Core Viewpoint - Evofem Biosciences is expanding its market presence by commercializing its hormone-free contraceptive PHEXXI in the UAE through a partnership with Pharma 1 Drug Store, targeting a launch in Q1 2026 after regulatory approval [1][2][6]. Group 1: Company Overview - Evofem Biosciences, Inc. focuses on innovative products for women's sexual and reproductive health, generating revenue from FDA-approved products including PHEXXI and SOLOSEC [5][6]. - Pharma 1 Drug Store LLC is an Emirati healthcare company with exclusive commercialization rights for PHEXXI in the Middle East, responsible for regulatory approvals and all commercial functions [2][8]. Group 2: Product Details - PHEXXI is the first FDA-approved locally-acting contraceptive gel, applied before intercourse to maintain a vaginal pH that is inhospitable to sperm and pathogens, without hormones [4]. - The product is expected to meet a growing demand for hormone-free contraception in the UAE and surrounding regions, as indicated by market research [2]. Group 3: Market Strategy - Pharma 1 is developing a commercial strategy for PHEXXI in the UAE, anticipating strong reception among OB/GYNs and women [2]. - The launch quantity order for PHEXXI is planned for July 2025, with the aim to diversify Evofem's revenue stream through sales in the UAE [1][2].

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36754 EVOFEM BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware 20-8527075 (State or other juris ...

Financial Performance - First quarter 2025 net sales were $0.8 million, a decrease from $3.6 million in the prior year period, attributed to order timing for PHEXXI[4] - Total operating expenses in Q1 2025 were $0.5 million, significantly lower than $6.4 million in the same period last year[5] - Evofem recorded income from operations of $0.3 million in Q1 2025, compared to a loss of $2.8 million in Q1 2024[7] - Net income attributable to common stockholders was $1.0 million in Q1 2025, a turnaround from a net loss of $4.9 million in Q1 2024, resulting in net income of $0.01 per basic share[7] Cash and Funding - Cash, cash equivalents, and restricted cash totaled $1.1 million as of March 31, 2025, up from $0.7 million at the end of 2024[8] - Evofem raised $1.5 million in April 2025 from the sale of senior subordinated notes and warrants[6] Cost Management and Development - Evofem aims to reduce PHEXXI manufacturing costs by 55% to 60% through a partnership with Windtree Therapeutics, Inc.[6] - Research and development expenses decreased by $5.6 million due to successful negotiations with vendors, with a 4% reduction excluding settlements compared to the prior year[11] Product Launch and Market Expansion - The commercial team relaunched SOLOSEC in November 2024 and is entering global markets, including a planned launch of PHEXXI in the UAE in early 2026[10] - The company strengthened its intellectual property with the issuance of an 11th U.S. patent for SOLOSEC, extending coverage to 2040[6]

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]

Financial Performance - Net sales for 2024 increased by 6% to $19.4 million compared to $18.2 million in 2023, primarily driven by PHEXXI sales and the addition of SOLOSEC[1][3] - Total operating expenses decreased by 27% to $26.4 million in 2024, excluding non-cash amortization expenses, reflecting the company's fiscal discipline[1][4] - Loss from operations improved by 57% to $7.7 million in 2024, compared to a loss of $17.8 million in the prior year[1][6] - The company recorded a net loss of $8.9 million in 2024, compared to a net income of $53.0 million in 2023, which was skewed by a large gain on extinguishment of debt[1][6] Sales and Marketing - Sales and marketing expenses as a percentage of net sales were 47% for 2024, a significant improvement from 64% in 2023 and 261% in 2022[1][5] - Fourth quarter net sales reached $7.1 million, up from $4.8 million in the same period last year, driven by increased PHEXXI sales and SOLOSEC revenue[1][7] Research and Development - Research and development costs decreased by 37% to $1.8 million in 2024, down from $2.9 million in 2023[1][8] Strategic Initiatives - Evofem acquired SOLOSEC in July 2024 and relaunched it in November 2024, diversifying its revenue stream[1][1][15] - Evofem aims to reduce PHEXXI manufacturing costs through a partnership with Windtree Therapeutics, enhancing U.S. operating margins and facilitating entry into new global markets[1][1] - The company plans to hold a special meeting of stockholders by September 26, 2025, to seek approval for a merger with Aditxt, which includes a funding commitment of $1.5 million[1][1]

Product Launch and Commercialization - PHEXXI, the first FDA-approved hormone-free contraceptive vaginal gel, was commercially launched in September 2020, with increased net product sales reported each year since[23]. - SOLOSEC was re-launched in the U.S. in November 2024 after acquiring global rights in July 2024, targeting bacterial vaginosis and Trichomonas vaginalis[24]. - The company plans to expand product commercialization globally through partnerships, including a licensing agreement for PHEXXI in the Middle East with Pharma 1 Drug Store, LLC[25]. - The company aims to commercialize SOLOSEC, an oral antimicrobial agent, which was relaunched in November 2024, to enhance its product offerings[53]. - The company intends to commercialize PHEXXI through strategic partnerships or license agreements outside the U.S.[52]. Financial Developments - A merger agreement with Aditxt, Inc. was entered into on December 11, 2023, with subsequent amendments made to the agreement throughout 2024[27][28][29][30]. - Aditxt agreed to pay the company $1.0 million as part of the fourth amendment to the merger agreement, which was received during Q2 2024[34]. - The merger agreement includes provisions for Aditxt to purchase shares of the company's Series F-1 Preferred Shares, totaling $2.5 million in investments by specified dates[37]. - The required consummation date for the merger has been extended multiple times, with the latest date set for September 30, 2025[42]. - The financial statements do not reflect the potential impact of the A&R Merger Agreement, which is subject to customary closing conditions[44]. - The company has raised over $500 million through multiple equity financing rounds since its transition to the public market in January 2018[49]. Market Analysis - The total U.S. contraceptive market was valued at $8.7 billion in 2024 and is expected to reach approximately $12 billion by 2030, with a compound annual growth rate of 4.7%[55]. - Approximately 23.3 million women in the U.S. who are at risk for pregnancy are not using hormone-based contraceptives as their primary form of contraception[60]. - The global market for non-hormonal contraceptives is projected to grow from $27.7 billion in 2022 to $52.2 billion by 2031[133]. - The U.S. is the largest commercial market for women's health products, with a dedicated sales team promoting SOLOSEC and PHEXXI directly to healthcare providers[80]. Product Efficacy and Safety - PHEXXI's mechanism of action maintains a vaginal pH of 3.5-4.5, creating an inhospitable environment for sperm and reducing sperm motility[70]. - In clinical trials, SOLOSEC demonstrated a 68% rate of patients not requiring additional treatment for BV after a single dose[77]. - SOLOSEC showed a cure rate of 92.2% for trichomoniasis in women, with male cure rates ranging from 91.7% to 100%[79]. - The Phase 2B/3 trial for EVO100 demonstrated statistically significant reductions in chlamydia and gonorrhea infections of 50% and 78%, respectively, compared to placebo[142]. Regulatory and Compliance Issues - The FDA granted EVO100 Fast Track Designation and designated it as a Qualified Infectious Disease Product (QIDP) for the prevention of chlamydia and gonorrhea[141]. - The company must obtain regulatory approvals in non-U.S. countries before commencing clinical trials or marketing products, which may take longer than FDA approval[191]. - The FDA may withdraw drug approvals if compliance with regulatory requirements is not maintained, leading to potential fines, product recalls, or withdrawal from the market[166]. - The company is subject to compliance with the U.S. Foreign Corrupt Practices Act (FCPA), which prohibits bribery of foreign officials to obtain business[187]. Intellectual Property - The company has approximately 36 issued patents and allowed applications related to PHEXXI, with some patents expiring as late as 2033[154]. - The company expects a Notice of Allowance for a patent that will extend SOLOSEC's IP protection by five years, from 2035 to 2040[155]. - SOLOSEC's intellectual property includes ten U.S. patents and one allowed patent, expected to protect SOLOSEC until 2040, with NCE-GAIN Exclusivity until September 15, 2027[176]. Healthcare Provider Engagement - The company targets approximately 3,000 healthcare providers in the OB/GYN space to promote SOLOSEC, focusing on building advocacy through national initiatives[85]. - The company has secured formulary inclusion for PHEXXI with a major PBM, covering approximately 46 million lives[94]. Pricing and Reimbursement - The pricing strategy for PHEXXI is set at $267.50 per box of 12 applicators, updated annually based on the consumer price index[90]. - The Affordable Care Act guarantees coverage for FDA-approved contraceptive products, including PHEXXI, with no out-of-pocket costs for women[101]. - As of January 1, 2023, most insurers and pharmacy benefit managers must provide coverage for FDA-approved contraceptive products like PHEXXI at $0 out-of-pocket cost[104]. Challenges and Barriers - SOLOSEC faces more barriers to patient access due to prior authorizations, but its one-and-done dosing improves compliance and eases approval processes[95]. - An estimated 72.7 million women of reproductive age (15-49) in the U.S. exist, with 13.0 million using no birth control method, putting them at risk of unintended pregnancy[114].

Financial Performance - Product sales for Q3 2024 were $4,496 million, a decrease of 12.06% from $5,112 million in Q3 2023[23] - The net loss for Q3 2024 was $2,365 million, compared to a net income of $66,005 million in Q3 2023[26] - The comprehensive loss for Q3 2024 was $3,291 million, compared to a comprehensive loss of $7,637 million in Q3 2023[26] - The net loss for the company as of September 30, 2024, was $2,365 million, compared to a net loss of $1,351 million as of June 30, 2024, indicating a significant increase in losses[31] - For the nine months ended September 30, 2024, the company reported a net loss of $5.823 million compared to a net income of $55.093 million in the same period of 2023[35] - The total balance as of September 30, 2023, was $828,552 million, with accumulated deficits amounting to $884,624 million[32] - The company has incurred operating losses and negative cash flows from operating activities since inception, highlighting ongoing financial challenges[45] Assets and Liabilities - As of September 30, 2024, total assets increased to $23,942 million from $10,554 million as of December 31, 2023[21] - Current liabilities totaled $76,286 million as of September 30, 2024, compared to $72,463 million as of December 31, 2023[21] - The accumulated deficit increased to $894,621 million as of September 30, 2024, from $888,699 million as of December 31, 2023[21] - As of September 30, 2024, the company had a working capital deficit of $67.7 million and an accumulated deficit of $894.6 million[45] Revenue and Sales Growth - Phexxi net sales have shown growth each year since its launch in September 2020, with key growth drivers expected in 2024 from expanded use among women taking oral birth control pills alongside GLP-1 medications[15] - Phexxi net product sales increased from $16.8 million in 2022 to $18.2 million in 2023, indicating a growth trend in revenue[37] - The market acceptance rate of Phexxi and SOLOSEC is a critical factor for future revenue projections[11] Acquisitions and Partnerships - The company acquired global rights to SOLOSEC in July 2024, which is expected to enhance commercialization efforts due to existing physician relationships[17] - The company plans to file for regulatory approval of Phexxi in the UAE in the fourth quarter of 2024 through its partnership with Pharma 1 Drug Store, LLC[16] - The company entered into a merger agreement with Aditxt, Inc., with the merger expected to close in 2025[38] Expenses and Cost Management - Total operating expenses for Q3 2024 were $6,936 million, down 20% from $8,664 million in Q3 2023[23] - Research and development expenses decreased to $332 million in Q3 2024 from $614 million in Q3 2023, a reduction of 45.96%[23] - Selling and marketing expenses were $2,382 million in Q3 2024, down 20.23% from $2,985 million in Q3 2023[23] Stock and Financing - The company issued 2,767,332 shares upon noncash exercise of purchase rights, contributing to its capital structure[32] - Stock-based compensation for the period was recorded at $268 million, highlighting the company's investment in employee incentives[32] - The company raised $1.260 million from the issuance of preferred stock and $1.000 million from the reinstatement of a merger agreement with a related party[35] - The company has been actively seeking non-dilutive financing and partnerships to support its commercialization efforts and expand revenue streams[45] Legal and Compliance Issues - The company is focused on improving its internal controls and procedures to address identified material weaknesses[11] - The company aims to achieve and sustain profitability while navigating potential legal actions and compliance with listing standards[11] - The company intends to contest the claims of default made by the Designated Agent regarding the Securities Purchase Agreement[112] Inventory and Assets Management - The total inventory as of September 30, 2024, was $1.463 million, a decrease from $1.697 million as of December 31, 2023[133] - The total amount of finished goods inventory as of September 30, 2024, was $177,000, down from $791,000 as of December 31, 2023[133] - The Company recorded a total of $1.3 million in additional write-downs of inventory during the year ended December 31, 2023[133] Financial Instruments and Liabilities - The total fair value of financial liabilities is $146,555,000, with Baker Notes contributing $106,869,000[139] - The carrying amount of Baker Notes increased from $99,460,000 on December 31, 2023, to $106,869,000 by September 30, 2024, reflecting a growth of approximately 7.1%[139] - The fair value of the Baker Notes is now determined using a Monte Carlo simulation-based model, which incorporates various factors including future revenues and debt covenants[145] Investor Relations and Agreements - The Company entered into support agreements with investors to vote in favor of the A&R Merger Agreement and against any Company Acquisition Proposal[209] - Investors agreed not to sell or transfer Subject Shares until specific conditions are met, including the termination of the A&R Merger Agreement or the effective acquisition by Aditxt[210] - The agreement includes provisions that prevent changes to the consideration payable to Investors without their consent, ensuring protection against adverse effects[210]

Financial Performance - Improved loss from operations to $2.4 million for Q3 2024, a 31% improvement from a loss of $3.6 million in Q3 2023 [5] - Net product sales decreased by 12% to $4.5 million in Q3 2024, down from $5.1 million in the prior year period [4] - Net loss attributable to common stockholders was $2.4 million, or a loss of $0.02 per share, for Q3 2024 [6] Operating Expenses - Total operating expenses were $6.9 million, a decrease of 20% compared to the prior year period [4] - Selling and marketing costs decreased by 20% to $2.4 million compared to the prior year quarter [8] - Research and development costs decreased by 46% to $0.3 million compared to the prior year quarter [8] Investments and Acquisitions - Aditxt, Inc. invested $5.0 million in Evofem since May 2024, including $1.3 million in Q3 2024 [2] - Acquired global rights to SOLOSEC, a single-dose oral antibiotic FDA-approved for bacterial vaginosis and trichomoniasis [2] - Licensed Phexxi commercial rights in the Middle East, with regulatory submission to the UAE Ministry of Health expected by year-end 2024 [2] Cash Position - At September 30, 2024, the company had $0.7 million of restricted cash, up from $0.6 million at December 31, 2023 [9]

Financial Performance - As of June 30, 2024, total assets decreased to $8.551 billion from $10.554 billion as of December 31, 2023, reflecting a decline of approximately 18.9%[19] - Current liabilities increased to $73.178 billion from $72.463 billion, representing a rise of about 1%[19] - The accumulated deficit as of June 30, 2024, was $892.251 million, up from $888.699 million at the end of 2023, indicating a worsening of approximately 0.6%[19] - Product sales for Q2 2024 reached $4,160 million, a significant increase from $2,458 million in Q2 2023, representing a growth of 69.2% year-over-year[21] - Total operating expenses for Q2 2024 were $5,549 million, down from $9,794 million in Q2 2023, a reduction of 43.0%[21] - The net income for Q2 2024 was $1,351 million, compared to a net loss of $8,558 million in Q2 2023, marking a turnaround of $9,909 million[24] - The company experienced a comprehensive income of $1,095 million in Q2 2024, compared to a loss of $190 million in Q2 2023[24] - The net income attributable to common stockholders for Q2 2024 was $1,304 million, a significant recovery from a loss of $8,558 million in Q2 2023[21] - The basic net income per share attributable to common stockholders was $0.02 in Q2 2024, compared to a loss of $5.43 in Q2 2023[21] - For the six months ended June 30, 2024, the net loss was $3.458 million, a significant improvement compared to a net loss of $10.912 million in the same period of 2023[31] Product Development and Market Expansion - Phexxi has shown net sales growth every year since its launch in September 2020, with key growth drivers expected from expanded use among women taking oral birth control pills alongside GLP-1 medications[13] - The company plans to re-launch SOLOSEC in the second half of 2024 after acquiring global rights to the product, which is aimed at treating bacterial vaginosis and trichomoniasis[15] - Phexxi was approved in Nigeria as Femidence™ on October 6, 2022, and is currently under review for approval in Mexico, Ethiopia, and Ghana[14] - The company has licensed commercial rights to Phexxi in the Middle East to Pharma 1 Drug Store, LLC, which plans to file for regulatory approval in the UAE in the second half of 2024[14] - The company aims to improve access to innovative options that impact women's daily lives through its product offerings[15] Operational Challenges and Financial Stability - The company anticipates continuing to incur net losses for the foreseeable future, with liquidity resources as of June 30, 2024, deemed insufficient to meet cash flow needs for the next twelve months[45] - The company has incurred operating losses and negative cash flows from operating activities since inception, raising substantial doubt about its ability to continue as a going concern[46] - As of June 30, 2024, the company had a working capital deficit of $66.0 million and an accumulated deficit of $892.3 million[42] - The company reported a net cash used in operating activities of $1.018 million for the six months ended June 30, 2024, compared to $6.434 million for the same period in 2023[31] - The three largest customers accounted for approximately 75% and 79% of gross product sales for the three and six months ended June 30, 2024, respectively[55] Debt and Financing Activities - The company entered into a merger agreement with Aditxt, Inc., expected to close in late 2024, which may impact future operations and financial stability[35] - The total potentially dilutive securities increased significantly from 191 million in 2023 to approximately 5.67 billion in 2024, primarily due to an increase in purchase rights and convertible debt[60] - The Company entered into eight Securities Purchase Agreements (SPAs) from December 2022 to September 2023, resulting in net proceeds of approximately $10.985 million[115] - The Company entered into the Fourth Amendment to the Baker Bros. Purchase Agreement on September 8, 2023, which allows for quarterly cash payments based on global net product revenue from Phexxi, starting in Q4 2023[94] - The cash payment structure is as follows: 3% on revenue ≤ $5 million, 4% on revenue > $5 million and ≤ $7 million, and 5% on revenue > $7 million[96] Inventory and Asset Management - As of June 30, 2024, total inventories were valued at $1.06 million, down from $1.70 million as of December 31, 2023[123] - The Company recorded a combined estimated reserve on obsolescence and excess inventory of $0.3 million as of both June 30, 2024, and December 31, 2023[123] - Total prepaid and other current assets decreased from $1,195,000 as of December 31, 2023, to $845,000 as of June 30, 2024, representing a decline of approximately 29.3%[124] - Net property and equipment decreased slightly from $1,203,000 as of December 31, 2023, to $1,187,000 as of June 30, 2024, a decrease of about 1.3%[125] Lease and Operating Expenses - For the three months ended June 30, 2024, total operating lease expenses amounted to $46,000, a decrease of 81.4% compared to $250,000 for the same period in 2023[146] - Cash paid for operating lease liabilities was $140,000 for the six months ended June 30, 2024, compared to $1,427,000 for the same period in 2023, indicating a substantial decrease of 90.2%[148] - The weighted average remaining lease term increased to 0.92 years as of June 30, 2024, compared to 0.75 years as of December 31, 2023[146] Shareholder and Stockholder Matters - The Company authorized 95,000 Series F-1 Convertible Preferred Shares with a conversion price of $0.0635 per share, which was later adjusted to $0.0154[162] - The Company recorded stock-based compensation expenses of $219,000 for the three months ended June 30, 2024, compared to $268,000 for the same period in 2023[172] - The Company will file a proxy statement with the U.S. SEC to recommend the adoption of the A&R Merger Agreement[193] - All outstanding stock options will be cancelled without any consideration at the Effective Time of the Merger[194]