For the transition period ~~from________~~from _______________ to ~~___________~~_______________

(Exact ~~Name~~name of Registrant as ~~Specified~~specified in ~~Its~~its Charter)

(~~Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)~~Registrant’s telephone number, including area code)

Indicate by check mark whether the ~~registrant:~~registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the ~~registrant~~Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically ~~and posted on its corporate Web site, if any,~~ every Interactive Data File required to be submitted ~~and posted~~ pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the ~~registrant~~Registrant was required to submit ~~and post~~ such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange ~~Act (Check one):~~Act:

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the ~~registrant~~Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

~~The number~~As of November 11, 2021, there were 424,928,670 shares ~~outstanding~~ of the registrant’s common stock, par value $0.001 per share, ~~as of October 30, 2017 was 216,429,642.~~outstanding.

	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, NaN issued		0			0
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 ~~footnotes~~notes are an integral part of these consolidated financial statements.

	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 ~~footnotes~~notes are an integral part of these consolidated financial statements.

	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 ~~footnotes~~notes are an integral part of these consolidated financial statements.

~~NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS~~Consolidated Statements of Cash Flows

	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.

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 ~~TherapeuticsMD,~~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 ~~Company, has three wholly owned subsidiaries, vitaMedMD, LLC,~~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 ~~Delaware limited liability company,~~relationship with, or ~~VitaMed; BocaGreenMD, Inc., a Nevada corporation,~~endorsement or BocaGreen; and VitaCare Prescription Services, Inc., a Florida corporation, or VitaCare. Unless the context otherwise requires, TherapeuticsMD, VitaMed, BocaGreen, and VitaCare collectively are sometimes referred to as “our company,” “we,” “our,” or “us.”

We are a women’s ~~health care~~healthcare company ~~focused on~~with a mission of creating and commercializing innovative products ~~targeted exclusively~~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. ~~Currently, we are focused on pursuing the regulatory approvals and pre-commercialization activities necessary for commercialization of our~~Our solutions range from a patient-controlled, long-lasting contraceptive to advanced hormone therapy pharmaceutical products. ~~Our drug candidates that~~We also have ~~completed clinical trials are designed to alleviate the symptoms~~a portfolio of and reduce the health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis and vaginal discomfort. We are developing these hormone therapy drug candidates, which contain estradiol and progesterone alone or in combination, with the aim of demonstrating clinical efficacy at lower doses, thereby enabling an enhanced side effect profile compared with competing products. With our SYMBODA™ technology, we are developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. In addition, we manufacture and distribute branded and generic prescription prenatal vitamins ~~as well as over-the-counter, or OTC, iron supplements.~~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.

~~NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS~~

~~The accompanying unaudited interim~~We prepared the consolidated financial statements included in this 10-Q Report following the requirements of ~~TherapeuticsMD, Inc.,~~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 ~~include our wholly owned subsidiaries,~~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 ~~audited~~ consolidated financial statements and accompanying notes ~~thereto~~ included in our 2020 Annual Report on Form 10-K ~~for~~(“2020 10-K Report”). Certain amounts in the year ended December 31, 2016, as filed with the Securities and Exchange Commission, or the SEC, from which we derived the accompanying consolidated balance sheet as of December 31, 2016. The accompanying unaudited interim consolidated financial statements and accompanying notes may not add due to rounding, and all percentages have been ~~prepared~~calculated using unrounded amounts.

We continue to be subject to risks and uncertainties in ~~accordance~~connection with ~~accounting principles generally accepted~~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.

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 2021. 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 ~~United States~~future.

While we currently believe that our COVID-19 contingency plan has the ability to mitigate many of ~~America,~~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 ~~GAAP~~,programs that we may undertake to address financial and operations challenges that we may face.

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 ~~interim~~the next twelve months from the issuance of these financial ~~information~~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 ~~instructions~~Financing Agreement covenants or satisfy our liquidity requirements until we are able to ~~Form 10-Q~~successfully commercialize IMVEXXY, BIJUVA, and ~~Article 10~~ANNOVERA. See also Note 3- Inventory for additional information regarding risks associated with our contract manufacturers, particularly for ANNOVERA. The presence of ~~Regulation S-X. Accordingly, since they~~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 ~~interim statements,~~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.

The accompanying unaudited ~~interim~~ consolidated financial statements do not include ~~all~~any adjustments that might be necessary if the Company is unable to continue as a going concern.

The significant accounting policies we use for quarterly financial reporting are disclosed in Note 2, Summary of Significant Accounting Policies of the ~~information and~~accompanying notes ~~required by GAAP for complete financial statements. The accompanying unaudited interim~~to the consolidated financial statements ~~reflect all adjustments, consisting of normal recurring adjustments, that are,~~included in our 2020 10-K Report, and in the ~~opinion of our management, necessary~~section below.

There have been no recently issued accounting standards not yet adopted by us which are expected, upon adoption, to ~~a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year or any other interim period in the future.~~

In May 2017, the Financial Accounting Standards Board, or FASB, issued an Accounting Standards Update, or ASU, that clarifies when changes to the terms or conditions of a share-based payment award must be accounted for as modifications. The new guidance will reduce diversity in practice and result in fewer changes to the terms of an award being accounted for as modifications. The new guidance will allow companies to make certain changes to awards without accounting for them as modifications. This guidance does not change the accounting for modifications. The guidance will be applied prospectively to awards modified on or after the adoption date and is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted, including in an interim period. We do not expect that adoption of this guidance will have a material ~~effect on our consolidated financial statements.~~

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230). ASU 2016-15 is intended to reduce the diversity in practice regarding how certain transactions are classified within the statement of cash flows. ASU 2016-15 is effective for public business entities for annual periods beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted with retrospective application. We do not expect that adoption of this guidance will have a material effect on our consolidated financial statements.

In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation: Improvements to Employee Share-Based Payment Accounting. This guidance simplifies several aspects of the accounting for employee share-based payment transactions for both public and nonpublic entities, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. The guidance is effective for public business entities for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. We adopted ASU 2016-09 effective January 1, 2017, electing to account for forfeitures when they occur. The impact from adoption of the provisions related to forfeiture rates was reflected in our consolidated financial statements on a modified retrospective basis, resulting in an adjustment of approximately $31,000 to retained earnings. The impact from adoption of the provisions related to excess tax benefits or deficiencies in the provision for income taxes rather than paid-in capital was adopted on a modified retrospective basis. Since we have a full valuation allowance on our net deferred tax assets, an amount equal to the cumulative adjustment made to retained earnings to recognize the previously unrecognized net operating losses from prior periods was made to the valuation allowance through retained earnings for the first quarter financial statements. Adoption of all other changes did not have an impact on our consolidated financial ~~statements.~~statements or processes.

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.

~~In February 2016,~~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 ~~FASB issued ASU 2016-02, Leases. This guidance requires lessees to record most leases on their balance sheets but recognize expenses on their income statements in a manner similar to~~ current accounting. The guidance also eliminates current real estate-specific provisions for all entities. For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases. The standard is effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. We are in the process of analyzing the quantitative impact of this guidance on our results of operations and financial position.COVID-19 pandemic, or other customer-specific factors. While we ~~are continuing~~actively manage our credit exposure and work to ~~assess all potential impacts of the standard,~~respond to both changes in our customers’ financial conditions or macroeconomic events, there can be no guarantee we ~~currently believe the impact of this standard~~ will be ~~primarily related~~able to ~~the accounting for our operating lease.~~

~~In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The standard’s core principle~~mitigate all of these risks successfully. Although we have historically not experienced significant credit losses, it is possible that ~~a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to~~there could be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under previous guidance. This may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. In July 2015, the FASB approved the proposal to defer the effective date of ASU 2014-09 standard by one year. Early adoption is permitted after December 15, 2016, and the standard is effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods therein. In 2016, the FASB issued final amendments to clarify the implementation guidance for principal versus agent considerations (ASU 2016-08), accounting for licenses of intellectual property and identifying performance obligations (ASU 2016-10), narrow-scope improvements and practical expedients (ASU 2016-12) and technical corrections and improvements to topic 606 (ASU 2016-20) in its new revenue standard. We have performed a preliminary review of the requirements of the new revenue standard and are monitoring the activity of the FASB and the transition resource group as it relates to specific interpretive guidance. We have reviewed customer contracts and applied the five-step model of the new standard to our contracts as well as compared the results to our current accounting practices. We are currently in the process of drafting disclosures required by the new standard. At this point of our analysis, we do not believe that the adoption of this standard will have a material ~~effect on our financial statements but will potentially expand our disclosures related to contracts with customers.~~

~~Fair Value~~adverse impact from potential adjustments of ~~Financial Instruments~~

~~Our financial instruments consist primarily of cash, accounts receivable, accounts payable and accrued expenses. The~~the carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments, which are considered Level 1 assets under the fair value hierarchy.

We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by Accounting Standards Codification, or ASC, 820, Fair Value Measurements. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3). Assets and liabilities recordedtrade receivables in the ~~consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows:~~future.

At September 30, 2017 and 2016, we had no assets or liabilities that were valued at fair value on a recurring basis. The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with our impairment test. There was no impairment of intangible assets or long-lived assets during the three and nine months ended September 30, 2017 and 2016.

~~Trade accounts receivable are customer obligations due under normal trade terms.~~ We review accounts receivable for uncollectible accounts ~~and credit card charge-backs~~ 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.~~conditions and we record an allowance that presents the net amount expected to be collected. We ~~consider~~evaluate trade accounts receivable ~~past due~~ for ~~more than 90 days to be delinquent.~~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.

~~We recognize revenue on arrangements~~The following sets forth activities in accordance with ASC 605, Revenue Recognition. We recognize revenue only when the price is fixed or determinable, persuasive evidence of an arrangement exists, the service is performed, and collectability is reasonably assured.our allowance for credit losses (in thousands):

~~Our OTC~~We rely on third parties to manufacture our finished products, and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products paywe have entered into long-term supply agreements for the ~~product directly while purchasers~~manufacture of ANNOVERA, IMVEXXY, and BIJUVA. We do not have a long-term supply agreement for the manufacture of our prescription ~~prenatal vitamin products pay~~vitamins. Additionally, we do not have long-term contracts for the ~~product primarily via third-party payers. Both OTC~~supply of the active pharmaceutical ingredient (“API”) used in ANNOVERA and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques. As of January 1, 2017, we ceased manufacturing and distributing our OTC product lines, except for Iron 21/7, which have declined steadily over time resulting in immaterial sales. The revenue that is generated by us from major customers is all generated from salesBIJUVA.

One of our ~~prescription prenatal vitamin products~~third party contract manufacturers that manufactures ANNOVERA has recently experienced an increase in difficulties with the manufacturing process for ANNOVERA, which ~~is disclosed~~has resulted in ~~Note 13. There~~batch failures. The challenges are ~~no major customers for our OTC prenatal vitamin or other products.~~

~~We generate OTC revenue from product sales primarily to retail consumers. We recognize revenue from product sales upon shipment, when the rights of ownership~~multifactorial and ~~risk of loss have passed to the consumer. We~~ include ~~outbound shipping~~variability in raw material supply and handling fees, if any, in revenues, net, and bill them upon shipment. We include shipping expenses in cost of goods sold. A majority of our OTC customers pay for our products with credit cards, and we usually receive the cash settlement in two to three banking days. Credit card sales minimize accounts receivable balances relative to OTC sales (Iron 21/7). We provide an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce OTC customers. We recognize revenue from OTC sales, net of estimated returns and sales discounts. As of January 1, 2017, we ceasednormal manufacturing ~~and distributing our OTC product lines, except for Iron 21/7, which have declined steadily over time resulting in immaterial sales.~~

We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacy distributors. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, wholesaler fees, customer rebates and estimated returns.

Revenue related to prescription products sold through wholesale distributors is recognized when the prescription products are shipped to the distributors and the control of the products passes to each distributor. We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture.

Prior to September 1, 2016, we recognized revenue related to prescription products sold through retail pharmacy distributors when the product was dispensed by the retail pharmacy distributor, at which point all revenue and discounts related to such product were known or determinable and there was no right of return with respect to such product. On September 1, 2016, we centralized the distribution channel for both our retail pharmacy distributors and wholesale distributors, in order to facilitate salesvariation due to a ~~broader population of retail pharmacies and~~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 ~~exposure to any one retail pharmacy. Beginning on September 1, 2016, all of our prescription products are distributed under~~ the ~~wholesale distributor model described above.~~

~~We offer various rebate programs~~manufacturing challenges, in ~~an effort to maintain~~August 2021 we filed a ~~competitive position in~~supplemental New Drug Application with the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. We record distributor fees based on amounts stated in contracts and estimate chargebacks based on the number of units sold each period.

We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements may include options, restricted stock, restricted stock units, performance-based awards, and share appreciation rights. We amortize such compensation amounts, if any, over the respective service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718, Compensation-Stock Compensation, to value options. Option valuation models require the input of assumptions, including the expected life of the stock-based awards, the estimated stock price volatility, the risk-free interest rate, and the expected dividend yield. The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the term of the instrument. Estimated volatility is a measure of the amount by which our stock price is expected to fluctuate each year during the term of the award. Prior to January 1, 2017, the expected volatility of share options was estimated based on a historical volatility analysis of peer entities whose stock prices were publicly available that were similar to our company with respect to industry, stage of life cycle, market capitalization, and financial leverage. On January 1, 2017, we started using our own stock price in our volatility calculation along with two other peer entities whose stock prices were publicly available that were similar to our company. Our calculation of estimated volatility is based on historical stock prices over a period equal to the expected term of the awards. The average expected life of warrants is based on the contractual terms of the awards. The average expected life of options is based on the contractual terms of the stock option using the simplified method. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash dividends. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, estimates of expected life of the share-based award, stock price volatility and risk-free interest rates. The assumptions used in calculating the fair value of share-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our share-based compensation expense could be materially different in the future.

Equity instruments (“instruments”) issued to non-employees are recorded on the basis of the fair value of the instruments, as required by ASC 505, Equity - Based Payments to Non-Employees, or ASC 505. ASC 505 defines the measurement date and recognition period for such instruments. In general, the measurement date is when either (a) a performance commitment, as defined, is reached or (b) the earlier of (i) the non-employee performance is complete or (ii) the instruments are vested. The estimated expense is recognized each period based on the current fair value of the award. As a result, the amount of expense related to awards to non-employees can fluctuate significantly during the period from the date of the grant through the final measurement date. The measured value related to the instruments is recognized over a period based on the facts and circumstances of each particular grant as defined in ASC 505.

We recognize the compensation expense for all share-based compensation granted based on the grant date fair value estimated in accordance with ASC 718. We generally recognize the compensation expense on a straight-line basis over the employee’s requisite service period.~~We adopted ASU 2016-09, effective January 1, 2017, electing to account for forfeitures when they occur. Prior to that,we estimated the forfeiture rate based on our historical experience of forfeitures.~~

Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, manufacturing, laboratory supplies, scale-up and validation costs, and other activities. Internal R&D activity expenses include salaries, benefits, and non-cash share-based compensation expenses. Advance payments to be expensed in future research and development activities are capitalized, and were $0 at September 30, 2017 and $228,933 at December 31, 2016, all of which were included in other current assets on the accompanying consolidated balance sheets. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal fees and costs. The activities undertaken by our regulatory consultants that were classified as R&D expenses include assisting, consulting with, and advising our in-house staff with respect to various U.S. Food and Drug Administration or(“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

assurance that such a modification will be approved by the FDA. If the FDA ~~submission processes, clinical trial processes,~~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 ~~scientific writing matters, including preparing protocols~~payable, which would have an adverse effect on our business, results of operations and ~~FDA submissions. Legal activities include professional research~~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 ~~advice regarding R&D, patents~~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 ~~regulatory matters. These consulting~~financial position and ~~legal expenses were direct costs associated with preparing, reviewing, and undertaking work for~~ability to meet our ~~clinical trials and investigative drugs. We charge internal R&D activities~~revenue and other ~~activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance~~covenants under our Financing Agreement.

Our inventory consisted of ~~a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when~~ the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions expense in the period in which the facts that give rise to the revision become known.following (in thousands):

We are managed and operated as one business, which is focused on creating and commercializing products targeted exclusively for women. Our business operations are managed by a single management team that reports to the Presidentrecorded depreciation expense of our company. We do not operate separate lines of business with respect to any of our products and we do not prepare discrete financial information with respect to separate products. All product sales are derived from sales in the United States. Accordingly, we view our business as one reportable operating segment.

~~Depreciation expense~~$0.2 million for the three months ended September 30, ~~2017~~2021 and ~~2016 was $35,622~~2020, and ~~$26,543 respectively, and $104,622 and $45,759~~$0.6 million for the nine months ended September 30, ~~2017~~2021 and ~~2016, respectively.~~2020.

The following ~~table sets forth the gross carrying amount~~provides information about our license rights and ~~accumulated amortization of our~~other intangible assets, ~~as of September 30, 2017 and December 31, 2016:~~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

We ~~capitalize external costs, consisting primarily of legal costs,~~recorded amortization expense related to ~~securing our patents and trademarks. Once a patent is granted, we amortize~~ the ~~approved hormone therapy drug candidate patents using the straight-line method over the estimated useful life~~exclusive license rights agreement (the “Population Council License Agreement”) with Population Council of approximately 20 years, which is the life of intellectual property patents. If the patent is not granted, we write-off any capitalized patent costs at that time. Trademarks are perpetual and are not amortized. During the nine months ended September 30, 2017 and year ended December 31, 2016, there was no impairment recognized related to intangible assets.

~~In addition to numerous pending patent applications, as of September 30, 2017, we had 17 issued patents, including:~~

~~Amortization expense was $18,433 and $13,917~~$0.8 million for the three months ended September 30, ~~2017~~2021 and ~~2016, respectively,~~2020, and ~~$52,321 and $38,560~~$2.3 million for the nine months ended September 30, ~~2017~~2021 and ~~2016, respectively. Estimated~~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 ~~for the next five years for the patent cost currently being amortized is as follows:~~

We calculate earnings per share, or EPS, in accordance with ASC 260, Earnings Per Share, which requires the computation and disclosure of two EPS amounts: basic and diluted. We compute basic EPS based on the weighted-average number of shares of common stock, par value $0.001 per share, or Common Stock, outstanding during the period. We compute diluted EPS based on the weighted-average number of shares of Common Stock outstanding plus all potentially dilutive shares of Common Stock outstanding during the period. Such potentially dilutive shares of Common Stock consist of options and warrants and were excluded from the calculation of diluted earnings per share because their effect would have been anti-dilutive due to the net loss reported by us. The table below presents potentially dilutive securities that could affect our calculation of diluted net loss per share allocable to common stockholders$0.1 million for ~~the periods presented.~~

~~At September 30, 2017, we had 10,000,000 shares of preferred stock, par value $0.001, authorized for issuance, of which no shares of preferred stock were issued or outstanding.~~

~~At September 30, 2017, we had 350,000,000 shares of Common Stock authorized for issuance, of which 216,429,642 shares of Common Stock were issued and outstanding.~~

On September 25, 2017, we entered into an underwriting agreement with J.P. Morgan Securities LLC relating to an underwritten public offering of 12,400,000 shares of our Common Stock at a price of $5.55 per share. The net proceeds to us from the offering were approximately $68,573,000, after deducting estimated offering expenses payable by us. The offering closed on September 28, 2017 and we issued 12,400,000 shares of Common Stock.

~~During~~ the three months ended September 30, ~~2017, certain individuals exercised stock options to purchase 2,500 shares of Common Stock~~ 2021 and 2020, and $0.2 millionfor ~~$255 in cash. During~~ the nine months ended September 30, ~~2017, certain individuals exercised stock options~~2021 and 2020, respectively.

We use a combination of qualitative and quantitative factors to ~~purchase 102,546 shares~~assess licensed rights and intangible assets for impairment. As a result of ~~Common Stock for $212,615 in cash.~~

~~On January 6, 2016,~~performing these assessments, we ~~entered into an underwriting agreement with Goldman Sachs & Co. and Cowen and Company, LLC,~~determined that no impairment existed as the representatives of the several underwriters, or the Underwriters, relating to an underwritten public offering of 15,151,515 shares of Common Stock at a public offering price of $8.25 per share. Under the terms of the underwriting agreement, we granted the Underwriters a 30-day option to purchase up to an aggregate of 2,272,727 additional shares of Common Stock, which option was exercised in full. The net proceeds to us from the offering were approximately $134,864,000, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on January 12, 2016 and we issued 17,424,242 shares of Common Stock.

During the three months ended September 30, 2016, certain individuals exercised stock options to purchase 127,109 shares of Common Stock. Stock options to purchase shares of Common Stock were exercised as follows: (i) 10,000 options for $1,018 in cash and (ii) 117,109 options, pursuant to the stock options’ cashless provision, wherein 78,017 shares of Common Stock were issued. During the nine months ended September 30, 2016, certain individuals exercised stock options to purchase 544,277 shares of Common Stock. Stock options to purchase shares of Common Stock were exercised as follows: (i) 427,168 options for $979,060 in cash and (ii) 117,109 options, pursuant to the stock options’ cashless provision, wherein 78,017 shares of Common Stock were issued.

As of September 30, ~~2017, we had warrants outstanding~~2021 and, therefore, recorded no write-downs to purchase an aggregate of 3,115,905 shares of Common Stock with a weighted-average contractual remaining life of approximately 2.08 years, and exercise prices ranging from $0.24 to $8.20 per share, resulting in a weighted average exercise price of $2.58 per share.

~~The valuation methodology used to determine the fair value~~any of our ~~warrants is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions, including volatility of the stock price, the risk-free interest rate~~licensed rights and the term of the warrant. During the nine months ended September 30, 2017, we granted warrants to purchase 125,000 shares of Common Stock to outside consultants at an exercise price of $6.83 per share. The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of five years; volatility of 63.24%; risk free rate of 1.47%; and dividend yield of 0%. The grant date fair value of the warrants was $3.67 per share. The warrants are vesting ratably over a 12-month period and have an expiration date of March 15, 2022. During the nine months ended September 30, 2016, we granted warrants to purchase 245,000 shares of Common Stock to outside consultants at a weighted average exercise price of $7.90 per share. The weighted average grant date fair value of these warrants was $4.78 per share. The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of five years; volatility of 74.10%-74.15%; risk free rate of 1.04%-1.28%; and dividend yield of 0%. These warrants vest and have expiration dates as follows: warrants to purchase 75,000 shares of Common Stock vested on April 21, 2016 and have an expiration date of April 21, 2021, warrants to purchase 50,000 shares of Common Stock vest ratably over a 24-month period and have an expiration date of April 21, 2021, and warrants to purchase 120,000 shares of Common Stock vest ratable over a 12-month period and have an expiration date of January 21, 2021.

~~During the three months ended September 30, 2017 and 2016, we recorded $101,376 and $137,161, respectively, and~~other intangible assets. However, during the nine months ended September 30, ~~2017~~2020, we wrote off $584,509 in costs related to trademarks and ~~2016~~patents.

Other accrued expenses and other current liabilities consisted of the following (in thousands):

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 ~~recorded $217,150~~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 ~~$820,751, respectively,~~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 ~~share-based compensation expense~~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 future principal payments under the Financing Agreement are as follows (in thousands), excluding the prepayment fees described above:

Interest expense and other financing costs consisted of the following (in thousands):

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):

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 ~~warrants.~~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, ~~2017,~~2021, we were in compliance, in all material respects, with our covenants under the Financing Agreement.

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 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.

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 ~~associated with these warrants totaled approximately $279,000.~~for that legal proceeding will be immediately expensed in the period in which we become aware of unsuccessful legal proceeding.

In ~~May 2013,~~November 2020, we entered into ~~a consulting agreement with Sancilio~~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 ~~Company, Inc.,~~sell shares of our common stock having an aggregate offering price of up to $50.0 million from time to time through or ~~SCI,~~ to ~~develop drug platforms~~the sales agent under the 2020 ATM Program. Sales of our common stock were permitted to be used in our hormone replacement drug candidates. These services include support of our efforts to successfully obtain FDA approval for our drug candidates, including a vaginal capsule for the treatment of vulvar and vaginal atrophy, or VVA. In connection with the agreement, SCI agreed to forfeit its rights to receive warrants to purchase 833,000 shares of Common Stock that were to be granted pursuant to the terms of a prior consulting agreement dated May 17, 2012. As consideration under the agreement, we agreed to issue to SCI a warrant to purchase 850,000 shares of Common Stock at $2.01 per share that has vested or will vest, as applicable, as follows:

In May 2012, we issued warrants to purchase an aggregate of 1,300,000 shares of Common Stock to SCI for services to be rendered over approximately five years beginning in May 2012. The warrants vested upon issuance. Services provided are to include (a) services in support of our drug development efforts, including services in support of our ongoing and future drug development and commercialization efforts, regulatory approval efforts, third-party investment and financing efforts, marketing efforts, chemistry, manufacturing and controls efforts, drug launch and post-approval activities, and other intellectual property and know-how transfer associated therewith; (b) services in support of our efforts to successfully obtain New Drug Approval; and (c) other consulting services as mutually agreed uponmade from time to time in ~~relation~~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 ~~new drug development opportunities.~~prevailing market prices, or as otherwise agreed to with the sales agent. The ~~warrants~~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 ~~valued~~completed when we sold an aggregate total of 28,600,689 shares of our common stock at ~~$1,532,228~~an average sale price of $1.75 per share. For the 2020 ATM Program, we 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 ~~issuance using an~~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.

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):

The aggregate intrinsic value of $2.57; a term of five years; a volatility of 44.71%; risk free rate of 0.74%; and a dividend yield of 0%. During the three months ended September 30, 2017 and 2016, we recorded $0 and $64,449, respectively, andwarrants exercised during the nine months ended September 30, ~~2017 and 2016, we recorded $128,898 and $193,347, respectively, as non-cash~~2021 was $1.1 million.

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 ~~these warrants in~~ the ~~accompanying consolidated statements~~TherapeuticsMD, Inc. 2019 Stock Incentive Plan (the “2019 Plan”) to increase the number of ~~operations. The contract will expire upon~~shares of our common stockavailable under the ~~commercial manufacture of a drug product.~~2019 Plan by 22,475,000 shares. As of September 30, ~~2017,~~2021, there were 10,182,803 shares of common stock available for issuance under the ~~SCI warrants issued~~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 ~~2013~~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 ~~fully amortized.~~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

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 3 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

During both the three months ended September 30, 2017 and 2016, no warrants were exercised. During the nine months ended September 30, 2017, certain individuals exercised warrants to purchase 2,476,666 shares

The aggregate intrinsic value of ~~Common Stock for $3,798,999 in cash. In addition,~~options exercised during the nine months ended September 30, ~~2017, certain individuals exercised warrants to purchase 6,590,000 shares~~2021 was less than $0.1 million.

The following table summarizes the status of Common Stock pursuant to the warrants’ cashless exercise provisions, wherein 4,762,208 shares of Common Stock were issued. During the nine months ended September 30, 2016, certain individuals exercised warrants to purchase 722,744 shares of Common Stock for $1,373,000 in cash.

~~In 2009, we adopted the 2009 Long Term Incentive Compensation Plan, or the 2009 Plan, to provide financial incentives to employees, directors, advisers, and consultants of~~ our company who are able to contribute towards the creation of or who have created stockholder value by providing them stock options and other stock and cash incentives, or the Awards. The Awards available under the 2009 Plan consist of stock options, stock appreciation rights, restricted stock, restricted stock units ~~performance stock, performance units,~~(“RSUs”) and ~~other stock or cash awards as described in~~related transactions, including the ~~2009 Plan. There are 25,000,000 shares authorized for issuance thereunder. Generally,~~Exchange Offer and the options vest annually over four years or as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they have vested and prior to the specified expirationAugust Inducement Grant since December 31, 2020 (in thousands, except weighed average grant date provided and applicable exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued. As of September 30, 2017, there were non-qualified stock options to purchase 18,592,959 shares of Common Stock outstanding under the 2009 Plan. As of September 30, 2017, there were 2,156,003 shares of Common Stock available to be issued under the 2009 Plan.fair value):

In 2012, we adopted the 2012 Stock Incentive Plan, or the 2012 Plan, a non-qualified plan that was amended in August 2013. The 2012 Plan was designed to serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants and advisors of our company. The Awards available under the 2012 Plan consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, and other stock or cash awards as described in the 2012 Plan. Generally, the options vest annually over four years or as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they have vested and prior to the specified expiration date provided and applicable exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued. There are 10,000,000 shares of Common Stock authorized for issuance thereunder. As of September 30, 2017, there were non-qualified stock options to purchase 4,790,141 shares of Common Stock outstanding under the 2012 Plan. As of September 30, 2017, there were 5,128,333 shares of Common Stock available to be issued under the 2012 Plan.

The ~~valuation methodology used to determine the fair~~aggregate intrinsic value of ~~stock options is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions including volatility of the stock price, the risk-free interest rate,~~RSUs vested and ~~the expected life of the stock options. The assumptions used in the Black-Scholes Model for options granted~~settled during the nine months ended September 30, ~~2017 and 2016 are set forth in the table below.~~2021 was $2.1 million.

~~A summary~~The following table summarizes the status of ~~activity under the 2009 and 2012 Plans~~our performance stock units (“PSUs”) and related ~~information follows:~~

~~At September 30, 2017, our outstanding stock options had exercise prices ranging from $0.10 to $8.92 per share. The weighted~~transactions, including the August Inducement Grant since December 31, 2020 (in thousands, except weighed average grant date fair ~~value~~value):

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 ~~options granted was $3.82~~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 ~~$4.70 during the nine months ended September 30, 2017 and 2016, respectively. Share-based~~we received proceeds of $0.1 million.

We recorded share-based compensation ~~expense for options recognized in our results of operations is based on vested awards. Share-based compensation expense~~ 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, ~~2017~~2021 and ~~2016 was $1,885,050~~2020, respectively, and ~~$3,982,759, respectively,~~$12.8 million and $8.5 million for the nine months ended September 30, ~~2017~~2021 and ~~2016 was $4,691,735 and $12,294,089,~~2020, respectively. At

As of September 30, ~~2017, total~~2021, we had $22.7 million of unrecognized ~~estimated~~share-based compensation ~~expense~~cost related to unvested options, ~~granted prior to that date was approximately $12,419,000. This~~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~~weighted average period of 2.2 ~~years. No tax benefit was realized due~~years as follows (in thousands):

The following table provides information about disaggregated revenue by product mix and service (in thousands):

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 ~~continued pattern~~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 ~~operating losses.~~the U.S., except for Canada and Israel.

~~NOTE 11 – INCOME TAXES~~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, 0 BIJUVA sales have been made through the Knight License Agreement. Additionally, as of September 30, 2021, 0 IMVEXXY sales have been made through either of the licensing agreements.

Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. 12.Income taxes

We do not expect to pay any significant federal or state income ~~tax for 2017~~taxes as a result of ~~(a)~~(i) the losses recorded during the three and nine months ended September 30, ~~2017, (b)~~2021 and 2020, (ii) additional losses expected for the remainder of ~~2017, and/~~2021 or ~~(c)~~losses recorded in 2020, or (iii) net operating ~~loss~~losses carry forwards from prior years. ~~Accounting standards require the consideration of~~

We recorded a full valuation allowance ~~for deferred tax assets if it is “more likely than not” that some component or all~~ of the ~~benefits of deferred tax assets will not be realized. As~~net operating losses for the three and nine months ended September 30, 2021 and 2020. Accordingly, there were 0 provisions for income taxes for the three and nine months ended September 30, 2021 and 2020. Additionally, as of September 30, ~~2017,~~2021 and December 31, 2020, we maintain a full valuation allowance for all deferred tax assets. ~~Based on these requirements,~~

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):

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 ~~provision or benefit~~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 ~~income taxes has been recorded. There were no recorded unrecognized tax benefits at~~ the ~~end~~three and nine months ended September 30, 2021 and 2020.

The following table sets forth the outstanding securities as of the ~~reporting period.~~

~~NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS~~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):

~~In July 2015,~~A member of our Board of Directors, J. Martin ~~Carroll,~~Carrol, is also a director of ~~our company, was appointed to the board of directors of Catalent, Inc.~~Catalent. From time to time, we have entered into agreements with Catalent ~~Inc.~~ and its affiliates ~~or Catalent,~~ in the normal course of business. Agreements with Catalent have been reviewed by independent directors of our ~~company~~Company, or a committee consisting of independent directors of our ~~company since July 2015. During~~Company. For manufacturing activities, Catalent billed us $1.1 million and $0.5 million for the three months ended September 30, ~~2017~~2021 and ~~2016, we were billed by Catalent approximately $186,000~~2020, respectively, and ~~$828,000, respectively,~~$2.6 million for ~~manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. During~~ the nine months ended September 30, ~~2017~~2021 and 2016, we were billed by Catalent approximately $2,646,000 and $2,907,000, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. 2020.As of September 30, ~~2017~~2021 and December 31, ~~2016, there were~~2020, we have estimated amounts ~~due~~payable to Catalent ~~of approximately $26,000~~totaling less than $0.1 million and ~~$57,000,~~$0.3 million, respectively.In addition, we have minimum purchase requirements in place with Catalent as disclosed in Note 9, Commitments and contingencies.

~~We purchase our products from several suppliers with approximately 100% and 97%~~A member of our ~~purchases supplied from one vendor~~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 ~~both~~the nine months ended September 30, 2021, and $0.1 million and $0.2 million for the three and nine months ended September 30, ~~2017~~2020, respectively.As of September 30, 2021 and ~~2016, respectively.~~December 31, 2020, we have 0 amounts payable to AIG.

We sell our ~~prescription prenatal vitamin~~ products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers. As a result of developments in the pharmaceutical industry that negatively affected independent pharmacies, including such pharmacies’ reliance on third-party payors, in 2016, we identified that payment periods for our retail pharmacy distributors were becoming longer than in prior years. As a result, during the third quarter of 2016, we centralized the distribution channel for both our retail pharmacy distributors and wholesale distributors, in order

Customers with product revenue equal to facilitate sales to a broader population of retail pharmacies and minimize business risk exposure to any one retail pharmacy. During the third quarter of 2016, we entered into new distribution agreements with our retail pharmacy distributors to effectuate this centralization which were effective September 1, 2016.

~~During both the nine months ended September 30, 2017 and 2016, four customers each generated more~~or greater than 10% of our total ~~revenue. Revenue generated from four major customers combined accounted for approximately 60% of our~~ revenue for ~~both~~ the nine months ended September 30, 2017 and 2016. During the nine months ended September 30, 2017, Pharmacy Innovations PA generated approximately $2,715,000 of our revenue, AmerisourceBergen generated approximately $1,716,000 of our revenue, Cardinal Health generated approximately $1,764,000 of our revenue and McKesson Corporation generated approximately $1,458,000 of our revenue. During the nine months ended September 30, 2016, Woodstock Pharmaceutical and Compounding generated approximately $2,247,000 of our revenue, Medical Center Pharmacy generated approximately $2,683,000 of our revenue, Due West Pharmacy generated approximately $1,890,000 of our revenue and Pharmacy Innovations generated approximately $2,113,000 of our revenue.

We lease administrative office space in Boca Raton, Florida pursuant to a non-cancelable operating lease that commenced on July 1, 2013 and originally provided for a 63-month term. On February 18, 2015, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. In addition, on April 26, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location. This agreement was effective beginning May 1, 2016 and extended the original expiration of the lease term to October 31, 2021. On October 4, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. This addendum is effective beginning November 1, 2016.

The rental expense related to our current lease during the three months ended September 30, 2017 and 2016 was approximately $257,000 and $182,000, respectively. The rental expense related to our current lease during the nine months ended September 30, 2017 and 2016 was approximately $772,000 and $482,000, respectively.

~~As of September 30, 2017, future minimum rental payments on non-cancelable operating leases are~~periods indicated were as follows:

~~Legal Proceedings~~Customers that accounted for 10% or greater of our accounts receivable as of the periods indicated were as follows:

~~On April 17, 2017, a securities class action lawsuit was filed against our company~~

We rely on third parties for the manufacture and ~~certain~~supply of our ~~officers and directors in the U.S. District Court~~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 ~~Southern District~~periods indicated were as follows:

Vendors that accounted for 10% or greater of ~~Florida (Case No. 9:17-cv-80473-RLR) that purported to state a claim for alleged violations of Sections 10(b) and 20(a)~~our accounts payable as of the ~~Securities Exchange Act of 1934,~~periods indicated were as amended, and Rule 10b-5 promulgated thereunder, based on statements made by the defendants concerning the NDA for TX-004HR. The complaint sought unspecified damages, interest, attorneys’ fees and other costs. On July 18, 2017, the complaint was voluntarily dismissed by the lead plaintiff without prejudice. We and certain of our officers and directors were are also subject to two shareholder derivative lawsuits regarding the NDA for TX-004HR, one filed in the U.S. District Court for the Southern District of Florida on May 30, 2017 (Case No. 9:17-cv-80686-RLR) and one filed in Florida state court in Palm Beach County on June 5, 2017 (Case No. 502017CA006289XXXXMB). These complaints were both voluntarily dismissed by the lead plaintiffs without prejudice on August 14, 2017.follows:

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion ~~and analysis provides information that we believe to be relevant to an assessment and understanding of our results of operations and financial condition for the periods described. This discussion~~ should ~~be read together with our consolidated financial statements and the notes to the financial statements, which are included in this Quarterly Report on Form 10-Q. This information should also~~ be read in conjunction with ~~the information contained in~~ our 2020 Annual Report on Form 10-K ~~for~~(“2020 10-K Report”), and the ~~year ended December 31, 2016 filed with the Securities and Exchange Commission, or the SEC, on February 28, 2017, or the Annual Report, including the audited~~consolidated financial statements and related notes ~~included therein. The reported results will not necessarily reflect future results of operations or financial condition.~~

~~In addition,~~ in Item 1, Financial Statements, appearing elsewhere in this this Quarterly Report on Form 10-Q ~~contains~~(“10-Q Report”). The following discussion may contain forward-looking statements, and our actual results may differ materially from the results suggested by these forward-looking statements. Factors that ~~involve substantial risks~~might cause such differences include, but are not limited to, those discussed in Part I, Item 1A of our 2020 10-K Report under the heading “Risk Factors,” as updated and ~~uncertainties.~~supplemented by Part II, Item 1A of this 10-Q Report. The Company assumes no obligation to revise or update any forward-looking statements for any reason, except as required by law. Certain amounts in the following discussion may not add due to rounding, and all percentages have been calculated using unrounded amounts.

This 10-Q Report may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may include, but are not limited to, statements relating to our objectives, plans, and strategies as well as statements, other than historical facts, that address activities, events, or developments that we intend, expect, project, believe, or anticipate will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” ~~“strategy”~~“strategy,” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements are made as of the date of this ~~Quarterly~~10-Q Report ~~on Form 10-Q~~ and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or ~~otherwise.~~ otherwise, except as required by law or by the rules and regulations of the SEC.

Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in our ~~Annual~~2020 10-K Report,as updated and supplemented by Part II, Item 1A of this 10-Q Report, and include the following: ~~our ability to resolve~~ the ~~deficiencies identified by~~effects of the U.S. Food and Drug Administration, or FDA, in our new drug application, or NDA, for our TX-004HR product candidate and the time frame associated with such resolution; whether we will be able to prepare an amended NDA for our TX-004HR product candidate and, if prepared, whether the FDA will accept and approve the NDA;COVID-19 pandemic; our ability to maintain or increase sales of our approved products; our ability to successfully commercialize IMVEXXY, BIJUVA, and ANNOVERA, and to develop and commercialize our hormone therapy drug candidates and obtain additional financing necessary ~~therefor;~~therefor, including pursuant to our 2021 ATM Program; our ability to maintain the listing of our common stock on Nasdaq; our ability to continue as a going concern; our commercialization, marketing, and manufacturing capabilities and strategy for our approved products; the size of markets and the potential market opportunity for which our products are approved and our ability to penetrate such markets; the rate and degree of market acceptance of our products; the willingness of healthcare providers to prescribe and patients to use our products; our ability to obtain additional financing when needed and to service our debt; our competitive position and the success of competing products that are or become available for the indications that we are pursuing; our intellectual property position; whether we will be able to ~~prepare an NDA for~~comply with the covenants and conditions under our ~~TX-001HR~~term loan facility, including product ~~candidate~~net revenue requirements and ~~if prepared, whether the FDA will accept and approve the NDA;~~liquidity requirements; the length, cost, and uncertain results of our clinical trials, ~~including any additional clinical trials that the FDA may require in connection with TX-004HR;~~ the potential of adverse side effects or other safety risks that could adversely affect the commercialization of our current or future approved products or preclude the approval of our ~~hormone therapy~~future drug candidates; whether the U.S. Food and Drug Administration (“FDA”) will approve the efficacy supplement for the lower dose of BIJUVA and the manufacturing supplement for ANNOVERA; our ability to protect our intellectual property, including with respect to the Paragraph IV notice letters we received regarding IMVEXXY and BIJUVA; the length, cost, and uncertain results of future clinical trials; our reliance on third parties to conduct our manufacturing, R&D and clinical ~~trials, research~~trials; potential disruptions in our supply chains related to our third party contract manufacturers and ~~development~~their ability to provide the materials necessary to manufacture our products, to successfully manufacture our products, and ~~manufacturing;~~to timely ship bulk and finished product to their intended destinations; the ability of our licensees to commercialize and distribute our products; the ability of our marketing contractors to market our products; the availability of reimbursement from government authorities and health insurance companies for our products; the impact of product liability lawsuits; and the influence of extensive and costly government ~~regulation.~~

~~Throughout this Quarterly Report on Form 10-Q,~~regulation; the terms “we,” “us,” “our,” “TherapeuticsMD,” or “our company” refer to TherapeuticsMD, Inc., a Nevada corporation, and unless specified otherwise, include our wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed; BocaGreenMD, Inc., a Nevada corporation, or BocaGreen; and VitaCarepotential disposition of vitaCare^™ Prescription Services, Inc. (“vitaCare Prescription Services”), a Florida corporation, or ~~VitaCare.~~any other divestitures we may pursue in the future; the volatility of the trading price of our common stock and the concentration of power in our stock ownership.

~~Our common stock, par value $0.001 per share, or~~During the ~~Common Stock, has been listed on~~first nine months of 2021, the ~~Nasdaq Global Select Market of The Nasdaq Stock Market LLC since October 9, 2017. Our Common Stock was previously listed on~~recovery from the ~~NYSE American, LLC. We maintain websites at www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com,~~COVID-19 pandemic drove improved access to health care providers for our sales force and ~~www.bocagreenmd.com. The information contained~~increased consumer demand for our products, which had a positive impact on our ~~websites or that can~~net product revenue relating to ANNOVERA, IMVEXXY, and BIJUVA. We believe the growth in our net product revenue will continue to be ~~accessed through~~affected by the pace of recovery from the COVID-19 pandemic.

Our portfolio of products focused on women’s health allows us to efficiently leverage our ~~websites does not constitute part~~sales and marketing plans to grow our pharmaceutical products. We are focused on activities necessary for the continued commercialization of ~~this Quarterly Report on Form 10-Q.~~

~~Research~~IMVEXXY, commercially launched in the third quarter of 2018; BIJUVA, commercially launched in the third quarter of 2019; and ~~Development~~

ANNOVERA, which we started selling in the third quarter of 2019 and commercially launched in March 2020, which was subsequently paused as a result of the COVID-19 pandemic and relaunched in July 2020. We ~~have obtained FDA acceptance~~continue to manufacture and distribute our prescription prenatal vitamin product lines, consisting of branded prenatal vitamins under vitaMedMD and authorized generic formulations of some of our ~~Investigational New Drug, or IND, applications to conduct clinical trials for five of our proposed hormone therapy drug products: TX-001HR, our oral combination of progesterone~~prescription prenatal vitamin products under BocaGreenMD.

IMVEXXY (estradiol vaginal inserts), 4-μg and estradiol; TX-002HR, our oral progesterone alone; TX-003HR, our oral estradiol alone; and TX-004HR, our applicator-free vaginal estradiol softgel with estradiol alone and TX-006HR our combination estradiol and progesterone10-μg

This pharmaceutical product ~~in a topical cream form. Our IND applications for TX-002HR and TX-003HR are currently inactive.~~

In December 2016, we announced positive top-line results from the recently completed the REPLENISH Trial, our phase 3 clinical trial of TX-001HR, our bio-identical hormone therapy combination of 17ß- estradiol and progesterone in a single, oral softgel drug candidate,is for the treatment of moderate to severe vasomotor symptoms, or VMS, due to menopause in post-menopausal women with an intact uterus. In December 2015, we completed the REJOICE Trial, our phase 3 clinical of TX-004HR, our applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate to severemoderate-to-severe dyspareunia (vaginal pain ~~during~~associated with sexual ~~intercourse)~~activity), a symptom of vulvar and vaginal atrophy due to menopause. The 4-μg formulation of IMVEXXY represents the lowest FDA approved dose of vaginal estradiol available. IMVEXXY is a small, digitally inserted, softgel vaginal insert that dissolves when inserted into the vagina. It is administered mess-free, without the need for an applicator, and can be used any time of day. IMVEXXY provides a mechanism of action and dosing that are familiar and comfortable for patients, with no patient education required for dose application or ~~VVA,~~applicators. IMVEXXY demonstrated efficacy as early as two weeks (secondary endpoint) and maintained efficacy through week 12 in clinical studies, with no increase in systemic hormone levels beyond the normal postmenopausal range (the clinical relevance of systemic absorption rates for vaginal estrogen therapies is not known).

As part of the FDA’s approval of IMVEXXY, we have committed to conduct a post-approval observational study to evaluate the risk of endometrial cancer in post-menopausal women with a uterus who use a low-dose vaginal ~~linings that do not receive enough estrogen. In~~estrogen unopposed by a progestogen. The FDA has also asked the ~~fourth quarter~~sponsors of ~~2016 we submitted an IND application for TX-006HR, our combination estradiol and progesterone drug candidate in a topical cream form, and intend~~other vaginal estrogen products to ~~commence phase 1 clinical trials of this drug candidate as early as 2018. In July 2014, we suspended enrollment~~participate in the ~~SPRY Trial, our phase 3 clinical trial for TX-002HR, our oral progesterone alone drug candidate, and, in October 2014, we stopped the trial in order to update the phase 3 protocol based on discussions~~observational study. In connection with the ~~FDA. We have currently suspended further~~observational study, we will be required to provide progress reports to the FDA on an annual basis. The development of this ~~drug candidate~~method is underway, and we do not believe that the costs will be material on an annual basis.

We market and sell IMVEXXY in the U.S. and have entered into licensing agreements with third parties to ~~prioritize our leading drug candidates. Our IND~~market and sell IMVEXXY outside of the U.S. 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 in Canada and Israel. We 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 for human use outside of the U.S., except for Canada and Israel. As of September 30, 2021, no IMVEXXY sales have been made through these licensing agreements.

This pharmaceutical product is ~~currently in inactive status.We have no current plans to conduct clinical trials for TX-003HR, our oral estradiol alone drug candidate,~~the first and ~~the IND application for this drug candidate is currently inactive.~~

~~TX-001HR is our bio-identical~~only FDA approved bioidentical hormone therapy combination of ~~17ß-~~ estradiol and progesterone in a single, oral ~~softgel drug candidate~~capsule for the treatment of ~~moderate to severe VMS~~moderate-to-severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause ~~including hot flashes, night sweats and sleep disturbances~~ in ~~post-menopausal~~ women with ~~an intact~~a uterus. The ~~hormone therapy drug candidate is bioidentical to – or having~~estrogen and progesterone in BIJUVA have the same chemical and molecular structure as - the hormones that are naturally ~~occur~~produced in a woman’s ~~body, namely~~body.

BIJUVA offers the convenience of a single-capsule combination of two hormones (estradiol and progesterone), which may improve a user’s compliance. The estradiol and progesterone in BIJUVA are plant-based, not animal-sourced, and ~~is being studied as~~does not contain peanut oil unlike other FDA approved progesterone products. BIJUVA provides a continuous-combined regimen, in which the combination of estrogen and progesterone are taken together in one product daily. If approved by the FDA, we believe this would represent the first time a combination productsustained steady state of estradiol ~~and progesterone bioidentical to the estradiol and progesterone produced by the ovaries would be approved for use in a single combined product.~~

On September 5, 2013, we began enrollment in the REPLENISH Trial, a multicenter, double-blind, placebo-controlled, phase 3 clinical trial of TX-001HR in postmenopausal women with an intact uterus. The trial was designed to evaluate the efficacy of TX-001HR for the treatment of moderate to severe VMS due to menopause and the endometrial safety of TX-001HR. Patients were assigned to one of five arms, four active and one placebo, and received study medication for 12 months. The primary endpoint for the reduction of endometrial hyperplasia was an incidence of endometrial hyperplasia of less than 1% at 12 months, as determined by endometrial biopsy. The primary endpoint for the treatment of moderate to severe VMS was the mean change of frequency and severity of moderate to severe VMS at weeks four and 12 compared to placebo, as measured by the number and severity of hot flashes. Only subjects experiencing a minimum daily frequency of seven moderate to severe hot flashes at screening were included in the VMS analysis, while all subjects were included in the endometrial hyperplasia analysis. The secondary endpoints included reduction in sleep disturbances and improvement in quality of life measures, night sweats and vaginal dryness, measured at 12 weeks, six months and 12 months. The trial evaluated 1,835 patients between 40 and 65 years old at 111 sites. On December 5, 2016, we announced positive topline data for the REPLENISH Trial.

~~The REPLENISH Trial evaluated four doses of TX-001HR and placebo; the doses studied were:~~

~~● TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg both achieved all four of the co-primary efficacy endpoints and the primary safety endpoint.~~

● TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg both demonstrated a statistically significant and clinically meaningful reduction from baseline in bothwhich reduced the frequency and severity of hot flashes ~~compared to placebo.~~in clinical studies with no demonstrated impact on a patient’s weight or blood pressure. Additionally, through clinical trials, BIJUVA has demonstrated endometrial safety and greater than 90% amenorrhea rates, while providing no clinically meaningful changes in mammograms.

~~● TX-001HR estradiol~~In January 2020, we submitted a New Drug Application (“NDA”), efficacy supplement for the 0.5 mg/~~progesterone 50 mg and TX-001HR estradiol 0.25 mg/progesterone 50 mg were not statistically significant at all of the co-primary efficacy endpoints. The estradiol 0.25 mg/progesterone 50~~100 mg dose ~~was included in the clinical trial as a non-effective dose~~of BIJUVA to ~~meet the recommendation of~~ the FDA ~~guidance to identify~~for review and potential approval. The NDA efficacy supplement used existing data from our Phase 3 REPLENISH trial for BIJUVA, for which we announced results in December 2016, together with additional information and analyses. In November 2020, we withdrew the ~~lowest effective dose.~~

~~● The incidence of consensus endometrial hyperplasia or malignancy was 0 percent across all four TX-001HR doses, meeting the recommendations established by the FDA’s draft guidance.~~

~~As outlined in the FDA guidance, the co-primary~~NDA efficacy endpoints in the REPLENISH Trial were the change from baseline in the number and severity of hot flashes at weeks four and 12 as compared to placebo. The primary safety endpoint was the incidence of endometrial hyperplasia with up to 12 months of treatment. General safety was also evaluated.

~~The results of the REPLENISH Trial are summarized in the table below (p-values of < 0.05 meet FDA guidance and support evidence of efficacy):~~

~~ŦPer FDA, consensus hyperplasia refers to the concurrence of two of the three pathologists be accepted as the final diagnosis.~~

supplement. We ~~had~~filed a ~~pre-NDA meeting for TX-001HR~~Formal Dispute Resolution Request (“FDRR”) with the FDA ~~on August 28, 2017. We anticipate~~ that disputed the FDA’s requirement that the NDA efficacy supplement meet approval standards that have not been required of other approved drugs in BIJUVA’s therapeutic class. In March 2021, the FDA granted the FDRR in our favor. In May 2021 we ~~will submit an~~resubmitted the NDA efficacy

supplement for ~~TX-001HR~~the 0.5 mg/100 mg dose of BIJUVA to the FDA ~~in the fourth quarter of 2017. Assuming that the~~for review and potential approval. The NDA isefficacy supplement has been accepted ~~60 days thereafter and an FDA~~for review ~~period of ten months from the receipt date to the Prescription Drug User Fee Act, or PDUFA, date for a non-new molecular entity, the NDA for TX-001HR could be approved~~ by the FDA ~~as soon as the fourth quarter of 2018.~~

~~TX-002HR is~~with a natural progesterone formulation for the treatment of secondary amenorrhea without the potentially allergenic component of peanut oil. The hormone therapy drug candidate is bioidentical to – or having the same chemical and molecular structure as - the hormones that naturally occur in a woman’s body. We believe it will be similarly effective to traditional treatments, but may demonstrate efficacy at lower dosages. In January 2014, we began recruitment of patients in the SPRY Trial, a phase 3 clinical trial designed to measure the safety and effectiveness of TX-002HR in the treatment of secondary amenorrhea. During the first two quarters of 2014, the SPRY Trial encountered enrollment challenges because of Institutional Review Board approved clinical trial protocols and FDA inclusion and exclusion criteria. In July 2014, we suspended enrollment and in October 2014 we stopped the SPRY Trial in order to update the phase 3 protocol based on discussions with the FDA. Our IND is currently in inactive status. We are considering updating the phase 3 protocol to, among other things, target only those women with secondary amenorrhea due to polycystic ovarian syndrome and to amend the primary endpoint of the trial. We believe that the updated phase 3 protocol, if proposed by us and approved by the FDA, would allow us to mitigate the enrollment challenges in, and shorten the duration of, the SPRY Trial. However, there can be no assurance that the FDA will approve the updated phase 3 protocol if we propose it. We have currently suspended further development of this drug candidate to prioritize our leading drug candidates.

TX-004HR is our applicator free vaginal estradiol softgel drug candidate for the treatment of VVA in post-menopausal women with vaginal linings that do not receive enough estrogen. We believe that our drug candidate will be at least as effective as the traditional treatments for VVA because of an early onset of action with less systemic exposure, inferring a greater probability of dose administration to the target tissue, and it will have an added advantage of being a simple, easier to use dosage form versus traditional VVA treatments. TX-004HR features our SYMBODA^TM technology. This allows for the production of cohesive, stable formulations and provides content uniformity and accuracy of dosing strengths for TX-004HR. We initiated the REJOICE Trial, a randomized, multicenter, double-blind, placebo-controlled phase 3 clinical trial during the third quarter of 2014 to assess the safety and efficacy of three doses – 25 mcg, 10 mcg and 4 mcg (compared to placebo) – of TX-004HR for the treatment of moderate to severe dyspareunia, or painful intercourse, as a symptom of VVA due to menopause.

On December 7, 2015, we announced positive top-line results from the REJOICE Trial. The pre-specified four co-primary efficacy endpoints were the changes from baseline to week 12 versus placebo in the percentage of vaginal superficial cells, percentage of vaginal parabasal cells, vaginal pH and severity of participants’ self-reported moderate to severe dyspareunia as the most bothersome symptom of VVA. The trial enrolled 764 postmenopausal women (40 to 75 years old) experiencing moderate to severe dyspareunia at approximately 89 sites across the United States and Canada. Trial participants were randomized to receive either TX-004HR at 25 mcg (n=190), 10 mcg (n=191), or 4 mcg (n=191) doses or placebo (n=192) for a total of 12 weeks, all administered once daily for two weeks and then twice weekly (approximately three to four days apart) for ten weeks. The 25 mcg dose of TX-004HR demonstrated highly statistically significant results at the p < 0.0001 level compared to placebo across all four co-primary endpoints. The 10 mcg dose of TX-004HR demonstrated highly statistically significant results at the p < 0.0001 level compared to placebo across all four co-primary endpoints. The 4 mcg dose of TX-004HR also demonstrated highly statistically significant results at the p < 0.0001 level compared to placebo for the endpoints of vaginal superficial cells, vaginal parabasal cells, and vaginal pH; the change from baseline compared to placebo in the severity of dyspareunia was statistically significant at the p = 0.0149 level. The FDA has previously indicated to us that in order to approve the drug based on a single trial, the trial would need to show statistical significance at the 0.01 level or lower for each endpoint, and that a trial that is merely statistically significant at a higher level may not provide sufficient evidence to support an NDA filing or approval of a drug candidate where the NDA relies on a single clinical trial. Statistical improvement over placebo was also observed for all three doses at the first assessment at week two and sustained through week 12. Vaginal dryness was a pre-specified key secondary endpoint. The 25 mcg and 10 mcg doses of TX-004HR demonstrated highly statistically significant results at the p < 0.0001 level compared to placebo for the endpoint of vaginal dryness. The 4 mcg dose of TX-004HR demonstrated statistically significant results at the p = 0.0014 level compared to placebo. The pharmacokinetic data for all three doses demonstrated negligible to very low systemic absorption of 17 beta estradiol, estrone and estrone conjugated, supporting the previous phase 1 trial data. TX-004HR was well tolerated, and there were no clinically significant differences compared to placebo-treated participants with respect to adverse events. There were no drug-related serious adverse events reported.

~~We submitted the NDA for TX-004HR with the FDA on July 7, 2016. The FDA determined that the NDA was sufficiently complete to permit a substantive review and accepted the NDA for filing with the PDUFA~~ target action date for the completion of the FDA’s review under the Prescription Drug User Fee Act of ~~May 7, 2017.~~March 21, 2022. Notwithstanding our FDRR, there can be no assurance that FDA will approve the 0.5 mg/100 mg dose of BIJUVA, or, if approved, the timing of such approval.

We market and sell BIJUVA in the U.S. and have entered into licensing agreements with third parties to market and sell BIJUVA outside of the U.S. We have entered into the Knight License Agreement with Knight pursuant to which we granted Knight an exclusive license to commercialize BIJUVA in Canada and Israel. We have entered into the Theramex License Agreement with Theramex pursuant to which we granted Theramex an exclusive license to commercialize BIJUVA for human use outside of the U.S., except for Canada and Israel. During the third quarter and the first nine months of 2021, we had BIJUVA sales of $0.7 million made through the Theramex License Agreement, and such sales were included as product revenue in the statement of operations. As of September 30, 2021, no BIJUVA sales have been made through the Knight License Agreement.

ANNOVERA (segesterone acetate (“SA”) and ethinyl estradiol (“EE”) vaginal system)

This pharmaceutical product is a one-year ring-shaped contraceptive vaginal system (“CVS”) and the first and only patient-controlled, procedure-free, reversible prescription contraceptive that can prevent pregnancy for up to a total of 13 cycles (one year). ANNOVERA, which is made with a silicone elastomer, contains SA, a 19-nor progesterone derivative also known as Nestorone^®, and EE. EE is an approved active ingredient in many marketed hormonal contraceptive products. SA is classified as a new chemical entity by the FDA and is a potent progestin that, based on pharmacological studies in animals and in vitro, does not bind to the androgen or estrogen receptors and has no glucocorticoid activity at contraceptive doses.

ANNOVERA can be inserted and removed by the woman herself without the aid of a healthcare provider and, unlike oral contraceptives, ANNOVERA does not require daily administration to obtain the contraceptive effect. After 21 days of use, the woman removes ANNOVERA for seven days, thereby providing a regular bleeding pattern (i.e., withdrawal/scheduled bleeding). The ~~NDA submission was~~same CVS is then re-inserted for additional 21/7-days in/out, for up to a total of 13 cycles (one year). ANNOVERA releases daily vaginal doses of both active ingredients (SA and EE). The claimed release rate of 150 µg/day SA and 13 µg/day EE is supported by the ~~complete TX-004HR clinical program, including positive results~~calculated average release rate from an ex vivo analysis of ANNOVERA used for 13 cycles and is also supported by data from 13 cycles of in vitro release.

ANNOVERA is commercially sold by us in the U.S. pursuant to the terms of the ~~phase 3 REJOICE Trial. The NDA submission included all three doses~~Population Council License Agreement with Population Council. As part of ~~TX-004HR (4 mcg, 10 mcg and 25 mcg) that were evaluated in~~ the ~~REJOICE Trial. If approved, the 4 mcg formulation would represent a lower effective dose than the currently available VVA therapies approved by the FDA.~~

~~On May 5, 2017, we received a Complete Response Letter, or CRL, from~~approval of ANNOVERA, the FDA ~~regarding~~has required a post-approval observational study be performed to measure the ~~NDA for TX-004HR. In~~risk of venous thromboembolism. We have agreed to perform and pay the ~~CRL,~~costs and expenses associated with this post-approval study, provided that if the ~~only approvability concern raised~~costs and expenses associated with such post-approval study exceed $20.0 million, half of such excess will offset against royalties or other payments owed by ~~the FDA was the lack of long-term safety data for TX-004HR beyond the 12-weeks studied in the phase 3 REJOICE Trial. The CRL did not identify any issues related~~us to the ~~efficacy~~Population Council under the Population Council License Agreement. Given the observational nature of ~~TX-004HR~~the study, we do not believe that the costs of the study will be material on an annual basis.

We believe that ANNOVERA competes across all the contraception options for women with a particular focus on those women seeking a long-lasting option without a procedure. For patients, ANNOVERA provides a single, long-lasting, reversible birth control product that does not require a procedure at the doctor’s office for insertion or removal, empowering women to be in control of their fertility and ~~did~~menstruation with a 21/7 regimen. We believe that ANNOVERA is a unique alternative for women who have previously chosen other forms of birth control. These include nulliparous women (or women who have never given birth), women who are considering an IUD but would rather not ~~identify any approvability issues related~~have a procedure, women who are between pregnancies but desire protection without a long-term commitment, and women who are not satisfied with oral options due to ~~chemistry, manufacturing and controls.~~ the daily usage or potential side effects.

We believe that the ~~NDA~~strong initial commercial net revenue per unit of ANNOVERA and commercial insurance adoption provide us with an opportunity to deploy additional financial resources to maximize ANNOVERA’s consumer-focused commercialization strategy and leverage the ability of doctor/patient choice of contraceptive to override insurance company formularies when necessary. As part of this strategy, we are pursuing distribution opportunities for ANNOVERA to provide women with additional access to ANNOVERA, particularly during the COVID-19 pandemic, with multiple telehealth platforms that extend the reach of ANNOVERA.

We manufacture and distribute our prescription prenatal vitamin product lines under our vitaMedMD brand name and authorized generic formulations of some of our prescription prenatal vitamin products under our BocaGreenMD Prena1 name. We will continue to support the vitaMedMD and BocaGreenMD products as they are important products to our core customers and help provide us with continued access to sell our women’s health portfolio. Our current prenatal vitamin product line features a unique, proprietary combination of FOLMAX™, FePlus™, and pur-DHA™ and includes the following products: vitaTrue™, vitaPearl™, vitaMedMD One Rx Prenatal Multivitamin, vitaMedMD RediChew^® Rx Prenatal Multivitamin, BocaGreenMD Prena1 True, BocaGreenMD

Prena1 Pearl, and BocaGreenMD Prena1 Chew. All of our prenatal vitamins are gluten, sugar, and lactose-free. A prenatal vitamin option that is both vegan and kosher is also available for women with special dietary needs. We believe our product attributes result in greater consumer acceptance and satisfaction than competitive products while offering the highest quality and patented ingredients.

Three months ended September 30, 2021 compared with three months ended September 30, 2020

Revenue. Our total revenue for the third quarter of 2021 was ~~approvable~~$25.4 million, an increase of $6.1 million, or 31.6%, compared to the third quarter of 2020. The following table sets forth our revenue during these periods (in thousands):

Our sales of ANNOVERA were $11.8 million for the third quarter of 2021, an increase of $5.4 million, or 83.9%, compared to the third quarter of 2020.This increase was primarily due to a 107.6% increase in sales volume, which was partially offset by a 11.4% decrease in the average sale price.

Our sales of IMVEXXY were $8.0 million for the third quarter of 2021, an increase of $1.2 million, or 17.2%, compared to the third quarter of 2020. This increase was primarily attributable to a 34.9% increase in the average sale price, which was partially offset by a 13.1% decrease in sales volume.

Our sales of BIJUVA were $3.3 million for the third quarter of 2021, an increase of $1.7 million, or 100.4%, compared to the third quarter of 2020. Included in our BIJUVA sales for the third quarter of 2021 was $0.7 million of sales made through the Theramex License Agreement. Without the sales made through the Theramex License Agreement, our sales of BIJUVA were $2.6 million for the third quarter of 2021, an increase of $1.0 million, or 58.0%, compared to the third quarter of 2020. Thisincreasewas primarily attributableto a 47.0% increase in the averagesaleprice and a 7.5% increase in sales volume.

Sales of our products utilize copay assistance programs that allow eligible enrolled patients to access the products at a reasonable cost regardless of insurance coverage. These programs may change from time to time, as ~~filed~~shown above with a change in the IMVEXXY copay assistance program. We expect that our net product revenue will improve from changes in our copay card price in the long term and increases in commercial and Medicare payer coverage when we fully complete the process needed to adjudicate ANNOVERA, IMVEXXY, and BIJUVA prescriptions at pharmacies.

Our prescription vitamin sales were $1.3 million for the third quarter of 2021, a decrease of $1.1 million, or 44.7%, compared to the third quarter of 2020. Thisdecreasewas primarily dueto a 32.8% decrease in sales volume and a 17.6% decrease in the average saleprice.

On a consolidated basis, our total product sales were $24.5 million for the third quarter of 2021, an increase of $7.1 million, or 41.1%, compared to the third quarter of 2020.

Our license revenue was $0.9 million for the third quarter of 2021, a decrease of $1.1 million, or 53.2%, compared to the third quarter of 2020.This decrease was entirely due to the timing of achieving previously established milestone payment targets.

Gross profit. Our gross profit for the third quarter of 2021 was $20.1 million, an increase of $4.1 million, or 25.3%, compared to the third quarter of 2020. The following table sets forth our gross profit during these periods (in thousands):

The increase in our gross profit was primarily a result of an increase of 41.1% in product revenue, partially offset by a 2.7% decrease in our product gross margin from 81.1% for the third quarter of 2020 to 78.4% for the third quarter of 2021. This decrease in product gross margins reflects the impact of $0.7 million of BIJUVA export sales, which were sold at cost.

Operating expenses. Total operating expenses for the third quarter of 2021 were $60.0 million, an increase of $19.0 million, or 46.3%, compared to the third quarter of 2020. Of the total increase, $7.3 million was related non-cash and cash severances recorded for certain former senior executives during the third quarter of 2021. The remining increase was $11.7 million, or 28.5%, compared to the third quarter of 2020. The type of operating expenses reported in prior periods have been ~~engaged~~reclassified to conform to the current period’s presentation. The following table sets forth our operating expense categories (in thousands):

Our selling and marketing costs were $30.0 million for the third quarter of 2021, an increase of $7.6 million, or 34.1%, compared to the third quarter of 2020. This increase was primarily due to $6.4 million in ~~discussions with~~higher advertising, $2.2 million in higher compensation and employee benefit costs to support the ~~FDA to address~~sales growth of our pharmaceutical products, reflecting the ~~concerns raised by the FDA~~continued impact of our formerly outsourced sales personnel who were onboarded in the ~~CRL.~~

~~On June 14, 2017, we participated~~third quarter of 2020, and $0.8 million in ~~a Type A Post-Action Meeting with~~higher marketing costs. These increases were partially offset by $1.6 million in lower outsourced sales personnel costs mainly attributable to the ~~Division~~onboarding of ~~Bone, Reproductive, and Urologic Products (DBRUP) of the FDA to discuss the CRL. The meeting enabled us to present new information that we believe could address concerns raised by the FDA~~such sales personnel in the ~~CRL~~third quarter of 2020 and ~~positively affect~~$0.5 million in lower product sample costs.

Our general and administrative costs were $28.4 million for the ~~status~~third quarter of 2021, an increase of $11.8 million, or 70.9%, compared to the ~~NDA~~third quarter of 2020. Of the total increase, $7.3 million was related to non-cash and cash severances recorded for ~~TX-004HR. We have received~~certain former senior executives during the ~~minutes~~third quarter of 2021. The remaining increase was $4.5 million, or 27.0%, compared to the ~~meeting~~third quarter of 2020. This increase was primarily related to $2.9 million in higher compensation and ~~per the FDA’s request, on July 5, 2017 formally submitted the new information for consideration~~employee benefit costs, of which $1.1 million was related to the ~~NDA for TX-004HR.~~

~~On August 3, 2017, we received a formal General Advice Letter from~~accrual of bonuses expected to be paid in the ~~FDA stating that an initial review~~first quarter of ~~this information has been completed~~2022, and ~~requesting that we submit~~$2.1 million in higher expenditures attributable to various professional fees, such as consulting, recruiting, legal, etc., in support of our efforts to expand the ~~additional endometrial safety information~~commercialization of our products. These increases were partially offset by $0.6 million in lower expenditures attributable to the ~~NDA for TX-004HR on or before September 18, 2017. On September 14, 2017, we submitted~~write-off of certain intangible assets during the ~~additional endometrial safety information that was requested by the FDA in the General Advice Letter to the NDA for TX-004HR. The submission includes a comprehensive, systematic review~~third quarter of ~~the medical literature on the use~~2020.

Our R&D costs consist mainly of vaginal estrogen products and the risk of endometrial hyperplasia or cancer, including the safety data from the recently published Women’s Health Initiative Observational Study, or WHI Study, of vaginal estrogen use in postmenopausal women and information on the relevance of the first uterine pass effect for low-dose vaginal estrogen products. The WHI Study demonstrated no significant difference in the risk of invasive breast cancer, stroke, colorectal cancer, endometrial cancer and venous thromboembolism in vaginal estrogen users versus non-users. The WHI Study also shows that, among women with an intact uterus, there was a decreased risk of cardiovascular disease, hip fracture and all-cause mortality in vaginal estrogen users versus non-users. The WHI Study evaluated over 4,000 women who used vaginal estrogens for a median duration of two to three years.

On November 3, 2017, we participated in an in-person meeting with DBRUP. At the meeting, DBRUP agreed to the resubmission of the NDA for the 4 mcg and 10 mcg doses of TX-004HR without the need for an additional pre-approval study. We will commit to conduct a post-approval observational study. We believe that we will be in a position to resubmit the NDA for TX-004HR within the coming weeks, with a potential approval of the NDA within two to six months after resubmission, depending on the classification of the review of the NDA.

As of September 30, 2017, we had 17 issued patents, which included 13 utility patents that relate to our combination progesterone and estradiol formulations, two utility patents that relate to TX-004HR, which establish an important intellectual property foundation for TX-004HR, one utility patent that relates to a pipeline transdermal patch technology, and one utility patent that relates to our OPERA^® ~~information technology platform.~~

A significant portion of our operating expenses to date have been incurred in research and development activities. Research and development expenses relate primarily to the discovery and development of our drug candidates. Our business model is dependent upon our company continuing to conduct a significant amount of research and development. Our research and development expenses consist primarily of expensescosts incurred under agreements with contract research organizations ~~or CROs, investigative sites~~(“CROs”) and ~~consultants~~other third parties that conduct our clinical ~~trials~~related studies, compensation, and ~~a substantial portion of our preclinical studies; employee-related expenses, which include salaries and benefits, and non-cash share-based compensation; the cost of~~benefit costs related employees engaged in R&D activities, costs to developing our chemistry, manufacturing, and controls capabilities, ~~and acquiring clinical trial materials;~~costs related to manufacturing validation, and costs associated with other research activities and regulatory approvals. ~~Other research and development costs listed below consist of costs incurred with respect~~With regards to ~~drug candidates that have not received IND application approval from the FDA.~~

We make payments to the CROs based on agreed upon terms that may include payments in advance of a study starting date. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Advance payments to be expensed in future research and development activities are capitalized, and were $0 at September 30, 2017 and $228,933 at December 31, 2016 which were included in other current assets on the accompanying consolidated balance sheets. CRO activity expenses include preclinical laboratory experiments and clinical trial studies.

~~The following table indicates our research and development expense by project/category for the periods indicated:~~

Research and development expenditures will continue to be incurred as we continue development of our drug candidates and advance the development of our proprietary pipeline of novel drug candidates. We expect to incur ongoing research and development costs as we develop our drug pipeline, continue stability testing and validation on our drug candidates, prepare regulatory submissions and work with regulatory authorities on existing submissions.

~~The~~ costs of clinical trials, they may vary significantly over the life of a project owing to a variety of factors that include, but are not limited to, the following: per patient trial costs; the number of patients that participate in the trials; the number of sites included in the trials; the length of time each patient is enrolled in the trial; the number of doses that patients receive; the drop-out or discontinuation rates of patients; the amount of time required to recruit patients for the trial; the duration of patient follow-up; and ~~the efficacy and safety profile of the drug candidate. We~~we base our expenses related to clinical trials on estimates ~~that are~~ based on our experience and estimates from CROs and other third parties. ~~Research and development~~R&D expenditures for the drug ~~candidates~~products will continue after the clinical trial completes for on-going stability and laboratory testing, regulatory submission, and response work.

~~Three months ended September 30, 2017 compared with three months ended September 30, 2016~~

~~Revenues~~Our R&D costs were $1.6 million for the three months ended September 30, 2017 decreased approximately $1,119,000, or 20%, to approximately $4,417,000, compared with approximately $5,536,000 for the three months ended September 30, 2016. This decrease was attributable tothird quarter of 2021, a decrease inof $0.4 million, or 20.8%, compared to the ~~average net revenue per unit~~third quarter of ~~our products and a slight~~2020. This decrease in the number of units sold. Cost of goods sold decreased approximately $536,000, or 43%, to approximately $701,000 for the three months ended September 30, 2017, compared with approximately $1,237,000 for the three months ended September 30, 2016. Our gross margin was approximately 84% and 78% for the three months ended September 30, 2017 and 2016, respectively. The increase in gross margin percentage was primarily attributable to the centralization of the distribution channel for both our retail pharmacy distributors and wholesale distributors, which, among other things, lowered the cost to package, prepare and deliver our products to customers.

~~Our principal operating~~$0.5 million in lower lab research costs, ~~include the following items as a percentage of total operating expenses.~~

~~Operating expenses decreased~~partially offset by approximately $10,879,000, or 37%, to approximately $18,548,000 for the three months ended September 30, 2017, from approximately $29,427,000 for the three months ended September 30, 2016 as a result of the following items:

Research and development costs for the three months ended September 30, 2017 decreased by approximately $8,227,000, or 56%, to approximately $6,437,000, compared with $14,664,000 for the three months ended September 30, 2016. Research and development costs include costs related to clinical trials as well as salaries, wages, non-cash$0.1 million in higher compensation and ~~benefits of personnel involved in research and development activities. Research and development costs decreased~~employee benefit costs. We have reduced our R&D expenditures since 2019 as ~~a direct result of~~we refocus our resources towards the completion of the REPLENISH Trial for TX-001HR, our combination estradiol and progesterone drug candidate. Research and developments costs during the three months ended September 30, 2017 included the following research and development projects.

During the three months ended September 30, 2017 and the period from February 2013 (project inception) through September 30, 2017, we have incurred approximately $3,066,000 and $107,987,000, respectively, in research and development costs with respect to TX-001HR, our combination estradiol and progesterone drug candidate.

During the three months ended September 30, 2017 and the period April 2013 (project inception) through September 30, 2017, we have incurred approximately $0 and $2,525,000, respectively, in research and development costs with respect to TX-002HR, our progesterone only drug candidate.

During the three months ended September 30, 2017 and the period from August 2014 (project inception) through September 30, 2017, we have incurred approximately $1,580,000 and $39,098,000, respectively, in research and development costs with respect to TX-004HR, our applicator-free vaginal estradiol softgel drug candidate.

For a discussion of the nature of efforts and steps necessary to complete these projects, see “Item 1. Business — Pharmaceutical Regulation” in our Annual Report and “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations – Overview – Research and Development” above. For a discussion of the risks and uncertainties associated with completing development of our products, see “Item 1A. Risk Factors — Risks Related to Our Business” in our Annual Report. For a discussion of the extent and nature of additional resources that we may need to obtain if our current liquidity is not expected to be sufficient to complete these projects, see “— Liquidity and Capital Resources” below. For a discussion as to whether a future milestone such as completion of a development phase, date of filing an NDA with a regulatory agency or approval from a regulatory agency can be reliably determined, see “Item 1. Business — Our Hormone Therapy Drug Candidates,” and “Item 1. Business — Pharmaceutical Regulation” in our Annual Report. Future milestones, including NDA submission dates and potential approval dates, are not easily determinable as such milestones are dependent on various factors related to our clinical trials, scale-up and manufacturing activities.

Human resource costs, including salaries, benefits and taxes, for the three months ended September 30, 2017 increased by approximately $1,000, or less than 1%, to approximately $5,966,000, compared with approximately $5,965,000 for the three months ended September 30, 2016, primarily as a result of a an increase of approximately $1,042,000 in personnel costs in sales, marketing and regulatory areas to supportcontinued commercialization of our ~~hormone therapy drug candidates partially offset by~~pharmaceutical products. Accordingly, we continue to deploy limited resources in the development of new products, to perform stability testing and validation on our pharmaceutical products, to develop and validate secondary manufacturers, to prepare regulatory submissions, and work with regulatory authorities on existing submissions.

Loss from operations. For the third quarter of 2021, we had a ~~decrease~~loss from operations of ~~approximately $1,041,000 in non-cash compensation expense included in this category related~~$39.9 million, compared to ~~employee stock option amortization.~~

~~Sales and marketing costs~~$25.0 million for the ~~three months ended September 30, 2017 decreased by approximately $1,038,000, or 25%,~~third quarter of 2020. Of the $14.9 million total increase, $7.3 million was related non-cash and cash severances recorded for certain former senior executives during the third quarter of 2021. The remaining increase of $7.6 million was attributable to approximately $3,163,000, compared with approximately $4,201,000 for the three months ended September 30, 2016, primarily as a result reduced spending associated with sales and marketing efforts to support commercialization of our hormone therapy drug candidates, partially offset by higher ~~costs related to outsourced sales personnel and their related expenses together with an increase in employee incentives.~~

Professional fees for the three months ended September 30, 2017 decreased by approximately $179,000, or 12%, to approximately $1,271,000, compared with approximately $1,450,000 for the three months ended September 30, 2016, primarily as a result of decreased consultingoperating expenses, partially offset by ~~a slight increase~~$4.1 million in ~~legal expenses.~~

Other operating expense for the three months ended September 30, 2017 decreased by approximately $1,436,000, or 46%, to approximately $1,711,000, compared with approximately $3,147,000 for the three months ended September 30, 2016, as a result of decrease in bad debt expense, partially offset by increased rent, information technology and other office expenses.

As a result of the foregoing, our operating loss decreased approximately $10,296,000, or 41%, to approximately $14,832,000 for the three months ended September 30, 2017, compared with approximately $25,128,000 for the three months ended September 30, 2016, primarily as a result of decreased research and development costs and reduced spending associated with sales and marketing efforts to support commercialization of our hormone therapy drug candidates, partially offset by higher ~~costs related to outsourced sales personnel and their related expenses, professional fees, and other operating expenses, as well a decrease in revenue.~~

~~As a result of the continued development of our hormone therapy drug candidates, we~~gross profit. We anticipate that we will continue to have operating losses for the near future until ~~our hormone therapy drug candidates~~we are ~~approved by the FDA~~able to successfully commercialize IMVEXXY, BIJUVA, and ~~brought to market,~~ANNOVERA, although there is no assurance that ~~we will attain such approvals or that any marketing of~~ our ~~hormone therapy drug candidates, if approved,~~efforts will be successful.

Other expense, net. For the third quarter of 2021, our non-operating ~~income increased by approximately $54,000, or 48%,~~expenses were $7.5 million, compared to ~~approximately $167,000~~$7.6 million for the ~~three months ended September 30, 2017~~third quarter of 2020. This $0.1 million decrease was attributable to $1.3 million in lower interest expense due to overall lower average debt balance during the third quarter of 2021 compared to the third quarter of 2020, partially offset by the recording of an $0.7 million accrual for interest prepayment fees in the third quarter of 2021 associated with ~~approximately $113,000 for~~our future debt service, and $0.5 million in higher amortization expense of deferred financing costs.

Net Loss. For the ~~comparable period in 2016, primarily as~~third quarter of 2021, we had a ~~result of increased interest income.~~

~~As a result of the net effects of the foregoing,~~ net loss ~~decreased approximately $10,350,000,~~of $47.4 million, or ~~41%, to approximately $14,665,000 for the three months ended September 30, 2017, compared with approximately $25,015,000 for the three months ended September 30, 2016. Net loss~~$0.11 per ~~share of Common Stock,~~ basic and diluted ~~was ($0.07)~~common share, compared to $32.6 million, or $0.12 per basic and diluted common share, for the ~~three months ended September 30, 2017, compared with ($0.13)~~third quarter of 2020. Our net loss for the ~~three months ended September 30, 2016.~~third quarter of 2021 included $7.3 million of non-cash and cash severances recorded for certain former senior executives. Without such severances, we would have had a net loss of $40.1 million, or $0.10 per basic and diluted common share, for the third quarter of 2021.

Nine months ended September 30, ~~2017~~2021 compared with nine months ended September 30, ~~2016~~2020

Revenue. Our total revenue for the first nine months of 2021 was $68.3 million, an increase of $26.0 million, or 61.4%, compared to the first nine months of 2020. The following table sets forth our revenue during these periods (in thousands):

~~Revenues~~ANNOVERA were $30.1 million for the first nine months ~~ended September 30, 2017 decreased approximately $2,216,000,~~of 2021, an increase of $19.6 million, or ~~15%~~186.0%, compared to ~~approximately $12,653,000, compared with approximately $14,869,000 for~~ the first nine months ~~ended September 30, 2016.~~ of 2020.This ~~decrease~~increase was ~~attributable~~primarily due to a 236.4% increase in sales volume, which was partially offset by a 15.0% decrease in the average ~~net revenue per unit~~sale price.

Our sales of ~~our products,~~IMVEXXY were $24.9 million for the first nine months of 2021, an increase of $6.5 million, or 35.7%, compared to the first nine months of 2020. This increase was primarily ~~related~~attributable to ~~higher estimates related to discounts and returns~~a 40.8% increase in ~~2017,~~the average sale price, which was partially offset by a ~~slight~~3.6% decrease in sales volume.

Our sales of BIJUVA were $7.9 million for the first nine months of 2021, an increase of $3.8 million, or 92.2%, compared to the first nine months of 2020. Included in our BIJUVA sales for the first nine months of 2021 was $0.7 million of sales made through the Theramex License Agreement. Without the sales made through the Theramex License Agreement, our sales of BIJUVA were $7.2 million for the third quarter of 2021, an increase of $3.1 million, or 75.2%, compared to the first nine months of 2020. Thisincreasewas primarily attributableto a 55.9% increase in the ~~number~~averagesaleprice and a 12.4% increase in salesvolume.

Sales of ~~units sold. Cost~~our products utilize copay assistance programs that allow eligible enrolled patients to access the products at a reasonable cost regardless of ~~goods sold decreased approximately $1,434,000, or 41%,~~insurance coverage. These programs may change from time to ~~approximately $2,042,000~~time, as shown above with a change in IMVEXXY copay assistance program. We expect that our net product revenue will improve from changes in our copay card price in the long term and increases in commercial and Medicare payer coverage when we fully complete the process needed to adjudicate ANNOVERA, IMVEXXY, and BIJUVA prescriptions at pharmacies.

Our prescription vitamin sales were $4.2 million for the first nine months ~~ended September 30, 2017,~~of 2021, a decrease of $3.1 million, or 42.4%, compared ~~with approximately $3,476,000~~to the first nine months of 2020. Thisdecreasewas primarily dueto a 29.6% decrease in salesvolumeanda 18.2% decrease in the average saleprice.

On a consolidated basis, our total product sales were $67.1 million for the first nine months ~~ended September 30, 2016.~~ of 2021, an increase of $26.8 million, or 66.5%, compared to the first nine months of 2020.

Our license revenue was $1.2 million for the first nine months of 2021, a decrease of $0.8 million, or 41.5%, compared to the first nine months of 2020.This decrease was entirely due to the timing of achieving previously established milestone payment targets.

Gross profit. Our gross ~~margin was approximately 84% and 77%~~profit for the first nine months ~~ended September 30, 2017 and 2016, respectively.~~ of 2021 was $54.2 million, an increase of $22.3 million, or 69.8%, compared to the first nine months of 2020. The following table sets forth our gross profit during these periods (in thousands):

The increase in our gross ~~margin percentage~~profit was primarily attributable to the centralization of the distribution channel for both our retail pharmacy distributors and wholesale distributors which, among other things, lowered the cost to package, prepare and deliver our products to customers.

~~Our principal operating costs include the following items as a percentage of total operating expenses.~~

Operating expenses decreased by approximately $12,147,000, or 15%, to approximately $66,559,000 for the nine months ended September 30, 2017, from approximately $78,706,000 for the nine months ended September 30, 2016 as a result of the following items:

Research and development costs for the nine months ended September 30, 2017 decreased by approximately $20,724,000, or 48%, to approximately $22,878,000, compared with $43,602,000 for the nine months ended September 30, 2016. Research and development costs include costs related to clinical trials as well as salaries, wages, non-cash compensation and benefits of personnel involved in research and development activities. Research and development costs decreased as a direct result of the completion of the REPLENISH Trial for TX-001HR, our combination estradiol and progesterone drug candidate. Research and developments costs during the nine months ended September 30, 2017 included the following research and development projects.

During the nine months ended September 30, 2017 and the period from February 2013 (project inception) through September 30, 2017, we have incurred approximately $11,971,000 and $107,987,000, respectively, in research and development costs with respect to TX-001HR, our combination estradiol and progesterone drug candidate.

During the nine months ended September 30, 2017 and the period April 2013 (project inception) through September 30, 2017, we have incurred approximately $0 and $2,525,000, respectively, in research and development costs with respect to TX-002HR, our progesterone only drug candidate.

During the nine months ended September 30, 2017 and the period from August 2014 (project inception) through September 30, 2017, we have incurred approximately $6,292,000 and $39,098,000, respectively, in research and development costs with respect to TX-004HR, our applicator-free vaginal estradiol softgel drug candidate.

Human resource costs, including salaries, benefits and taxes, for the nine months ended September 30, 2017 increased by approximately $106,000, or less than 1%, to approximately $17,415,000, compared with approximately $17,309,000 for the nine months ended September 30, 2016, primarily as a result of an increase of ~~approximately $4,636,000~~66.5% in product revenue and a 4.8% increase in our product gross margin from 74.2% for the first nine months of 2020 to 79.0% for the first nine months of 2021. This increase was mainly due to $1.1 million in lower inventory obsolescence charges for the first nine months of 2021 compared to the first nine months of 2020, and an overall improvement in the profit margins of our products of 0.9%.

Operating expenses. Total operating expenses for the first nine months of 2021 were $158.6 million, an increase of $5.7 million, or 3.7%, compared to the first nine months of 2020. Of the total increase, $7.3 million was related non-cash and cash severances recorded for certain former senior executives during the third quarter of 2021. Without such severances, our total operating expenses for the first nine months of 2021 would have decreased by $1.6 million, or 1.0%, compared to the first nine months of 2020. The type of operating expenses reported in prior periods have been reclassified to conform to the current period’s presentation. The following table sets forth our operating expense categories (in thousands):

Our selling and marketing costs were $86.2 million for the first nine months of 2021, a decrease of $4.9 million, or 5.3%, compared to the first nine months of 2020. This decrease was primarily due to $13.4 million in lower outsourced sales personnel costs mainly attributable to the onboarding of such sales personnel in ~~sales,~~the third quarter of 2020, $5.5 million in lower product sample costs mainly due to the third quarter of 2020 write down of product samples, primarily related to BIJUVA, and $2.5 million in lower marketing costs primarily related to a national selling and ~~regulatory areas~~marketing event that occurred during the first nine months of 2020 prior to ~~support commercialization of our hormone therapy drug candidates~~the COVID-19 pandemic. These decreases were partially offset by ~~a decrease~~$9.3 million in higher advertising expenditures, $6.4 million in higher salaries and employee benefit costs to support the sales growth of ~~approximately $4,530,000~~our pharmaceutical products, reflecting the continued impact of our formerly outsourced sales personnel who were onboarded in ~~non-cash compensation expense included~~the third quarter of 2020, and $0.9 million and in ~~this category~~higher costs related to ~~employee stock option amortization.~~

~~Sales~~physician education expenses and transportation expenses for traveling sales staff. Overall, our lower selling and marketing costs for the first nine months ~~ended September 30, 2017 increased by approximately $8,794,000, or 113%, to approximately $16,590,000, compared with approximately $7,796,000~~of 2021 reflect our cost cutting initiatives put in place at the beginning of the COVID-19 pandemic.

Our general and administrative costs were $66.7 million for the first nine months ~~ended September 30, 2016, primarily as a result~~ of ~~increased expenses in~~2021, an increase of $13.0 million, or 24.1%, compared to the first ~~half~~nine months of ~~2017 associated with sales~~2020. Of the total increase, $7.3 million was related non-cash and ~~marketing efforts to support commercialization of our hormone therapy drug candidates, which were curtailed in~~cash severances recorded for certain former senior executives during the third quarter of ~~2017 due~~2021. The remaining increase was $5.7 million, or 10.5%, compared to the ~~status~~first nine months of 2020. This increase was primarily attributable to $4.5 million in higher compensation and employee benefit costs, of which $2.3 million was related to the ~~NDA for TX-004HR,~~accrual of bonuses expected to be paid in the first quarter of 2022, $1.4 million in higher costs ~~related~~attributable to ~~outsourced sales personnel~~bad debt expense and ~~their related expenses which started~~insurance, and $1.1 million in higher professional fees, such as consulting, recruiting, legal, etc., in support of our efforts to expand the ~~fourth quarter~~commercialization of ~~2016, together with an increase in employee incentives.~~

Professional fees for the nine months ended September 30, 2017 increased by approximately $447,000, or 12%, to approximately $4,062,000, compared with approximately $3,615,000 for the nine months ended September 30, 2016, primarily as a result of increased legal and other professional expenses,our products. These increases were partially offset by $1.3 million in lower expenditures attributable to information technology and dues and subscriptions.

Our R&D costs were $5.7 million for the first nine months of 2021, a decrease of $2.4 million, or 29.5%, compared to the first nine months of 2020. This decrease was primarily attributable to $1.6 million in ~~consulting expenses.~~lower lab research costs, $0.4 million in lower compensation and employee benefit costs and $0.3 million in lower legal and professional fees. We have reduced our R&D expenditures since 2019 as we refocus our resources towards the continued commercialization of our pharmaceutical products. Accordingly, we continue to deploy limited resources in the development of new products, to perform stability testing and validation on our pharmaceutical products, to develop and validate secondary manufacturers, to prepare regulatory submissions, and work with regulatory authorities on existing submissions.

~~Other operating expense~~Loss from operations. For the first nine months of 2021, we had a loss from operations of $104.4 million, compared to $120.9 million for the first nine months ~~ended September 30, 2017 decreased by approximately $770,000, or 12%,~~of 2020. This $16.5 million improvement was attributable to ~~approximately $5,614,000, compared with approximately $6,384,000 for the nine months ended September 30, 2016, as a result~~higher gross profit of ~~a decrease in bad debt expense as well as decreased investor relations expenses,~~$22.3 million, partially offset by ~~increased rent, information technology and other office~~$5.7 million in higher operating expenses.

~~As a result of the foregoing, our operating~~Our loss ~~decreased approximately $11,365,000, or 17%, to approximately $55,948,000~~from operations for the first nine months ~~ended September 30, 2017, compared with approximately $67,313,000~~of 2021 included $7.3 million of non-cash and cash severances recorded for certain former senior executives. Without such severances, we would have had a loss from operations of $97.1 million for the first nine months ~~ended September 30, 2016, primarily as a result~~ of decreased research and development costs and other operating expenses, partially offset by increased personnel costs, sales and marketing expenses to support commercialization of our hormone therapy drug candidates, higher costs related to outsourced sales personnel and their related expenses and professional fees as well a decrease in revenue.

~~As a result of the continued development of our hormone therapy drug candidates, we~~2021. We anticipate that we will continue to have operating losses for the near future until ~~our hormone therapy drug candidates~~we are ~~approved by the FDA~~able to successfully commercialize IMVEXXY, BIJUVA, and ~~brought to market,~~ANNOVERA, although there is no assurance that our efforts will be successful.

Other expense, net. For the first nine months of 2021, our non-operating expenses were $25.1 million, compared to $20.5 million for the first nine months of 2020. This $4.6 million increase was primarily attributable to a $4.0 million increase in interest prepayment fees, including the recording of an $1.5 million accrual for interest prepayment fees in the first nine months of 2021 associated with our future debt service, and $2.5 million in higher amortization expense of deferred financing costs. These increases were partially offset by $2.1 million in lower interest expense due to overall lower average debt balance during the first nine months of 2021 compared to the first nine months of 2020.

Net Loss. For the first nine months of 2021, we ~~will attain~~had a net loss of $129.5 million, or $0.33 per basic and diluted common share, compared to $141.4 million, or $0.52 per basic and diluted common share, for the first nine months of 2020. Our net loss for the first nine months of 2021 included $7.3 million of non-cash and cash severances recorded for certain former senior executives. Without such ~~approvals~~severances, we would have had a net loss of $122.2 million, or ~~that any marketing~~$0.31 per basic and diluted common share, for the first nine months of 2021.

Our primary use of cash is to fund the continued commercialization of our hormone therapy ~~drug candidates, if approved, will be successful.~~

Other non-operating income increased by approximately $176,000, or 64%, to approximately $450,000 for the nine months ended September 30, 2017, compared with approximately $274,000 for the comparable period in 2016, primarily as a result of increased interest income.

As a result of the net effects of the foregoing, net loss decreased approximately $11,541,000, or 17%, to approximately $55,498,000 for the nine months ended September 30, 2017, compared with approximately $67,039,000 for the nine months ended September 30, 2016. Net loss per share of Common Stock, basic and ~~diluted, was ($0.27) for the nine months ended September 30, 2017, compared with ($0.34) for the nine months ended September 30, 2016.~~

contraceptive products. We have funded our operations primarily through public offerings of our ~~Common Stock~~common stock and private placements of equity and debt securities. ~~Since 2014, we received approximately $337,582,000 in net proceeds from the issuance of shares of Common Stock.~~ As of September 30, ~~2017,~~2021, we had cash ~~and~~totaling $104.8 million. We maintain cash ~~equivalents totaling~~at financial institutions that at times may exceed the Federal Deposit Insurance Corporation insured limits of approximately ~~$148,293,000, however, changing circumstances may cause us~~$0.3 million per bank. We have never experienced any losses related to ~~consume funds significantly faster than we currently anticipate, and we may need to spend more money than currently expected because of circumstances beyond our control.~~these funds.

~~On September 25, 2017,~~In November 2020, we entered into an ~~underwriting agreement~~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 prices prevailing at the time of sale, at prices related to prevailing market prices, or as otherwise agreed to with ~~J.P. Morgan Securities LLC relating~~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, we 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 ~~12,400,000~~our common stock, pursuant to which we issued 59,459,460 shares of our ~~Common Stock~~common stock at aan offering price of ~~$5.55~~$1.85 per share,~~. The~~ and we received net proceeds ~~to us from the offering were approximately $68,573,000,~~of $96.6 million, after deducting the underwriting discounts and commissions and estimated offering ~~expenses payable by us. The~~expenses.

In March 2021, we entered into an at-the-market offering ~~closed on September 28, 2017 and we issued 12,400,000~~program (the “2021 ATM Program”) relating to shares of our ~~Common Stock. We intend~~common stock. The 2021 ATM Program permits us to ~~use a majority~~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 ~~from~~of $38.8 million, after deducting discounts and commissions to the sales agent and estimated offering expenses. Subsequently, through the date of this ~~offering~~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.

The following table reflects the major categories of cash flows for each of the periods (in thousands).

Operating Activities. The principal use of cash in operating activities was to fund ~~pre-commercialization and~~our current expenditures in support of our continued commercialization activities for IMVEXXY, BIJUVA, and ANNOVERA, sales, marketing, scale-up and manufacturing activities, adjusted for non-cash items. For the first nine months of 2021, net cash used in operating activities was $103.1 million, compared to net cash used in operating activities of $129.1 million for the first nine months of 2020. This decrease of $26.0 million, or 20.1%, was primarily due to a $12.0 million decrease in our ~~TX-004HR~~net loss, a $12.2 million decrease in cash usage related to changes in operating assets and ~~TX-001HR drug candidates. We~~liabilities, and a $2.8 million increase in non-cash expenditure adjustments.

Investing Activities. For the first nine months of 2021, net cash used in investing activities was $0.7 million, compared to net cash used in investing activities of $1.1 million for the first nine months of 2020. This decrease of $0.4 million, or 35.8%, was primarily due to lower patent related costs.

Financing Activities. Financing activities currently ~~intend to fund~~represent the ~~remainder~~principal source of our ~~pre-commercialization and commercialization expenses~~cash flow. For the first nine months of 2021, net cash provided by financing activities was $128.2 million, compared to net cash provided by financing activities of $49.0 million for the first nine months of 2020. This increase of $79.2 million, or 161.5%, was primarily related to sales of our ~~TX-004HR and TX-001HR drug candidates through~~common stock, consisting of $182.9 million in net proceeds in 2021, partially offset by a $50.0 million in repayment of debt in 2021, a $3.9 million increase in the payment of debt financing fees in 2021, and ~~are currently engaged~~$50.0 million in ~~discussions to secure~~borrowing of debt ~~financing commitments during~~in 2020.

For additional details, see the ~~fourth quarter~~consolidated statements of ~~2017. If we are successful~~cash flows in ~~obtaining these commitments, we currently anticipate we would begin to draw on them following approval of either TX-004HR or TX-001HR.~~ Item 1, Financial Statements, appearing elsewhere in this 10-Q Report.

During the nine months ended September 30, 2017, certain individuals exercised warrants to purchase 2,476,666 shares of Common Stock for $3,798,999 in cash. During the nine months ended September 30, 2017, certain individuals exercised stock options to purchase 102,546 shares of Common Stock for $212,615 in cash.

As a result of developments in the pharmaceutical industry that negatively affected independent pharmacies, including such pharmacies’ reliance on third party payors, in 2016, we identified that payment periods for our retail pharmacy distributors were becoming longer than in prior years. As a result, during the third quarter of 2016, we centralized the distribution channel for both our retail pharmacy distributors and wholesale distributors, in order to facilitate sales to a broader population of retail pharmacies and minimize business risk exposure to any one retail pharmacy. During the third quarter of 2016, we entered into new distribution agreements with our retail pharmacy distributors to effectuate this centralization which were effective September 1, 2016.

~~For the three months ended September 30, 2017, our~~Receivable. Our net days sales outstanding or(“DSO”) is calculated by dividing average gross accounts receivable less the reserve for doubtful accounts, chargebacks, and payment discounts by the average daily net product revenue during the last four quarters for each respective quarterly period. Our net DSO was 91126 days as of September 30, 2021, compared to 92165 days ~~for the year ended~~as of December 31, ~~2016. We anticipate that our~~2020 and 128 days as of September 30, 2020. Our gross DSO is calculated by dividing average gross accounts receivable by the average daily gross product revenue to distributors during the last four quarters for each respective quarterly period. Our gross DSO was 61 days as of September 30, 2021, compared to 67 days as of December 31, 2020 and 50 days as of September 30, 2020. Our DSO have fluctuated and will continue to fluctuate in the future ~~based upon a~~due to variety of factors, including longer payment terms associated with the ~~centralization~~continued commercialization of ~~the distribution channel for both our retail pharmacy distributors~~IMVEXXY, BIJUVA, and ~~wholesale distributors in September 2016, as compared to the terms previously provided to our retail pharmacy distributors,~~ANNOVERA and changes in the healthcare ~~industry~~industry. Our exposure to credit losses may increase if our customers are adversely affected by changes in healthcare laws, coverage, and ~~specific terms~~reimbursement, economic pressures or uncertainty associated with local or global economic recessions, disruption associated with the COVID-19 pandemic, or other customer-specific factors. 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.

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 resulting 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 NDA to modify the manufacturing (testing) specification to allow for normal manufacturing variation that would increase the consistency of manufacturing and supply of ANNOVERA. There can be no 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 ~~extended in connection~~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 ~~launch~~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 ~~hormone therapy drug candidates, if approved.~~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.

Debt. We ~~believe that~~had $200.0 million and $250.0 million in term loans outstanding under our ~~existing cash will allow~~Financing Agreement as of September 30, 2021 and December 31, 2020, respectively. For additional information, see Note 8, Debt in Item 1, Financial Statements, appearing elsewhere in this 10-Q Report.

The Financing Agreement requires us to ~~fund~~maintain a minimum unrestricted cash balance of $60.0 million. As of the filing date of this 10-Q Report, our ~~operating plan through at least~~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 12twelve months from the date of this ~~quarterly report. However, if~~10-Q Report. In order to address our projected capital needs, we are pursuing various equity financing and other alternatives including the ~~commercialization~~sale of ~~our hormone therapy drug candidates is delayed, our existing cash~~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 insufficient to satisfy our liquidity requirements until we are able to commercialize our hormone therapy drug candidates. If our available cash is insufficient to satisfy our liquidity requirements, we may curtail our sales, marketing and other pre-commercialization efforts and we may seek to sell additional equity or debt securities or obtain a credit facility. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends.limited by market conditions. To the extent that we raise additional capital through the sale of ~~equity or convertible debt~~such securities, the ownership interests of our existing ~~shareholders~~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 ~~shareholders. If~~stockholders.

Along with considering additional financings, we ~~raise additional funds through collaborations, strategic alliances, or licensing arrangements~~have reviewed numerous potential scenarios in connection with ~~third parties,~~steps that we may ~~have~~take to ~~relinquish valuable rights to~~reduce our ~~technologies, future revenue streams, research programs, or proposed products. Additionally,~~operating expenses. Based on our analysis, we ~~may have to grant licenses on terms~~believe that ~~may not be favorable to us.~~

~~We need substantial amounts of~~our existing cash to complete the clinical development of and commercialize of our hormone therapy drug candidates. The following table sets forth the primary sources and uses of cash for each of the periods set forth below:

The principal use of cash in operating activities for the nine months ended September 30, 2017 was to fund our current expenses primarily related to supporting clinical development, scale-up and manufacturing activities and future commercial activities, adjusted for non-cash items. The increase of approximately $1,826,000 in cash used in operating activities for the nine months ended September 30, 2017 comparedreserves along with ~~the comparable period in the prior year was due primarily to lower non-cash compensation expense coupled with changes in the components of working capital and decreased net loss.~~

A decrease in spending on patent and trademarks and fixed assets resulted in a decrease in cash used in investing activities for the nine months ended September 30, 2017 compared with the same period in 2016.

~~Financing activities represent the principal source of our cash flow. Our financing activities for the nine months ended September 30, 2017 included approximately $68,573,000 in~~potential proceeds from the sale of ~~Common Stock~~certain non-core assets of the Company and ~~approximately $4,011,000 in~~ proceeds from potential future financings, if available to us, would be sufficient to meet our cash needs arising in the ~~exercise~~ordinary course of ~~options~~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 ~~warrants.~~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 Inventory above 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.

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 have to 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 ~~provided~~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.

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.

For additional information, see the discussion of our risks and uncertainties related to COVID-19 in Note 1, Basis of presentation and summary of significant accounting policies in Item 1, Financial Statements, appearing elsewhere in this 10-Q Report, and in our 2020 10-K Report.

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. 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. In order to address our projected capital needs, we are pursuing various equity financing ~~activities during~~and other alternatives including the ~~nine months ended September 30, 2016, included approximately $134,864,000~~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 ~~Common Stock~~certain non-core assets of the Company and ~~approximately $2,352,000 in~~ proceeds from potential future financings, if available to us, would be sufficient to meet our cash needs arising in the ~~exercise~~ordinary course of ~~options and warrants.~~

~~Recently Issued Accounting Pronouncements~~business for the next twelve months from the date of this Quarterly Report on Form 10-Q.

~~In May 2017,~~If we are unsuccessful with future financings and if the ~~Financial Accounting Standards Board,~~successful commercialization of IMVEXXY, BIJUVA, or ~~FASB, issued~~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. If we are unable to comply with these covenants 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 Accounting Standards Update, or ASU, that clarifies when changes to the terms or conditions of a share-based payment award must be accounted for as modifications. The new guidance will reduce diversity in practice and result in fewer changes to the terms of an award being accounted for as modifications. The new guidance will allow companies to make certain changes to awards without accounting for them as modifications. This guidance does not change the accounting for modifications. The guidance will be applied prospectively to awards modified on or after the adoption date and is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted, including in an interim period. We do not expect that adoption of this guidance will have a materialadverse effect on our ~~consolidated financial statements.~~

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230). ASU 2016-15 is intended to reduce the diversity in practice regarding how certain transactions are classified within the statement of cash flows. ASU 2016-15 is effective for public business, entities for annual periods beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted with retrospective application. We do not expect that adoption of this guidance will have a material effect on our consolidated financial statements.

In February 2016, the FASB issued ASU 2016-02, Leases. This guidance requires lessees to record most leases on their balance sheets but recognize expenses on their income statements in a manner similar to current accounting. The guidance also eliminates current real estate-specific provisions for all entities. For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases. The standard is effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. We are in the process of analyzing the quantitative impact of this guidance on our results of operations and financial ~~position. While~~condition. 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 ~~continuing~~unable to ~~assess all potential impacts~~comply with these covenants of the ~~standard, we currently believe~~Financing Agreement, all or a portion of our obligations under the ~~impact~~Financing Agreement may be declared immediately due and payable, which would have an adverse effect on our business, results of operations and financial condition.

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.

Information regarding new accounting pronouncements is included in Note 1, Basis of presentation and summary of significant accounting policies in Item 1, Financial Statements appearing elsewhere in this ~~standard will be primarily~~10-Q Report.

The determination of a transaction price is one of the five-steps which we access in accordance with the revenue recognition accounting guidance. The transaction price of a contract is the amount of consideration which we expect to be entitled to in exchange for ~~our operating lease.~~

~~In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The standard’s core principle is that a company will recognize revenue when it transfers~~transferring promised goods or services to ~~customers in an amount that reflects~~a customer. Prescription products are sold at fixed wholesale acquisition cost (“WAC”), determined based on our list price. However, the ~~consideration to which~~total transaction price is variable as it is calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees. These estimates are based on the ~~company expects~~amounts earned or to be ~~entitled in exchange for those goods~~claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or ~~services.~~a current liability (if the amount is payable to a party other than a customer). In ~~doing so, companies will need~~order to ~~use more judgment~~determine the transaction price, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and ~~make more estimates than under previous guidance. This may include identifying performance obligations~~circumstances relative to the contract or each variable consideration. The estimated amount of variable consideration is included in the ~~contract, estimating~~transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative product revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. In determining amounts of variable consideration to include in ~~the~~a contract’s transaction price, we rely on our historical experience and ~~allocating~~other evidence that supports our qualitative assessment of whether product revenue would be subject to a significant reversal. We consider all the ~~transaction price~~facts and circumstances associated with both the risk of a product revenue reversal arising from an uncertain future

event and the magnitude of the reversal if that uncertain event were to ~~each separate performance obligation. In July 2015,~~occur. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the ~~FASB approved~~future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the ~~proposal~~period such changes in estimates become known.

We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to ~~defer~~and up to 12 months following product expiration. ANNOVERA cannot be returned before the ~~effective~~expiration date and expired ANNOVERA can be returned up to 12 months past the expiration date. Our prescription vitamins, IMVEXXY and BIJUVA currently have a shelf life of 24 months from the date of ~~ASU 2014-09 standard~~manufacture and ANNOVERA currently has a shelf life of 18 months from the date of manufacture. We do not allow product returns for prescription products that have been dispensed to a patient. We estimate the amount of our product sales that may be returned by ~~one year. Early adoption is permitted after December 15, 2016,~~our customers and the standard is effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods therein. In 2016, the FASB issued final amendments to clarify the implementation guidance for principal versus agent considerations (ASU 2016-08), accounting for licensesrecord this estimate as a reduction of intellectual property and identifying performance obligations (ASU 2016-10), narrow-scope improvements and practical expedients (ASU 2016-12) and technical corrections and improvements to topic 606 (ASU 2016-20) in its newproduct revenue standard. We have performed a preliminary review of the requirements of the new revenue standard and are monitoring the activity of the FASB and the transition resource group as it relates to specific interpretive guidance. We have reviewed customer contracts and applied the five-step model of the new standard to our contracts as well as compared the results to our current accounting practices. We are currently in the ~~process~~period the related product revenue is recognized. Where historical rates of ~~drafting disclosures required by~~return exist, we use history as a basis to establish a returns reserve for products shipped to wholesalers. For our newly launched products, for which the ~~new standard.~~right of return exists but for which we currently do not have history of product returns, we estimate returns based on available industry data, our own sales information and our visibility into the inventory remaining in the distribution channel. At ~~this point~~the end of each reporting period, we may decide to constrain product revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products currently being shipped, price changes of competitive products and any introductions of generic products. We recognize the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration. Since our ~~analysis,~~returns primarily consist of expired and short dated products that will not be resold, we do not ~~believe~~record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of product revenue is deferred due to the anticipated return).

We offer various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that ~~the adoption of this standard will~~we have ~~a material effect~~offered based on our ~~financial statements but~~experience and industry averages, which is reviewed, and adjusted, if necessary, on a quarterly basis. Estimates relating to these rebates and coupons are deducted from gross product revenue at the time the product revenue is recognized. We record distributor fees based on amounts stated in contracts. We estimate chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience. We provide invoice discounts to our customers for prompt payment. Estimates relating to invoice discounts and chargebacks are deducted from gross product revenue at the time the product revenue is recognized.

We offer a co-pay assistance program for eligible enrolled patients whose out of pocket costs are reduced to a more affordable price. This allows patients to access the product at a reasonable cost and is in line with our responsible pricing approach. We reimburse pharmacies for this discount through third-party vendors. The variable consideration is estimated based on contract prices, the estimated percentage of patients that will ~~potentially expand~~utilize the copay assistance, the average assistance paid, the estimated levels of inventory in the distribution channel and the current level of prescriptions covered by patients’ insurance. Payers may change coverage levels for our ~~disclosures~~prescription products positively or negatively, at any time up to the time that we have formerly contracted coverage with the payer. As such, the net transaction price of our prescription products is susceptible to such changes in coverage levels, which are outside of our influence. As a result, we constrain variable consideration for our prescription products to an amount that will not result in a significant product revenue reversal in future periods. Our ability to estimate the net transaction price for our prescription products is constrained by our estimates of the amount to be paid for the co-pay assistance program which is directly related to ~~contracts with customers.~~the level of prescriptions paid for by insurance. As such, we record an accrual to reduce gross sales for the estimated co-pay and other patient assistance based on currently available third-party data and our internal analyses.

We had a cash balance of $104.8 million as of September 30, 2021. We hold certain portions of our cash balances in overnight money market placements all of which are fully available to us to support our cash flow requirements. The primary objective of our investment policy is to preserve principal and maintain proper liquidity to meet operating needs. Our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure to any single issue, issuer, or type of investment. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. To minimize this risk, we intend to maintain an investment portfolio that may include cash, cash equivalents and investment securities available-for-sale in a variety of securities which may include money market funds, government and non-government debt securities and commercial paper, all with various maturity dates. Due to the low risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our portfolio.

Our ~~market risk~~debt under the Financing Agreement accrues interest at either (i) 3-month LIBOR plus 7.75%, subject to a LIBOR floor of 2.70% or (ii) the prime rate plus 6.75%, subject to a prime rate floor of 5.20%. Based on our debt under the Financing Agreement balance of $200.0 million as of September 30, 2021, a 1.0% change in interest rates would result in an impact to loss before income taxes of $2.0 million per annum.

LIBOR is expected to be discontinued after 2021, with one-month LIBOR being discontinued in 2023. The Financing Agreement provides procedures for determining a replacement or alternative rate in the event that LIBOR is unavailable. We may also continue to elect the prime rate in the event that LIBOR is unavailable regardless of whether a replacement or alternative rate has been determined. The prime rate or LIBOR replacement or alternative rate may be more or less favorable to us than LIBOR. Due to these features of the Financing Agreement, we do not ~~changed materially from~~believe that the ~~interest rate risk disclosed in Item 7A of~~LIBOR transition will have a material impact on our ~~Annual Report.~~financial statements.

Disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports filed or submitted under the Securities Exchange Act of 1934, as amended ~~or the Exchange Act,~~(the “Exchange Act”), is recorded, processed, summarized and reported, within the time period specified in the ~~SEC’s~~SEC's rules and forms and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, in order to allow timely decisions ~~in connection with~~regarding required disclosure.

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this ~~Quarterly Report on Form 10-Q.~~10-Q Report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this ~~Quarterly~~10-Q Report ~~on Form 10-Q~~ were effective in providing reasonable assurance that information required to be disclosed by us in reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, misstatements, errors, and instances of fraud, if any, within our company have been or will be prevented or detected. Further, internal controls may become inadequate as a result of changes in conditions, or through the deterioration of the degree of compliance with policies or procedures.

~~During the three months ended September 30, 2017, there~~There were no changes in our internal control over financial reporting that ~~have~~ materially affected, or are reasonably likely to materially affect, our internal control over financial ~~reporting.~~reporting during the three months ended September 30, 2021.

~~On April 17, 2017, a securities class action lawsuit was filed against our company~~From time to time, we are involved in litigation and ~~certain~~proceedings in the ordinary course of our ~~officers~~business. Other than the legal proceedings disclosed in Note 9, Commitments and ~~directors~~contingencies in ~~the U.S. District Court for the Southern District of Florida (Case No. 9:17-cv-80473-RLR)~~Part I, Item 1, Financial Statements, appearing elsewhere in this 10-Q Report, we are not involved in any legal proceeding that ~~purported to state~~we believe would have a ~~claim for alleged violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder, based~~material effect on statements made by the defendants concerning the NDA for TX-004HR. The complaint sought unspecified damages, interest, attorneys’ fees and other costs. On July 18, 2017, the complaint was voluntarily dismissed by the lead plaintiff without prejudice. We and certain of our officers and directors are also subject to two shareholder derivative lawsuits regarding the NDA for TX-004HR, one filed in the U.S. District Court for the Southern District of Florida on May 30, 2017 (Case No. 9:17-cv-80686-RLR) and one filed in Florida state court in Palm Beach County on June 5, 2017 (Case No. 502017CA006289XXXXMB). These complaints were both voluntarily dismissed by the lead plaintiffs without prejudice on August 14, 2017.business or financial condition.

~~There~~The business, financial condition and operating results of the Company can be affected by a number of factors, whether currently known or unknown, including but not limited to those described in Part I, Item 1A of the 2020 10-K Report under the heading “Risk Factors,” any one or more of which could, directly or indirectly, cause the Company’s actual financial condition and operating results to vary materially from past, or from anticipated future, financial condition and operating results. Any of these factors, in whole or in part, could materially and adversely affect the Company’s business, financial condition, operating results and stock price. Except as set forth below, there have been no material changes to the Company’s risk factors ~~previously disclosed~~since the 2020 10-K Report.

Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock.

On September 15, 2021, we received a deficiency letter (the “Notice”) from the Listing Qualifications Department (the “Staff”) of Nasdaq notifying us that for the prior 30 consecutive business days, the bid price for our common stock had closed below $1.00 per share, which is the minimum closing price required to maintain continued listing on the Nasdaq Global Select Market under Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Requirement”).The Notice had no immediate effect on the listing of our common stock. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have 180 calendar days to regain compliance with the Minimum Bid Requirement (the “Compliance Period”). To regain compliance, the closing bid price of our common stock must be at least $1.00 per share for a minimum of ten consecutive business days during the Compliance Period, at which time the Staff will provide written notification that the Company complies with the Minimum Bid Requirement. The Compliance Period expires on March 14, 2022.

If we do not regain compliance within the Compliance Period, we may be eligible for an additional 180 calendar day compliance period. To qualify, we would need to meet the continued listing requirement for market value of publicly held shares and all other Nasdaq listing standards, with the exception of the Minimum Bid Requirement, and provide written notice to the Staff of our intention to cure the deficiency during the second 180 calendar day compliance period, including by effecting a reverse stock split, if necessary. However, if it appears to the Staff that we will not be able to cure the deficiency, or if we do not meet the other listing standards, the Staff could provide notice that our common stock will become subject to delisting. In the event we receive notice that our common stock is being delisted, Nasdaq rules permit us to appeal any such delisting determination by the Staff to a Hearings Panel.

We will continue to monitor the closing bid price of our common stock and are evaluating available options to regain compliance with the Minimum Bid Requirement, including by effecting a reverse stock split. There can be no assurance that we will be able to regain compliance with the Minimum Bid Requirement or that we will otherwise remain in compliance with the other listing standards for the Nasdaq listing requirements. If we are unable to comply with the Nasdaq listing requirements, our common stock could be delisted from Nasdaq, which could have material adverse effects on our ability to finance our operations and our stockholders’ ability to monetize the investment in our ~~Annual Report.~~Company.

Even after the approval of IMVEXXY, BIJUVA, and ANNOVERA, and even if we obtain regulatory approval for other pharmaceutical product candidates, we will still face extensive, ongoing regulatory requirements and review, and our products may face future development and regulatory difficulties.

With respect to IMVEXXY, BIJUVA, and ANNOVERA, the FDA may still impose significant restrictions on a product’s indicated uses or marketing or to the conditions for approval or impose ongoing requirements for potentially costly post-approval studies, including phase 4 clinical trials or post-market surveillance. As a condition to granting marketing approval of a product, the FDA may require a company to conduct additional clinical trials. The results generated in these post-approval clinical trials could result in loss of marketing approval, changes in product labeling, or new or increased concerns about side effects or efficacy of a product. For example, the labeling for IMVEXXY, BIJUVA, and ANNOVERA contains restrictions on use and warnings. The Food and Drug Administration Amendments Act of 2007 (“FDAAA) gives the FDA enhanced post-market authority, including the Risk Evaluation and Mitigation Strategy (“REMS”) explicit authority to require post-market studies and clinical trials, labeling changes based on new safety information, and compliance with FDA-approved REMS programs. IMVEXXY, BIJUVA, and ANNOVERA will also be subject to ongoing FDA requirements governing the manufacturing, labeling, packaging, storage, distribution, safety surveillance and reporting, advertising, promotion, record keeping, and reporting of safety and other post-market information. The FDA’s exercise of

its authority could result in delays or increased costs during product development, clinical trials and regulatory review, increased costs to comply with additional post-approval regulatory requirements, and potential restrictions on sales of approved products. Foreign regulatory agencies often have similar authority and may impose comparable requirement.

As part of the FDA’s approval of IMVEXXY, we have committed to conduct a post-approval observational study to evaluate the risk of endometrial cancer in post-menopausal women with a uterus who use a low-dose vaginal estrogen unopposed by a progestogen such as IMVEXXY. As part of the FDA’s approval of ANNOVERA, the FDA has required four non-closed post-marketing studies, including both post-marketing reviews and post-marketing commitments. Each study has a timeline for completion and submission of a final report to the FDA. If a post-approval study is not fulfilled according to FDA requirements, the FDA may impose certain further requirements and/or penalties against the holder of the NDA. For ANNOVERA, certain of the studies are being performed by the Population Council. To the extent that the Population Council does not fulfil these studies to the FDA’s satisfaction, FDA may impose additional requirements and penalties against us, as we hold the NDA for ANNOVERA. In July 2021, we received a letter from the FDA indicating that the post-marketing commitment study being conducted by the Population Council for ANNOVERA to characterize the in vivo release rate of ANNOVERA was not fulfilled to FDA’s satisfaction. In addition, the final reports for the two post-marketing requirement studies being performed by the Population Council for ANNOVERA were not submitted by the initial listed submission deadline, which deadlines have since been extended by FDA. We are working with Population Council to complete the post-marketing commitment study to the FDA’s satisfaction and reduce the delay in submitting the post-marketing requirement final reports. To the extent that the Population Council does not fulfil these studies to the FDA’s satisfaction, the FDA may impose additional requirements and penalties against us, as we hold the NDA for ANNOVERA.

Post-marketing studies, whether conducted by us or by others and whether mandated by regulatory agencies or voluntary, and other emerging data about marketed products, such as adverse event reports, may also adversely affect sales of our pharmaceutical product candidates once approved, and potentially our other marketed products. Further, the discovery of significant problems with a product similar to one of our products that implicate (or are perceived to implicate) an entire class of products could have an adverse effect on sales of our approved products. Accordingly, new data about our products could negatively affect demand because of real or perceived side effects or uncertainty regarding efficacy and, in some cases, could result in product withdrawal or recall. Furthermore, new data and information, including information about product misuse, may lead government agencies, professional societies, and practice management groups or organizations involved with various diseases to publish guidelines or recommendations related to the use of our products or the use of related therapies or place restrictions on sales. Such guidelines or recommendations may lead to lower sales of our products.

The holder of an approved NDA also is subject to obligations to monitor and report adverse events and instances of the failure of a product to meet the specifications in the NDA. Application holders must submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labeling, or manufacturing process. Application holders must also submit advertising and other promotional material to the FDA and report on ongoing clinical trials. Legal requirements have also been enacted to require disclosure of certain clinical trial results on a publicly available database.

Manufacturers of pharmaceutical products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with the FDA’s current Good Manufacturing Practice regulations and other regulatory requirements, such as adverse event reporting. If we or a regulatory agency discovers problems with a product, such as adverse events of unanticipated severity or frequency or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility, or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing, requiring new warnings or other labeling changes to limit use of the drug, requiring that we conduct additional clinical trials, imposing new monitoring requirements, or requiring that we establish a REMS program. Advertising and promotional materials must comply with FDA rules in addition to other potentially applicable federal and state laws and are subject to review by FDA. If the FDA raises concerns regarding our promotional materials or messages, we may be required to modify or discontinue using them and may be required to provide corrective information. Should we fail to comply with these requirements, we may be subject to significant liability including civil and administrative actions as well as criminal sanctions.

Commercial products must now meet the requirements of the Drug Supply Chain Security Act (“DSCSA”) which imposes obligations on manufacturers of prescription pharmaceutical products for commercial distribution, regulating the distribution of the products at the federal level, and sets certain standards for federal or state registration and compliance of entities in the supply chain (manufacturers and re-packagers, wholesale distributors, third-party logistics providers, and dispensers). The DSCSA preempts previously enacted state pedigree laws and the pedigree requirements of the Prescription Drug Marketing Act (“PDMA”) and its implementing regulations. Trading partners within the drug supply chain must now ensure certain product tracing requirements are met that they are doing business with other authorized trading partners; and they are required to exchange transaction information, transaction history, and transaction statements. Product identifier information (an aspect of the product tracing scheme) is also now required. The DSCSA requirements, development of standards, and the system for product tracing have been and will continue to be phased in over a period

of years, with FDA indicating enforcement discretion on certain aspects due to the COVID-19 pandemic. The distribution of product samples continues to be regulated under the PDMA, and some states also impose regulations on drug sample distribution.

Our activities are also potentially subject to federal and state consumer protection and unfair competition laws. If we or our third-party suppliers fail to comply with applicable regulatory requirements, a regulatory agency may take any of the following actions:

Our dependence upon third parties for the manufacture and supply of our existing women’s healthcare products may cause delays in, or prevent us from, successfully commercializing, and marketing our products.

We do not currently have, nor do we currently plan to build or acquire, the infrastructure or capability to internally manufacture our existing women’s healthcare products, IMVEXXY, BIJUVA, and ANNOVERA. We have relied, and will continue to rely, on third parties to manufacture these products in accordance with our specifications and in compliance with applicable regulatory requirements, includingthe FDA’s current Good Manufacturing Practice (“cGMPs”). We have entered into long-term supply agreements with Catalent Pharma Solutions, LLC for the commercial supply of IMVEXXY and BIJUVA. Under the terms of the agreements, we are obligated to purchase certain minimum annual amounts of each product. We have also entered into a long-term supply contract with QPharma AB, now known as Sever Pharma Solutions, for ANNOVERA. Under the terms of the QPharma AB agreement, we are obligated to purchase certain minimum annual amounts of ANNOVERA. We depend on Lang, a full-service, private label and corporate brand manufacturer, to supply our vitaMedMD and BocaGreen products. We do not have long-term contracts for the commercial supply of our vitaMedMD and BocaGreen products, however, in certain circumstances, including our failure to satisfy our production forecasts to Lang, we may be obligated to reimburse Lang for the costs of excess raw materials purchased by Lang that it cannot use in another product category that it then sells.

Regulatory requirements could pose barriers to the manufacture of our women’s healthcare products and our pharmaceutical product candidates. Holders of NDAs, or other forms of FDA approvals or clearances, or those distributing a regulated product under their own name, are ultimately responsible for compliance with manufacturing obligations even if the manufacturing is conducted by a third-party contract manufacturing organization (“CMO”). All of our existing products are manufactured by CMOs. These CMOs are required by the terms of our contracts to manufacture our products in compliance with the applicable regulatory requirements. The CMO that manufactures IMVEXXY and BIJUVA has previously been inspected by the FDA and received Form 483 observations with respect to its softgel manufacturing plant that is used for the manufacture of the commercial supply of IMVEXXY and BIJUVA. The CMO that manufactures ANNOVERA has previously been inspected by the FDA and received Form 483 observations with respect to its facility that is used for the commercial supply of ANNOVERA. We believe that corrective actions to address the compliance issues identified in the referenced Forms 483 have been implemented by the CMOs; however, the FDA has not yet reinspected the CMOs to confirm that the corrective actions were implemented as described to the agency in the respective Form 483 responses.

If our manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA and any applicable foreign regulatory authority, our regulatory submissions may be delayed or disapproved, and our marketed products may be affected. If these facilities are not in compliance for the manufacture of our products, we may need to find alternative manufacturing facilities, which would result in substantial disruptions of our sales of existing products and significant delays of up to several years in obtaining approval for our pharmaceutical product candidates. In addition, our manufacturers will be subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign agencies for compliance with cGMPs and similar regulatory requirements. After generally suspending in-person inspections due to COVID-19, the FDA announced it would resume domestic facility inspections, although the agency continues its general suspension of foreign facility inspections (although “mission-critical” inspections may be considered on a case-by-case basis). Because of the global pandemic, decision-making around facility inspections by the FDA (including preapproval inspections) continues to evolve. Failure by any of our manufacturers to comply with applicable cGMP regulations or other applicable requirements could result in sanctions being imposed on us, including fines, injunctions, civil penalties, violation letters, delays, suspensions or withdrawals of approvals, operating restrictions, interruptions in supply, recalls, withdrawals, issuance of safety alerts, and criminal prosecutions, any of which

could have an adverse impact on our business, financial condition, results of operations, and prospects. We do not currently have alternative manufacturers, and we may not be able to enter into a long-term agreement with alternative manufacturers, or do so on commercially reasonable terms, and if we do enter into agreements with alternative manufacturers, those alternative manufacturers may not be approved by the FDA, any of which could have an adverse impact on our business. We also could experience manufacturing delays if our CMOs give greater priority to the supply of other products over our products and proposed products to the delay or other detriment of our products and proposed products, or otherwise do not satisfactorily perform according to the terms of their agreements with us. Finally, we could experience manufacturing delays or interruptions as a result of the ongoing COVID-19 pandemic.

One of our third party contract manufacturer has recently experienced an increase in difficulties with the manufacturing process for ANNOVERA resulting 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 NDA with the FDA to modify the manufacturing (testing) specification to allow for normal manufacturing variation that would increase the consistency of manufacturing and supply of ANNOVERA. There can be no assurance that such a modification will be approved by the FDA. If the FDA fails to approve the requested modification by the 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 revenue 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.

We have also experienced greater than expected raw materials for ANNOVERA being out of specification. If any of our third party CMOs 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, or if the manufacturing specification modifications that we have requested are not approved by the FDA, 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.

We also do not have long-term contracts for the supply of the API used in BIJUVA, and ANNOVERA. If any supplier of the API or other products used in our products or pharmaceutical product candidates experiences any significant difficulties in its respective manufacturing processes, does not comply with the terms of an agreement between us, or does not devote sufficient time, energy, and care to providing our manufacturing needs, we could experience significant interruptions in the supply of our products or pharmaceutical product candidates, which could impair our ability to supply our products or pharmaceutical product candidates at the levels required for commercialization and prevent or delay their successful commercialization.

Pursuant to the requirements of the Securities Exchange Act of 1934, the ~~Company~~registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

~~Nevada~~	~~87-0233535~~
Nevada	87-0233535
(State or ~~Other Jurisdiction of Incorporation or Organization)~~other jurisdiction	(I.R.S. Employer Identification No.)
of incorporation or organization)
~~6800 Broken Sound Parkway NW, Third Floor,~~
951 Yamato Road, Suite 220
Boca Raton, ~~FL 33487~~Florida	~~(561) 961-1900~~ 33431
(Address of ~~Principal Executive Offices)~~principal executive offices)	(~~Issuer’s Telephone Number)~~Zip Code)

	Trading
Title of Each Class	symbol	Name of each exchange on which registered
Common Stock, par value $0.001 per share	TXMD	The Nasdaq Stock Market LLC

~~Large accelerated filer ☒~~	~~Accelerated filer ☐~~
Large Accelerated Filer	☐	Accelerated filer	☐
Non-accelerated filer ☐	☒	Smaller reporting company ☐	☒
~~(Do not check if a smaller reporting company)~~	Emerging growth company	☐

			~~Page~~
~~PART I - FINANCIAL INFORMATION~~

	~~Item. 1~~	~~Financial Statements~~

		Consolidated Balance Sheets ~~as of September 30, 2017 (Unaudited) and December 31, 2016~~	3 1

		Consolidated Statements of Operations ~~for the Three and Nine Months Ended September 30, 2017 (Unaudited) and 2016 (Unaudited)~~	4 2
	Consolidated Statements of Stockholders’ Equity (Deficit)		3
		Consolidated Statements of Cash Flows ~~for the Nine Months Ended September 30, 2017 (Unaudited) and 2016 (Unaudited)~~	5 4

		Notes to Unaudited Consolidated Financial Statements	6 5

	Item 2.	~~Management’s~~Management's Discussion and Analysis of Financial Condition and Results of Operations	21 19

	Item 3.	Quantitative and Qualitative Disclosures about Market ~~Risks~~Risk	36 31

	Item 4.	Controls and Procedures	36 31
Part II – Other Information
~~Part II - OTHER INFORMATION~~ Item 1.	Legal Proceedings	32
Item 1A.	Risk Factors		32
Item 2.	~~Item 1.~~Unregistered Sales of Equity Securities and Use of Proceeds	~~Legal Proceedings~~	37 35
Item 3.	Defaults Upon Senior Securities		35
Item 4.	~~Item 1A.~~Mine Safety Disclosures	~~Risk Factors~~	37 35
Item 5.	Other Information		35
	Item 6.	Exhibits	37

	September 30, 2017			December 31, 2016
	(Unaudited)

ASSETS
Current Assets:
Cash	$	148,292,654		$	131,534,101
Accounts receivable, net of allowance for doubtful accounts of $377,929 and $376,374, respectively		4,392,635			4,500,699
Inventory		1,293,517			1,076,321
Other current assets		3,001,777			2,299,052
Total current assets		156,980,583			139,410,173

Fixed assets, net		448,066			516,839

Other Assets:
Intangible assets, net		2,793,421			2,405,972
Security deposit		139,036			139,036
Total other assets		2,932,457			2,545,008
Total assets	$	160,361,106		$	142,472,020

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable	$	4,199,369		$	7,358,514
Other current liabilities		6,677,232			7,624,085
Total current liabilities		10,876,601			14,982,599

Commitments and Contingencies - See Note 14

Stockholders’ Equity:
Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding		—			—
Common stock - par value $0.001; 350,000,000 shares authorized; 216,429,642 and 196,688,222 issued and outstanding, respectively		216,430			196,688
Additional paid in capital		514,499,865			436,995,052
Accumulated deficit		(365,231,790	)		(309,702,319	)
Total stockholders’ equity		149,484,505			127,489,421
Total liabilities and stockholders’ equity	$	160,361,106		$	142,472,020


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

~~THERAPEUTICSMD, INC. AND SUBSIDIARIES~~ Part I – Financial Information		Page
~~INDEX~~ Item. 1.

~~THERAPEUTICSMD, INC. AND SUBSIDIARIES~~ 36
Signatures~~CONSOLIDATED BALANCE SHEETS~~		37

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2017			2016			2017			2016

Revenues, net	$	4,417,598		$	5,535,685		$	12,653,495		$	14,869,023

Cost of goods sold		700,814			1,237,446			2,042,174			3,475,997
Gross profit		3,716,784			4,298,239			10,611,321			11,393,026

Operating expenses:
Sales, general, and administration		12,057,868			14,721,710			43,524,412			35,019,268
Research and development		6,436,802			14,664,123			22,878,037			43,602,333
Depreciation and amortization		54,055			40,460			156,943			84,319
Total operating expense		18,548,725			29,426,293			66,559,392			78,705,920

Operating loss		(14,831,941	)		(25,128,054	)		(55,948,071	)		(67,312,894	)

Other income:
Miscellaneous income		167,300			109,942			442,322			265,879
Accreted interest		—			2,451			7,699			7,850
Total other income		167,300			112,393			450,021			273,729

Loss before taxes		(14,664,641	)		(25,015,661	)		(55,498,050	)		(67,039,165	)

Provision for income taxes		—			—			—			—

Net loss	$	(14,664,641	)	$	(25,015,661	)	$	(55,498,050	)	$	(67,039,165	)

Net loss per share, basic and diluted	$	(0.07	)	$	(0.13	)	$	(0.27	)	$	(0.34	)

Weighted average number of common shares outstanding		207,938,338			196,502,327			203,282,335			195,912,173

	Nine Months Ended
	September 30, 2017			September 30, 2016

CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(55,498,050	)	$	(67,039,165	)
Adjustments to reconcile net loss to net cash flows used in operating activities:
Depreciation of fixed assets		104,622			45,759
Amortization of intangible assets		52,321			38,560
Provision for doubtful accounts		1,555			2,261,568
Share-based compensation		5,037,783			13,385,215
Changes in operating assets and liabilities:
Accounts receivable		106,509			(4,245,151	)
Inventory		(217,196	)		(153,245	)
Other current assets		(831,623	)		379,930
Accounts payable		(3,159,145	)		1,098,245
Other current liabilities		(946,853	)		703,895
Net cash used in operating activities		(55,350,077	)		(53,524,389	)

CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs		(439,770	)		(541,686	)
Purchase of fixed assets		(35,849	)		(307,714	)
Payment of security deposit		—			(14,036	)
Net cash used in investing activities		(475,619	)		(863,436	)

CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs		68,572,635			134,863,475
Proceeds from exercise of warrants		3,798,999			1,373,000
Proceeds from exercise of options		212,615			979,060
Net cash provided by financing activities		72,584,249			137,215,535

Increase in cash		16,758,553			82,827,710
Cash, beginning of period		131,534,101			64,706,355
Cash, end of period	$	148,292,654		$	147,534,065

	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

	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

	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

	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

Year Ending December 31,		Estimated Amortization
	2017(3 months)	$	18,433
	2018	$	73,732
	2019	$	73,732
	2020	$	73,732
	2021	$	73,732
	Thereafter	$	804,567

	September 30, 2017		December 31, 2016
Finished product	$	1,293,517	$	1,062,285
Raw material		—		14,036
TOTAL INVENTORY	$	1,293,517	$	1,076,321

	September 30, 2017		December 31, 2016
Prepaid manufacturing costs	$	999,508	$	991,809
Prepaid sales and marketing costs		535,936		—
Prepaid insurance		953,792		628,039
Prepaid research and development costs		—		100,035
Prepaid consulting		—		128,898
Prepaid vendor deposits		5,000		44,311
Other prepaid costs		507,541		405,960
TOTAL OTHER CURRENT ASSETS	$	3,001,777	$	2,299,052

	September 30, 2017			December 31, 2016
Accounting system	$	301,096		$	301,096
Equipment		247,568			215,182
Computer hardware		80,211			80,211
Furniture and fixtures		116,542			113,079
Leasehold improvements		37,888			37,888
		783,305			747,456
Accumulated depreciation		(335,239	)		(230,617	)
TOTAL FIXED ASSETS	$	448,066		$	516,839

	September 30, 2017
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizing intangible assets:
OPERA^®software patent	$	31,951	$	(7,988	)	$	23,963		12
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		1,247,181		(153,216	)		1,093,965		15.25
Hormone therapy drug candidate patents (pending)		1,474,061		—			1,474,061		n/a
Non-amortizing intangible assets:
Multiple trademarks		201,432		—			201,432		indefinite
Total	$	3,046,368	$	(252,947	)	$	2,793,421

	September 30, 2017		December 31, 2016
Accrued clinical trial costs	$	556,048	$	1,281,080
Accrued payroll, bonuses and commission costs		2,662,359		3,531,440
Accrued compensated absences		952,587		665,561
Accrued legal and accounting expense		366,828		176,518
Accrued sales and marketing costs		69,041		665,773
Other accrued expenses		319,015		224,865
Allowance for wholesale distributor fees		145,563		76,510
Accrued royalties		93,870		26,507
Allowance for coupons and returns		1,218,249		794,816
Accrued rent		293,672		181,015
TOTAL OTHER CURRENT LIABILITIES	$	6,677,232	$	7,624,085

	Nine Months Ended September 30,
	2017		2016
Stock options		23,383,100		20,705,923
Warrants		3,115,905		12,060,571
		26,499,005		32,766,494

	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

	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

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

Year Ending December 31,
2021 (3 months)	$	1,532
2022		6,346
2023		4,990
2024		394
	$	13,262

	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

	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

	Nine Months Ended
	September 30, 2017	September 30, 2016
Risk-free interest rate	1.84-2.01%	1.13-1.70%
Volatility	61.56-63.95%	70.26-71.22%
Term (in years)	5.5-6.25	6.00-6.25
Dividend yield	0.00%	0.00%

	Number of Shares Underlying Stock Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance at December 31, 2016		21,767,854		$	3.56		5.8	$	60,495,730
Granted		2,184,500		$	6.61
Exercised		(102,546	)	$	2.07			$	452,287
Expired/Forfeited		(466,708	)	$	6.52
Balance at September 30, 2017		23,383,100		$	3.79		5.4	$	52,467,444
Vested and Exercisable at September 30, 2017		18,883,183		$	3.15		4.6	$	52,059,288
Unvested at September 30, 2017		4,499,917		$	6.46		8.6	$	408,156

	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

Year Ending December 31,
2021 (3 months)	$	3,280
2022		10,693
2023		6,206
2024		2,465
2025		6
	$	22,650

	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

Years Ending December 31,
2017 (3 months)	$	224,632
2018		951,194
2019		1,094,116
2020		1,113,069
2021		943,127
Total minimum lease payments	$	4,326,138

	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

	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