Loading...
•
Dec 31, 2019
Veru Q1 2020 Earnings Report
Net revenues increased by 66% and gross profit rose by 57%, driven by FC2 prescription sales, increased public sector sales of FC2, and growing demand for PREBOOST®/Roman® Swipes product.
Key Takeaways
Veru Inc. reported a strong fiscal 2020 first quarter with a 66% increase in net revenues and a 57% rise in gross profit, primarily driven by growth in FC2 prescription sales and increased demand for PREBOOST®/Roman® Swipes. The company continues to invest in its prostate and oncology drug pipeline.
Net revenues increased 66% to $10.6 million from $6.4 million.
Gross profit increased 57% to $7.3 million from $4.6 million.
FC2 US prescription net revenues increased 148% to $6.1 million from $2.4 million.
The Phase 1b portion of the clinical trial for VERU-111 was completed and Phase 2 was initiated.
Forward Guidance
Veru anticipates initiating a pivotal Phase 3 clinical trial to evaluate Zuclomiphene for the treatment of ADT-induced moderate to severe hot flashes in men with prostate cancer by early summer and plans to submit an Investigational New Drug (IND) application for VERU-100 by the end of next quarter.
Positive Outlook
- Initiation of Phase 3 clinical trial for Zuclomiphene by early summer.
- Submission of IND application for VERU-100 by the end of next quarter.
- NDA submission for TADFIN expected in the second half of 2020.
- Plan to launch TADFIN in the U.S. via telemedicine.
- Advancement of Tamsulosin XR capsules to avoid the “food effect”.
Challenges Ahead
- Potential delays in the timing of and results from clinical trials and studies.
- Risk that clinical results will not support marketing approval and commercialization.
- Potential delays in the timing of any submission to the FDA and regulatory approval of products under development.
Historical Earnings Impact
Analyze how earnings announcements historically affect stock price performance
Avg. Return Before/After Earnings
Loading earnings performance data...
Loading earnings reaction data...