capability in 3 of the 4 most populous countries in the world - China, India and Indonesia.

Indonesia distributor appointed with commercial activity commenced

Number of Women of Screening Age: 95,961,293*

• Distributor Appointed: Following the completion of product registration, TruScreen appointed a new Indonesian medical products distributor PT Mawar Mitra Medika with commercial sales commenced in the world’s largest Islamic nation, with a population spread over 14,000 islands. TruScreen offers an ideal solution to providing screening to a geographically dispersed and diverse population.

• AI presentation by CEO to MOH officials and KOL’s. In December 2024, TruScreen presented to an AI Health webinar organised by Austrade and the Indonesian Ministry of Health. TruScreen was one of only two companies invited to present at this webinar, a recognition of our growing reputation as a leader in AI innovative health technology with a particular relevance to developing or Low- and Middle-Income Countries (LMIC’s).

Uzbekistan

Number of Women of Screening Age: 11,617,411*

• National Screening Program: TruScreen is in the final stage of product registration by the National Pharmaceutical Safety Committee. This approval is a prerequisite for a pilot screening program in Tashkent. TruScreen is dealing directly with senior Ministry of Health officials who insist on a direct relationship with TruScreen with no intermediaries. The proposed public cervical cancer screening program is expected to see 14 Women and Children’s healthcare clinics in Tashkent adopting the TruScreen technology. Following the successful implementation of screening in Tashkent it is expected that the program will then extend to cervical screening in other provinces of Uzbekistan.

Mexico

Number of Women of Screening Age: 45,983,174*

• Public Sector Focus: Distributor Sunbird continues to engage with the newly elected government officials to introduce TruScreen to the public health sector.

• Leveraging the government's focus on AI in medicine. Leveraging this focus, Sunbird is in advanced discussions with IMSS, (the nation’s largest public health insurer covering 38% of the population) for TruScreen inclusion in their planned cervical cancer screening program.

Zimbabwe

Number of Women of Screening Age: 5,152,773

• Ministry of Health Re-Validation for Public Screening Programs: Following changes of personnel in the Zimbabwe Ministry of Health the formal re-validation program for TruScreen was delayed to Q2 of FY 2026. Once the re-validation has commenced the tenders for public screening in metropolitan and regional Zimbabwe will resume.

Jordan, Palestine and Rwanda

Number of Women of Screening Age: approx. 8,849,008

• Following our distributor in Jordan, Palestine and Rwanda, Sadaf Medical, featuring TruScreen in seminars and trade shows in these countries, commercial sales have commenced to Jordan and Rwanda.

TruScreen results and suitability in emerging markets continues to be validated by independent studies and the World Health Organization

• October 2024 - UNITAID, a World Health Organisation (WHO) agency featuring health solutions for Low- and Middle-Income countries, included TruScreen in its report “Screening and treatment of pre-cancerous lesions for secondary prevention of cervical cancer”. TruScreen was the only opto-electrical device included in the technology landscape report.

• October 2024 - TruScreen was selected as a ‘Top 6 Pick’ - 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.

• November 2024 – following the UNITAID inclusion, TruScreen were invited to present at the World Health Organisation (WHO) key meeting to further the use of AI technologies for screening of cervical cancer in Edinburgh, and were the only opto-electric tissue differentiating medical device company invited to participate.

• November 2024 - An Obstetrics and Gynaecology Hospital of Fudan University study (n=1908) concluded that TruScreen optoelectronic real time screening detection accuracy outperformed liquid-based cytology (LBC) in patients with type 3 cervical transformation zone. The report was published by leading research journal, Germany’s Springer Nature.

• July 2024/April 2025 - The preliminary publication in July 2024 of a Saudi Arabia study investigating TruScreen’s performance versus pap smears in cervical cancer detection, was peer reviewed and published by globally renowned BMC Women’s Health. The study, entitled “Beyond Tradition: Investigating TruScreen’s Performance Versus Pap Smear in Cervical Cancer Detection” 1 tested 507 women and was first published on Research Square1 Link on 25 July 2024. Results showed that TruScreen demonstrated:

o High Sensitivity: TruScreen 83.3%, compared to Pap Smear 66.7%

o High Specificity: TruScreen 95%, compared to Pap Smear 98.2%

• April and May 2025 – TruScreen and the Baylor Foundation Eswatini agree on the validation and initial product training for TruScreen to be used for a pilot program to screen women in Eswatini, formally Swaziland

Corporate

Appointments

Dr. Cheung was appointed Chair of the Company’s Technology Committee during the year.

With over 20 years of experience as a medical device engineer and specialist in product research and development, Dr. Cheung brings significant expertise to assist the board in further developing the Company’s technology pathways.

The Company has appointed Hall Chadwick NZ Limited as auditors replacing RSM Hayes Audit.

Looking Ahead

With a significant investment in market access in FY2025 the formalisation of a number of new country relationships and agreements, TruScreen expects to increase revenue in FY2026 to NZ $2.8m.

Sales growth will be underpinned by a forecast 15 % increase in China sales, the resumption of the Zimbabwe government public screening programs, the commencement of the Vietnam Ho Chi Minh City public screening program, the forecast first year of sales in India and Indonesia – the second and fourth most populated countries in the world, and sales of the Dalton HPV test kits and analyser devices.

TruScreen CEO Martin Dillon commented “Whilst FY2025 was slower than expected in sales and other revenue, the restructuring of the business and the major achievements highlighted in the preceding paragraphs place TruScreen at an inflexion point in our commercial growth.

TruScreen will remain focused on China as well as the growing sales channel of public screening programs. The programs will screen thousands of women in Zimbabwe, Vietnam, Uzbekistan, Mexico and Eswatini. This new sales channel will add to our current business model of accessing the screening market through the public and private health systems.”

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