Otsuka Holdings (4578.T): Final Phase 3 results for Voyxaxt - exceptional event suppression of 97.1%, somewhat positive

Otsuka issued a press release disclosing the final Phase 3 trial results for Voyxact at the American Society of Nephrology. It had already announced the renal function improvement effects in August, but has now disclosed data for the first time on composite renal events during the trial, including renal function decline and renal failure. Voyxact delivered 97.1% event suppression relative to placebo, so events were almost entirely suppressed, which we consider an impressive result. The company also completed its data submission to the FDA on October 6, with approval expected by April 2027 at the earliest. Since the main data had already come out in August, we judge this to be slightly positive, and we will be watching the battle for market share with competing drugs. We remain bullish with a Buy rating and a target price of ¥18,600 (price ¥12,395), implying 50.1% expected share price return and 51.7% expected total return. Our target price is derived from a 10-year DCF using a 2% risk-