Veru(US:VERU)2023-08-10 18:30Financial Data and Key Metrics Changes - For Q3 2023, net revenues were $3.3 million, down from $9.6 million in the prior year [63] - Prescription business net revenues decreased from $6.7 million to $863,000 due to the Chapter 11 bankruptcy of the pill club [63] - Gross profit was $1.2 million or 37% of net revenues, compared to $7.1 million or 74% in the prior year [64] - Operating income for the quarter was $4.9 million, a significant improvement from an operating loss of $21.8 million in the prior year [68] - Net income for Q3 2023 was $6.3 million or $0.07 per diluted share, compared to a net loss of $22.2 million or $0.28 per diluted share in the prior year [70] Business Line Data and Key Metrics Changes - The FC2 female condom business generated over $213 million in net revenue since 2017, with a 115% increase in new prescriptions during Q3 2023 [52][57] - Global public sector net revenues were $2.5 million, down from $2.9 million in the prior year [64] - The U.S. prescription business net revenues were $5.2 million, down from $29.9 million in the prior year [71] Market Data and Key Metrics Changes - The company is experiencing a significant market opportunity in the contraceptive market, with a potential market opportunity for FC2 exceeding $400 million [55] - The company has seen a 115% increase in volume in the U.S. public sector for Q3 2023 compared to Q3 2022 [58] Company Strategy and Development Direction - The company is focused on obtaining regulatory clarity for two major Phase 3 clinical trials for Enobosarm and Sabizabulin [90] - Plans to expand the evaluation of Sabizabulin beyond COVID-19 to include all types of viral-induced lung infections [92] - The company aims to leverage partnerships for Enobosarm and Sabizabulin as a source of non-dilutive capital [96] Management's Comments on Operating Environment and Future Outlook - The company has successfully reduced expenses following the FDA's declination of the EUA for Sabizabulin, with a cash burn of $7.3 million in Q3 2023 [94] - The current cash position is $16 million, with expectations of $14 million in gross promissory notes receivable [94] - The company is actively seeking partnerships to enhance financial flexibility and shareholder value [95] Other Important Information - The company sold its Entadfi product for $20 million, recording a pre-tax gain of $17.5 million [68] - The company is pursuing smallpox and Ebola virus treatments, with a scheduled pre-IND meeting with the FDA [50] Q&A Session Summary Question: How much flexibility does the company have on OpEx to potentially extend the runway beyond the guidance for 12 months? - The company is exploring options to manage cash burn and may slow down drug development or focus on one program at a time to match spending with available resources [88] Question: Can the company comment on the status of the dual test mono trial and if data will be available? - The company is focused on obtaining regulatory clarity for the Phase 3 clinical trials and will provide updates as they progress [90]