Lipocine Announces Financial Results for the Full Year Ended December 31, 2024

Core Insights - Lipocine Inc. reported financial results for the year ended December 31, 2024, showing a net income of approximately $8,400 compared to a net loss of $16.4 million in 2023, indicating a significant turnaround in financial performance [6][19] - The company is advancing its product candidates, including LPCN 1154 for postpartum depression, LPCN 2401 for obesity management, and LPCN 1148 for decompensated cirrhosis, with ongoing clinical studies and potential partnerships [2][3][12] Financial Performance - As of December 31, 2024, Lipocine had $21.6 million in unrestricted cash and equivalents, a slight decrease from $22.0 million in 2023 [6] - The company recognized revenue of $11.2 million in 2024, a significant increase from a net reversal of variable consideration revenue of $2.9 million in 2023, primarily driven by license and royalty revenue [7][18] - Research and development expenses decreased to $7.4 million in 2024 from $10.2 million in 2023, attributed to the completion of certain clinical studies and reduced costs in other areas [8] Product Development - LPCN 1154, an oral formulation of brexanolone, is being developed for postpartum depression, with a Phase 3 safety and efficacy study expected to start in Q2 2025 following FDA guidance [2] - LPCN 2401 is positioned as a once-daily oral treatment for obesity management, showing positive Phase 2 study results and potential for partnership [2][12] - LPCN 1148 is aimed at treating decompensated cirrhosis, with positive Phase 2 trial results published, and has received fast track designation from the FDA [3][12] Partnerships and Licensing - Lipocine entered into a license agreement with Verity Pharma for the marketing of TLANDO, with expected total license fees of $11 million, and potential milestone payments of up to $259 million [11] - The company is exploring additional partnerships for its product candidates, including LPCN 1154, LPCN 2401, and LPCN 1148, to enhance commercialization efforts [2][12]