Risk Factors Update Summary
- Payors in the U.S. increasingly employ formularies to control costs, demand rebates, and use cost containment strategies.
- Market consolidation increases negotiating power, leading to higher rebates and utilization management tools.
- Added discussion of potential impacts on pipeline delivery, loss of continuity, knowledge, and inefficiency.
- Increased interest in cost-containment strategies for specialty pharmaceuticals may impact pricing and access.
- Recent impairments of IPR & D assets discussed in Note 4, impacting intangible assets.
- Market consolidation may lead to greater pricing pressure from payors, driving patients to lower-cost alternatives.
- Changes in tax laws effective since January 1, 2024, including the proposed "Tax Relief for American Families and Workers Act of 2024".
- Revenue concentration decreased from 82% to 64% for top products, with Comirnaty and Paxlovid dropping from 57% to 19%.
- Anticipate reduced revenues from patent expiries in 2026-2030 due to patent-based expirations.
- Increased competition from generic manufacturers may result in challenges related to patent infringement and validity.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
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