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Femasys | 10-K: FY2024 Annual Report

Femasys | 10-K: FY2024 Annual Report

Femasys | 10-K:2024財年年報
美股SEC公告 ·  03/27 13:30

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Femasys Inc. reported a 52% increase in annual revenue to $1.63 million for FY2024, driven primarily by FemaSeed product sales of $0.51 million following its commercialization. The net loss widened to $18.82 million from $14.25 million in 2023, reflecting increased investments in commercialization and R&D activities. The company ended the year with $3.45 million in cash.In March 2025, Femasys achieved a significant milestone with CE mark certification under EU MDR for the FemBloc delivery system, marking its first regulatory approval worldwide. The company has also completed an expedited G12 Special MDR Audit for the FemBloc blended polymer component, with CE mark approval expected by mid-2025. Strategic distribution partnerships were established in Spain to support the European commercialization.The company continues to advance its pivotal U.S. clinical trial for FemBloc permanent birth control, while expanding commercial partnerships for FemaSeed with prominent fertility centers including Boston IVF, HRC Fertility, and CNY Fertility. Management expects current cash resources and anticipated revenues to fund operations into Q3 2025, though additional financing will be required to support ongoing development and commercialization efforts.
Femasys Inc. reported a 52% increase in annual revenue to $1.63 million for FY2024, driven primarily by FemaSeed product sales of $0.51 million following its commercialization. The net loss widened to $18.82 million from $14.25 million in 2023, reflecting increased investments in commercialization and R&D activities. The company ended the year with $3.45 million in cash.In March 2025, Femasys achieved a significant milestone with CE mark certification under EU MDR for the FemBloc delivery system, marking its first regulatory approval worldwide. The company has also completed an expedited G12 Special MDR Audit for the FemBloc blended polymer component, with CE mark approval expected by mid-2025. Strategic distribution partnerships were established in Spain to support the European commercialization.The company continues to advance its pivotal U.S. clinical trial for FemBloc permanent birth control, while expanding commercial partnerships for FemaSeed with prominent fertility centers including Boston IVF, HRC Fertility, and CNY Fertility. Management expects current cash resources and anticipated revenues to fund operations into Q3 2025, though additional financing will be required to support ongoing development and commercialization efforts.
Femasys Inc. 報告稱2024財年營業收入同比增長52%,達163萬美元,主要得益於FemaSeed產品銷售額達到51萬美元,這得益於其商業化。淨虧損從2023年的1425萬美元擴大至1882萬美元,反映了在商業化和研發活動中的投資增加。公司年末現金餘額爲345萬美元。2025年3月,Femasys在歐盟MDR下獲得了FemBloc輸送系統的CE標誌認證,標誌着其首次獲得全球監管批准。公司還完成了FemBloc混合聚合物組件的加速G12特殊MDR審核,預計在2025年中期獲得CE標誌批准。在西班牙建立了戰略分銷合作伙伴關係,以支持歐洲的商業化。公司繼續推進FemBloc永久避孕的關鍵美國臨牀試驗,同時與波士頓IVF、HRC生育和CNY生育等著名生育中心擴大FemaSeed的商業合作。管理層預計當前的現金資源和預計營業收入將支持運營到2025年第3季度,儘管還需要額外融資來支持持續的發展和商業化工作。
Femasys Inc. 報告稱2024財年營業收入同比增長52%,達163萬美元,主要得益於FemaSeed產品銷售額達到51萬美元,這得益於其商業化。淨虧損從2023年的1425萬美元擴大至1882萬美元,反映了在商業化和研發活動中的投資增加。公司年末現金餘額爲345萬美元。2025年3月,Femasys在歐盟MDR下獲得了FemBloc輸送系統的CE標誌認證,標誌着其首次獲得全球監管批准。公司還完成了FemBloc混合聚合物組件的加速G12特殊MDR審核,預計在2025年中期獲得CE標誌批准。在西班牙建立了戰略分銷合作伙伴關係,以支持歐洲的商業化。公司繼續推進FemBloc永久避孕的關鍵美國臨牀試驗,同時與波士頓IVF、HRC生育和CNY生育等著名生育中心擴大FemaSeed的商業合作。管理層預計當前的現金資源和預計營業收入將支持運營到2025年第3季度,儘管還需要額外融資來支持持續的發展和商業化工作。

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