Veru(US:VERU)2023-05-11 19:28Financial Data and Key Metrics Changes - Overall net revenues for Q1 2023 were $2.5 million, a significant decrease from $14.1 million in the prior year quarter [47] - The operating loss for the quarter was $35.6 million, compared to $5 million in the prior year quarter, reflecting increased operating expenses and reduced revenues [52] - The net loss for the quarter was $36.8 million or $0.46 per diluted common share, compared to a net loss of $6.4 million or $0.08 per diluted common share in the prior year quarter [54] Business Line Data and Key Metrics Changes - Revenue from the US prescription business decreased to $163,000 from $11.6 million in the prior year period, attributed to challenges faced by telemedicine customers [47] - Net revenue for the global public health sector business was $2.3 million, slightly down from $2.6 million in the prior year period [48] - Gross profit was $700,000 or 28% of net revenues, down from $11.8 million or 84% of net revenues in the prior year period, primarily due to decreased sales in the US FC2 prescription business [48] Market Data and Key Metrics Changes - The company is seeing improvements in FC2 revenues in Q2 fiscal year 2023, indicating a potential recovery in sales [66] - The telemedicine sector and global public health orders had underperformed, but market conditions are improving [46] Company Strategy and Development Direction - The company is focused on developing sabizabulin for COVID-19 and other viral diseases, with plans to expand its investigation into other infectious disease indications [33][61] - The company has established a commercialization infrastructure for sabizabulin and is preparing for potential launches in the US and internationally [29][63] - There is a near-term strategy to drive FC2 sales through partnerships with telemedicine and internet pharmacy services [65] Management's Comments on Operating Environment and Future Outlook - Management emphasized the ongoing need for effective treatments for COVID-19, highlighting the mortality rates and the lack of adequate approved alternatives [60][61] - The company is in a holding pattern regarding clinical trials while awaiting regulatory decisions on sabizabulin [62] - Management expressed confidence in the potential for sabizabulin to address unmet medical needs in ARDS and other viral infections [88] Other Important Information - The company has paused some spending and is evaluating clinical trial priorities to conserve cash while awaiting regulatory decisions [44][62] - The cash balance as of December 31, 2022, was $46.9 million, with net working capital of $32.9 million [55] Q&A Session Summary Question: What gives you confidence that HHS won't follow the White House in winding down the COVID emergency? - Management clarified that HHS governs the FDA and has its own emergency declaration, which remains in effect despite the White House's plans [70][71] Question: Can you elaborate on the cash situation and spending pause? - Management indicated that spending was ramped up in anticipation of EUA approval but has since been paused to conserve cash while awaiting regulatory decisions [72][73] Question: Are you pulling back on enrollment in oncology trials? - Management confirmed that enrollment timelines may be extended as they evaluate cash flow and prioritize trials [78][80] Question: Can the company advance Sabizabulin into a clinical trial for ARDS excluding COVID-19 patients? - Management acknowledged the potential to explore ARDS indications but emphasized the need to wait for regulatory clarity [87][90] Question: Do you expect FC2 sales to return to previous levels? - Management noted that they are starting to see revenues return to previous levels, contingent on resolving customer issues [93] Question: Is it correct that Veru may terminate one of the ongoing breast cancer or prostate cancer trials due to budgeting priorities? - Management stated that no decisions have been made yet, but they are looking at all options to prioritize trials that are closest to completion [95][96]