Posted Financial Results for 2Q/FY2021

On October 29, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for the first six months (April 1, 2021 – September 30, 2021) of the fiscal year 2021 (FY2021) ending March 31, 2022 (Press release, Astellas, OCT 29, 2021, View Source [SID1234592166]).

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1. Qualitative information on consolidated financial results for the first six months of FY2021
(1) Business performance
Consolidated financial results (core basis) in the first six months of FY2021 are shown in the table below. While revenue increased, core operating profit and core profit decreased.

Revenue
-Main products XTANDI for the treatment of prostate cancer, XOSPATA for the treatment of acute myeloid leukemia and PADCEV for the treatment of urothelial cancer showed steady growth as expected. In addition, the sales growth of EVRENZO for the treatment of renal anemia and Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB") contributed to revenue as well.
-Moreover, other factor for the increase in sales in the first six months of FY2021 was the sales of pharmacologic stress agent Lexiscan returning to pre-pandemic level which decreased mainly in the first quarter 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 and distribution for Celecox for the treatment of inflammation and pain and 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 six months of FY2021 increased by 5.9% compared to those in the corresponding period of the previous fiscal year ("year-on-year") to ¥651.7 billion.

Core operating profit / Core profit
-Gross profit increased by 6.3% year-on-year to ¥526.9 billion. The cost-to-revenue ratio fell by 0.3 percentage points year-on-year to 19.1%, mainly due to changes in product mix
.-Selling, general and administrative expenses increased by 11.7% year-on-year to ¥270.5 billion. The total amount increased mainly due to the increase of copromotion fees associated with the growth of sales of XTANDI in the United States (increase of ¥10.2 billion year-on-year), investment in systems associated with globalization (increase of approximately ¥5.0 billion year-on-year), the increase in sales promotion expenses for new product launch readiness (increase of approximately ¥3.0 billion year-on-year), and the impact of the foreign exchange rates (increase of ¥8.4 billion year-on-year).

Excluding co-promotion fees of XTANDI in the United States, selling, general and administrative expenses increased by 10.0% year-on-year to ¥199.4 billion.-Research and development (R&D) expenses increased by 6.6% year-on-year to ¥119.1 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 Rx+ business (related to iota).

-Amortisation of intangible assets increased by 7.2% year-on-year to ¥12.4 billion. 3

As a result of the above, core operating profit decreased by 3.8% year-on-year to ¥125.3 billion, and core profit decreased by 7.0% year-on-year to ¥98.8 billion.

Impact of exchange rate on financial results
The exchange rates for the yen in the first six months of FY2021 are shown in the table below. The resulting impacts were a ¥24.5 billion increase in revenue and a ¥11.5 billion increase in core operating profit compared with if the exchange rates of the first six months of FY2020 were applied.