SAN DIEGO--(BUSINESS WIRE)---- $EVFM #Fierce--Evofem CEO's fiery keynote address at Fierce JPM Week 2026 calls for "Ground-Up Reset†of Women's Health. Replay now live at fiercejpmweek.com. ...

SAN DIEGO--(BUSINESS WIRE)---- $EVFM #sayvagina--Evofem launched SayVaginaStore.com, expanding its 'Say Vagina' campaign addressing widespread censorship of female anatomical terms in the media. ...

Core Insights - Evofem Biosciences is set to launch PHEXX®, a hormone-free contraceptive vaginal gel, in the UAE by 2026 following favorable pricing certificates from the Emirates Drug Establishment [1][2][3] Group 1: Product Overview - PHEXX® is the first and only locally-acting contraceptive gel approved by the FDA, designed to be applied before intercourse and works by maintaining a vaginal pH that is inhospitable to sperm [4] - The product contains lactic acid, citric acid, and potassium bitartrate, and is applied using a pre-filled applicator [4] Group 2: Market Expansion - The issuance of pricing certificates is a significant step for Evofem to diversify its revenue streams and enter new markets, particularly in the GCC and MENA regions [2][3] - Pharma 1, Evofem's licensee, holds exclusive commercialization rights for PHEXX® and SOLOSEC® in six GCC states and plans to expand into 15 additional countries [3] Group 3: Regulatory and Commercial Strategy - Pharma 1 is responsible for all aspects of distribution, sales, marketing, and regulatory approvals for PHEXX® and SOLOSEC® in the licensed territory [3] - The company aims to submit PHEXX® for marketing approval in other licensed countries following its approval in the UAE [3]

Financial Performance - Net sales increased by 10% to $5.0 million in Q3 2025, compared to $4.5 million in the prior year quarter[4] - Operating income of $1.0 million was reported for Q3 2025, a significant improvement from a loss of $2.4 million in the same quarter last year[8] - Total operating expenses decreased by 42% to $4.0 million in Q3 2025, down from $6.9 million in the prior year quarter[7] - The net loss attributable to common stockholders was $1.7 million in Q3 2025, compared to a net loss of $2.4 million in Q3 2024, equating to a loss of $0.01 per share[9] - Restricted cash increased to $0.8 million as of September 30, 2025, compared to $0.7 million as of December 31, 2024[10] - The company reported a total stockholders' deficit of $75.1 million as of September 30, 2025[16] Cost Management - The company achieved a reduction in manufacturing costs by approximately 50% for both PHEXX and SOLOSEC, enhancing per-unit profit and facilitating entry into price-sensitive global markets[4] Regulatory and Clinical Developments - SOLOSEC was submitted for marketing approval in the UAE in Q3 2025 under a License and Supply Agreement with Pharma 1[4] - The company is conducting a Phase 4 clinical trial for SOLOSEC, hypothesizing a 1.75 lower rate of repeat infections compared to metronidazole[4] Corporate Actions - Evofem terminated the merger agreement with Aditxt following stockholder disapproval on October 20, 2025[5]

Core Insights - Evofem Biosciences reported a 10% increase in net sales for Q3 2025, reaching $5.0 million compared to $4.5 million in the same quarter last year, driven by effective sales strategies and marketing initiatives [2][11] - The company achieved operating income of $1.0 million in Q3 2025, a significant improvement from a loss of $2.4 million in the prior year quarter [4][11] - Total operating expenses decreased by 42% to $4.0 million in Q3 2025 from $6.9 million in the same period last year, primarily due to reduced general and administrative costs and a one-time accounting gain [3][11] Financial Performance - Net loss attributable to common stockholders was $1.7 million in Q3 2025, an improvement from a net loss of $2.4 million in Q3 2024, translating to a loss of $0.01 per share compared to $0.02 per share in the prior year [5][15] - The company had restricted cash of $0.8 million as of September 30, 2025, up from $0.7 million at the end of 2024 [6] Product and Market Developments - Evofem is advancing strategies to reduce manufacturing costs by approximately 50% for its products PHEXX and SOLOSEC, which is expected to enhance profitability and facilitate entry into price-sensitive global markets [11] - SOLOSEC has been submitted for marketing approval in the United Arab Emirates under a licensing agreement, indicating ongoing expansion efforts [11] - Patient recruitment is ongoing for a Phase 4 clinical trial evaluating SOLOSEC's effectiveness compared to metronidazole for treating Trichomonas vaginalis, with promising hypotheses regarding cost-effectiveness [11] Corporate Actions - Following a Special Meeting of Stockholders on October 20, 2025, Evofem terminated its merger agreement with Aditxt after stockholders did not approve the transaction [11]

Financial Performance - Product sales for the three months ended September 30, 2025, were $4.952 million, an increase from $4.496 million in the same period of 2024, representing a growth of approximately 10.2%[18] - The net loss attributable to common stockholders for the three months ended September 30, 2025, was $1.680 million, compared to a net loss of $2.370 million for the same period in 2024, indicating an improvement of approximately 29.2%[18] - Net loss for the three months ended September 30, 2025, was $1,569 million, compared to a loss of $2,365 million for the same period in 2024, representing a 33.5% improvement[21] - For the nine months ended September 30, 2025, the net loss totaled $5,823 million, slightly improved from $6,485 million in the same period of 2024, showing a 10.2% reduction[21] - The company reported a comprehensive loss of $6,681 million for the nine months ended September 30, 2025, compared to $6,485 million in 2024, indicating a 3% increase[21] Operating Expenses - Total operating expenses for the nine months ended September 30, 2025, were $10.595 million, a decrease from $18.932 million in the same period of 2024, reflecting a reduction of about 43.7%[18] - Research and development expenses for the nine months ended September 30, 2025, were $3.819 million, a significant increase compared to $1.196 million in the same period of 2024[18] Cash and Assets - Cash and cash equivalents as of September 30, 2025, were reported at $0, while total current assets decreased to $7.918 million from $13.609 million as of December 31, 2024[16] - The balance of common stock as of June 30, 2025, was $831,424 thousand, an increase from $829,026 thousand as of September 30, 2024[21] - Cash, cash equivalents, and restricted cash at the end of the period were $840,000, up from $722,000 at the end of the previous year[29] Liabilities - Total liabilities as of September 30, 2025, were $83.976 million, a decrease from $90.264 million as of December 31, 2024, showing a reduction of approximately 6.5%[16] - The company has identified material weaknesses in internal controls and is working on remediation efforts[9] - As of September 30, 2025, the Company reported a working capital deficit of $70.3 million and an accumulated deficit of $900.2 million[41] Regulatory and Market Presence - The company anticipates potential changes in regulatory mandates that could impact the coverage of FDA-approved contraceptive products[14] - The company is focused on expanding its market presence and improving its sales and marketing capabilities, particularly after product rebranding efforts[9] Financing and Debt - Interest pertaining to the Baker Notes for the three months ended September 30, 2025, was approximately $2.9 million, and for the nine months ended September 30, 2025, it was approximately $8.5 million[85] - The Baker Notes have a principal amount of up to $25.0 million, with an interest rate of 10.0% per annum[84] - The Company intends to contest the claims of default made by the Designated Agent and Purchasers under the Baker Bros. SPA[110] Inventory and Cost of Goods Sold - The Company expects to significantly reduce its cost of goods sold (COGS) once PHEXX is manufactured under the Windtree License and Supply Agreement[175] - The Company recorded a total of $1.684 million in inventories as of September 30, 2025, compared to $1.577 million as of December 31, 2024[146] Stock and Equity - The Company issued 5,300,000 shares of common stock upon noncash exercise of purchase rights during the reporting period[21] - The Series E-1 Convertible Preferred Stock was authorized to increase from 2,300 to 10,000 shares to facilitate dividend payments in kind, with a conversion price of $0.40 per share[204] - The Series F-1 Shares rank higher than all Common Stock regarding preferences for dividends and distributions upon liquidation[206] Future Outlook - The Company anticipates continuing to incur net losses for the foreseeable future, raising substantial doubt about its ability to continue as a going concern[47] - The Company plans to generate recurring product revenue from PHEXX and SOLOSEC, restructure payables, and seek additional funding through various financing options[45]

Core Points - Evofem Biosciences' shareholders did not approve the merger with Aditxt, leading to the termination of the merger agreement [1] - The company is now focusing on regaining a national stock listing and securing growth capital to achieve sustainable positive EBITDA by 2027 [2] - Evofem has two FDA-approved products: PHEXXI, a hormone-free contraceptive gel, and SOLOSEC, an oral antibiotic for bacterial vaginosis and trichomoniasis [3][5] Company Strategy - The company aims to deliver value for investors and healthcare providers by executing its long-term growth strategy [2] - Collaboration with Aditxt is expected to enhance the commercialization of Mitomic diagnostic tests for women's health conditions [2] Financial Performance - Evofem has experienced four consecutive years of net sales growth as of 2024 [3]

Core Viewpoint - Evofem Biosciences, Inc. has announced that its licensee Pharma 1 has filed for regulatory approval in the UAE to commercialize SOLOSEC, an FDA-approved treatment for bacterial vaginosis and trichomoniasis, targeting a launch in the first half of 2026 [1][2]. Company Overview - Evofem Biosciences focuses on innovative products for women's sexual and reproductive health, generating revenue from two FDA-approved products, SOLOSEC and PHEXXI [9][10]. - Pharma 1, an Emirati healthcare company, holds exclusive commercialization rights for SOLOSEC and PHEXXI in the MENA region, including the UAE, Kuwait, Saudi Arabia, and Qatar [2][13]. Product Details - SOLOSEC is a single-dose oral treatment for bacterial vaginosis and trichomoniasis, providing a complete course of therapy in just one dose [4][11]. - The prevalence of bacterial vaginosis in the MENA region ranges from 25% to 41%, with an estimated 1.0 million to 1.7 million women affected in the UAE alone [4][5]. Market Opportunity - The Gulf Cooperation Council (GCC) region has millions affected by bacterial vaginosis and trichomoniasis, indicating a significant market opportunity for SOLOSEC [2][6]. - The WHO estimated 156.3 million new cases of trichomoniasis globally in 2020, highlighting the ongoing need for effective treatments [5][8]. Strategic Goals - Pharma 1 aims to develop a commercial strategy for SOLOSEC and expects strong reception in the medical community and among patients seeking convenient treatment options [2][3]. - Evofem views this filing as a critical step towards expanding its revenue streams beyond the U.S. market [2][3].

Core Insights - Evofem Biosciences emphasizes the importance of access to contraception for health, future, and freedom on World Contraception Day [1] - The company aims to challenge the status quo in women's health by providing innovative, hormone-free contraceptive options [2][3] - Evofem's commitment includes education and awareness campaigns to reduce stigma around women's health issues [3][4] Product Offerings - PHEXXI is highlighted as the first and only hormone-free, on-demand contraceptive vaginal gel, applied before sexual activity [6] - SOLOSEC is an FDA-approved single-dose oral treatment for bacterial vaginosis and trichomoniasis, targeting women and individuals aged 12 and older [7] Company Vision and Initiatives - Evofem is dedicated to breaking barriers and expanding global access to women's health products [4] - The "Say Vagina" initiative has reached millions, aiming to improve health education and confront stigma [3][10]

Core Insights - Evofem Biosciences, Inc. has successfully concluded its "Say Vagina" campaign, which aimed to normalize clinical anatomical language and combat censorship in medical terminology, resulting in significant engagement and awareness [1][3][9] - The campaign led to a 130% increase in traffic to PHEXXI.com, making PHEXXI the most followed contraceptive brand on social media among healthcare providers [1][9] - Evofem plans to maintain the momentum from the campaign by launching SayVaginaStore.com, with proceeds from merchandise sales going to sexual and reproductive health charities [3] Company Overview - Evofem is focused on commercializing innovative products to address unmet needs in women's sexual and reproductive health, generating revenue from two FDA-approved products: PHEXXI and SOLOSEC [4][6] - PHEXXI is the first and only hormone-free, on-demand prescription contraceptive vaginal gel, while SOLOSEC is an FDA-approved oral antibiotic for treating bacterial vaginosis and trichomoniasis [5][6] Campaign Impact - The "Say Vagina" campaign generated over 2.5 million views across social media platforms and significantly increased engagement with patients, providers, and educators [9] - CEO Saundra Pelletier emphasized the campaign's role in transforming shame into empowerment and fostering open dialogue about women's health [3] Future Plans - Evofem is preparing for a Special Meeting of Stockholders on September 26, 2025, to discuss a merger with Aditxt, Inc., which will result in Evofem becoming a wholly owned subsidiary of Aditxt [8][10][14]