Opthea (OPT) H1 2025 earnings summary

Executive summary

• Net loss before tax for the half year ended December 31, 2024 was US$137.9 million, up from US$106.7 million year-over-year, mainly due to a US$26.7 million fair value loss on investor options and higher interest expense on the Development Funding Agreement (DFA).

• Cash and cash equivalents at period end were US$131.9 million, down from US$172.5 million at June 30, 2024, with a runway through key Phase 3 topline data readouts in 2025.

• The company completed key milestones in its Phase 3 clinical trials for sozinibercept (OPT-302) in wet AMD, with topline data for COAST expected in early Q2 2025 and ShORe in mid-2025.

• Significant expansion of executive and commercial teams, new board appointments, and inclusion in the S&P/ASX 300 Index in preparation for potential FDA approval and US launch.

Financial highlights

• Revenue from ordinary activities decreased 60% year-over-year to US$24,000.

• Net loss after tax attributable to members increased 30% to US$131.9 million compared to the prior period.

• R&D expenses decreased to US$69.7 million (from US$87.2 million), while administrative expenses rose to US$15.5 million (from US$6.7 million) due to team expansion.

• Basic loss per share was US10.82 cents, improved from US17.18 cents year-over-year.

• No dividends declared or paid during the period.

Outlook and guidance

• Cash runway expected to fund operations through at least Q3 2025 and anticipated topline data readouts for COAST (early Q2 2025) and ShORe (mid-2025), but additional capital will be required for commercialization and to meet DFA obligations.

• Key objectives for the next 12 months include delivering topline data for COAST and ShORe, completing commercial validation batches, and preparing for a potential Biologics License Application filing in H1 2026.

• The company is evaluating opportunities to raise additional capital ahead of regulatory approval and commercialization.