Veru Inc (VERU)

Veru Inc. (NASDAQ: VERU) - Comprehensive Overview

Company Profile:

Detailed History and Background:

Veru Inc. (NASDAQ: VERU) is a pharmaceutical company founded in 1994 with its headquarters in Miami, Florida. Initially known as DuraMed Pharmaceuticals, the company engaged in the development and commercialization of generic and branded drugs. In 2006, it acquired Theramex, a leading European women's healthcare company, and shifted its focus towards women's health and oncology. In 2015, the company separated its women's health business, re-establishing itself as Veru focusing on oncology and other unmet medical needs.

Core Business Areas:

• Oncology: Veru's primary focus is the development and commercialization of treatments for prostate cancer and other cancers. This includes their lead product, sabizabulin, and ongoing clinical trials for additional novel treatments.
• COVID-19 Treatments: Veru is developing and marketing a monoclonal antibody therapy, ensifentrine, for the treatment of COVID-19.
• Women's Health: Through its acquired company, Veru continues to manufacture and distribute Theramex's portfolio of women's health products including hormone therapies and contraceptives.

Leadership Team and Corporate Structure:

• Mitch Steiner, Executive Chairman and Chief Executive Officer
• Robert Eder, Chief Accounting Officer
• James K. O'Connell, Chief Financial Officer
• Dr. Michael Detke, Chief Scientific Officer
• Dr. Joseph Hernandez, President
• Dr. Jeffrey Kindler, Chief Medical Officer

Top Products and Market Share:

• Sabizabulin (formerly VERU-111): This oral therapy is approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in men who have received prior androgen receptor-directed therapy and a taxane-based chemotherapy. While its market share in the global mCRPC market remains nascent, it competes with established drugs like Xtandi and Erleada.

• Ensifentrine (formerly VERU-110): This inhaled, synthetic protease inhibitor is under review by the FDA for the treatment of mild to moderate COVID-19 in adults at high risk for progression to severe illness. If approved, it will likely compete with other COVID-19 treatments like Paxlovid and Lagevrio.

• Theramex Women's Health Products: This portfolio comprises numerous well-established brands such as Duoluton, Elleste Solo, and Provera, holding strong market positions within their respective categories.

Total Addressable Market:

The global oncology market is estimated to reach a value of $307.3 billion by 2027, while the global COVID-19 treatment market is projected to reach $6.3 billion by 2028. Additionally, the women's health market is estimated to reach $64.5 billion by 2026. Veru operates within these vast markets with its diverse product portfolio.

Financial Performance:

• Revenue:
  • 2021: $33.6 million
  • 2022: $64.5 million
  • 2023 YTD: $13.7 million
• Net Income:
  • 2021: ($224.5 million)
  • 2022: ($210.7 million)
  • 2023 YTD: ($45.5 million)
• Earnings per Share (EPS):
  • 2021: ($3.05)
  • 2022: ($3.35)
  • 2023 YTD: ($2.14)

Veru is currently a pre-profitability company, investing heavily in research and development. Its revenue primarily comes from the sale of its women's health products and research contracts.

Dividends and Shareholder Returns:

Veru does not currently pay divid