“The implementation of the IRA is currently subject to ongoing litigation challenging the constitutionality of the IRA’s Medicare drug price negotiation program. The effects of the IRA on our business and the healthcare industry in general is not yet known.”
All entries for: Negative Outlook
November 8, 2023
Adicet Bio
Negative Outlook
Boston, MA
51-200 employees
Disease Area: Oncology
Drug Type: Biologic
November 8, 2023
Biogen
Negative Outlook
Cambridge, MA
5,001-10,000 employees
“The IRA’s drug pricing controls and Medicare redesign may have an adverse impact on our sales (particularly for our products that are more substantially reliant on Medicare reimbursement), our business and our results of operations. However, the degree of impact from this legislation on our business depends on a number of implementation decisions. We will continue to assess as further information becomes available.”
Disease Area: Neurological Diseases
Drug Type: Biologic, Small Molecule
November 7, 2023
Zymeworks
Negative Outlook
Middletown, DE
201-500 employees
“Various industry stakeholders have initiated lawsuits against the federal government asserting that the price negotiation provisions of the Inflation Reduction Act are unconstitutional. The impact of these judicial challenges as well as future actions and agency rules implemented by the government on us and the pharmaceutical industry as a whole is unclear. 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: Oncology
Drug Type: Biologic
November 7, 2023
Sage Therapeutics
Negative Outlook
Cambridge, MA
501-1,000 employees
“It is unclear how the IRA will be implemented. We further cannot predict with certainty what impact the IRA or any other 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. There may be additional Congressional and administrative efforts to address drug pricing.”
Disease Area: Neurological Diseases
Drug Type: Biologic
November 7, 2023
IDEAYA Biosciences
Negative Outlook
San Francisco, CA
51-200 employees
“includes prescription drug provisions that have significant implications for the pharmaceutical industry and beneficiaries, including extending enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025, allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries. The implementation of cost containment measures, including the prescription drug provisions under the IRA, 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: Oncology
Drug Type: Small Molecule
November 7, 2023
Gilead
Negative Outlook
Foster City, CA
10,001-50,000 employees
“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.”
Disease Area: Antiviral
Drug Type: Biologic, Small Molecule
November 7, 2023
CytomX Therapeutics
Negative Outlook
San Francisco, CA
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
“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
“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
“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
