SUSMED,Inc. Q4 FY2025 earnings call

Corporate Vision & Core Platforms

• Mission is to achieve "Sustainable Medicine" via ICT-enabled digital healthcare, with three core technology platforms:
  • QDTx: Therapeutic app development platform that enables parallel development of multiple pipelines with a small, lean team, and supports efficient co-development with external pharmaceutical partners
  • SUSMED SourceDataSync (SDS): Blockchain-powered clinical trial system that automates regulatory compliance work to reduce costs and improve efficiency for internal development and external pharmaceutical/medical device clients
  • Awesome Intelligence: Machine learning automated analysis system for aggregated post-launch real-world medical big data, currently used in joint projects with pharmaceutical wholesalers and diagnostic device algorithm development

Pipeline Development Progress

• Lead insomnia disorder therapeutic app received partial change approval from Japan's Ministry of Health, Labour and Welfare (MHLW), with insurance listing procedures now in progress; Shionogi & Co. is collaborating on post-listing commercial planning
• Multiple late and early-stage pipelines are progressing as planned:
  • Joint specific clinical research for tinnitus therapeutic app with Kyorin Pharmaceutical has been completed with positive results, which will be presented at an academic conference in October 2025
  • Joint PMS/PMDD (obstetrics and gynecology indication) therapeutic app development with Asuka Pharmaceutical: specific clinical research started in January 2025, first patient enrolled in February 2025, with a 0.1 billion yen milestone payment recognized in Q3 revenue
  • Corporate clinical trial for recurrent/progressive cancer patient therapeutic app initiated in April 2025
  • Clinical research for vertigo therapeutic app continues in partnership with Niigata University
  • Diagnostic program medical device development is also ongoing

Platform Business Operational Progress

• SDS clinical trial system has been launched for use in an investigator-initiated antibody drug trial at the National Center of Neurology and Psychiatry, adding to existing active trial deployments
• A blockchain-powered venous disease registry system for real-world data collection has been launched, expanding SDS use cases beyond traditional clinical trials

DTx Product Segment: Total revenue of 0.3 billion yen, segment profit of 118 million yen, contributing 65% of total company revenue. DTx Platform Segment (includes clinical trial systems and related services): Total revenue of 162 million yen, segment profit of 33 million yen, contributing 35% of total company revenue.

• For the 2026 June fiscal year, the top priority is to complete insurance listing for the insomnia therapeutic app and initiate commercial sales
• Full earnings guidance for 2026 June fiscal year is not provided at this time, as insurance pricing and final listing timing remain unconfirmed
• Management will continue advancing multiple pipeline development, targeting trial initiations, study completions, and result publication for ongoing programs
• The DTx platform business will focus on expanding active deployment track records to drive revenue growth
• Management confirms the company's financial position remains strong, with 4.4 billion yen in cash and cash equivalents at period end, and no immediate need for additional capital raising

• No explicit material operational or financial risks were disclosed in the available transcript. The primary uncertainty is the unconfirmed timeline and final pricing outcome for the insomnia therapeutic app's Japanese national health insurance listing

Q: The prior insomnia app insurance listing application was withdrawn because it was framed as supporting in-person CBT-I, which did not receive insurance approval. Has the revised application addressed this barrier, and what are the remaining hurdles to insurance listing?

A: The 2024 Japanese medical fee revision changed the insurance evaluation framework for program medical devices, moving from a technical fee model to evaluating the device itself as a specific insurance medical material. The revised application frames the app as a standalone insomnia treatment, rather than an adjunct to in-person CBT-I, and includes comparator data vs. traditional sleep medications that was not included in prior submissions. Partial change approval has already been granted, and the application now aligns with the new regulatory framework, resolving the core barrier from the prior attempt.