What is baked into the negative 8% to 10% PYLARIFY revenue guidance for FY26, particularly concerning the upcoming POSLUMA versus PYLARIFY head-to-head study readout at ASCO?

Management expressed concerns about the POSLUMA study's design, citing lack of randomization, no truth standard, potential for false positives, and not being powered for statistical significance. They also noted that patients in the study were not allowed to void prior to scans, which is not standard clinical practice. The results of this study are not factored into the FY26 PYLARIFY forecast. “The results of that study really do not bake into our forecast.”

Clarify Q4 FY25 PYLARIFY pricing and unit growth, and provide more detail on FY26 market assumptions for PYLARIFY, including unit and price components.

Q4 PYLARIFY performance was strong, with 4% volume growth and favorable gross-to-net price changes. For FY26, management assumes low single-digit volume growth, similar to 2025. Pricing assumes continued incremental price erosion, moving from mid-teens to high-teens gross-to-net adjustment, as a competitor may use pricing to gain share after losing pass-through status. The company will remain disciplined on pricing. “So the guide assumes that we see sort of a continuation of some incremental price that would sort of move us from sort of the mid-teens of where we are now to maybe the high teens as we progress through the year from a gross to net adjustment perspective.”

Elaborate on the strategy to pursue value-maximizing alternatives for radiotherapeutic assets, excluding PNT2003, and whether this includes near-term business development or specific product features.

The strategy is a natural outcome of the company's broad portfolio, aiming to ensure the value of each asset is considered. Lantheus will focus on diagnostic assets, and for therapeutics (excluding PNT2003), it will explore external or partnered alternatives to advance them. This involves defining stage gates to highlight clinical utility and value. The company remains open to opportunistic tuck-in acquisitions for diagnostic opportunities. “So we've chosen to focus in on the diagnostic assets. And as you'll see, I had a pipeline slide in the middle of my presentation and also showed again at the end. It really is a very broad portfolio there.”

LNTH

Lantheus (LNTH) Q4 FY25 earnings call: guidance and Q&A

Earnings call· Dec 2025 (Q4 FY25)· Health Care· Feb 26, 2026

Source: earnings call transcript

Executive summary

Lantheus Q4 FY25 — Strategic Focus on Radiodiagnostics and Strong Pipeline Progress

Lantheus is sharpening its strategic focus on radiodiagnostics, divesting its legacy SPECT business and pursuing value-maximizing alternatives for radiotherapeutic assets. The company anticipates multiple FDA approvals in 2026, setting the stage for accelerated revenue and earnings growth in 2027, despite an expected PYLARIFY net revenue decline in FY26. Management is prioritizing commercial execution and pipeline advancement while optimizing its cost structure to deliver on EPS targets.

Highlights

Impacted approximately 7 million patients in 2025, underscoring real-world importance.
Neuraceq contributed $31 million in Q4 and is expected to grow triple digits (140-150%) in FY26.
DEFINITY remained a strong contributor with $85.3 million in Q4 and over 80% market share.
PYLARIFY volume was up approximately 4% year-over-year in Q4, demonstrating resilience in a competitive market.
Multiple potential FDA approvals in 2026 for new PSMA PET formulation, OCTEVY, PNT2003, and MK-6240.

Concerns

PYLARIFY net revenue is forecast to decline 8% to 10% year-over-year in FY26 due to pricing decisions and competitive dynamics.
Gross profit margin decreased by 289 basis points year-over-year in Q4 to 65.1%.
Operating profit decreased by 8.5% in Q4 to $138.9 million.
Free cash flow was $81.4 million in Q4, a decrease of $60 million from the prior year period.
A $9 million headwind is expected in FY26 net interest expense due to lost interest income from 2025 M&A and share repurchases.

Guidance & targets

Category	Target	Timeline	Confidence
Worldwide Net Revenue	$1.4 billion to $1.45 billion high materiality	FY26	High
PYLARIFY Net Revenue Growth	declining 8% to 10% high materiality	FY26	High
Neuraceq Growth	triple digits (140% to 150%) medium materiality	FY26	High
DEFINITY Growth	low to mid-single digits medium materiality	FY26	High
Gross Margin	approximately 65.5% high materiality	FY26	High
R&D as % of Revenue	10% to 11% medium materiality	FY26	High
G&A as % of Net Revenue	10% low materiality	FY26	High
Net Interest Expense and Other	$5 million of expense medium materiality	FY26	High
Effective Tax Rate	26% low materiality	FY26	High
Fully Diluted Shares Outstanding	66 million shares low materiality	FY26	High
Adjusted EPS	$5.00 to $5.25 high materiality	FY26	High
New PSMA PET Formulation PDUFA Date	March 6 high materiality	Q1 FY26	High
New PSMA PET Formulation Commercial Launch	Q4 2026 high materiality	Q4 FY26	High
New PSMA PET Formulation HCPCS Code and TPT Status	in place by October 1 high materiality	Q4 FY26	High
OCTEVY PDUFA Date	March 29 high materiality	Q1 FY26	High
OCTEVY Commercial Launch	second half of this year high materiality	H2 FY26	High
PNT2003 Court Ruling	midyear high materiality	mid-2026 · FY26	High
MK-6240 PDUFA Date	August 13 high materiality	Q3 FY26	High
CEO Search Completion	progressing high materiality	ongoing	Medium
M&A Activity	no significant M&A activity medium materiality	FY26	High
Radiotherapeutic Assets Strategy	pursue value-maximizing alternatives high materiality	FY26	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
Radiopharmaceutical Oncology Comprised solely of PYLARIFY. Full year revenue was $989.1 million, down 6.5% from prior year. Results were above expectation due to price and volume favorability. PYLARIFY volume: up 4% year-over-year	$240.2 million	-9.7%	flat sequentially	—
Precision Diagnostics Driven by Neuraceq acquisition. Full year revenue was $330.2 million, up 3.9%. DEFINITY revenue: $85.3 millionDEFINITY growth: -1% (due to prior year competitor supply challenges)Neuraceq revenue: $31 millionNeuraceq revenue since acquisition (late July): $51.4 million	$143.2 million	22%	—	—
TechneLite and other SPECT Full year revenue was $111.4 million. This business was divested effective January 1, 2026.	$26.9 million	—	—	—
Strategic Partnerships and Other Strong quarter due to MK-6240 and a $6 million milestone receipt relating to an out-licensed asset. Full year revenue was $59.4 million. MK-6240 contribution: slightly less than half of full year amount	$23.3 million	203.3%	—	—

Deals & partnerships

Neuraceq Acquisition of beta-amyloid-targeted PET radiodiagnostic.

Neuraceq now serves as the commercial cornerstone of the Alzheimer's disease portfolio. Acquired in late July 2025.

OCTEVY Acquisition of neuroendocrine PET radiodiagnostic product candidate.

Currently under FDA review. Upon approval, it will broaden offerings to existing customers.

Legacy SPECT business Divestiture of legacy SPECT business.

Completed on January 1, 2026. Strategic intent is to prioritize investment in innovative PET radiodiagnostics.

Risks & headwinds

PYLARIFY Net Revenue Decline FY26

8% to 10% decline

Mitigation:Maintaining pricing discipline, focusing on volume growth, and preparing for seamless transition to new PSMA PET formulation.

Competitive Pricing Dynamics FY26

Modest price erosion

Mitigation:Company will remain disciplined and not chase business that is not good for long-term value; leveraging operational excellence and supply continuity.

Lost Interest Income FY26

$9 million headwind

Mitigation:Optimizing cost structure and focusing on high-return investments to offset financial impact.

Increased R&D Spend FY26

200 basis points increase (10-11% of revenue)

Mitigation:Investments are planned for phase-gated projects, anchored by GRPR diagnostic agent, with expectation of future returns.

Hatch-Waxman Litigation for PNT2003 mid-2026

Court ruling midyear

Mitigation:Awaiting court ruling; product remains a natural fit for the portfolio and customer base.

POSLUMA vs PYLARIFY Study Design Concerns ASCO readout

Study not powered for statistical significance, no randomization, no truth standard, patients not allowed to void prior to scan

Mitigation:Management believes the study design is flawed and its results are not factored into PYLARIFY's FY26 forecast.

What to watch in Q1 FY26

New PSMA PET Formulation FDA Approval

March 6, 2026

Current Under FDA review

Target Approval decision

Why it matters

This approval is crucial for the company's prostate cancer franchise and its planned transition from PYLARIFY, impacting future revenue growth and market leadership.

First, our new PSMA PET formulation with a PDUFA date of March 6, offers the same diagnostic properties of PYLARIFY with a similar safety and efficacy profile while delivering manufacturing efficiencies that will immediately improve supply availability.

Find out whether LNTH delivers this. Inve re-checks your case every morning.

Q&A highlights

Assuming FDA approval for the new PSMA PET agent on March 6, what is the timing for securing coding and transitional pass-through (TPT) reimbursement, and how will the transition from PYLARIFY be managed, especially with long-term contracts?

Management expects to have the HCPCS code and TPT status in place by October 1, 2026, following a June 1 application for TPT. The operational rollout will be a regional, rolling basis in Q4 2026 to ensure supply continuity and minimize disruption, with significant revenue impact expected in 2027. This approach is informed by prior F-18 product launches.

“We would anticipate that we would have in place by October 1, our HCPCS code and after having submitted our transitional pass-through application by June 1, that, that will also be in place by October 1. And it's very important that those events precede your commercial entry into the market.”

asked by Anthony Petrone · answered by Mary Heino

2 min read 5 chapters

Detailed narrative

Strategic Refocus on Radiodiagnostics

Lantheus is strategically narrowing its focus to innovative PET radiodiagnostics, having completed the divestiture of its legacy SPECT business on January 1, 2026. This shift aims to prioritize investment and commercialization efforts in high-growth areas, leveraging the company's existing nuclear medicine customer base.

The company believes this focused approach will deliver sustainable and attractive revenue growth in the mid and long term, optimizing its cost structure to support EPS targets.

Pipeline Strategy and Value Maximization

The company has built a broad radiodiagnostic pipeline, including the acquired Neuraceq and OCTEVY, and advanced Lantheus 2401 to Phase III-ready status. While committed to its diagnostic portfolio, Lantheus is pursuing value-maximizing alternatives for its radiotherapeutic assets (excluding PNT2003), recognizing that it cannot advance the entire portfolio internally.

This process is expected to take most of 2026, aiming to unlock shareholder value not currently reflected in the stock price or guidance.

Commercial Execution and Launch Preparedness

Lantheus is intensely focused on commercial execution and revenue generation from current assets, alongside preparing for multiple upcoming launches. Key to this is ensuring market access, coding, and broad payer coverage are in place before commercial launch, particularly for the new PSMA PET formulation and OCTEVY.

The company plans a rolling regional rollout for the new PSMA PET formulation in Q4 2026 to minimize risk and ensure supply continuity, with material impact expected in 2027.

Neuraceq Growth and Market Opportunity

Neuraceq, acquired in late July 2025, contributed $31 million in Q4 and is projected for triple-digit inorganic growth in FY26. The growth is driven by expanding the PMF manufacturing network (adding 6 sites in 2026 to the initial 16), increasing penetration in existing accounts, and leveraging relationships with PYLARIFY customers.

The expanding Alzheimer's disease PET imaging market, fueled by disease-modifying therapies and guideline changes, presents a significant opportunity for Neuraceq.

PYLARIFY Performance and Competitive Landscape

PYLARIFY, the market-leading PSMA PET agent, posted solid Q4 performance with volume up 4% year-over-year, despite a competitive market and pricing concessions in Q2 2025. Management expects PYLARIFY net revenue to decline 8-10% in FY26 due to pricing decisions and potential competitive dynamics as another F-18 agent's pass-through period ends. The company remains disciplined on pricing, refusing to chase business that would erode long-term value.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.