Outlook Therapeutics (OTLK) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Key milestones and strategic updates

• Achieved first-ever EU and UK marketing authorizations for bevacizumab in ophthalmology, targeting wet AMD, with plans to expand into DME and BRVO clinical trials in coming years.

• Ongoing market access work in Europe, focusing on pricing negotiations and potential partnerships, with initial launches planned for the UK and Germany in 2025.

• U.S. clinical development continues with the NORSE EIGHT trial, aiming for BLA resubmission in Q1 2025 and potential FDA approval in the second half of 2025.

• Secured 10 years of market exclusivity in Europe and expect 12 years in the U.S. upon FDA approval.

• Financially, reported $32 million in cash and equivalents, closed a $172 million private placement, and attracted top-tier institutional healthcare investors.

Clinical data and product differentiation

• NORSE TWO pivotal trial showed statistically significant superiority over Lucentis, with 42% of patients gaining 15 letters vs. 23% for Lucentis (p=0.0052).

• NORSE EIGHT trial, initiated in 2024, mirrors NORSE TWO dosing and endpoints, with top-line data expected in Q4 2024.

• Product designed specifically for ophthalmology, with stricter specifications for particulates, osmolarity, pH, and protein concentration compared to oncology versions.

• Studies show repackaged off-label bevacizumab often has lower drug protein content, leading to frequent patient switching to approved brands.

• Engaged Cencora (AmerisourceBergen) for regulatory and launch support in both Europe and the U.S.

Market opportunity and pricing strategy

• Retina anti-VEGF market estimated at $16 billion globally, with $8–9 billion in the U.S. and $3–4 billion in Europe.

• Deep market research revealed 85% of U.S. and 82% of EU/UK physicians are interested in an approved ophthalmic bevacizumab.

• Off-label bevacizumab costs under $100/injection, while branded options range from $1,850–$2,500 and biosimilars $1,130–$1,340.

• Actual average cost per injection, due to frequent switching, is closer to $1,000.

• Pricing strategy shaped by payer input, aiming to launch at a price below the current average, potentially making it a first-line treatment.