Kissei Pharmaceutical's operating profit recovered to ¥1.69bn in the six months to September 2026, against a loss of ¥6.84bn a year earlier, but net profit attributable to owners of the parent fell 33.3% to ¥5.19bn from ¥7.78bn. Sales were ¥45.50bn, down 0.7%. The gap between the two lines is special losses on assets tied to the company's treatment for microscopic polyangiitis and granulomatosis with polyangiitis.
Where the profit went
Ordinary profit was ¥2.92bn, compared with a ¥5.62bn loss. Kissei's interim earnings summary attributes the return to profit mainly to a drop in R&D spending after last year's expense for in-licensed technology; the supplementary briefing puts R&D at ¥7.31bn, from ¥16.33bn. The cost-of-sales ratio rose, which Kissei ties to lower sales of the drug and of technology fees.
Special losses were ¥4.31bn, against ¥166mn a year earlier. They include a ¥2.16bn impairment of long-term prepaid expenses and a ¥2.13bn inventory valuation loss. Special gains of ¥8.06bn, including ¥8.04bn from investment securities sales, cushioned the result but were smaller than the ¥15.20bn of the prior-year half.
| Item | Prior year | Current year |
|---|---|---|
| Sales | 45,831 | 45,503 |
| Operating profit (loss) | -6,837 | 1,694 |
| Ordinary profit (loss) | -5,622 | 2,923 |
| Special losses | 166 | 4,313 |
| Net profit attributable to owners of parent | 7,784 | 5,191 |
Why the assets were written down
Kissei says it booked the losses on assets tied to the drug, mainly inventory and long-term prepaid expenses, because administrative procedures including cancellation of the marketing approval are being advanced. The segment note says the impairment rests on an accounting estimate made on that premise.
The chronology Kissei reports runs as follows. From 15 May 2026 it began information activities urging cautious prescribing. On 21 May it revised the Japanese package insert for severe liver dysfunction and issued a safety bulletin (a blue letter). Kissei also received, and has answered, a reporting order from the health minister seeking fact-finding on the reliability of international phase III trial data, which has been questioned in the US and Europe, and on the drug's safety.
At the Pharmaceutical Affairs Council's second drug committee on 21 October, the health ministry's review of Kissei's answer was reported. According to Kissei, the committee confirmed that the reliability of materials submitted at approval review may be problematic and that it is difficult to judge that the drug's benefit outweighs its risks. It also noted that the disease is serious and rare, so treatment changes for current patients should be judged case by case. The ministry then issued a notice the same day asking medical institutions, for the time being, to follow specified handling of the drug.
Kissei's earnings release does not say the approval has been cancelled or when that might happen. It describes cancellation as part of procedures under way.
Guidance: operating up, net profit down
Sales of the drug were ¥3.14bn in the half, down 44.0%. The supplementary briefing shows a full-year forecast for the drug of ¥3.7bn, down 67.9%.
For the year to March 2027, Kissei raised its sales forecast by ¥300mn to ¥89.0bn. It cut its outlook for the drug by ¥1.5bn and added ¥1.8bn elsewhere, mainly from information services orders. Operating profit is now guided to ¥2.5bn and ordinary profit to ¥4.4bn, up ¥500mn and ¥400mn from the July guide. Net profit is guided to ¥10.0bn, down ¥3.3bn from July and 27.4% lower than the prior year.
Kissei attributes the net cut to the interim special losses. Full-year special items are still planned at ¥14.0bn, as originally guided, with ¥6.0bn of investment securities sale gains expected in the second half. The dividend forecast is unchanged: ¥105 at the interim stage, including a ¥40 80th-anniversary payment, and ¥65 at year-end, for ¥170 in total.