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Lantheus Holdings, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 7 May 2026: press release. Guidance figures: 2 kept. The quarter’s numbers.

Key takeaways

  • Worldwide revenue rose 1.2%: Worldwide revenue was $377.3 million, up 1.2% from $372.8 million. The prior-year quarter included $25.2 million of SPECT revenue, which does not appear after the divestiture. Source
  • GAAP EPS rose; adjusted EPS fell: GAAP diluted EPS was $1.80 against $1.02, including a $59.3 million gain on the business sale and a $14.9 million unrealized investment gain. Adjusted diluted EPS was $1.46, down 4.6% from $1.53. Source
  • PYLARIFY sales fell 6.5%: PYLARIFY sales were $240.9 million against $257.7 million, down 6.5%. PYLARIFY is the largest product line, at roughly 64% of quarterly revenue. Source
  • PYLARIFY TruVu reformulation approved: PYLARIFY TruVu is a new formulation of the PSMA PET agent, described by the company as designed for manufacturing efficiency and supply flexibility. Source
  • PNT2003 launch timing still open: Management said PNT2003 launch timing will consider the FDA approval timing, along with manufacturing and commercial strategy to ensure launch success. Source
  • Adjusted operating margin declined: Adjusted operating income was 34.2% of revenue, against 38.7% a year earlier. Amortization of acquired intangible assets rose to $16.7 million from $8.0 million. Source
  • Free cash flow reached $121.9 million: Operating cash flow was $125.1 million and capital expenditures were $3.2 million, giving free cash flow of $121.9 million, against $98.8 million a year earlier. Source
  • Focus narrows to PET radiodiagnostics: Management said it will prioritize radiodiagnostics in capital deployment while evaluating the best path to maximize value from its radiotherapeutic assets. Source

“During the quarter, we secured FDA approval for PYLARIFY TruVu and achieved tentative approval for PNT2003.”

Mary Anne Heino, Chief Executive Officer of Lantheus

Guidance

AreaPeriodFigureAgainst last quarter
Worldwide revenue SourceFY 2026$1.4 billion - $1.45 billionKept
Adjusted fully diluted EPS (non-GAAP) SourceFY 2026$5.00 - $5.25Kept

What changed from last quarter

  • Guidance kept: Revenue and adjusted diluted EPS guidance for 2026 were reaffirmed without change from the February 26, 2026 release. Source
  • New: FDA approved PYLARIFY TruVu, a new formulation of PYLARIFY, after the March 6, 2026 action date listed in the prior release. Source
  • New: PNT2003 received FDA tentative approval; the prior release described it as awaiting FDA approval and resolution of Hatch-Waxman litigation. Source
  • New: The FDA extended the PDUFA date for LNTH-2501 by three months to June 29, 2026, to review manufacturing-related information. Source

Results and growth drivers

  • Worldwide revenue rose 1.2%: Worldwide revenue was $377.3 million, up 1.2% from $372.8 million. The prior-year quarter included $25.2 million of SPECT revenue, which does not appear after the divestiture. Source
  • GAAP EPS rose; adjusted EPS fell: GAAP diluted EPS was $1.80 against $1.02, including a $59.3 million gain on the business sale and a $14.9 million unrealized investment gain. Adjusted diluted EPS was $1.46, down 4.6% from $1.53. Source
  • Operating income fell 20.3%: Operating income was $81.3 million, down 20.3%. Adjusted operating income was $129.1 million, down 10.5%, equal to 34.2% of revenue against 38.7% a year earlier. Source

Segments and product lines

  • PYLARIFY sales fell 6.5%: PYLARIFY sales were $240.9 million against $257.7 million, down 6.5%. PYLARIFY is the largest product line, at roughly 64% of quarterly revenue. Source
  • DEFINITY sales rose 6.8%: DEFINITY, reported under cardiology, had sales of $84.6 million against $79.2 million a year earlier, an increase of 6.8%. Source
  • Neuraceq contributed $35.4 million: Neuraceq sales were $35.4 million. The year-earlier quarter showed no Neuraceq revenue; the Q4 2025 release reported $31.0 million. Source
  • SPECT revenue ended with divestiture: SPECT contributed $25.2 million in the prior-year quarter and nothing in the first quarter 2026, after the business was sold to SHINE effective January 1, 2026. Source
  • Partnership and other revenue rose 52.1%: Strategic partnerships and other revenue was $16.3 million, up 52.1% from $10.7 million. Source

“all as we lay the groundwork for growth acceleration beginning in 2027.”

Mary Anne Heino, Chief Executive Officer of Lantheus

Pipeline and approvals

  • PYLARIFY TruVu reformulation approved: PYLARIFY TruVu is a new formulation of the PSMA PET agent, described by the company as designed for manufacturing efficiency and supply flexibility. Source
  • PNT2003 launch timing still open: Management said PNT2003 launch timing will consider the FDA approval timing, along with manufacturing and commercial strategy to ensure launch success. Source
  • Alzheimer's and pipeline named as priorities: For the rest of 2026 the CEO named expanding the Alzheimer's imaging portfolio and advancing the prioritized pipeline as focus areas. Source

Costs, margins and pricing

  • Operating expenses rose 10.3%: Total operating expenses were $149.6 million against $135.6 million. Sales and marketing rose to $52.7 million from $42.5 million, and R&D rose to $39.4 million from $36.3 million. Source
  • Gross profit fell as costs rose: Cost of goods sold rose to $146.4 million from $135.1 million, and gross profit was $230.9 million against $237.7 million. Source
  • Adjusted operating margin declined: Adjusted operating income was 34.2% of revenue, against 38.7% a year earlier. Amortization of acquired intangible assets rose to $16.7 million from $8.0 million. Source

Capital, cash and returns to shareholders

  • Free cash flow reached $121.9 million: Operating cash flow was $125.1 million and capital expenditures were $3.2 million, giving free cash flow of $121.9 million, against $98.8 million a year earlier. Source
  • Cash rose to $498.6 million: Cash and equivalents were $498.6 million, against $359.1 million at December 31, 2025. The total includes $31.4 million of proceeds from the SPECT sale to SHINE. Source
  • Revolving credit line of $750 million: The company has access to up to $750.0 million under a revolving line of credit. Source
  • Long-term notes receivable appeared: The balance sheet shows long-term notes receivable of $92.1 million at March 31, 2026, against none at December 31, 2025. The release does not describe them. Source
  • Share repurchases reported for Q4 2025: The prior release reported $100 million of share repurchases in the fourth quarter of 2025. The first quarter 2026 release does not report repurchases in the quarter.

Strategy and investment

  • Focus narrows to PET radiodiagnostics: Management said it will prioritize radiodiagnostics in capital deployment while evaluating the best path to maximize value from its radiotherapeutic assets. Source
  • Growth acceleration aimed at 2027: The CEO describes the 2026 actions as groundwork for growth acceleration beginning in 2027. Source
  • PSMA PET leadership ahead of conversion: The CEO named sustaining leadership in PSMA PET as the 2026 focus while preparing for the PYLARIFY TruVu conversion later this year. Source

Coming up, as management said on 7 May 2026

  • PYLARIFY TruVu phased launch: Launch is planned to begin in phases in the fourth quarter of 2026, timed to coding, coverage, payment and customer and PMF readiness. Source
  • LNTH-2501 FDA action date June 29: The FDA extended the review by three months to June 29, 2026, to review manufacturing-related information. Source

Figures management reported

FigureReported
PYLARIFY product sales Source$240.9 million, down 6.5% from $257.7 million
DEFINITY product sales Source$84.6 million, up 6.8% from $79.2 million
Neuraceq product sales Source$35.4 million
R&D spend Source$39.4 million, against $36.3 million
FDA approvals and tentative approvals SourcePYLARIFY TruVu approved; PNT2003 tentative approval
Hatch-Waxman stay (PNT2003) Source30-month stay; expiry date not stated
PDUFA date (LNTH-2501) SourceJune 29, 2026

Risks management discussed

  • Operational: The TruVu phased launch depends on FDA approval for each PET manufacturing facility and on coding, coverage and payment, which management ties to the timing of the launch. Source
  • Regulatory: PNT2003 launch timing depends on final FDA approval, expiry of the 30-month Hatch-Waxman stay, resolution of related legal proceedings, and manufacturing and commercial strategy. Source
  • Regulatory: The LNTH-2501 review extension concerns manufacturing-related information, and management states it is not related to efficacy or safety data. Source

Earlier plans management reported on

  • Not stated: In the February 26, 2026 release the company said it would ensure launch readiness with up to four FDA approvals this year. The first quarter release reports one approval and one tentative approval.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.