Opthea (OPT) H2 2024 earnings summary

Executive summary

• Completed enrollment in two pivotal Phase 3 wet AMD trials (COAST and ShORe), enrolling nearly 2,000 patients across 300+ sites.

• Raised $295.1 million through multiple financings, extending cash runway through expected topline data in 2025.

• Strengthened leadership with key executive and board appointments to support regulatory and launch readiness for sozinibercept.

• Presented evidence and expert support for sozinibercept as a potential first-in-class therapy to improve visual outcomes in wet AMD in 20 years.

Financial highlights

• Net loss for FY2024 was $220.2 million, up 55% year-over-year from $142.5 million; net loss per share (diluted) was $34.51 vs. $32.20.

• Adjusted Non-IFRS net loss was $174.0 million, up 28% from $135.5 million; adjusted net loss per share (diluted) was $27.27 vs. $30.61.

• Operating expenses rose to $192.1 million from $150.4 million, mainly due to Phase 3 trial and CMC activities.

• Cash and cash equivalents at June 30, 2024, were $172.5 million; pro-forma post-July 2024 financing, cash is $207.3 million.

• Net cash used in operating activities was $(161.0) million, compared to $(120.6) million in the prior year.

Outlook and guidance

• Topline results from COAST Phase 3 trial expected in early Q2 2025; ShORe topline results expected by mid-2025.

• Cash runway expected to fund operations through both Phase 3 topline data readouts.

• Ongoing preparations for Biologics License Application (BLA) and potential launch of sozinibercept.