Reg FD Disclosure · Company Update

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549   FORM 8-K   CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): May 20, 2022   TherapeuticsMD, Inc. (Exact Name of Registrant as Specified in its Charter)   Nevada   001-00100   87-0233535 (State or Other Jurisdiction of Incorporation)   (Commission File Number)   (IRS Employer Identification No.)   951 Yamato Road , Suite 220 Boca Raton , FL 33431 (Address of Principal Executive Office) (Zip Code)   Registrant’s telephone number, including area code:   (561) 961-1900   Not Applicable (Former name or former address, if changed since last report)   Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:   ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)     ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)     ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))     ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))   Securities registered pursuant to Section 12(b) of the Act:   Title of Each Class Trading Symbol Name of Each Exchange on Which Registered Common Stock, par value $0.001 per share TXMD The Nasdaq Stock Market LLC   Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230-405) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐       Item 7.01 Regulation FD Disclosure. On May 20, 2022, TherapeuticsMD, Inc., a Nevada corporation (the “Company”), issued a press release announcing the response from the U.S. Food and Drug Administration (the “FDA”) described in Item 8.01 of this Current Report on Form 8-K. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information in this Item 7.01 and in Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liabilities under that section, and shall not be deemed to be incorporated by reference into the filings of the Company under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filings. Item 8.01 Other Events. On May 20, 2022, t he Company announced that the FDA approved the minor revisions to the  in vitro  release testing specification for ANNOVERA® requested by the Company in the Supplemental New Drug Application (“sNDA”) previously submitted to the FDA. The approval followed the Company’s amendment to the sNDA in response to the FDA’s recommendations and requests for additional information that could support approval of revisions to certain manufacturing testing limits. Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit Index Exhibit No.   Description       99.1   Press Release dated May 20, 2022 .       104   Cover Page Interactive Data File (the cover page tags are embedded within the Inline XBRL document).       SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.   Date:  May 20, 2022   THERAPEUTICSMD, INC.           /s/ Michael C. Donegan     Michael C. Donegan     Interim Chief Financial Officer, Chief Accounting Officer and Vice President Finance