UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-00100 THERAPEUTICSMD, INC. (Exact name of Registrant as specified in its Charter) (State or ...

TherapeuticsMD® For Her. For Life. | --- | --- | --- | --- | |-------|---------------------------------------------------------------------------------|-------|-------| | | | | | | | Building the Premier Women's Health Company Q3 2021 Earnings November 11, 2021 | | | | | FOR INVESTOR PRESENTATION PURPOSES ONLY. | | | Forward-Looking Statements This presentation by TherapeuticsMD, Inc. (referred to as "we," "our," or "the Company") may contain forward-looking statements. Forward-looking statements may includ ...

TherapeuticsMD, Inc. (NASDAQ:TXMD) Q3 Earnings Conference Call November 11, 2021 8:30 AM ET Company Participants Lisa Wilson – Investor Relations Rob Finizio – Chief Executive Officer Hugh O’Dowd – President James D'Arecca – Chief Financial Officer Mark Glickman – Chief Commercial Officer Conference Call Participants Louise Chen – Cantor Fitzgerald Annabel Samimy – Stifel Douglas Tsao – HC Wainwright Operator Good morning, ladies and gentlemen. Thank you for joining us for TherapeuticsMD, Third Quarter ...

TherapeuticsMD® For Her. For Life. ■ | --- | --- | --- | |-------|----------------------------------------------|-------| | | | | | | Building the Premier Women's Health Company | | Forward-Looking Statements | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-00100 THERAPEUTICSMD, INC. (Exact name of Registrant as specified in its Charter) of incorporati ...

TherapeuticsMD, Inc. (NASDAQ:TXMD) Q2 2021 Earnings Conference Call August 4, 2021 8:30 AM ET Company Participants Lisa Wilson – Investor Relations Rob Finizio – Chief Executive Officer James D’Arecca – Chief Financial Officer Dawn Halkuff – Chief Commercial Officer Mitchell Krassan – Chief Strategy and Performance Officer Conference Call Participants Louise Chen – Cantor Annabel Samimy – Stifel Douglas Tsao – H.C. Wainwright Operator Good morning, ladies and gentlemen. Thank you for joining us for the Ther ...

Financial Performance - Total net product revenue increased by 60% in 1Q21 compared to 1Q20[11] - ANNOVERA net revenue increased by 285%[11] - BIJUVA net revenue increased by 120%[11] - The company reduced debt to $184 million by a $50 million cash payment[14] - Operating expenses were reduced by $16 million to $44.5 million compared to 1Q20[14] - Gross margin was 76%, impacted by $0.9 million in write-offs of production-related costs for ANNOVERA[14] ANNOVERA Performance and Strategy - ANNOVERA total prescriptions (TRx) grew by 164% year-over-year and 5% quarter-over-quarter in 1Q21[19] - Net revenue per unit for ANNOVERA was $1,071 in 1Q21, with an expected annual average of ~$1,100[11, 19] - The number of prescribers for ANNOVERA increased by approximately 17% in 1Q21 compared to 4Q20, from ~2,700 to ~3,160[19] IMVEXXY Performance - IMVEXXY net revenue increased by 10%[11] - Net revenue per unit improved to $61[11]

[Part I – Financial Information](index=4&type=section&id=Part%20I%20%E2%80%93%20Financial%20Information) [Financial Statements (Unaudited)](index=4&type=section&id=Item%2E%201%2E%20Financial%20Statements%20%28Unaudited%29) This section presents TherapeuticsMD, Inc.'s unaudited consolidated financial statements for Q1 2021, including balance sheets, income statements, equity statements, cash flows, and detailed accounting notes [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Total assets increased to $239.3 million by March 31, 2021, driven by higher cash, while liabilities decreased and stockholders' deficit significantly improved due to equity financing Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $137,617 | $80,486 | | Total current assets | $187,042 | $128,404 | | Total assets | $239,306 | $181,610 | | **Liabilities & Equity** | | | | Total current liabilities | $61,284 | $59,238 | | Long-term debt, net | $178,970 | $237,698 | | Total liabilities | $248,784 | $305,611 | | Total stockholders' deficit | $(9,478) | $(124,001) | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Q1 2021 net revenue grew 62.2% to $19.9 million, narrowing operating loss to $(29.3) million and net loss to $(39.4) million due to higher gross profit and reduced expenses Q1 2021 vs Q1 2020 Statement of Operations (in thousands, except per share data) | Metric | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Product revenue, net | $19,632 | $12,251 | | Total revenue, net | $19,866 | $12,251 | | Gross profit | $15,179 | $9,536 | | Total operating expenses | $44,457 | $60,458 | | Loss from operations | $(29,278) | $(50,922) | | Net loss | $(39,383) | $(56,849) | | Loss per common share | $(0.11) | $(0.21) | [Consolidated Statements of Stockholders' Equity (Deficit)](index=6&type=section&id=Consolidated%20Statements%20of%20Stockholders%27%20Equity%20%28Deficit%29) Stockholders' deficit significantly improved to $(9.5) million in Q1 2021, driven by $150.9 million from 92.9 million common stock issuances, partially offset by net loss - The company issued **92.9 million shares** for the sale of common stock, resulting in net proceeds of **$150.9 million** in Q1 2021[14](index=14&type=chunk) - The net loss of **$39.4 million** increased the accumulated deficit, partially offsetting the capital raised[14](index=14&type=chunk) [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Q1 2021 saw net cash used in operations at $(38.4) million, while financing activities provided $95.9 million, leading to a $57.1 million net cash increase and a $137.6 million quarter-end balance Q1 2021 vs Q1 2020 Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,380) | $(39,111) | | Net cash used in investing activities | $(438) | $(443) | | Net cash provided by financing activities | $95,949 | $48,822 | | **Net increase in cash** | **$57,131** | **$9,268** | | **Cash, end of period** | **$137,617** | **$170,098** | [Notes to Unaudited Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) Notes detail the company's women's healthcare business, COVID-19 impacts, debt specifics, disaggregated revenue, and patent litigation for IMVEXXY and BIJUVA - The company is a women's healthcare company focused on commercializing products for pregnancy prevention through menopause, including IMVEXXY®, BIJUVA®, and ANNOVERA®[21](index=21&type=chunk) - The company continues to face risks from the COVID-19 pandemic but has implemented measures like virtual detailing and cost-saving initiatives to mitigate the impact. The full future impact remains uncertain[24](index=24&type=chunk)[25](index=25&type=chunk)[27](index=27&type=chunk) - The company is involved in patent infringement lawsuits against Teva and Amneal, who are seeking to market generic versions of IMVEXXY and BIJUVA, respectively[56](index=56&type=chunk)[57](index=57&type=chunk) Disaggregated Revenue by Product (in thousands) | Product | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | ANNOVERA | $8,750 | $2,273 | | IMVEXXY | $7,012 | $6,392 | | BIJUVA | $2,445 | $1,112 | | Prescription vitamin | $1,425 | $2,474 | | **Product revenue, net** | **$19,632** | **$12,251** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2021 financial performance, noting a 62.2% revenue increase to $19.9 million, reduced operating loss, improved liquidity from equity offerings, and critical accounting estimates [Business Overview and Product Portfolio](index=18&type=section&id=Business%20overview) TherapeuticsMD is a women's healthcare company commercializing products for contraception and menopause, including IMVEXXY, BIJUVA, and ANNOVERA, alongside prenatal vitamins - The company's mission is to create and commercialize innovative products for women's health, from pregnancy prevention through menopause[84](index=84&type=chunk) - Key pharmaceutical products being commercialized are: - **IMVEXXY:** For treatment of moderate-to-severe dyspareunia due to menopause - **BIJUVA:** The first FDA-approved bioidentical hormone therapy combination of estradiol and progesterone for moderate-to-severe vasomotor symptoms - **ANNOVERA:** A one-year, patient-controlled, reversible contraceptive vaginal system[87](index=87&type=chunk)[90](index=90&type=chunk)[95](index=95&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20operations) Q1 2021 total revenue rose 62.2% to $19.9 million, driven by ANNOVERA sales, while operating expenses fell 26.5%, significantly reducing operating and net losses Q1 2021 vs Q1 2020 Revenue by Product (in thousands) | Product | Q1 2021 | Q1 2020 | Change (%) | | :--- | :--- | :--- | :--- | | ANNOVERA | $8,750 | $2,273 | +285.0% | | IMVEXXY | $7,012 | $6,392 | +9.7% | | BIJUVA | $2,445 | $1,112 | +119.9% | | **Total Product Revenue** | **$19,632** | **$12,251** | **+60.2%** | - Total operating expenses decreased by **$16.0 million (26.5%)** YoY, mainly due to a **$15.9 million** reduction in selling and marketing costs reflecting cost-cutting initiatives[110](index=110&type=chunk)[112](index=112&type=chunk) - Net loss improved to **$39.4 million** in Q1 2021, compared to a net loss of **$56.8 million** in Q1 2020[119](index=119&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20capital%20resources) The company ended Q1 2021 with **$137.6 million** cash, bolstered by **$150.9 million** from equity offerings, ensuring sufficient liquidity and debt covenant compliance - The company ended Q1 2021 with a cash balance of **$137.6 million**[120](index=120&type=chunk) - Significant capital was raised in Q1 2021: - **2020 ATM Program:** Completed, raising a total of **$47.3 million** in net proceeds - **February 2021 Public Offering:** Raised **$96.6 million** in net proceeds - **2021 ATM Program:** Initiated in March, raising **$7.0 million** in net proceeds through March 31, 2021[121](index=121&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk) - The company is required to maintain a minimum unrestricted cash balance of **$60.0 million** under its Financing Agreement and was in compliance as of the filing date[131](index=131&type=chunk) [Critical Accounting Estimates](index=25&type=section&id=Critical%20accounting%20estimates) Critical accounting estimates primarily involve variable sales deductions like returns, rebates, and co-pay assistance, requiring significant judgment, especially for new products lacking historical data - The transaction price for products is variable due to deductions for returns, chargebacks, rebates, and coupons, which are estimated based on historical experience and other data[136](index=136&type=chunk) - For newly launched products, return estimates are based on industry data, sales information, and inventory levels in the distribution channel, as historical return data is not yet available[137](index=137&type=chunk) - Estimating the cost of the co-pay assistance program is a key challenge, as it is based on assumptions about patient utilization and insurance coverage, which are subject to change[139](index=139&type=chunk)[141](index=141&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) Primary market risk is interest rate sensitivity on **$200.0 million** variable-rate debt; a 1.0% rate change impacts annual loss by **$2.0 million**, while cash investments are low-risk - The company's debt under the Financing Agreement accrues interest at a variable rate tied to LIBOR or the prime rate[143](index=143&type=chunk) - Based on the **$200.0 million** debt balance as of March 31, 2021, a **1.0%** change in interest rates would result in an annual impact of **$2.0 million** to the loss before income taxes[143](index=143&type=chunk) [Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2021, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of the end of the period covered by the report, the company's disclosure controls and procedures were effective at a reasonable assurance level[145](index=145&type=chunk) - There were no changes in internal control over financial reporting during the first quarter of 2021 that materially affected, or are reasonably likely to materially affect, internal controls[148](index=148&type=chunk) [Part II – Other Information](index=27&type=section&id=Part%20II%20%E2%80%93%20Other%20Information) [Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is not involved in any material legal proceedings beyond the patent litigation for IMVEXXY and BIJUVA disclosed in Note 9 of the financial statements - The company is not involved in any material legal proceedings other than those disclosed in Note 9, which concern patent challenges from Teva and Amneal[149](index=149&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the company's risk factors have occurred since the 2020 Annual Report on Form 10-K filing - There have been no material changes to the Company's risk factors since the 2020 10-K Report[150](index=150&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In Q1 2021, the company issued **563,000** common shares from warrant exercises, including a cash exercise for **205,000** shares yielding **$50,000** for working capital, exempt from registration - During Q1 2021, warrants to purchase an aggregate of **563,000** shares of common stock were exercised. This included a cash exercise for **205,000** shares yielding **$50,000** and a cashless exercise resulting in the issuance of **298,000** shares[151](index=151&type=chunk) [Defaults Upon Senior Securities](index=27&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - None[152](index=152&type=chunk) [Mine Safety Disclosures](index=27&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[153](index=153&type=chunk) [Other Information](index=27&type=section&id=Item%205.%20Other%20Information) The company reported no other information for this item - None[154](index=154&type=chunk) [Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including financing agreement amendments, equity offering sales agreements, and CEO/CFO certifications

TherapeuticsMD, Inc. (NASDAQ:TXMD) Q1 2021 Earnings Conference Call May 6, 2021 8:30 AM ET Company Participants Nichol Ochsner - Vice President of Investor Relations Rob Finizio - Chief Executive Officer James D'Arecca - Chief Financial Officer Dawn Halkuff - Chief Commercial Officer Mitchell Krassan - Chief Strategy & Performance Officer Conference Call Participants Dana Flanders - Guggenheim Partners Douglas Tsao - H.C. Wainwright Operator Good morning, ladies and gentlemen. Thank you for joining us for T ...

TherapeuticsMD® 1 For Her. For Life. Building the Premier Women's Health Company Our focus for 2021 is on executing our plans to accelerate revenue growth March 9, 2021 Forward-Looking Statements 2 This presentation by TherapeuticsMD, Inc. (referred to as "we," "our," or the "Company") may contain forward-looking statements. 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 add ...