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FDA Orange Book Lists New U.S. Patent for SOLOSEC, Evofem Biosciences' "One and Done" Oral Treatment for Bacterial Vaginosis and Trichomoniasis
Prnewswire· 2025-08-19 13:39
Core Points - Evofem Biosciences has secured a new U.S. patent for SOLOSEC, extending its market exclusivity until December 2041, which enhances the company's intellectual property portfolio and benefits stakeholders [2][4] - SOLOSEC is the first and only FDA-approved single-dose oral treatment for bacterial vaginosis (BV) and trichomoniasis, addressing a significant unmet need in women's sexual health [2][9] - The company is conducting a Phase 4 clinical trial to compare the effectiveness and cost-effectiveness of SOLOSEC against metronidazole, with expectations of lower reinfection rates in the SOLOSEC group [4] Company Overview - Evofem Biosciences focuses on innovative products for women's sexual and reproductive health, generating revenue from two FDA-approved products [5] - The company is in the process of a merger with Aditxt, Inc., which will result in Evofem becoming a wholly owned subsidiary of Aditxt [6] Industry Context - Trichomoniasis is the most common non-viral sexually transmitted infection globally, with approximately 6.9 million new infections occurring annually in the U.S., highlighting the need for effective treatment options [3][8]
Evofem CEO Saundra Pelletier Honored with Trailblazing Female Founders Award at STIMULATE Conference
Prnewswire· 2025-08-05 12:46
Core Points - Evofem Biosciences, Inc. CEO Saundra Pelletier is receiving the Trailblazing Female Founders Award at the 2025 STIMULATE Conference, highlighting her leadership in the sexual wellness industry [1][2] - The STIMULATE Conference is the only North American event dedicated to sexual wellness, innovation, and empowerment, recognizing female founders who are transforming reproductive health discussions [2] - The award coincides with Say Vagina Month, a campaign by Evofem aimed at destigmatizing vaginal health and promoting accurate language in healthcare [3] Company Overview - Evofem is focused on addressing unmet needs in women's sexual and reproductive health through innovative products, generating revenue from two FDA-approved products [6] - The company relaunched SOLOSEC in November 2024 and is promoting it alongside PHEXXI to OB/GYNs in the U.S., with plans to enter global markets through strategic partnerships [7] - Evofem has entered into a definitive agreement to be acquired by Aditxt, Inc., aiming to enhance women's health initiatives within Aditxt's social innovation platform, with a targeted close in the second half of 2025 [8] Product Information - PHEXXI® is the first and only hormone-free, on-demand prescription contraceptive vaginal gel, which has shown that nearly 90% of women using it improved or maintained their sexual satisfaction [4] - SOLOSEC® is an FDA-approved oral antibiotic for treating bacterial vaginosis and trichomoniasis, providing a complete course of therapy in just one dose [10]
Evofem Reports Fourth Consecutive Year of Net Sales Growth
Prnewswire· 2025-03-24 12:30
Core Insights - Evofem Biosciences reported a 6% increase in net sales for 2024, reaching $19.4 million, primarily driven by the sales of PHEXXI, a hormone-free contraceptive gel [1][4] - The company successfully reduced total operating expenses by 27% to $27.0 million, reflecting improved fiscal discipline [5][6] - The acquisition and relaunch of SOLOSEC contributed to revenue diversification and growth [2][4] Financial Performance - For the year ended December 31, 2024, net sales were $19.4 million compared to $18.2 million in 2023, with lower returns enhancing the gross to net ratio [4] - Total operating expenses decreased from $36.1 million in 2023 to $27.0 million in 2024, excluding a non-cash amortization expense of $0.6 million related to SOLOSEC [5][10] - The loss from operations improved significantly to $7.7 million in 2024 from $17.8 million in the previous year [6][7] Sales and Marketing Efficiency - Sales and marketing expenses as a percentage of net sales were 47% for 2024, the most favorable ratio since the launch of PHEXXI in 2020 [6][11] - In the fourth quarter of 2024, sales and marketing expenses were 31% of net sales, indicating improved efficiency [11] Quarterly Highlights - In Q4 2024, net sales reached $7.1 million, up from $4.8 million in Q4 2023, driven by increased PHEXXI sales and the addition of SOLOSEC [8][9] - Total operating expenses for Q4 2024 were $8.1 million, a slight decrease from $8.2 million in the prior year [9][10] - The loss from operations for Q4 2024 improved to $1.0 million compared to a loss of $3.4 million in Q4 2023 [11] Strategic Initiatives - The company is pursuing a merger with Aditxt, which includes a funding commitment of $1.5 million to be completed by April 7, 2025 [3] - A sourcing partnership with Windtree Therapeutics aims to reduce PHEXXI manufacturing costs and enhance U.S. operating margins [3] Product Portfolio - Evofem's product lineup includes PHEXXI, a hormone-free contraceptive gel, and SOLOSEC, an oral treatment for bacterial vaginosis and trichomoniasis, which was relaunched in November 2024 [2][16]