TOKYO, April 27, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that it booked an impairment loss in the fourth quarter of the fiscal year ended March 31, 2021 (April 1, 2020 to March 31, 2021) and that there are differences between the financial forecasts (Full basis), which were reported on October 30, 2020, and the actual results for the fiscal year 2020.
(1) Booking and details of impairment loss
Astellas booked an impairment loss of ¥58.8 billion as other expenses in the fourth quarter of fiscal year 2020 not included in the financial forecasts (Full basis) announced on October 30, 2020.
In December 2020, Astellas was notified that the U.S. Food and Drug Administration (FDA) lifted the clinical hold for the ASPIRO clinical trial evaluating investigational gene therapy AT132 in patients with X-linked myotubular myopathy (XLMTM). Astellas then reassessed the development plan and recognized a delay in approval timing in the U.S. and Europe. Astellas also revised the likely approved population from our initial assessment. As a result of these updates, Astellas booked an impairment loss.
Astellas is deeply committed to the continued safe development of AT132 for the families and patients living with XLMTM, a disease with no existing treatments. There is no change to our plan to continue development. We will conduct future discussions with regulators on the path forward toward registration filings for AT132.
(2) The Differences Between Financial Forecasts (announced on October 30, 2020) and Actual results for the Year Ended March 31, 2021 (IFRS basis)
| Actual fiscal Year 2020 |
Forecasts fiscal year 2020 |
Change | Change (%) |
(Ref.) Actual fiscal year 2019 |
|
| Revenue | 1,249,528 | 1,256,500 | -6,972 | -0.6 | 1,300,843 |
| Operating profit | 136,051 | 210,500 | -74,449 | -35.4 | 243,991 |
| Profit before tax |
145,324 | 209,500 | -64,176 | -30.6 | 245,350 |
| Profit for the year |
120,589 | 169,500 | -48,911 | -28.9 | 195,411 |
Operating profit and other line items (Full basis) were lower than the forecasts due to the such matters as impairment loss of intangible assets as discussed above.
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