Concerns on Profitability: “There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. For example, in August 2022, the Inflation Reduction Act of 2022 (the “IRA”) was signed into law… The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products. Such reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates”
All entries for: Oncology
Adicet Bio
Negative Outlook
Boston, MA
51-200 employees
Recursion Pharmaceuticals
Neutral Outlook
Salt Lake City, UT
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]”
IDEAYA Biosciences
Negative Outlook
San Francisco, CA
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.”
Halozyme Therapeutics
Negative Outlook
San Diego, CA
201-500 employees
Potential “Material Adverse Impact”: “In this dynamic environment, we are unable to predict which or how many federal policy, legislative or regulatory changes may ultimately be enacted. To the extent federal government initiatives decrease or modify the coverage or reimbursement available for our or our partners’ products, limit or impact our decisions regarding the pricing of biopharmaceutical products or otherwise reduce the use of our or our partners’ U.S. products, such actions could have a material adverse effect on our business and results of operations.”
CytomX Therapeutics
Negative Outlook
San Francisco, CA
51-200 employees
Concerns on Raising Investments: “In addition, we have incurred and will continue to incur additional costs associated with operating as a public company. However, financial market conditions, including the public equity markets, and government regulation, including the Inflation Reduction Act of 2022, signed into law by President Biden in August 2022, may make it difficult for biotechnology companies to raise additional funds. We cannot predict when or if market conditions will change”
Coherus BioSciences
Negative Outlook
Camarillo, CA
201-500 employees
• “Material Adverse Effect”: “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” • Concerns on Biosimilars: “…it is currently unclear how the IRA will be effectuated, and while the impact of the IRA on our business and the pharmaceutical industry cannot yet be fully determined, it is likely to be significant. In particular, if a product becomes subject to the IRA negotiation provision and related price cap, that may significantly alter the economic rationale for developing and commercializing a biosimilar.”
Merck
Negative Outlook
Rahway, NJ
50,001+ 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”
IGM Biosciences
Negative Outlook
Mountain View, CA
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”
Alkermes
Negative Outlook
Dublin, Ireland
1,001-5,000 employees
On the Alkermes (ALKS) Q3 2022 earnings call, CEO Richard Pops announced the approval by the Board of Directors to explore separating its commercial-stage neuroscience business and development-stage oncology business, partly due to the impacts of the Inflation Reduction Act (IRA).
Alkermes
Negative Outlook
Dublin, Ireland
1,001-5,000 employees
Impact to “Varying Degrees”: “The Inflation Reduction Act includes several provisions that will impact our business to varying degrees, including those that impose new manufacturer financial liability on all drugs in Medicare Part D beginning in 2025, allow the U.S. government to negotiate prices for some drugs covered under Medicare Part B and Part D beginning in 2026, and require companies to pay rebates to Medicare for drug prices that increase faster than inflation beginning in 2023”
