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CLOSED · 03:00 ET
Market ClerkRecap
Tue Oct 27 · markets closed1 signal on Oct 26140 insider buys this week · $73.9MCIRO short report next: Oct 30The week ahead

EVFM

Evofem Biosciences, Inc.
OTC · HEALTH CARE · PHARMACEUTICAL PREPARATIONS
0.01
+0.00 +0.00%
USD · close Oct 26
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Work order
39
FLAG · shorts 39
Insiders, 90 days
0
no open-market filings in 90 days
Congress, 90 days
0 / 0
no disclosures naming it
Big money
0 / 15
none of the tracked funds disclose it
Calls on record
0
nobody we score has called it yet
MKT CAP $928KP/E —DIV YIELD —FCF YIELD -51.42%REV TTM $18M +4.5%NET INCOME −$15.3MNET DEBT $10.6M52W 0.01 – 0.01SEC XBRL · TTM TO Invalid Date

How EVFM rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
51%
of sentences unchanged
Added
297
new sentences
Dropped
404
sentences removed
Length
−3,760
words, now 36,693

New in FY2025

  • We may not be able to refinance, extend or repay our substantial indebtedness owed to our secured and unsecured lenders, which would have a material adverse effect on our financial condition and ability to continue as a going concern. ● Our audited consolidated financial statements include a statement that there is a substantial doubt about our ability to continue as a going concern. ● We have incurred significant losses and negative cash flows since our inception and anticipate we will continue to incur significant losses and negative cash flow for the foreseeable future.
  • We may never be profitable and our operating results may differ from any guidance we may announce. ● We must raise significant additional funds to finance our operations and to remain a going concern.
  • If we are unable to raise additional capital when needed or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our business initiatives. ● We are solely focused in women’s health and may be unfavorably impacted by weak investor sentiment and a lack of interest in the category.
  • Our ability to access capital and to advance our candidates could be adversely impacted. ● We have certain obligations pursuant to our issued and outstanding senior secured notes, promissory notes, convertible notes and related note purchase agreements, and our failure to comply with these obligations could have a material adverse effect on our business, intellectual property, financial condition, or results of operations. ● We have a limited number of shares of Common Stock available for future issuance which could adversely affect our ability to raise capital or consummate strategic transactions. ● Use of net operating loss carryforwards may be limited and U.S. federal income tax reform could adversely affect us.
  • Risks Related to Potential Bankruptcy ● We are subject to risks and uncertainties associated with potential bankruptcy proceedings including a long and protracted restructuring, from which our business could suffer. ● As of December 31, 2025, we have negative stockholders’ equity.
  • If we are unable to raise additional capital, or otherwise become unable to satisfy our obligations as they become due, we may become insolvent and face the risk of bankruptcy. ● Our financial results may be volatile and may not reflect historical trends.
  • Risks Related to Commercialization of PHEXX, SOLOSEC, and Any Other Approved Products ● Our success will depend heavily on whether we can successfully commercialize PHEXX for prevention of pregnancy, and SOLOSEC, for the treatment of bacterial vaginosis (BV) and trichomoniasis (Trich). ● If we are unable to maintain effective internal sales and marketing capabilities, or to enter into agreements with third parties to market and sell our products, our ability to continue to successfully commercialize our products and generate revenue would be adversely affected. ● Our use of social media platforms to market and promote our prescription products, presents risks and operational challenges. ● We face competition from other medical device, biotechnology, and biopharmaceutical companies and our operating results will suffer if we are unable to compete effectively. ● PHEXX, SOLOSEC, and any other approved products we promote may not gain sufficient market acceptance among physicians, patients or the medical community, thereby limiting our potential to generate revenue, which will undermine our future growth prospects. ● The telehealth market continues to develop.
  • If the telehealth industry encounters negative publicity over privacy issues, fails to engage sufficient numbers of providers, or if limitations on reimbursement or new state law regulatory requirements impede our ability to implement our telehealth strategy, the growth of our business may be harmed. ● The success of PHEXX will depend on the availability of competitive products and women’s preferences. ● The commercial success of PHEXX, SOLOSEC and/or any future products we promote will depend in significant measure on the label claims that the FDA or other regulatory authorities approve for those products. ● The FDA and other regulatory agencies actively enforce laws and regulations prohibiting the promotion of off-label uses for prescription drugs and medical devices.
  • If we are found or alleged to have improperly promoted our commercial product for off-label uses, we may become subject to significant liability. ● If we suffer negative publicity concerning the safety or efficacy of our products, our reputation and the commercialization of such products could be harmed. ● We rely, and expect to continue to rely, on market research conducted internally to evaluate the potential commercial acceptance of PHEXX for the prevention of pregnancy. ● There can be no assurance on the accuracy or completeness of certain facts, forecasts and other statistics obtained from various government publications, market data providers and other independent third-party sources, including industry expert reports, contained in this Annual Report or other statements we may make from time to time. ● The proportion of the contraceptive market that is made up of generic products continues to increase, making the introduction of a branded contraceptive difficult and expensive. ● Even though we have received approval from the FDA in the U.S. to market PHEXX for the prevention of pregnancy, and, as Femidence, by the National Agency for Food and Drug Administration and Control of Nigeria, and to market SOLOSEC for the treatment of BV and Trich, we may fail to receive similar approvals in other territories outside the U.S.
  • Risks Related to Our Post-Marketing Legal and Regulatory Compliance ● Even though we have obtained FDA approval for PHEXX for prevention of pregnancy and of SOLOSEC for the treatment of BV and Trich, we remain subject to ongoing regulatory requirements. ● Developments after a product reaches the market may adversely affect sales of the product. ● Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of our Products. ● If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business, financial condition or results of operations. ● The FDA and other regulatory agencies actively enforce the laws and regulations relating to the promotion of our products.
  • Risks Related to Our Intellectual Property ● ThereapeuticsMD may take adverse action against the Company and its use of the PHEXX mark. ● If we are unable to obtain and maintain patent protection for PHEXX or SOLOSEC, or if the scope of the patent protection we have or will obtain is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to our products and technology, and our ability to successfully commercialize PHEXX and/or SOLOSEC may be adversely affected. ● We may not be able to protect our intellectual property and proprietary rights throughout the world. ● Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements. ● Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products. ● Issued patents covering PHEXX or SOLOSEC could be found invalid or unenforceable if challenged in court or before administrative bodies in the U.S. or abroad. ● An Event of Default under the secured notes issued pursuant to the Baker Bros.
  • Purchase Agreement, as amended, could allow the secured creditor to take possession of all assets owned by us, including any directly owned intellectual property pertaining to PHEXX. ● The Company received two Notice of Defaults from their largest creditor, Future Pak, LLC, alleging a number of Events of Default, accelerating the Principal due and payable and declaring the termination of the existing Forbearance Agreement. ● We may be subject to claims challenging the inventorship of our patents and other intellectual property. ● If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed. ● We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers. ● We may be at risk that our former employees may wrongfully use or disclose our trade secrets. ● We may be subject to claims that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property. ● Third-party claims of intellectual property infringement induced intellectual property infringement, misappropriation or other violation against us or our collaborators may prevent or delay the commercialization of our product. ● In the ordinary course of business, we have been and again may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming, and unsuccessful. ● If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected. ● Intellectual property rights do not necessarily address all potential threats.
  • Risks Related to Our Reliance on Third Parties ● Our success relies on third-party suppliers and two contract manufacturers. ● We have no significant internal distribution capabilities. ● We rely on third parties for the delivery of telehealth services through the PHEXX telehealth platform. ● If we are unable to enter into or maintain strategic relationships or collaborations with respect to PHEXX for the prevention of pregnancy, or if we are unable to realize the potential benefits from such collaborations, our business, financial condition, commercialization prospects and results of operations may be materially adversely affected. ● We enter into various contracts in the normal course of our business in which we indemnify the other party to the contract.
  • Risks Related to Our Commercialization of Health Care Products ● Our products may face follow-on competition sooner than anticipated. ● Changes in health care laws and regulations may eliminate current requirements for health insurance plans to cover and reimburse FDA-cleared or FDA-approved contraceptive products without cost sharing, which could reduce demand for products such as PHEXX. ● Despite FDA-approval for our products and even if we are successful in obtaining additional products to commercialize in the U.S., revenues may be adversely affected if our products do not obtain coverage and adequate reimbursement from third-party payers in the U.S. ● The pharmaceutical and medical device industries are highly regulated and subject to various fraud and abuse, data privacy, transparency, and other health care laws, including, without limitation, the U.S.
  • Federal False Claims Act and the FCPA. ● Health care legislative reform measures may have a negative impact on our business and results of operations.
  • If we experience difficulties in managing this growth or are unable to attract and retain management and other key personnel, we may be unable to successfully commercialize our products or otherwise implement our business plan. ● Our current or future employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with legal requirements or regulatory standards. ● We may be vulnerable to disruption, damage and financial obligations as a result of information technology system failures, cybersecurity breaches, loss of data or other disruptions that could compromise our proprietary information or other sensitive information. ● We expect to continue to incur increased costs as a result of operating as a public company and our management will be required to devote substantial time to compliance initiatives and corporate governance practices. ● The inability to attract and retain qualified key management personnel would impair our ability to implement our business plan. ● In connection with the departure of key personnel, we may be subject to certain separation payments, legal actions or other claims. ● We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations.
  • We can face criminal liability and other serious consequences for violations which can harm our business. ● We or the third parties upon whom we depend may be adversely affected by earthquakes, medical epidemics or pandemics, or other natural disasters including wildfires.
  • Risks Related to Our Common and Preferred Stock ● There can be no assurance that we will be able to comply with the continued listing standards of OTCID. ● Our stock price is and may continue to be volatile. ● There may not be an active, liquid trading market for our equity securities. ● Because our Common Stock is subject to the “penny stock” rules, brokers cannot generally solicit the purchase of our Common Stock, which adversely affects its liquidity and market price. ● We may need to increase in our authorized capital, effectuate a reverse split or obtain effective waivers from derivative securityholders. ● Our Common Stock could be further diluted as the result of the issuance of additional shares of Common Stock, convertible securities, warrants or options. ● A significant portion of our total outstanding shares of Common Stock may be sold into the public market at any time, which could cause the market price of our Common Stock to drop significantly, even if our business is performing well. ● We are and may continue to be subject to short-selling strategies. ● We identified material weaknesses in our internal controls over financial reporting as of December 31, 2025 and 2024 and these or other material weaknesses could continue to materially impair our ability to report accurate financial information in a timely manner. ● We are a “smaller reporting company”, and the reduced disclosure requirements applicable to smaller reporting companies may make our Common Stock less attractive to investors. ● We do not anticipate paying any cash dividends on our Common Stock in the foreseeable future; capital appreciation, if any, will be your sole source of gain as a holder of our Common Stock. ● Provisions in our amended and restated certificate of incorporation, our bylaws or Delaware law might discourage, delay or prevent a change in control of the Company or changes in our management and, therefore, depress the trading price of our Common Stock. ● Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us. ● Our business could be negatively affected as a result of the actions of activist stockholders. ● We may become a defendant in one or more stockholder derivative or class-action litigation(s), and any such future lawsuit(s) may adversely affect our business, financial condition, results of operations and cash flows.
  • As of February 28, 2026, we had approximately $12.7 million in accounts payable with approximately $10.4 million that is over 90 days past due.
  • If we are unable to repay these amounts, as well as our existing debt obligations at maturity, and we are otherwise unable to extend the maturity dates or refinance these obligations, we will be in default.
  • Our audited consolidated financial statements include a statement that there is a substantial doubt about our ability to continue as a going concern and a continuation of negative financial trends could result in our inability to continue as a going concern.
  • Our management has determined that there is substantial doubt about our ability to continue as a going concern over the next 12 months from the filing date of March 11, 2026.
  • Our independent auditors have included a “going concern” explanatory paragraph in their report on our consolidated financial statements as of and for the year ended December 31, 2025 as filed in this Annual Report on Form 10-K.
  • There is no assurance that we will be able to raise additional capital to fund our operations or that debt or equity financings will be available in sufficient amounts or on acceptable terms.
  • We have incurred yearly losses and negative cash flows since our inception, other than net income of $0.4 million (excluding deemed dividends) for the year ended December 31, 2025, primarily attributable to a non-cash gain on change in accounting estimates on contingent royalty liability and settlement of a portion of its trade payables with vendors, and net income of $53.0 million (excluding deemed dividends) for the year ended December 31, 2023, which was primarily attributable to a non-cash gain on debt extinguishment.
  • As of December 31, 2025, we had an accumulated deficit of $897.4 million.
  • To date, we have devoted substantially all our financial resources to the development and commercialization of PHEXX for hormone-free contraception, to clinical trials investigating the potential utility of PHEXX for the prevention of chlamydia and gonorrhea, and development of our other product candidates, as well as providing general and administrative support for our operations.
  • Our utilization of cash has historically been highly dependent on these development programs and the commercialization of PHEXX in the U.S.
  • In October 2022, we discontinued our clinical programs to allocate capital to fund our continued commercialization efforts.
  • To date, we have financed our operations primarily through the sale of equity securities, promissory notes, warrants, convertible notes, convertible preferred stock and through other debt arrangements.
  • The amount of our future net losses will depend, in large part, on our ability to generate revenue from the sale of PHEXX and SOLOSEC, the rate of our future expenditures and our ability to obtain additional funding through equity or debt financings, strategic collaborations or grants which may be particularly challenging or impossible in light of market conditions.
  • We expect to continue to incur significant operating expenses and to continue to incur significant losses for the foreseeable future as we: ● incur sales, marketing, and distribution costs to commercialize PHEXX and SOLOSEC; ● incur costs associated with the commercial manufacturing of PHEXX and SOLOSEC; ● implement post-approval changes and process improvements to manufacturing; ● seek regulatory and marketing approvals for PHEXX and/or SOLOSEC outside the US; ● seek reimbursement for PHEXX, SOLOSEC, or any product(s) we may commercialize in the future ● continue our efforts to identify, assess, acquire, and/or commercialize other products; ● make milestone, royalty or other payments under third-party license agreements; ● make payments related to debt agreements; ● seek to maintain, protect, and expand our intellectual property portfolio; and ● seek to attract and retain skilled personnel.
  • Due to the recurring losses, negative cash flows from operating activities since inception, and a net working deficit at December 31, 2025, the report of our independent registered public accountant on our consolidated financial statements as of and for the year ended December 31, 2025 filed with this Annual Report on Form 10-K for the year ended December 31, 2025 includes explanatory language describing the existence of substantial doubt about our ability to continue as a going concern.
  • In addition, our management has further determined that there is a substantial doubt about our ability to continue as a going concern over the next 12 months from the filing date of March 11, 2026.
  • Our current business is substantially dependent on the commercial success of PHEXX, and to a lesser extent, SOLOSEC.
  • The commercial launch of PHEXX took place on September 8, 2020, and although we have generated revenue from sales of PHEXX, we may never achieve or sustain profitability, even with the addition of revenue from SOLOSEC since we acquired global rights to the product in July 2024.
  • Our ability to generate revenue and achieve and sustain profitability depends on our ability, alone or with strategic collaborators, to successfully commercialize PHEXX and SOLOSEC and, to a lesser extent, any future products we may license, acquire, or otherwise commercialize.
  • Our ability to generate future revenue from product sales depends heavily on our success in many areas, including, but not limited to: ● the rate and degree of market acceptance for PHEXX, SOLOSEC and any other products in our commercial portfolio; ● the effectiveness of our commercialization strategies, either directly or with distribution partners, including the effectiveness of our sales force, the PHEXX telehealth platform, media and digital campaigns, and contracted tele-sales vendor; ● reimbursement and pricing for PHEXX, SOLOSEC and any other approved products in our commercial portfolio in amounts that support profitability; ● successfully competing against other products; ● manufacturing PHEXX and SOLOSEC and establishing and maintaining supply and manufacturing relationships with third parties that are commercially feasible, as well as complying with applicable regulatory requirements and meeting our supply needs in sufficient quantities to meet market demand for our products; ● obtaining and maintaining regulatory approval of PHEXX (Femidence) and/or SOLOSEC in territories outside of the U.S.; ● protecting, maintaining and enforcing our intellectual property rights, including patents, trade secrets and know-how; ● negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter; and ● attracting, hiring and retaining qualified personnel.
  • In addition, we provide co-pay assistance to commercially insured patients with an approved PHEXX or SOLOSEC prescription and utilize a sample program to promote demand for our products.
  • While the co-pay program reduces the amount of profit we realize per unit sold, it is a value-add program to patients that we aim to continue in 2026.

and 257 more.

Gone since FY2024

  • We may not be able to refinance, extend or repay our substantial indebtedness owed to our secured and unsecured lenders, which would have a material adverse effect on our financial condition and ability to continue as a going concern. ● We have incurred significant losses and negative cash flows since our inception and anticipate we will continue to incur significant losses and negative cash flow for the foreseeable future. ● We must raise significant additional funds to finance our operations and to remain a going concern.
  • If we are unable to raise additional capital when needed or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our business initiatives. ● We have a limited number of shares of common stock available for future issuance which could adversely affect our ability to raise capital or consummate strategic transactions.
  • Risks Related to the Aditxt Merger ● Failure to complete the merger could negatively impact our stock price and the future business and financial results of the Company. ● We may not be able to effect the merger pursuant to the Merger Agreement and we could incur substantial costs. ● While the Merger Agreement is in effect, we are subject to certain interim covenants. ● The announcement and pendency of the merger could cause disruptions in our business, which could have an adverse effect on our business and financial results. ● Certain provisions of the Merger Agreement may discourage third parties from submitting alternative acquisition proposals. ● We may be subject to litigation relating to the Merger.
  • Risks Related to Potential Bankruptcy ● We are subject to risks and uncertainties associated with potential bankruptcy proceedings including a long and protracted restructuring.
  • Risks Related to Commercialization and sales expansion of our Products ● We face competition from other medical device, biotechnology, and biopharmaceutical companies and our operating results will suffer if we are unable to compete effectively.
  • Risks Related to Regulatory Approval of our Products ● We may fail to receive approval to market our products outside the U.S.
  • Risks Related to Our Post-Marketing Legal and Regulatory Compliance ● Developments after a product reaches the market may adversely affect sales of the product. ● Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of our Products. ● The FDA and other regulatory agencies actively enforce the laws and regulations relating to the promotion of our products.
  • Risks Related to Our Intellectual Property Our rights to develop and commercialize PHEXXI are subject, in part, to the terms and conditions of licenses granted to us by third parties.
  • The patent protection and patent prosecution of PHEXXI are dependent on third parties. ● If we are unable to obtain and maintain patent protection for PHEXXI or SOLOSEC, or if the scope of the patent protection we have or will obtain is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to our products and technology, and our ability to successfully commercialize PHEXXI and/or SOLOSEC may be adversely affected. ● We may not be able to protect our intellectual property and proprietary rights throughout the world. ● If we do not obtain patent term extensions (PTE) for PHEXXI, our business may be materially harmed. ● An Event of Default under the secured notes issued pursuant to the Baker Bros.
  • Purchase Agreement, as amended, could allow the secured creditor to take possession of all assets owned by us, including any directly owned intellectual property pertaining to PHEXXI. ● The Company received two Notice of Defaults from their largest creditor, Future Pak, LLC, alleging a number of Events of Default, accelerating the Principal due and payable and declaring the termination of the existing Forbearance Agreement.
  • Risks Related to Our Reliance on Third Parties ● Our success relies on third-party suppliers and two contract manufacturers, one each for PHEXXI and SOLOSEC. ● We have no significant internal distribution capabilities.
  • Risks Related to Our Commercialization of Health Care Products ● Changes in health care laws and regulations may eliminate current requirements for health insurance plans to cover and reimburse FDA-cleared or FDA-approved contraceptive products without cost sharing, which could reduce demand for products such as PHEXXI. ● Increasing scrutiny of healthcare economics may influence prescribing and utilization practices, which could reduce demand for branded products such as PHEXXI and SOLOSEC. ● Health care legislative reform measures may have a negative impact on our business and results of operations.
  • Risks Related to Our Common and Preferred Stock ● Our management has identified material weakness in our internal controls and procedures. ● Our stock price is and may continue to be volatile. ● There may not be an active, liquid trading market for our equity securities. ● Because our Common Stock is subject to the “penny stock” rules, brokers cannot generally solicit the purchase of our Common Stock, which adversely affects its liquidity and market price. ● We may not obtain shareholder approval to approve an increase in the authorized, reverse split or other corporate action relating to the common stock when and if needed. ● Our common stock could be further diluted as the result of the issuance of additional shares of common stock, convertible securities, warrants or options. ● We are and may continue to be subject to short-selling strategies. ● Our business could be negatively affected as a result of the actions of activist stockholders. ● We may become a defendant in one or more stockholder derivative or class-action litigation(s), and any such future lawsuit(s) may adversely affect our business, financial condition, results of operations and cash flows.
  • As of February 28, 2025, we had approximately $11.2 million in accounts payable with approximately $9.5 million that is over 90 days past due.
  • If we are unable to repay these amounts, as well as our existing debt obligations at maturity, and we are otherwise unable to extend the maturity dates or refinance these obligations, we would be in default.
  • Our audited consolidated financial statements included a statement that there is a substantial doubt about our ability to continue as a going concern and a continuation of negative financial trends could result in our inability to continue as a going concern.
  • Our management has determined that there is substantial doubt about our ability to continue as a going concern over the next 12 months from the filing date of March 24, 2025.
  • Our independent auditors have included a “going concern” explanatory paragraph in their report on our consolidated financial statements as of and for the year ended December 31, 2024 as filed in this Annual Report on Form 10-K.
  • There is no assurance that we will be able to raise additional capital to fund our operations or that debt or equity financing will be available in sufficient amounts or on acceptable terms.
  • We have incurred yearly losses and negative cash flows since our inception, other than the net income of $53.0 million (excluding deemed dividends) for the year ended December 31, 2023, which was primarily attributable to a non-cash gain on debt extinguishment.
  • As of December 31, 2024, we had an accumulated deficit of $897.7 million.
  • To date, we have devoted substantially all our financial resources to the development and commercialization of PHEXXI for hormone-free contraception and to the development of EVO100 for the prevention of chlamydia and gonorrhea and our other product candidates, as well as providing general and administrative support for our operations.
  • Our utilization of cash has historically been highly dependent on these development programs and the commercialization of PHEXXI in the U.S.
  • In October 2022, we discontinued development of EVO100 and have no plans to advance clinical development of this program or to significantly invest in other clinical programs or product candidates for the foreseeable future.
  • We plan to allocate capital to fund our continued commercialization efforts.
  • To date, we have financed our operations primarily through the sale of equity securities, notes, warrants, convertible notes, convertible preferred stock and through other debt arrangements.
  • The amount of our future net losses will depend, in large part, on our ability to generate revenue from the sale of PHEXXI and SOLOSEC, the rate of our future expenditures and our ability to obtain additional funding through equity or debt financings, strategic collaborations or grants which may be particularly challenging or impossible in light of market conditions.
  • We expect to continue to incur significant operating expenses and to continue to incur significant losses for the foreseeable future as we: ● incur sales, marketing, and distribution costs to commercialize PHEXXI and SOLOSEC; ● incur costs associated with the commercial manufacturing of PHEXXI and SOLOSEC; ● implement post-approval changes and process improvements to manufacturing; ● seek regulatory and marketing approvals for PHEXXI and/or SOLOSEC outside the US; ● seek reimbursement for PHEXXI, SOLOSEC, or any product(s) we may commercialize in the future ● continue our efforts to identify, assess, acquire, and/or commercialize other products; ● make milestone, royalty or other payments under third-party license agreements; ● make payments related to debt agreements; ● seek to maintain, protect, and expand our intellectual property portfolio; and ● seek to attract and retain skilled personnel.
  • Due to the recurring losses, negative cash flows from operating activities since inception, and net working capital at December 31, 2024, the report of our independent registered public accountant on our consolidated financial statements as of and for the year ended December 31, 2024 filed with this Annual Report on Form 10-K for the year ended December 31, 2024 includes explanatory language describing the existence of substantial doubt about our ability to continue as a going concern.
  • In addition, our management has further determined that there is a substantial doubt about our ability to continue as a going concern over the next 12 months from the filing date of March 24, 2025.
  • Although we have generated revenue from product sales, we may never be profitable.
  • Our current business is substantially dependent on the commercial success of PHEXXI, and to a lesser extent, SOLOSEC.
  • The commercial launch of PHEXXI took place on September 8, 2020, and although we have generated revenue from sales of PHEXXI, we may never achieve or sustain profitability, even with the addition of revenue from SOLOSEC since we acquired global rights to the product in July 2024.
  • Our ability to generate revenue and achieve and sustain profitability depends on our ability, alone or with strategic collaborators, to successfully commercialize PHEXXI and SOLOSEC and, to a lesser extent, any future products we may license, acquire, or otherwise commercialize.
  • Our ability to generate future revenue from product sales depends heavily on our success in many areas, including, but not limited to: ● the rate and degree of market acceptance for PHEXXI, SOLOSEC and any other products in our commercial portfolio; ● the effectiveness of our commercialization strategies, either directly or with distribution partners, including the effectiveness of our sales force, the PHEXXI telehealth platform, media and digital campaigns, and contracted tele-sales vendor; ● reimbursement and pricing for PHEXXI, SOLOSEC and any other approved products in our commercial portfolio in amounts that support profitability; ● successfully competing against other products; ● manufacturing PHEXXI and SOLOSEC and establishing and maintaining supply and manufacturing relationships with third parties that are commercially feasible, as well as complying with applicable regulatory requirements and meeting our supply needs in sufficient quantities to meet market demand for our products; ● obtaining regulatory approval of PHEXXI (Femidence) and/or SOLOSEC in territories outside of the U.S.; ● protecting, maintaining and enforcing our intellectual property rights, including patents, trade secrets and know-how; ● negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter; and ● attracting, hiring and retaining qualified personnel.
  • In addition, we provide co-pay assistance to commercially insured patients with an approved PHEXXI or SOLOSEC prescription and utilize a sample program to promote demand for our products.
  • While the co-pay program reduces the amount of profit we realize per unit sold, it is a value-add program to patients that we aim to continue in 2025.
  • Because of the expense to run the program, we will look to modify the business rules surrounding the co-pay program in the future, particularly as payers increasingly cover PHEXXI at $0 co-pay to comply with HRSA guidelines; compliance was mandated beginning January 1, 2023 and enforcement action is anticipated.
  • If we are not able to generate sufficient net sales of our products, the net sales of our products is not sufficiently profitable, we fail to meet our guidance, or our information or metrics is not indicative of our future results of operations, this could materially and adversely affect our business results of operations, the price of our common stock, our financial condition and our ability to raise additional capital.
  • We will need to raise significant additional funds to finance our operations, including the commercialization of PHEXXI and SOLOSEC, and to remain a going concern.

and 364 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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