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EVFM on OTC

Evofem Biosciences, Inc.

Evofem Biosciences, Inc. is an American pharmaceutical preparations company based in San Diego.2 Its shares trade on OTC under the symbol EVFM.2

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Last updated Oct 21, 2026.

Overview

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  • TickerEVFM on OTC2
  • IndustryPharmaceutical Preparations2
  • HeadquartersSan Diego, United States2
  • Incorporated inDE3
  • Business address12400 High Bluff Drive, Suite 600, San Diego, Ca 921303
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI5493007VAGG43TIEJW572
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O CORPORATION SERVICE COMPANY, 19808 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 40557782

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No. 539. August 2025. Data table for Figure 1, sourced from National Survey of Family Growth (NSFG) 2022–2023.4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

16.7%Operating margin5
1.9%Net margin5
4.2%Revenue growth, 20255
-$2.0MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue23¢$4.6M
  • Other costs63¢$12.8M
  • Interest12¢$2.4M
  • Income tax0¢$2.0K
  • Profit2¢$391.0K

Out of $20.2M in revenue.5

Financial statements

Revenue6789105$20.2M in 2025
0$10.0M$20.0M$30.0M2019: $0$020192020: $446.0K$446.0K20202021: $8.2M$8.2M2021+1748%2022: $16.8M$16.8M2022+104%2023: $18.2M$18.2M2023+8%2024: $19.4M$19.4M2024+6%2025: $20.2M$20.2M2025+4%
Operating income6789105$3.4M in 2025
-$200.0M-$150.0M-$100.0M-$50.0M0$50.0M2019: -$52.7M-$52.7M20192020: -$103.6M-$103.6M2020+96%2021: -$166.8M-$166.8M2021+61%2022: -$84.1M-$84.1M2022−50%2023: -$17.8M-$17.8M2023−79%2024: -$7.7M-$7.7M2024−57%2025: $3.4M$3.4M2025
Net income6789105$391.0K in 2025
-$300.0M-$200.0M-$100.0M0$100.0M2019: -$80.0M-$80.0M20192020: -$142.3M-$142.3M2020+78%2021: -$205.2M-$205.2M2021+44%2022: -$76.7M-$76.7M2022−63%2023: $53.0M$53.0M20232024: -$8.9M-$8.9M20242025: $391.0K$391.0K2025
Fiscal year2019202020212022202320242025
Revenue$06$446.0K7$8.2M8$16.8M9$18.2M10$19.4M5$20.2M5
Cost of revenue$06$468.0K7$4.1M8$4.4M9$6.5M10$3.8M5$4.6M5
Research and development$22.2M6$17.1M7$33.1M8$25.0M9$2.9M10$1.8M10
Operating expenses$175.0M8$101.0M9$36.1M10$27.0M5$16.8M5
Operating income-$52.7M6-$103.6M7-$166.8M8-$84.1M9-$17.8M10-$7.7M5$3.4M5
Interest$06$2.1M7$2.7M8$2.2M9$2.3M10$2.2M5$2.4M5
Income before tax-$205.2M8-$76.7M9$53.0M10-$8.9M5$393.0K5
Income tax$4.0K6$4.0K7$17.0K8$44.0K9$17.0K10$2.0K5
Net income-$80.0M6-$142.3M7-$205.2M8-$76.7M9$53.0M10-$8.9M5$391.0K5
Earnings per share-$2.127-$23.638-$167.429$10.3610-$0.115$0.005
Earnings per share (diluted)-$2.127-$23.638-$167.429$0.0510-$0.115$0.005
Shares (weighted, basic)8.7M shares8466.0K shares94.8M shares1080.0M shares5123.7M shares5
Shares (weighted, diluted)8.7M shares8466.0K shares9984.0M shares1080.0M shares56.4B shares5

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Corporate structure

Evofem Biosciences, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Evofem Biosciences, Inc.

  • Hub Cyber Security Ltd. Filed SCHEDULE 13D on Evofem Biosciences, Inc., latest Aug 4, 2026
  • CVI Investments, Inc. Filed SC 13G/A on Evofem Biosciences, Inc., latest Feb 14, 2024 (3 filings since Feb 14, 2022)
  • Todd Stewart Cox Filed SC 13G/A on Evofem Biosciences, Inc., latest Aug 10, 2022 (2 filings since Jul 19, 2022)
  • Evofem Biosciences, Inc. San Diego, California, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Evofem Biosciences, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$534.0K5 Dec 31, 2025$1.2M5 Dec 31, 2024−53.9%
Accumulated depreciation$116.0K5 Dec 31, 2025$701.0K5 Dec 31, 2024−83.5%
Property and equipment, net$418.0K5 Dec 31, 2025$458.0K5 Dec 31, 2024−8.7%
Operating-lease assets (leased space)$182.0K5 Dec 31, 2025$89.0K5 Dec 31, 2024+104.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$578.0K5 Dec 31, 2025$741.0K5 Dec 31, 2024−22.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, gross$5.5M5 Dec 31, 2025$10.2M5 Dec 31, 2024−46.5%
Accumulated amortization$1.1M5 Dec 31, 2025$619.0K5 Dec 31, 2024+80.6%
Finite-lived intangibles, net$4.3M5 Dec 31, 2025$9.6M5 Dec 31, 2024−54.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$1.1M5 Dec 31, 2025$1.6M5 Dec 31, 2024−28.4%
Raw materials$206.0K5 Dec 31, 2025$350.0K5 Dec 31, 2024−41.1%
Work in process$301.0K5 Dec 31, 2025$982.0K5 Dec 31, 2024−69.3%
Finished goods$622.0K5 Dec 31, 2025$245.0K5 Dec 31, 2024+153.9%

Properties, in its own words

Our corporate headquarters are now virtual and are located at 7770 Regents Rd, Suite 113-618, San Diego, California. We maintain this address for mail service.

We believe that our existing facilities are adequate for our current needs.

Item 2 of the 10-K filed Mar 11, 2026.4

Leadership

Who has led Evofem Biosciences, Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. George W. Mahaffey2014–2015
  2. Saundra L. Pelletier2018–2023

President

  1. George W. Mahaffey2014–2015

Chief financial officer

  1. Susan A. Knudson2014–2017
201520202025
Board members and other officers (24)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerIvy Zhang named Oct 11, 2023 to Jul 2, 202538
  • Executive OfficerJustin File named Feb 3, 2023 to Mar 6, 202339
  • DirectorTony O'Brian named Feb 3, 2023 to Mar 6, 202339

Former names

  • Neothetics, Inc.Sep 12, 2014 to Jan 5, 20183

Timeline

  1. Oct 15, 20268-K Entered a material agreement40
  2. Sep 23, 20268-K Entered a material agreement41
  3. Jul 20, 20268-K Regulation FD disclosure42
  4. Jul 14, 20268-K Entered a material agreement; New debt or obligation43
  5. May 18, 20268-K Results of operations44
  6. Apr 30, 20268-K Entered a material agreement; Regulation FD disclosure45
  7. Apr 16, 20268-K Entered a material agreement46
  8. Mar 19, 20268-K Ended a material agreement47
  9. Mar 11, 20268-K Results of operations; Regulation FD disclosure48
  10. Jan 12, 20268-K Regulation FD disclosure49
  11. Nov 26, 20258-K Bylaws or fiscal year changed; Shareholder vote50
  12. Nov 13, 20258-K Results of operations51
  13. Jan 18, 2018New chief executive Saundra L. Pelletier becomes CEO13
  14. Nov 19, 2014New chief executive George W. Mahaffey becomes CEO14
  15. Feb 1, 2007Founded Evofem Biosciences, Inc. is founded2

Calendar

When it reported results

  1. May 18, 2026Reported quarterly or annual results44
  2. Mar 11, 2026Reported quarterly or annual results48
  3. Nov 13, 2025Reported quarterly or annual results51
  4. Aug 14, 2025Reported quarterly or annual results52
  5. May 15, 2025Reported quarterly or annual results53
  6. Mar 24, 2025Reported quarterly or annual results54
  7. Nov 14, 2024Reported quarterly or annual results55
  8. Aug 14, 2024Reported quarterly or annual results56

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

238 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 131 major events, 22 insider forms, 6 large holders, 7 private raises, 51 other. The latest 20:

  1. Oct 15, 20268-K EDGAR
  2. Sep 23, 20268-K EDGAR
  3. Aug 14, 202610-Q EDGAR
  4. Aug 4, 2026SCHEDULE 13D EDGAR
  5. Jul 20, 20268-K EDGAR
  6. Jul 14, 20268-K EDGAR
  7. May 18, 20268-K EDGAR
  8. May 15, 202610-Q EDGAR
  9. Apr 30, 20268-K EDGAR
  10. Apr 16, 20268-K EDGAR
  11. Mar 19, 20268-K EDGAR
  12. Mar 11, 20268-K EDGAR
  13. Mar 11, 202610-K EDGAR
  14. Jan 12, 20268-K EDGAR
  15. Nov 26, 20258-K EDGAR
  16. Nov 13, 20258-K EDGAR
  17. Nov 13, 202510-Q EDGAR
  18. Oct 29, 2025DEF 14A EDGAR
  19. Oct 20, 2025PRE 14A EDGAR
  20. Oct 20, 20258-K EDGAR

The 238 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

6 open-market trades by officers, directors and large owners since October 2021: 4 buys and 2 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jan 12, 2024Zhang YanCFOSale104$0.04$4Form 4
Dec 21, 2023Kamdar Kim P.DirectorSale10$0.62$6Form 4
May 27, 2022PELLETIER SAUNDRA LChief Executive OfficerBuy141,000$0.35$49.4KForm 4
Dec 20, 2021Fitzpatrick Alexander AGeneral Counsel and SecretaryBuy25,000$0.39$9.8KForm 4
Dec 20, 2021File Justin J.Chief Financial OfficerBuy40,594$0.37$15.0KForm 4
Dec 20, 2021PELLETIER SAUNDRA LChief Executive OfficerBuy135,000$0.38$51.3KForm 4

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2024Saundra Pelletier$579.8K$1.2M60
2024Ivy Zhang$450.0K$695.3K60
2023Chief Executive Officer$560.3K$1.5M60
2023Chief Financial Officer and Secretary$293.6K$438.8K60
2023Justin J. FileFormer Chief Financial Officer$177.9K$353.4K60
2023Katherine AtkinsonFormer Chief Commercial Officer$97.2K$135.5K60

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Jun 26, 2025Raised $925,000 in a private offering of equity Form D: 1 investor so far Form D
  2. Apr 8, 2025Raised $750,000 in a private offering of equity Form D: $1.5 million offered in all Form D
  3. Aug 9, 2024Raised $500,000 in a private offering of equity Form D: 1 investor so far Form D
  4. Jul 12, 2024Raised $500,000 in a private offering of equity Form D: 1 investor so far Form D
  5. Sep 27, 2023Raised $2.9 million in a private offering of debt Form D: 14 investors so far Form D
  6. Feb 17, 2023Raised $1.4 million in a private offering of debt Form D: 4 investors so far Form D
  7. Dec 20, 2022Raised $2.3 million in a private offering of securities Form D: 8 investors so far Form D

SEC filer profile

How Evofem Biosciences, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGAREvofem Biosciences, Inc.1
  • CIK0001618835
  • Employer ID (EIN)20-85270754
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address12400 High Bluff Drive, Suite 600, San Diego, CA 921301
  • Phone(858) 550-19001
  • Shares outstanding132,530,081 as of Aug 12, 202612
  • Public float$1.2M as of Jun 30, 20254
  • AuditorBPM LLP, Sacramento, California PCAOB ID 207; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceSep 12, 20141
  • Filings802 in all: 8-K (234), 4 (232), 3 (36), 10-Q (35), SC 13G/A (24), CORRESP (18), SC 13G (16), DEF 14A (14)1
    All 50 form types

    DEFA14A (14), EFFECT (13), 10-K (12), 424B5 (12), SC 13D/A (12), UPLOAD (12), 8-K/A (11), D (11), S-8 (11), 4/A (10), PRE 14A (8), S-3 (8), 424B3 (7), 425 (6), S-1 (5), S-1/A (5), SC 13D (3), 3/A (2), 424B4 (2), 8-A12B (2), CT ORDER (2), FWP (2), NT 10-Q (2), PREM14A (2), RW (2), 10-K/A (1), 25-NSE (1), 5 (1), CERTNAS (1), DEF 14C (1), DEFM14A (1), DEFR14A (1), DRS (1), NT 10-K (1), POS EX (1), PRE 14C (1), PRER14A (1), S-1MEF (1), S-3/A (1), S-4 (1), S-4/A (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 11, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Oct 29, 2025
    Latest 8-K (8-K) Oct 15, 2026

Risk factors and legal proceedings

The risks Evofem Biosciences, Inc. names in Item 1A of its 10-K filed Mar 11, 2026: 71 risks under these headings, as written.4

  • Risks Related to Our Financial Condition and Capital Requirements
  • Risks Related to Potential Bankruptcy
  • Risks Related to Commercialization of PHEXX, SOLOSEC, and Any Other Approved Products
  • Risks Related to Our Post-Marketing Legal and Regulatory Compliance
  • Risks Related to Our Intellectual Property
  • Risks Related to Our Reliance on Third Parties
  • Risks Related to Our Commercialization of Health Care Products
  • Risks Related to Our Business Operations
  • Risks Related to Our Common and Preferred Stock
  • We are currently over 90 days past due on a significant amount of vendor obligations. 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 and a continuation of negative financial trends could result in our inability 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.
The other 68 risks
  • We may never be profitable. Our operating results may differ from any guidance we may announce.
  • We will need to raise significant additional funds to finance our operations, including the commercialization of PHEXX and SOLOSEC, 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 or to cease our operations entirely.
  • 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.
  • Given our current financial condition, we have considered and may continue to consider filing for bankruptcy protection. While we have not initiated bankruptcy proceedings, we caution that trading in our securities is highly speculative and poses substantial risks relating to the potential of bankruptcy proceedings. Trading prices for our securities may bear little or no relationship to the actual recovery, if any, by holders of our securities in Bankruptcy proceedings, if any.
  • We are subject to risks and uncertainties associated with potential bankruptcy proceedings.
  • 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 businesses could suffer from a long and protracted restructuring.
  • In certain instances, a Chapter 11 case may be converted to a case under Chapter 7 of the Bankruptcy Code.
  • If we choose to file under Chapter 11, we may be subject to claims that will not be discharged in the bankruptcy proceedings, which could have a material adverse effect on our financial condition and results of operations.
  • Our financial results may be volatile and may not reflect historical trends.
  • 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.
  • Our commercial strategy includes positioning PHEXX for women using GLP-1 receptor agonists, and if clinical guidance, prescribing patterns or regulatory interpretations do not support this positioning, our anticipated market opportunity and sales growth could be adversely affected.
  • 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.
  • 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 to limit commercialization of our products. If we are unable to obtain adequate insurance or are required to pay for liabilities resulting from a claim excluded from, or beyond the limits of, our insurance coverage, a material liability claim could adversely affect our financial condition.
  • 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.
  • TherapeuticsMD 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 our products and their underlying technologies, 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 product and technology, and our ability to successfully commercialize our products 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.
  • The Company received two Notice of Defaults (on September 27, 2024 and October 27, 2024) 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.
  • Our success relies on third-party suppliers and two contract manufacturers. Any failure by these third parties, including their inability to successfully perform and comply with regulatory requirements, could negatively impact our business and our ability to develop and market our products, and our business could be substantially harmed.
  • We have no significant internal distribution capabilities. We intend to engage third-party distributors for distribution of products outside the U.S., if approved, and have engaged additional third-party wholesale distributors for the distribution of our products in the U.S. Our inability to identify, or enter into an agreement with, any such third-party distributor, would likely have a material adverse effect on our business and operations.
  • We rely on third parties for the delivery of telehealth services through the PHEXX telehealth platform. Failure of these third parties to provide services of a suitable quality, in accordance with applicable regulations and within acceptable time frames may cause the delay or failure of our telehealth strategy.
  • 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. In the event we must perform under these indemnification provisions, it could have a material adverse effect on our business, financial condition and results of operations.
  • 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. Our management expects our success will be dependent on the willingness or ability of patients to pay out-of-pocket for our products should they not be able to obtain third-party reimbursement or should such reimbursement be limited.
  • 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 Anti-Kickback Statute, 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.
  • We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage.
  • Our business may be adversely affected by unfavorable macroeconomic conditions, including potential future pandemics, geopolitical conflicts and other factors.
  • As we mature and expand our sales and marketing infrastructure, we will need to expand the size of our organization. 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.

Legal proceedings

From time to time, we may be involved in various actual and threatened legal proceedings, claims, investigations and government inquiries arising in the ordinary course of our business, including intellectual property, securities, stockholder derivative claims, employment, governance, workplace culture, contractual rights, false or misleading advertising, or other legal claims relating to our products and operations. Any proceedings, claims or inquiries involving us, whether successful or not, may be time consuming, result in costly litigation, unfavorable outcomes, increased costs of business, may require us to change our business practices or products, require significant amount of management’s time, may harm our reputation or otherwise harm our business and future financial results.

The opening of Item 3, Legal Proceedings.4

Sources

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