What Integra LifeSciences Holdings Corp. told the SEC could break it.

About 26% of Integra's 2025 revenue came from products containing bovine-derived tissue (dermal regeneration, duraplasty, wound care, bone void fillers, nerve/tendon repair), exposing it to tissue availability, yield/quality, and animal-source regulatory scrutiny.

“In 2025, 26% of our revenues derived from products containing material derived from bovine tissue.”

Quality and operational issues (including the Boston recall) and higher manufacturing costs materially affected Integra's 2025 revenue and expenses, cutting gross margin to 50.9% from 54.8% in 2024.

“For the year ended December 31, 2025, gross margins were impacted by quality and operational issues, which affected both revenue and expenses, as well as higher manufacturing costs and cost of tariffs.”

U.S. tariffs announced in April 2025 on imports from dozens of countries (including China and the EU), plus reciprocal measures, contributed to higher cost of goods — the cost of tariffs was cited among factors compressing Integra's 2025 gross margin to 50.9%.

“In April 2025, the U.S. government announced new tariffs on goods imported into the U.S. from dozens of countries, including China and the European Union member states.”

Integra relies on independent suppliers — some of them sole-source — for raw materials, packaging, components, sterilization services and some finished goods (including handheld surgical instruments and dural sealants), risking inventory shortages from any single-vendor disruption.

“We rely on independent suppliers and third-party providers in our supply chain for raw materials, packaging materials and components, sterilization services, and some finished goods; we could experience inventory shortages if any of these suppliers encounter a manufacturing or distribution disruption.”