Veru(US:VERU)2021-05-12 19:17Financial Data and Key Metrics Changes - Overall net revenues increased by 34% to $13.3 million from $9.9 million in the prior-year second quarter [75] - Gross profit was $10.9 million or 82% of net revenue compared to $7.4 million or 75% of net revenues in the prior-year quarter [76] - The bottom line for the second quarter fiscal 2021 was a net loss of $2.8 million or $0.04 per diluted common share compared to a net loss of $811,000 or $0.01 per diluted common share in the prior-year second quarter [78] Business Line Data and Key Metrics Changes - The US prescription business reported record quarterly sales of $10.3 million, an increase of 48% from $7 million in the prior-year second quarter [75] - Net revenue from the US prescription business was up 49% to $19.4 million from $13 million in the prior-year period [80] - Operating expenses for the quarter increased to $12.4 million compared to the prior-year quarter of $7.7 million, driven primarily by research and development costs [77] Market Data and Key Metrics Changes - The global public sector business was up 11% to $7.7 million [80] - The company sold 171,900 units year-to-date in fiscal 2020 compared to 247,200 units year-to-date in fiscal 2021, an increase of 44% [74] Company Strategy and Development Direction - The company is focused on transforming into a late clinical-stage oncology biopharmaceutical company, supported by revenue from its sexual health business [88] - Plans to enroll potentially up to five registration studies and two Phase II studies in the calendar year, including studies for prostate and breast cancer [93] - The company continues to explore strategic alternatives regarding its legacy female health business [92] Management's Comments on Operating Environment and Future Outlook - The company expects to have a record year in revenue based on year-to-date performance [91] - Management believes that the strong cash position will allow substantial investment in clinical development programs [91] - The company is committed to pursuing the COVID-19 indication despite it not being a primary focus [68] Other Important Information - The company has net operating loss carryforwards for US federal tax purposes of $41.7 million [84] - The company plans to launch TADFIN via third-party telemedicine channels if approved, which should provide near-term revenue [71] Q&A Session All Questions and Answers Question: Could you give us just a little more color in terms of what the impetus was to reformulate the drug? - The reformulation was aimed at improving oral bioavailability, and no further operational work is required for the upcoming clinical trials [99][100] Question: Is there an expectation that there will be some cut-off of AR expression for the enobosarm development program? - There is indeed a correlation between AR expression levels and treatment efficacy, and data supporting this will be presented at the ASCO meeting [101][106]