Risk-factor diff
FY 2025 10-K vs. FY 2024Net-new paragraphs in the most recent 10-K's Item 1A. Companies rarely add risk language without a real reason — additions here are often a leading signal of management concerns.
“our ability to obtain and/or maintain regulatory exclusivities, including orphan drug exclusivity for LUMRYZ;”
“with respect to LUMRYZ, our ability and the ability of our certified pharmacies, physicians and patients to meet the requirements under the REMS, and physician and patient perception and assessment of the burdens associated with obtaining LUMRYZ in compliance with the REMS;”
“regulatory developments and actions related to the manufacture, commercialization or continued use of our products, including FDA actions such as the issuance or modification of a REMS or issuance of an untitled or warning letter, or conduct of an audit by the FDA, the DEA, or another regulatory authority in which a manufacturing or quality deficiency is identified;”
“issuance and/or implementation of rules by CMS or other federal agencies that lessen the net revenue we receive on the sale of our products or that serve to alter the prices of competitors’ products with which we compete;”
“the impact of participation in the MDRP and 340B programs on the sales of our products, including the net revenue received from such sales;”
Policies & disclosures
Clawback, anti-hedging, stock ownership, and related-party policies will populate from extracted proxy sections.