“Adverse Effects”: “…the recently enacted federal Inflation Reduction Act (IRA) contains provisions that could have an adverse effect on our ability to generate revenue, attain profitability, or commercialize our product candidates if approved, as the statute includes provisions intended to reduce the cost of prescription drugs under Medicare. In addition to the direct impact of the IRA on federal drug reimbursement, the statute may also lead to similar reductions in payments from private payers. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect [List of items]”
All entries for: Multiple
November 8, 2022
Recursion Pharmaceuticals
Neutral Outlook
Salt Lake City, UT
201-500 employees
201-500 employees
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 3, 2022
Regeneron
Neutral Outlook
Tarrytown, NY
10,001-50,000 employees
10001-50000 employees
• 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”
Disease Area: Multiple
Drug Type: Biologic, Small Molecule
November 3, 2022
IGM Biosciences
Negative Outlook
Mountain View, CA
201-500 employees
201-500 employees
Potential “Material Adverse Effect”: “The implementation of cost containment measures, including the prescription drug provisions under the Inflation Reduction Act, as well as other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved. Complying with any new legislation and regulatory changes could be time-intensive and expensive, resulting in a material adverse effect on our business”
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 2, 2022
Acadia Pharmaceuticals
Negative Outlook
San Diego, CA
10,001-50,000 employees
10001-50000 employees
EVP & CFO Mark Schneyer stated that ACAD’s increased gross-to-net adjustment (18.6% from 15.2%) is primarily due to increasing 340B volumes and “…a higher gross-to-net adjustment to account for in-channel inventory rebates associated with the inflation Reduction Act (IRA).”
Disease Area: Multiple
Drug Type: 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 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
