Commission File Number 001-00100 TherapeuticsMD, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________________ to ________________________ (Exact Name of Registrant as Specified in Its Charter) (State or Other ...

Financial Data and Key Metrics Changes - In Q4 2019, total net revenue from product sales increased by 94% to $15.9 million from $8.2 million in Q3 2019, exceeding the upper end of guidance by $650,000 [30] - The net loss for Q4 2019 was $49.4 million, compared to a net loss of $32 million in Q3 2019, which included license revenue [35] - Operating cash burn for Q4 was $51 million, with a cash balance of $160.8 million as of December 31, 2019 [36] Business Line Data and Key Metrics Changes - IMVEXXY's net revenue grew by 33% to $6.3 million in Q4 2019, driven by an increase in net revenue per unit from $35 to $51 [31] - BIJUVA's net revenue was $1.2 million in Q4 2019, a 147% increase over Q3, with units sold increasing by 37% [32] - ANNOVERA generated $5.8 million in net revenue in Q4 2019, with an average net revenue per unit of approximately $1,350 [33] Market Data and Key Metrics Changes - IMVEXXY achieved 72% unrestricted commercial coverage, while BIJUVA secured 56% unrestricted commercial coverage [10][12] - ANNOVERA achieved 75% commercial coverage within four months of its limited launch [9] Company Strategy and Development Direction - The company aims to pivot from a clinical development focus to a fully integrated commercial sales and marketing organization in 2020 [13] - The strategy for 2020 includes prioritizing ANNOVERA as the lead product, with a focus on consumer advertising and expanding patient access through new channels [18][22] - The company plans to create a revenue inflection point for its portfolio, with substantial payer coverage and a well-trained sales force [13][28] Management's Comments on Operating Environment and Future Outlook - Management anticipates that 2020 will be a transformative year, projecting net revenue between $90 million to $110 million, with significant growth expected in the second half of the year [38] - The company expects Q1 revenue to be impacted by high deductible and annual copay resets, projecting it to be below Q4 2019 revenue [38] Other Important Information - The company received the first $50 million tranche of additional borrowing under its term loan facility [36] - The full launch of ANNOVERA is scheduled for March 1, 2020, with increased marketing spend planned for IMVEXXY and ANNOVERA [39] Q&A Session Summary Question: Can you quantify ANNOVERA stocking and the $90 million to $110 million sales guidance for 2020? - The goal was to sell 2,800 units for ANNOVERA, and demand has been strong, with over 1,000 prescriptions sold in the first five weeks of 2020. The sales guidance is not broken out by product [43][44][45] Question: How do you expect net price to trend for IMVEXXY and BIJUVA? - The company believes it can achieve a net revenue target of over $100 for IMVEXXY, with several factors influencing pricing [49][50] Question: What are the pushes and pulls to revenue guidance? - The guidance accounts for expected coverage decisions from major Part D payers and the reorganization of the sales force, which is expected to enhance brand focus [54][55] Question: What percentage of patients will use ANNOVERA for continuous use? - The company does not promote off-label use and cannot quantify the percentage of patients using it continuously, but there is significant interest in the long-lasting option [87][88][90]

TherapeuticsMD® 4Q 2019 Earnings February 20, 2020 Building the Premier Women's Health Company Forward- Looking Statements 2 This presentation by TherapeuticsMD, Inc. (referred to as "we" and "our") 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 address activities, events or developments that we intend, expect, project, believe or anti ...

1 Investor Presentation November 19, 2019 Building a Premier Women's Health Portfolio TherapeuticsMD® For Her. For Life. Forward-Looking Statements This presentation by TherapeuticsMD, Inc. (referred to as "we" and "our") 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 address activities, events or developments that we intend, expect, p ...

PART I - FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item.%201%20Financial%20Statements) The financial statements detail the company's financial position and performance, showing increased liabilities, a shift to stockholders' deficit, and higher revenue despite widening net losses from commercialization [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Total assets increased to $250.0 million, while liabilities surged to $271.2 million from new debt, shifting to a $21.2 million stockholders' deficit Consolidated Balance Sheet Highlights (Unaudited) | Account | Sep 30, 2019 ($) | Dec 31, 2018 ($) | | :--- | :--- | :--- | | **Total Assets** | **249,961,911** | **211,983,924** | | Cash | 155,330,050 | 161,613,077 | | Inventory | 10,532,844 | 3,267,670 | | License rights, net | 39,984,002 | 20,000,000 | | **Total Liabilities** | **271,190,840** | **114,459,803** | | Long-term debt | 194,361,169 | 73,381,014 | | **Total Stockholders' (Deficit) Equity** | **(21,228,929)** | **97,524,121** | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Q3 2019 net revenue surged to $23.7 million, narrowing operating loss, while nine-month net revenue grew to $33.7 million, but net loss widened to $126.7 million Q3 2019 vs Q3 2018 Statement of Operations (Unaudited) | Metric | Q3 2019 ($) | Q3 2018 ($) | | :--- | :--- | :--- | | Total revenue, net | 23,719,741 | 3,473,535 | | Gross profit | 22,275,433 | 2,774,417 | | Operating loss | (27,071,250) | (34,361,247) | | Net loss | (31,966,593) | (35,605,302) | | Net loss per share | (0.13) | (0.16) | Nine Months 2019 vs 2018 Statement of Operations (Unaudited) | Metric | Nine Months 2019 ($) | Nine Months 2018 ($) | | :--- | :--- | :--- | | Total revenue, net | 33,745,257 | 11,009,937 | | Gross profit | 30,289,262 | 9,223,035 | | Operating loss | (106,813,201) | (92,099,537) | | Net loss | (126,709,485) | (93,226,179) | | Net loss per share | (0.53) | (0.42) | [Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity shifted from a $97.5 million positive balance to a $21.2 million deficit, primarily due to a $126.7 million net loss - The company's accumulated deficit grew from **$(519.3) million** at the end of 2018 to **$(646.0) million** as of September 30, 2019, due to ongoing net losses[12](index=12&type=chunk) - Share-based compensation contributed approximately **$8.0 million** to additional paid-in capital during the first nine months of 2019[12](index=12&type=chunk) [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $114.9 million, offset by $111.8 million from financing, resulting in a $6.3 million net cash decrease and a $155.3 million period-end balance Cash Flow Summary (Nine Months Ended Sep 30) | Cash Flow Activity | 2019 ($) | 2018 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | (114,900,319) | (78,666,841) | | Net cash used in investing activities | (3,178,375) | (20,826,686) | | Net cash provided by financing activities | 111,795,667 | 162,357,192 | | **(Decrease) increase in cash** | **(6,283,027)** | **62,863,665** | | **Cash, end of period** | **155,330,050** | **189,999,293** | - Financing activities in 2019 were driven by **$200 million** in proceeds from a new Financing Agreement, which was used in part to repay **$81.7 million** of a previous Credit Agreement[14](index=14&type=chunk) [Notes to Unaudited Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) The notes detail the company's transition to a commercial entity, outlining key accounting policies, significant debt and license agreements, and a subsequent equity offering [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's transition to a commercial entity, highlighting increased revenue from product sales and a license fee, alongside rising operating expenses and new financing [Overview](index=34&type=section&id=MD%26A%20Overview) The company has transitioned from R&D to commercialization, launching key products IMVEXXY, BIJUVA, and ANNOVERA, and securing international licensing agreements - The company has transitioned from being predominately focused on R&D to one focused on **commercializing its drugs** following FDA approvals in 2018[128](index=128&type=chunk) - Key commercial products are **IMVEXXY**, **BIJUVA**, and the licensed product **ANNOVERA**, with a full launch of ANNOVERA expected in Q1 2020[128](index=128&type=chunk) - The company entered an exclusive license agreement with **Theramex** to commercialize **BIJUVA** and **IMVEXXY** outside of the U.S., Canada, and Israel[128](index=128&type=chunk) [Product Commercialization Status](index=35&type=section&id=Product%20Commercialization%20Status) The company is actively commercializing IMVEXXY, BIJUVA, and ANNOVERA, achieving broad payer coverage and patient reach, with ANNOVERA's full launch planned for Q1 2020 - **IMVEXXY** achieved unrestricted coverage with **8 of the top 10 commercial payers** and had approximately **95,300 patients** with at least one paid prescription by September 30, 2019[134](index=134&type=chunk)[135](index=135&type=chunk) - **BIJUVA**, launched in April 2019, achieved coverage with **5 of the top 10 commercial payers** and had approximately **9,100 patients** with at least one paid prescription by September 30, 2019[142](index=142&type=chunk)[143](index=143&type=chunk) - **ANNOVERA** began a 'test and learn' market introduction in Q3 2019 with a full launch expected in Q1 2020, pursuing distribution opportunities with direct-to-consumer platforms[149](index=149&type=chunk)[150](index=150&type=chunk) [Research and Development Expenses](index=39&type=section&id=Research%20and%20Development%20Expenses) R&D expenses decreased by 39% to $4.1 million in Q3 2019 and by 25% to $15.4 million for the nine-month period, reflecting a shift to commercial focus R&D Expense by Project (in thousands) | Project | Q3 2019 ($) | Q3 2018 ($) | Nine Months 2019 ($) | Nine Months 2018 ($) | | :--- | :--- | :--- | :--- | :--- | | TX 001-HR (BIJUVA) | 454 | 3,017 | 2,869 | 8,432 | | TX 004-HR(IMVEXXY) | 527 | 764 | 1,869 | 3,922 | | ANNOVERA | 396 | — | 2,109 | — | | Other R&D | 2,701 | 2,927 | 8,513 | 8,192 | | **Total** | **4,078** | **6,708** | **15,360** | **20,546** | - Total R&D costs incurred since project inception are approximately **$130.1 million** for **BIJUVA** and **$47.6 million** for **IMVEXXY**[174](index=174&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) Q3 2019 revenues surged to $23.7 million, narrowing operating loss, while nine-month revenues grew to $33.7 million, but operating loss widened to $106.8 million due to increased expenses Q3 2019 vs Q3 2018 Results (in thousands) | Metric | Q3 2019 ($) | Q3 2018 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Product revenue, net | 8,213 | 3,474 | 4,739 | | License revenue | 15,506 | — | 15,506 | | Operating loss | (27,072) | (34,361) | (7,289) | | Net loss | (31,967) | (35,605) | (3,638) | Nine Months 2019 vs 2018 Results (in thousands) | Metric | Nine Months 2019 ($) | Nine Months 2018 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Product revenue, net | 18,239 | 11,010 | 7,229 | | License revenue | 15,506 | — | 15,506 | | Operating loss | (106,813) | (92,100) | (14,713) | | Net loss | (126,709) | (93,226) | (33,483) | - The increase in Q3 2019 revenue was primarily driven by a one-time license fee of **$15.5 million** from **Theramex** and a **$4.6 million** increase in **IMVEXXY** sales[159](index=159&type=chunk) - Operating expenses for the nine months ended Sep 30, 2019 increased by **$35.8 million (35%)** year-over-year, mainly due to higher sales & marketing (**$16.8M**) and human resources (**$13.9M**) costs to support product commercialization[180](index=180&type=chunk) [Liquidity and Capital Resources](index=45&type=section&id=Liquidity%20and%20Capital%20Resources) The company held $155.3 million in cash, funded operations via a new $300 million debt facility, and subsequently raised $77.0 million from an equity offering, ensuring sufficient liquidity - The company had cash and cash equivalents of approximately **$155.3 million** as of September 30, 2019[191](index=191&type=chunk) - In April 2019, the company entered a new **$300 million** secured term loan facility, drawing an initial **$200 million**[195](index=195&type=chunk) - Subsequent to the quarter end, on October 29, 2019, the company closed a public offering of common stock, raising net proceeds of approximately **$77.0 million**[194](index=194&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its $200 million variable-rate debt, with a 1.0% change impacting pre-tax income by $2.0 million annually - The company is exposed to interest rate risk from its **$200 million** outstanding balance on the Financing Agreement[208](index=208&type=chunk) - A **1.0%** change in interest rates is estimated to impact pre-tax income by approximately **$2.0 million** per year[208](index=208&type=chunk) [Item 4. Controls and Procedures](index=49&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that disclosure controls and procedures were effective as of the end of the reporting period[210](index=210&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[213](index=213&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=50&type=section&id=Item%201.%20Legal%20Proceedings) The company settled with the SEC for Regulation FD violations, paying a $200,000 penalty, and is not involved in other material legal proceedings - In August 2019, the company settled with the SEC for violations of Regulation FD, agreeing to pay a **$200,000** penalty without admitting or denying the findings[214](index=214&type=chunk) [Item 1A. Risk Factors](index=50&type=section&id=Item%201A.Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K - No material changes to risk factors were reported for the period[216](index=216&type=chunk) [Item 6. Exhibits](index=51&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including supply and lease agreements, CEO/CFO certifications, and XBRL data files - Exhibits filed include a Commercial Supply Agreement with QPharma AB, a lease agreement, CEO/CFO certifications, and XBRL data files[218](index=218&type=chunk)

TherapeuticsMD, Inc. (NASDAQ:TXMD) Q3 2019 Earnings Conference Call November 6, 2019 4:30 PM ET Company Participants Nichol Ochsner - Vice President, Investor Relations Robert Finizio - Chief Executive Officer Dan Cartwright - Chief Financial Officer Dawn Halkuff - Chief Commercial Officer Conference Call Participants Annabel Samimy - Stifel Sudan Naveen Loganathan - Cantor Fitzgerald Ekaterina Knyazkova - JPMorgan Douglas Tsao - HCW Operator Good afternoon, ladies and gentlemen. Thank you for joining us fo ...

1 3Q 2019 Earnings November 6, 2019 Building a Premier Women's Health Portfolio TherapeuticsMD® For Her. For Life. Forward-Looking Statements This presentation by TherapeuticsMD, Inc. (referred to as "we" and "our") 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 address activities, events or developments that we intend, expect, project ...

Imvexxy - Imvexxy's launch strategy is showing strong results and is on track[9] - Imvexxy's market share reached 9% by month 14[13] - Imvexxy patients average 38 fills per year, higher than vaginal creams (15 fills/year) and vaginal tablets (35 fills/year)[18] Bijuva - Bijuva launched in April 2019, targeting the separate bio-identical Estrogen & Progesterone pills segment[40] - As of August 2019, Bijuva had approximately 14,200 total paid scripts dispensed to patients and approximately 5,300 total paid scripts in August alone[45] - As of August 2019, Bijuva had approximately 6,800 total patients and approximately 3,000 total prescribers[45] Annovera - Annovera's test and learn market introduction has begun, with a full launch expected in Q1 2020[67] - The unique commercial payer environment for Annovera provides the expectation for initial net revenue of at least $1,100 per unit[67] - 44% commercial coverage was achieved in under one month of Annovera being available in the channel[67] Market Overview - The VVA (Vulvar and Vaginal Atrophy) market exceeds $17 billion in gross revenue annually[29, 30]

(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, 2019 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q 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 No. 001-00100 THERAPEUTICSMD, INC. (Exact Name of Registrant as Specified in Its Charter) Nevada 87-0233535 (State or Ot ...

TherapeuticsMD, Inc. (NASDAQ:TXMD) Q2 2019 Earnings Conference Call August 6, 2019 4:30 PM ET Company Participants Nichol Ochsner - Vice President of Investor Relations Robert Finizio - Chief Executive Officer Daniel Cartwright - Chief Financial Officer Dawn Halkuff - Chief Commercial Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Annabel Samimy - Stifel Jay Olson - Oppenheimer Operator Good afternoon, ladies and gentlemen. Thank you for joining us for the TherapeuticsMD Second Quarter ...