-- BV Market Projected to Reach $1.0 Billion in the U.S. by 2033 -- -- BV Affects 21 Million U.S. Women; As many as 50% Experience Recurrent BV Within Six Months of Treatment -- SAN DIEGO, June 11, 2025 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. (OTCPK: EVFM) today announced that a study of SOLOSEC® (secnidazole) 2 g oral granules for recurrent bacterial vaginosis (BV) presented at the 2025 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeti ...

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]

Core Insights - Evofem Biosciences reported a decrease in net sales for Q1 2025, totaling $0.8 million compared to $3.6 million in Q1 2024, attributed to order timing and magnitude shifts for PHEXXI [3][4] - The company achieved a net income of $1.0 million in Q1 2025, a significant improvement from a net loss of $4.9 million in the same quarter of the previous year [4] - Evofem's operating expenses decreased to $0.5 million in Q1 2025 from $6.4 million in Q1 2024, primarily due to reduced research and development costs [3][7] Financial Performance - Net sales for Q1 2025 were $0.8 million, down from $3.6 million in Q1 2024, reflecting a shift in order timing for PHEXXI [3] - Total operating expenses were $0.5 million in Q1 2025, significantly lower than $6.4 million in the prior year [3] - Income from operations was $0.3 million in Q1 2025, compared to a loss of $2.8 million in Q1 2024 [4] Income and Earnings - Net income attributable to common stockholders was $1.0 million in Q1 2025, equating to $0.01 per basic share, compared to a net loss of $4.9 million or $(0.16) per share in Q1 2024 [4][14] - The company recorded a significant reduction in research and development expenses, down by $5.6 million due to successful negotiations with vendors [7] Liquidity and Cash Position - As of March 31, 2025, the company had cash, cash equivalents, and restricted cash totaling $1.1 million, an increase from $0.7 million at the end of 2024 [5] - In April 2025, Evofem raised $1.5 million from the sale of senior subordinated notes and warrants [6][8] Strategic Developments - Evofem is partnering with Windtree Therapeutics to reduce PHEXXI manufacturing costs by 55% to 60% [6] - The company strengthened its intellectual property with the issuance of the 11th U.S. patent for SOLOSEC, extending coverage to 2040 [6] - Evofem is expanding into global markets, including a planned launch of PHEXXI in the UAE in early 2026 through a partnership with Pharma 1 Drug Store LLC [10]