SAN DIEGO, Oct. 20, 2025 /PRNewswire/ --Å Evofem Biosciences. Inc. (OTCID: EVFM) ("Evofem" or the "Company"), today announced that at a Special Meeting of Stockholders held this morning, its stockholders did not approve the proposal to adopt the Amended and Restated Merger Agreement dated July 12, 2024, as subsequently amended (the "Merger Agreement"), between the Company, Aditxt, Inc. (NASDAQ: ADTX), and Adifem, Inc., a wholly owned subsidiary of Aditxt, under which Aditxt intended to acquire Evofem. As a ...

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]

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]

[FORM 10-Q Cover Page](index=1&type=section&id=FORM%2010-Q%20Cover%20Page) Provides basic filing information for the Form 10-Q, identifying the registrant and outstanding common stock shares - Registrant: **Evofem Biosciences, Inc.**[1](index=1&type=chunk) - Filing Period: Quarterly period ended **June 30, 2025**[1](index=1&type=chunk) Registrant Status | Status | Indication | | :--- | :--- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Non-accelerated filer | ☒ | | Smaller reporting company | ☒ | | Emerging growth company | ☐ | - Common stock outstanding as of August 9, 2025: **118,656,354 shares**[5](index=5&type=chunk) [Table of Contents](index=3&type=section&id=Table%20of%20Contents) Indexes the various parts and items of the Form 10-Q, including financial information and other disclosures - The report is structured into **Part I (Financial Information)** and **Part II (Other Information)**[7](index=7&type=chunk) - Part I includes **Financial Statements**, **Management's Discussion and Analysis**, **Quantitative and Qualitative Disclosures About Market Risk**, and **Controls and Procedures**[7](index=7&type=chunk) - Part II includes **Legal Proceedings**, **Risk Factors**, **Unregistered Sales of Equity Securities**, **Defaults Upon Senior Securities**, **Mine Safety Disclosures**, **Other Information**, and **Exhibits**[7](index=7&type=chunk) [FORWARD-LOOKING STATEMENTS](index=4&type=section&id=FORWARD-LOOKING%20STATEMENTS) Outlines forward-looking statements, primarily in MD&A, with a cautionary note on potential material differences in actual results - Forward-looking statements are primarily found in **"Management's Discussion and Analysis of Financial Condition and Results of Operations"**[9](index=9&type=chunk) - Key areas of forward-looking statements include the consummation of the **Merger Agreement**, ability to continue as a **going concern**, commercialization of **SOLOSEC** and **PHEXXI**, remediation of **internal control weaknesses**, ability to **raise capital**, achieve **profitability**, and comply with **debt arrangements**[10](index=10&type=chunk)[15](index=15&type=chunk) - Cautionary statement: **Actual results may differ materially** from projections due to **known and unknown risks and uncertainties**. The company does not assume any obligation to update forward-looking statements, except as required by applicable law[12](index=12&type=chunk) [PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed balance sheets reflect changes in total assets, liabilities, and stockholders' deficit for the period Condensed Consolidated Balance Sheet Highlights (in thousands) | Item | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Total current assets | $8,970 | $13,609 | $(4,639) | | Total assets | $14,382 | $23,789 | $(9,407) | | Total current liabilities | $73,893 | $80,448 | $(6,555) | | Total liabilities | $79,212 | $90,264 | $(11,052) | | Total stockholders' deficit | $(69,616) | $(71,257) | $1,641 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statements of operations show net income/loss and product sales trends for the three and six months ended June 30 Condensed Consolidated Statements of Operations Highlights (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $4,825 | $4,160 | $5,670 | $7,763 | | Total operating expenses | $6,076 | $5,549 | $6,594 | $11,996 | | Loss from operations | $(1,251) | $(1,389) | $(924) | $(4,233) | | 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 EPS | $(0.02) | $0.02 | $(0.01) | $(0.07) | | Diluted EPS | $(0.02) | $(0.00) | $(0.01) | $(0.07) | - Product sales, net, increased by **16%** for the three months ended **June 30, 2025**, compared to the prior year, but decreased by **27%** for the six months ended **June 30, 2025**, primarily due to lower **PHEXXI** sales volume, partially offset by **SOLOSEC** addition and increased WAC[19](index=19&type=chunk)[258](index=258&type=chunk)[265](index=265&type=chunk) [Condensed Consolidated Statements of Comprehensive Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Operations) Statements of comprehensive operations detail comprehensive income/loss for the three and six months ended June 30 Condensed Consolidated Statements of Comprehensive Operations Highlights (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net income (loss) | $(1,784) | $1,351 | $(828) | $(3,458) | | Change in fair value of financial instruments attributed to credit risk change | $(573) | $(256) | $74 | $68 | | Comprehensive income (loss) | $(2,357) | $1,095 | $(754) | $(3,390) | [Condensed Consolidated Statements of Convertible and Redeemable Preferred Stock and Stockholders' Deficit](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Convertible%20and%20Redeemable%20Preferred%20Stock%20and%20Stockholders%27%20Deficit) Details changes in convertible and redeemable preferred stock and stockholders' deficit, including stock-based compensation and net income/loss Stockholders' Deficit Changes (in thousands) | Item | Balance as of Dec 31, 2024 | Stock-based compensation | Change in fair value of financial instruments | Series E-1 Shares dividends | Net income (loss) | Balance as of June 30, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Total Stockholders' Deficit | $(71,257) | $101 | $74 | $(4) | $(828) | $(69,616) | - Issuance of common stock upon noncash exercise of purchase rights added **$1 thousand** to common stock and **$1 thousand** to additional paid-in capital for the six months ended **June 30, 2025**[25](index=25&type=chunk) - Issuance of **Aditxt Notes – Related Party** added **$2,296 thousand** to additional paid-in capital for the six months ended **June 30, 2025**[25](index=25&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Statements of cash flows show net cash used in operating activities and provided by financing activities for the six months ended June 30 Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(2,359) | $(1,018) | $(1,341) | | Net cash used in investing activities | $(59) | $(14) | $(45) | | Net cash provided by financing activities | $2,425 | $1,144 | $1,281 | | Net change in cash, cash equivalents and restricted cash | $7 | $112 | $(105) | | Cash, cash equivalents and restricted cash, end of period | $748 | $692 | $56 | - Primary sources of cash from financing activities for the six months ended **June 30, 2025**, included **$2.4 million** from **Aditxt Notes – Related Party** and **$383 thousand** from short-term debt and Notes[29](index=29&type=chunk)[284](index=284&type=chunk) - Primary uses of cash from operating activities for the six months ended **June 30, 2025**, included payments of routine trade payables (**$0.7 million**), contingent liabilities (**$0.4 million**), and inventory purchases (**$0.5 million**)[282](index=282&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures for the unaudited financial statements, including going concern risk and accounting policies [1. Description of Business and Basis of Presentation](index=13&type=section&id=1.%20Description%20of%20Business%20and%20Basis%20of%20Presentation) Describes the company's business, commercialized products, and going concern risk, along with management's liquidity plans - **Evofem** commercializes **PHEXXI** (non-hormonal contraceptive vaginal gel, **FDA approved May 2020**) and **SOLOSEC** (single-dose oral antimicrobial for BV and trichomoniasis, **global rights acquired July 2024**, relaunched **November 2024**)[30](index=30&type=chunk)[31](index=31&type=chunk)[32](index=32&type=chunk) - The company's strategy includes global commercialization through partnerships, with **PHEXXI** and **SOLOSEC** licensed in **MENA** to **Pharma 1 Drug Store**. **PHEXXI** was approved in **Nigeria** and submitted for approval in **Mexico, Ethiopia, and Ghana**[33](index=33&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk) - The company has incurred operating losses and negative cash flows since inception, with a working capital deficit of **$64.9 million** and an accumulated deficit of **$898.5 million** as of **June 30, 2025**, raising **substantial doubt** about its ability to continue as a **going concern**[42](index=42&type=chunk)[48](index=48&type=chunk) - Management's plans to meet cash flow needs include generating **product revenue**, earning **milestone payments** from **Pharma 1**, **restructuring payables**, and obtaining **additional funding** through the **A&R Merger Agreement with Aditxt**, **non-dilutive financings**, or other partnerships[46](index=46&type=chunk)[48](index=48&type=chunk) - The company's common stock was moved from **OTCQB** to **OTC Pink Current** on **April 23, 2025**, and then to **Over-the-Counter Integrated Disclosure (OTCID)** on **July 1, 2025**, due to non-compliance with minimum bid price requirements[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk) [2. Summary of Significant Accounting Policies](index=15&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Details significant accounting policies, including segment reporting, credit risk, EPS calculations, and recently issued accounting pronouncements - The company operates and manages its business as **one operating segment**, with the CEO as the chief operating decision-maker[52](index=52&type=chunk) - Significant estimates are made for **revenue variable consideration**, **expected credit losses**, **fair value of financial instruments**, **inventory valuation**, and **deferred tax assets**[51](index=51&type=chunk) - The company is subject to credit risk from trade accounts receivable, with its three largest customers accounting for approximately **80%** of gross product sales and **90%** of trade accounts receivable as of **June 30, 2025**[55](index=55&type=chunk)[57](index=57&type=chunk) Potentially Dilutive Securities Excluded from Diluted EPS (in thousands) | Security Type | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Options to purchase common stock | 3,372 | 3,713 | | Warrants to purchase common stock | 263,062,099 | 20,807,539 | | Purchase rights to purchase common stock | 1,513,848,899 | 1,546,948,899 | | Convertible debt | 2,969,614,658 | 2,528,800,006 | | Series E-1 Shares | 149,350,650 | 127,801,537 | | Series F-1 Shares | 1,706,493,507 | 1,446,753,247 | | Total | 6,602,373,185 | 5,671,114,941 | - **No significant new accounting standards** were adopted during the six months ended **June 30, 2025**. Several ASUs (**2023-06, 2023-09, 2024-03, 2025-01, 2024-04, 2025-05**) are issued but not yet effective, and the company is evaluating their potential impact[65](index=65&type=chunk)[67](index=67&type=chunk)[68](index=68&type=chunk)[69](index=69&type=chunk)[70](index=70&type=chunk)[71](index=71&type=chunk) [3. Revenue](index=17&type=section&id=3.%20Revenue) Explains revenue recognition from product sales, adjusted for various variable considerations based on historical data and market information - Revenue is recognized when control of **PHEXXI** and **SOLOSEC** is transferred to the customer, typically upon receipt[74](index=74&type=chunk) - Revenue is recorded net of reserves for **variable consideration**, including distribution service fees, prompt pay and other discounts, product returns, chargebacks, rebates, and patient support programs[76](index=76&type=chunk)[84](index=84&type=chunk) Variable Consideration Recorded (in millions) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Contra trade accounts receivable | $0.1 | $0.3 | | Other current liabilities | $7.4 | $7.2 | [4. Debt](index=19&type=section&id=4.%20Debt) Details various debt instruments, including Baker Notes, Adjuvant Notes, SSNs, and Aditxt Notes, and related default situations - **Baker Notes** (originally **$25.0 million** principal) are now held by **Future Pak, LLC**, and are subject to a **Notice of Event of Default** from **September 2024**, claiming acceleration of repayment of the outstanding balance (approximately **$107.0 million**). The company disputes this claim[87](index=87&type=chunk)[106](index=106&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk) - **Adjuvant Notes** (**$25.0 million** principal) are unsecured convertible promissory notes with a **7.5%** annual interest rate, convertible into common stock. The company was in default as of **September 30, 2023**, but Adjuvant forbore the default[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk)[119](index=119&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - The company issued **Senior Subordinated Notes (SSNs)** and **Aditxt Notes** (total principal **$3.7 million** from **April-June 2025**) with warrants, which are unsecured senior subordinated notes with an **8%** interest rate (subject to increase to **12%** upon default) and a **three-year maturity**[124](index=124&type=chunk)[125](index=125&type=chunk)[129](index=129&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) Summary of SSNs and Aditxt Notes at Issuance (in thousands) | Notes | Principal At Issuance | Net Proceeds Before Issuance costs | Common Warrants | Maturity Date | Conversion Price At Issuance | Conversion Price At 6/30/2025 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | December 2022 Notes | $2,308 | $1,500 | 369,230 | 12/21/2025 | $6.25 | $0.0154 | | February 2023 Notes | $1,385 | $900 | 653,538 | 2/17/2026 | $2.50 | $0.0154 | | March 2023 Notes | $600 | $390 | 240,000 | 3/17/2026 | $2.50 | $0.0154 | | March 2023 Notes | $538 | $350 | 258,584 | 3/20/2026 | $2.50 | $0.0154 | | April 2023 Notes | $769 | $500 | 615,384 | 3/6/2026 | $1.25 | $0.0154 | | July 2023 Notes | $1,500 | $975 | 1,200,000 | 3/6/2026 | $1.25 | $0.0154 | | August 2023 Notes | $1,000 | $650 | 799,999 | 8/4/2026 | $1.25 | $0.0154 | | September 2023 Notes | $2,885 | $1,875 | 26,997,041 | 9/26/2026 | $0.13 | $0.0154 | | Aditxt April Note | $2,308 | $1,500 | 149,850,150 | 4/8/2028 | $0.0154 | $0.0154 | | Aditxt June Note | $1,423 | $925 | 92,407,592 | 6/26/2028 | $0.0154 | $0.0154 | - The company entered into an insurance premium finance agreement in **June 2025** for **$0.4 million** at **7.82%** annual interest, recorded as short-term debt[137](index=137&type=chunk) [5. Balance Sheet Details](index=28&type=section&id=5.%20Balance%20Sheet%20Details) Provides a breakdown of specific balance sheet accounts, including inventories, prepaid assets, intangible assets, and accrued expenses Inventories (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Raw materials | $111 | $350 | | Work in process | $752 | $982 | | Finished goods | $1,043 | $245 | | Total | $1,906 | $1,577 | Prepaid and Other Current Assets (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Insurance | $868 | $391 | | PDUFA fees | $202 | $606 | | Outside service retainers | $90 | $160 | | Short-term deposits | $125 | $127 | | Other | $97 | $175 | | Total | $1,382 | $1,459 | Intangible Asset, Net (in thousands) | Item | Useful Life | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | :--- | | Intellectual property | 16 years | $5,688 | $10,216 | | Less: accumulated amortization | | $(950) | $(619) | | Total, net | | $4,738 | $9,597 | - The intangible asset, related to the **SOLOSEC acquisition**, decreased by **$4.5 million** for the six months ended **June 30, 2025**, due to fair value adjustments[142](index=142&type=chunk) Accrued Expenses (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Clinical trial related costs | $- | $2,498 | | Accrued royalty | $1,962 | $1,976 | | Accrued compensation for non-employee directors | $627 | $505 | | Other | $738 | $530 | | Total | $3,327 | $5,509 | [6. Fair Value of Financial Instruments](index=29&type=section&id=6.%20Fair%20Value%20of%20Financial%20Instruments) Details fair value measurements of financial liabilities, including convertible debt and derivative liabilities, primarily classified as Level 3 Fair Value of Convertible Debt Instruments (in thousands) | Debt Instrument | Fair Value (June 30, 2025) | Fair Value (December 31, 2024) | Leveling | | :--- | :--- | :--- | :--- | | Baker Notes | $14,609 | $13,801 | Level 3 | | December 2022 Notes | $14 | $118 | Level 3 | | February 2023 Notes | $14 | $120 | Level 3 | | March 2023 Notes | $17 | $147 | Level 3 | | April 2023 Notes | $12 | $108 | Level 3 | | July 2023 Notes | $19 | $161 | Level 3 | | August 2023 Notes | $16 | $136 | Level 3 | | September 2023 Notes | $45 | $383 | Level 3 | | Aditxt Notes | $35 | $- | Level 3 | | Total Fair Value | $14,781 | $14,974 | N/A | Derivative Liabilities (in thousands) | Item | Fair Value (June 30, 2025) | Fair Value (December 31, 2024) | Leveling | | :--- | :--- | :--- | :--- | | Purchase rights | $3 | $1,359 | Level 3 | | Total derivative liabilities | $3 | $1,359 | N/A | - The fair value of **Baker Notes** increased by **$1.0 million** for the six months ended **June 30, 2025**, while total **SSNs** and **Aditxt Notes** decreased by **$1.1 million**[146](index=146&type=chunk) - **Derivative liabilities (purchase rights)** decreased significantly from **$1.359 million** at **December 31, 2024**, to **$3 thousand** at **June 30, 2025**, primarily due to a change in fair value presented in the condensed consolidated statements of operations[146](index=146&type=chunk)[148](index=148&type=chunk) - Valuation methodologies for **Baker Notes**, **SSNs**, **Aditxt Notes**, and **Purchase Rights** involve **Monte Carlo simulations** and **Option-Pricing Models (OPM)** using **Level 3 assumptions**, including future revenues, discount rates, and expected volatility[149](index=149&type=chunk)[150](index=150&type=chunk)[151](index=151&type=chunk) - The **SOLOSEC asset acquisition intangible asset** and **contingent liabilities** are valued using a **Monte Carlo simulation model**, with changes in fair value recorded as adjustments to both the contingent liabilities and the **SOLOSEC IP intangible asset**[153](index=153&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk)[156](index=156&type=chunk) [7. Commitments and Contingencies](index=34&type=section&id=7.%20Commitments%20and%20Contingencies) Outlines various commitments and contingencies, including SOLOSEC acquisition obligations, leases, and legal proceedings - The **SOLOSEC acquisition** was accounted for as an **asset acquisition**, with future sales-based payments recorded as **contingent liabilities** and total consideration as an **intangible asset**[157](index=157&type=chunk) - Commitments related to **SOLOSEC** include purchasing finished goods inventory from the seller through **November 2026** (expected **$3.5 million** total, **$0.4 million** in **H1 2025**) and quarterly royalty payments based on net revenue (immaterial in **H1 2025**)[158](index=158&type=chunk)[159](index=159&type=chunk) SOLOSEC Contingent Liabilities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Contingent liabilities – current | $100 | $700 | | Contingent liabilities – noncurrent | $4,900 | $9,700 | - The company leases **20 vehicles** under operating leases, with a weighted average remaining lease term of **1.83 years** and a weighted average discount rate of **12%** as of **June 30, 2025**[161](index=161&type=chunk)[164](index=164&type=chunk) - A supply and manufacturing agreement for **PHEXXI** resulted in **$0.8 million** in purchases for the six months ended **June 30, 2025**[165](index=165&type=chunk) - The company entered into a **License and Supply Agreement** with **Windtree Therapeutics, Inc.** (a related party) to manufacture **PHEXXI**, expecting to **significantly reduce COGS**. No transactions have occurred yet[166](index=166&type=chunk) - The company is involved in a **trademark dispute** with **TherapeuticsMD, Inc.**, requiring a **PHEXXI name change**. The company failed to meet the original settlement timeline but received **FDA approval** for a new name in **April 2025**. Accrued settlement amounts are **$0.4 million** as of **June 30, 2025**[171](index=171&type=chunk) - The company received multiple **notices of default** from **Future Pak, LLC** (holder of **Baker Notes**) claiming events of default and acceleration of repayment, which the company **strongly disputes**[173](index=173&type=chunk)[174](index=174&type=chunk)[175](index=175&type=chunk) - The **U.S. patent** licensed from **Rush University** for **PHEXXI** expired on **March 6, 2025**, ending royalty obligations to **Rush University**. **PHEXXI** remains protected by **four additional Orange Book patents** solely owned by **Evofem**[176](index=176&type=chunk)[177](index=177&type=chunk) [8. Convertible and Redeemable Preferred Stock and Stockholders' Deficit](index=39&type=section&id=8.%20Convertible%20and%20Redeemable%20Preferred%20Stock%20and%20Stockholders%27%20Deficit) Details outstanding warrants, preferred stock, common stock, and purchase rights, including changes in authorized shares - As of **June 30, 2025**, **263,062,099 warrants** to purchase common stock remain outstanding at a weighted average exercise price of **$0.18 per share**[183](index=183&type=chunk) - The **A&R E-1 Certificate of Designations**, effective **September 30, 2025**, increases authorized **Series E-1 Preferred Stock** from **2,300** to **10,000 shares** to allow for in-kind dividend payments. **Series E-1 shares** are convertible at **$0.0154 per share** as of **June 30, 2025**[185](index=185&type=chunk)[186](index=186&type=chunk) - **Series F-1 Preferred Stock** (**26,280 shares outstanding**) is convertible at **$0.0154 per share** and is held by **Aditxt**[187](index=187&type=chunk)[188](index=188&type=chunk) - The number of authorized common stock shares was increased to **3,000,000,000** effective **September 14, 2023**[190](index=190&type=chunk) - **Purchase Rights** for **1,513,848,899 shares** of common stock remain outstanding as of **June 30, 2025**, expiring **June 28, 2027**[192](index=192&type=chunk) Common Stock Reserved for Future Issuance (as of June 30, 2025) | Item | Common Equivalent Shares | | :--- | :--- | | Common stock issuable upon the exercise of stock options outstanding | 3,372 | | Common stock issuable upon the exercise of common stock warrants | 10,595,019 | | Common stock available for future issuance under the 2019 ESPP | 509 | | Common stock available for future issuance under the Amended and Restated 2014 Plan | 5,789 | | Common stock available for future issuance under the Amended Inducement Plan | 609 | | Common stock reserved for the exercise of purchase rights | 741,490,642 | | Common stock reserved for the conversion of convertible notes | 413,458,756 | | Common stock reserved for the conversion of series E-1 preferred stock | 59,319,137 | | Total common stock reserved for future issuance | 1,224,873,833 | [9. Stock-based Compensation](index=45&type=section&id=9.%20Stock-based%20Compensation) Reports stock-based compensation expense for the three and six months ended June 30, and unrecognized compensation for employee stock options Stock-based Compensation Expense (in thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $- | $10 | $1 | $26 | | Selling and marketing | $2 | $24 | $5 | $59 | | General and administrative | $29 | $185 | $95 | $371 | | Total | $31 | $219 | $101 | $456 | - Unrecognized stock-based compensation expense for employee stock options was approximately **$0.1 million** as of **June 30, 2025**, with a weighted-average remaining recognition period of **0.2 years**[196](index=196&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=46&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's perspective on financial condition, operations, commercial strategies, and liquidity challenges, including the Aditxt merger [Overview](index=46&type=section&id=Overview) Provides an overview of Evofem's commercial-stage focus on women's health products, PHEXXI and SOLOSEC, and global expansion strategies - **Evofem** commercializes **PHEXXI**, the first and only non-hormonal prescription contraceptive vaginal gel, and **SOLOSEC**, an **FDA-approved single-dose oral antimicrobial** for **bacterial vaginosis (BV)** and **trichomoniasis**[199](index=199&type=chunk)[200](index=200&type=chunk)[202](index=202&type=chunk) - **PHEXXI** has achieved **net sales growth** in each consecutive year since its **September 2020** launch, with **2025 growth drivers** including social media campaigns, medical conferences, and expanding use with **GLP-1 prescription medications**[201](index=201&type=chunk) - The company acquired **global rights to SOLOSEC** in **July 2024** and relaunched the brand in **November 2024**, leveraging existing commercial infrastructure[202](index=202&type=chunk) - Global expansion is pursued through ex-U.S. partnerships, with **PHEXXI** and **SOLOSEC** licensed to **Pharma 1** in **MENA**, and **PHEXXI** approved in **Nigeria** and submitted for approval in **Mexico, Ethiopia, and Ghana**[203](index=203&type=chunk)[204](index=204&type=chunk)[205](index=205&type=chunk)[206](index=206&type=chunk) - A **Phase 4 clinical trial** for **SOLOSEC**, funded by **NIH**, is underway to evaluate its efficacy and cost-effectiveness against metronidazole for trichomoniasis in men and women[207](index=207&type=chunk)[208](index=208&type=chunk) [Recent Developments](index=48&type=section&id=Recent%20Developments) Highlights recent developments including stock market tier changes, preferred stock adjustments, Aditxt Notes issuance, and merger agreement amendments - Company's common stock began trading on the **Over-the-Counter Integrated Disclosure (OTCID)** market tier on **July 1, 2025**[209](index=209&type=chunk) - Authorized shares of **Series E-1 Preferred Stock** increased from **2,300** to **10,000**, effective **September 30, 2025**, to allow for in-kind dividend payments[210](index=210&type=chunk) - Issued **Aditxt April Note ($2.3 million principal)** and **Aditxt June Note ($1.4 million principal)** with warrants, generating approximately **$2.4 million** in net proceeds[211](index=211&type=chunk)[212](index=212&type=chunk)[213](index=213&type=chunk) - The **A&R Merger Agreement with Aditxt** has been amended **five times**, with the latest amendment (**March 22, 2025**) extending the consummation date to **September 30, 2025**, and including a **$1.5 million Fifth Parent Investment**[215](index=215&type=chunk)[216](index=216&type=chunk)[225](index=225&type=chunk) - A condition of the merger closing is the full payment of the **Baker Notes** outstanding balance, not to exceed the Repurchase Price[226](index=226&type=chunk) [PHEXXI as a Contraceptive; Commercial Strategies](index=50&type=section&id=PHEXXI%20as%20a%20Contraceptive%3B%20Commercial%20Strategies) Details PHEXXI's promotion, commercial strategies for 2025, and efforts to increase access through pharmacy partnerships and government programs - **PHEXXI** is a non-hormonal prescription contraceptive vaginal gel, launched in **September 2020**, promoted to HCPs and available via telehealth[228](index=228&type=chunk) - Key **growth drivers for 2025** include social media campaigns, strategic medical conferences, and expanding use in women taking **GLP-1 medications** (e.g., Ozempic, Mounjaro, Zepbound) where oral birth control may be less effective[201](index=201&type=chunk)[231](index=231&type=chunk) - The company is focusing on **pharmacy partnerships** to increase access, having expanded its network with a major national chain and two regional partners[233](index=233&type=chunk) - **PHEXXI** is covered by a major PBM (**46 million lives**) and the U.S. Department of Veterans Affairs (**13.7 million lives**). The company participates in **Medicaid** and **340B programs**, with approximately **83%** of commercial and Medicaid **PHEXXI** prescriptions approved by payers[234](index=234&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk) - Effective **January 1, 2023**, most insurers and PBMs must provide **$0 out-of-pocket coverage** for **FDA-approved contraceptives** like **PHEXXI**[236](index=236&type=chunk) [SOLOSEC](index=52&type=section&id=SOLOSEC) Describes SOLOSEC as an FDA-approved single-dose antimicrobial for BV and trichomoniasis, emphasizing its efficacy and compliance benefits - **SOLOSEC** is an **FDA-approved single-dose oral antimicrobial** for **bacterial vaginosis (BV)** and **Trichomonas vaginalis (trichomoniasis)** in individuals **12 years** and older[238](index=238&type=chunk)[248](index=248&type=chunk) - **BV** affects an estimated **21 million women** in the U.S. and is associated with increased risk of STIs and other health complications if untreated[239](index=239&type=chunk)[240](index=240&type=chunk) - **SOLOSEC** demonstrated **clinically and statistically significant efficacy** for **BV** (**68%** did not require additional treatment) and a **92.2% cure rate** for trichomoniasis in women in clinical trials[242](index=242&type=chunk)[245](index=245&type=chunk) - A **single-dose regimen** is a significant differentiator for **SOLOSEC**, addressing non-compliance issues common with multi-day treatments for **BV** and **trichomoniasis**[241](index=241&type=chunk)[245](index=245&type=chunk) - An investigator-led **Phase 4 clinical trial**, funded by **NIH**, is evaluating **SOLOSEC's** efficacy and cost-effectiveness for trichomoniasis in men and women against multi-dose metronidazole[246](index=246&type=chunk) [Financial Operations Overview](index=52&type=section&id=Financial%20Operations%20Overview) Outlines revenue recognition, operating expenses (COGS, R&D, S&M, G&A), and other income/expense components of the company's financial operations - Revenue is recognized from unit shipments of **PHEXXI** and **SOLOSEC**, adjusted for **variable consideration** like patient support programs[249](index=249&type=chunk) - Cost of goods sold includes purchased materials, direct labor, and manufacturing overhead. **Rush royalty payments ended** due to patent expiration, but quarterly royalties are now paid under the **SOLOSEC Asset Purchase Agreement**[250](index=250&type=chunk)[251](index=251&type=chunk) - Research and development expenses focus on continuous improvements, product characterization, and raw material evaluation, with **no significant investment in clinical development** anticipated for the foreseeable future[253](index=253&type=chunk) - Selling and marketing expenses cover **PHEXXI** and **SOLOSEC commercialization**, telehealth platform, training, and **PDUFA fees**. General and administrative expenses include salaries, benefits, business development, investor relations, and professional fees[254](index=254&type=chunk)[255](index=255&type=chunk) - Other income (expense) primarily consists of **interest expense** and **fair value adjustments of financial instruments**[256](index=256&type=chunk) [Results of Operations](index=55&type=section&id=Results%20of%20Operations) Provides a comparative analysis of financial performance for the three and six months ended June 30, detailing changes in sales and expenses [Three Months Ended June 30, 2025 Compared to Three Months Ended June 30, 2024](index=55&type=section&id=Three%20Months%20Ended%20June%2030%2C%202025%20Compared%20to%20Three%20Months%20Ended%20June%2030%2C%202024) Compares financial performance for the three months ended June 30, 2025, versus 2024, highlighting changes in sales, expenses, and other income Financial Performance (Three Months Ended June 30, in thousands) | Item | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $4,825 | $4,160 | $665 | 16% | | Cost of goods sold | $755 | $769 | $(14) | (2)% | | Research and development, net | $746 | $270 | $476 | 176% | | Selling and marketing | $2,625 | $2,243 | $382 | 17% | | General and administrative | $1,843 | $2,267 | $(424) | (19)% | | Total other income (expense), net | $(526) | $2,748 | $(3,274) | (119)% | - Increase in R&D expenses primarily due to a **$0.3 million increase** in outside services and a **$0.1 million increase** in facilities costs[260](index=260&type=chunk) - Increase in S&M expenses primarily due to a **$0.3 million increase** related to the **PDUFA fee for SOLOSEC**[261](index=261&type=chunk) [Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024](index=56&type=section&id=Six%20Months%20Ended%20June%2030%2C%202025%20Compared%20to%20Six%20Months%20Ended%20June%2030%2C%202024) Compares financial performance for the six months ended June 30, 2025, versus 2024, detailing changes in sales, expenses, and other income Financial Performance (Six Months Ended June 30, in thousands) | Item | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $5,670 | $7,763 | $(2,093) | (27)% | | Cost of goods sold | $1,120 | $1,453 | $(333) | (23)% | | Research and development, net | $(4,289) | $864 | $(5,153) | (596)% | | Selling and marketing | $5,225 | $4,588 | $637 | 14% | | General and administrative | $4,208 | $5,091 | $(883) | (17)% | | Total other income, net | $103 | $783 | $(680) | (87)% | - Decrease in R&D expenses primarily due to a **$5.6 million reduction** from trade payable negotiations and a **$0.2 million decrease** in personnel costs, partially offset by a **$0.6 million increase** in facilities and outside services[267](index=267&type=chunk) - Decrease in total other income, net, due to a lower **gain on the change in fair value of financial instruments** (**$1.4 million** in **2025** vs. **$4.1 million** in **2024**) and the absence of a **$1.1 million gain on debt extinguishment** in **2025**[271](index=271&type=chunk)[272](index=272&type=chunk) [Liquidity and Capital Resources](index=58&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses the company's working capital deficit, accumulated deficit, cash position, and management's plans to address going concern risk - As of **June 30, 2025**, the company had a **working capital deficit of $64.9 million** and an **accumulated deficit of $898.5 million**[274](index=274&type=chunk) - Cash and cash equivalents were **$0.7 million** as of **June 30, 2025**, all of which is **restricted cash**, deemed **insufficient to fund operations for the next 12 months**, raising **substantial doubt** about the company's ability to continue as a **going concern**[274](index=274&type=chunk)[278](index=278&type=chunk) - Management's plans to meet cash flow needs include generating revenue from **PHEXXI** and **SOLOSEC**, **restructuring current payables**, and obtaining **additional funding** through capital stock issuance, **non-dilutive financings**, collaborations, or business combinations (e.g., **Aditxt merger**)[277](index=277&type=chunk) - The company's independent registered public accounting firm's opinion on **2024** and **2023** audited financial statements includes an explanatory paragraph regarding **substantial doubt about its ability to continue as a going concern**[281](index=281&type=chunk) Summary Statement of Cash Flows (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(2,359) | $(1,018) | $(1,341) | (132)% | | Net cash used in investing activities | $(59) | $(14) | $(45) | (321)% | | Net cash provided by financing activities | $2,425 | $1,144 | $1,281 | 112% | | Net change in cash, cash equivalents and restricted cash | $7 | $112 | $(105) | (94)% | [Contractual Obligations and Commitments](index=60&type=section&id=Contractual%20Obligations%20and%20Commitments) Outlines the company's contractual obligations, including operating leases, PHEXXI supply agreements, and SOLOSEC acquisition commitments - **Operating lease right-of-use assets** and **lease liabilities** were **$0.2 million** as of **June 30, 2025**[286](index=286&type=chunk) - Purchases under the **PHEXXI supply and manufacturing agreement** were **$0.8 million** for the six months ended **June 30, 2025**[287](index=287&type=chunk) - Commitments related to the **SOLOSEC asset acquisition** include inventory purchases through **November 2026** and **contingent liabilities** and quarterly royalties based on **SOLOSEC net revenue**[288](index=288&type=chunk) - **Royalty costs** to **Rush University** for **PHEXXI** ended for the three and six months ended **June 30, 2025**, due to the expiration of the **Rush patent**[289](index=289&type=chunk) [Other Matters](index=60&type=section&id=Other%20Matters) Refers to Note 2 for accounting pronouncements and confirms no material changes to critical accounting policies since the 2024 Form 10-K - Information on **recently issued accounting pronouncements** is provided in **Note 2**[290](index=290&type=chunk) - **No material changes** to **critical accounting policies** since the **2024 Form 10-K**[291](index=291&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=60&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) States that no quantitative and qualitative disclosures about market risk are applicable for the reporting period - **Not applicable** for this reporting period[292](index=292&type=chunk) [Item 4. Controls and Procedures](index=60&type=section&id=Item%204.%20Controls%20and%20Procedures) Concludes that disclosure controls and procedures were ineffective due to material weaknesses, with ongoing remediation efforts - CEO and CFO concluded that disclosure controls and procedures were **not effective** as of **June 30, 2025**, due to **material weaknesses in internal control over financial reporting**[294](index=294&type=chunk) - Management believes the condensed consolidated financial statements **fairly present** the financial condition, results of operations, and cash flows in all material respects, despite the ineffective controls[295](index=295&type=chunk) - **Remediation activities** for identified material weaknesses are ongoing, but there is no assurance of completion or prevention of future weaknesses[296](index=296&type=chunk) - **No material changes** in internal control over financial reporting occurred during the latest fiscal quarter, apart from ongoing remediation activities[297](index=297&type=chunk) [PART II. OTHER INFORMATION](index=62&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=62&type=section&id=Item%201.%20Legal%20Proceedings) Refers to Note 7 for disclosures regarding legal proceedings, indicating relevant information is provided within the financial statement notes - Refer to **Note 7 - Commitments and Contingencies** for disclosures on legal proceedings[300](index=300&type=chunk) [Item 1A. Risk Factors](index=62&type=section&id=Item%201A.%20Risk%20Factors) States that there have been no material changes to the risk factors disclosed in the company's Form 10-K for the year ended December 31, 2024 - **No material changes** to risk factors since the **Form 10-K for the year ended December 31, 2024**[301](index=301&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=62&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Indicates that there were no unregistered sales of equity securities or use of proceeds to report for the period - **None to report**[302](index=302&type=chunk) [Item 3. Defaults Upon Senior Securities](index=62&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Confirms that the company does not have any defaults on any Senior Securities as of the filing date - **No defaults** on any **Senior Securities** as of the filing date[303](index=303&type=chunk) [Item 4. Mine Safety Disclosures](index=62&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) States that mine safety disclosures are not applicable to the company - **Not applicable**[304](index=304&type=chunk) [Item 5. Other Information](index=62&type=section&id=Item%205.%20Other%20Information) Reports no Rule 10b5-1 or non-Rule 10b5-1 trading arrangements by directors or officers during the three months ended June 30, 2025 - **No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements** were entered into, modified, or terminated by directors or officers during the three months ended **June 30, 2025**[305](index=305&type=chunk) [Item 6. Exhibits](index=62&type=section&id=Item%206.%20Exhibits) Lists the exhibits filed as part of the Form 10-Q, including merger amendments, agreements, and certifications - The exhibit index includes **amendments to the Amended and Restated Plan of Merger**, **License and Supply Agreements**, **Securities Purchase Agreements**, and **certifications** (e.g., **31.1, 31.2, 32.1**)[308](index=308&type=chunk)[310](index=310&type=chunk) - **Financial information** in **XBRL format** is furnished electronically[311](index=311&type=chunk) [Signatures](index=64&type=section&id=Signatures) Contains the required signatures for the Form 10-Q, certifying its submission pursuant to the Securities Exchange Act of 1934 - Report signed by **Ivy Zhang, Chief Financial Officer** (**Principal Financial Officer and Principal Accounting Officer**) on **August 14, 2025**[316](index=316&type=chunk)

[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)

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].

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]