+ commentary on the disease background, current standard of care and evolving market dynamics

• Asthma is a chronic lung disease characterized by inflammation & resulting narrowing of the airways. It affects people of all ages, but often starts in childhood. The precise etiology is unknown

Prevalence: 350M+ WW (~40M in US, incl. ~6M children)

3. 4K die every year in the US

• COPD is a chronic, slowly progressive and only partly reversible airflow obstruction. Smoking drives >80% of cases. It involves 2 related diseases: chronic bronchitis & emphysema

Prevalence: 125M+ WW (17M in US & 3rd leading cause of death), although underdiagnosed

• Most asthma patients are successfully managed on inhaled corticosteroids (ICS), LABAs & LAMAs. While only ~10-15% of asthma patients have severe disease, they account for >60% of total costs due to hospitalizations for exacerbations. Refer to the GINA guidelines for the complete SoC
• COPD is trickier. Pharmacological treatments can't reverse underlying tissue scarring but can relieve symptoms & reduce exacerbations. By the time of diagnosis, the disease may have been progressing for decades, so the prognosis is usually poor. Refer to the GOLD guidelines for the complete SoC
• GSK has historically dominated this space via inhalation devices, accounting for >30% of 2022 sales - a rate that is expected to hold through the next generation of treatments thanks to a broad portfolio across various classes

AstraZeneca (~18% of sales) is also a major player

• Moving forward, inhibitors of pro-inflammatory cytokines (i.e. IL-4, IL-5) are aiming to address severe asthma & COPD. Dupixent, Nucala, Tezspire & Others have racked up billions in asthma sales

Dupixent may be the first biologic approved in COPD after stellar BOREAS data in Mar, as long as it is confirmed in the parallel Ph3 NOTUS trial

• Key upcoming catalysts to watch:
• Regeneron / Sanofi Dupixent NOTUS data (1H'24) to confirm BOREAS readout in COPD
• GSK MATINEE readout in 2024
• AstraZeneca CRESCENDO data and Fasenra / tozorakimab regulatory submission in 2024+
• Connect Biopharma topline Ph3 data for CBP-201 in 2024
• This space has attracted tons of investor interest due to attractive market dynamics
• >100M patients & growing in wealthy 7MM markets
• Unmet need, particularly for severe patients
• Historically difficult to genericize
• Pharma interest supports M&A (i.e. $2B Bellus Health $GSK deal)
• Asthma / COPD is a class of drugs that is heavily managed by payors, particularly in community practices. Products with the least burdensome payor restrictions see preferential uptake, giving an edge to established incumbents with broad portfolios