• Potential for REGN Drugs Being Selected: “Notably, the U.S. Congress recently passed the Inflation Reduction Act (the “IRA”), which includes measures allowing the government to negotiate prices of certain prescription drugs under Medicare (including those covered under Medicare Part B, such as EYLEA and, potentially in the future, aflibercept 8 mg)” • Uncertainty: “While enacted into law, it is unclear how the provisions of the IRA will be implemented and the extent to which the policy changes will ultimately impact reimbursement levels of our marketed products covered under Medicare Part B (such as EYLEA) or our product candidates that may in the future be covered under Medicare Part B (such as aflibercept 8 mg)” • Potential for “Material Adverse Impact”: “A reduction in the availability or extent of reimbursement from U.S. government programs (including as a result of the legislation, proposals, initiatives, and developments described above) could have a material adverse effect on the sales of EYLEA or our other marketed products. Economic pressure on state budgets may also have a similar impact”
All entries for: Neutral Outlook
Regeneron
Neutral Outlook
Tarrytown, NY
10,001-50,000 employees
Pfizer
Neutral Outlook
New York, NY
50,001+ employees
General Impact: “Governmental laws and regulations affecting our operations, including, without limitation, the recently enacted Inflation Reduction Act of 2022, changes in laws and regulations or their interpretation, including, among others, changes in tax laws and regulations internationally and in the U.S”
Sanofi
Neutral Outlook
Paris, France
50,001+ employees
SA CO Paul Hudson stated that the IRA “…will likely create significant uncertainties across our industry,” highlighting investments into future R&D. However, Mr. Hudson noted that SA is “well positioned in the short term” to navigate IRA challenges. 1. And that the orphan drug exemption to price setting is only applicable to drugs with only one indication, which disincentivizes pursuing additional indications 2. The discrepancy between the eligibility dates of biologics and small-molecule drugs for price setting
Alnylam
Neutral Outlook
Cambridge, MA
1,001-5,000 employees
General Impact: “The effect of Inflation Reduction Act of 2022 on our business and the healthcare industry in general is not yet known…The financial impact of the U.S. healthcare reform legislation over the next few years will depend on a number of factors, including, but not limited, to the policies reflected in implementing regulations and guidance, and changes in sales volumes for products affected by the new system of rebates, discounts and fees”
