“includes prescription drug provisions that have significant implications for the pharmaceutical industry and beneficiaries, including extending enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025, allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries. 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. “
All entries for: Small Molecule
IDEAYA Biosciences
Negative Outlook
San Francisco, CA
51-200 employees
Gilead
Negative Outlook
Foster City, CA
10,001-50,000 employees
“While the full impact of the Act on our business and the pharmaceutical industry remains uncertain at this time, we anticipate that the Act will increase our payment obligations under the redesigned Part D discount program, limit the prices we can charge for our products, and increase the rebates we must provide government programs for our products, thereby reducing our profitability and negatively impacting our financial results.”
Acadia Pharmaceuticals
Negative Outlook
San Diego, CA
10,001-50,000 employees
TCJA: “Effective January 1, 2022, the Tax Cuts and Jobs Act eliminated the option to deduct research and development expenses for tax purposes in the year incurred and requires taxpayers to capitalize and subsequently amortize such expenses over five years for research activities conducted in the United States and over 15 years for research activities conducted outside the United States”
Merck
Negative Outlook
Rahway, NJ
50,001+ employees
“Pursuant to the IRA’s Program, discussions with the government will occur in 2023 and 2024, with government price-setting becoming effective on January 1, 2026. The Company has sued the U.S. government regarding the IRA’s Program (see Note 10 to the condensed consolidated financial statements). Furthermore, the Biden Administration and
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Congress continue to discuss legislation designed to control health care costs, including the cost of drugs. The Company anticipates all of these actions and additional actions in the future will negatively affect sales and profits.”
Regeneron
Neutral Outlook
Tarrytown, NY
10,001-50,000 employees
“The IRA did not have a material impact on the Company’s financial statements for the three and nine months ended September 30, 2023.”
Exelixis
Negative Outlook
Alameda, CA
1,001-5,000 employees
Bristol Myers Squibb
Negative Outlook
Princeton, NJ
10,001-50,000 employees
“On June 16, 2023, BMS filed a lawsuit against the U.S. Department of Health & Human Services and the Centers for Medicare & Medicaid Services, et al., challenging the constitutionality of the drug-pricing program in the IRA. That program requires pharmaceutical companies, like BMS, under the threat of significant penalties, to sell certain of their medicines at government-dictated prices”
Alkermes
Negative Outlook
Dublin, Ireland
1,001-5,000 employees
Pfizer
Layoffs
New York, NY
50,001+ employees
“Pfizer is conducting layoffs at its Boulder, CO research facility, months after announcing a retreat from a significant chunk of its early-stage research… The facility specialized in small molecule discovery, and housed nearly 300 employees, according to Pfizer’s website.”
Bristol Myers Squibb
Discontinued Research
Princeton, NJ
10,001-50,000 employees
BMS, whose blood thinner Eliquis (apixaban) is also on the list, wrote via email that it, too, is discontinuing certain oncology programs due to the IRA, including a late-stage registration trial for the multiple myeloma drug iberdomide. “Much of our progress against cancer is the result of post-approval research for patients, [and] as a result of the IRA, this research and progress is now at risk,” the BMS spokesperson wrote.
2 Discontinued Research Programs: iberdomide clinical trial; unnamed oncology programs
