• Potential Significant Impact if Drugs Selected: “It is too soon to tell how the U.S. government will set these prices as the law specifies a ceiling price, but not a minimum or floor price. One or more significant Lilly products may be selected, which would have the effect of accelerating revenue erosion prior to patent expiry. The effect of reducing prices and reimbursement for certain of our products could significantly impact our business and consolidated results of operations” • Small Molecule Investment Strategy: “The IRA may meaningfully influence our and pharmaceutical industry business strategies. In particular it may reduce the attractiveness of investment in small molecule innovation” • Potential Legal Uncertainty: “Provisions of the IRA may be subject to legal challenges or other reformation, and the full effect of the IRA on our business and the pharmaceutical industry remains uncertain. Additional policies, regulations, legislation, or enforcement, including those proposed and/or pursued by the U.S. Congress and executive branch of the U.S. administration and other regulatory authorities worldwide, could adversely impact our business and consolidated results of operations”
All entries for: Biologic
Eli Lilly & Company
Negative Outlook
Indianapolis, IN
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
AbbVie
Negative Outlook
Chicago, IL
50,001+ employees
Andrew Baum of Citigroup asked how ABBV anticipates pricing pressure assuming CMS selects Imbruvica for the Drug Price Negotiation Program and whether they expect it before 2026 due to expected contracting on formulary placement.
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”
Alnylam
Discontinued Drug, Discontinued Research
Cambridge, MA
1,001-5,000 employees
“In addition to the updated Helios-B plan, Alnylam also announced Thursday that it’s having second thoughts about developing RNA interference therapy for Stargardt disease, a rare genetic eye disease that can cause vision loss. Alnylam said it will not launch a phase 3 study of Amvuttra in Stargardt in late 2022 as previously announced.
“Alnylam attributed the pause to Biden’s Inflation Reduction Act, which allows Medicare to directly negotiate prices of some high-expenditure drugs. Drugs with one single orphan drug designation is exempt from potential price negotiations, a term that may discourage companies from exploring approvals in additional indications, Alnylam CEO Yvonne Greenstreet noted on the call. Because Amvuttra and Onapttro already has an orphan status in ATTR, an additional orphan label could theoretically open it for potential pricing scrutiny.”
1 Discontinued Drug: Amvuttra (biologic) in Stargardt disease
1 Discontinued Research Program
Bristol Myers Squibb
Negative Outlook
Princeton, NJ
10,001-50,000 employees
General Impact: “We continue to evaluate the impact of the IRA legislation on our results of operations and it is possible that these changes may result in a material impact on our business and results of operations.”
Biogen
Negative Outlook
Cambridge, MA
5,001-10,000 employees
IRA is Notable Example of Pricing Pressure: “Drug prices are under significant scrutiny in the markets in which our products are prescribed, for example the Inflation Reduction Act of 2022 (the IRA) has certain provisions related to drug pricing. We expect drug pricing and other health care costs to continue to be subject to intense political and societal pressures on a global basis” • Uncertainty: “The overall impact that the IRA will have on our business, results of operations and financial condition, and the impact on the pharmaceutical industry as a whole is not yet known. We will continue to assess as further information becomes available”
