Earlier this year, the new Presidential Administration introduced a series of policies, legislative proposals and regulatory actions that have impacted the business and regulatory environment and contributed to a climate of uncertainty—particularly in the biopharmaceutical sector. These developments gave companies much to address in their first quarter 10-Q filings. To shed light on how biopharmaceutical companies addressed these developments, we conducted a survey of the Q1 Quarterly Reports of the top 100 biopharmaceutical companies. Our analysis revealed that most companies are actively assessing the potential impact of these changes, with more than two-thirds (68%) of companies updating their risk factors and more than half (53%) updating their Management’s Discussion & Analysis (MD&A) accordingly. Below is a summary of the key disclosure changes, with a focus on topics of heightened relevance to the industry—including tariffs, changes in laws related to Medicaid or Medicare, federal workforce disruptions and other issues such as the Section 232 investigation and the Section 340B Drug Pricing Program.
Tariffs
Tariffs emerged as the most commonly addressed issue, with 79% of companies adding disclosures related to their potential impact (e.g., as a result of increases in supply chain costs). Companies took varied approaches in presenting this information, with some including it in MD&A, others in the risk factors section, and many including the disclosure in both. The level of detail also varied significantly: 38% offered in-depth analysis exceeding a full paragraph, 14% included a few sentences, and 27% provided only a brief mention. The table below outlines the key substantive topics addressed in these disclosures:
| Disclosure | Prevalence | Breakdown |
| Actual impact on Q1 results | 7% |
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| Expected impact on future results | 61% |
|
| Investigation by the Department of Commerce under Section 232 of the Trade Expansion Act into imports of pharmaceuticals | 16% |
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The disclosures suggest that while tariffs are a significant concern, the specific impacts may not yet be fully realized, and thus difficult to predict or quantify.
Federal Reduction in Force
Following tariffs, the most frequently addressed change in company disclosures pertained to the mass layoffs of federal workers and disruptions within key government agencies—most notably the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), and the National Institutes of Health (NIH). In total, 58% of companies added disclosure, primarily in the risk factors section, related to the federal government’s reduction in force. Of these, 36% provided detailed discussion, while 21% included more limited references. Many companies expressed concern that these workforce reductions could lead to delays in the development and approval of drugs and therapies.
Inflation
Inflation was another common area receiving updated disclosures, with 32% of companies updating their 10-Qs to reflect its potential impact. In most cases, inflation was mentioned as one of several macroeconomic factors, rather than discussed in detail. While many companies focused on inflationary pressures within the United States, some also highlighted inflation trends in other countries.
Drug Pricing and Reimbursement
A quarter of companies (25%) added disclosures addressing recent and anticipated changes to laws affecting the pricing and reimbursement framework for drug products. Notably, 13% referenced the April 2025 Executive Order, which, among other directives, instructed HHS to collaborate with Congress on aligning the treatment of small molecule drugs and biologics under the Medicare price-setting provisions of the Inflation Reduction Act. This Executive Order also targeted reforms to Medicaid drug rebates and payment methodologies to obtain pharmaceutical products at lower costs. 8% of companies included specific disclosures regarding potential impacts on the Section 340B Drug Pricing Program. Additionally, 5% of companies disclosed potential implications of the June 2025 Executive Order, which advocated for a most-favored-nation approach to prescription drug pricing in the United States.
Looking Ahead
As you prepare your Q2 and future 10-Qs, it will be important to consider not only the disclosure trends highlighted above, but continued shifts in the business and regulatory environment. In particular, attention should be paid to the most recent tariff measures announced in July, as well as the enactment of the new tax legislation in the “One Big Beautiful Bill Act.” These developments may require timely updates to both risk factors and MD&A sections, depending on their potential impact on your company’s operations, financial results, and strategic outlook. Gibson Dunn attorneys are available to assist clients as they prepare their quarterly filings and consider how the evolving business and regulatory landscape impacts their disclosures.
We thank the following summer associates for their contributions to the data for this blog post: Kat Finseth, Nael Kim, Joe Kumar, Helena Lin and Nick Osorio.