What Lantheus Holdings, Inc. told the SEC could break it.

Lantheus relies on sole suppliers for critical inputs to its top products — the specially designed chemistry synthesis boxes and consumables for PYLARIFY and Neuraceq, and the lipid blend material and perflutren gas for DEFINITY — and on Jubilant HollisterStier as the significant/sole-source manufacturer of DEFINITY; loss of any of these would disrupt production with no near-term alternative.

“we purchase certain components and raw materials from sole suppliers (including, for example, the specially designed chemistry synthesis boxes and consumables used in the manufacturing of each of PYLARIFY and Neuraceq and the lipid blend material and perflutren gas used in the manufacturing of DEFINITY).”

PYLARIFY, Lantheus's largest product, faces reimbursement and competitive pressure: the loss of Transitional Pass-Through (TPT) Status and related Medicare fee-for-service changes weaken its payment position just as the expiry of its new chemical entity exclusivity in 2026 opens the door to generic entrants and Ga-68/Cu-64 PSMA competitors, so continued revenue depends on clinically differentiating PYLARIFY despite worse reimbursement.

“Continued substantial revenue contribution from PYLARIFY will also depend on our ability to clinically differentiate PYLARIFY from competitive products so that customers continue to choose PSMA PET with PYLARIFY for appropriate patients because of its clinical differentiation and despite the loss of TPT Status and the related changes to Medicare fee-for-service”