(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

Indicate by check mark whether the 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 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 every Interactive Data File required to be submitted 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 was required to submit 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):

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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐No ☒

The number of shares outstanding of the registrant’s common stock, par value $0.001 per share, as of ~~November 4, 2019~~August 3, 2020 was ~~271,177,076~~272,294,380.

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

The accompanying footnotes are an integral part of these consolidated financial statements.

TherapeuticsMD, Inc., a Nevada corporation, or TherapeuticsMD or the Company, has 3wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed; BocaGreenMD, Inc., a Nevada corporation, 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.” TherapeuticsMD^®, vitaMedMD^®, BocaGreenMD^®, IMVEXXY^®, BIJUVA^®and ~~BIJUVA~~ANNOVERA^® are registered trademarks of our ~~company and ANNOVERA~~^™ ~~is a licensed trademark of our~~ company.

We are a women’s healthcare company ~~focused on~~with a mission of creating and commercializing innovative products to support the lifespan of women ~~and championing awareness of women’s healthcare issues, specifically, for~~from pregnancy prevention ~~pregnancy, childbirth, nursing, pre-menopause, and~~through menopause. At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women. Our solutions range from a patient-controlled, long-lasting contraceptive to advanced hormone therapy pharmaceutical ~~products to patient-controlled, long-acting contraceptive.~~products. We also manufacture and distribute branded and generic prescription prenatal vitamins under the ~~vitaMedMD®~~vitaMedMD and ~~BocaGreenMD®~~BocaGreenMD brands.

~~With our SYMBODA™ technology, we are developing and commercializing advanced hormone therapy pharmaceutical~~ Our portfolio of products ~~to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. Our commercialization plan~~focused on women’s health allows us to efficiently leverage our sales and ~~grow our~~ marketing ~~and sales organization~~plan to ~~commercialize~~grow our recently approved products. During 2018, the U.S. Food and Drug Administration, or FDA, approval of our ~~drugs~~pharmaceutical products has transitioned our company from predominately focused on conducting research and development to one focused on commercializing our ~~drugs.~~pharmaceutical products. In July 2018, we launched our FDA-approved product, IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy, or VVA, due to menopause. In April 2019, we launched our FDA-approved product BIJUVA (estradiol and progesterone) capsules, our hormone therapy combination of bio-identical 17ß-estradiol and bio-identical progesterone in a single, oral softgel capsule, for the treatment of moderate-to-severe vasomotor symptoms, or VMS, due to menopause in women with a ~~uterus, which was approved by the FDA on October 28, 2018.~~uterus. In October 2019, we began a test and learn market introduction for our FDA-approved product ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system), the first and only patient-controlled, procedure-free, reversible prescription contraceptive option for ~~women, which was approved by the FDA on August 10, 2018. We expect~~women. Although we expected to commence the full commercial launch of ANNOVERA in the first quarter of 2020, as a result of the uncertainty surrounding the COVID-19 pandemic, we paused the commercial launch of ANNOVERA and deferred sales and marketing initiatives into subsequent quarters as the pandemic began to negatively affect our revenue growth. We resumed the launch of ANNOVERA on July 1, 2020. On July 30, 2018, we entered into an exclusive license agreement, or the Population Council License Agreement, with the Population Council, Inc., or the Population Council, to commercialize ANNOVERA in the U.S. In addition, on July 30, 2018, we entered into a license and supply agreement, or the Knight License Agreement, with Knight Therapeutics Inc., or Knight, pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel. On June 6, 2019, we entered into an exclusive license and supply agreement, or the Theramex License Agreement, with Theramex HQ UK Limited, or Theramex, to commercialize BIJUVA and IMVEXXY outside of the U.S., excluding Canada and Israel, or the Theramex Territory.

NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS

The accompanying unaudited interim consolidated financial statements of TherapeuticsMD, Inc., which include our wholly owned subsidiaries, should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, ~~2018,~~2019, as filed with the Securities and Exchange Commission, or the SEC, from which we derived the accompanying consolidated balance sheet as of December 31, ~~2018.~~2019. The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying unaudited interim consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited interim consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of our management, necessary 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.

We are subject to risks and uncertainties as a result of the COVID-19 pandemic. The extent of the impact of the COVID-19 pandemic on our business is highly uncertain and difficult to predict. We continue to provide an uninterrupted supply of our portfolio of products for patients. We have sufficient inventory of finished product to meet anticipated demand through at least the early fourth quarter of 2020. Additionally, we currently do not foresee any interruption in our ability to continue to manufacture additional product to be used beyond this period and have sufficient active pharmaceutical ingredients on hand for the continued manufacture of our products.

Since the early phase of the COVID-19 pandemic, we have been using substantial virtual options to ensure business continuity. Our VitaCare Prescription Services patient model assists patients in obtaining easy and convenient access to their prescriptions for products at a retail pharmacy of their choice, including via home delivery retail 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 to ensure patients have 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 currently have mailing options in place for these materials. We also have business continuity plans and infrastructure in place that allows for virtual detailing.

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, which included negotiating lower fees or suspending services from third party vendors; implementing a company-wide hiring freeze; delaying or cancelling non-critical information technology projects; and eliminating travel, entertainment, meeting, and event expenses. These savings can be extended further throughout 2020 or expanded depending on the impact of the COVID-19 pandemic.

As a result of the COVID-19 pandemic, our second quarter 2020 product revenues were reduced, which impacted our results of operations. As of the date of issuance of these consolidated financial statements, the future extent to which the COVID-19 pandemic may materially impact our financial condition, liquidity, or results of operations remains uncertain. We are continuing to assess the effect the COVID-19 pandemic on our operations by monitoring the spread of COVID-19 and the various actions implemented to combat the virus throughout the world.

While we currently believe that our COVID-19 contingency plan has the ability to mitigate the effect 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 are uncertain. Our future results of operations and liquidity could be materially adversely affected by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions, uncertain demand, and the impact of any initiatives or programs that we may undertake to address financial and operations challenges that we may face.

Although there is uncertainty related to the anticipated impact of the COVID-19 pandemic on our future results, we believe that our current cash reserves and the recent steps we have taken to reduce our operating expenses will help us manage our business through the pandemic. We have reviewed numerous potential scenarios in connection with the impact of COVID-19 on our business and, based on our analysis, we believe that our existing cash reserves, our currently anticipated operating cash flows, and proceeds from potential future financings, if available to us, will 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. However, if the successful commercialization of IMVEXXY, BIJUVA, or ANNOVERA is delayed, or the impact of the COVID-19 pandemic on our business is worse than we anticipate, our existing cash reserves and proceeds from potential future financings, if available to us, may be insufficient to satisfy our liquidity requirements until we are able to successfully commercialize IMVEXXY, BIJUVA, and ANNOVERA. If our available cash is insufficient to satisfy our liquidity requirements, we may curtail our sales, marketing, and other commercialization efforts and we may seek to sell additional equity or debt securities. Our ability to sell equity securities will be limited by market conditions. Our ability to sell debt securities or obtain additional debt financing is restricted pursuant to the Financing Agreement. To the extent that we raise additional capital through the sale of equity or convertible debt securities, to the extent permitted under the Financing Agreement, the ownership interests of our existing stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. If we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, certain of which are restricted under the Financing Agreement, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or proposed products, if permitted under the Financing Agreement. Additionally, we may have to grant licenses on terms that may not be favorable to us.

In August 2018, the Financial Accounting Standards Board, or the FASB, issued Accounting Standards Update, or ASU, 2018-13 which eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. The FASB developed the amendments to Accounting Standards Codification, or ASC, 820 as part of its broader disclosure framework project, which aims to improve the effectiveness of disclosures in the notes to financial statements by focusing on requirements that clearly communicate the most important information to users of the financial statements. The new guidance is effective for all entities for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years. An entity is permitted to early adopt either the entire standard or only the provisions that eliminate or modify requirements. We ~~are currently evaluating the effect of this guidance on our disclosures.~~

In June 2018, the FASB issued ASU 2018-07 to simplify the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expands the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in an entity’s own operations and supersedes the guidance in ASC 505-50. The guidance is effective for public business entities in annual periods beginning after December 15, 2018, and interim periods within those annual periods. Early adoption is permitted, including in an interim period for which financial statements have not been issued, but not before an entity adopts ASC 606. We adopted this standard on January 1, ~~2019~~2020, and the adoption ~~of this standard~~ did not have a material effect on our ~~consolidated financial statements.~~disclosures.

In ~~February~~June 2016, the FASB issued ASU ~~2016-02, Leases. This guidance requires lessees~~No. 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The amendments in this update require a financial asset (or a group of financial assets) measured at amortized cost basis to ~~record most leases~~be presented at the net amount expected to be collected based on ~~their balance sheets while recognizing expenses on their income statements~~historical experience, current conditions, and reasonable supportable forecasts. The amendments 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 wasthis update are effective for public business entities for ~~annual periods beginning after December 15, 2018,~~fiscal years, and interim periods within those ~~years. In July 2018,~~fiscal years, beginning after December 15, 2019, with early adoption permitted no sooner than the ~~FASB amended~~first quarter of 2019. A modified retrospective approach is required for all investments, except debt securities for which an other-than-temporary impairment had been recognized prior to the ~~new leases standard~~effective date, which will require a prospective transition approach and ~~issued~~should be applied either prospectively or retrospectively depending on the nature of the disclosure. The adoption of ASU ~~2018-11, Leases, (Topic 842): Targeted Improvements to give entities another option for transition~~2016-13 requires expanded quantitative and ~~to provide lessors with a practical expedient. We~~qualitative disclosures about the Company’s expected credit losses. Effective January 1, 2020, we adopted ASU ~~2016-02 on January 1, 2019 utilizing~~2016-13 under a modified retrospective approach for all financial assets measured at amortized cost. There was no adjustment recorded for the ~~alternative transition method allowed for under~~cumulative effect of adopting ASU ~~2018-11 and we recorded a $3.8 million~~ ~~right of use asset and a $4.1 million~~ ~~liability related to~~2016-13. The adoption ~~of this standard. In addition, upon commencement of additional lease space in the third quarter of 2019 (as disclosed in Note 15) we recorded an additional $7.4 million~~ ~~right of use asset and an additional $7.2 million~~ ~~liability related to~~expanded disclosures about our new lease space. Comparative financial information was not adjusted and will continue to be reported under ASC 840. We also elected the transition relief package of practical expedients and as a result we did not assess (1) whether existing or expired contracts contain leases, (2) lease classification for any existing or expired leases, and (3) whether lease origination costs qualified as initial direct costs. We elected the short-term lease practical expedient by establishing an accounting policy to exclude leases with a term of 12 months or less. We elected not to separate lease components from non-lease components for our specified asset classes. Additionally, the adoption of the new standard resulted in increased disclosure requirements in our quarterly and annual filings.credit losses.

Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force), the American Institute of Certified Public Accountants and the SEC did not, and are not expected to, have a material effect on our results of operations or financial position.

Our financial instruments consist primarily of cash, accounts receivable, accounts payable, accrued expenses and long-term debt. 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. The carrying amount for long-term debt as of September 30, 2019 (as disclosed in Note 9), approximates fair value based on market activity for other debt instruments with similar characteristics and comparable risk (Level 2).

~~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 recorded in the consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows:

~~At September 30, 2019 and 2018, 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 the company’s impairment test on an annual basis.

Trade accounts receivable are customer obligations due under normal trade terms. We review accounts receivable for uncollectible accounts and credit card chargebacks 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 evaluate trade accounts receivable ~~aged more than 90 days~~ for delinquency. We write off delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers. We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts. To the extent data we use to calculate these estimates does not accurately reflect bad debts, adjustments to these reserves may be required. Our exposure to credit losses may increase if our customers are adversely affected by changes in healthcare laws, coverage, and reimbursement, economic pressures or uncertainty associated with local or global economic recessions, disruption associated with the current COVID-19 pandemic, or other customer-specific factors. 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.

~~NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS~~Fair Value of Financial Instruments

Our financial instruments consist primarily of cash, accounts receivable, accounts payable, accrued expenses and long-term debt. 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. The carrying amount for long-term debt as of June 30, 2020 (as disclosed in Note 9) approximates fair value based on market activity for other debt instruments with similar characteristics and comparable risk (Level 2).

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 ASC 820, Fair Value Measurements, or ASC 820. 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 recorded in the consolidated balance sheet at fair value are categorized based on a hierarchy of inputs, as follows:

At June 30, 2020 and 2019, we had 0 assets or liabilities that were valued at fair value on a recurring basis.

The fair value of indefinite-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with any required impairment test. There was 0 impairment of intangible assets during the six months ended June 30, 2020. During the six months ended June 30, 2019, we wrote off $78,864 in costs related to trademarks and patents, including the net carrying amount of the OPERA patent.

We ~~adopted~~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 include options, restricted stock, restricted stock units, performance-based awards, share appreciation rights, and employee share purchase plans. 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 ~~606~~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. On January 1, ~~2018~~2017, we began using our own stock price in our volatility calculation along with the other peer entities whose stock prices were publicly available that were similar to our company and in 2019 we started using only our own stock price in the volatility calculation. Our calculation of estimated volatility is based on historical stock prices over a period equal to the expected term of the awards. On January 1, 2020, we began calculating the expected term of our stock-based awards, which represents the period that the stock-based awards are expected to be outstanding. Prior to January 1, 2020, the average expected life of options was based on the contractual terms of the stock option using the ~~modified retrospective method~~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. The assumptions used in calculating the fair value of stock-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. We recognize the compensation expense for ~~all contracts not completed~~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. Effective January 1, 2017, we account for forfeitures when they occur. On January 1, 2019, we adopted ASU 2018-07 which simplified the accounting for share-based payments to non-employees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expanded the scope of ASC 718 to include share-based payments granted to non-employees in exchange for goods or services used or consumed in an entity’s own operations and superseded the guidance in ASC 505-50. Prior to January 1, 2019, equity instruments issued to non-employees were recorded on a fair value basis, as required by ASC 505, Equity - Based Payments to Non-Employees.

We grant performance-based stock units and restricted stock units for shares of common stock, par value $0.001 per share, or Common Stock, to employees. We value our restricted stock units and our performance-based stock units by reference to our stock price on the date of ~~adoption.~~grant. We recognize compensation expense for restricted stock units based on a straight-line basis over the requisite service period of the entire award. We recognize performance-based restricted stock as compensation expense based on the most likely probability of attaining the prescribed performance and over the requisite service period beginning at its grant date and through the date the restricted stock vests. The number of target shares that vest are determined based on the level of attainment of the targets. If a minimum level of performance is attained for the awards, restricted stock is issued based on the level of attainment.

In accordance with ASC 606, ~~states that a contract is considered “completed” if all (or substantially all) of the revenue was recognized in accordance~~Revenue from Contracts with revenue guidance that was in effect before the date of initial application. Because all (or substantially all) of the revenue related to sales of our products has been recognized under ASC 605 prior to the date of initial application of the new standard, the contracts are considered completed under ASC 606. Based on our evaluation of ASC 606, we concluded that a cumulative adjustment was not necessary upon implementation of ASC 606 on January 1, 2018. In accordance withCustomers, or ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods or services. The provisions of ASC 606 include a five-step process by which we determine revenue recognition, depicting the transfer of goods or services to customers in amounts reflecting the payment to which we expect to be entitled in exchange for those goods or services. ASC 606 requires us to apply the following steps: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, we satisfy the performance obligation.

As of ~~September~~June 30, ~~2019,~~2020, our products consisted primarily of prescription vitamins and our FDA-approved products: IMVEXXY, which we began selling during the third quarter of 2018, BIJUVA, which we began selling in the second quarter of 2019, and ANNOVERA, which we ~~began~~started selling in the third quarter of 2019. As a result of the uncertainty surrounding the COVID-19 pandemic, we paused the commercial launch of ANNOVERA in the first quarter of 2020 and deferred sales and marketing initiatives into subsequent quarters. We resumed the launch of ANNOVERA on July 1, 2020.

We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacies. We have one performance obligation related to prescription products sold through wholesale distributors, which is to transfer promised goods to a customer, and two performance obligations related to products sold through retail pharmacies, which are to: (1) transfer promised goods and (2) provide customer service for an immaterial fee. We treat shipping as a fulfillment activity rather than as a separate obligation. We recognize prescription revenue only when we satisfy performance obligations by transferring a promised good or service to a customer. A good or service is considered to be transferred when the customer receives the goods or service or obtains control. Control refers to the customer’s ability to direct the use of, and obtain substantially all of the remaining benefits from, an asset. Based on our contracts, we invoice customers once our performance obligations have been satisfied, at which point payment is unconditional. We disclose receivables from contracts with customers separately in the statement of financial position. Payment for goods or services sold by us is typically due between 30 and 60 days after an invoice is sent to the customer.

The transaction price of a contract is the amount of consideration which we expect to be entitled to in exchange for transferring promised goods or services to a customer. Prescription products are sold at fixed wholesale acquisition cost, or WAC, determined based on our list price. However, the 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 amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). In order to 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 circumstances relative to the contract or each variable consideration. The estimated amount of variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative 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 a contract’s transaction price, we rely on our historical experience and other evidence that supports our qualitative assessment of whether revenue would be subject to a significant reversal. We consider all the facts and circumstances associated with both the risk of a revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the 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 and up to 12 months following product expiration. Our ~~prescription products~~vitamins and IMVEXXY currently have a shelf life of 24 months from the date of manufacture and BIJUVA and ANNOVERA currently have 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 our customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. Where historical rates of 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 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 the end of each reporting period, we may decide to constrain 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 returns primarily consist of expired and short dated products that will not be resold, we do not 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 revenue is deferred due to the anticipated return). Return estimates are recorded in ~~the accrued expenses and~~ other current liabilities on the consolidated balance sheet.

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 we have offered based on our 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 revenues at the time the revenues are recognized. We record distributor fees based on amounts stated in contracts. Rebate and coupon estimates and distributor fees are recorded in ~~accrued expenses and~~ other current liabilities on the consolidated balance sheet. We estimate chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience. Estimates related to distributors fees, rebates, coupons and returns are disclosed in Note 8. We provide invoice discounts to our customers for prompt payment. Estimates relating to invoice discounts and chargebacks are deducted from gross product revenues at the time the revenues are recognized.

As part of commercial launches for our FDA-approved prescription products, we ~~introduce~~introduced a co-pay assistance program ~~where~~for eligible enrolled patients whose out of pocket ~~cost is~~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. We consider certain payments as consideration paid to the customer and reflect such payments as a reduction of the transaction price as we do not receive a distinct good or service related to these payments. The variable consideration is estimated based on contract prices, the estimated percentage of patients that will 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 prescription products positively or negatively, at any time up to the time that we have formally 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 the influence of the Company. As a result, we constrain ~~revenue recognized~~variable consideration for our prescription products to an amount that will not result in a significant 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 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 re-evaluate ~~any constraint~~variable consideration each reporting period.

License arrangements may consist of non-refundable upfront license fees, exclusive licensed rights to patented or patent pending technology, and various performance or sales milestones and future product royalty payments. Some of these arrangements ~~are~~may include multiple ~~element arrangements.~~performance obligations. Non-refundable up-front fees that are not contingent on any future performance by us, and do not require continuing involvement on our part, are recognized as revenue when the ~~license term commences and~~right to use functional IP is transferred to the ~~licensed data or technology is delivered.~~customer.

The following table provides information about disaggregated revenue by product mix for the three and ~~nine~~six months ended ~~September~~June 30, 2020 and 2019:

On July 30, 2018, we entered into the Population Council License Agreement to commercialize ANNOVERA in the U.S. We began selling ANNOVERA in a “test and learn” market introduction in the third quarter of 2019. As a result of the uncertainty surrounding the COVID-19 pandemic, we paused the commercial launch of ANNOVERA in the first quarter of 2020 and deferred sales and marketing initiatives into subsequent quarters.

Under the terms of the Population Council License Agreement, we paid the Population Council a milestone payment of $20,000,000 within 30 days following the approval by the FDA of the new drug application, or NDA, for ANNOVERA and $20,000,000 within 30 days following the first commercial batch release of ANNOVERA. Both milestone payments of $20,000,000 were recorded as license rights in the consolidated balance sheets. We started amortizing license rights in the third quarter of 2019 once ANNOVERA became commercially available for use. The cost is amortized over the remaining useful life over which the license rights will contribute directly or indirectly to our cash flows, which is estimated to be the remaining patent life of the product, which expires in December 2032. The cost is amortized using the straight-line method as the pattern of economic benefit cannot be reliably determined. During the three and ~~2018:~~six months ended June 30, 2020, we recorded $754,102 and $1,499,613, respectively, in amortization expense related to the license fee which was recorded as a component of cost of sales.

The Population Council is also eligible to receive milestone payments and royalties from commercial sales of ANNOVERA. We are responsible for marketing expenses related to the commercialization of ANNOVERA. In addition, we are required to pay the Population Council, on a quarterly basis, step-based royalty payments based on annual net sales of ANNOVERA in the U.S. by the Company and its affiliates and permitted licensees as follows: (i) if annual net sales are less than or equal to $50,000,000, a royalty of 5% of net sales; (ii) for annual net sales greater than $50,000,000 and less than or equal to $150,000,000, a royalty of 10% of such net sales; and (iii) for net sales greater than $150,000,000, a royalty of 15% of such net sales. The annual royalty rate will be reduced to 50% of the initial rate during the six-month period beginning on the date of the first arms-length commercial sale of a generic equivalent of the one-year vaginal contraceptive system that is launched by a third party in the U.S., and thereafter will be reduced to 20% of the initial rate. We are required to pay the Population Council milestone payments of $40 million upon cumulative net sales of ANNOVERA in the U.S. by us and our affiliates and permitted sublicensees of each of $200 million, $400 million and $1 billion. The Population Council has agreed to perform and pay the costs and expenses associated with four post-approval studies required by the FDA for ANNOVERA and we have agreed to perform and pay the costs and expenses associated with a post approval study required by the FDA to measure risk for venous thromboembolism, provided that if the costs and expenses associated with such post-approval study exceed $20,000,000, half of such excess will be offset against royalties or other payments owed by us to the Population Council under the Population Council License Agreement. We and the Population Council have agreed to form a joint product committee responsible for overseeing activities under the Population Council License Agreement. We will be responsible for all aspects of promotion, product positioning, pricing, education programs, publications, sales messages and any additional desired clinical studies for the one-year vaginal contraceptive system, subject to oversight and decisions made by the joint product committee. The Population Council License Agreement includes exclusive rights for us to negotiate co-development of two other investigational vaginal contraceptive systems in development by the Population Council.

Cost of sales includes the cost of inventory, manufacturing, manufacturing overhead and supply chain costs, and product shipping and handling costs. ~~Certain license agreements require the~~The Population Council License Agreement requires payment of royalties based on the sale of future products. Such royalties are recorded as a component of cost of sales. Additionally, the amortization of license fees or milestone payments related to licensed products are classified as components of cost of sales to the extent such payments become due in the future.

We ~~measure the compensation costs of share-based compensation arrangements based on the grant-date fair value~~evaluate inventory quarterly and ~~recognize the costs~~records an allowance for obsolescence primarily associated with materials that are not currently or likely to be used in production in the ~~financial statements over the period during which employees are required~~near future. As of June 30, 2020 and December 31, 2019 , we recorded an inventory obsolescence reserve primarily related to ~~provide services. Share-based compensation arrangements include options, restricted stock, restricted stock units, performance-based awards, share appreciation rights,~~BIJUVA, of $5,965,139 and ~~employee share purchase plans. We amortize such compensation amounts, if any, over the respective service periods~~$0, respectively, as a result 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 lifeimpact of the ~~stock-based awards,~~COVID-19 pandemic on our business, which decreased demand of our products.

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 executive leadership team that is chaired by the ~~estimated stock price volatility, the risk-free interest rate,~~Chief Executive Officer of our Company, who oversees all operations. We do not operate separate lines of business with respect to any of our products 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 expectedwe do not prepare discrete financial information with respect to fluctuate each year during the term of the award. On January 1, 2017, we began using our own stock price in our volatility calculation along with the other peer entities whose stock prices were publicly available that were similar to our company and in 2019 we started using only our own stock priceseparate products. All product sales are derived from sales in the volatility calculation. 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 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 thatUnited States. Accordingly, 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 representview 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. We recognize the compensation expense for 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. Effective January 1, 2017, we account for forfeitures when they occur.business as one reportable operating segment.

On January 1, 2019, we adopted ASU 2018-07 which simplified the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new guidance expanded the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in an entity’s own operations and superseded the guidance in ASC 505-50. Prior to January 1, 2019, equity instruments issued to non-employees were recorded on a fair value basis, as required by ASC 505, Equity - Based Payments to Non-Employees.

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, scale-up and validation costs, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and other 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 FDA submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. These consulting expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance 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~~to expenses in the period in which the facts that give rise to the revision become known.

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 President 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 for the three months ended ~~September~~June 30, ~~2019~~2020 and ~~2018~~2019 was $~~90,700~~188,810 and $~~42,221~~66,556, respectively, and for the six months ended June 30, 2020 and 2019 was $~~223,750~~387,649 and $~~121,423~~133,049 ~~for the nine months ended September 30, 2019 and 2018,~~, respectively.

The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of ~~September~~June 30, ~~2019~~2020 and December 31, ~~2018:~~2019:

We capitalize external costs, consisting primarily of legal costs, 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 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~~six months ended ~~September~~June 30, 2019, we wrote off $78,864in costs related to trademarks and patents, including the net carrying amount of the OPERA patent.

As of ~~September~~June 30, ~~2019,~~2020, we had 2635 issued domestic ~~or U.S.,~~ patents and 2835 issued foreign patents, including:

3 domestic patents that relate to estradiol and progesterone product candidates. These patents establish an important intellectual property foundation for BIJUVA and are owned by us. The domestic patents will expire in 2032. The foreign patents will expire no earlier than 2032. In addition, we have pending patent applications relating to BIJUVA in the U.S., Argentina, Australia, Brazil, Canada, China, Europe, Israel, Japan, Mexico, New Zealand, Russia, South Africa, and South Korea;

~~NaN~~ ~~domestic patents (~~4 ~~utility and~~ 1 ~~design) and~~ 13 ~~foreign patents (~~3 ~~utility and~~ 10 design) that relate to IMVEXXY. These patents establish an important intellectual property foundation for IMVEXXY and are owned by us. The domestic patents will expire in 2032 or 2033. The foreign utility patents will expire no earlier than 2033. The foreign design patents provide protection expiring no earlier than 2025. In certain jurisdictions, the foreign design patents provide protection through at least 2037. In addition, we have pending patent applications related to IMVEXXY in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, New Zealand, Russia, South Africa, and South Korea;

~~NaN~~ domestic utility patent that relates to our topical-cream candidates, which is owned by us. The domestic patent will expire in 2035. We have pending patent applications with respect to our topical-cream candidates in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea;

~~NaN~~ ~~domestic utility patent and~~ 5 foreign patents that relate to our transdermal-patch candidates, which are owned by us. The domestic utility patent will expire in 2032. The foreign patents will expire no earlier than 2033. We have pending patent applications with respect to our transdermal-patch candidates in the U.S., Brazil, Canada, Europe, Mexico, and South Africa;

~~NaN~~ ~~domestic utility patent that relates to our OPERA information-technology platform, which is owned by us and will expire in 2031;~~

~~NaN~~ ~~domestic utility patent that relates to a product candidate containing d-limonene, which is owned by us and will expire in 2036; and~~

~~NaN~~ domestic utility patents that relate to TX-009HR, a progesterone and estradiol product candidate, which are owned by us and will expire in 2037. We have pending patent applications with respect to TX-009HR in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, New Zealand, Russia, South Africa, and South Korea.

Amortization expense was $~~51,259~~ 67,748and $~~31,100~~48,503 for the three months ended ~~September~~June 30, ~~2019~~2020 and ~~2018,~~2019, respectively, and $~~140,206~~130,902 and $~~77,123~~88,948 for the ~~nine~~six months ended ~~September~~June 30, 2020 and 2019, ~~and 2018,~~ respectively.

Estimated amortization expense, based on current patent cost being amortized, for the next five years ~~for the patent costs currently being amortized~~ is as ~~follows:~~follows:

Year Ending December 31, Estimated Amortization
2019 (3 months) $ 51,259
2020 $ 205,035
2021 $ 205,035
2022 $ 205,035
2023 $ 205,035

~~License Agreement with the Population Council~~

On July 30, 2018, we entered into the Council License Agreement to commercialize ANNOVERA in the U.S. ANNOVERA became commercially available in the third quarter of 2019 and we expect the full commercial launch in the first quarter of 2020.

~~Under the terms of the Council License Agreement, we paid the Population Council a milestone payment of $20,000,000~~ within 30 days following approval by the FDA of the new drug application, or NDA, for ANNOVERA. The first commercial batch of ANNOVERA was released during the third quarter of 2019 and we are required to pay the Population Council $~~20,000,000~~ ~~as a result of the commercial batch release. Both milestone payments of $20,000,000~~ were recorded as finite-lived intangible asset in the consolidated balance sheet as of September 30, 2019. We started amortizing the intangible asset in the third quarter of 2019 once ANNOVERA became commercially available for use. The cost is amortized over the remaining useful life over which an intangible asset will contribute directly or indirectly to our cash flows. During both the three and nine months ended September 30, 2019, we recorded $~~15,998~~ ~~in amortization expense related to the license fee which was recorded as a component of cost of sales.~~

The Population Council is also eligible to receive milestone payments and royalties from commercial sales of ANNOVERA. We will assume responsibility for marketing expenses related to the commercialization of ANNOVERA. In addition, we are required to pay the Population Council, on a quarterly basis, step-based royalty payments based on annual net sales of ANNOVERA in the U.S. by the Company and its affiliates and permitted licensees as follows: (i) if annual net sales are less than or equal to $~~50,000,000, a royalty of~~ 5~~% of net sales; (ii) for annual net sales greater than $50,000,000~~ ~~and less than or equal to $150,000,000, a royalty of~~ 10~~% of such net sales; and (iii) for net sales greater than $150,000,000, a royalty of~~ 15~~% of such net sales. The annual royalty rate will be reduced to~~ 50% of the initial rate during the six-month period beginning on the date of the first arms-length commercial sale of a generic equivalent of the one-year vaginal contraceptive system that is launched by a third party in the U.S., and thereafter will be reduced to 20% of the initial rate. The Population Council has agreed to perform and pay the costs and expenses associated with four post-approval studies required by the FDA for ANNOVERA and we have agreed to perform and pay the costs and expenses associated with a post approval study required by the FDA to measure risk for venous thromboembolism, provided that if the costs and expenses associated with such post-approval study exceed $~~20,000,000~~, half of such excess will be offset against royalties or other payments owed by us to the Population Council under the Council License Agreement. We and the Population Council have agreed to form a joint product committee responsible for overseeing activities under the Council License Agreement. We will be responsible for all aspects of promotion, product positioning, pricing, education programs, publications, sales messages and any additional desired clinical studies for the one-year vaginal contraceptive system, subject to oversight and decisions made by the joint product committee. The Council License Agreement includes exclusive rights for us to negotiate co-development of two other investigational vaginal contraceptive systems in development by the Population Council.

~~THERAPEUTICSMD, INC. AND SUBSIDIARIES~~

~~NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS~~

We assess our intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist. If impairment indicators are present or changes in circumstance suggest that impairment may exist, we perform a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, we would determine the fair value of the intangible asset and recognize an impairment loss if the carrying value of the intangible asset exceeds its fair value. We also evaluate the remaining useful life of intangible assets subject to amortization on a periodic basis to determine whether events and circumstances would indicate impairment or warrant a revision to the remaining useful life. If the estimate of an intangible asset’s remaining useful life is changed, we will amortize the remaining carrying value of the intangible asset prospectively over the revised remaining useful life.

~~License Agreement with Knight Therapeutics Inc.~~

On July 30, 2018, we entered into a license and supply agreement, or the Knight License Agreement, with Knight pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel. Pursuant to the terms of the Knight License Agreement, Knight will pay us a milestone fee upon first regulatory approval in Canada of each of IMVEXXY and BIJUVA, sales milestone fees based upon certain aggregate annual sales in Canada and Israel of each of IMVEXXY and BIJUVA and royalties based on aggregate annual sales of each of IMVEXXY and BIJUVA in Canada and Israel. Knight will be responsible for all regulatory and commercial activities in Canada and Israel related to IMVEXXY and BIJUVA. We may terminate the Knight License Agreement if Knight does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize IMVEXXY and BIJUVA in Canada and Israel within certain specified time periods. We also may terminate the Knight License Agreement if Knight challenges our patents. Either party may terminate the Knight License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters. In connection with the Knight License Agreement, Knight entered into a subscription agreement with us, pursuant to which Knight purchased ~~3,921,568~~ ~~shares of our Common Stock concurrent with the closing of the underwritten public offering of Common Stock at a price of $5.10, for proceeds of $20,000,000, on August 6, 2018.~~

~~License Agreement with Theramex~~

On June 6, 2019, we entered into an exclusive license and supply agreement, or the License Agreement, with Theramex, a leading, global specialty pharmaceutical company dedicated to women’s health, to commercialize BIJUVA and IMVEXXY outside of the U.S., excluding Canada and Israel, or the Territory. Under the terms of the License Agreement, Theramex paid us EUR 14 million in cash as an upfront fee on August 5, 2019. Within thirty days of signing the License Agreement, we provided Theramex the regulatory materials and clinical data that were necessary for Theramex to obtain marketing authorizations and other applicable regulatory approvals for commercializing BIJUVA and IMVEXXY. We recognized the revenue related to the upfront fee, which was a non-refundable payment, during the third quarter of 2019, at a point in time when Theramex was able to use and benefit from the license which was when the knowledge transfer of regulatory documents occurred. We are eligible to receive additional milestone payments comprised of (i) up to an aggregate of EUR 2 ~~million in regulatory milestone payments based on regulatory approvals for BIJUVA and IMVEXXY in certain specified markets and (ii) up to an aggregate of EUR~~ ~~27.5~~ million in sales milestone payments to be paid in escalating tranches based on Theramex first attaining certain aggregate annual net sales milestones of BIJUVA and IMVEXXY in the Territory ranging from EUR 25 ~~million to EUR~~ ~~100~~ million. We are also entitled to receive quarterly royalty payments on net sales of BIJUVA and IMVEXXY in the Territory. Theramex will be responsible for all regulatory and commercial activities for BIJUVA and IMVEXXY in the Territory. Theramex may sublicense its rights to commercialize BIJUVA and IMVEXXY in the Territory, except for certain specified markets. We may terminate the License Agreement if Theramex does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize BIJUVA and IMVEXXY within certain specified time periods. We also may terminate the License Agreement if Theramex challenges our patents. Either party may terminate the License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters.

~~THERAPEUTICSMD, INC. AND SUBSIDIARIES~~

~~NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS~~

On April 24, 2019, we entered into a Financing Agreement, as amended, or the Financing Agreement, with TPG Specialty Lending, Inc., as administrative agent, or the Administrative Agent, various lenders from time to time party thereto, and certain of ~~the Company’s~~our subsidiaries party thereto from time to time as guarantors, which provides us with up to a $300,000,000first lien secured term loan credit facility, or the Facility. The Facility provides for availability to us in three tranches: (i) $200,000,000was drawn upon entering into the Financing Agreement; (ii) $50,000,000 ~~will be available to us upon the designation~~was drawn on February 18, 2020 following our achievement of ~~our ANNOVERA product as a new category of birth control by the FDA on or prior to December 31, 2019 and satisfaction (or waiver) of other customary conditions precedent; and (iii)~~more than $~~50,000,000~~11,000,000 ~~will be available to us upon our achieving $11,000,000~~in net revenues ~~as defined in the Financing Agreement,~~ from ~~our~~ IMVEXXY, BIJUVA and ANNOVERA ~~products~~ for the fourth quarter of 2019 and ~~satisfaction (or waiver)~~(iii) $50,000,000 was previously available to us in the Administrative Agent’s sole and absolute discretion either contemporaneously with the delivery of ~~other customary conditions precedent.~~our financial statements for the quarter ended June 30, 2020 or at such earlier date as the Administrative Agent may have consented to. We and the Administrative Agent are not moving forward with the undrawn $50,000,000 tranche under the Financing Agreement, which was designed to be drawn following the successful full commercial launch of ANNOVERA in the second quarter of 2020, due to the pause in the launch timing caused by the COVID-19 pandemic. However, the Administrative Agent has agreed to continue to discuss with us the terms upon which additional financing could be made available to us by the Administrative Agent in the future at our request and in its discretion. Borrowings under the Facility accrue interest at either (i) 3-month LIBORplus 7.75%, subject to a LIBOR floor of 2.70% or (ii) the prime rateplus 6.75%, subject to a prime rate floor of 5.2% as selected by us. Interest on amounts borrowed under the Facility ~~will be~~is payable quarterly. The outstanding principal amount of the Facility is payable in 4equal quarterly installments beginning on June 30, 2023, with the Facility maturing on March 31, 2024. We have the right to prepay borrowings under the Facility in whole or in part at any time, subject to a prepayment fee on the principal amount being prepaid of (i) 30.0% for the first two years following the initial funding date of the applicable borrowing, (ii) 5.0% for the third year following the initial funding date of the applicable borrowing, (iii) 3.0% for the fourth year following the initial funding date of the applicable borrowing and (iv) 1.0% for the fifth year following the initial funding date of the applicable borrowing but prior to March 31, 2024. In connection with the initial borrowing under the Facility, we paid, for the benefit of the lenders, a facility fee equal to 2.5% of the initial amount borrowed and will be required to pay such a facility fee in connection with any subsequent borrowings under the Facility. We are also required to pay the Administrative Agent and the lenders an annual administrative fee in addition to other fees and expenses. The Financing Agreement contains customary mandatory prepayments, restrictions and covenants applicable to us that are customary for financings of this type. Among other requirements, we are required to (i) maintain a minimum unrestricted cash balance of $~~50,000,000, which will increase to $~~60,000,000 ~~if we draw either the second or third tranche of the Facility,~~, and (ii) achieve certain minimum consolidated net revenue amounts attributable to commercial sales of our IMVEXXY, BIJUVA and ANNOVERA products beginning with the fiscal quarter ending December 31, 2020. The Financing Agreement also includes other representations, warranties, indemnities and events of default that are customary for financings of this type, including an event of default relating to a change of control of the Company. Upon or after an event of default, the Administrative Agent and the lenders may declare all or a portion of our obligations under the Financing Agreement to be immediately due and payable and exercise other rights and remedies provided for under the Financing Agreement. The obligations of our company and its subsidiaries under the Financing Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a first priority perfected security interest in all existing and ~~after-acquired~~after acquired assets of our company and its subsidiaries. The obligations under the Financing Agreement will be guaranteed by each of our future direct and indirect subsidiaries, subject to certain exceptions.

On May 1, 2018, we entered into a Credit and Security Agreement, or the Credit Agreement, with MidCap Financial Trust, or MidCap, as agent, or Agent, and as lender, and the additional lenders party thereto from time to time (together with MidCap as a lender, the Lenders), as amended. The Credit Agreement provided a secured term loan facility in an aggregate principal amount of up to $200,000,000, or the Term Loan. Under the terms of the Credit Agreement, the Term Loan was available to be made in 3 separate tranches, with each tranche to be made available to us, at our option, upon our achievement of certain milestones. Amounts borrowed under the Term Loan bore interest at a rate equal to the sum of (i) one-month LIBOR (subject to a LIBOR floor of 1.50%) plus (ii) 7.75% per annum.

On April 24, 2019, we terminated the Credit Agreement. A portion of the initial tranche of borrowing under the Financing Agreement in the amount of approximately $81,661,000was used to repay all amounts outstanding under the Credit Agreement, which included a prepayment fee of 44%%, a repayment fee of 44% % and other fees and expenses payable to the lenders under the Credit Agreement. As a result of the termination of the Credit Agreement, we recorded $10,057,632in loss on extinguishment of debt in the ~~accompanying unaudited consolidated financial statements. Interest on amounts borrowed under the Term Loan was due and payable monthly in arrears.~~second quarter of 2019. Interest expense for the ~~nine~~six months ending ~~September~~June 30, 2019 related to the Credit Agreement was $1,816,747. During the ~~nine~~six months ended ~~September~~June 30, 2019, and prior to the repayment of the Credit Agreement, we amortized $120,146of deferred financing fees as interest expense in the accompanying unaudited consolidated financial statements.

As of ~~September~~June 30, ~~2019,~~2020, we had $~~200,000,000~~250,000,000 in borrowings outstanding under the Financing Agreement, which are classified as long-term debt in the accompanying ~~unaudited~~ consolidated financial statements. We incurred $~~6,652,270~~7,902,270 in deferred financing fees related to the Financing Agreement. Deferred financing fees related to the entire Financing Agreement have been allocated pro rata between the funded and unfunded ~~portions of each tranche.~~tranches. Allocated deferred financing fees related to ~~Tranche 1~~the two tranches of borrowings that we received of $~~6,101,513~~7,626,891 have been reflected as a debt discount and are accreted to interest expense using the effective interest method. Deferred financing fees associated with an unfunded ~~tranches were~~tranche are deferred as assets until ~~the Tranche 2 and Tranche 3 milestones have~~such tranche has been ~~met.~~drawn. As of ~~September~~June 30, ~~2019,~~2020, deferred financing fees related to ~~Tranche 2 and Tranche 3~~ the unfunded tranche of $50,000,000 were included in other current assets in the accompanying consolidated financial statements. During the three and ~~nine~~six months ended ~~September~~June 30, ~~2019,~~2020, we amortized $~~265,949~~373,034 and $~~462,683~~692,442, respectively, of deferred financing fees related to ~~Tranche 1~~ the two tranches that have been received as interest expense in the accompanying ~~unaudited~~consolidated financial statements. During the three and six months ended June 30, 2019, we amortized $196,734, of deferred financing fees related to the Financing Agreement as interest expense in the accompanying consolidated financial statements. Interest on amounts borrowed under the Financing Agreement is due and payable quarterly in arrears. Interest expense for the three and ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020 was $~~5,333,056~~6,653,819 and $~~9,318,056~~12,596,458, respectively. The overall effective interest rate under the Financing Agreement was approximately 1111% % as of ~~September~~June 30, ~~2019.~~

As of ~~September~~June 30, ~~2019~~2020 and December 31, ~~2018,~~2019, the carrying value of our debt consisted of the following:

~~THERAPEUTICSMD, INC. AND SUBSIDIARIES~~On April 27, 2020, we received a loan pursuant to the Paycheck Protection Program under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), as administered by the U.S. Small Business Administration. The loan in the principal amount of $6,477,094 (the “PPP Loan”) was disbursed by Bank of America, NA, a national banking association, pursuant to a promissory note issued by the Company. Although we believed, in good faith, we were qualified for the PPP Loan under the available regulations, as a result of newly-issued guidance, particularly with respect to publicly traded companies receiving funding under the CARES Act, we voluntarily returned the PPP Loan proceeds on May 14, 2020.

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 our Common Stock outstanding plus all potentially dilutive shares of our Common Stock outstanding during the period. Such potentially dilutive shares of our Common Stock consist of options, warrants and restricted stock ~~awards~~units and were excluded from the calculation of diluted ~~EPS~~earnings per share because their effect would have been ~~antidilutive~~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 for the periods presented.

At ~~September~~June 30, ~~2019,~~2020, we had 10,000,000 shares of preferred stock, par value $0.001 per share, authorized for issuance, of which no0 shares ~~of preferred stock~~ were issued or outstanding.

At ~~September~~June 30, ~~2019,~~2020, we had ~~350,000,000~~ 600,000,000shares of Common Stock authorized for issuance, of which ~~241,277,076~~272,294,380 shares of Common Stock were issued and outstanding.

Issuances During the Three and ~~Nine~~Six Months ~~Ended September~~ended June 30, ~~2019~~2020

During the three months ended ~~September~~June 30, ~~2019, certain individuals exercised~~2020, stock options to purchase an aggregate of ~~55,236~~313,638 shares of Common Stock were exercised for $~~8,549~~94,075 in cash. During the ~~nine~~six months ended ~~September~~June 30, ~~2019, certain individuals exercised~~2020, stock options to purchase an aggregate of ~~331,619~~664,304 shares of Common Stock were exercised for $~~108,656~~166,184 in cash.

During the three months ended June 30, 2019, no options to purchase shares of Common Stock were exercised. During the six months ended June 30, 2019, stock options to purchase an aggregate of 276,383 shares of Common Stock were exercised for $100,107 in cash. Also, during the same period, stock options to purchase an aggregate of 12,097 shares of Common Stock were exercised pursuant to the options’ cashless exercise provisions, wherein an aggregate of 11,834 shares of Common Stock were issued.

~~During the three months ended September 30, 2018, certain individuals exercised stock options to purchase~~ ~~1,052,300~~ ~~shares of Common Stock for $107,318~~ ~~in cash. During the nine months ended September 30, 2018, certain individuals exercised stock options to purchase~~ ~~1,446,876~~ ~~shares of Common Stock for $1,236,313~~ ~~in cash. Also, during the nine months ended September 30, 2018, stock options to purchase~~ ~~10,000~~ ~~shares of Common Stock were exercised pursuant to the options’ cashless exercise provisions, wherein~~ ~~9,841~~ ~~shares of Common Stock were issued.~~

~~On August 1, 2018, we entered into an underwriting agreement with Goldman Sachs & Co. LLC, as representative of the underwriters, relating to an underwritten public offering of~~ ~~12,745,098~~ ~~shares of our Common Stock at a price of $5.10~~ ~~per share. We granted the underwriters an option, exercisable for a period of~~ 30 ~~days, to purchase up to~~ ~~1,911,764~~ additional shares of Common Stock. On August 2, 2018, the underwriters exercised the option in full. The net proceeds from the offering, including the exercise of the option to purchase additional shares, were approximately $~~69,908,000~~, after deducting the underwriting discount and offering expenses payable by us. The offering closed on August 6, 2018. In connection with the Knight License Agreement, Knight entered into a subscription agreement with us, pursuant to which Knight purchased $~~20,000,000~~ ~~of shares of our Common Stock concurrently with the closing of the underwritten public offering of Common Stock on August 6, 2018.~~

As of ~~September~~June 30, ~~2019,~~2020, we had warrants outstanding to purchase an aggregate of ~~1,832,571~~1,782,571 shares of Common Stock with a weighted-average contractual remaining life of approximately ~~2.2~~1.5 years,, and exercise prices ranging from $0.24 to $8.20 per share, resulting in a weighted average exercise price of $~~2.62~~2.51 per share.

The valuation methodology used to determine the fair value 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, dividend ~~rate~~yield and the term of the warrant.

During the ~~nine~~six months ended ~~September~~June 30, 2020, no warrants were granted. During the six months ended June 30, 2019, we granted warrants to purchase an aggregate of 75,000shares of Common Stock to outside consultants at an exercise price of $5.63. The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of ~~5 years~~;five years; volatility of 60.8%; risk free rate of 2.52%; and dividend yield of 0%. The grant date fair value of the warrants was $3.00per share. The warrants ~~are vesting~~vested ratably over a 12 ~~month~~ -month period and have an expiration date of February 12, 2024.

During the ~~nine~~six months ended ~~September~~June 30, ~~2018, we granted~~2020, no warrants ~~to purchase~~ ~~175,000~~ ~~shares of Common Stock to outside consultants at an exercise price of $5.16. The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of~~ ~~5 years; volatility of~~ ~~62.1%; risk free rate of~~ ~~2.36%; and dividend yield of~~ 0~~%. The grant date fair value of the warrants was $2.79~~ ~~per share. The warrants vest ratably over a~~ ~~12 month~~ ~~period and have an expiration date of March 15, 2023.~~were exercised. During the ~~three~~six months ended ~~September 30, 2019 and 2018, we recorded $56,418~~ ~~and $150,977, respectively, and during the nine months ended September 30, 2019 and 2018, we recorded $198,306~~ ~~and $407,292~~, respectively, as share based compensation expense in the accompanying consolidated financial statements related to warrants. As of September 30, 2019, total unrecognized estimated compensation expense related to the unvested portion of these warrants was approximately $~~83,000, which is expected to be recognized over a weighted-average period of~~ ~~0.4 years~~.

~~During the nine months ended September~~June 30, 2019, warrants to purchase an aggregate of 1,250,000 shares of Common Stock were exercised pursuant to the warrants’ cashless exercise provisions, wherein an aggregate of 471,184 shares of Common Stock were issued. ~~During~~

We recorded share-based compensation expense related to warrants previously issued of $0 and $56,172 for the ~~nine~~three months ended ~~September~~June 30, ~~2018,~~ 2020 and 2019, respectively, and $027,446 ~~warrants were exercised.~~and $141,888 for the six months ended June 30, 2020 and 2019, respectively, in the accompanying consolidated financial statements. At June 30, 2020, there was no unrecognized compensation expense remaining related to unvested warrants.

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, and other stock or cash awards as described in the 2009 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. As of ~~September~~June 30, ~~2019,~~2020, there were non-qualified stock options to purchase an aggregate of ~~15,028,509~~14,024,041 shares of Common Stock outstanding under the 2009 Plan. Effective upon our adoption of the TherapeuticsMD, Inc. 2019 Stock Incentive Plan, or the 2019 Plan, on June 20, 2019, no future awards may be made under the 2009 Plan.

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. As of ~~September~~June 30, ~~2019,~~2020, there were non-qualified stock options to purchase an aggregate of ~~6,316,474~~6,308,599 shares of Common Stock outstanding and an aggregate of ~~1,040,000~~890,000 restricted stock ~~awards~~units under the 2012 Plan. Effective upon our adoption of the 2019 Plan, no future awards may be made under the 2012 Plan.

On June 20, 2019, we adopted the 2019 Plan 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 2019 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 2019 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.

As of ~~September~~June 30, ~~2019,~~2020, there were ~~13,779,632~~3,286,444 shares of Common Stock available for issuance ~~thereunder,~~under the 2019 Plan, consisting of (i) ~~11,294,999~~453,772 new shares, (ii) ~~2,395,333~~2,403,208 unallocated shares previously available for issuance under the 2012 Plan that were not then subject to outstanding “Awards” (as defined in the 2012 Plan), and (iii) ~~89,300~~429,464 unallocated shares previously available for issuance under the 2009 Plan that were not then subject to outstanding “Awards” (as defined in the 2009 Plan). Any shares subject to outstanding options or other equity “Awards” under the 2019 Plan, the 2012 Plan and the 2009 Plan that are forfeited, expire or otherwise terminate without issuance of the underlying shares, or if any such Award is settled for cash or otherwise does not result in the issuance of all or a portion of the shares subject to such Award (other than shares tendered or withheld in connection with the exercise of an Award or the satisfaction of withholding tax liabilities), the shares to which 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 ~~September~~June 30, ~~2019,~~2020, there were non-qualified stock options to purchase an aggregate of ~~3,505,001~~4,257,501 shares of Common Stock outstanding under the 2019 Plan and an aggregate of ~~200,000~~5,139,957 restricted stock ~~awards~~units and 2,422,885 performance stock units outstanding under the 2019 Plan.

The valuation methodology used to determine the fair 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, and the expected life of the stock options.

The ranges of assumptions used in the Black-Scholes Model ~~for options granted~~ during the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020 and ~~2018~~2019 are set forth in the table below.

A summary of option activity under the 2009, 2012 and 2019 Plans and related information during the six months ended June 30, 2020 is as follows:

At ~~September~~June 30, ~~2019,~~2020, our outstanding ~~stock~~ options had exercise prices ranging from $~~0.19~~0.20 to $8.92 per share. ~~The weighted average grant date fair value per share of options granted was $1.84~~ ~~and $3.27~~ ~~during the nine months ended September 30, 2019 and 2018, respectively.~~ Share-based compensation expense ~~for~~related to options recognized in our results of operations for the three months ended ~~September~~June 30, 2020 and 2019 ~~and 2018 ($~~was $~~2,194,667~~1,160,510 and $~~2,109,218~~2,230,829, ~~respectively)~~respectively, and for the ~~nine~~six months ended ~~September~~June 30, 2020 and 2019 ~~and 2018 ($~~was $~~6,568,736~~2,997,141 and $~~5,981,343~~4,374,069, ~~respectively)~~respectively, and it is based on ~~vested awards.~~awards vested. At ~~September~~June 30, ~~2019,~~2020, total unrecognized estimated compensation expense related to unvested options ~~granted prior to that date~~ was approximately $~~13,468,000~~7,703,000, which may be adjusted for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of ~~2.4 years~~2.2. years. No tax benefit was realized due to a continued pattern of operating losses.

~~Restricted~~ stock ~~awards~~units granted under our 2009, 2012 and 2019 Plans entitle the holder to receive, at the end of vesting period, a specified number of shares of our Common Stock. Share-based compensation expense is measured by the market value of our Common Stock on the day of the grant. The shares vest ratably over the period specified in the grant. There is no partial vesting and any unvested portion is forfeited.

~~On December 13, 2018, we granted~~ ~~1,040,000~~Performance stock units will vest if certain performance targets are achieved. If minimum performance thresholds are achieved, each award will convert into Common Stock at a defined ratio depending on the degree of achievement of the performance target designated by each individual award. If minimum performance thresholds are not achieved, then no shares will be issued. We recognize performance-based restricted stock ~~units to certain executive employees which will vest~~as compensation expense based on the most likely probability of attaining the prescribed performance and over the requisite service period beginning at ~~the end of the third year. The~~its grant date ~~fair value was $4.06~~ ~~per unit. On July 30, 2019, we granted~~ ~~200,000~~and through the date the restricted stock ~~units~~vests. The expected levels of achievement are reassessed over the requisite service periods and, to ~~certain executive employees which will vest~~the extent that the expected levels of achievement change, stock-based compensation is adjusted and recorded on ~~January 31, 2022. The grant date fair value was $~~the consolidated statements of income and the remaining unrecognized stock-based compensation is recognized over the remaining requisite service period.

During the three and ~~nine~~six months ended ~~September~~June 30, 2020 we recorded $1,842,316 and $2,345,693, respectively, and during the three and six months ended June 30, 2019 we recorded $~~384,061~~350,263 and $~~1,080,738~~696,676, respectively, in share-based compensation expense related to restricted stock units and performance stock units. As of June 30, 2020, we recognized performance-based compensation expense using our assessment of the most likely probability of attaining EBITDA break-even which would result in vesting two times the base number of performance stock units. At ~~September~~June 30, ~~2019,~~2020, total unrecognized estimated compensation expense related to unvested restricted stock units and performance stock unitswas approximately $~~3,505,000~~13,161,000, which may be adjusted if certain performance targets are achieved or for future changes in forfeitures. This cost is expected to be recognized over a weighted-average period of ~~2.2 years. At September 30, 2019, we had~~ ~~1,240,000~~1.9 ~~restricted~~years.

* The number of performance stock ~~awards outstanding.~~units (PSUs) represents the base number of PSUs that may vest. The actual number of PSUs that will vest will be between zero and two times the base number of PSUs depending on the Company’s achievement of break-even quarterly EBITDA.

On ~~July 1, 2018, we issued cash-settled SARs~~June 18, 2020, our stockholders approved the TherapeuticsMD, Inc. 2020 Employee Stock Purchase Plan (the “ESPP”), which reserved 5,400,000 shares of Common Stock for purchase. The ESPP permits eligible employee participants to ~~certain consultants and employees. The SARs plan year began on July 1, 2018 and ended on or immediately following June 30, 2019. SARs were granted with~~purchase Common Stock at a ~~grant~~ price per share which is equal to ~~the market value of a share of our Common Stock on the date of grant. Cash-settled SARs provided for the cash payment~~85% of the ~~excess~~lesser of (a) the fair market value of ~~our Common Stock~~the shares on ~~June 30, 2019 over~~ the ~~grant price. Cash-settled SARs have no effect on dilutive shares or shares outstanding as any appreciation of our Common Stock over the grant price is paid in cash and not in Common Stock.~~

~~Cash settled SARs were recorded in our consolidated balance sheets as a liability until the~~offering date of ~~exercise. The fair value of each SAR award was estimated using~~ the ~~Black-Scholes valuation model. In accordance with ASC Topic 718, “Stock Compensation,” the fair value of each SAR award was recalculated at the end of each reporting~~offering period ~~and the liability and expense adjusted based on the new fair value and the percent vested. At June 30, 2019,~~or (b) the fair market value of ~~our Common Stock was lower than~~ the ~~grant price of SARs and, as a result,~~shares on the ~~recorded liability was reversed and no cash payment was made.~~purchase date.

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. We do not expect to pay any significant federal or state income tax for ~~2019~~2020 as a result of (i) the losses recorded during the ~~nine~~six months ended ~~September~~June 30, ~~2019,~~2020, (ii) additional losses expected for the remainder of ~~2019,~~2020, and/or (iii) net operating loss carry forwards from prior years. Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is ~~"more~~“more likely than ~~not"~~not” that some component or all of the benefits of deferred tax assets will not be realized. As of ~~September~~June 30, ~~2019,~~2020, we maintain a full valuation allowance for all deferred tax assets. Based on these requirements, no provision or benefit for income taxes has been recorded. There were no recorded unrecognized tax benefits at the end of the reporting period.

In July 2015, J. Martin Carroll, a director of our company, was appointed to the board of directors of Catalent, Inc. 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, or a committee consisting of independent directors of our company, since July 2015. During the three months ended ~~September~~June 30, ~~2019~~2020 and ~~2018,~~2019, we were billed by Catalent approximately $~~2,196,000~~741,000 and $~~830,000~~974,000, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. During the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020 and ~~2018,~~2019, we were billed by Catalent approximately $~~4,118,000~~2,044,000 and $~~2,774,000~~2,371,000, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. As of ~~September~~June 30, ~~2019~~2020 and December 31, ~~2018,~~2019, there were amounts due to Catalent of approximately $~~425,000~~592,000 and $35,000, respectively. In addition, we have minimum purchase requirements in place with Catalent as disclosed in Note 15, Commitments and Contingencies.

In April 2020, Karen L. Ling, Executive Vice President and Chief Human Resources Officer of American International Group, Inc., or AIG, was appointed to our board of directors. 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, since April 2020. During the three and six months ended June 30, 2020, we were billed by AIG approximately $72,000 and $~~88,000~~143,000, ~~respectively.~~respectively, for various insurance coverage for our Company.

We purchase our prescription products from several suppliers with approximately 3618%, 2836%, and 2639% of our purchases supplied by 3three vendors each, respectively, during the ~~nine~~six months ended ~~September~~June 30, ~~2019. Approximately~~2020, and 14%, ~~100~~18%, 31% and 37% of our ~~products were manufactured~~purchases supplied by 1 ~~vendor related to~~four vendors each, ~~of IMVEXXY and prenatal vitamins~~respectively, during the ~~nine~~six months ended ~~September~~June 30, ~~2018.~~2019.

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. During the ~~nine~~six months ended ~~September~~June 30, ~~2019,~~2020, 4 customers each ~~generated more than~~ 10~~% of our total prescription revenues. During the nine months ended September 30, 2018,~~ 4 ~~customers each generated~~accounted for more than 10% of our total prescription revenues. Prescription revenue ~~generated~~ from the 4four customers combined accounted for approximately 6870% of our prescription revenue for the ~~nine~~six months ended ~~September~~June 30, 2020. During the six months ended June 30, 2019, ~~and~~3 customers each generated more than 10% of our prescription ~~revenue~~revenues. Revenue generated from the 4three customers combined accounted for approximately 7160% of our prescription revenue for the ~~nine~~six months ended ~~September~~June 30, ~~2018.~~2019.

During the ~~nine~~six months ended ~~September~~June 30, ~~2019, PI Services accounted for approximately $1,935,000~~ ~~of our prescription revenue,~~2020, Pillpack, Inc. accounted for approximately $~~6,397,000~~5,707,000 of our prescription revenue, Cardinal Health accounted for approximately $3,772,000 of our prescription revenue, McKesson Corporation accounted for approximately $3,356,000 of our prescription revenue, and Pharmacy Innovation PA accounted for approximately $3,178,000 of our prescription revenue. During the six months ended June 30, 2019, Pillpack, Inc. accounted for approximately $3,615,000 of our prescription revenue, AmerisourceBergen accounted for approximately $~~2,226,000~~1,365,000 of our prescription revenue and Cardinal Health accounted for approximately $~~1,863,000~~1,048,000 of our prescription revenue. ~~During the nine months ended September 30, 2018, PI Services accounted for approximately $1,559,000~~ ~~of our prescription revenue, Pillpack, Inc. accounted for approximately $3,057,000~~ ~~of our prescription revenue, AmerisourceBergen accounted for approximately $1,834,000~~ ~~of our prescription revenue and Cardinal Health accounted for approximately $1,399,000~~ ~~of our prescription revenue.~~

We adopted ASC 842 effective January 1, 2019. Substantially all our operating lease right-of-use assets and operating lease liabilities represent leases for office space used to conduct our business. Upon adoption, we ~~have~~ recognized a right-of-use asset and a lease liability for all leases that have commenced as of January 1, 2019. The right-of-use assets represent the right to use the leased asset for the lease term. The lease liabilities represent the present value of the lease payments under the lease. The right-of-use asset is initially measured at cost, which primarily comprises the initial amount of the lease liability, plus any initial direct costs incurred, less any lease incentives received. All right-of-use assets are reviewed for impairment. The lease liability is initially measured at the present value of the lease payments, discounted using our secured incremental borrowing rate for the same term as the underlying lease because the rates are not implicit in the leases. Some of our leases contain variable lease payments, including payments based on an index or rate. Variable lease payments based on an index or rate are initially measured using the index or rate in effect at lease commencement. Additional payments based on the change in an index or rate, or payments based on a change in our portion of the operating expenses are recorded as a period expense when incurred. Lease modifications result in remeasurement of the lease liability. Included in lease expense are any variable lease payments incurred in the period that were not included in the initial lease liability.

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~~-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 isbecame effective beginning November 1, 2016.

In October 2018, we entered into a lease for new corporate offices in Boca Raton, Florida. The lease includes 56,212 rentable square feet, or the full premises, of which the lease on 7,561 square feet commenced in 2018 and the lease on the remaining 48,651 square feet commenced in August 2019, or the full premises commencement date. The lease will expire 11 years ~~years~~ after the full premises commencement date, unless terminated earlier in accordance with the terms of the lease. We have the option to extend the term of the lease for 2 additional consecutive periods of 5five years ~~years.~~. The extension option is not included in the determination of the lease term as it is not reasonably certain to be exercised. The term of the lease includes escalating rent and free rent periods. We are also responsible for certain other operating costs under the lease, including electricity and utility expenses. In June 2019, we entered into an agreement with the same lessors to lease additional 6,536 square feet of administrative office space in the same location, pursuant to an addendum to such lease, which ~~is expected to commence as soon as the fourth quarter of 2019.~~commenced in May 2020.

The following table reconciles the undiscounted cash flows for all operating leases at ~~September~~June 30, ~~2019~~2020 to the operating lease liabilities recorded on the balance sheet:

During the three and ~~nine~~six months ended ~~September~~June 30, 2020, operating lease expense related to our real estate leases was approximately $595,000 and $1,158,000, respectively, and variable lease expense was insignificant for the same periods. During the three and six months ended June 30, 2019, operating lease expense related to our real estate leases was approximately $~~458,000~~295,000 and $~~1,062,000~~590,000, respectively, and variable lease expense was insignificant for the ~~three and nine months ended September 30, 2019. Rent expense totaled $257,000~~same periods. ~~and $772,000~~ ~~during the three and nine months ended September 30, 2018, respectively.~~

~~We have license agreements with third parties that provide~~The Population Council License Agreement provides for ~~minimum royalty, license, and exclusivity~~future milestone payments to be paid by us for access to certain technologies. In addition, we pay royalties as a percent of revenue as described in Note 7, Intangible Assets, to these consolidated financial statements.

We have a manufacturing and supply ~~agreement~~agreements whereby we are required to purchase from Catalent a minimum number of softgels during the first contract year and a higher number of softgels after the first contract year. If the minimum order quantities of specific products are not met, we are required to pay Catalent 50% of the difference between the total amount we would have paid to Catalent if the minimum requirement had been fulfilled and the sum of all purchases of our products from Catalent during the contract year. In addition, we have a manufacturing and supply agreement whereby we are required to purchase a minimum number of units of ANNOVERA during a contract year. As of June 30, 2020, we have met our contract year purchase commitments with Catalent.

From time to time, we are involved in litigation and proceedings in the ordinary course of business. We are not currently involved in any legal proceeding that we believe would have a material effect on our consolidated financial condition, results of operations, or cash flows.

As of June 30, 2020 and 2019, we had no off-balance sheet arrangements that have had or are reasonably likely to have current or future effects on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

We have entered into employment agreements with certain of our executives that provide for compensation and certain other benefits. Under certain circumstances, including a change in control, some of these agreements provide for severance or other payments, if those circumstances occur during the term of the employment agreement.

On ~~October 24, 2019,~~August 5, 2020, we entered into ~~an underwriting agreement~~Amendment No. 5 to the Financing Agreement (the “Amendment”) with ~~J.P. Morgan Securities LLC, as representative of~~ the ~~underwriters, relating~~Administrative Agent, various lenders from time to ~~an underwritten public offering of~~ ~~26,000,000~~ ~~shares~~time party thereto, and certain of our ~~Common Stock at~~subsidiaries party thereto from time to time as guarantors. The Amendment adjusts the covenant in the Financing Agreement regarding our achievement of minimum consolidated net revenue attributable to commercial sales of our IMVEXXY, BIJUVA and ANNOVERA products to reflect the impact of COVID-19 on our business. The covenant is effective beginning with the fiscal quarter ending December 31, 2020. In connection with the Amendment and in lieu of a ~~public offering price of $2.75~~ ~~per share. We granted~~cash amendment fee, we issued to the ~~underwriters an option, exercisable for a period of~~ 30 ~~days,~~Administrative Agent and the lenders under the Financing Agreement warrants to purchase ~~up to~~an aggregate of approximately ~~3,900,000~~4,750,000 ~~additional~~ shares of Common Stock ~~which was exercised in full.~~with an exercise price of $1.58 per share and a ten year term (the “Lender Warrants”). The ~~net proceeds~~Lender Warrants were issued pursuant to an exemption from registration under the ~~offering~~Securities Act of 1933, as amended, and no registration rights were ~~approximately $77.0 million, after deducting the underwriting discount~~issued. The Lender Warrants do not have anti-dilution protection, other than for customary stock splits and ~~offering expenses payable by us. The offering closed on October 29, 2019.~~similar transactions.

Item 2. ~~Management’s~~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 unaudited 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 Annual Report on Form 10-K for the year ended December 31, ~~2018~~2019 filed with the Securities and Exchange Commission, or the SEC, on February ~~27, 2019,~~24, 2020, or our Annual Report, including the audited financial statements and notes included therein. The reported results will not necessarily reflect future results of operations or financial condition.

In addition, this Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. 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” 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 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, 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 Report, and include the following: the effects of the COVID-19 pandemic; our ability to maintain or increase sales of our approved products; our ability to ~~develop~~successfully commercialize IMVEXXY®, BIJUVA®, and ~~commercialize IMVEXXY, BIJUVA, ANNOVERA and our hormone therapy drug candidates~~ANNOVERA® and obtain additional financing necessary therefor; 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; 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 comply with the covenants and conditions under our term loan facility, ~~including the conditions to draw additional tranches thereunder;~~ the length, cost and uncertain results of our clinical trials, the potential of adverse side effects or other safety risks that could adversely affect the commercialization of our current or future approved ~~products;~~products or preclude the approval of our future drug candidates; whether the U.S. Food and Drug Administration (FDA) will approve the efficacy supplement for the lower dose of BIJUVA; 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 ~~clinical trials,~~manufacturing, research and development and ~~manufacturing;~~clinical trials; the ability of our licensees to commercialize and distribute ~~IMVEXXY and BIJUVA;~~our products; the ability of our marketing contractors to market ANNOVERA; 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.~~regulation; the volatility of the trading price of our common stock; and the concentration of power in our stock ownership.

Throughout this Quarterly Report on Form 10-Q, 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 VitaCare Prescription Services, Inc., a Florida corporation, or VitaCare.

This Quarterly Report on Form 10-Q includes our trademarks, trade names and service marks, such as ~~vitaMedMD~~^®vitaMedMD®, ~~BocaGreenMD~~^®BocaGreenMD®, ~~IMVEXXY~~^®IMVEXXY®, ~~BIJUVA~~^®BIJUVA® and ~~ANNOVERA~~^™ANNOVERA® which are protected under applicable intellectual property laws and are the property of, or licensed to, our company. ~~This Quarterly Report on Form 10-Q also contains trademarks, trade names and service marks of other companies, which are the property of their respective owners.~~ Solely for convenience, trademarks, trade names and service marks referred to in this ~~quarterly report~~Quarterly Report on Form 10-Q may appear without the ®, ™ or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.

~~We are~~TherapeuticsMD is a women’s healthcare company ~~focused on~~with a mission of creating and commercializing innovative products to support the lifespan of women ~~and championing awareness of women’s healthcare issues, specifically, for~~from pregnancy prevention ~~pregnancy, childbirth, nursing, pre-menopause, and~~through menopause. At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women. Our solutions range from a patient-controlled, long-lasting contraceptive to advanced hormone therapy pharmaceutical ~~products to patient-controlled, long-acting contraceptive.~~products. We also ~~manufacture and distribute~~have a portfolio of branded and generic prescription prenatal vitamins under the vitaMedMD^® and BocaGreenMD^® ~~brands.~~ brands that furthers our women’s healthcare focus.

We have also entered into ~~an exclusive~~ license ~~agreement, or the Population Council License Agreement,~~agreements with the Population Council, Inc., or the Population Council, to commercialize ANNOVERA in the U.S. In addition, on July 30, 2018, we entered into a license and supply agreement with Knight Therapeutics Inc., or Knight, pursuant to which we granted Knight an exclusive licensestrategic partners to commercialize IMVEXXY and BIJUVA in Canada and Israel. On June 6, 2019, we entered into an exclusive license and supply agreement, or the License Agreement, with Theramex HQ UK Limited, or Theramex, to commercialize BIJUVA and IMVEXXY outside of the U.S.~~, excluding Canada and Israel, or the Territory.~~

Our common stock, par value $0.001 per share, or the Common Stock, is traded on the Nasdaq Global Select Market of The Nasdaq Stock Market LLC, or the Nasdaq, under the symbol “TXMD.” We maintain websites at www.therapeuticsmd.comas well as various product websites. The information contained on our websites or that can be accessed through our websites does not constitute part of this Quarterly Report on Form 10-Q.

Our business has been, and we anticipate that it will continue to be, impacted by the coronavirus (COVID-19) pandemic. During the second quarter of 2020, all of our products were affected by the COVID-19 pandemic, primarily due to our sales force having limited access to healthcare professionals and our patients deferring visits to healthcare professionals. In particular, we paused the full commercial launch of ANNOVERA in March 2020 as we deferred sales and marketing initiatives. As live interactions resumed toward the latter portion of the second quarter of 2020 when healthcare professional offices opened, we resumed the full launch of ANNOVERA on July 1, 2020.

At this time, the extent of the impact of the COVID-19 pandemic on our business is highly uncertain and difficult to predict. We developed a comprehensive COVID-19 contingency plan designed to preserve the value of our investments in our sales and marketing infrastructure, protect our balance sheet during this period of market disruption, and meet the needs of our patients and prescribers. This contingency plan was designed to be implemented in stages as we continue to evaluate the length of time that COVID-19 may impact our business, which is intended to allow us to conserve our financial resources during the COVID-19 pandemic and re-scale our sales and marketing activity when conditions warrant.

Our COVID-19 contingency plan is designed to support our strategy of driving revenues by prioritizing ANNOVERA as the lead product, IMVEXXY in the second position and BIJUVA in the third position. As part of this plan, we reduced our marketing focus on BIJUVA so that we can prioritize driving our revenue growth for ANNOVERA and IMVEXXY. Our COVID-19 contingency plan includes containing costs and cutting spending, preparing for a potential longer-term impact throughout the year, leveraging vitaCare to continue to meet the needs of our patients and prescribers, and ensuring continued availability of our products to patients.

The COVID-19 pandemic accelerated our focus on reducing our operating expenses. During the second quarter of 2020, we deferred consumer and healthcare practitioner, or HCP, marketing spend for ANNOVERA and IMVEXXY and initiated other measures to reduce our operating expenses. As live interactions resumed toward the latter portion of the second quarter of 2020 when healthcare professional offices opened, we resumed the full commercial launch of ANNOVERA on July 1, 2020 and currently intend to launch the initial consumer marketing campaign for IMVEXXY in August 2020.

We plan to further reduce quarterly operating expenses for the third and fourth quarters of 2020. These cost cuts and reductions included permanent cost savings that had been identified by management, as well as the interim cessation of certain spending that may be restarted in future quarters. These cost cuts included:

We anticipate that these savings can be extended further throughout 2020 or expanded depending on the impact of the COVID-19 pandemic.

Our sales force continues to function utilizing digital engagement tools and tactics and virtual detailing to remain engaged with prescribers and distribution channels and supplement live interactions, which began to pick up as the second quarter progressed and physician offices opened.

As of the date of this Quarterly Report on Form 10-Q, we are providing continued access to our products for patients.

As of the date of this Quarterly Report on Form 10-Q, we do not anticipate a shortage of our products due to the COVID-19 pandemic.

While we currently believe that our COVID-19 contingency plan has the ability to mitigate the effect 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 “stay at home,” quarantine or “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 are uncertain and cannot be predicted. Our future results of operations and liquidity could be materially adversely affected by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions, uncertain demand, and the impact of any initiatives or programs that we may undertake to address financial and operations challenges that we may face.

Our business may also be affected by negative impacts of the COVID-19 pandemic on capital markets and economies worldwide, and it is possible that the pandemic could cause a local and/or global economic recession. While policymakers globally have responded with fiscal policy actions to support the healthcare industry and economy as a whole, the magnitude and overall effectiveness of these actions remains uncertain.

In May ~~30,~~ 2018, ~~we announced that~~ the FDA ~~had~~ approved the 4-μg and 10-μg doses of IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of VVA, due to menopause. The 4-μg formulation of IMVEXXY represents the lowest FDA-approved dose of vaginal estradiol available.

~~On July 9, 2018, we launched~~ IMVEXXY 10-μg became available for commercial distribution in July 2018 and both doses were commercially available in September 2018.

IMVEXXY is a small, digitally inserted, softgel vaginal insert that dissolves completely. 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 ~~our~~no patient education required for dose application or applicators. IMVEXXY demonstrated efficacy as early ~~experience program to a targeted sample~~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 ~~healthcare providers, or HCPs, throughout the U.S. The national launch~~systemic absorption rates for vaginal estrogen therapies is not known).

As part of the ~~10-μg dose of IMVEXXY began in August 2018, and the 4-μg dose of IMVEXXY launched on September 13, 2018. Since FDA~~FDA’s approval of ~~our NDA for~~ IMVEXXY, we have ~~been focused on executing our launch plan.~~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. The ~~key objectives~~FDA has also asked the sponsors of our launch plan include: (i) providing broad commercial access at the retail level and with commercial payers, (ii) increasing awareness and appreciation of the clinical and patient features of IMVEXXY amongst HCPs, (iii) designing and deploying our customer facing model, and (iv) developing our internal capabilities (for example,other vaginal estrogen products to participate in the ~~areas~~observational study. In connection with the observational study, we will be required to provide progress reports to the FDA on an annual basis. The development of ~~finance, human resources, medical affairs,~~this method is underway, and we do not believe that the costs will be material on an annual basis. In addition, the FDA asked for post-approval information ~~technology, data analytics, pharmacovigilance capacity and compliance)~~with respect to ~~support our commercial-stage company. We have made progress in each of these key strategic areas:~~certain characteristics related to the product’s specifications, which we submitted to the FDA.

On October ~~28,~~ 2018, the FDA approved BIJUVA (estradiol and progesterone) capsules, 1 mg/100 mg, the first and only FDA-approved bioidentical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate-to-severe ~~vasomotor symptoms, or~~ VMS (commonly known as hot flashes or flushes), due to menopause in women with a uterus. The estrogen and progesterone in BIJUVA have the same ~~chemical and~~ molecular structure as the hormones that are naturally produced in a woman’s body. ~~Following meetings~~We launched BIJUVA in April 2019.

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 contain no peanut allergens. BIJUVA provides a sustained steady state of estradiol which reduced the frequency and severity of hot flashes in clinical studies with ~~the FDA, we plan to submit~~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.

We submitted a New Drug Application, ~~(NDA)~~or NDA, efficacy supplement for the 0.5/100 mg dose of BIJUVA to the FDA in ~~the fourth quarter of 2019~~late January 2020 for review and potential ~~approval using~~approval. The NDA efficacy supplement uses existing data from our Phase 3 REPLENISH trial for BIJUVA, for which we announced results in December 2016, together with additional information and analyses. The REPLENISH trial was the first time that a combination of bio-identical estradiol and bio-identical progesterone used in a continuous combined daily fashion demonstrated safety and efficacy data to support FDA-approval, when the 1/100 mg dose of BJIUVA was approved. We do not anticipate that the FDA will require any new clinical trials in connection with our submission of the NDA efficacy ~~supplement. If~~supplement, however, there is no assurance that will be the case. The NDA efficacy supplement has been accepted for review by the FDA ~~we expect that the NDA efficacy supplement will be reviewed, under current~~and has a Prescription Drug User Fee Act ~~timeline goals, within ten months of receipt by~~target action date for the ~~FDA.~~

We launched BIJUVA on April 17, 2019 with a similar model to IMVEXXY. The key objectives of our launch plan include: (i) broad commercial access at the retail level and with commercial payers, (ii) increasing awareness and appreciationcompletion of the ~~clinical~~FDA’s review of November 16, 2020. Despite the FDA’s acceptance of the NDA efficacy supplement and ~~patient features~~previous approval of the 1/100 mg dose of BJIUVA, there can be no assurance that the 0.5/100 mg dose of BIJUVA amongst HCPs, (iii) expanding and leveraging our existing customer facing model, and (iv) leverage our internal capabilities (for example, in the areas of finance, human resources, information technology, data analytics and compliance) to support the launch of BIJUVA.will be approved.

Our initial focus has been on key OB/GYN targets, particularly those that already adopted IMVEXXY, to deliver the core clinical messages as well as provide information on our patient affordability and adherence programs. In support of BIJUVA, our field force expanded to approximately 200 territories in April 2019. In addition, we will continue to deploy our BIO-IGNITE program with a fuller expansion towards the end of 2019 into 2020 when we have achieved coverage for the majority of commercial insurance plans that is beyond the six month payer block.

We launched our patient affordability and adherence program for BIJUVA, similar to IMVEXXY, to help patients manage out-of-pocket costs and improve patient education with the goal of increasing patient adherence and compliance for an improved treatment experience. As of September 30, 2019, approximately 88% of our total BIJUVA fills have utilized the patient savings programs. Prior to October 1, 2019, enrolled patients did not pay more than $35 for a prescription of BIJUVA. Starting October 1, 2019, enrolled patients pay as little as $35 for a prescription of BIJUVA with commercial insurance coverage and pay as little as $50 for a prescription of BIJUVA without commercial insurance coverage. As of September 30, 2019, we have approximately 9,100 patients who have received at least one paid BIJUVA prescription filled at a pharmacy.

We believe that the successful launch of IMVEXXY allows us to leverage existing contracts with our third-party logistics partner and our distribution partners. We anticipate similar timing regarding commercial payer coverage as we experienced with IMVEXXY as many commercial payers employ “new-to-market blocks” for newly launched brands while they make their decision on coverage. However, our ability to leverage existing payer contracts by amending to include BIJUVA, along with our recent experience with the payers may simplify and accelerate the process. Through September 30, 2019, we achieved unrestricted coverage with five of the top ten commercial payers of VMS products by commercial payer lives and we continue to sign new agreements with payers to cover BIJUVA. Although Medicare is a small percentage of the VMS market, as of September 30, 2019, two of the top six Medicare Part D payers of VMS products was adjudicating BIJUVA.

With the approval of BIJUVA, the FDA required a post-approval commitment to further develop and validate our in-vitro dissolution method to show how BIJUVA is released from the capsule in an in-vitro setting for quality control assessments. The development of this method and validation were completed and submitted to the FDA as required in our approval.

Our hormone therapy pharmaceutical products are characterized by safety and efficacy profiles that can be consistently manufactured to target specifications. This provides an alternative to the non-FDA approved compounded bio-identical market. We believe that our FDA-approved pharmaceutical products offer advantages in terms of demonstrated safety and efficacy, consistency in the hormone dose, lower patient cost due to the increased likelihood of insurance coverage and improved access as a result of availability from major retail pharmacy chains rather than custom order or formulation by individual compounders.

In July ~~30,~~ 2018, we entered into an exclusive license agreement with the Population Council to commercialize in the U.S. ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system), the first and only patient-controlled, procedure-free, reversible prescription contraceptive that can prevent pregnancy for up to a ~~full year,~~total of 13 cycles (one year), which was approved by the FDA in August 2018. In October 2019, we began a “test and learn” market introduction phase of launch for ANNOVERA. We paused the planned full commercial launch of ANNOVERA in March 2020 due to the impact of the COVID-19 pandemic and resumed this initiative on ~~August 10, 2018.~~July 1, 2020.

ANNOVERA was classified by the FDA as a “new chemical entity,” or NCE, and thus has five years of regulatory exclusivity under the Drug Price Competition and Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman Act. ANNOVERA is a one-year ring-shaped contraceptive vaginal system, or CVS. ANNOVERA, which is made with a silicone elastomer, contains segesterone acetate, a 19-nor progesterone derivative also known as ~~Nestorone~~^®Nestorone®, or ~~NES,~~SA, and ethinyl estradiol, or EE. EE is an approved active ingredient in many marketed hormonal contraceptive products. Segesterone acetate, ~~a new chemical entity,~~an NCE, is a potent ~~progestin. Segestrone acetate also~~progestin that, based on pharmacological studies in animals and in vitro, does not bind to the androgen or estrogen receptors and has no glucocorticoid ~~effects~~activity at contraceptive doses. ~~NES~~SA has been evaluated in 51 clinical studies across these delivery systems with more than 26,794 cycles of exposure.

ANNOVERA can be inserted and removed by the woman herself without the aid of a healthcare provider and, unlike oral contraceptives, ~~or OCs,~~ 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 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 ~~(NES~~(SA and EE). The claimed release rate of 150 μg/day ~~NES~~SA and 13/day μg EE is supported by the 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.

We launched ANNOVERA in the third quarter of 2019 with limited sales and a full-scale launch expected in the first quarter of 2020. In October 2019, we began a “test and learn” market introduction phase of launch for ANNOVERA, with 36 of our existing sales representatives currently promoting ANNOVERA in addition to our other products, and our 23 regional sales managers and 12 compounding KAMs introducing ANNOVERA to top targeted healthcare practitioners outside of these 36 territories.

We believe that the strong initial commercial net revenue per unit of ANNOVERA and rapid 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 a generic equivalent has not been established. As part of this strategy, we are pursuing distribution opportunities for ANNOVERA with multiple direct-to-consumer contraceptive platforms that are both low cost to TXMD and offer an attractive return to the platforms.

We continue to dialogue with the FDA regarding the potential inclusion of ANNOVERA as a new class of contraception for women in the FDA’s Birth Control Guide, which would require private health plans to cover ANNOVERA with no patient out-of-pocket costs as part of the Affordable Care Act. Eight states require insurance coverage of prescription contraception with co-pay regardless of inclusion in the FDA’s Birth Control Guide and 11 states, plus Washington D.C., require coverage of prescription contraception with no co-pay regardless of inclusion in the FDA’s Birth Control Guide. We believe that a recent reorganization of the FDA’s Division of Bone Reproductive and Urologic Products (DBRUP) may delay a decision regarding the inclusion of ANNOVERA as a new class of contraception for women in the FDA’s Birth Control Guide beyond the fourth quarter of this year, which could affect our ability to borrow an additional tranche of $50 million under our financing agreement, or the Financing Agreement, with TPG Specialty Lending, Inc., as administrative agent, or the Administrative Agent. Given the strong initial commercial net revenue per unit of ANNOVERA and rapid commercial insurance adoption during our “test and learn” market introduction phase of launch, as well as the potential for the FDA’s decision regarding the inclusion of ANNOVERA as a new class of contraception to come after the fourth quarter of this year, we have begun discussions with the Administrative Agent about revising the draw trigger for this $50 million tranche in order to take into account the positive ANNOVERA launch trends that we are experiencing. The Administrative Agent has informed us that it is open to considering a revision to the terms and timing of this draw trigger, although there is no assurance that we and the Administrative Agent will agree on any such revisions.

As part of the approval of ANNOVERA, the FDA has required a post-approval observational study be performed to measure the risk of venous thromboembolism. ~~A draft~~In accordance with the post-marketing requirements, the full protocol ~~submission~~ for the study was submitted to the FDA in August 2019. We have agreed to perform and pay the costs and expenses associated with this post-approval study, provided that if the costs and expenses associated with such post-approval study exceed $20 million, half of such excess will offset against royalties or other payments owed by us to the Population Council under the Population Council License Agreement. Given the observational nature of the study, we do not believe that the costs of the study will be material on an annual basis.

We believe that ANNOVERA will compete across all the contraception options for women with 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 complete control of their fertility and 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 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 the daily usage or potential side effects.

We believe that the 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 direct-to-consumer contraceptive platforms that extend the reach of our products. However, as a result of the COVID-19 pandemic, we have deferred a significant portion of our planned 2020 marketing spend for ANNOVERA.

We are commercializing the products in our portfolio through a common model focused on the belief that providing good experiences for both HCPs and patients will drive profitability for TherapeuticsMD. Given that our portfolio focus is exclusively in women’s health, we believe that each new product launch will allow us to further leverage our existing infrastructure and build out our reputation as the premier women’s health organization in the U.S. Below is more detail on our commercialization model:

HCP Education - Initially, we focus on the high writing and high potential HCPs in each territory to gain a full understanding of their prescribing behavior and practices. Our focus is on driving initial prescriptions of these writers for each new product launch and utilizing the time to also pull through on our portfolio of existing products. Once regular writing is established with the initial group of HCPs, we expand our reach to a larger set of HCPs writing in the category. We educate HCPs on our products primarily with our field sales organization supplemented by non-personal promotion. Our sales force currently targets approximately 130 territories, which includes the most significant part of the addressable markets across our product portfolio. As of ~~September~~June 30, 2020, at least 18,500 HCPs had written at least one prescription of IMVEXXY and at least 5,800 HCPs had written at least one prescription of BIJUVA, the majority of which are also IMVEXXY writers demonstrating the value of portfolio and focus. In addition, as of June 30, 2020, approximately 2,000 HCPs had written at least one prescription of ANNOVERA. In addition to our sales organization, we leverage non-personal promotion (multi-channel advertising) to targets and non-targets that drive awareness, education, and action. These efforts allow for pull through of the sales organization efforts and identification of new targets that have interest in writing prescriptions for one or more of our products. We believe this will drive increased prescribing for our products and lift the overall writing universe and our products top of mind in the HCP community.

BIO-IGNITE - In addition to our sales organization calling on HCPs, we have a Key Account Management, or KAM, team to support our existing BIO-IGNITE pharmacy partners and additional pharmacies that wish to enroll in the BIO-IGNITE program. Additionally, KAM’s are focusing on supporting current prescribers of BIJUVA as well as high decile prescribers of hormone therapy for menopause.

Payer Access - With the ever-changing payer environment, it is critical to maximize breadth of coverage as quickly as possible to not inhibit patient access to product. We do this while working to negotiate the best possible contracts for us. Many commercial payers employ “new-to-market blocks” for newly launched products until the payers have the opportunity to make a coverage decision based upon their internal review of the product. When a product is not covered, the patient is responsible to pay the full price for the medication, which can significantly limit utilization of the product. As we seek to increase the number of lives covered by commercial payers, it is our objective to continue to seek unrestricted coverage. As of June 30, 2020, we have obtained coverage for the majority of commercial payers for IMVEXXY and BIJUVA and continue to seek unrestricted coverage from the remaining commercial insurance plans that we have not yet contracted with to provide affordable access for patients. For IMVEXXY, we achieved unrestricted coverage with the top ten commercial payers of VVA products by commercial payer lives and we continue to sign new agreements with other payers to cover IMVEXXY. In addition, as of June 30, 2020, four of the top eight Medicare Part D payers of VVA products were adjudicating IMVEXXY, with additional decisions for other Medicare Part D payers expected during the second half of 2020. For BIJUVA, through June 30, 2020, we have achieved unrestricted coverage with eight of the top ten commercial payers of VMS products by commercial payer lives and we continue to sign new agreements with payers to cover BIJUVA. Although Medicare is a small percentage of the VMS market, as of June 30, 2020, two of the top six Medicare Part D payers of VMS products were adjudicating BIJUVA.

For ANNOVERA, we believe that its unique characteristics will assist us in pursuing favorable commercial payer coverage, including only one pharmacy fill fee per year and no office visit or procedure fees. We have made substantial progress in achieving unrestricted access to ANNOVERA through commercial payers, including having achieved adjudication with five of the top ten commercial payers by commercial payer lives as of June 30, 2020, and we continue to pursue discussions with several of the country’s largest commercial insurers to further expand coverage. As of June 30, 2020, approximately 66% of the commercial payer market covered ANNOVERA with unrestricted access under pharmacy benefits and approximately 78% covered ANNOVERA with step or prior authorization access.

In February 2020, we entered into an agreement with Afaxys Pharma, LLC, a pharmaceutical company focused on serving women in the public health system, to market ANNOVERA in the U.S. public health sector. As part of the Population Council License Agreement, we have agreed to provide significantly reduced pricing to federally designated Title X family planning clinics serving underrepresented women. We also have agreements to market ANNOVERA to the U.S. Department of Defense, the U.S. Department of Veteran’s Affairs, and in Puerto Rico.

Supply - We want to ensure our products are available in all classes of trade and delivery systems. We offer our products through traditional chain wholesalers (Cardinal, McKesson and AmerisourceBergen) and independent retail pharmacies, community compounding pharmacies with our BIO-IGNITE program, and online pharmacies. We continue to develop unique opportunities to sell direct to pharmacies to streamline distribution and better control costs.

Patient Affordability Programs - We have affordability and adherence programs in place for patients so that we can support appropriate use of our products by patients. Our co-pay assistance programs allow all patients to access our products at a reasonable cost.

We continue to support our patient education and affordability program that allows all eligible patients who enroll to receive IMVEXXY and BIJUVA at a reasonable cost. When a product is not covered by a patient’s commercial insurance, the patient is responsible to pay the full price for the medication, which can significantly limit a patient’s ability to pay and subsequent utilization of the product. For IMVEXXY and BIJUVA, enrolled patients pay as little as $35 for a prescription with commercial insurance coverage and pay as little as $50 for a prescription without commercial insurance coverage. For ANNOVERA, for commercially insured patients, we offer patients assistance for as low as $60 for an annual prescription. Many patients will not need a co-pay assistance program for ANNOVERA given the requirements of the ACA at the federal level and similar laws at the state level.

Patient Adherence - Establishing compliance and adherence programs that make getting on a prescription medication and obtaining prescribed refills easy and convenient for the patient and HCPs is a critical lever in our commercial model. Our focus is on minimizing complications in patients filling their first prescription and engaging with them throughout the life of their treatment to ensure patients stay on and use therapy for the appropriate length of time. We have delivered effective patient engagement programs for all of our products.

Consumer Communication - Another critical level in the commercial model is consumer outreach. Our initial focus is on those patients who are already predisposed to seek treatment, such as those patients new to therapy, and those patients dissatisfied with their current therapy. Next, we are focused on expanding the market by energizing patients who are experiencing bothersome symptoms but who have not been motived to seek treatment. Methods of communication include online and offline media and span branded and unbranded communication to ensure we drive action from awareness of symptoms to desire to speak to an HCP to acquire a prescription.

Under the terms of the Population Council License Agreement, we paid the Population Council a milestone payment of $20 million within 30 days following approval by the FDA of the NDA for ANNOVERA. The first commercial batch of ANNOVERA was released during the third quarter of 2019, and we paid the Population Council a second milestone payment of $20 million as a result of the commercial batch release. The Population Council is eligible to receive additional milestone payments and royalties from commercial sales of ANNOVERA, as detailed below. We assumed responsibility for marketing expenses related to the commercialization of ANNOVERA. We are required to pay the Population Council additional milestone payments of $40 million upon cumulative net sales of ANNOVERA in the U.S. by us and our affiliates and permitted sublicensees of each of $200 million, $400 million and $1.0 billion.

In addition, we are required to pay the Population Council, on a quarterly basis, step-based royalty payments based on annual net sales of ANNOVERA in the U.S. by us and our affiliates and permitted sublicensees as follows:

The annual royalty rate will be reduced to 50% of the initial rate during the six-month period beginning on the date of the first arms-length commercial sale of a generic equivalent of ANNOVERA that is launched by a third party in the U.S., and thereafter will be reduced to 20% of the initial rate.

The Population Council has agreed to perform and pay the costs and expenses associated with two post-approval studies required by the FDA for ANNOVERA and we have agreed to perform and pay the costs and expenses associated with a post-approval study required by the FDA to measure risk for venous thromboembolism, provided that if the costs and expenses associated with such post-approval study exceed $20 million, half of such excess will be offset against royalties or other payments owed by us to the Population Council under the Population Council License Agreement. We and the Population Council formed a joint product committee responsible for overseeing activities under the Population Council License Agreement. We are responsible for all aspects of promotion, product positioning, pricing, education programs, publications, sales messages and any additional desired clinical studies for the one-year vaginal contraceptive system, subject to oversight and decisions made by the joint product committee.

Unless earlier terminated, the Population Council License Agreement will remain in effect until the later of the expiration of the last-to-expire of the Population Council’s U.S. patents that are licensed to us, or the date following such expiration that follows a continuous period of six months during which we and our affiliates have not made a commercial sale of ANNOVERA in the U.S. The Population Council License Agreement may also be terminated for certain breach and bankruptcy-related events and by us on 180 days’ prior notice to the Population Council.

As part of the Population Council License Agreement, we have the exclusive right to negotiate co-development and U.S. marketing rights for two other investigational vaginal contraceptive systems in development by the Population Council.

In July 2018, we entered into a license and supply agreement, or the Knight License Agreement, with Knight pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel. Pursuant to the terms of the Knight License Agreement, Knight will pay us a milestone fee upon the first regulatory approval in Canada of each of IMVEXXY and BIJUVA, sales milestone fees based upon certain aggregate annual sales in Canada and Israel of each of IMVEXXY and BIJUVA and royalties based on aggregate annual sales of each of IMVEXXY and BIJUVA in Canada and Israel. In October 2019 and November 2019, Knight’s New Drug Submissions for IMVEXXY and BIJUVA, respectively, were accepted for review by Health Canada. Knight will be responsible for all regulatory and commercial activities in Canada and Israel related to IMVEXXY and BIJUVA. We may terminate the Knight License Agreement if Knight does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize IMVEXXY and BIJUVA in Canada within certain specified time periods. We also may terminate the Knight License Agreement if Knight challenges our patents. Either party may terminate the Knight License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters. As part of the Knight License Agreement, Knight is prohibited from exporting IMVEXXY and BIJUVA to the United States.

In June 2019, we entered into a licensing and supply agreement, or the Theramex License Agreement, with Theramex pursuant to which we granted Theramex an exclusive, perpetual license to commercialize BIJUVA and IMVEXXY for human use outside of the U.S., except for Canada and Israel, or the Theramex Territory. Pursuant to the terms of the Theramex License Agreement, Theramex paid us an upfront fee of EUR 14 million in cash. We are also eligible to receive up to an additional EUR 29.5 million in cash milestone payments, comprised of (i) an aggregate of EUR 2 million in regulatory milestone payments based on regulatory approvals for each of BIJUVA and IMVEXXY in certain specified markets and (ii) an aggregate of EUR 27.5 million in sales milestone payments to be paid in escalating tranches based on Theramex first attaining certain aggregate annual net sales milestones in the Theramex Territory ranging from EUR 25 million to EUR 100 million. We are also entitled to receive quarterly royalty payments based on net sales of BIJUVA and IMVEXXY in the Theramex Territory. Theramex has agreed to submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize BIJUVA and IMVEXXY in certain specified markets within certain specified time periods and we may terminate the Theramex License Agreement if Theramex does not submit certain of such regulatory applications, submissions and/or registrations. We may also terminate the Theramex License Agreement if Theramex challenges our patents. Either party may terminate the Theramex License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters. Theramex may sublicense its rights to commercialize BIJUVA and IMVEXXY in the Theramex Territory, except for certain specified markets. Pursuant to the terms of the Theramex License Agreement, we agreed to supply, or cause to be supplied, BIJUVA and IMVEXXY to Theramex. We and Theramex have agreed to form a joint product committee responsible for advising and overseeing activities under the Theramex License Agreement.

As of June 30, 2020, we had 2835 issued foreign patents and 2635 issued domestic or, U.S., patents, which included 1214 domestic utility patents that relate to BIJUVA, three domestic patents that relate to estradiol and progesterone product candidates, ~~five~~ten domestic patents that relate to IMVEXXY, which establish an important intellectual property foundation for IMVEXXY, one domestic utility patent that relates to a pipeline transdermal patch technology, one domestic utility patent that relates to our topical-cream candidates, ~~one~~two domestic ~~utility patent~~patents that ~~relates~~relate to ~~a product candidate~~formulations containing ~~d-limonene,~~progesterone, one domestic utility patent that relates to our OPERA® information technology platform that we wrote off in the second quarter of 2019, and ~~two~~three domestic utility patents that relate to TX-009HR, our progesterone and estradiol drug candidate.

A significant portion of our historical operating expenses ~~to date~~ have been incurred in research and development activities. Research and development expenses relate primarily to the ~~discovery~~development, support and ~~development~~maintenance of our drug candidates. ~~Our business model is dependent upon our company continuing to conduct research and development.~~ Our research and development expenses consist primarily of expenses incurred under agreements with contract research organizations, or CROs, and consultants that conduct our clinical and preclinical studies; ~~employee-related~~employee related expenses, which include salaries and benefits, and non-cash share-based compensation; the cost of developing our chemistry, manufacturing, and controls capabilities, and costs associated with other research activities and regulatory approvals. Other research and development costs listed below consist of costs incurred with respect to drug candidates that have not received Investigational New Drug ~~application~~Application approval from the FDA.

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

Research and development expenditures have been reduced as we refocused our resources towards the commercialization of our approved pharmaceutical products. We will continue to ~~be incurred~~deploy limited resources as we develop our drug pipeline, continue stability testing and validation on our ~~drugs,~~pharmaceutical products, develop and validate secondary manufacturers, prepare regulatory submissions and work with regulatory authorities on existing submissions.

The costs of clinical trials may vary significantly over the life of a project owing to a variety of factors. 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 expenditures for the drug candidates will continue after the trial completes for on-going stability and laboratory testing, regulatory submission and response work. For a discussion of the nature of efforts, steps and costs necessary to complete these projects, see “Item 1. Business — Research and Development” and “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations — Research and Development Expenses” contained in our Annual Report.

Three months ended ~~September~~June 30, ~~2019~~2020 compared with three months ended ~~September~~June 30, ~~2018~~2019

~~Product revenue~~Revenue is recorded net of sales discounts, chargebacks, wholesaler fees, customer rebates, coupons and estimated returns. ~~Product revenue~~We launched IMVEXXY in the third quarter of 2018 and BIJUVA in the second quarter of 2019. We started selling ANNOVERA in the third quarter of 2019. We paused the planned full commercial launch of ANNOVERA in March 2020 due to the impact of the COVID-19 pandemic, and resumed this initiative on July 1, 2020. Revenue for the three months ended ~~September~~June 30, ~~2019~~2020 increased approximately ~~$4,739,000,~~$4,622,000, or ~~136%~~76%, to approximately ~~$8,213,000,~~$10,701,000, compared with approximately ~~$3,474,000~~$6,079,000 for the three months ended ~~September~~June 30, ~~2018. Product revenue~~2019. Revenue increased primarily due to ~~an increase in~~continued ramping of sales of ~~approximately $4,560,000 of~~ IMVEXXY ~~in the current period, partially offset by a decrease in prenatal vitamin~~and BIJUVA and pre-launch sales of ~~approximately $711,000. Product revenue for~~ANNOVERA during the three months ended ~~September~~June 30, 2019 also included sales of BIJUVA of approximately $490,000 and sales of ANNOVERA of approximately $400,000. The revenue decrease related to our prenatal vitamins was primarily affected by lower number of units sold2020, as compared to the prior year period, partially offset by impacts from the COVID-19 pandemic. Our revenue in the prior year period only consisted of sales of IMVEXXY, BIJUVA and our prenatal vitamins.

Sales of IMVEXXY increased approximately $1,963,000 as compared to the prior period, primarily due to a higher number of units sold and increased net revenue per unit and sales of BIJUVA increased approximately $1,218,000 as compared to the prior period, primarily due to a higher number of units sold and increased net revenue per unit. ~~We launched IMVEXXY in~~Revenue for the ~~third quarter~~three months ended June 30, 2020 also included sales of ~~2018, BIJUVA in~~ANNOVERA of approximately $1,835,000. In addition, during the ~~second quarter~~three months ended June 30, 2020, our prenatal vitamin sales decreased approximately $394,000 due to decreased number of ~~2019 and ANNOVERA in~~units sold, partially offset by increased net revenue per unit as compared to the ~~third quarter of 2019. Since~~prior year period.

During the launches ~~revenues related to~~of IMVEXXY and BIJUVA ~~have been greatly affected by the~~we introduced co-pay assistance programs ~~that we introduced to launch these products,~~ which ~~allows~~allow eligible enrolled patients to access the products at a reasonable cost regardless of insurance coverage. We expect that our product ~~revenues to~~revenue will improve in the long term as commercial and Medicare payer coverage increases, and plans complete the process needed to adjudicate IMVEXXY, BIJUVA, and ANNOVERA prescriptions at pharmacies. In addition to our product revenue, during the three months ended September 30, 2019, we recognized license revenue of approximately $15,506,000 from the upfront fee, which was a non-refundable payment, payable to us by Theramex under the terms of the License Agreement, which we recognized at the point in time when Theramex was able to use and benefit from the license, which was when the knowledge transfer of regulatory documents occurred.

Cost of goods sold increased approximately ~~$745,000,~~$3,151,000, or ~~107%~~252%, to approximately ~~$1,444,000~~$4,400,000 for the three months ended ~~September~~June 30, ~~2019,~~2020, as compared with approximately ~~$699,000~~$1,249,000 for the three months ended ~~September~~June 30, ~~2018.~~2019. This increase in cost of goods sold is attributable to the 76% increase in revenue as compared to the prior period, royalty fees of approximately $92,000 and amortization of our license fee of approximately $754,000 related to ANNOVERA, as well as approximately $1,944,000 of inventory obsolescence expense primarily related to BIJUVA recorded during the three months ended June 30, 2020. Our gross margin related to prescription products was approximately ~~82%~~59% and ~~80%~~79% for the three-month periods ended ~~September~~June 30, ~~2019~~2020 and ~~2018,~~2019, respectively. The change in our gross margin between the two periods is primarily related to the change in product mix ~~between the two periods.~~

~~Operating Expenses~~and its related costs as well as inventory obsolescence expense described above.

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

~~Operating expenses~~Our operating costs have increased ~~by approximately $12,211,000, or 33%,~~as we continue to ~~approximately $49,347,000 for~~support the launch of our new pharmaceutical products in the market. We started selling ANNOVERA in the third quarter of 2019. We paused the planned full commercial launch of ANNOVERA in March 2020 due to the impact of the COVID-19 pandemic, and resumed this initiative on July 1, 2020. During the three months ended ~~September~~June 30, 2019, ~~from approximately $37,136,000 for~~we were primarily focused on growing sales of IMVEXXY and our prenatal vitamins, as well as BIJUVA, which was launched in the ~~three months ended September 30, 2018~~second quarter of 2019. Our principal operating costs include the following items as a ~~result~~percentage of ~~the following items:~~total operating expenses:

Sales and marketing costs, excluding human resources costs, for the three months ended ~~September~~June 30, ~~2019~~2020 increased by approximately ~~$5,970,000,~~$2,361,000, or ~~36%~~11%, to approximately ~~$22,547,000,~~$23,339,000, compared with approximately ~~$16,577,000~~$20,978,000 for the three months ended ~~September~~June 30, ~~2018, primarily as a result of increased expenses associated with~~2019. The sales and marketing ~~efforts~~costs, excluding human resources costs, increased due to ~~support launch~~higher advertising expense, which was partially offset by cost cutting initiatives put in place at the beginning of the COVID-19 pandemic, including reducing consulting and ~~commercialization~~agency fees. Sales and marketing costs, excluding human resources costs, during the three months ended June 30, 2020 also reflect the write down of ~~our prescription products, including costs~~product samples of approximately $3,900,000, primarily related to ~~outsourced sales personnel and their related expenses,~~BIJUVA, partially offset by lower physician education ~~advertising~~ and ~~travel~~training expenses ~~related~~caused by restrictions on in-person speaker programs due to ~~product commercialization. We expect sales and marketing expenses to continue to increase as we continue~~ the ~~launch of BIJUVA and ANNOVERA and continue to support our growing business and commercialization of our products.~~COVID-19 pandemic.

Human resources costs, including salaries, benefits and taxes, for the three months ended ~~September~~June 30, ~~2019~~2020 increased by approximately ~~$4,596,000,~~$3,569,000, or ~~52%~~28%, to approximately ~~$13,507,000,~~$16,115,000, compared with approximately ~~$8,911,000~~$12,546,000 for the three months ended ~~September~~June 30, ~~2018,~~2019, primarily as a result of an increase of approximately ~~$4,259,000~~$2,901,000 in personnel costs in sales, marketing and regulatory areas to support the commercialization of our prescription products and an increase of approximately ~~$337,000~~$668,000 in non-cash compensation expense included in this category related to employee stock-based compensation during ~~2019~~2020 as compared to ~~2018.~~2019.

Product research and development costs for the three months ended ~~September~~June 30, ~~2019~~2020 decreased by approximately ~~$2,630,000,~~$2,222,000, or ~~39%~~45%, to approximately ~~$4,078,000,~~$2,742,000, compared with approximately ~~$6,708,000~~$4,964,000 for the three months ended ~~September~~June 30, ~~2018.~~2019. Research and development costs include costs related to manufacturing validation and early development trials, as well as salaries, wages, non-cash compensation, and benefits of personnel involved in research and development activities. Research and development ~~costs decreased primarily~~expenditures have been reduced as ~~a result~~we refocused our resources towards the commercialization of ~~certain employees~~our approved pharmaceutical products. We continue to deploy limited resources as we develop our drug pipeline, continue stability testing and ~~activities that were previously classified as research~~validation on our pharmaceutical products, develop and ~~development being transferred to operations as they began to support commercial~~validate secondary manufacturers, prepare regulatory submissions and ~~launch efforts after the FDA approvals of IMVEXXY and BIJUVA.~~work with regulatory authorities on existing submissions.

For a discussion of the nature of efforts, steps and costs related to our research and development projects, see “Item 1. Business — Research and Development” and “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations — Research and Development Expenses” contained in our Annual Report.

Professional fees and consulting costs for the three months ended ~~September~~June 30, ~~2019 increased~~2020 decreased by approximately ~~$2,450,000,~~$400,000, or ~~148%~~12%, to approximately ~~$4,100,000,~~$2,991,000, compared with approximately ~~$1,650,000~~$3,391,000 for the three months ended ~~September~~June 30, ~~2018,~~2019, primarily as a result of ~~increased~~decreased recruiting and consulting fees.

All other operating ~~expense~~expenses for the three months ended ~~September~~June 30, ~~2019~~2020 increased by approximately ~~$1,825,000,~~$1,564,000, or ~~55%~~34%, to approximately ~~$5,115,000,~~$6,152,000, compared with approximately ~~$3,290,000~~$4,588,000 for the three months ended ~~September~~June 30, ~~2018,~~2019, primarily as a result of increased information technology, ~~travel,~~ dues and subscriptions, ~~allowance for bad debt expense,~~rent, and insurance, ~~and~~partially offset by lower other office and travel expenses ~~primarily~~due to ~~support commercialization of our new drugs.~~travel restrictions caused by the COVID-19 pandemic.

As a result of the foregoing, our operating loss ~~decreased~~increased approximately ~~$7,289,000,~~$3,401,000, or ~~21%~~8%, to approximately ~~$27,072,000~~$45,038,000 for the three months ended ~~September~~June 30, ~~2019,~~2020, compared with approximately ~~$34,361,000~~$41,637,000 for the three months ended ~~September~~June 30, ~~2018,~~2019, primarily as a result of ~~increased total net revenue, partially offset by~~ an increase in total operating ~~expenses.~~expenses to support commercialization and launch efforts related to our pharmaceutical products, as well as write off of product samples and inventory due to the COVID-19 pandemic, partially offset by increased total net revenue.

We anticipate that we will continue to have operating losses for the near future until we successfully commercialize IMVEXXY, BIJUVA, and ANNOVERA, although there is no assurance that any commercialization of IMVEXXY, BIJUVA and ANNOVERA will be successful.

Other ~~non-operating expense,~~non-operating expenses, net ~~increased~~decreased by approximately ~~$3,651,000,~~$6,662,000, or ~~293%~~49%, to an expense of approximately ~~$4,895,000~~$6,938,000 for the three months ended ~~September~~June 30, ~~2019,~~2020, compared with an expense of approximately ~~$1,244,000~~$13,600,000 for the three months ended ~~September~~June 30, ~~2018,~~2019, primarily as a result of the loss on extinguishment of debt ~~and~~of approximately $10,058,000 incurred during the three months ended June 30, 2019, partially offset by increased interest expense related to our Financing Agreement. For more information regarding our Financing Agreement, see “Liquidity and Capital Resources” below.

Because of the net effects of the foregoing, net loss decreased approximately ~~$3,638,000,~~$3,261,000, or ~~10%~~6%, to approximately ~~$31,967,000~~$51,976,000 for the three months ended ~~September~~June 30, ~~2019,~~2020, compared with approximately ~~$35,605,000~~$55,237,000 for the three months ended ~~September~~June 30, ~~2018.~~2019. Net loss per share of Common Stock, basic and diluted, was ($~~0.13)~~0.19) and ($~~0.16)~~0.23) for the three months ended ~~September~~June 30, 2020 and 2019, ~~and 2018,~~ respectively.

~~Nine~~Six months ended ~~September~~June 30, ~~2019~~2020 compared with ~~nine~~six months ended ~~September~~June 30, ~~2018~~2019

~~Product revenue~~Revenue is recorded net of sales discounts, chargebacks, wholesaler fees, customer rebates, coupons and estimated returns. Product revenue for the nine months ended September 30, 2019 increased approximately $7,229,000, or 66%, to approximately $18,239,000, compared with approximately $11,010,000 for the nine months ended September 30, 2018. Product revenue increased primarily due to an increase in sales of approximately $9,693,000 of IMVEXXY in the current period partially offset by a decrease in prenatal vitamin sales of approximately $3,489,000. Product revenue during the nine months ended September 30, 2019 also included sales of BIJUVA of approximately $625,000 and sales of ANNOVERA of approximately $400,000. The revenue decrease related to our prenatal vitamins was primarily affected by lower number of units sold as compared to the prior year period. We launched IMVEXXY in the third quarter of 2018 and BIJUVA in the second quarter of ~~2019 and~~2019. We started selling ANNOVERA in the third quarter of 2019. ~~Since~~We paused the ~~launches, revenues related~~planned full commercial launch of ANNOVERA in March 2020 due to the impact of the COVID-19 pandemic, and resumed this initiative on July 1, 2020.

Revenue for the six months ended June 30, 2020 increased approximately $12,926,000, or 129%, to approximately $22,952,000, compared with approximately $10,026,000 for the six months ended June 30, 2019. Revenue increased primarily due to continued ramping of sales of IMVEXXY and BIJUVA ~~have been greatly affected~~and pre-launch sales of ANNOVERA, partially offset by impacts from the COVID-19 pandemic. Our revenue in the prior year period only consisted of sales of IMVEXXY, BIJUVA and our prenatal vitamins.

Sales of IMVEXXY increased approximately $6,346,000 as compared to the prior period, which was primarily due to a higher number of units sold and increased net revenue per unit, and sales of BIJUVA increased approximately $2,329,000 as compared to the prior period, which was primarily due to a higher number of units sold and increased net revenue per unit. Revenue for the six months ended June 30, 2020 also included sales of ANNOVERA of approximately $4,108,000. In addition, during the six months ended June 30, 2020, our prenatal vitamin sales increased approximately $143,000 due to increased net revenue per unit as compared to the prior year period, partially offset by a decreased number of units sold.

During the launches of IMVEXXY and BIJUVA, we introduced co-pay assistance programs ~~that we introduced to launch these products,~~ which ~~allows~~allow eligible enrolled patients to access the products at a reasonable cost regardless of insurance coverage. We expect that our product ~~revenues to~~revenue will improve in the long term as commercial and Medicare payer coverage increases, and plans complete the process needed to adjudicate IMVEXXY, BIJUVA, and ANNOVERA prescriptions at pharmacies. In addition to our product revenue, during the nine months ended September 30, 2019, we recognized license revenue of approximately $15,506,000 from the upfront fee, which was a non-refundable payment, payable to us by Theramex under the terms of the License Agreement, which we recognized at the point in time when Theramex was able to use and benefit from the license, which was when the knowledge transfer of regulatory documents occurred.

Cost of goods sold increased approximately ~~$1,669,000,~~$5,104,000, or ~~93%~~254%, to approximately ~~$3,456,000~~$7,116,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2019,~~2020, compared with approximately ~~$1,787,000~~$2,012,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019. This increase is attributable to a 129% increase in revenue as compared to the prior period, royalty fees of approximately $205,000, and amortization of our license fee related to ANNOVERA of approximately $1,500,000, as well as $2,080,000 inventory obsolescence expense, primarily ~~due~~related to ~~an increased number of units sold.~~BIJUVA, recorded during the six months ended June 30, 2020. Our gross margin ~~for our~~related to prescription products was approximately ~~81%~~69% and ~~84%~~80% for the ~~nine months~~six-month periods ended ~~September~~June 30, ~~2019~~2020 and ~~2018,~~2019, respectively. The change in our gross margin between the two periods is primarily related to the change in product mix ~~between the two periods.~~

~~Operating Expenses~~and its related costs, as well as inventory obsolescence expense described above.

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

Our operating costs have increased ~~by approximately $35,779,000, or 35%,~~as we continue to ~~approximately $137,102,000 for~~support the ~~nine~~launch of our new pharmaceutical products in the market. We commercially launched ANNOVERA in early March 2020, which was subsequently paused due to the outbreak of the COVID-19 pandemic. During the six months ended ~~September~~June 30, 2019, ~~from approximately $101,323,000 for~~we were primarily focused on growing sales of IMVEXXY and our prenatal vitamins, as well as BIJUVA, which was launched in the ~~nine months ended September 30, 2018~~second quarter of 2019. Our principal operating costs include the following items as a ~~result~~percentage of ~~the following items:~~total operating expenses:

Sales and marketing costs, excluding human resources costs, for the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020 increased by approximately ~~$16,842,000,~~$16,878,000, or ~~39%~~44%, to approximately ~~$60,537,000,~~$54,869,000, compared with approximately ~~$43,695,000~~$37,991,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019. This increase was primarily ~~as a result of increased~~due to higher expenses associated with sales and marketing efforts to support the significant initiatives related to the launch ~~and~~of ANNOVERA in March 2020, which was subsequently paused as a result of the COVID-19 pandemic, as well as continuing to support the commercialization of ~~our prescription products,~~BIJUVA and IMVEXXY, which was partially offset by cost cutting initiatives put in place at the beginning of the COVID-19 pandemic, including reducing consulting and agency fees. Sales and marketing costs, excluding human resources costs, during the six months ended June 30, 2020, also reflect the write down of product samples of approximately $5,100,000, primarily related to ~~outsourced sales personnel and their related expenses,~~BIJUVA, which was partially offset by lower physician education and ~~product samples, advertising and travel~~training expenses ~~related~~caused by restrictions on in-person speaker programs due to ~~product commercialization. We expect sales and marketing expenses to continue to increase as we continue~~ the ~~launch of BIJUVA and ANNOVERA, and continue to support our growing business and commercialization of our products.~~COVID-19 pandemic.

Human resources costs, including salaries, benefits and taxes, for the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020 increased by approximately ~~$13,866,000,~~$8,690,000, or ~~60%~~37%, to approximately ~~$37,162,000,~~$32,345,000, compared with approximately ~~$23,296,000~~$23,655,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, primarily as a result of an increase of approximately ~~$12,278,000~~$7,977,000 in personnel costs in sales, marketing and regulatory areas to support commercialization of our prescription products and an increase of approximately ~~$1,588,000~~$713,000 in non-cash compensation expense included in this category related to employee stock-based compensation during ~~2019~~2020 as compared to ~~2018.~~2019.

~~Research~~Product research and development costs for the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020 decreased by approximately ~~$5,186,000,~~$5,271,000, or ~~25%~~47%, to approximately ~~$15,360,000,~~$6,011,000, compared with approximately ~~$20,546,000~~$11,282,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2018.~~2019. Research and development costs ~~included~~include costs related to ~~on-going stability~~manufacturing validation and ~~laboratory testing,~~ early development trials, as well as salaries, wages, non-cash compensation, and benefits of personnel involved in research and development activities. Research and development ~~costs decreased for~~expenditures have been reduced as we refocused our resources towards the ~~nine months ended September 30, 2019~~commercialization of our approved pharmaceutical products. We continue to deploy limited resources as ~~compared to the prior period primarily as a result of lower costs related to scale-up~~we develop our drug pipeline, continue stability testing and ~~manufacturing activities as well as decreased pre-clinical~~validation on our pharmaceutical products, develop and validate secondary manufacturers, prepare regulatory submissions and work with regulatory authorities on existing submissions.

Professional fees and consulting costs for the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020 increased by approximately ~~$4,614,000,~~$297,000, or ~~85%~~5%, to approximately ~~$10,025,000,~~$6,222,000, compared with approximately ~~$5,411,000~~$5,925,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, primarily as a result of increased ~~recruiting~~legal, accounting and ~~consulting~~other professional fees, partially offset by ~~lower legal~~reduced recruiting and consulting fees.

All other operating expense for the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020 increased by approximately ~~$5,643,000,~~$3,447,000, or ~~67%~~39%, to approximately ~~$14,018,000,~~$12,350,000, compared with approximately ~~$8,375,000~~$8,903,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, primarily as a result of increased information technology, ~~travel, allowance for bad debt expense,~~dues and subscriptions, rent, and insurance, ~~and~~partially offset by lower other office and travel expenses ~~primarily~~due to ~~support commercialization of our new drugs.~~travel restrictions caused by the COVID-19 pandemic.

As a result of the foregoing, our operating loss increased approximately ~~$14,713,000,~~$16,219,000, or ~~16%~~20%, to approximately ~~$106,813,000~~$95,961,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2019,~~2020, compared with approximately ~~$92,100,000~~$79,742,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, primarily as a result of ~~increased personnel costs, sales and marketing~~an increase in total operating expenses to support commercialization ~~of our prescription products, including costs~~and launch efforts related to ~~outsourced sales personnel~~our pharmaceutical products, as well as write off of product samples and ~~their related expenses, professional fees and other operating expenses,~~inventory due to the COVID-19 pandemic, as described above, partially offset by ~~a decrease in research and development costs and an increase in~~increased total net revenue.

Other non-operating expense, ~~increased~~net decreased by approximately ~~$18,770,000~~$2,136,000, or 14%, to an expense of approximately ~~$19,896,000~~$12,865,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020, compared with an expense of approximately ~~$1,126,000~~$15,001,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2018,~~ 2019, primarily as a result of the loss on extinguishment of debt ~~and~~of $10,058,000 incurred during the six months ended June 30, 2019, partially offset by increased interest expense related to our Financing Agreement. For more information regarding our Financing Agreement, see “Liquidity and Capital Resources” below.

Because of the net effects of the foregoing, net loss increased approximately ~~$33,483,000,~~$14,083,000, or ~~36%~~15%, to approximately ~~$126,709,000~~$108,826,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2019,~~2020, compared with approximately ~~$93,226,000~~$94,743,000 for the ~~nine~~six months ended ~~September~~June 30, ~~2018.~~2019. Net loss per share of Common Stock, basic and diluted, was ($~~0.53)~~0.40) and ($~~0.42)~~0.39) for the ~~nine~~six months ended ~~September~~June 30, 2020 and 2019, ~~and 2018,~~ respectively.

We have funded our operations primarily through public offerings of our Common Stock and private placements of equity and debt securities. For the ~~three years~~three-year period ended December 31, ~~2018,~~2019, we received approximately ~~$293,344,000~~$236,000,000 in net proceeds from the issuance of shares of our Common Stock. As of ~~September~~June 30, ~~2019,~~2020, we had cash and cash equivalents totaling approximately ~~$155,330,000, however,~~$113,839,000. However, changing circumstances may cause us 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.

Our net days sales outstanding, or net DSO, is calculated by dividing gross accounts receivable less the reserve for doubtful accounts, chargebacks and payment discounts by the average daily net product revenues during the quarter. We also disclose gross DSO, which includes the calculation of gross accounts receivable divided by the average daily gross product revenues to distributors during the quarter. For the three months ended ~~September~~June 30, ~~2019,~~2020, our gross DSO was 4655 days compared to 7755 days for the three months ended December 31, ~~2018~~2019 and our net DSO was ~~172~~156 days for the three months ended ~~September~~June 30, ~~2019~~2020 compared to ~~200~~141 days for the three months ended December 31, ~~2018. Our DSO decreased primarily due to more favorable arrangements with customers that we entered into in the second quarter of~~ 2019. We anticipate that our DSO will fluctuate in the future based upon a variety of factors, including longer payment terms associated with the ~~launch~~launches of IMVEXXY, BIJUVA, and ANNOVERA and changes in the healthcare industry. 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 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.

On October 29, 2019, we closed our underwritten public offering of 29,900,000 shares of our common stock at a price to the public of $2.75 per share, inclusive of the underwriters’ option to purchase additional shares of common stock, which option was exercised in full. We received net proceeds from the offering of approximately $77.0 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

Although there is uncertainty related to the ~~fourth quarter of 2019 and satisfaction (or waiver) of other customary conditions precedent. A portion~~anticipated impact of the ~~initial tranche~~COVID-19 pandemic on our future results, we believe that our current cash reserves and the recent steps we have taken to reduce our operating expenses will help us manage our business through the pandemic. We have reviewed numerous potential scenarios in connection with the impact of ~~borrowing under the Facility in the amount of approximately $81,661,000 was used to repay all amounts outstanding under~~COVID-19 on our ~~prior financing agreement with MidCap Financial Trust, or the MidCap Agreement. As a result of the termination of the MidCap Agreement,~~business and, based on our analysis, we ~~recorded $10,057,632 in loss on extinguishment of debt in our unaudited consolidated financial statements. We~~ believe that our existing cash reserves, our currently anticipated operating cash flows, and ~~availability under~~proceeds from potential future financings, if available to us, will be sufficient to meet our cash needs arising in the ~~Facility will allow us to fund our operating plan through at least~~ordinary course of business for the next 12twelve months from the date of this Quarterly ~~Report.~~Report on Form 10-Q. However, if the successful commercialization of IMVEXXY, BIJUVA, or ANNOVERA is delayed, or the impact of the COVID-19 pandemic on our business is worse than we anticipate, our existing cash reserves and ~~availability under the Facility,~~proceeds from potential future financings, if ~~we are able~~available to ~~access such funds,~~us, may be insufficient to satisfy our liquidity requirements until we are able to successfully commercialize IMVEXXY, BIJUVA, and ~~ANNOVERA and we may not be able to access funds under the Facility.~~ANNOVERA. If our available cash is insufficient to satisfy our liquidity requirements, we may curtail our sales, marketing, and other commercialization ~~and pre-commercialization~~ efforts and we may seek to sell additional equity or debt securities. Our ability to sell equity securities will be limited by market conditions. Our ability to sell debt securities or obtain additional debt financing is restricted pursuant to the Financing Agreement. To the extent that we raise additional capital through the sale of equity or convertible debt securities, to the extent permitted under the Financing Agreement, 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.~~stockholders. If we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, certain of which are restricted under the Financing Agreement, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or proposed products, if permitted under the Financing Agreement. Additionally, we may have to grant licenses on terms that may not be favorable to us.

On June 6, 2019, we entered into an exclusive license and supply agreement, or the License Agreement, with Theramex, a leading, global specialty pharmaceutical company dedicated to women’s health, to commercialize BIJUVA and IMVEXXY outside of the U.S., excluding Canada and Israel, or the Territory. Under the terms of the License Agreement, Theramex paid us EUR 14 million in cash as an upfront fee on August 5, 2019. Within thirty days of signing the License Agreement, we provided Theramex the regulatory materials and clinical data that were necessary for Theramex to obtain marketing authorizations and other applicable regulatory approvals for commercializing BIJUVA and IMVEXXY. We recognized the revenue related to the upfront fee, which was a non-refundable payment, during the third quarter of 2019, at a point in time when Theramex was able to use and benefit from the license which was when the knowledge transfer of regulatory documents occurred. We are eligible to receive additional milestone payments comprised of (i) up to an aggregate of EUR 2 million in regulatory milestone payments based on regulatory approvals for BIJUVA and IMVEXXY in certain specified markets and (ii) up to an aggregate of EUR 27.5 million in sales milestone payments to be paid in escalating tranches based on Theramex first attaining certain aggregate annual net sales milestones of BIJUVA and IMVEXXY in the Territory ranging from EUR 25 million to EUR 100 million. We are also entitled to receive quarterly royalty payments on net sales of BIJUVA and IMVEXXY in the Territory. Theramex will be responsible for all regulatory and commercial activities for BIJUVA and IMVEXXY in the Territory. Theramex may sublicense its rights to commercialize BIJUVA and IMVEXXY in the Territory, except for certain specified markets. We may terminate the License Agreement if Theramex does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize BIJUVA and IMVEXXY within certain specified time periods. We also may terminate the License Agreement if Theramex challenges our patents. Either party may terminate the License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters.

We need substantial amounts of cash to complete the launch and commercialization of our hormone therapy and contraceptive drugs. 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~~six months ended ~~September~~June 30, ~~2019~~2020 was to fund our current expenses primarily related to supporting commercialization activities for IMVEXXY, BIJUVA, and ANNOVERA, sales, marketing, scale-up and manufacturing activities and clinical development, adjusted for non-cash items. The increase of approximately ~~$36,233,000~~$6,422,000 in cash used in operating activities for the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020 compared with the ~~comparable period in the~~ prior year period was primarily due ~~primarily~~ to an increase in our net loss and changes in the components of working capital ~~partially offset by an increase~~as well as decrease in non-cash items.

Investing activities include costs related to patents and fixed assets. Investing activities for the ~~nine~~six months ended ~~September~~June 30, ~~2019~~2020 decreased by approximately $1,070,000 primarily due to ~~a $20,000,000 payment for an intellectual property license fee that occurred~~lower costs related to the purchase of fixed assets during the ~~nine~~six months ended ~~September~~June 30, ~~2018, partially offset by higher spending related to patent, trademark and fixed asset costs during~~2020 compared with the ~~nine months ended September 30, 2019.~~prior year period.

Financing activities currently represent the principal source of our cash flow. Our financing activities for the ~~nine~~six months ended ~~September~~June 30, 2020 provided net cash of approximately $48,916,000 which consisted of the funding from our Financing Agreement of $50,000,000 and the exercise of options to purchase Common Stock of approximately $166,000, partially offset by the payment of deferred financing fees of $1,250,000. Our financing activities for the six months ended June 30, 2019 provided net cash of approximately ~~$111,796,000~~$111,787,000, which consisted of the net funding from our Facility of approximately $193,348,000 and the exercise of options and warrants to purchase Common Stock of approximately ~~$109,000,~~$100,000, partially offset by the repayment of ~~our Credit~~the MidCap Agreement of approximately $81,661,000. Our financing activities for the nine months ended September 30, 2018 provided net cash of approximately $162,357,000, which consisted of the net funding from our Credit Agreement of approximately $71,213,000 and the exercise of options to purchase Common Stock of approximately $1,236,000 and approximately $89,908,000 in proceeds from the sale of our Common Stock.

In ~~February~~June 2016, the FASB issued ASU ~~2016-02, Leases. This guidance requires lessees~~No. 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The amendments in this update require a financial asset (or a group of financial assets) measured at amortized cost basis to ~~record most leases~~be presented at the net amount expected to be collected based on ~~their balance sheets while recognizing expenses on their income statements~~historical experience, current conditions, and reasonable supportable forecasts. The amendments 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 isthis update are effective for public business entities for ~~annual periods beginning after December 15, 2018,~~fiscal years, and interim periods within those ~~years. In July 2018,~~fiscal years, beginning after December 15, 2019, with early adoption permitted no sooner than the ~~FASB amended~~first quarter of 2019. A modified retrospective approach is required for all investments, except debt securities for which an other-than-temporary impairment had been recognized prior to the ~~new leases standard~~effective date, which will require a prospective transition approach and ~~issued~~should be applied either prospectively or retrospectively depending on the nature of the disclosure. The adoption of ASU ~~2018-11, Leases, (Topic 842): Targeted Improvements to give entities another option for transition~~2016-13 requires expanded quantitative and ~~to provide lessors with a practical expedient. We~~qualitative disclosures about the Company’s expected credit losses. Effective January 1, 2020, we adopted ASU ~~2016-02 on January 1, 2019 utilizing~~2016-13 under a modified retrospective approach for all financial assets measured at amortized cost. There was no adjustment recorded for the ~~alternative transition method allowed for under~~cumulative effect of adopting ASU ~~2018-11 and we recorded a $3.8 million right of use asset and a $4.1 million liability related to~~2016-13. The adoption of this standard. In addition, upon commencement of additional lease space in the third quarter of 2019, we recorded an additional $7.4 million right of use asset and an additional $7.2 million liability related toexpanded disclosures about our new lease space. Comparative financial information was not adjusted and will continue to be reported under ASC 840. We also elected the transition relief package of practical expedients and as a result we did not assess (1) whether existing or expired contracts contain leases, (2) lease classification for any existing or expired leases, and (3) whether lease origination costs qualified as initial direct costs. We elected the short-term lease practical expedient by establishing an accounting policy to exclude leases with a term of 12 months or less. We elected not to separate lease components from non-lease components for our specified asset classes. Additionally, the adoption of the new standard resulted in increased disclosure requirements in our quarterly and annual filings.credit losses.

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.

~~As of April 24, 2019, we repaid all amounts outstanding under the MidCap Agreement and became subject to market risk in connection with borrowings under the Financing Agreement.~~ Amounts borrowed under the Financing Agreement ~~will~~ accrue 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%. Considering the total outstanding principal balance under the Financing Agreement of ~~approximately $200,000,000~~$250,000,000 at ~~September~~June 30, ~~2019,~~2020, a 1.0% change in interest rates would result in an impact to ~~income~~loss before income taxes of ~~approximately $2,000,000~~$2,500,000 per year.

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, 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. 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 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~~June 30, ~~2019,~~2020, 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.

In August 2019, without admitting or denying the findings, we consented to an order issued by the Securities and Exchange Commission charging us with violations of Regulation FD in connection with communications during 2017 regarding TX-004HR and agreed to pay a $200,000 penalty.

From time to time, we are involved in litigation and proceedings in the ordinary course of our business.

On February 20, 2020, we received a Paragraph IV certification notice letter, or the IMVEXXY Notice Letter, regarding an Abbreviated New Drug Application, or ANDA, submitted to the FDA by Teva Pharmaceuticals USA, Inc., or Teva. The ANDA seeks approval from the FDA to commercially manufacture, use, or sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY. In the IMVEXXY Notice Letter, Teva alleges that TherapeuticsMD patents listed in the FDA’s Orange Book that claim compositions and methods of IMVEXXY, or 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. On April 1, 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 ~~currently involved~~infringed. A trial date has not been set.

On March 17, 2020, we received a Paragraph IV certification notice letter, or the BIJUVA Notice Letter, regarding an ANDA submitted to the FDA by Amneal Pharmaceuticals, or Amneal. The ANDA seeks approval from the FDA to commercially manufacture, use, or sell a generic version of BIJUVA. In the BIJUVA Notice Letter, Amneal alleges that TherapeuticsMD patents listed in the FDA’s Orange Book that claim compositions and methods of BIJUVA, or 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. On April 29, 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 the FDA. We are seeking, among other relief, an order that the effective date of any ~~legal proceeding~~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 ~~we believe would have a material effect on our business or financial condition.~~ the BIJUVA Patents are invalid and not infringed. A trial date has not been set.

~~There~~Except as set forth below, there have been no material changes with respect to ~~the~~those risk factors previously disclosed in Item 1A “Risk Factors” in Part I of our Annual Report.

Our financial condition and results of operations for fiscal year 2020 and beyond may be materially adversely affected by the ongoing COVID-19 (coronavirus) pandemic.

The outbreak of the novel COVID-19 (coronavirus) has evolved into a global pandemic. COVID-19 has spread to many regions of the world, including virtually all of the United States. Our business has been, and we anticipate that it will continue to be, impacted by the COVID-19 pandemic. During the second quarter of 2020, all of our products were affected by the COVID-19 pandemic, primarily due to our sales force having limited access to healthcare professionals and our patients deferring visits to healthcare professionals. While we have developed a comprehensive COVID-19 contingency plan designed to preserve the value of our investments in our sales and marketing infrastructure, protect our balance sheet during this period of market disruption and meet the needs of our patients and prescribers, the severity of the impact of the COVID-19 pandemic on our business and operating results will depend on future developments that are highly uncertain and cannot be accurately predicted.

Stay at home, quarantine and social distancing orders and closures and restrictions on travel have negatively affected the ability of our sales force to access healthcare providers to promote our products and the ability of patients to visit their healthcare professionals for non-emergent matters. Our sales force is currently functioning using a hybrid model of office visits where possible and digital engagement tools and tactics and virtual detailing, which may be less effective than our ordinary course sales and marketing programs. Increases in unemployment could reduce access to commercial health insurance for our patients, thus limiting payer coverage for our products, which could lead to increased use of our co-pay assistance programs and negatively affect our results of operations.

Our future results of operations and liquidity could be materially adversely affected by, and we may require an increased level of working capital as a result of, extended billing and collection cycles as a result of displaced employees at our company, payers, revenue cycle management contractors, or otherwise; delays in payments of outstanding receivable amounts beyond normal payment terms; supply chain disruptions; uncertain demand; and the impact of any initiatives or programs that we may undertake to address financial and operations challenges that we may face.

Additionally, although we currently continue to have uninterrupted wholesale and retail distribution of our products and we do not anticipate a shortage of our products due to COVID-19 at this time, disruptions may occur for our customers or suppliers that may materially affect our ability to obtain supplies or other components for our products, manufacture additional products or deliver inventory in a timely manner. This would result in lost sales, additional costs, or penalties, or damage to our reputation.

We may also experience other unknown impacts from COVID-19 that cannot be predicted. Accordingly, disruptions to our business as a result of COVID-19 could result in a material adverse effect on our business, results of operations, financial condition and prospects in the near-term and beyond 2020.

On August 5, 2020, we and our subsidiaries entered into Amendment No. 5 to the Financing Agreement, or Amendment No. 5, with the Administrative Agent and the lenders party thereto, pursuant to which we modified the minimum consolidated net revenue requirements attributable to commercial sales of our IMVEXXY, BIJUVA, and ANNOVERA products, which requirements are effective beginning with the fiscal quarter ending December 31, 2020. The foregoing summary of Amendment No. 5 does not purport to be complete and is subject to, and qualified in its entirety by, the full text of Amendment No. 5, a copy of which is filed as Exhibit 10.4 to this Quarterly Report on Form 10-Q and is incorporated herein by reference.

In lieu of a cash amendment fee, to induce the lenders to enter into Amendment No. 5, on August 5, 2020, we issued warrants, or the Warrants, to the lenders under the Financing Agreement to purchase an aggregate of approximately 4,750,000 shares of Common Stock, pursuant to a subscription agreement among the parties, or the Subscription Agreement. The Warrants have an exercise price of $1.58 per share of Common Stock and an expiration date of August 5, 2030. The Warrants may also be exercised via cashless exercise pursuant to the terms thereof. Each lender represented to us, among other things, that it was an “accredited investor” (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended, or the Securities Act), and we issued the Warrants, and would issue the shares of Common Stock issuable upon exercise thereof, in reliance upon an exemption from registration contained in Section 4(a)(2) under the Securities Act and Regulation D promulgated thereunder. The Warrants and shares of Common Stock issuable upon exercise thereof may not be offered, sold, pledged, or otherwise transferred in the United States absent registration or an applicable exemption from the registration requirements under the Securities Act. No registration rights were issued pursuant to the Warrants or Subscription Agreement. The Warrants do not have anti-dilution protection, other than for customary stock splits and similar transactions. The Subscription Agreement contains customary representations and warranties of the parties, certain affirmative covenants of our company, and an obligation of our company to indemnify the lenders in connection therewith. The foregoing summary of the Warrants and Subscription Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the form of Warrant and Subscription Agreement, copies of which are filed as Exhibits 4.1 and 10.5, respectively, to this Quarterly Report on Form 10-Q and are incorporated herein by reference.

On August 4, 2020, Michael Donegan, our Vice President, Finance, was appointed as our Chief Accounting Officer and Principal Accounting Officer. The role of Principal Accounting Officer was previously held by James C. D’Arecca, our Chief Financial Officer and Principal Financial Officer. For more information about Mr. Donegan, including his business experience and role with our company, and his compensation, please see our definitive proxy statement on Schedule 14A filed with the SEC on May 4, 2020.

There are no arrangements or understandings between Mr. Donegan and any other person pursuant to which he was appointed as our Chief Accounting Officer and Principal Accounting Officer and no family relationship between Mr. Donegan and any director or executive officer of our company. Other than as described in our definitive proxy statement on Schedule 14A filed with the SEC on May 4, 2020 under the section “Executive Compensation”, since the beginning of our last fiscal year, we have not engaged in any transactions, and there are no proposed transactions, or series of similar transactions, in which we were or are to be a participant and in which Mr. Donegan had a direct or indirect material interest in which the amount involved exceeds or exceeded $120,000.

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

	Nevada			87-0233535
(State or Other Jurisdiction of Incorporation or Organization)			(I.R.S. Employer Identification No.)

951 Yamato Road, Suite 220, Boca Raton, FL		33431
(Address of Principal Executive Offices)	(Zip Code)

Title of Each Class	Trading 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 ☒		Accelerated filer ☐
Non-accelerated filer ☐		Smaller reporting company☐
		Emerging growth company ☐

THERAPEUTICSMD, INC. AND SUBSIDIARIES
INDEX

			Page
PART I - FINANCIAL INFORMATION			3


	~~Item. 1~~Item 1.	Financial Statements	3

		Consolidated Balance Sheets as of ~~September~~June 30, ~~2019~~2020 (Unaudited) and December 31, ~~2018~~2019	3

		Consolidated Statements of Operations for the Three and ~~Nine~~Six Months Ended ~~September~~June 30, ~~2019~~2020 (Unaudited) and ~~2018~~2019 (Unaudited)	4

		Consolidated Statements of ~~Stockholders’~~Stockholders' (Deficit) Equity for the Three and ~~Nine~~Six Months Ended ~~September~~June 30, ~~2019~~2020 (Unaudited) and ~~2018~~2019 (Unaudited)	5

		Consolidated Statements of Cash Flows for the ~~Nine~~Six Months Ended ~~September~~June 30, ~~2019~~2020 (Unaudited) and ~~2018~~2019 (Unaudited)	6

		Notes to Unaudited Consolidated Financial Statements	7

	Item 2.	~~Management’s~~Management's Discussion and Analysis of Financial Condition and Results of Operations	2824

	Item 3.	Quantitative and Qualitative Disclosures about Market Risk	4442

	Item 4.	Controls and Procedures	42

~~Item 4.~~Part II - OTHER INFORMATION			~~Controls and Procedures~~43
	44
	Item 1.	Legal Proceedings	43

	Item 1A.	Risk Factors	43

	Item 5.	Other Information	43

~~Part II - OTHER INFORMATION~~

~~Item 1.~~	~~Legal Proceedings~~	45

~~Item 1A.~~	~~Risk Factors~~	45

Item 6.	Exhibits	4644

~~PART I - FINANCIAL INFORMATION~~

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

		September 30, 2019			December 31, 2018
		(Unaudited)							June 30, 2020			December 31, 2019
									(Unaudited)
ASSETS	ASSETS							ASSETS
Current Assets:
Cash		$	155,330,050		$	161,613,077			$	113,839,234		$	160,829,713
Accounts receivable, net of allowance for doubtful accounts of $691,699 and $596,602, respectively			15,323,614			11,063,821
Inventory			10,532,844			3,267,670
Accounts receivable, net of allowance for doubtful accounts of $722,240 and $904,040, respectively										18,290,784			24,395,958
Inventory, net										10,172,312			11,860,716
Other current assets			10,578,260			10,834,693				6,641,587			11,329,793
Total current assets			191,764,768			186,779,261				148,943,917			208,416,180

Fixed assets, net			2,338,346			472,683				2,145,926			2,507,775

Other Assets:
License rights, net			39,984,002			20,000,000				37,721,695			39,221,308
Intangible assets, net			4,942,151			4,092,679				5,942,873			5,258,211
Right of use asset			10,459,635			—
Right of use assets										10,337,577			10,109,154
Other assets			473,009			639,301				446,925			473,009
Total other assets			55,858,797			24,731,980				54,449,070			55,061,682
Total assets		$	249,961,911		$	211,983,924			$	205,538,913		$	265,985,637

LIABILITIES AND STOCKHOLDERS’ EQUITY
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY								LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY
Current Liabilities:
Accounts payable		$	24,133,506		$	22,743,841			$	17,270,319		$	19,181,212
Other current liabilities			43,196,032			18,334,948				29,213,411			33,823,613
Total current liabilities			67,329,538			41,078,789				46,483,730			53,004,825

Long-Term Liabilities:
Long-term debt			194,361,169			73,381,014				243,801,705			194,634,643
Operating lease liability			9,500,133			—				9,307,361			9,145,049
Other long-term liabilities										35,000			—
Total long-term liabilities										253,144,066			203,779,692
Total liabilities			271,190,840			114,459,803				299,627,796			256,784,517

Commitments and Contingencies - See Note 15

Stockholders’ Equity:
Stockholders' (Deficit) Equity:
Preferred stock - par value $0.001; 10,000,000 shares authorized; 0 shares issued and outstanding			—			—				—			—
Common stock - par value $0.001; 350,000,000 shares authorized: 241,277,076 and 240,462,439 issued and outstanding, respectively			241,277			240,463
Common stock - par value $0.001; 600,000,000 and 350,000,000 shares authorized: 272,294,380 and 271,177,076 issued and outstanding, respectively										272,294			271,177
Additional paid-in capital			624,515,559			616,559,938				709,885,568			704,351,222
Accumulated deficit			(645,985,765	)		(519,276,280	)			(804,246,745	)		(695,421,279	)
Total stockholders’ (deficit) equity			(21,228,929	)		97,524,121
Total liabilities and stockholders’ equity		$	249,961,911		$	211,983,924
Total stockholders' (deficit) equity										(94,088,883	)		9,201,120
Total liabilities and stockholders' equity									$	205,538,913		$	265,985,637


	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2019			2018			2019			2018

Product revenue, net	$	8,213,341		$	3,473,535		$	18,238,857		$	11,009,937
License revenue		15,506,400			—			15,506,400			—
Total revenue, net		23,719,741			3,473,535			33,745,257			11,009,937

Cost of goods sold		1,444,308			699,118			3,455,995			1,786,902

Gross profit		22,275,433			2,774,417			30,289,262			9,223,035

Operating expenses:
Sales, general, and administrative		45,126,986			30,354,072			121,378,519			80,578,079
Research and development		4,077,738			6,708,271			15,359,988			20,545,948
Depreciation and amortization		141,959			73,321			363,956			198,545
Total operating expenses		49,346,683			37,135,664			137,102,463			101,322,572

Operating loss		(27,071,250	)		(34,361,247	)		(106,813,201	)		(92,099,537	)

Other expense
Loss on extinguishment of debt		—			—			(10,057,632	)		—
Miscellaneous income		703,662			809,022			1,878,980			1,457,817
Interest expense		(5,599,005	)		(2,053,077	)		(11,717,632	)		(2,584,459	)
Total other expense		(4,895,343	)		(1,244,055	)		(19,896,284	)		(1,126,642	)

Loss before income taxes		(31,966,593	)		(35,605,302	)		(126,709,485	)		(93,226,179	)

Provision for income taxes		—			—			—			—

Net loss	$	(31,966,593	)	$	(35,605,302	)	$	(126,709,485	)	$	(93,226,179	)

Loss per share, basic and diluted:

Net loss per share, basic and diluted	$	(0.13	)	$	(0.16	)	$	(0.53	)	$	(0.42	)

Weighted average number of common shares outstanding, basic and diluted		241,261,299			228,107,240			241,163,994			220,466,673

					Additional
	Common Stock				Paid in		Accumulated
	Shares		Amount		Capital		Deficit			Total

Balance, December 31, 2017		216,429,642	$	216,430	$	516,351,405	$	(386,659,120	)	$	129,908,715

Shares issued for exercise of options, net		154,632		154		43,902		—			44,056
Share-based compensation		—		—		1,751,358		—			1,751,358
Net loss		—		—		—		(24,401,829	)		(24,401,829	)

Balance, March 31, 2018		216,584,274		216,584		518,146,665		(411,060,949	)		107,302,300

Shares issued for exercise of options, net		249,785		250		1,084,689		—			1,084,939
Share-based compensation		—		—		2,377,082		—			2,377,082
Net loss		—		—		—		(33,219,048	)		(33,219,048	)

Balance, June 30, 2018		216,834,059		216,834		521,608,436		(444,279,997	)		77,545,273

Shares issued for exercise of options, net		1,052,300		1,053		106,265		—			107,318
Shares issued in offering, net		18,578,430		18,578		89,889,219		—			89,907,797
Share-based compensation		—		—		2,260,195		—			2,260,195
Net loss		—		—		—		(35,605,302	)		(35,605,302	)

Balance, September 30, 2018		236,464,789	$	236,465	$	613,864,115	$	(479,885,299	)	$	134,215,281


Balance, December 31, 2018		240,462,439	$	240,463	$	616,559,938	$	(519,276,280	)	$	97,524,121

Shares issued for exercise of options and warrants, net		759,401		759		99,348		—			100,107
Share-based compensation		—		—		2,575,369		—			2,575,369
Net loss		—		—		—		(39,506,375	)		(39,506,375	)

Balance, March 31, 2019		241,221,840		241,222		619,234,655		(558,782,655	)		60,693,222

Share-based compensation		—		—		2,637,264		—			2,637,264
Net loss		—		—		—		(55,236,517	)		(55,236,517	)

Balance, June 30, 2019		241,221,840	$	241,222	$	621,871,919	$	(614,019,172	)	$	8,093,969

Shares issued for exercise of options, net		55,236		55		8,494		—			8,549
Share-based compensation						2,635,146		—			2,635,146
Net loss		—		—		—		(31,966,593	)		(31,966,593	)

Balance, September 30, 2019		241,277,076	$	241,277	$	624,515,559	$	(645,985,765	)	$	(21,228,929	)


	Nine Months Ended
	September 30,
	2019			2018

CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(126,709,485	)	$	(93,226,179	)

Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of fixed assets		223,750			121,423
Amortization of intangible assets		140,206			77,123
Write off of patent and trademark cost		78,864			—
Non-cash operating lease expense		711,836			—
Provision for doubtful accounts		95,097			231,475
Loss on extinguishment of debt		10,057,632			—
Share-based compensation		7,859,357			6,388,635
Amortization of intellectual property license fee		15,998
Amortization of deferred financing fees		582,829			149,909
Changes in operating assets and liabilities:
Accounts receivable		(4,354,890	)		(8,705,325	)
Inventory		(7,265,174	)		(892,863	)
Other current assets		(1,128,515	)		1,233,482
Accounts payable		1,389,665			7,284,493
Accrued expenses and other liabilities		3,402,511			8,670,986

Net cash used in operating activities		(114,900,319	)		(78,666,841	)

CASH FLOWS FROM INVESTING ACTIVITIES
Payment for intellectual property license		—			(20,000,000	)
Patent costs		(1,068,542	)		(748,906	)
Purchase of fixed assets		(2,089,413	)		(66,295	)
Payment of security deposit		(20,420	)		(11,485	)

Net cash used in investing activities		(3,178,375	)		(20,826,686	)

CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from Financing Agreement		200,000,000			—
Proceeds from exercise of options and warrants		108,656			1,236,313
Proceeds from sale of common stock, net of costs		—			89,907,797
Proceeds from Credit Agreement		—			75,000,000
Payment of deferred financing fees		(6,652,270	)		(3,786,918	)
Repayment of Credit Agreement		(81,660,719	)		—

Net cash provided by financing activities		111,795,667			162,357,192

(Decrease) increase in cash		(6,283,027	)		62,863,665
Cash, beginning of period		161,613,077			127,135,628
Cash, end of period	$	155,330,050		$	189,999,293

Supplemental disclosure of cash flow information

Interest paid	$	12,446,792		$	1,759,316

Non-cash investing activity

Amount accrued for intellectual property license	$	20,000,000		$	—


	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2020			2019			2020			2019
Product revenue, net	$	10,701,033		$	6,078,865		$	22,951,690		$	10,025,516

Cost of goods sold		4,400,485			1,248,860			7,115,536			2,011,687

Gross profit		6,300,548			4,830,005			15,836,154			8,013,829

Operating expenses:
Sales, general, and administrative		48,340,628			41,387,451			105,267,649			76,251,533
Research and development		2,742,032			4,964,368			6,010,861			11,282,250
Depreciation and amortization		256,557			115,059			518,551			221,997
Total operating expenses		51,339,217			46,466,878			111,797,061			87,755,780

Operating loss		(45,038,669	)		(41,636,873	)		(95,960,907	)		(79,741,951	)

Other (expense) income
Loss on extinguishment of debt		—			(10,057,632	)		—			(10,057,632	)
Miscellaneous income		88,858			486,597			424,340			1,175,318
Interest expense		(7,026,853	)		(4,028,609	)		(13,288,899	)		(6,118,627	)
Total other expense		(6,937,995	)		(13,599,644	)		(12,864,559	)		(15,000,941	)

Loss before income taxes		(51,976,664	)		(55,236,517	)		(108,825,466	)		(94,742,892	)

Provision for income taxes		—			—			—			—

Net loss	$	(51,976,664	)	$	(55,236,517	)	$	(108,825,466	)	$	(94,742,892	)

Loss per share, basic and diluted:

Net loss per share, basic and diluted	$	(0.19	)	$	(0.23	)	$	(0.40	)	$	(0.39	)

Weighted average number of common shares outstanding, basic and diluted		271,876,238			241,221,840			271,667,879			241,114,532

	~~Level 1~~	~~unadjusted quoted prices in active markets for identical assets or liabilities;~~
	~~Level 2~~	quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and
	~~Level 3~~	~~unobservable inputs for the asset or liability.~~

	Three Months Ended June 30,				Six Months Ended June 30,
	2020		2019		2020		2019
Prescription vitamins	$	2,428,382	$	2,822,872	$	4,902,073	$	4,758,844
IMVEXXY		5,085,190		3,121,711		11,477,791		5,132,390
BIJUVA		1,352,001		134,282		2,463,605		134,282
ANNOVERA		1,835,460		—		4,108,221		—
Net revenue	$	10,701,033	$	6,078,865	$	22,951,690	$	10,025,516

	Three Months Ended September 30,				Nine Months Ended September 30,
	2019		2018		2019		2018
Prescription vitamins	$	2,550,330	$	3,261,459	$	7,309,174	$	10,797,861
IMVEXXY		4,772,354		212,076		9,904,744		212,076
BIJUVA		490,705		—		624,987		—
ANNOVERA		399,952		—		399,952		—
License revenue		15,506,400		—		15,506,400		—
Net revenue	$	23,719,741	$	3,473,535	$	33,745,257	$	11,009,937

	September 30, 2019		December 31, 2018
Finished product	$	5,011,192	$	2,908,958
Work in process		1,005,575		339,312
Raw material		4,516,077		19,400
TOTAL INVENTORY	$	10,532,844	$	3,267,670

	September 30, 2019			December 31, 2018			June 30, 2020			December 31, 2019
Accounting system	$	301,096		$	301,096		$	301,096		$	301,096
Equipment		1,371,390			490,576			1,645,446			1,619,646
Furniture and fixtures		1,294,241			116,542			1,406,858			1,406,858
Computer hardware		80,211			80,211			80,211			80,211
Leasehold improvements		68,788			37,888			68,788			68,788
		3,115,726			1,026,313
TOTAL FIXED ASSETS								3,502,399			3,476,599
Accumulated depreciation		(777,380	)		(553,630	)		(1,356,473	)		(968,824	)
TOTAL FIXED ASSETS, NET	$	2,338,346		$	472,683		$	2,145,926		$	2,507,775

	June 30, 2020
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
Approved hormone therapy drug candidate patents	$	3,997,263	$	(609,982	)	$	3,387,281		12.5
Hormone therapy drug candidate patents (pending)		2,216,911		—			2,216,911		n/a

Non-amortizable intangible assets:
Multiple trademarks		338,681		—			338,681		indefinite
TOTAL	$	6,552,855	$	(609,982	)	$	5,942,873

	December 31, 2019
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
Approved hormone therapy drug candidate patents	$	3,463,082	$	(478,983	)	$	2,984,099		13

Hormone therapy drug candidate patents (pending)		1,979,299		—			1,979,299		n/a

Non-amortizable intangible assets:
Multiple trademarks		294,813		—			294,813		indefinite
TOTAL	$	5,737,194	$	(478,983	)	$	5,258,211

	June 30, 2020		December 31, 2019
Finished products	$	3,923,210	$	4,976,910
Work in process		1,551,079		1,182,059
Raw materials		4,698,023		5,701,747
TOTAL INVENTORY, NET	$	10,172,312	$	11,860,716

	June 30, 2020		December 31, 2019
Prepaid sales and marketing costs	$	1,474,007	$	1,583,698
Debt financing fees on undrawn tranches (Note 9)		275,378		550,757
Prepaid insurance		1,081,540		1,812,135
Prepaid manufacturing		794,010		2,595,721
Other prepaid costs		3,016,652		4,787,482
TOTAL OTHER CURRENT ASSETS	$	6,641,587	$	11,329,793

	September 30, 2019
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted-Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
Approved hormone therapy drug candidate patents		3,138,308		(421,694	)		2,716,614		13.25 years
Hormone therapy drug candidate patent (pending)		1,937,691		—			1,937,691		n/a
Non-amortizable intangible assets:
Multiple trademarks		287,846		—			287,846		indefinite
TOTAL	$	5,363,845	$	(421,694	)	$	4,942,151

	December 31, 2018
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted-Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
OPERA^® software patent	$	31,951	$	(10,484	)	$	21,467		10.75 years
Development costs of corporate website		91,743		(91,743	)		—		n/a
Approved hormone therapy drug candidate patents		2,234,129		(282,485	)		1,951,644		14 years
Hormone therapy drug candidate patents (pending)		1,855,279		—			1,855,279		n/a
Non-amortizable intangible assets:
Multiple trademarks		264,289		—			264,289		indefinite
TOTAL	$	4,477,391	$	(384,712	)	$	4,092,679

Year Ending December 31,	Estimated Amortization
2020 (6 months)	$	135,495
2021	$	270,990
2022	$	270,990
2023	$	270,990
2024	$	270,990

Year Ending December 31,		Estimated Amortization
	2019 (3 months)	$	51,259
	2020	$	205,035
	2021	$	205,035
	2022	$	205,035
	2023	$	205,035

	June 30, 2020		June 30, 2019
Stock options		24,590,141		22,072,469
Warrants		1,782,571		1,832,571
Performance stock units		2,422,885		—
Restricted stock units		6,029,957		1,040,000
		34,825,554		24,945,040

	Three and Nine months ended
	September 30, 2019		September 30, 2018
Stock options		24,849,984		24,837,349
Warrants		1,832,571		3,007,571
Restricted stock awards		1,240,000		—
TOTAL		27,922,555		27,844,920

	Nine months ended September 30,
	2019	2018
Risk-free interest rate	1.83-2.54%	2.78-2.82%
Volatility	61.25-64.49%	61.8-63.34%
Term (in years)	5.5-6.5	5.5-6.25
Dividend yield	0.00%	0.00%

	June 30, 2020			June 30, 2019
Weighted average grant date fair value	$	0.95		$	2.57
Risk-free interest rate		0.34-1.68%			2.19-2.54%
Volatility		63.53-67.92%			61.25-61.85%
Term (in years)		6-6.8			5.5-6.25
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, 2018		20,872,824		$	4.93		5.94 years	$	12,239,876
Granted		4,419,501		$	3.13
Exercised		(343,716	)	$	0.32			$	1,426,828
Expired/Forfeited		(98,625	)	$	5.63
Balance at September 30, 2019		24,849,984		$	4.67		6.05 years	$	13,761,778
Vested and Exercisable at September 30, 2019		17,601,027		$	4.85		4.81 years	$	9,745,527
Unvested at September 30, 2019		7,248,957		$	4.22		9.06 years	$	4,016,251

	Number of Shares Under Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance at December 31, 2019		25,030,234		$	4.65		5.84	$	3,668,171
Granted		736,500		$	1.58
Exercised		(664,304	)	$	0.25			$	1,027,627
Expired		(197,914	)	$	2.53
Cancelled/Forfeited		(314,375	)	$	3.82
Balance at June 30, 2020		24,590,141		$	4.70		5.59	$	721,720
Vested and Exercisable at June 30, 2020		19,725,267		$	5.02		4.80	$	673,250
Unvested at June 30, 2020		4,864,874		$	3.42		8.83	$	48,470

	Restricted Stock Units				Performance Stock Units
	Number of Shares			Weighted Average Grant Date Fair Value	Number of Shares			Weighted Average Grant Date Fair Value
Balance at December 31, 2019	1,240,000		$	3.56	—		$	—
Granted	5,102,817		$	1.40	2,585,745		$	1.08
Vested/Released	(301,500	)	$	1.78	(151,500	)	$	1.14
Forfeited	(11,360	)	$	1.07	(11,360	)	$	1.07
Balance at June 30, 2020	6,029,957		$	1.83	2,422,885	*	$	1.08

Supplemental lease information:	June 30, 2020			December 31, 2019
Right-of-use asset	$	10,337,577		$	10,109,154
Short-term operating lease liability (included in Other current liabilities)	$	2,107,413		$	1,501,539
Long-term operating lease liability	$	9,307,361		$	9,145,049
Weighted average remaining term		9 years			9 years
Weighted average discount rate		8.3	%		8.25	%

Supplemental cash flow information for the six months ended	June 30, 2020			June 30, 2019
Cash paid for amounts included in the measurement of lease liabilities for operating lease	$	670,793		$	564,092
Right-of-use assets obtained in exchange for lease obligation	$	998,821		$	3,760,171

Supplemental lease information at September 30, 2019
Right-of-use asset	$	10,459,635
Short-term operating lease liability (included in Other current liabilities)	$	1,242,290
Long-term operating lease liability	$	9,500,133
Weighted average remaining term		9 Years
Weighted average discount rate		8.25	%

Supplemental cash flow information for nine months ended September 30, 2019
Cash paid for amounts included in the measurement of lease liabilities for operating lease	$	849,440
Right-of-use assets obtained in exchange for lease obligation	$	11,171,471


Years Ending December 31,
2019 (3 months)	$	314,670
2020		1,566,617
Years Ended December 31,
2020 (6 months)				$	946,852
2021		2,198,541			2,334,582
2022		1,262,302			1,413,289
2023		1,293,859			1,443,143
2024					1,476,534
Thereafter		9,363,136			8,947,869
Total undiscounted lease payments		15,999,125			16,562,269
Less: imputed interest		(5,256,702	)		(5,147,495	)
Present value of lease payments	$	10,742,423		$	11,414,774

Annual Net Sales	Royalty Rate
Less than or equal to $50.0 million		5	%
Greater than $50.0 million and less than or equal to $150.0 million		10	%
Greater than $150.0 million		15	%

	Three Months Ended September 30,				Nine Months Ended September 30,				Three Months Ended June 30,				Six Months Ended June 30,
	2019		2018		2019		2018		2020		2019		2020		2019
	(000s)				(000s)					(000s)				(000s)
TX 001-HR (BIJUVA)	$	454	$	3,017	$	2,869	$	8,432	$	530	$	905	$	1,117	$	2,415
TX 004-HR(IMVEXXY)		527		764		1,869		3,922		376		577		757		1,342
ANNOVERA		396		—		2,109		—		493		840		868		1,714
Other research and development		2,701		2,927		8,513		8,192		1,343		2,642		3,269		5,811
Total	$	4,078	$	6,708	$	15,360	$	20,546	$	2,742	$	4,964	$	6,011	$	11,282

Exhibit	Date	~~Date~~	Description
3.1*	June 22, 2020	Composite Amended and Restated Articles of Incorporation of TherapeuticsMD, Inc., as amended.
4.1*	August 5, 2020	Form of Warrant to Purchase Common Stock issued by TherapeuticsMD, Inc. to the Subscribers party to that certain Subscription Agreement, dated as of August 5, 2020.
10.1*+	April 17, 2020	Amendment No. 2 to Financing Agreement, by and among TherapeuticsMD, Inc., VitaMedMD, LLC, BocagreenMD, Inc., VitaCare Prescription Services, Inc., TPG Specialty Lending, Inc. and the lenders thereto.

10.2*	May 1, 2020	Amendment No. 3 to Financing Agreement, by and among TherapeuticsMD, Inc., VitaMedMD, LLC, BocagreenMD, Inc., VitaCare Prescription Services, Inc., TPG Specialty Lending, Inc., and the lenders thereto.
10.3*	May 13, 2020	Amendment No. 4 to Financing Agreement, by and among TherapeuticsMD, Inc., VitaMedMD, LLC, BocagreenMD, Inc., VitaCare Prescription Services, Inc., TPG Specialty Lending, Inc., and the lenders thereto.
10.4*	August 5, 2020	~~September 28, 2018~~Amendment No. 5 to Financing Agreement, by and among TherapeuticsMD, Inc., VitaMedMD, LLC, BocagreenMD, Inc., VitaCare Prescription Services, Inc., TPG Specialty Lending, Inc., and the lenders thereto.
10.5*	~~Commercial Supply~~August 5, 2020	Subscription Agreement, by and among TherapeuticsMD, Inc. and the Subscribers identified on the Schedule of Subscribers attached thereto.
10.6*	June 1, 2020	Employment Agreement, by and between TherapeuticsMD, Inc. and ~~QPharma AB.~~ James C. D’Arecca.
~~10.2*+~~10.7	June 18, 2020	~~October 5, 2018~~	~~Lease by and between 951 Yamato Acquisition Company, LLC and~~ TherapeuticsMD, Inc. 2020 Employee Stock Purchase Plan (incorporated herein by reference to Appendix B of the Registrant’s Definitive Proxy Statement on Schedule 14A filed on May 4, 2020).
31.1*	August 6, 2020	~~November 8, 2019~~	Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) .

31.2*	August 6, 2020	~~November 8, 2019~~	Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) .
32.1**	August 6, 2020	~~November 8, 2019~~	Section 1350 Certification of Chief Executive Officer .
32.2**	August 6, 2020	~~November 8, 2019~~	Section 1350 Certification of Chief Financial Officer .
101.INS*	n/a	~~n/a~~	XBRL Instance Document – the instance document does not appear in the Interactive Data file because its XBRL tags are embedded within the Inline XBRL document .
101.SCH*	n/a	~~n/a~~	XBRL Taxonomy Extension Schema Document .
101.CAL*	n/a	~~n/a~~	XBRL Taxonomy Extension Calculation Linkbase Document .
101.DEF*	n/a	~~n/a~~	XBRL Taxonomy Extension Definition Linkbase Instance Document .
101.LAB*	n/a	~~n/a~~	XBRL Taxonomy Extension Label Linkbase Instance Document .
101.PRE*	n/a	~~n/a~~	XBRL Taxonomy Extension Presentation Linkbase Instance Document .
104*	n/a	~~n/a~~	Cover Page Interactive Data File (formatted as Inline XBRL and Contained in Exhibit 101) .

**	~~Furnished herewith.~~
+	Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(10). The omitted information is not material and would likely cause competitive harm to the Company if publicly disclosed.