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Jun 30, 2020
Veru Q3 2020 Earnings Report
Net revenues increased due to higher U.S. prescription sales of FC2.
Key Takeaways
Veru Inc. reported an increase in net revenues for the fiscal 2020 third quarter, driven by strong U.S. prescription sales of FC2 and a solid contribution from PREBOOST® / Roman Swipes®, along with lower operating expenses.
Net revenues increased 6% to $10.3 million.
FC2 U.S. prescription sales climbed 23% to $5.4 million.
Operating loss narrowed to $1.4 million from $1.8 million.
Net loss was $3.0 million, or $0.05 per share.
Forward Guidance
The company plans to submit the final Phase 3 protocol to the FDA in the fourth quarter of the current calendar year and anticipates commencing the global Phase 3 pivotal clinical study in the first quarter of calendar year 2021.
Positive Outlook
- Received positive FDA input, agreement, and regulatory guidance regarding the design of the pivotal Phase 3 registration clinical trial for VERU-111.
- The proposed indication of metastatic castration and novel androgen receptor targeting agent resistant prostate cancer, which is prior to IV chemotherapy population, being acceptable.
- An open label, randomized, active control study using an alternative novel androgen receptor targeting agent as the active control is reasonable.
- A primary endpoint for the trial of radiographic progression-free survival.
- Patient enrollment of the Phase 2 trial is nearing completion and we are already observing some significant PSA declines.
Historical Earnings Impact
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