“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.”
All entries for: Biologic
November 13, 2023
IGM Biosciences
Negative Outlook
Mountain View, CA
201-500 employees
201-500 employees
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 9, 2023
Xilio Therapeutics
Negative Outlook
Waltham, MA
51-200 employees
51-200 employees
Disease Area: Oncology
Drug Type: Biologic
November 9, 2023
Recursion Pharmaceuticals
Neutral Outlook
Salt Lake City, UT
201-500 employees
201-500 employees
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 9, 2023
Context Therapeutics
Negative Outlook
Philadelphia, PA
1-50 employees
1-50 employees
Disease Area: Oncology
Drug Type: Biologic
November 9, 2023
Beigene
Negative Outlook
Cambridge, MA
5,001-10,000 employees
5001-10000 employees
“For example, the Inflation Reduction Act of 2022 (“IRA”) contains several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025, thereby effectively eliminating the coverage gap; impose new manufacturer financial liability on certain drugs under Medicare Part D; allow the U.S. government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition; require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation; and delay until January 1, 2032 the implementation of the U.S. Department of Health and Human Services (“HHS”) rebate rule that would have limited the fees that pharmacy benefit managers can charge. Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one orphan designation and for which the only approved indication is for that disease or condition. If a product receives multiple rare disease designations or has multiple approved indications, it may not qualify for the orphan drug exemption.”
Disease Area: Oncology
Drug Type: Biologic
November 8, 2023
Adicet Bio
Negative Outlook
Boston, MA
51-200 employees
51-200 employees
“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.”
Disease Area: Oncology
Drug Type: Biologic
November 8, 2023
Pfizer
Neutral Outlook
New York, NY
50,001+ employees
50001+ 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 8, 2023
Biogen
Negative Outlook
Cambridge, MA
5,001-10,000 employees
5001-10000 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
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: Multiple, Oncology, Therapeutics
Drug Type: Biologic
November 7, 2023
Sage Therapeutics
Negative Outlook
Cambridge, MA
501-1,000 employees
501-1000 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
