Evofem Biosciences, Inc.
For the period ended Jun 30, 2025. Filed Aug 14, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 14, 2025
EVFM$0.48-23.4%Stored close · as of Aug 10, 2022
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0001641172-25-010529
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001641172-25-023741
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 120 previous paragraphs and 127 current paragraphs.
68 unchanged; 37 reworded; 19 added; 15 removed; 0 previous and 3 current paragraphs rearranged.
Tables are not compared: 12 previous and 18 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (19)
Current report
In the second quarter of 2025, enrollment commenced in an investigator-led randomized, open-label, parallel Phase 4 clinical trial to evaluate the efficacy and cost-effectiveness of secnidazole (SOLOSEC® 2 g, one dose administered one time) versus metronidazole (Flagyl® 500 mg, administered twice daily for seven days) for the treatment of trichomoniasis in men and women. Study investigators hypothesize that, in the current clinical trial, the rate of repeat infections withT. vaginalis will be 1.75 lower in the SOLOSEC arm versus the multi-dose oral metronidazole arm and that single-dose SOLOSEC will have higher initial cost but will be more cost effective compared to multi-dose metronidazole, largely due to lower breakthrough rates of infection. This trial is funded directly by the National Institutes of Health (NIH).
Current report
At market open on July 1, 2025, the Company’s common stock was moved to and began trading on the Over-the-Counter Integrated Disclosure (OTCID), the new basic reporting market tier launched by the OTC Markets Group.
Current report
Increase to Authorized Series E-1 Preferred Stock
Current report
On June 30, 2025, the holders of record of a majority of the issued and outstanding shares of the Company’s Series E-1 Preferred Stock (the Required Holders) by written consent in lieu of a meeting approved the Amended and Restated Certificate of Designations of Series E-1 Convertible Preferred Stock (the A&R E-1 Certificate of Designations). The Certificate of Designations increases the total authorized shares of Series E-1 Preferred Stock form 2,300 to 10,000 in order to authorize sufficient number of shares for the payment of dividends “in kind” in the form of additional shares of preferred stock, and to update certain definitions. The A&R E-1 Certificate of Designations will become effective with the Delaware Secretary of State on September 30, 2025.
Current report
Aditxt Notes and Warrants
Current report
In both the Aditxt April Offering and the Aditxt June Offering, Aditxt paid approximately $650 for each $1,000 of the principal amount of the Notes and Warrants and the Company issued a total of 242,257,742 warrants to purchase shares of common stock with an exercise price of $0.0154. In each of the Aditxt April Notes and the Aditxt June Notes, the notes are unsecured senior subordinated notes, have an interest rate of 8%, and mature three years from the respective issuance dates. The net proceeds after the offering costs to the Company from the Aditxt April Offering and Aditxt June Offering were approximately $2.4 million. Assuming the applicable conversion price per share, the Aditxt Notes could be converted into 245,086,947 shares of common stock as of June 30, 2025.
Current report
The Aditxt April Notes’ and the Aditxt June Notes’ interest rates are subject to increase to 12% upon an event of default and they have no Company right to prepayment prior to maturity; however, the Company has the option to redeem the respective notes at a redemption premium of 32.5%. Aditxt can also require the Company to redeem the notes a) at the respective premium rate tied to the occurrence of certain subsequent transactions, and b) in the event of subsequent placements (as defined). Also, pursuant to the terms of the respective SPAs, Aditxt has certain rights to participate in subsequent issuances of the Company’s securities, subject to certain exceptions. Additionally, the conversion rate and warrant strike price are subject to adjustment upon the issuance of other securities (as defined) below the stated conversion rate and strike price at issuance.
Current report
In May 2025, an investigator-led clinical trial entitled ‘Once Weekly Secnidazole Granules for the Treatment of Recurrent Bacterial Vaginosis’ was presented at the 2025 ACOG Annual Clinical and Scientific Meeting; the abstract was subsequently published inObstetrics & Gynecology. In this focused clinical study of 24 women with recurrent 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 by offering a simpler treatment option for long-term symptom control.
Current report
A Phase 4 investigator-led randomized, open-label, parallel arm clinical trial is underway to evaluate the efficacy and cost-effectiveness of secnidazole (SOLOSEC 2 g, one dose administered one time) versus metronidazole (Flagyl® 500 mg, administered twice daily for seven days) for the treatment of trichomoniasis in men and women. Study investigators hypothesize that, in the current clinical trial, the rate of repeat infections withT. vaginalis will be 1.75 lower in the SOLOSEC arm versus the multi- dose oral metronidazole arm and that single-dose SOLOSEC will have higher initial cost but will be more cost effective compared to multi-dose metronidazole, largely due to lower breakthrough rates of infection. This trial is funded by the National Institutes of Health (NIH).
Current report
The increase in product sales, net, primarily reflects the addition of SOLOSEC in the current year as well as the increased WAC that took effect January 1, 2025 and continued improvements to the gross to net percentage.
Current report
The increase in research and development expenses was primarily due to an increase in outside services of $0.3 million and an increase in facilities costs of $0.1 million.
Current report
The decrease in general and administrative expenses was primarily due to an approximately $0.4 million decrease in facilities and professional services costs.
Current report
Total other income (expense), net, for the three months ended June 30, 2024 primarily included a $3.3 million gain on the change in fair value of financial instruments, partially offset by $0.5 million in interest expense related to the Adjuvant Note.
Current report
Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024 (in thousands):
Current report
Net Product Sales
Current report
The decrease in product sales, net, was primarily due to lower PHEXXI sales volume, partially offset by the addition of SOLOSEC in the current year and the increased PHEXXI WAC that took effect January 1, 2025.
Current report
The increase in selling and marketing expenses was primarily due to a $0.3 million increase related to the PDUFA fee for SOLOSEC. There was also an increase in facilities and outside services costs of $0.2 million.
Current report
Total other income, net
Current report
Total other income, net, for the six months ended June 30, 2025 primarily included a $1.4 million gain on the change in fair value of financial instruments partially offset by $1.2 million interest expense related to the Adjuvant Note.
Removed paragraphs (15)
Previous report
Aditxt Note and Warrant Issuance
Previous report
Adjuvant Notes Call Option
Previous report
On April 10, 2025, Aditxt, the Company and Adjuvant Global Health Technology Fund, L.P. and Adjuvant Global Fund DE, L.P. (collectively, Adjuvant) entered into a Call Option Agreement wherein Adjuvant granted to Aditxt, a call option to purchase, at the sole discretion of Aditxt, all of the convertible Adjuvant Notes and Rights to receive common stock (the Securities) held by Adjuvant for an aggregate purchase price of $13.0 million. The call option can be exercised at any time after the satisfaction in full of the repayment obligations under the Company’s Baker Notes and until June 30, 2025. If the obligations under the Company’s senior secured creditor are not satisfied by May 31, 2025, Adjuvant is free to transfer the Securities to another purchaser and the Call Option Agreement shall be extinguished and terminate.
Previous report
Cost of Goods Sold
Previous report
Research and Development Expenses
Previous report
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. Additionally, the amounts related to noncash stock-based compensation expenses decreased to nearly zero, or by 96%, payroll related expenses decreased by $0.2 million, or 60%, outside services costs increased by $0.2 million, or 169%, and other costs increased immaterially, or 19%. We do not anticipate investing in clinical development for the foreseeable future.
Previous report
Selling and Marketing Expenses
Previous report
Our selling and marketing expenses increased slightly in the three months ended March 31, 2025 compared to the prior year, due in part to the addition of expenses related to adding SOLOSEC, most significantly the additional PDUFA fee, as well as our investment in certain marketing and DTC initiatives for PHEXXI.
Previous report
General and Administrative Expenses
Previous report
Our general and administrative expenses decreased in the three months ended March 31, 2025 compared to the three months ended March 31, 2024 primarily due to a decrease in personnel costs.
Previous report
The decrease in product sales, net, primarily reflects a decrease in the sales volume in the current period due to the significant amount of PHEXXI purchases by wholesalers in December 2024 ahead of the January 2025 price increase. There was also a price increase in January 2024, but the December 2023 purchases were not as significant and as such, the first quarter of 2024 was not as heavily impacted.
Previous report
Cost of Goods Sold
Previous report
Research and Development Expenses
Previous report
Selling and Marketing Expenses
Previous report
General and Administrative Expenses
Reworded paragraphs (37)
Previous wording
s Discussion and Analysis of Financial Condition and Results of Operations
Current wording
Item 2. Management**’s Discussion and Analysis of Financial Condition and Results of Operations
Previous wording
Approved by the FDA on May 22, 2020, PHEXXI 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 PHEXXI is a non-hormonal contraceptive, it is not associated with side effects of exogenous hormone use like 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 Heath Statistics (NCHS), more than 23.3 million women in the U.S. will not use a hormonal contraceptive.
Current wording
Approved by the FDA on May 22, 2020, PHEXXI 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 PHEXXI is a non-hormonal contraceptive, it is not associated with side effects of exogenous hormone use, which 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 23.3 million women in the U.S. will not use a hormonal contraceptive.
Previous wording
We licensed exclusive commercial rights in the Middle East to Pharma 1 Drug Store, an emerging Emirati health care company, for PHEXXI on July 17, 2024, as amended on May 3, 2025. Under this agreement, the licensed territory includes the United Arab Emirates (UAE), Kuwait, Saudi Arabia, Qatar and certain other countries in the region. Pharma 1 is responsible for obtaining and maintaining any regulatory approvals required to market and sell PHEXXI, and will handle all aspects of distribution, sales and marketing, pharmacovigilance and all other commercial functions in these countries. Evofem will supply product to Pharma 1 at cost-plus. Pharma 1 is on track to file for regulatory approval of PHEXXI in the UAE in the second quarter of 2025.
Current wording
We licensed exclusive commercial rights for PHEXXI in MENA to Pharma 1 Drug Store, an emerging Emirati health care company. Under the License and Supply Agreement dated on July 17, 2024, as amended on May 3, 2025, the licensed territory includes the UAE, Kuwait, Saudi Arabia, Qatar, Oman, and Jordan, with potential to expand into 15 other countries in the region. Pharma 1 is responsible for obtaining and maintaining any regulatory approvals required to market and sell PHEXXI, and will handle all aspects of distribution, sales and marketing, pharmacovigilance and all other commercial functions in these countries. Evofem will supply product to Pharma 1 at cost-plus. Pharma 1 filed for regulatory approval of PHEXXI in the UAE in June 2025.
Previous wording
The Aditxt Offering closed on April 8, 2025 and, as a result, the Company issued Aditxt Notes in an aggregate principal amount of $2.3 million and Aditxt Warrants to purchase 149,850,150 shares of common stock with an exercise price of $0.0154. Aditxt paid approximately $650 for each $1,000 of the principal amount of Notes and Warrants. The net proceeds after the offering costs to the Company from the Aditxt Offering were approximately $1.5 million. The Company waived Aditxt’s default under the terms of the A&R Merger Agreement due to the full Fifth Parent Investment not being made by the deadline set forth in the Fifth Amendment.
Current wording
On April 8, 2025, the Company entered into a securities purchase agreement (the Aditxt April SPA) with Aditxt providing for the sale and issuance of senior subordinated convertible notes due in the aggregate original principal amount of $2.3 million (the Aditxt April Note) and warrants to purchase an aggregate of 149,850,150 shares (the Aditxt April Warrants) of common stock of the Company, par value $0.0001 (collectively, the Aditxt April Offering). The Company waived Aditxt’s default under the terms of the A&R Merger Agreement due to the full Fifth Parent Investment not being made by the deadline set forth in the Fifth Amendment.
Previous wording
On April 8, 2025, the Company entered into a securities purchase agreement (Aditxt SPA) with Aditxt providing for the sale and issuance of senior subordinated convertible notes due in the aggregate original principal amount of $2.3 million (the Aditxt Notes) and warrants to purchase an aggregate of 149,850,150 shares (the Aditxt Warrants) of common stock the Company, par value $0.0001 (collectively, the Aditxt Offering).
Current wording
On June 26, 2025, the Company entered into a securities purchase agreement (the Aditxt June SPA) with Aditxt providing for the sale and issuance of senior subordinated convertible notes due in the aggregate original principal amount of $1.4 million (the Aditxt June Note, or together with the Aditxt April Note, the Aditxt Notes) and warrants to purchase an aggregate of 92,407,592 shares (the Aditxt June Warrants) of common stock of the Company, par value $0.0001 (collectively, the Aditxt June Offering).
Previous wording
On December 11, 2023, the Company entered into an Agreement and Plan of Merger, as amended, (the Merger Agreement) with Aditxt, Inc., a Delaware corporation (Aditxt), Adifem, Inc., a Delaware corporation and wholly-owned Subsidiary of Aditxt (Merger Sub), pursuant to which, and on the terms and subject to the conditions thereof, Merger Sub will merge with and into the Company, with the Company surviving as a wholly owned subsidiary of Aditxt (the Merger).
Current wording
On December 11, 2023, the Company entered into an Agreement and Plan of Merger, as amended, (the Merger Agreement) with Aditxt, Inc., a Delaware corporation (Aditxt), and Adifem, Inc., a Delaware corporation and wholly-owned Subsidiary of Aditxt (Merger Sub), pursuant to which, and on the terms and subject to the conditions thereof, Merger Sub will merge with and into the Company, with the Company surviving as a wholly owned subsidiary of Aditxt (the Merger).
Previous wording
On July 12, 2024, the Company, the Merger Sub and Aditxt entered into the Amended and Restated Merger Agreement, as amended (the A&R Merger Agreement). Except as described below, the terms and provisions of the A&R Merger Agreement are consistent with the terms and provision of the original Merger Agreement.
Current wording
On July 12, 2024, the Company, the Merger Sub and Aditxt entered into the Amended and Restated Merger Agreement, as amended (the A&R Merger Agreement). Except as described below, the terms and provisions of the A&R Merger Agreement are consistent with the terms and provisions of the original Merger Agreement.
Previous wording
On September 23, 2024, the Company filed a preliminary proxy statement with the SEC. Subject to certain exceptions, the Company’s Board of Directors will recommend that the A&R Merger Agreement be adopted by the Company’s stockholders at a special meeting of the Company’s stockholders (the Company Board Recommendation). However, subject to the satisfaction of certain terms and conditions, the Company and the Board are permitted to take certain actions which may, as more fully described in the A&R Merger Agreement, include changing the Company Board Recommendation and entering into a definitive agreement with respect to a Company Change of Recommendation (as defined in the A&R Merger Agreement) if the Company Board or any committee thereof determines in good faith, after consultation with the Company’s outside legal and financial advisors and after taking into account relevant legal, financial, regulatory, estimated timing of consummation and other aspects of such proposal that the Company Board considers in good faith and the Person or group making such proposal, would, if consummated in accordance with its terms, result in a transaction more favorable to the Company Shareholders than the Merger. If the Company has a Company Change of Recommendation, the Company must provide Aditxt with a ten (10) calendar day written notice thereof and negotiate with Aditxt in good faith to provide a competing offer.
Current wording
On September 23, 2024, the Company filed a preliminary proxy statement with the SEC, which was subsequently withdrawn from consideration by the shareholders. Subject to certain exceptions, the Company’s Board of Directors recommended that the A&R Merger Agreement be adopted by the Company’s stockholders at a special meeting of the Company’s stockholders (the Company Board Recommendation). However, subject to the satisfaction of certain terms and conditions, the Company and the Board were permitted to take certain actions which may, as more fully described in the A&R Merger Agreement, include changing the Company Board Recommendation and entering into a definitive agreement with respect to a Company Change of Recommendation (as defined in the A&R Merger Agreement) if the Company Board or any committee thereof determines in good faith, after consultation with the Company’s outside legal and financial advisors and after taking into account relevant legal, financial, regulatory, estimated timing of consummation and other aspects of such proposal that the Company Board considers in good faith and the Person or group making such proposal, would, if consummated in accordance with its terms, result in a transaction more favorable to the Company Shareholders than the Merger. If the Company has a Company Change of Recommendation, the Company must provide Aditxt with a ten (10) calendar day written notice thereof and negotiate with Aditxt in good faith to provide a competing offer.
Previous wording
On March 22, 2025, the Company, Parent and Merger Sub entered into the fifth amendment to the A&R Merger Agreement (the Fifth Amendment), to (i) change the required consummation date to September 30, 2025; (ii) add a Fifth Parent Investment of $1.5 million to be completed by April 7, 2025; and (iii) add a special meeting consummation date being on or prior to September 26, 2025.
Current wording
On March 22, 2025, the Company, Parent and Merger Sub entered into the fifth amendment to the A&R Merger Agreement (the Fifth Amendment), to (i) change the required consummation date to September 30, 2025; (ii) add a Fifth Parent Investment of $1.5 million to be completed by April 7, 2025; and (iii) add a special meeting consummation date being on or prior to September 26, 2025. The Fifth Parent Investment was completed in late April 2025. The Company waived Aditxt’s default under the terms of the A&R Merger Agreement due to the full Fifth Parent Investment not being made by the deadline set forth in the Fifth Amendment.
Previous wording
The A&R Merger Agreement, as amended, entered into on July 12, 2024, has as a condition of closing that the outstanding balance of the Baker Notes plus all accrued and unpaid interest thereon, in an amount not to exceed the Repurchase Price, shall have been paid in full. As discussed above, the A&R Merger Agreement was amended on August 16, 2024, September 6, 2024, October 2, 2024, November 19, 2024, and March 22, 2025; none of the amendments updated this closing condition.
Current wording
The A&R Merger Agreement, as amended, has as a condition of closing that the outstanding balance of the Baker Notes plus all accrued and unpaid interest thereon in an amount not to exceed the Repurchase Price, shall have been paid in full. As discussed above, the A&R Merger Agreement was amended on August 16, 2024, September 6, 2024, October 2, 2024, November 19, 2024, and March 22, 2025; none of the amendments updated this closing condition.
Previous wording
Our comprehensive commercial strategy for PHEXXI includes marketing and product awareness campaigns targeting women of reproductive potential in the U.S., including the approximately 23.3 million women who are not using hormonal contraception and the approximately 20.0 million women who are using a prescription 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.
Current wording
Our comprehensive commercial strategy for PHEXXI includes marketing and product awareness campaigns targeting HCPs and women of reproductive potential in the U.S., including the approximately 23.3 million women who are not using hormonal contraception and the approximately 20.0 million women who are using a prescription 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.
Previous wording
Key growth drivers for 2025 include initiatives to expand use of PHEXXI 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.
Current wording
Key growth drivers for 2025 include social media campaigns, participation in strategic medical conferences, and initiatives to expand use of PHEXXI 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.
Previous wording
As a result, to comply with these Guidelines, payers are increasingly covering PHEXXI by:
Current wording
To comply with these federal guidelines, payers are increasingly covering PHEXXI by:
Previous wording
In clinical trials, SOLOSEC demonstrated clinically and statistically significant efficacy in the treatment of BV with just one dose; 68% of patients treated with SOLOSEC did not require any additional treatment for BV. Guidelines for the American College of Obstetricians and Gynecologists (ACOG) in 2020 and the U.S. Centers for Disease Control (CDC) in 2021 each include single dose SOLOSEC for the treatment of BV.
Current wording
In clinical trials, SOLOSEC demonstrated clinically and statistically significant efficacy in the treatment of BV with just one dose; 68% of patients treated with SOLOSEC did not require any additional treatment for BV. Guidelines from the American College of Obstetricians and Gynecologists (ACOG) in 2020 and the U.S. Centers for Disease Control (CDC) in 2021 each include single dose SOLOSEC for the treatment of BV.
Previous wording
Inventory costs include all purchased materials, direct labor, and manufacturing overhead. In addition, in prior years we were obligated to pay quarterly royalty payments pursuant to our license agreement with Rush University, in amounts equal to a single-digit percentage of the gross amounts we receive on a quarterly basis, less certain deductions incurred in the quarter based on a sliding scale. We were also obligated to pay a minimum annual royalty amount of $0.1 million to the extent these earned royalties were less than or equal to $0.1 million in a given year. Due to the patent expiration, no royalty costs were recorded for the three months ended March 31, 2025, while $0.2 million was incurred for the three months ended March 31, 2024 and was included in the costs of goods sold in the condensed consolidated financial statements. No further royalties are due to Rush University now that the patent has expired.
Current wording
Inventory costs include all purchased materials, direct labor, and manufacturing overhead. In addition, in prior years we were obligated to pay quarterly royalty payments pursuant to our license agreement with Rush University, in amounts equal to a single-digit percentage of the gross amounts we receive on a quarterly basis, less certain deductions incurred in the quarter based on a sliding scale. We were also obligated to pay a minimum annual royalty amount of $0.1 million, Due to the patent expiration, no royalty costs were recorded for the three and six months ended June 30, 2025, while $0.2 million and $0.4 million were incurred for the three and six months ended June 30, 2024 and were included in the costs of goods sold in the condensed consolidated statements of operations. No further royalties are due to Rush University now that the patent has expired.
Previous wording
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, adjusted for co-pay program costs. There are no minimum quarterly or annual royalty amounts. Such royalty costs were $0.1 million for the three months ended March 31, 2025.
Current wording
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, 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, 2025.
Previous wording
We expense internal and third-party research and development expenses as incurred.
Current wording
We expense internal and third-party research and development expenses as incurred. We do not anticipate significant investment in clinical development for the foreseeable future.
Previous wording
Our selling and marketing expenses consist primarily of PHEXXI and SOLOSEC commercialization costs, the PHEXXI telehealth platform, training, salaries, benefits, travel, noncash stock-based compensation expense, and other related costs for our employees and consultants.
Current wording
Our selling and marketing expenses consist primarily of PHEXXI and SOLOSEC commercialization costs, the PHEXXI telehealth platform, training, salaries, benefits, travel, noncash stock-based compensation expense, PDUFA fees, and other related costs for our employees and consultants.
Previous wording
Other income (expense) consists primarily of interest expense and the fair value adjustments of financial instruments issued in various capital raise transactions, including loss on issuance of financial instruments, quarterly change in fair value adjustments, and gains or losses on debt extinguishment. The change in fair value of financial instruments was recognized as a result of mark-to-market adjustments for those financial instruments. Additionally, other income (expense) also includes a gain (loss) on debt modification or extinguishment and loss on issuance of financial instruments in the prior year period.
Current wording
Other income (expense) consists primarily of interest expense and the fair value adjustments of financial instruments issued in various capital raise transactions, including loss on issuance of financial instruments, quarterly change in fair value adjustments, and gains or losses on debt extinguishment. The change in fair value of financial instruments was recognized as a result of mark-to-market adjustments for those financial instruments. Additionally, other income (expense) includes a gain (loss) on debt modification or extinguishment and loss on issuance of financial instruments in the prior year period.
Previous wording
The increase in selling and marketing expenses was primarily due to a $0.2 million increase related to the PDUFA fee for SOLOSEC and $0.1 million related to marketing and DTC promotion costs, including media agency fees.
Current wording
The increase in selling and marketing expenses was primarily due to a $0.3 million increase related to the PDUFA fee for SOLOSEC.
Previous wording
Total other income (expense), 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 income (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 partially.
Previous wording
The decrease in cost of goods sold was primarily due to the decrease in sales in the current period as compared to the same period in the prior year, as well as the end of the Rush royalty as described above. The decreases were offset by a reduction to the SOLOSEC inventory balance related to finished goods that the Company anticipates will be destroyed as part of the upcoming conversion to the Evofem labeled product.
Current wording
The decrease in cost of goods sold was primarily due to the decrease in sales in the current period as compared to the same period in the prior year as well as the end of the Rush royalty as described above.
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
The decrease in research and development expenses was primarily due to the negotiation of a portion of the Company’s trade payables, which resulted in a $5.6 million reduction in research and development expenses in the current period. There was also a decrease of $0.2 million in personnel costs. The decreases were partially offset by an increase of $0.6 million in facilities and outside services costs.
Previous wording
The decrease in general and administrative expenses was primarily due to a $0.3 million decrease in personnel costs and a decrease of $0.1 million in facilities and outside services costs.
Current wording
The decrease in general and administrative expenses was primarily due to a $0.3 million decrease in personnel costs and a $0.5 million reduction in facilities costs.
Previous wording
Total other income (expense), net, for the three months ended March 31, 2024 primarily included a loss on the issuance of financial instruments related to the anti-dilution adjustment for the purchase rights and $0.6 million of interest expense related to the Adjuvant Note partially offset by gains related to the re-assignment of the Baker Notes of $1.1 million and $0.8 million from the change in fair value of financial instruments.
Current wording
Total other income, net, for the six months ended June 30, 2024 primarily included a $4.1 million gain on the change in fair value of financial instruments and a gain of $1.1 million related to the Baker Notes extinguishment. The gains were offset by a $3.3 million loss on the issuance of financial instruments related to the anti-dilution adjustment for the purchase rights and $1.1 million interest expense related to the Adjuvant Note.
Previous wording
As of March 31, 2025, we had a working capital deficit of $65.0 million and an accumulated deficit of $896.7 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, 2025, we had approximately $1.1 million in cash and cash equivalents, including $0.9 million of restricted cash 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, 2025 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, 2025, we had a working capital deficit of $64.9 million and an accumulated deficit of $898.5 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, 2025, we had approximately $0.7 million in cash and cash equivalents, all of which is restricted cash 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 June 30, 2025 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
We have incurred losses and negative cash flows from operating activities since inception. In 2024, we focused on further improving and increasing PHEXXI access, acquired global rights to SOLOSEC, and delivered our fourth consecutive year of PHEXXI net sales growth. We also paid our outstanding balance, including interest and penalties, to the FDA for the fiscal years 2023, 2024, and the 2025 PDUFA invoices for PHEXXI and SOLOSEC.
Current wording
We have incurred losses and negative cash flows from operating activities since inception. In 2024, we focused on further improving and increasing PHEXXI access, acquired global rights to SOLOSEC, and delivered our fourth consecutive year of PHEXXI net sales growth.
Previous wording
In 2025, we will continue to focus on top-line growth while maintaining a lean operating structure. We will continue to explore opportunities for organic growth, entry into new markets, and potential expansion of our product offerings beyond PHEXXI and SOLOSEC.
Current wording
In 2025, we continue to focus on top-line growth while maintaining a lean operating structure. We will continue to explore opportunities for organic growth, entry into new markets including those covered by our license and supply agreements with Pharma 1, and potential expansion of our product offerings beyond PHEXXI and SOLOSEC.
Previous wording
As of March 31, 2025, the Company’s significant commitments include the Baker Notes, Adjuvant Notes, and SSNs as described in Note 4 - Debt and fleet leases, Rush University royalty, SOLOSEC contingent liability, 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 PHEXXI and SOLSOEC. Management’s plans to meet the Company’s cash flow needs in the next 12 months include generating revenue from the sale of PHEXXI 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 financings, or through collaborations or partnerships with other companies, including license agreements for PHEXXI and/or SOLOSEC in the U.S. or foreign markets, or other potential business combinations.
Current wording
As of June 30, 2025, the Company’s significant commitments include the Baker Notes, Adjuvant Notes, SSNs, and Aditxt Notes as described in Note 4 - Debt and fleet leases, Rush University royalty, SOLOSEC contingent liability, 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 PHEXXI 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 PHEXXI 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 financings, or through collaborations or partnerships with other companies, including license agreements for PHEXXI and/or SOLOSEC in the U.S. or foreign markets, or other potential business combinations.
Previous wording
If the Company is not able to obtain the required funding through a significant increase in revenue, equity or debt financings, license agreements for PHEXXI in the U.S. or foreign markets, or other means, is enjoined from selling under the PHEXXI mark, or is unable to obtain funding on terms favorable to the Company, there will be a material adverse effect on commercialization and development operations and the Company’s ability to execute its strategic development plan for future growth. If the Company cannot successfully raise additional funding and implement its strategic development plan, the Company may be forced to make further reductions in spending, including spending in connection with its commercialization activities, extend payment terms with suppliers, liquidate assets where possible at a potentially lower amount than as recorded in the condensed consolidated financial statements, suspend or curtail planned operations, or cease operations entirely. Any of these could materially and adversely affect the Company’s liquidity, financial condition and business prospects, and the Company would not be able to continue as a going concern. The Company has concluded that these circumstances and the uncertainties associated with the Company’s ability to obtain additional equity or debt financing on terms that are favorable to the Company, or at all, and otherwise succeed in its future operations raise substantial doubt about the Company’s ability to continue as a going concern.
Current wording
If the Company is not able to obtain the required funding through a significant increase in revenue, equity or debt financings, license agreements for our products in the U.S. or foreign markets, or other means, or is unable to obtain funding on terms favorable to the Company, there will be a material adverse effect on commercialization and development operations and the Company’s ability to execute its strategic development plan for future growth. If the Company cannot successfully raise additional funding and implement its strategic development plan, the Company may be forced to make further reductions in spending, including spending in connection with its commercialization activities, extend payment terms with suppliers, liquidate assets where possible at a potentially lower amount than as recorded in the condensed consolidated financial statements, suspend, or curtail planned operations, or cease operations entirely. Any of these could materially and adversely affect the Company’s liquidity, financial condition and business prospects, and the Company would not be able to continue as a going concern. The Company has concluded that these circumstances and the uncertainties associated with the Company’s ability to obtain additional equity or debt financing on terms that are favorable to the Company, or at all, and otherwise succeed in its future operations raise substantial doubt about the Company’s 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, 2024 and 2023 contains 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, 2025 and for the three months ended March 31, 2025 and 2024 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, 2024 and 2023 contains 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, 2025 and for the three and six months ended June 30, 2025 and 2024 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, 2025, the primary source of cash, cash equivalents and restricted cash was related to collection of the accounts receivable from the increased sales in December 2024 ahead of the January 2025 price increase as well as due to continued efforts to restrict spending across the organization. During the three months ended March 31, 2024, the primary reason for net cash, cash equivalents and restricted cash provided in operating activities was due to the limited spending in operations across all functions of the Company.
Current wording
Cash Flows from Operating Activities. During the six months ended June 30, 2025, the primary use of cash, cash equivalents and restricted cash was related to the payment of routine trade payables of $0.7 million, contingent liabilities of $0.4 million, and the purchase of inventory of $0.5 million. During the six months ended June 30, 2024, the primary use of net cash, cash equivalents and restricted cash used in operating activities was minimal due to the limited spending in operations across all functions of the Company.
Previous wording
Cash Flows from Investing Activities. During the three months ended March 31, 2025, the primary use of cash, cash equivalents and restricted cash was the payment of amounts related to the acquisition of SOLOSEC which had previously been recorded as accounts payable. During the three months ended March 31, 2024, the use of cash, cash equivalents and restricted cash was immaterial.
Current wording
Cash Flows from Investing Activities. During the six months ended June 30, 2025, the primary use of cash, cash equivalents and restricted cash was the payment of amounts related to the acquisition of SOLOSEC which had previously been recorded as accounts payable. During the six months ended June 30, 2024, the primary use of cash, cash equivalents and restricted cash was the purchase of computer equipment for the Company’s sales force.
Previous wording
Cash Flows from Financing Activities. During the three months ended March 31, 2025, the primary use of cash, cash equivalents and restricted cash was the payment of short-term debt.
Current wording
Cash Flows from Financing Activities. During the six months ended June 30, 2025, the primary source of cash, cash equivalents and restricted cash 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. During the six months ended June 30, 2024, the primary source of cash, cash equivalents, and restricted cash was from the $1.0 million received from Aditxt in order to reinstate the Merger Agreement as described above as well as the finance agreement with First Insurance Funding for $0.4 million, offset by $0.3 million payments under the Baker Notes.
Previous wording
Operating lease right**-of-**use assets and lease liabilities were $0.1 million each on both March 31, 2025 and December 31, 2024. 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 $0.2 million and $0.1 million on June 30, 2025 and December 31, 2024, respectively. 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 PHEXXI, with potential to manufacture other product candidates, in accordance with all applicable current good manufacturing practice regulations. There were approximately $0.8 million in purchases under the supply and manufacturing agreement for the three months ended March 31, 2025 and no such purchases during the three months ended March 31, 2024.
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 PHEXXI, with potential to manufacture other product candidates, in accordance with all applicable current good manufacturing practice regulations. 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, and $0.3 million in such purchases during the three and six months ended June 30, 2024.
Previous wording
As described in Note 7 - Commitments and Contingencies, royalty costs owed to Rush University pursuant to the Rush License Agreement were $0.2 million for the three months ended March 31, 2024. No such amounts were incurred for the three months ended March 31, 2025 due to the expiration of the Rush patent. As of both March 31, 2025 and December 31, 2024, approximately $2.0 million were included in accrued expenses in the condensed consolidated balance sheets.
Current wording
As described in Note 7 - Commitments and Contingencies, royalty costs owed to Rush University pursuant to the Rush License Agreement were $0.2 million and $0.4 million for the three and six months ended June 30, 2024. No such amounts were incurred for the three and six months ended June 30, 2025 due to the expiration of the Rush patent. As of both June 30, 2025 and December 31, 2024, approximately $2.0 million were included in accrued expenses in the condensed consolidated balance sheets.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
The Company also licensed commercial rights to SOLOSEC in MENA to Pharma 1 on May 19, 2025. Under this agreement, the licensed territory includes the UAE, Kuwait, Saudi Arabia, Qatar, Oman, and Jordan, with potential to expand into 15 other countries in the region. Pharma 1 is responsible for obtaining and maintaining any regulatory approvals required to market and sell SOLOSEC, and will handle all aspects of distribution, sales and marketing, pharmacovigilance and all other commercial functions in these countries. Evofem will supply product to Pharma 1 at a specified cost per unit. Pharma 1 is expected to file for regulatory approval of SOLOSEC in the UAE in the third quarter of 2025.
Current report — wording carried from elsewhere
On July 24, 2025 the Company filed a preliminary proxy statement with the SEC to solicit the approval of the Merger at a special meeting of the stockholders.
Current report — wording carried from elsewhere
The immaterial decrease in cost of goods sold was primarily due to the end of the Rush royalty as described above partially offset by the addition of SOLOSEC costs of goods sold.