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Mar 31, 2023
Veru Q2 2023 Earnings Report
Reported second quarter financial results and provided a business update.
Key Takeaways
Veru Inc. reported a decrease in net revenues to $6.6 million from $13.0 million, a decrease in gross profit to $4.1 million from $11.2 million, and a net loss of $38.8 million, or $0.48 per share, compared to a net loss of $14.2 million, or $0.18 per share for the second quarter of fiscal year 2022. The company sold ENTADFI® for $20 million, plus up to an additional potential $80 million from sales milestones and entered into a common stock purchase agreement with Lincoln Park Capital for up to $100 million.
Reached agreement with FDA on confirmatory Phase 3 clinical trial design for sabizabulin treatment of hospitalized COVID-19 adult patients at high risk for ARDS, including two planned interim efficacy analyses.
ENTADFI® product sold for $20 million, plus up to an additional potential $80 million from sales milestones.
Common stock purchase agreement with Lincoln Park Capital for up to $100 million provides financial flexibility.
Reported positive preclinical data for sabizabulin for influenza induced ARDS and for poxvirus.
Veru
Veru
Forward Guidance
The company is focused on advancing its clinical development programs, including enobosarm for metastatic breast cancer and sabizabulin for SARS-CoV-2 viral ARDS, with potential Phase 3 clinical data results expected in 2024. They are also expanding enobosarm into bone-only metastatic breast cancer and sabizabulin into influenza-induced ARDS.
Positive Outlook
- FDA clarity received to continue advancing ENABLAR-2 Phase 2b/3 clinical trial for metastatic breast cancer.
- Agreement reached to pursue confirmatory Phase 3 clinical trial for hospitalized COVID-19 adult patients at high risk for ARDS.
- Cash burn rate reduced.
- Available capital increased through the completed ENTADFI sale and the Lincoln Park Capital transaction.
- Seeking partnerships for clinical drug candidates.
Challenges Ahead
- FDA declined to grant Emergency Use Authorization (EUA) for sabizabulin for hospitalized COVID-19 patients at high risk for ARDS in February 2023.
- Net revenues decreased to $6.6 million from $13.0 million.
- Gross profit decreased to $4.1 million from $11.2 million.
- Operating loss was $39.4 million versus $11.8 million.
- Net loss was $38.8 million, or $0.48 per share, compared to $14.2 million, or $0.18 per share.