Sumitomo Pharma Co., Ltd. - Myovant Sciences and Pfizer Receive U.S. FDA Approval of MYFEMBREE, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis

Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President, and CEO: Hiroshi Nomura; Securities Code: 4506, Prime Market of TSE) announced today that on August 5, 2022, its consolidated subsidiary, Myovant Sciences Ltd. and Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved MYFEMBREE as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months as per the attachment.

As the result of this approval, Myovant will receive US$100 million in regulatory milestone payments for the U.S. FDA approval from Pfizer, and the Company will record approximately US$38 million as deferred revenue in its consolidated revenue for the fiscal year ending March 31, 2023. This approval has not been taken into consideration in its consolidated financial forecasts for the fiscal year ending March 31, 2023. The impact of this approval on its consolidated financial results is minimal. The Company will make an announcement if any other disclosure is required.

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