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Jun 30, 2023
Veru Q3 2023 Earnings Report
Veru reported financial results for the third quarter of fiscal year 2023 and provided a business update.
Key Takeaways
Veru Inc. reported a net income of $6.3 million, or $0.07 per share, compared to a net loss of $22.2 million, or $0.28 per share for Q3 2022. The company's cash burn was $7.3 million, a reduction of $16.1 million compared to the prior quarter. They also sold ENTADFI® to Blue Water Biotech for $20 million upfront, with potential for up to an additional $80 million from sales milestones.
Received further regulatory clarity from FDA on Phase 3 ENABLAR-2 study, with potential for accelerated approval pathway in metastatic breast cancer.
Planned expansion of sabizabulin Phase 3 confirmatory study to include all types of viral induced lung infections in hospitalized patients at risk for ARDS.
Reported positive preclinical data for sabizabulin against both influenza and poxvirus, with an FDA preIND meeting for sabizabulin against poxvirus set for August 2023.
ENTADFI® product sold for $20 million, plus up to an additional potential $80 million from sales milestones.
Veru
Veru
Forward Guidance
Veru is focused on advancing its clinical programs for enobosarm and sabizabulin, expanding its sexual health business, and managing its cash flow.
Positive Outlook
- Potential accelerated approval pathway for enobosarm in metastatic breast cancer.
- Expansion of sabizabulin study to include all viral induced lung infections.
- Positive preclinical data for sabizabulin against influenza and poxvirus.
- Growing FC2 prescriptions through the telehealth platform.
- Potential for additional revenue from ENTADFI sales milestones.
Challenges Ahead
- Clinical trials may be unsuccessful.
- Enrollment in clinical studies may be insufficient.
- Need for new COVID-19 treatments may be reduced.
- Government actions may limit opportunities for sabizabulin.
- Difficulty in increasing sales of FC2.