• Income Taxes: “Pending further guidance, it is possible that the IRA could increase our tax liability, which could in turn adversely impact our business and future profitability. The IRA or future changes in U.S. tax laws could have a material adverse impact on the value of our deferred tax assets and liabilities, could result in significant one-time charges, and could increase our future U.S. tax expense.” • General Impact: “The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. It is currently unclear how the IRA will be effectuated but it is likely to have a significant negative impact on the pharmaceutical industry”
All entries for: Biologic
November 2, 2022
Horizon Therapeutics
Negative Outlook
Deerfield, IL
1,001-5,000 employees
1001-5000 employees
Disease Area: Therapeutics
Drug Type: Biologic
November 2, 2022
Gilead
Negative Outlook
Foster City, CA
10,001-50,000 employees
10001-50000 employees
• Potential for Limiting Prices, More Rebates: “We are continuing to evaluate the impact of the Act on our business, but it is possible that the Act could have the effect of limiting the prices we can charge and increasing the rebates we must provide government programs for our products, thereby reducing our profitability and negatively impacting our financial results” • Additional Leg/Rulemaking: “We cannot be sure whether additional legislation or rulemaking related to the Act will be issued or enacted, or what impact, if any, such changes will have on the profitability of our business in the future” • Uncertainty: “These initiatives and such other legislation may cause added pricing pressures on our products, and the resulting impact on our business is uncertain”
Disease Area: Antiviral
Drug Type: Biologic, Small Molecule
November 1, 2022
Eli Lilly & Company
Negative Outlook
Indianapolis, IN
10,001-50,000 employees
10001-50000 employees
• 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”
Disease Area: Multiple, Oncology
Drug Type: Biologic
November 1, 2022
Pfizer
Neutral Outlook
New York, NY
50,001+ employees
50001+ 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”
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
October 28, 2022
Sanofi
Neutral Outlook
Paris, France
50,001+ employees
50001+ 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
Disease Area: Neurological Diseases, Oncology
Drug Type: Biologic, Small Molecule
October 28, 2022
AbbVie
Negative Outlook
Chicago, IL
50,001+ employees
50001+ 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.
Disease Area: Oncology
Drug Type: Biologic
October 27, 2022
Alnylam
Negative Outlook
Cambridge, MA
1,001-5,000 employees
1001-5000 employees
Disease Area: Multiple
Drug Type: Biologic
October 27, 2022
Alnylam
Negative Outlook
Cambridge, MA
1,001-5,000 employees
1001-5000 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”
Disease Area: Multiple
Drug Type: Biologic
October 27, 2022
Alnylam
Discontinued Drug, Discontinued Research
Cambridge, MA
1,001-5,000 employees
1001-5000 employees
“Alnylam Pharmaceuticals Inc. said it’s stopping work on a treatment for a rare eye disease because of a new US drug-pricing law with the potential to limit how much it could charge for the medication in the future.
Alnylam will not begin a planned late-stage trial of its drug Amvuttra for Stargardt disease, which causes blindness, while it examines the Inflation Reduction Act, the company said Thursday in its third-quarter earnings statement.”
1 Discontinued Drug: Amvuttra (biologic)
1 Discontinued Research Program
Disease Area: Rare Diseases
Drug Type: Biologic
October 26, 2022
Bristol Myers Squibb
Negative Outlook
Princeton, NJ
10,001-50,000 employees
10001-50000 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.”
Drug Type: Biologic, Small Molecule
