Evofem Biosciences, Inc.
For the period ended Dec 31, 2025. Filed Mar 11, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 11, 2026
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-K
Period ended 2024-12-31; filed 2025-03-24.
0001641172-25-000188
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-11.
0001493152-26-009686
Item 7. 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 146 previous paragraphs and 131 current paragraphs.
50 unchanged; 53 reworded; 25 added; 43 removed; 0 previous and 3 current paragraphs rearranged.
Tables are not compared: 13 previous and 12 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 (25)
Current report
We intend to expand the global reach of our products and further increase our global potential through ex-U.S. partnerships or licensing agreements for PHEXX and SOLOSEC.
Current report
23 Daniels K and Abma J. Current Contraceptive Status Among Females Ages 15–49: United States, 2022–2023. NCHS Data Brief No. 539. August 2025. Data table for Figure 1, sourced from National Survey of Family Growth (NSFG) 2022–2023. https://www.cdc.gov/nchs/data/databriefs/db539.pdf
Current report
Under the 2020 Global Health Agreement with Adjuvant Capital, the Company has also submitted marketing applications for PHEXX under the trademark Femidence™ in Nigeria, Ethiopia, and Ghana. Femidence was approved in Nigeria on October 6, 2022, by the National Agency for Food and Drug Administration and Control. In October 2021, the Company submitted Femidence for approval in Mexico. The Company has not allocated resources to follow up with these regulatory bodies or advance commercialization in Nigeria due to fiscal constraints since October 2022.
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
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 report
24 Daniels K and Abma J. Current Contraceptive Status Among Females Ages 15–49: United States, 2022–2023. NCHS Data Brief No. 539. August 2025. Data table for Figure 1, sourced from National Survey of Family Growth (NSFG) 2022–2023. https://www.cdc.gov/nchs/data/databriefs/db539.pdf
Current report
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 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 Trich 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 directly funded by the National Institutes of Health (NIH).
Current report
Inventory costs include all purchased materials, direct labor, and manufacturing overhead. In addition, in prior years we accrued quarterly royalty amounts that would have been due pursuant to our license agreement with Rush University had their application for patent term extension (PTE) been granted. The royalty expenses accrued were amounts equal to a single-digit percentage of our gross quarterly receipts, less certain deductions incurred in the quarter based on a sliding scale. Due to the patent expiration, no royalty costs were recorded for the year ended December 31, 2025. For the year ended December 31, 2024, $0.8 million was included in the costs of goods sold in the consolidated statement of operations. As described in Note 7 – Commitments and Contingencies, no further royalties are payable to Rush University now that the patent has expired. The amounts that had been previously accrued but were unpaid as of December 31, 2024 were reversed in the current period, which had a favorable impact on the total operating expenses during the year ended December 31, 2025 of approximately $1.9 million that is not expected to be repeated in future periods. Due to the materiality and the one-time nature of the reversal, the amount was included in the gain on change in accounting estimates on contingent royalty liability in the consolidated statement of operations.
Current report
In the year ended December 31, 2025, cost of goods sold also included a loss on inventory write-down for excess and obsolescence as well as a loss on inventory purchase commitment of approximately $1.0 million. Less than $0.1 million was recorded related to inventory write-down for excess and obsolescence in the year ended December 31, 2024.
Current report
The fair value of the Baker Notes was $15.5 million and $13.8 million as of December 31, 2025 and 2024, respectively.
Current report
Fair Value of the Exchanged SSNs and Aditxt Notes
Current report
The fair value of the Exchanged SSNs and Aditxt Notes was determined by estimating the fair value of the Market Value of Invested Capital (MVIC) of the Company on a going-concern basis. This was estimated using a form of the market approach where comparable market revenue multiples were selected and applied to the Company’s forward revenue forecast to ultimately derive a MVIC indication. An option-pricing model (OPM) was then applied to value the Exchanged SSNs by allocating the estimated MVIC through the Company’s capital structure including the more senior notes payoff in a hypothetical exit event. Under the OPM, each debt or equity class is modeled as a call option with a distinct claim on the total value of the Company. The option’s exercise price is based on the Company’s total value available for each participating security holder. By constructing a series of options in which the exercise price is set at incremental levels of value, which correspond to the value necessary for each level of equity to participate, we determined the incremental option value of each series. When multiplied by the percentage of ownership of each equity class participating, the result is the incremental value allocated to each class under that series.
Current report
The increase in product sales, net, reflects the impact of the PHEXX price increase that took effect on January 1, 2025, slight improvements in gross-to-net, and sales of SOLOSEC for the entire year in 2025 compared to only a partial year in 2024. The increase was partially offset by a small decrease in the number of PHEXX units sold in 2025.
Current report
The increase in cost of goods sold was primarily due to the write-down of $0.7 million for SOLOSEC inventory which is identified as excess based on current demand forecasts and expected expiration dates, coupled with a $0.3 million loss related to a firm inventory purchase commitment for SOLOSEC. This decrease was partially offset by the absence of expense related to the contingent Rush Royalty liability in the current year while it was recorded in the prior year.
Current report
Gain on Change in Accounting Estimates on Contingent Royalty Liability
Current report
The gain on change in accounting estimates on contingent royalty liability was due to the reversal of previously accrued but unpaid amounts related to the Rush Royalty as a result of the additional information obtained during the third quarter of 2025, including clarification by the FDA that no PTE should be granted. See Note 7 – Commitments and Contingencies for more information regarding this reversal.
Current report
Amortization of Intangible Asset
Current report
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. Such decrease was partially offset by a full-year of amortization in 2025, versus only a partial-year of amortization in 2024 following the close of the SOLOSEC acquisition in July 2024.
Current report
The decrease in research and development expenses was primarily due to the settlement of a portion of the Company’s trade payables and accrued liabilities, which resulted in a $5.6 million reduction in research and development expenses in the current period. The decrease was partially offset by a $0.4 million increase in outside services costs.
Current report
The increase in selling and marketing expenses was primarily due to a $0.3 million increase in PDUFA fees and outside services and an increase of $0.2 million in sales support costs.
Current report
As described in Note 4 - Debt, during the year ended December 31, 2025, we entered into 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 and quarterly cash payments due under the Fourth Baker Amendment.
Current report
Cash Flows from Operating Activities. During the year ended December 31, 2025, the primary use of cash, cash equivalents and restricted cash in operating activities was driven by net income of $0.4 million less net adjustments to reconcile net income to net restricted cash and cash equivalents used in operating activities of $3.0 million. The cash used in operating activities was also driven by the increase in trade accounts receivable of $2.6 million as well as decreases in accrued compensation of $0.9 million, contingent liabilities of $0.5 million, and the purchase of inventory of $0.3 million. The use of cash, cash equivalents, and restricted cash in operating activities was partially offset by an increase in accrued expenses and other liabilities of $4.5 million and decreases in prepaid expenses and other current assets of $0.4 million and in accounts payable of $0.2 million.
Current report
During the year ended December 31, 2024, the primary use of restricted cash and cash equivalents in operating activities was driven by net loss of $8.9 million offset by net adjustments to reconcile net loss to net cash, cash equivalents, and restricted cash used in operating activities of $4.1 million. The cash used in operating activities was also driven by the payment of trade payables of $0.9 million, a decrease in prepaid and other assets of $0.3 million, and lower customer collections of $4.1 million, partially offset by increases in accrued expenses and other liabilities of $5.3 million, and accrued compensation of $0.9 million.
Removed paragraphs (43)
Previous report
Outside the U.S., PHEXXI was approved in Nigeria on October 6, 2022, as Femidence™ by the National Agency for Food and Drug Administration and Control. To-date, PHEXXI has been submitted for approval in Mexico, Ethiopia and Ghana. We intend to commercialize PHEXXI in all other global markets through partnerships or licensing agreements.
Previous report
Recent Developments
Previous report
Notice of Default and Termination of Forbearance Agreement
Previous report
On September 27, 2024, Future Pak, LLC, as agent for the Purchasers (in such capacity, the Designated Agent) provided a Notice of Event of Default and Reservation of Rights (the Notice of Default) relating to the Securities Purchase and Security Agreement dated April 23, 2020, as amended (SPA), by and among the Company, Designated Agent, as certain guarantors and the purchasers (each a “Purchaser” and collectively Purchasers). The 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, an Event of Default has occurred under Section 9.1(e) of the SPA.
Previous report
According to the Notice of Default, the Designated Agent has accelerated repayment of the outstanding principal balance owed by the Company under the Securities Purchase Agreement. If all Purchasers exercise the Section 5.7 Option (as defined below), the repurchase price would be equal to $106.8 million. 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).
Previous report
On October 27, 2024, the Designated Agent sent an amended and supplemented notice to the Notice of Default which adds additional claims of default based on the Company’s current repayment agreements of existing obligations, including obligations owed to the U.S. Department of Health and Human Services, an Event of Default has occurred under Section 9.1(e) of the Securities Purchase and Security Agreement dated April 23, 2020, as amended. Furthermore, the Amended Notice stated that, because the events of default described in the Amended Notice of Default are not the certain prior events of default listed in the Forbearance Agreement (the Specified Defaults), the Designated Agent and the holders of the senior secured promissory notes described in the SPA thereby provided notice to the Company that the Forbearance Agreement is terminated as of October 27, 2024.
Previous report
Subsequently, on November 8, 2024, the Designated Agent sent an amended and supplemented notice to the Notices (the Third Amended Notice of Default) which adds new claims of default based on (i) the Company’s failure to maintain a cash position of $1.0 million or greater, as required under Section 5(b) of the Forbearance Agreement (ii) the Company’s failure to deliver financial and operating reports in accordance with the timeline required under the Section 8.1(n) of the Baker Stock Purchase Agreement, and (iii) to clarify the outstanding balance under the notes of the Baker Stock Purchase Agreement plus all accrued and unpaid interest thereon, in the sum of approximately is $107.0 million as opposed to the Repurchase Price as defined in the Fourth Amendment.
Previous report
The Company strongly disagrees with the Designated Agent’s claim that any Event of Default has occurred. The Company intends to vigorously contest any attempt by the Designated Agent and the Purchasers to exercise their default rights and remedies under the SPA.
Previous report
Aditxt Merger
Previous report
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).
Previous report
On July 12, 2024, the Company, the Merger Sub and Aditxt entered into the Amended and Restated Merger Agreement (the A&R Merger Agreement) which amends and restates in its entirety the Agreement and Plan of Merger (as amended January 10, 2024, January 30, 2024, February 29, 2024, and May 2, 2024 (collectively, the Original 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.
Previous report
At the Effective Time of the Merger:
Previous report
Further, Aditxt agreed to, on or prior to: (a) July 12, 2024, purchase 500 shares of the Company’s Series F-1 Preferred Shares for an aggregate purchase price of $0.5 million (the July Purchase) (b) August 9, 2024, purchase an additional 500 shares of F-1 Preferred Shares for an aggregate purchase price of $0.5 million (the August Purchase), (c) the earlier of August 30, 2024 or within five business days of the closing of a public offering by Aditxt resulting in aggregate net proceeds to Aditxt of no less than $20.0 million, purchase an additional 2,000 shares of F-1 Preferred Shares for an aggregate purchase price of $2.0 million (the Third Parent Equity Investment); and (d) September 30, 2024, purchase an additional 1,000 shares of F-1 Preferred Stock at an aggregate purchase price of $1.0 million (the Fourth Parent Equity Investment). The July Purchase and subsequent August Purchase of 500 shares of the Company’s Series F-1 Preferred Shares in each respective purchase were completed as scheduled.
Previous report
On August 16, 2024, the Company, Parent and Merger Sub entered into the first amendment to the A&R Merger Agreement (the First Amendment), to change the funding date for the Third Parent Equity Investment Date (as defined in the A&R Merger Agreement) from August 30, 2024 to the earlier of (i) September 6, 2024 or (ii) within five (5) business days of the closing of a public offering by Parent resulting in aggregate net proceeds to Parent of no less than $20.0 million.
Previous report
On September 6, 2024, the Company, Parent and Merger Sub entered into the second amendment to the A&R Merger Agreement (the Second Amendment), to (i) change the date of the Third Parent Equity Investment Date and Fourth Parent Equity Investment Date (as defined in the A&R Merger Agreement) from September 6, 2024 and September 30, 2024 to September 30, 2024 and October 31, 2024, respectively and (ii) to change the required consummation date to November 29, 2024.
Previous report
On October 2, 2024, the Company, Parent and Merger Sub entered into the third amendment to the A&R Merger Agreement (the Third Amendment), to (i) change the date of the Third Parent Equity Investment Date (as defined in the A&R Merger Agreement) from September 30, 2024 to October 2, 2024, (ii) change the Third Parent Equity Investment from 1,500 shares of Series F-1 Preferred Shares to 720 shares of Series F-1 Preferred Shares, and (iii) amend the Fourth Parent Equity Investment (as defined in the A&R Merger Agreement) from 1,500 shares of Series F-1 Preferred Shares to 2,280. The Third and Fourth Parent Equity Investments were timely completed on October 2 and October 28, 2024, respectively.
Previous report
On November 19, 2024, the Company, Parent and Merger Sub entered into the fourth amendment to the A&R Merger Agreement (the Fourth Amendment) to change the required consummation date to January 31, 2025.
Previous report
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 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.
Previous report
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.
Previous report
On December 23, 2024, Evofem announced its decision to cancel its special meeting and the withdrawal from consideration by the stockholders of the Company the proposals set forth in its preliminary proxy statement.
Previous report
In connection with the Merger Agreement, Aditxt, the Company and the holders (the Holders) of certain senior indebtedness of Evofem (the Notes) entered into an Assignment Agreement dated December 11, 2023 (the December Assignment Agreement), pursuant to which the Holders assigned the Notes to Aditxt in consideration for the issuance by Aditxt of (i) an aggregate principal amount of $5.0 million in secured notes of Aditxt due on January 2, 2024 (the January 2024 Secured Notes), (ii) an aggregate principal amount of $8.0 million in secured notes of Aditxt due on September 30, 2024 (the September 2024 Secured Notes), (iii) an aggregate principal amount of $5.0 million in ten-year unsecured notes (the Unsecured Notes), and (iv) payment of $0.2 million in respect of net sales of PHEXXI in respect of the calendar quarter ended September 30, 2023.
Previous report
On February 26, 2024, Aditxt and the Holders entered into an Assignment Agreement (the February Assignment Agreement), pursuant to which the Company consented to the assignment of all remaining amounts due under the Notes from Aditxt back to the Holders.
Previous report
On February 29, 2024, as part of the Third Amendment, Aditxt agreed to have, as a condition of closing, that the outstanding balance, plus all accrued and unpaid interest thereon, in an amount not to exceed the Repurchase Price, shall have been paid in full. The A&R Merger Agreement, as amended, entered into on July 12, 2024, maintains the same condition to closing. 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 report
Payer wins in 2024 include the removal of the Prior Authorization requirement for PHEXXI by the Washington State Health Care Authority effective January 1, 2024, and, as a result of the Company’s successful renegotiation, a 7.4% reduction in the rebate paid by the Company to Medi-Cal on PHEXXI prescriptions dispensed to Medi-Cal members. The approval rate was over 80% for all of 2024.
Previous report
Since the second quarter of 2022, we have been under contract with one of the largest pharmacy benefit managers (PBMs) in the nation, which added PHEXXI to its formulary with no restrictions for most women covered by the plan. The agreement was retroactive and took effect January 1, 2022 and is representative of approximately 46 million lives.
Previous report
Research has shown that as many as 50% of patients with BV do not adhere to a full course of metronidazole treatment (500mg BID x 7d) 14 doses. 58% of women who do not complete therapy will have a recurrence within one year. Noncompliance to a multiple-day metronidazole regimen is a contributing factor to persistent BV.
Previous report
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.
Previous report
For the year ended December 31, 2024, there was an approximate 7% increase in net product sales as a result of an increase to the PHEXXI wholesale acquisition cost (WAC) in January 2024, more favorable PHEXXI payer coverage despite a single digit decrease in unit shipments to customers compared to the year ended December 31, 2023, and the addition of SOLOSEC net revenue in the current year. Gross revenues, as discussed in Note 3 - Revenue, were adjusted for variable consideration, including our patient support programs.
Previous report
Inventory costs include all purchased materials, direct labor and manufacturing overhead. In addition, we are 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 are also obligated to pay a minimum annual royalty amount of $0.1 million to the extent these earned royalties do not equal or exceed $0.1 million in a given year. Such royalty costs were $0.8 million and $0.7 million for the years ended December 31, 2024 and 2023, respectively, and were included in the costs of goods sold in the consolidated financial statements. No further royalties will be due to Rush University after the patent expiration.
Previous report
As anticipated, research and development expenses continued to decrease in the year ended December 31, 2024 compared to the year ended December 31, 2023; we do not anticipate investing in clinical development for the foreseeable future. Specifically, the amounts related to noncash stock-based compensation expenses decreased by $0.1 million, or 72%, payroll related expenses decreased by $0.6 million, or 44%, outside services costs increased by $0.3 million, or 54%, and other costs decreased by $0.8 million, or 70%. Allocated third-party development expenses had a benefit of approximately $0.1 million in the prior year and no activity in the current year.
Previous report
In connection with our overall cost reduction strategy, our selling and marketing expenses continued to decrease in the year ended December 31, 2024 compared to the prior year. Key drivers were reductions in media and marketing activities for PHEXXI, including direct to consumer (DTC) and HCP advertising and termination of the sample program.
Previous report
Our general and administrative expenses decreased in the year ended December 31, 2024 compared to the year ended December 31, 2023 primarily due to a decreased use of professional and other outside services.
Previous report
From the third quarter of 2022 through the second quarter of 2023, the fair value of the Baker Notes issued, as described in Note 4 - Debt, and subsequent changes in fair value recorded at each reporting date, was determined by estimating the fair value of the Market Value of Invested Capital (MVIC) of the Company. This was estimated using forms of the cost and market approaches. In the cost approach, an adjusted net asset value method was used to determine the net recoverable value of the Company, including an estimate of the fair of the Company’s intellectual property. The estimated fair value of the Company’s intellectual property was valued using a relief from royalty method which required management to make significant estimates and assumptions related to forecasts of future revenue, and the selection of the royalty and discount rates. The guideline public company method served as another valuation indicator. In this form of the market approach, comparable market revenue multiples were selected and applied to the Company’s forward revenue forecast to ultimately derive a MVIC indication. If the resulting fair value from these approaches was not estimated as greater than the contractual payout, the fair value of the Baker Notes became only the Company MVIC available for distribution to this first lien note holder.
Previous report
The fair value of the Baker Notes was $13.8 million and $13.5 million as of December 31, 2024 and 2023, respectively.
Previous report
The increase in product sales, net, was primarily due to the impact of the PHEXXI price increase that took effect on January 1, 2024, lower returns leading to a better gross to net ratio, and sales of SOLOSEC commencing mid July 2024.
Previous report
The decrease in cost of goods sold was primarily due to the units sold in the prior year having been re-packaged to reflect the extended shelf life approved by the FDA in June 2022; this added costs to re-worked units that were sold in the prior year, whereas the units sold in the current year did not need to be re-packaged. Finally, there was a $1.1 million inventory excess and obsolescence reserve recorded in the 2023 period that was not repeated in the current year.
Previous report
The decrease in research and development expenses was primarily due to a decrease of approximately $0.7 million in personnel costs and a decrease of approximately $0.9 million in clinical and facilities costs, which was partially offset by an increase in outside services costs of $0.5 million.
Previous report
The decrease in selling and marketing expenses was primarily due to a $1.1 million decrease in marketing and DTC promotion costs, including media agency fees, a $1.1 million decrease in personnel costs due to reduced headcount and lower noncash stock-based compensation, and a $0.7 million decrease in facilities costs. The decreases were partially offset by an increase of $0.5 million in outside services and other costs.
Previous report
Total other income, net, for the year ended December 31, 2023 primarily included a $75.3 million gain related to the Baker Fourth Amendment, which was treated as a debt extinguishment and $4.9 million in gain on the change in the fair value of financial instruments as a result of mark-to-market adjustments. The gains were partially offset by $6.8 million in loss on the issuance of financial instruments and $2.3 million of interest expense related to the Adjuvant Note.
Previous report
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 2025 Prescription Drug User Fee Act (PDUFA) invoices for PHEXXI and the 2025 PDUFA invoice for SOLOSEC.
Showing the first 40 of 43 passages. Open the source sections for the rest.
Reworded paragraphs (53)
Previous wording
We 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. 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 smoke. 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, 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 15.923 million women in the U.S. will not use a hormonal contraceptive.
Previous wording
Evofem has delivered PHEXXI net sales growth in each consecutive year since it was launched in Sept 2020. Key growth drivers for 2025 include expanded 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
Evofem has delivered PHEXX net sales growth in each consecutive year since it was launched in September 2020. Key growth drivers for 2025 included 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 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 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.
Previous wording
On July 17, 2024, we licensed exclusive commercial rights to PHEXXI in the Middle East to Pharma 1 Drug Store, an emerging Emirati health care company. 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 PHEXXI to Pharma 1 at cost-plus. Pharma 1 is expected to file for regulatory approval of PHEXXI in the UAE in the first half of 2025.
Current wording
We licensed exclusive commercial rights for PHEXX 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 PHEXX, 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 PHEXX in the UAE in June 2025.
Previous wording
We halted clinical development of our investigational product candidates in October 2022 to focus resources on growing domestic sales of PHEXXI for the prevention of pregnancy.
Current wording
We halted clinical development of our investigational product candidates in October 2022 to focus resources on growing domestic sales of PHEXX for the prevention of pregnancy.
Previous wording
PHEXXI as a Contraceptive; Commercial Strategies
Current wording
PHEXX as a Contraceptive; Commercial Strategies
Previous wording
In September 2020, we commercially launched PHEXXI in the United States. Our sales force promotes PHEXXI directly to obstetrician/gynecologists and their affiliated health professionals, who collectively write the majority of prescriptions for contraceptive products. Our sales force comprises approximately 16 regional sales representatives, two business directors and an SVP of Commercial Operations, supported by a self-guided virtual health care provider (HCP) learning platform. Additionally, we offer women direct access to PHEXXI via a telehealth platform. Using this platform, women can directly meet with an HCP to determine their eligibility for a PHEXXI prescription and, if eligible, have the prescription written by the HCP, then filled and mailed directly to them by a third-party pharmacy.
Current wording
In September 2020, we commercially launched PHEXX in the United States. Our sales force promotes PHEXX 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 regional sales representatives, sales managers, business directors, and a Senior Vice President of Commercial Operations. Additionally, we offer women direct access to PHEXX via a telehealth platform. Using this platform, women can directly meet with an HCP to determine their eligibility for a PHEXX prescription and, if eligible, have the prescription written by the HCP, then filled and mailed directly to them by a third-party pharmacy.
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 PHEXX includes marketing and product awareness campaigns targeting HCPs and women of reproductive potential in the U.S., including the approximately 15.924 million women who are not using hormonal contraception and the approximately 10.3 million women who are using a short-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.
Previous wording
Key growth drivers for 2025 include expanded 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 included 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 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
We continue working to increase the number of lives covered and to gain a preferred formulary position for PHEXXI.
Current wording
We continue working to increase the number of lives covered and to gain a preferred formulary position for PHEXX.
Previous wording
An additional 13.7 million lives are covered under our December 2020 contract award from the U.S. Department of Veterans Affairs.
Current wording
Approximately 13.7 million lives are covered under our December 2020 contract award from the U.S. Department of Veterans Affairs.
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 PHEXXI on January 1, 2021. As of May 2024, Medicaid provides health coverage to approximately 73.8 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 the U.S. 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 May 2025, Medicaid provides health coverage to approximately 70.5 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
Approximately 83% of commercial and Medicaid PHEXXI prescriptions are being approved by payers.
Current wording
As of December 2025, approximately 83% of commercial and Medicaid PHEXX prescriptions were being approved by payers.
Previous wording
PHEXXI 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.”
Current wording
PHEXX 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.”
Previous wording
Effective as of January 1, 2023, most insurers and PBMs must provide coverage, with no out-of-pocket costs (e.g. $0 copay) to the subscriber or dependent, for FDA-approved contraceptive products, like PHEXXI, prescribed by healthcare providers.
Current wording
Effective as of January 1, 2023, most insurers and PBMs must provide coverage, with no out-of-pocket costs (e.g., $0 copay) to the subscriber or dependent, for FDA-approved contraceptive products, like PHEXX, prescribed by healthcare providers.
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 PHEXX by:
Previous wording
In July 2024, we expanded our commercial portfolio by acquiring global rights to SOLOSEC® (secnidazole) 2g 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:
Current wording
In July 2024, we expanded our commercial portfolio by acquiring global rights to SOLOSEC® (secnidazole) 2 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:
Previous wording
SOLOSEC has the same call point as PHEXXI, enabling us to leverage our commercial infrastructure and strong physician relationships. We re-launched the brand in November 2024.
Current wording
SOLOSEC has the same call point as PHEXX, enabling us to leverage our commercial infrastructure and strong physician relationships. We re-launched the brand in November 2024.
Previous wording
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.
Current wording
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 Trich.
Previous wording
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, chlamydia, gonorrhea and HIV, as well as transmission of STIs to a partner. Additional risks include developing pelvic inflammatory disease (PID), which can threaten a women’s fertility, and complications with gynecological surgery.
Current wording
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, Trich, chlamydia, gonorrhea, and HIV, as well as transmission of STIs to a partner. Additional risks include developing pelvic inflammatory disease (PID), which can threaten a woman’s fertility, and complications with gynecological surgery.
Previous wording
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; and ACOG and the CDC no longer recommend single dose metronidazole to treat Trich in women.
Current wording
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; both ACOG and the CDC no longer recommend single dose metronidazole to treat Trich in women.
Previous wording
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. We have recognized net product sales in the U.S. since the commercial launch of PHEXXI in September 2020; SOLOSEC net product sales were added to our revenue beginning in July 2024.
Current wording
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 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, were adjusted for variable consideration, including our patient support programs.
Previous wording
We are also obligated to pay quarterly royalty 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 the year ended December 31, 2024.
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 approximately $0.1 million and immaterial for the years ended December 31, 2025 and 2024, respectively.
Previous wording
We expense internal and third-party research and development expenses as incurred. The following table summarizes research and development expenses by product candidate (in thousands):
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 PHEXX and SOLOSEC commercialization costs, the PHEXX telehealth platform, training, salaries, benefits, travel, noncash stock-based compensation expense, other related costs for our employees and consultants, and the Prescription Drug User Fee Act (PDUFA) fees we are required to pay to the FDA for our products.
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 in the current period and loss on issuance of financial instruments in each of the presented periods.
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, 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.
Previous wording
Our consolidated financial statements have been prepared in accordance with generally accepted accounting principles (GAAP) in the U.S. The preparation of consolidated financial statements requires us to make use of estimates, assumptions and judgments that affect the reported amounts of assets, expenses, and liabilities, as well as the disclosure of contingent liabilities on the date of the consolidated financial statements. Management bases its estimates, assumptions, and judgments on historical experience and on various other factors it believes to be reasonable under the circumstances. Different estimates, assumptions and judgments may change the estimate used in the preparation of our consolidated financial statements, which, in turn, could materially change our results from those reported. Management evaluates its use of estimates, assumptions, and judgments on an ongoing basis. However, if our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may have a material adverse effect on our consolidated statements of operations, liquidity, and financial condition. We believe the following critical accounting policies involve significant areas where management applies estimates, assumptions, and judgments in the preparation of our consolidated financial statements. See Note 2 - Summary of Significant Accounting Policies.
Current wording
Our consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the U.S. (GAAP). The preparation of consolidated financial statements requires us to make use of estimates, assumptions and judgments that affect the reported amounts of assets, expenses, and liabilities, as well as the disclosure of contingent liabilities on the date of the consolidated financial statements. Management bases its estimates, assumptions, and judgments on historical experience and on various other factors it believes to be reasonable under the circumstances. Different estimates, assumptions and judgments may change the estimate used in the preparation of our consolidated financial statements, which, in turn, could materially change our results from those reported. Management evaluates its use of estimates, assumptions, and judgments on an ongoing basis. However, if our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may have a material adverse effect on our consolidated statements of operations, liquidity, and financial condition. We believe the following critical accounting policies involve significant areas where management applies estimates, assumptions, and judgments in the preparation of our consolidated financial statements. See Note 2 - Summary of Significant Accounting Policies.
Previous wording
The Company recognizes revenue from the sale of our products in accordance with ASC 606,Revenue from Contracts with Customers(ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) Identify the contract(s) with a customer; (2) Identify the performance obligations in the contract; (3) Determine the transaction price; (4) Allocate the transaction price to the performance obligations in the contract; (5) Recognize revenue when (or as) the entity satisfies a performance obligation.
Current wording
We recognize revenue from the sale of our products in accordance with ASC 606,Revenue from Contracts with Customers(ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
Previous wording
In accordance with ASC 606, the Company recognizes revenue when its performance obligation is satisfied by transferring control of the product to a customer. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers consist of wholesale distributors, retail pharmacies, and a mail-order specialty pharmacy. Payment terms vary by customer, but typically range from 31 to 66 days and include prompt pay discounts. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the consolidated balance sheets, net of various allowances as described in the Trade Accounts Receivable policy in Note 2 - Summary of Significant Accounting Policies.
Current wording
In accordance with ASC 606, we recognize revenue when our performance obligation is satisfied by transferring control of the product to a customer. Any payments received before we satisfy our performance obligations are considered deferred revenue until the obligations are satisfied. In accordance with our contracts with customers, control of the product is transferred upon the conveyance of title, which typically occurs when the product is sold to and received by a customer. Our customers are primarily located in the U.S., and as of the fourth quarter of 2025, in the UAE, and consist of wholesale distributors, retail pharmacies, and mail-order specialty pharmacies. Payment terms typically range from 31 to 66 days, include prompt pay discounts, and vary by customer. Trade accounts receivable due to us from contracts with customers are stated separately in the consolidated balance sheets, net of various allowances as described in the Trade Accounts Receivable policy in Note 2 - Summary of Significant Accounting Policies.
Previous wording
The amount of revenue recognized is equal to the amount of consideration which is expected to be received from the sale of product to its customers. Revenue is only recognized when it is probable that a significant reversal will not occur in future periods. To determine the amount of revenue to recognize, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue.
Current wording
The amount of revenue recognized is equal to the amount of consideration that is expected to be received from the sale of product to our customers. Revenue is only recognized when the performance obligation is satisfied. To determine whether a significant reversal will occur in future periods, we assess both the likelihood and magnitude of any such potential reversal of revenue.
Previous wording
Our products are sold to customers at the wholesale acquisition cost. However, the Company records product revenue net of estimates for applicable variable consideration.
Current wording
Our products are sold to customers at the wholesale acquisition cost. However, we record product revenue net of estimates for applicable variable consideration.
Previous wording
Revenue recognition is subject to uncertainty due to the variable consideration estimates that are required to be made by management. These estimates include chargebacks, rebates and patient support programs. Management must estimate and accrue for these amounts primarily by estimating the portion of product in the distribution supply channel at the reporting date that will be sold through to an entity or end user that will result in a variable consideration expense, which is recorded as a reduction of revenue. To accomplish this, management relies on historical sales data showing the amount of various end-user consumer types, inventory reports from the wholesale distributors and mail-order specialty pharmacy, and other relevant data reports. The recorded variable consideration is directly sensitive to the estimated inputs made by management that are used in the calculation. The total reserves for variable consideration was $7.2 million and $3.5 million, as of December 31, 2024 and 2023, respectively.
Current wording
Revenue recognition is subject to uncertainty due to the variable consideration estimates that are required to be made by management. These estimates include chargebacks, rebates, and patient support programs. Management must estimate and accrue for these amounts primarily by estimating the portion of product in the distribution supply channel at the reporting date that will be sold through to an entity or end user that will result in a variable consideration expense, which is recorded as a reduction of revenue. To accomplish this, management relies on historical sales data showing the amount of various end-user consumer types, inventory reports from the wholesale distributors and mail-order specialty pharmacy, and other relevant data reports. The recorded variable consideration is directly sensitive to the estimated inputs made by management that are used in the calculation. The total reserves for variable consideration were $11.7 million and $7.2 million, as of December 31, 2025 and 2024, respectively.
Previous wording
Starting in the third quarter of 2023, the fair value of the Baker Notes is determined using a Monte Carlo simulation-based model. The Monte Carlo simulation was used to take into account several embedded features and factors, including the exercise of the repurchase right, the Company’s future revenues, meeting certain debt covenants, the maturity term of the note and dissolution. For the dissolution scenario, the cost approach, an adjusted net asset value method was used to determine the net recoverable value of the Company, including an estimate of the fair value of the Company’s intellectual property. The estimated fair value of the Company’s intellectual property was valued using a relief from royalty method which required management to make significant estimates and assumptions related to forecasts of future revenue, and the selection of the royalty (5.0%) and discount (15.0%) rates.
Current wording
The fair value of the Baker Notes is determined using a Monte Carlo simulation-based model and is subject to uncertainty due to the assumptions used in the model. The fair value of the Baker Notes is sensitive to these estimated inputs made by management that are used in the calculation. The Monte Carlo simulation takes into account several embedded features and factors and management inputs, including the exercise of the repurchase rights, the Company’s future revenues, meeting certain debt covenants, the maturity term of the note and dissolution. For the dissolution scenario, the cost approach, an adjusted net asset value method was used to determine the net recoverable value of the Company, including an estimate of the fair value of the Company’s intellectual property. The estimated fair value of the Company’s intellectual property was valued using a relief from royalty method which required management to make significant estimates and assumptions related to forecasts of future revenues, and the selection of the royalty (5.0%) and discount (17.0%) rates.
Previous wording
The fair value of the Baker Notes is subject to uncertainty due to the assumptions that are used in the Monte Carlo simulation-based model. These factors include but are not limited to the Company’s future revenue, and the probability and timing of the exercise of the repurchase right. The fair value of the Baker Notes is sensitive to these estimated inputs made by management that are used in the calculation.
Current wording
The fair value of the Baker Notes is subject to uncertainty due to the assumptions that are used in the Monte Carlo simulation-based model. These factors include but are not limited to the Company’s future revenues, and the probability and timing of the exercise of the repurchase right. The fair value of the Baker Notes is sensitive to these estimated inputs made by management that are used in the calculation.
Previous wording
The fair value of the total SOLOSEC consideration, including cash paid and future sales-based payments, is determined using a Monte Carlo simulation model, which assumes the Company’s revenue follows a geometric Brownian motion. Using specific revenue factors, including expected growth, risk adjustments, and revenue volatility, future revenues were simulated through the Earnout Term to assess whether sales-based payments would be triggered in each relevant period, as stipulated by the SOLOSEC Asset Purchase Agreement. The average output of the Monte Carlo simulations for each period provides the expected payment value, which is then discounted to its present value to derive the fair value of future sales-based payments and recorded as contingent liabilities. The discount rate is based on (i) the risk-free rate, plus (ii) a credit spread reflecting the Company’s interest-bearing debt, (iii) an additional spread to account for credit migration as of the valuation date, and (iv) a further incremental spread to reflect that the contingent liabilities is subordinated obligations relative to the Company’s other debt obligations.
Current wording
The fair value of the total consideration, including cash paid and future sales-based payments, is determined using a Monte Carlo simulation model, which assumes the Company’s revenue follows a geometric Brownian motion. Using specific revenue factors, including expected growth, risk adjustments, and revenue volatility, future revenues were simulated through the Earnout Term to assess whether sales-based payments would be triggered in each relevant period, as stipulated by the SOLOSEC Asset Purchase Agreement. The average output of the Monte Carlo simulations for each period provides the expected payment value, which is then discounted to its present value to derive the fair value of future sales-based payments and recorded as contingent liabilities. The discount rate is a market index rate based on the Company’s credit risk.
Previous wording
The fair value of the SOLOSEC contingent liabilities will be updated at each reporting period using the methodology described above. Any changes to the fair value will be recorded as an adjustment to the carrying value of both the contingent liabilities and the SOLOSEC IP intangible asset as per ASC 323,Investments – Equity Method and Joint Ventures (ASC 323). Periodic intangible amortization will also be updated based on the new fair value of the SOLOSEC IP.
Current wording
The fair value of the SOLOSEC contingent liabilities will be updated at each reporting period using the methodology described above. Any changes to the fair value will be recorded as an adjustment to the carrying value of both the contingent liabilities and the SOLOSEC Intellectual Property (IP) intangible asset as per ASC 323,Investments – Equity Method and Joint Ventures (ASC 323). Periodic intangible amortization will also be prospectively updated based on the new fair value of the SOLOSEC IP.
Previous wording
The fair value of the SOLOSEC intangible asset and contingent liabilities were $10.2 million (before accumulated amortization) and $9.6 million, respectively as of December 31, 2024.
Current wording
The fair value of the SOLOSEC contingent liabilities were $4.7 million and $9.6 million as of December 31, 2025 and 2024, respectively.
Previous wording
Fair Value of Stock Options, Purchase Rights, and Warrants
Current wording
Fair Value of Stock Options, Preferred Stock, Purchase Rights, and Warrants
Previous wording
Upon issuance of financial instruments, they are initially measured at fair value and reviewed for the appropriate classification (liability or equity). Financial instruments determined to require liability accounting are subsequently re-measured with changes in fair value being recognized as a component of other income (expense), net in the consolidated statements of operations. Financial instruments are valued using an option pricing model (OPM), such as Black-Scholes, based on the applicable assumptions, which include the exercise price of the warrants, option, or purchase right, time to expiration, expected volatility of our peer group, risk-free interest rate, and expected dividends. The Company re-evaluates the classification of its financial instruments at each balance sheet to determine the proper balance sheet classification for them. The assumptions used in the OPM are considered level 3 assumptions and include, but are not limited to, the market value of invested capital, the Company’s cumulative equity value as a proxy for the exercise price, the expected term the instruments will be held prior to exercise and a risk-free interest rate, and probability of change of control events.
Current wording
Upon issuance of financial instruments, they are initially measured at fair value and reviewed for the appropriate classification (liability or equity). Financial instruments determined to require liability accounting are subsequently re-measured with changes in fair value being recognized as a component of other income (expense), net in the consolidated statements of operations. Financial instruments are valued using an OPM, such as Black-Scholes, based on the applicable assumptions, which include the exercise price of the warrant, option, or purchase right, time to expiration, expected volatility of our peer group, risk-free interest rate, and expected dividends. The Company re-evaluates the classification of its financial instruments at each balance sheet to determine their proper balance sheet classification. The assumptions used in the OPM are considered level 3 assumptions and include, but are not limited to, the market value of invested capital, the Company’s cumulative equity value as a proxy for the exercise price, the expected term the instruments will be held prior to exercise and a risk-free interest rate, and probability of change of control events.
Previous wording
The decrease in general and administrative expenses was primarily due to a $3.6 million decrease in facilities and outside services costs and a $1.2 million decrease in professional services fees related to legal and finance as well as a decrease of $0.1 million in personnel costs partially offset by the $0.8 million contingent liability recognized in conjunction with the potential settlement with TherapeuticsMD and a $0.7 million impairment of construction in-process.
Current wording
The decrease in general and administrative expenses was primarily due to a $1.6 million decrease in personnel costs, a $1.3 million decrease in business insurance and facilities costs due to a non-recurring impairment ofproperty and equipment recorded in 2024, and a $1.2 million decrease in professional services fees related to legal and finance.
Previous wording
Total other expense, net, for the year ended December 31, 2024 primarily included a $3.3 million loss on the issuance of financial instruments related to the anti-dilution adjustment for the purchase rights and $2.2 million interest expense related to the Adjuvant Note and $0.2 million interest expense related to Medicaid payments. The losses were partially offset by a $3.7 million gain on the change in fair value of financial instruments and a gain of $1.0 million related to the Baker Notes extinguishment.
Current wording
Total other expense, net, for the year ended December 31, 2024 primarily included a $3.3 million loss on the issuance of financial instruments related to the anti-dilution adjustment for the purchase rights, $2.2 million of interest expense related to the Adjuvant Note, and $0.2 million interest expense related to Medicaid payments. These expenses were partially offset by a $3.7 million gain on the change in fair value of financial instruments and a $1.0 million gain related to the Baker Notes extinguishment.
Showing the first 40 of 53 pairs. Open the source sections for the rest.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
We are a San Diego-based commercial-stage biopharmaceutical company with a strong focus on innovation in women’s health. We currently commercialize two FDA-approved products: PHEXX® (lactic acid, citric acid and potassium bitartrate) vaginal gel and SOLOSEC®(secnidazole) 2 g oral granules.
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 filed for regulatory approval of SOLOSEC in the UAE in September 2025.
Current report — wording carried from elsewhere
Total other expense, net, for the year ended December 31, 2025 included $2.6 million of interest expense primarily related to the Adjuvant Note and a $0.4 million loss on the change in fair value of financial instruments.