TherapeuticsMD(US:TXMD)2022-03-23 20:54Financial 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].