Impact to DAXXIFY: “ It is currently unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry… Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of, or affect the price that we may charge for, DAXXIFY™, or any future product candidates including an onabotulinumtoxinA biosimilar”
All entries for: Biologic
November 8, 2022
Revance Therapeutics
Negative Outlook
Nashville, TN
501-1,000 employees
501-1000 employees
Disease Area: Therapeutics
Drug Type: Biologic
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
Protagonist Therapeutics
Discontinued Drug, Discontinued Research
Newark, CA
51-200 employees
51-200 employees
Paused trials of rusfertide in additional indications: “In keeping with our organizational prioritization of rusfertide in PV, plans to initiate trials of rusfertide in additional disease indications have been paused. This decision was influenced in part by the recent enactment of the Inflation Reduction Act in the United States and includes previously planned trials of rusfertide in the subset of hereditary hemochromatosis patients with chronic arthropathy”
1 Discontinued Drug: rusfertide (biologic)
1 Discontinued Research Program
Disease Area: Immune Diseases
Drug Type: Biologic
November 8, 2022
Halozyme Therapeutics
Negative Outlook
San Diego, CA
201-500 employees
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.”
Disease Area: Oncology
Drug Type: Biologic
November 8, 2022
CytomX Therapeutics
Negative Outlook
San Francisco, CA
51-200 employees
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”
Disease Area: Oncology
Drug Type: Biologic
November 8, 2022
Coherus BioSciences
Negative Outlook
Camarillo, CA
201-500 employees
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.”
Disease Area: Oncology
Drug Type: Biologic
November 4, 2022
Amgen
Negative Outlook
Thousand Oaks, CA
10,001-50,000 employees
10001-50000 employees
Impact on Sales: “The IRA’s drug pricing controls and Medicare redesign is likely to have a material adverse effect on our sales (particularly for our products that are more substantially reliant on Medicare reimbursement), our business and our results of operations”• Uncertainty: “However, as the degree of impact from this legislation on our business depends on a number of implementation decisions, the extent of the IRA’s impact on our sales and, in turn, our business remains unclear”
Drug Type: Biologic
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
