Lantheus Holdings (LNTH) risk factors, FY2025 10-K

Lantheus Holdings's FY2025 10-K, filed Feb 26, 2026, lists 52 risk factors in 6 groups. Against the prior year's 43: 16 new, 7 dropped, 17 substantially reworded.

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Risk factors listed
526 groups
New this year
16vs 43 last year
Dropped
7since the prior 10-K
Substantially reworded
17of those kept
Section length
25k wordsItem 1A

What the changes say

  • Lantheus faces upcoming generic expiration risks for PYLARIFY in May 2026.
  • Executive leadership turnover occurred with CEO Brian Markison retiring.
  • The company expanded its share buyback program to $400.0 million.

What changed since the prior 10-K

New

  • NewRisks Related to Our Portfolio of Commercial Products

    Potential generic competitors may seek to enter the market as a result of regulatory exclusivity expiration, including the expiry of NCE regulatory exclusivity for PYLARIFY in May 2026

    PYLARIFY faces potential generic competition following the expiration of its NCE regulatory exclusivity on May 26, 2026.

  • NewRisks Related to Our Portfolio of Commercial Products

    For Neuraceq, our competitors currently include Lilly and GE Healthcare

    Competitors like Lilly and GE Healthcare compete with our product candidates such as Neuraceq, MK-6240, and NAV-4694.

  • NewRisks Related to Reimbursement and Regulation

    Reducing prospective payment levels for applicable diagnosis-related groups in the hospital inpatient setting

    CMS adjustments and prospective payment level reductions for diagnosis-related groups in hospital settings can lower our reimbursement rates.

  • NewRisks Related to Reimbursement and Regulation

    Reforms to the United States healthcare system, including changes to policies, guidelines and practices of regulatory authorities, may adversely affect our business

    The OBBBA signed into law on July 4, 2025, will reduce patient coverage under Medicaid.

  • NewRisks Related to Our Intellectual Property and Related Legal Proceedings

    The cost to defend our patents may be significant and may result in litigation which could be costly and time consuming

    Defending our patents in proceedings like European opposition hearings involves significant costs and management time.

  • NewRisks Related to Our Business Operations and Financial Results

    Changes to management or other key personnel, including the recent turnover in our leadership and senior management team, could have an adverse effect on our business

    CEO Brian Markison retired and President Paul Blanchfield left, bringing leadership turnover and transition risks.

  • NewRisks Related to Our Business Operations and Financial Results

    Our business depends on our ability to effectively manage existing products, successfully develop and launch new products and indications, generate actionable insights from data, and adapt to rapid technological and medical practice changes

    Our business requires continuous investment to adapt to rapid technological and medical practice changes in diagnostic imaging.

  • NewRisks Related to Our Business Operations and Financial Results

    Risks associated with acquiring intellectual property, including potential disputes regarding acquired companies’ intellectual property

    Divesting our SPECT business to SHINE requires providing time-consuming transition services that may distract personnel.

  • NewRisks Related to Our Business Operations and Financial Results

    Diversion of our management’s and other personnel’s time and attention to identify, assess and acquire potential additional products, businesses or technologies

    Acquisition efforts compete with larger pharmaceutical companies and risk management distraction and timing delays in revenue generation.

  • NewRisks Related to Our Business Operations and Financial Results

    Our use of artificial intelligence (“AI”) or other emerging technologies could adversely affect our business, results of operations, financial condition and cash flows

    Using artificial intelligence introduces risks of deficient recommendations and exacerbated cybersecurity challenges.

  • NewRisks Related to Our and our Strategic Partners’ Portfolios of Clinical Development Candidates

    We may not, or may take longer to, realize the expected benefits and opportunities related to, investments we have made to develop our new formulation of our prostate-specific membrane antigen (“PSMA”) PET Imaging Agent

    Our new PSMA PET imaging agent formulation has an FDA PDUFA date of March 6, 2026, with no guarantee of approval or TPT status.

  • NewRisks Related to Our and our Strategic Partners’ Portfolios of Clinical Development Candidates

    We may not, or may take longer to, realize the expected benefits and opportunities related to our acquisition of the rights to LNTH-2501

    We acquired Evergreen and LNTH-2501 with an FDA PDUFA date of March 29, 2026, introducing complex kit supply chain risks.

  • NewRisks Related to Our and our Strategic Partners’ Portfolios of Clinical Development Candidates

    As part of our acquisition of Life Molecular, we acquired LNTH-2620, a next-generation radioactive tracer used in PET scans to detect and visualize tau protein tangles in the brain, a key biomarker for Alzheimer’s disease and other neurodegenerative disorders. LNTH-2620 is currently in a Phase 3 study

  • NewRisks Related to Our Capital Structure

    Place us at a competitive disadvantage to competitors that have relatively less debt than we have

  • NewRisks Related to Our Capital Structure

    Changing economic conditions

  • NewRisks Related to Our Capital Structure

    Our business and operations could be negatively affected by any pending or future securities litigation or claims that we have otherwise engaged in wrongdoing

Dropped

  • DroppedRisks Related to Our Portfolio of Commercial Products

    Potential generic competitors as a result of patent and regulatory exclusivity expirations

  • DroppedRisks Related to Our Portfolio of Commercial Products

    Our just-in-time manufacturing of radiopharmaceutical products relies on the reliability of our equipment and processes, the timely receipt of radioactive raw materials and the timely shipment of finished goods, and any disruption of our supply or distribution networks could have a negative effect on our business

    Covered the NCE-1 date for PYLARIFY as May 26, 2025.

  • DroppedRisks Related to Reimbursement and Regulation

    Reforms to the U.S. healthcare system may adversely affect our business

  • DroppedRisks Related to Our Business Operations and Financial Results

    If we lose the services of our key personnel, our business could be adversely affected

  • DroppedRisks Related to Our Business Operations and Financial Results

    Our business depends on our ability to successfully introduce new products and adapt to a changing technology and medical practice landscape

    Covered just-in-time manufacturing risks and short half-lives like F-18's 110-minute half-life.

  • DroppedRisks Related to our and our Strategic Partners’ Portfolios of Clinical Development Candidates

    We may not, or may take longer to, realize the expected benefits and opportunities related to, investments we have made to develop diagnostic product candidates to be used in diagnosing, staging and monitoring Alzheimer’s disease

  • DroppedRisks Related to our and our Strategic Partners’ Portfolios of Clinical Development Candidates

    In addition, we are dependent on POINT to develop commercial product capacity and manufacture for both PNT2002 and PNT2003

Reworded

  • 90% rewrittenRisks Related to Our Portfolio of Commercial Products

    We can give no assurance that Curium Pharma (“Curium”) will continue to be successful with its commercialization of PYLCLARI in Europe or that GE Healthcare will successfully develop and commercialize piflufolastat F-18 in Japan

    Added GE Healthcare developing piflufolastat F-18 in Japan alongside Curium in Europe.

    Was: We can give no assurance that Curium will continue to be successful with its commercialization of piflufolastat F-18 in Europe

  • 87% rewrittenRisks Related to Our Portfolio of Commercial Products

    We face significant competition in our business and may not be able to compete effectively

    Added potential future competition from generic applicants ahead of PYLARIFY's NCE exclusivity expiry in May 2026.

  • 80% rewrittenRisks Related to Our Business Operations and Financial Results

    Any constraint on the availability of staff at imaging centers and hospitals and PET scanners could impact our ability to continue to generate substantial revenue from PYLARIFY, grow Neuraceq, and successfully launch and commercialize radiodiagnostic products in our pipeline

    Added staff availability at imaging centers and hospitals as a critical constraint alongside PET scanner capacity.

    Was: Any constraint on the availability of PET scanners could impact our ability to grow PYLARIFY and to successfully launch and commercialize radiodiagnostic products in our pipeline

  • 78% rewrittenRisks Related to Our Business Operations and Financial Results

    We may be adversely affected by prevailing economic conditions and financial, business and other factors beyond our control

    Added tariff policies and government actions as potential macro economic risk factors.

  • 70% rewrittenRisks Related to Our and our Strategic Partners’ Portfolios of Clinical Development Candidates

    Even if clinical development candidates receive regulatory approval, we can give no assurance that they can be successfully commercialized

    Changed GE Healthcare commercialization of Flyrcado from a successful status to uncertainty on whether they will continue success.

  • 69% rewrittenRisks Related to Our Capital Structure

    Repurchases by us of our common stock may affect the value of our common stock and reduces cash available for other purposes

    Updated the stock repurchase program to a $400.0 million authorization through December 31, 2027, replacing the 2024 program.

    Was: Repurchases by us of our common stock may affect the value of our common stock

  • 68% rewrittenRisks Related to Our Business Operations and Financial Results

    Our future growth may depend on our ability to identify and acquire or in-license additional products, businesses or technologies, and if we do not successfully do so, we may have limited growth opportunities and it could result in significant impairment charges or other adverse financial consequences

    Removed a bulleted list detailing specific financial and operational risks of acquisitions.

  • 63% rewrittenRisks Related to Our and our Strategic Partners’ Portfolios of Clinical Development Candidates

    We may not, or may take longer to, realize the expected benefits and opportunities related to, the POINT Biopharma Global Inc. (“POINT”) License Agreements

    Reordered the mention of PNT2003 and PNT2002 product candidates in the POINT License Agreements.

    Was: We may not, or may take longer to, realize the expected benefits and opportunities related to, the POINT License Agreements

  • 55% rewrittenRisks Related to Our Business Operations and Financial Results

    We may be limited in our ability to utilize, or may not be able to utilize, net operating loss carryforwards to reduce our future tax liability

  • 53% rewrittenRisks Related to Our Intellectual Property and Related Legal Proceedings

    If we are unable to protect our intellectual property, our competitors could develop and market products with features similar to our products, and demand for our products may decline

  • 46% rewrittenRisks Related to Our Capital Structure

    Our stock price has fluctuated significantly, which could cause the value of your investment in our common stock to decline, and you may not be able to resell your shares at or above your purchase price

    Was: Our stock price could fluctuate significantly, which could cause the value of your investment in our common stock to decline, and you may not be able to resell your shares at or above your purchase price

  • 45% rewrittenRisks Related to Our Portfolio of Commercial Products

    We obtain a substantial portion of our products from third party manufacturers and suppliers

  • 34% rewrittenRisks Related to Our and our Strategic Partners’ Portfolios of Clinical Development Candidates

    We have been and expect to continue to be dependent on partners for the development of certain product candidates, which expose us to the risk of reliance on these partners

  • 31% rewrittenRisks Related to Our Portfolio of Commercial Products

    We depend on some of our PMF partners to generate sales, accept, produce and deliver orders, collect payments and report related information for PYLARIFY

  • 30% rewrittenRisks Related to Our Business Operations and Financial Results

    We use hazardous materials in our business and must comply with environmental laws and regulations, which can be expensive

  • 28% rewrittenRisks Related to Our Capital Structure

    We have indebtedness that may limit our financial and operating activities and may adversely affect our ability to incur additional debt to fund future needs

  • 26% rewrittenRisks Related to Our Intellectual Property and Related Legal Proceedings

    We are involved in various legal proceedings that are uncertain, costly and time-consuming and could have a material adverse impact on our business, financial condition and results of operations

All 52 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Portfolio of Commercial Products

  1. 01We depend on some of our PMF partners to generate sales, accept, produce and deliver orders, collect payments and report related information for PYLARIFY31% rewritten
  2. 02Potential generic competitors may seek to enter the market as a result of regulatory exclusivity expiration, including the expiry of NCE regulatory exclusivity for PYLARIFY in May 2026New
  3. 03We obtain a substantial portion of our products from third party manufacturers and suppliers45% rewritten
  4. 04We can give no assurance that Curium Pharma (“Curium”) will continue to be successful with its commercialization of PYLCLARI in Europe or that GE Healthcare will successfully develop and commercialize piflufolastat F-18 in Japan90% rewritten
  5. 05We face significant competition in our business and may not be able to compete effectively87% rewritten
  6. 06For Neuraceq, our competitors currently include Lilly and GE HealthcareNew
  7. 07Ultrasound enhancing agents may cause side effects which could limit our ability to sell DEFINITY

Risks Related to Reimbursement and Regulation

  1. 08Reducing prospective payment levels for applicable diagnosis-related groups in the hospital inpatient settingNew
  2. 09Reforms to the United States healthcare system, including changes to policies, guidelines and practices of regulatory authorities, may adversely affect our businessNew
  3. 10Our business and industry are subject to complex and costly regulations. If government regulations are interpreted or enforced in a manner adverse to us or our business, we may be subject to enforcement actions, penalties, exclusion and other material limitations on our operations
  4. 11Our marketing and sales practices may contain risks that could result in significant liability, require us to change our business practices, and restrict our operations in the future

Risks Related to Our Intellectual Property and Related Legal Proceedings

  1. 12We are involved in various legal proceedings that are uncertain, costly and time-consuming and could have a material adverse impact on our business, financial condition and results of operations26% rewritten
  2. 13If we are unable to protect our intellectual property, our competitors could develop and market products with features similar to our products, and demand for our products may decline53% rewritten
  3. 14The cost to defend our patents may be significant and may result in litigation which could be costly and time consumingNew

Risks Related to Our Business Operations and Financial Results

  1. 15Changes to management or other key personnel, including the recent turnover in our leadership and senior management team, could have an adverse effect on our businessNew
  2. 16Any constraint on the availability of staff at imaging centers and hospitals and PET scanners could impact our ability to continue to generate substantial revenue from PYLARIFY, grow Neuraceq, and successfully launch and commercialize radiodiagnostic products in our pipeline80% rewritten
  3. 17Our business depends on our ability to effectively manage existing products, successfully develop and launch new products and indications, generate actionable insights from data, and adapt to rapid technological and medical practice changesNew
  4. 18We may be adversely affected by prevailing economic conditions and financial, business and other factors beyond our control78% rewritten
  5. 19Risks associated with acquiring intellectual property, including potential disputes regarding acquired companies’ intellectual propertyNew
  6. 20Our future growth may depend on our ability to identify and acquire or in-license additional products, businesses or technologies, and if we do not successfully do so, we may have limited growth opportunities and it could result in significant impairment charges or other adverse financial consequences68% rewritten
  7. 21Diversion of our management’s and other personnel’s time and attention to identify, assess and acquire potential additional products, businesses or technologiesNew
  8. 22Challenges with product quality or product performance, including defects, caused by us or our manufacturers or suppliers could result in a decrease in customers and revenues, unexpected expenses and loss of market share
  9. 23In the ordinary course of business, we may be subject to product liability claims and lawsuits, including potential class actions, alleging that our products have resulted or could result in an unsafe condition or injury
  10. 24We use hazardous materials in our business and must comply with environmental laws and regulations, which can be expensive30% rewritten
  11. 25Our business is subject to international economic, political and other risks that could negatively affect our results of operations or financial position
  12. 26We face currency and other risks associated with international sales
  13. 27Our business depends on the continued effectiveness and availability of our information technology infrastructure, and failures of this infrastructure could harm our operations
  14. 28Our use of artificial intelligence (“AI”) or other emerging technologies could adversely affect our business, results of operations, financial condition and cash flowsNew
  15. 29A disruption in our computer networks, including those related to cybersecurity, could adversely affect our business, results of operations, financial condition and cash flows
  16. 30We may be limited in our ability to utilize, or may not be able to utilize, net operating loss carryforwards to reduce our future tax liability55% rewritten

Risks Related to Our and our Strategic Partners’ Portfolios of Clinical Development Candidates

  1. 31We may not, or may take longer to, realize the expected benefits and opportunities related to, investments we have made to develop our new formulation of our prostate-specific membrane antigen (“PSMA”) PET Imaging AgentNew
  2. 32We may not, or may take longer to, realize the expected benefits and opportunities related to our acquisition of the rights to LNTH-2501New
  3. 33As part of our acquisition of Life Molecular, we acquired LNTH-2620, a next-generation radioactive tracer used in PET scans to detect and visualize tau protein tangles in the brain, a key biomarker for Alzheimer’s disease and other neurodegenerative disorders. LNTH-2620 is currently in a Phase 3 studyNew
  4. 34We may not, or may take longer to, realize the expected benefits and opportunities related to, the POINT Biopharma Global Inc. (“POINT”) License Agreements63% rewritten
  5. 35The process of developing new drugs and obtaining regulatory approval is complex, time-consuming and costly, and the outcome is not certain
  6. 36Even if clinical development candidates receive regulatory approval, we can give no assurance that they can be successfully commercialized70% rewritten
  7. 37We have been and expect to continue to be dependent on partners for the development of certain product candidates, which expose us to the risk of reliance on these partners34% rewritten

Risks Related to Our Capital Structure

  1. 38Repurchases by us of our common stock may affect the value of our common stock and reduces cash available for other purposes69% rewritten
  2. 39The conditional conversion feature of the 2.625% Convertible Senior Notes due December 2027, if triggered, may adversely affect our financial condition and operating results
  3. 40The issuance or sale of shares of our common stock, or rights to acquire shares of our common stock, could depress the trading price of our common stock
  4. 41We have indebtedness that may limit our financial and operating activities and may adversely affect our ability to incur additional debt to fund future needs28% rewritten
  5. 42Place us at a competitive disadvantage to competitors that have relatively less debt than we haveNew
  6. 43We may not be able to generate sufficient cash flow to meet our debt service obligations
  7. 44Despite our indebtedness, we may incur more debt, which could exacerbate the risks described above
  8. 45Our 2022 Revolving Facility contains restrictions that will limit our flexibility in operating our business
  9. 46U.S. credit markets may impact our ability to obtain financing or increase the cost of future financing, including interest rate fluctuations based on macroeconomic conditions that are beyond our control
  10. 47Our stock price has fluctuated significantly, which could cause the value of your investment in our common stock to decline, and you may not be able to resell your shares at or above your purchase price46% rewritten
  11. 48Changing economic conditionsNew
  12. 49Our business and operations could be negatively affected by any pending or future securities litigation or claims that we have otherwise engaged in wrongdoingNew
  13. 50If securities or industry analysts do not publish research or reports about our business, if they adversely change their recommendations regarding our stock, or if our results of operations do not meet their expectations, our stock price and trading volume could decline
  14. 51We do not anticipate paying any cash dividends for the foreseeable future, and accordingly, stockholders must rely on stock appreciation for any return on their investment
  15. 52Anti-takeover provisions in our charter documents and Delaware law and certain provisions in the Notes and Indenture may make an acquisition of us more difficult

Other Lantheus Holdings 10-Ks

  • FY2024 10-K risk factors
    43 risks

    Dependence on PMF partners and third-party manufacturers for just-in-time radiopharmaceutical distribution.

    Filed Feb 26, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.