"The newly ratified House Bill 3489 addresses a critical need by empowering pharmacists across Illinois to prescribe a full range of contraceptive options while expanding access to non-hormonal choices like PHEXXI, ensuring women have timely access to the methods that best suit their individual health needs and preferences," said Saundra Pelletier, Evofem's CEO. -- Passage of House Bill 3489 allows Illinois pharmacists to prescribe non-hormonal and emergency contraceptives -- -- Ensures a broader range of c ...

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 June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Registrant's telephone number, including area code: (858) 550-1900 N/A (Former name or former address, if changed since last report.) Securities registered pursuant to Section 12(b) of the A ...

[Q2 2025 Earnings Highlights and Business Update](index=1&type=section&id=Q2%202025%20Earnings%20Highlights%20and%20Business%20Update) Evofem Biosciences achieved net sales growth and improved operating loss in Q2 2025, demonstrating positive financial performance [Financial Performance Highlights](index=1&type=section&id=Financial%20Performance%20Highlights) Evofem Biosciences achieved net sales growth and improved operating loss in Q2 2025, demonstrating positive financial performance | Metric | Q2 2025 | Q2 2024 | Change | | :------------------- | :-------- | :-------- | :--- | | Net Sales | $4.8 million | $4.2 million | +14.3% | | Operating Loss | $1.3 million | $1.4 million | Improved | [Strategic Business Developments](index=1&type=section&id=Strategic%20Business%20Developments) The company made significant progress in product cost optimization, international market expansion, marketing, and clinical trials - The company is pursuing a strategy to reduce manufacturing costs for PHEXXI and SOLOSEC by approximately **50%**, aiming to increase unit margins and facilitate entry into price-sensitive global markets[2](index=2&type=chunk) - PHEXXI's marketing application has been submitted in the UAE through licensee Pharma 1 Drug Store, with SOLOSEC's application planned for Q3 2025, targeting six Middle Eastern countries and potential expansion to 15 other MENA countries[2](index=2&type=chunk) - PHEXXI gained significant brand awareness through viral content on TikTok, achieving over **7 million views** and **24,000+ comments**[2](index=2&type=chunk) - SOLOSEC is undergoing an NIH-funded Phase 4 clinical trial to evaluate its efficacy and cost-effectiveness in treating trichomoniasis[2](index=2&type=chunk) - SOLOSEC demonstrated effectiveness in treating recurrent bacterial vaginosis (BV) with once-weekly dosing, showing recurrence rates comparable to or better than CDC-recommended suppressive therapy at the 2025 ACOG Annual Meeting[6](index=6&type=chunk) - Evofem launched the "Say Vagina Month" public awareness campaign to destigmatize vaginal health and advocate for medically accurate, empowering language, which generated strong social media engagement and a **250% increase** in unique visitors to Phexxi.com in the first week[6](index=6&type=chunk) [CEO Commentary](index=2&type=section&id=CEO%20Commentary) CEO Ms. Pelletier noted a rebound in Q2 net sales and anticipates further brand awareness and sales growth from Q3 social media marketing - CEO stated that Q2 net sales rebounded, increasing by **16%** compared to the prior year period[3](index=3&type=chunk) - Bold social media marketing campaigns and media coverage in Q3 are expected to translate into higher PHEXXI awareness, conversion, and sales[3](index=3&type=chunk) [Detailed Second Quarter Financial Results](index=2&type=section&id=Detailed%20Second%20Quarter%20Financial%20Results) This section provides a detailed breakdown of the company's financial performance for the second quarter [Net Sales Analysis](index=2&type=section&id=Net%20Sales%20Analysis) Q2 2025 net sales increased by 16% year-over-year, driven by SOLOSEC, higher PHEXXI WAC, and improved gross-to-net percentage | Metric | Q2 2025 (thousand dollars) | Q2 2024 (thousand dollars) | Year-over-Year Growth | | :----------- | :---------------- | :---------------- | :------- | | Net Sales | 4,825 | 4,160 | 16.0% | - Net sales growth was primarily attributed to the inclusion of SOLOSEC, an increase in PHEXXI's wholesale acquisition cost (WAC) effective January 1, 2025, and continued improvement in the gross-to-net percentage[4](index=4&type=chunk) [Operating Expenses Breakdown](index=2&type=section&id=Operating%20Expenses%20Breakdown) Total operating expenses increased in Q2 2025 due to higher sales and marketing and R&D costs related to SOLOSEC, partially offset by reduced G&A expenses | Metric | Q2 2025 (thousand dollars) | Q2 2024 (thousand dollars) | Change (thousand dollars) | | :-------------------- | :---------------- | :---------------- | :------------ | | Total Operating Expenses | 6,076 | 5,549 | +527 | | Sales and Marketing Expenses | 2,625 | 2,243 | +382 | | Research and Development Expenses | 746 | 270 | +476 | | General and Administrative Expenses | 1,843 | 2,267 | -424 | | Amortization of Intangible Assets | 107 | - | +107 | - The increase in sales and marketing expenses was primarily related to the payment of Prescription Drug User Fee Act (PDUFA) fees for SOLOSEC, while the increase in R&D expenses was also related to SOLOSEC, acquired in Q3 2024[7](index=7&type=chunk) - A non-cash amortization expense of **$0.1 million** related to the SOLOSEC acquisition was recorded in Q2 2025, with no comparable expense in the prior year period[7](index=7&type=chunk) [Net Loss and Per Share Data](index=3&type=section&id=Net%20Loss%20and%20Per%20Share%20Data) The company improved its operating loss in Q2 2025, but a decrease in other income led to an increased net loss attributable to common stockholders | Metric | Q2 2025 (thousand dollars) | Q2 2024 (thousand dollars) | Change (thousand dollars) | | :--------------------------------- | :---------------- | :---------------- | :------------ | | Operating Loss | (1,251) | (1,389) | Improved 138 | | Net Income (Loss) Attributable to Common Stockholders | (1,785) | 1,304 | Decreased 3,089 | | Basic and Diluted Net Income (Loss) Per Share | $(0.02) | $0.02 (Basic) / $(0.00) (Diluted) | Decreased | [Liquidity and Corporate Strategy](index=3&type=section&id=Liquidity%20and%20Corporate%20Strategy) This section outlines the company's financial liquidity position and its strategic plans, including a pending merger [Liquidity Position](index=3&type=section&id=Liquidity%20Position) As of June 30, 2025, the company maintained stable cash and cash equivalents and raised funds through senior subordinated notes and warrants | Metric | June 30, 2025 (thousand dollars) | December 31, 2024 (thousand dollars) | | :-------------------- | :--------------------- | :---------------------- | | Cash and Cash Equivalents | - | - | | Restricted Cash | 748 | 741 | - In April and June 2025, Evofem raised **$2.4 million** in net proceeds through the sale of senior subordinated notes and warrants to Aditxt, Inc[9](index=9&type=chunk) [Aditxt Merger Agreement](index=3&type=section&id=Aditxt%20Merger%20Agreement) Evofem is advancing its merger with Aditxt, expecting to become a wholly-owned subsidiary upon shareholder approval and fulfillment of closing conditions - Evofem is proceeding with plans to convene a special meeting of stockholders to approve the Amended and Restated Merger Agreement (A&R Merger Agreement), with Evofem expected to become a wholly-owned subsidiary of Aditxt upon approval and satisfaction of all closing conditions[9](index=9&type=chunk)[14](index=14&type=chunk) - The completion of the merger transaction is contingent on several conditions, including Evofem stockholder approval and Aditxt raising sufficient funds to fulfill its closing obligations, specifically paying approximately **$15 million** to satisfy cash payments to Evofem's senior secured noteholders[16](index=16&type=chunk) [Company and Product Information](index=3&type=section&id=Company%20and%20Product%20Information) This section provides an overview of Evofem Biosciences, its product portfolio, and its market expansion strategies [About Evofem Biosciences](index=3&type=section&id=About%20Evofem%20Biosciences) Evofem Biosciences commercializes innovative products for women's sexual and reproductive health, with revenue from two FDA-approved products - Evofem Biosciences is dedicated to commercializing innovative products addressing unmet needs in women's sexual and reproductive health[11](index=11&type=chunk) - The company's revenue is derived from the sale of two FDA-approved products[11](index=11&type=chunk) [Product Portfolio Overview](index=3&type=section&id=Product%20Portfolio%20Overview) Evofem's portfolio includes PHEXXI, a hormone-free, on-demand contraceptive vaginal gel, and SOLOSEC, an FDA-approved single-dose oral antibiotic for BV and trichomoniasis - PHEXXI (lactic acid, citric acid, and potassium bitartrate) is the first and only hormone-free, on-demand prescription vaginal gel for contraception[13](index=13&type=chunk) - SOLOSEC® (secnidazole) 2g oral granules is an FDA-approved oral antibiotic for the treatment of bacterial vaginosis (BV) and trichomoniasis, offering a single-dose complete course of therapy[13](index=13&type=chunk) [Market Expansion and Commercial Strategy](index=3&type=section&id=Market%20Expansion%20and%20Commercial%20Strategy) The company is actively expanding globally by promoting SOLOSEC and PHEXXI to OB/GYNs in the US and through licensing agreements in international markets - Evofem's commercial team relaunched SOLOSEC in November 2024, promoting it alongside PHEXXI to OB/GYNs in the United States[12](index=12&type=chunk) - The company is entering global markets through licensing agreements with companies like Pharma 1 Drug Store LLC, with PHEXXI and SOLOSEC anticipated to launch in the UAE in 2026[12](index=12&type=chunk) [Condensed Consolidated Financial Statements](index=6&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents the company's condensed consolidated balance sheets and statements of operations [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, the balance sheet shows zero cash and cash equivalents, stable restricted cash, decreased net trade receivables, and improved total liabilities and shareholder deficit | Metric | June 30, 2025 (thousand dollars) | December 31, 2024 (thousand dollars) | | :------------------------------------------------- | :--------------------- | :---------------------- | | Cash and Cash Equivalents | - | - | | Restricted Cash | 748 | 741 | | Trade Accounts Receivable, Net | 4,934 | 9,832 | | Total Current Liabilities | 73,893 | 80,448 | | Total Stockholders' Deficit | (69,616) | (71,257) | | Total Liabilities, Convertible and Redeemable Preferred Stock, and Stockholders' Deficit | 14,382 | 23,789 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) In Q2 2025, net sales increased and operating loss narrowed, but a decrease in other income (primarily fair value changes in financial instruments) led to an increased net loss | Metric | Q2 2025 (thousand dollars) | Q2 2024 (thousand dollars) | H1 2025 (thousand dollars) | H1 2024 (thousand dollars) | | :--------------------------------- | :---------------- | :---------------- | :---------------- | :---------------- | | Net Product Sales | 4,825 | 4,160 | 5,670 | 7,763 | | Cost of Sales | 755 | 769 | 1,120 | 1,453 | | Amortization of Intangible Assets | 107 | - | 330 | - | | Research and Development Expenses | 746 | 270 | (4,289) | 864 | | Sales and Marketing | 2,625 | 2,243 | 5,225 | 4,588 | | General and Administrative | 1,843 | 2,267 | 4,208 | 5,091 | | Total Operating Expenses | 6,076 | 5,549 | 6,594 | 11,996 | | Operating Loss | (1,251) | (1,389) | (924) | (4,233) | | Other Income (Expense), Net | (526) | 2,748 | 103 | 783 | | Net Income (Loss) | (1,784) | 1,351 | (828) | (3,458) | | Net Income (Loss) Attributable to Common Stockholders | (1,785) | 1,304 | (832) | (3,552) | | Basic Net Income (Loss) Per Share | (0.02) | 0.02 | (0.01) | (0.07) | | Diluted Net Income (Loss) Per Share | (0.02) | (0.00) | (0.01) | (0.07) | [Important Disclosures and Contact Information](index=4&type=section&id=Important%20Disclosures%20and%20Contact%20Information) This section provides crucial legal disclosures regarding forward-looking statements, offers, and company contact details [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements about future events and financial performance, subject to risks and uncertainties that may cause actual results to differ materially - This press release contains forward-looking statements regarding the anticipated impact of social media activities and media coverage, the timing of PHEXXI and SOLOSEC approval and launch in the UAE, and the filing of proxy materials for the special meeting of stockholders[16](index=16&type=chunk) - Forward-looking statements involve risks and uncertainties, and actual results may differ materially from those discussed or implied, with the company undertaking no obligation to update any forward-looking statements unless required by law[16](index=16&type=chunk) [No Offer or Solicitation](index=5&type=section&id=No%20Offer%20or%20Solicitation) This press release does not constitute a solicitation of proxy, consent, or authorization for any securities, nor an offer to sell or buy any securities - This press release does not constitute a solicitation of proxy, consent, or authorization with respect to any securities, nor an offer to sell or a solicitation of an offer to buy any securities[18](index=18&type=chunk) [Company Contacts](index=5&type=section&id=Company%20Contacts) Contact information for media, investors, and potential partners is provided, along with the company's social media presence - The company maintains official accounts on social media platforms including LinkedIn, TikTok, Instagram, X, and Facebook[19](index=19&type=chunk) - Media inquiries can be directed to media@evofem.com, while investors and potential partners can contact Amy Raskopf, Chief Business Development Officer[19](index=19&type=chunk)

-- Increased Net Sales and Improved Loss from Operations in Q2 2025 vs. Prior Year Quarter -- -- Evofem Advances Plans for Special Meeting of Stockholders to Approve the A&R Merger Agreement and Become a Wholly-owned Subsidiary of Aditxt -- SAN DIEGO, Aug. 14, 2025 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. (Evofem or the Company) (OTCID: EVFM), today announced financial results for the three- and six-month periods ended June 30, 2025 and provided a business update. Notable developmen ...

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]

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]

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]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for Q1 2025 show a significant decrease in total assets to $12.9 million, a net income of $0.96 million, and substantial doubt about going concern [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $12.9 million from $23.8 million, primarily due to a reduction in trade accounts receivable Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $221 | $0 | | Trade accounts receivable, net | $1,149 | $9,832 | | Total current assets | $5,873 | $13,609 | | Intangible asset, net | $6,487 | $9,597 | | **Total assets** | **$12,877** | **$23,789** | | **Liabilities & Stockholders' Deficit** | | | | Accounts payable | $11,224 | $16,172 | | Notes - carried at fair value | $14,327 | $14,974 | | Convertible notes, net - Adjuvant | $31,346 | $30,769 | | Total current liabilities | $70,854 | $80,448 | | **Total liabilities** | **$77,679** | **$90,264** | | **Total stockholders' deficit** | **($69,587)** | **($71,257)** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net product sales decreased by 77% to $0.85 million, while a $5.6 million gain from payables settlement led to a net income of $0.95 million Condensed Consolidated Statements of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Product sales, net | $845 | $3,603 | | Cost of goods sold | $365 | $684 | | Research and development, net | ($5,035) | $594 | | Selling and marketing | $2,600 | $2,345 | | General and administrative | $2,365 | $2,824 | | **Income (loss) from operations** | **$327** | **($2,844)** | | **Net income (loss)** | **$956** | **($4,809)** | | Net income (loss) attributable to common stockholders | $953 | ($4,856) | | **Basic EPS** | **$0.01** | **($0.16)** | | **Diluted EPS** | **$0.00** | **($0.16)** | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities increased to $0.56 million, driven by a decrease in receivables and a gain on payables settlements Summary of Cash Flows (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $560 | $123 | | Net cash used in investing activities | ($57) | ($14) | | Net cash used in financing activities | ($135) | $0 | | **Net change in cash, cash equivalents and restricted cash** | **$368** | **$109** | | Cash, cash equivalents and restricted cash, end of period | $1,109 | $689 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business, critical going concern doubt, complex debt structures, and subsequent delisting from OTCQB - The company's financial statements are prepared on a going concern basis, but management has concluded that circumstances raise substantial doubt about the company's ability to continue as a going concern. As of March 31, 2025, the company had a working capital deficit of **$65.0 million** and an accumulated deficit of **$896.7 million**[39](index=39&type=chunk)[40](index=40&type=chunk)[45](index=45&type=chunk) - On September 27, 2024, Future Pak, LLC, the holder of the Baker Notes, issued a Notice of Event of Default, claiming the company breached covenants and accelerated repayment. The company strongly disagrees with the claim and intends to vigorously contest it[102](index=102&type=chunk)[106](index=106&type=chunk)[155](index=155&type=chunk) - The company settled a trademark dispute with TherapeuticsMD, which requires changing the name of PHEXXI. The company failed to meet the July 2024 deadline and has accrued **$0.9 million** for a probable settlement[153](index=153&type=chunk) - The company's common stock was delisted from the OTCQB and began trading on the OTCPK on April 23, 2025, for failing to maintain a minimum bid price of **$0.01 per share**[42](index=42&type=chunk)[181](index=181&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=43&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the 77% sales decrease, a $5.6 million gain from payables settlement, and reiterates substantial doubt about going concern due to a $65.0 million working capital deficit - Management confirms that cash and cash equivalents as of March 31, 2025, are insufficient to fund operations for the next 12 months, raising substantial doubt about the company's ability to continue as a going concern[246](index=246&type=chunk)[250](index=250&type=chunk) - The company is pursuing a merger with Aditxt, Inc., which has been amended multiple times. A condition of closing is the full repayment of the Baker Notes. Aditxt has provided several rounds of funding through preferred share purchases and convertible notes[197](index=197&type=chunk)[208](index=208&type=chunk) - Key growth drivers for PHEXXI in 2025 include targeting women who use GLP-1 medications for weight loss (which can reduce oral contraceptive efficacy) and expanding pharmacy partnerships[189](index=189&type=chunk)[212](index=212&type=chunk) [Results of Operations](index=51&type=section&id=Results%20of%20Operations) Net product sales declined by 77% due to wholesaler purchasing, while R&D expenses showed a net benefit from a $5.6 million gain on settlements Comparison of Results for the Three Months Ended March 31 (in thousands) | Item | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $845 | $3,603 | ($2,758) | (77)% | | Cost of goods sold | $365 | $684 | ($319) | (47)% | | Research and development | ($5,035) | $594 | ($5,629) | (948)% | | Selling and marketing | $2,600 | $2,345 | $255 | 11% | | General and administrative | $2,365 | $2,824 | ($459) | (16)% | - The decrease in net product sales was primarily due to significant wholesaler purchases of PHEXXI in December 2024 ahead of a January 2025 price increase, which reduced Q1 2025 sales volume[239](index=239&type=chunk) - The significant negative R&D expense in Q1 2025 was the result of the company negotiating and settling a portion of its trade payables, leading to a **$5.6 million** gain recorded as a reduction in R&D expenses[232](index=232&type=chunk)[241](index=241&type=chunk) [Liquidity and Capital Resources](index=52&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces substantial doubt about going concern with a $65.0 million working capital deficit and insufficient cash for the next 12 months - The company had a working capital deficit of **$65.0 million** and an accumulated deficit of **$896.7 million** as of March 31, 2025[246](index=246&type=chunk) - Management's plans to meet cash flow needs include generating product revenue, restructuring payables, and obtaining additional funding through the Aditxt merger, non-dilutive financing, or other partnerships[43](index=43&type=chunk)[249](index=249&type=chunk) - If additional funding is not secured, the company may be forced to make further spending reductions, liquidate assets, suspend or curtail planned operations, or cease operations entirely[250](index=250&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=54&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable to the company for this reporting period - The company states that Quantitative and Qualitative Disclosures about Market Risk are not applicable[263](index=263&type=chunk) [Item 4. Controls and Procedures](index=54&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective as of March 31, 2025, due to identified material weaknesses - As a result of material weaknesses identified in the 2024 Annual Report, the CEO and CFO have concluded that disclosure controls and procedures are not effective as of March 31, 2025[265](index=265&type=chunk) - Management is continuing to implement its remediation plan for the identified material weaknesses, but cannot provide assurance as to when the remediation will be complete[267](index=267&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=56&type=section&id=Item%201.%20Legal%20Proceedings) The company refers to Note 7 for details on legal proceedings, including a trademark dispute and a contested default notice from a senior debt holder - For details on legal proceedings, the report directs readers to Note 7 - Commitments and Contingencies[271](index=271&type=chunk) [Item 1A. Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors) The company states there have been no material changes to the risk factors disclosed in its 2024 Form 10-K - There have been no material changes to the risk factors previously disclosed in the company's 2024 Form 10-K[272](index=272&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=56&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[273](index=273&type=chunk) [Item 3. Defaults Upon Senior Securities](index=56&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults on senior securities as of the filing date, despite other notes detailing a contested default notice - The company reports no defaults on senior securities as of the filing date. However, Note 4 and Note 7 detail a Notice of Default from Future Pak, LLC, which the company is actively disputing[274](index=274&type=chunk)[102](index=102&type=chunk)[155](index=155&type=chunk) [Item 5. Other Information](index=56&type=section&id=Item%205.%20Other%20Information) No directors or officers entered into, modified, or terminated a Rule 10b5-1 trading arrangement during the first quarter of 2025 - No directors or officers entered into, modified, or terminated a Rule 10b5-1 trading plan during the quarter[276](index=276&type=chunk) [Item 6. Exhibits](index=56&type=section&id=Item%206.%20Exhibits) This section provides an index of all exhibits filed with the Quarterly Report on Form 10-Q, including merger agreement amendments and certifications - The report includes an index listing all exhibits filed, such as amendments to the merger agreement and officer certifications[277](index=277&type=chunk)[278](index=278&type=chunk)

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]