TherapeuticsMD, Inc. 10-Q

Item 1. Financial Statements TherapeuticsMD, Inc. and Subsidiaries Consolidated Balance Sheets (In thousands, except per share data) September 30, 2021 December 31, 2020 (Unaudited) Assets: Current assets: Cash $ 104,841 $ 80,486 Accounts receivable, net of allowance for credit losses of $ 1,351 and $ 1,118 as of September 30, 2021 and December 31, 2020, respectively 37,402 32,382 Inventory 7,362 7,993 Prepaid and other current assets 10,374 7,543 Total current assets 159,979 128,404 Fixed assets, net 1,388 1,942 License rights and other intangible assets, net 39,617 41,445 Right of use assets 8,391 9,566 Other non-current assets 253 253 Total assets $ 209,628 $ 181,610 Liabilities and stockholders' equity (deficit): Current liabilities: Current maturities of long-term debt $ 15,000 $ — Accounts payable 19,592 21,068 Accrued expenses and other current liabilities 51,674 38,170 Total current liabilities 86,266 59,238 Long-term debt, net 171,738 237,698 Operating lease liabilities 8,226 8,675 Other non-current liabilities 758 — Total liabilities 266,988 305,611 Commitments and contingencies (Note 9) Stockholders' equity (deficit): Preferred stock, par value $ 0.001 ; 10,000 shares authorized, none issued — — Common stock, par value $ 0.001 ; 600,000 shares authorized, 424,879 and 299,765 issued and outstanding as of September 30, 2021 and December 31, 2020, respectively 425 300 Additional paid-in capital 950,615 754,644 Accumulated deficit ( 1,008,400 ) ( 878,945 ) Total stockholders' deficit ( 57,360 ) ( 124,001 ) Total liabilities and stockholders' equity $ 209,628 $ 181,610 The accompanying notes are an integral part of these consolidated financial statements. 1 TherapeuticsMD, Inc. and Subsidiaries Consolidated Statements of Operations (Unaudited - in thousands, except per share data) Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Revenue, net: Product $ 24,469 $ 17,342 $ 67,102 $ 40,294 License 937 2,000 1,171 2,000 Total revenue, net 25,406 19,342 68,273 42,294 Cost of goods sold 5,282 3,279 14,101 10,394 Total gross profit 20,124 16,063 54,172 31,900 Operating expenses: Selling and marketing 30,005 22,373 86,193 91,056 General and administrative 28,435 16,637 66,691 53,740 Research and development 1,605 2,027 5,666 8,038 Total operating expenses 60,045 41,037 158,550 152,834 Loss from operations ( 39,921 ) ( 24,974 ) ( 104,378 ) ( 120,934 ) Other (expense) income: Interest expense and other financing costs ( 7,518 ) ( 7,680 ) ( 25,341 ) ( 20,969 ) Other income, net 19 42 264 466 Total other (expense), net ( 7,499 ) ( 7,638 ) ( 25,077 ) ( 20,503 ) Loss before income taxes ( 47,420 ) ( 32,612 ) ( 129,455 ) ( 141,437 ) Provision for income taxes — — — — Net loss $ ( 47,420 ) $ ( 32,612 ) $ ( 129,455 ) $ ( 141,437 ) Loss per common share, basic and diluted $ ( 0.11 ) $ ( 0.12 ) $ ( 0.33 ) $ ( 0.52 ) Weighted average common shares, basic and diluted 422,216 272,565 388,111 271,969 The accompanying notes are an integral part of these consolidated financial statements. 2 TherapeuticsMD, Inc. and Subsidiaries Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited - in thousands) Common Stock Additional Paid in Accumulated Shares Amount Capital Deficit Total Balance, January 1, 2021 299,765 $ 300 $ 754,644 $ ( 878,945 ) $ ( 124,001 ) Shares issued for sale of common stock, net of cost 92,870 93 150,806 — 150,899 Shares issued for exercise of warrants, net of cashless exercises 503 — 50 — 50 Shares issued for vested restricted stock units 52 — — — — Share-based compensation — — 2,957 — 2,957 Net loss — — — ( 39,383 ) ( 39,383 ) Balance, March 31, 2021 393,190 393 908,457 ( 918,328 ) ( 9,478 ) Shares issued for sale of common stock, net of cost 125 — 163 — 163 Shares issued for exercise of warrants 600 1 227 — 228 Shares issued for exercise of options 54 — 21 — 21 Shares issued for vested restricted stock units 929 1 ( 1 ) — — Shares issued for sale of common stock related to employee stock purchase plan 150 — 134 — 134 Share-based compensation — — 2,510 — 2,510 Net loss — — — ( 42,652 ) ( 42,652 ) Balance, June 30, 2021 395,048 395 911,511 ( 960,980 ) ( 49,074 ) Shares issued for sale of common stock, net of cost 28,770 29 31,790 — 31,819 Shares issued for exercise of options 7 — 3 — 3 Shares issued for vested restricted stock units 1,054 1 ( 1 ) — — Share-based compensation — — 7,312 — 7,312 Net loss — — — ( 47,420 ) ( 47,420 ) Balance, September 30, 2021 424,879 $ 425 $ 950,615 $ ( 1,008,400 ) $ ( 57,360 ) Balance, January 1, 2020 271,177 $ 271 $ 704,351 $ ( 695,421 ) $ 9,201 Shares issued for exercise of options 351 — 72 — 72 Shares issued for vested restricted stock units 150 — — — — Share-based compensation — — 2,366 - 2,366 Net loss — — — ( 56,849 ) ( 56,849 ) Balance, March 31, 2020 271,678 271 706,789 ( 752,270 ) ( 45,210 ) Shares issued for exercise of options 313 1 94 — 95 Shares issued for vested restricted stock units 303 — — — — Share-based compensation — — 3,003 — 3,003 Net loss — — — ( 51,976 ) ( 51,976 ) Balance, June 30, 2020 272,294 272 709,886 ( 804,246 ) ( 94,088 ) Shares issued for exercise of options and warrants, net 518 1 105 — 106 Warrants issued in relation to debt financing agreement — — 7,428 — 7,428 Share-based compensation — — 3,133 — 3,133 Net loss — — — ( 32,612 ) ( 32,612 ) Balance, September 30, 2020 272,812 $ 273 $ 720,552 $ ( 836,858 ) $ ( 116,033 ) The accompanying notes are an integral part of these consolidated financial statements. 3 TherapeuticsMD, Inc. and Subsidiaries Consolidated Statements of Cash Flows (Unaudited - in thousands) Nine Months Ended September 30, 2021 2020 Cash flows from operating activities: Net loss $ ( 129,455 ) $ ( 141,437 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 3,091 3,039 Charges (credits) to provision for doubtful accounts 540 ( 47 ) Inventory charge 1,082 5,744 Debt financing fees 4,158 1,645 Share-based compensation 12,779 8,502 Other 726 1,719 Changes in operating assets and liabilities: Accounts receivable ( 5,560 ) 384 Inventory ( 451 ) ( 3,816 ) Prepaid and other current assets ( 2,831 ) 2,038 Accounts payable ( 1,476 ) ( 3,072 ) Accrued expenses and other current liabilities 13,504 ( 3,813 ) Other non-current liabilities 758 — Total adjustments 26,320 12,323 Net cash used in operating activities ( 103,135 ) ( 129,114 ) Cash flows from investing activities: Payment of patent related costs ( 675 ) ( 1,065 ) Purchase of fixed assets ( 34 ) ( 39 ) Net cash used in investing activities ( 709 ) ( 1,104 ) Cash flows from financing activities: Proceeds from sale of common stock, net of costs 182,881 — Proceeds from exercise of options and warrants 302 272 Proceeds from sale of common stock related to employee stock purchase plan 134 — Repayments of debt ( 50,000 ) — Borrowings of debt — 50,000 Payment of debt financing fees ( 5,118 ) ( 1,250 ) Net cash provided by financing activities 128,199 49,022 Net increase (decrease) in cash 24,355 ( 81,196 ) Cash, beginning of period 80,486 160,830 Cash, end of period $ 104,841 $ 79,634 Supplemental disclosure of noncash financing activities: Warrants issued in relation to debt financing agreement $ — $ 7,428 Supplemental disclosure of cash flow information: Interest paid $ 19,675 $ 12,032 The accompanying notes are an integral part of these consolidated financial statements. 4 TherapeuticsMD, Inc. and Subsidiaries Notes to the Consolidated Financial Statements (Unaudited) 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 Report”) as “TherapeuticsMD,” “we,” “our” and “us.” This 10-Q Report includes our trademarks, trade names and service marks, such as TherapeuticsMD ® , vitaMedMD ® , BocaGreenMD ® , vitaCare TM , IMVEXXY ® , BIJUVA ® and ANNOVERA ® , which are protected under applicable intellectual property laws and are the property of, or licensed to, the Company. Solely for convenience, trademarks, trade names and service marks referred to in this 10-Q Report may appear without the ® , TM or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties. 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 Report following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting principles generally accepted in the U.S. (“U.S. GAAP”) can be condensed or omitted. 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 Report should be read in conjunction with the consolidated financial statements and accompanying notes included in our 2020 Annual Report on Form 10-K (“2020 10-K Report”). Certain amounts in the consolidated financial statements and accompanying notes may not add due to rounding, and all percentages have been calculated using unrounded amounts. Risks and uncertainties related to COVID-19 We continue to be subject to risks and uncertainties in connection with the COVID-19 pandemic. The extent of the future impact of the COVID-19 pandemic on our business continues to be highly uncertain and difficult to predict. The ultimate global recovery from the pandemic will be dependent on, among other things, actions taken by governments and businesses to contain and combat the virus, including any variant strains, the speed and effectiveness of vaccine production and global distribution, as well as how quickly, and to what extent, normal economic and operating conditions can resume on a sustainable basis globally. Since the early phase of the COVID-19 pandemic, we have been using substantial virtual options to ensure business continuity. One of our subsidiaries, vitaCare ™ Prescription Services, Inc. (“vitaCare Prescription Services”), a Florida corporation, assists patients in obtaining easy and convenient access to their prescriptions for products at a pharmacy of their choice, including via home delivery pharmacy options. We have also partnered with independent community pharmacies and multiple third-party online pharmacies and telemedicine providers that focus on contraception or menopause which provide patients real-time access to both diagnosis and treatment. We continue to support prescribers’ needs with samples and product materials through our sales force. If access is restricted, we have mailing options in place for these materials. We also have business continuity plans and infrastructure in place that allows for live virtual e-detailing of our products. As part of our response to the COVID-19 pandemic, we implemented measures to reduce marketing expenses for 2020. We also implemented cost saving measures in 2020, which included negotiating lower fees or suspending services from third party vendors; implementing a company-wide hiring restriction; delaying or cancelling non-critical information technology projects; and eliminating non-essential travel, entertainment, meeting, and event expenses. In addition, we are planning to implement a significant cost savings initiative that is designed to reduce our annual costs in 2022 by at least $ 40.0 million. This figure does not include cost savings from, or the costs associated with the sale of an interest in vitaCare Prescription Services, which annualized cost savings are estimated at approximately $ 20.0 million. 5 The full impact of the COVID-19 pandemic continues to evolve. However, we remain committed to the execution of our corporate goals, despite the ongoing COVID-19 pandemic, as demonstrated in part by the increase in product revenue throughout 202 1 . As of the date of issuance of these consolidated financial statements, the future extent to which the COVID-19 pandemic may continue to materially impact our financial condition, liquidity, or results of operations remains uncertain. We are continuing to assess the effect of the COVID-19 pandemic on our operations by monitoring the spread of COVID-19 and the various actions implemented to combat the pandemic throughout the world. Even after the COVID-19 pandemic has subsided, we may continue to experience adverse impacts to our business as a result of any economic recession or depression that has occurred or may occur in the future. While we currently believe that our COVID-19 contingency plan has the ability to mitigate many of the negative effects of the COVID-19 pandemic on our business, the severity of the impact of the COVID-19 pandemic on our business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic, the duration of “social distancing” orders, the ability of our sales force to access healthcare providers to promote our products, increases in unemployment, which could reduce access to commercial health insurance for our patients, thus limiting payer coverage for our products, and the impact of the pandemic on our global supply chain, all of which remain uncertain. Our future results of operations and liquidity could be materially adversely affected by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions, uncertain demand, and the impact of any initiatives or programs that we may undertake to address financial and operations challenges that we may face. Going Concern As of the filing date of this Quarterly Report on Form 10-Q, our cash balance was above the $ 60.0 million balance as required by the Financing Agreement described below in Note 8. Based on our current projections, we will need to raise additional capital to remain in compliance with this minimum cash balance covenant for the next twelve months from the issuance of these financial statements. To address our projected capital needs, we are pursuing various equity financing and other alternatives including the sale of an interest in vitaCare Prescription Services for which we commenced a sale process. 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. 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. Along with considering additional financings, we have reviewed numerous potential scenarios in connection with steps that we may take to reduce our operating expenses. Based on our analysis, we believe that our existing cash reserves along with potential proceeds from the sale of certain non-core assets of the Company and proceeds from potential future financings, if available to us, would be sufficient to meet our cash needs arising in the ordinary course of business for the next twelve months from the date of this Quarterly Report on Form 10-Q. If we are unsuccessful with future financings and if the successful commercialization of IMVEXXY, BIJUVA, or ANNOVERA is delayed, or the continued impact of the COVID-19 pandemic or issues in our supply chains related to our third party contract manufacturers on our business is worse than we anticipate, our existing cash reserves would be insufficient to maintain compliance with the Financing Agreement covenants or satisfy our liquidity requirements until we are able to successfully commercialize IMVEXXY, BIJUVA, and ANNOVERA. See also Note 3- Inventory for additional information regarding risks associated with our contract manufacturers, particularly for ANNOVERA. The presence of these projected factors in conjunction with the uncertainty of the capital markets raises substantial doubt about the Company's ability to continue as a going concern for the next twelve months from the issuance of these financial statements. Additionally, if circumstances were to require our independent registered public accounting firm to include a going concern uncertainty in their report on our annual consolidated financial statements, such matter would also take us out of compliance with certain of the Financing Agreement covenants. If we are unable to achieve any of the total minimum net revenue requirements or otherwise comply with any other covenant of the Financing Agreement, all or a portion of our obligations under the Financing Agreement may be declared immediately due and payable, which would have an adverse effect on our business, results of operations and financial condition. 6 The accompanying unaudited consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern. 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 Report, and in the section below. 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, including type of operating expenses, reported in prior periods in the financial statements have been reclassified to conform to the current period’s presentation. 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 pandemic, or other customer-specific factors. While we actively manage our credit exposure and work to respond to both changes in our customers’ financial conditions or macroeconomic events, there can be no guarantee we will be able to mitigate all of these risks successfully. Although we have historically not experienced significant credit losses, it is possible that there could be a material adverse impact from potential adjustments of the carrying amount of trade receivables in the future. We review accounts receivable for uncollectible accounts and provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, reasonable supportable forecasts and existing economic conditions and we record an allowance that presents the net amount expected to be collected. We evaluate trade accounts receivable for delinquency. We write off delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers. We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts. To the extent data we use to calculate these estimates does not accurately reflect bad debts, adjustments to these reserves may be required. 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 540 Write-off of uncollectible receivables ( 307 ) Balance as of September 30, 2021 $ 1,351 3. Inventory We rely on third parties to manufacture our finished products, and we have entered into long-term supply agreements for the manufacture of ANNOVERA, IMVEXXY, and BIJUVA. We do not have a long-term supply agreement for the manufacture of our prescription vitamins. Additionally, we do not have long-term contracts for the supply of the active pharmaceutical ingredient (“API”) used in ANNOVERA and BIJUVA. One of our third party contract manufacturers that manufactures ANNOVERA has recently experienced an increase in difficulties with the manufacturing process for ANNOVERA, which has resulted in batch failures. The challenges are multifactorial and include variability in raw material supply and normal manufacturing variation due to a semi-manual process. This has recently resulted in challenges to supply ANNOVERA consistently within the approved specification at a rate that meets the projected demand for ANNOVERA. To mitigate the manufacturing challenges, in August 2021 we filed a supplemental New Drug Application with the U.S. Food and Drug Administration (“ FDA”) to modify the manufacturing (testing) specifications for ANNOVERA to allow for normal manufacturing variation that would increase the consistency of manufacturing and supply of ANNOVERA. There can be no 7 assurance that such a modification will be approved by the FDA. If the FDA fails to approve the requested modification by the Prescription Drug User Fee Act (“ PDUFA ”) date of December 12, 2021, our third party contract manufacturer may not be able to supply us with sufficient ANNOVERA to adequately supply the market or generate sufficient revenue to meet the covenants under the Financing Agreement. If we are unable to achieve any of the total minimum net revenue requirements or otherwise comply with any other covenant of the Financing Agreement, all or a portion of our obligations under the Financing Agreement may be declared immediately due and payable, which would have an adverse effect on our business, results of operations and financial condition. If any of our third party contract manufacturers or any suppliers of raw materials or API experience further difficulties, do not comply with the terms of an agreement between us, or do not devote sufficient time, energy, and care to providing our manufacturing needs, we could experience additional interruptions in the supply of our products, which may have a material adverse impact on our revenue, results of operations and financial position and ability to meet our revenue and other covenants under our Financing Agreement. Our inventory consisted of the following (in thousands): September 30, 2021 December 31, 2020 Raw materials $ 3,487 $ 4,423 Work in process 688 220 Finished products 3,187 3,350 Inventory $ 7,362 $ 7,993 4 . Prepaid and other current assets Our prepaid and other current assets consisted of the following (in thousands): September 30, 2021 December 31, 2020 Insurance $ 3,801 $ 2,568 Paragraph IV legal proceeding costs 2,858 — Other 3,715 4,975 Prepaid and other current assets $ 10,374 $ 7,543 5 . Fixed assets Our fixed assets, net consisted of the following (in thousands): September 30, 2021 December 31, 2020 Furniture and fixtures $ 1,407 $ 1,407 Computer and office equipment 1,855 1,784 Computer software 375 412 Leasehold improvements 80 80 Fixed assets 3,717 3,683 Less: accumulated depreciation and amortization 2,329 1,741 Fixed assets, net $ 1,388 $ 1,942 We recorded depreciation expense of $ 0.2 million for the three months ended September 30, 2021 and 2020, and $ 0.6 million for the nine months ended September 30, 2021 and 2020. 8 6. Licensed rights and other intangible assets The following provides information about our license rights and other intangible assets, net (in thousands): September 30, 2021 December 31, 2020 Gross Gross Carrying Accumulated Carrying Accumulated Amount Amortization Net Amount Amortization Net Licensed rights and intangible assets subject to amortization: License rights $ 40,000 $ 6,070 $ 33,930 $ 40,000 $ 3,803 $ 36,197 Hormone therapy drug patents 4,732 985 3,747 4,045 749 3,296 Hormone therapy drug patents applied and pending approval 1,596 — 1,596 1,629 — 1,629 License rights and other intangible assets subject to amortization 46,328 7,055 39,273 45,674 4,552 41,122 Intangible assets not subject to amortization: Trademarks/trade name rights 344 — 344 323 — 323 License rights and other intangible assets, net $ 46,672 $ 7,055 $ 39,617 $ 45,997 $ 4,552 $ 41,445 Licensed rights We recorded amortization expense related to the exclusive license rights agreement (the “Population Council License Agreement”) with Population Council of $ 0.8 million for the three months ended September 30, 2021 and 2020, and $ 2.3 million for the nine months ended September 30, 2021 and 2020. Other intangible assets As of September 30, 2021, we had a total of 87 patents, of which 46 were domestic. As of December 31, 2020, we had a total of 77 patents, of which 38 were domestic. We recorded amortization expense related to patents of $ 0.1 million for the three months ended September 30, 2021 and 2020, and $ 0.2 million for the nine months ended September 30, 2021 and 2020, respectively. We use a combination of qualitative and quantitative factors to assess licensed rights and intangible assets for impairment. As a result of performing these assessments, we determined that no impairment existed as of September 30, 2021 and, therefore, recorded no write-downs to any of our licensed rights and other intangible assets. However, during the nine months ended September 30, 2020, we wrote off $ 584,509 in costs related to trademarks and patents. 7 . Accrued expenses and other current liabilities Other accrued expenses and other current liabilities consisted of the following (in thousands): September 30, 2021 December 31, 2020 Payroll and related costs $ 14,346 $ 11,179 Rebates 15,421 11,011 Sales returns and coupons 3,200 7,057 Sales and marketing 6,223 228 Wholesale distributor fees 4,626 2,632 Professional fees 2,477 925 Other accrued expenses and current liabilities 5,381 5,138 Accrued expenses and other current liabilities $ 51,674 $ 38,170 9 8 . Debt We are party to a Financing Agreement, as amended (the “Financing Agreement”), with Sixth Street Specialty Lending, Inc., as administrative agent (the “Administrative Agent”), various lenders from time-to-time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors. Interest on amounts borrowed under the Financing Agreement is due and payable quarterly in arrears, and the Financing Agreement matures on March 31, 2024. 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 accompanying 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. In March 2021, we entered into Amendment No. 8 to the Financing Agreement (“Amendment No. 8”) pursuant to which, among other amendments, the minimum quarterly product net revenue requirements attributable to commercial sales of IMVEXXY, BIJUVA, and ANNOVERA were revised, the amortization and prepayment terms of the borrowings under the Financing Agreement were revised, and the Administrative Agent consented to a framework for our potential disposition of our vitaCare Prescription Services business. With respect to amortization and prepayment terms of the borrowings under the Financing Agreement, in connection with Amendment No. 8, we (i) repaid $ 50.0 million in principal under the Financing Agreement during the three months ended March 31, 2021, plus a 5.0 % prepayment fee and (ii) agreed to make additional quarterly principal repayments plus the prepayment fees described below starting on March 31, 2022 through March 31, 2024. Additionally, in connection with Amendment No. 8, the prepayment fees on principal amounts being prepaid under the Financing Agreement were revised as follows: (i) 30.0 % of the principal amount being repaid through March 31, 2022 (excluding the scheduled $ 5.0 million principal repayment on such date, which is subject to a 5.0 % prepayment fee); (ii) 5.0 % of the principal amount being repaid from April 1, 2022 through March 31, 2023; (iii) 3.0 % 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. Our debt consisted of the following (in thousands): September 30, 2021 December 31, 2020 Financing Agreement $ 200,000 $ 250,000 Less: deferred financing fees 13,262 12,302 Debt, net 186,738 237,698 Current maturities of long-term debt 15,000 — Long-term debt $ 171,738 $ 237,698 Our future principal payments under the Financing Agreement are as follows (in thousands), excluding the prepayment fees described above: Due on March 31, June 30, September 30, December 31, Total 2022 $ 5,000 $ 5,000 $ 5,000 $ 10,000 $ 25,000 2023 10,000 41,250 41,250 41,250 133,750 2024 41,250 — — — 41,250 $ 200,000 10 Interest and financing costs Interest expense and other financing costs consisted of the following (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Interest expense $ 5,391 $ 6,727 $ 17,175 $ 19,324 Interest prepayment fees 650 — 4,008 — Financing fees amortization 1,477 953 4,158 1,645 Interest expense and other financing costs $ 7,518 $ 7,680 $ 25,341 $ 20,969 Both Amendment No. 7 and No. 8 were accounted for as debt modification in accordance with U.S. GAAP. Accordingly, the unamortized deferred financing fees at each amendment date and the financing fee of $ 5.0 million for Amendment No. 7 are being deferred. These deferred financing fees are being amortized over the remining term of our Financing Agreement. The estimated future amortization of our deferred financing fees is as follows (in thousands): Year Ending December 31, 2021 (3 months) $ 1,532 2022 6,346 2023 4,990 2024 394 $ 13,262 Debt covenants compliance The Financing Agreement requires us to have a minimum unrestricted cash balance of $ 60.0 million. As of the filing date of this 10-Q Report, our cash balance was above the required minimum balance. Based on our current projections, we will need to raise additional capital to 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 Report. See Note 1 – Basis of presentation and summary of significant accounting policies - Going Concern above. The Financing Agreement also requires us to maintain certain minimum quarterly product net revenue requirements and several other restrictive covenants, which could also be affected by the continued impact of the COVID-19 pandemic or issues in our supply chains related to our third-party contract manufacturers. These and other terms in the Financing Agreement must be monitored closely for compliance and could restrict our ability to grow our business or enter into transactions that we believe would be beneficial to our business. If we are unable to maintain the minimum unrestricted cash balance, achieve any of the total minimum net revenue requirements or otherwise comply with any other covenant of the Financing Agreement, all or a portion of our obligations under the Financing Agreement may be declared immediately due and payable, which would have an adverse effect on our business, results of operations and financial condition. As of September 30, 2021, we were in compliance, in all material respects, with our covenants under the Financing Agreement. 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 11 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 have met our minimum purchase number of units in all material respects. 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. 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. On September 2, 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 FDA from granting final approval of the ANDA for 30 months from the date of the 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. 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 stay for the period in which the BIJUVA litigation has been stayed. As of September 30, 2021, in the aggregate, we have incurred and recorded paragraph IV legal proceeding costs amounting to $ 2.9 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. 1 0 . 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 $ 50.0 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 12 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 3.0 % 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 28,600,689 shares of our common stock at an average sale price of $ 1.75 per share . For the 2020 ATM Program, w e received net proceeds of $ 48.1 million, after deducting the discounts and commissions to the sales agent and estimated offering expenses . In February 2021, we closed on an underwritten public offering of our common stock, pursuant to which we issued 59,459,460 shares of our common stock at an offering price of $ 1.85 per share, and we received net proceeds of $ 96.6 million, after deducting the underwriting discounts and commissions and estimated offering expenses. In March 2021, we entered into an at-the-market equity 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 $ 100.0 million from time to time through or to the sales agent under the 2021 ATM Program. 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 sales agent will be entitled to compensation at a fixed commission rate of 3.0 % 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 September 30, 2021, we have sold a total of 33,705,315 shares of our common stock under the 2021 ATM Program at an average sale price of $ 1.21 per share and we received estimated net proceeds of $ 38.8 million, after deducting discounts and commissions to the sales agent and estimated offering expenses. Subsequently, through the date of this 10-Q Report, 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. Warrants The following tables summarizes the status of our outstanding and exercisable warrants and related transactions since December 31, 2020 (in thousands, except weighed average exercise price and weighted average remaining contractual life data): Warrants outstanding and exercisable Warrants Weighted Average Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (in Years) As of December 31, 2020 6,535 $ 1.55 $ 1,041 7.3 Exercised ( 1,163 ) 0.31 Expired ( 245 ) 4.80 As of September 30, 2021 5,127 $ 1.52 $ - 8.6 The aggregate intrinsic value of warrants exercised during the nine months ended September 30, 2021 was $ 1.1 million. Share-based compensation payment plans At the 2021 annual meeting of stockholders of the Company, held on May 27, 2021, our stockholders among other things approved the First Amendment to the TherapeuticsMD, Inc. 2019 Stock Incentive Plan (the “2019 Plan”) to increase the number of shares of our common stock available under the 2019 Plan by 22,475,000 shares. As of September 30, 2021, there were 10,182,803 shares of common stock available for issuance under the 2019 Plan, consisting of (i) new shares, (ii) unallocated shares previously available for issuance under the 2012 Stock Incentive Plan (the “2012 Plan”) that were not then subject to outstanding “Awards” (as defined in the 2012 Plan), and (iii) unallocated shares previously available for issuance under the 2009 Long-Term Incentive Compensation Plan (the “2009 Plan” and together with the 2019 Plan and the 2012 Plan, the “Plans”) that were not then subject to outstanding “Awards” (as defined in the 2009 Plan). Any shares subject to outstanding options or other equity “Awards” under the 2019 Plan, the 2012 Plan and the 2009 Plan that are forfeited, expire or otherwise terminate without issuance of the underlying shares, or if any such Award is settled for cash or otherwise does not result in the issuance of all or a portion of the shares subject to such Award (other than shares tendered or withheld in connection with the exercise of an Award or the satisfaction of withholding tax liabilities), the shares to which 13 those Awards were subject, shall, to the extent of such forfeiture, expiration, termination, cash settlement or non-issuance, again be available for delivery with respect to Awards under the 2019 Plan. As of December 31, 2020 , there were 2,583,565 shares of common stock available for issuance under the 2019 Plan. In August 2021, the Company hired a new President and granted an “inducement grant” under Listing Rule 5635(c)(4) of The Nasdaq Stock Market LLC (“Nasdaq”) of 2,750,000 restricted stock units designated as “Time-Based Units” and 2,750,000 restricted stock units designated as “Performance Units” (the “August Inducement Grant”). The Time-Based Units and Performance Units were granted pursuant to certain Inducement Grant Restricted Stock Unit Agreement; accordingly, these equity awards were not counted against the shares of common stock available for issuance under the 2019 Plan. At the 2021 annual meeting of stockholders of the Company, our stockholders approved an Offer to Exchange Eligible Options for New Restricted Stock Units (the “Exchange Offer”). The Exchange Offer allowed certain employee option holders, excluding the Company’s named executive officers, advisers, consultants, contractors, or present or past non-employee directors, to exchange some or all of their outstanding options to purchase shares of common stock that were granted before August 26, 2019, and had a per share exercise price equal to or greater than $ 5.01 (“Eligible Options”), for an award of restricted stock units of the Company (“New RSUs”), subject to specified conditions. In September 2021, following the expiration of the Exchange Offer, 69 eligible employees elected to exchange Eligible Options, and the Company accepted for cancellation Eligible Options to purchase an aggregate of 4,493,000 shares of common stock, representing approximately 91.5 % of the total shares of common stock underlying the Eligible Options. Also, in September 2021, promptly following the expiration of the Exchange Offer, the Company granted 700,264 New RSUs in exchange for the cancellation of the tendered Eligible Options. The New RSUs vest in three equal annual installments beginning on September 29, 2022, subject to the terms and conditions of the 2019 Plan. The following table summarizes the status of our outstanding and exercisable options and related transactions under the Plans, including the Exchange Offer, since December 31, 2020 (in thousands, except weighed average exercise price and weighted average remaining contractual life data): Options awards outstanding Options awards exercisable Options Awards Weighted Average Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (in Years) Options Awards Weighted Average Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (in Years) As of December 31, 2020 23,782 $ 4.80 $ 152 5.2 19,863 $ 5.06 $ 117 4.6 Granted 60 1.21 Exercised ( 61 ) 0.40 Cancelled/Forfeited ( 4,885 ) 4.95 Expired ( 483 ) 5.59 As of September 30, 2021 18,413 $ 4.40 $ 21 4.2 17,228 $ 4.53 $ 21 3.9 The aggregate intrinsic value of options exercised during the nine months ended September 30, 2021 was less than $ 0.1 million. The following table summarizes the status of our restricted stock units (“RSUs”) and related transactions, including the Exchange Offer and the August Inducement Grant since December 31, 2020 (in thousands, except weighed average grant date fair value): RSUs awards outstanding RSUs awards vested and not settled RSUs Weighted Average Grant Date Fair Value Aggregate Intrinsic Value RSUs Weighted Average Grant Date Fair Value Aggregate Intrinsic Value As of December 31, 2020 7,061 $ 1.76 $ 8,544 — $ — $ — Granted 11,684 1.09 Vested and settled ( 2,034 ) 1.17 Cancelled/Forfeited ( 593 ) 1.92 As of September 30, 2021 16,118 $ 1.34 $ 11,927 2,566 $ 1.79 $ 2,566 The aggregate intrinsic value of RSUs vested and settled during the nine months ended September 30, 2021 was $ 2.1 million. 14 The following table summarizes the status of our performance stock units (“ PSUs”) and related transactions, including the August Inducement Grant since December 31, 2020 (in thousands, except weighed average grant date fair value): PSUs awards outstanding PSUs awards vested and not settled PSUs Weighted Average Grant Date Fair Value Aggregate Intrinsic Value PSUs Weighted Average Grant Date Fair Value Aggregate Intrinsic Value As of December 31, 2020 2,404 $ 1.08 $ 2,909 — $ — $ — Granted 7,337 1.05 Vested and settled — — Cancelled/Forfeited ( 72 ) 1.07 As of September 30, 2021 9,669 (1) $ 1.06 $ 7,155 1,680 $ 1.16 $ 1,243 (1) The number of PSUs represents the base number of PSUs that may vest. The actual number of PSUs that will vest will be between zero and 14,901,178 depending on the Company’s achievement of certain revenue milestones over the period from 2021 through 2023 and certain earnings before interest, taxes, depreciation and amortization (EBITDA) milestones between 2021 and 2023. In June 2020, our stockholders approved the TherapeuticsMD, Inc. 2020 Employee Stock Purchase Plan (“ESPP”), which reserved 5,400,000 shares of our common stock for purchase by eligible employees. The ESPP permits eligible employees to purchase our common stock at a price per share which is equal to 85 % of the lesser of (i) the fair market value of the shares on the offering date of the offering period or (ii) the fair market value of the shares on the purchase date. In May 2021, 150,078 shares were sold under the ESPP at an average sale price of $ 0.89 per share and we received proceeds of $ 0.1 million. We recorded share-based compensation related to previously issued options, RSU and PSUs, as well as shares of common stock issued under the ESPP totaling $ 7.3 million and $ 3.1 million for the three months ended September 30, 2021 and 2020, respectively, and $ 12.8 million and $ 8.5 million for the nine months ended September 30, 2021 and 2020, respectively. As of September 30, 2021, we had $ 22.7 million of unrecognized share-based compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under the ESPP, which is included as additional paid-in capital in the accompanying consolidated balance sheets and may be adjusted for future changes in forfeitures. The unrecognized share-based compensation cost as of September 30, 2021 is expected to be recognized as share-based compensation over a weighted average period of 2.2 years as follows (in thousands): Year Ending December 31, 2021 (3 months) $ 3,280 2022 10,693 2023 6,206 2024 2,465 2025 6 $ 22,650 15 1 1 . Revenue The following table provides information about disaggregated revenue by product mix and service (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Product revenue: ANNOVERA $ 11,807 $ 6,419 $ 30,112 $ 10,527 IMVEXXY 8,016 6,841 24,866 18,319 BIJUVA 3,298 1,646 7,899 4,110 Prescription vitamin 1,348 2,436 4,225 7,338 Product revenue, net 24,469 17,342 67,102 40,294 License revenue 937 2,000 1,171 2,000 Total revenue, net $ 25,406 $ 19,342 $ 68,273 $ 42,294 We have 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. We also have entered into a licensing and supply agreement (the “Theramex License Agreement”) with Theramex HQ UK Limited (“Theramex”) pursuant to which we granted Theramex an exclusive license to commercialize IMVEXXY and BIJUVA for human use outside of the U.S., except for Canada and Israel. For the three months and nine months ended September 30, 2021, we recorded BIJUVA sales of $ 0.7 million made through the Theramex License Agreement. As of September 30, 2021, no BIJUVA sales have been made through the Knight License Agreement. Additionally, as of September 30, 2021, no IMVEXXY sales have been made through either of the licensing agreements. 12. Income taxes We do not expect to pay any significant federal or state income taxes as a result of (i) the losses recorded during the three and nine months ended September 30, 2021 and 2020, (ii) additional losses expected for the remainder of 2021 or losses 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 and nine months ended September 30, 2021 and 2020. Accordingly, there were no provisions for income taxes for the three and nine months ended September 30, 2021 and 2020. Additionally, as of September 30, 2021 and December 31, 2020, we maintain a full valuation allowance for all deferred tax assets. 13. 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 September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Numerator: Net loss $ ( 47,420 ) $ ( 32,612 ) $ ( 129,455 ) $ ( 141,437 ) Denominator: Weighted average common shares for basic loss per common share 422,216 272,565 388,111 271,969 Effect of dilutive securities — — — — Weighted average common shares for diluted loss per common share 422,216 272,565 388,111 271,969 Loss per common share, basic and diluted $ ( 0.11 ) $ ( 0.12 ) $ ( 0.33 ) $ ( 0.52 ) Since we reported a net loss for the three and nine months ended September 30, 2021 and 2020, 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 share are the same for the three and nine months ended September 30, 2021 and 2020. 16 The following table sets forth the outstanding securities as of the periods presented which were not included in the calculation of diluted earnings per common share during the respective three and nine months ended September 30, 2021 and 2020 (in thousands): As of September 30, 2021 2020 Stock options 18,413 24,590 RSUs 16,118 6,030 PSUs 9,669 2,423 Warrants 5,127 1,783 49,327 34,826 1 4 . 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. For manufacturing activities, Catalent billed us $ 1.1 million and $ 0.5 million for the three months ended September 30, 2021 and 2020, respectively, and $ 2.6 million for the nine months ended September 30, 2021 and 2020. As of September 30, 2021 and December 31, 2020, we have estimated amounts payable to Catalent totaling less than $ 0.1 million and $ 0.3 million, respectively. In addition, we have minimum purchase requirements in place with Catalent as disclosed in Note 9, Commitments and contingencies. A member of our Board of Directors, Karen L. Ling, was 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. For various insurance premiums, AIG billed us less than $ 0.1 million for the nine months ended September 30, 2021, and $ 0.1 million and $ 0.2 million for the three and nine months ended September 30, 2020, respectively. As of September 30, 2021 and December 31, 2020, we have no amounts payable to AIG. 1 5 . 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 total revenue for the periods indicated were as follows: Nine Months Ended September 30, 2021 2020 Customer A 10 % 14 % Customer B 16 % 8 % Customer C 18 % 9 % Customer D * 8 % Customer E 12 % * * 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: September 30, 2021 December 31, 2020 Customer A * 17 % Customer B 22 % 19 % Customer C 32 % 25 % Customer D * 11 % * Balance was less than 10 % of accounts receivable, gross 17 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 total purchases for the periods indicated were as follows: Nine Months Ended September 30, 2021 2020 Catalent 27 % 39 % Vendor A 41 % 18 % Vendor B 30 % 36 % * 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: September 30, 2021 December 31, 2020 Vendor E 15 % 17 % Vendor F 23 % 16 % Vendor G * 10 % Vendor H 15 % * * Balance was less than 10 % of total accounts payable 18