About TherapeuticsMD

TherapeuticsMD, Inc. (TherapeuticsMD) operates as a pharmaceutical royalty company. The company primarily collects royalties from its licensee. TherapeuticsMD owns or has rights to trademarks, service marks, or trade names that were previously used in connection with the operation of its business, or are licensed by another party, including TherapeuticsMD, vitaMedMD, BocaGreenMD, vitaCareTM, BIJUVA, and IMVEXXY, which are protected under applicable intellectual property laws and are the property of the company. On December 30, 2022 (the Closing Date), the company completed a transaction (the Mayne Transaction) with Mayne Pharma LLC, a Delaware limited liability company (Mayne Pharma) and subsidiary of Mayne Pharma Group Limited, an Australian public company, pursuant to which the company and its subsidiaries granted Mayne Pharma an exclusive license to commercialize the company's IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands (collectively, the Licensed Products) in the United States and its possessions and territories; assigned to Mayne Pharma the company's exclusive license to commercialize ANNOVERA (together with the 'Licensed Products', collectively, the 'Products') in the United States and its possessions and territories; and sold certain other assets to Mayne Pharma in connection therewith. As part of the approval of ANNOVERA, the FDA has required a post-approval observational study be performed to measure the risk of venous thromboembolism. In August 2021, the company filed a supplemental New Drug Application (NDA) with the FDA to modify the testing specifications for ANNOVERA to allow increased consistency of supply of ANNOVERA. In May 2022, the FDA approved the supplemental NDA for ANNOVERA. With the FDA approval of the supplemental NDA, the company expects the third-party contract manufacturer will be able to supply sufficient ANNOVERA to better meet customer demand. The company's obligations to perform the post-approval study have been transferred to Mayne Pharma as part of the Mayne License Agreement. Pursuant to a License Agreement, dated December 4, 2022, between the company and Mayne Pharma (the Mayne License Agreement), the company granted Mayne Pharma, on the Closing Date, an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories; and an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import, and have imported the Licensed Products outside the United States for commercialization in the United States and its possessions and territories. Pursuant to a Transaction Agreement, dated December 4, 2022, between the company and Mayne Pharma (the Transaction Agreement), the company sold to Mayne Pharma, at closing, certain assets for Mayne Pharma to commercialize the Products in the United States, including the company's exclusive license from the Population Council to commercialize ANNOVERA (the Transferred Assets). The company also has license agreements with strategic partners to commercialize IMVEXXY and BIJUVA outside of the U.S. In July 2018, the company entered into a license and supply agreement (the Knight License Agreement) with Knight Therapeutics Inc. (Knight) pursuant to which it granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel. In June 2019, the company entered into an exclusive license and supply agreement (the Theramex License Agreement) with Theramex HQ UK Limited (Theramex) to commercialize IMVEXXY and BIJUVA outside of the U.S., excluding Canada and Israel. In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries. In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries. The company collects royalties on sales of ANNOVERA, IMVEXXY, and BIJUVA under the TherapeuticsMD brand, prescription prenatal vitamins under its vitaMedMD brand name, and authorized generic formulations of its prescription prenatal vitamin products under BocaGreenMD brand name. Intellectual Property Patents and Trademarks As of December 31, 2022, the company has 54 issued domestic patents and 47 issued foreign patents, as well as 60 pending patent applications (47 foreign and 13 domestic), including: 22 issued domestic patents and 19 issued foreign patents that relate to BIJUVA. These patents establish an important intellectual property foundation for BIJUVA and are owned by the company. The domestic patents will expire in 2032. The foreign patents will expire no earlier than 2032. In addition, the company has pending patent applications relating to BIJUVA in the U.S., Argentina, Australia, Brazil, China, Europe, Israel, Japan, Mexico, New Zealand, Russia, South Africa, and South Korea; 22 issued domestic patents (20 utility and two design) and 25 foreign patents (16 utility and nine design) that relate to IMVEXXY. These patents establish an important intellectual property foundation for IMVEXXY and are owned by the company. The domestic patents will expire between 2032 and 2034. The foreign utility patents will expire no earlier than 2033. The foreign design patents provide protection expiring no earlier than 2025. In certain countries, the foreign design patents provide protection through at least 2037. In addition, the company has pending patent applications related to IMVEXXY in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, New Zealand, Russia, South Africa, and South Korea; One issued domestic utility patent that relates to the company's topical-cream candidates, which is owned by it and will expire in 2035; One issued domestic utility patent and one issued foreign patent that relate to the company's transdermal-patch candidates, which are owned by it. The domestic utility patent will expire in 2032. The foreign patent will expire in 2033. The company has a pending patent application with respect to its transdermal-patch candidates in Brazil; Two issued domestic utility patents that relate to estradiol and progesterone product candidates, which are owned by the company and will expire in 2032; Three issued domestic utility patents that relate to TX-009HR, a progesterone and estradiol product candidate, which are owned by the company and will expire in 2037; and Three issued domestic and two issued foreign patents that relate to formulations containing progesterone, which are owned by the company. The domestic patents will expire between 2032 and 2036. The foreign patents will expire no earlier than 2033. The company holds multiple U.S. trademark registrations and has numerous pending trademark applications. Mayne Pharma licensed the U.S. patents and trademarks for the company's commercial products. Under the terms of the Mayne License Agreement, Mayne Pharma exclusively took over prosecution of its U.S. patent and trademark portfolio and enforcement of its licensed patents and trademarks. Licensed Menopause Portfolio IMVEXXY On December 30, 2022, the company granted an exclusive license to commercialize its IMVEXXY in the United States and its possessions and territories to Mayne Pharma. IMVEXXY is a small, digitally inserted, softgel vaginal insert that dissolves when inserted into the vagina. It is administered mess-free, without the need for an applicator, and can be used any time of day. IMVEXXY provides a mechanism of action and dosing that is comfortable for patients, with no patient education required for dose application or applicators. Additionally, the dose packaging for IMVEXXY is designed to optimize compliance and convenience for users. IMVEXXY demonstrated efficacy as early as two weeks (secondary endpoint) and maintained efficacy through week 12 in clinical studies, with no increase in systemic hormone levels beyond the normal postmenopausal range (the clinical relevance of systemic absorption rates for vaginal estrogen therapies is not known). The company previously granted licenses to commercialize its IMVEXXY product outside of the United States to Theramex and Knight. As part of the FDA's approval of IMVEXXY, the company is committed to conduct a post-approval observational study to evaluate the risk of endometrial cancer in post-menopausal women with a uterus who use a low-dose vaginal estrogen unopposed by a progestogen. The obligation to conduct this study was transferred to Mayne Pharma as part of the License Agreement. BIJUVA On December 30, 2022, the company granted an exclusive license commercialize its BIJUVA in the United States and its possessions and territories to Mayne Pharma. BIJUVA offers the convenience of a single-capsule combination of two hormones (estradiol and progesterone), which may improve a user's compliance. BIJUVA provides a sustained steady state of estradiol, which reduced the frequency and severity of hot flashes in clinical studies with no demonstrated impact on a patient's weight or blood pressure. Additionally, through clinical trials, BIJUVA has demonstrated endometrial safety and greater than 90% amenorrhea rates, while providing no clinically meaningful changes in mammograms, or in coagulation or lipid parameters, and while providing clinically meaningful improvements in quality of life and sleep disturbance. In December 2021, the FDA approved the supplemental NDA for the 0.5 mg/100 mg dose of BIJUVA. The company previously granted licenses to commercialize its BIJUVA product outside of the United States to Theramex and Knight. With the approval of BIJUVA, the FDA required a post-approval commitment to further develop and validate the company's in-vitro dissolution method to show how BIJUVA is released from the capsule in an in-vitro setting for quality control assessments. The development of this method and validation were completed and submitted to the FDA as required in the company's approval. Licensed Prenatal Vitamin Products On December 30, 2022, the company granted an exclusive license to commercialize, in the United States and its possessions and territories, its prescription prenatal vitamin product lines under its vitaMedMD brand name and authorized generic formulations of some of its prescription prenatal vitamin products under its BocaGreenMD Prena1 name to Mayne Pharma. Manufacturing of Licensed Products As of December 30, 2022, the company was no longer responsible for any manufacturing and have no manufacturing contracts. All manufacturing responsibility has been transferred to Mayne Pharma. Mayne Pharma sources third-party contract manufacturing organizations (CMOs), for the commercial supply of the Products. The CMOs are responsible for the manufacture of licensed products in accordance with the product specifications and applicable regulatory requirements. There are long-term supply agreements with Catalent Pharma Solutions, LLC (Catalent) for the commercial supply of the company's IMVEXXY and BIJUVA, and Sever Pharma Solution, both of which have their establishments registered with FDA, for the supply of ANNOVERA. Mayne Pharma uses third-party manufacturers to manufacture and package the vitamin and supplement products that the company licensed to them, as well as meet applicable contract and regulatory requirements. They obtain all the company's vitaMedMD and BocaGreen products from Lang Pharma Nutrition (Lang), a full-service, private label and corporate brand manufacturer specializing in premium health benefit driven products, including medical foods, nutritional supplements, beverages, bars, and functional foods in the dietary supplement category. vitaCare Divestiture On April 14, 2022, the company completed the divestiture of vitaCare Prescription Services, Inc. (vitaCare). Regulations In February 2020, the company received a Paragraph IV certification notice letter (the IMVEXXY Notice Letter) regarding an ANDA submitted to FDA by Teva Pharmaceuticals USA, Inc. (Teva). In March 2020, the company received a Paragraph IV certification notice letter (the BIJUVA Notice Letter) regarding an ANDA submitted to FDA by Amneal Pharmaceuticals (Amneal). In April 2020, the company filed a complaint for patent infringement against Amneal in the U.S. District Court for the District of New Jersey arising from Amneal's ANDA filing with FDA. In December 2021, the company entered into a settlement agreement (the Settlement Agreement) with Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals, LLC and Amneal Pharmaceuticals of New York LLC (collectively Amneal) to resolve the litigation over its patents listed in FDA's Orange Book that claim compositions and methods of BIJUVA (the BIJUVA Patents). Under the terms of the Settlement Agreement, the company granted Amneal a non-exclusive, non-transferable, royalty-free license to commercialize Amneal's generic formulation of BIJUVA in the U.S. commencing in May 2032 (180 days before the expiration date in November 2032 for the last to expire of its BIJUVA Patents), or earlier under certain circumstances customary for settlement agreements of this nature. History TherapeuticsMD, Inc., a Nevada corporation, was founded in 2008.