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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.
Veru
Veru
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.
- Risk that the Company’s products may not be commercially successful.
- Risks relating to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations.