TherapeuticsMD, Inc. 10-Q

Item 1. Financial statements TherapeuticsMD, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (in thousands, except per share data) June 30, 2024 December 31, 2023 (Unaudited) Assets: Current assets: Cash and cash equivalents $ 5,232 $ 4,327 Royalty receivable, current portion 2,908 3,090 Prepaid and other current assets 3,683 4,035 Current assets of discontinued operations — 344 Total current assets 11,823 11,796 License rights and other intangible assets, net 4,524 6,098 Right of use assets 6,497 6,873 Royalty receivable, long term 17,224 18,484 Other non-current assets 58 58 Total assets $ 40,126 $ 43,309 Liabilities and stockholders’ equity: Current liabilities: Accounts payable $ 143 $ 27 Accrued expenses and other current liabilities 2,676 3,133 Current liabilities of discontinued operations 2,996 3,694 Total current liabilities 5,815 6,854 Operating lease liabilities 6,004 6,532 Other non-current liabilities 637 636 Total liabilities 12,456 14,022 Commitments and contingencies (Note 6) Stockholders’ equity: Common stock, par value $ 0.001 ; 32,000 shares authorized, 11,532 issued and outstanding as of June 30, 2024 and December 31, 2023 11 11 Additional paid-in capital 979,124 978,917 Accumulated deficit ( 951,465 ) ( 949,641 ) Total stockholders’ equity 27,670 29,287 Total liabilities and stockholders’ equity $ 40,126 $ 43,309 The accompanying notes are an integral part of these condensed consolidated financial statements. 1 TherapeuticsMD, Inc. and Subsidiaries Condensed Consolidated Statements of Operations (Unaudited - in thousands, except per share data) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Revenue, net: License and service revenue $ 234 $ 437 $ 547 $ 853 Operating expenses: Selling, general and administrative 1,233 2,781 2,555 5,837 Impairment of long-lived assets (Note 4) 1,261 — 1,261 — Depreciation & amortization 180 128 313 155 Total operating expenses 2,674 2,909 4,129 5,992 Loss from operations ( 2,440 ) ( 2,472 ) ( 3,582 ) ( 5,139 ) Other income (expense): Interest expense and other financing costs ( 5 ) ( 45 ) ( 5 ) ( 95 ) Miscellaneous income 1,395 103 1,728 510 Total other income, net 1,390 58 1,723 415 Loss from continuing operations before income taxes ( 1,050 ) ( 2,414 ) ( 1,859 ) ( 4,724 ) Provision for income taxes — — — — Loss from continuing operations, net of income taxes ( 1,050 ) ( 2,414 ) ( 1,859 ) ( 4,724 ) (Loss) income from discontinued operations, net of income taxes ( 40 ) — 35 ( 1,293 ) Net loss $ ( 1,090 ) $ ( 2,414 ) $ ( 1,824 ) $ ( 6,017 ) Loss per common share, basic and diluted: Continuing operations ( 0.09 ) ( 0.24 ) ( 0.16 ) ( 0.47 ) Discontinued operations, net ( 0.00 ) — 0.00 ( 0.13 ) Net loss per common share, basic and diluted $ ( 0.09 ) $ ( 0.24 ) $ ( 0.16 ) $ ( 0.60 ) Weighted average common shares, basic 11,532 10,219 11,532 9,988 Weighted average common shares, diluted 11,532 10,219 11,532 9,988 The accompanying notes are an integral part of these condensed consolidated financial statements. 2 TherapeuticsMD, Inc. and Subsidiaries Condensed Consolidated Statements of Stockholders’ Equity (Unaudited - in thousands) Common Stock Additional Paid in Accumulated Shares Amount Capital Deficit Total Balance, January 1, 2024 11,532 $ 11 $ 978,917 $ ( 949,641 ) $ 29,287 Share-based compensation — — 111 — 111 Net loss — — — ( 734 ) ( 734 ) Balance, March 31, 2024 11,532 $ 11 $ 979,028 $ ( 950,375 ) $ 28,664 Share-based compensation — — 96 — 96 Net loss — — — ( 1,090 ) ( 1,090 ) Balance, June 30, 2024 11,532 $ 11 $ 979,124 $ ( 951,465 ) $ 27,670 Common Stock Additional Paid in Accumulated Shares Amount Capital Deficit Total Balance, January 1, 2023 9,498 $ 9 $ 974,497 $ ( 939,363 ) $ 35,143 Shares issued for vested restricted stock units 455 1 - - 1 Share-based compensation - - 483 - 483 Net loss - - - ( 3,603 ) ( 3,603 ) Balance, March 31, 2023 9,953 $ 10 $ 974,980 $ ( 942,966 ) $ 32,024 Shares issued for vested restricted stock units 60 - - - - Shares issued for sale of common stock related to private placement sale 313 1 1,149 - 1,150 Share-based compensation - - 437 - 437 Shares issued for exercise of warrants 249 - - - - Net loss - - - ( 2,414 ) ( 2,414 ) Balance, June 30, 2023 10,575 $ 11 $ 976,566 $ ( 945,380 ) $ 31,197 The accompanying notes are an integral part of these condensed consolidated financial statements. 3 TherapeuticsMD, Inc. and Subsidiaries Condensed Consolidated Statements of Cash Flows (Unaudited - in thousands) Six Months Ended June 30, 2024 2023 Cash flows from operating activities: Net loss $ ( 1,824 ) $ ( 6,017 ) Less: income (loss) from discontinued operations, net of tax 35 ( 1,293 ) Net loss from continuing operations ( 1,859 ) ( 4,724 ) Adjustments to reconcile net loss to net cash provided by (used in) continuing operating activities: Depreciation and amortization 313 156 Impairment of long-lived assets (Note 4) 1,261 59 Share-based compensation 207 921 Other 376 ( 78 ) Changes in operating assets and liabilities: Other assets 1,260 464 Prepaid and other current assets 534 150 Accounts payable 116 ( 654 ) Accrued expenses and other current liabilities ( 457 ) ( 7,362 ) Lease liabilities ( 528 ) — Other non-current liabilities 1 ( 1,025 ) Total adjustments 3,083 ( 7,369 ) Net cash provided by (used in) continuing operating activities 1,224 ( 12,093 ) Cash flows from financing activities: Proceeds from sale of common stock, net of costs — 1,150 Net cash provided by continuing financing activities — 1,150 Discontinued operations: Net cash used in operating activities ( 319 ) ( 25,752 ) Net cash provided by financing activities — 1,107 Net cash used in discontinued operations ( 319 ) ( 24,645 ) Net increase (decrease) in cash 905 ( 35,588 ) Cash and cash equivalents - continuing operations, beginning of period 4,327 49,317 Total cash and cash equivalents, end of period $ 5,232 $ 13,729 The accompanying notes are an integral part of these condensed consolidated financial statements. 4 TherapeuticsMD, Inc. and Subsidiaries Notes to the Condensed Consolidated Financial Statements (Unaudited) 1. Business, basis of presentation, new accounting standards and summary of significant accounting policies General TherapeuticsMD, Inc. (the “Company”), a Nevada corporation, and its condensed consolidated subsidiaries are referred to collectively in this Quarterly Report on Form 10-Q (“10-Q Report”) as “TherapeuticsMD,” “we,” “our” and “us.” This 10-Q Report includes trademarks, trade names and service marks, such as TherapeuticsMD®, vitaMedMD®, BocaGreenMD® , IMVEXXY®, and BIJUVA®, which are protected under applicable intellectual property laws and are the property of, or licensed by or to, us. Solely for convenience, trademarks, trade names and service marks referred to in this 10-Q Report may appear without the ®, TM or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties. TherapeuticsMD was previously a women’s healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause. In December 2022, we changed our business to become a pharmaceutical royalty company, currently receiving royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories. On December 30, 2022 (the “Closing Date”), we completed a transaction (the “Mayne Transaction”) with Mayne Pharma LLC, a Delaware limited liability company (“Mayne Pharma”) and subsidiary of Mayne Pharma Group Limited, an Australian public company, in which we and our subsidiaries (i) granted Mayne Pharma an exclusive license to commercialize our IMVEXXY, BIJUVA and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands (collectively, the “Licensed Products”) in the United States and its possessions and territories, (ii) assigned to Mayne Pharma our exclusive license to commercialize ANNOVERA® (together with the Licensed Products, collectively, the “Products”) in the United States and its possessions and territories, and (iii) sold certain other assets to Mayne Pharma in connection therewith. In a License Agreement, dated December 4, 2022, between TherapeuticsMD and Mayne Pharma (the “Mayne License Agreement”), we granted Mayne Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization in the United States and its possessions and territories. Under the Mayne License Agreement, Mayne Pharma will pay us milestone payments of each of (i) $ 5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 100.0 million, (ii) $ 10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 200.0 million and (iii) $ 15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 300.0 million. Further, Mayne Pharma will pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0 % on the first $ 80.0 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments, for a period of 20 years following the Closing Date. The royalty rate will decrease to 2.0 % on a Product-by-Product basis upon the earlier to occur of (i) the expiration or revocation of the last patent covering a Product and (ii) a generic version of a Product launching in the United States. Mayne Pharma will pay us minimal annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3 %, subject to certain further adjustments, including as described below. Upon the expiry of the 20 -year royalty term, the licenses granted to Mayne Pharma under the Mayne License Agreement will become a fully paid-up and royalty free license for the Licensed Products. 5 Under the Transaction Agreement, dated December 4, 2022, between TherapeuticsMD and Mayne Pharma (the “Transaction Agreement”), we sold to Mayne Pharma, at closing, certain assets for Mayne Pharma to commercialize the Products in the United States, including, with the Population Council’s consent, our exclusive license from the Population Council to commercialize ANNOVERA (the “Transferred Assets”). The total consideration from Mayne Pharma to TherapeuticsMD for the purchase of the Transferred Assets and the grant of the licenses under the Mayne Transaction Agreement was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition of net working capital as determined in accordance with the Transaction Agreement and subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million at closing for prepaid royalties in connection with the Mayne License Agreement Amendment (as defined below) and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended. The acquisition of net working capital was determined in accordance with the Transaction Agreement and included significant estimates which could change materially for a period of up to two years following the Closing Date. On the Closing Date, TherapeuticsMD and Mayne Pharma entered into Amendment No. 1 to the Mayne License Agreement (the “Mayne License Agreement Amendment”). Pursuant to the Mayne License Agreement Amendment, Mayne Pharma agreed to pay us approximately $ 1.0 million in prepaid royalties on the Closing Date. The prepaid royalties reduced the first four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $ 257 thousand per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such quarterly royalty payment was paid to us. We and Mayne Pharma settled the $ 1.5 million of consideration due to Mayne Pharma for the assumed obligations under a long-term services agreement, including our minimum payment obligations thereunder. As the parties agreed, during the second quarter of 2023 Mayne Pharma held back our royalty payment of $ 0.6 million and we funded an additional $ 0.9 million in August 2023 to settle the original $ 1.5 million payable. As part of the transformation that included the Mayne License Agreement, historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in our condensed consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in our condensed consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in Note 2 of our condensed consolidated financial statements. We also have license agreements with strategic partners to commercialize IMVEXXY and BIJUVA outside of the U.S. ● In July 2018, we entered into a license and supply agreement (the “Knight License Agreement”) with Knight Therapeutics Inc. (“Knight”) pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel. Knight obtained regulatory approval for IMVEXXY and BIJUVA and began commercialization efforts in 2024. ● In September 2019, we entered into an exclusive license and supply agreement (the “Theramex License Agreement”) with Theramex HQ UK Limited (“Theramex”) to commercialize IMVEXXY and BIJUVA outside of the U.S., excluding Canada and Israel. In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries. In connection with our transformation into a pharmaceutical royalty company, the termination of our executive management team (except for Mr. Marlan Walker, our former General Counsel and current Chief Executive Officer) and all other employees was completed by December 31, 2022. Severance obligations for all employees other than executive officers were paid in full in January 2023 and severance obligations for terminated executive officers have been paid in accordance with their employment agreements and separation agreements as previously disclosed. As of December 31, 2023 and June 30, 2024, we employed one full-time employee primarily engaged in an executive position. We have engaged external consultants who support our relationship with current partners and assist with certain financial, legal, and regulatory matters and the continued wind-down of our historical business operations. On August 15, 2023, we entered into a master services agreement with JZ Advisory Group, pursuant to which Joseph Ziegler would serve as our Principal Financial Officer. On August 17, 2023 Michael C. Donegan notified us of his decision to resign from the positions of Principal Financial and Accounting Officer of our Company effective as of August 17, 2023. Mr. Ziegler succeeded Mr. Donegan as Principal Financial and Accounting Officer as of the date of Mr. Donegan’s resignation. 6 Going concern Following the transaction with Mayne Pharma, our primary source of revenue is from royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories. We may need to raise additional capital to provide additional liquidity to fund our operations until we become cash flow positive. To address our capital needs, we may pursue various equity and debt financing and other alternatives. The equity financing alternatives may include the private placement of equity, equity-linked, or other similar instruments or obligations with one or more investors, lenders, or other institutional counterparties or an underwritten public equity or equity-linked securities offering. Our ability to sell equity securities may be limited by market conditions, including the market price of our common stock, and our available authorized shares. To the extent that we raise additional capital through the sale of such securities, the ownership interests of our existing stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. If we are not successful in obtaining additional financing, we could be forced to discontinue or curtail our business operations, sell assets at unfavorable prices, or merge, consolidate, or combine with a company with greater financial resources in a transaction that might be unfavorable to us. On May 1, 2023, we entered into a Subscription Agreement (the “Subscription Agreement”) with Rubric Capital Management LP (“Rubric”), pursuant to which we agreed to sell to Rubric, or one or more of its affiliates, up to an aggregate of 5,000,000 shares of our common stock, par value $ 0.001 per share (our “Common Stock”), from time to time during the term of the Subscription Agreement in separate draw-downs at our election. On June 29, 2023, we issued and sold 312,525 shares of Common Stock at a price per share equal to $ 3.6797 pursuant to the Subscription Agreement. We received gross proceeds of $ 1.15 million from the draw down, before expenses. On November 15, 2023, Rubric drew down an additional 877,192 shares of Common Stock at a price per share equal to $ 2.2761 . We received gross proceeds of $ 2.0 million from the drawdown, before expenses. In February 2024, the Company received Mayne Pharma’s calculation of allowance for payer rebates and wholesale distributor fees pursuant to the Transaction Agreement which differed significantly from the Company’s estimate of the allowances. The Company and Mayne Pharma intend to resolve this matter through the dispute resolution process outlined in the Transaction Agreement. The Company continues to believe its estimated allowances for payer rebates and wholesale distributor fees are reasonable. The outcome of this matter is uncertain at this point. As a result, the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees. As of June 30, 2024, the Company believes no additional accrual is required for amounts that may be owed for the allowance for returns under the Transaction Agreement. The Company has not recorded any contingent gains or receivables for any such allowances. Management continues to monitor the unresolved and pending net working capital items as changes to estimated amounts owed or amounts due from Mayne Pharma may be material. If Mayne Pharma’s sales of Licensed Products grow more slowly than expected or decline, if the net working capital settlement with Mayne Pharma under the Transaction Agreement is greater than our current estimates, if we are unsuccessful with future financings or the supply chains related to the third-party contract manufacturers are worse than we anticipate, our existing cash reserves may be insufficient to satisfy our liquidity requirements. The potential impact of these factors in conjunction with the uncertainty of the capital markets raises substantial doubt about our ability to continue as a going concern for the next twelve months from the issuance of these financial statements. The accompanying consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern. 7 Basis of presentation We prepared the condensed consolidated financial statements included in this 10-Q Report following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting principles generally accepted in the U.S. (“U.S. GAAP”) for complete financial statements can be condensed or omitted. However, except as disclosed herein, there has been no material change in the information disclosed in the notes included in our 2023 Annual Report on Form 10-K (the “2023 10-K Report”). As part of the transformation as a result of the Mayne Transaction, historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in the condensed consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the condensed consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in Note 2 of the condensed consolidated financial statements. Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these interim financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair presentation of the financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in this 10-Q Report should be read in conjunction with the consolidated financial statements and accompanying notes included in our 2023 10-K Report. Certain amounts in the consolidated financial statements and accompanying notes may not add due to rounding, and all percentages have been calculated using unrounded amounts. Certain prior period amounts have been reclassified to conform to current-period presentation. New accounting standards Adoption of new accounting standards In December 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-09, “Income Taxes (Topic 740) - Improvements to Income Tax Disclosures.” ASU 2023-09 enhances the transparency and decision usefulness of income tax disclosures by requiring consistent categories and greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. ASU 2023-09 will be effective for the Company in its income tax disclosure included in its 2025 Annual Report on Form 10-K and will be applied on a prospective basis. However, retrospective application is permitted. Early adoption is also permitted. The Company is evaluating the impact of ASU 2023-09 on the Company’s income tax disclosures and on its consolidated financial statements. Estimates and assumptions The preparation of our condensed consolidated financial statements in conformity with U.S. GAAP requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenue and expenses during the reporting periods. We evaluate our estimates and assumptions based on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ, at times in material amounts, from these estimates under different assumptions or conditions. 8 Significant accounting policies The significant accounting policies we use for quarterly financial reporting are disclosed in Note 1 of the notes to the consolidated financial statements included in our 2023 10-K report. 2. Discontinued Operations As discussed in Note 1, we changed our business in 2022 by licensing our products to receive royalties and future sales related milestone payments, after granting an exclusive license to commercialize our IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands in the United States and assigning our exclusive license to commercialize ANNOVERA to Mayne Pharma. This plan represented a strategic shift having a major effect on our operations and financial results. Upon our conversion from a commercial pharmaceutical company to a licensing only company with the consummation of the Mayne Transaction, we classified all direct revenues, costs and expenses related to commercial operations, within income (loss) from discontinued operations, net of tax, in the condensed consolidated statements of operations for all periods presented. We have not allocated any amounts for shared general and administrative operating support expense to discontinued operations. Additionally, the related assets and liabilities have been reported as assets and liabilities of discontinued operations in our condensed consolidated balance sheets as of June 30, 2024 and December 31, 2023. As described in Note 1, the acquisition of net working capital by Mayne Pharma was determined in accordance with the Transaction Agreement and included significant estimates which could change materially for a period of up to two years following the Closing Date. Our estimate of net working capital at closing was determined in accordance with the Transaction Agreement which establishes the process for the determination of final net working capital. Refer to Note 6 for a further discussion of net working capital contingencies. The following table presents results of discontinued operations (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 General and administrative expenses $ 105 $ — $ 160 $ 335 Total operating expenses 105 — 160 335 Operating loss from discontinued operations ( 105 ) — ( 160 ) ( 335 ) Other income (expense), net 65 — 195 ( 958 ) Total other income (expense), net 65 — 195 ( 958 ) (Loss) income from discontinued operations, net $ ( 40 ) $ — $ 35 $ ( 1,293 ) 9 The following table presents the carrying amounts of the classes of assets and liabilities of discontinued operations as of June 30, 2024 and December 31, 2023 (in thousands): June 30, 2024 December 31, 2023 Assets: Accounts receivable $ - $ 344 Liabilities: Accrued expenses and other current liabilities $ 2,996 $ 3,694 3. Prepaid and other current assets Our prepaid and other current assets consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands): June 30, 2024 December 31, 2023 Insurance $ 168 $ 253 Capitalized legal 2,334 2,334 Other 1,181 1,448 Prepaid and other current assets $ 3,683 $ 4,035 4. Licensed rights and other intangible assets The following provides information about our license rights and other intangible assets, net as of June 30, 2024 and December 31, 2023 (in thousands): June 30, 2024 December 31, 2023 Gross Carrying Amount Accumulated Amortization Net Gross Carrying Amount Accumulated Amortization Net Intangible assets subject to amortization: Hormone therapy drug patents $ 5,753 $ 1,862 $ 3,891 $ 6,818 $ 1,871 $ 4,947 Hormone therapy drug patents applied and pending approval 324 — 324 842 — 842 Intangible assets subject to amortization 6,077 1,862 4,215 7,660 1,871 5,789 Intangible assets not subject to amortization: Trademarks/trade name rights 309 — 309 309 — 309 License rights and other intangible assets, net $ 6,386 $ 1,862 $ 4,524 $ 7,969 $ 1,871 $ 6,098 We recorded, in continuing operations, amortization expense related to patents of $ 180 thousand and $ 19 thousand for the three months ended June 30, 2024 and 2023, respectively, and $ 313 thousand and $ 39 thousand for the six months ended June 30, 2024 and 2023, respectively. The Company conducts regular reviews of the individual patents and portfolios. As a result of this review, also based on input from its licensing partners, for the six months ended June 30, 2024, the Company determined it had an indicator of impairment, as it had abandoned the legal right and title to a portion of its granted patent portfolio and had ceased pursuit of a portion of its pending patents based on input from its licensing partners. The Company recognized an impairment loss of $ 1,261 thousand related to those abandoned patents and applications, which is classified as an impairment of long-lived assets on the Company’s consolidated statements of operations. 10 Our intangible assets subject to amortization are expected to be amortized as follows (in thousands): Year ending December 31, 2024 $ 192 2025 384 2026 384 2027 384 2028 384 Thereafter 2,163 Total $ 3,891 5. Accrued expenses and other current liabilities Other accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2024 December 31, 2023 Payroll and related costs $ 526 $ 762 Professional fees 270 489 Operating lease liabilities 1,589 1,473 Other accrued expenses and current liabilities 291 409 Accrued expenses and other current liabilities $ 2,676 $ 3,133 6. Commitments and contingencies Mayne Pharma Agreement Mayne Pharma paid us approximately $ 12.1 million at closing on December 30, 2022, for the acquisition of net working capital, subject to certain adjustments as determined in accordance with the Transaction Agreement. While the Transaction Agreement calls for much of the net working capital to be trued-up shortly after the Closing Date in 2023, for a period of one year following the Closing Date in the case of payer rebates and wholesale distributor fees and two years following the Closing Date in the case for allowance for returns, net working capital amounts will be adjusted to arrive at final net working capital under the Transaction Agreement. In September 2023, we increased certain accrual estimates including increasing our working capital adjustment accrual by $ 2.0 million for amounts anticipated to be owed under the Transaction Agreement. In December 2023, we made a $ 5.5 million payment to Mayne Pharma to settle certain working capital amounts that were required to be trued-up shortly after the Closing Date, excluding the allowance for returns, allowance for payer rebates, and allowance for wholesale distributor fees. Of the $ 5.5 million, $ 2.0 million increased the allowance for net working capital allowances remaining to be trued up. The Company’s estimate of the allowance for payer rebates and wholesale distributor fees was determined in accordance with the Transaction Agreement which establishes the process for the determination of net working capital. In February 2024, the Company received Mayne Pharma’s calculation of allowance for payer rebates and wholesale distributor fees which differed significantly from the Company’s estimate of the allowances. The Company and Mayne Pharma intend to resolve this matter through the dispute resolution process outlined in the Transaction Agreement. The Company believes its estimated allowances for payer rebates and wholesale distributor fees are reasonable. The timing and outcome of this matter is uncertain at this point. As a result, the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees. As of June 30, 2024, the Company believes no additional accrual is required for amounts that may be owed for the allowance for returns. The Company has not recorded any contingent gains or receivables for any such allowances. Management continues to monitor the unresolved and pending net working capital items as changes to estimated amounts owed or amounts due from Mayne Pharma that may be material. 11 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. The length of the stay of the IMVEXXY litigation is dependent on further action by Teva. We have incurred and recorded legal costs amounting to $ 2,334 thousand in prepaid expenses and other current assets as of June 30, 2024, for the IMVEXXY Paragraph IV legal proceeding since we believe that we will successfully prevail in this legal proceeding. Upon the successful conclusion of the legal proceeding, the related capitalized legal costs will be reclassified to patents, in license rights and other intangible assets, net, in the accompanying condensed consolidated balance sheets, and such costs will be amortized over the remaining useful life of the patents. If we are unsuccessful in this legal proceeding, then the related capitalized legal costs for this legal preceding and any unamortized IMVEXXY patent costs that were previously capitalized will be immediately expensed in the period in which we become aware of an unsuccessful legal proceeding. In June 2024, Mayne received a Paragraph IV certification notice letter (the “Sun Notice Letter”) regarding an ANDA submitted to the FDA by Sun Pharma Inc. (“Sun Pharma”). 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 Sun Notice Letter, Sun Pharma alleges that the IMVEXXY Patents are invalid, unenforceable, and/or will not be infringed by Sun Pharma’s commercial manufacture, use, or sale of its proposed generic drug product. The IMVEXXY Patents identified in the Sun Notice Letter expire in 2032 or 2033. In July 2024, we and Mayne Pharma filed a complaint for patent infringement against Sun Pharma in the United States District Court for the District of New Jersey arising from Sun Pharma’s ANDA filing with the FDA. We are seeking, among other relief, an order that the effective date of any FDA approval of Sun Pharma’s ANDA would be a date no earlier than the expiration of the IMVEXXY Patents and equitable relief enjoining Sun Pharma from infringing the IMVEXXY Patents. Beginning on December 30, 2022 and per the Mayne License Agreement, Mayne Pharma is responsible for all enforcement of our patents, including the responsibility for and costs of litigation discussed above with respect to Teva and Sun Pharma. From time to time, we are involved in other litigations and proceedings in the ordinary course of business. We are currently not involved in any other litigations and proceedings that we believe would have a material effect on our condensed consolidated financial condition, results of operations, or cash flows. Off-balance sheet arrangements As of June 30, 2024 and December 31, 2023 there were no off-balance sheet arrangements that have had or are reasonably likely to have current or future effects on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that we consider material. Employment agreements In connection with our transformation into a pharmaceutical royalty company, the termination of our executive management team (except for Mr. Marlan Walker, our former General Counsel and current Chief Executive Officer) and all other employees was completed by December 30, 2022. Severance obligations for all employees other than executive officers were paid in full in the first quarter of 2023. As of June 30, 2024, we employ one full-time employee primarily engaged in an executive position. We have engaged external consultants who support our relationship with current partners and assist with certain financial, legal, and regulatory matters and the continued wind-down of our historical business operations. In the aggregate, as of June 30, 2024, we have accrued severance liabilities for executive termination obligations of $ 112 thousand. 12 7. Stockholders’ equity Warrants As of June 30, 2024, the following table summarizes the status of our outstanding and exercisable warrants and related transactions since December 31, 2023 (in thousands, except weighted average exercise price and weighted average remaining contractual life data): Warrants Outstanding and exercisable Warrants Weighted Average Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (in Years) As of January 1, 2024 99 $ 66.61 $ — 6.5 Expired ( 2 ) 281.50 — — As of June 30, 2024 97 $ 63.33 $ — 6.1 Share-based compensation payment plans As of June 30, 2024, 106,799 shares of common stock were subject to outstanding awards under our share-based payment award plans and inducement grants (calculated using the base number of PSUs that may vest). As of June 30, 2024, 403,369 shares of common stock were available for future grants of share-based payment awards under the TherapeuticsMD, Inc. 2019 Stock Incentive Plan. The following table summarizes the status of our outstanding and exercisable options and related transactions since December 31, 2023 (in thousands, except weighted average exercise price and weighted average remaining contractual life data): Outstanding Exercisable Options Awards Weighted Average Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (in Years) Options Awards Weighted Average Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (in Years) As of January 1, 2024 72 $ 258.55 — 3.0 73 $ 258.46 — 3.0 Expired ( 9 ) 217.57 — — — — — — As of June 30, 2024 63 $ 264.14 — 2.9 64 $ 264.02 — 2.9 The following table summarizes the status of our RSUs and related transactions since December 31, 2023 (in thousands, except weighted average grant date fair value): RSUs awards outstanding RSUs Weighted Average Grant Date Fair Value Aggregate Intrinsic Value As of January 1, 2024 40 $ 9.67 89.60 Vested ( 2 ) 23.42 — As of June 30, 2024 38 $ 9.01 $ 60.73 The following table summarizes the status of our PSUs and related transactions since December 31, 2023 (in thousands, except weighted average grant date fair value): Outstanding PSUs (1) Weighted Average Grant Date Fair Value Aggregate Intrinsic Value Unvested, as of January 1, 2024 14 $ 50.87 $ 32.57 Vested ( 7 ) 60.50 16.16 Cancelled/Forfeited ( 2 ) 58.68 — Unvested, as of June 30, 2024 5 $ 34.50 $ 8.37 (1) The number of PSUs represents the base number of PSUs that may vest. 13 Share-based payment compensation cost Share-based payment compensation expense for PSUs is based on 100 % vesting which was a part of the termination benefits for all employees who were terminated in 2022. We recorded share-based payment award compensation costs related to previously issued options, RSU and PSUs, as well as shares of common stock issued under our employee stock purchase plan (“ESPP”) totaling $ 96 thousand and $ 437 thousand for the three months ended June 30, 2024 and 2023, respectively, and $ 207 thousand and $ 919 thousand for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had $ 81 thousand of unrecognized share-based payment award compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under our ESPP, which may be adjusted for future changes in forfeitures and is included as additional paid-in capital in the accompanying condensed consolidated balance sheets. No tax benefit was realized due to a continued pattern of net losses. The unrecognized compensation cost of $ 81 thousand is expected to be recognized as share-based payment award compensation over a weighted average period of 0.7 years. 8. Revenue Pursuant to the Mayne License Agreement, the Company granted Mayne Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization in the United States and its possessions and territories. Pursuant to the Mayne License Agreement, Mayne Pharma will make one-time, milestone payments to the Company of each of (i) $ 5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 100.0 million, (ii) $ 10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 200.0 million and (iii) $ 15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 300.0 million. Further, Mayne Pharma will pay to the Company royalties on net sales of all Products in the United States at a royalty rate of 8.0 % on the first $ 80 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments, for a period of 20 years following the Closing Date. The royalty rate will decrease to 2.0 % on a Product-by-Product basis upon the earlier to occur of (i) the expiration or revocation of the last patent covering a Product and (ii) a generic version of a Product launching in the United States. Mayne Pharma will pay to the Company minimal annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3 %, subject to certain further adjustments, including as described below. Upon the expiry of the 20 -year royalty term, the licenses granted to Mayne Pharma under the Mayne License Agreement will become a fully paid-up and royalty free license for the Licensed Products. 9. Income taxes We do not expect to pay any significant federal or state income taxes as a result of (i) the losses recorded during the three and six months ended June 30, 2024 and 2023, (ii) additional losses expected for the remainder of 2024 or losses recorded in 2023, or (iii) net operating losses carry forwards from prior years. We recorded a full valuation allowance of the net operating losses for the three and six months ended June 30, 2024 and 2023. Accordingly, there were no provisions for income taxes for the three and six months ended June 30, 2024 and 2023. Additionally, as of June 30, 2024 and December 31, 2023, we maintain a full valuation allowance for all deferred tax assets. 10. Income (Loss) per common share The following table sets forth the computation of basic and diluted (loss) per common share for the periods presented (in thousands, except per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Numerator: Loss from continuing operations, net of income taxes $ ( 1,050 ) $ ( 2,414 ) $ ( 1,859 ) $ ( 4,724 ) (Loss) income from discontinued operations, net of income taxes ( 40 ) — 35 ( 1,293 ) Net loss $ ( 1,090 ) $ ( 2,414 ) $ ( 1,824 ) $ ( 6,017 ) Denominator: Weighted average common shares for basic loss per common share 11,532 10,219 11,532 9,988 Effect of dilutive securities — — — — Weighted average common shares for diluted loss per common share 11,532 10,219 11,532 9,988 Loss per common share, continuing operations Basic $ ( 0.09 ) $ ( 0.24 ) $ ( 0.16 ) $ ( 0.47 ) Diluted $ ( 0.09 ) $ ( 0.24 ) $ ( 0.16 ) $ ( 0.47 ) Loss per common share, discontinued operations Basic $ — $ — $ — $ ( 0.13 ) Diluted $ — $ — $ — $ ( 0.13 ) 14 Since we reported a net loss from continuing operations for the three and six months ended June 30, 2024 and 2023, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities. Therefore, our basic and diluted loss per common share and our basic and diluted weighted average common shares are the same for the three and six months ended June 30, 2024 and 2023. The following table sets forth the outstanding securities as of the periods presented which were not included in the calculation of diluted earnings per common share during the respective three and six months ended June 30, 2024 and 2023 (in thousands): As of June 30, 2024 2023 Stock options 63 82 RSUs 38 124 PSUs 5 14 Warrants 97 99 203 319 11. Related parties On August 23, 2022, we appointed Mr. Justin Roberts as a director to fill a newly created vacancy on our Board of Directors. Mr. Roberts was elected to serve as a director at our combined 2022 and 2023 Annual Meeting held on June 26, 2023. Mr. Roberts will serve until our next Annual Meeting of Stockholders or until his successor is duly elected or appointed or his earlier death or resignation. As a director of our Company, Mr. Roberts is entitled to receive compensation in the same manner as our other non-employee directors, described in the section entitled “Director Compensation” in our Amendment No. 1 to Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission on April 29, 2024, but he has elected not to receive any compensation for his service as a non-employee director at this time. Mr. Roberts currently serves as a Partner of Rubric. On July 29, 2022, September 30, 2022, October 28, 2022, and May 1, 2023, we entered into subscription agreements with Rubric. On December 30, 2022, in accordance with the terms of the Certificate of Designation, we redeemed all 29,000 outstanding shares of Series A Preferred Stock previously issued to affiliates of Rubric at a purchase price of $ 1,333 per share and also paid certain affiliates of Rubric approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously entered into between us and Rubric. On June 29, 2023, we issued and sold 312,525 shares of Common Stock to Rubric at a price per share equal to $ 3.6797 pursuant to the Subscription Agreement and received gross proceeds of $ 1.15 million, before expenses. On November 15, 2023 Rubric drew down an additional 877,192 shares of Common Stock at a price per share equal to $ 2.2761 . We received gross proceeds of $ 2.0 million from the drawdown, before expenses. 12. Business concentrations TherapeuticsMD was previously a women’s healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause. In December 2022, we changed our business to become a pharmaceutical royalty company, currently receiving royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories. As part of the transformation that included the Mayne License Agreement, historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in our condensed consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in our condensed consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in Note 2. For the three and six months ended June 30, 2024, 100 % of license revenue related to Mayne Pharma, Theramex and Knight. As of June 30, 2024, we had a royalty receivable of $ 2,908 thousand relating to the short-term portion of receivable from Mayne Pharma, Theramex and Knight and $ 17,224 thousand relating to the long-term portion of royalty receivable which includes royalties recognized from the minimum annual royalty that Mayne Pharma is obligated to pay to us under the Mayne License Agreement. 15