About Veru
Veru Inc. operates as a late clinical stage biopharmaceutical company. The company focuses on developing novel medicines for the treatment of metabolic diseases, oncology, and acute respiratory distress syndrome (ARDS). The company's drug development program includes two late-stage new chemical entities, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: enobosarm initially as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness; and subject to the availability of sufficient funding, enobosarm for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting. Sabizabulin, a microtubule disruptor, is being developed for the treatment of hospitalized patients with viral-induced ARDS. The company also has an FDA-approved commercial product, the FC2 Female Condom (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections. The company intends to submit an IND for enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness in the fourth quarter of 2023. Subject to receiving clearance of its IND, the company plans to conduct a Phase 2b multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness, with the first data from the trial expected in the second half of 2024. On March 30, 2023, and November 3, 2023, the company meets with the FDA to discuss the design of its Phase 3 clinical trial in patients with AR+ ER+ HER2- metastatic breast cancer who have tumor progression while receiving palbociclib (a CDK 4/6 inhibitor) plus an estrogen blocking agent (nonsteroidal aromatase inhibitor or selective estrogen receptor degrader). The design of the Phase 3 clinical trial was amended following the company's November 3, 2023, meeting with the FDA to implement the recommendations that were provided by the FDA. The company began patient enrollment in April 2022. As of August 2023, the company had completed the target enrollment of three patients in the Stage 1a portion of the Phase 3 clinical trial to assess the safety and pharmacokinetics of the combination of abemaciclib and enobosarm. In January 2022, the company entered into a clinical trial collaboration and supply agreement through which Eli Lilly and Company supplies abemaciclib for the ENABLAR-2 trial. The company is developing sabizabulin 9mg, which has both host targeted antiviral and broad anti-inflammatory properties, as a two-pronged approach to the treatment of hospitalized patients with viral lung infection at high risk for ARDS and death. The company has completed positive Phase 2 and positive Phase 3 COVID-19 clinical trials, which have demonstrated that sabizabulin treatment resulted in a mortality benefit in hospitalized moderate to severe patients with COVID-19 viral lung infection at high risk for ARDS and death. The FDA granted Fast Track designation to the company's COVID-19 program in January 2022. On May 10, 2022, the company had a pre-EUA meeting with the FDA to discuss next steps, including the submission of an EUA application regarding sabizabulin for COVID-19. In June 2022, the company submitted a request for FDA Emergency Use Authorization. In February 2023, the FDA declined to grant its request for Emergency Use Authorization for sabizabulin. In September 2023, the company received positive feedback from the FDA on the design of a Phase 3 clinical trial to evaluate sabizabulin in viral-induced ARDS. The company's sexual health program consists of FC2, the only FDA-approved, female-controlled, hormone-free female condom indicated for the prevention of pregnancy and sexually transmitted infections, including HIV/AIDS. FC2 is the only FDA-approved single use internal condom for the prevention of pregnancy, sexually transmitted infections (STIs), and HIV/AIDs. Most of the company's net revenues are derived from sales of FC2 in the commercial and public health sectors. FC2 is the only FDA approved for market female use product that protects against unintended pregnancies, the transmission of STIs and HIV/AIDs. FC2 is currently reimbursable by prescription under the Affordable Care Act (ACA). The company has built the infrastructure to allow for broad access across the U.S. The company has a limited number of customers in the global public health sector that include large global agencies, such as the United Nations Population Fund (UNFPA) and the United States Agency for International Development (USAID), the Brazil Ministry of Health through Semina Indústria e Comercio Ltda (Semina), the company's distributor in Brazil, and the Republic of South Africa health authorities that purchase through the company's various local distributors. Other customers in the global public health sector include ministries of health or other governmental agencies, which either purchase directly or via in-country distributors, local sexual health distributors and non-governmental organizations (NGOs). The company has sold more than 750 million female condoms worldwide and FC2 has been distributed in the U.S. and 149 other countries. A significant number of countries with the highest demand potential are in the developing world. The incidence of HIV/AIDS, other STIs, and unintended pregnancy in these countries represents a remarkable potential for significant sales of a product that benefits some of the world's most underprivileged people. The company has distribution agreements and other arrangements with commercial partners which market FC2 as a consumer health product through distributors and retailers in several countries, including Brazil, Spain, France, and the United Kingdom. These agreements are generally exclusive for a single country. Under these agreements, the company sells FC2 to the distributor partners, who market and distribute the product to consumers in the established territory. The company had another FDA-approved product, ENTADFI (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia that was approved by the FDA in December 2021. This product was part of the company's sexual health program. Strategy The company's strategy focuses primarily on the clinical development and commercialization of novel medicines for metabolic diseases, metastatic breast cancer, and viral-induced ARDS. In addition, the company seeks to operate and grow its sexual health program to help fund its clinical development efforts. The key elements of the company's strategy are to develop enobosarm for metabolic diseases; develop enobosarm for advanced breast cancer; develop sabizabulin for viral-induced ARDS subject to accessing government or pharmaceutical partnership funding; and grow its sexual health program to invest proceeds in the clinical development of its drug pipeline. Government Regulation FC2 was approved for market by the FDA, via a Premarket Approval Application (PMA), as a Class III medical device in 2009. On September 21, 2018, the FDA issued a final order reclassifying female condom from Class III to Class II medical devices, renaming them single-use internal condoms and requiring new devices in this category to submit a 510(k) premarket notification and comply with various special controls. The company is required to register its manufacturing establishments with the FDA and list FC2 with the FDA as a commercially distributed device. The company must comply with the FDA's Quality System Regulation (QSR), which requires that devices be manufactured and records be maintained in a prescribed manner with respect to, among other things, manufacturing, testing, and control activities. The company must comply with the Medical Device Reporting (MDR) regulation, which requires that it provides information to the FDA whenever evidence reasonably suggests that one of its FC2 devices may have caused or contributed to a death or serious injury, or where a malfunction has occurred that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. The company must also maintain records of any corrections or removal of FC2 and make reports to the FDA of certain corrections or removals. The company is required to comply with FDA requirements for labeling, promotion and advertising. Because FC2 is a commercially distributed medical device, the facilities in which FC2 is manufactured and tested are subject to periodic FDA inspection to ensure compliance with regulatory requirements, including the QSR and MDR regulations. The company's most recent FDA inspection of its U.K. and Malaysian facilities was completed in September 2010 and November 2019, respectively. Drug development via Section 505(b)(1) of the FDCA is typically used for novel drugs that have not previously been approved by the FDA for commercial sale in the U.S or a new indication for a drug previously approved by the FDA for commercial sale in the U.S. 505(b)(1) drug development stipulates that all of the studies required for approval are conducted by or for the company. Enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness, enobosarm for AR+ ER+ HER2- metastatic breast cancer, and sabizabulin for certain hospitalized patients with viral-induced ARDS are expected to follow this regulatory pathway. The company's business activities must comply with numerous healthcare laws, including but not limited to, the federal health care program anti-kickback statute (the AKS) and state equivalents, the Federal False Claims Act and state equivalents, federal and state health care practitioner payment sunshine laws, federal and state health information privacy laws, state price increase transparency laws, and various federal laws requiring price reporting or discounted pricing to the government. Other countries where the company conducts business have similar anti-corruption laws, including the United Kingdom's Bribery Act. FC2 has MSAP and ISO13485 approval by regulatory authorities which covers Australian TGA, Brazil ANVISA, Health Canada, and other jurisdictions. Also, FC2 received the CE Mark which allows it to be marketed throughout the EU. The company manufactures and warehouses FC2 within a leased facility with approximately 45,800 square feet of space in Selangor D.E., Malaysia. Production capacity at this facility is approximately 100 million units of FC2 annually. This facility is subject to periodic inspection by the FDA to ensure compliance with current Good Manufacturing Practices (cGMP), as well as the Germany-based notified body, which is responsible for CE and ISO accreditation. Intellectual Property Enobosarm and Related Compounds License The company holds an exclusive worldwide license to 16 issued U.S. patents, six pending U.S. patent applications, 74 patents and patent applications in countries outside the U.S., and one pending PCT application, including issued molecule and polymorph composition of matter and method of use patents in the U.S, EU and Japan, relating to its enobosarm drug candidate and related compounds, and their use in breast cancer. Further, one of the pending patent applications is related to the use of enobosarm in combination with or following GLP-1 receptor agonists in obese and overweight adult patients to increase or preserve muscle and bone, as well as the use of SARMs generally for the treatment of obesity and chronic weight management. This license contains provisions requiring milestone and royalty payments to the licensor (University of Tennessee Research Foundation). The patents relating to enobosarm and related compounds have statutory expiration dates from 2024 to 2034, with the patent application related to the use of enobosarm in combination with or following GLP-1 receptor agonists in obese and overweight adult patients to increase or preserve muscle and bone, as well as the use of SARMs generally for the treatment of obesity and chronic weight management, would expire in 2044, if issued. In the U.S., patent term adjustments or patent term extensions could result in later expiration dates with a maximum five-year patent term extension expected because of clinical development and FDA review time. In addition, as a new chemical entity, enobosarm could qualify for 10 years of regulatory market exclusivity in the European Union countries and 7.5 years of regulatory market exclusivity in Japan. Lastly, regarding the patent application related to the use of enobosarm in combination with or following GLP-1 receptor agonists in obese and overweight adult patients to increase or preserve muscle and bone, as well as the use of SARMs generally for the treatment of obesity and chronic weight management, the company engages an independent third-party search firm to perform a prior art search and this independent firm has identified no prior art likely to prevent issuance of the claims of the patent application. Sabizabulin and Related Compounds License. The company holds an exclusive worldwide license to twelve issued U.S. patents, three pending U.S. patent applications and 84 patents and patent applications in countries outside the United States, including issued patents in the EU and Japan, relating to its sabizabulin drug candidates and related compounds, and oncology methods of use. This license contains provisions requiring upfront, milestone and royalty payments to the licensor (Ohio State Innovation Foundation). The patents and applications relating to sabizabulin and related compounds have statutory expiration dates from 2029 to 2039. In the U.S., patent term adjustments or patent term extensions could result in later expiration dates with a maximum five-year patent term extension expected because of clinical development and FDA review time. In addition, as a new chemical entity, sabizabulin could qualify for 10 years of regulatory market exclusivity in Europe and 7.5 years of regulatory market exclusivity in Japan. Uses of Sabizabulin and Related Compounds Owned by the company Sabizabulin is a new chemical entity which has not been approved for any indication anywhere in the world. The company has one U.S. patent, six U.S. applications, 44 patents and patent applications in countries outside of the United States, and two pending PCT applications from which it will enter more countries outside of the United States, including pending patents in the EU and Japan relating to the polymorphs of its sabizabulin drug candidate and non-oncology methods of use of its sabizabulin drug candidate and related compounds. The patents and patent applications relate to completed phase III and planned clinical trials to test sabizabulin for infectious and/or inflammatory diseases including viral ARDS. The patents and patent applications related to the ongoing and planned clinical trials have statutory expiration dates from 2041 to 2043. In the U.S., patent term adjustments or patent term extensions could result in later expiration dates with a maximum five-year patent term extension expected because of clinical development and FDA review time. In addition, as a new chemical entity, sabizabulin could qualify for 10 years of regulatory market exclusivity in the European Union countries and 7.5 years of regulatory market exclusivity in Japan. Other Non-Sabizabulin Anti-Tubulin Compounds License The company holds an exclusive worldwide license to one U.S. patent application and eleven patents and patent applications in countries outside the U.S. This license is relating to non-sabizabulin anti-tubulin compounds. This license contains provisions requiring diligence milestones, and upfront, milestone and royalty payments to the licensor (University of Tennessee Research Foundation). Any patents issuing from these patents and patent applications would expire in April 2042. FC2 patents have been issued by the United States, South Africa, Mexico, Brazil and India. The patents cover key aspects of FC2, including its overall design and manufacturing process. The patents have expiration dates in 2023 and 2024. Trademarks: The company has a registration for the trademark FC2 Female Condom and the FC2 Female Condom stylized logo in the U.S. The company has filed applications in the U.S. for the trademarks Veru and Veru together with the chevron. The company has filed applications or secured registrations in 40 countries or jurisdictions around the world to protect the various names and symbols used in marketing its Female Condoms. Research and Development For the year ended September 30, 2023, the company's research and development expenses were $51.1 million. Significant Customers The company's two largest customers in fiscal 2023 accounted for 47% of its net revenues, including The Pill Club, which represented 24% of its net revenues. In the U.S. market, it has experienced fast growth in prescription sales of FC2 in prior years largely through supply agreements with leading telemedicine providers. Because FC2 is multipurpose prevention technology that provides prevention of pregnancy and transmission of STIs, including HIV/AIDS, it is an integral part of HIV/AIDS prevention and family planning programs throughout the world. Within the global public health sector are large global agencies, such as UNFPA, USAID, the U.K.'s Foreign, Commonwealth and Development Office (FCDO), DKT and Population Services International (PSI), other social marketing groups, various government health agencies, and NGOs. Within the global public health sector, the company's most significant customers are either global public health sector agencies, country specific ministries of health, or those who facilitate their purchases and/or distribution. Regulation The company's operations in Malaysia are audited and certified against ISO 14001, the environmental management standard that was developed by the International Organization for Standardization (ISO) to help organizations manage the environmental impacts of their processes, products, and services. The company's business activities, including but not limited to, research, sales, promotion, distribution, medical education, and other activities will be subject to regulation by numerous regulatory and law enforcement authorities in the United States in addition to the FDA, including potentially the Department of Justice, the Department of Health and Human Services and its various divisions, including the Centers for Medicare and Medicaid Services, and state and local governments. The company's business activities must comply with numerous healthcare laws, including but not limited to, the federal health care program anti-kickback statute (the AKS) and state equivalents, the Federal False Claims Act and state equivalents, federal and state health care practitioner payment sunshine laws, federal and state health information privacy laws, state price increase transparency laws, and various federal laws requiring price reporting or discounted pricing to the government. The company and its business activities are subject to the Medicare/Medicaid civil monetary penalties statute, which imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent. History The company was incorporated in 1971. It was formerly known as The Female Health Company and changed its name to Veru Inc. in 2017.
