On July 30, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for the first three months (April 1, 2021 – June 30, 2021) of the fiscal year 2021 (FY2021) ending March 31, 2022 (Press release, Astellas, JUL 30, 2021, View Source [SID1234585456]).
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1. Qualitative information on consolidated financial results for the first three months of FY2021 (1) Business performance
Revenue-Sales of XTANDI for the treatment of prostate cancer and Strategic products XOSPATA for the treatment of acute myeloid leukemia, PADCEV for the treatment of urothelial cancer and Evrenzo for the treatment of renal anemia increased as expected.
-Moreover, factors for the increase in sales in the first three months of FY2021 included the growth of sales of Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB"), and the sales of pharmacologic stress agent Lexiscan returning to pre-pandemic level which decreased mainly in the corresponding period of the previous fiscal year because of the impact of the spread of COVID-19.
-The sales growth of the products above offset the sales decrease mainly due to the termination of sales promotion activities for Celecox for the treatment of inflammation and pain, the transfer of manufacturing rights of Lipitor for the treatment of hypercholesterolemia, and the divestiture of Eligard for the treatment of prostate cancer.
As a result of the above, revenue in the first three months of FY2021 increased by 6.2% compared to those in the corresponding period of the previous fiscal year ("year-on-year") to ¥326.1 billion. Core operating profit/ Core profit-Gross profit increased by 6.7% year-on-year to ¥263.9 billion. The cost-to-revenue ratio fell by 0.4 percentage points year-on-year to 19.1%, mainly due to changes in product mix.-Selling, general and administrative expenses increased by 13.5% year-on-year to ¥137.1 billion.
The total amount increased due to the up-front investment to support CSP2021 initiatives (increase of Approx. ¥3.0 billion year-on-year), the increase of co-promotion fees associated with the growth of sales of XTANDI in the United States (increase of ¥3.0 billion year-on-year), the impact of the exchange rate (increase of ¥4.4 billion year-on-year), and moreover there was a one-off increase factor from the decrease of expenses for sales promotion activities and travel expenses due to the impact of the spread of COVID-19 in the corresponding period of the previous fiscal year (increase of Approx. ¥6.0 billion year-on-year). Excluding co-promotion fees associated with the growth of sales of XTANDI in the United States, selling, general and administrative expenses increased by 15.0% year-on-year to ¥102.6 billion.
-Research and development (R&D) expenses increased by 1.8% year-on-year to ¥58.3 billion. While there was a decrease in development expenses for fezolinetant, a selective neurokinin-3 receptor antagonist, for which patient enrollment in Phase III trials in the United States and Europe has been completed, the total amount increased mainly due to increases in development expenses for zolbetuximab, an anti-Claudin 18.2 monoclonal antibody and R&D investment for 3 Primary Focus, such as genetic regulation, cell therapy and immuno-oncology.-Amortisation of intangible assets increased by 1.8% year-on-year to ¥6.0 billion.
As a result of the above, core operating profit decreased by 0.9% year-on-year to ¥62.8 billion, and core profit decreased by 5.3% year-on-year to ¥49.2 billion. Impact of exchange rate on financial results The exchange rates for the yen in the first three months of FY2021 are shown in the table below. The resulting impacts were a ¥13.6 billion increase in revenue and a ¥6.1 billion increase in core operating profit compared with if the exchange rates of the first three months of FY2020 were applied.