All entries for: Biologic

November 8, 2022

Protagonist Therapeutics

Discontinued Drug, Discontinued Research

Newark, CA

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

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

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

• “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

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

Horizon Therapeutics

Negative Outlook

Deerfield, IL

1,001-5,000 employees

1001-5000 employees

• Income Taxes: “Pending further guidance, it is possible that the IRA could increase our tax liability, which could in turn adversely impact our business and future profitability. The IRA or future changes in U.S. tax laws could have a material adverse impact on the value of our deferred tax assets and liabilities, could result in significant one-time charges, and could increase our future U.S. tax expense.” • General Impact: “The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. It is currently unclear how the IRA will be effectuated but it is likely to have a significant negative impact on the pharmaceutical industry”

Disease Area: Therapeutics

Drug Type: Biologic

November 2, 2022

Gilead

Negative Outlook

Foster City, CA

10,001-50,000 employees

10001-50000 employees

• Potential for Limiting Prices, More Rebates: “We are continuing to evaluate the impact of the Act on our business, but it is possible that the Act could have the effect of limiting the prices we can charge and increasing the rebates we must provide government programs for our products, thereby reducing our profitability and negatively impacting our financial results” • Additional Leg/Rulemaking: “We cannot be sure whether additional legislation or rulemaking related to the Act will be issued or enacted, or what impact, if any, such changes will have on the profitability of our business in the future” • Uncertainty: “These initiatives and such other legislation may cause added pricing pressures on our products, and the resulting impact on our business is uncertain”

Disease Area: Antiviral

Drug Type: Biologic, Small Molecule