Sales volatility and supply shortages due to a limited range of indications

「For congenital giant pigmented nevus and epidermolysis bullosa, orders declined as treatment for eligible patients had largely run its course, but the company will evaluate treatment outcomes and promote initiatives aimed at wider adoption.」

「Sales in the regenerative medicine products business for the six months ended the interim period amounted to ¥633.552 million, down 14.8% year on year, mainly due to a decline in orders for JACE, the autologous cultured epidermis product. In burns, orders declined in the first quarter as the increase in the cancellation rate had an impact. For congenital giant pigmented nevus, orders declined as the number of patients eligible for the new combination therapy had largely run its course.」

「Sales in the ophthalmology and other businesses for the cumulative period amounted to ¥100.520 million, down 2.8% year on year. Sales in ophthalmology had expanded following the launch of Ocural after Nepic, but orders at key facilities have slowed somewhat as transplantation for patients eligible for Ocural has largely run its course.」

「JACE sales for the cumulative period amounted to ¥588.106 million, down 23.5% year on year. The number of patients with severe burns remained lower than expected. In addition, sales for congenital giant pigmented nevus and epidermolysis bullosa declined from the same period of the previous year because treatment of patients on waiting lists had largely run its course and patients reduced hospital visits due to COVID-19.」

「For congenital giant pigmented nevus and epidermolysis bullosa, sales declined from the same period of the previous year due to the completion of treatment for patients on waiting lists and severely ill patients, as well as treatment cancellations caused by the seventh wave of COVID-19.」

「JACE sales for the cumulative period amounted to ¥174.948 million, down 21.2% year on year. Sales declined from the same period of the previous year due to the high number of transplant cancellations caused by patient deaths in severe burns, as well as the completion of treatment for patients on the waiting list and severely ill patients with congenital giant pigmented nevus and epidermolysis bullosa.」

「JACC sales for the six months ended the second quarter amounted to ¥175.222 million, down 4.7% year on year. It took time to expand orders from some existing facilities, resulting in an overall decline in sales from the same period of the previous year.」

「JACC sales for the nine months ended the third quarter amounted to ¥260.395 million, down 15.2% year on year. As the company continued to be forced to refrain from visiting medical institutions and conducting sales activities at new facilities, it worked to raise awareness of JACC and provide information on the usefulness of its collagen membrane through new sales methods, including physician seminars held using online tools. However, sales declined year on year as the COVID-19 pandemic led patients to avoid or postpone non-urgent surgeries and restrictions on sports reduced the number of affected patients.」

「JACE sales for the fiscal year amounted to ¥914.391 million, down 11.4% year on year. Orders did not grow because the number of severe burns was low. Sales for congenital giant pigmented nevus declined substantially as treatment of patients on the waiting list had largely run its course.」

「JACE sales for the nine months ended the third quarter amounted to ¥634.284 million, down 9.0% year on year. The product for epidermolysis bullosa, which was listed for insurance coverage in July, got off to a smooth start and secured orders. However, in addition to the low number of severe burns, the decline in sales for congenital giant pigmented nevus resulting from the completion of treatment for patients on the waiting list had a significant impact, and overall JACE sales declined from the same period of the previous year.」

「JACE sales for the six months ended the second quarter amounted to ¥423.119 million, down 11.3% year on year. Preparations for the smooth launch of the product for epidermolysis bullosa, which was listed for insurance coverage in July, progressed well and orders were secured. However, sales for severe burns remained broadly flat from the same period of the previous year, while sales for congenital giant pigmented nevus declined more than expected because treatment of patients on the waiting list had largely run its course. Overall JACE sales declined from the same period of the previous year.」

「JACE sales for the fiscal year amounted to ¥1,031.525 million, down 4.4% year on year. JACE for severe burns struggled through the first three quarters as the number of severe burns remained low, but sales in the fourth quarter substantially exceeded those of the same quarter of the previous year.」

「Sales declined year on year, largely because the number of severe burns remained low after the start of the current fiscal year. For congenital giant pigmented nevus, orders were secured steadily, partly as a result of intensified sales activities at key facilities, but sales declined compared with the same period of the previous year, when demand from patients on the waiting list was concentrated shortly after the product was launched.」

「This product is indicated for the treatment of severe burns, specifically extensive severe burns where sufficient donor skin cannot be secured for autologous skin grafting and where the combined area of deep second-degree and third-degree burn wounds accounts for at least 30% of the body surface area. As a result, the market size is extremely limited.」