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Dec 31, 2020
Veru Q1 2021 Earnings Report
Net revenues increased by 38% and gross profit rose by 49%, setting new quarterly records.
Key Takeaways
Veru Inc. reported a strong fiscal 2021 first quarter, with net revenues increasing by 38% and gross profit rising by 49%. The company is advancing its oncology drug pipeline and anticipates submitting a New Drug Application with the FDA for TADFIN.
Net revenues increased 38% to $14.6 million.
Gross profit rose 49% to $10.8 million.
FC2 prescription net revenues climbed 50% to $9.1 million.
Company anticipates submitting TADFIN New Drug Application with FDA next week.
Forward Guidance
Veru plans to submit the TADFIN NDA and is driving prostate and breast cancer drug candidates into registration clinical studies. They anticipate potential for five registration clinical trials for one COVID-19 and four oncology indications to commence in calendar year 2021.
Positive Outlook
- Plan to submit the TADFIN NDA next week.
- Driving prostate cancer drug candidates, VERU-111 and VERU-100, as well as breast cancer drug candidates, Enobosarm and VERU-111 for triple negative breast cancer, into registration clinical studies.
- Positive clinical efficacy and safety results from the Phase 2 clinical study that evaluated VERU-111 treatment in hospitalized patients with COVID-19 and at high risk for ARDS.
- Anticipates the potential for five registration clinical trials for one COVID-19 and four oncology indications to commence in calendar year 2021.
- The pivotal Phase 3, open label, randomized, active control ARTEST study is anticipated to commence next quarter.
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