Financial Performance - The company reported a loss from operations of $45.1 million and interest expense of $26.1 million for the six months ended June 30, 2022[104]. - Total revenue for Q2 2022 was $28.6 million, an increase of $5.6 million, or 24.2%, compared to Q2 2021[119]. - ANNOVERA sales were $18.3 million for Q2 2022, an increase of $8.7 million, or 91.2%, compared to Q2 2021[120]. - IMVEXXY sales were $6.7 million for Q2 2022, a decrease of $3.2 million, or 32.2%, compared to Q2 2021[121]. - BIJUVA sales were $2.7 million for Q2 2022, an increase of $0.5 million, or 23.1%, compared to Q2 2021[122]. - Gross profit for Q2 2022 was $23.8 million, an increase of $5.0 million, or 26.2%, compared to Q2 2021[125]. - Total operating expenses for Q2 2022 were $42.7 million, a decrease of $11.4 million, or 21.1%, compared to Q2 2021[126]. - Net income for Q2 2022 was $112.3 million, or $12.83 per basic common share, including a non-recurring gain of $142.8 million from the vitaCare divestiture[131]. - Total revenue for the first six months of 2022 was $47.9 million, an increase of $5.0 million, or 11.7%, compared to the first six months of 2021[132]. - IMVEXXY sales for the first six months of 2022 were $13.6 million, a decrease of $3.2 million, or 19.1%, compared to the first six months of 2021[133]. - BIJUVA sales for the first six months of 2022 were $5.2 million, an increase of $0.6 million, or 13.3%, compared to the first six months of 2021[134]. - Prescription vitamin sales decreased to $1.8 million for the first six months of 2022, down $1.0 million or 37.1% compared to the same period in 2021[137]. - Total product sales increased to $47.4 million for the first six months of 2022, an increase of $4.8 million or 11.3% compared to the first six months of 2021[137]. - Gross profit for the first six months of 2022 was $38.3 million, an increase of $4.2 million or 12.5% compared to the same period in 2021[139]. - Total operating expenses decreased to $83.4 million for the first six months of 2022, a decrease of $15.1 million or 15.4% compared to the first six months of 2021[140]. - Net income for the first six months of 2022 was $63.3 million, or $7.29 per basic common share, including a non-recurring gain of $142.8 million from the sale of the vitaCare business[146]. Cash Flow and Liquidity - Net cash used in operating activities was $44.9 million for the first six months of 2022, a decrease of $20.0 million or 30.8% compared to the same period in 2021[151]. - Net cash provided by investing activities was $142.3 million for the first six months of 2022, an increase of $142.9 million or 27110.8% compared to the first six months of 2021[152]. - Net cash used in financing activities was $125.0 million for the first six months of 2022, a change of $221.4 million or 229.7% compared to the same period in 2021[153]. - As of June 30, 2022, the company had cash totaling $26.3 million[147]. - The company had $90.8 million in term loans outstanding under its Financing Agreement as of June 30, 2022, down from $200.0 million as of December 31, 2021[157]. Divestiture and Strategic Actions - The company completed the divestiture of vitaCare Prescription Services, receiving net proceeds of $142.6 million and recognizing a gain on sale of $143.4 million[96]. - The company may receive up to an additional $7.0 million in earn-out consideration from the vitaCare divestiture, contingent on vitaCare's financial performance through 2023[96]. - The company has a long-term services agreement with vitaCare to utilize its platform for product support post-divestiture[98]. - The company is pursuing various equity and debt refinancing options to address capital needs, including potential Chapter 11 protection if financing fails[105]. Product Development and Market Conditions - ANNOVERA, a contraceptive product, is expected to meet future demand with increased manufacturing capacity following FDA approval of a supplemental NDA[114]. - The company has implemented significant cost-saving measures in response to the COVID-19 pandemic, including reducing marketing expenses and hiring restrictions[101]. - The company continues to face uncertainties related to the COVID-19 pandemic, which may impact financial condition and liquidity[102]. - The company’s product portfolio includes IMVEXXY, BIJUVA, and ANNOVERA, with ongoing commercialization efforts since their respective launches[111]. Financial Position - Current liabilities exceeded current assets by $65.4 million, and total liabilities exceeded total assets by $26.1 million as of June 30, 2022[104]. - The company qualifies as a "smaller reporting company" under Rule 12b-2 of the Securities Exchange Act of 1934[160]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its reporting status[160].

Financial Data and Key Metrics Changes - Total net revenue for Q2 2022 was $28.6 million, an increase of 24% compared to Q2 2021 [6] - Total operating expenses decreased by $11.4 million or 21% during the quarter [6][16] - Gross profit rose by 26% to $23.8 million [6][15] Business Line Data and Key Metrics Changes - Sales of ANNOVERA reached $18.3 million, an increase of 91.2% compared to Q2 2021, primarily due to increased sales volume [12] - IMVEXXY sales were $6.7 million, a decrease of 32.2% compared to Q2 2021, attributed to lower sales volume and average sales price [13] - BIJUVA sales increased to $2.7 million, up 23.1% compared to Q2 2021, driven by a Theramex license agreement and increased sales volume [13] - Prescription vitamin sales decreased to $0.9 million, down 35.5% compared to Q2 2021, due to lower sales volume and average sales price [14] Market Data and Key Metrics Changes - ANNOVERA prescriptions grew 28% compared to Q2 2021, reaching an all-time high of 901 prescriptions in the last week of the quarter [22] - New prescribers for ANNOVERA increased to 12,000, indicating strong demand and growth potential [23] - IMVEXXY added 1,606 new prescribers, exceeding 30,000 since launch, despite a slight decline in total prescriptions [25] Company Strategy and Development Direction - The company completed the divestiture of the vitaCare business unit, allowing for a more focused business strategy [7] - The FDA approved a supplemental new drug application for ANNOVERA, expected to reduce manufacturing batch rejections and increase product supply [8] - The company is evaluating options for refinancing current debt and pursuing strategic alternatives to support operations and growth [10] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the ambiguity in the operating environment but expressed confidence in the team's performance and commitment [32] - The company is optimistic about the demand for ANNOVERA and believes the recent revenue performance reflects genuine end demand [34][36] - Management addressed concerns about rejection rates for ANNOVERA, stating that root causes have been identified and resolved [42][43] Other Important Information - The company recognized a gain of $143.4 million from the sale of the vitaCare business [20] - Net cash used in operating activities was $15.4 million for the quarter, with $26.3 million in cash as of June 30, 2022 [21] Q&A Session Summary Question: Employee retention rates in the sales force amid uncertainty - Management remains encouraged by the commitment of the field force despite ambiguity, with turnover rates being reasonable [31][33] Question: Revenue performance of ANNOVERA and demand reflection - Revenue performance is primarily based on demand, with a restocking of channels occurring due to previous inventory concerns [36] Question: Concerns about rejection rates affecting long-term product opportunity - Management confirmed that rejection rates for ANNOVERA have been addressed and do not expect them to impact long-term opportunities [42][43] Question: Vision for the company post-tender process - The company is focused on maintaining operations and meeting demand while evaluating all options for long-term financial strength [46]

TherapeuticsMD® | --- | --- | --- | |-------------------------------------------------------------------------------|-------|-------| | | | | | Building the Premier Women's Health Company Q2 2022 Earnings August 15, 2022 | | | | FOR INVESTOR PRESENTATION PURPOSES ONLY. | | | Forward-Looking Statements This presentation by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD's objectives, plans and s ...

Financial Data and Key Metrics Changes - The company's net product revenue for Q1 2022 was $19.3 million, a slight increase of 3.5% compared to $18.7 million in Q4 2021, but a decrease of 2.7% from $19.9 million in Q1 2021 [8][12] - Gross profit for Q1 2022 was $14.5 million, down 4.7% from Q1 2021, but up 3.8% from Q4 2021 [18] - Selling and marketing costs decreased by 21.3% year-over-year to $18.9 million, and general and administrative costs increased by 11% to $20.4 million compared to Q1 2021 [19][20] Business Line Data and Key Metrics Changes - ANNOVERA sales were $8.5 million in Q1 2022, down 2.7% from Q1 2021, but up 8.7% from Q4 2021 [13][14] - IMVEXXY net revenue remained flat at $7 million compared to Q1 2021, but increased by 4.5% from Q4 2021 [14] - BIJUVA sales increased by 4.7% year-over-year to $2.6 million, but decreased by 4.5% quarter-over-quarter [15] Market Data and Key Metrics Changes - Total quarterly prescriptions for ANNOVERA increased by 27% compared to Q1 2021, despite supply challenges [29] - The company is seeing early improvements in demand for IMVEXXY and BIJUVA following strategic realignments [30][32] Company Strategy and Development Direction - The company is focused on optimizing sales targeting and leveraging all three product assets effectively [26] - There is an emphasis on building inventory for ANNOVERA to meet growing demand, with expectations of improved manufacturing in Q2 2022 [28][29] - The management believes that the new commercial plan is yielding positive results, with increased sales productivity and robust demand for products [33] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that ANNOVERA supply challenges peaked in Q1 2022 and expects incremental improvement as the year progresses [8] - The company has paused offering full-year guidance for 2022 until clarity on capital structure and FDA feedback is received [9] Other Important Information - The company completed the $150 million divestiture of vitaCare, receiving approximately $138.5 million in cash [11] - Net cash used in operating activities was $29.5 million for Q1 2022, with $30.4 million in cash as of March 31, 2022 [25] Q&A Session Summary Question: What are the expectations for ANNOVERA's supply challenges? - Management believes that supply challenges peaked in Q1 2022 and anticipates improvements in manufacturing throughout Q2 [8][29] Question: How is the company addressing sales productivity? - The company is focusing on optimizing sales targeting and leveraging all three product assets effectively, which has already shown positive results [26][33]

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 March 31, 2022 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 incorporat ...

Financial Performance and Market Trends - The company received a cash payment of $150.0 million from the sale of vitaCare, with potential additional earn-out consideration of up to $7.0 million based on vitaCare's financial performance through 2023[21]. - The global market for women's health therapeutics is projected to grow from $31.5 billion in 2019 to $41.2 billion by 2025, at a CAGR of 4.7%[42]. - The U.S. contraceptive market size is expected to reach $9.9 billion by 2027, expanding at a CAGR of 4.3% from 2020 to 2027[45]. - In 2021, the FDA-approved prescription market in the U.S. for contraceptive products generated $5.4 billion in gross sales from over 69 million prescriptions[60]. - The menopause market is projected to grow from $5.7 billion in 2019 to $7.7 billion by 2025 at a CAGR of 5.4%[42]. Product Development and FDA Approvals - The FDA-approved product IMVEXXY was launched in July 2018 for the treatment of moderate-to-severe dyspareunia, with the product approved by the FDA in May 2018[23]. - The FDA-approved product BIJUVA was launched in April 2019 for the treatment of moderate-to-severe vasomotor symptoms, with the product approved by the FDA in October 2018[23]. - The FDA approved the supplemental NDA for the 0.5 mg/100 mg dose of BIJUVA in December 2021[69]. - IMVEXXY demonstrated efficacy as early as two weeks in clinical studies, maintaining efficacy through week 12[61]. - The FDA has required a post-approval observational study for ANNOVERA to measure the risk of venous thromboembolism[54]. Sales and Marketing Strategies - The company has established relationships with some of the largest OB/GYN practices, leveraging these connections to increase sales of its products[32]. - The company utilizes a national sales force to market its products primarily in the OB/GYN market, enhancing customer experience and access to care[31]. - The company aims to penetrate the compounding market with FDA-approved products, positioning BIJUVA as a proven alternative to non-FDA approved compounded hormone therapy products[38]. - The company has established patient affordability programs to support access to its products[83]. - The company aims for 100% customer satisfaction, maintaining a fully staffed customer care center to enhance customer relationships and facilitate repeat purchases[110]. Revenue Contributions and Product Performance - For 2021, 44.2% of the consolidated product revenue was generated by ANNOVERA, while IMVEXXY contributed 36.8%[60][64]. - BIJUVA generated 12.3% of consolidated product revenue in 2021, up from 10.1% in 2020 and 5.4% in 2019[72]. - The prenatal vitamin products contributed 6.7% of consolidated product revenue in 2021[75]. - The total FDA-approved prescription market for estrogen and progestin products in the U.S. generated $2.1 billion in gross sales from 23.5 million prescriptions in 2021[68]. Regulatory Compliance and Challenges - The company is required to report adverse reactions and production problems to the FDA as part of its post-approval regulation compliance[129]. - The company’s contract manufacturer, Catalent, received a Form FDA 483 in 2019, indicating that objectionable conditions were found but no regulatory action was recommended[132]. - The company relies on third parties for the production of clinical and commercial quantities of its drugs and drug candidates, which may face compliance issues from future FDA inspections[133]. - The FDA has broad authority to enforce federal law applicable to dietary supplements, including the ability to issue public warnings and request recalls of unsafe products[152]. - The company must comply with federal and state healthcare laws, including the Anti-Kickback Statute and the False Claims Act, which impose significant penalties for non-compliance[155]. Strategic Partnerships and Licensing - The company has entered into license agreements with strategic partners to commercialize its products outside of the U.S.[20]. - Theramex paid an upfront fee of EUR 14 million (approximately $15.5 million) for the license agreement related to BIJUVA and IMVEXXY[93]. - The company is eligible for additional sales milestone payments up to EUR 27.5 million based on annual net sales milestones of BIJUVA and IMVEXXY outside the U.S.[95]. - The Population Council received a total of $40.0 million in milestone payments related to ANNOVERA, with additional payments contingent on cumulative net sales milestones of $200.0 million, $400.0 million, and $1.0 billion[86]. Human Capital and Workforce Management - As of December 31, 2021, the company had 416 employees, with a focus on maintaining a good relationship with its workforce and no collective bargaining agreements in place[165]. - The company has implemented a human capital strategy focused on attracting talent, engaging the workforce, developing leaders, and promoting its culture, earning recognition as a "Top Workplace" in 2020[164]. - The company has a sales force primarily composed of employees, with limited contract sales agents, focusing on key markets such as 340B entities and the Department of Defense[165]. Market Competition and Intellectual Property - The company received a Paragraph IV certification notice letter from Teva Pharmaceuticals regarding an ANDA submission, indicating potential competition for its products[142]. - The company entered into a settlement agreement with Amneal Pharmaceuticals to resolve patent litigation, allowing Amneal to market a generic version of BIJUVA starting in May 2032[144]. - The company has 46 issued domestic patents and 47 issued foreign patents as of December 31, 2021, with 86 pending patent applications[116]. - The company holds multiple U.S. trademark registrations and has numerous pending trademark applications, which are valuable for marketing its products[119].

TherapeuticsMD® For Her. For Life. | --- | --- | --- | --- | |-------|-------------------------------------------------------|------------------------|-------| | | | | | | | Building the Premier Q4 2021 Earnings March 10, 2022 | Women's Health Company | | | | FOR INVESTOR PRESENTATION PURPOSES ONLY. | | | Forward-Looking Statements This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to Therapeu ...

TherapeuticsMD, Inc. (NASDAQ:TXMD) Q4 2021 Earnings Conference Call March 10, 2022 8:30 AM ET Company Participants Lisa Wilson - Investor Relations Hugh O’Dowd - Chief Executive Officer James D’Arecca - Chief Financial Officer Mark Glickman - Chief Business Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Douglas Tsao - H.C. Wainwright Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timestamps within the transcript are desi ...

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 ...