Lantheus (NASDAQ:LNTH) executives on the company’s fourth-quarter and full-year 2025 earnings call outlined a sharpened strategic focus on PET radiodiagnostics, progress integrating recent acquisitions, and expectations for 2026 that anticipate limited near-term revenue contribution from pending product approvals due to launch timing and reimbursement preparation.
Leadership update and portfolio repositioning
Mary Anne Heino, serving as interim CEO and executive chairperson while the board searches for a permanent chief executive, said the CEO search is “successfully progressing” and that she is “pleased with the candidates” the company has met. She added that the pool of candidates with deep radiopharmaceutical experience is relatively narrow given the industry’s size.
- The acquisition of Neuraceq, a beta-amyloid PET radiodiagnostic positioned as the “commercial cornerstone” of the company’s Alzheimer’s disease portfolio.
- The acquisition of OCTEVY, a neuroendocrine PET radiodiagnostic candidate currently under FDA review, which management said complements Lantheus’ nuclear medicine customer base.
Heino also said Lantheus completed the divestiture of its legacy SPECT business effective Jan. 1, 2026, calling it foundational historically but no longer aligned with the company’s forward investment priorities in PET radiodiagnostics.
Commercial performance: PYLARIFY, Neuraceq, and DEFINITY
Chief Commercial Officer Amanda Morgan said Lantheus is driving commercial readiness ahead of multiple launches, beginning with its new PSMA PET formulation. She characterized PYLARIFY as the company’s “market-leading agent,” noting fourth-quarter volume was up approximately 4% year over year in a “highly competitive market,” driven by “commercial execution and pricing discipline.” Morgan said most of 2025 volume came from long-standing accounts.
On pricing, Morgan referenced concessions made late in the second quarter of 2025 that reset 340B pricing in the fourth quarter. She said the company’s “best price” was unchanged in the second half of 2025 and that there will be no further change to 340B pricing in the first half of 2026.
Neuraceq contributed $31 million in the fourth quarter, which Morgan attributed to “strong commercial execution.” Management said it plans to support growth by adding manufacturing capacity, including onboarding six additional PMF sites in 2026. Later in the Q&A, Heino clarified Neuraceq had 16 PMF sites at the time of acquisition and that expansion of the geographic footprint is a primary growth lever, alongside deeper penetration in existing accounts and leveraging Lantheus’ relationships with nuclear medicine customers.
DEFINITY delivered over $85 million in fourth-quarter revenue, and Morgan said it remains the market leader with “more than 80% share” as it approaches its 25th year on the market.
Pipeline and regulatory milestones in 2026
Management repeatedly stressed that while it expects several approvals in 2026, it does not anticipate “meaningful revenue contribution” this year due to launch sequencing, coding, access, and reimbursement work that precede broad commercial rollouts.
Morgan laid out near-term regulatory timelines for several registrational-stage assets:
- New PSMA PET formulation (PDUFA March 6): Morgan said it offers similar diagnostic properties and safety/efficacy profile to PYLARIFY while improving manufacturing efficiency and supply availability. Heino later said the company expects an HCPCS code and transitional pass-through status by Oct. 1, assuming a pass-through application is submitted by June 1.
- OCTEVY (PDUFA March 29): a gallium-based PET diagnostic for neuroendocrine tumors, which management said could launch with transitional pass-through reimbursement if approved and would be offered through existing radiopharmacy networks.
- PNT2003: described as a “radioequivalent formulation of Lutathera” for gastroenteropancreatic neuroendocrine tumors. Morgan said the company is awaiting FDA approval and anticipates a mid-year court ruling in Hatch-Waxman litigation.
- MK-6240 (PDUFA Aug. 13): a tau-targeted PET radiodiagnostic for Alzheimer’s disease. Morgan said it is widely used in late-stage Alzheimer’s drug development and is the imaging agent for treatment eligibility in 17 pharma-sponsored programs.
For the new PSMA PET formulation, management said the operational transition from PYLARIFY will occur on a rolling regional basis in the fourth quarter of 2026, with “material commercial impact” beginning in 2027. In response to an analyst question, Heino described a strategy intended to avoid supply disruptions and said the product’s name would be introduced after approval.
2025 financial results and 2026 outlook
CFO Rob Marshall reported fourth-quarter revenue of $406.8 million, up 4%, and full-year revenue of $1.546 billion, up 0.5%. PYLARIFY generated $240.2 million in fourth-quarter revenue and $989.1 million for the full year, down 6.5% year over year but “above expectation” due to price and volume favorability compared with prior estimates.
Precision Diagnostics revenue was $143.2 million in the fourth quarter, up 22%, driven by DEFINITY net sales of $85.3 million and Neuraceq’s contribution. Strategic partnerships and other revenue rose to $23.3 million in the quarter, which Marshall attributed to a “strong quarter for MK-6240” and recognition of a $6 million milestone related to an out-licensed asset.
Gross margin was 65.1% in the quarter, down 289 basis points from the prior year, driven mainly by lower PYLARIFY net price and the inclusion of Evergreen and Neuraceq volumes versus the prior-year period. Adjusted EPS for the fourth quarter was $1.67, while full-year adjusted EPS was $6.08, down 10% from the prior year.
Lantheus reported fourth-quarter operating cash flow of $90.2 million and free cash flow of $81.4 million, with the year-over-year decline largely attributed to working-capital changes tied to the SPECT divestiture cutover and other timing items. The company repurchased $100 million of shares in the quarter, leaving $200 million remaining under its authorization, and ended the period with $359.1 million in cash and cash equivalents net of restricted cash.
For 2026, Marshall guided to worldwide net revenue of $1.4 billion to $1.45 billion, reflecting the removal of SPECT revenue and the expectation that newly approved products will not contribute meaningfully in 2026. Management expects PYLARIFY net revenue to decline 8% to 10% year over year, consisting of increased volume offset by modest price erosion, and expects Neuraceq to grow “triple digits” inorganically. DEFINITY is expected to grow low- to mid-single digits. The company guided to 2026 EPS of $5.00 to $5.25, with gross margin modeled around 65.5% and R&D expected at 10% to 11% of revenue.
Focus on radiodiagnostics and reviewing therapeutic assets
Heino and Marshall said the company is optimizing its cost structure to align with a diagnostic-focused strategy and is “pursu[ing] value-maximizing alternatives” for radiotherapeutic pipeline assets. Heino said the company is not referring to PNT2003 in that review given its proximity to potential approval and its fit with Lantheus’ customer base. Management said it does not anticipate significant M&A in 2026 but remains open to “opportunistic tuck-in acquisitions” aligned with diagnostics.
Looking into 2026, Heino summarized priorities that include sustaining PYLARIFY volume growth, executing a seamless transition to the new PSMA PET formulation beginning in the fourth quarter, expanding Neuraceq’s manufacturing footprint, advancing FDA-reviewed assets through approval milestones, and allocating capital with discipline while maintaining financial flexibility.
About Lantheus (NASDAQ:LNTH)
Lantheus Holdings, Inc is a global life sciences company specializing in the development, manufacturing and commercialization of diagnostic imaging agents and radiopharmaceuticals. Headquartered in North Billerica, Massachusetts, Lantheus focuses on products that enhance the detection and management of cardiovascular and oncologic diseases. The company’s portfolio spans ultrasound-enhancing agents, molecular imaging tracers for positron emission tomography (PET), and emerging theranostic platforms designed to pair diagnostic and therapeutic applications.
The diagnostic imaging segment includes ultrasound contrast agents such as DEFINITY® (perflutren lipid microsphere) and Sonazoid® (perflubutane), which improve the visualization of cardiac structures and blood flow.
