U.S. Policy & Pricing RiskRegulatory changes such as IRA Part D reform and potential MFN pricing create structural downside to U.S. pricing power. Given the U.S. is a core market, sustained policy-driven price pressure could compress margins, reduce cash flows, and force strategic repricing or cost responses over multiple years.
Seqirus Segment VolatilitySeqirus' dependence on seasonal vaccine cycles and tender-driven demand makes its revenue inherently volatile. Persistent softness in core markets undermines segment predictability; the planned demerger acknowledges structural underperformance and raises execution risk as an independent entity.
Competition In EU Iron MarketGeneric entrants eroding Ferinject's EU performance show some product lines are exposed to commoditization. This structural competitive pressure can lower volumes and prices, creating long-term margin headwinds unless CSL secures differentiation, pricing agreements, or new indications.