“We expect the IRA to negatively impact sales and profits and may lead to further political pressure, or legislative, regulatory, or other efforts to introduce lower prices reduce spending on the Medicare and Medicaid programs expand and strengthen the affordable care act and lower, the overall spending by the government and prescription medicines. In addition, various state legislature and regulators have an acted or pursuing policy changes that could further increase pricing pressure on our products as a result we expect the healthcare industry in the US will continue to be subject to increase pricing and spending pressure.”
All entries for: Multiple
March 31, 2024
Takeda
Negative Outlook
Cambridge, MA
10,001-50,000 employees
Disease Area: Multiple
Drug Type: Biologic, Small Molecule
November 13, 2023
IGM Biosciences
Negative Outlook
Mountain View, CA
201-500 employees
“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.”
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 9, 2023
Recursion Pharmaceuticals
Neutral Outlook
Salt Lake City, UT
201-500 employees
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 8, 2023
Pfizer
Neutral Outlook
New York, NY
50,001+ employees
“The drug pricing provisions of the IRA, which was signed into law in August 2022, began to be implemented in 2023 and implementation efforts will continue over the next several years. In August 2023, the Biden Administration unveiled the first round of medicines subject to the “Medicare Drug Price Negotiation Program,” which requires manufacturers of select drugs to engage in a process with the Federal government to set new Medicare prices which would go into effect in 2026. Among the medicines included in the first round is Eliquis. We continue to evaluate the impact of the IRA on our business, operations and financial condition and results as the full effect of the IRA on our business and the pharmaceutical industry remains uncertain. In addition, changes to the Medicaid program or the federal 340B drug pricing program, including legal or legislative developments at the federal or state level with respect to the 340B program, could have a material impact on our business.”
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 3, 2023
Acadia Pharmaceuticals
Negative Outlook
San Diego, CA
10,001-50,000 employees
TCJA: “Effective January 1, 2022, the Tax Cuts and Jobs Act eliminated the option to deduct research and development expenses for tax purposes in the year incurred and requires taxpayers to capitalize and subsequently amortize such expenses over five years for research activities conducted in the United States and over 15 years for research activities conducted outside the United States”
Disease Area: Multiple
Drug Type: Small Molecule
November 2, 2023
Alnylam
Negative Outlook
Cambridge, MA
1,001-5,000 employees
“Under the IRA, a second FDA approval for vutrisiran for Stargardt Disease would cause us to lose the single-orphan exemption for AMVUTTRA from Medicare price negotiation. As a result, in October 2022, we announced we would not pursue a Phase 3 clinical trial to study vutrisiran in Stargardt Disease. The effect of the IRA on our business and the healthcare industry in general continues to develop and may have additional adverse impacts on our company or our industry.”
Disease Area: Multiple
Drug Type: Biologic
November 2, 2023
Regeneron
Neutral Outlook
Tarrytown, NY
10,001-50,000 employees
“The IRA did not have a material impact on the Company’s financial statements for the three and nine months ended September 30, 2023.”
Disease Area: Multiple
Drug Type: Biologic, Small Molecule
November 2, 2023
Eli Lilly & Company
Negative Outlook
Indianapolis, IN
10,001-50,000 employees
“Global concern over access to and affordability of pharmaceutical products continues to drive regulatory and legislative debate and action, as well as worldwide cost containment efforts by governmental authorities. Such measures include the use of mandated discounts, price reporting requirements, mandated reference prices, restrictive formularies, changes to available intellectual property protections, as well as other efforts. In August 2022, the U.S. government enacted the Inflation Reduction Act of 2022 (IRA).”
Disease Area: Multiple, Oncology
Drug Type: Biologic
October 27, 2023
Vir Biotechnology
Negative Outlook
San Francisco, CA
201-500 employees
“Accordingly, while it is currently unclear how the IRA will be effectuated, we cannot predict with certainty what impact any federal or state health reforms will have on us, but such changes could impose new or more stringent regulatory requirements on our activities or result in reduced reimbursement for our products, any of which could adversely affect our business, results of operations and financial condition.”
Disease Area: Antiviral, Multiple, Oncology
Drug Type: Biologic, Small Molecule
October 26, 2023
Bristol Myers Squibb
Negative Outlook
Princeton, NJ
10,001-50,000 employees
“On June 16, 2023, BMS filed a lawsuit against the U.S. Department of Health & Human Services and the Centers for Medicare & Medicaid Services, et al., challenging the constitutionality of the drug-pricing program in the IRA. That program requires pharmaceutical companies, like BMS, under the threat of significant penalties, to sell certain of their medicines at government-dictated prices”
Disease Area: Multiple
Drug Type: Biologic, Small Molecule
