PCK.ASX: Quarterly Activities/Appendix 4C Cash Flow Report

Quarterly Activities/Appendix 4C Cash Flow Report

Stock	Painchek Ltd (PCK.ASX)
Release Time	31 Jan 2025, 8:24 a.m.
Price Sensitive	Yes

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PainChek reports quarterly update, FDA clearance on track

Key Points

US FDA De Novo regulatory clearance submission, final decision expected by May 2025
Global 100,000 contracted licences with an ARR of $4.8M once fully implemented
Positive results from PainChek® Infant Early Access Programme, app now available on Apple App Store

Full Summary

PainChek Ltd has reported its quarterly activities and cashflow report for the quarter ended 31 December 2024. Key highlights include the submission of the PainChek Adult App to the US FDA for De Novo regulatory clearance, which is expected to provide the basis for expansion into the US market. The company has 100,000 contracted licences globally with an ARR of $4.8M once fully implemented, representing a 22% increase on the prior year. Implemented licences reached 68,458 with an ARR of $3.3M, an 18% increase on the prior year and 11% increase from the previous quarter. The company continues to gain new clients and retain long-term customers, with over 50% of existing implemented customers using PainChek for over 3 years. The company also reported positive results from the PainChek® Infant Early Access Programme, with the Infant App now available on the Apple App Store to drive greater recruitment. The company has engaged with direct-to-consumer marketing specialists and channel partners to support the upcoming Infant App launch in Q2 CY2025. Other highlights include the commencement of a trial at the Royal Edinburgh hospital in the UK, and the expansion into the home care and disability sectors in Australia.

Guidance

The company expects to receive FDA clearance for the PainChek Adult App in the first half of 2025, which could provide a potential value of $100 million USD per annum in the US aged care market alone.

Outlook

In 2025, the company plans to build on the existing 100,000+ commercial licences in the aged care sector by expanding into the new and larger home care and hospital markets, driven by new local and international government policies. The company also expects to launch the PainChek Infant App for the direct-to-consumer (parental) market in the second quarter of CY2025.