“U.S. government plans to rein in drug prices could discourage work in some of Novartis’s most promising areas of research, the Swiss drugmaker warned on Friday, urging Washington to rethink the “unintended” effects of its new rules… Lawmakers’ intention may be to favour sophisticated biologics over seemingly more conventional chemical drugs, but some of the most promising new treatment approaches belong to the latter group, said Victor Bulto, Novartis’s President Innovative Medicines for the U.S. market. “The most concerning piece in that legislation for us is the price setting after nine years for small molecules and 13 years for biologics,” Bulto told Reuters.”
All entries for: Small Molecule
April 25, 2023
Biogen
Negative Outlook
Cambridge, MA
5,001-10,000 employees
5001-10000 employees
Disease Area: Neurological Diseases
Drug Type: Biologic, Small Molecule
January 20, 2023
Novartis
Negative Outlook
Basel, Switzerland
50,001+ employees
50001+ employees
Disease Area: Multiple, Oncology
Drug Type: Small Molecule
November 9, 2022
Beigene
Negative Outlook
Cambridge, MA
5,001-10,000 employees
5001-10000 employees
Concern on Impact to Commercial Market: “Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private 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 medicines and drug candidates”
Disease Area: Neurological Diseases
Drug Type: Biologic, Small Molecule
November 8, 2022
Recursion Pharmaceuticals
Neutral Outlook
Salt Lake City, UT
201-500 employees
201-500 employees
“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]”
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 8, 2022
IDEAYA Biosciences
Negative Outlook
San Francisco, CA
51-200 employees
51-200 employees
Concerns on Profitability & Revenue: “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 8, 2022
Cerevel Therapeutics
Negative Outlook
Cambridge, MA
201-500 employees
201-500 employees
Impact TBD: “The effect of IRA on our business and the healthcare industry in general is not yet known. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit a company’s revenue generated from the sale of any approved products. Even if we do receive a favorable coverage determination for our products by third-party payors, coverage policies and third-party payor reimbursement rates may change at any time”
Disease Area: Neurological Diseases
Drug Type: Small Molecule
November 7, 2022
Atea Pharmaceuticals
Negative Outlook
Boston, MA
51-200 employees
51-200 employees
Likely Signigifant: “Most significantly, on August 16, 2022, President Biden signed the IRA into law. This statute marks the most significant action by Congress with respect to the pharmaceutical industry since adoption of the ACA in 2010… For that and other reasons, it is currently unclear how the IRA will be effectuated, and while the impact of the IRA on the pharmaceutical industry and our business cannot yet be fully determined, it is likely to be significant.”
Disease Area: Antiviral
Drug Type: 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
Merck
Negative Outlook
Rahway, NJ
50,001+ employees
50001+ employees
• IRA & 9-Month Period in 2022: “…the Company’s sales performance in the first nine months of 2022 was negatively affected by other cost-reduction measures taken by governments and other third parties to lower health care costs. In the U.S., Congress recently passed the Inflation Reduction Act, which makes significant changes to how drugs are covered and paid for under the Medicare” • General Impact: “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 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
