Evofem Biosciences, Inc.

Previous wording

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

Current wording

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. will not use a hormonal contraceptive.2

Previous wording

In an investigator-led clinical study of SOLOSEC in 24 women with recurrent bacterial vaginosis (BV), once-weekly dosing with 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.

Current wording

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 wording

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 in high-demand areas, improving patient access while supporting more cost-effective and scalable pull-through.

Current wording

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 address high-demand areas, improving patient access while supporting more cost-effective and scalable pull-through.

Previous wording

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 PHEXX on January 1, 2021. As of January 2026, Medicaid provides health coverage to approximately 68.0 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.

Current wording

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 PHEXX on January 1, 2021. As of February 2026, Medicaid provides health coverage to approximately 67.7 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.

Previous wording

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.

Current wording

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.

Previous wording

Our revenue recognition is based on unit shipments to our customers, which consist of wholesale distributors, retail pharmacies, telehealth companies, and mail-order specialty pharmacies. 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.

Current wording

Our revenue recognition is based on unit shipments to our customers, which consist of wholesale distributors, retail pharmacies, telehealth companies, mail-order specialty 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.

Previous wording

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 million for each of the three months ended March 31, 2026 and 2025.

Current wording

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 immaterial for each of the three and six months ended June 30, 2026 and were immaterial for each of the three and six months ended June 30, 2025.

Previous wording

During the three months ended March 31, 2025, the Company negotiated a portion of its trade payables with numerous vendors, which resulted in a $5.6 million reduction in research and development expenses.

Current wording

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

Previous wording

The increase in product sales, net, primarily reflects the increase in WAC for PHEXX as well as increased product sales, net, related to SOLOSEC due to an increase in both unit sales and WAC. The increases were partially offset by a decrease in the PHEXX sales volume in the current period due to the significant amount of PHEXX purchases by wholesalers in December 2025 ahead of the January 2026 price increase.

Current wording

The decrease in product sales, net, primarily reflects a decrease in PHEXX units sold due to the significant amount of PHEXX purchases by wholesalers in December 2025 ahead of the January 2026 price increase, as well as the temporary and now-resolved exclusion of PHEXX from certain state Medicaid and public health programs while transitioning to the new NDC number. This was partially offset by an increase in SOLOSEC units sold, the increase in WAC and improved gross-to-net realization for both products.

Previous wording

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.

Current wording

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

Previous wording

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

Current wording

The decrease in selling and marketing expenses was primarily due to a $0.3 million decrease in business development and distribution costs, primarily related to the termination of a commercial rebate program 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.

Previous wording

General and administrative expenses were materially unchanged from the prior year.

Current wording

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

Previous wording

Total other income(expense), net, for the three months ended March 31, 2026 primarily included a loss of $0.2 million related to the change in fair value of financial instruments and $0.7 million of interest expense primarily related to the Adjuvant Note.

Current wording

Total other expense, net, for the three months ended June 30, 2026 primarily included a loss of $5.7 million related to the change in fair value of financial instruments, a loss of $2.2 million related to the partial extinguishment and reissuance of the of the Exchanged SSNs acquired by HUB, and $0.6 million of interest expense, primarily related to the Adjuvant Note.

Previous wording

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

Current wording

Total other expense, net, for the three months ended June 30, 2025 primarily included $0.6 million of interest expense related primarily to the Adjuvant Note, partially offset by a gain of $0.1 million related to the change in fair value of financial instruments.

Previous wording

The increase in cost of goods sold was primarily due to the write-off in the current quarter of $0.2 million of expired raw materials held by the Company’s PHEXX manufacturer, partially offset by the reduced units sold in the current quarter.

Current wording

The decrease 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 $0.1 million of excess SOLOSEC.

Previous wording

During the three months ended March 31, 2025, the Company settled a portion of its trade payables with numerous vendors, which resulted in a one-time $5.6 million reduction in research and development expenses; such settlement did not recur in the current quarter.

Current wording

During the six months ended June 30, 2025, the Company settled a portion of its trade payables with numerous vendors, which resulted in a one-time $5.6 million reduction in research and development expenses; such settlement did not recur in the current period.

Previous wording

As of March 31, 2026, we had a working capital deficit of $72.7 million and an accumulated deficit of $902.9 million. We have financed 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 March 31, 2026, we had approximately $2.4 million in 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 cash and cash equivalents include amounts held in checking accounts. Management believes that the Company’s cash and cash equivalents as of March 31, 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.

Current wording

As of June 30, 2026, we had a working capital deficit of $82.5 million and an accumulated deficit of $914.0 million. We have financed 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 June 30, 2026, we had approximately $0.3 million comprised entirely of restricted cash and 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 June 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.

Previous wording

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.

Current wording

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.

Previous wording

In 2026, we will continue to focus on top-line growth and while maintaining a lean operating structure. We will continue to explore 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.

Current wording

In 2026, we have continued to focus on top-line growth while maintaining a lean operating structure. We have also continued exploring opportunities for strategic options, organic growth, entry into new markets, and potential expansion of our product offerings beyond PHEXX and SOLOSEC.

Previous wording

If we are unable to continue as a going concern, we may have to liquidate our assets and, in doing so, we may receive less than the value at which those assets are carried on our consolidated financial statements. Any of these developments would materially and adversely affect the price of our stock and the value of an investment in our stock. As a result, our interim condensed consolidated financial statements include explanatory disclosures expressing substantial doubt about our ability to continue as a going concern.

Current wording

If we are unable to continue as a going 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 at which those assets are carried on our consolidated financial statements. Any of these developments would materially and adversely affect the price of our stock and the value of an investment in our stock. As a result, our interim condensed consolidated financial statements include explanatory disclosures expressing substantial doubt about our ability to continue as a going concern.

Previous wording

The opinion of our independent registered public accounting firm on our audited consolidated financial statements as of and for the 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 March 31, 2026 and December 31, 2025 and for the three months ended March 31, 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.

Current wording

The opinion of our independent registered public accounting firm on our audited consolidated financial statements as of and for the 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 June 30, 2026 and December 31, 2025 and for the three and six months ended June 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.

Previous wording

Cash Flows from Operating Activities. During the three months ended March 31, 2026, the primary source of net cash and cash equivalents and net restricted cash and cash equivalents in operating activities was the decrease in trade accounts receivable of $11.9 million, partially offset by decreases in accrued expenses and other liabilities of $1.6 million, accounts payable of $1.6 million, and accrued compensation of $1.1 million as well as an increase in prepaid and other current assets of $0.1 million and the purchase of inventory of $0.8 million. The net loss of $5.5 million plus $1.2 million net adjustments to reconcile net loss to net cash and cash equivalents and net restricted cash and cash equivalents provided by operating activities also offset the cash provided.

Current wording

Cash Flows from Operating Activities. During the six months ended June 30, 2026, the net loss of $16.5 million less $9.9 million net adjustments to reconcile net loss to net restricted cash and cash equivalents used in operating activities was the primary source of the cash used. Also contributing to the net restricted cash and cash equivalents used in operating activities were the decreases in accounts payable of $1.6 million, accrued expenses and other liabilities of $1.0 million, accrued compensation of $0.4 million, and contingent liabilities of $0.1 million as well as the purchase of inventory of $1.0 million, partially offset by a decrease in trade accounts receivable of $10.0 million.

Previous wording

During the three months ended March 31, 2025, the primary source of net cash and cash equivalents and net restricted cash and cash equivalents in operating activities was driven by net income of $1.0 million offset by net adjustments to reconcile net income to net cash and cash equivalents and net restricted cash and cash equivalents used in operating activities of $5.7 million. The cash provided was also impacted by increased customer collections of $8.7 million and a decrease in prepaid and other assets of $0.1 million. The cash provided by operating activities was partially offset by payments of trade payables of $1.8 million, inventory purchases of $0.9 million, and payment of accrued compensation of $0.8 million.

Current wording

During the six months ended June 30, 2025, the primary use of net restricted cash and cash equivalents in operating activities was driven by net loss of $0.8 million and net adjustments to reconcile net loss to net restricted cash and cash equivalents used in operating activities of $5.1 million. The cash used was also impacted by payments of trade payables of $0.7 million, inventory purchases of $0.5 million, an increase in contingent liabilities of $0.4 million, and payment of accrued compensation of $0.2 million. The cash used by operating activities was partially offset by increased customer collections of $4.9 million, an increase in accrued expenses and other liabilities of $0.5 million, and a decrease in prepaid and other assets of $0.1 million.

Previous wording

Cash Flows from Investing Activities. During the three months ended March 31, 2026, the primary use of net cash and cash equivalents and net restricted cash and cash equivalents was the purchase of computer equipment. During the three months ended March 31, 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.

Current wording

Cash Flows from Investing Activities. During the six months ended June 30, 2026, the primary use of net restricted cash and cash equivalents was the purchase of computer equipment. During the six months ended June 30, 2025, the primary use of 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.

Previous wording

Cash Flows from Financing Activities. During the three months ended both March 31, 2026 and 2025, the primary use of net cash and cash equivalents and net restricted cash and cash equivalents was the payment of short-term debt and notes carried at fair value.

Current wording

Cash Flows from Financing Activities. During the six months ended June 30, 2026, the primary source of net restricted cash and cash equivalents was the $0.7 million received from HUB in advance of the July 2026 HUB Note and the financing agreement with First Insurance Funding for total net proceeds to the Company of $0.4 million. These proceeds were partially offset by the payment of short-term debt and Notes – carried at fair value of $0.5 million. During the six months ended June 30, 2025, the primary source of net restricted cash and cash equivalents was related to the Aditxt Notes and the financing agreement with First Insurance Funding for total net proceeds to the Company of approximately $2.8 million, partially offset by the payment of short-term debt of $0.4 million.

Previous wording

Operating lease right**-of-**use assets and lease liabilities 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.

Current wording

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 December 31, 2025. See Note 7- Commitments and Contingencies for more detailed discussions on leases and financial statements information under ASC 842,Leases.

Previous wording

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 million and $0.8 million in purchases under the supply and manufacturing agreement for the three months ended March 31, 2026 and 2025, respectively.

Current wording

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 $0.4 million and $1.3 million in purchases under the supply and manufacturing agreement for the three and six months ended June 30, 2026, 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.

Previous wording

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.

Current wording

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

Previous wording

As described in Note 7 - Commitments and Contingencies, as of July 14, 2024, the Company is obligated to pay 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 months ended March 31, 2026 and 2025, and no milestones triggering payment of any contingent liabilities were attained. As of March 31, 2026, $0.1 million and $1.1 million related to 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.

Current wording

As described in Note 7 - Commitments and Contingencies, as of July 14, 2024, the Company is obligated to pay 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 the three and six months ended June 30, 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 June 30, 2026, $0.1 million and $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.