SEC Disclosure

As public companies prepare their third quarter Form 10-Q filings, the rapidly shifting policy landscape has created new disclosure challenges for the life sciences sector. The recently announced pharmaceutical tariffs and ongoing government shutdown both carry potential financial and operational implications that warrant close attention. For biotech companies, these developments underscore the need for clear, proactive disclosure around supply chain resilience, pricing exposure, and regulatory uncertainty. In this post, we outline key disclosure considerations to help issuers navigate this evolving environment and manage investor expectations heading into the end of the year.

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.