Expanding revenue from core products and strengthening the product portfolio

「Since its launch, Izcargo® for IV infusion 10 mg has been steadily penetrating the market, generating a ¥1,047 million increase in sales, or 18.3%, from the previous fiscal year.」

「In the sales business, a supply problem arose at a competitor for the core product Growject® in fiscal 2023. The production division responded by making bold and rapid changes to its manufacturing plan and increasing production, while the sales division coordinated its activities accordingly and fulfilled its obligation to ensure a stable supply as an alternative product. As a result, Growject® sales expanded to approximately 1.5 times their previous level, and the company has maintained a high market share in the current fiscal year. For Izcargo®, sales have continued to grow as the entire company has worked to build an evidence base and provide information.」

「Sales of the recombinant natural human growth hormone preparation Growject® increased despite a drug price revision in April 2024, as sales volume rose substantially. Izcargo® for IV infusion 10 mg also performed well, but product sales were approximately unchanged from the same period a year earlier due partly to lower sales of the renal anemia treatment.」

「In fiscal 2023, sales of the company's core product, the recombinant natural human growth hormone preparation Growject®, increased substantially, achieving the leading share of Japan's growth hormone market. In addition, the company began joint promotion in Japan with Sumitomo Pharma Co., Ltd. for Izcargo®, a recombinant treatment for mucopolysaccharidosis type II, in April 2023, which contributed to sales growth.」

「Growject® 9,320 13,995 50.1 Izcargo® for IV infusion 3,380 4,046 19.7 Contract revenue 5,010 7,112 42.0」

「Revenue was ¥24.272 billion, up 55.8% year on year. Although the recombinant natural human growth hormone formulation 「グロウジェクト®」 was subject to a drug price revision in April 2023, sales volumes increased significantly. Renal anemia treatments and 「イズカーゴ®点滴静注用10mg」 also performed well.」

「Although the recombinant natural human growth hormone formulation 「グロウジェクト®」 and renal anemia treatments were subject to a drug price revision in April 2023, sales volumes increased significantly, and 「イズカーゴ®点滴静注用10mg」 also performed well.」

「Since its launch, 「イズカーゴ®点滴静注用10mg」 has steadily penetrated the market, generating an increase in revenue of ¥1.424 billion, or 47.4%, from the previous fiscal year. Revenue is expected to continue increasing in the fiscal year ending March 2024.」

「Sales volumes of the recombinant natural human growth hormone formulation 「グロウジェクト®」 increased, but revenue was affected by the drug price revision in April 2022. Although renal anemia treatments, which were also subject to a drug price revision, recorded a significant decline in revenue, combined revenue from core products was at the same level as the previous year, helped by the substantial contribution from 「イズカーゴ®点滴静注用10mg」, listed for reimbursement in May 2021.」

「Although renal anemia treatments, which were also subject to a drug price revision, recorded a significant decline in revenue, combined revenue from core products was at the same level as the previous year, helped by the substantial contribution from 「イズカーゴ®点滴静注用10mg」, listed for reimbursement in May 2021.」

「Sales volumes of the recombinant natural human growth hormone formulation 「グロウジェクト®」 increased, but revenue was affected by the drug price revision in April 2022. Although renal anemia treatments, which were also subject to a drug price revision, recorded a significant decline in revenue, combined revenue from core products exceeded the previous-year level, helped by the substantial contribution from 「イズカーゴ®点滴静注用10mg」, listed for reimbursement in May 2021. Outside the core products, contract revenue increased, but total revenue declined year on year, mainly because the Company completed as scheduled its contract manufacturing of AstraZeneca’s COVID-19 vaccine drug substance in Japan.」

「Since its launch in May 2021, 「イズカーゴ®点滴静注用10mg」 has steadily penetrated the market and generated revenue above the initial forecast. Revenue is also expected to increase in the fiscal year ending March 2023.」

「Sales volumes of the recombinant natural human growth hormone formulation 「グロウジェクト®」 increased and revenue remained solid despite the drug price revision in April 2021. Although renal anemia treatments, which were also subject to a drug price revision, recorded a significant decline in revenue, combined revenue from core products exceeded the previous-year level, helped by the substantial contribution from 「イズカーゴ®点滴静注用10mg」, which was listed for reimbursement in May 2021.」

「Combined revenue from core products exceeded the previous-year level. Factors included the launch in May 2021 of 「イズカーゴ®点滴静注用10mg」, which was listed for reimbursement, and higher sales volumes of the recombinant natural human growth hormone formulation 「グロウジェクト®」 despite the drug price revision in April 2021.」

「Revenue was ¥9.813 billion, up 89.4% year on year. Sales of the core product recombinant natural human growth hormone formulation 「グロウジェクト®」 and other products exceeded the previous-year level as sales volumes increased, despite the drug price revision in April 2021. Total revenue also increased year on year, driven by the start of sales in March 2021 of AstraZeneca’s COVID-19 vaccine drug substance and the launch in May 2021 of 「イズカーゴ®点滴静注用10mg」, which was listed for reimbursement.」

「Revenue from the human growth hormone formulation 「グロウジェクト®」 exceeded the previous fiscal year as sales volumes increased, despite the drug price revision in April 2020.」

「「グロウジェクト®」 9,606 10,011 4.2 Regenerative medicine product 「テムセル®HS注」 2,347 1,656 △29.4 「エポエチンアルファBS注『JCR』」 3,791 2,598 △17.3 「ダルベポエチンアルファBS注『JCR』」 649 3,027 366.1 「アガルシダーゼベータBS点滴静注『JCR』」 213 346 62.7 Contract revenue 1,002 1,772 76.9」

「Revenue from core products including the recombinant natural human growth hormone formulation 「グロウジェクト®」 exceeded the previous-year level as sales volumes increased, despite the drug price revision in April 2020.」

「Despite a drug price revision in April 2020, revenue increased as sales volumes of core products grew.」

「Revenue from the core product human growth hormone formulation 「グロウジェクト®」 increased by ¥672 million, or 5.6%, year on year, due to market penetration of the liquid formulation and stronger promotional activities.」

「In terms of sales, revenue from the core product recombinant natural human growth hormone formulation 「グロウジェクト®」 increased with higher sales volume to ¥9.606 billion, up ¥555 million year on year. Revenue from the regenerative medicine product 「テムセル®HS注」 also grew steadily to ¥2.347 billion, up ¥793 million. The Fabry disease treatment 「アガルシダーゼベータBS点滴静注JCR」, launched in November of the year before last, recorded revenue of ¥213 million. In addition, sales of the jointly developed long-acting erythropoiesis-stimulating agent darbepoetin alfa BS injection 「JCR」 began in November of the previous year, generating revenue of ¥649 million.」

「On 20 September, the Company obtained marketing approval for the long-acting erythropoiesis-stimulating agent darbepoetin alfa BS injection 「JCR」, jointly developed with キッセイ薬品工業株式会社.」

「In terms of sales, revenue from the core product recombinant natural human growth hormone formulation 「グロウジェクト®」 increased with higher sales volume to ¥3.143 billion, up ¥254 million year on year. Revenue from 「エポエチンアルファBS注JCR」 and 「テムセル®HS注」 also grew steadily to ¥1.193 billion, up ¥80 million, and ¥712 million, up ¥169 million, respectively. The Fabry disease treatment 「アガルシダーゼベータBS点滴静注JCR」, launched in November of the previous year, recorded revenue of ¥65 million, bringing total Group revenue to ¥5.155 billion, up ¥477 million year on year.」

「Revenue from the core product 「グロウジェクト®」 continued to grow steadily, supported by detailed regional marketing and the effect of the liquid formulation launched in January of the previous year, reaching ¥11.978 billion, up ¥483 million from the previous fiscal year. 「エポエチンアルファBS注JCR」 and 「テムセル®HS注」 also performed steadily, and contract revenue increased, bringing pharmaceuticals business revenue to ¥22.887 billion, up ¥2.709 billion from the previous fiscal year.」

「In terms of sales, despite a reduction in the drug price, revenue from the core product recombinant natural human growth hormone formulation 「グロウジェクト®」 increased with higher sales volume to ¥9.051 billion, up ¥275 million year on year. Revenue from 「エポエチンアルファBS注JCR」 and 「テムセル®HS注」 also grew steadily to ¥3.462 billion, up ¥289 million, and ¥1.554 billion, up ¥440 million, respectively. In November of the previous year, the Company began selling 「アガルシダーゼ　ベータBS点滴静注『JCR』」 (development code: JR-051), an enzyme replacement therapy for Fabry disease and Japan’s first domestically produced treatment for a lysosomal disease, recording revenue of ¥40 million.」

「In terms of sales, despite a reduction in the drug price, revenue from the core product recombinant natural human growth hormone formulation 「グロウジェクト®」 increased with higher sales volume to ¥5.845 billion, up ¥243 million year on year. Revenue from the recombinant human erythropoietin formulation 「エポエチンアルファBS注JCR」 and regenerative medicine product 「テムセル®HS注」 also grew steadily to ¥2.166 billion, up ¥68 million, and ¥989 million, up ¥403 million, respectively.」

「In terms of sales, despite a reduction in the drug price, revenue from the core product recombinant natural human growth hormone formulation 「グロウジェクト®」 increased with higher sales volume to ¥2.888 billion, up ¥150 million year on year. Revenue from the regenerative medicine product 「テムセル®HS注」 also grew steadily to ¥543 million, up ¥271 million. Meanwhile, although sales volume of the recombinant human erythropoietin formulation 「エポエチンアルファBS注JCR」 increased, revenue declined to ¥1.113 billion, down ¥75 million year on year.」

「In terms of sales, revenue from the core product recombinant natural human growth hormone formulation 「グロウジェクト®」 continued to grow, helped by the liquid formulation 「グロウジェクト®皮下注6mg・12mg」 and its dedicated injector 「グロウジェクター®L」, launched in January of the previous year. The recombinant human erythropoietin formulation 「エポエチンアルファBS注JCR」 and regenerative medicine product 「テムセル®HS注」 also performed steadily, and all 3 core products generated higher revenue than in the previous fiscal year.」

「Revenue from the core products 「グロウジェクト®」, 「エポエチンアルファBS注JCR」 and 「テムセル®HS注」 was ¥8.775 billion, up ¥917 million year on year; ¥3.173 billion, up ¥334 million; and ¥1.113 billion, up ¥617 million, respectively. Contract revenue of ¥1.625 billion, up ¥815 million, was also recorded, bringing pharmaceuticals business revenue to ¥14.915 billion, up ¥2.125 billion year on year.」

「The core product recombinant natural human growth hormone formulation 「グロウジェクト®」 continued to grow in revenue, helped by the liquid formulation 「グロウジェクト®皮下注6mg・12mg」 and its dedicated injector 「グロウジェクター®L」, both launched in January. The recombinant human erythropoietin formulation 「エポエチンアルファBS注JCR」 and regenerative medicine product 「テムセル®HS注」 also performed steadily, and all 3 core products generated higher revenue year on year.」

「The core product recombinant natural human growth hormone formulation 「グロウジェクト®」 continued to grow in revenue, helped by the liquid formulation 「グロウジェクト®皮下注6mg・12mg」 and its dedicated injector 「グロウジェクター®L」, both launched in January. The recombinant human erythropoietin formulation 「エポエチンアルファBS注JCR」 and regenerative medicine product 「テムセル®HS注」 also performed steadily, and all 3 core products generated higher revenue year on year.」

「In January, the Company launched the highly anticipated liquid formulation 「グロウジェクト®皮下注6mg・12mg」, which does not require reconstitution, together with its dedicated injector 「グロウジェクター®L」. New adoptions and prescriptions have increased, including among users who had previously been cautious about using electric injectors. Since its launch, sales of 「エポエチンアルファBS注JCR」 have grown steadily, and the product maintains a volume-based share of more than 60% among short-acting erythropoietin formulations used to treat renal anemia during dialysis.」

「Revenue from both core products, 「グロウジェクト®」 and 「エポエチンアルファBS注JCR」, increased to ¥7.858 billion, up ¥236 million year on year, and ¥2.839 billion, up ¥94 million, respectively.」

「In terms of sales, volumes of the core product recombinant natural human growth hormone formulation 「グロウジェクト®」 grew steadily, absorbing the impact of the drug price reduction and driving revenue growth. The recombinant human erythropoietin formulation for the treatment of renal anemia, 「エポエチンアルファBS注JCR」, and the regenerative medicine product 「テムセル®HS注」, launched in February, also performed steadily, exceeding the initial plan. On 8 August, the Company obtained marketing approval for the liquid formulation 「グロウジェクト®皮下注」 as a new dosage form of the core product recombinant natural human growth hormone formulation 「グロウジェクト®」.」

「In the pharmaceuticals business, although sales were affected by the reduction in drug prices in April, sales volumes of both core products, 「グロウジェクト®」 and 「エポエチンアルファBS注JCR」, continued to grow steadily from the previous fiscal year. Revenue was ¥2.570 billion and ¥978 million, respectively, up ¥183 million and ¥1 million year on year. The regenerative medicine product 「テムセル®HS注」, launched in February, also contributed to revenue. However, revenue from urine-derived products and active pharmaceutical ingredients for anticancer drugs declined year on year, resulting in pharmaceuticals business revenue of ¥3.677 billion, down ¥368 million year on year.」

「Since sales began in 1993, the existing product 「グロウジェクト®」 has been developed and supplied with additional indications and easier-to-use injection devices, with improving patients’ quality of life as the first priority. This year, the Company expects to launch a liquid formulation that does not require reconstitution, and intends to achieve further growth through synergies with the existing formulation. Sales of 「エポエチンアルファBS注JCR」 have been growing steadily, and the Company intends to further expand its share, supported by policies promoting the adoption of biosimilars. In 2019, the Company launched the biosimilar of the next-generation drug darbepoetin alfa (development code: JR-131), and will pursue a business strategy aimed at maximizing the benefits of each product.」