What Catalyst Pharmaceuticals, Inc. told the SEC could break it.

Catalyst's products and their inputs are exposed to escalating pharmaceutical trade policy. In September 2025 the administration announced plans to impose up to 100% tariffs on imported branded or patented pharmaceutical products (subject to exceptions), with uncertainty over whether such tariffs would apply to imported API or bulk drug products. Separately, U.S.-China tariffs affect imports of components and raw materials. Because Catalyst sources finished products and APIs from third parties — including AGAMREE from Switzerland-based Santhera and FYCOMPA from Eisai's manufacturers — new tariffs could materially raise its cost of goods, on top of drug-pricing pressure from the IRA and proposed Most-Favored-Nation pricing.

“in September 2025, the Trump Administration announced plans to impose up to 100% tariffs on imported branded or patented pharmaceutical products, subject to certain exceptions.”

Catalyst outsources all manufacturing and relies on single or limited sources for the supply and manufacture of many critical components, so a business interruption at those sources would be especially damaging. Notably, it relies on Santhera and Santhera's supplier as the sole source of supply for AGAMREE® (it is working to qualify a second supplier), and it depends on the same third-party manufacturers Eisai used for FYCOMPA®; FIRDAPSE® is sourced from more than one supplier. If it cannot continue these third-party relationships or a supplier fails to meet requirements, it could face delays in commercialization while it locates and qualifies alternatives — a lengthy process for regulated drug products.

“the Company relies on single or limited sources for the supply and manufacture of many critical components, a business interruption affecting such sources would exacerbate any negative consequences to the Company.”