Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2021 | May 06, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2021 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2021 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-00100 | |
Entity Registrant Name | THERAPEUTICSMD, INC. | |
Entity Central Index Key | 0000025743 | |
Entity Tax Identification Number | 87-0233535 | |
Entity Incorporation, State or Country Code | NV | |
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 | |
City Area Code | 561 | |
Local Phone Number | 961-1900 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | TXMD | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 393,190,000 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current Assets: | ||
Cash | $ 137,617 | $ 80,486 |
Accounts receivable, net of allowance of credit losses of $1,231 and $1,118 as of March 31, 2021 and December 31, 2020, respectively | 33,719 | 32,382 |
Inventory | 7,346 | 7,993 |
Prepaid and other current assets | 8,360 | 7,543 |
Total current assets | 187,042 | 128,404 |
Fixed assets, net | 1,812 | 1,942 |
License rights and other intangible assets, net | 40,994 | 41,445 |
Right of use assets | 9,205 | 9,566 |
Other non-current assets | 253 | 253 |
Total assets | 239,306 | 181,610 |
Current Liabilities: | ||
Current maturities of long-term debt | 5,000 | |
Accounts payable | 10,310 | 21,068 |
Accrued expenses and other current liabilities | 45,974 | 38,170 |
Total current liabilities | 61,284 | 59,238 |
Long-term debt, net | 178,970 | 237,698 |
Operating lease liabilities | 8,530 | 8,675 |
Total liabilities | 248,784 | 305,611 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity (deficit): | ||
Preferred stock, par value $ 0.001; 10,000 shares authorized, none issued | 0 | 0 |
Common stock, par value $ 0.001; 600,000 shares authorized, 393,190 and 299,765 issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 393 | 300 |
Additional paid-in capital | 908,457 | 754,644 |
Accumulated deficit | (918,328) | (878,945) |
Total stockholders' deficit | (9,478) | (124,001) |
Total liabilities and stockholders' equity (deficit) | $ 239,306 | $ 181,610 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Accounts Receivable, Allowance for Credit Loss | $ 1,231 | $ 1,118 |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 600,000,000 | 600,000,000 |
Common Stock, Shares, Issued | 393,190,000 | 299,765,000 |
Common Stock, Shares, Outstanding | 393,190,000 | 299,765,000 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Total revenue, net | $ 19,866 | $ 12,251 |
Cost of goods sold | 4,687 | 2,715 |
Gross profit | 15,179 | 9,536 |
Operating expenses: | ||
Selling, general and administrative | 42,407 | 57,189 |
Research and development | 2,050 | 3,269 |
Total operating expenses | 44,457 | 60,458 |
Loss from operations | (29,278) | (50,922) |
Other (expense) income: | ||
Interest expense and other financing costs | (10,227) | (6,262) |
Other income, net | 122 | 335 |
Other (expense), net | (10,105) | (5,927) |
Loss before income taxes | (39,383) | (56,849) |
Provision for income taxes | 0 | 0 |
Net loss | $ (39,383) | $ (56,849) |
Loss per share, basic and diluted: | ||
Loss per common share, basic and diluted | $ (0.11) | $ (0.21) |
Weighted average common shares, basic and diluted | 347,219 | 271,460 |
Product [Member] | ||
Total revenue, net | $ 19,632 | $ 12,251 |
License [Member] | ||
Total revenue, net | $ 234 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] |
Beginning balance, value at Dec. 31, 2019 | $ 9,201 | $ 271 | $ 704,351 | $ (695,421) |
Beginning balance, shares at Dec. 31, 2019 | 271,177,000 | |||
Shares issued for exercise of options and warrants | 72 | 72 | ||
Shares issued for exercise of options and warrants, net (in shares) | 351,000 | |||
Share-based compensation | 2,366 | 2,366 | ||
Shares issued for vested restricted stock units (in shares) | 150,000 | |||
Net loss | (56,849) | (56,849) | ||
Ending balance, value at Mar. 31, 2020 | (45,210) | $ 271 | 706,789 | (752,270) |
Ending balance, shares at Mar. 31, 2020 | 271,678,000 | |||
Beginning balance, value at Dec. 31, 2020 | $ (124,001) | $ 300 | 754,644 | (878,945) |
Beginning balance, shares at Dec. 31, 2020 | 299,765,000 | 299,765,000 | ||
Shares issued for sale of common stock, net of cost, value | $ 150,899 | $ 93 | 150,806 | |
Shares issued for sale of common stock, net of cost, shares | 92,870,000 | |||
Shares issued for exercise of options and warrants | 50 | 50 | ||
Shares issued for exercise of options and warrants, net (in shares) | 503,000 | |||
Share-based compensation | 2,957 | 2,957 | ||
Shares issued for vested restricted stock units (in shares) | 52,000 | |||
Net loss | (39,383) | (39,383) | ||
Ending balance, value at Mar. 31, 2021 | $ (9,478) | $ 393 | $ 908,457 | $ (918,328) |
Ending balance, shares at Mar. 31, 2021 | 393,190,000 | 393,190,000 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (39,383) | $ (56,849) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,019 | 1,008 |
Charges (credits) to provision for doubtful accounts | 230 | (123) |
Inventory charge | 502 | 136 |
Debt financing fees | 1,272 | 320 |
Non-cash operating lease expense | 216 | 352 |
Share-based compensation | 2,957 | 2,366 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (1,567) | 3,855 |
Inventory | 145 | (2,883) |
Prepaid and other current assets | (817) | 4,436 |
Accounts payable | (10,758) | 9,533 |
Accrued expenses and other current liabilities | 7,804 | (1,262) |
Total adjustments | 1,003 | 17,738 |
Net cash used in operating activities | (38,380) | (39,111) |
Cash flows from investing activities: | ||
Payment of patent related costs | (375) | (422) |
Purchase of fixed assets | (63) | (21) |
Net cash used in investing activities | (438) | (443) |
Cash flows from financing activities: | ||
Proceeds from sale of common stock, net of costs | 150,899 | |
Proceeds from exercise of options and warrants | 50 | 72 |
Repayments of debt | (50,000) | |
Borrowings of debt | 50,000 | |
Payment of debt financing fees | (5,000) | (1,250) |
Net cash provided by financing activities | 95,949 | 48,822 |
Net increase in cash | 57,131 | 9,268 |
Cash, beginning of period | 80,486 | 160,830 |
Cash, end of period | 137,617 | 170,098 |
Supplemental disclosure of cash flow information: | ||
Interest paid | $ 8,955 | $ 5,893 |
Basis of presentation and summa
Basis of presentation and summary of significant accounting policies | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of presentation and summary of significant accounting policies | 1. Basis of presentation and summary of significant accounting policies General TherapeuticsMD, Inc., a Nevada corporation (the “Company”), and its consolidated subsidiaries are referred to collectively in this Quarterly Report on Form 10-Q (“10-Q 10-Q ® ® ® ® ® ® 10-Q ® TM SM We are 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. At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women. Our solutions range from a patient-controlled, long-lasting contraceptive to advanced hormone therapy pharmaceutical products. We also have a portfolio of branded and generic prescription prenatal vitamins under the vitaMedMD and BocaGreenMD brands. Our portfolio of products focused on women’s health allows us to efficiently leverage our sales and marketing plan to grow our recently approved products. Principles of consolidation We prepared the consolidated financial statements included in this 10-Q Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these interim financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair statement of the financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in this 10-Q 10-K 10-K Risks and uncertainties related to COVID-19 We continue to be subject to risks and uncertainties in connection with the COVID-19 COVID-19 Since the early phase of the COVID-19 ™ e-detailing As part of our response to the COVID-19 non-critical non-essential The full impact of the COVID-19 COVID-19 COVID-19 COVID-19 COVID-19 COVID-19 While we currently believe that our COVID-19 COVID-19 COVID-19 Significant accounting policies The significant accounting policies we use for quarterly financial reporting are disclosed in Note 2, Summary of Significant Accounting Policies of the accompanying notes to the consolidated financial statements included in our 2020 10-K Accounting standards issued but not yet adopted There have been no recently issued accounting standards not yet adopted by us which are expected, upon adoption, to have a material impact on our consolidated financial statements or processes. Reclassification Certain amounts reported in prior periods in the financial statements have been reclassified to conform to the current period’s presentation. |
Accounts receivable
Accounts receivable | 3 Months Ended |
Mar. 31, 2021 | |
Receivables [Abstract] | |
Accounts receivable | 2. Accounts receivable We extend credit on an unsecured basis to most of our customers. Our exposure to credit losses may increase if our customers are adversely affected by changes in healthcare laws, coverage, and reimbursement, economic pressures or uncertainty associated with local or global economic recessions, disruption associated with the current COVID-19 W The following sets forth activities in our allowance for credit losses (in thousands): Total Balance as of January 1, 2021 $ 1,118 Charges to provision for credit losses 230 Write-off (117 ) Balance as of March 31, 2021 $ 1,231 |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | 3. Inventory W Our inventory consisted of the following (in thousands): March 31, December 31, Raw materials $ 4,487 $ 4,423 Work in process 222 220 Finished products 2,637 3,350 Inventory $ 7,346 $ 7,993 |
Prepaid and other current asset
Prepaid and other current assets | 3 Months Ended |
Mar. 31, 2021 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid and other current assets | 4. Prepaid and other current assets Our prepaid and other current assets consisted of the following (in thousands): March 31, December 31, Insurance $ 1,522 $ 2,568 Paragraph IV legal proceeding costs 1,926 — Other 4,912 4,975 Prepaid and other current assets $ 8,360 $ 7,543 |
Fixed assets, net
Fixed assets, net | 3 Months Ended |
Mar. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Fixed assets, net | 5. Fixed assets, net Our fixed assets, net consisted of the following (in thousands): March 31, December 31, Furniture and fixtures $ 1,407 $ 1,407 Computer and office equipment 1,810 1,784 Computer software 450 412 Leasehold improvements 80 80 Fixed assets 3,747 3,683 Less: accumulated depreciation and amortization 1,935 1,741 Fixed assets, net $ 1,812 $ 1,942 For the three months ended March 31, 2021 and 2020, we recorded depreciation expense of $ thousand and $ thousand, respectively. |
License rights and other intang
License rights and other intangible assets, net | 3 Months Ended |
Mar. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
License rights and other intangible assets, net | 6. License rights and other intangible assets, net The following provides information about our license rights and other intangible assets, net (in thousands): March 31, 2021 December 31, 2020 Gross Accumulated Net Gross Accumulated Net Intangible assets subject to amortization License rights agreement $ 40,000 $ 4,559 $ 35,441 $ 40,000 $ 3,803 $ 36,197 Hormone therapy drug patents 4,181 818 3,363 4,045 748 3,297 Hormone therapy drug patents applied and pending approval 1,857 — 1,857 1,628 — 1,628 46,038 5,377 40,661 45,673 4,551 41,122 Intangible assets not subject to amortization Trademarks/trade name rights 333 — 333 323 — 323 $ 46,371 $ 5,377 $ 40,994 $ 45,996 $ 4,551 $ 41,445 During the three months ended March 31, 2021 and 2020, we recorded $ 756 thousand and $ 746 thousand, respectively, in amortization expense related to an exclusive license agreement (the “Population Council License Agreement”) with Population Council to commercially manufacture and sell ANNOVERA in the U.S., which was recorded as a component of cost of sales. As of March 31, 2021 and December 31, 2020, respectively, we had a total of 79 patents, of which 40 were domestic, and a total of 77 patents, of which 38 were domestic. We recorded $ 70 thousand and $ 63 thousand of amortization expense related to patents for the three months ended March 31, 2021 and 2020, respectively. We use a combination of qualitative and quantitative factors to assess intangible assets for impairment. As a result of performing these assessments, we determined that no impairment existed as of March 31, 2021 and, therefore, recorded no write-downs to any of our intangible assets. |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 3 Months Ended |
Mar. 31, 2021 | |
Payables and Accruals [Abstract] | |
Accrued expenses and other current liabilities | 7. Accrued expenses and other current liabilities Other accrued expenses and other current liabilities consisted of the following (in thousands): March 31, December 31, Payroll and related costs $ 8,311 $ 11,179 Rebates 12,691 11,011 Sales returns and coupons 5,676 7,057 Wholesale distributor fees 4,243 2,632 Professional fees 6,198 925 Other accrued expenses and current liabilities 8,855 5,366 Accrued expenses and other current liabilities $ 45,974 $ 38,170 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt | 8. Debt W In January 2021, we entered into Amendment No. 7 to the Financing Agreement (“Amendment No. 7”) pursuant to which, among other amendments, the minimum quarterly product net revenue requirements attributable to commercial sales of IMVEXXY, BIJUVA, and ANNOVERA for the fiscal quarters ending March 31, 2021 and June 30, 2021 were reduced, and we paid an amendment financing fee of $5.0 million, which was included as a component of deferred financing fees in long-term debt in the accompany consolidated balance sheets. Additionally, in connection with entering into Amendment No. 7, the warrants issued to the Administrative Agent and the lenders under the Financing Agreement on August 5, 2020 were further amended to provide for an additional adjustment to the exercise price if we conducted certain dilutive issuances prior to March 31, 2021. No such adjustments were made to the exercise price of these warrants prior to the expiration of such period. I No. 8, we (i) repaid $ million in principal under the Financing Agreement during the three months ended March 31 , 2021 , plus a % prepayment fee, and (ii) agreed to make additional principal repayments as follows: (x) $ million on each of March 31 , 2022 , June 30 , 2022 and September 30 , 2022 ; (y) $ million on each of December 31 , 2022 and March 31 , 2023 ; and (z) $ million on each of June 30 , 2023 , September 30 , 2023 , December 31 , 2023 and March 31 , 2024 , plus the prepayment fees described in the following sentence. In connection with Amendment No . 8 , the prepayment fees on principal amounts being prepaid under the Financing Agreement were revised as follows: (i) % of the principal amount being repaid through March 31 , 2022 (excluding the scheduled $ million principal repayment on such date, which is subject to a % prepayment fee); (ii) % of the principal amount being repaid from April 1 , 2022 through March 31 , 2023 ; (iii) % of the principal amount being repaid from April 1 , 2023 through March 31 , 2024 ; and (iv) thereafter, none , in each case subject to certain limited exceptions, including with respect to a repayment in full of the obligations under the Financing Agreement. Ou r March 2021 December 31, Financing Agreement $ 200,000 $ 250,000 Less: deferred financing fees 16,030 12,302 Debt, net 183,970 237,698 Current maturities of long-term debt 5,000 — Long-term debt $ 178,970 $ 237,698 Interest and financing costs Interest expense and other financing costs consisted of the following (in thousands): Three Months Ended 2021 2020 Interest expense $ 6,455 $ 5,942 Interest prepayment fees 2,500 — Financing fees amortization 1,272 320 Interest expense and other financing costs $ 10,227 $ 6,262 A Year Ended 2021 (9 months) $ 4,377 2022 5,875 2023 5,078 2024 700 $ 16,030 Debt covenants compliance The Financing Agreement requires us to have a minimum unrestricted cash balance of $ million. As of the filing date of this 10-Q anticipate that we will remain in compliance with the minimum cash balance covenant for the next twelve months from the issuance of the consolidated financial statements included in this 10-Q COVID-19 10-Q COVID-19 T |
Commitments and contingencies
Commitments and contingencies | 3 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | 9. Commitments and contingencies Minimum purchase commitments We have manufacturing and supply agreements whereby we are required to purchase from Catalent, Inc. (“Catalent”) a minimum number of units of BIJUVA and IMVEXXY softgels during each respective annual contract year. The annual contract period for BIJUVA and IMVEXXY ends each April and July, respectively. If the minimum order quantities of BIJUVA or IMVEXXY are not met, we are required to pay a minimum commitment fee equal to 50% or 60 %, respectively, of the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of BIJUVA or IMVEXXY during each product’s respective contract year. Additionally, with another third-party manufacturer, we have a manufacturing and supply agreement whereby we are required to purchase a minimum number of units of ANNOVERA during a contract year. The annual contract period for ANNOVERA ends each August. If the minimum order quantities of ANNOVERA are not met, we are required to pay a minimum commitment fee equal to the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of ANNOVERA during the contract year. For each of the three annual contract years ending in 2021, we expect to meet our minimum purchase number of units in all material respects, accordingly, we believe that minimum commitment fees that we may pay, if any, will not have a material impact to our financial position and operating results. For annual contract years ending in 2022 and thereafter, we will continue to evaluate whether we will be able to meet each annual contract year’s respective minimum purchase commitment and will record a liability for estimated minimum commitment fees if we believe that we will not be able to reasonably meet the minimum purchase commitment. 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 FDA by Teva Pharmaceuticals USA, Inc. (“Teva”). The ANDA seeks approval from 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 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. A trial date has not been set. In March 2020, we received a Paragraph IV certification notice letter (the “BIJUVA Notice Letter”) regarding an ANDA submitted to FDA by Amneal Pharmaceuticals (“Amneal”). The ANDA seeks approval from FDA to commercially manufacture, use, or sell a generic version of BIJUVA. In the BIJUVA Notice Letter, Amneal alleges that TherapeuticsMD patents listed in FDA’s Orange Book that claim compositions and methods of BIJUVA (the “BIJUVA Patents”) are invalid, unenforceable, and/or will not be infringed by Amneal’s commercial manufacture, use, or sale of its proposed generic drug product. The BIJUVA Patents identified in the BIJUVA Notice Letter expire in 2032. In April 2020, we filed a complaint for patent infringement against Amneal in the United States District Court for the District of New Jersey arising from Amneal’s ANDA filing with FDA. We are seeking, among other relief, an order that the effective date of any FDA approval of Amneal’s ANDA would be a date no earlier than the expiration of the BIJUVA Patents and equitable relief enjoining Amneal from infringing the BIJUVA Patents. Amneal has filed its answer and counterclaim to the complaint, alleging that the BIJUVA Patents are invalid and not infringed. A trial date has not been set. In February 2021, the District Court entered an order temporarily staying all proceedings in the BIJUVA litigation. The District Court stay also extends the 30-month As of March 31, 2021, in the aggregate, we have incurred and recorded paragraph IV legal proceeding costs amounting to $1.9 million in prepaid expenses and other current assets in the accompanying consolidated balance sheets since we believe that we will successfully prevail in these two legal proceedings. Upon the successful conclusion of each of the above legal proceeding, the related capitalized legal costs for that legal proceeding 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 of the respective patent. If we are unsuccessful in either one of the above legal proceedings, then the related capitalized legal costs and respective unamortized patent costs for that legal proceeding will be immediately expensed in the period in which we become aware of unsuccessful legal proceeding. |
Stockholders' equity (deficit)
Stockholders' equity (deficit) | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Stockholders' equity | 10. Stockholders’ equity (deficit) Common stock In November 2020, we entered into an at-the-market offering program (the “2020 ATM Program”) relating to shares of our common stock. The 2020 ATM Program permitted us to offer and sell shares of our common stock having an aggregate offering price of up to million from time to time through or to the sales agent under the 2020 ATM Program. Sales of our common stock were permitted to be made from time to time in at-the-market offerings as defined in Rule 415 of the Securities Act of 1933, as amended (the “Securities Act”), including by means of ordinary broker’s transactions on the Nasdaq Stock Exchange or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices, or as otherwise agreed to with the sales agent. The sales agent was entitled to compensation at a fixed commission rate of of the aggregate gross sales price per share sold. As of February 8, 2021, sales of shares of our common stock under the 2020 ATM Program were completed when we sold an aggregate total of million shares of our common stock at an average sale price of per share, and we received net proceeds of million, after deducting the underwriting discounts and commissions and estimated offering expenses. In February 2021, we closed on an underwritten public offering of our common stock, pursuant to which we issued an aggregate total of million shares of our common stock at an offering price of million, after deducting the underwriting discounts and commissions and estimated offering expenses. In March 2021, we entered into an at-the-market offering program (the “2021 ATM Program”) relating to shares of our common stock. The 2021 ATM Program permits us to offer and sell shares of our common stock having an aggregate offering price of up to million from time to time through or to the under the 2021 ATM Program sales agent. Sales of our common stock may be made from time to time in at-the-market offerings as defined in Rule 415 of the Securities Act, including by means of ordinary broker’s transactions on the Nasdaq Stock Exchange or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices, or as otherwise agreed to with the sales agent. The investment bank will be entitled to compensation at a fixed commission rate of of the aggregate gross sales price per share sold. The sales agent is not required to sell any specific number or dollar amounts of securities but will act as sales agent and use commercially reasonable efforts to sell on our behalf all of the shares of common stock requested to be sold by us, consistent with its normal trading and sales practices, on mutually agreed terms between us and the sales agent. Through March 31, 2021, we have sold million shares of our common stock at an average sale price of per share and we received estimated net proceeds of million, after deducting the underwriting discounts and commissions and estimated offering expenses. Subsequently, and through the date of this 10-Q Report filing, we have not sold any additional shares of our common stock under the 2021 ATM Program. Future sales, if any, under the 2021 ATM Program will depend on a variety of factors, including among others, market conditions, the trading price of our common stock, determinations by us of the appropriate sources of funding, and potential uses of funding available to us. Restricted stock units During the three months ended March 31, 2021, we granted 327 thousand restricted stock units (“RSUs”) at a weighted average grant date fair value of $1.58 per unit. The weighted average vesting life of these RSUs was 2.1 years. Additionally, we settled 52 thousand vested RSUs during the three months ended March 31, 2021 and the weighted average grant date fair value of these RSUs was $1.86 per unit. Furthermore, during the three months ended March 31, 2021, there were 732 thousand RSUs that vested, but were not yet settled as of March 31, 2021, and for which the weighted average grant date fair value was $1.07 per unit. We anticipate that settlement of these RSUs will occur in May 2021. Warrants In March 2021, a warrant holder exercised the holder’s right to purchase an aggregate of thousand shares of our common stock were issued. In total, during the three months ended March 31, 2021, warrants to purchase an aggregate of |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2021 | |
Disaggregation of Revenue [Abstract] | |
Revenue | 11. Revenue The following table provides information about disaggregated revenue by product mix and service (in thousands): Three Months Ended March 31, 2021 2020 ANNOVERA $ 8,750 $ 2,273 IMVEXXY 7,012 6,392 BIJUVA 2,445 1,112 Prescription vitamin 1,425 2,474 Product revenue, net 19,632 12,251 License revenue 234 — Total revenue, net $ 19,866 $ 12,251 |
Operating expenses
Operating expenses | 3 Months Ended |
Mar. 31, 2021 | |
Operating Expenses [Abstract] | |
Operating expenses | 12. Operating expenses The following provides information about operating expenses (in thousands): Three Months Ended March 31, 2021 2020 Compensation and employee benefits $ 19,891 $ 18,018 Selling and marketing 13,865 29,742 General and administrative 8,651 9,429 Research and development 2,050 3,269 Total operating expenses $ 44,457 $ 60,458 Our compensation and employee benefits exclude those employees who perform research & development (“R&D”) related activities. Our R&D costs consist mainly of costs incurred under agreements with contract research organizations (“CROs”) and other third parties that conduct our clinical related studies, compensation and benefit costs related employees engaged in R&D activities, costs to developing our chemistry, manufacturing, and controls capabilities, costs related to manufacturing validation, and costs associated with other research activities and regulatory approvals. With regards to costs of clinical trials, they may vary significantly over the life of a project owing to a variety of factors and we base our expenses related to clinical trials on estimates based on our experience and estimates from CROs and other third parties. R&D expenditures for the drug products will continue after the clinical trial completes for on-going |
Income taxes
Income taxes | 3 Months Ended |
Mar. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income taxes | 13. Income taxes We do not expect to pay any significant federal or state income taxes as a result of (i) the losses recorded during the three months ended March 31, 2021 and 2020, (ii) additional losses expected for the remainder of 2021 or recorded in 2020, or (iii) net operating losses carry forwards from prior years. We recorded a full valuation allowance of the net operating losses for the three months ended March 31, 2021 and 2020. Accordingly, there were s |
Loss per common share
Loss per common share | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Loss per common share | 14. Loss per common share The following table sets forth the computation of basic and diluted loss per common share for the periods presented (in thousands, except per share amounts): Three Months Ended 2021 2020 Numerator: Net loss $ (39,383 ) $ (56,849 ) Denominator: Weighted average common shares for basic loss per common share 347,219 271,460 Effect of dilutive securities — — Weighted average common shares for diluted loss per common share 347,219 271,460 Loss per common share, basic and diluted $ (0.11 ) $ (0.21 ) S The following table sets forth the securities which are not included in the calculation of diluted earnings per common share (in thousands): Three Months Ended 2021 2020 Stock options 23,710 25,155 RSUs 7,326 4,474 PSUs 2,393 2,384 Warrants 5,852 1,833 39,281 33,846 |
Related parties
Related parties | 3 Months Ended |
Mar. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Parties | 15. Related parties A member of our Board of Directors, J. Martin Carrol, is also a director of Catalent. From time to time, we have entered into agreements with Catalent and its affiliates in the normal course of business. Agreements with Catalent have been reviewed by independent directors of our Company, or a committee consisting of independent directors of our Company. During the three months ended March , and , we were billed by Catalent of $ thousand and $ million, respectively, for manufacturing activities. As of March , and December , , we have estimated amounts payable to Catalent totaling $ thousand and $ thousand, respectively. In addition, we have minimum purchase requirements in place with Catalent as disclosed in Note , Commitments and contingencies. A member of our Board of Directors, Karen L. Ling, is an executive vice president and chief human resources officer of American International Group, Inc. (“AIG”). From time to time, we have entered into agreements with AIG in the normal course of business. Agreements with AIG have been reviewed by independent directors of our Company, or a committee consisting of independent directors of our Company. During the three months ended March 31, 2021 and 2020, we were billed by AIG of $13 thousand and $71 thousand, respectively, for various insurance premiums. As of March 31, 2021 and December 31, 2020, we have no amounts payable to AIG. |
Business concentrations
Business concentrations | 3 Months Ended |
Mar. 31, 2021 | |
Risks and Uncertainties [Abstract] | |
Business concentrations | 16. Business concentrations We sell our products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers. Customers with product revenue equal to or greater than 10% of our Three Months Ended 2021 2020 Customer A 13% 26% Customer B 18% 18% Customer C 22% 15% Customer D * 10% * Less than 10% of total product revenue Customers that accounted for 10% or greater of our accounts receivable as of the periods indicated were as follows: March 31, December 31, Customer A 14% 17% Customer B 20% 19% Customer C 33% 25% Customer D * 11% * Balance was less than 10% of total accounts receivable We rely on third parties for the manufacture and supply of our products, as well as third-party logistics providers. In instances where these parties fail to perform their obligations, we may be unable to find alternatives suppliers or satisfactorily deliver our products to our customers on time, if at all. Vendors with product purchases equal to or greater than 10% of our Three Months Ended 2021 2020 Catalent 29% 24% Vendor A 33% 28% Vendor B 32% 32% Vendor C * 13% * Less than 10% of total product purchases Vendors that accounted for 10% or greater of our accounts payable as of the periods indicated were as follows: March 31, December 31, Vendor D 19% * Vendor E * 17% Vendor F * 16% Vendor G * 10% * Balance was less than 10% of total accounts payable |
Basis of presentation and sum_2
Basis of presentation and summary of significant accounting policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
General | General TherapeuticsMD, Inc., a Nevada corporation (the “Company”), and its consolidated subsidiaries are referred to collectively in this Quarterly Report on Form 10-Q (“10-Q 10-Q ® ® ® ® ® ® 10-Q ® TM SM We are 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. At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women. Our solutions range from a patient-controlled, long-lasting contraceptive to advanced hormone therapy pharmaceutical products. We also have a portfolio of branded and generic prescription prenatal vitamins under the vitaMedMD and BocaGreenMD brands. Our portfolio of products focused on women’s health allows us to efficiently leverage our sales and marketing plan to grow our recently approved products. |
Principles of consolidation | Principles of consolidation We prepared the consolidated financial statements included in this 10-Q Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these interim financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair statement of the financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in this 10-Q 10-K 10-K |
Risks and uncertainties related to COVID-19 | Risks and uncertainties related to COVID-19 We continue to be subject to risks and uncertainties in connection with the COVID-19 COVID-19 Since the early phase of the COVID-19 ™ e-detailing As part of our response to the COVID-19 non-critical non-essential The full impact of the COVID-19 COVID-19 COVID-19 COVID-19 COVID-19 COVID-19 While we currently believe that our COVID-19 COVID-19 COVID-19 |
Significant accounting policies | Significant accounting policies The significant accounting policies we use for quarterly financial reporting are disclosed in Note 2, Summary of Significant Accounting Policies of the accompanying notes to the consolidated financial statements included in our 2020 10-K |
Accounting standards issued but not yet adopted | Accounting standards issued but not yet adopted There have been no recently issued accounting standards not yet adopted by us which are expected, upon adoption, to have a material impact on our consolidated financial statements or processes. |
Reclassification | Reclassification Certain amounts reported in prior periods in the financial statements have been reclassified to conform to the current period’s presentation. |
Accounts receivable (Tables)
Accounts receivable (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Receivables [Abstract] | |
Summary of accounts receivable allowance for credit losses | The following sets forth activities in our allowance for credit losses (in thousands): Total Balance as of January 1, 2021 $ 1,118 Charges to provision for credit losses 230 Write-off (117 ) Balance as of March 31, 2021 $ 1,231 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Inventory Disclosure [Abstract] | |
inventory consisted of the following | W Our inventory consisted of the following (in thousands): March 31, December 31, Raw materials $ 4,487 $ 4,423 Work in process 222 220 Finished products 2,637 3,350 Inventory $ 7,346 $ 7,993 |
Prepaid and other current ass_2
Prepaid and other current assets (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
prepaid and other current assets consisted of the following | Our prepaid and other current assets consisted of the following (in thousands): March 31, December 31, Insurance $ 1,522 $ 2,568 Paragraph IV legal proceeding costs 1,926 — Other 4,912 4,975 Prepaid and other current assets $ 8,360 $ 7,543 |
Fixed assets, net (Tables)
Fixed assets, net (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment [Table Text Block] | Our fixed assets, net consisted of the following (in thousands): March 31, December 31, Furniture and fixtures $ 1,407 $ 1,407 Computer and office equipment 1,810 1,784 Computer software 450 412 Leasehold improvements 80 80 Fixed assets 3,747 3,683 Less: accumulated depreciation and amortization 1,935 1,741 Fixed assets, net $ 1,812 $ 1,942 |
License rights and other inta_2
License rights and other intangible assets, net (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
The following provides information about our license rights and other intangible assets, net | The following provides information about our license rights and other intangible assets, net (in thousands): March 31, 2021 December 31, 2020 Gross Accumulated Net Gross Accumulated Net Intangible assets subject to amortization License rights agreement $ 40,000 $ 4,559 $ 35,441 $ 40,000 $ 3,803 $ 36,197 Hormone therapy drug patents 4,181 818 3,363 4,045 748 3,297 Hormone therapy drug patents applied and pending approval 1,857 — 1,857 1,628 — 1,628 46,038 5,377 40,661 45,673 4,551 41,122 Intangible assets not subject to amortization Trademarks/trade name rights 333 — 333 323 — 323 $ 46,371 $ 5,377 $ 40,994 $ 45,996 $ 4,551 $ 41,445 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Payables and Accruals [Abstract] | |
Schedule Of Other accrued expenses and other current liabilities | Other accrued expenses and other current liabilities consisted of the following (in thousands): March 31, December 31, Payroll and related costs $ 8,311 $ 11,179 Rebates 12,691 11,011 Sales returns and coupons 5,676 7,057 Wholesale distributor fees 4,243 2,632 Professional fees 6,198 925 Other accrued expenses and current liabilities 8,855 5,366 Accrued expenses and other current liabilities $ 45,974 $ 38,170 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Out debt consisted of the following | Ou r March 2021 December 31, Financing Agreement $ 200,000 $ 250,000 Less: deferred financing fees 16,030 12,302 Debt, net 183,970 237,698 Current maturities of long-term debt 5,000 — Long-term debt $ 178,970 $ 237,698 |
Interest expense and other financing costs consisted of the following | Interest expense and other financing costs consisted of the following (in thousands): Three Months Ended 2021 2020 Interest expense $ 6,455 $ 5,942 Interest prepayment fees 2,500 — Financing fees amortization 1,272 320 Interest expense and other financing costs $ 10,227 $ 6,262 |
Future estimated amortization of our deferred financing fees | The future estimated amortization of our deferred financing fees is as follows (in thousands): Year Ended 2021 (9 months) $ 4,377 2022 5,875 2023 5,078 2024 700 $ 16,030 |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Disaggregation of Revenue [Abstract] | |
Summary of information about disaggregated revenue by product mix | The following table provides information about disaggregated revenue by product mix and service (in thousands): Three Months Ended March 31, 2021 2020 ANNOVERA $ 8,750 $ 2,273 IMVEXXY 7,012 6,392 BIJUVA 2,445 1,112 Prescription vitamin 1,425 2,474 Product revenue, net 19,632 12,251 License revenue 234 — Total revenue, net $ 19,866 $ 12,251 |
Operating expenses (Tables)
Operating expenses (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Operating Expenses [Abstract] | |
Schedule of Information About Operating Expenses | The following provides information about operating expenses (in thousands): Three Months Ended March 31, 2021 2020 Compensation and employee benefits $ 19,891 $ 18,018 Selling and marketing 13,865 29,742 General and administrative 8,651 9,429 Research and development 2,050 3,269 Total operating expenses $ 44,457 $ 60,458 |
Loss per common share (Tables)
Loss per common share (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Summary of computation of basic and diluted loss per common share | The following table sets forth the computation of basic and diluted loss per common share for the periods presented (in thousands, except per share amounts): Three Months Ended 2021 2020 Numerator: Net loss $ (39,383 ) $ (56,849 ) Denominator: Weighted average common shares for basic loss per common share 347,219 271,460 Effect of dilutive securities — — Weighted average common shares for diluted loss per common share 347,219 271,460 Loss per common share, basic and diluted $ (0.11 ) $ (0.21 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | The following table sets forth the securities which are not included in the calculation of diluted earnings per common share (in thousands): Three Months Ended 2021 2020 Stock options 23,710 25,155 RSUs 7,326 4,474 PSUs 2,393 2,384 Warrants 5,852 1,833 39,281 33,846 |
Business Concentrations (Tables
Business Concentrations (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Disclosure of Revenue and Purchases [Line Items] | |
Summary Of Customers With Product Revenue For The Periods Indicated Were As Follows | Customers with product revenue equal to or greater than 10% of our Three Months Ended 2021 2020 Customer A 13% 26% Customer B 18% 18% Customer C 22% 15% Customer D * 10% |
Summary Of Vendors With Product Purchases For The Periods | Vendors with product purchases equal to or greater than 10% of our Three Months Ended 2021 2020 Catalent 29% 24% Vendor A 33% 28% Vendor B 32% 32% Vendor C * 13% |
Accounts Receivable [Member] | |
Disclosure of Revenue and Purchases [Line Items] | |
Summary Of Customers With Product Revenue For The Periods Indicated Were As Follows | Customers that accounted for 10% or greater of our accounts receivable as of the periods indicated were as follows: March 31, December 31, Customer A 14% 17% Customer B 20% 19% Customer C 33% 25% Customer D * 11% |
Accounts Payable [Member] | |
Disclosure of Revenue and Purchases [Line Items] | |
Summary Of Vendors With Product Purchases For The Periods | Vendors that accounted for 10% or greater of our accounts payable as of the periods indicated were as follows: March 31, December 31, Vendor D 19% * Vendor E * 17% Vendor F * 16% Vendor G * 10% |
Accounts receivable - Summary O
Accounts receivable - Summary Of Accounts Receivable Allowance For Credit Losses (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Credit Loss [Abstract] | |
Beginning balance | $ 1,118 |
Charges to provision for credit losses | 230 |
Write-off of uncollectible receivables | (117) |
Ending Balance | $ 1,231 |
Inventory consisted of the foll
Inventory consisted of the following (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 4,487 | $ 4,423 |
Work in process | 222 | 220 |
Finished products | 2,637 | 3,350 |
Inventory | $ 7,346 | $ 7,993 |
Prepaid and other current ass_3
Prepaid and other current assets consisted of the following (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Insurance | $ 1,522 | $ 2,568 |
Paragraph IV legal proceeding costs | 1,926 | |
Other | 4,912 | 4,975 |
Prepaid and other current assets | $ 8,360 | $ 7,543 |
Fixed assets, net consisted of
Fixed assets, net consisted of the following (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Fixed assets | $ 3,747 | $ 3,683 |
Less: accumulated depreciation and amortization | 1,935 | 1,741 |
Fixed assets, net | 1,812 | 1,942 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets | 1,407 | 1,407 |
Computer and office equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets | 1,810 | 1,784 |
Computer software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets | 450 | 412 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets | $ 80 | $ 80 |
Fixed assets, net (Details Narr
Fixed assets, net (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation | $ 193 | $ 199 |
License rights and other inta_3
License rights and other intangible assets, net - The following provides information about our license rights and other intangible assets, net (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Gross | $ 46,038 | $ 45,673 |
Finite-Lived Intangible Assets, Accumulated Amortization | 5,377 | 4,551 |
Finite-Lived Intangible Assets, Net | 40,661 | 41,122 |
Intangible Assets, Gross (Excluding Goodwill) | 46,371 | 45,996 |
Intangible Assets, Net (Excluding Goodwill) | 40,994 | 41,445 |
Trademarks and Trade Names [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible Assets, Gross (Excluding Goodwill) | 333 | 323 |
Intangible Assets, Net (Excluding Goodwill) | 333 | 323 |
License rights agreement [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Gross | 40,000 | 40,000 |
Finite-Lived Intangible Assets, Accumulated Amortization | 4,559 | 3,803 |
Finite-Lived Intangible Assets, Net | 35,441 | 36,197 |
Hormone Therapy Drug Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Gross | 4,181 | 4,045 |
Finite-Lived Intangible Assets, Accumulated Amortization | 818 | 748 |
Finite-Lived Intangible Assets, Net | 3,363 | 3,297 |
Hormone Therapy Drug Candidate Patents - applied and Pending [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Gross | 1,857 | 1,628 |
Finite-Lived Intangible Assets, Net | $ 1,857 | $ 1,628 |
License rights and other inta_4
License rights and other intangible assets, net (Details Narrative) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2021USD ($)patents | Mar. 31, 2020USD ($) | Dec. 31, 2020patents | |
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | patents | 79 | 77 | |
Domestic US Patents | |||
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | patents | 40 | 38 | |
Licensing Agreements [Member] | Cost of Sales [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Amortization of intangible assets | $ | $ 756 | $ 746 | |
Patents [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Amortization of intangible assets | $ | $ 70 | $ 63 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities - Other accrued expenses and other current liabilities consisted of the following (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Payroll and related costs | $ 8,311 | $ 11,179 |
Rebates | 12,691 | 11,011 |
Sales returns and coupons | 5,676 | 7,057 |
Wholesale distributor fees | 4,243 | 2,632 |
Professional fees | 6,198 | 925 |
Other accrued expenses and current liabilities | 8,855 | 5,366 |
Accrued expenses and other current liabilities | $ 45,974 | $ 38,170 |
Debt - Our debt consisted of th
Debt - Our debt consisted of the following (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||
Less: deferred financing fees | $ 16,030 | $ 12,302 |
Debt, net | 183,970 | 237,698 |
Current maturities of long-term debt | 5,000 | |
Long-term Debt | 178,970 | 237,698 |
Financing Agreement [Member] | ||
Debt Instrument [Line Items] | ||
Financing Agreement | $ 200,000 | $ 250,000 |
Debt - Interest expense and oth
Debt - Interest expense and other financing costs consisted of the following (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Interest Expense and Financing Costs of Debt [Line Items] | ||
Interest expense | $ 6,455 | $ 5,942 |
Interest prepayment fees | 2,500 | |
Financing fees amortization | 1,272 | 320 |
Interest expense and other financing costs | $ 10,227 | $ 6,262 |
Debt - Future estimated amortiz
Debt - Future estimated amortization of our deferred financing fees is as follows (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Estimated Future Amortization Of Deferred Financing Fee Disclosure [Line Items] | ||
Deferred financing fees | $ 16,030 | $ 12,302 |
2021 | ||
Estimated Future Amortization Of Deferred Financing Fee Disclosure [Line Items] | ||
Deferred financing fees | 4,377 | |
2022 | ||
Estimated Future Amortization Of Deferred Financing Fee Disclosure [Line Items] | ||
Deferred financing fees | 5,875 | |
2023 | ||
Estimated Future Amortization Of Deferred Financing Fee Disclosure [Line Items] | ||
Deferred financing fees | 5,078 | |
2024 | ||
Estimated Future Amortization Of Deferred Financing Fee Disclosure [Line Items] | ||
Deferred financing fees | $ 700 |
Debt (Details Narrative)
Debt (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Debt Instrument [Line Items] | ||
Repayments of Debt | $ 50,000 | |
Debt Financing Fee Paid | 5,000 | $ 1,250 |
Deferred Offering Costs | $ 5,000 | |
Repayment on March 31, 2022 [Member] | ||
Debt Instrument [Line Items] | ||
Prepayment fee percentage | 30.00% | |
Repayments on March 31, 2022, June 30, 2022 and September 30, 2022 [Member] | ||
Debt Instrument [Line Items] | ||
Additional principal repayment | $ 5,000 | |
Repayments on December 31, 2022 and March 31, 2023 [Member] | ||
Debt Instrument [Line Items] | ||
Additional principal repayment | 10,000 | |
Repayments on June 30, 2023, September 30, 2023, December 31, 2023 and March 31, 2024 [Member] | ||
Debt Instrument [Line Items] | ||
Additional principal repayment | $ 41,250 | |
Repayment on April 1, 2022 through March 31, 2023 [Member] | ||
Debt Instrument [Line Items] | ||
Prepayment fee percentage | 5.00% | |
Repayments from April 1, 2023 through March 31, 2024 [Member] | ||
Debt Instrument [Line Items] | ||
Prepayment fee percentage | 3.00% | |
Financing Agreement [Member] | Forecasted debt covenant compliance [Member] | ||
Debt Instrument [Line Items] | ||
Minimum cash balance requirement under credit agreement | $ 60,000 | |
Financing Agreement Amendment 7 [Member] | Long-term Debt [Member] | ||
Debt Instrument [Line Items] | ||
Debt Financing Fee Paid | 5,000 | |
Imvexxy Bijuva And Annovera [Member] | ||
Debt Instrument [Line Items] | ||
Repayments of Debt | $ 50,000 | |
Prepayment fee percentage | 5.00% | |
Financing Agreement Amendment No 8 [Member] | Repayment on March 31, 2022 [Member] | ||
Debt Instrument [Line Items] | ||
Prepayment fee percentage | 5.00% | |
Additional principal repayment | $ 5,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) $ in Millions | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Prepaid Expenses and Other Current Assets [Member] | Paragraph Four Certification Notice Letter [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Legal proceeding costs | $ 1.9 |
BIJUVA [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Minimum supply commitment fee percentage payable | 50.00% |
IMVEXXY [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Minimum supply commitment fee percentage payable | 60.00% |
Stockholders' equity (deficit)
Stockholders' equity (deficit) (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Feb. 08, 2021 | Mar. 31, 2021 | Feb. 28, 2021 | Nov. 30, 2020 | Mar. 31, 2021 |
Common Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Shares Issued, Price Per Share | $ 1.85 | ||||
Stock Issued During Period, Shares, New Issues | 59,500,000 | 92,870,000 | |||
Proceeds from Stock Plans | $ 47,300 | $ 96,600 | |||
Common Stock [Member] | 2020 ATM Program [Member] | |||||
Class of Stock [Line Items] | |||||
Percentage Of Commission Rate Gross Sales Price | 3.00% | 3.00% | |||
Sale of Stock, Number of Shares Issued in Transaction | 28,600,000 | ||||
Public offering of common stock authorized for sale | $ 50,000 | ||||
Common Stock [Member] | 2021 ATM Program [Member] | |||||
Class of Stock [Line Items] | |||||
Percentage Of Commission Rate Gross Sales Price | 3.00% | ||||
Sale of Stock, Price Per Share | $ 1.75 | $ 1.59 | $ 1.59 | ||
Proceeds from Stock Plans | $ 7,000 | ||||
Sale of Stock, Number of Shares Issued in Transaction | 4,800,000 | ||||
Public offering of common stock authorized for sale | $ 100,000 | ||||
Restricted Stock Units (RSUs) [Member] | |||||
Class of Stock [Line Items] | |||||
Number of shares granted | 327,000 | ||||
Weighted average grant date fair value granted | $ 1.58 | ||||
Weighted average vesting life | 2 years 1 month 6 days | ||||
Number of shares vested | 52,000 | ||||
Weighted average grant date fair value vested | $ 1.86 | ||||
Number of shares vested but not yet settled | 732,000 | ||||
Anticipated Settlement of shares | 2021-05 | ||||
Weighted average grant date fair value | $ 1.07 | $ 1.07 | |||
Warrant [Member] | Common Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 358,000 | 358,000 | |||
Number Of Warrants Or Rights Issued | 298,000 | 298,000 | |||
Stock Issued During Period, Shares, New Issues | 205,000 | ||||
Weighted average grant date warrant fair value | 563,000 | 563,000 | |||
Weighted average exercise price of warrants | $ 0.24 | ||||
Public offering of common stock authorized for sale | $ 50 |
Revenue - Summary of informati
Revenue - Summary of information about disaggregated revenue by product mix (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Disaggregation of Revenue [Line Items] | ||
Revenue from Contract with Customer, Including Assessed Tax | $ 19,866 | $ 12,251 |
ANNOVERA [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenue from Contract with Customer, Including Assessed Tax | 8,750 | 2,273 |
IMVEXXY [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenue from Contract with Customer, Including Assessed Tax | 7,012 | 6,392 |
BIJUVA [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenue from Contract with Customer, Including Assessed Tax | 2,445 | 1,112 |
Prescription Vitamins [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenue from Contract with Customer, Including Assessed Tax | 1,425 | 2,474 |
Product [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenue from Contract with Customer, Including Assessed Tax | 19,632 | 12,251 |
License [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenue from Contract with Customer, Including Assessed Tax | $ 234 | $ 0 |
Operating Expenses (Details)
Operating Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Operating Expenses [Line Items] | ||
Research and development | $ 2,050 | $ 3,269 |
Total operating expenses | 44,457 | 60,458 |
Operating Expense [Member] | ||
Operating Expenses [Line Items] | ||
Compensation and employee benefits | 19,891 | 18,018 |
Selling and marketing | 13,865 | 29,742 |
General and administrative | 8,651 | 9,429 |
Research and development | 2,050 | 3,269 |
Total operating expenses | $ 44,457 | $ 60,458 |
Income Tax (Details Narrative)
Income Tax (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Provision for income taxes | $ 0 | $ 0 |
Loss per common share - Summary
Loss per common share - Summary of computation of basic and diluted loss per common share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Numerator: | ||
Net loss | $ (39,383) | $ (56,849) |
Denominator: | ||
Weighted average common shares for basic loss per common share | 347,219 | 271,460 |
Effect of dilutive securities | 0 | 0 |
Weighted average common shares for diluted loss per common share | 347,219 | 271,460 |
Loss per common share, basic and diluted | $ (0.11) | $ (0.21) |
Schedule of calculation of dilu
Schedule of calculation of diluted net loss per share allocable to common stockholders (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 39,281 | 33,846 |
Stock options [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 23,710 | 25,155 |
RSUs [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 7,326 | 4,474 |
PSUs [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 2,393 | 2,384 |
Warrant [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 5,852 | 1,833 |
Related parties (Details)
Related parties (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Catalent [Member] | |||
Related Party Transaction [Line Items] | |||
Amount billed | $ 772,000 | $ 1,300,000 | |
Accounts Payable, Related Parties, Current | 639,000 | $ 276,000 | |
American International Group [Member] | |||
Related Party Transaction [Line Items] | |||
Amount billed | 13,000 | $ 71,000 | |
Accounts Payable, Related Parties, Current | $ 0 | $ 0 |
Business concentrations - Summa
Business concentrations - Summary Of Customers With Product Revenue For The Periods Indicated Were As Follows (Details) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Customer A [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 13.00% | 26.00% |
Customer A [Member] | Accounts Receivable [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 14.00% | 17.00% |
Customer B [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 18.00% | 18.00% |
Customer B [Member] | Accounts Receivable [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 20.00% | 19.00% |
Customer C [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 22.00% | 15.00% |
Customer C [Member] | Accounts Receivable [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 33.00% | 25.00% |
Customer D [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 10.00% | |
Customer D [Member] | Accounts Receivable [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 11.00% |
Business concentrations - Sum_2
Business concentrations - Summary Of The Vendors With Product Purchases For The Periods (Details) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Catalent [Member] | ||
Disclosure Of Vendors With Product Purchases and Accounts Payable For The Periods [Line Items] | ||
Concentration Risk, Percentage | 29.00% | 24.00% |
Vendor A [Member] | ||
Disclosure Of Vendors With Product Purchases and Accounts Payable For The Periods [Line Items] | ||
Concentration Risk, Percentage | 33.00% | 28.00% |
Vendor B [Member] | ||
Disclosure Of Vendors With Product Purchases and Accounts Payable For The Periods [Line Items] | ||
Concentration Risk, Percentage | 32.00% | 32.00% |
Vendor C [Member] | ||
Disclosure Of Vendors With Product Purchases and Accounts Payable For The Periods [Line Items] | ||
Concentration Risk, Percentage | 13.00% | |
Vendor D [Member] | Accounts Payable [Member] | ||
Disclosure Of Vendors With Product Purchases and Accounts Payable For The Periods [Line Items] | ||
Concentration Risk, Percentage | 19.00% | |
Vendor E [Member] | Accounts Payable [Member] | ||
Disclosure Of Vendors With Product Purchases and Accounts Payable For The Periods [Line Items] | ||
Concentration Risk, Percentage | 17.00% | |
Vendor F [Member] | Accounts Payable [Member] | ||
Disclosure Of Vendors With Product Purchases and Accounts Payable For The Periods [Line Items] | ||
Concentration Risk, Percentage | 16.00% | |
Vendor G [Member] | Accounts Payable [Member] | ||
Disclosure Of Vendors With Product Purchases and Accounts Payable For The Periods [Line Items] | ||
Concentration Risk, Percentage | 10.00% |
Business concentrations (Detail
Business concentrations (Details Narrative) | 3 Months Ended |
Mar. 31, 2021 | |
Maximum [Member] | Customer Concentration Risk [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Maximum [Member] | Accounts Receivable [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Maximum [Member] | Supplier Concentration Risk [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Maximum [Member] | Accounts Payable [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Minimum [Member] | Customer Concentration Risk [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Minimum [Member] | Accounts Receivable [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Minimum [Member] | Supplier Concentration Risk [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Minimum [Member] | Accounts Payable [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |