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Femasys | 10-Q: Q2 2024 Earnings Report

Femasys | 10-Q: Q2 2024 Earnings Report

Femasys | 10-Q:2024財年二季報
美股SEC公告 ·  08/08 08:49

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Femasys, a biomedical company specializing in women's reproductive health solutions, reported a decrease in sales for the three months ended June 30, 2024, with a 30.9% drop to $221,484 compared to the same period in 2023. The company's net loss widened by 61.9% year-on-year to $4,684,574. Research and development expenses rose by 29.4%, primarily due to increased material and development costs, while sales and marketing expenses surged by 656.6% as the company prepared for the commercialization of FemaSeed. Despite the increased losses, Femasys secured $6.85 million in financing and completed enrollment for the FemaSeed pivotal trial, indicating progress towards commercial launch. The company also received European Union Medical Device Regulation (EU MDR) and CE Mark certification for several products, including FemaSeed. Looking forward, Femasys expects to commence FemaSeed sales in the second half of 2024 and is exploring strategic partnerships for distribution in Europe. However, the company acknowledges the need for additional financing to continue operations beyond July 2025 and has expressed substantial doubt about its ability to continue as a going concern without securing further funds.
Femasys, a biomedical company specializing in women's reproductive health solutions, reported a decrease in sales for the three months ended June 30, 2024, with a 30.9% drop to $221,484 compared to the same period in 2023. The company's net loss widened by 61.9% year-on-year to $4,684,574. Research and development expenses rose by 29.4%, primarily due to increased material and development costs, while sales and marketing expenses surged by 656.6% as the company prepared for the commercialization of FemaSeed. Despite the increased losses, Femasys secured $6.85 million in financing and completed enrollment for the FemaSeed pivotal trial, indicating progress towards commercial launch. The company also received European Union Medical Device Regulation (EU MDR) and CE Mark certification for several products, including FemaSeed. Looking forward, Femasys expects to commence FemaSeed sales in the second half of 2024 and is exploring strategic partnerships for distribution in Europe. However, the company acknowledges the need for additional financing to continue operations beyond July 2025 and has expressed substantial doubt about its ability to continue as a going concern without securing further funds.
生物醫藥公司Femasys專注於女性生殖健康解決方案,報告稱2024年6月30日結束的三個月銷售額下降了30.9%,至221,484美元,相比2023年同期下降了61.9%的淨虧損達到4,684,574美元。由於材料和開發成本增加,研發費用上升了29.4%,而銷售和市場費用激增了656.6%,因爲公司準備商業化FemaSeed。儘管虧損增加,Femasys獲得了685萬美元的融資,並完成了FemaSeed的關鍵試驗招募,表明向商業化推出的進展。該公司還獲得了歐洲聯盟醫療器械法規(EU MDR)和CE標誌認證,認證了多種產品,包括FemaSeed。展望未來,Femasys計劃在2024年下半年開始銷售FemaSeed,並正探討在歐洲的分銷戰略合作伙伴。然而,公司認識到需要額外融資才能在2025年7月之後繼續運營,並表示對於沒有獲得更多資金的情況下能否繼續作爲擁有經營能力的企業存在重大疑慮。
生物醫藥公司Femasys專注於女性生殖健康解決方案,報告稱2024年6月30日結束的三個月銷售額下降了30.9%,至221,484美元,相比2023年同期下降了61.9%的淨虧損達到4,684,574美元。由於材料和開發成本增加,研發費用上升了29.4%,而銷售和市場費用激增了656.6%,因爲公司準備商業化FemaSeed。儘管虧損增加,Femasys獲得了685萬美元的融資,並完成了FemaSeed的關鍵試驗招募,表明向商業化推出的進展。該公司還獲得了歐洲聯盟醫療器械法規(EU MDR)和CE標誌認證,認證了多種產品,包括FemaSeed。展望未來,Femasys計劃在2024年下半年開始銷售FemaSeed,並正探討在歐洲的分銷戰略合作伙伴。然而,公司認識到需要額外融資才能在2025年7月之後繼續運營,並表示對於沒有獲得更多資金的情況下能否繼續作爲擁有經營能力的企業存在重大疑慮。
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