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Jun 30, 2022
Veru Q3 2022 Earnings Report
Reported a decrease in revenue and a net loss, while progressing sabizabulin treatment for COVID-19 towards regulatory decisions.
Key Takeaways
Veru Inc. reported a 46% decrease in total net revenues, a 49% decrease in gross profit, and a net loss of $22.2 million for the third quarter of fiscal year 2022. The company is progressing with regulatory submissions for sabizabulin as a treatment for COVID-19.
Total net revenues decreased 46% to $9.6 million from $17.7 million.
US FC2 prescription net revenues decreased 50% to $6.7 million from $13.5 million.
Operating loss was $21.8 million versus $2.9 million.
Net loss was $22.2 million, or $0.28 per share, compared to $2.7 million, or $0.03 per share.
Veru
Veru
Forward Guidance
The company anticipates significant near-term revenue from sabizabulin for the treatment of hospitalized COVID-19 patients at high risk for ARDS, pending EUA from the U.S. FDA. They also expect historical ordering patterns from telemedicine customers to resume in future quarters and anticipate new revenues from the launch of ENTADFI™.
Positive Outlook
- Potential for significant near-term revenue from sabizabulin if EUA is granted.
- Expect historical ordering patterns from telemedicine customers to resume.
- Anticipate new revenues from the launch of ENTADFI™.
- The UK’s Medicines and Healthcare Products Regulatory Agency’s decision to expedite review of a marketing authorization application for sabizabulin.
- European Medicines Agency’s Emergency Task Force’s decision to initiate data review, for the first time ever under their article 18, for potential emergency use of sabizabulin in European Union member countries.
Challenges Ahead
- Decrease in the third quarter FC2 net revenues in the U.S. prescription channel.
- Lower volume from telemedicine customers due to business challenges.
- Uncertainty as to timing of the resumption of historical ordering patterns.
- COVID-19 new cases and hospitalizations are on the rise again with both summer and fall-winter surges expected.
- The death rate in hospitalized patients with moderate to severe COVID-19 who are at risk for ARDS remains unacceptably high with current standard of care.