SUSMED,Inc.

Business Details

A segment developing therapeutic apps (Software as a Medical Device) that address unmet medical needs. The segment holds multiple pipelines including the App for Insomnia Disorder as its flagship, as well as apps for tinnitus, PMS, and an ACP App for Advanced Cancer Patients. The revenue model consists of milestone income based on partnership agreements with pharmaceutical companies and royalties following product launch. Currently, there are no products at the sales stage, and all revenue depends on temporary income such as milestones.

Recent Overview

Milestone income declined significantly year-on-year, resulting in a segment loss.

DTx Product Business revenue for the cumulative third quarter of FY2026 (ending June 2026) was ¥100 million (down 44.9% from ¥300 million in the same period of the prior year). While the prior-year period included milestone income of ¥300,000 thousand under the agreement with Aska Pharmaceutical, the current period recorded only ¥100,000 thousand in milestone income from Aska Pharmaceutical. As a result, segment profit/loss fell from a profit of ¥172 million in the same period of the prior year to a loss of ¥56 million. On the other hand, pipeline development continues to progress, including the commencement of a confirmatory trial for the App for Tinnitus Treatment and progress in preparations for insurance listing of the App for Insomnia Disorder.

Key Products

Growth Drivers

• Receipt of future milestone income (up to ¥4.1 billion in total) based on the sales partnership agreement with Shionogi & Co., Ltd., following confirmation of insurance points and realization of insurance listing and product launch for the App for Insomnia Disorder
• Expected receipt of future development-stage milestone income (up to ¥2.3 billion in total) under the PMS app agreement with Aska Pharmaceutical
• Commencement of the confirmatory trial for the App for Tinnitus Treatment and increased milestone terms due to the addition of the Company's role under the signed memorandum
• Generation of future milestones through progress in clinical trials across multiple pipelines (ACP, renal rehabilitation, dizziness)
• Promotion of social implementation of the ACP app through the joint industry-academia course established with The Jikei University School of Medicine

Risks

• The insurance points for the App for Insomnia Disorder have not yet been determined, making the timing and level of insurance listing uncertain, and therefore full-year earnings forecasts cannot be disclosed
• There are currently zero products at the sales stage, and milestone income depends on the progress of contracts with pharmaceutical companies, resulting in a temporary and irregular revenue structure
• Operating cash flow has remained negative on a continuing basis, and impairment losses continue to be recorded on company-wide assets (¥2,510 thousand in the cumulative third quarter period)
• Risk that clinical trials for multiple pipelines may fail to obtain approval, or that sufficient insurance points may not be obtained even after approval
• Customer concentration risk, with the majority of revenue dependent on contracts with a single or small number of pharmaceutical companies (in the cumulative third quarter period, milestone income from Aska Pharmaceutical alone accounted for 100% of business revenue)