Exclusive Summary

• 1) First-line ERA backbone for PAH with strong evidence and once-daily 10 mg adherence; 2) 2026–2028 is the key patent/litigation expiry window in major markets, enabling first-wave generic capture; 3) US FDA GMP and US registration de-risk quality and enable reliance registrations globally; 4) ≥30% price reduction versus brand (brand annual cost >$80k in US) supports tenders and self-pay access; 5) REMS/pregnancy-testing compliance support and stable supply reduce partners’ operational risk.