Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 27, 2024 | Jun. 30, 2023 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Interactive Data Current | Yes | ||
ICFR Auditor Attestation Flag | false | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Documents Incorporated by Reference [Text Block] | Part III (Items 10, 11, 12, 13 and 14) of this annual report on Form 10-K is incorporated by reference from the definitive Proxy Statement for the 2024 Annual Meeting of Stockholders or an amendment to this annual report on Form 10-K to be filed with the Securities and Exchange Commission no later than 120 days after the end of the registrant’s fiscal year covered by this report. | ||
Entity Information [Line Items] | |||
Entity Registrant Name | THERAPEUTICSMD, INC. | ||
Entity Central Index Key | 0000025743 | ||
Entity File Number | 001-00100 | ||
Entity Tax Identification Number | 87-0233535 | ||
Entity Incorporation, State or Country Code | NV | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Shell Company | false | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Public Float | $ 34,439,072 | ||
Entity Contact Personnel [Line Items] | |||
Entity Address, Address Line One | 951 Yamato Road | ||
Entity Address, Address Line Two | Suite 220 | ||
Entity Address, City or Town | Boca Raton | ||
Entity Address, State or Province | FL | ||
Entity Address, Postal Zip Code | 33431 | ||
Entity Phone Fax Numbers [Line Items] | |||
City Area Code | 561 | ||
Local Phone Number | 961-1900 | ||
Entity Listings [Line Items] | |||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | TXMD | ||
Security Exchange Name | NASDAQ | ||
Entity Common Stock, Shares Outstanding | 11,532,443 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Auditor [Table] | |
Auditor Name | GRANT THORNTON LLP |
Auditor Firm ID | 248 |
Auditor Location | Miami, Florida |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Cash and cash equivalents | $ 4,327 | $ 38,067 |
Restricted cash | 11,250 | |
Royalty receivable, current portion | 3,090 | |
Prepaid and other current assets | 4,035 | 6,034 |
Current assets of discontinued operations | 344 | |
Total current assets | 11,796 | 55,351 |
Fixed assets, net | 78 | |
License rights and other intangible assets, net | 6,098 | 6,943 |
Royalty receivable, long term | 18,484 | 20,253 |
Other non-current assets | 58 | 253 |
Right of use assets | 6,873 | 7,580 |
Total assets | 43,309 | 90,458 |
Accounts payable | 27 | 2,162 |
Accrued expenses and other current liabilities | 3,133 | 18,846 |
Current liabilities of discontinued operations | 3,694 | 25,831 |
Total current liabilities | 6,854 | 46,839 |
Operating lease liabilities, non-current | 6,532 | 7,369 |
Other non-current liabilities | 636 | 1,107 |
Total liabilities | 14,022 | 55,315 |
Commitments and contingencies (Note 8) | ||
Common stock, par value $0.001; 32,000 and 12,000 shares authorized, 11,532 and 9,498 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively | 11 | 9 |
Additional paid-in capital | 978,917 | 974,497 |
Accumulated deficit | (949,641) | (939,363) |
Total stockholders’ equity | 29,287 | 35,143 |
Total liabilities and stockholders’ equity | $ 43,309 | $ 90,458 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common Stock, Par or Stated Value Per Share | $ / shares (in Dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 32,000,000 | 12,000,000 |
Common Stock, Shares, Issued | 11,532,000 | 9,498,000 |
Common Stock, Shares, Outstanding | 11,532,000 | 9,498,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue, net: | ||
Total revenue, net | $ 1,302 | $ 69,963 |
Cost of revenue | 1,397 | |
Gross profit | 1,302 | 68,566 |
Operating expenses: | ||
Selling, general and administrative | 8,903 | 56,710 |
Depreciation & amortization | 922 | 1,193 |
Restructuring | 9,472 | |
Total operating expenses | 9,825 | 67,375 |
Income (loss) from operations | (8,523) | 1,191 |
Other income (expense): | ||
Miscellaneous income (expense) | 781 | (117) |
Total other income (loss), net | 781 | (117) |
Income (loss) from continuing operations before income taxes | (7,742) | 1,074 |
Benefit (provision) for income taxes | 43 | |
Net income (loss) from continuing operations | (7,699) | 1,074 |
Income (loss) from discontinued operations, net of income taxes | (2,579) | 110,923 |
Net income (loss) | $ (10,278) | $ 111,997 |
Income (loss) per common share, basic: | ||
Continuing operations (in Dollars per share) | $ (0.74) | $ 0.12 |
Discontinued operations, net (in Dollars per share) | (0.25) | 12.29 |
Net income (loss) per common share, basic (in Dollars per share) | (0.98) | 12.41 |
Income (loss) per common share, diluted: | ||
Continuing operations (in Dollars per share) | (0.74) | 0.11 |
Discontinued operations, net (in Dollars per share) | (0.25) | 11.84 |
Net income (loss) per common share, diluted (in Dollars per share) | $ (0.98) | $ 11.96 |
Weighted average common shares, basic (in Shares) | 10,441 | 9,028 |
Weighted average common shares, diluted (in Shares) | 10,441 | 9,366 |
Net income (loss) | $ (10,278) | $ 111,997 |
Other comprehensive income | ||
Comprehensive income (loss): | (10,278) | 111,997 |
License and service revenue | ||
Revenue, net: | ||
Total revenue, net | $ 1,302 | $ 69,963 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders’ (Deficit) Equity - USD ($) $ in Thousands | Common Stock | Additional Paid in Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2021 | $ 9 | $ 957,730 | $ (1,051,360) | $ (93,621) |
Balance (in Shares) at Dec. 31, 2021 | 8,597,000 | |||
Shares issued for sale of common stock, net of cost | 2,454 | 2,454 | ||
Shares issued for sale of common stock, net of cost (in Shares) | 565,000 | |||
Lender warrants | 2,727 | 2,727 | ||
Rounding for fractional shares in connection with the reverse stock split | ||||
Rounding for fractional shares in connection with the reverse stock split (in Shares) | 142,000 | |||
Shares issued for vested restricted and performance stock units | ||||
Shares issued for vested restricted and performance stock units (in Shares) | 189,000 | |||
Shares issued for sale of common stock related to employee stock purchase plan | 14 | 14 | ||
Shares issued for sale of common stock related to employee stock purchase plan (in Shares) | 5,000 | |||
Share-based payment award compensation costs | 11,572 | 11,572 | ||
Net income (loss) | 111,997 | 111,997 | ||
Balance at Dec. 31, 2022 | $ 9 | 974,497 | (939,363) | 35,143 |
Balance (in Shares) at Dec. 31, 2022 | 9,498,000 | |||
Shares issued for vested restricted stock units | $ 1 | 1 | ||
Shares issued for vested restricted stock units (in Shares) | 844,000 | |||
Share-based compensation | 1,271 | 1,271 | ||
Shares issued for sale of common stock related to private placement sale | $ 1 | 3,149 | 3,150 | |
Shares issued for sale of common stock related to private placement sale (in Shares) | 1,190,000 | |||
Net income (loss) | (10,278) | (10,278) | ||
Balance at Dec. 31, 2023 | $ 11 | $ 978,917 | $ (949,641) | $ 29,287 |
Balance (in Shares) at Dec. 31, 2023 | 11,532,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Statement of Cash Flows [Abstract] | ||
Net income (loss) | $ (10,278) | $ 111,997 |
Less: Income (loss) from discontinued operations, net of tax | (2,579) | 110,923 |
Net income (loss) from continuing operations | (7,699) | 1,074 |
Adjustments to reconcile net income (loss) to net cash provided by (used in) continuing operating activities: | ||
Depreciation and amortization | 922 | 1,193 |
Share-based payment compensation costs | 1,271 | 11,572 |
Make-whole payment accretion | (354) | |
Other | (129) | (40) |
Changes in operating assets and liabilities: | ||
Prepaid and other current assets | 1,999 | 620 |
Other assets | (1,126) | (7,636) |
Accounts payable | (2,135) | (1,211) |
Accrued expenses and other current liabilities | (15,713) | 4,262 |
Other non-current liabilities | (471) | (121) |
Total adjustments | (15,382) | 8,285 |
Net cash provided by (used in) continuing operating activities | (23,081) | 9,359 |
Cash flows from continuing investing activities: | ||
Receipts (payment) for patents | (355) | |
Net cash used in continuing investing activities | (355) | |
Cash flows from continuing financing activities: | ||
Proceeds from sale of common stock, net of costs | 3,151 | 2,454 |
Proceeds from sale of common stock related to employee stock purchase plan | 14 | |
Repayments of debt | (219,432) | |
Proceeds from Series A Preferred Stock, net of transaction costs | 21,684 | |
Repurchase of Preferred Stock at liquidation preference | (38,657) | |
Proceeds from make-whole derivative | 3,322 | |
Repayment of make-whole derivative | (2,969) | |
Payment of debt financing fees | (1,622) | |
Net cash provided by (used in) continuing financing activities | 3,151 | (235,206) |
Discontinued operations: | ||
Net cash used in operating activities | (25,060) | (13,437) |
Net cash provided by investing activities | 0 | 223,834 |
Net cash provided by financing activities | 0 | 0 |
Net cash provided by (used in) discontinued operations | (25,060) | 210,397 |
Net decrease in cash | (44,990) | (15,805) |
Cash and restricted cash - continuing operations, beginning of period | 49,317 | 64,907 |
Cash and restricted cash - discontinued operations, beginning of period | 215 | |
Total cash and restricted cash, end of period | 4,327 | 49,317 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 13,545 | |
Supplemental disclosure of noncash financing activities: | ||
Warrants issued in relation to debt financing agreement | $ 2,727 |
Business, Basis of Presentation
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Abstract] | |
Business, basis of presentation, new accounting standards and summary of significant accounting policies | 1. Business, basis of presentation, new accounting standards and summary of significant accounting policies General TherapeuticsMD, Inc. (the “Company”), a Nevada corporation, and its consolidated subsidiaries are referred to collectively in this Annual Report on Form 10-K (“2023 10-K Report”) as “TherapeuticsMD,” “we,” “our” and “us.” This 2023 10-K Report includes trademarks, trade names and service marks, such as TherapeuticsMD ® ® ® ® ® ® 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 ® 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 one-time 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 minimum 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. 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 under the Transaction Agreement and the grant of the licenses under the Mayne License 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 for the assumed obligations under a long-term services agreement (see the section entitled “vitaCare Divestiture” below for a discussion of the long-term services agreement), including our minimum payment obligations thereunder. As the parties agreed, during the second quarter of 2023, Mayne Parma 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 consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in our consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in Note 2. 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. ● 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 were paid in accordance with their employment agreements and separation agreements as previously disclosed. As of December 31, 2022 and 2023, 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 and Accounting 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. vitaCare Divestiture On April 14, 2022, we completed the divestiture of our former subsidiary vitaCare Prescription Services, Inc. (“vitaCare”) with the sale of all of vitaCare’s issued and outstanding capital stock (the “vitaCare Divestiture”). We received net proceeds of $142.6 million, after deducting transaction costs of $7.2 million, and we recognized a gain on sale of business of $143.4 million. Included in the net proceeds amount was $11.3 million of customary holdbacks as provided in the stock purchase agreement (the “Purchase Agreement”) which we received in 2023. Additionally, the Purchase Agreement provides that we may receive up to an additional $7.0 million in earn-out consideration, contingent upon vitaCare’s financial performance through 2023 as determined in accordance with the terms of the Purchase Agreement; however, we do not believe this earnout will be realized. We will record the contingent consideration at the settlement amount if and when the consideration is realized or realizable. The Purchase Agreement contains customary representations and warranties, covenants, and indemnities of the parties thereto. The commitments under a long-term services agreement related to vitaCare were transferred to Mayne Pharma as part of the Mayne Transaction. The divestiture of vitaCare was determined to be a component of discontinued operations in December 2022, when we changed our business by becoming a royalty company and as a result vitaCare activities were reclassified to discontinued operations for 2023 and 2022. Going concern On December 4, 2022, we entered into agreements with Mayne Pharma pursuant to which we granted Mayne Pharma an exclusive license to commercialize IMVEXXY, BIJUVA, and prescription prenatal vitamin products (in the United States and its possessions and territories), (ii) assign to Mayne Pharma our exclusive license to commercialize ANNOVERA in the United States and its possessions and territories, and (iii) sell certain other assets to Mayne Pharma. The total consideration from Mayne Pharma to the TherapeuticsMD for the purchase of the Transferred Assets under the Transaction Agreement and the grant of the licenses under the Mayne License Agreement consisted of (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 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 and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended. On the Closing Date, we repaid all obligations under the Financing Agreement, dated as of April 24, 2019, as amended, with Sixth Street Specialty Lending, Inc., as administrative agent, the various lenders from time-to-time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors (the “Financing Agreement”) and the Financing Agreement was terminated. 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 1,000,000 shares of Common Stock at a price per share equal to $2.28. 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 which differed significantly from the Company’s estimate of the allowances. The Company believes its estimated allowances for payer rebates and wholesale distributor fees are reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement. Given the recent receipt of Mayne Pharma’s allowance calculation and the nature of the estimates involved, 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 December 31, 2023, 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 that may be material. If Mayne Pharma’s sales of IMVEXXY, BIJUVA, or ANNOVERA 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 if 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. A. Basis of presentation The consolidated financial statements and related notes include our parent company and all wholly owned subsidiaries. The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the Unites States of America (“U.S. GAAP”). Our fiscal year-end is as of and for the year ended December 31st for each year presented. All intercompany transactions among our businesses have been eliminated. As part of the transformation and as a result of the vitaCare divestiture and the Mayne Transaction, historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in the consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the consolidated balance sheet. Additional disclosures regarding discontinued operations are provided in Note 2 of these consolidated financial statements. Certain amounts in the notes to the consolidated financial statements may not add due to rounding. Certain prior period amounts have been reclassified to conform to current-period presentation. B. 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. C. Discontinued Operations Discontinued operations comprise activities that were disposed of at the end of the period, represent a separate major line of business that can be clearly distinguished for operational and financial reporting purposes and represent a business shift having a major effect on the Company’s operations and financial results according to Accounting Standard Codification (“ASC”) Topic 205, Presentation of Financial Statements. An adjustment has been made to the consolidated statements of operations for the twelve months ended December 31, 2023 and 2022 to reclassify commercial activities and vitaCare activities to discontinued operations as both components, in the aggregate, represented a business shift that will have a major effect on the Company’s operations and financial results. No amounts for shared general and administrative operating support expense were allocated to discontinued operations. As required by the terms of the Financing Agreement, the proceeds from both transactions were used to fully repay our outstanding debt borrowings. As a result, interest expense and amortization of deferred financing costs as well as expense for accretion of Series A Preferred Stock and loss on extinguishment of debt are included within income (loss) from discontinued operations, net of tax. Additionally, the related assets and liabilities have been reported as assets and liabilities of discontinued operations in the Company’s consolidated balance sheet as of December 31, 2023 and 2022. For additional information, see Note 2 - Discontinued Operations. D. Estimates and assumptions The preparation of consolidated financial statements in conformity to 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 financial statements and the reported amounts of revenue and expenses during the reporting period. We evaluate our estimated 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. E. Cash and Restricted Cash For the purpose of the statements of cash flows, all highly liquid investments with an original maturity of three months or less are considered to be cash equivalents. The carrying value of these investments approximates fair value. We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $0.25 million per bank. We have never experienced any losses related to these funds. Restricted cash was comprised of escrowed funds deposited with a bank relating to the vitaCare Divestiture. All restrictions were lifted in March 2023. F. Fair Value Measurements Fair value is the price to sell an asset or transfer a liability and therefore represents an exit price in the principal market (or in the absence of a principal market, the most advantageous market). It represents a market-based measurement that contemplates a hypothetical transaction between market participants at the measurement date. The unique characteristics of an asset or liability and the availability of observable prices affect the number of valuation approaches and/or techniques used in a fair value analysis. We measure fair value using observable and unobservable inputs. We give the highest priority to quoted prices (unadjusted) in active markets for identical assets or liabilities (Level 1 inputs) and the lowest priority to unobservable inputs (Level 3 inputs). We apply the following fair value hierarchy: ● Level 1 - Quoted prices (unadjusted) in active markets for identical assets and liabilities. ● Level 2 - Quoted prices in non-active markets or in active markets for similar assets or liabilities, observable inputs other than quoted prices; and inputs that are not directly observable but are corroborated by observable market data. ● Level 3 - Inputs that are unobservable. The carrying amount of our cash, restricted cash, accounts receivable, accounts payable and accrued expenses approximate their fair value because of the short-term maturity of such instruments, which are considered Level 1 under the fair value hierarchy. G. Fixed assets Fixed assets are carried at cost less accumulated depreciation and amortization. We charge maintenance costs, which do not significantly extend the useful lives of the respective assets, and repair costs to operating expenses as incurred. We compute depreciation using the straight-line method over the estimated useful lives of the related assets, which range from three to seven years. Leasehold improvements are depreciated over the shorter of their useful life or the term of the lease. Long-lived assets held and used by us, including fixed assets, are assessed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. We capitalize software and software development costs incurred to create and acquire computer software for internal use, principally related to software coding and application development. We begin to capitalize software development costs when both the preliminary project stage is completed, and it is probable that the software will be used as intended. Capitalized software costs include only external direct costs and services utilized in developing or obtaining computer software. Capitalized software costs are amortized on a straight-line basis when placed into service over the estimated useful life, generally five to seven years. H. License rights and other intangibles assets We record license rights and other intangible assets at cost, which includes external costs, consisting primary of legal costs, incurred in securing our patents and trademarks. License rights costs related to ANNOVERA were amortized until December 30, 2022 over the useful life over which the license rights would contribute directly or indirectly to our cash flows. The cost was amortized using the straight-line method as the pattern of economic benefit could not be reliably determined. On December 30, 2022, we assigned our ANNOVERA license to Mayne Pharma and included the remaining ANNOVERA license cost of $30.2 million in our calculation of the gain on sale of assets. In addition, amortization of license rights of $3.0 million for 2022 was reclassified to discontinued operations. Intangible assets subject to amortization, such as patents, are amortized over the useful life of the patent using the straight-line method. If the patent is not granted, we write off any capitalized patent costs at that time. Intangible assets not subject to amortization, such as trademarks, are perpetual and have indefinite lives. We review license rights and other intangible assets subject to amortization on a periodic basis to determine whether events and circumstances would indicate impairment or warrant a revision to their remaining useful lives. We assess other intangible assets not subject to amortization for potential impairment at least annually during the fourth quarter of each year, or more frequently if events occur or circumstances change that would more likely than not reduce the fair value of the intangible assets below their carrying value. I. Segment reporting We manage and operate as one business, which prior to December 2022 was focused on creating and commercializing products targeted exclusively for women and after we signed Mayne License Agreement, is focused on collecting royalties from licensing our products. Our business is led by our chief executive officer. We do not operate separate lines of business with respect to any of our products, and we do not prepare discrete financial information with respect to separate products. Accordingly, we view our business as one reportable operating segment. J. Revenue recognition We determine the amount of revenue to be recognized through application of the following steps: ● Identification of the contract with a customer; ● Identification of the performance obligations in the contract; ● Determination of the transaction price; ● Allocation of the transaction price to the performance obligations in the contract; and ● Recognition of revenue when or as we satisfy the performance obligations. A performance obligation is a promise in a contract to transfer a product or service to a customer. A good or service is considered to be transferred when the customer receives the goods or service or obtains control, and we treat shipping as a fulfillment activity rather than as a separate obligation. We generally recognize revenue at a point in time when all of our performance obligations under the terms of a contract are satisfied. Revenue is recognized upon transfer of control of promised products or services in an amount that reflects the consideration we expect to receive in exchange for those products or services. The collectability of consideration on the contract is reasonably assured before revenue is recognized. To the extent that customer payment has been received before all recognition criteria are met, these revenues are initially deferred in other accruals on the balance sheet and the revenue is recognized in the period that all recognition criteria have been met. License revenue License arrangements may consist of non-refundable upfront license fees, exclusive licensed rights to patented or patent pending technology, and various performance or sales milestones and future product royalty payments. Some of these arrangements may include multiple performance obligations. Non-refundable up-front fees that are not contingent on any future performance by us, and do not require continuing involvement on our part, are recognized as revenue when the right to use functional intellectual property is transferred to the customer. On December 30, 2022, we granted an exclusive license to commercialize our prescription products and assigning the Company’s exclusive license to commercialize ANNOVERA to Mayne Pharma, which resulted in a business shift that had a major effect on our operations and financial results. As part of the transformation that included the Mayne License Agreement, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date. As of December 31, 2022, we are no longer directly engaged in the sale of prescription products. Under the terms of the Mayne License Agreement, we received $140 million at closing and we are eligible to receive additional payments in the aggregate of up to an additional $30 million, based on the achievement of sales milestones (collectively, the “Milestone Amounts”). The proceeds at closing were allocated between consideration for the sale of ANNOVERA and the initial license fee for the Licensed Products, as the sale of ANNOVERA was accounted for under ASC 610-20, Gains and Losses from Derecognition of Nonfinancial Assets in arriving at the gain on disposal (see Note 2), while the license grant of the other products were recognized under the provisions of ASC 606, Revenue from Contracts with Customers, as a license of functional intellectual property. The proceeds were allocated among the Licensed Products on the relative net present value of forecasted future product sales from those products. The Milestone Amounts will be recognized, as applicable, in subsequent periods based on actual product sales that exceed the respective net sales milestones as such variable consideration is constrained by the occurrence of the subsequent sales. Our royalty revenue in 2023 primarily related to royalties provided for under the Mayne License Agreement based on Mayne Pharma’s sales of the licensed products subject to that agreement. Under the Mayne License Agreement, the Company is entitled to earn royalties on net sales of all of the Licensed Products at a royalty rate of (i) 8% on the first $80 million of net sales of the Licensed Products and (ii) 7.5% on net sales of all of the Licensed Products after the first $80 million of net sales. The royalty rate is subject to a 2% reduction upon the earlier to occur of (i) the expiration or revocation of the last valid claim covering a Licensed Product, and (ii) a generic product launch (a “LOE”). We are entitled to minimum annual royalties beginning with the year ending December 31, 2023 ($3 million annual minimum) and continuing with 3% annual increases through the year ending December 31, 2034 (the “Minimum Annual Royalty”). The total Minimum Annual Royalty we are entitled to is $42.6 million, and this total amount was allocated among the Licensed Products on the relative net present value of forecasted future product sales from those products. The portion allocated to consideration for the sale of ANNOVERA was attributed towards the gain on disposal of that asset. For the remaining portion allocated to the license grants for the other products, we determined that the minimum guarantee underlying the Minimum Annual Royalty should be treated as fixed consideration and recognized under ASC 606 at the point in time when the license was transferred. Since the Minimum Annual Royalty will be received in annual installments through 2034, we determined the transaction price allocated under ASC 606 contained a significant financing component, and we therefore determined the initial royalty revenue and corresponding receivable based on the present value of the allocated Minimum Annual Royalty. The present value was calculated using a discount rate of 10.45%, based on the credit characteristics of Mayne Pharma and the timing of future payments, and the value will be accreted to full value through the earlier of January 1, 2034 or a LOE. This royalty receivable is a contract asset as of December 31, 2022 and 2023, and is further subject to offset by Mayne Pharma (see L. Contract Assets and Liabilities below). Royalty revenue earned in excess of the Minimum Annual Royalty will be recognized under ASC 606, which pr |
Discontinued Operations
Discontinued Operations | 12 Months Ended |
Dec. 31, 2023 | |
Discontinued Operations [Abstract] | |
Discontinued Operations | 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 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. As required by the terms of the Financing Agreement, proceeds from the Mayne Transaction and the vitaCare Divestiture were used to fully repay our outstanding debt borrowings, and as a result interest expense and amortization of deferred financing costs as well as expense for accretion of Series A Preferred Stock and loss on extinguishment of debt are included within income (loss) from discontinued operations, net of tax (as disclosed below). Additionally, the related assets and liabilities have been reported as assets and liabilities of discontinued operations in our consolidated balance sheet as of December 31, 2023 and 2022. The total consideration from Mayne Pharma consisted of (i) a cash payment of $140.0 million at closing, (ii) a cash payment of $12.1 million for the acquisition of net working capital subject to certain adjustments, (iii) a cash payment of approximately $1.0 million for prepaid royalties in connection with the Mayne License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended. 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. The determination of final net working capital includes significant estimates which could change materially for a period of up to two years following the Closing Date. The following table presents results of discontinued operations (in thousands): Years ended December 31, 2023 2022 Product revenue, net $ (833 ) $ 80,749 Cost of goods sold — 15,640 Gross profit (loss) (833 ) 65,109 Operating expenses: Selling and marketing — 75,208 General and administrative 481 11,301 Research and development — 4,942 Restructuring charges — 6,180 Total operating expenses 481 97,631 Loss from discontinued operations (1,314 ) (32,522 ) Other income (expense): Gain on sale of vitaCare — 143,384 Gain on ANNOVERA sale — 62,031 Loss on the extinguishment of debt — (8,380 ) Interest expense and other financing costs — (36,065 ) Expense for accretion of Series A Preferred Stock — (16,973 ) Loss on disposal of assets (1,150 ) — Other expense, net (115 ) — Total other income (expense), net (1,265 ) 143,997 Loss before from income taxes (2,579 ) 111,475 Benefit (provision) for income taxes — (552 ) Net income (loss) from discontinued operations $ (2,579 ) $ 110,923 The following table presents the carrying amounts of the classes of assets and liabilities of discontinued operations (in thousands): As of December 31, 2023 2022 Assets: Current assets: Accounts receivable $ 344 $ — Total assets 344 — Current liabilities: Accounts payable $ — $ 12,243 Accrued expenses and other current liabilities 3,694 13,588 Total liabilities $ 3,694 $ 25,831 |
Prepaid and Other Current Asset
Prepaid and Other Current Assets | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid and Other Current Assets [Abstract] | |
Prepaid and other current assets | 3. Prepaid and other current assets Our prepaid and other current assets consisted of the following (in thousands): December 31, 2023 2022 Insurance $ 253 $ 1,167 Capitalized legal 2,334 2,334 Other 1,448 2,533 Prepaid and other current assets $ 4,035 $ 6,034 |
Fixed Assets
Fixed Assets | 12 Months Ended |
Dec. 31, 2023 | |
Fixed Assets [Abstract] | |
Fixed assets | 4. Fixed assets Our fixed assets, net consisted of the following (in thousands): December 31, 2023 2022 Furniture and fixtures $ 931 $ 931 Computer and office equipment 1,167 1,168 Computer software 375 375 Leasehold improvements 49 49 Fixed assets 2,522 2,523 Less: accumulated depreciation and amortization 2,522 2,445 Fixed assets, net $ — $ 78 We recorded in continuing operations, depreciation expense of $0.1 million for 2023 and $0.6 million for 2022. |
Licensed Rights and Other Intan
Licensed Rights and Other Intangible Assets | 12 Months Ended |
Dec. 31, 2023 | |
Licensed Rights and Other Intangible Assets [Abstract] | |
Licensed rights and other intangible assets | 5. Licensed rights and other intangible assets The following provides information about our license rights and other intangible assets, net (in thousands): As of December 31, 2023 As of December 31, 2022 Gross Gross Carrying Accumulated Carrying Accumulated Amount Amortization Net Amount Amortization Net Intangible assets subject to amortization: Hormone therapy drug patents $ 6,818 $ 1,871 $ 4,947 $ 6,225 $ 1,598 $ 4,627 Hormone therapy drug patents applied and pending approval 842 — 842 1,995 — 1,995 Intangible assets subject to amortization 7,660 1,871 5,789 8,220 1,598 6,622 Intangible assets not subject to amortization: Trademarks/trade name rights 309 — 309 321 — 321 Intangible assets, net $ 7,969 $ 1,871 $ 6,098 $ 8,541 $ 1,598 $ 6,943 We recorded, in continuing operations, amortization expense related to patents of $0.8 million for 2023, of which $0.5 million is accelerated amortization as a result of a review of our intangible assets, and $0.6 million for 2022. We recorded amortization expense related to the exclusive license rights agreement with Population Council of $3.0 million for 2022, which was reclassified to discontinued operations after we completed transaction with Mayne Pharma in December 2022, and excluded from the table above. Our intangible assets subject to amortization are expected to be amortized as follows (in thousands): Year ending December 31, 2024 533 2025 445 2026 445 2027 445 2028 445 Thereafter 5,347 Total $ 7,660 We use a combination of qualitative and quantitative factors to assess licensed rights and intangible assets for impairment. In the year ending December 31, 2023, we have not impaired any of our hormone therapy drug patent assets. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Expenses and Other Current Liabilities [Abstract] | |
Accrued expenses and other current liabilities | 6. Accrued expenses and other current liabilities Other accrued expenses and other current liabilities consisted of the following (in thousands): As of December 31, 2023 2022 Payroll and related costs $ 762 $ 8,748 Accrued contract termination costs — 4,700 Research and development expenses — 978 Professional fees 489 415 Operating lease liabilities 1,473 1,390 Prepaid royalty — 1,011 Other accrued expenses and current liabilities 409 1,604 Accrued expenses and other current liabilities $ 3,133 $ 18,846 We expense advertising costs when incurred, which amounted to $13.2 million for 2022, which was reclassified to discontinued operations as a result of our business shift following the Mayne Transaction. We incurred no advertising costs in 2023. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2023 | |
Debt [Abstract] | |
Debt | 7. Debt Financing agreement We were party to the Financing Agreement with Sixth Street Specialty Lending, Inc., as administrative agent, various lenders from time-to-time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors. On December 30, 2022, we repaid all obligations under the Financing Agreement and the Financing Agreement was terminated. Interest and financing costs Included in miscellaneous income in 2023 is $0.3 million of interest income and $0.2 million of interest expense. In 2022 and recorded in discontinued operations, we recognized $13.5 million of debt-related interest expense and $22.5 million of financing fees amortization. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies [Abstract] | |
Commitments and contingencies | 8. Commitments and contingencies Leases In October 2018, we entered into a lease for executive, administrative, operations and sales offices in Boca Raton, Florida. The lease includes 62,748 rentable square feet, or the full premises, of which the lease on 7,561 square feet commenced in 2018 and the lease on 48,651 square feet commenced in August 2019, or the full premises commencement date. In June 2019, we entered into an agreement with the same lessors to lease 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. As a result of shifting our business to become a license company and terminating our employees, we have sublet the majority of our headquarters and are in the process of subleasing the remainder. We anticipate that sublease income will approximate the amounts due under our existing leases, therefore no impairment of the right of use asset was recorded in 2023. For 2023 and 2022, operating lease expense As of December 31, 2023, our remaining lease payments were as follows (in thousands): Year ending December 31, 2024 1,477 2025 1,513 2026 1,551 2027 1,590 2028 1,630 Thereafter 2,664 Total undiscounted lease payments 10,425 Less: imputed interest 2,420 Present value of lease payments $ 8,005 The following table sets forth supplemental balance sheet information related to leases (in thousands): As of December 31, 2023 2022 Assets: Operating lease right-of-use assets $ 6,873 $ 7,580 Liabilities: Operating lease liabilities current (included in accrued expenses and other current liabilities) $ 1,473 $ 1,390 Operating lease liabilities, non-current $ 6,532 7,369 Total operating lease liabilities $ 8,005 $ 8,759 The following table presents other information related to leases: As of December 31, 2023 2022 Weighted average remaining term (years) - operating leases 6.7 7.7 Weighted average discount rate - operating leases 8.3 % 8.3 % Cash paid for amounts included in the measurement of lease liabilities from operating lease (in thousands) $ 1,443 $ 1,413 Right-of-use assets obtained in exchange for new operating lease obligations (non-cash in thousands) $ — $ — 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 revised certain accrual estimates including increasing our working capital adjustment accrual from $3.5 million to $5.5 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. 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 believes its estimated allowances for payer rebates and wholesale distributor fees are reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement. Given the recent receipt of Mayne Pharma’s allowance calculation and the nature of the estimates involved, 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. Additionally and as of December 31, 2023, 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. Population Council License Agreement Under the terms of our license agreement with the Population Council, Inc. (the “Population Council License Agreement”), we paid the Population Council a milestone payment of $20.0 million in 2018, which was within 30 days following the approval by the FDA of the New Drug Application (“NDA”) for ANNOVERA, and $20.0 million in 2019 following the first commercial batch release of ANNOVERA. The aggregate $40.0 million of milestone payments were recorded as license rights. The Population Council was also eligible to receive future payments upon the achievement of certain commercial sales milestones of ANNOVERA. On December 30, 2022, we assigned the ANNOVERA license to Mayne Pharma. Our rights and obligations under the Population Council License Agreement have been transferred to Mayne Pharma and may revert back to us upon the occurrence of certain events. 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 $2.3 million in prepaid expenses and other current assets as of December 31, 2023, 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 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. Beginning on December 30, 2022 and per the Mayne License Agreement, Mayne Pharma is responsible for all enforcement of our patents, including the litigation discussed above with respect to Teva. In September 2023, one of our former contractors retained to market ANNOVERA under Title X, filed a lawsuit that accused us of breach of contract. We answered their complaint and filed breach of contract counterclaims. From time to time, we are involved in other litigations and proceedings in the ordinary course of business. We are not currently involved in any other litigations and proceedings that we believe would have a material effect on our consolidated financial condition, results of operations, or cash flows. Off-balance sheet arrangements As of December 31, 2023 and 2022 we had 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 December 31, 2023, 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. The separation of our former Interim Co-Chief Executive Officers, former Interim Chief Financial Officer and other executives from TherapeuticsMD was each a termination without “Good Cause,” as defined in their respective employment agreements. In the aggregate, as of December 31, 2023, we have accrued severance liabilities for executive termination obligations of $0.4 million. |
Stockholders_ Equity (Deficit)
Stockholders’ Equity (Deficit) | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders’ Equity (Deficit) [Abstract] | |
Stockholders’ Equity (Deficit) | 9. Stockholders’ Equity Increase of authorized shares On June 26, 2023, at our combined 2022 and 2023 Annual Meeting, our stockholders approved an amendment to our Amended and Restated Articles of Incorporation to increase the number of authorized shares of Common Stock from 12 million shares to 32 million shares. Warrants As of December 31, 2023, the following table summarizes the status of our outstanding and exercisable warrants and related transactions since December 31, 2021 (in thousands, except weighted average exercise price and weighted average remaining contractual life data): Warrants outstanding and exercisable Warrants Weighted Aggregate Weighted Balance, December 31, 2021 103 $ 76.19 $ — 8.3 Granted 436 0.14 Expired (3 ) 341.5 Balance, December 31, 2022 536 13.10 2,427 9.3 Exercised (435 ) 0.01 (2,270 ) Expired (2 ) 0.89 Balance, December 31, 2023 99 $ 66.61 $ 1,793 6.5 We used the Black Scholes option pricing model to estimate the fair value of the warrants issued. The weighted average fair value of the warrants issued in 2022 was $0.13 per warrant and the assumptions used to determine such fair value were as follows: expected term of 10 years, volatility of 69.4%, dividend yields of 0% and risk-free interest rates of 2.9%. Share-based compensation payment plans As of December 31, 2023, 126,573 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 December 31, 2023, 394,669 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 (each adjusted to account for the Reverse Stock Split) since December 31, 2022 (in thousands, except weighed average exercise price and weighted average remaining contractual life data): Outstanding Exercisable Options Weighted Average Exercise Aggregate Weighted Average Remaining Contractual Life Options Weighted Aggregate Weighted Average Remaining Contractual Life (in Years) As of January 1, 2022 353 $ 225.98 — 3.8 336 230.93 $ — 3.6 Granted — — — — — — — — Exercised — — — — — — — — Cancelled/Forfeited (4 ) 94.99 — — — — — — Expired (177 ) 226.56 — — — — — — As of December 31, 2022 172 228.28 — 3.6 170 229.43 — 3.6 Granted — — — — — — — — Exercised — — — — — — — — Cancelled/Forfeited — — — — — — — — Expired (100 ) 206.15 — — — — — — As of December 31, 2023 72 $ 258.55 $ — 3.0 73 258.46 $ — 3.0 The following table summarizes the status of our RSUs and related transactions (each adjusted to account for the Reverse Stock Split) (in thousands, except weighed average grant date fair value): RSUs awards outstanding RSUs Weighted Aggregate Balance, January 1, 2022 272 $ 58.00 $ 4,890.00 Granted 170 16.05 Vested (327 ) 48.20 Cancelled/Forfeited (58 ) 37 Balance, as of December 31, 2022 57 14.57 318.63 Granted 163 4.82 — Vested (180 ) 6.83 — Cancelled/Forfeited — — — Balance, as of December 31, 2023 40 $ 9.67 $ 89.6 The following table summarizes the status of our PSUs and related transactions for each for the following years (each adjusted to account for the Reverse Stock Split) (in thousands, except weighed average grant date fair value): PSUs Weighted Aggregate Balance, December 31, 2021 164 $ 51.50 $ 2,953 Granted 63 34.50 Vested and settled (133 ) 47.12 (2,382.98 ) Cancelled/Forfeited (75 ) (44.85 ) Unvested, as of January 1, 2023 19 52.15 107.55 Granted — — — Vested (5 ) 56.05 (10.72 ) Cancelled/Forfeited — — — Unvested, as of December 31, 2023 14 $ 50.87 $ 33 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 $1.3 million for 2023 and $11.6 million for 2022. As of December 31, 2023, we had $0.3 million 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 consolidated balance sheets. No tax benefit was realized due to a continued pattern of net losses. The unrecognized compensation cost as of December 31, 2023 of $0.3 million is expected to be recognized as share-based payment award compensation over a weighted average period of 0.8 years. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2023 | |
Revenue [Abstract] | |
Revenue | 10. 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 minimum 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. In 2023, we recorded BIJUVA license sales of $0.3 million made through the Theramex License Agreement and $1.0 million pertaining to our licensed products with Mayne Pharma, which was recorded as license revenue. Additionally, we recognized $0.5 million in other income pertaining to royalty sales of ANNOVERA. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes [Abstract] | |
Income Taxes | 11. Income taxes Our income (loss) from continuing operations before income taxes is as follows (in thousands): Year Ending December 31, 2023 2022 United States $ (7,742 ) $ 1,074 For the year ended December 31, 2023, there was no provision for income taxes in discontinued operations, current or deferred. For the year ended, December 31, 2023, we recorded a benefit of 0.5% in continuing operations. For the year ended December 31, 2022, there was 0% and 0.5% provision for income taxes in continuing and discontinued operations, respectively, current or deferred. As of December 31, 2023, we had federal net operating loss (“NOL”) carryforwards of $577.0 million, which is available to offset future taxable income. Approximately $19.2 million of the federal NOLs can be carried forward for 20 years and will begin to expire in 2035. The remaining $557.8 million can be carried forward indefinitely. In the event of future income, the NOL deduction arising from NOLs generated in taxable years beginning in 2021 will be limited to 80% of the excess taxable income. The Company experienced an ownership change pursuant to IRC Sec. 382. As a result, our NOLs carryforward as of December 31, 2023 will be limited. A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows: 2023 2022 Federal statutory tax rate $ (1,626 ) 21.0 % 21.0 % State tax rate, net of federal tax benefit — 0.0 % 3.9 % Adjustment in valuation allowances (22,173 ) 286.4 % (3,228.6 )% Excess stock benefits 2,460 (31.8 )% 835.2 % Interest expense accretion 35 (0.5 )% 0.0 % Permanent and other differences 21,261 (274.6 )% 2,368.5 % (Benefit) provision for income taxes $ (43 ) 0.5 % 0.0 % We do not expect to pay any significant federal or state income taxes as a result of (i) the losses recorded during 2023, (ii) net operating losses carry forwards from prior years. Deferred income taxes result from temporary differences between the amount of assets and liabilities recognized for financial reporting and tax purposes. The components of the net deferred tax assets as of December 31, 2023 and 2022 are as follows: December 31, 2023 2022 Deferred income tax assets (liabilities): Net operating loss $ 158,040 $ 176,631 Share-based payment compensation 3,339 8,590 Interest expense limitation 19,547 19,707 Gain on sale of ANNOVERA (3,401 ) (3,624 ) Accrual for sales returns and coupons 288 — R&D credit 186 186 Other, net 256 (1,062 ) Deferred income tax asset 178,255 (200,428 ) Valuation allowance (178,255 ) 200,428 Deferred income tax assets, net $ — $ — We believe that it is more likely than not that we will not generate sufficient future taxable income to realize tax benefits related to our deferred tax assets and as such, a valuation allowance has been established against all the deferred tax assets as of both December 31, 2023 and 2022. Since our first year of operations in 2011, we generated net operating losses, and our U.S. federal and state tax returns remain open to examination. As of December 31, 2023 and 2022, we had no |
Income (Loss) Per Common Share
Income (Loss) Per Common Share | 12 Months Ended |
Dec. 31, 2023 | |
Income (loss) per common share [Abstract] | |
Income (Loss) Per Common Share | 12. Income (loss) per common share The following table sets forth the computation of basic and diluted income (loss) per common share (each adjusted to account for the Reverse Stock Split) for the periods presented (in thousands, except per share amounts): Years Ending December 31, 2023 2022 Numerator: Net income (loss) from continuing operations $ (7,699 ) $ 1,074 Net income (loss) from discontinued operations (2,579 ) 110,923 Net income (loss) $ (10,278 ) $ 111,997 Denominator: Weighted average common shares for basic income (loss) per common share 10,441 9,028 Effect of dilutive securities — 338 Weighted average common shares for diluted income (loss) per common share 10,441 9,366 Income (loss) per common share, continuing operations Basic $ (0.74 ) $ 0.12 Diluted $ (0.74 ) $ 0.11 Income (loss) per common share, discontinued operations Basic $ (0.25 ) $ 12.29 Diluted $ (0.25 ) $ 11.84 Since we reported a net loss from continuing operations for 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 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 2023 and 2022 (in thousands): December 31, 2023 2022 Stock options 72 172 RSUs 40 — PSUs 14 — Warrants 99 101 225 273 |
Related parties
Related parties | 12 Months Ended |
Dec. 31, 2023 | |
Related parties [Abstract] | |
Related parties | 13. 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, 2022, filed with the Securities and Exchange Commission on May 1, 2023, 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. 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. |
Business Concentrations
Business Concentrations | 12 Months Ended |
Dec. 31, 2023 | |
Business Concentrations [Abstract] | |
Business Concentrations | 14. 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 consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in our consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in Note 2. For the year ended December 31, 2023, 100% of license revenue related to Mayne Pharma and Theramex. As of December 31, 2023, we had a royalty receivable of $3.1 million relating to the short-term portion of receivable from Mayne Pharma and Theramex and $18.5 million relating to the long-term portion of royalty receivable which includes royalties recognized from the minimum annual royalty that Mayne Pharma is obligated to pay to us under the Mayne License Agreement. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events Effective March 22, 2024, Tommy G. Thompson resigned as the Company’s Executive Chairman of the Board and was reappointed as the Company’s Chairman of the Board. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (10,278) | $ 111,997 |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
General | General TherapeuticsMD, Inc. (the “Company”), a Nevada corporation, and its consolidated subsidiaries are referred to collectively in this Annual Report on Form 10-K (“2023 10-K Report”) as “TherapeuticsMD,” “we,” “our” and “us.” This 2023 10-K Report includes trademarks, trade names and service marks, such as TherapeuticsMD ® ® ® ® ® ® 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 ® 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 one-time 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 minimum 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. 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 under the Transaction Agreement and the grant of the licenses under the Mayne License 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 for the assumed obligations under a long-term services agreement (see the section entitled “vitaCare Divestiture” below for a discussion of the long-term services agreement), including our minimum payment obligations thereunder. As the parties agreed, during the second quarter of 2023, Mayne Parma 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 consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in our consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in Note 2. 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. ● 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 were paid in accordance with their employment agreements and separation agreements as previously disclosed. As of December 31, 2022 and 2023, 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 and Accounting 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. |
vitaCare Divestiture | vitaCare Divestiture On April 14, 2022, we completed the divestiture of our former subsidiary vitaCare Prescription Services, Inc. (“vitaCare”) with the sale of all of vitaCare’s issued and outstanding capital stock (the “vitaCare Divestiture”). We received net proceeds of $142.6 million, after deducting transaction costs of $7.2 million, and we recognized a gain on sale of business of $143.4 million. Included in the net proceeds amount was $11.3 million of customary holdbacks as provided in the stock purchase agreement (the “Purchase Agreement”) which we received in 2023. Additionally, the Purchase Agreement provides that we may receive up to an additional $7.0 million in earn-out consideration, contingent upon vitaCare’s financial performance through 2023 as determined in accordance with the terms of the Purchase Agreement; however, we do not believe this earnout will be realized. We will record the contingent consideration at the settlement amount if and when the consideration is realized or realizable. The Purchase Agreement contains customary representations and warranties, covenants, and indemnities of the parties thereto. The commitments under a long-term services agreement related to vitaCare were transferred to Mayne Pharma as part of the Mayne Transaction. The divestiture of vitaCare was determined to be a component of discontinued operations in December 2022, when we changed our business by becoming a royalty company and as a result vitaCare activities were reclassified to discontinued operations for 2023 and 2022. |
Going Concern | Going concern On December 4, 2022, we entered into agreements with Mayne Pharma pursuant to which we granted Mayne Pharma an exclusive license to commercialize IMVEXXY, BIJUVA, and prescription prenatal vitamin products (in the United States and its possessions and territories), (ii) assign to Mayne Pharma our exclusive license to commercialize ANNOVERA in the United States and its possessions and territories, and (iii) sell certain other assets to Mayne Pharma. The total consideration from Mayne Pharma to the TherapeuticsMD for the purchase of the Transferred Assets under the Transaction Agreement and the grant of the licenses under the Mayne License Agreement consisted of (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 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 and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended. On the Closing Date, we repaid all obligations under the Financing Agreement, dated as of April 24, 2019, as amended, with Sixth Street Specialty Lending, Inc., as administrative agent, the various lenders from time-to-time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors (the “Financing Agreement”) and the Financing Agreement was terminated. 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 1,000,000 shares of Common Stock at a price per share equal to $2.28. 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 which differed significantly from the Company’s estimate of the allowances. The Company believes its estimated allowances for payer rebates and wholesale distributor fees are reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement. Given the recent receipt of Mayne Pharma’s allowance calculation and the nature of the estimates involved, 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 December 31, 2023, 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 that may be material. If Mayne Pharma’s sales of IMVEXXY, BIJUVA, or ANNOVERA 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 if 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. |
Basis of presentation | A. Basis of presentation The consolidated financial statements and related notes include our parent company and all wholly owned subsidiaries. The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the Unites States of America (“U.S. GAAP”). Our fiscal year-end is as of and for the year ended December 31st for each year presented. All intercompany transactions among our businesses have been eliminated. As part of the transformation and as a result of the vitaCare divestiture and the Mayne Transaction, historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in the consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the consolidated balance sheet. Additional disclosures regarding discontinued operations are provided in Note 2 of these consolidated financial statements. Certain amounts in the notes to the consolidated financial statements may not add due to rounding. Certain prior period amounts have been reclassified to conform to current-period presentation. |
New accounting standards | B. 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. |
Discontinued Operations | C. Discontinued Operations Discontinued operations comprise activities that were disposed of at the end of the period, represent a separate major line of business that can be clearly distinguished for operational and financial reporting purposes and represent a business shift having a major effect on the Company’s operations and financial results according to Accounting Standard Codification (“ASC”) Topic 205, Presentation of Financial Statements. An adjustment has been made to the consolidated statements of operations for the twelve months ended December 31, 2023 and 2022 to reclassify commercial activities and vitaCare activities to discontinued operations as both components, in the aggregate, represented a business shift that will have a major effect on the Company’s operations and financial results. No amounts for shared general and administrative operating support expense were allocated to discontinued operations. As required by the terms of the Financing Agreement, the proceeds from both transactions were used to fully repay our outstanding debt borrowings. As a result, interest expense and amortization of deferred financing costs as well as expense for accretion of Series A Preferred Stock and loss on extinguishment of debt are included within income (loss) from discontinued operations, net of tax. Additionally, the related assets and liabilities have been reported as assets and liabilities of discontinued operations in the Company’s consolidated balance sheet as of December 31, 2023 and 2022. For additional information, see Note 2 - Discontinued Operations. |
Estimates and assumptions | D. Estimates and assumptions The preparation of consolidated financial statements in conformity to 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 financial statements and the reported amounts of revenue and expenses during the reporting period. We evaluate our estimated 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. |
Cash and Restricted Cash | E. Cash and Restricted Cash For the purpose of the statements of cash flows, all highly liquid investments with an original maturity of three months or less are considered to be cash equivalents. The carrying value of these investments approximates fair value. We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $0.25 million per bank. We have never experienced any losses related to these funds. Restricted cash was comprised of escrowed funds deposited with a bank relating to the vitaCare Divestiture. All restrictions were lifted in March 2023. |
Fair Value Measurements | F. Fair Value Measurements Fair value is the price to sell an asset or transfer a liability and therefore represents an exit price in the principal market (or in the absence of a principal market, the most advantageous market). It represents a market-based measurement that contemplates a hypothetical transaction between market participants at the measurement date. The unique characteristics of an asset or liability and the availability of observable prices affect the number of valuation approaches and/or techniques used in a fair value analysis. We measure fair value using observable and unobservable inputs. We give the highest priority to quoted prices (unadjusted) in active markets for identical assets or liabilities (Level 1 inputs) and the lowest priority to unobservable inputs (Level 3 inputs). We apply the following fair value hierarchy: ● Level 1 - Quoted prices (unadjusted) in active markets for identical assets and liabilities. ● Level 2 - Quoted prices in non-active markets or in active markets for similar assets or liabilities, observable inputs other than quoted prices; and inputs that are not directly observable but are corroborated by observable market data. ● Level 3 - Inputs that are unobservable. The carrying amount of our cash, restricted cash, accounts receivable, accounts payable and accrued expenses approximate their fair value because of the short-term maturity of such instruments, which are considered Level 1 under the fair value hierarchy. |
Fixed assets | G. Fixed assets Fixed assets are carried at cost less accumulated depreciation and amortization. We charge maintenance costs, which do not significantly extend the useful lives of the respective assets, and repair costs to operating expenses as incurred. We compute depreciation using the straight-line method over the estimated useful lives of the related assets, which range from three to seven years. Leasehold improvements are depreciated over the shorter of their useful life or the term of the lease. Long-lived assets held and used by us, including fixed assets, are assessed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. We capitalize software and software development costs incurred to create and acquire computer software for internal use, principally related to software coding and application development. We begin to capitalize software development costs when both the preliminary project stage is completed, and it is probable that the software will be used as intended. Capitalized software costs include only external direct costs and services utilized in developing or obtaining computer software. Capitalized software costs are amortized on a straight-line basis when placed into service over the estimated useful life, generally five to seven years. |
License rights and other intangibles assets | H. License rights and other intangibles assets We record license rights and other intangible assets at cost, which includes external costs, consisting primary of legal costs, incurred in securing our patents and trademarks. License rights costs related to ANNOVERA were amortized until December 30, 2022 over the useful life over which the license rights would contribute directly or indirectly to our cash flows. The cost was amortized using the straight-line method as the pattern of economic benefit could not be reliably determined. On December 30, 2022, we assigned our ANNOVERA license to Mayne Pharma and included the remaining ANNOVERA license cost of $30.2 million in our calculation of the gain on sale of assets. In addition, amortization of license rights of $3.0 million for 2022 was reclassified to discontinued operations. Intangible assets subject to amortization, such as patents, are amortized over the useful life of the patent using the straight-line method. If the patent is not granted, we write off any capitalized patent costs at that time. Intangible assets not subject to amortization, such as trademarks, are perpetual and have indefinite lives. We review license rights and other intangible assets subject to amortization on a periodic basis to determine whether events and circumstances would indicate impairment or warrant a revision to their remaining useful lives. We assess other intangible assets not subject to amortization for potential impairment at least annually during the fourth quarter of each year, or more frequently if events occur or circumstances change that would more likely than not reduce the fair value of the intangible assets below their carrying value. |
Segment reporting | I. Segment reporting We manage and operate as one business, which prior to December 2022 was focused on creating and commercializing products targeted exclusively for women and after we signed Mayne License Agreement, is focused on collecting royalties from licensing our products. Our business is led by our chief executive officer. We do not operate separate lines of business with respect to any of our products, and we do not prepare discrete financial information with respect to separate products. Accordingly, we view our business as one reportable operating segment. |
Revenue recognition | J. Revenue recognition We determine the amount of revenue to be recognized through application of the following steps: ● Identification of the contract with a customer; ● Identification of the performance obligations in the contract; ● Determination of the transaction price; ● Allocation of the transaction price to the performance obligations in the contract; and ● Recognition of revenue when or as we satisfy the performance obligations. A performance obligation is a promise in a contract to transfer a product or service to a customer. A good or service is considered to be transferred when the customer receives the goods or service or obtains control, and we treat shipping as a fulfillment activity rather than as a separate obligation. We generally recognize revenue at a point in time when all of our performance obligations under the terms of a contract are satisfied. Revenue is recognized upon transfer of control of promised products or services in an amount that reflects the consideration we expect to receive in exchange for those products or services. The collectability of consideration on the contract is reasonably assured before revenue is recognized. To the extent that customer payment has been received before all recognition criteria are met, these revenues are initially deferred in other accruals on the balance sheet and the revenue is recognized in the period that all recognition criteria have been met. License revenue License arrangements may consist of non-refundable upfront license fees, exclusive licensed rights to patented or patent pending technology, and various performance or sales milestones and future product royalty payments. Some of these arrangements may include multiple performance obligations. Non-refundable up-front fees that are not contingent on any future performance by us, and do not require continuing involvement on our part, are recognized as revenue when the right to use functional intellectual property is transferred to the customer. On December 30, 2022, we granted an exclusive license to commercialize our prescription products and assigning the Company’s exclusive license to commercialize ANNOVERA to Mayne Pharma, which resulted in a business shift that had a major effect on our operations and financial results. As part of the transformation that included the Mayne License Agreement, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date. As of December 31, 2022, we are no longer directly engaged in the sale of prescription products. Under the terms of the Mayne License Agreement, we received $140 million at closing and we are eligible to receive additional payments in the aggregate of up to an additional $30 million, based on the achievement of sales milestones (collectively, the “Milestone Amounts”). The proceeds at closing were allocated between consideration for the sale of ANNOVERA and the initial license fee for the Licensed Products, as the sale of ANNOVERA was accounted for under ASC 610-20, Gains and Losses from Derecognition of Nonfinancial Assets in arriving at the gain on disposal (see Note 2), while the license grant of the other products were recognized under the provisions of ASC 606, Revenue from Contracts with Customers, as a license of functional intellectual property. The proceeds were allocated among the Licensed Products on the relative net present value of forecasted future product sales from those products. The Milestone Amounts will be recognized, as applicable, in subsequent periods based on actual product sales that exceed the respective net sales milestones as such variable consideration is constrained by the occurrence of the subsequent sales. Our royalty revenue in 2023 primarily related to royalties provided for under the Mayne License Agreement based on Mayne Pharma’s sales of the licensed products subject to that agreement. Under the Mayne License Agreement, the Company is entitled to earn royalties on net sales of all of the Licensed Products at a royalty rate of (i) 8% on the first $80 million of net sales of the Licensed Products and (ii) 7.5% on net sales of all of the Licensed Products after the first $80 million of net sales. The royalty rate is subject to a 2% reduction upon the earlier to occur of (i) the expiration or revocation of the last valid claim covering a Licensed Product, and (ii) a generic product launch (a “LOE”). We are entitled to minimum annual royalties beginning with the year ending December 31, 2023 ($3 million annual minimum) and continuing with 3% annual increases through the year ending December 31, 2034 (the “Minimum Annual Royalty”). The total Minimum Annual Royalty we are entitled to is $42.6 million, and this total amount was allocated among the Licensed Products on the relative net present value of forecasted future product sales from those products. The portion allocated to consideration for the sale of ANNOVERA was attributed towards the gain on disposal of that asset. For the remaining portion allocated to the license grants for the other products, we determined that the minimum guarantee underlying the Minimum Annual Royalty should be treated as fixed consideration and recognized under ASC 606 at the point in time when the license was transferred. Since the Minimum Annual Royalty will be received in annual installments through 2034, we determined the transaction price allocated under ASC 606 contained a significant financing component, and we therefore determined the initial royalty revenue and corresponding receivable based on the present value of the allocated Minimum Annual Royalty. The present value was calculated using a discount rate of 10.45%, based on the credit characteristics of Mayne Pharma and the timing of future payments, and the value will be accreted to full value through the earlier of January 1, 2034 or a LOE. This royalty receivable is a contract asset as of December 31, 2022 and 2023, and is further subject to offset by Mayne Pharma (see L. Contract Assets and Liabilities below). Royalty revenue earned in excess of the Minimum Annual Royalty will be recognized under ASC 606, which provides revenue recognition constraints by requiring the recognition of revenue at the later of the following: 1) when the subsequent sale occurs or 2) when the performance obligation to which some or all of the sales-based royalty has been allocated has been satisfied (or partially satisfied). We applied the royalty recognition constraint required under the guidance for sales-based royalties, which requires a sales-based royalty to be recorded no sooner than the underlying sale. Therefore, royalties on sales of products commercialized by Mayne Pharma will be recognized in the subsequent periods that the Licensed Products are sold. In 2023, we recorded BIJUVA license sales of $0.3 million made through the Theramex License Agreement and $1.0 million pertaining to our licensed products with Mayne Pharma, which was recognized as license revenue. Additionally, we recognized $0.5 million in other income pertaining to royalty sales of ANNOVERA. |
Cost of revenue | K. Cost of revenue Cost of revenue includes the cost of inventory, manufacturing, manufacturing overhead and supply chain costs and product shipping and handling costs. Costs related to the Population Council License Agreement, which were based on our net sales of ANNOVERA, and amortization of license rights were reclassified to discontinued operations for 2022 as a result of the transaction with Mayne Pharma. |
Share-based payment awards | M. Share-based payment awards We account for share-based payment awards on a fair value basis of the equity instrument issued. Under fair value accounting, the grant-date fair value of the share-based payment award is amortized as compensation expense, on a straight-line basis, over the service period (generally, the vesting period) for both graded and cliff vesting awards. We have elected to account for forfeitures as they occur. Common stock reverse stock split On May 6, 2022, we completed a reverse stock split of our Common Stock. As a result, shares of our outstanding Common Stock were split at a ratio of 50-for-1 (the “Reverse Stock Split”) with any fractional shares resulting from the Reserve Stock Split rounded up to the next whole share of Common Stock. The number of authorized shares of Common Stock was also correspondingly reduced from 600.0 million shares to 12.0 million shares to give effect to the Reverse Stock Split. Additionally, all rights to receive shares of Common Stock under outstanding warrants, options, restricted stock units (“RSUs”) and performance stock units (“PSUs”) were adjusted to give effect of the Reverse Stock Split. Furthermore, remaining shares of Common Stock available for future issuance under share-based payment award plans and our employee stock purchase plan were adjusted to give effect of the Reverse Stock Split. Pursuant to Section 78.209 of the Nevada Revised Statutes, the approval of our stockholders was not required for our Board of Directors (the “Board”) to effectuate the Reverse Stock Split. All historical numbers of shares of Common Stock and per share data have been adjusted to give effect to the Reverse Stock Split. Additionally, since the Common Stock par value was unchanged, historical amounts for Common Stock and additional paid-in capital have been adjusted to give effect to the Reverse Stock Split. Increase of authorized shares On June 26, 2023, at our combined 2022 and 2023 Annual Meeting, our stockholders approved an amendment to our Amended and Restated Articles of Incorporation to increase the number of authorized shares of Common Stock from 12 million shares to 32 million shares. |
Income taxes | N. Income taxes Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating loss and income tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted income tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in income tax rates is recorded as a component of the income tax provision in the period that includes the enactment date. Regular assessments are made on the likelihood that our deferred tax assets will be recovered from our future taxable income. Our evaluation is based on estimates, assumptions, and includes an analysis of available positive and negative evidence, giving weight based on the evidence’s relative objectivity. Sources of positive evidence include estimates of future taxable income, future reversal of existing taxable temporary differences, taxable income in carryback years, and available tax planning strategies. Sources of negative evidence include current and cumulative losses in recent years, losses expected in early future years, any history of operating losses or tax credit carryforwards expiring unused, and unsettled circumstances that, if unfavorably resolved, would adversely affect future profit levels. The remaining carrying value of our deferred tax assets, after recording the valuation allowance on our deferred tax assets, is based on our present belief that it is more likely than not that we will be able to generate sufficient future taxable income to utilize such deferred tax assets. The amount of the remaining deferred tax assets considered recoverable could be adjusted if our estimates of future taxable income during the carryforward period change favorably or unfavorably. To the extent we believe that it is more likely than not that some or all the remaining deferred tax assets will not be realized, we must establish a valuation allowance against those deferred tax assets, resulting in additional income tax expense in the period such determination is made. To the extent a valuation allowance currently exists, we will continue to monitor all positive and negative evidence until we believe it is more likely than not that it is no longer necessary, resulting in an income tax benefit in the period such determination is made. Our policy is to recognize both interest and penalties related to uncertain tax positions as part of the income tax provision. Significant judgment is required in evaluating our tax positions, and in determining our provisions for income taxes, our deferred tax assets and liabilities and any valuation allowance recorded against our net deferred tax assets. We establish reserves when, despite our belief that the income tax return positions are fully supportable, certain positions are likely to be challenged and we may ultimately not prevail in defending those positions. |
Earnings per common share | O. Earnings per common share Basic earnings or loss per common share is computed by dividing net income or loss available to common stockholders by the sum of the weighted average number of shares of common stock. Diluted earnings per common share is computed by dividing net income available to common stockholders by the sum of the weighted average number of shares of common stock and the number of additional shares of common stock that would have been outstanding if our outstanding potentially dilutive securities had been issued. Potentially dilutive securities include awards of non-vested or vested and not settled restricted stock units, performance stock units where the performance requirements have been met and not settled, warrants and options. The dilutive effect of potentially dilutive securities is reflected in diluted earnings per common share by application of the treasury stock method, except if its impact is anti-dilutive. Under the treasury stock method, an increase in the fair market value of our common stock can result in a greater dilutive effect from potentially dilutive securities. |
Leases | P. Leases We determine if an arrangement is a lease at inception. Determining whether a contract contains a lease includes judgment regarding whether the contract conveys the right to control the use of identified property or equipment for a period of time in exchange for consideration. We account for our lease-related assets and liabilities based on their classification as operating leases or finance leases, following the relevant accounting guidance. For all the lessee arrangements, we have elected an accounting policy to combine non-lease components with the related-lease components and treat the combined items as a lease for accounting purposes. We measure lease related assets and liabilities based on the present value of lease payments, including in-substance fixed payments, variable payments that depend on an index or rate measured at the commencement date, and the amount we believe is probable we will pay the lessor under residual value guarantees when applicable. We discount lease payments based on our estimated incremental borrowing rate at lease commencement (or modification), which is primarily based on our estimated credit rating, the lease term at commencement, and the contract currency of the lease arrangement. We have elected to exclude short-term leases (leases with an original lease term less than one year) from the measurement of lease-related assets and liabilities. We test right-of-use assets in an operating or finance lease at the asset group level (because these assets are long-lived nonfinancial assets and should be accounted for the same way as other long-lived nonfinancial assets) whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. We sublease our unoccupied facilities to third parties. Any impairment to the associated right-of-use asset, leasehold improvements, or other assets as a result of the sublease is recognized in the period when a decision to sublease is made and recorded in our consolidated statement of operations. We recognize sublease income on a straight-line basis over the sublease term. |
Loss Contingencies | Q. Loss Contingencies In determining whether an accrual for a loss contingency is required, we first assess the likelihood of occurrence of the future event or events that will confirm the loss. When a loss is probable (the future event or events are likely to occur) and the amount of the loss can be reasonably estimated, the estimated loss is accrued. If the reasonable estimate of the loss is a range and an amount within the range appears to be a better estimate than any other amount within the range, that amount should be accrued. However, if no amount within the range is a better estimate, the minimum amount in the range should be accrued. When a loss is reasonably possible (the chance of the future event or events occurring is more than remote but less than likely), no accrual is recognized. See Note 8 for more information. |
Restructuring charges | R. Restructuring charges During the year ended December 31, 2022, the Company initiated and completed a restructuring plan that resulted in a reduction of its workforce to one employee. One-time termination benefits include severance, continuation of health insurance coverage, and other benefits for a specified period of time, as well as contract terminations and fixed assets write-downs, which resulted in $15.7 million of restructuring costs for the year ended December 31, 2022. There were no restructuring costs incurred during the year ended December 31, 2023. Restructuring costs have been recognized in the accompanying consolidated statement of operations as follows (in thousands): Year ended 2022 Executive termination benefits $ 3,897 Consulting and legal expenses 3,060 Other contract termination costs 2,515 Total restructuring expenses - general and administrative expenses $ 9,472 Employee termination benefits $ 4,813 Other contract termination costs 1,367 Total restructuring expenses - discontinued operations $ 6,180 At December 31, 2023 and 2022 respectively, $2.5 million and $6.2 million of restructuring costs were included in current liabilities of discontinued operations in the accompanying consolidated balance sheets. At December 31, 2022, $9.3 million related to restructuring costs was included in accrued expenses and other current liabilities. |
Reclassification of prior year presentation | S. Reclassification of prior year presentation Certain prior year amounts have been reclassified for consistency with the current year presentation. |
Contract Assets and Liabilities | L. Contract Assets and Liabilities Contract assets totaling $21.6 million as of December 31, 2023, include royalties recognized from the Minimum Annual Royalty (see J. Revenue Recognition above). |
Business, Basis of Presentati_2
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Abstract] | |
Summary of Restructuring Cost Recognition | Restructuring costs have been recognized in the accompanying consolidated statement of operations as follows (in thousands): Year ended 2022 Executive termination benefits $ 3,897 Consulting and legal expenses 3,060 Other contract termination costs 2,515 Total restructuring expenses - general and administrative expenses $ 9,472 Employee termination benefits $ 4,813 Other contract termination costs 1,367 Total restructuring expenses - discontinued operations $ 6,180 |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Discontinued Operations [Abstract] | |
Schedule of Discontinued Operations | The following table presents results of discontinued operations (in thousands): Years ended December 31, 2023 2022 Product revenue, net $ (833 ) $ 80,749 Cost of goods sold — 15,640 Gross profit (loss) (833 ) 65,109 Operating expenses: Selling and marketing — 75,208 General and administrative 481 11,301 Research and development — 4,942 Restructuring charges — 6,180 Total operating expenses 481 97,631 Loss from discontinued operations (1,314 ) (32,522 ) Other income (expense): Gain on sale of vitaCare — 143,384 Gain on ANNOVERA sale — 62,031 Loss on the extinguishment of debt — (8,380 ) Interest expense and other financing costs — (36,065 ) Expense for accretion of Series A Preferred Stock — (16,973 ) Loss on disposal of assets (1,150 ) — Other expense, net (115 ) — Total other income (expense), net (1,265 ) 143,997 Loss before from income taxes (2,579 ) 111,475 Benefit (provision) for income taxes — (552 ) Net income (loss) from discontinued operations $ (2,579 ) $ 110,923 |
Schedule of Classes of Liabilities of Discontinued Operations | The following table presents the carrying amounts of the classes of assets and liabilities of discontinued operations (in thousands): As of December 31, 2023 2022 Assets: Current assets: Accounts receivable $ 344 $ — Total assets 344 — Current liabilities: Accounts payable $ — $ 12,243 Accrued expenses and other current liabilities 3,694 13,588 Total liabilities $ 3,694 $ 25,831 |
Prepaid and Other Current Ass_2
Prepaid and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid and Other Current Assets [Abstract] | |
Schedule of Prepaid and Other Current Assets | Our prepaid and other current assets consisted of the following (in thousands): December 31, 2023 2022 Insurance $ 253 $ 1,167 Capitalized legal 2,334 2,334 Other 1,448 2,533 Prepaid and other current assets $ 4,035 $ 6,034 |
Fixed Assets (Tables)
Fixed Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fixed Assets [Abstract] | |
Schedule of Fixed Assets, Net | Our fixed assets, net consisted of the following (in thousands): December 31, 2023 2022 Furniture and fixtures $ 931 $ 931 Computer and office equipment 1,167 1,168 Computer software 375 375 Leasehold improvements 49 49 Fixed assets 2,522 2,523 Less: accumulated depreciation and amortization 2,522 2,445 Fixed assets, net $ — $ 78 |
Licensed Rights and Other Int_2
Licensed Rights and Other Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Licensed Rights and Other Intangible Assets [Abstract] | |
Schedule of License Rights and Other Intangible Assets, Net | The following provides information about our license rights and other intangible assets, net (in thousands): As of December 31, 2023 As of December 31, 2022 Gross Gross Carrying Accumulated Carrying Accumulated Amount Amortization Net Amount Amortization Net Intangible assets subject to amortization: Hormone therapy drug patents $ 6,818 $ 1,871 $ 4,947 $ 6,225 $ 1,598 $ 4,627 Hormone therapy drug patents applied and pending approval 842 — 842 1,995 — 1,995 Intangible assets subject to amortization 7,660 1,871 5,789 8,220 1,598 6,622 Intangible assets not subject to amortization: Trademarks/trade name rights 309 — 309 321 — 321 Intangible assets, net $ 7,969 $ 1,871 $ 6,098 $ 8,541 $ 1,598 $ 6,943 |
Schedule of Intangible Assets Subject To Amortization | Our intangible assets subject to amortization are expected to be amortized as follows (in thousands): Year ending December 31, 2024 533 2025 445 2026 445 2027 445 2028 445 Thereafter 5,347 Total $ 7,660 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Expenses and Other Current Liabilities [Abstract] | |
Schedule of Other Accrued Expenses and Other Current Liabilities | Other accrued expenses and other current liabilities consisted of the following (in thousands): As of December 31, 2023 2022 Payroll and related costs $ 762 $ 8,748 Accrued contract termination costs — 4,700 Research and development expenses — 978 Professional fees 489 415 Operating lease liabilities 1,473 1,390 Prepaid royalty — 1,011 Other accrued expenses and current liabilities 409 1,604 Accrued expenses and other current liabilities $ 3,133 $ 18,846 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies [Abstract] | |
Schedule of Remaining Lease Payments | As of December 31, 2023, our remaining lease payments were as follows (in thousands): Year ending December 31, 2024 1,477 2025 1,513 2026 1,551 2027 1,590 2028 1,630 Thereafter 2,664 Total undiscounted lease payments 10,425 Less: imputed interest 2,420 Present value of lease payments $ 8,005 |
Schedule of Supplemental Balance Sheet Information Related to Leases | The following table sets forth supplemental balance sheet information related to leases (in thousands): As of December 31, 2023 2022 Assets: Operating lease right-of-use assets $ 6,873 $ 7,580 Liabilities: Operating lease liabilities current (included in accrued expenses and other current liabilities) $ 1,473 $ 1,390 Operating lease liabilities, non-current $ 6,532 7,369 Total operating lease liabilities $ 8,005 $ 8,759 |
Schedule of Other Information Related to Leases | The following table presents other information related to leases: As of December 31, 2023 2022 Weighted average remaining term (years) - operating leases 6.7 7.7 Weighted average discount rate - operating leases 8.3 % 8.3 % Cash paid for amounts included in the measurement of lease liabilities from operating lease (in thousands) $ 1,443 $ 1,413 Right-of-use assets obtained in exchange for new operating lease obligations (non-cash in thousands) $ — $ — |
Stockholders_ Equity (Deficit)
Stockholders’ Equity (Deficit) (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders’ Equity (Deficit) [Abstract] | |
Schedule of Outstanding and Exercisable Warrants and Related Transactions | As of December 31, 2023, the following table summarizes the status of our outstanding and exercisable warrants and related transactions since December 31, 2021 (in thousands, except weighted average exercise price and weighted average remaining contractual life data): Warrants outstanding and exercisable Warrants Weighted Aggregate Weighted Balance, December 31, 2021 103 $ 76.19 $ — 8.3 Granted 436 0.14 Expired (3 ) 341.5 Balance, December 31, 2022 536 13.10 2,427 9.3 Exercised (435 ) 0.01 (2,270 ) Expired (2 ) 0.89 Balance, December 31, 2023 99 $ 66.61 $ 1,793 6.5 |
Schedule of Stock Options Activity | The following table summarizes the status of our outstanding and exercisable options and related transactions (each adjusted to account for the Reverse Stock Split) since December 31, 2022 (in thousands, except weighed average exercise price and weighted average remaining contractual life data): Outstanding Exercisable Options Weighted Average Exercise Aggregate Weighted Average Remaining Contractual Life Options Weighted Aggregate Weighted Average Remaining Contractual Life (in Years) As of January 1, 2022 353 $ 225.98 — 3.8 336 230.93 $ — 3.6 Granted — — — — — — — — Exercised — — — — — — — — Cancelled/Forfeited (4 ) 94.99 — — — — — — Expired (177 ) 226.56 — — — — — — As of December 31, 2022 172 228.28 — 3.6 170 229.43 — 3.6 Granted — — — — — — — — Exercised — — — — — — — — Cancelled/Forfeited — — — — — — — — Expired (100 ) 206.15 — — — — — — As of December 31, 2023 72 $ 258.55 $ — 3.0 73 258.46 $ — 3.0 |
Schedule of the Status of our Unvested and Related Transactions | The following table summarizes the status of our RSUs and related transactions (each adjusted to account for the Reverse Stock Split) (in thousands, except weighed average grant date fair value): RSUs awards outstanding RSUs Weighted Aggregate Balance, January 1, 2022 272 $ 58.00 $ 4,890.00 Granted 170 16.05 Vested (327 ) 48.20 Cancelled/Forfeited (58 ) 37 Balance, as of December 31, 2022 57 14.57 318.63 Granted 163 4.82 — Vested (180 ) 6.83 — Cancelled/Forfeited — — — Balance, as of December 31, 2023 40 $ 9.67 $ 89.6 PSUs Weighted Aggregate Balance, December 31, 2021 164 $ 51.50 $ 2,953 Granted 63 34.50 Vested and settled (133 ) 47.12 (2,382.98 ) Cancelled/Forfeited (75 ) (44.85 ) Unvested, as of January 1, 2023 19 52.15 107.55 Granted — — — Vested (5 ) 56.05 (10.72 ) Cancelled/Forfeited — — — Unvested, as of December 31, 2023 14 $ 50.87 $ 33 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes [Abstract] | |
Schedule of Income (Loss) from Continuing Operations Before Income Taxes | Our income (loss) from continuing operations before income taxes is as follows (in thousands): Year Ending December 31, 2023 2022 United States $ (7,742 ) $ 1,074 |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows: 2023 2022 Federal statutory tax rate $ (1,626 ) 21.0 % 21.0 % State tax rate, net of federal tax benefit — 0.0 % 3.9 % Adjustment in valuation allowances (22,173 ) 286.4 % (3,228.6 )% Excess stock benefits 2,460 (31.8 )% 835.2 % Interest expense accretion 35 (0.5 )% 0.0 % Permanent and other differences 21,261 (274.6 )% 2,368.5 % (Benefit) provision for income taxes $ (43 ) 0.5 % 0.0 % |
Schedule of Components of Net Deferred Income Tax Asset | Deferred income taxes result from temporary differences between the amount of assets and liabilities recognized for financial reporting and tax purposes. The components of the net deferred tax assets as of December 31, 2023 and 2022 are as follows: December 31, 2023 2022 Deferred income tax assets (liabilities): Net operating loss $ 158,040 $ 176,631 Share-based payment compensation 3,339 8,590 Interest expense limitation 19,547 19,707 Gain on sale of ANNOVERA (3,401 ) (3,624 ) Accrual for sales returns and coupons 288 — R&D credit 186 186 Other, net 256 (1,062 ) Deferred income tax asset 178,255 (200,428 ) Valuation allowance (178,255 ) 200,428 Deferred income tax assets, net $ — $ — |
Income (Loss) Per Common Share
Income (Loss) Per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income (loss) per common share [Abstract] | |
Summary of Computation of Basic and Diluted Income (Loss) Per Common Share | The following table sets forth the computation of basic and diluted income (loss) per common share (each adjusted to account for the Reverse Stock Split) for the periods presented (in thousands, except per share amounts): Years Ending December 31, 2023 2022 Numerator: Net income (loss) from continuing operations $ (7,699 ) $ 1,074 Net income (loss) from discontinued operations (2,579 ) 110,923 Net income (loss) $ (10,278 ) $ 111,997 Denominator: Weighted average common shares for basic income (loss) per common share 10,441 9,028 Effect of dilutive securities — 338 Weighted average common shares for diluted income (loss) per common share 10,441 9,366 Income (loss) per common share, continuing operations Basic $ (0.74 ) $ 0.12 Diluted $ (0.74 ) $ 0.11 Income (loss) per common share, discontinued operations Basic $ (0.25 ) $ 12.29 Diluted $ (0.25 ) $ 11.84 |
Schedule of Outstanding Securities | 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 2023 and 2022 (in thousands): December 31, 2023 2022 Stock options 72 172 RSUs 40 — PSUs 14 — Warrants 99 101 225 273 |
Business, Basis of Presentati_3
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies (Details) | 1 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Nov. 15, 2023 USD ($) $ / shares shares | Jun. 09, 2023 USD ($) $ / shares shares | May 06, 2022 shares | Apr. 14, 2022 USD ($) | Aug. 31, 2023 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2034 USD ($) | May 01, 2023 $ / shares shares | |
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Period of royalty payments | 20 years | |||||||||
General | $ 140,000,000 | |||||||||
Acquisition of net working capital | 12,100,000 | |||||||||
Cash received for prepaid royalties | 1,000,000 | |||||||||
Prepaid royalty liabilities | 1,000,000 | |||||||||
Quarterly royalty payment | $ 257 | |||||||||
Quarterly royalty payment, interest per annum | 19% | |||||||||
Royalty payment | $ 600,000 | |||||||||
Restricted cash | $ 11,250,000 | |||||||||
Shares of common stock (in Shares) | shares | 11,532,000 | 9,498,000 | ||||||||
Par value per share (in Dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||||||||
General and administrative operating support expense | $ 8,903,000 | $ 56,710,000 | ||||||||
Cash FDIC insured amount | 250,000 | |||||||||
Amortization of intangible assets | $ 500,000 | |||||||||
Number of reportable segment | 1 | |||||||||
Number of operating segment | 1 | |||||||||
Payments to acquire businesses | $ 140,000,000 | |||||||||
Present value of annual minimum royalty discount rate | 10.45% | |||||||||
License sales | $ 300,000 | |||||||||
License revenue | 1,000,000 | |||||||||
Royalty sales | 500,000 | |||||||||
Contract assets | $ 21,600,000 | |||||||||
Reverse stock split, description | shares of our outstanding Common Stock were split at a ratio of 50-for-1 | |||||||||
Number of authorized shares of common stock (in Shares) | shares | 32,000,000 | 12,000,000 | ||||||||
Loss contingency accrual | $ 0 | |||||||||
Employees after workforce reduction | 1 | |||||||||
Restructuring charges including discontinued operations | $ 15,700,000 | |||||||||
Accrued expenses and other current liabilities | 409,000 | 1,604,000 | ||||||||
Accrued Expenses And Other Current Liabilities [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Restructuring costs | 2,500,000 | |||||||||
Current Liabilities For Discontinued Operations [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Restructuring costs | 6,200,000 | |||||||||
Accrued expenses and other current liabilities | $ 9,300,000 | |||||||||
Maximum [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Additional milestone payments to be received on achievement of sales milestone payments | $ 30,000,000 | |||||||||
Number of authorized shares of common stock (in Shares) | shares | 12,000,000 | 32,000,000 | ||||||||
Minimum [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Number of authorized shares of common stock (in Shares) | shares | 12,000,000 | |||||||||
Vita Care Divestiture [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Proceeds from sale of business, net of transaction costs | $ 142,600,000 | |||||||||
Transaction costs | 7,200,000 | |||||||||
Gain on sale of business | 143,400,000 | |||||||||
Vita Care Divestiture [Member] | Maximum [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Contingent cash consideration from sale of business | 7,000,000 | |||||||||
Annoveras [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Gain on intangible assets write off | $ 30,200,000 | |||||||||
Annoveras [Member] | Discontinued Operations [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
General and administrative operating support expense | $ 0 | |||||||||
Licensing Agreements [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Amortization of intangible assets | $ 3,000,000 | |||||||||
Royalty Agreements [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Decrease in royalty rate on product-by-product basis | 2% | |||||||||
Minimal annual royalty payment | $ 3,000,000 | |||||||||
Inflation rate adjusted for minimal annual royalty payment | 3% | |||||||||
Milestone Payments One [Member] | Royalty Agreements [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Threshold annual net sales to determine royalty rate | $ 80,000,000 | |||||||||
Royalty Rate One [Member] | Royalty Agreements [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Royalty rate as percentage on net sales | 8% | |||||||||
Threshold annual net sales to determine royalty rate | $ 80,000,000 | |||||||||
Royalty Rate Two [Member] | Royalty Agreements [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Royalty rate as percentage on net sales | 7.50% | |||||||||
Common Stock [Member] | Maximum [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Number of authorized shares of common stock (in Shares) | shares | 600,000,000 | |||||||||
Forecast [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Aggregate minimum annual royalty Payments due | $ 42,600,000 | |||||||||
Mayne License Agreement [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Period of royalty payments | 20 years | |||||||||
Decrease in royalty rate on product-by-product basis | 2% | |||||||||
Minimal annual royalty payment | $ 3,000,000 | |||||||||
Period of minimal annual royalty payment | 12 years | |||||||||
Inflation rate adjusted for minimal annual royalty payment | 3% | |||||||||
Prepaid royalty liabilities | $ 1,000,000 | |||||||||
Royalty payment payable under long term service agreement | 1,500,000 | |||||||||
Additional fund | $ 900,000 | |||||||||
Accounts Payable and Other Accrued Liabilities | $ 1,500,000 | |||||||||
Cash received in acquire businesses | 140,000,000 | |||||||||
Proceeds from acquire businesses net of working capital adjustments | 12,100,000 | |||||||||
Mayne License Agreement [Member] | Milestone Payments One [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
One-time milestone payments | 5,000,000 | |||||||||
Threshold net sales amount to determine one-time milestone payment | 100,000,000 | |||||||||
Mayne License Agreement [Member] | Milestone Payments Two [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
One-time milestone payments | 10,000,000 | |||||||||
Threshold net sales amount to determine one-time milestone payment | 200,000,000 | |||||||||
Mayne License Agreement [Member] | Milestone Payments Three [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
One-time milestone payments | 15,000,000 | |||||||||
Threshold net sales amount to determine one-time milestone payment | $ 300,000,000 | |||||||||
Mayne License Agreement [Member] | Royalty Rate One [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Royalty rate as percentage on net sales | 8% | |||||||||
Threshold annual net sales to determine royalty rate | $ 80,000,000 | |||||||||
Mayne License Agreement [Member] | Royalty Rate Two [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Royalty rate as percentage on net sales | 7.50% | |||||||||
Threshold annual net sales to determine royalty rate | $ 80,000,000 | |||||||||
Stock Purchase Agreement [Member] | Vita Care Divestiture [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Restricted cash | $ 11,300,000 | |||||||||
Rubric Capital Management L P [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Shares of common stock (in Shares) | shares | 5,000,000 | |||||||||
Par value per share (in Dollars per share) | $ / shares | $ 2.28 | $ 0.001 | ||||||||
Shares, Issued (in Shares) | shares | 312,525 | |||||||||
Shares Issued, Price Per Share (in Dollars per share) | $ / shares | $ 3.6797 | |||||||||
Gross proceeds | $ 2,000,000 | $ 1,150,000 | ||||||||
Shares of common stock (in Shares) | shares | 1,000,000 | |||||||||
Theramex License Agreements [Member] | Bijuvas [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
License sales | $ 300,000 | |||||||||
Land and Building [Member] | Maximum [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Useful life of assets | 7 years | |||||||||
Land and Building [Member] | Minimum [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Useful life of assets | 3 years | |||||||||
Software and Software Development Costs [Member] | Maximum [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Useful life of assets | 7 years | |||||||||
Software and Software Development Costs [Member] | Minimum [Member] | ||||||||||
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies [Line Items] | ||||||||||
Useful life of assets | 5 years |
Business, Basis of Presentati_4
Business, Basis of Presentation, New Accounting Standards and Summary of Significant Accounting Policies (Details) - Summary of Restructuring Cost Recognition - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Restructuring Cost and Reserve [Line Items] | ||
Total restructuring expenses - general and administrative expenses | $ 9,472 | |
Total restructuring expenses - discontinued operations | 6,180 | |
Executive Termination Benefits [Member] | ||
Restructuring Cost and Reserve [Line Items] | ||
Total restructuring expenses - general and administrative expenses | 3,897 | |
Consulting And Legal Expenses [Member] | ||
Restructuring Cost and Reserve [Line Items] | ||
Total restructuring expenses - general and administrative expenses | 3,060 | |
Other Contract Termination Costs [Member] | ||
Restructuring Cost and Reserve [Line Items] | ||
Total restructuring expenses - general and administrative expenses | 2,515 | |
Total restructuring expenses - discontinued operations | 1,367 | |
Employee Termination Benefits [Member] | ||
Restructuring Cost and Reserve [Line Items] | ||
Total restructuring expenses - discontinued operations | $ 4,813 |
Discontinued Operations (Detail
Discontinued Operations (Details) - Discontinued Operations [Member] - Annoveras [Member] | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Discontinued Operations [Line Items] | |
General and administrative | $ 0 |
Cash payment | 140,000,000 |
Net working capital | 12,100,000 |
Prepaid royalties | $ 1,000,000 |
Discontinued Operations (Deta_2
Discontinued Operations (Details) - Schedule of Discontinued Operations - Discontinued Operations [Member] - Annoveras [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Discontinued Operations (Details) - Schedule of Discontinued Operations [Line Items] | ||
Product revenue, net | $ (833) | $ 80,749 |
Cost of goods sold | 15,640 | |
Gross profit (loss) | (833) | 65,109 |
Operating expenses: | ||
Selling and marketing | 75,208 | |
General and administrative | 481 | 11,301 |
Research and development | 4,942 | |
Restructuring charges | 6,180 | |
Total operating expenses | 481 | 97,631 |
Loss from discontinued operations | (1,314) | (32,522) |
Other income (expense): | ||
Gain on sale of vitaCare | 143,384 | |
Gain on ANNOVERA sale | 62,031 | |
Loss on the extinguishment of debt | (8,380) | |
Interest expense and other financing costs | (36,065) | |
Expense for accretion of Series A Preferred Stock | (16,973) | |
Loss on disposal of assets | (1,150) | |
Other expense, net | (115) | |
Total other income (expense), net | (1,265) | 143,997 |
Loss before from income taxes | (2,579) | 111,475 |
Benefit (provision) for income taxes | (552) | |
Net income (loss) from discontinued operations | $ (2,579) | $ 110,923 |
Discontinued Operations (Deta_3
Discontinued Operations (Details) - Schedule of Classes of Liabilities of Discontinued Operations - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule Of Classes Of Liabilities Of Discontinued Operations Abstract | ||
Accounts receivable | $ 344 | |
Total assets | 344 | |
Accounts payable | 12,243 | |
Accrued expenses and other current liabilities | 3,694 | 13,588 |
Total liabilities | $ 3,694 | $ 25,831 |
Prepaid and Other Current Ass_3
Prepaid and Other Current Assets (Details) - Schedule of Prepaid and Other Current Assets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule of Prepaid and Other Current Assets [Abstract] | ||
Insurance | $ 253 | $ 1,167 |
Capitalized legal | 2,334 | 2,334 |
Other | 1,448 | 2,533 |
Prepaid and other current assets | $ 4,035 | $ 6,034 |
Fixed Assets (Details)
Fixed Assets (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fixed Assets [Abstract] | ||
Depreciation expense | $ 0.1 | $ 0.6 |
Fixed Assets (Details) - Schedu
Fixed Assets (Details) - Schedule of Fixed Assets, Net - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Fixed assets | $ 2,522 | $ 2,523 |
Less: accumulated depreciation and amortization | 2,522 | 2,445 |
Fixed assets, net | 78 | |
Furniture and fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets | 931 | 931 |
Computer and office equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets | 1,167 | 1,168 |
Computer software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets | 375 | 375 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets | $ 49 | $ 49 |
Licensed Rights and Other Int_3
Licensed Rights and Other Intangible Assets (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Licensed Rights and Other Intangible Assets [Line Items] | ||
Amortization expense | $ 0.5 | |
Patents [Member] | ||
Licensed Rights and Other Intangible Assets [Line Items] | ||
Amortization expense | $ 0.8 | $ 0.6 |
Licensing Agreements [Member] | ||
Licensed Rights and Other Intangible Assets [Line Items] | ||
Amortization expense | $ 3 |
Licensed Rights and Other Int_4
Licensed Rights and Other Intangible Assets (Details) - Schedule of License Rights and Other Intangible Assets, Net - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Licensed Rights and Other Intangible Assets (Details) - Schedule of License Rights and Other Intangible Assets, Net [Line Items] | ||
Gross Carrying Amount | $ 7,969 | $ 8,541 |
Accumulated Amortization | 1,871 | 1,598 |
Net | 6,098 | 6,943 |
Hormone Therapy Drug Patents [Member] | ||
Licensed Rights and Other Intangible Assets (Details) - Schedule of License Rights and Other Intangible Assets, Net [Line Items] | ||
Gross Carrying Amount | 6,818 | 6,225 |
Accumulated Amortization | 1,871 | 1,598 |
Net | 4,947 | 4,627 |
Hormone therapy drug patents applied and pending approval [Member] | ||
Licensed Rights and Other Intangible Assets (Details) - Schedule of License Rights and Other Intangible Assets, Net [Line Items] | ||
Gross Carrying Amount | 842 | 1,995 |
Accumulated Amortization | ||
Net | 842 | 1,995 |
Intangible Assets Subject to Amortization [Member] | ||
Licensed Rights and Other Intangible Assets (Details) - Schedule of License Rights and Other Intangible Assets, Net [Line Items] | ||
Gross Carrying Amount | 7,660 | 8,220 |
Accumulated Amortization | 1,871 | 1,598 |
Net | 5,789 | 6,622 |
Trademarks and Trade Names [Member] | ||
Licensed Rights and Other Intangible Assets (Details) - Schedule of License Rights and Other Intangible Assets, Net [Line Items] | ||
Gross Carrying Amount | 309 | 321 |
Accumulated Amortization | ||
Net | $ 309 | $ 321 |
Licensed Rights and Other Int_5
Licensed Rights and Other Intangible Assets (Details) - Schedule of Intangible Assets Subject To Amortization $ in Thousands | Dec. 31, 2022 USD ($) |
Schedule of Intangible Assets Subject To Amortization [Abstract] | |
2024 | $ 533 |
2025 | 445 |
2026 | 445 |
2027 | 445 |
2028 | 445 |
Thereafter | 5,347 |
Total | $ 7,660 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Accrued Expenses and Other Current Liabilities [Abstract] | |
Advertising expense | $ 13.2 |
Accrued Expenses and Other Cu_4
Accrued Expenses and Other Current Liabilities (Details) - Schedule of Other Accrued Expenses and Other Current Liabilities - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule of Other Accrued Expenses and Other Current Liabilities [Abstract] | ||
Payroll and related costs | $ 762 | $ 8,748 |
Accrued contract termination costs | 4,700 | |
Research and development expenses | 978 | |
Professional fees | 489 | 415 |
Operating lease liabilities | 1,473 | 1,390 |
Prepaid royalty | 1,011 | |
Other accrued expenses and current liabilities | 409 | 1,604 |
Accrued expenses and other current liabilities | $ 3,133 | $ 18,846 |
Debt (Details)
Debt (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Debt [Abstract] | ||
Interest expense | $ 0.3 | $ 0.2 |
Deb interest expense | $ 13.5 | |
Financing fees amortization | $ 22.5 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) $ in Millions | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2019 USD ($) m² | Dec. 31, 2018 USD ($) m² | Jun. 30, 2019 m² | Oct. 31, 2018 m² | |
Commitments and Contingencies [Line Items] | |||||||
Rentable square feet (in Square Meters) | m² | 48,651 | 7,561 | 6,536 | 62,748 | |||
Lease expiry year | 11 years | ||||||
Lease extend term | two | ||||||
Lease consecutive periods | 5 years | ||||||
Operating Lease, Liability, Statement of Financial Position [Extensible Enumeration] | lease expense | lease expense | |||||
Operating lease expense | $ 2.3 | $ 2.1 | |||||
Rental income | 1.3 | 0 | |||||
Commercial batch release amount | $ 20 | ||||||
Chief Financial Officer [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Executive termination obligations | 0.4 | ||||||
Paragraph Four Certification Notice Letter [Member] | Prepaid Expenses and Other Current Assets [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Legal costs | 2.3 | ||||||
Mayne Pharma Agreement [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Acquisition of net working capital | $ 12.1 | ||||||
Working capital amounts | 5.5 | ||||||
Mayne Pharma Agreement [Member] | Minimum [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Incremental accrual for net working capital | $ 3.5 | ||||||
Mayne Pharma Agreement [Member] | Maximum [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Incremental accrual for net working capital | $ 5.5 | ||||||
Population Council License Agreement [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Milestone payment | $ 20 | ||||||
Population Council License Agreement [Member] | Annoveras [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Aggregate of milestone payments | $ 40 |
Commitments and Contingencies_3
Commitments and Contingencies (Details) - Schedule of Remaining Lease Payments - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule of Remaining Lease Payments [Abstarct] | ||
2024 | $ 1,477 | |
2025 | 1,513 | |
2026 | 1,551 | |
2027 | 1,590 | |
2028 | 1,630 | |
Thereafter | 2,664 | |
Total undiscounted lease payments | 10,425 | |
Less: imputed interest | 2,420 | |
Present value of lease payments | $ 8,005 | $ 8,759 |
Commitments and Contingencies_4
Commitments and Contingencies (Details) - Schedule of Supplemental Balance Sheet Information Related to Leases - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule Of Supplemental Balance Sheet Information Related To Leases Abstract | ||
Operating lease right-of-use assets | $ 6,873 | $ 7,580 |
Operating lease liabilities current (included in accrued expenses and other current liabilities) | 1,473 | 1,390 |
Operating lease liabilities, non-current | 6,532 | 7,369 |
Total operating lease liabilities | $ 8,005 | $ 8,759 |
Commitments and Contingencies_5
Commitments and Contingencies (Details) - Schedule of Other Information Related to Leases - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of Other Information Related to Leases [Abstract] | ||
Weighted average remaining term (years) - operating leases | 6 years 8 months 12 days | 7 years 8 months 12 days |
Weighted average discount rate - operating leases | 8.30% | 8.30% |
Cash paid for amounts included in the measurement of lease liabilities from operating lease (in thousands) | $ 1,443 | $ 1,413 |
Right-of-use assets obtained in exchange for new operating lease obligations (non-cash in thousands) |
Stockholders_ Equity (Deficit_2
Stockholders’ Equity (Deficit) (Details) - USD ($) | 12 Months Ended | ||
Jan. 26, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Stockholders’ Equity (Deficit) [Line Items] | |||
Warrant per share | $ 0.13 | ||
Expected term | 10 years | ||
Percentage of volatility | 69.40% | ||
Expected dividend rate | 0% | ||
Percentage of risk free interest | 2.90% | ||
Share-based payment arrangement, expense | $ 1,300,000 | $ 11,600,000 | |
Total unrecognized share based compensation | 300,000 | ||
Unrecognized compensation cost | $ 300,000 | ||
Share-based compensation over a weighted average period | 9 months 18 days | ||
Two Thousand Nineteen Stock Incentive Plan [Member] | |||
Stockholders’ Equity (Deficit) [Line Items] | |||
Remaining shares of common stock available for future issuance | 394,669,000 | ||
Minimum [Member] | |||
Stockholders’ Equity (Deficit) [Line Items] | |||
Common stock shares authorized | 12,000,000 | ||
Maximum [Member] | |||
Stockholders’ Equity (Deficit) [Line Items] | |||
Common stock shares authorized | 32,000,000 | ||
Phantom Share Units (PSUs) [Member] | |||
Stockholders’ Equity (Deficit) [Line Items] | |||
Number of shares outstanding | 126,573,000 | ||
Performance Shares [Member] | |||
Stockholders’ Equity (Deficit) [Line Items] | |||
Vesting percentage | 100% |
Stockholders_ Equity (Deficit_3
Stockholders’ Equity (Deficit) (Details) - Schedule of Outstanding and Exercisable Warrants and Related Transactions - Warrant [Member] - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stockholders’ Equity (Deficit) (Details) - Schedule of Outstanding and Exercisable Warrants and Related Transactions [Line Items] | ||
Beginning balance, Warrants | 536 | 103 |
Beginning balance, Weighted Average Exercise Price | $ 13.1 | $ 76.19 |
Warrants, Aggregate Intrinsic Value | $ 2,427 | |
Warrants, Weighted Average Remaining Contractual Life | 8 years 3 months 18 days | |
Exercised, Warrants | (435) | |
Exercised, Weighted Average Exercise Price | $ 0.01 | |
Exercised, Weighted Average Exercise Price | $ (2,270) | |
Granted, Warrants | 436 | |
Granted, Weighted Average Exercise Price | $ 0.14 | |
Expired, Warrants | (2) | (3) |
Expired, Weighted Average Exercise Price | $ 0.89 | $ 341.5 |
Ending balance, Warrants | 99 | 536 |
Ending balance, Weighted Average Exercise Price | $ 66.61 | $ 13.1 |
Warrants, Aggregate Intrinsic Value | $ 1,793 | $ 2,427 |
Warrants, Weighted Average Remaining Contractual Life | 6 years 6 months | 9 years 3 months 18 days |
Stockholders_ Equity (Deficit_4
Stockholders’ Equity (Deficit) (Details) - Schedule of Stock Options Activity - USD ($) | 12 Months Ended | ||
Jan. 01, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of Stock Options Activity [Abstract] | |||
Options awards outstanding, Beginning balance | 353,000 | 172,000 | 353,000 |
Options awards outstanding, weighted average exercise price, Beginning balance | $ 225.98 | $ 228.28 | $ 225.98 |
Options awards outstanding, aggregate intrinsic value | |||
Options awards outstanding, Weighted Average Remaining Contractual Life (in Years) | 3 years 9 months 18 days | ||
Options awards exercisable, Beginning balance | 336,000 | 170,000 | 336,000 |
Options awards exercisable, weighted average exercise price, Beginning balance | $ 230.93 | $ 229.43 | $ 230.93 |
Options awards exercisable, Aggregate Intrinsic Value | |||
Options awards exercisable, Weighted Average Remaining Contractual Life (in Years) | 3 years 7 months 6 days | 3 years | 3 years 7 months 6 days |
Options awards outstanding, Cancelled/Forfeited | (4,000) | ||
Options awards outstanding Weighted Average Exercise Price, Cancelled/Forfeited | $ 94.99 | ||
Options awards outstanding, Expired | (100,000) | (177,000) | |
Options awards outstanding Weighted Average Exercise Price, Expired | $ 206.15 | $ 226.56 | |
Options awards outstanding, Ending balance | 72,000 | 172,000 | |
Options awards outstanding, weighted average exercise price, Ending balance | $ 258.55 | $ 228.28 | |
Options awards outstanding, aggregate intrinsic value | |||
Options awards outstanding, Weighted Average Remaining Contractual Life (in Years) | 3 years | 3 years 7 months 6 days | |
Options awards exercisable, Ending balance | 73,000 | 170,000 | |
Options awards exercisable, weighted average exercise price, Ending balance | $ 258.46 | $ 229.43 | |
Options awards exercisable, Aggregate Intrinsic Value |
Stockholders_ Equity (Deficit_5
Stockholders’ Equity (Deficit) (Details) - Schedule of the Status of our Unvested and Related Transactions - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Restricted Stock Units (RSUs) [Member] | ||
Stockholders’ Equity (Deficit) (Details) - Schedule of the Status of our Unvested and Related Transactions [Line Items] | ||
Unvested, Beginning balance (in Shares) | 57 | 272 |
Weighted Average Grant Date Fair Value, Beginning balance | $ 14.57 | $ 58 |
Aggregate Intrinsic Value, Beginning balance | $ 318.63 | $ 4,890 |
Unvested, Granted (in Shares) | 163 | 170 |
Weighted Average Grant Date Fair Value, Granted | $ 4.82 | $ 16.05 |
Aggregate Intrinsic Value, Granted | ||
Unvested, Vested (in Shares) | (180) | (327) |
Weighted Average Grant Date Fair Value, Vested | $ 6.83 | $ 48.2 |
Aggregate Intrinsic Value, Vested | ||
Unvested, Cancelled/Forfeited (in Shares) | (58) | |
Weighted Average Grant Date Fair Value, Cancelled/Forfeited | $ (37) | |
Weighted Average Grant Date Fair Value, Cancelled/Forfeited | $ 37 | |
Aggregate Intrinsic Value, Cancelled/Forfeited | ||
Unvested Ending balance (in Shares) | 40 | 57 |
Weighted Average Grant Date Fair Value, Ending balance | $ 9.67 | $ 14.57 |
Aggregate Intrinsic Value, Ending balance | $ 89.6 | $ 318.63 |
Performance Shares [Member] | ||
Stockholders’ Equity (Deficit) (Details) - Schedule of the Status of our Unvested and Related Transactions [Line Items] | ||
Unvested, Beginning balance (in Shares) | 19 | 164 |
Weighted Average Grant Date Fair Value, Beginning balance | $ 52.15 | $ 51.5 |
Aggregate Intrinsic Value, Beginning balance | $ 107.55 | $ 2,953 |
Unvested, Granted (in Shares) | 63 | |
Weighted Average Grant Date Fair Value, Granted | $ 34.5 | |
Aggregate Intrinsic Value, Granted | ||
Unvested, Vested (in Shares) | (5) | (133) |
Weighted Average Grant Date Fair Value, Vested | $ 56.05 | $ 47.12 |
Aggregate Intrinsic Value, Vested | $ (10.72) | $ (2,382.98) |
Unvested, Cancelled/Forfeited (in Shares) | (75) | |
Weighted Average Grant Date Fair Value, Cancelled/Forfeited | $ (44.85) | |
Weighted Average Grant Date Fair Value, Cancelled/Forfeited | $ 44.85 | |
Aggregate Intrinsic Value, Cancelled/Forfeited | ||
Unvested Ending balance (in Shares) | 14 | 19 |
Weighted Average Grant Date Fair Value, Ending balance | $ 50.87 | $ 52.15 |
Aggregate Intrinsic Value, Ending balance | $ 33 | $ 107.55 |
Revenue (Details)
Revenue (Details) | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Revenue [Line Items] | |
Period of minimal annual royalty payment | 20 years |
License sale | $ 300,000 |
License revenue | 1,000,000 |
Royalty sales | $ 500,000 |
Mayne License Agreement [Member] | |
Revenue [Line Items] | |
Period of minimal annual royalty payment | 20 years |
Decrease in royalty rate on product-by-product basis | 2% |
Minimal annual royalty payment | $ 3,000,000 |
Period of minimal annual royalty payment | 12 years |
Inflation rate adjusted for minimal annual royalty payment | 3% |
Mayne License Agreement [Member] | Milestone Payments 1 [Member] | |
Revenue [Line Items] | |
One-time milestone payments | $ 5,000,000 |
Threshold net sales amount to determine one-time milestone payment | 100,000,000 |
Mayne License Agreement [Member] | Milestone Payments 2 [Member] | |
Revenue [Line Items] | |
One-time milestone payments | 10,000,000 |
Threshold net sales amount to determine one-time milestone payment | 200,000,000 |
Mayne License Agreement [Member] | Milestone Payments 3 [Member] | |
Revenue [Line Items] | |
One-time milestone payments | 15,000,000 |
Threshold net sales amount to determine one-time milestone payment | $ 300,000,000 |
Mayne License Agreement [Member] | Royalty Rate 1 [Member] | |
Revenue [Line Items] | |
Royalty rate as percentage on net sales | 8% |
Threshold annual net sales to determine royalty rate | $ 80,000,000 |
Mayne License Agreement [Member] | Royalty Rate 2 [Member] | |
Revenue [Line Items] | |
Royalty rate as percentage on net sales | 7.50% |
Threshold annual net sales to determine royalty rate | $ 80,000,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Taxes [Line Items] | ||
Provision for income taxes continuing and discontinued operations | 0.50% | |
Operating loss (“NOL”) carryforwards | $ 577 | |
Carried forward | 20 years | |
Excess taxable income | 80% | |
Unrecognized tax benefits | ||
Minimum [Member] | ||
Income Taxes [Line Items] | ||
Provision for income taxes continuing and discontinued operations | 0% | |
Maximum [Member] | ||
Income Taxes [Line Items] | ||
Provision for income taxes continuing and discontinued operations | 0.50% | |
Expiration Period 20 Years [Member] | ||
Income Taxes [Line Items] | ||
Operating loss (“NOL”) carryforwards | $ 19.2 | |
Expiration Period Indefinite [Member] | ||
Income Taxes [Line Items] | ||
Operating loss (“NOL”) carryforwards | $ 557.8 |
Income Taxes (Details) - Schedu
Income Taxes (Details) - Schedule of Income (Loss) from Continuing Operations Before Income Taxes - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
United States [Member] | ||
Income Taxes (Details) - Schedule of Income (Loss) from Continuing Operations Before Income Taxes [Line Items] | ||
United States | $ (7,742) | $ 1,074 |
Income Taxes (Details) - Sche_2
Income Taxes (Details) - Schedule of Effective Income Tax Rate Reconciliation - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of Effective Income Tax Rate Reconciliation [Abstract] | ||
Federal statutory tax rate (in Dollars) | $ (1,626) | |
Federal statutory tax rate, percentage | 21% | 21% |
State tax rate, net of federal tax benefit (in Dollars) | ||
State tax rate, net of federal tax benefit, percentage | 0% | 3.90% |
Adjustment in valuation allowances (in Dollars) | $ (22,173) | |
Adjustment in valuation allowances, percentage | 286.40% | (3228.60%) |
Excess stock benefits (in Dollars) | $ 2,460 | |
Excess stock benefits, percentage | (31.80%) | 835.20% |
Interest expense accretion (in Dollars) | $ 35 | |
Interest expense accretion, percentage | (0.50%) | 0% |
Permanent and other differences (in Dollars) | $ 21,261 | |
Permanent and other differences, percentage | (274.60%) | 2,368.50% |
(Benefit) provision for income taxes (in Dollars) | $ (43) | |
(Benefit) provision for income taxes, percentage | 0.50% | 0% |
Income Taxes (Details) - Sche_3
Income Taxes (Details) - Schedule of Components of Net Deferred Income Tax Asset - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred income tax assets (liabilities): | ||
Net operating loss | $ 158,040 | $ 176,631 |
Share-based payment compensation | 3,339 | 8,590 |
Interest expense limitation | 19,547 | 19,707 |
Gain on sale of ANNOVERA | (3,401) | (3,624) |
Accrual for sales returns and coupons | 288 | |
R&D credit | 186 | 186 |
Other, net | 256 | (1,062) |
Deferred income tax asset | 178,255 | (200,428) |
Valuation allowance | (178,255) | 200,428 |
Deferred income tax assets, net |
Income (Loss) Per Common Shar_2
Income (Loss) Per Common Share (Details) - Schedule of Computation of Basic and Diluted Income (Loss) Per Common Share - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Numerator: | ||
Net income (loss) from continuing operations (in Dollars) | $ (7,699) | $ 1,074 |
Net income (loss) from discontinued operations (in Dollars) | (2,579) | 110,923 |
Net income (loss) (in Dollars) | $ (10,278) | $ 111,997 |
Denominator: | ||
Weighted average common shares for basic income (loss) per common share (in Shares) | 10,441 | 9,028 |
Effect of dilutive securities (in Shares) | 338 | |
Weighted average common shares for diluted income (loss) per common share (in Shares) | 10,441 | 9,366 |
Income (loss) per common share, continuing operations | ||
Basic | $ (0.74) | $ 0.12 |
Diluted | (0.74) | 0.11 |
Income (loss) per common share, discontinued operations | ||
Basic | (0.25) | 12.29 |
Diluted | $ (0.25) | $ 11.84 |
Income (Loss) Per Common Shar_3
Income (Loss) Per Common Share (Details) - Schedule of Outstanding Securities - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of Outstanding Securities [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 225 | 273 |
Stock options [Member] | ||
Schedule of Outstanding Securities [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 72 | 172 |
RSUs [Member] | ||
Schedule of Outstanding Securities [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 40 | |
PSUs [Member] | ||
Schedule of Outstanding Securities [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 14 | |
Warrants [Member] | ||
Schedule of Outstanding Securities [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 99 | 101 |
Related parties (Details)
Related parties (Details) - Rubric Capital Management L P [Member] - USD ($) $ / shares in Units, $ in Thousands | Nov. 15, 2023 | Jun. 28, 2023 | Dec. 30, 2022 |
Related parties [Line Items] | |||
Common stock shares issued | 312,525,000 | ||
Price per share | $ 2.2761 | $ 3.6797 | |
Gross proceeds | $ 2,000 | $ 1,150 | |
Additional shares of common stock | 877,192,000 | ||
Subscription Agreement [Member] | Series A Preferred Stock [Member] | |||
Related parties [Line Items] | |||
Outstanding shares | 29,000,000 | ||
Preferred stock at a purchase price | $ 1,333 | ||
Preferred stock investor | $ 3,000 |
Business Concentrations (Detail
Business Concentrations (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Theramex [Member] | |
Business Concentrations [Line Items] | |
Customer license revenue percentage | 100% |
Mayne Pharma [Member] | |
Business Concentrations [Line Items] | |
Royalty receivable short term portion | $ 3.1 |
Royalty receivable long term portion | $ 18.5 |