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Lantheus Holdings, Inc. (LNTH)

Business Summary

Lantheus Holdings, Inc. is a leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes. The company classifies its products into three categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue. The industry is highly competitive and continually evolving, with competition based on brand recognition, product quality, price, and innovation. The company operates in a highly regulated industry subject to comprehensive governmental regulation both within and outside the United States, including by the FDA, NRC, and various state and foreign agencies.

The company believes its key product characteristics, such as proven efficacy, reliability and safety, coupled with core competencies like efficient manufacturing processes, an established distribution network, an experienced field sales organization, and customer service focus, distinguish it from competitors. For PYLARIFY, principal competitors include Telix Pharmaceuticals Limited, Blue Earth Diagnostics Ltd. (a subsidiary of Bracco), and Novartis AG. For DEFINITY, competitors include GE Healthcare and Bracco. For Neuraceq, competitors include Lilly and GE Healthcare. The company estimates that DEFINITY had over 80% share of the U.S. segment for ultrasound enhancing agents in echocardiography procedures as of December 31, 2025.

The company generates revenue through the sale of its commercial products, primarily to hospitals, independent imaging centers, and government facilities in the United States, and through a combination of direct distribution and third-party distribution relationships outside the United States. Revenue is also derived from licensing and royalty arrangements, strategic partnerships with pharmaceutical companies and academic institutions, and contract development and manufacturing organization (CDMO) services. The company's commercial products are used by cardiologists, neurologists, oncologists, and other healthcare professionals in various clinical settings.

The Radiopharmaceutical Oncology category consists of PYLARIFY, an F-18-labeled PET imaging agent targeting PSMA, approved by the FDA in May 2021 and commercially launched in the United States in June 2021. PYLARIFY is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer. For the year ended December 31, 2025, PYLARIFY generated revenue of $989,116 thousand . The Precision Diagnostics category includes DEFINITY, an injectable ultrasound enhancing agent used in echocardiography exams, which generated revenue of $330,248 thousand in 2025. This category also includes Neuraceq, an F-18 labeled PET imaging agent for Alzheimer's disease, which generated revenue of $51,447 thousand in 2025 following its acquisition in July 2025. TechneLite, another product in this category, generated revenue of $86,803 thousand in 2025.

The Strategic Partnerships and Other Revenue category generated $59,379 thousand in 2025. This includes revenue from partnerships with pharmaceutical companies and academic institutions, royalties and milestone payments from strategic partners, and CDMO revenue generated by Evergreen. The category also includes digital solutions like aBSI and aPROMISE (PYLARIFY AI), which are FDA cleared and CE Marked. Other notable revenue sources include the flurpiridaz (Flyrcado) license with GE Healthcare and the RELISTOR royalty, for which the company retained rights to future sales-based milestone payments after selling the net sales royalty asset in August 2023.

During 2025, the company announced multiple strategic transactions. On April 1, 2025, it acquired Evergreen Theragnostics, Inc. for an upfront payment of $276.4 million in cash, with potential additional milestone payments of up to $727.5 million . On July 21, 2025, it acquired Life Molecular Imaging Limited for an upfront payment of $352.9 million in cash, with potential additional earn-out and milestone payments of up to $400.0 million . On July 31, 2025, the Board authorized a program to repurchase up to $400.0 million of shares of common stock through December 31, 2027. The company also announced the sale of its SPECT business to SHINE Technologies, LLC, which was completed on January 1, 2026, for total consideration of up to $155.0 million . In August 2025, the FDA accepted the NDA for a new formulation of its PSMA PET imaging agent, setting a PDUFA target action date of March 6, 2026 .

For the fiscal year ended December 31, 2025, total revenues were $1,541,609 thousand , compared to $1,533,910 thousand in 2024, representing an increase of 0.5% . Net income was $233,559 thousand in 2025, compared to $312,442 thousand in 2024, a decrease of 25.2% . Diluted EPS was $3.41 in 2025 versus $4.36 in 2024. Operating income was $310,832 thousand in 2025, compared to $456,979 thousand in 2024, a decrease of 32.0% . The decrease in net income and operating income was primarily driven by a decrease in PYLARIFY net sales price and an increase in operating expenses, partially offset by revenue from acquisitions.

Business Outlook & Financial Sufficiency

A major growth vector is the new formulation of the F-18 PSMA PET imaging agent. The FDA accepted the NDA in August 2025 and set a PDUFA target action date of March 6, 2026 . The new formulation was designed to enhance product stability and increase batch production, with the potential to enhance supply flexibility and improve operating leverage across the network. If approved, the company plans to apply for CMS reimbursement, including seeking three years of TPT Status. Another key growth vector is the Alzheimer's disease franchise, including MK-6240, NAV-4694, and LNTH-2620. The FDA accepted the NDA for MK-6240 and set a PDUFA target action date of August 13, 2026 . MK-6240 is being used in over 100 ongoing academic and industry sponsored clinical trials. NAV-4694 is in Phase 3 development. The company also has an exclusive licensing agreement with GE Healthcare to develop, manufacture, and commercialize piflufolastat F-18 in Japan, with an upfront license fee and potential development milestones and tiered royalties.

The company's gross profit decreased by 4.7% in 2025 compared to 2024, primarily due to a decrease in PYLARIFY net sales price. Cost of goods sold increased by 9.9% to $599,657 thousand in 2025. Operating expenses increased by 16.9% to $631,120 thousand , driven by increases in general and administrative expenses (42.0% ) and research and development expenses (5.5% ). The company expects its cost of product sales and other operating expenses to change in line with periodic inflationary changes.

The company relies on a network of third-party manufacturers and suppliers for a substantial portion of its products, including PYLARIFY and Neuraceq, which are manufactured by a nationwide network of PMFs. The company also has an in-house FDA-approved manufacturing facility for DEFINITY at its North Billerica campus. The company has a manufacturing and supply agreement with Jubilant HollisterStier for DEFINITY that expires on December 31, 2027 . The company is investing in its technology infrastructure and has a Chief Information Officer and Chief Information Security Officer overseeing cybersecurity risks.

Research and development expenses were $177,308 thousand in 2025, $168,098 thousand in 2024, and $77,707 thousand in 2023. Capital expenditures were $36.1 million in 2025. The company has a share repurchase program authorized in July 2025 to repurchase up to $400.0 million of shares through December 31, 2027. As of December 31, 2025, approximately $200.0 million remained available for repurchase. The company does not anticipate paying any cash dividends for the foreseeable future.

The company faces significant headwinds from the expiration of TPT Status for PYLARIFY on December 31, 2024 . While CMS has maintained separate payment for PYLARIFY based on MUC, this rate is lower than the ASP-based payments made during TPT Status. Other competitive PSMA PET imaging agents continue to have TPT Status, providing a financial incentive to use those agents. The company also faces headwinds from the disparity in MUC payment rates for Neuraceq compared to competitive products. Additionally, the company faces risks from potential generic competition for PYLARIFY following the expiry of its NCE exclusivity in May 2026 and for DEFINITY following the expiration of its Orange Book-listed composition of matter patent in June 2019 .

The company faces constraints related to the availability of staff at imaging centers and hospitals and PET scanners, which could impact its ability to generate revenue from PYLARIFY, grow Neuraceq, and successfully launch new products. The company also faces risks from changes to management, including the recent turnover in leadership, and the need to successfully integrate acquisitions, including Life Molecular and Evergreen. The company is subject to extensive government regulation, and changes in healthcare laws, such as the One Big Beautiful Bill Act, could reduce patient coverage and reimbursement rates.

Management Sentiments & Priorities

Management's overall tone is focused on strategic transformation and positioning the company as a leading radiopharmaceutical company. Key themes include sharpening strategic focus through the sale of the SPECT business to focus on innovative PET radiodiagnostics and microbubbles, and advancing the pipeline through acquisitions and internal development. Management emphasizes the importance of the new formulation of the PSMA PET imaging agent, with a PDUFA target action date of March 6, 2026 , and the Alzheimer's disease franchise, including MK-6240 with a PDUFA target action date of August 13, 2026 , and LNTH-2501 with a PDUFA target action date of March 29, 2026 . The company is also focused on expanding its strategic partnerships, including the exclusive licensing agreement with GE Healthcare for piflufolastat F-18 in Japan. Management acknowledges the challenges from the expiration of TPT Status for PYLARIFY and the competitive landscape, but expresses confidence in the company's ability to clinically and commercially differentiate its products.

Financial Details

For the fiscal year ended December 31, 2025, total revenues were $1,541,609 thousand , compared to $1,533,910 thousand in 2024. Net income was $233,559 thousand in 2025, compared to $312,442 thousand in 2024. Diluted EPS was $3.41 in 2025 versus $4.36 in 2024. Operating income was $310,832 thousand in 2025, compared to $456,979 thousand in 2024. Gross profit was $941,952 thousand in 2025, compared to $988,291 thousand in 2024. The company had cash and cash equivalents of $359,121 thousand as of December 31, 2025, compared to $912,814 thousand as of December 31, 2024. Total debt, net of current portion, was $568,678 thousand as of December 31, 2025, compared to $565,279 thousand as of December 31, 2024. The company reported an unrealized loss on investment in equity securities of $8,617 thousand in 2025, compared to $43,564 thousand in 2024. The effective tax rate was 25.6% in 2025, compared to 27.5% in 2024. For the Radiopharmaceutical Oncology segment, PYLARIFY revenue was $989,116 thousand in 2025, a decrease of 6.5% from $1,057,834 thousand in 2024. For the Precision Diagnostics segment, total revenue was $493,114 thousand in 2025, an increase of 12.7% from $437,510 thousand in 2024.

Risk Factors

The continued substantial revenue contribution from PYLARIFY is dependent on maintaining adequate coding, coverage, and payment, which has been impacted by the expiration of TPT Status on December 31, 2024 , and the ability to clinically and commercially differentiate PYLARIFY from competitive products, including those with TPT Status. The company faces the risk of generic competition for PYLARIFY following the expiry of its NCE exclusivity in May 2026 and for DEFINITY following the expiration of its Orange Book-listed composition of matter patent in June 2019 . The company is subject to extensive government regulation, and changes in healthcare laws, such as the One Big Beautiful Bill Act, could reduce patient coverage and reimbursement rates. The company has significant indebtedness, including $575.0 million in aggregate principal amount of 2.625% Convertible Senior Notes due December 2027, and a $750.0 million revolving credit facility, which could limit financial and operating activities. The company is involved in various legal proceedings, including a patent infringement lawsuit related to PNT2003 and a putative securities class action, which could be costly and time-consuming.

References

  1. [1] Item 7, MD&A — Revenues
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  6. [6] Item 1, Business — 2025 Transactions
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  9. [9] Item 1, Business — 2025 Transactions
  10. [10] Item 5, Market for Registrant's Common Equity — Issuer Purchases of Equity Securities
  11. [11] Item 1, Business — 2025 Transactions
  12. [12] Item 7, MD&A — Recent Developments
  13. [13] Item 8, Financial Statements — Consolidated Statements of Operations
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  15. [15] Item 7, MD&A — Results of Operations
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  23. [23] Item 7, MD&A — Results of Operations
  24. [24] Item 7, MD&A — Recent Developments
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  26. [26] Item 7, MD&A — Results of Operations
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  28. [28] Item 8, Financial Statements — Consolidated Statements of Operations
  29. [29] Item 7, MD&A — Results of Operations
  30. [30] Item 8, Financial Statements — Consolidated Statements of Operations
  31. [31] Item 7, MD&A — Results of Operations
  32. [32] Item 7, MD&A — Results of Operations
  33. [33] Item 1, Business — Manufacturing and Supply Arrangements
  34. [34] Item 8, Financial Statements — Consolidated Statements of Operations
  35. [35] Item 8, Financial Statements — Consolidated Statements of Operations
  36. [36] Item 8, Financial Statements — Consolidated Statements of Operations
  37. [37] Item 7, MD&A — Net Cash Used in Investing Activities
  38. [38] Item 5, Market for Registrant's Common Equity — Issuer Purchases of Equity Securities
  39. [39] Item 5, Market for Registrant's Common Equity — Issuer Purchases of Equity Securities
  40. [40] Item 1A, Risk Factors — Risks Related to Our Portfolio of Commercial Products
  41. [41] Item 1A, Risk Factors — Risks Related to Our Portfolio of Commercial Products
  42. [42] Item 1A, Risk Factors — Risks Related to Our Portfolio of Commercial Products
  43. [43] Item 1A, Risk Factors — Risks Related to Our Portfolio of Commercial Products
  44. [44] Item 1A, Risk Factors — Risks Related to Our Portfolio of Commercial Products
  45. [45] Item 1A, Risk Factors — Risks Related to Our Portfolio of Commercial Products
  46. [46] Item 8, Note 12 — Long-Term Debt and Other Borrowings
  47. [47] Item 7, MD&A — External Sources of Liquidity
  48. [48] Item 7, MD&A — Recent Developments
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  50. [50] Item 7, MD&A — Recent Developments
  51. [51] Item 8, Financial Statements — Consolidated Statements of Operations
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  61. [61] Item 8, Financial Statements — Consolidated Balance Sheets
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  64. [64] Item 8, Financial Statements — Consolidated Balance Sheets
  65. [65] Item 8, Financial Statements — Consolidated Statements of Operations
  66. [66] Item 8, Financial Statements — Consolidated Statements of Operations
  67. [67] Item 7, MD&A — Income Tax Expense
  68. [68] Item 7, MD&A — Income Tax Expense
  69. [69] Item 7, MD&A — Revenues
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Analysis on 9/30/2026