Veru (VERU) Q3 2024 earnings summary

Executive summary

• Achieved full enrollment of over 150 patients in the Phase 2b QUALITY clinical trial of enobosarm for muscle preservation and weight loss in obesity, with topline results expected January 2025.

• Focused on late-stage development of enobosarm, an oral SARM, in combination with GLP-1 receptor agonists to address muscle loss and augment fat loss in overweight or obese patients, especially older adults.

• Net revenues for Q3 2024 were $4.0 million, up 18% year-over-year, with a net loss of $11.0 million, improved from $12.5 million in Q3 2023.

• Research and development expenses decreased significantly as the company prioritized enobosarm and paused other programs.

• Cash and cash equivalents increased to $29.2 million as of June 30, 2024, up from $9.6 million at September 30, 2023.

Financial highlights

• Q3 2024 net revenues were $4 million, up from $3.3 million year-over-year; global public sector sales rose to $3.4 million, while US prescription sales declined to $552,000.

• Gross profit was $1.3 million (34% margin), up from $1.2 million (37% margin) year-over-year; margin decline due to sales mix shift.

• Operating expenses dropped to $12.4 million from $19.7 million, mainly due to lower R&D and SG&A costs.

• Net loss for Q3 was $11 million (7 cents/share), improved from $12.5 million (14 cents/share) year-over-year.

• For the nine months ended June 30, 2024, net loss was $29.3 million, down from $85 million in the prior year period.

Outlook and guidance

• Topline results from the Phase 2b QUALITY trial expected in January 2025; extension study results anticipated in Q2 2025.

• Plans to engage with FDA and potential partners after Phase 2b data readout.

• Sufficient cash and expected FC2 sales to fund operations for at least the next 12 months and through key clinical milestones.

• Advancement of sabizabulin for ARDS and oncology programs contingent on securing external funding.