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”
All entries for: Oncology
November 8, 2022
CytomX Therapeutics
Negative Outlook
San Francisco, CA
51-200 employees
Disease Area: Oncology
Drug Type: Biologic
November 8, 2022
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.”
Disease Area: Oncology
Drug Type: Biologic
November 3, 2022
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”
Disease Area: Oncology
Drug Type: Biologic, Small Molecule
November 3, 2022
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”
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 2, 2022
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).
Disease Area: Oncology
Drug Type: Small Molecule
November 2, 2022
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”
Disease Area: Oncology
Drug Type: Small Molecule
November 1, 2022
Eli Lilly & Company
Negative Outlook
Indianapolis, IN
10,001-50,000 employees
• Potential Significant Impact if Drugs Selected: “It is too soon to tell how the U.S. government will set these prices as the law specifies a ceiling price, but not a minimum or floor price. One or more significant Lilly products may be selected, which would have the effect of accelerating revenue erosion prior to patent expiry. The effect of reducing prices and reimbursement for certain of our products could significantly impact our business and consolidated results of operations” • Small Molecule Investment Strategy: “The IRA may meaningfully influence our and pharmaceutical industry business strategies. In particular it may reduce the attractiveness of investment in small molecule innovation” • Potential Legal Uncertainty: “Provisions of the IRA may be subject to legal challenges or other reformation, and the full effect of the IRA on our business and the pharmaceutical industry remains uncertain. Additional policies, regulations, legislation, or enforcement, including those proposed and/or pursued by the U.S. Congress and executive branch of the U.S. administration and other regulatory authorities worldwide, could adversely impact our business and consolidated results of operations”
Disease Area: Multiple, Oncology
Drug Type: Biologic
November 1, 2022
Pfizer
Neutral Outlook
New York, NY
50,001+ employees
General Impact: “Governmental laws and regulations affecting our operations, including, without limitation, the recently enacted Inflation Reduction Act of 2022, changes in laws and regulations or their interpretation, including, among others, changes in tax laws and regulations internationally and in the U.S”
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 1, 2022
Eli Lilly & Company
Negative Outlook
Indianapolis, IN
10,001-50,000 employees
“The law “may reduce the attractiveness of investment in small molecule innovation,” Lilly wrote in its quarterly earnings filing, referring to drugs that are made as pills or tablets.”
Disease Area: Oncology
Drug Type: Small Molecule
November 1, 2022
Exelixis
Negative Outlook
Alameda, CA
1,001-5,000 employees
• General Impact: “Although public rulemaking and related agency guidance for the Inflation Reduction Act has yet to be issued and it is uncertain what impact the Inflation Reduction Act will ultimately have upon our business, over time the Inflation Reduction Act could reduce the revenues we are able to collect from sales of our products and increase our government discount and rebate liabilities” • Uncertainty: “In addition, we cannot know the final form or timing of any other legislative, regulatory and/or administrative measures, and some of these pending and enacted legislative proposals or executive rulemaking, if implemented without successful legal challenges, would likely have a significant and far-reaching impact on the biopharmaceutical industry and therefore also likely have a material adverse impact on our business, financial condition and results of operations”
Disease Area: Oncology
Drug Type: Small Molecule
