MIZUHO MEDY CO.,LTD.

Business Details

A single-segment business that plans, develops, manufactures, and sells immunochromatographic infectious disease test kits and gene POCT testing systems for hospitals and physicians in private practice. In the first quarter of FY2026 (ending December 2026), of the ¥2,208 million in net sales, the hospital/physician field accounted for ¥2,114 million (95.7%), with COVID-19 test kits (¥1,317 million) and influenza test kits as the mainstay products. Sales are primarily indirect through pharmaceutical wholesalers. The OTC and other field (pregnancy and ovulation test kits) accounted for ¥93 million (4.2%).

Recent Overview

In the first quarter of FY2026 (ending December 2026), both sales and profit declined sharply year on year

Net sales for the first quarter (January–March) of FY2026 (ending December 2026) were ¥2,208 million (down 16.7% year on year), and operating profit was ¥759 million (down 32.3%). The main cause was a significant decline in the scale of the winter COVID-19 outbreak compared to the prior year, which led to a sharp drop in shipments of the gene test kit (Smart Gene SARS-CoV-2) to approximately 14,000 tests (versus approximately 50,000 tests in the same period of the prior year). On the other hand, due to increased demand for combination testing amid the resurgence of influenza B in February 2026, shipments of the CoV/Flu combination test kit increased to approximately 1.75 million tests (versus approximately 1.67 million tests in the same period of the prior year). Because a foreign exchange gain of ¥30 million was recorded as non-operating income, the decline in ordinary profit (down 22.6%) was smaller than the decline in operating profit (down 32.3%). There has been no change to the full-year earnings forecast (net sales of ¥11,428 million, operating profit of ¥4,414 million), and the full-year dividend forecast of ¥100 per share (unchanged from the prior year) has also been maintained.

Key Products

Growth Drivers

• Continued demand for CoV/Flu combination test kits: Amid growing need for simultaneous outbreaks and differentiation between influenza and COVID-19, shipments of the CoV/Flu combination test kit maintained an increasing trend, reaching approximately 1.75 million tests in the first quarter of FY2026 (ending December 2026), versus approximately 1.67 million tests in the same period of the prior year
• Expansion of test items in the Smart Gene series: A robust new product pipeline is in place, including preparations for the launch of H.pylori S (manufacturing and marketing approval obtained in June 2025), the Bordetella pertussis nucleic acid kit awaiting approval, and preparations for the launch of the carbapenemase detection kit "Quick Chaser CARBA RESIST-6 RUO" in the first half of 2026
• Cumulative installed base of 5,900 Smart Gene units: Stable demand for dedicated reagents (such as H.pylori G) is expanding as the device becomes more widely adopted. Enhancement of device value through the addition of new test items is boosting reagent demand
• Recovery in the OTC field: Pregnancy test kits and ovulation test kits achieved sales growth amid changes in the market environment, recording ¥93 million in the first quarter of FY2026 (ending December 2026), up 12.2% year on year
• Development of next-generation gene POCT devices: The company is advancing further reductions in measurement time and development of a gene multiplex testing system, aiming to strengthen medium- to long-term product competitiveness
• Full-year earnings forecast maintained at net sales of ¥11,428 million (up 1.5% year on year): Demand recovery is expected for the infectious disease season from the second quarter onward

Risks

• Uncertainty in the scale of infectious disease outbreaks: The scale of the winter COVID-19 outbreak was smaller than in the prior year, causing net sales for the first quarter of FY2026 (ending December 2026) to decline sharply by 16.7% year on year. The risk of quarterly results fluctuating significantly depending on the timing and scale of infectious disease outbreaks continues
• Continued shift from gene test kits to antigen test kits: Shipments of Smart Gene SARS-CoV-2 fell sharply to approximately 14,000 tests (versus approximately 50,000 tests in the same period of the prior year). Shrinking demand for the high-margin gene test kits pushed down the operating margin (34.4% in the first quarter, versus 42.4% in the same period of the prior year)
• Dependence on COVID-19 test kits: COVID-19 test kit sales in the first quarter of FY2026 (ending December 2026) accounted for ¥1,317 million (59.6% of net sales), posing a risk that a decline in the outbreak scale or changes in testing systems for this disease will directly affect business results
• Fluctuations in the outbreak scale of other infectious disease items: The RSV/human metapneumovirus antigen combination detection kit, Mycoplasma pneumoniae, and other items did not experience outbreaks as large as in the prior year, causing sales of other test kits and instruments to decline sharply by 32.8% year on year
• Foreign exchange risk: While a foreign exchange gain of ¥30 million was recorded in the first quarter of FY2026 (ending December 2026) due to the period-end revaluation of foreign-currency-denominated assets, there remains a risk that sharp fluctuations in exchange rates could significantly affect profit and loss
• Risk of seasonal sales concentration: Sales continue to be concentrated in the infectious disease season (autumn/winter), with the progress rate for the first quarter (January–March) against the full-year forecast standing at only 19.3%