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Jun 30, 2021
Veru Q3 2021 Earnings Report
Net revenues and gross profit increased, setting new quarterly records.
Key Takeaways
Veru Inc. reported a significant increase in net revenues and gross profit for the third quarter of fiscal year 2021. Net revenues increased by 71% to $17.7 million, and gross profit increased by 113% to $13.9 million. The company is focused on advancing its late-stage drug pipeline for oncology and COVID-19.
Net revenues increased 71% to $17.7 million.
Gross profit rose 113% to $13.9 million.
FC2 prescription net revenues climbed 150% to $13.5 million.
Initiated Phase 3 VERACITY clinical trial for metastatic castration resistant prostate cancer and Phase 2 VERU-100 clinical trial for advanced prostate cancer.
Veru
Veru
Forward Guidance
Veru anticipates starting Phase 3 ARTEST clinical trial of enobosarm monotherapy, Phase 2b clinical trial of enobosarm in combination with abemaciclib, and Phase 2b clinical trial for metastatic triple negative breast cancer in the second half of the calendar year.
Positive Outlook
- Phase 3 ARTEST clinical trial of enobosarm monotherapy in a 3rd line metastatic setting in AR+ ER+ HER2- metastatic breast cancer.
- Phase 2b clinical trial of enobosarm in combination with abemaciclib, CDK 4/6 inhibitor, in a 2nd line metastatic setting in AR+ ER+ HER2- metastatic breast cancer.
- Phase 2b clinical trial evaluating sabizabulin monotherapy and sabizabulin + Trodelvy® (sacituzumab govitecan-hziy) combination therapy versus Trodelvy® monotherapy in metastatic triple negative breast cancer.
- PDUFA date for TADFIN for the treatment of Benign Prostatic Hyperplasia is on track for December 2021.
- Initiated Phase 3 VERACITY clinical trial for metastatic castration resistant prostate cancer.
Challenges Ahead
- COVID-19 remains a severe threat with few effective therapies to complement the COVID-19 vaccination strategy.
- Almost all patients will develop resistance to CDK 4/6 inhibitors.
- The development of the Company’s product portfolio and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development.
- The ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules.
- The possibility that as vaccines become widely distributed the need for new COVID-19 treatment candidates may be reduced or eliminated.