TruScreen Half Year Results

TruScreen Unaudited Interim Results for the Half Year Ended 30 September 2023

Highlights for Half Year ended 30 September 2023

• Product sales up 33% on same period prior year
• Strong performance from major market China
• Opening of new market in Saudi Arabia and good progress in Zimbabwe and other markets indicate a strong H2 FY 2024.

Cervical cancer screening technology company, TruScreen Group Limited (NZX/ASX: TRU) (‘TruScreen’ or ‘the Company), is pleased to provide its unaudited financial results for the six months to 30 September 2023 (1H FY24), along with the following operational update. TruScreen reports according to the New Zealand financial year, which runs from 1 April to 31 March.

Revenue from sale of goods increased by 33% over the same period prior year to $0.98 million. The China business is growing strongly and will be well supported by Zimbabwe, Saudi Arabia, Vietnam and Mexico in H2 2024. The Company reported an operating loss of $1.35 million (1H FY22: $1.22 million). The increase in operating loss was attributed to lower margin on device sales into China, to accelerate SUS pull through, and compliance costs associated with new regulatory reporting requirements in China and Europe.

SUS unit sales were up 28% over the previous year and device sales were 100% up on the previous year with sales of Made in China devices to China’s new private health check market.
Net operating cash outflow was $1.4 million (1H FY23: $1.2 million). The reduced cash flow is attributable to a lower Australian research and development tax offset receipt in the current half year.

As at 30 September 2023, the Company had cash and cash equivalents of $0.8 million.

Half-Year Commentary

TruScreen has maintained its revenue base despite disruptive and challenging market conditions.

Market developments
China

China’s operations, through its distributor Beijing Siweixiangtai Tech Co. Ltd (SWXT), is experiencing rapid growth building on the recent recognition of the technology in a China Blue Paper “Cervical Cancer Three Stage Standardized Prevent and Treatment” published on 28 April 2023. In China, Blue Papers are promulgated to act as the definitive position on leading edge developments in all industries and are recognised as an endorsement by the leaders in the relevant field.

In addition, the CSCCP (Chinese Society of Colposcopy and Cervical Pathology) China Cervical Cancer Screening Management Guideline was the first national medical guideline in the world to recommend TruScreen as a new method for cervical cancer screening.

TruScreen has more than 100 devices installed in hospitals and clinics in 22 provinces in China. In addition, a growing pipeline includes, 14 hospital tenders won and awaiting installation, 26 hospitals which have approved TruScreen and are awaiting tender and 74 Hospitals where TruScreen has obtained OBGYN department acceptance, awaiting hospital approval.

Zimbabwe

TruScreen have just been awarded a further order of SUS (Single Use Sensor) with gross sales value NZ$300,000 to be delivered in Q3 FY 2024. The Ministry of Health’s collaboration with the National Aids Council screening program in Masvingo Province has already screened over 14,000 women, and is a precursor to a national roll out.

Middle East

The largest private health services provider in the middle east, Dr. Sulaiman Al-Habib Medical Group (DSAMG) in Saudi Arabia, completed its first clinical evaluation in the Middle East, of 507 women, during the period. The analysis of the results showed that TruScreen’s sensitivity was 83.3% and specificity was 95%, compared to 83.3% and 98% for the placebo Liquid Based Cytology (LBC). This demonstrates TruScreen’s efficacy while providing real time results and resolving many of the issues faced with potential patient follow-up when using LBC. The clinical evaluation manuscript has been submitted for publication in the European Journal of Gynaecology.

The commencement of commercial operations at the DSAMG is an important reference for neighbouring markets in the middle east.

Vietnam

The Ministry of Health has approved 2 key hospitals with a further 4 hospitals well advance in the approval process. A recent visit by TruScreen CEO to Vietnam confirmed Vietnam as a key market for the Company which is expected to contribute to further growth in H2 FY 2024.

Other markets

During the period, TruScreen was listed on the Innovation Register, by the Polish Ministry of Health. This accreditation increases awareness among healthcare clinicians. There is an ‘at risk’ population of 17.1 million and high cervical cancer rates (3,515 cases and 1,858 deaths annually) from lack of national screening for cervical cancer.

Our Mexican distributor, Sunbird Medical has applied for access to the public hospital system to Cofepris, the national regulator. A decision is expected in FY2024, and if successful we expect TruScreen to be available to public hospitals and clinics.

Regulatory Compliance

The investment and transition of our regulatory processes to comply with the new Medical Device Regulation (MDR) is well advanced, for compliance by May 2024. Our China NMPA variation application was also advanced during the half year. The variation seeks approval for the latest Device software updates and recertification to the updated NMPA standards, and will further strengthen TruScreen’s position in the Chinese market.

Outlook

The results for the half year provide optimism for our commercial successes in China and other markets, while investing $332,000 (2022: $410,000) in non-recurring costs, in complying with the new MDR global processes and seeking approval from China’s NMPA for our device software updates. These costs will cease by end FY2024. At the August 2023 Annual General we indicated to shareholders that further growth funding is required to maintain the commercialisation momentum that we have generated over the past year.

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

Dr Beata Edling
Chief Executive Officer
[email protected]

Guy Robertson
Chief Financial Officer
[email protected]

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