Lantheus NASDAQ: LNTH reported what management described as a strong start to 2026, citing solid performance from its three core commercial products—PYLARIFY, Neuraceq® and DEFINITY—and progress on multiple regulatory and pipeline milestones during the first quarter.
On the call, CEO and Executive Chairperson Mary Anne Heino said 2026 is “a year of commercial execution and regulatory milestones,” with the company making “deliberate choices about where we focus our commercial effort and deploying capital so we’re positioned to deliver solid results in 2026 and accelerate growth in 2027.”
PYLARIFY TruVu approval and transition planning
Heino highlighted the March 6 FDA approval of PYLARIFY TruVu, a new PSMA PET imaging formulation. She said PYLARIFY TruVu offers the same diagnostic properties as PYLARIFY with a similar safety and efficacy profile, with the key benefit being “larger batch sizes” at manufacturing sites equipped with high-energy cyclotrons.
Heino said Lantheus estimates that more than 70% of current PYLARIFY supply is produced at PET manufacturing facility (PMF) sites with high-energy cyclotrons, which she said positions the company to “optimize the benefit” of TruVu. In the Q&A, she further explained the operational setup at PMFs, noting TruVu will require different cassettes used on synthesis boxes to produce the final imaging agent.
Chief Commercial Officer Amanda Morgan said the company has submitted an application for a HCPCS code and is preparing to apply for transitional pass-through (TPT) status. She said the company is also working with PMF partners to obtain FDA approvals for each manufacturing site ahead of a conversion targeted to begin in the fourth quarter.
Heino emphasized that PYLARIFY will not be phased out and instead will be “transitioned directly” to TruVu, with only one of the two products available in a given market at a time. She said the transition will be a “geographically a site-by-site conversion,” and Lantheus intends to initiate conversions only after reimbursement coding is in place and customers and payer systems are ready to submit and process claims. Morgan said the new formulation offers operational advantages, including “enhanced stability at higher radioactive concentrations,” which could support serving more patients or reaching sites farther from manufacturing locations.
Commercial performance across oncology, neurology, and cardiology
Morgan said first-quarter performance reflected “continued commercial execution across our portfolio,” pointing to volume growth and “disciplined performance” across the core brands.
- PYLARIFY: Morgan said U.S. volume increased approximately 5.8% year-over-year, with stable net average selling price (ASP) and volume sequentially “despite ongoing competitive activity.”
- Neuraceq®: Morgan reported $35.4 million in first-quarter revenue, up 14.3% compared to the fourth quarter of 2025. She described Neuraceq as “the second most utilized and fastest-growing beta amyloid PET imaging agent in the U.S.” and said growth was driven by increased utilization in existing accounts, expanding adoption of Alzheimer’s disease-modifying therapies (DMTs), and clinical guidelines that support earlier diagnostic use.
- DEFINITY®: Morgan reported $84.6 million in revenue, up approximately 6.8% year-over-year, attributing the increase primarily to higher volume demand. She said DEFINITY maintains more than 80% market share.
In response to an analyst question on the competitive landscape, Heino said the company is tracking copper-based PSMA products in late-stage development, but does not expect them to enter the market in 2026. She also referenced two other gallium-based PSMA products worldwide that could potentially be brought to the U.S., though she said they are not viewed as imminent.
Financial results and updated reporting categories
CFO Bob Marshall reported first-quarter revenue of $377.3 million, up 1.2% versus the prior-year quarter. Excluding $25.2 million of SPECT revenues from the year-ago period (the SPECT business was divested on Jan. 1), Marshall said revenue increased 8.6%.
Marshall said Lantheus has reconfigured revenue reporting into new categories—oncology, neurology, cardiology, and strategic partnerships and other—plus a category reflecting the divested SPECT business in prior periods. Under the new breakdown, he reported:
- Oncology (PYLARIFY): $240.9 million, down 6.5% year-over-year.
- Neurology (Neuraceq®): $35.4 million.
- Cardiology (DEFINITY®): $84.6 million, up 6.8% year-over-year.
- Strategic partnerships and other: $16.3 million, up 52.1%, which Marshall attributed to strength in the Pharma Solutions portfolio and the addition of the Evergreen CDMO business; he said MK-6240 represented over half the revenue in this category.
Gross margin was 67.0%, flat year-over-year. Marshall said results benefited from the SPECT divestiture, PYLARIFY and DEFINITY volumes, and DEFINITY price, offset by a decrease in PYLARIFY net price and the inclusion of Evergreen, as well as near-term margin dilution from Neuraceq relative to the company average.
Operating profit was $129.1 million, down 10.5%. Reported net income was $118.4 million, and adjusted net income was $95.8 million, down 12.5% from the prior-year period. GAAP diluted EPS was $1.80 and adjusted EPS was $1.46.
Operating cash flow was $125.1 million, up from $107.6 million a year earlier. Capital expenditures totaled $3.2 million, and free cash flow was $121.9 million. Marshall said the company ended the quarter with $498.6 million in cash and cash equivalents (net of restricted cash), had $200 million remaining under its buyback authorization, and access to an undrawn $750 million bank revolver.
Guidance reiterated; pipeline and regulatory updates
Marshall reiterated full-year 2026 guidance, keeping revenue expectations at $1.4 billion to $1.45 billion and adjusted EPS at $5.00 to $5.25. He said the company remains “vigilant to the market” and competitive dynamics, referencing ongoing competitor activity and pass-through changes for one competitor later in the year.
Heino also commented on market growth expectations for PSMA PET imaging diagnostics, saying 2025 market growth was “high teens to low 20s%,” while the company expects low-teens growth in 2026 based on triangulated data sources.
On the pipeline, Heino noted the FDA extended the PDUFA date for Actevi by three months to June 29, 2026, to allow additional time to review manufacturing-related information. She said the company is advancing launch readiness through the second half of 2026, targeting a full commercial launch in early 2027.
Heino also discussed PNT2003, which received tentative FDA approval in March as “the first radio equivalent to LUTATHERA” for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). She said launch timing will depend on final FDA approval, expiration of the 30-month Hatch-Waxman stay and related legal proceedings, and manufacturing and commercial strategy. Marshall added that 2026 guidance does not include material contributions from potential approvals this year.
Heino highlighted MK-6240, a registrational-stage tau-targeted PET imaging agent for Alzheimer’s disease, stating it is the leading imaging agent supporting late-stage DMT development and is being used in 17 current pharma-sponsored AD therapeutic programs. She said MK-6240 has a PDUFA date of Aug. 13. She also said Lantheus-2401, a GRPR-targeted PET radiodiagnostic for prostate cancer, is advancing toward its planned registrational program this year and could complement PSMA PET by identifying disease in patients who may be PSMA negative or equivocal.
Finally, Heino provided an update on the company’s CEO search, saying the board has narrowed candidates to “a small number of highly qualified” individuals.
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.
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