- Pharming Group N.V. press release ( OTCPK:PHGUF ): 9M GAAP EPS of $0.04.
- Revenue of $151M (-8.0% Y/Y).
- 2022 Outlook: Single digit growth in Group revenues from RUCONEST® sales. Quarterly fluctuations are expected.
- Subject to a positive outcome from the FDA review, we anticipate marketing authorization in the US for leniolisib at the end of Q1 2023, with an anticipated launch and commercialization in Q2 2023.
- Subject to a positive outcome from the EMA review, we anticipate a positive opinion from the CHMP for leniolisib, followed by the issuance of an MAA by the European Commission towards the end of H1 2023. Initial commercial launches in EU markets are planned for H2 2023.
- Following an anticipated positive CHMP opinion, we intend to submit an ECDRP filing for leniolisib with the MHRA in the UK in H2 2023.
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Pharming Group N.V. GAAP EPS of $0.04, revenue of $151M