Veru (NasdaqCM:VERU) Q4 2025 Earnings Call December 17, 2025 08:00 AM ET Company Participants Rohan Mathur - Biopharma Equity Research Associate Michele Greco - Chief Financial Officer and Chief Administrative Officer Mitchell Steiner - Chairman, CEO and President Sam Fisch - Executive Director of Investor Relations and Corporate Communications Conference Call Participants William Wood - Research Analyst Operator Good morning, ladies and gentlemen, and welcome to Veru Inc.'s Investors Conference Call. All p ...

Financial Data and Key Metrics Changes - The net loss from continuing operations for fiscal year 2025 was $15.7 million, or $1.07 per diluted common share, compared to a net loss of $35.3 million, or $2.61 per diluted common share in the prior year [27] - Research and development costs increased to $15.6 million in fiscal 2025 from $12.8 million in the prior year, primarily due to expenses related to the phase 2b obesity clinical study for Enobosarm [25] - Selling, general and administrative expenses decreased to $19.9 million in fiscal 2025 from $24.6 million in the prior year, mainly due to a reduction in share-based compensation expenses [25] Business Line Data and Key Metrics Changes - The company sold the FC2 female condom business for $18 million in cash, resulting in net proceeds of approximately $16.5 million after selling costs, but incurred a loss of approximately $4.1 million on the sale [22][23] - The gain on the sale of ENTADFI assets was $10.8 million in fiscal 2025, compared to a gain of $1.2 million in the prior year [25] Market Data and Key Metrics Changes - The company reported that as of September 30, 2025, cash, cash equivalents, and restricted cash balance was $15.8 million, down from $24.9 million as of September 30, 2024 [28] - The net working capital was $11.1 million on September 30, 2025, compared to $23.4 million on September 30, 2024 [29] Company Strategy and Development Direction - The company is focusing exclusively on drug development following the sale of the FC2 female condom business, which represents a strategic shift [23] - The planned phase 2b plateau clinical trial will target patients with a BMI greater than or equal to 35 and age greater than or equal to 65, aiming to assess the ability of Enobosarm treatment to break through the weight loss plateau [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the regulatory landscape evolving for muscle-preservation drugs for obesity treatment, with at least two possible regulatory pathways for Enobosarm [15] - The company highlighted the importance of addressing the weight loss plateau experienced by many patients on GLP-1 receptor agonists, indicating a significant market opportunity [18][42] Other Important Information - The company completed a public offering on October 31, 2025, resulting in net proceeds of approximately $23.4 million [24] - The company used cash of $30 million for operating activities in fiscal 2025, compared to $21.7 million in the prior year [29] Q&A Session Summary Question: Will any GLP-1 be allowed in your phase 2b, or will it be limited to just tirzepatide? - Management indicated that they will choose one GLP-1 receptor agonist to avoid variability in the study, with tirzepatide currently being the placeholder [32][33] Question: How does the FDA's guidance affect the phase 3 transition? - Management explained that the phase 2b study is designed to mirror phase 3 criteria, allowing for a clear understanding of incremental weight loss and functional endpoints [34][35] Question: What patient population is being targeted in the Plateau study? - The focus is on patients over 65 with physical limitations, as this group is seen as most in need and informative for assessing physical function [37][39]