Mereo Biopharma Group (MREO) Jefferies London Healthcare Conference 2024 summary

Program overviews and development status

• Two late-stage rare disease programs: setrusumab for osteogenesis imperfecta (OI) in phase III, and alvelestat for alpha-1 antitrypsin deficiency (AATD) phase III ready by year-end, pending funding.

• Setrusumab phase III studies are fully enrolled, with data expected in 2025.

• Alvelestat phase II completed; phase III protocol aligned with FDA and EMA, focusing on clinical outcomes.

• Both programs target large market opportunities, each exceeding $1 billion.

Partnership and commercial strategy

• Setrusumab partnered with Ultragenyx, which funds global pivotal studies and CMC activities.

• $245 million in potential milestones, with tiered double-digit royalties from Ultragenyx for non-EU territories.

• EU commercialization retained, with plans to launch first in Germany, focusing on pediatrics.

• Expectation of a bolus of patients at launch due to awareness campaigns and patient identification.

Market opportunity and pricing

• Analyst consensus for setrusumab in OI is $1.2–$2 billion globally; EU5 opportunity estimated at EUR 500 million.

• Addressable EU population estimated at 25,000, with 85% covered by current phase III studies.

• Real-world evidence registries being established to support pricing and reimbursement.

• Pricing strategy uses Crysvita as an analog, targeting EUR 60,000–80,000 per year, with country-specific negotiations.