アステラス製薬（4503） – Notice Regarding Impairment Loss for Products under Development

Press Release Notice Regarding Impairment Loss for Products under Development TOKYO, April 22, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that it will book an impairment loss in the fourth quarter of the fiscal year ended March 31, 2022 (April 1, 2021 to March 31, 2022) and the first quarter of the fiscal year ending March 31, 2023 (April 1, 2022 to March 31, 2023) as follows. (1) Details of impairment loss (the fourth quarter of fiscal year 2021) For the following reasons, Astellas will book an impairment loss of approximately ¥50 billion as other expenses in the fourth quarter of fiscal year 2021 not included in the financial forecasts (Full basis) announced on October 29, 2021. Astellas received reports of serious adverse events in patients who participated in the ASPIRO clinical trial evaluating investigational gene therapy AT132 in patients with X-linked myotubular myopathy. In September 2021, Astellas voluntarily suspended screening and dosing. After that, Astellas received the clinical hold for the ASPIRO clinical trial from the US Food and Drug Administration (FDA). Astellas then reassessed the development plan and recognized a delay in approval timing. Astellas also revised the eligible treatment population based upon an anticipated future product label compared to our initial assessment. As a result of reevaluation of the intangible asset based on the updated assumptions, Astellas will book an impairment loss of intangible assets as other expenses. It has decided to terminate the development of the DNA vaccine ASP2390, which is currently in Phase 1 study for house dust mite-induced allergic rhinitis patients. As a result of this termination, Astellas will book an impairment loss of intangible assets as other expenses. It has decided to terminate the development of the GITR agonistic antibody ASP1951, which is currently in Phase 1 study for cancer patients. As a result of this termination, Astellas will book an impairment loss of goodwill as other expenses. 1 (2) Details of impairment loss (the first quarter of fiscal year 2022) Based upon recent preclinical study data, the research and development of gene therapy programs AT702, AT751 and AT753 for Duchenne muscular dystrophy. As a result of this termination, Astellas will book an impairment loss of intangible assets of $ 170 million as other expenses in the first quarter of fiscal year 2022. Regarding (1) above, the impact from this matter is not reflected in Astellas’ consolidated financial forecasts for the fiscal year ending March 31, 2022 that were announced in October 2021. In addition to (2) above, the financial impact of this matter will be included in the announcement of financial results on April 27, 2022. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en. Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. ### 2 Contacts for inquiries or additional information: Astellas Pharma Inc. Corporate Advocacy & Relations +81-3-3244-3201 3