Evofem Biosciences, Inc.
For the period ended Sep 30, 2025. Filed Nov 13, 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.
Sep 30, 2025 · Filed Nov 13, 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 2025-06-30; filed 2025-08-14.
0001641172-25-023741
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001493152-25-022275
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 127 previous paragraphs and 126 current paragraphs.
50 unchanged; 49 reworded; 26 added; 26 removed; 2 previous and 1 current paragraphs rearranged.
Tables are not compared: 18 previous and 20 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 (26)
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
Aditxt Merger Termination
Current report
On October 20, 2025, the Company held a Special Meeting of Stockholders. After the Company’s stockholders did not approve a proposal to approve the transactions contemplated by the A&R Merger Agreement, the Company delivered a notice of termination to Aditxt notifying it that the Company was exercising its right to terminate the A&R Merger Agreement effective October 20, 2025. The termination was in accordance with (i) Section 8.1(b)(ii), which allows either party to terminate the A&R Merger Agreement if the Merger shall not have been consummated on or before 5:00 p.m. Eastern Time, on September 30, 2025, and (ii) as per Section 8.1(b)(iv), which allows either party to terminate the A&R Merger Agreement if the Company Shareholder Approval shall not have been obtained at a duly held Company Shareholders Meeting at which a vote was taken on the approval of the Agreement and the Transactions, including the Merger.
Current report
As a result of the termination of the A&R Merger Agreement, all other ancillary agreements related to the A&R Merger Agreement, with the exception of the obligations under the Non-Disclosure Agreement, entered into by and between the Company and Aditxt, as of October 23, 2023, terminated concurrently with the termination of the A&R Merger Agreement. No consideration was paid in connection with the termination.
Current report
We are now pursuing a new path, including aiming to re-list our stock on the Nasdaq Capital Market or a comparable national market and complete a fundraising round to provide critical capital for sales and marketing initiatives designed to catalyze our net sales growth over the next 18-24 months.
Current report
Adjuvant Amendment
Current report
On October 13, 2025, we entered into a Third Amendment to our Securities Purchase Agreement with Adjuvant Global Health Technology Fund, which extended the maturity and payment terms of the Adjuvant Notes. See Note 10 — Subsequent Events.
Current report
2025 Equity Incentive Plan
Current report
On October 3, 2025, our Board approved the 2025 Equity Incentive Plan authorizing up to 50 million shares, subject to stockholder approval at the 2025 Annual Meeting. No awards have been granted under the plan to date.
Current report
The immaterial increase in cost of goods sold was in line with the increased product sales, net, partially offset by the lack of accrual for the Rush Royalty contingent liability in the current year.
Current report
Gain on Change in Accounting Estimates on Contingent Royalty Liability
Current report
The $1.9 million 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 three months ended September 30, 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 was primarily due to the decrease in the intangible value due to the prior quarterly valuation of the SOLOSEC contingent liability.
Current report
The immaterial increase in selling and marketing expenses reflects a $0.1 million increase in personnel costs, partially offset by a decrease in business development and outside services expenses.
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 three months ended September 30, 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 increase in amortization of intangible asset was primarily due to the timing of the SOLOSEC acquisition. Because the acquisition closed in July 2024, the prior year amortization was therefore only for a partial portion of the nine-month period while the current year is for the entire nine-month period.
Current report
Total Other Income (Expense), Net
Current report
Total other expense, net, for the nine months ended September 30, 2025 primarily included a $1.9 million interest expense related to the Adjuvant Note and a loss on the change in fair value of financial instruments of $0.5 million, including a gain related to the purchase rights of $0.2 million and a loss related to the Baker Notes of $0.7 million. Historically the changes in fair value related to the Baker Notes have been recorded in the condensed consolidated statements of comprehensive operations as the changes were determined to be related to changes in the Company’s credit risk. However, in the three months ended September 30, 2025, the primary driver for the increase in the fair value of the Baker Notes is related to the Company not retiring the notes by September 8, 2025, which caused the total amount legally payable to repurchase the notes to increase by approximately $2.8 million.
Current report
The Company expects future equity-based compensation expense to increase following stockholder approval of the 2025 Equity Incentive Plan, which authorizes up to 50 million additional shares.
Current report
Potential Impact of Federal Government Shutdown
Current report
Certain functions of the U.S. federal government, including the Food and Drug Administration (FDA) and other agencies that regulate or reimburse our products, may be limited or delayed in the event of a government shutdown. A prolonged shutdown could delay FDA reviews or other regulatory interactions, temporarily slow processing of payor or government program reimbursements, or defer implementation of new coverage or public-health initiatives. At this time, management does not expect any material adverse impact on our ongoing commercial operations, but we continue to monitor the situation.
Current report
Cash Flows from Operating Activities. During the nine months ended September 30, 2025, the primary use of cash, cash equivalents and restricted cash in operating activities was driven by net loss of $2.4 million plus net adjustments to reconcile net loss to net cash, cash equivalents, and restricted cash used in operating activities of $4.4 million. The increase in cash used in operating activities was also driven by the payment of trade payables of $1.4 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 the collection of $5.4 million of accounts receivable and increases in accrued expenses and other liabilities of $1.0 million and prepaid expenses of $0.5 million.
Current report
During the nine months ended September 30, 2024, the primary use of cash, cash equivalents and restricted cash in operating activities was driven by net loss of $5.8 million offset by net adjustments to reconcile net loss to net cash, cash equivalents, and restricted cash used in operating activities of $1.0 million. The cash used in operating activities was also driven by the payment of trade payables of $0.2 million, partially offset by the collection of $0.3 million of accounts receivable, $0.2 million fewer inventory purchases, and increases in accrued expenses and other liabilities of $2.2 million, accrued compensation of $0.6 million, and prepaid expenses of $0.2 million.
Removed paragraphs (26)
Previous 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.
Previous report
Increase to Authorized Series E-1 Preferred Stock
Previous 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.
Previous report
Aditxt Notes and Warrants
Previous report
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 report
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 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.
Previous 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.
Previous report
Aditxt Merger
Previous report
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 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 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 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 December 23, 2024, Evofem announced the withdrawal from consideration by the stockholders of the Company the proposals set forth in its preliminary proxy statement and its decision to cancel its planned special meeting.
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 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 report
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 report
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.
Previous report
Previous contracting efforts have validated our access strategy. With PHEXXI approval rates consistently above 80%, the Company has taken a step back from broad payer contracting and has leaned into developing more pharmacy partnerships. We’ve recently expanded our network with a major national chain and two trusted regional partners, boosting access and supporting smarter, more targeted pull-through.
Previous report
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.
Previous report
Total other income, net
Previous 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.
Previous report
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.
Reworded paragraphs (49)
Previous wording
Item 2. Management**’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
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: PHEXXI® (lactic acid, citric acid and potassium bitartrate) vaginal gel and SOLOSEC®(secnidazole) 2 g oral granules.
Current wording
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.
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, 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.
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, 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
Evofem has delivered PHEXXI net sales growth in each consecutive year since it was launched in September 2020. 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.
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 include social media campaigns, participation in strategic medical conferences, and initiatives to expand use of PHEXX in women who take oral birth control pills in conjunction with GLP-1 prescription medications like 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 United States Prescribing Information (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 intend to expand the global reach of our products and further increase our global potential through ex-U.S. partnerships or licensing agreements for PHEXXI and SOLOSEC.
Current wording
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.
Previous 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.
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
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 wording
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.
Previous wording
Additionally, PHEXXI was approved in Nigeria on October 6, 2022, as Femidence™ by the National Agency for Food and Drug Administration and Control. PHEXXI has also been submitted for approval in Mexico, Ethiopia and Ghana.
Current wording
Additionally, PHEXX was approved in Nigeria on October 6, 2022, as Femidence™ by the National Agency for Food and Drug Administration and Control. PHEXX has also been submitted for approval in Mexico, Ethiopia and Ghana.
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 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 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 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.
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 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 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.
Current wording
Key growth drivers for 2025 include social media campaigns, participation in strategic medical conferences, and initiatives to expand use of PHEXX in women who take oral birth control pills in conjunction with GLP-1 prescription medications like 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
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.
Current wording
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 PHEXX 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 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 July 2025, approximately 86% of commercial and Medicaid PHEXX prescriptions are 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
To comply with these federal guidelines, payers are increasingly covering PHEXXI by:
Current wording
To comply with these federal guidelines, payers are increasingly covering PHEXX by:
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
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, 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 woman’s fertility, and complications with gynecological surgery.
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), 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).
Current wording
On July 12, 2024, the Company entered into an Agreement and Plan of Merger, as amended, (the A&R 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
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. Gross revenues, as discussed in Note 3 - Revenue, are adjusted for variable consideration, including our patient support programs.
Current wording
Our revenue recognition is based on unit shipments 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 PHEXX in September 2020; SOLOSEC net product sales were added to our revenue beginning in July 2024. Gross revenues, as discussed in Note 3 - Revenue, are adjusted for variable consideration, including our patient support programs.
Previous wording
Inventory costs include all purchased materials, direct labor, and manufacturing overhead. 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.
Current wording
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 PTE been granted. The royalty expense accrued were 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. Due to the patent expiration, no royalty costs were recorded for the three and nine months ended September 30, 2025, while $0.2 million and $0.6 million were recorded for the three and nine months ended September 30, 2024 and were included in the costs of goods sold in the condensed consolidated statements of operations. As described in Note 7 – Commitments and Contingencies, no further royalties are due to Rush University now that the patent has expired and 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 three months ended September 30, 2025 of approximately $1.9 million that is not expected to be repeated in further 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 condensed consolidated statements of operations.
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 immaterial for each of the three and six months ended June 30, 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 and approximately $0.1 million for the three and nine months ended September 30, 2025, respectively.
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, PDUFA fees, 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, 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) 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.
Previous wording
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 wording
The increase in product sales, net, primarily reflects a full quarter of SOLOSEC in the current year period as well as the increased PHEXX WAC that took effect January 1, 2025.
Previous wording
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 wording
The increase in research and development expenses was primarily due to a $0.1 million increase in personnel costs.
Previous wording
The decrease in general and administrative expenses was primarily due to an approximately $0.4 million decrease in facilities and professional services costs.
Current wording
The decrease in general and administrative expenses was primarily due to an approximately $0.8 million decrease in professional services costs and a reduction of approximately $0.2 million in personnel costs.
Previous 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.
Current wording
Total other expense, net, for the three months ended September 30, 2025 primarily included $0.7 million of interest expense related primarily to the Adjuvant Note and a loss of $1.8 million related to the change in fair value of financial instruments including adjustments related to the purchase rights of $1.1 million and those related to the Baker Notes of $0.7 million. Historically the changes in fair value related to the Baker Notes have been recorded in the condensed consolidated statements of comprehensive operations as the changes were determined to be related to changes in the Company’s credit risk. However, in the three months ended September 30, 2025, the primary driver for the increase in the fair value of the Baker Notes is related to the Company not retiring the notes by September 8, 2025, which caused the total amount legally payable to repurchase the notes to increase by approximately $2.8 million.
Previous wording
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 wording
Total other income, net, for the three months ended September 30, 2024 primarily included a $0.8 million gain on the change in fair value of financial instruments, partially offset by $0.6 million in interest expense related to the Adjuvant Note and loss on the debt extinguishment of $0.1 million.
Previous wording
Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024 (in thousands):
Current wording
Nine Months Ended September 30, 2025 Compared to Nine Months Ended September 30, 2024 (in thousands):
Previous wording
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 wording
The decrease in product sales, net, was primarily due to lower PHEXX sales volume, partially offset by the addition of SOLOSEC in the current year and the increased PHEXX WAC that took effect January 1, 2025.
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.
Current wording
The decrease in cost of goods sold in the current year was due primarily to the lower product sales, net as well as the lack of expense related to the Rush Royalty liability in the current year, which was an expense in the prior year.
Previous 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.
Current wording
The decrease in research and development expenses was primarily due to the negotiation 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 an increase of $0.7 million in facilities and outside services costs.
Previous wording
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 wording
The increase in selling and marketing expenses was primarily due to a $0.3 million increase related to the PDUFA fee for SOLOSEC as well as an increase in facilities and outside services costs of $0.3 million.
Previous 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.
Current wording
The decrease in general and administrative expenses was primarily due to a $1.0 million decrease in professional services, a $0.4 million decrease in personnel costs, and a $0.4 million reduction in facilities costs.
Previous 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.
Current wording
Total other income, net, for the nine months ended September 30, 2024 primarily included a $4.9 million gain on the change in fair value of financial instruments and a gain of $1.0 million related to the Baker Notes extinguishment. The gains were partially offset by a $3.3 million loss on the issuance of financial instruments related to the anti-dilution adjustment for the purchase rights and $1.7 million of interest expense related to the Adjuvant Note.
Showing the first 40 of 49 pairs. Open the source sections for the rest.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
The increase in selling and marketing expenses was primarily due to a $0.3 million increase related to the PDUFA fee for SOLOSEC.
Previous report — wording carried elsewhere
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.