“While the full impact of the Act on our business and the pharmaceutical industry remains uncertain at this time, we anticipate that the Act will increase our payment obligations under the redesigned Part D discount program, limit the prices we can charge for our products, and increase the rebates we must provide government programs for our products, thereby reducing our profitability and negatively impacting our financial results.”
All entries for: Biologic
November 7, 2023
Gilead
Negative Outlook
Foster City, CA
10,001-50,000 employees
10001-50000 employees
Disease Area: Antiviral
Drug Type: Biologic, Small Molecule
November 7, 2023
CytomX Therapeutics
Negative Outlook
San Francisco, CA
51-200 employees
51-200 employees
“IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023), and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025). The IRA permits the Secretary of the Department of Health and Human Services (HHS) to implement many of these provisions through guidance, as opposed to regulation, for the initial years. For that and other reasons, it is currently unclear how the IRA will be effectuated. These laws and future laws may negatively impact the ability of biotechnology companies, including us, to raise funds from investors for or to obtain collaboration partners who assist us in the funding of research and development of future medicines”
Disease Area: Oncology
Drug Type: Biologic
November 6, 2023
AbbVie
Negative Outlook
Chicago, IL
50,001+ employees
50001+ employees
“In August 2023, as part of the Inflation Reduction Act (IRA) of 2022, the company’s oncology product Imbruvica sold in the United States (U.S.) was included on the list of products selected for negotiation by the Centers for Medicare & Medicaid Services. The selection resulted in a significant decrease in the estimated future cash flows for the product and represented a triggering event.”
Disease Area: Oncology
Drug Type: Biologic
November 6, 2023
Halozyme Therapeutics
Negative Outlook
San Diego, CA
201-500 employees
201-500 employees
“The Inflation Reduction Act of 2022” was enacted which will, among other things, allow and require the federal government to negotiate prices for some drugs covered under Medicare Part B and Part D, require drug companies to pay rebates to Medicare if prices rise faster than inflation for drugs used by Medicare beneficiaries and cap out-of-pocket spending for individuals enrolled in Medicare Part D.”
Disease Area: Oncology
Drug Type: Biologic
November 6, 2023
Coherus BioSciences
Negative Outlook
Camarillo, CA
201-500 employees
201-500 employees
“Healthcare reform measures, including the Inflation Reduction Act of 2022 (the “IRA”), may increase the difficulty and cost for us to obtain marketing approval for and commercialize our products, affect the prices we may set, and have a material adverse effect on our business and results of operations.”
Disease Area: Oncology
Drug Type: Biologic
November 3, 2023
Merck
Negative Outlook
Rahway, NJ
50,001+ employees
50001+ employees
“Pursuant to the IRA’s Program, discussions with the government will occur in 2023 and 2024, with government price-setting becoming effective on January 1, 2026. The Company has sued the U.S. government regarding the IRA’s Program (see Note 10 to the condensed consolidated financial statements). Furthermore, the Biden Administration and
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Congress continue to discuss legislation designed to control health care costs, including the cost of drugs. The Company anticipates all of these actions and additional actions in the future will negatively affect sales and profits.”
Disease Area: Oncology
Drug Type: Biologic, Small Molecule
November 2, 2023
Alnylam
Negative Outlook
Cambridge, MA
1,001-5,000 employees
1001-5000 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
10001-50000 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
Mirum Pharmaceuticals
Negative Outlook
Foster City, CA
51-200 employees
51-200 employees
“We expect that the Affordable Care Act, the IRA and other healthcare reform measures that may be adopted in the future may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from third-party payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our approved medicines and our product candidates, if approved.”
Disease Area: Rare Diseases
Drug Type: Biologic
November 2, 2023
Eli Lilly & Company
Negative Outlook
Indianapolis, IN
10,001-50,000 employees
10001-50000 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
