EVFM 10-K & 10-Q changes, risk factors and insider trading

Risks Related to Commercialization of PHEXX, SOLOSEC, and salesAny expansionOther of ourApproved Products

As of February 28, 2025,2026, we had approximately $11.2$12.7 million in accounts payable with approximately $9.5$10.4 million that is over 90 days past due. If we are unable to repay these amounts, as well as our existing debt obligations at maturity, and we are otherwise unable to extend the maturity dates or refinance these obligations, we wouldwill be in default. We cannot provide any assurances that we will be able to raise the necessary amount of capital to repay these obligations or that we will be able to extend the maturity dates or otherwise refinance these obligations. Upon a default, our secured lenders would have the right to exercise their rights and remedies to collect, which would include foreclosing on our assets. Accordingly, a default would have a material adverse effect on our business, and we would likely be forced to seek bankruptcy protection.

Our audited consolidated financial statements includedinclude a statement that there is a substantial doubt about our ability to continue as a going concern and a continuation of negative financial trends could result in our inability to continue as a going concern.

Additionally, if our operating results fail to improve, we could violate additional debt covenants, our liquidity could be further adversely impactedimpacted, and we may need to seek additional sources of funding. There is no assurance that we will be able to raise additional capital to fund our operations or that debt or equity financingfinancings will be available in sufficient amounts or on acceptable terms. If our operating results fail to improve, then our financial condition could render us unable to continue as a going concern.

We have incurred yearly losses and negative cash flows since our inception, other than net income of $0.4 million (excluding deemed dividends) for the year ended December 31, 2025, primarily attributable to a non-cash gain on change in accounting estimates on contingent royalty liability and settlement of a portion of its trade payables with vendors, and net income of $53.0 million (excluding deemed dividends) for the year ended December 31, 2023, which was primarily attributable to a non-cash gain on debt extinguishment. As of December 31, 2024,2025, we had an accumulated deficit of $897.7$897.4 million. Negative cash flows from our operations are expected to continue for the foreseeable future. To date, we have devoted substantially all our financial resources to the development and commercialization of PHEXXI PHEXX for hormone-free contraception andcontraception, to clinical trials investigating the developmentpotential utility of EVO100PHEXX for the prevention of chlamydia and gonorrheagonorrhea, and development of our other product candidates, as well as providing general and administrative support for our operations. Our utilization of cash has historically been highly dependent on these development programs and the commercialization of PHEXXIPHEXX in the U.S. In October 2022, we discontinued development of EVO100 and have no plans to advance clinical development of this program or to significantly invest in otherour clinical programs or product candidates for the foreseeable future. We plan to allocate capital to fund our continued commercialization efforts. Our cash expenses will also continue to be dependent on the terms and conditions of our contracts with service providers and any license partners.

To date, we have financed our operations primarily through the sale of equity securities, promissory notes, warrants, convertible notes, notes, convertible preferred stock and through other debt arrangements. The amount of our future net losses will depend, in large part, on our ability to generate revenue from the sale of PHEXXIPHEXX and SOLOSEC, the rate of our future expenditures and our ability to obtain additional funding through equity or debt financings, strategic collaborations or grants which may be particularly challenging or impossible in light of market conditions. The commercialization and development of biopharmaceutical products involves a substantial degree of risk.

TheDue net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. Due to the recurring losses, negative cash flows from operating activities since inception, and a net working capitaldeficit at December 31, 2024, 2025, the report of our independent registered public accountant on our consolidated financial statements as of and for the year ended December 31, 20242025 filed with this Annual Report on Form 10-K for the year ended December 31, 20242025 includes explanatory language describing the existence of substantial doubt about our ability to continue as a going concern. In addition, our management has further determined that there is a substantial doubt about our ability to continue as a going concern over the next 12 months from the filing date of March 24,11, 2025.2026.

Although we have generated revenue from product sales, weWe may never be profitable. Our operating results may differ from any guidance we may announce.

Our current business is substantially dependent on the commercial success of PHEXXI,PHEXX, and to a lesser extent, SOLOSEC. The commercial launch launch of PHEXXIPHEXX took place on September 8, 2020, and although we have generated revenue from sales of PHEXXI,PHEXX, we may never achieve or sustain profitability, even with the addition of revenue from SOLOSEC since we acquired global rights to the product in July 2024. Our ability to generate revenue and achieve and sustain profitability depends on our ability, alone or with strategic collaborators, to successfully commercialize PHEXXIPHEXX and SOLOSEC and, to a lesser extent, any future products we may license, acquire, or otherwise commercialize. Our ability to generate future revenue from product sales depends heavily on our success in many areas, including, but not limited to:

From time to time, we may provide guidance as to our anticipated future performance and certain unit shipment information, prescription and prescriber statistics, website and search statistics and other metrics. We may fail to achieve the performance described in any such guidance, and any information or metrics we may provideprovide, may be not be indicative of future results. In addition, we provide co-pay assistance to commercially insured patients with an approved PHEXXIPHEXX or SOLOSEC prescription and utilize a sample program to promote demand for our products. While the co-pay program reduces the amount of profit we realize per unit sold, it is a value-add program to patients that we aim to continue in 2025.2026. Because of the expense to run the program, we will look to modify the business rules surrounding the co-pay program in the future, particularly as payers increasingly cover PHEXXIPHEXX at $0 co-pay to comply with HRSA guidelines; compliance was mandated beginning January 1, 2023 and enforcement action is anticipated. If we are not able to generate sufficient net sales of our products, the net sales of our products isare not sufficiently profitable, we fail to meet our guidance, or our information or metrics is not indicative of our future results of operations, this could materially and adversely affect our business results of operations, the price of our Common common stock,Stock, our financial condition and our ability to raise additional capital.

We will need to raise significant additional funds to finance our operations, including the commercialization of PHEXXIPHEXX and SOLOSEC, and to remain a going concern. If we are unable to raise additional capital when needed or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our business initiatives or to cease our operations entirely.

We have incurred significant losses and negative cash flows since our inception.inception and have approximately $10.4 million in over 90 days past due payables as of February 28, 2026. We believe our existing capital resources as of the filing of this Annual Report are sufficient to fund our planned operations intofor a limited period, likely not past the first half of 2025.2026. Our ability to raise additional funds will will depend, in part, on our ability to successfully commercialize PHEXXIPHEXX and SOLOSEC (collectively our Products) in the U.S. If, for whatever reason,If we are unsuccessful in these efforts, it may make any necessary debt, equity or alternative financing more difficult, more costly and more dilutive. Attempting to secure additional financingfinancings will divert our management team from our day-to-day activities, which may may adversely affect our ability to commercialize our Products. In addition, we cannot guarantee that future financing(s) will be available available in sufficient amounts or on terms acceptable to us, if at all. Furthermore, the global credit and financial markets have experienced experienced extreme volatility and disruptions in recent history, particularly for life science companies. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing(s) more difficult, more costly and more dilutive. If we are unable to raise additional funds when needed or on acceptable terms, we may be unable to continue commercializing our products. In addition, we may be required to delay, scale back or eliminate some or all of our business initiatives or be forced to cease operations entirely. To the extent we raise additional capital through the sale of equity, convertible debt or other securities convertible into equity, the ownership interest of our stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Future debt financings, if available at all, would likely involve agreements with additional covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, making additional product acquisitions, or declaring dividends. If we raise additional funds through strategic collaborations, alternative non-dilutive financing, such as royalty-based financing, or licensing arrangements with third parties, we may have to relinquish valuable rights to our products, or future revenue streams or grant licenses on terms that are not favorable to us.

Women’s health has historically been an underfunded sector. Recently, a number of public companies focused in women’s health have failed to achieve expected commercial success and struggled to access sufficient capital. We are solely focused in women’s health and may be unfavorably impacted by weak investor sentiment and a lack of interest in the category. Our ability to access capital and to advance our candidates could be adversely impacted.

Women’s health has historically been an underfunded sector. Recently, a number of public companies focused in women’s health have failed to achieve expected commercial success and struggled to access sufficient capital. We are solely focused in women’s health, and primarily in the areas of contraception, vaginal health, reproductive health, and sexual health. The sector has historically been underfunded, with only about one percent of healthcare research and innovation in the U.S. invested in female-specific conditions beyond oncology according to market research.research22. The failure of the women’s health sector to receive consistent and committed investment fuels investor sentiment that market opportunities for new products in women’s health are limited. Our stock price and our ability to access additional capital on acceptable terms when needed may be adversely impacted by unfavorable investor perception of market opportunities for women’s health products, and our business, operating results, financial condition, and prospects could suffer.

In April 2020, we entered into a Securities Purchase and SecuritiesSecurity Agreement (the Baker Bros. Purchase Agreement) with certain institutional investors and their designated agent pursuant to which we issued and sold secured convertible promissory notes in an aggregate principal amount of $25.0 million and warrants to purchase shares of our commonCommon stock.Stock. In November 2021, we entered into the first amendment to theThe Baker Bros. Purchase AgreementAgreement, which extendedis thesecured affirmativeby substantially covenantall of our assets, was amended from time to achievetime $100.0as milliondisclosed in cumulative net sales of PHEXXI by June 30, 2022 to June 30, 2023.herein. On MarchJuly 7,23, 2023,2024, Baker Bros. Advisors,assigned LPthe Baker Notes to Future Pak, LLC (the Designated AgentAssignee) provided a Notice of Event of Default and Reservation of Rights (the NoticeJuly 2024 Assignment). The terms of Default)the relatingBaker Notes were not changed in connection with the assignment from Baker to the Baker Bros. Purchase Agreement.Assignee.

22 Evaluate Pharma (2025). Kearney analysis. https://www.evaluate.com/ as cited in the World Economic Forum white paper Prescription for Change: Policy Recommendations for Women’s Health Research (May 2025). https://reports.weforum.org/docs/WEF_Prescription_for_Change_2025.pdf On September 27, 2024, theAssignee, Assignee, as agent for the Purchaserspurchasers (in such capacity, the Designated Agent) provided a Notice of Event of Default and Reservation of Rights (the September 2024 Notice of Default) relating to the SecuritiesBaker Bros. Purchase and Security Agreement dated April 23, 2020, as amended, by and among the Company, Designated Agent, as certain guarantors and the purchasers (each a Purchaser and collectively Purchasers).Agreement. The September 2024 Notice of Default claims that by entering into arrangements to repay certain existing obligations, including obligations owed to the U.S. Department of Health and Human Services (HHS), an Event of Default has occurred under Section 9.1(e) of the SPA.Baker Bros. Purchase Agreement. According to the September 2024 Notice of Default, the Designated Agent has accelerated repayment of the outstanding principal balance owed by the Company under the Securities Baker Bros. Purchase Agreement. IfThe allDesignated PurchasersAgent exerciseprovided two additional notices asserting additional events of default under the Sectionrelevant 5.7governing Option (as defined below), the repurchase price would be equal to the total outstanding balance, including principal and accrued interest. Pursuant to Section 5.7(b) of the SPA, upon the occurrence of an Event of Default, each Purchaser may elect, at its option, to require the Company to repurchase the Note held by such Purchaser (or any portion thereof) at a repurchase price equal to two times the sum of the outstanding principal balance and all accrued and unpaid interest thereon, due within three business days after such Purchaser delivers a notice of such election (the Section 5.7 Option).documents.

We are currently authorized to issue 3,000,000,000 shares of commonCommon stockStock under our amended and restated certificate of incorporation. As of MarchFebruary 14,28, 20252026, we have issued 113,356,354126,685,925 shares of commonCommon stockStock and approximately 964 million1,395,303,768 shares of commonCommon stockStock were committed for issuance giving effect to the assumed exercise of all outstanding warrants, options, purchase rights and the assumed conversion of all issued and outstanding convertible notes after accounting for the security holders who have waived the requirement for shares to be reserved for conversion of their instruments. TheCertain conversionoutstanding pricesconvertible securities contain price adjustment provisions that may result in the issuance of theadditional Adjuvantshares Convertibleif Notes (aswe amended) and Senior Subordinate Notes may also be subject to adjustment depending on the price of issuances incomplete future financings at prices below the applicable conversion or exercise asprice. describedAs above.a These adjustments would further increaseresult, the number of authorized but unissued shares of commonCommon stock to be reserved as a result of these adjustments. Due to the limited number of authorized shares common stockStock available for future issuance, weissuance may not be ableinsufficient to support raise additional equity capitalfinancings or completestrategic atransactions mergerwithout orfirst other business combination unless we increase the number of shares we are authorized to issue. We would need to seekobtaining stockholder approval to increase the number of ourauthorized shares. authorized shares of Common Stock, and weThere can providebe no assurance that westockholders would succeedapprove insuch amendingan amendment to our amended and restated certificate of incorporationincorporation. to increase the number of shares of Common StockIf we are unable to increase our authorized share capital when needed, our ability to issueraise whichcapital, refinance indebtedness, or consummate a merger or other strategic transaction could negativelybe impactmaterially ouradversely business, prospects, and results of operations.affected.

Our ability to utilize our net operating loss (NOL) carryforwards and other tax attributes to offset future taxable income or tax liabilities may be limited as a result of ownership changes. Corresponding rules may apply under state tax laws. Even if there is no limitation on utilization of our NOL carryforwards as the result of an ownership change, the utilization of NOL carryforwards may be limited by other applicable laws. Pursuant to the TCJATax Cuts and Jobs Act passed in December 2017, carryforwards originating from a loss incurred in a year after 2017 are limited and may reduce taxable income in any post-2020 year by no more than 80% of the pre-NOL taxable income in such year. The Coronavirus Aid, Relief and Economic Security Act (the CARES Act) temporarily suspended this 80% taxable income limitation, allowing an NOL carryforward to fully offset taxable income in tax years beginning before January 1, 2021. Additional legislation or regulation which could affect our tax burden could be enacted by any governmental authority. We cannot predict the timing or extent of such tax-related developments which could have a negative impact on our financial results, including a potential increase in federal corporate tax rates generally. We cannot estimate how the changes in tax law from this legislation will affect our tax liability in future years, but we have recorded a valuation allowance related to our NOLs and other deferred tax assets due to the uncertainty of the ultimate realization of the future benefits from those assets. We have established a full valuation allowance for our deferred tax assets due to uncertainties as to their utilization. While we use our best judgment in attempting to quantify and reserve for our tax obligations.obligations, there is no guarantee that our estimates are accurate. A challenge by a taxing authority, our ability to utilize tax benefits such as carryforwards or tax credits, or a deviation from other tax-related assumptions may cause actual results to deviate from previous estimates.

Given our current financial condition, we have considered and may continue to consider filing for bankruptcy protection. While we have not initiated bankruptcy proceedings, we caution that trading in our securities is highly speculative and poses substantial risks relating relating to the potential of bankruptcy proceedings should we fail to consummate a strategic transaction such as the Merger (as defined in Note 1 - Business).proceedings. Trading prices for our securities may bear little or no relationship to the actual recovery, if any, by holders of our securities in Bankruptcy proceedings, if any.

Further, we may currently, or in the future, be operating in the “zone of insolvency” as described under Delaware law, which is our our jurisdiction of incorporation. Generally, a corporation’s directors owe a fiduciary duty to the corporation’s shareholders shareholders and not to its creditors. However, when a corporation is operating in the “zone of insolvency,” some courts have concluded that the fiduciary duty of directors shiftsmay shift to include creditors. Delaware courts have taken the position that directors of a corporation operating in the zone of insolvency continue to owe a fiduciary duty to the corporation’s stockholders but also owe such duty to its creditors. Accordingly, our management and directors may be required to consider their duties with regard to both stockholders and creditors in their decision making processes.

Our future results could be dependent upon the successful confirmation and implementation of a bankruptcy plan or other alternative restructuring transaction, including a sale of all or substantially all of our assets. A long period of operations under Bankruptcy Court protection could have a material adverse effect on our business, financial condition, results of operations and liquidity. Failure to obtain confirmation of a Chapter 11 plan or approval and consummation of an alternative restructuring transaction in a timely manner may harm our ability to obtain financing to fund our operations, and there is a significant risk that the value of our securities and assets would be substantially eroded to the detriment of all stakeholders. If a Chapter 11 plan that complies with the applicable provisions of the Bankruptcy Code cannot be agreed upon, it is possible that we would have to liquidate our assets, in which case it is likely that holders of claims would receive substantially less favorable treatment than they would receive if we were to emerge as a viable, reorganized entity.

If filed, as long as bankruptcy proceedings continue, we will be required to incur substantial costs for professional fees and other expenses associated with the administration of the Chapter 11 or Chapter 7bankruptcy proceedings. Chapter 11Such proceedings may also require us to seek debtor-in-possession financing to fund operations. If we are unable to obtain such financing on favorable terms or at all, our chances of successfully reorganizing our business may be seriously jeopardized, the likelihood that we instead will be required to liquidate our assets may be enhanced, and, as a result, any securities in us could become further devalued or become worthless.

WeApproved are a San Diego-based commercial-stage biopharmaceutical company with a strong focus on innovation in women’s health. Our first commercial product, PHEXXI, was approved by the FDA on May 22, 2020.2020, PHEXXIPHEXX is the first and only non-hormonal prescription contraceptive gel. It is locally acting, with no systemic activity, and used on-demand by women only when they have sex. Because PHEXXIPHEXX is a non-hormonal contraceptive, it is not associated with side effects of exogenous hormone useuse. likeIn some women, these side effects may include depression, weight gain, headaches, loss of libido, mood swings and irritability. Taking hormones may not be right for some women, especially those with certain medical conditions, including clotting disorders hormone-sensitive cancer, diabetesdiabetes, or a BMI over 30, or those who are breast feeding or who smoke. MorePer the National Center for Health Statistics (NCHS), more than 23.315.923 million women in the U.S. will not use a hormonal contraceptive.

Evofem has delivered PHEXXIPHEXX net sales growth in each consecutive year since it was launched in SeptSeptember 2020. Key growth drivers for 2025 included include expandedsocial media campaigns, participation in strategic medical conferences, and initiatives to expand use of PHEXXIPHEXX in women who take oral birth control pills in conjunction with GLP-1 prescription medications like Ozempic, Mounjaro and Zepbound for weight loss. These drugs may make oral birth control pills less effective at certain points in the dosing schedule. Per the USPI,products’ USPIs, prescribers are instructed to “advise patients using oral contraceptives to switch to a non-oral contraceptive method or or add a barrier method” to prevent unintended pregnancy during these times.

We halted clinical development of our investigational product candidates in October 2022 to focus resources on growing domestic sales of PHEXXI PHEXX for the prevention of pregnancy.

PHEXXIPHEXX as a Contraceptive; Commercial Strategies

In September 2020, we commercially launched PHEXXIPHEXX in the United States. Our sales force promotes PHEXXIPHEXX directly to obstetrician/gynecologists (OB/GYNs) and their affiliated health professionals, who collectively write the majority of prescriptions for contraceptive products. Our sales force comprises approximately 16 regional sales representatives, twosales managers, business directorsdirectors, and ana Senior SVPVice President of Commercial Operations, supported by a self-guided virtual health care provider (HCP) learning platform.Operations. Additionally, we offer women direct access to PHEXXIPHEXX via a telehealth platform. Using this platform, women can directly meet with an HCP to determine their eligibility for a PHEXXIPHEXX prescription and, if eligible, have have the prescription written by the HCP, then filled and mailed directly to them by a third-party pharmacy.

Our comprehensive commercial strategy for PHEXXIPHEXX includes marketing and product awareness campaigns targeting HCPs and women of reproductive potential potential in the U.S., including the approximately 23.315.924 million women who are not using hormonal contraception and the approximately 20.0 10.3 million women who are using a prescriptionshort-acting hormonal contraceptive, some of whom, particularly oral birth control pill users, may be ready to move to an FDA-approved, non-invasive, non-systemic hormone-free contraceptive, as well as certain identified target HCP segments. In addition to marketing and product awareness campaigns, our commercial strategy includes payer outreach and execution of our consumer digital and media strategy.

Key growth drivers for 2025 includeincluded expandedsocial media campaigns, participation in strategic medical conferences, and initiatives to expand use of PHEXXIPHEXX in women who take oral birth control pills in conjunction with GLP-1 prescription medications like Ozempic, Mounjaro and Zepbound for weight loss. These drugs may make oral birth control pills less effective at certain points in the dosing schedule. Per the USPI, prescribers are instructed to “advise patients using oral contraceptives to switch to a non-oral contraceptive method or add a barrier method” to prevent unintended pregnancy during these times.

An additionalApproximately 13.7 million lives are covered under our December 2020 contract award from the U.S. Department of Veterans Affairs.

We also participate in government programs, including the 340B and the Medicaid Drug Rebate Program. As a result of our participation in the Medicaid National Drug Rebate Program, the U.S. Medicaid population gained access to PHEXXIPHEXX on January 1, 2021. As of May 2024,2025, Medicaid provides health coverage to approximately 73.870.5 million members; nearly two-thirds of adult women enrolled in Medicaid are in their reproductive years (19-44). Additionally, we recently began participating in a 340B Group Purchasing Organization (GPO) that serves safety-net clinics throughout throughout the U.S. in June 2024. This GPO has over 6,500 members, which expands our reach among safety-net providers.

ApproximatelyAs of December 2025, approximately 83% of commercial and Medicaid PHEXXIPHEXX prescriptions arewere being approved by payers.

PHEXXIPHEXX is classified in the databases and pricing compendia of Medi-Span and First Databank, two major drug information databases that payers can consult for pricing and product information, as the first and only “Vaginal pH Modulator.”

Effective as of January 1, 2023, most insurers and PBMs must provide coverage, with no out-of-pocket costs (e.g.e.g., $0 copay) to the subscriber or dependent, for FDA-approved contraceptive products, like PHEXXI,PHEXX, prescribed by healthcare providers.

AsTo a result, to comply with these Guidelines,federal guidelines, payers are increasingly covering PHEXXIPHEXX by:

In July 2024, we expanded our commercial portfolio by acquiring global rights to SOLOSEC® (secnidazole) 2g2 g oral granules, a single-dose oral antimicrobial agent that provides a complete course of therapy with just one dose for the treatment of two common sexual health infections. SOLOSEC is FDA-approved for the treatment of:

SOLOSEC has the same call point as PHEXXI,PHEXX, enabling us to leverage our commercial infrastructure and strong physician relationships. We re-launched the brand in November 2024.

Bacterial vaginosis (BV) affects an estimated 21 million women in the U.S., approximately 29% of the U.S. population, making it the most common vaginal condition in women ages 15-44. It results from an overgrowth of bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms including odor and discharge. Of interest, BV raises the pH of the vagina, making it a more friendly environment for trichomoniasis and other STIs; approximately 20% of BV patients also have trichomoniasis.Trich.

If left untreated, BV can have serious health consequences. Untreated or improperly treated BV is associated with increased risk of infection with STIs like HPV, herpes, trichomoniasis,Trich, chlamydia, gonorrheagonorrhea, and HIV, as well as transmission of STIs to a partner. Additional risks include developing pelvic inflammatory disease (PID), which can threaten a women’swoman’s fertility, and complications with gynecological surgery.

SOLOSEC’s one-and-done dosing and the resulting high level of compliance is believed to be a significant differentiator. Non-compliance to a multi-day metronidazole regimen is a contributing factor to persistent Trich or BV; andboth ACOG and the CDC no longer recommend single dose metronidazole to treat Trich in women.

Our revenue recognition is based on unit shipments from our third-party logistics warehouse to our customers, which consist of wholesale distributors, retail pharmacies, telehealth companies, and a mail-order specialty pharmacy.pharmacies. We have recognized net product sales in the U.S. since the commercial launch of PHEXXIPHEXX in September 2020; SOLOSEC net product sales were added to our revenue beginning in July 2024. Gross revenues, as discussed in Note 3 - Revenue, were adjusted for variable consideration, including our patient support programs.

Approved by the FDA on May 22, 2020, PHEXX is the first and only non-hormonal prescription contraceptive gel. It is locally acting, with no systemic activity, and used on-demand by women only when they have sex. Because PHEXX is a non-hormonal contraceptive, it is not associated with side effects of exogenous hormone use. In some women, these side effects may include depression, weight gain, headaches, loss of libido, mood swings and irritability. Taking hormones may not be right for some women, especially those with certain medical conditions, including clotting disorders hormone-sensitive cancer, diabetes, or a BMI over 30, or those who are breast feeding or who smoke. Per the National Center for Health Statistics (NCHS), more than 15.9 million women in the U.S. who will not use a hormonal contraceptive.2 Evofem has delivered PHEXX net sales growth in each consecutive year since it was launched in September 2020. Key growth drivers for 2026 include social media campaigns, participation in strategic medical conferences, and initiatives to expand use of PHEXX in women who take oral birth control pills in conjunction with GLP-1 prescription medications like Mounjaro and Zepbound for weight loss. These drugs may make oral birth control pills less effective at certain points in the dosing schedule. Per the products’ USPIs, prescribers are instructed to “advise patients using oral contraceptives to switch to a non-oral contraceptive method or add a barrier method” to prevent unintended pregnancy during these times.

In an investigator-led clinical study of SOLOSEC in 24 women with recurrent bacterial vaginosis (BV), once-weekly dosing with SOLOSEC demonstrated efficacy matching or potentially surpassing outcomes of current CDC-recommended suppressive treatments. These promising results underscore SOLOSEC’s potential to redefine the standard of care for recurrent BV – offering a simpler treatment option for long-term symptom control. The study was presented at the 2025 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting.

Previous contracting efforts have validated our access strategy. With PHEXX approval rates consistently above 80%, the Company has shifted from broad payer contracting to strengthening pharmacy partnerships. In 2025, we expanded our network in two of our highest-volume markets — California and the Northeast — by adding new partners in California and a regional distributor with more than 90 pharmacies in the Northeast. These targeted partnerships represent low-hanging fruit inaddress high-demand areas, improving patient access while supporting more cost-effective and scalable pull-through.

We also participate in government programs, including the 340B and the Medicaid Drug Rebate Program. As a result of our participation in in the Medicaid National Drug Rebate Program, the U.S. Medicaid population gained access to PHEXX on January 1, 2021. As of JanuaryFebruary 2026, 2026, Medicaid provides health coverage to approximately 68.067.7 million members; nearly two-thirds of adult women enrolled in Medicaid are in their reproductive years (19-44). Additionally, we began participating in a 340B Group Purchasing Organization (GPO) that serves safety-net clinics throughout the U.S. in June 2024. This GPO has over 6,500 members, which expands our reach among safety-net providers.

In 2022, Evofem developed and introduced a new contraceptive educational chart for patients and HCPs that details high-level information about birth control methods currently available to women in the U.S., including the vaginal pH modulator. This new contraceptive educational tool has been extremely well received and has had a positive impact with HCPs and patients alike.

Our revenue recognition is based on unit shipments to our customers, which consist of wholesale distributors, retail pharmacies, telehealth telehealth companies, and mail-order specialty pharmacies.pharmacies, sites participating in the Phase 4 NIH-funded clinical trial, and, in the UAE, our licensee, Pharma 1. We have recognized net product sales in the U.S. since the commercial launch of PHEXX in September 2020; SOLOSEC net product sales were added to our revenue beginning in July 2024. Gross revenues, as discussed in Note 3 - Revenue, are adjusted for variable consideration, including our patient support programs.

Inventory costs include all purchased materials, direct labor, and manufacturing overhead. We are obligated to pay quarterly royalties under the SOLOSEC Asset Purchase Agreement dated July 14, 2024; this royalty is based on a percentage of SOLOSEC net sales in the U.S., adjusted for co-pay program costs. There are no minimum quarterly or annual royalty amounts. Such royalty costs were less than $0.1 millionimmaterial for each of the three and six months ended MarchJune 31,30, 2026 and were immaterial for each of the three and six months ended June 30, 2025.

During the threesix months ended MarchJune 31,30, 2025, the Company negotiated a portion of its trade payables with numerous vendors, which resulted in a a $5.6 million one-time reduction in research and development expenses.

Three Months Ended MarchJune 31,30, 2026 Compared to Three Months Ended MarchJune 31,30, 2025 (in thousands):

The increasedecrease in cost of goods sold was primarily due to the decrease in product sales, net partially offset by a write-off in the current quarter of $0.2$0.1 million of expiredexcess rawSOLOSEC materials held by the Company’s PHEXX manufacturer, partially offset by the reduced units sold in the current quarter.inventory.

The decrease in amortization of intangible asset primarily reflects the decrease in value of the SOLOSEC intangible asset in 2025 based on the quarterly valuations of the related contingent liabilities. As the asset value decreases, the quarterly amortization also decreases.

The decrease in selling and marketing expenses was primarily due to a $0.2$0.3 million decrease in personnelbusiness costsdevelopment and adistribution costs, $0.2 million decrease in distribution costsprimarily related to the termination of a commercial servicesrebate agreementprogram to better align resources with core business priorities, a $0.2 million decrease in personnel costs, and a $0.1 million decrease related to travel and other expense.

General and administrative expenses were materially unchanged from the priorprior-year year.period.

Total other income (expense), net, for the threesix months ended MarchJune 31,30, 2026 primarily included a loss of $0.2$5.9 million related to the change in fair value of financial instrumentsinstruments, a loss of $2.2 million related to the partial extinguishment and $0.7reissuance of the of the Exchanged SSNs acquired by HUB, and $1.4 million of interest expense primarily related to the Adjuvant Note.

Total other income,income (expense), net, for the threesix months ended MarchJune 31,30, 2025 primarily included a gain of $1.2$1.4 million related to the change in in fair value of financial instruments partially offset by $0.6$1.2 million of interest expense related primarily to the Adjuvant Note.

As of MarchJune 31,30, 2026, we had a working capital deficit of $72.7$82.5 million and an accumulated deficit of $902.9$914.0 million. We have financed our our operations to date primarily through the issuance of preferred stock, common stock, warrants and convertible and term notes; cash received from private placement transactions; and, to a lesser extent, product sales. As of MarchJune 31,30, 2026, we had approximately $2.4 $0.3 million in comprised entirely of restricted cash and cash equivalents, including $0.9 million of restricted cash equivalents available for use as prescribed in the Adjuvant Notes (as defined in Note 4 - Debt). Our restricted cash and cash equivalents include amounts held in checking accounts. Management believes that the Company’s cash and cash equivalents as of MarchJune 31,30, 2026 are insufficient to fund operations for at least the next 12 months from the date on which this Quarterly Report on Form 10-Q is filed with the SEC.

Since inception, we have regularly incurred losses and negative cash flows from operating activities. In 2025, we focused on further improving and increasing PHEXX and SOLOSEC access and delivered our fifth consecutive year of net sales growth. We have restructured some of our trade payables with extended terms and implemented measures to better align our cost structure with projected revenues. As discussed in Note 7 – Commitments and Contingencies, a significant portion of our trade payables are over 90 days old; a large portion of which relate to amounts due under a rebate program we are no longer participating in as well as amounts due related to various services we no longer receive.

In 2026, we willhave continuecontinued to focus on top-line growth and while maintaining a lean operating structure. We willhave continuealso tocontinued exploreexploring opportunities opportunities for Nasdaq listing of our Common Stock and other strategic options, organic growth, entry into new markets, and potential expansion of our product offerings beyond PHEXX and SOLOSEC.

As of MarchJune 31,30, 2026 the Company’s significant commitments include the Baker Notes, Adjuvant Notes, SSNs, and Aditxt Notes as described in Note 4 - Debt and the potential settlement amount with TherapeuticsMD as described in Note 7 - Commitments and Contingencies. The purpose of these commitments is to further the commercialization of PHEXX and SOLOSEC. Management’s plans to meet the Company’s cash flow needs in the next 12 months include generating revenue from the sale of PHEXX and SOLOSEC, further restructuring of the Company’s current payables, and obtaining additional funding through means such as the issuance of its capital stock, non-dilutive or dilutive financings, or through collaborations or partnerships with other companies, including license agreements for PHEXX and/or SOLOSEC in the U.S. or foreign markets, or other potential business combinations.

If we are unable to continue as a going concern,concern due to our significant debt, much of which is due within the next six to twelve months, due to the default which Future Pak has alleged, or any number of other factors, we may have to liquidate our assets and, in doing so, we may receive less than the value value at which those assets are carried on our consolidated financial statements. Any of these developments would materially and adversely adversely affect the price of our stock and the value of an investment in our stock. As a result, our interim condensed consolidated financial financial statements include explanatory disclosures expressing substantial doubt about our ability to continue as a going concern.

The opinion of our independent registered public accounting firm on our audited consolidated financial statements as of and for the years years ended December 31, 2025 and 2024 contained an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern. Future reports on our consolidated financial statements may include an explanatory paragraph with respect to our ability to continue as a going concern. Our unaudited condensed consolidated financial statements as of MarchJune 31,30, 2026 and December 31, 2025 and for the three and six months ended MarchJune 31,30, 2026 and 2025 included in this Quarterly Report do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts of liabilities that might be necessary should we be unable to continue our operations.

During the threesix months ended MarchJune 31,30, 2025, the primary sourceuse of net cash and cash equivalents and net restricted cash and cash equivalents in operating activities was driven by net incomeloss of $1.0$0.8 million offset byand net adjustments to reconcile net incomeloss to net cash and cash equivalents and net restricted cash and cash equivalents used in operating activities of $5.7$5.1 million. The cash providedused was also impacted by increased customer collectionspayments of $8.7trade millionpayables of $0.7 million, inventory purchases of $0.5 million, an increase in contingent liabilities of $0.4 million, and a decrease in prepaid and other assetspayment of $0.1accrued compensation of $0.2 million. The cash providedused by operating activities was partially offset by paymentsincreased customer collections of trade$4.9 payablesmillion, an increase in accrued expenses and other liabilities of $1.8$0.5 million, inventory purchases of $0.9 million, and paymenta decrease in prepaid and other assets of accrued compensation of $0.8$0.1 million.

Cash Flows from Investing Activities. During the threesix months ended MarchJune 31,30, 2026, the primary use of net cash andrestricted cash equivalents and net restricted cash and cash equivalents was the purchase of computer equipment. During the threesix months ended MarchJune 31,30, 2025, the primary use of net cash and cash equivalents and net restricted cash and cash equivalents was the payment of amounts related to the acquisition of SOLOSEC which had previously been recorded as accounts payable.

Operating lease right-of-use assets and lease liabilities were $0.1 million each on June 30, 2026 and were $0.2 million each on both March 31, 2026 and December 31, 2025. See Note 7- Commitments and Contingencies for more detailed discussions on leases and financial statements information under ASC 842, Leases.

As described in Note 7 - Commitments and Contingencies, in November 2019, the Company entered into a supply and manufacturing agreement with a third-party to manufacture PHEXX, with potential to manufacture other product candidates, in accordance with all applicable current good manufacturing practice regulations. There were approximately $0.9$0.4 million and $0.8$1.3 million in purchases under the supply and manufacturing agreement for the three and six months ended MarchJune 31,30, 20262026, respectively. There were $0.1 million and $0.8 million in purchases under the supply and manufacturing agreement for the three and six months ended June 30, 2025, respectively.

As described in Note 7 - Commitments and Contingencies, the Company no longer owes any royalties to Rush University pursuant due to the expiration of the Rush patent.

As described in Note 7 - Commitments and Contingencies, as of July 14, 2024, the Company is obligated to pay a a quarterly royalty in amounts equal to a certain percentage of the SOLOSEC U.S. net revenue. There are no minimum quarterly or annual royalty payment amounts. Such royalty costs were less than $0.1 million for each of the three and six months ended MarchJune 31,30, 2026 and 2025,2026, respectively, and no milestones triggering payment of any contingent liabilities were attained. Such royalty costs were less than $0.1 million for each of the three and six months ended June 30, 2025. As of MarchJune 31,30, 2026, $0.1 million and $1.1$1.2 million related to the estimated fair value of the future payments related to the SOLOSEC acquisition, including sales-based payments, one-time payment, and quarterly royalty payments, was included in contingent liabilities – current and contingent liabilities – noncurrent, respectively, in the condensed consolidated balance sheet. Such amounts were $0.1 million and $4.6 million, respectively, as of December 31, 2025.