Lipocine (LPCN) investor relations material

Executive summary

• Achieved key pipeline milestones, notably completing Phase 3 study visits for LPCN 1154 in postpartum depression, with top-line results expected in April 2026.

• Advanced multiple neuroactive steroid programs, including LPCN 2201 for major depressive disorder and LPCN 2101 for epilepsy, with Phase 2 studies planned.

• Expanded TLANDO licensing agreements internationally, including new partnerships in Brazil and ongoing commercialization efforts in North America, South Korea, and GCC countries.

Financial highlights

• Reported full-year 2025 revenue of $2.0 million, down from $11.2 million in 2024, primarily due to lower license revenue.

• Net loss for 2025 was $9.6 million, or ($1.69) per diluted share, compared to net income of $8,352 in 2024.

• Research and development expenses increased to $8.6 million in 2025 from $7.4 million in 2024, reflecting higher clinical study costs.

• General and administrative expenses decreased to $3.8 million from $5.0 million year-over-year.

• Interest and investment income declined to $0.7 million from $1.2 million due to lower cash balances.

Outlook and guidance

• Top-line results from the Phase 3 LPCN 1154 study for postpartum depression expected in April 2026; NDA submission anticipated mid-2026.

• Phase 2 proof-of-concept studies planned for LPCN 2101 (epilepsy) and potentially LPCN 2401 (obesity management), pending regulatory guidance and resource prioritization.

• Exploring additional TLANDO partnerships outside current licensed territories.