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Evofem Reports Financial Results for Third Quarter of 2025, Provides Business Update
Prnewswire· 2025-11-13 21:05
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]
Evofem Announces Voting Results from Special Meeting of Stockholders
Prnewswire· 2025-10-20 20:19
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]
Evofem Biosciences Honors World Contraception Day
Prnewswire· 2025-09-26 12:15
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]
Evofem's "Say Vagina" Campaign Generates More than 2.5 Million Views Across Social Media Platforms
Prnewswire· 2025-09-11 13:18
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]
Illinois Pharmacists Can Prescribe PHEXXI Starting January 2026 Under Newly-passed Law
Prnewswire· 2025-08-21 12:56
Core Points - Illinois enacted House Bill 3489 on August 15, 2025, allowing pharmacists to prescribe a broader range of contraceptives, including non-hormonal options like PHEXXI, effective January 1, 2026 [1][3][4] - The legislation aims to improve access to contraceptive choices for women in Illinois, addressing individual health needs and preferences [2][3] - PHEXXI is the first hormone-free, on-demand prescription contraceptive vaginal gel, approved by the FDA in May 2020, and is designed to be used before sexual intercourse [5][8] Company Overview - Evofem Biosciences is focused on commercializing innovative products for women's sexual and reproductive health, generating revenue from PHEXXI and SOLOSEC [5] - The company is involved in a merger agreement with Aditxt, Inc. and Adifem, Inc., with a definitive proxy filing expected soon [6] Product Information - PHEXXI is administered vaginally and is designed to be used 0-60 minutes before intercourse, providing a discreet contraceptive method [8][10] - The product is suitable for women of any body mass index (BMI) and has been clinically shown to increase sexual satisfaction [10]
Evofem Reports Positive Financial Results for Second Quarter of 2025, Provides Business Update
Prnewswire· 2025-08-14 12:46
Core Viewpoint - Evofem Biosciences reported a 16% increase in net sales for Q2 2025 compared to the same quarter last year, driven by the addition of SOLOSEC and a price increase for PHEXXI, while also improving its loss from operations [2][3][4]. Financial Performance - Net sales for Q2 2025 were $4.8 million, up from $4.2 million in Q2 2024 [3][6]. - Total operating expenses increased to $6.1 million in Q2 2025 from $5.5 million in the prior year [3][7]. - Loss from operations improved to $1.3 million in Q2 2025, compared to $1.4 million in Q2 2024 [4][6]. - Net loss attributable to common stockholders was $1.8 million in Q2 2025, a decline from a net income of $1.3 million in Q2 2024, resulting in a net loss of $(0.02) per share [4][18]. Liquidity and Capital Raising - Evofem raised $2.4 million in net proceeds from the sale of senior subordinated notes and warrants to Aditxt, Inc. in April and June 2025 [5][8]. - As of June 30, 2025, the company had cash and cash equivalents of $0.7 million [8]. Strategic Developments - Evofem is advancing plans for a Special Meeting of Stockholders to approve the A&R Merger Agreement with Aditxt, which will make Evofem a wholly-owned subsidiary of Aditxt [5][11]. - The company is working on reducing manufacturing costs by approximately 50% for PHEXXI and SOLOSEC to enhance profitability and market entry [6]. Market Initiatives - PHEXXI gained significant attention through a viral TikTok campaign, achieving over 7 million views and 24,000+ comments [6]. - Evofem declared August as "Say Vagina Month" to promote awareness and engagement around vaginal health, resulting in a 250% increase in unique visits to Phexxi.com during the campaign's first week [6]. Product Approvals and Trials - PHEXXI has been submitted for marketing approval in the UAE, with SOLOSEC expected to follow in Q3 2025 [6][10]. - Patient recruitment is ongoing for a Phase 4 clinical trial evaluating SOLOSEC's effectiveness compared to metronidazole for treating Trichomonas vaginalis [6].
Phexxi -- A Non‑Hormonal Birth Control Brand -- Goes Viral with Microfeminism on TikTok, Featured by BuzzFeed and Scary Mommy
Prnewswire· 2025-07-15 13:12
Core Insights - PHEXXI, a non-hormonal birth control brand, has sparked a national conversation on microfeminism through a viral TikTok with over 10 million views, highlighting women's empowerment and daily practices of microfeminism [1][2][3] - The brand's messaging aligns with the cultural shift towards women's autonomy and choice in health, emphasizing that microfeminism involves small, intentional acts that reclaim equity [3][4] - Evofem Biosciences, the creator of PHEXXI, is focused on addressing unmet needs in women's sexual and reproductive health, with two FDA-approved products generating revenue [5][7] Company Overview - Evofem Biosciences, Inc. is commercializing innovative products for women's sexual and reproductive health, including PHEXXI and SOLOSEC, both of which are FDA-approved [5][7] - The company is in the process of being acquired by Aditxt, which aims to enhance its social innovation platform with a dedicated women's health program, targeting a close in the second half of 2025 [6] Product Details - PHEXXI is the first and only hormone-free, on-demand prescription contraceptive vaginal gel, applied 0-60 minutes before sexual activity, available in boxes of 12 pre-filled applicators [7] - SOLOSEC is an FDA-approved oral antibiotic for treating bacterial vaginosis and trichomoniasis, providing a complete course of therapy in just one dose [7]
Windtree Advances Lower Cost Manufacturing of PHEXXI, Evofem's Hormone-Free, On-Demand Prescription Contraceptive Gel
Globenewswire· 2025-06-26 20:05
Core Insights - Windtree Therapeutics has entered a contract with a Chinese pharmaceutical manufacturer to produce Evofem's PHEXXI, aiming to reduce manufacturing costs by over 50% by the end of 2026 [1][2][3] - The tech transfer process is currently underway, with validation batch manufacturing expected to begin in 2026, which is anticipated to generate revenue for Windtree [2][3] - Evofem has experienced four consecutive years of net sales growth for PHEXXI and is preparing to enter the UAE market in early 2026 [3] Company Developments - The manufacturing contract is part of a broader License and Supply Agreement established in March 2025 between Windtree and Evofem [4] - Windtree aims to become a revenue-generating company across various growing industries, focusing on overall profitability [5]
Notable Data on Evofem's SOLOSEC in Recurrent Bacterial Vaginosis (BV) Released at ACOG Annual Meeting
Prnewswire· 2025-06-11 12:14
Core Insights - The market for bacterial vaginosis (BV) treatments in the U.S. is projected to reach $1.0 billion by 2033, driven by increasing incidence, public health awareness, and improved diagnostics [3][4]. Company Overview - Evofem Biosciences, Inc. is focused on women's sexual and reproductive health, with two FDA-approved products generating revenue [8]. - The company relaunched SOLOSEC in November 2024 and is promoting it alongside PHEXXI to OB/GYNs in the U.S. [9]. - Evofem is entering global markets through strategic partnerships, including a license agreement for launching products in the UAE in 2026 [9]. Product Development - SOLOSEC (secnidazole) is being studied for its efficacy in managing recurrent BV, with a recent study showing that once-weekly dosing may match or exceed the effectiveness of current CDC-recommended treatments [2][3]. - The study involved 24 women and indicated that the once-weekly dosing could improve adherence compared to more complex treatment regimens [3][5]. - SOLOSEC is currently approved for treating BV in women aged 12 and older, but its use for recurrent BV is still investigational [5][7]. Market Dynamics - BV affects approximately 21 million women in the U.S., with up to 50% experiencing recurrence within six months of treatment [4][6]. - The high recurrence rate of BV presents a significant burden on patients and the healthcare system, highlighting the need for more effective treatment options [4][6]. Strategic Initiatives - Evofem has entered into a definitive agreement to be acquired by Aditxt, Inc., aiming to enhance its focus on women's health innovations [10].
Evofem Signs SOLOSEC License Agreement for Middle East with Pharma 1
Prnewswire· 2025-05-21 12:59
Core Viewpoint - Evofem Biosciences and Pharma 1 have entered into a License and Supply Agreement for the commercialization of SOLOSEC in the Middle East, targeting regulatory submission in the UAE by mid-2025 [1][2][4] Group 1: Agreement Details - The agreement includes an upfront payment, milestone payments based on regulatory achievements, and sales-based milestone payments to Evofem for the exclusive rights to SOLOSEC in the region [2] - Pharma 1 will be responsible for obtaining regulatory approvals and managing all commercial functions related to SOLOSEC in the Middle East [7] Group 2: Market Opportunity - Bacterial vaginosis (BV) and trichomoniasis are prevalent in the Gulf Cooperation Council (GCC) region, with BV affecting 25% to 41% of women in the MENA region, translating to approximately 1.0 million to 1.7 million women in the UAE alone [4][6] - Trichomoniasis has an estimated prevalence of 4.7% among women in the MENA region, with higher rates in intermediate- and high-risk populations [6] Group 3: Product Information - SOLOSEC is an FDA-approved single-dose oral treatment for BV and trichomoniasis, providing a complete course of therapy in just one dose [11] - The product is manufactured in the United States, which enhances its appeal in markets where quality and regulatory trust are critical [3]