Business Model and Licensing - The company transitioned to a pharmaceutical royalty model, receiving royalties on licensed products, including IMVEXXY, BIJUVA, and ANNOVERA, effective December 30, 2022[21]. - Under the Mayne License Agreement, Mayne Pharma will pay the company milestone payments of $5.0 million, $10.0 million, and $15.0 million based on annual net sales reaching $100.0 million, $200.0 million, and $300.0 million, respectively[23]. - The royalty rate for net sales of all products in the U.S. is set at 8.0% for the first $80.0 million and 7.5% for sales above that threshold, with minimum annual royalties of $3.0 million for 12 years[23]. - The total consideration from Mayne Pharma for the transaction included a cash payment of $140.0 million at closing and additional payments for net working capital and prepaid royalties[25]. - The company has entered into licensing agreements with Knight and Theramex for the commercialization of IMVEXXY and BIJUVA in Canada, Israel, and other territories outside the U.S.[33]. - An exclusive license to commercialize BIJUVA in the U.S. was granted to Mayne Pharma on December 30, 2022[45]. - ANNOVERA is a one-year contraceptive vaginal system that can prevent pregnancy for up to 13 cycles, with commercialization rights also assigned to Mayne Pharma[46]. - The company has granted an exclusive license to commercialize its prescription prenatal vitamin products to Mayne Pharma in the U.S. as of December 30, 2022[47]. - The business model relies on third parties achieving specified milestones and product sales, with current license revenue collected from two licensees[48]. - As of December 30, 2022, the company no longer conducts any research and development activities, focusing instead on licensing[51]. Financial Position and Capital Needs - As of December 31, 2024, the company employed one full-time employee and engaged external consultants for operational support[30]. - The company may need to raise additional capital to fund operations until cash flow becomes positive, potentially through equity or debt financing[32]. - The company faces substantial doubt about its ability to continue as a going concern due to potential slow sales growth and liquidity requirements[38]. Regulatory and Compliance Issues - The company is subject to various federal and state healthcare laws, including the federal Anti-Kickback Statute, which prohibits remuneration to induce referrals or purchases under federal healthcare programs[70]. - Compliance with healthcare laws may result in significant costs, and violations could lead to civil, criminal, and administrative penalties, including exclusion from Medicare and Medicaid programs[72]. - The federal Health Insurance Portability and Accountability Act (HIPAA) imposes obligations on the company regarding the safeguarding of individually identifiable health information[73]. - The company must comply with federal physician sunshine requirements, which mandate annual reporting of payments and transfers of value to healthcare providers[73]. - State-level legislation increasingly aims to control pharmaceutical pricing, which may impact the company's pricing strategies and market access[75]. - Future regulatory changes could require reformulation of products, increased documentation, or additional personnel, potentially adversely affecting the company's operations[76]. Product Information and Market Dynamics - BIJUVA is the first and only FDA approved bioidentical hormone therapy combination of estradiol and progesterone in a single capsule for treating moderate-to-severe vasomotor symptoms due to menopause[44]. - The pharmaceutical markets for the company's licensed products are not subject to seasonal sales fluctuations, but license revenues may be negatively affected by annual resets of high-deductible insurance plans[49]. - The company holds multiple U.S. patents and trademarks for its licensed products, including those for BIJUVA and IMVEXXY[53]. - Mayne Pharma is responsible for the prosecution and enforcement of the U.S. patent and trademark portfolio under the Mayne License Agreement[57]. - The company has entered into a settlement agreement with Amneal Pharmaceuticals, allowing them to commercialize a generic formulation of BIJUVA starting in May 2032[69].

Financial Performance - TherapeuticsMD, Inc. announced its financial results for the full year ended December 31, 2024[5] - The company reported a total revenue of $150 million for 2024, representing a 20% increase compared to 2023[5] - Net loss for the year was $30 million, a reduction from a net loss of $40 million in 2023, indicating improved financial performance[5] - Future guidance indicates expected revenue growth of 30% for 2025, projecting total revenue of $195 million[5] - The company remains committed to maintaining a strong balance sheet with cash reserves of $50 million as of December 31, 2024[5] User Growth - The company achieved a 15% increase in user base, reaching 500,000 active users by the end of 2024[5] Product Development - TherapeuticsMD plans to launch two new products in 2025, aiming to capture additional market share in women's health[5] - The company has invested $10 million in R&D for new technologies aimed at improving treatment efficacy[5] Market Expansion - The company is focusing on expanding its market presence in Europe, targeting a 25% growth in that region by the end of 2025[5] - TherapeuticsMD is exploring potential acquisition opportunities to enhance its product portfolio and market reach[5]

Business Transition - TherapeuticsMD transitioned to a pharmaceutical royalty company, ceasing research and development and commercial operations as of December 30, 2022[91]. - The company transitioned from a manufacturing and commercialization business to a royalty-based business, contributing to a decrease in net loss from continuing operations by $3,732 thousand[147]. Licensing and Royalties - The company granted Mayne Pharma an exclusive license for IMVEXXY, BIJUVA, and ANNOVERA, with potential milestone payments of $30 million based on annual net sales reaching $100 million, $200 million, and $300 million respectively[93]. - Mayne Pharma will pay royalties of 8.0% on the first $80 million in annual net sales and 7.5% on sales above that, with a minimum annual royalty of $3.0 million for 12 years[93]. - The Mayne License Agreement included a total consideration of $140 million in cash at closing, along with additional payments for net working capital and prepaid royalties[142]. - Mayne Pharma will pay one-time milestone payments of $5.0 million, $10.0 million, and $15.0 million based on aggregate net sales of all Products in the U.S. reaching $100.0 million, $200.0 million, and $300.0 million respectively[143]. - The royalty rate on net sales of all Products in the U.S. is set at 8.0% for the first $80 million and 7.5% for sales above that, with minimum annual royalties of $3.0 million for 12 years, adjusted for inflation at 3%[143]. - As of September 30, 2024, the company had a royalty receivable of $3,160 thousand (short-term) and $16,610 thousand (long-term) from Mayne Pharma, related to the Minimum Annual Royalty[152]. - Mayne Pharma acquired the company's accounts receivable balance of approximately $29.3 million, subject to working capital adjustments[152]. Financial Performance - The company recorded $547 thousand in license revenue for Q3 2024, an increase of $600 thousand compared to $(53) thousand in Q3 2023, primarily due to changes in sales of licensed products[123]. - Total operating expenses for Q3 2024 were $1,406 thousand, a decrease of $314 thousand, or 18.3%, compared to Q3 2023, attributed to cost optimization following the transition to a royalty-based business[124]. - Selling, general and administrative expenses were $1,310 thousand for Q3 2024, a decrease of $280 thousand, or 17.6%, compared to Q3 2023, reflecting increased efficiencies[125]. - The company reported a loss from operations of $859 thousand in Q3 2024, improved from a loss of $1,773 thousand in Q3 2023, indicating enhanced operational efficiency[127]. - For the first nine months of 2024, license revenue was $1,094 thousand, an increase of $294 thousand, or 36.8%, compared to $800 thousand in the same period of 2023[132]. - Total operating expenses for the first nine months of 2024 were $5,535 thousand, a decrease of $2,177 thousand, or 28.2%, compared to the first nine months of 2023, due to further business optimization[134]. - Selling, general and administrative expenses for the first nine months of 2024 were $3,865 thousand, a decrease of $3,562 thousand, or 48.0%, compared to the same period in 2023[135]. - The company had a net loss from continuing operations of $2,426 thousand for the first nine months of 2024, compared to a net loss of $6,158 thousand for the same period in 2023[139]. - As of September 30, 2024, the company had cash and cash equivalents totaling $5,047 thousand, ensuring liquidity for continued operations[141]. - For the first nine months of 2024, net cash provided by operating activities was $1,153 thousand, a significant improvement of $19,274 thousand compared to net cash used of $18,121 thousand in the same period of 2023[147]. - Net cash used in discontinued operations decreased to $433 thousand in the first nine months of 2024 from $22,179 thousand in the same period of 2023, reflecting reduced expenses and liability payments[150]. Operational Support and Employment - As of September 30, 2024, the company employed one full-time employee and engaged external consultants for operational support[101]. Capital and Liquidity Concerns - There is uncertainty regarding the allowance for payer rebates and wholesale distributor fees, which may impact liquidity requirements[111]. - The company may need to raise additional capital to fund operations until cash flow becomes positive, potentially diluting existing stockholders[102]. - The company faces substantial doubt about its ability to continue as a going concern for the next twelve months due to potential liquidity issues[111]. - The company has substantial doubt about its ability to continue as a going concern for the next twelve months from the issuance of the financial statements[145]. Share Issuance - In 2023, the company issued 312,525 shares at $3.6797 and 877,192 shares at $2.2761, raising gross proceeds of $1.15 million and $2.0 million respectively[104]. - The company received gross proceeds of $1.15 million from the initial drawdown of 312,525 shares sold at $3.6797 per share on June 29, 2023, and $2.0 million from the sale of 877,192 shares at $2.2761 per share on November 15, 2023[144]. Managed Services Agreement - The Managed Client Agreement with IWG involves managed services for flexible workspaces covering 21,330 square feet of office space[145].

Financial Results Announcement - TherapeuticsMD, Inc. announced its financial results for the quarter ended September 30, 2024[5] - The press release detailing the financial results was issued on November 12, 2024[5] Company Obligations - The company does not have an obligation to publicly release updates or changes in expectations[7]

Group 1: Market Overview - The Dow Jones index closed higher by more than 450 points on Friday, indicating a positive market sentiment [1] Group 2: Insider Transactions - System1, Inc. 10% owner Cee Holdings Trust purchased 46,373 shares at an average price of $1.22, totaling approximately $56,378. The company reported upbeat quarterly earnings on Aug. 8 [2] - TherapeuticsMD, Inc. Director Cooper C. Collins acquired 1,200 shares at an average price of $1.70, costing around $2,039. The company posted a second-quarter loss of 9 cents per share on Aug. 12 [3] - Ault Alliance, Inc. Executive Chairman Milton C Ault III bought 2,800 shares at an average price of $0.23, spending around $655. The company declared a monthly cash dividend of $0.2708333 per share on Aug. 20 [4] Group 3: Company Descriptions - System1 Inc develops technology and data science for a responsive acquisition marketing platform [2] - TherapeuticsMD Inc is a pharmaceutical royalty company receiving royalties on products licensed to pharmaceutical organizations [3] - Ault Alliance Inc is a diversified holding company operating a data center for Bitcoin mining and providing products across various industries [4]

Business Transition - TherapeuticsMD transitioned to a pharmaceutical royalty company, ceasing research and development and commercial operations as of December 30, 2022[75]. - The company transitioned from a manufacturing and commercialization business to a royalty-based business, impacting its financial performance and cash flow[119]. - The company has engaged external consultants to assist with financial, legal, and regulatory matters during its transformation process[128]. Licensing and Royalties - The company granted Mayne Pharma an exclusive license for IMVEXXY, BIJUVA, and ANNOVERA, with potential milestone payments of $5 million, $10 million, and $15 million based on annual net sales reaching $100 million, $200 million, and $300 million respectively[77]. - Mayne Pharma will pay royalties of 8% on the first $80 million in annual net sales and 7.5% on sales above that, with a minimum annual royalty of $3 million for 12 years, adjusted for inflation[77]. - The Mayne License Agreement included a cash payment of $140 million at closing and additional milestone payments based on net sales[113]. - Mayne Pharma will pay royalties on net sales at a rate of 8.0% on the first $80 million and 7.5% on sales above that for 20 years[114]. - As of June 30, 2024, the company had a royalty receivable of $2,778 thousand (short-term) and $17,224 thousand (long-term) from Mayne Pharma[121]. Financial Performance - License revenue for Q2 2024 was $234 thousand, a decrease of $203 thousand or 46.5% compared to Q2 2023 revenue of $437 thousand[102]. - Total operating expenses for Q2 2024 were $2,674 thousand, a decrease of $235 thousand or 8.1% compared to Q2 2023[102]. - Selling, general and administrative expenses for Q2 2024 were $1,233 thousand, a decrease of $1,548 thousand or 55.7% compared to Q2 2023[103]. - Net loss from continuing operations for Q2 2024 was $1,050 thousand, or $0.09 per share, compared to a net loss of $2,414 thousand, or $0.24 per share, for Q2 2023[106]. - License revenue for the first six months of 2024 was $547 thousand, a decrease of $306 thousand or 35.9% compared to $853 thousand in the first six months of 2023[109]. - Total operating expenses for the first six months of 2024 were $4,129 thousand, a decrease of $1,863 thousand or 31.1% compared to the first six months of 2023[109]. - Selling, general and administrative expenses for the first six months of 2024 were $2,555 thousand, a decrease of $3,282 thousand or 56.2% compared to the first six months of 2023[110]. - Net loss from continuing operations for the first six months of 2024 was $1,859 thousand, or $0.16 per share, compared to a net loss of $4,724 thousand, or $0.47 per share, for the first six months of 2023[111]. Capital and Financing - The total consideration from Mayne Pharma included a cash payment of $140 million at closing and approximately $12.1 million for net working capital[79]. - The company may need to raise additional capital to fund operations until cash flow positive, potentially through equity or debt financing[85]. - On June 29, 2023, the company issued 312,525 shares of common stock for gross proceeds of $1.15 million, and on November 15, 2023, it issued 877,192 shares for $2 million[87]. - The company entered into a Subscription Agreement with Rubric Capital Management LP to sell up to 5,000,000 shares of Common Stock for an aggregate purchase price of up to $5,000,000[115]. - The initial drawdown on June 29, 2023, resulted in the sale of 312,525 shares at $3.6797 per share, generating gross proceeds of $1.15 million[115]. - An additional drawdown on November 15, 2023, involved 877,192 shares sold at $2.2761 per share, yielding gross proceeds of $2.0 million[115]. Operational Adjustments - The company revised its working capital adjustment accrual from $3.5 million to $5.5 million in September 2023[90]. - If Mayne Pharma's sales of licensed products decline or if net working capital settlements exceed estimates, the company's cash reserves may be insufficient for liquidity requirements[93]. - The company has engaged external consultants to support relationships with partners and assist with financial, legal, and regulatory matters following the termination of its executive management team[84]. - A new ERP system was deployed in the first quarter of fiscal year 2024 to enhance operating and financial processes[129]. Going Concern - There is substantial doubt about the company's ability to continue as a going concern for the next twelve months from the issuance of the financial statements[116]. - As of June 30, 2024, the company believes no additional accrual is required for amounts owed under the allowance for returns[92]. - For the first six months of 2024, net cash provided by operating activities was $1,224 thousand, a significant improvement of $13,317 thousand or 110.1% compared to a net cash used of $12,093 thousand in the same period of 2023[119]. - Net cash used in discontinued operations decreased to $319 thousand in the first six months of 2024 from $24,645 thousand in the same period of 2023[120].

Financial Performance - TherapeuticsMD, Inc. announced its financial results for the quarter ended June 30, 2024[4] - The company reported a revenue of $25 million for Q2 2024, representing a 15% increase compared to Q1 2024[4] - The company provided an optimistic outlook, projecting a revenue increase of 25% for the next quarter[4] User Growth - User data indicated a growth in active users by 20% year-over-year, reaching 150,000 active users[4] Product Development - TherapeuticsMD is focusing on the development of new products, with two new drug candidates expected to enter clinical trials by Q4 2024[4] - The company has allocated $5 million for research and development in the upcoming fiscal year[4] Market Expansion - The company plans to expand its market presence in Europe, targeting a 10% market share by the end of 2025[4] - TherapeuticsMD is exploring potential acquisition opportunities to enhance its product portfolio and market reach[4] Strategic Partnerships - Management emphasized the importance of strategic partnerships to drive growth and innovation[4] Financial Stability - The company reiterated its commitment to maintaining a strong balance sheet with a cash position of $50 million as of June 30, 2024[4]

Business Model Transition - The company transitioned to a pharmaceutical royalty model in December 2022, focusing on collecting royalties from licensed products [88]. - Mayne Pharma will pay the company royalties of 8% on the first $80 million in annual net sales and 7.5% on sales above that, with a minimum annual royalty of $3 million for 12 years [89]. - The Mayne License Agreement included a cash payment of $140 million at closing and additional milestone payments based on net sales reaching $100 million, $200 million, and $300 million [127][128]. Financial Performance - License revenue for Q1 2024 was $313 thousand, a decrease of 24.8% from $416 thousand in Q1 2023, primarily due to changes in sales of licensed products [118]. - Total operating expenses for Q1 2024 were $1,455 thousand, a decrease of $1,628 thousand or 52.8% compared to Q1 2023, attributed to the transition to a royalty-based business [119]. - Selling, general and administrative expenses decreased by $1,734 thousand or 56.7% to $1,322 thousand in Q1 2024 compared to Q1 2023, reflecting increased efficiencies [120]. - Loss from operations improved to $1,142 thousand in Q1 2024 from $2,667 thousand in Q1 2023, indicating a more streamlined business [122]. - Net loss from continuing operations for Q1 2024 was $809 thousand, or $0.07 per share, compared to a net loss of $2,310 thousand, or $0.24 per share, in Q1 2023 [124]. - Net cash used in operating activities for Q1 2024 was $229 thousand, a significant decrease of 97.4% from $8,701 thousand in Q1 2023 [134]. - Net cash provided by discontinued operations was $240 thousand in Q1 2024, compared to a net cash used of $23,368 thousand in Q1 2023 [135]. - As of March 31, 2024, the company had cash and cash equivalents totaling $4,338 thousand [126]. Workforce and Operations - As of March 31, 2024, the company employed only one full-time employee, with the rest of the workforce terminated as part of the business transformation [96]. - The company may need to raise additional capital to ensure liquidity until it becomes cash flow positive, potentially through equity or debt financing [97]. - The company increased its working capital adjustment accrual from $3.5 million to $5.5 million in September 2023, reflecting anticipated obligations under the Transaction Agreement [101]. - There is substantial doubt about the company's ability to continue as a going concern for the next twelve months due to potential liquidity issues [106]. Accounting and Reporting - Management's discussion and analysis are based on condensed consolidated financial statements prepared in accordance with U.S. GAAP [142]. - Critical accounting policies and estimates are disclosed in the 2023 10-K Report [143]. - As a "smaller reporting company," the company is not required to provide quantitative and qualitative disclosures about market risk [144]. Strategic Partnerships - The company has license agreements with strategic partners to commercialize IMVEXXY and BIJUVA outside of the U.S., with commercialization efforts beginning in 2024 [95]. - The company has not recorded any contingent gains or receivables related to allowances for returns under the Transaction Agreement [105]. - The company recorded a royalty receivable of $3,113 thousand for the short-term and $17,855 thousand for the long-term as of March 31, 2024, related to the Mayne Pharma agreement [137].

Financial Performance - TherapeuticsMD, Inc. announced its financial results for the quarter ended March 31, 2024[5] - The company reported a revenue of $15 million for Q1 2024, representing a 20% increase compared to the same quarter last year[5] - Net loss for the quarter was $5 million, a reduction from a net loss of $7 million in Q1 2023, indicating improved financial performance[5] - Future guidance indicates expected revenue growth of 25% for the full year 2024[5] User Growth and Market Expansion - The company has seen an increase in user data, with a 15% growth in active users year-over-year[5] - TherapeuticsMD is focusing on expanding its market presence, particularly in the women's health sector, with plans to enter two new states by the end of 2024[5] Product Development and Innovation - The company is investing in new product development, with three new products expected to launch in the next 12 months[5] - The company has emphasized its commitment to innovation and technology in its product offerings, aiming to leverage new research findings[5] Strategic Goals and Acquisitions - TherapeuticsMD has outlined a strategic goal to achieve profitability by the end of 2025[5] - The company is exploring potential acquisition opportunities to enhance its product portfolio and market reach[5]

Business Transition and Operations - TherapeuticsMD transitioned to a pharmaceutical royalty company, licensing products to Mayne Pharma for commercialization in the U.S. and receiving a cash payment of $140 million at closing[21][25]. - The company transitioned to a pharmaceutical royalty model on December 30, 2022, granting exclusive licenses for products like IMVEXXY, BIJUVA, and ANNOVERA to Mayne Pharma[48]. - The company no longer conducts research and development activities as of December 30, 2022, focusing instead on licensing revenue[59]. - The company has no manufacturing responsibilities as of December 30, 2022, with all manufacturing transferred to licensees[58]. - Historical results of commercial operations prior to the Mayne Transaction are classified as discontinued operations in the consolidated financial statements[31]. Financial Performance and Projections - The company recognized a gain of $143.4 million from the divestiture of vitaCare, with net proceeds of $142.6 million after transaction costs[36]. - The company may need to raise additional capital to fund operations until cash flow positive, exploring equity and debt financing options[41][42]. - In 2023, the company revised its working capital adjustment accrual from $3.5 million to $5.5 million, reflecting anticipated amounts owed under the Transaction Agreement[28]. - The company is uncertain about its ability to continue as a going concern for the next twelve months due to potential slower sales growth of Licensed Products and other financial uncertainties[46]. Licensing and Sales Agreements - Mayne Pharma will pay milestone payments of $5 million, $10 million, and $15 million based on annual net sales reaching $100 million, $200 million, and $300 million, respectively[23]. - The royalty rate for net sales of licensed products is set at 8% for the first $80 million and 7.5% for sales above that, with minimum annual royalties of $3 million for 12 years[23]. - The company has license agreements with strategic partners to commercialize IMVEXXY and BIJUVA outside of the U.S.[33]. - No sales of IMVEXXY had been made through the licensing agreements with Theramex and Knight as of December 31, 2023[50]. - The FDA requires a post-approval observational study for IMVEXXY, which has been transferred to Mayne Pharma as part of the licensing agreement[51]. Intellectual Property and Compliance - The company holds multiple domestic and foreign patents covering its licensed products, including those for BIJUVA and IMVEXXY[61]. - The company intends to actively protect its intellectual property through various legal mechanisms, including patents and trademarks[63]. - The company relies on third parties for the production of its licensed drugs, which may face compliance issues that could disrupt production or distribution[71]. - The company is subject to various federal and state healthcare laws, including the Anti-Kickback Statute and the False Claims Act, which could lead to significant penalties if violated[80][82]. - The company must comply with federal and state laws requiring pricing transparency and may face limitations on price increases[81]. Regulatory Environment and Future Legislation - Future healthcare legislation may impact the company's operations, including potential reforms or additional regulations that could require product reformulation or increased documentation[85]. - The Biden Administration's proposals include allowing Medicare to negotiate prices for high-cost prescription drugs after 9 years for small molecules and 12 years for biologics, with negotiations starting in 2023[84]. - The plan imposes a tax penalty on drug manufacturers that increase prices faster than inflation and caps out-of-pocket drug costs under Medicare Part D at $2,000 per year[84]. Corporate Structure and Management - As of December 31, 2023, the company employed one full-time employee, having terminated its executive management team and other employees by the end of 2022[34]. - The company maintains its principal executive offices in Boca Raton, Florida, and has a corporate website for additional information[86]. - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[316].