INDIVIOR PLC

Current report

The Company omits its existing risk factor“Our ordinary shares are listed to trade on more than one stock exchange, and this may result in price variations.”

Previous report

The Company replaces its existing risk factor pertaining to tariffs with the following:

Previous report

Recently proposed tariffs on pharmaceutical products, and potential reciprocal responses by other countries, may adversely affect our revenues or profitability.

Previous report

The U.S. federal government recently made comments regarding tariffs of 25% or more. The government indicated that such tariff rates might increase substantially over the course of the year to allow manufacturers a phase-in period that would allow for the potential on-shoring of manufacturing. It is unclear at this time whether and to what extent such tariffs will take place, or how affected countries may react. At this time, few details are available, and policy details appear to be subject to negotiation and future change. The ultimate impact on Indivior will depend on the exact terms and timing of any tariff.

Previous report

We operate as a multi-national group of companies. We manufacture SUBLOCADE and SUBOXONE FILM primarily in the U.S. and therefore we do not expect these products to be directly affected by the tariffs. However, we import certain raw materials or intermediate products, including the active pharmaceutical ingredient (API) from the U.K., EU, and Australia. Also, most of our intellectual property is owned by a U.K. subsidiary and licensed within the Group. If implemented, we expect any tariff to be applied by the U.S. to have only a modest impact on both SUBLOCADE and SUBOXONE Film as we manufacture the active pharmaceutical ingredient (API) for these products at our plant in the U.K. Other impacts of the proposed tariffs remain unclear and any tariffs that would treat foreign entities that manufacturer and sell in the U.S., even to an affiliated entity could materially impact our operations. Additionally, our products move through various countries at various stages of the production cycle, and goods may move through multiple European countries, that could be subject to tariffs applied by the U.S.

Previous report

In the event the U.S. implements tariffs, we may face retaliatory tariffs levied by impacted countries. We export a significant amount of our finished products from the U.S. to Canada, Australia, the U.K., and the EU.

Previous report

We have limited ability to avoid any applicable tariffs in the short or medium term due to existing manufacturing commitments and the time needed to transfer technology and have a new manufacturing site validated by the FDA and other regulators. Our current plans to manufacture some of our requirements for SUBLOCADE at our Raleigh Manufacturing Facility beginning in late 2026 contemplate that the API would be provided by our existing U.K. plant.

Previous report

We have limited capacity to raise prices to recover costs of tariffs because, for example, the federal Inflation Reduction Act limits US pharma price increases to no greater than a certain inflation rate, and increases in excess of inflation trigger a 100% excise tax.