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TXMD on Nasdaq

TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an American pharmaceutical preparations company based in Boca Raton.2 Its shares trade on Nasdaq under the symbol TXMD.2

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Last updated Oct 21, 2026.

Overview

Compare with Xenetic Biosciences (United States), Aptevo Therapeutics Inc. or Upstream Bio, Inc., or pick any stock.

  • TickerTXMD on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersBoca Raton, United States2
  • Incorporated inNV3
  • Business address951 Yamato Road, Suite 220, Boca Raton, Fl 334313
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI5299004JS7RE49QHRW302
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressc/o Paracorp Incorporated, 318 N Carson St #208, 89701 Carson City, United States2
  • Registered withBusiness Center (Secretary of State), NV201015484002

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2025 10-K Report, this information could prove to be inaccurate as a result of a variety of matters.5 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

-145.3%Operating margin6
-18.8%Net margin6
71.6%Revenue growth, 20256
-2.1%Return on equity6

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Regions

United States brought in 59% of the revenue TherapeuticsMD, Inc. broke down this way in fiscal 2025.

  1. United States$1.8M659%up 60% from 2024
  2. Outside the United States$1.2M641%up 93% from 2024
Regions by year
Regions20242025
United States$1.1M$1.8M
Outside the United States$638.0K$1.2M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Other costs100¢$3.0M

Out of $3.0M in revenue.6 The company lost money this year.

Financial statements

Revenue7896$3.0M in 2025−94% since 2019
0$20.0M$40.0M$60.0M$80.0M2019: $49.6M$49.6M20192020: $64.9M$64.9M2020+31%2021: $2.6M$2.6M2021−96%2022: $70.0M$70.0M2022+2619%2023: $1.3M$1.3M2023−98%2024: $1.8M$1.8M2024+35%2025: $3.0M$3.0M2025+72%
Gross profit7810$1.3M in 2023−97% since 2019
0$20.0M$40.0M$60.0M$80.0M2019: $43.3M$43.3M20192020: $48.9M$48.9M2020+13%2021: $1.2M$1.2M2021−98%2022: $68.6M$68.6M2022+5755%2023: $1.3M$1.3M2023−98%
Operating income781096-$4.4M in 2025−97% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M0$50.0M2019: -$151.2M-$151.2M20192020: -$155.5M-$155.5M2020+3%2021: -$79.6M-$79.6M2021−49%2022: $1.2M$1.2M20222023: -$8.5M-$8.5M20232024: -$6.1M-$6.1M2024−28%2025: -$4.4M-$4.4M2025−28%
Net income781096-$569.0K in 2025−100% since 2019
-$200.0M-$100.0M0$100.0M$200.0M2019: -$176.1M-$176.1M20192020: -$183.5M-$183.5M2020+4%2021: -$172.4M-$172.4M2021−6%2022: $112.0M$112.0M20222023: -$10.3M-$10.3M20232024: -$2.2M-$2.2M2024−79%2025: -$569.0K-$569.0K2025−74%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
License revenue$3.0M$1.8M
General and administrative$6.9M$6.1M
Write-off and impairment of patents$176.0K$1.3M
Depreciation & amortization$384.0K$509.0K
Total operating expenses$7.4M$7.9M
Loss from operations-$4.4M-$6.1M
Interest income, net$142.0K$135.0K
Sublease income$1.8M$1.4M
Miscellaneous income$1.7M$2.3M
Total other income$3.7M$3.8M
Loss from continuing operations before income taxes-$653.0K-$2.3M
Income tax benefit$31.0K
Net loss from continuing operations-$653.0K-$2.3M
Income from discontinued operations, net of income taxes$84.0K$131.0K
Net loss-$569.0K-$2.2M
Continuing operations (in Dollars per share)-$0-$0
Discontinued operations, net (in Dollars per share)$0$0
Net loss per common share, basic (in Dollars per share)-$0.05-$0.19
Continuing operations (in Dollars per share)-$0-$0
Discontinued operations, net (in Dollars per share)$0$0
Net loss per common share, diluted (in Dollars per share)-$0.05-$0.19
Weighted average common shares, basic (in Shares)11.6M shares11.5M shares
Weighted average common shares, diluted (in Shares)11.6M shares11.5M shares

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Corporate structure

TherapeuticsMD, Inc. sits at the top of its group. 3 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of TherapeuticsMD, Inc.

  • Baselake Partners, LP Filed SCHEDULE 13G/A on TherapeuticsMD, Inc., latest Aug 5, 2026 (2 filings since Apr 6, 2026)
  • Clearline Capital LP Filed SCHEDULE 13G on TherapeuticsMD, Inc., latest Feb 12, 2025 (2 filings since Nov 12, 2024)
  • Rubric Capital Management LP Filed SC 13D/A on TherapeuticsMD, Inc., latest Nov 17, 2023 (4 filings since Aug 8, 2022)
  • BlackRock Filed SC 13G/A on TherapeuticsMD, Inc., latest Jul 8, 2022 (2 filings since Feb 1, 2022)
  • Beryl Capital Management LLC Filed SC 13G on TherapeuticsMD, Inc., latest Jun 3, 2022
  • Robert J. Smith Filed SC 13D/A on TherapeuticsMD, Inc., latest Mar 23, 2022
  • PRICE T ROWE ASSOCIATES INC /MD/ Filed SC 13G/A on TherapeuticsMD, Inc., latest Feb 14, 2022
  • TherapeuticsMD, Inc. Boca Raton, Florida, United States
    • BocagreenMD, Inc. Subsidiary · Nevada, United States
    • VitaMedMD, LLC Subsidiary · Delaware, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What TherapeuticsMD, 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
Operating-lease assets (leased space)$5.3M6 Dec 31, 2025$6.1M6 Dec 31, 2024−13.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$5.1M9 Dec 31, 2024$4.3M9 Dec 31, 2023+16.9%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$3.8M6 Dec 31, 2025$4.3M6 Dec 31, 2024−13.0%
Finite-lived intangibles, gross$6.2M6 Dec 31, 2025$6.4M6 Dec 31, 2024−3.1%
Accumulated amortization$2.4M6 Dec 31, 2025$2.1M6 Dec 31, 2024+17.7%
Finite-lived intangibles, net$3.3M6 Dec 31, 2025$3.7M9 Dec 31, 2024−11.8%

Properties, in its own words

We operate from a fully remote environment. We have a lease in Boca Raton, Florida that includes 62,748 rentable square feet, or the full premises, of which the lease of 7,561 square feet commenced in 2018 and the lease of 55,187 square feet commenced in August of 2019, or the full premises commencement date. In June 2019, we entered into an agreement with the same lessors to lease an additional 6,536 square feet of administrative office space in the same location, pursuant to an addendum to such lease, which commenced in May 2020. The lease will expire 11 years after the full premises commencement date, unless terminated earlier in accordance with the terms of the lease. We have the option to extend the term of the lease for two additional consecutive periods of five years. The extension option is not included in the determination of the lease term as it is not reasonably certain to be exercised. The term of the lease includes escalating rent and free rent periods. We are also responsible for certain other operating costs under the lease, including electricity and utility expenses. We have sublet all of our leased property in Boca Raton as a result of shifting our business to become a pharmaceutical royalty company and terminating our employees.

Item 2 of the 10-K filed Mar 30, 2026.5

Leadership

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

Chief executive

  1. Sky B. Kelley2009
  2. Robert Cambridge2009
  3. Robert G. Finizio2011–2021
  4. John C.k. Milligan Iv.2021
  5. Hugh O'Dowd2022
  6. Brian Bernick2022
  7. Mark A. Glickman2022
  8. Marlan D. Walker2023–now

Chair

  1. Robert G. Finizio2012
  2. Tommy Thompson2013

President

  1. Gerald L. Jensen2006–2007
  2. Gregory Woodhill2008
  3. Sky B. Kelley2009
  4. Robert Cambridge2009
  5. Jeffrey D. Howes2011
  6. John C.k. Milligan Iv.2011–2021
  7. Hugh O'Dowd2021

Chief financial officer

  1. Gregory Woodhill2008
  2. Donald R. Mastropietro2009
  3. Daniel A. Cartwright2011–2020
  4. James Darecca2020–2021
  5. Michael C. Donegan2022
2010201520202025
Board members and other officers (37)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorJustin C. Roberts named Oct 17, 2022 to Jul 11, 202362
  • DirectorAngus C. Russell named Aug 16, 2022 to Nov 14, 202263

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • BocagreenMD, Inc. Nevada4
  • VitaMedMD, LLC Delaware4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • AMHN, Inc.Sep 30, 2009 to Sep 14, 20113
  • CROFF ENTERPRISES INCNov 17, 1997 to Sep 4, 20093
  • CROFF OIL COOct 3, 1995 to Apr 1, 19973

Timeline

  1. Aug 11, 20268-K Results of operations; Regulation FD disclosure64
  2. May 12, 20268-K Results of operations; Regulation FD disclosure65
  3. Mar 30, 20268-K Results of operations; Regulation FD disclosure66
  4. Jan 21, 20268-K Change of auditor67
  5. Dec 16, 20258-K Shareholder vote68
  6. Nov 13, 20258-K Results of operations; Regulation FD disclosure69
  7. Aug 12, 20258-K Results of operations; Regulation FD disclosure70
  8. May 13, 20258-K Results of operations; Regulation FD disclosure71
  9. Apr 9, 20258-K Other events72
  10. Mar 27, 20258-K Results of operations; Regulation FD disclosure73
  11. Dec 5, 20248-K Shareholder vote74
  12. Nov 12, 20248-K Results of operations; Regulation FD disclosure75
  13. Feb 13, 2023New chief executive Marlan D. Walker becomes CEO14
  14. Dec 9, 2022New chief executive Mark A. Glickman becomes CEO17
  15. Sep 16, 2022New chief executive Brian Bernick becomes CEO16
  16. Mar 28, 2022New chief executive Hugh O'Dowd becomes CEO15
  17. May 12, 2021New chief executive John C.k. Milligan Iv. becomes CEO18
  18. Oct 11, 2011New chief executive Robert G. Finizio becomes CEO19
  19. Aug 19, 2009New chief executive Robert Cambridge becomes CEO21
  20. Jul 31, 2009New chief executive Sky B. Kelley becomes CEO20

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/202676

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results64
  2. May 12, 2026Reported quarterly or annual results65
  3. Mar 30, 2026Reported quarterly or annual results66
  4. Nov 13, 2025Reported quarterly or annual results69
  5. Aug 12, 2025Reported quarterly or annual results70
  6. May 13, 2025Reported quarterly or annual results71
  7. Mar 27, 2025Reported quarterly or annual results73
  8. Nov 12, 2024Reported quarterly or annual results75

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

Filings

212 filings to the SEC since October 2021: 10 annual reports, 15 quarterly reports, 65 major events, 76 insider forms, 13 large holders, 4 private raises, 29 other. The latest 20:

  1. Aug 11, 202610-Q QUARTERLY REPORT EDGAR
  2. Aug 11, 20268-K CURRENT REPORT EDGAR
  3. Aug 5, 2026SCHEDULE 13G/A EDGAR
  4. May 12, 202610-Q QUARTERLY REPORT EDGAR
  5. May 12, 20268-K CURRENT REPORT EDGAR
  6. Apr 6, 2026SCHEDULE 13G EDGAR
  7. Apr 1, 202610-K/A ANNUAL REPORT EDGAR
  8. Apr 1, 2026NT 10-K NOTIFICATION OF LATE FILING EDGAR
  9. Mar 30, 20268-K CURRENT REPORT EDGAR
  10. Mar 30, 202610-K ANNUAL REPORT EDGAR
  11. Jan 21, 20268-K CURRENT REPORT EDGAR
  12. Dec 29, 20254 EDGAR
  13. Dec 16, 20258-K CURRENT REPORT EDGAR
  14. Nov 13, 20258-K CURRENT REPORT EDGAR
  15. Nov 12, 202510-Q QUARTERLY REPORT EDGAR
  16. Nov 5, 20254 EDGAR
  17. Nov 5, 20254 EDGAR
  18. Nov 5, 20254 EDGAR
  19. Nov 5, 20254 EDGAR
  20. Nov 3, 2025ARS EDGAR

The 212 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

32 open-market trades by officers, directors and large owners since October 2021: 16 buys and 16 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 23, 2025Thompson Tommy GDirectorBuy8,400$1.67$14.0KForm 4
Apr 14, 2025Thompson Tommy GDirectorBuy325$1.00$325Form 4
Apr 14, 2025Walker Marlan DChief Executive OfficerBuy490$1.00$490Form 4
Apr 10, 2025Walker Marlan DChief Executive OfficerBuy1,167$0.86$1.0KForm 4
Apr 9, 2025Walker Marlan DChief Executive OfficerBuy1,136$0.87$988Form 4
Aug 22, 2024Collins Cooper C.DirectorBuy4,094$1.73$7.1KForm 4
Aug 21, 2024Collins Cooper C.DirectorBuy1,200$1.70$2.0KForm 4
Dec 7, 2023Walker Marlan DChief Executive OfficerSale4,550$2.24$10.2KForm 4
Dec 6, 2023Walker Marlan DChief Executive OfficerSale14,500$2.31$33.5KForm 4
Apr 26, 2023Walker Marlan DChief Executive OfficerSale692$3.64$2.5KForm 4
Apr 12, 2023Walker Marlan DChief Executive OfficerSale1,170$3.65$4.3KForm 4
Jan 27, 2023Donegan Michael CPrin. Fin. and Acctg. OfficerSale49$5.09$249Form 4
Jan 26, 2023Donegan Michael CPrin. Fin. and Acctg. OfficerSale1,648$5.08$8.4KForm 4
Jan 24, 2023Donegan Michael CPrin. Fin. and Acctg. OfficerSale7$5.31$37Form 4
Jan 23, 2023Donegan Michael CPrin. Fin. and Acctg. OfficerSale1,302$5.34$7.0KForm 4
Dec 30, 2022Rubric Capital Management LPDirectorSale29,000$1,333.00$38.7MForm 4
Dec 9, 2022Bernick BrianCo-Chief Executive OfficerSale320$6.31$2.0KForm 4
Dec 9, 2022Rubric Capital Management LPDirectorBuy14,825$6.09$90.3KForm 4
Dec 8, 2022Rosen David Efraim10% ownerBuy300$5.83$1.7KForm 4
Dec 7, 2022Naughton Gail KDirectorSale3,922$5.26$20.6KForm 4

All 32 trades can be filtered by person here when JavaScript is on.

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
2024Marlan D. Walker51$500.0K$759.2K84
2024Joseph Ziegler51$120.0K$120.0K84
2023Chief Executive Officer$476.5K$1.0M84
2023Principal Financial and Accounting Officer$52.9K$82.9K84

Money raised

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

  1. Jun 29, 2023Raised $1.1 million in a private offering of equity Form D: $5 million offered in all Form D
  2. Oct 28, 2022Raised $7 million in a private offering of equity Form D: 6 investors so far Form D
  3. Sep 30, 2022Raised $7 million in a private offering of equity Form D: 6 investors so far Form D
  4. Jul 29, 2022Raised $15 million in a private offering of equity Form D: 6 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 46. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Rubric Capital Management LP1,192,191$2.6M0.0%No change
Clearline Capital LP635,222$1.4M0.1%No change
Vanguard Capital Management LLC353,697$781.7K0.0%No change
Tejara Capital Ltd344,482$761.3K0.3%−1,370
ADAR1 Capital Management, LLC342,447$756.8K0.0%+133,237
Renaissance Technologies LLC146,599$324.0K0.0%+399
Morgan Stanley129,217$285.6K0.0%No change
BlackRock, Inc.115,145$254.5K0.0%No change
Geode Capital Management, LLC105,849$234.0K0.0%−3,968
Citadel Advisors LLC86,095$190.3K0.0%+17,781
Vanguard Fiduciary Trust Co63,831$141.1K0.0%No change
State Street Corp30,100$66.5K0.0%No change
XTX Topco Ltd21,246$47.0K0.0%−6,241
Dimensional Fund Advisors LP19,719$43.6K0.0%+9,013
Northern Trust Corp18,556$41.0K0.0%+2,463
Bridgeway Capital Management, LLC17,000$37.6K0.0%No change
Osaic Holdings, Inc.15,198$33.6K0.0%+15,045
Vanguard Global Advisers, LLC4,937$10.9K0.0%No change
UBS Group AG4,660$10.3K0.0%+4,329
Tower Research Capital LLC (TRC)1,582$3.5K0.0%+73
SBI Securities Co., Ltd.1,263$2.8K0.0%+996
Smartleaf Asset Management LLC601$1.3K0.0%No change
Royal Bank Of Canada833$1.0K0.0%+643
Banque Cantonale Vaudoise7$1.0K0.0%No change
Jpmorgan Chase & Co293$6570.0%No change

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

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

  • Name on EDGARTherapeuticsMD, Inc.1
  • CIK0000025743
  • Employer ID (EIN)87-02335355
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inNevada5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address951 Yamato Road, Suite 220, Boca Raton, FL 334311
  • Phone561-961-19001
  • Shares outstanding11,574,362 as of Aug 9, 202612
  • Public float$9.0M as of Jun 30, 20255
  • AuditorCarr, Riggs & Ingram, L.L.C., Palm Beach Gardens, FL PCAOB ID 213; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceAug 16, 19951
  • Filings1,176 in all: 4 (359), 8-K (271), 10-Q (93), SC 13G/A (50), 3 (40), SC 13D (33), 10-K (31), UPLOAD (30)1
    All 62 form types

    5 (21), DEF 14A (19), DEFA14A (15), 424B5 (14), CORRESP (14), SC 13G (13), 8-K/A (12), SC 13D/A (10), 424B2 (9), 10-K/A (8), EFFECT (8), SC TO-T/A (8), 424B3 (7), PRE 14A (7), D (6), S-8 (6), 10-Q/A (5), 4/A (5), CT ORDER (5), SC 14D9/A (5), ARS (4), NT 10-K (4), POS AM (4), PRE 14C (4), PRER14A (4), S-3 (4), SEC STAFF LETTER (4), 3/A (3), DEF 14C (3), PRER14C (3), SC 14D9 (3), 424B7 (2), 8-A12B (2), FWP (2), NT 10-Q (2), POSASR (2), S-3ASR (2), SC TO-I (2), SC TO-I/A (2), SCHEDULE 13G (2), 10QSB (1), 144 (1), 25 (1), AW (1), CERTNAS (1), CERTNYS (1), PREM14A (1), S-1 (1), S-3MEF (1), S-8 POS (1), SC TO-C (1), SC TO-T (1), SC14D9C (1), SCHEDULE 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 30, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Nov 3, 2025
    Latest 8-K (8-K) Aug 11, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareTXMDThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 30, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks TherapeuticsMD, Inc. names in Item 1A of its 10-K filed Mar 30, 2026: 51 risks under these headings, as written.5

  • Risks related to our business
  • We currently derive all revenue from royalties related to sales of our licensed women’s healthcare products, and the failure of our licensees to maintain or increase sales of these products could have an adverse effect on our business, financial condition, results of operations, and growth prospects.
  • We have incurred net losses in the past and may not be able to maintain or increase profitability in the future.
  • There is substantial doubt about our ability to continue as a going concern.
  • We have experienced significant turnover in our top executives, and our business could be adversely affected by these and other transitions in our senior management team.
  • We currently depend on the services of Marlan D. Walker as our Chief Executive Officer and sole employee. Should we lose Mr. Walker due to death, disability, retirement or otherwise, such loss could adversely affect our business, management and operations.
  • Our dependence upon third parties for the manufacture and supply of our existing women’s healthcare products may cause delays in or prevent our licensees from successfully commercializing and marketing our products.
  • The commercial success of our existing products will depend upon gaining and retaining significant market acceptance of these products among physicians and payers.
  • Coverage and reimbursement may not be available for our products, which could make it difficult for our licensees to sell our products profitably.
  • Our revenue, results of operations and financial position could be affected by our ongoing disputes with Mayne Pharma.
  • Unfavorable global economic conditions could harm our business, financial condition or results of operations.
  • We sublease our properties, which could expose us to possible liabilities and losses.
The other 40 risks
  • Licensing of intellectual property involves complex legal, business, and scientific issues, and disputes could jeopardize our rights under such agreements.
  • We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
  • Our products and our licensees are subject to extensive and costly government regulation.
  • Current or future legislation or regulations may adversely affect reimbursement from government healthcare programs and third-party payers.
  • Time and costs associated with winding down our general and administrative, commercial, and research and development activities may be significant.
  • Even after the approval of IMVEXXY, BIJUVA, and ANNOVERA, the products and the holder of the marketing authorizations will still face extensive, ongoing regulatory requirements and review, and the products may face future development and regulatory difficulties.
  • Government authorities continue to pursue actions against pharmaceutical companies for violations of fraud, abuse and other laws.
  • If our dietary supplement, hormone therapy pharmaceutical products or patient-controlled, long-acting contraceptive products do not have the effects intended or cause undesirable side effects, our business may suffer.
  • Our products face significant competition from branded and generic products, and our operating results will suffer if we fail to compete effectively.
  • Our future success depends on our ability to attract and retain qualified personnel.
  • Our financial condition and results of operations may be adversely affected by any future pandemics or epidemics.
  • Failure to obtain regulatory approval outside the U.S. will prevent our licensees from marketing our hormone therapy pharmaceutical products in non-U.S. markets.
  • Our success is tied to our licensees’ distribution channels.
  • Our ability to utilize net operating loss carryforwards may be limited.
  • Any failure of our licensees to adequately maintain a sales force or adequately promote our products will impede our growth.
  • Risks related to our intellectual property
  • If our efforts or the efforts of our licensees to protect the proprietary nature of the intellectual property covering our hormone therapy pharmaceutical products and other products are not adequate, we may not be able to compete effectively in our market.
  • We must rely on Mayne Pharma to file lawsuits or take other actions to protect or enforce our patents and they may not take such actions or be successful.
  • Risks related to ownership of our common stock
  • We may be treated as a “public shell” company which could have negative consequences, including potential Nasdaq delisting of our common stock.
  • Our principal stockholder owns a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • If we fail to maintain proper internal controls, our ability to produce accurate financial statements or comply with applicable regulations could be impaired.
  • We do not currently intend to pay dividends on our common stock so any returns may be limited to the value of our stock.
  • Some provisions of our charter documents and Nevada law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management.
  • General risks related to our business
  • Our business may be affected by unfavorable publicity or lack of consumer acceptance.
  • Our licensees may initiate product recalls or withdrawals or may be subject to regulatory enforcement actions that could negatively affect our business.
  • Product liability lawsuits could divert our resources, result in substantial liabilities, and reduce the commercial potential of our products.
  • A failure to maintain optimal inventory levels to meet commercial demand for our products could harm our and our licensees’ reputation and subject us to financial losses.
  • Our business may be impacted by new or changing tax laws or regulations and actions by federal, state, and/or local agencies, or how judicial authorities apply tax laws.
  • We may not be able to maintain effective and efficient information systems or properly safeguard our information systems.
  • Our failure to comply with foreign data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
  • Our employees and business partners may not appropriately secure and protect confidential information in their possession.
  • Employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
  • General risks related to our intellectual property
  • If we are sued for infringing intellectual property rights of third parties, litigation will be costly and time consuming and could prevent or delay us from developing or commercializing our pharmaceutical product candidates.
  • If we are unable to protect the confidentiality of certain information, the value of our products and technology could be adversely affected.
  • If the Company’s continued exploration of strategic alternatives is unsuccessful, our financial condition and results of operations may be materially adversely affected.
  • We may be subject to claims that our former employees wrongfully used or disclosed alleged trade secrets of their former employers or of other third parties with whom we have obligations of confidentiality.
  • General risks related to ownership of our Common Stock
  • The market price of our common stock may be highly volatile, and you could lose all or part of your investment.
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
  • Future sales and issuances of equity securities, convertible securities or other securities could result in additional dilution of the percentage ownership of holders of our common stock.

Legal proceedings

In February 2020, we received a Paragraph IV certification notice letter (the “IMVEXXY Notice Letter”) regarding an Abbreviated New Drug Application (“ANDA”) submitted to the FDA by Teva Pharmaceuticals USA, Inc. (“Teva”). The ANDA seeks approval from the FDA to commercially manufacture, use, or sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY. In the IMVEXXY Notice Letter, Teva alleges that TherapeuticsMD patents listed in the FDA’s Orange Book that claim compositions and methods of IMVEXXY (the “IMVEXXY Patents”) are invalid, unenforceable, and/or will not be infringed by Teva’s commercial manufacture, use, or sale of its proposed generic drug product. The IMVEXXY Patents identified in the IMVEXXY Notice Letter expire in 2032 or 2033. In April 2020, we filed a complaint for patent infringement against Teva in the United States District Court for the District of New Jersey arising from Teva’s ANDA filing with the FDA. We are seeking, among other relief, an order that the effective date of any FDA approval of Teva’s ANDA would be a date no earlier than the expiration of the IMVEXXY Patents and equitable relief enjoining Teva from infringing the IMVEXXY Patents. Teva has filed its answer and counterclaim to the complaint, alleging that the IMVEXXY Patents are invalid and not infringed. In July 2021, following a proposal by Teva, the District Court entered an order temporarily staying all proceedings in the IMVEXXY litigation, which order was filed under seal. In September 2021, the District Court made available a public version of the order following the parties’ agreement to a consent motion to redact information Teva contended was confidential. The order provides that the statutory stay that prevents the FDA from granting final approval of the ANDA for 30 months from the date of the IMVEXXY Notice Letter will be extended for the number of days that the stay of the IMVEXXY litigation is in place. In November 2024, the court lifted the stay.

The opening of Item 3, Legal Proceedings.5

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