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What changed in Lantheus Holdings, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Lantheus Holdings, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+804 added−700 removedSource: 10-K (2026-02-26) vs 10-K (2025-02-26)

Top changes in Lantheus Holdings, Inc.'s 2025 10-K

804 paragraphs added · 700 removed · 517 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

180 edited+71 added−74 removed174 unchanged
Biggest changeOur principal competitors for our current commercial products and leading clinical development candidates include large, global companies that are more diversified than we are and that have substantial financial, manufacturing, sales and marketing, distribution and other resources. • For PYLARIFY, our principal competitors are currently Telix Pharmaceuticals Limited, Novartis AG, and Blue Earth Diagnostics Ltd., a subsidiary of Bracco Diagnostics Inc.
Biggest changeOur competitors for our current commercial products and leading clinical development candidates include large, global companies that are more diversified than we are and that have substantial financial, manufacturing, sales and marketing, distribution and other resources. • For PYLARIFY, our principal competitors are currently Telix Pharmaceuticals Limited, Blue Earth Diagnostics Ltd., a subsidiary of Bracco and Novartis AG, as well as other non-PSMA PET imaging agents; and there is the potential for future competition from others who may submit regulatory applications in anticipation of PYLARIFY’s NCE exclusivity expiry in May 2026. • For DEFINITY, our competitors currently include GE Healthcare and Bracco, as well as echocardiography without ultrasound enhancing agents and other non-echocardiography agents, and there is the potential for future competition from generic manufacturers who may submit regulatory applications using DEFINITY as the reference listed drug (RLD). • For Neuraceq, our competitors currently include Lilly and GE Healthcare.
On March 1, 2024, we transferred the fixed assets and associated lease of our Somerset, New Jersey facility to Perspective, and the parties entered into a transition services arrangement pursuant to which we provided certain services relating to final disposal of radioactive waste and certain other related services.
On March 1, 2024, we transferred the fixed assets and associated lease of our Somerset, New Jersey facility to Perspective, and the parties entered into a transition services arrangement pursuant to which we provided to Perspective certain services relating to final disposal of radioactive waste and certain other related services.
PNT2003 POINT is responsible for curating all data, analysis and other information necessary for regulatory approval, and supporting us in the preparation of regulatory filings for PNT2003. We are responsible for preparing for and seeking regulatory approval of all such applications, as well as performing and funding all future development and commercialization following such approval.
POINT is responsible for curating all data, analysis and other information necessary for regulatory approval, and supporting us in the preparation of regulatory filings for PNT2003. We are responsible for preparing for and seeking regulatory approval of all such applications, as well as performing and funding all future development and commercialization following such approval.
MK-6240 is currently in Phase 3 development and is also being used in over 100 ongoing academic and industry trials, many for late-stage therapeutic candidates. • NAV-4694 is an investigational late-stage F-18-labeled PET imaging agent that targets beta amyloid in Alzheimer’s disease, NAV-4694 is currently in Phase 3 development and is also being used in academic and industry sponsored clinical trials. • PNT2002 is an investigational PSMA-targeted radiopharmaceutical therapy for the treatment of mCRPC.
MK-6240 is also being used in over 100 ongoing academic and industry trials, many for late-stage therapeutic candidates. • NAV-4694 is an investigational late-stage F-18-labeled PET imaging agent that targets beta amyloid in Alzheimer’s disease, NAV-4694 is currently in Phase 3 development and is also being used in academic and industry sponsored clinical trials. • PNT2002 is an investigational PSMA-targeted radiopharmaceutical therapy for the treatment of mCRPC.
This period is generally one-half the time between the effective date of an IND and the submission date of an NDA, plus the time between the submission date of an NDA and the approval of that application.
This period is generally one-half the time between the effective date of an IND application and the submission date of an NDA, plus the time between the submission date of an NDA and the approval of that application.
Strategic Partnerships and Other Revenue Our commercial products in our Strategic Partnerships and Other Revenue product category include the following: • Automated Bone Scan Index (“aBSI”) automatically calculates the disease burden of prostate cancer by detecting and classifying bone scan tracer uptakes as metastatic or benign lesions using an artificial neural network. aBSI is FDA cleared and received a European Conformity Marking (“CE mark”). • aPROMISE, or PYLARIFY AI, is artificial intelligence medical device software that is designed to allow HCPs and researchers to perform standardized quantitative assessment of PSMA PET/CT images in prostate cancer, including those images obtained by using PYLARIFY.
Strategic Partnerships and Other Revenue Our commercial products in our Strategic Partnerships and Other Revenue product category include the following: • Automated Bone Scan Index (“aBSI”) automatically calculates the disease burden of prostate cancer by detecting and classifying bone scan tracer uptakes as metastatic or benign lesions using an artificial neural network. aBSI is FDA cleared and received a European Conformity Marking (“CE Mark”). • aPROMISE, or PYLARIFY AI, is AI medical device software that is designed to allow HCPs and researchers to perform standardized quantitative assessment of PSMA PET/CT images in prostate cancer, including those images obtained by using PYLARIFY.
Failure to comply with data protection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties and requirements to take corrective actions), private litigation (which may result in the award of damages against us), and/or adverse publicity, and could negatively affect our operating results, business, and reputation.
Failure to comply with data protection and privacy laws and regulations could result in government enforcement actions (which could include civil or criminal penalties and requirements to take corrective actions), private litigation (which may result in the award of damages against us), and/or adverse publicity, and could negatively affect our operating results, business, and reputation.
In addition, manufacturers of commercial PET products such as PYLARIFY, including radiopharmacies, hospitals, and academic medical centers, are required to submit either an NDA or ANDA in order to produce PET drugs for clinical use, or produce the drugs under an IND.
In addition, manufacturers of commercial PET products such as PYLARIFY and Neuraceq, including radiopharmacies, hospitals, and academic medical centers, are required to submit either an NDA or ANDA in order to produce PET drugs for clinical use, or produce the drugs under an IND.
Once the IND becomes effective, including review and approval by any IRB serving any of the institutions participating in the clinical trial, the clinical trial program may begin. Each new clinical trial protocol must be submitted to the FDA before the trial may begin.
Once the IND application becomes effective, including review and approval by any IRB serving any of the institutions participating in the clinical trial, the clinical trial program may begin. Each new clinical trial protocol must be submitted to the FDA before the trial may begin.
Preclinical tests include laboratory evaluations of product chemistry, toxicity, formulation, and stability, as well as animal studies to assess its potential safety and efficacy. This testing culminates in the submission of the IND to the FDA.
Preclinical tests include laboratory evaluations of product chemistry, toxicity, formulation, and stability, as well as animal studies to assess its potential safety and efficacy. This testing culminates in the submission of the IND application to the FDA.
If this happens, the Company could elect to pursue Hatch-Waxman litigation and trigger the 30-month stay described above, see “Intellectual Property Matters – Patent-related Aspects of Regulatory Matters” above for more information; during the stay, the FDA is prohibited from approving, other than as a tentative approval, the challenger’s application until the lawsuit is settled or there is a decision on the merits favorable to applicant.
If this happens, we could elect to pursue Hatch-Waxman litigation and trigger the 30-month stay described above, see “Intellectual Property Matters – Patent-related Aspects of Regulatory Matters” above for more information; during the stay, the FDA is prohibited from approving, other than as a tentative approval, the challenger’s application until the lawsuit is settled or there is a decision on the merits favorable to applicant.
We also have a Supplier Code of Conduct, and we seek to do business with minority-owned, female-owned and other diverse businesses and organizations (including those owned or operated by veterans and disabled veterans) that appropriately reflect the communities in which we operate and the customer base we serve, equip us with a deeper understanding of challenges impacting our communities and customers, and enable us to provide more innovative solutions and better outcomes.
We also have a Supplier Code of Conduct, and we seek to do business with minority-owned, female-owned and other inclusive businesses and organizations (including those owned or operated by veterans and disabled veterans) that appropriately reflect the communities in which we operate and the customer base we serve, equip us with a deeper understanding of challenges impacting our communities and customers, and enable us to provide more innovative solutions and better outcomes.
Our commercial products are used by cardiologists, internal medicine physicians, nuclear medicine physicians, oncologists, radiologists, sonographers, technologists, and urologists working in a variety of clinical settings.
Our commercial products are used by cardiologists, internal medicine physicians, neurologists, nuclear medicine physicians, oncologists, radiologists, sonographers, technologists, and urologists working in a variety of clinical settings.
New drugs, however, may apply for TPT Status in which case they are provided a separate payment at ASP plus a certain additional percent for two to three years, regardless of whether they would ordinarily be packaged. TPT Status applies to approximately 20% of patients with traditional Medicare FFS insurance coverage who are treated in the hospital outpatient setting.
New drugs, however, may apply for TPT Status in which case they are provided a separate payment at ASP plus a certain additional percent for two to three years, regardless of whether they would ordinarily be packaged. TPT Status applies to patients with traditional Medicare FFS insurance coverage who are treated in the hospital outpatient setting.
We are also subject to trade control regulations and trade sanctions laws that restrict the movement of certain goods, currency, products, materials, services and technology to, and certain operations in, various countries or with certain persons. Our ability to transfer people and products among certain countries may be subjected to these laws and regulations.
We are also subject to trade control regulations and trade sanctions laws that restrict or prohibit the movement of certain goods, currency, products, materials, software, services and technology to, and certain operations in, various countries or with certain persons. Our ability to transfer people and products among certain countries may be subjected to these laws and regulations.
Oncology As we continue to pursue expanding strategic partnerships, our Biomarker Solutions activities in oncology include: • Prostate Cancer – We collaborate with pharmaceutical companies developing therapies and diagnostics in prostate cancer. ▪ Curium (our licensee for piflufolastat F-18 in Europe) is commercializing piflufolastat F-18 under the name PYLCLARI in Europe.
Oncology As we continue to pursue expanding strategic partnerships, our Biomarker Solutions activities in oncology include: • Prostate Cancer – We collaborate with pharmaceutical companies developing therapies and diagnostics in prostate cancer. • Curium Pharma (“Curium”) (our licensee for piflufolastat F-18 in Europe) is commercializing piflufolastat F-18 under the name PYLCLARI in Europe.
“ Management’s Discussion and Analysis of Financial Condition and Results of Operations - Comparison of the Periods Ended December 31, 2024 and 2023 - Revenues” of this Form 10-K for further information on total revenue contributed by PYLARIFY since its approval.
“ Management’s Discussion and Analysis of Financial Condition and Results of Operations - Comparison of the Periods Ended December 31, 2025 and 2024 - Revenues” of this Form 10-K for further information on total revenue contributed by PYLARIFY since its approval.
POINT will be responsible for all manufacturing of PNT2003, subject to certain exceptions described in the license and collaboration agreement between our subsidiary, Lantheus Three and POINT, dated November 11, 2022 (the “PNT2003 License Agreement”). On January 11, 2024, we announced that our Abbreviated New Drug Application (“ANDA”) for PNT2003 had been accepted for filing by the FDA.
POINT will be responsible for all manufacturing of PNT2003, subject to certain exceptions described in the license and collaboration agreement between our subsidiary, Lantheus Three and POINT, dated November 11, 2022 (the “PNT2003 License Agreement”). On January 11, 2024, we announced that our Abbreviated New Drug Application (“ANDA”) for PNT2003 had been accepted for filing by the U.S.
In March 2024, we received FDA approval for our supplemental new drug application for the use of DEFINITY in pediatric patients with suboptimal echocardiograms. The FDA decision was based on usage data from three pediatric clinical trials conducted with DEFINITY.
In March 2024, we received FDA approval for our supplemental application for the use of DEFINITY in pediatric patients with suboptimal echocardiograms. The FDA decision was based on usage data from three pediatric clinical trials conducted with DEFINITY.
Manufacturing and Supply Arrangements We currently have the following technology transfer and manufacturing and supply agreements in place for some of our major products: • PYLARIFY —We have entered into commercial supply agreements with different PMF networks.
Manufacturing and Supply Arrangements We currently have the following technology transfer and manufacturing and supply agreements in place for some of our major products: • PYLARIFY and Neuraceq —We have entered into separate commercial supply agreements with different PMF networks.
Although the IRA provides for a limited number of categorical exclusions from Medicare negotiation, radiopharmaceuticals are not among those categorical exclusions. CMS will implement the first year of Medicare negotiation, which will be restricted to Part D drugs, starting in calendar years 2026 and 2027. In addition, the statute provided for redesign of the Medicare Part D benefit.
Although the IRA provides for a limited number of categorical exclusions from Medicare negotiation, radiopharmaceuticals are not among those categorical exclusions. CMS is implementing the first year of Medicare negotiation, which will be restricted to Part D drugs, starting in calendar years 2026 and 2027. In addition, the statute provided for redesign of the Medicare Part D benefit.
We review third party proprietary rights, including patents and patent applications, as available, in an effort to develop an effective intellectual property strategy, avoid infringement of third party proprietary rights, identify licensing opportunities and monitor the intellectual property owned by others. Description of Patent Rights Patents grant the legal right to exclude others from practicing an invention.
We review third party proprietary rights, including patents and patent applications, as available, in an effort to develop an effective intellectual property strategy, avoid infringement of third party proprietary rights, identify licensing opportunities and monitor the intellectual property owned by others. 16 Table of Contents Description of Patent Rights Patents grant the legal right to exclude others from practicing an invention.
Precision Diagnostics Our commercial products in our Precision Diagnostics category include the following: • DEFINITY is an injectable ultrasound enhancing agent with perflutren-containing lipid microspheres, or microbubbles, that is used in echocardiography exams.
Precision Diagnostics Our commercial products in our Precision Diagnostics category include the following: • DEFINITY, an injectable ultrasound enhancing agent with perflutren-containing lipid microspheres, or microbubbles, which is used in echocardiography exams.
Our Digital Solutions business focuses on developing and commercializing 510(k) cleared and CE marked digital applications to enhance the performance of imaging agents; our Digital Solutions portfolio currently includes aBSI, aPROMISE, and PYLARIFY AI.
Our Digital Solutions business focuses on developing and commercializing 510(k) cleared and CE Marked digital applications to enhance the performance of imaging agents; our Digital Solutions portfolio currently includes aBSI and aPROMISE.
In addition, if a product that has Orphan Drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to Orphan Drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period 20 Table of Contents of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or where the manufacturer is unable to assure sufficient product quantity.
In addition, if a product that has Orphan Drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to Orphan Drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or where the manufacturer is unable to assure sufficient product quantity.
Further, the radiopharmaceutical and biopharmaceutical industry continues to evolve strategically, with several market participants recently acquired by larger companies that may have more significant resources than ours.
Further, the radiopharmaceutical and biopharmaceutical industry continues to evolve strategically, with several market participants previously acquired by larger companies that may have more significant resources than ours.
PNT2002 — We exclusively license granted U.S. patents and pending U.S. patent applications, as well as pending patent applications in jurisdictions outside of the U.S. directed to formulations, use, and manufacturing of PNT2002. The granted U.S. patents expire in 2041.
PNT2002 — We exclusively license granted U.S. patents and pending U.S. patent applications, as well as pending patent applications in jurisdictions outside of the United States directed to formulations, use, and manufacturing of PNT2002. The granted U.S. patents expire in 2041.
Pursuant to our license agreement with Bausch, we are eligible to receive one-time sales milestone payments upon achievement of specified U.S. net sales targets, including: U.S.
Pursuant to our license agreement with Bausch, we are eligible to receive one-time sales milestone payments upon achievement of specified United States. net sales targets, including: U.S.
We also established various employee recognition award programs to recognize and reward employees for specific outstanding accomplishments and to foster a positive employee relations climate. Health, Wellness and Safety 28 Table of Contents We are committed to the health and safety of our employees, patients and other partners in the healthcare community.
We also established various employee recognition award programs to recognize and reward employees for specific outstanding accomplishments and to foster a positive employee relations climate. Health, Wellness and Safety We are committed to the health and safety of our employees, patients and other partners in the healthcare community.
Our reports filed with, or furnished to, the SEC are also available on the SEC’s website at www.sec.gov, and for Form 10-K and Form 10-Q, in an Inline Extensible Business Reporting Language (“iXBRL”) format. iXBRL is an electronic coding language used to create interactive financial statement data over the Internet.
Our reports filed with, or furnished to, the SEC are also available on the SEC’s website at www.sec.gov, and for Form 10-K and Form 10-Q, in an Inline Extensible Business Reporting Language (“iXBRL”) format. iXBRL is an electronic coding language used to create interactive financial statement data over the Internet. 29 Table of Contents
In addition, the FDA may require Phase 4 testing which involves clinical trials designed to further assess a drug product’s safety and effectiveness after NDA approval. The FDA also may impose one or more Risk Evaluation and Mitigation Strategies (“REMS”) to ensure that the benefits of a product outweigh its risks.
In addition, the FDA may require Phase 4 testing which involves clinical trials designed to further assess a drug product’s safety and effectiveness after NDA approval. The FDA also may impose one or more Risk Evaluation and Mitigation Strategies (“REMS”) and Elements to Assure Safe Use to ensure that the benefits of a product outweigh its risks.
On January 26, 2024, we were sued in the District Court for the District of Delaware by Advanced Accelerator Applications USA, Inc. and Advanced Accelerator Applications SA, each a Novartis entity, for patent infringement in response to our ANDA filing and Paragraph IV certification, consistent with the process established by the Hatch-Waxman Act.
Food and Drug Administration (“FDA”). On January 26, 2024, we were sued in the District Court for the District of Delaware by Advanced Accelerator Applications USA, Inc. and Advanced Accelerator Applications SA, each a Novartis entity, for patent infringement in response to our ANDA filing and Paragraph IV certification, consistent with the process established by the Hatch-Waxman Act.
Third-party payors in the U.S. include private payors, including managed care providers, and State and Federal healthcare programs, such as Medicare and Medicaid. The process for determining whether a payor will provide coverage for a product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the product.
Third-party payors in the United States include private payors, including managed care providers, and State and Federal healthcare programs, such as Medicare and Medicaid. The process for determining whether a payor will provide coverage for a product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the product.
“Risk Factors” of this Form 10-K for information regarding certain risks related to reimbursement and regulation. Environmental Matters We are subject to various federal, state and local laws and regulations relating to the protection of the environment, human health and safety in the U.S. and in other jurisdictions in which we operate.
“Risk Factors” of this Form 10-K for information regarding certain risks related to reimbursement and regulation. Environmental Matters We are subject to various federal, state and local laws and regulations relating to the protection of the environment, human health and safety in the United States, and in other jurisdictions in which we operate.
Regulatory Matters Food and Drug Laws The development, manufacture and commercialization of our products are subject to comprehensive governmental regulation both within and outside the U.S. A number of factors substantially increase the time, difficulty, and costs incurred in obtaining and maintaining the approval to market newly developed and existing products.
Regulatory Matters Food and Drug Laws The development, manufacture and commercialization of our products are subject to comprehensive governmental regulation both within and outside the United States. A number of factors substantially increase the time, difficulty, and costs incurred in obtaining and maintaining the approval to market newly developed and existing products.
Health and Safety Laws We are also subject to various federal, state and local laws, regulations and recommendations, both in the U.S. and abroad, relating to safe working conditions, laboratory and manufacturing practices and the use, transportation and disposal of hazardous or potentially hazardous substances. See Part I, Item 1A.
Health and Safety Laws We are also subject to various federal, state and local laws, regulations and recommendations, both in the United States and abroad, relating to safe working conditions, laboratory and manufacturing practices and the use, transportation and disposal of hazardous or potentially hazardous substances. See Part I, Item 1A.
Accordingly, we could be subject to criminal penalties if we knowingly obtain or disclose individually identifiable health information from a HIPAA-covered entity in a manner that is not authorized or permitted. 25 Table of Contents In addition, a growing number of jurisdictions outside of the United States have enacted robust data protection laws. Certain of these laws have extraterritorial application.
Accordingly, we could be subject to criminal penalties if we knowingly obtain or disclose individually identifiable health information from a HIPAA-covered entity in a manner that is not authorized or permitted. In addition, a growing number of jurisdictions outside of the United States have enacted robust data protection and privacy laws. Certain of these laws have extraterritorial application.
Diversity, Inclusion, Ethics and Compliance We believe that supporting our local community and instilling a diverse, inclusive, ethical and compliant culture makes us an employer of choice, allows us to maintain good standing with the regulatory authorities and our customers, and benefits our stockholders in the long run.
Inclusion, Ethics and Compliance We believe that supporting our local community and instilling an inclusive, ethical and compliant culture makes us an employer of choice, allows us to maintain good standing with our employees, the regulatory authorities and our customers, and benefits our stockholders in the long run.
Currently, the process required by the FDA before a drug product may be marketed in the U.S. generally involves the following: • Completion of preclinical laboratory tests, animal studies and formulation studies according to current Good Laboratory Practices regulations; • Submission to the FDA of an investigational new drug application (“IND”) which must become effective before human clinical trials may begin, including review and approval by any institutional review board (“IRB”), serving any of the institutions participating in the clinical trials; • Performance of adequate and well-controlled human clinical trials according to current Good Clinical Practices and other requirements, to establish the safety and efficacy of the proposed drug product for its intended use; • Submission to the FDA of an NDA for a new drug or ANDA for a generic drug; • Satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug product is produced to assess compliance with current Good Manufacturing Practices (“cGMPs”) regulations; and • FDA review and approval of the NDA or ANDA.
Currently, the process required by the FDA before a drug product may be marketed in the United States generally involves the following: • Completion of preclinical laboratory tests, animal studies and formulation studies according to current Good Laboratory Practices regulations; • Submission to the FDA of an IND application which must become effective before human clinical trials may begin, including review and approval by any institutional review board (“IRB”), serving any of the institutions participating in the clinical trials; • Performance of adequate and well-controlled human clinical trials according to current Good Clinical Practices and other requirements, to establish the safety and efficacy of the proposed drug product for its intended use; • Submission to the FDA of an NDA for a new drug or ANDA for a generic drug; • Satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug product is produced to assess compliance with cGMP regulations; and • FDA review and approval of the NDA or ANDA.
According to the American Cancer Society, prostate cancer is the second most common cancer in American men - one in eight American men will be diagnosed with prostate cancer in their lifetimes and over 3.3 million American men are living with prostate cancer today.
According to the American Cancer Society, prostate cancer is the second most common cancer in American men - one in eight American men will be diagnosed with prostate cancer in their lifetimes and over 3.7 million American men are currently living with prostate cancer.
Customers No customer accounted for greater than 10% of revenues for the years ended December 31, 2024, 2023, and 2022. Backlog Our backlog consists of orders for which a delivery schedule within the next twelve months has been specified. Orders included in backlog may be canceled or rescheduled by customers at any time with the exception of TechneLite orders.
Customers No customer accounted for greater than 10% of revenues for the years ended December 31, 2025, 2024, and 2023. Backlog Our backlog consists of orders for which a delivery schedule within the next twelve months has been specified. Orders included in backlog may be canceled or rescheduled by customers at any time.
In many countries, the healthcare professionals we regularly interact with may meet the FCPA’s definition of a foreign government official. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect their transactions and to devise and maintain an adequate system of internal accounting controls. Those laws also include the U.K.
In many countries, the healthcare professionals we regularly interact with may meet the FCPA’s definition of a foreign government official. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect their transactions and to devise and maintain an adequate system of internal accounting controls.
The finished PYLARIFY is then quality control tested and transferred to a radiopharmacist who prepares and dispenses patient-specific doses from the final product. Because each of the PMFs manufacturing PYLARIFY is deemed by the FDA to be a separate manufacturing site, each requires separate FDA approval.
The finished PYLARIFY or Neuraceq is then quality control tested and transferred to a radiopharmacist who prepares and dispenses patient-specific doses from the final product. Because each of the PMFs manufacturing PYLARIFY and Neuraceq is deemed by the FDA to be a separate manufacturing site, each requires separate FDA approval for each product manufactured.
On January 8, 2024, we entered into multiple strategic agreements with Perspective, a radiopharmaceutical company that is pursuing advanced treatment applications for cancers throughout the body.
Strategic Agreements with Perspective Therapeutics, Inc. On January 8, 2024, we entered into multiple strategic agreements with Perspective Therapeutics, Inc. (“Perspective”), a radiopharmaceutical company that is pursuing advanced treatment applications for cancers throughout the body.
The GDPR also imposes strict rules on the transfer of personal data out of the European Union to the United States. Failure to comply with the requirements of the GDPR and the related national data protection laws of the European Union Member States may result in significant fines and other administrative penalties.
The GDPR also imposes strict rules on the transfer of personal data out of the EEA to the United States. Failure to comply with the requirements of the GDPR and the related national data protection laws of the European Economic Area Member States may result in significant fines and other administrative penalties.
Exclusive License for Radiopharm Theranostics Limited On June 15, 2024, we entered into an agreement with Radiopharm to acquire all of Radiopharm’s global, exclusive rights to two licensed preclinical assets for an upfront payment of $2.0 million (the “Radiopharm Asset Purchase”).
Radiopharm Theranostics Limited On June 15, 2024, we entered into an agreement with Radiopharm Theranostics Limited (“Radiopharm”) to acquire all of Radiopharm’s rights to two licensed preclinical assets for an upfront payment of $2.0 million (the “Radiopharm Asset Purchase”).
DEFINITY — A portfolio of patents protects the use and manufacturing of DEFINITY and also the VIALMIX RFID device, both in the U.S. and internationally. Currently, there are nine Orange Book-listed patents for DEFINITY. Our longest duration Orange Book-listed DEFINITY patent extends until May 2037.
DEFINITY — A portfolio of patents protects the use and manufacturing of DEFINITY and also the VIALMIX RFID device, both in the United States and internationally. Currently, there are nine Orange Book-listed patents for DEFINITY. Our longest duration Orange Book-listed DEFINITY patent extends until May 2037.
If our filing is stayed for the full 30-month period and we are successful in obtaining FDA approval, we would expect to launch PNT2003 in 2026, although there can be no assurance of that approval or timing.
If our filing is stayed for the full 30-month period and we are successful in obtaining FDA approval, we could launch PNT2003 in 2026, although there can be no assurance of that approval or timing.
Precision Diagnostics DEFINITY is the most utilized ultrasound enhancing agent in the U.S. and is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
Precision Diagnostics DEFINITY DEFINITY is the most utilized ultrasound enhancing agent in the United States and is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
Other Materials We have additional supply arrangements for active pharmaceutical ingredients, excipients, packaging materials and other materials and components, some of which are sole-sourced, and all of which we currently believe are either in good standing or replaceable without any material disruption to our business. See Part I, Item 1A.
Other Materials We have additional supply arrangements for active pharmaceutical ingredients, excipients, packaging materials and other materials and components, some of which are sole-sourced, and all of which we currently believe are either in good standing or replaceable without any material disruption to our business.
The FDA approved drugs listed in the Orange Book can serve as a basis for comparison by the FDA when evaluating the bioequivalence of new generic drugs.
The FDA approved 17 Table of Contents drugs listed in the Orange Book can serve as a basis for comparison by the FDA when evaluating the bioequivalence of new generic drugs.
In the U.S. for PYLARIFY, we have patents listed in the FDA’s publication, “ Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”), including composition of matter patents, the last of which expires in 2037.
In the United States for PYLARIFY, we have patents listed in the FDA’s publication, “ Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”), including composition of matter patents, the last of which expires in 2037.
Under the agreement, we received an upfront cash payment of $5.0 million and are eligible to receive up to $60.0 million in regulatory and sales milestone payments, tiered double-digit royalties on U.S. sales, and mid-single digit 11 Table of Contents royalties on sales outside of the U.S.
Under the agreement, we received an upfront cash payment of $5.0 million and are eligible to receive up to $60.0 million in regulatory and sales milestone payments, tiered double-digit royalties on U.S. sales, and mid-single digit royalties on sales outside of the United States.
“Risk Factors” of this Form 10-K for information regarding certain risks associated with our raw materials and supply arrangements. Manufacturing The commercial manufacture of PYLARIFY requires us to create a field-based network of specialized PMFs with radioisotope-producing cyclotrons.
See Part I, Item 1A. “Risk Factors” of this Form 10-K for information regarding certain risks associated with our raw materials and supply arrangements. Manufacturing The commercial manufacture of PYLARIFY and Neuraceq requires us to create a field-based network of specialized PMFs with radioisotope-producing cyclotrons.
In the U.S. for DEFINITY, we have Orange Book-listed method-of-use patents, the last of which expires in 2037, as well as additional manufacturing patents that are not Orange Book-listed expiring in 2037.
In the United States for DEFINITY, we have Orange Book-listed method-of-use patents, the last of which expires in 2037, as well as additional manufacturing patents that are not Orange Book-listed expiring in 2037.
Intellectual Property Protection on Selected Assets Our IP assets include patents that we own and those to which we have licenses. We typically seek patent protection in major markets around the world, including, among others, the U.S., Canada, Western Europe, Asia, Central America, and South America.
Intellectual Property Protection on Selected Assets Our intellectual property (“IP”) assets include patents that we own and those to which we have licenses. We typically seek patent protection in major markets around the world, including, among others, the United States, Canada, Western Europe, Asia, Central America, and South America.
We plan to continue working with CMS on the potential adoption of payment based on Average Sales Price (“ASP”) in the future. We have been reporting ASP since our first dose sold, helping to provide a clear path forward for CMS to potentially make payments based on ASP instead of mean unit cost (“MUC”).
We plan to continue working with CMS on the potential adoption of payment based on Average Sales Price (“ASP”) rather than MUC in the future. We have been reporting ASP since our first dose sold, helping to provide a clear path forward for CMS to potentially make payments based on ASP instead of MUC.
In 2011 Progenics licensed 7 Table of Contents methylnaltrexone (“MNTX”) along with products containing MNTX, including both approved forms of RELISTOR, to Salix Pharmaceuticals, Inc., a Bausch Health Companies, Inc. (“Bausch”) and on August 2, 2023, we sold the right to the RELISTOR net sales royalties under that license agreement and retained the rights to future sales-based milestone payments.
In 2011 Progenics licensed methylnaltrexone (“MNTX”) and products containing MNTX, including both approved forms of RELISTOR, to Salix Pharmaceuticals, Inc., an affiliate of Bausch Health Companies, Inc. (“Bausch”) and on August 2, 2023, we sold the right to the RELISTOR net sales royalties under that license agreement and retained the rights to future sales-based milestone payments.
The radioisotope used in PYLARIFY is F-18, which has a 110 minute half-life, requiring that this agent be manufactured and distributed rapidly to end-users. After being made on a cyclotron at a PMF, the F-18 is combined with certain chemical ingredients in specially designed chemistry synthesis boxes to manufacture PYLARIFY.
The radioisotope used in both PYLARIFY and Neuraceq is F-18, which has a 110-minute half-life, requiring that this agent be manufactured and distributed rapidly to end-users. After being made on a cyclotron at a PMF, the F-18 is combined with certain specifically designed ingredients in chemistry synthesis boxes to manufacture PYLARIFY or Neuraceq, as applicable.
For more information, see Note 21, “Acquisition of Assets” to our consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K.
For more information, see Note 19, “Acquisitions” to our consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K.
PYLARIFY sales are generated in the U.S. through an internal PYLARIFY sales team, as well as a sales team at some of our PMF partners. Sales of DEFINITY are generated in the U.S. through an internal DEFINITY sales team.
PYLARIFY sales are generated in the United States through an internal PYLARIFY sales team, as well as a sales team at some of our PMF partners. Sales of DEFINITY are generated in the United States through an internal DEFINITY sales team.
The GDPR applies to an entity established in the European Union (“EU”) and extraterritorially to an entity outside of the EU that offers goods or services to, or monitors the behavior of, individuals located in the EU. Certain “special categories” of personal data, including data concerning health, are subject to enhanced protections under the GDPR.
The GDPR applies to an entity established in the European Economic Area (“EEA”) and extraterritorially to an entity outside of the EEA that offers goods or services to, or monitors the behavior of, individuals located in the EEA. Certain “special categories” of personal data, including data concerning health, are subject to enhanced protections under the GDPR.
In addition, we are subject to similar antitrust and anti-competition laws in foreign countries. We believe we are in compliance with such laws, however, any violation could create a substantial liability for us and also cause a loss of reputation in both foreign and domestic markets.
In addition, we are subject to similar 26 Table of Contents antitrust and anti-competition laws in foreign countries. We believe we are in compliance with such laws, however, any violation could create a substantial liability for us and also cause reputational harm in both foreign and domestic markets.
We are entitled to milestone and royalty-based payments for Flyrcado. Seasonality We have some modest seasonality for our products as patients may seek to schedule diagnostic imaging and other procedures less frequently during the summer vacation months and over the year-end holidays.
Flyrcado is licensed to GE Healthcare and we are entitled to milestone and royalty-based payments for Flyrcado. 14 Table of Contents Seasonality We have some modest seasonality for our products as patients may seek to schedule diagnostic imaging and other procedures less frequently during the summer vacation months and over the year-end holidays.
PYLARIFY’s current competition is primarily two Gallium-68 (“Ga-68”)-based PSMA imaging agents, an F-18-based PSMA imaging agent, and other non-PSMA-based imaging agents commonly referred to as conventional imaging.
PYLARIFY’s current competition includes three Gallium-68 (“Ga-68”)-based PSMA imaging agents, an F-18-based PSMA imaging agent, and other non-PSMA-based imaging agents commonly referred to as conventional imaging.
Assuming that between 20% and 30% of echocardiograms produce suboptimal images, as stated in the clinical literature, we estimate that approximately 5 to 10 million echocardiograms in 2023 produced suboptimal images. Since its launch in 2001, DEFINITY has been used in imaging procedures in more than 28 million echocardiograms throughout the world.
Assuming that between 20% and 30% of echocardiograms produce suboptimal images, as stated in the clinical literature, we estimate that approximately 5 to 9 million echocardiograms in 2024 produced suboptimal images. Since its launch in 2001, DEFINITY has been used in imaging procedures in approximately 33 million echocardiograms throughout the world.
We believe this diagnostic agent candidate could have broad potential applicability and use in oncology as well as inflammatory diseases. In 2024, we completed a Phase 1 study for LNTH-1363S to evaluate the pharmacokinetics, biodistribution and radiation dosimetry in adult healthy volunteers and initiated a Phase 1/2a study.
We believe this diagnostic agent candidate could have broad potential applicability and use in oncology as well as inflammatory diseases. We completed a Phase 1 study for LNTH-1363S to evaluate the pharmacokinetics, biodistribution and radiation dosimetry in adult healthy volunteers and are now enrolling patients diagnosed with sarcoma in a Phase 1/2a study.
The Federal Trade Commission shares jurisdiction with the FDA over the promotion and advertising of certain medical devices. The FDA can also impose restrictions on the sale, distribution or use of medical devices at the time of their clearance or approval, or subsequent to marketing. Currently, medical devices comprise only a small portion of our revenues.
The Federal Trade Commission shares jurisdiction with the FDA over the promotion and advertising of certain medical devices. The FDA can also impose restrictions on the sale, distribution or use of medical devices at the time of their clearance or approval, or subsequent to marketing.
We estimate that, as of December 31, 2024, DEFINITY had over 80% share of the U.S. segment for ultrasound enhancing agents in echocardiography procedures. DEFINITY currently competes with two other FDA-approved ultrasound enhancing agents, as well as echocardiography without the use of ultrasound enhancing agents and non-echocardiography imaging modalities.
We estimate that, as of December 31, 2025, DEFINITY had over 80% share of the U.S. segment for ultrasound enhancing agents in echocardiography procedures. DEFINITY currently competes with two other FDA-approved ultrasound enhancing agents, as well as echocardiography without the use of ultrasound enhancing agents and non-echocardiography imaging modalities from GE Healthcare and Bracco Diagnostics Inc. (“Bracco”).
Our continued growth of PYLARIFY will depend on our ability to clinically and commercially differentiate PYLARIFY from other products on the market and to maintain PYLARIFY as the most utilized PSMA PET imaging agent in a competitive space.
The continued substantial revenue contribution from PYLARIFY will depend on our ability to clinically and commercially differentiate PYLARIFY from other products on the market and to maintain PYLARIFY as a widely utilized PSMA PET imaging agent in a competitive space.
In September 2020, the FDA granted 510(k) clearance for the use of aBSI as software-as-a-medical device on a GE Healthcare imaging system. • EXINI was granted 510(k) clearance by the FDA in the U.S. and received a CE mark in Europe for aPROMISE. We launched aPROMISE under the name PYLARIFY AI in the U.S.
In September 2020, the FDA granted 510(k) clearance for the use of aBSI as software-as-a-medical device on a GE Healthcare imaging system. • EXINI was granted 510(k) clearance by the FDA in the United States and received a CE Mark in Europe for aPROMISE, which is available under the name PYLARIFY AI in the United States.
Net Sales Levels in any Single Calendar Year Payment In excess of $150 million $15.0 million In excess of $200 million $20.0 million In excess of $300 million $30.0 million In excess of $750 million $50.0 million In excess of $1 billion $75.0 million During the fourth quarter of 2023, the Company earned the $15.0 million sales-based milestone payment listed above and did not earn a sales-based milestone payment in 2024.
Net Sales Levels in any Single Calendar Year Payment In excess of $150 million $15.0 million In excess of $200 million $20.0 million In excess of $300 million $30.0 million In excess of $750 million $50.0 million In excess of $1 billion $75.0 million During the fourth quarter of 2023, we earned the sales-based milestone payments listed above of $15.0 million.
We manufacture, finish and distribute our radiopharmaceutical products on a just-in-time basis, and supply our customers with these products either by next day delivery services or by ground or air custom logistics.
We manufacture, finish and distribute our radiopharmaceutical products, including PYLARIFY and Neuraceq, through a network of specialized manufacturers on a just-in-time basis, and supply our customers with these products either by next day delivery services or by ground or air custom logistics.
We expect LNTH-2401 could be used as a companion diagnostic to LNTH-2402. • LNTH-2402 , also known as 177Lu-DOTA-RM2, is a novel gastrin-releasing peptide receptor targeted radiotherapeutic for solid tumors including prostate, breast, lung and other cancers.
We expect LNTH-2401 could be used both as a standalone diagnostic imaging agent and as a companion diagnostic to LNTH-2402. • LNTH-2402 , also known as 177Lu-DOTA-RM2, is a novel GRPR targeted radiotherapeutic for solid tumors including prostate, breast, lung and other cancers.
Our Strategic Partnerships and Other Revenue, also includes revenue derived from partnerships with pharmaceutical companies and academic institutions that use our investigational products, such as MK-6240 and NAV-4694, in clinical trials as research tools, as well as royalties and other milestone payments received from our strategic partners that have commercialized products pursuant to license arrangements with us.
Our Strategic Partnerships and Other Revenue, also includes revenue derived from partnerships with pharmaceutical companies and academic institutions that use our commercial or investigational products in clinical trials as research tools, as well as royalties and other milestone payments received from our strategic partners that have commercialized products pursuant to license arrangements with us, as well as CDMO revenue generated by Evergreen.
Below is a description of the roles played by patents in relevant regulatory framework. First, in seeking approval for a drug through an NDA, including a 505(b)(2) NDA, applicants are required to list with the FDA each patent with claims that cover the applicant’s drug, which is later published in the Orange Book.
First, in seeking approval for a drug through an NDA, including a 505(b)(2) NDA, applicants are required to list with the FDA each patent with claims that cover the applicant’s drug, which is later published in the Orange Book.
Additional Information about our Product Categories Radiopharmaceutical Oncology PYLARIFY is the most utilized radiopharmaceutical diagnostic agent indicated for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and in patients with suspected recurrence based on elevated PSA levels.
Additional Information about our Product Categories Radiopharmaceutical Oncology 8 Table of Contents PYLARIFY is a widely utilized radiopharmaceutical diagnostic agent indicated for PET imaging of prostate-specific membrane antigen (“PSMA”)-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and in patients with suspected recurrence based on elevated PSA levels.
“Risk Factors-Ultrasound enhancing agents may cause side effects which could limit our ability to sell DEFINITY,” of this Form 10-K for more information. We continue to actively pursue additional patents in connection with DEFINITY, both in the U.S. and internationally.
“Risk Factors-Ultrasound enhancing agents may cause side effects which could limit our ability to sell DEFINITY,” of this Form 10-K for more information. We continue to prosecute and maintain patents and patent applications in connection with DEFINITY, both in the United States and internationally.
Continued growth and revenue contribution from PYLARIFY will also depend on our ability to differentiate PYLARIFY, including through flexible and dependable access to PYLARIFY nationally, a best-in-class customer experience and through long-term strategic contracts. 8 Table of Contents We actively pursue patents in connection with PYLARIFY, both in the U.S. and internationally.
Continued substantial revenue contribution from PYLARIFY will also depend on our ability to differentiate PYLARIFY, including through flexible and dependable access to PYLARIFY nationally, a best-in-class customer experience and through strategic contracts. We actively pursue patents in connection with PYLARIFY, both in the United States and internationally.
In the United States, several state legislatures are considering enacting or have enacted new data privacy legislation. One example of such legislation that has already been passed is the California Consumer Privacy Act (“CCPA”), which took effect on January 1, 2020 and imposes many requirements on certain for-profit businesses that process the personal information of California residents.
In the United States, several state legislatures are considering enacting or have enacted new data privacy legislation. Such examples of legislation that have been passed are the California Consumer Privacy Act (“CCPA”) and the California Privacy Rights Act (“CPRA”), which imposes many requirements on certain for-profit businesses that process the personal information of California residents.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeOur principal competitors for our current commercial products and leading clinical development candidates include large, global companies that are more diversified than we are and that have substantial financial, manufacturing, sales and marketing, distribution and other resources: • For PYLARIFY, our competitors currently include approved imaging agents from Telix Pharmaceuticals Limited, Novartis AG, and Blue Earth, a subsidiary of Bracco. • For DEFINITY, our competitors currently include GE Healthcare and Bracco.
Biggest changeOur competitors for our current commercial products and leading clinical development candidates include large, global companies that are more diversified than we are and that have substantial financial, manufacturing, sales and marketing, distribution and other resources: • For PYLARIFY, our competitors currently include approved imaging agents from Telix Pharmaceuticals Limited, Blue Earth, a subsidiary of Bracco, and Novartis AG, as well as other non-PSMA PET imaging agents, and there is the potential for future competition from others who may submit regulatory applications in anticipation of PYLARIFY’s NCE exclusivity expiry in May 2026. • For DEFINITY, our competitors currently include GE Healthcare and Bracco, as well as echocardiography without ultrasound enhancing agents and other non-echocardiography agents, and there is the potential for future competition from generic manufacturers who may submit regulatory applications using DEFINITY as the reference listed drug (RLD). • For Neuraceq, our competitors currently include Lilly and GE Healthcare.
On December 20, 2022, we announced the closing of a set of strategic collaborations with an affiliate of POINT, in which we were granted a license to exclusive worldwide rights (excluding Japan, South Korea, China (including Hong Kong, Macau and Taiwan), Singapore and Indonesia) to co-develop and commercialize POINT’s PNT2002 and PNT2003 product candidates (the “POINT License Agreements”).
On December 20, 2022, we announced the closing of a set of strategic collaborations with an affiliate of POINT, in which we were granted a license to exclusive worldwide rights (excluding Japan, South Korea, China (including Hong Kong, Macau and Taiwan), Singapore and Indonesia) to co-develop and commercialize POINT’s PNT2003 and PNT2002 product candidates (the “POINT License Agreements”).
Additionally, if we fail to comply with our obligations under the POINT License Agreements, then POINT may conclude that we have materially breached and may terminate one or both of the POINT License Agreements, in which event we may lose our rights to develop and market PNT2002 and PNT2003 or incur liability for damages.
Additionally, if we fail to comply with our obligations under the POINT License Agreements, then POINT may conclude that we have materially breached and may terminate one or both of the POINT License Agreements, in which event we may lose our rights to develop and market PNT2003 and PNT2002 or incur liability for damages.
On December 8, 2022, we issued $575.0 million in aggregate principal amount of 2.625% Convertible Senior Notes due 2027 (the “Notes”), which included $75.0 million in aggregate principal amount of Notes sold pursuant to the full exercise of the initial purchasers’ option to purchase additional Notes.
On December 8, 2022, we issued $575.0 million in aggregate principal amount of 2.625% Convertible Senior Notes due December 2027 (the “Notes”), which included $75.0 million in aggregate principal amount of Notes sold pursuant to the full exercise of the initial purchasers’ option to purchase additional Notes.
If such a right becomes available again and if one or more holders elect to convert their Notes, unless we elect to satisfy our conversion obligation by arranging for one or more financial institutions to take the Notes from converting holders and pay such holders in accordance with the Indenture, we would be required to settle any converted principal amount of such Notes through the payment of cash and by paying or delivering, at our election, cash, shares of our common stock, or a combination of cash and shares, with respect to the remainder of our conversion obligation in excess of the aggregate principal amount of the Notes being converted, which could adversely affect our liquidity or, if we elect to settle our conversion obligation in excess of the aggregate principal amount of the Notes being converted in shares of common stock (whether in whole or in part), could dilute the ownership interests of our existing common stockholders.
However, if such a right becomes available again and if one or more holders elect to convert their Notes, unless we elect to satisfy our conversion obligation by arranging for one or more financial institutions to take the Notes from converting holders and pay such holders in accordance with the Indenture, we would be required to settle any converted principal amount of such Notes through the payment of cash and by paying or delivering, at our election, cash, shares of our common stock, or a combination of cash and shares, with respect to the remainder of our conversion obligation in excess of the aggregate principal amount of the Notes being converted, which could adversely affect our liquidity or, if we elect to settle our conversion obligation in excess of the aggregate principal amount of the Notes being converted in shares of common stock (whether in whole or in part), could dilute the ownership interests of our existing common stockholders.
For example, although our licensee, GE Healthcare, has received FDA approval of Flyrcado (flurpiridaz F-18) for coronary artery disease diagnosis, there is no guarantee that GE Healthcare will be successful in its commercialization of Flyrcado, which may delay or prevent us from being able to generate additional future royalty revenue from product sales.
For example, although our licensee, GE Healthcare, has received FDA approval of Flyrcado (flurpiridaz F-18) for coronary artery disease diagnosis, there is no guarantee that GE Healthcare will continue to be successful in its commercialization of Flyrcado, which may delay or prevent us from being able to generate additional future royalty revenue from product sales.
Our indebtedness and any future indebtedness we incur could: • Require us to dedicate a substantial portion of cash flow from operations to the payment of interest on and principal of our indebtedness, thereby reducing the funds available for other purposes, including for working capital, capital expenditures and acquisitions; 49 Table of Contents • Make it more difficult for us to satisfy and comply with our obligations with respect to our outstanding indebtedness, namely the payment of interest and principal; • Make it more difficult to refinance the outstanding indebtedness; • Subject us to increased sensitivity to interest rate increases; • Make us more vulnerable to economic downturns, adverse industry or company conditions or catastrophic external events; • Limit our ability to withstand competitive pressures; • Reduce our flexibility in planning for or responding to changing business, industry and economic conditions; and • Place us at a competitive disadvantage to competitors that have relatively less debt than we have.
Our indebtedness and any future indebtedness we incur could: • Require us to dedicate a substantial portion of cash flow from operations to the payment of interest on and principal of our indebtedness, thereby reducing the funds available for other purposes, including for working capital, capital expenditures and acquisitions; • Make it more difficult for us to satisfy and comply with our obligations with respect to our outstanding indebtedness, namely the payment of interest and principal; 54 Table of Contents • Make it more difficult to refinance the outstanding indebtedness; • Subject us to increased sensitivity to interest rate increases; • Make us more vulnerable to economic downturns, adverse industry or company conditions or catastrophic external events; • Limit our ability to withstand competitive pressures; • Reduce our flexibility in planning for or responding to changing business, industry and economic conditions; and • Place us at a competitive disadvantage to competitors that have relatively less debt than we have.
If FDA approval of manufacturing sites is delayed or withdrawn, if FDA requirements relating to site approval change, or our PMF sites experience manufacturing issues, our business, results of operations, financial condition and cash flows could be adversely affected. We rely on Jubilant HollisterStier (“JHS”) as a substantial supplier of DEFINITY.
If FDA approval of manufacturing sites is delayed or withdrawn, if FDA requirements relating to site approval change, or our PMF sites experience manufacturing issues, our business, results of operations, financial condition and cash flows could be adversely affected. We rely on Jubilant HollisterStier as a substantial supplier of DEFINITY.
Both before and after the approval of our products in development, we, our products, development products, operations, facilities, suppliers, distributors, contract manufacturers, contract research organizations and contract testing laboratories are subject to extensive and, in certain circumstances, expanding regulation by federal, state and local government agencies in the U.S., as well as non-U.S. and transnational laws and regulations, with regulations differing from country to country and even state to state, including, among other things, anti-trust and competition laws and regulations, and data privacy laws and regulations such as the General Data Protection Regulation in the European Union and the California Consumer Privacy Act and the California Privacy Rights Act.
Both before and after the approval of our products in development, we, our products, development products, operations, facilities, suppliers, distributors, contract manufacturers, contract research organizations and contract testing laboratories are subject to extensive and, in certain circumstances, expanding regulation by federal, state and local government agencies in the United States., as well as non-U.S. and transnational laws and regulations, with regulations differing from country to country and even state to state, including, among other things, anti-trust and competition laws and regulations, and data privacy laws and regulations such as the General Data Protection Regulation in the European Union and the California Consumer Privacy Act and the California Privacy Rights Act.
As of December 31, 2024, we had approximately $575.0 million of total principal indebtedness remaining under the Notes and availability of $750.0 million under our five-year revolving credit facility, which was amended in December 2024 (as amended, the “2022 Revolving Facility”).
As of December 31, 2025, we had approximately $575.0 million of total principal indebtedness remaining under the Notes and availability of $750.0 million under our five-year revolving credit facility, which was amended in December 2024 (as amended, the “2022 Revolving Facility”).
These covenants limit our and our restricted subsidiaries’ ability to, among other things: • Maintain net leverage above certain specified levels; • Maintain interest coverage below certain specified levels; • Incur additional debt; • Pay dividends or make other distributions; • Redeem stock; • Issue stock of subsidiaries; • Make certain investments; • Create liens; • Enter into transactions with affiliates; and • Merge, consolidate or transfer all or substantially all of our assets. 50 Table of Contents A breach of any of these covenants could result in a default under the 2022 Revolving Facility.
These covenants limit our and our restricted subsidiaries’ ability to, among other things: • Maintain net leverage above certain specified levels; • Maintain interest coverage below certain specified levels; • Incur additional debt; • Pay dividends or make other distributions; • Redeem stock; • Issue stock of subsidiaries; • Make certain investments; • Create liens; • Enter into transactions with affiliates; and • Merge, consolidate or transfer all or substantially all of our assets. 55 Table of Contents A breach of any of these covenants could result in a default under the 2022 Revolving Facility.
For example: • We might not have been the first to make the inventions covered by each of our pending patent applications and issued patents, and we could lose our patent rights as a result; • We might not have been the first to file patent applications for these inventions or our patent applications may not have been timely filed, and we could lose our patent rights as a result; • Others may independently develop similar or alternative technologies or duplicate any of our technologies; • It is possible that none of our pending patent applications will result in any further issued patents; • Our issued patents may not provide a basis for commercially viable drugs, may not provide us with any protection from unauthorized use of our intellectual property by third parties, and may not provide us with any competitive advantages; • The validity or enforceability of our patent applications or patents may be subject to challenge through interferences, oppositions, post-grant review, ex-parte re-examinations, inter partes review or similar administrative proceedings; • While we generally apply for patents in those countries where we intend to make, have made, use or sell patented products, we may not be able to accurately predict all of the countries where patent protection will ultimately be desirable and may be precluded from doing so at a later date; • We may choose not to seek patent protection in certain countries where the actual cost outweighs the perceived benefit at a certain time; • Patents issued in foreign jurisdictions may have different scopes of coverage than our U.S. patents and so our products may not receive the same degree of protection in foreign countries as they would in the U.S.; • We may not develop additional proprietary technologies that are patentable; • The patents of others may have an adverse effect on our business; or • The cost to defend our patents may be significant and may result in litigation which could be costly and time consuming.
For example: • We might not have been the first to make the inventions covered by each of our pending patent applications and issued patents, and we could lose our patent rights as a result; • We might not have been the first to file patent applications for these inventions or our patent applications may not have been timely filed, and we could lose our patent rights as a result; • Others may independently develop similar or alternative technologies or duplicate any of our technologies; 41 Table of Contents • It is possible that none of our pending patent applications will result in any further issued patents; • Our issued patents may not provide a basis for commercially viable drugs, may not provide us with any protection from unauthorized use of our intellectual property by third parties, and may not provide us with any competitive advantages; • The validity or enforceability of our patent applications or patents may be subject to challenge through interferences, oppositions, post-grant review, ex-parte re-examinations, inter partes review or similar administrative proceedings; • While we generally apply for patents in those countries where we intend to make, have made, use or sell patented products, we may not be able to accurately predict all of the countries where patent protection will ultimately be desirable and may be precluded from doing so at a later date; • We may choose not to seek patent protection in certain countries where the actual cost outweighs the perceived benefit at a certain time; • Patents issued in foreign jurisdictions may have different scopes of coverage than our U.S. patents and so our products may not receive the same degree of protection in foreign countries as they would in the United States; • We may not develop additional proprietary technologies that are patentable; • The patents of others may have an adverse effect on our business; or • The cost to defend our patents may be significant and may result in litigation which could be costly and time consuming.
It also requires us to keep books and records that accurately and fairly reflect our transactions. Because of the predominance of government-sponsored healthcare systems around the world, many of our customer relationships outside of the U.S. are, either directly or indirectly, with governmental entities and are therefore subject to the FCPA and similar anti-bribery laws in non-U.S. jurisdictions.
It also requires us to keep books and records that accurately and fairly reflect our transactions. Because of the predominance of government-sponsored healthcare systems around the world, many of our customer relationships outside of the United States are, either directly or indirectly, with governmental entities and are therefore subject to the FCPA and similar anti-bribery laws in non-U.S. jurisdictions.
We operate in many parts of the world that have experienced governmental corruption to some degree, and in certain circumstances strict compliance with anti-bribery laws may conflict with local customs and practices. Despite our training and compliance programs, our internal control policies and procedures may not always protect us from reckless or criminal acts committed by our employees or agents.
We operate in many parts of the world that have experienced governmental corruption to some degree, and in certain circumstances compliance with anti-bribery laws may conflict with local customs and practices. Despite our training and compliance programs, our internal control policies and procedures may not always protect us from criminal acts committed by our employees or agents.
The potential for future generic entrants to the market due to the expiry PYLARIFY’s new chemical entity exclusivity period in 2026 could also generate increased competition for PYLARIFY.
The potential for future generic entrants to the market due to the expiry of PYLARIFY’s new chemical entity exclusivity period in 2026 could also generate increased competition for PYLARIFY.
Future acquisitions or in-licenses, however, may entail numerous operational and financial risks, including: • A reduction of our current financial resources; • Incurrence of substantial debt or dilutive issuances of securities to pay for acquisitions; • Difficulty or inability to secure financing to fund development activities for those acquired or in-licensed technologies; • Higher than expected acquisition, integration or operational costs; • Increased amortization expenses; • Difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel or of retaining key personnel; and • Diversion of our management’s and other personnel’s time and attention to identify, assess and acquire potential additional products, businesses or technologies.
Future acquisitions or in-licenses, however, may entail numerous operational and financial risks, including: • A reduction of our current financial resources; • Incurrence of substantial debt or dilutive issuances of securities to pay for acquisitions; • Difficulty or inability to secure financing to fund development activities for those acquired or in-licensed technologies; • Higher than expected acquisition, integration or operational costs; • Increased amortization expenses; 46 Table of Contents • Difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel or of retaining key personnel; and • Diversion of our management’s and other personnel’s time and attention to identify, assess and acquire potential additional products, businesses or technologies.
Our collaborators are also subject to similar development, regulatory, manufacturing, cyber-security and competitive risks as us, which may further impede their ability to successfully perform the collaborative activities for which they are responsible. Setbacks of these types to our collaborators could have a material adverse effect on our business, results of operations and financial condition.
Our collaborators are also subject to similar development, regulatory, manufacturing, cyber-security and competitive risks as us, which may further impede their ability to successfully perform the collaborative activities for which they are responsible. Setbacks of these types to our collaborators could have a material adverse effect on our business, results of operations, financial condition and cash flows.
Historically, after TPT Status expired, diagnostic radiopharmaceuticals, such as, PYLARIFY, would not have been separately reimbursed in the hospital outpatient setting but rather would be bundled into the facility payment a hospital receives for a PET/CT imaging procedure, and the facility payment may not have adequately covered the total cost of the procedure with the diagnostic radiopharmaceutical for all hospitals.
After expiry of TPT Status, diagnostic radiopharmaceuticals, such as, PYLARIFY, historically would not have been separately reimbursed in the hospital outpatient setting but rather would be bundled into the facility payment a hospital receives for a PET/CT imaging procedure, and the facility payment may not have adequately covered the total cost of the procedure with the diagnostic radiopharmaceutical for all hospitals.
Risks Related to Our Business Operations and Financial Results We may not be able to hire or retain the number of qualified personnel, particularly scientific, medical and sales personnel, required for our business, which would harm the expansion of our internal research and development capabilities, sales of our products and approval timelines for and commercialization of our product candidates and limit our ability to grow.
Risks Related to Our Business Operations and Financial Results We may not be able to hire or retain the number of qualified personnel, particularly scientific, medical and sales personnel, required for our business, which would harm the expansion of our internal research and development (“R&D”) capabilities, sales of our products and approval timelines for and commercialization of our product candidates and limit our ability to grow.
The finished PYLARIFY is then quality control tested and transferred to a radiopharmacist who prepares and dispenses patient-specific doses from the final product.
The finished product is then quality control tested and transferred to a radiopharmacist who prepares and dispenses patient-specific doses from the final product.
Possible consequences of those actions could include: • Substantial modifications to our business practices and operations; • Significantly reduced demand for our products (if products become ineligible for reimbursement under federal and state healthcare programs); • A total or partial shutdown of production in one or more of the facilities where our products are produced while the alleged violation is being remediated; • Delays in or the inability to obtain future pre-market clearances or approvals; and • Withdrawals or suspensions of our current products from the market.
Possible consequences of those actions could include: • Substantial modifications to our business practices and operations; • Significantly reduced demand for our products (if products become ineligible for reimbursement under federal and state healthcare programs); 39 Table of Contents • A total or partial shutdown of production in one or more of the facilities where our products are produced while the alleged violation is being remediated; • Delays in or the inability to obtain future pre-market clearances or approvals; and • Withdrawals or suspensions of our current products from the market.
Obtaining adequate coding, coverage, and payment for PYLARIFY is critical, including not only coverage from Medicare, Medicaid and other government payors, as well as private payors, but also appropriate payment levels to adequately cover our customers’ costs of using PYLARIFY in PET/computed tomography (“CT”) imaging procedures.
Ensuring adequate coding, coverage, and payment for PYLARIFY is critical, including not only coverage from Medicare, Medicaid and other government payors, as well as private payors, but also appropriate payment levels to adequately cover our customers’ costs of using PYLARIFY in PET/computed tomography (“CT”) imaging procedures.
In addition, for reasons of quality assurance or cost-effectiveness, we purchase certain components and raw materials from sole suppliers (including, for example, the specially designed chemistry synthesis boxes and consumables used in the manufacturing of PYLARIFY and the lipid blend material and perflutren gas used in the manufacturing of DEFINITY).
In addition, for reasons of quality assurance or cost-effectiveness, we purchase certain components and raw materials from sole suppliers (including, for example, the specially designed chemistry synthesis boxes and consumables used in the manufacturing of each of PYLARIFY and Neuraceq and the lipid blend material and perflutren gas used in the manufacturing of DEFINITY).
The NDA must include extensive nonclinical and clinical data and supporting information to establish the product’s safety and effectiveness for each indication. The NDA must also include significant information regarding the chemistry, manufacturing and controls for the product. The FDA review process can take many years to complete, and approval is never guaranteed.
The NDA must include extensive non-clinical and clinical data and supporting information to establish the product’s safety and effectiveness for each indication. The NDA must also include significant information regarding the chemistry, manufacturing and controls for the product. The FDA review process can take many years to complete, and approval is never guaranteed.
Any of the foregoing risks could have a material adverse effect on our business, results of operations and financial condition. The process of developing new drugs and obtaining regulatory approval is complex, time-consuming and costly, and the outcome is not certain.
Any of the foregoing risks could have a material adverse effect on our business, results of operations, financial condition and cash flows. The process of developing new drugs and obtaining regulatory approval is complex, time-consuming and costly, and the outcome is not certain.
A number of other factors may cause significant delays in the completion of our development programs and clinical trials, including unexpected delays in the initiation of clinical sites, slower than projected enrollment, competition with ongoing clinical trials and scheduling conflicts with participating clinicians, regulatory requirements, limits on manufacturing capacity and failure of an investigational product to meet required standards for administration to humans.
A number of other factors may cause significant delays in the completion of our development programs and clinical trials, including unexpected delays in the initiation of clinical sites, slower 51 Table of Contents than projected enrollment, competition with ongoing clinical trials and scheduling conflicts with participating clinicians, regulatory requirements, limits on manufacturing capacity and failure of an investigational product to meet required standards for administration to humans.
In addition, demand for new products may be limited unless we obtain favorable reimbursement (including coding, coverage and payment) from governmental and private third party payors at the time of the product’s introduction, which will depend, in part, on our ability to demonstrate that a new agent has a positive impact on clinical outcomes.
In addition, demand for new products may be limited unless we obtain favorable reimbursement (including coding, coverage and payment) from governmental and private third party payors at the time of the product’s introduction, which will depend, in part, on our ability to demonstrate that a new agent has a positive impact on clinical outcomes, and to maintain favorable reimbursement relative to competitive products.
To date, we have not experienced any known material cybersecurity attacks. 45 Table of Contents 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.
To date, we have not experienced any known material cybersecurity attacks. 49 Table of Contents 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.
In addition, the supply-demand dynamics of the industry are complex because of large market positions of some participants, legacy businesses, government subsidies (in particular, relating to the manufacture of radioisotopes), and group purchasing arrangements and there are often limited sources available for isotopes and raw materials used in the manufacturing of our product and product candidates.
In addition, the supply-demand dynamics of the industry are complex because of large market positions of some participants, legacy businesses, government subsidies (in particular, relating to the manufacture of radioisotopes), and group purchasing arrangements and there are often limited sources available for isotopes and raw materials, including components and equipment, used in the manufacturing of our product and product candidates.
Moreover, if one or more of the analysts who cover us downgrades our stock, or if our results of operations do not meet their expectations, our stock price could also decline. 51 Table of Contents We 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.
Moreover, if one or more of the analysts who cover us downgrades our stock, or if our results of operations do not meet their expectations, our stock price could also decline. We 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.
In either case, and in other cases, our obligations under the Notes and the Indenture could increase the cost of acquiring us or otherwise discourage a third party from acquiring us or removing incumbent management, including in a transaction that holders of our common stock may view as favorable. Item 1B. Unresolved Staff Comments None.
In either case, and in other cases, our obligations under the Notes and the Indenture could increase the cost of acquiring us or otherwise discourage a third party from acquiring us or removing incumbent management, including in a transaction that holders of our common stock may view as favorable. Item 1B. Unr esolved Staff Comments None.
We cannot anticipate all the ways in which the current or future economic climate and financial market conditions could adversely impact our business. We are exposed to risks associated with reduced profitability and the potential financial instability of our customers, many of which may be adversely affected by volatile conditions in the financial markets.
We cannot anticipate all the ways in which the current or future economic climate, financial market conditions and government actions could adversely impact our business. We are exposed to risks associated with reduced profitability and the potential financial instability of our customers, many of which may be adversely affected by conditions in the financial markets.
Violations of these laws are punishable by criminal or civil sanctions, including substantial fines, imprisonment and exclusion from participation in healthcare programs such as Medicare and Medicaid, as well as health programs outside the U.S., and even settlement of alleged violations can result in the imposition of corporate integrity agreements that could subject us to additional compliance and reporting requirements and impact our business practices.
Violations of these laws are punishable by criminal or civil sanctions, including substantial fines, imprisonment and exclusion from participation in healthcare programs such as Medicare and Medicaid, as well as health programs outside the United States, and even settlement of alleged violations can result in the imposition of corporate integrity agreements that could subject us to additional compliance and reporting requirements and impact our business practices.
However, we can give no assurances that we will be successful in those efforts or that the availability of TPT Status for other diagnostic radiopharmaceuticals will not impact clinical decision making regarding which product to use for all patient populations, which could have an adverse effect on our business, results of operations, financial condition and cash flows.
However, we can give 30 Table of Contents no assurances that we will be successful in those efforts or that the availability of TPT Status for other diagnostic radiopharmaceuticals will not continue to impact clinical decision making regarding which product to use for all patient populations, which could have an adverse effect on our business, results of operations, financial condition and cash flows.
“Business—Regulatory Matters—Hatch-Waxman Act” of this 47 Table of Contents Form 10-K); provided, however, that seeking regulatory approval under such pathways may subject the product candidate to litigation brought by an innovator of similar drugs under the Hatch-Waxman Act, as is the case with the PNT2003 Litigation.
“Business—Regulatory Matters—Hatch-Waxman Act” of this Form 10-K); provided, however, that seeking regulatory approval under such pathways may subject the product candidate to litigation brought by an innovator of similar drugs under the Hatch-Waxman Act, as is the case with the PNT2003 Litigation.
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. Securities markets worldwide have experienced, and may continue to experience, significant price and volume fluctuations.
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. Securities markets worldwide have experienced, and may continue to experience, significant price and volume fluctuations.
Radiopharmaceutical products, including PYLARIFY and our TechneLite generators, rely on radioisotopes with limited half-lives. As a result, we or our partners must manufacture, finish and distribute these products on a just-in-time basis, because the underlying radioisotope is in a constant state of decay.
Radiopharmaceutical products, including PYLARIFY and Neuraceq, rely on radioisotopes with limited half-lives. As a result, we or our partners must manufacture, finish and distribute these products on a just-in-time basis, because the underlying radioisotope is in a constant state of decay.
As a result, in October 2007, 33 Table of Contents the FDA requested that we and GE Healthcare, which distributes Optison, a competitor to DEFINITY, add a boxed warning to these products emphasizing the risk for serious cardiopulmonary reactions and that the use of these products was contraindicated in certain patients.
As a result, in October 2007, the FDA requested that we and GE Healthcare, which distributes Optison, a competitor to DEFINITY, add a boxed warning to these products emphasizing the risk for serious cardiopulmonary reactions and that the use of these products was contraindicated in certain patients.
Accordingly, our business is subject to risks associated with doing business internationally, including: • Less stable political and economic environment and changes in a specific country’s or region’s political or economic conditions; • Changes in trade policies, regulatory requirements and other barriers, including, for example, U.S. trade sanctions against Iran and those countries and entities doing business with Iran, which could adversely impact international isotope production and, indirectly, our global supply chain; • Changes to, or the imposition of new tariffs or customs duties; • Potential global disruptions in air transport, which could adversely affect our international supply chains for radioisotopes, as well as international distribution channels for our commercial products; • Entering into, renewing or enforcing commercial agreements with international governments or provincial authorities or entities directly or indirectly owned or controlled by such governments or authorities, such as our Chinese development and commercialization partner, Double-Crane; • International customers which are agencies or institutions owned or controlled by foreign governments; • Local business practices which may be in conflict with the FCPA and the Bribery Act; • Currency fluctuations; • Unfavorable labor regulations; • Greater difficulties in relying on non-U.S. courts to enforce either local or U.S. laws, particularly with respect to intellectual property; • Greater potential for intellectual property piracy; • Greater difficulties in managing and staffing non-U.S. operations, including our EXINI operations in Sweden; • The need to ensure compliance with the numerous in-country and international regulatory and legal requirements applicable to our business in each of these jurisdictions and to maintain an effective compliance program to ensure compliance with these requirements, including in connection with the General Data Protection Regulation in the EU; 44 Table of Contents • Changes in public attitudes about the perceived safety of nuclear facilities; • Civil unrest or other catastrophic events; and • Longer payment cycles of non-U.S. customers and difficulty collecting receivables in non-U.S. jurisdictions.
Accordingly, our business is subject to risks associated with doing business internationally, including: • Less stable political and economic environment and changes in a specific country’s or region’s political or economic conditions; • Changes in trade policies, regulatory requirements and other barriers, including, for example, U.S. trade sanctions against Iran and those countries and entities doing business with Iran, which could adversely impact international isotope production and, indirectly, our global supply chain; • Changes to, or the imposition of new tariffs or customs duties; • Potential global disruptions in air transport, which could adversely affect our international supply chains for radioisotopes, as well as international distribution channels for our commercial products; • Entering into, renewing or enforcing commercial agreements with international governments or provincial authorities or entities directly or indirectly owned or controlled by such governments or authorities; • International customers which are agencies or institutions owned or controlled by foreign governments; • Local business practices which may be in conflict with the FCPA and the Bribery Act; • Currency fluctuations; • Unfavorable labor regulations; • Greater difficulties in relying on non-U.S. courts to enforce either local or U.S. laws, particularly with respect to intellectual property; • Greater potential for intellectual property piracy; • Greater difficulties in managing and staffing non-U.S. operations; • The need to ensure compliance with the numerous in-country and international regulatory and legal requirements applicable to our business in each of these jurisdictions and to maintain an effective compliance program to ensure compliance with these requirements, including in connection with the General Data Protection Regulation in the EEA; • Changes in public attitudes about the perceived safety of nuclear facilities; • Civil unrest or other catastrophic events; and • Longer payment cycles of non-U.S. customers and difficulty collecting receivables in non-U.S. jurisdictions.
Item 1A. Risk Factors You should carefully consider the following risks. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that adversely affect our business.
Item 1A. Ri sk Factors You should carefully consider the following risks. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that adversely affect our business.
To obtain regulatory approval for these products, we must conduct extensive human tests, which are referred to as clinical trials, as well as meet other rigorous regulatory requirements, as further described in Part I, Item 1. “Business—Regulatory Matters” to this Form 10-K.
To obtain regulatory approval for these products, we may need to conduct extensive human tests, which are referred to as clinical trials, as well as meet other rigorous regulatory requirements, as further described in Part I, Item 1. “Business—Regulatory Matters” to this Form 10-K.
In addition, in the U.S., it has become increasingly common for patent infringement actions to prompt claims that antitrust laws have been violated during the prosecution of the patent or during litigation involving the defense of that patent. Such claims by direct and indirect purchasers and other payors are typically filed as class actions.
In addition, in the United States, it has become increasingly common for patent infringement actions to prompt claims that antitrust laws have been violated during the prosecution of the patent or during litigation involving the defense of that patent. Such claims by direct and indirect purchasers and other payors are typically filed as class actions.
For example, in 2022, CMS reduced Medicare fee schedule payments rates in the agency’s final rulemaking, while a larger cut was put forth in the proposed rulemaking earlier that year. 34 Table of Contents For 2023, CMS had finalized a reduction in the Medicare fee schedule payments rates, which was revised by Congress, pursuant to the Consolidated Appropriations Act, 2023, to a lesser reduction.
For example, in 2022, CMS reduced Medicare fee schedule payments rates in the agency’s final rulemaking, while a larger cut was put forth in the proposed rulemaking earlier that year. For 2023, CMS had finalized a reduction in the Medicare fee schedule payments rates, which was revised by Congress, pursuant to the Consolidated Appropriations Act, 2023, to a lesser reduction.
In addition, the successful integration of acquired businesses requires significant efforts and expense across all operational areas, including research and development, manufacturing, sales and marketing, finance, legal, and information technologies. There can be no assurance that any of our acquisitions will be successful or will be, or will become or remain, profitable.
In addition, the successful integration of acquired businesses requires significant efforts and expense across all operational areas, including R&D, manufacturing, sales and marketing, finance, legal, and information technologies. There can be no assurance that any of our acquisitions will be successful or will be, or will become or remain, profitable.
In the U.S. and Europe, regulatory authorities have continued to challenge as anti-competitive so-called “reverse payment” settlements between branded and generic drug manufacturers. We may also be subject to other antitrust litigation involving competition claims unrelated to patent infringement and prosecution.
In the United States and Europe, regulatory authorities have continued to challenge as anti-competitive so-called “reverse payment” settlements between branded and generic drug manufacturers. We may also be subject to other antitrust litigation involving competition claims unrelated to patent infringement and prosecution.
Our commercial success will depend in part on obtaining and maintaining patent and trade secret protection of our commercial products and technologies and products in development, as well as successfully enforcing and defending these patents and trade secrets against third parties and their challenges, both in the U.S. and in foreign countries.
Our commercial success will depend in part on obtaining and maintaining patent and trade secret protection of our commercial products and technologies and products in development, as well as successfully enforcing and defending these patents and trade secrets against third parties and their challenges, both in the United States and in foreign countries.
During periods of volatility and disruption in the U.S., European, or global credit markets, obtaining additional or replacement financing may be more difficult and the cost of issuing new debt or replacing or repaying our 2022 Revolving Facility could be higher than under our current 2022 Revolving Facility.
During periods of volatility and disruption in the United States, European, or global credit markets, obtaining additional or replacement financing may be more difficult and the cost of issuing new debt or replacing or repaying our 2022 Revolving Facility could be higher than under our current 2022 Revolving Facility.
Examples of these changes include: • Reducing payments for certain imaging procedures when performed together with other imaging procedures in the same family of procedures on the same patient on the same day in the physician office and free-standing imaging facility setting; • Making significant revisions to the methodology for determining the practice expense component of the Medicare payment applicable to the physician office and free-standing imaging facility settings which results in reduced payments for certain services; • Revising payment policies and reducing payment amounts for imaging procedures performed in the hospital outpatient settings, including the new payment policy for diagnostic radiopharmaceuticals that currently provides separate payment for PYLARIFY at a rate that reflects MUC, which is lower than the rate paid during TPT Status; and • Reducing prospective payment levels for applicable diagnosis-related groups in the hospital inpatient setting.
Examples of these changes include: • Reducing payments for certain imaging procedures when performed together with other imaging procedures in the same family of procedures on the same patient on the same day in the physician office and free-standing imaging facility setting; • Making significant revisions to the methodology for determining the practice expense component of the Medicare payment applicable to the physician office and free-standing imaging facility settings which results in reduced payments for certain services; • Revising payment policies and reducing payment amounts for imaging procedures performed in the hospital outpatient settings, including the new payment policy for diagnostic radiopharmaceuticals beginning in 2025 that currently provides separate payment for PYLARIFY at a rate that reflects MUC, which is lower than the rate paid during TPT Status, and that establishes an MUC reimbursement rate for Neuraceq below that of competitive products; and • Reducing prospective payment levels for applicable diagnosis-related groups in the hospital inpatient setting.
Our dependence upon third parties for the manufacture and supply of a substantial portion of our products and certain key components and raw materials and upon our in-house manufacturing for DEFINITY could prevent us from delivering our products to our customers in the required quantities, within the required timeframes, or at all, which could result in order cancellations and decreased revenues.
Our dependence upon third parties for the manufacture and supply of a substantial portion of our products, including PYLARIFY and Neuraceq, and certain key components and raw materials and upon our in-house manufacturing for DEFINITY could prevent us from delivering our products to our customers in the required quantities, within the required timeframes, or at all, which could result in order cancellations, decreased revenues and reputational harm.
We obtain a substantial portion of our products from third party manufacturers and suppliers. 31 Table of Contents PYLARIFY is manufactured by a nationwide network of PMFs with radioisotope-producing cyclotrons. The radioisotope in PYLARIFY is fluorine-18, which has a 110-minute half-life, so PYLARIFY is manufactured and distributed rapidly to end-users.
We obtain a substantial portion of our products from third party manufacturers and suppliers. 33 Table of Contents PYLARIFY and Neuraceq are manufactured by a nationwide network of PMFs with radioisotope-producing cyclotrons. The radioisotope in both PYLARIFY and Neuraceq is fluorine-18, which has a 110-minute half-life, so PYLARIFY and Neuraceq are manufactured and distributed rapidly to end-users.
PYLARIFY currently competes with two commercially available Ga-68-based PSMA PET imaging agents from Telix Pharmaceuticals Limited and Novartis AG and an F-18 PSMA PET imaging agent from Blue Earth Diagnostics Ltd. (“Blue Earth”), as well as other non-PSMA PET imaging agents.
PYLARIFY currently competes with three commercially available Gallium-68-based PSMA PET imaging agents, two from Telix Pharmaceuticals Limited and one from Novartis AG and an F-18 PSMA PET imaging agent from Blue Earth Diagnostics Ltd. (“Blue Earth”), as well as other non-PSMA PET imaging agents.
Subsequently, the Medicare Access and CHIP Reauthorization Act of 2015 significantly revised the methodology for updating the Medicare physician fee schedule. In 2017, Congress enacted legislation that effectively eliminated the Healthcare Reform Act’s “individual mandate” beginning in 2019. Congress continues to consider other healthcare reform legislation.
Subsequently, the Medicare Access and CHIP Reauthorization Act of 2015 significantly revised the methodology for updating the Medicare physician fee schedule. In 2017, Congress enacted legislation that effectively eliminated the Healthcare Reform Act's “individual mandate” beginning in 2019.
We are not permitted to market our products in development in the U.S. or other countries until we have received requisite regulatory approvals. For example, securing FDA approval for a new drug requires the submission of an NDA to the FDA for our products in development.
We are not permitted to market our products in development in the United States or other countries until we have received requisite regulatory approvals. For example, securing FDA approval for a new drug requires the submission of an NDA to the FDA for our products in development.
For example, the radioisotope used in PYLARIFY is F-18, which has a 110 minute half-life, requiring that this product be manufactured and distributed within the same day to end-users. After being made on a cyclotron at a PMF, the F-18 is then combined with certain chemical ingredients in specially designed chemistry synthesis boxes to manufacture PYLARIFY.
For example, the radioisotope used in PYLARIFY and Neuraceq is F-18, which has a 110-minute half-life, requiring that this product be manufactured and distributed within the same day to end-users. After being made on a cyclotron at a PMF, the F-18 is then combined with certain specially designed ingredients in a chemistry synthesis box to manufacture either PYLARIFY or Neuraceq.
Such opposition proceedings are increasingly common in the European Union (“EU”) and are costly to defend. The initiation, defense and prosecution of intellectual property suits (including Hatch-Waxman related litigation), interferences, oppositions and related legal and administrative proceedings are costly, time consuming to pursue and result in a diversion of resources, including a significant amount of management time.
Such opposition proceedings are increasingly common in the European Economic Area (“EEA”) and are costly to defend. The initiation, defense and prosecution of intellectual property suits (including Hatch-Waxman related litigation), interferences, oppositions and related legal and administrative proceedings are costly, time consuming to pursue and result in a diversion of resources, including a significant amount of management time.
We face currency and other risks associated with international sales. We generate revenue from export sales, as well as from operations conducted outside the United States. Operations outside the U.S. expose us to risks including fluctuations in currency values, trade restrictions, tariff and trade regulations, U.S. export controls, U.S. and non‑U.S. tax laws, shipping delays and economic and political instability.
We generate revenue from export sales, as well as from operations conducted outside the United States. Operations outside the United States expose us to risks including fluctuations in currency values, trade restrictions, tariff and trade regulations, U.S. export controls, U.S. and non‑U.S. tax laws, shipping delays and economic and political instability.
In the U.S., the FDA regulates, among other things, the pre-clinical testing, clinical trials, manufacturing, safety, efficacy, potency, labeling, storage, record keeping, quality systems, advertising, promotion, sale, distribution, and import and export of drug products.
In the United States, the FDA regulates, among other things, the pre-clinical testing, clinical trials, manufacturing, safety, efficacy, potency, labeling, storage, record keeping, quality systems, advertising, promotion, sale, distribution, and import and export of drug products.
Patent and Trademark Office (“USPTO”) adversarial proceeding. Patent litigation is complex and can be protracted and expensive, so if we were to receive such a Notice and to challenge the applicant, this could have a negative effect on our business, results of operations and financial condition.
Patent litigation is complex and can be protracted and expensive, so if we were to receive such a notice and to challenge the applicant, this could have a negative effect on our business, results of operations and financial condition.
In addition, changes in either the patent laws or in interpretations of patent laws in the U.S. or other countries may diminish the value of our intellectual property and we may not receive the same degree of protection in every jurisdiction.
In addition, changes in either the patent laws or in interpretations of patent laws in the United States or other countries may diminish the value of our intellectual property and we may not receive the same degree of protection in every jurisdiction.
The Notes were issued under an indenture, dated as of December 8, 2022 (the “Indenture”), among Lantheus Holdings, LMI, and U.S. Bank Trust Company, National Association (“U.S. Bank”), as Trustee.
The Notes were issued under an indenture, dated as of December 8, 2022 (the “Indenture”), among Lantheus Holdings, Lantheus Medical, and U.S. Bank Trust Company, National Association, as Trustee.
While we believe that both MK-6240, as a tau imaging agent, and NAV-4694, as a beta amyloid imaging agent, have the potential to play an important role in diagnosing, staging and monitoring Alzheimer’s disease, we can give no assurance that we will be successful with continued development, regulatory approval and commercialization of these product candidates or that disagreements with the counterparties to our license agreements for MK-6240 and NAV-4694 or the former stockholders of the companies we acquired who could receive future milestone and royalty-based payments will not arise over proprietary rights, contract interpretation or the preferred course of product research, development or marketing that might cause delays or termination of the license agreements, or might result in litigation or arbitration, which could be time-consuming and expensive.
While we believe that both MK-6240 and LNTH-2620, as tau imaging agents, and NAV-4694, as a beta amyloid imaging agent, have the potential to expand our Neurology franchise that also includes Neuraceq and play an important role in diagnosing, staging and monitoring Alzheimer’s disease, we can give no assurance that we will be successful with continued development, 50 Table of Contents regulatory approval and commercialization of these product candidates or that disagreements with the counterparties to our license agreements or the former stockholders of the companies we acquired who could receive future milestone and royalty-based payments will not arise, including disagreements over proprietary rights, contract interpretation or the preferred course of product research, development or marketing that might cause delays or termination of the license agreements, or might result in litigation or arbitration, which could be time-consuming and expensive.
Risks Related to Reimbursement and Regulation Many of our customers are highly dependent on payments from third-party payors, including government sponsored programs, particularly Medicare, in the U.S. and other countries in which we operate, and reductions in third party coverage and reimbursement rates for our products (or services provided by healthcare providers using our products) could adversely affect our business and results of operations.
Risks Related to Reimbursement and Regulation Many of our customers are highly dependent on payments from third-party payors, including government sponsored programs, particularly Medicare, in the United States and other countries in which we operate, and reductions in third party coverage and reimbursement rates for our products (or services provided by healthcare providers using our products) could adversely affect our business, results of operations, financial condition and cash flows.
Although we have not had any material difficulty in the past in hiring or retaining qualified personnel, if we are unable to retain our existing personnel, or attract and train additional qualified personnel, either because of competition in our industry for these personnel or due to insufficient financial resources, then timelines for the approval and commercialization of our product candidates could be impacted, our growth could be limited and it could have a material adverse effect on our business.
If we are unable to retain our existing personnel, or attract and train additional qualified personnel, either because of competition in our industry for these personnel or due to insufficient financial resources, then timelines for the approval and commercialization of our product candidates could be impacted, our growth could be limited and it could have a material adverse effect on our business.
We, or our business partners, may be subject to claims that we, or our partners, have infringed, misappropriated or otherwise violated the patent or other intellectual property rights of a third party. The outcome of any of these claims is uncertain and any unfavorable result could adversely affect our business, financial condition and results of operations.
The outcome of any of these claims is uncertain and any unfavorable result could adversely affect our business, results of operations, financial condition and cash flows. We, or our business partners, may be subject to claims by third parties that we, or our partners, have infringed, misappropriated or otherwise violated third-party intellectual property rights.
Enforcing a claim that a third party improperly 39 Table of Contents obtained and is using our trade secrets is expensive, time consuming and resource intensive, and the outcome is unpredictable. In addition, courts outside the U.S. are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.
Enforcing a claim that a third party improperly obtained and is using our trade secrets is expensive, time consuming and resource intensive, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.
The growth of our business is also dependent on our ability to continue to grow the appropriate use of DEFINITY in suboptimal echocardiograms. DEFINITY currently competes with ultrasound enhancing agents produced by GE Healthcare Limited (“GE Healthcare”) and Bracco Diagnostics Inc. (“Bracco”), as well as echocardiography without ultrasound enhancing agents and other non-echocardiography agents.
The growth of our business is also dependent on our ability to continue to grow the appropriate use of DEFINITY in suboptimal echocardiograms. DEFINITY currently competes with ultrasound enhancing agents produced by GE HealthCare Limited (“GE Healthcare”) and Bracco Diagnostics Inc.
These acquisitions involve numerous risks and operational, financial, and managerial challenges, including the following, any of which could adversely affect our business, financial condition, or results of operations: • Coordinating or consolidating geographically separate organizations and integrating personnel with different business backgrounds and corporate cultures; • Integrating previously autonomous departments, including those in accounting and administrative functions; • Integrating financial information and management systems; • The pace of our acquisition activity and the related diversion of already limited resources and management and other personnel time; • Disruption of our ongoing business; • Difficulties in integrating new operations, technologies, products, and personnel; • Inconsistencies in standards, controls, procedures, and policies; • Lack of synergies, if synergies are anticipated, or the inability to realize expected synergies and cost-savings; • Underperformance of any acquired technology, product candidate, or business relative to our expectations and the price we paid; • Managing the risks of entering markets or types of businesses in which we have limited or no direct experience; 41 Table of Contents • Exposure to unforeseen liabilities; • The potential loss of key employees and strategic partners of acquired companies; and • Risks associated with acquiring intellectual property, including potential disputes regarding acquired companies’ intellectual property.
Our completed and any potential future acquisitions involve numerous risks and operational, financial, and managerial challenges, including the following, any of which could adversely affect our business, results of operations, financial condition and cash flows: • Coordinating or consolidating geographically separate organizations and integrating personnel with different business backgrounds and corporate cultures; • Integrating previously autonomous departments, including those in accounting and administrative functions; • Integrating financial information and management systems; • The pace of our acquisition activity and the related diversion of already limited resources and management and other personnel time; • Difficulties in integrating new operations, technologies, products, and personnel, including the time it may take to effectively prioritize and communicate decisions across a broader organization and portfolio; • Inconsistencies in standards, controls, procedures, and policies; • Lack of synergies, if synergies are anticipated, or the inability to realize expected synergies and cost-savings; • Underperformance of any acquired technology, product candidate, or business relative to our expectations and the price we paid; • Managing the risks of entering markets or types of businesses in which we have limited or no direct experience; • Exposure to unforeseen liabilities; • The potential loss of key employees and strategic partners of acquired companies; and • Risks associated with acquiring intellectual property, including potential disputes regarding acquired companies’ intellectual property.
Because each of the PMFs manufacturing PLYARIFY is deemed by the FDA to be a separate manufacturing site, each has to be separately approved by the FDA.
Because each of the PMFs manufacturing PLYARIFY and Neuraceq is deemed by the FDA to be a separate manufacturing site, each has to be separately approved by the FDA to manufacture each product.
To remain competitive in our industry, we must employ information technologies to support manufacturing processes, quality processes, distribution, research and development and regulatory applications to capture, manage and analyze large streams of data in compliance with applicable regulatory requirements.
To remain competitive in our industry, we must employ information technologies to collect and analyze data and to support manufacturing processes, quality processes, ordering requirements and preferences, distribution, research and development, regulatory applications, commercialization efforts and strategic planning to capture, manage and analyze large streams of data in compliance with applicable regulatory requirements.
Markets outside of the U.S. also have requirements for approval of products with which we must comply prior to marketing.
Markets outside of the United States also have requirements for approval of products with which we must comply prior to marketing.
We may be limited in our ability to use these tax loss carryforwards to reduce our future U.S. federal and state income tax liabilities if our future income is not sufficient to absorb the losses, or if we were to experience another “ownership change” as specified in Section 382 of the Internal Revenue Code including if we were to issue a certain amount of equity securities, certain of our stockholders were to sell shares of our common stock, or we were to enter into certain strategic transactions.
Additionally, we may be limited in our ability to use our U.S. federal and state tax loss carryforwards or if we were to experience another “ownership change” as specified in Section 382 of the Internal Revenue Code including if we were to issue a certain amount of equity securities, certain of our stockholders were to sell shares of our common stock, or we were to enter into certain strategic transactions.
We currently have pre-clinical and clinical development programs in the U.S., and are exploring additional lifecycle management opportunities for some of our current products, including PYLARIFY.
We currently have pre-clinical and clinical development programs and are exploring additional lifecycle management opportunities for some of our current products, including PYLARIFY and Neuraceq.
Reforms to the U.S. healthcare system may adversely affect our business. A significant portion of our patient volume is derived from U.S. government healthcare programs, principally Medicare, which are highly regulated and subject to frequent and substantial changes.
Reforms to the United States healthcare system, including changes to policies, guidelines and practices of regulatory authorities, may adversely affect our business. A significant portion of our patient volume is derived from U.S. government healthcare programs, principally Medicare, which are highly regulated and subject to frequent and substantial changes.
We also have similar adverse event and production reporting obligations outside of the U.S., including to the EMA and MHRA.
We also have similar adverse event and production reporting obligations outside of the United States, including to the EMA and MHRA.
We may not, or may take longer to, realize the expected benefits and opportunities related to, the POINT License Agreements.
We may not, or may take longer to, realize the expected benefits and opportunities related to, the POINT Biopharma Global Inc. (“POINT”) License Agreements.
In November 2024, CMS released the final rule for its calendar year 2025 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2025 OPPS Rule”).
In November 2024, the Centers for Medicare & Medicaid Services (“CMS”) released the final rule for its calendar year 2025 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2025 OPPS Rule”).
However, our management does not expect that our cybersecurity program will prevent or detect all occurrences of cybersecurity incidents, material or otherwise, and there is potential risk that certain cybersecurity breaches may go undetected for a period of time.
We believe that our cybersecurity program is designed to effectively mitigate the risks of material cybersecurity incidents. However, our management does not expect that our cybersecurity program will prevent or detect all occurrences of cybersecurity incidents, material or otherwise, and there is potential risk that certain cybersecurity breaches may go undetected for a period of time.
If this happens, we could elect to pursue Hatch-Waxman litigation and trigger the 30-month stay described under Part I, Item 1., “ Business - Intellectual Property Matters – Patent-related Aspects of Regulatory Matters,” of this Form 10-K, during which the FDA would be prohibited from granting full approval to the challenger’s application until the expiration of the 30-month stay and/or until the lawsuit is settled.
If a Paragraph IV Certification is made, we could elect to pursue Hatch-Waxman litigation and trigger the 30-month stay described under Part I, Item 1., “ Business - Intellectual Property Matters – Patent-related Aspects of Regulatory Matters,” of this Form 10-K, during which period the FDA would be prohibited from granting full approval to the challenger’s application.
If Medicare and other third party payors do not provide adequate reimbursement for the costs of our products (or services provided by healthcare providers using our products), deny the coverage of the products (or those services), or reduce current levels of reimbursement, healthcare professionals may not prescribe our products and providers and suppliers may not purchase our products.
If Medicare and other third party payors do not provide adequate reimbursement for the costs of our products (or services provided by healthcare providers using our products), deny the coverage of the products (or those services), reduce current levels of reimbursement, or reimburse competitive products at a higher rate than that available for our products, healthcare professionals may not prescribe our products and providers and suppliers may not purchase our products.
We, along with our counterparty in the POINT License Agreements, may not be able to meet expected or planned regulatory milestones and timelines due to a number of factors, including, with respect to PNT2003, the PNT2003 Litigation, which could postpone FDA approval for up to 30 months.
We, along with our counterparty in the POINT License Agreements, may not be able to meet expected or planned regulatory milestones and timelines due to a number of factors, including, with respect to PNT2003, the PNT2003 Litigation, which could postpone FDA approval for up to 30 months or result in us being further delayed in launching PNT2003 or requiring us to seek a license for intellectual property rights.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeA summary of these results are also reported by the Audit Committee to the Board at least annually. Management, including our Chief Information Officer, who has over 25 years of experience serving primarily in the life science industry and is a recognized industry leader, is responsible for monitoring and assessing cybersecurity risks.
Biggest changeManagement, including our Chief Information Officer, who has over 30 years of experience serving primarily in the life science industry and is a recognized industry leader, and our Chief Information Security Officer, who has nearly 30 years of cybersecurity experience across multiple industries, and is responsible for monitoring and assessing cybersecurity risks.
Cybersecurity and data privacy are regular topics on the Audit Committee’s agenda and management reviews at least quarterly the results of cybersecurity monitoring and discusses performance metrics, any incidents identified and potential recommended modifications to our technology, organization training, awareness and governance with our Audit Committee.
Cybersecurity and data privacy are regular topics on the Audit Committee’s agenda and management reviews at least quarterly the results of cybersecurity monitoring and discusses performance metrics, any cybersecurity incidents identified and potential recommended modifications to our technology, organization training, awareness and governance with our Audit Committee.
We may face threats to our networks from unauthorized access, security breaches and other system disruptions. Despite our security measures, our infrastructure may be vulnerable to external or internal attacks. Any such security breach may compromise information stored on our networks and may result in significant data losses or theft of sensitive or proprietary information.
We may face threats to our networks from unauthorized access, security breaches and other system disruptions. Despite our preventative actions or security measures, our infrastructure may be vulnerable to external or internal attacks or failures. Any such security breach may compromise information stored on our networks and may result in significant data losses or theft of sensitive or proprietary information.
In addition, a cybersecurity attack 52 Table of Contents could result in other negative consequences, including disruption of our internal operations, increased cybersecurity protection costs, lost revenue, regulatory actions or litigation. Any disruption of internal operations could also have a material adverse impact on our results of operations, financial condition and cash flows.
In addition, a cybersecurity attack could result in other negative consequences, including disruption of our internal operations, increased cybersecurity protection costs, lost revenue, regulatory actions or litigation. Any disruption of internal operations could also have a material adverse impact on our results of operations, financial condition and cash flows.
Item 1C. Cybersecurity Risk management and strategy With respect to cybersecurity risks, we have invested and continually invest in new cybersecurity services, technologies, and capabilities.
Item 1C. Cy bersecurity Risk management and strategy With respect to cybersecurity risks, we have invested and continually invest in cybersecurity services, technologies, and capabilities.
If the cybersecurity team determines that an incident could reasonably be expected to have an impact on the financial condition or operations of the Company, it escalates the incident to the crisis management team, which includes executive management. The crisis management team further evaluates the potential impact and materiality of an event and the appropriate response required.
If the cybersecurity team determines that an incident could reasonably be expected to have an impact on the financial condition, operations or reputation of the Company, it escalates the incident to the crisis management team, which includes executive management.
We also perform third-party cybersecurity audits at least annually and conduct third-party security reviews and testing of our network, processes and systems periodically.
We also conduct third-party security reviews and testing of our network, processes and systems periodically.
The crisis management team coordinates the appropriate response effort and communicates, as applicable, to the Audit Committee. To the extent that cybersecurity incident is determined to be material, the appropriate public disclosures are made. We monitor material risks from cybersecurity threats relating to potential compromises of sensitive information at our third-party business partners where relevant and reevaluate these risks periodically.
To the extent that cybersecurity incident is determined to be material or otherwise reportable under applicable law, the appropriate disclosures are made. We monitor material risks from cybersecurity threats relating to potential compromises of sensitive information at our third-party business partners where relevant and reevaluate these risks periodically.
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The crisis management team further evaluates the potential impact and 57 Table of Contents materiality of an event and the appropriate response required. The crisis management team coordinates the appropriate response effort and communicates, as applicable, to the Audit Committee.
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A summary of these results are also reported by the Audit Committee to the Board at least annually.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeNorth Billerica, Massachusetts Manufacturing, Laboratory, Mixed Use and Other Office Space 354,000 Owned N/A Bedford, Massachusetts Executive Offices, Laboratory, Office Space 88,200 Leased February 2040 New York, New York Office Space 26,000 Leased* September 2030 Canada Quebec Mixed Use and Office Space 1,106 Leased May 2025 Quebec Distribution Center and Office Space 1,433 Leased May 2025 Sweden Lund Office Space 4,000 Leased December 2027 * On October 11, 2021, we entered into an agreement to sublease our office space at the World Trade Center in New York City to an unrelated third party.
Biggest change(“SHINE”). As a result of the sale, SHINE received 292,215 square feet of the North Billerica, Massachusetts campus that manufactures the SPECT products. (2) On October 11, 2021, we entered into an agreement to sublease our office space at the World Trade Center in New York City to an unrelated third party.
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Item 2. Properties The following table summarizes information regarding our significant leased and owned properties, as of December 31, 2024: Location Purpose Square Footage Ownership Lease Term End U.S.
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Pr operties The following table summarizes information regarding our significant leased and owned properties, as of December 31, 2025: Location Purpose Square Footage Ownership Lease Term End United States North Billerica, Massachusetts Manufacturing, Laboratory, Mixed Use and Other Office Space 354,000 Owned (1) N/A Bedford, Massachusetts Executive Offices, Laboratory, Office Space 88,181 Leased February 2040 Bedford, Massachusetts Office Space 41,229 Leased July 2028 New York, New York Office Space 26,558 Leased (2) September 2030 Springfield, New Jersey Manufacturing 13,079 Owned N/A Germany Berlin Office Space 11,657 Leased December 2031 58 Table of Contents (1) On January 1, 2026, we sold our single-photon emission computerized tomography (“SPECT”) business to SHINE Technologies, LLC.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Legal Proceedings Information with respect to certain legal proceedings is included in Note 19, “Commitments and Contingencies,” to the consolidated financial statements contained in Part II, Item 8. “Financial Statements and Supplementary Data,” of this Form 10-K and is incorporated herein by reference. 53 Table of Contents Item 4.
Biggest changeItem 3. Le gal Proceedings Information with respect to certain legal proceedings is included in Note 17, “Commitments and Contingencies,” to the consolidated financial statements contained in Part II, Item 8. “Financial Statements and Supplementary Data,” of this Form 10-K and is incorporated herein by reference. Item 4.
Mine Safety Disclosures Not applicable 54 Table of Contents PART II
Mi ne Safety Disclosures Not applicable 59 Table of Contents PA RT II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest change(3) Reflects the approximate dollar value of shares of our common stock that may be purchased under the 2024 Program, which expires in November 2025. 56 Table of Contents Securities Authorized for Issuance under Equity Compensations Plans The information required with respect to this item is incorporated herein by reference to our Definitive Proxy Statement for our 2024 Annual Meeting of Stockholders to be filed with the SEC no later than 120 days after the close of our year ended December 31, 2024. 57 Table of Contents Item 6. [Reserved] 58 Table of Contents
Biggest change(2) Reflects shares of our common stock repurchased under the 2025 Program, which expires in December 2027. 61 Table of Contents Securities Authorized for Issuance under Equity Compensations Plans The information required with respect to this item is incorporated herein by reference to our Definitive Proxy Statement for our 2026 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission no later than 120 days after the close of our year ended December 31, 2025.
The actual timing, number and dollar amount of repurchase transactions will be determined by our management, in its discretion and will depend on a number of factors, including but not limited to, the market price of our common stock.
The actual timing, manner, number and dollar amount of repurchase transactions will be determined by our management, in its discretion and will depend on a number of factors, including but not limited to, the market price of our common stock.
The 2015 Equity Incentive Plan, adopted by us on June 24, 2015, as amended on April 26, 2016 and as further amended on April 27, 2017, April 24, 2019, April 28, 2021, April 28, 2022, April 25, 2024 and October 22, 2024 (the “2015 Plan”), provides for the withholding of shares to satisfy minimum statutory tax withholding obligations.
The 2015 Equity Incentive Plan, adopted by us on June 24, 2015, as amended on April 26, 2016 and as further amended on April 27, 2017, February 20, 2019, April 24, 2019, April 28, 2021, April 28, 2022, April 25, 2024, October 22, 2024 and April 28, 2025 (the “2015 Plan”), provides for the withholding of shares to satisfy minimum statutory tax withholding obligations.
The following table presents information with respect to purchases of common stock we made during the three months ended December 31, 2024.
The following table presents information with respect to purchases of common stock we made during the three months ended December 31, 2025.
The graph assumes a hypothetical $100 investment in our common stock and in each of the comparative indices on December 31, 2019.
The graph assumes a hypothetical $100 investment in our common stock and in each of the comparative indices on December 31, 2020.
The following graph provides a comparison of the cumulative total shareholder return on our common shares with that of the cumulative total shareholder return on the (i) Russell 2000 Index, (ii) the NASDAQ US Small Cap Index and (iii) the NASDAQ US Mid Cap Index, commencing on December 31, 2019 and ending December 31, 2024.
The following graph provides a comparison of the cumulative total shareholder return on our shares of common stock with that of the cumulative total shareholder return on the (i) Russell 2000 Index, (ii) the NASDAQ US Small Cap Index and (iii) the NASDAQ US Mid Cap Index, commencing on December 31, 2020 and ending December 31, 2025.
This number does not include stockholders for whom shares are held in “nominee” or “street” name. Performance Graph The performance graph set forth below shall not be deemed “soliciting material” or to be “filed” with the SEC.
This number does not include stockholders for whom shares are held in “nominee” or “street” name. Performance Graph The performance graph set forth below shall not be deemed “soliciting material” or to be “filed” with the Securities and Exchange Commission.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock trades on the NASDAQ Global Market under the symbol “LNTH”. Holders of Record On February 20, 2025, there were approximately 29 stockholders of record of our common stock.
Item 5. Ma rket for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock trades on the NASDAQ Global Market under the symbol “LNTH”. Holders of Record On February 23, 2026, there were approximately 28 stockholders of record of our common stock.
Our historic share price performance is not necessarily indicative of future share price performance. ________________________________ * Assumes hypothetical investment of $100 in our common stock and each of the indices on December 31, 2019, including reinvestment of dividends. 55 Table of Contents Performance Graph Data The following table sets forth the cumulative total shareholder return on the hypothetical $100 investment in our common stock and each of the comparative indices on December 31, 2019: Date Lantheus Holdings, Inc.
Our historic share price performance is not necessarily indicative of future share price performance. * Assumes hypothetical investment of $100 in our common stock and each of the indices on December 31, 2020, including reinvestment of dividends. 60 Table of Contents Performance Graph Data The following table sets forth the cumulative total shareholder return on the hypothetical $100 investment in our common stock and each of the comparative indices on December 31, 2020: Lantheus NASDAQ US NASDAQ US Holdings, Russell 2000 Small Cap Index Mid Cap Index Date Inc.
Such repurchases may be made from time to time via open market purchases at prevailing market prices, in privately negotiated transactions, block trades, or pursuant to trades intending to comply with Rule 10b5-1 under the Securities Exchange Act of 1934, as amended or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations.
The 2025 Program authorizes us to purchase shares of our common stock from time to time via open market purchases at prevailing market prices, in privately negotiated transactions, block trades, or pursuant to trades intending to comply with Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations.
Period Total Number of Shares Purchased (1) Average Price Paid per Share (1) Total Number of Shares Purchased as Part of Publicly Announced Programs (2) Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (3) October 2024 4,214 $ 113.55 — — November 2024 909,932 $ 89.48 907,279 $168.8 million December 2024 210,837 $ 89.92 208,729 $150.0 million Total 1,124,983 1,116,008 $150.0 million ________________________________ (1) Includes shares withheld to satisfy minimum statutory tax withholding amounts due from employees related to the receipt of stock which resulted from the exercise for vesting of equity awards.
Period Total Number of Shares Purchased (1) Average Price Paid per Share Total Number of Shares Purchased as Part of the 2025 Program (2) Approximate Dollar Value of Shares that May Yet Be Purchased Under the 2025 Program (2) October 2025 5,468 $ 56.22 — $300.0 million November 2025 1,218,175 $ 54.52 1,215,731 $231.9 million December 2025 564,670 $ 60.81 554,913 $200.0 million Total 1,788,313 1,770,644 $200.0 million (1) Includes shares withheld to satisfy minimum statutory tax withholding amounts due from employees related to the receipt of stock which resulted from the exercise for vesting of equity awards.
Issuer Purchases of Equity Securities In November 2024, our Board authorized a program to repurchase up to $250 million of our common stock during the next twelve months (the “2024 Program”).
Issuer Purchases of Equity Securities On July 31, 2025, our Board of Directors (the “Board”) authorized a program to repurchase up to $400.0 million of shares of our common stock through December 31, 2027 (the “2025 Program”).
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(“LNTH”) Russell 2000 Index (“^RUT”) NASDAQ US Small Cap Index (“^NQUSS”) NASDAQ US Mid Cap Index (“^NQUSM”) 12/31/19 $ 100.00 $ 100.00 $ 100.00 $ 100.00 12/31/20 $ 65.77 $ 118.36 $ 121.47 $ 114.72 12/31/21 $ 140.86 $ 134.57 $ 141.02 $ 135.48 12/31/22 $ 248.46 $ 105.56 $ 109.85 $ 110.45 12/31/23 $ 302.29 $ 121.49 $ 127.34 $ 128.72 12/31/24 $ 436.18 $ 133.66 $ 141.10 $ 147.55 Dividend Policy We did not declare or pay any dividends in 2024, and we do not currently intend to pay dividends in the foreseeable future.
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(“LNTH”) Index (“^RUT”) Index (“^NQUSS”) (“^NQUSM”) 12/31/2020 $ 100.00 $ 100.00 $ 100.00 $ 100.00 12/31/2021 $ 214.16 $ 113.69 $ 116.10 $ 118.09 12/31/2022 $ 377.76 $ 89.18 $ 90.44 $ 96.28 12/31/2023 $ 459.60 $ 102.64 $ 104.83 $ 112.20 12/31/2024 $ 663.16 $ 112.93 $ 116.17 $ 128.62 12/31/2025 $ 493.33 $ 125.68 $ 127.83 $ 137.80 Dividend Policy We did not declare or pay any dividends in 2025, and we do not currently intend to pay dividends in the foreseeable future.
Removed
(2) Include the repurchases of an aggregate total approximately 1.1 million shares of our common stock under the 2024 Program.
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The 2025 Program replaced the program authorized by the Board in November 2024 for $250.0 million (the “2024 Program”), including the remaining unused amounts under the 2024 Program.
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The 2025 Program does not obligate us to acquire any particular amount of our common stock, and we may suspend or discontinue the 2025 Program at any time.
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Item 6. [R eserved] 62 Table of Contents

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeRevenues are summarized by product category on a net basis as follows: Year Ended December 31, 2024 vs. 2023 (in thousands) 2024 2023 2022 Change $ Change % PYLARIFY $ 1,057,834 $ 851,303 $ 527,405 $ 206,531 24.3 % Other radiopharmaceutical oncology 384 3,130 4,102 (2,746) (87.7) % Total radiopharmaceutical oncology 1,058,218 854,433 531,507 203,785 23.9 % DEFINITY 317,792 279,768 244,993 38,024 13.6 % TechneLite 95,487 87,370 88,864 8,117 9.3 % Other precision diagnostics 24,231 22,980 22,825 1,251 5.4 % Total precision diagnostics 437,510 390,118 356,682 47,392 12.1 % Strategic Partnerships and other revenue 38,182 51,878 46,872 (13,696) (26.4) % Total revenues $ 1,533,910 $ 1,296,429 $ 935,061 $ 237,481 18.3 % The increase in revenues for the year ended December 31, 2024, as compared to 2023, is primarily due to increased PYLARIFY and DEFINITY sales volume, as well as revenue generated from sales for investigational use of NAV-4694 and MK-6240.
Biggest changeThis category of revenues also includes royalties and other milestone payments received from our strategic partners that have commercialized products pursuant to license arrangements with us as well as CDMO revenue generated by Evergreen, which we acquired on April 1, 2025. 70 Table of Contents Revenues are summarized by product category on a net basis as follows: Year Ended December 31, 2025 vs. 2024 (in thousands) 2025 2024 2023 Change $ Change % PYLARIFY $ 989,116 $ 1,057,834 $ 851,303 $ (68,718 ) (6.5 )% Other radiopharmaceutical oncology — 384 3,130 (384 ) (100.0 )% Total radiopharmaceutical oncology 989,116 1,058,218 854,433 (69,102 ) (6.5 )% DEFINITY 330,248 317,792 279,768 12,456 3.9 % Neuraceq 51,447 — — 51,447 100.0 % TechneLite 86,803 95,487 87,370 (8,684 ) (9.1 )% Other precision diagnostics 24,616 24,231 22,980 385 1.6 % Total precision diagnostics 493,114 437,510 390,118 55,604 12.7 % Strategic partnerships and other revenue 59,379 38,182 51,878 21,197 55.5 % Total revenues $ 1,541,609 $ 1,533,910 $ 1,296,429 $ 7,699 0.5 % The increase in revenues for the year ended December 31, 2025, as compared to 2024, was primarily driven by revenues generated from sales of Neuraceq subsequent to our acquisition of Life Molecular in July 2025 and revenue from CDMO services generated subsequent to our acquisition of Evergreen in April 2025, in both cases, for which there were no comparable amounts in the same period of 2024, as well as by an increase in DEFINITY sales volume and a milestone achievement for the first commercial sale of Flyrcado by GE Healthcare and achievement of a clinical trial sales milestone with AstraZeneca.
The amendment also, among other things, (i) reduces the ranges of margins based on our Total Net Leverage Ratio (as defined in the 2022 Revolving Facility) used to calculate interest for the revolving loans and (ii) reduces the maximum unused commitment fee from 0.35% per annum to 0.30% per annum.
The amendment also, among other things, (i) reduces the ranges of margins based on our Total Net Leverage Ratio (as defined in the 2022 Revolving Facility) used to calculate interest for the revolving loans and (ii) reduces the maximum unused commitment fee from 0.35% per annum to 0.30% per annum.
On December 8, 2022, we issued $575.0 million in aggregate principal amount of 2.625% Convertible Senior Notes due 2027 (the “Notes”), which includes $75.0 million in aggregate principal amount of Notes sold pursuant to the full exercise of the initial purchasers’ option to purchase additional Notes.
On December 8, 2022, we issued $575.0 million in aggregate principal amount of 2.625% Convertible Senior Notes due December 2027 (the “Notes”), which includes $75.0 million in aggregate principal amount of Notes sold pursuant to the full exercise of the initial purchasers’ option to purchase additional Notes.
Net Cash (Used in) Provided by Financing Activities Net cash used in financing activities during the year ended December 31, 2024 is primarily attributable to the repurchase of our common stock for approximately $100.0 million, the payments for minimum statutory tax withholding related to net share settlement of equity awards of $22.6 million and the payment of $2.3 million of financing costs related to the refinancing of our credit facility described below, offset by proceeds of $6.7 million from stock option exercises.
Net cash used in financing activities during the year ended December 31, 2024 is primarily attributable to the repurchase of our common stock for approximately $100.0 million, the payments for minimum statutory tax withholding related to net share settlement of equity awards of $22.6 million and the payment of $2.3 million of financing costs related to the refinancing of our credit facility described below, offset by proceeds of $6.7 million from stock option exercises.
We derive our revenues through arrangements with customers for product sales, as well as licensing and royalty arrangements. We sell our products primarily to hospitals, independent diagnostic testing facilities, and radiopharmacies, and we consider customer purchase orders, which in some cases are governed by master sales or group purchasing organization agreements, to be contracts with our customers.
We derive our revenues through arrangements with customers for product sales, as well as licensing and royalty arrangements and CDMO contracts. We sell our products primarily to hospitals, independent diagnostic testing facilities, and radiopharmacies, and we consider customer purchase orders, which in some cases are governed by master sales or group purchasing organization agreements, to be contracts with our customers.
While we generally believe that we will be able to offset some of the effect of price-level changes by adjusting our product prices and implementing operating efficiencies, any material unfavorable changes in price levels could have a material adverse effect on our financial condition, results of operations and cash flows.
While we generally believe that we will be able to offset some of the effect of price-level changes by adjusting our product prices and implementing operating efficiencies, any material unfavorable changes in price levels could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Expansion of Strategic Partnerships and Other Revenue We continue to seek ways to further increase the overall value of our portfolio of products and product candidates. We are evaluating a number of different opportunities to collaborate, in-license or acquire additional products, product candidates, businesses and technologies to drive our future growth.
Expansion of Strategic Partnerships and Other Revenue We continue to seek ways to increase the overall value of our portfolio of products and product candidates. We are evaluating a number of different opportunities to collaborate, in-license or acquire additional products, product candidates, businesses and technologies to drive our future growth.
If we experience one or more of these events in the future, we may be required to further implement expense reductions, such as a delay or elimination of discretionary spending in all functional areas, as well as scaling back select operating and strategic initiatives.
If we experience one or more of these events in the future, we may be required to implement expense reductions, such as a delay or elimination of discretionary spending in all functional areas, as well as scaling back select operating and strategic initiatives.
These rebates and allowances result from performance-based offers that are primarily based on attaining contractually specified sales volumes and growth, Medicaid rebate programs for our products, administrative fees of group purchasing organizations and certain distributor related commissions.
These rebates result from performance-based offers that are primarily based on attaining contractually specified sales volumes and growth, Medicaid rebate programs for our products, administrative fees of group purchasing organizations and certain distributor-related commissions.
The calculation of the accrual for these rebates and allowances is based on an estimate of the third-party’s expected purchases and the resulting applicable contractual rebate to be earned over a contractual period.
The calculation of the accrual for these rebates is based on an estimate of the third-party’s expected purchases and the resulting applicable contractual rebate to be earned over a contractual period.
On June 18, 2024, we acquired Meilleur, including its asset NAV-4694, an investigational F-18-labeled PET imaging agent that targets beta amyloids in Alzheimer’s disease. We made an upfront payment of approximately $32.9 million to the Meilleur Stockholders on June 18, 2024 and paid an additional $10.0 million in August 2024 after the successful completion of a technology transfer.
On June 18, 2024, we acquired Meilleur, including its asset NAV-4694, an investigational late-stage F-18-labeled PET imaging agent that targets beta amyloids in Alzheimer’s disease. We made an upfront payment of approximately $32.9 million to the Meilleur Stockholders on June 18, 2024 and paid an additional $10.0 million in August 2024 after the successful completion of a technology transfer.
In addition to these arrangements, we also enter into licensing agreements under which we license certain rights to third parties. The terms of these arrangements typically include payment to us of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; and royalties on net sales of licensed products.
In addition to these arrangements, we also enter into licensing agreements under which we license certain rights to third parties. The terms of these arrangements typically include payment to us of one or more of the following: non-refundable, up-front license fees; development services, regulatory and commercial milestone payments; manufacturing, and royalties on net sales of licensed products.
As of December 31, 2024, these contingent payments were not expected to be payable within twelve months due to the uncertainty around the timing of the future cash flows. Our other long-term liabilities in the consolidated balance sheet include unrecognized tax benefits and related interest and penalties.
As of December 31, 2025, these contingent payments were not expected to be payable within twelve months due to the uncertainty around the timing of the future cash flows. Our other long-term liabilities in the consolidated balance sheet include unrecognized tax benefits and related interest and penalties.
“Risk Factors” and “Cautionary Note Regarding Forward Looking Statements.” included in this Form 10-K. This section discusses 2024 and 2023 items and year-to-year comparisons between 2024 and 2023. Discussions of 2022 items and year-to-year comparisons between 2023 and 2022 have been excluded from this Form 10-K and can be found in “Part II, Item 7.
“Risk Factors” and “Cautionary Note Regarding Forward Looking Statements.” included in this Form 10-K. This section discusses 2025 and 2024 items and year-to-year comparisons between 2025 and 2024. Discussions of 2023 items and year-to-year comparisons between 2024 and 2023 have been excluded from this Form 10-K and can be found in “Part II, Item 7.
Our material cash requirements include the following contractual and other obligations. Debt We completed a sale of $575.0 million in aggregate principal amount of the Notes due in 2027. As of December 31, 2024, we had no amounts of principal due within the next twelve months.
Our material cash requirements include the following contractual and other obligations. Debt We completed a sale of $575.0 million in aggregate principal amount of the Notes due in December 2027. As of December 31, 2025, we had no amounts of principal due within the next twelve months.
Finally, we will pay to the Cerveau Stockholders up to double-digit royalty payments for research revenue and commercial sales. As of December 31, 2024, these contingent payments were not expected to be payable due to the uncertainty around the timing of the future cash flows.
Finally, we will pay to the Cerveau Stockholders up to double-digit royalty payments for research revenue and commercial sales. As of December 31, 2025, these contingent payments were not expected to be payable due to the uncertainty around the timing of the future cash flows.
In November 2024, CMS released the final rule for its calendar year 2025 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2025 OPPS Rule”), which recognizes the value and need for broad access to diagnostic radiopharmaceuticals.
In November 2024, CMS released the final rule for its calendar year 2025 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2025 OPPS Rule”), which recognized the value and need for broad access to diagnostic radiopharmaceuticals.
License Agreements We have entered into license agreements in which fixed payments have been committed to be paid on an annual basis. As of December 31, 2024, we had no amount of fixed license payments due within twelve months.
License Agreements We have entered into license agreements in which fixed payments have been committed to be paid on an annual basis. As of December 31, 2025, we had no amount of fixed license payments due within twelve months.
We classify IPR&D intangible assets acquired in a business combination as an indefinite-lived intangible asset until the completion or abandonment of the associated research and development efforts. Upon completion of the associated research and development efforts, we will determine the useful life and begin amortizing the assets to reflect their use over their remaining lives.
We classify IPR&D intangible assets acquired in a business combination as an indefinite-lived intangible asset until the completion or abandonment of the associated R&D efforts. Upon completion of the associated R&D efforts, we will determine the useful life and begin amortizing the assets to reflect their use over their remaining lives.
Since inception, we have not engaged in any other off-balance sheet arrangements, including structured finance, special purpose entities, or variable interest entities. 73 Table of Contents Effects of Inflation We do not believe that inflation has had a significant impact on our results of operations.
Since inception, we have not engaged in any other off-balance sheet arrangements, including structured finance, special purpose entities, or variable interest entities. Effects of Inflation We do not believe that inflation has had a significant impact on our results of operations.
For more information on our cash requirements under the Notes, see Note 12, “Long-Term Debt, Net, and Other Borrowings” to our consolidated consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K. Leases We have operating lease arrangements for certain facilities, including corporate and manufacturing space.
For more information on our cash requirements under the Notes, see Note 12, “Long-Term Debt and Other Borrowings, Net of Current Portion” to our consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K. Leases We have operating lease arrangements for certain facilities, including corporate and manufacturing space.
PNT2003 64 Table of Contents Under the terms of the PNT2003 License Agreement, we paid POINT an upfront payment of $10.0 million, and could pay up to an additional $34.5 million in milestone payments upon the achievement of specified U.S. and ex-U.S. regulatory milestones.
PNT2003 Under the terms of the PNT2003 License Agreement, we paid POINT an upfront payment of $10.0 million, and could pay up to an additional $34.5 million in milestone payments upon the achievement of specified U.S. and ex-U.S. regulatory milestones.
Net Cash Provided by Operating Activities Net cash provided by operating activities of $544.8 million during the year ended December 31, 2024 was primarily comprised of net income adjusted for the net effect of non-cash items such as unrealized loss on investment in equity securities, charges incurred in connection with the Perspective IPR&D exclusive license options, charges related to Radiopharm’s licensed assets, charges related to Life Molecular’s RM2 license, gains on disposal of our Somerset Facility and a portion of our North Billerica, Massachusetts facility, depreciation, amortization and accretion expense and stock-based compensation expense.
Net cash provided by operating activities of $544.8 million during the year ended December 31, 2024 was primarily comprised of net income adjusted for non-cash items such as unrealized loss on investment in equity securities, charges incurred in connection with the Perspective in-process R&D (“IPR&D”) exclusive license options, charges related to Radiopharm’s licensed assets, charges related to Life Molecular’s RM2 license, gains on disposal of our Somerset Facility and a portion of our North Billerica, Massachusetts facility, depreciation, amortization and accretion expense and stock-based compensation expense.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis of our financial condition and results of operations should be read together with the consolidated financial statements and the related notes included in Item 8 of this Annual Report on Form 10-K (“Form 10-K”).
Item 7. Man agement’s Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis of our financial condition and results of operations should be read together with the consolidated financial statements and the related notes included in Item 8 of this Annual Report on Form 10-K (“Form 10-K”).
PYLARIFY is indicated for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and in patients with suspected recurrence based on elevated prostate-specific antigen levels. PYLARIFY is available through a diverse, multi-partner network of PET manufacturing facilities (“PMFs”), including both commercial and academic partners.
PYLARIFY is indicated for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and in patients with suspected recurrence based on elevated prostate-specific antigen levels. PYLARIFY is available through a diverse, multi-partner network of PMFs, including both commercial and academic partners.
If our capital resources become insufficient to meet our future capital requirements, we would need to finance our cash needs through public or private equity offerings, debt financings, assets securitizations, sale-leasebacks or other financing or strategic alternatives, to the extent such transactions are permissible under the covenants of our 2022 Credit Agreement.
If our capital resources become insufficient to meet our future capital requirements, we would need to finance our cash needs through public or private equity offerings, debt financings, assets securitizations, sale-leasebacks or other financing or strategic alternatives, to the extent such transactions are permissible under the covenants of our 2022 Revolving Facility.
These amounts do not include potential milestone or contractual payment obligations contingent upon the achievement or occurrence of future milestones or events under our license agreements, because they are contingent and the amounts and timing of such potential obligations are unknown or uncertain. We may be required to pay approximately $3.7 billion in contingent payments under our license agreements.
These amounts do not include potential milestone or contractual payment obligations contingent upon the achievement or occurrence of future milestones or events under our license agreements, because they are contingent and the amounts and timing of such potential obligations are unknown or uncertain. We may be required to pay approximately $4.9 billion in contingent payments under our license agreements.
For more information on potential milestone and royalty payments related to the product candidates listed above, see Note 21, "Acquisition of Assets" to our consolidated consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K. PNT2002 Under the terms of the PNT2002 License Agreement, we paid POINT Biopharma Global Inc.
For more information on potential milestone and royalty payments related to the product candidates listed above, see Note 19, "Acquisitions" to our consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K. PNT2002 Under the terms of the PNT2002 License Agreement, we paid POINT Biopharma Global Inc.
Radiopharmaceutical finished goods, such as doses of PYLARIFY, cannot be kept in inventory because of their limited shelf lives and are subject to just-in-time manufacturing, processing, and distribution, which takes place at multiple PMF manufacturing partner sites that produce and deliver doses for us across the U.S.
Radiopharmaceutical finished goods, such as doses of PYLARIFY and Neuraceq, cannot be kept in inventory because of their limited shelf lives and are subject to just-in-time manufacturing, processing, and distribution, which takes place at multiple PMF manufacturing partner sites that produce and deliver doses for us across the United States.
If any of these transactions require an amendment or waiver under the covenants in our 2022 Credit Agreement, which could result in additional expenses associated with obtaining the amendment or waiver, we will seek to obtain such an amendment or waiver to remain in compliance with those covenants.
If any of these transactions require an amendment or waiver under the covenants in our 2022 Revolving Facility, which could result in additional expenses associated with obtaining the amendment or waiver, we will seek to obtain such an amendment or waiver to remain in compliance with those covenants.
However, we cannot provide assurance that such an amendment or waiver would be granted, or that additional capital will be available on acceptable terms, if at all. At December 31, 2024, our only current committed external source of funds is our borrowing availability under our 2022 Revolving Facility.
However, we cannot provide assurance that such an amendment or waiver would be granted, or that additional capital will be available on acceptable terms, if at all. 75 Table of Contents At December 31, 2025, our only current committed external source of funds is our borrowing availability under our 2022 Revolving Facility.
Additionally, we could pay the Meilleur Stockholders up to double-digit royalty payments for research revenue and commercial sales. As of December 31, 2024, these contingent payments were not expected to be payable due to the uncertainty around the timing of the future cash flows.
Additionally, we could pay the Meilleur Stockholders up to double-digit royalty payments for research revenue and commercial 76 Table of Contents sales. As of December 31, 2025, these contingent payments were not expected to be payable due to the uncertainty around the timing of the future cash flows.
As we continue to grow our microbubble platform, our activities include: • Expansion of Label – In March 2024, we received FDA approval for our supplemental new drug application for the use of DEFINITY in pediatric patients with suboptimal echocardiograms.
As we continue to grow our Microbubble Platform, our activities include: • Expansion of Label – In March 2024, we received FDA approval for our supplemental NDA for the use of DEFINITY in pediatric patients with suboptimal echocardiograms.
Our IPR&D intangible assets include intangible assets acquired in a business combination that are used in research and development activities but have not yet reached technological feasibility, regardless of whether they have alternative future use.
Our IPR&D intangible assets include intangible assets acquired in a business combination that are used in R&D activities but have not yet reached technological feasibility, regardless of whether they have alternative future use.
Based on our current operating plans, we believe our balance of cash and cash equivalents, which totaled $912.8 million as of December 31, 2024, along with cash generated by ongoing operations and continued access to our 2022 Revolving Facility, will be sufficient to satisfy our cash requirements over the next twelve months and beyond.
Based on our current operating plans, we believe our balance of cash and cash equivalents, which totaled $359.1 million as of December 31, 2025, along with cash generated by ongoing operations and continued access to our 2022 Revolving Facility, will be sufficient to satisfy our cash requirements over the next twelve months and beyond.
Our Strategic Partnerships and Other Revenue category includes our Strategic Partnerships, Digital Solutions, and Biomarker Solutions businesses and is focused on enabling precision medicine with biomarkers and digital solutions. • Strategic Partnerships – We seek to monetize our assets through our Strategic Partnerships business, which includes biomarkers and digital solutions in support of our partners’ therapeutic development, out-licensing agreements for non-core assets and optimization of our assets geographically.
Our Strategic Partnerships and Other Revenue category includes our Strategic Partnerships, Digital Solutions, Biomarker Solutions and CDMO services and is focused on enabling precision medicine with biomarkers, digital solutions, as well as providing CDMO services. • Strategic Partnerships – We seek to monetize our assets through our Strategic Partnerships business, which includes biomarkers and digital solutions in support of our partners’ therapeutic development, out-licensing agreements for non-core assets and optimization of our assets geographically.
As of December 31, 2024, we had unrecognized tax benefits of $7.3 million, which included interest and penalties, classified as noncurrent liabilities. At this time, we are unable to make a reasonably reliable estimate of the timing of payments in individual years in connection with these tax liabilities.
As of December 31, 2025, we had unrecognized tax benefits of $29.6 million, which included interest and penalties, classified as noncurrent liabilities. At this time, we are unable to make a reasonably reliable estimate of the timing of payments in individual years in connection with these tax liabilities.
For more information on the 2022 Revolving Facility, see Note 12, “Long-Term Debt, Net, and Other Borrowings” to our consolidated consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K. As of December 31, 2024, we were in compliance with all financial and other covenants under the 2022 Credit Agreement.
For more information on the 2022 Revolving Facility, see Note 12, “Long-Term Debt and Other Borrowings, Net of Current Portion” to our consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K. As of December 31, 2025, we were in compliance with all financial and other covenants under the 2022 Revolving Facility.
For further information on possible funding requirements resulting from our asset acquisitions, see Note 21, "Acquisition of Assets" to our consolidated consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K.
For further information on possible funding requirements resulting from our asset acquisitions, see Note 19, “ Acquisitions” to our consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K.
Exclusive License for Radiopharm Theranostics Limited On June 15, 2024, we entered into an agreement with Radiopharm to acquire global, exclusive rights to two licensed preclinical assets for an upfront payment of $2.0 million (the “Radiopharm Asset Purchase”).
Radiopharm Theranostics Limited On June 15, 2024, we entered into an agreement with Radiopharm Theranostics Limited (“Radiopharm”) to acquire all of Radiopharm’s rights to two licensed preclinical assets for an upfront payment of $2.0 million (the “Radiopharm Asset Purchase”).
We had $912.8 million of cash and cash equivalents as of December 31, 2024. Our 2022 Revolving Facility contains a number of affirmative, negative, reporting and financial covenants, in each case subject to certain exceptions and materiality thresholds.
We had $359.1 million of cash and cash equivalents as of December 31, 2025. Our 2022 Revolving Facility contains a number of affirmative, negative, reporting and financial covenants, in each case subject to certain exceptions and materiality thresholds.
We could pay additional milestone payments upon achievement of specified U.S. regulatory milestones related to NAV-4694. We could also pay double-digit milestone payments upon achievement of specified annual commercial sales and double-digit royalty payments for research revenue and commercial sales. Research revenue is derived from partnerships with pharmaceutical companies and academic institutions that use NAV-4694 in clinical trials.
We could also pay double-digit milestone payments upon achievement of specified annual commercial sales and double-digit royalty payments for research revenue and commercial sales. Research revenue is derived from partnerships with pharmaceutical companies and academic institutions that use NAV-4694 in clinical trials.
For more information, see Note 21, "Acquisition of Assets" to our consolidated consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K.
For more information, see Note 19, "Acquisitions" to our consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K.
In addition, from January 1, 2022 to December 31, 2024, PYLARIFY had TPT Status from the Centers for Medicare and Medicaid Services (“CMS”) in the hospital outpatient setting, enabling traditional Medicare FFS to provide separate payment for PYLARIFY in addition to the payment for the PET/computed tomography (“CT”) procedure in that setting.
In addition, from January 1, 2022 to December 31, 2024, PYLARIFY had TPT Status from CMS in the hospital outpatient setting, enabling traditional Medicare FFS to provide separate payment for PYLARIFY in addition to the payment for the PET/computed tomography procedure in that setting.
Purchase Obligations We have purchase obligations that primarily consist of noncancelable obligations related to minimum quantities of goods or services that have been committed to be purchased on an annual basis. As of December 31, 2024, we had minimum purchase obligations of $11.3 million, with $5.9 million due within twelve months.
Purchase Obligations We have purchase obligations that primarily consist of noncancelable obligations related to minimum quantities of goods or services that have been committed to be purchased on an annual basis. As of December 31, 2025, we had minimum purchase obligations of $23.5 million, with $14.8 million due within twelve months.
Liquidity and Capital Resources Cash Flows The following table provides information regarding our cash flows: Year Ended December 31, (in thousands) 2024 2023 2022 Net cash provided by operating activities $ 544,750 $ 305,260 $ 281,781 Net cash (used in) provided by investing activities $ (226,015) $ 5,939 $ (276,547) Net cash (used in) provided by financing activities $ (118,536) $ (13,062) $ 311,691 For a discussion of our liquidity and capital resources related to our cash flow activities for the fiscal year ended December 31, 2022, see Part II, Item 7.
Liquidity and Capital Resources Cash Flows The following table provides information regarding our cash flows: Year Ended December 31, (in thousands) 2025 2024 2023 Net cash provided by operating activities $ 390,141 $ 544,750 $ 305,260 Net cash (used in) provided by investing activities $ (627,168 ) $ (226,015 ) $ 5,939 Net cash used in financing activities $ (316,584 ) $ (118,536 ) $ (13,062 ) For a discussion of our liquidity and capital resources related to our cash flow activities for the fiscal year ended December 31, 2023, see Part II, Item 7.
External Sources of Liquidity In December 2024, we entered into an amendment to the 2022 Revolving Facility that, among other things, extended the maturity date from December 2, 2027 to December 19, 2029, increased the 2022 Revolving Facility from $350.0 million to $750.0 million and increased the additional amount that LMI may request to add to the increased revolving commitment by $350.0 million.
External Sources of Liquidity In December 2024, we entered into an amendment to our five-year revolving credit facility (as amended, the “2022 Revolving Facility”) that, among other things, extended the maturity date from December 2, 2027 to December 19, 2029, increased the 2022 Revolving Facility from $350.0 million to $750.0 million and increased the additional amount that Lantheus Medical may request to add to the increased revolving commitment by $350.0 million.
For more information, see Note 21, "Acquisition of Assets" to our consolidated consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K. Strategic Agreements with Perspective Therapeutics, Inc. On January 8, 2024, we entered into multiple strategic agreements with Perspective Therapeutics, Inc.
For more information, see Note 19, “ Acquisitions” and Note 4, "Fair Value of Financial Instruments" to our consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K. Strategic Agreements with Perspective Therapeutics, Inc. On January 8, 2024, we entered into multiple strategic agreements with Perspective Therapeutics, Inc.
The rule provides separate payment for those diagnostic radiopharmaceuticals with per day costs greater than $630 based on mean unit cost (“MUC”) for the approximately 20% of patients with traditional Medicare FFS insurance coverage who are treated in the hospital outpatient setting.
The CMS 2025 OPPS Rule provided separate payment for those diagnostic radiopharmaceuticals with per day costs greater than $630 based on their mean unit cost (“MUC”) for patients with traditional Medicare FFS insurance coverage who are treated in the hospital outpatient setting.
Previously, on July 3, 2024,we acquired from Life Molecular the global rights to its clinical stage RM2, a gastrin-releasing peptide receptor (“GRPR”)-targeting agent, including the associated novel, clinical-stage radiotherapeutic and radiodiagnostic pair, previously referred to as 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2 (and which we now refer to as LNTH-2402 and LNTH-2401, respectively), for an upfront payment of $35.0 million plus a $1.0 million payment made prior to the acquisition, and potential regulatory milestone payments plus royalties (the “RM2 Asset Purchase”).
Previously, on July 3, 2024,we acquired from Life Molecular the global rights to RM2, its clinical stage, gastrin-releasing peptide receptor (“GRPR”)-targeting agent, including the associated novel, clinical-stage radiotherapeutic and radiodiagnostic pair, previously referred to as 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2 (and which we now refer to as LNTH-2402 and LNTH-2401, respectively), for an upfront payment of $35.0 million plus a $1.0 million payment made prior to the acquisition (the “RM2 Asset Purchase”), pursuant to the Sublicense, Development and Collaboration Agreement, by and between us and Life Molecular, dated as of June 27, 2024 (the “RM2 Sublicense Agreement”).
The strategic goal of our Biomarker Solutions business is to gain early access to innovation, de-risk the development, generate data, embed our technologies in the clinical ecosystem and establish the clinical utility of product candidates and research tools in our pipeline. Our biomarkers are intended to support patient selection and the monitoring of disease progression.
The strategic goal of our Biomarker Solutions business is to gain early access to innovation, de-risk the development, generate data, embed our technologies in the clinical ecosystem and establish the clinical utility of product candidates and research tools in our pipeline.
The fair values assigned to tangible and intangible assets acquired and liabilities assumed are based on our estimates and assumptions, as well as other information we have compiled, including valuations that utilize customary valuation procedures and techniques.
Transaction costs and restructuring costs associated with a business combination are expensed as incurred. The fair values assigned to tangible and intangible assets acquired and liabilities assumed are based on our estimates and assumptions, as well as other information we have compiled, including valuations that utilize customary valuation procedures and techniques.
The method used to estimate the fair values of intangible assets incorporates significant assumptions regarding the estimates a market participant would make in order to evaluate an asset, including a market participant’s use of the asset and the appropriate discount rates.
Each asset acquired and liability assumed is measured at fair value from the perspective of a market participant. The method used to estimate the fair values of intangible assets incorporates significant assumptions regarding the estimates a market participant would make in order to evaluate an asset, including a market participant’s use of the asset and the appropriate discount rates.
“Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024.
“Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission on February 26, 2025.
As of December 31, 2024, the liability for this decommissioning obligation, which was approximately $23.3 million, was measured at the present value of the obligation expected to be incurred of approximately $25.1 million.
As of December 31, 2025, the liability for this decommissioning obligation, which was approximately $0.1 million, was measured at the present value of the obligation expected to be incurred of approximately $20.4 million.
On March 1, 2024, we transferred the fixed assets and associated lease of our Somerset, New Jersey facility (the “Somerset Facility”) to Perspective, and the parties entered into a transition services arrangement pursuant to which we provided certain services relating to final disposal of radioactive waste and certain other related services. 60 Table of Contents On March 6, 2024, we purchased 60,431,039 Perspective Shares at a price of $0.95 per share.
On March 1, 2024, we transferred the fixed assets and associated lease of our Somerset, New Jersey facility (the “Somerset Facility”) to Perspective, and the parties entered into a transition services arrangement pursuant to which we provided to Perspective certain services relating to final disposal of radioactive waste and certain other related services.
Other Strategic Changes As part of our evolution into a fully integrated radiopharmaceutical company, during 2024, we reviewed our current capabilities and skillsets and began implementing organizational changes deemed necessary to best position us to execute on our long-term strategy. These changes included transitioning approximately 60 employees out of the Company.
Other Strategic Changes During 2024, we reviewed our current capabilities and skillsets and “began implementing organizational changes deemed necessary to best position us to execute on our long-term strategy. These changes included transitioning approximately 75 employees out of the Company.
For more information, see Note 21, "Acquisition of Assets" to our consolidated consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K.
For more information, see Note 19, "Acquisitions" and Note 4, "Fair Value of Financial Instruments" to our consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Form 10-K.
We classify our products in three categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue. Our leading Radiopharmaceutical Oncology products help healthcare professionals (“HCPs”) Find, Fight and Follow cancer. Our leading Precision Diagnostic products assist HCPs to Find and Follow diseases, with a focus in cardiology.
We classify our products into three product categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue. Our Radiopharmaceutical Oncology product helps healthcare professionals (“HCPs”) Find, Fight and Follow cancer. Our Precision Diagnostic products assist HCPs to Find and Follow diseases.
Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024. Overview Our Business We are the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes.
Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on February 26, 2025. Overview Our Business We are the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes.
GRPR is a member of the bombesin G protein-coupled receptor family, which has been found to be overexpressed in multiple cancers, including prostate, breast and lung. First-in-human dosimetry showed a favorable safety and dosimetry profile and confirmed preclinical data demonstrating dose-dependent efficacy of LNTH-2402. We intend to begin a Phase 1/2a study with LNTH-2402 in prostate cancer patients in 2025.
GRPR is a member of the bombesin G protein-coupled receptor family, which has been found to be overexpressed in multiple cancers. First-in-human dosimetry showed a favorable safety and dosimetry profile and confirmed preclinical data demonstrating dose-dependent efficacy of LNTH-2402.
As of December 31, 2024, we had fixed operating lease payment obligations of $94.9 million, with $5.4 million payable within twelve months. We have lease arrangements for certain equipment. As of December 31, 2024, we had fixed finance lease payment obligations of $1.8 million, with $1.0 million payable within twelve months.
As of December 31, 2025, we had fixed operating lease payment obligations of $86.1 million, with $7.2 million payable within twelve months. We have lease arrangements for certain equipment. As of December 31, 2025, we had fixed finance lease payment obligations of $1.3 million, with $0.8 million payable within twelve months.
Acquired IPR&D is recognized at fair value and initially characterized as an indefinite-lived intangible asset, irrespective of whether the acquired IPR&D has an alternative future use. Any excess purchase price over the fair value of the net tangible and intangible assets acquired is allocated to goodwill. Transaction costs and restructuring costs associated with a business combination are expensed as incurred.
Acquired IPR&D is recognized at fair value and initially characterized as an indefinite-lived intangible asset, irrespective of whether the acquired 78 Table of Contents IPR&D has an alternative future use. Any excess purchase price over the fair value of the net tangible and intangible assets acquired is allocated to goodwill.
Funding Requirements Our future capital requirements will depend on many factors, including: • The level of product sales and the pricing environment of our currently marketed products, particularly PYLARIFY and DEFINITY, as well as any additional products that we may market in the future; • Revenue mix shifts and associated volume and selling price changes that could result from additional competition or changes in customers’ product demand; • The continued costs of the ongoing commercialization of our products; • Our investment in the further clinical development and commercialization of products and development candidates, as well as whether we exercise our option and co-development rights under the Perspective agreements; • The costs of acquiring or in-licensing, developing, obtaining regulatory approval for, and commercializing, new products, businesses or technologies, including any potential related milestone or royalty payments, together with the costs of pursuing opportunities that are not eventually consummated; • The costs of investing in our facilities, equipment, and technology infrastructure; • The costs and timing of establishing or amending manufacturing and supply arrangements for commercial supplies of our products and raw materials and components; • Our ability to have products manufactured and released from manufacturing sites in a timely manner in the future, or to manufacture products at our in-house manufacturing facilities in amounts sufficient to meet our supply needs; • The costs of further commercialization of our existing products, particularly in international markets, including product marketing, sales and distribution and whether we obtain local partners to help share such commercialization costs; • The legal costs relating to maintaining, expanding and enforcing our intellectual property portfolio, pursuing insurance or other claims and defending against product liability, regulatory compliance, intellectual property or other claims, including the patent infringement claim related to the filing of our ANDA for PNT2003; • The cost of interest on any additional borrowings which we may incur under our financing arrangements; and • The impact of sustained inflation on our costs of goods sold and operating expenses. 71 Table of Contents Disruption in our financial performance could occur if we experience significant adverse changes in product or customer mix, broad economic downturns, sustained inflation, adverse industry or company conditions or catastrophic external events, including pandemics, natural disasters and political or military conflict.
Funding Requirements Our future capital requirements will depend on many factors, including: • The level of product sales and the pricing environment of our currently marketed products, particularly PYLARIFY, DEFINITY and Neuraceq, as well as any additional products that we may market in the future; • Revenue mix shifts and associated volume and selling price changes that could result from additional competition or changes in customers’ product demand; • The continued costs of the ongoing commercialization of our products; • The costs involved in launch preparation activities in anticipation of potential regulatory approvals; • The costs to successfully integrate acquisitions, including of Life Molecular and Evergreen, which could be impacted by unforeseen expenses related to integration activities and liabilities within those businesses; • Our investment in the further clinical development and commercialization of products and development candidates, as well as whether we exercise our option and co-development rights under certain license agreements; • The costs of acquiring or in-licensing, developing, obtaining regulatory approval for, and commercializing, new products, businesses or technologies, including any potential related milestone or royalty payments, together with the costs of pursuing opportunities that are not eventually consummated; • The costs of investing in our facilities, equipment, and technology infrastructure; • The costs and timing of establishing or amending manufacturing and supply arrangements for commercial supplies of our products and raw materials and components; • Our ability to have products manufactured and released from manufacturing sites in a timely manner in the future, or to manufacture products at our in-house manufacturing facilities in amounts sufficient to meet our supply needs; • The costs of further commercialization of our existing products, particularly in international markets, including product marketing, sales and distribution and whether we obtain local partners to help share such commercialization costs; • The legal costs relating to maintaining, expanding and enforcing our intellectual property portfolio, pursuing insurance or other claims and defending against product liability, regulatory compliance, intellectual property, security law or other claims, including the patent infringement claim related to the filing of our ANDA for PNT2003, our patent infringement lawsuit against a healthcare-related imaging software developer and the putative securities class action against us; • The cost of interest on any additional borrowings which we may incur under our financing arrangements; • The impact of sustained inflation on our costs of goods sold and operating expenses; and • Our ability to continuously improve our operating efficiencies and control and reduce costs.
Such repurchases may be made from time to time via open market purchases at prevailing market prices, in privately negotiated transactions, block trades, or pursuant to trades intending to comply with Rule 10b5-1 under the Securities Exchange Act of 1934, as amended or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations.
The 2025 Program authorizes us to purchase shares of our common stock from time to time via open market purchases at prevailing market prices, in privately negotiated transactions, block trades, or pursuant to trades intending to comply with Rule 10b5-1 under the Exchange Act or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations.
Other Long-Term Liabilities Our other long-term liabilities in the consolidated balance sheet include the fair values of contingent consideration liabilities including contingent consideration liabilities related to a previous acquisition completed by Progenics in 2013. We may be required to pay up to approximately $85.0 million related to the contingent consideration.
Other Long-Term Liabilities Our other long-term liabilities in the consolidated balance sheet include the fair values of contingent consideration liabilities related to a previous acquisition completed by Progenics in 2013, and resulting from the Evergreen Merger and LMI Acquisition in 2025. We may be required to pay up to approximately $1.24 billion related to the contingent consideration.
Our ability to fund our future capital needs will be affected by our ability to continue to generate cash from operations and may be affected by our ability to access the capital markets, money markets or other sources of funding, as well as the capacity and terms of our financing arrangements.
Our ability to fund our future capital needs will be affected by our ability to continue to generate cash from operations and may be affected by our ability to access the capital markets, money markets or other sources of funding, as well as the capacity and terms of our financing arrangements. 74 Table of Contents We may from time to time repurchase or otherwise retire our debt and take other steps to reduce our debt or otherwise improve our balance sheet.
For the year ended December 31, 2024, we recorded unrealized losses on the investments in Radiopharm and Perspective of $2.6 million and $41.0 million, respectively.
For the year ended December 31, 2025, we recorded an unrealized loss on the investment in Radiopharm of $3.6 million and recorded an unrealized loss on the investment in Perspective of $5.1 million. This is compared to unrealized losses on the investments in Radiopharm and Perspective of $2.6 million and $41.0 million, respectively, for the year ended December 31, 2024.
Net Cash (Used in) Provided by Investing Activities Net cash used in investing activities during the year ended December 31, 2024 was driven by an upfront option payment of $28.0 million to Perspective, $36.0 million of payments for the RM2 Asset Purchase, $42.9 million payments to the Meilleur Stockholders for the acquisition of Meilleur, $2.0 million for the Radiopharm Asset Purchase, $83.2 million for the purchase of equity securities in Perspective and Radiopharm, and $51.6 million of capital expenditures, partially offset by net cash proceeds of $17.8 million from the sale of the Somerset Facility and a portion of our North Billerica, Massachusetts facility, and associated assets.
Net cash used in investing activities during the year ended December 31, 2024 was driven by an upfront option payment of $28.0 million to Perspective, $36.0 million of payments for the RM2 Asset Purchase, $42.9 million payments to the Meilleur Stockholders for the acquisition of Meilleur, $2.0 million for the Radiopharm Asset Purchase, $83.2 million for the purchase of equity securities in Perspective and Radiopharm, and $51.6 million of capital expenditures, partially offset by net cash proceeds of $17.8 million from the sale of the Somerset Facility and a portion of our North Billerica, Massachusetts facility, and associated assets. 73 Table of Contents Net Cash Used in Financing Activities Net cash used in financing activities during the year ended December 31, 2025 is primarily attributable to the repurchase of our common stock for approximately $300.0 million, the payments for minimum statutory tax withholding related to net share settlement of equity awards of $26.3 million and payments for finance leases of $1.1 million, offset by proceeds of $10.9 million from stock option exercises and issuance of common stock.
The amount of debt that may be retired, if any, could be material and would be decided at the sole discretion of our Board and will depend on market conditions, our cash position and other considerations.
These actions may include prepayments of our term loans or other retirements or refinancing of outstanding debt, privately negotiated transactions or otherwise. The amount of debt that may be retired, if any, could be material and would be decided at the sole discretion of our Board and will depend on market conditions, our cash position and other considerations.
We paid the Cerveau Stockholders an additional $10.0 million in May 2023 upon the successful completion of a technology transfer. We could pay up to an additional $51.0 million in milestone payments upon achievement of specified U.S. regulatory milestones related to MK-6240.
We could pay up to an additional $51.0 million in milestone payments upon achievement of specified U.S. regulatory milestones related to MK-6240.
“Business - Other Notable Transactions” of this Form 10-K. • For MK-6240, we acquired the right to the investigational asset for an upfront payment of $35.3 million in February 2023 and an additional $10.0 million in May 2023 upon the successful completion of a technology transfer and will potentially make additional milestone and royalty payments.
The application for approval of LNTH-2501 was submitted under FDA’s 505(b)(2) pathway. • For MK-6240, we acquired the right to the investigational asset for an upfront payment of $35.3 million in February 2023 and an additional $10.0 million in May 2023 upon the successful completion of a technology transfer and will potentially make additional milestone and royalty payments.
Rebates and Allowances Estimates for rebates and allowances represent our estimated obligations under contractual arrangements with third parties. Rebate accruals and allowances are recorded in the same period the related revenue is recognized, resulting in a reduction to revenue and the establishment of a liability which is included in accrued expenses and other liabilities in our consolidated balance sheets.
Rebate accruals are recorded in the same period the related revenue is recognized, resulting in a reduction of revenue and the establishment of a liability which is included in accrued expenses and other current liabilities in our consolidated balance sheets.
The successful growth of PYLARIFY is dependent on our ability to maintain PYLARIFY as the most utilized PSMA PET imaging agent in an increasingly competitive space. PYLARIFY’s competition includes two commercially available gallium-68-based PSMA imaging agents, an approved F-18-based PSMA imaging agent, and other non-PSMA-based imaging agents commonly referred to as conventional imaging.
The continued substantial revenue contribution from PYLARIFY is dependent on our ability to maintain PYLARIFY as a widely utilized PSMA PET imaging agent in an increasingly competitive space. PYLARIFY’s competition includes three Ga-68-based PSMA imaging agents, an F-18-based PSMA imaging agent, and other non-PSMA-based imaging agents commonly referred to as conventional imaging.
As part of the accounting for these arrangements, we develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in a contract.
As part of the accounting for these arrangements, we develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in a contract. These key assumptions may include market conditions, reimbursement rates for personnel costs, development timelines and probabilities of regulatory success.
Recent Accounting Standards Refer to Note 2, “Summary of Significant Accounting Policies,” in the accompanying consolidated financial statements located under Item 8 of this Form 10-K for information regarding recently issued accounting standards that may have a significant impact on our business.
Recent Accounting Standards Refer to Note 2, “Summary of Significant Accounting Policies,” in the accompanying consolidated financial statements located under Item 8 of this Form 10-K for information regarding recently issued accounting standards that may have a significant impact on our business. 77 Table of Contents Critical Accounting Policies The discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States.
We believe that our diagnostic products provide information that enables HCPs to better detect and characterize, or rule out, disease, with the potential to achieve better patient outcomes, reduce patient risk and limit overall costs. We produce and market our products throughout the United States (the “United States” or “U.S.”), selling primarily to hospitals, independent diagnostic testing facilities, and radiopharmacies.
We believe that our diagnostic products provide information that enables HCPs to better detect and characterize, or rule out, disease, with the potential to achieve better patient outcomes, reduce patient risk, and limit overall costs.
Sale of RELISTOR Licensed Intangible Asset Associated with Net Sales Royalties On August 2, 2023, we sold the right to our RELISTOR net sales royalties, which is classified as a licensed intangible asset (“RELISTOR royalty asset”), under our license agreement with Bausch Health Companies, Inc. (“Bausch”); we retained the rights to future sales-based milestone payments.
On August 2, 2023, we sold the right to our RELISTOR royalty asset under our license agreement with Salix Pharmaceuticals, Inc., an affiliate of Bausch Health Companies, Inc.; we retained the rights to future sales-based milestone payments.
We may redeem for cash all or any portion of the Notes, at our option, on or after December 22, 2025 if the closing sale price per share of our common stock exceeds 130% of the conversion price of the Notes for a specified period of time.
Future interest payments associated with the Notes total $29.3 million, with $15.3 million payable within twelve months. We may redeem for cash all or any portion of the Notes, at our option, if the closing sale price per share of our common stock exceeds 130% of the conversion price of the Notes for a specified period of time.
Our business and financial performance have been, and continue to be, affected by the following: Continued Growth of PYLARIFY PYLARIFY, an F-18-labeled PET imaging agent targeting prostate-specific membrane antigen (“PSMA”), was approved by the FDA in May 2021 and commercially launched in the U.S. in June 2021.
Key Factors Affecting Our Results Our business and financial performance have been, and continue to be, impacted by the following: PYLARIFY and PSMA PET Revenue PYLARIFY, an F-18-labeled PET imaging agent targeting PSMA, was approved by the FDA in May 2021 and commercially launched in the United States in June 2021.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeDuring the years ended December 31, 2024, 2023 and 2022, the net impact of foreign currency changes on transactions was a loss of $0.7 million, $0.1 million and $0.3 million, respectively. From time to time, we enter into foreign currency forward contracts primarily to reduce the effects of fluctuating foreign currency exchange rates.
Biggest changeIntercompany transactions between entities that use different functional currencies also expose us to foreign currency risk. 79 Table of Contents During the years ended December 31, 2025, 2024 and 2023, the net impact of foreign currency changes on transactions was a loss of $1.0 million, $0.7 million and $0.1 million, respectively.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk We are exposed to market risk from changes in interest rates and foreign currency exchange rates. We may from time to time use derivative financial instruments or other financial instruments to hedge these economic exposures related to foreign currencies. We do not hold or issue financial instruments for trading purposes.
Item 7A. Qu antitative and Qualitative Disclosures about Market Risk We are exposed to market risk from changes in interest rates and foreign currency exchange rates. We may from time to time use derivative financial instruments or other financial instruments to hedge these economic exposures related to foreign currencies. We do not hold or issue financial instruments for trading purposes.
As of 75 Table of Contents December 31, 2024, there was availability of $750.0 million on the 2022 Revolving Facility. Any increase in the interest rate under the 2022 Revolving Facility may have a negative impact on our future earnings to the extent we have outstanding borrowings under the 2022 Revolving Facility.
As of December 31, 2025, there was availability of $750.0 million on the 2022 Revolving Facility. Any increase in the interest rate under the 2022 Revolving Facility may have a negative impact on our future earnings to the extent we have outstanding borrowings under the 2022 Revolving Facility.
Foreign Currency Risk We face exposure to movements in foreign currency exchange rates whenever we, or any of our subsidiaries, enter into transactions with third parties that are denominated in currencies other than our, or that subsidiary’s, functional currency. Intercompany transactions between entities that use different functional currencies also expose us to foreign currency risk.
Foreign Currency Risk We face exposure to movements in foreign currency exchange rates whenever we, or any of our subsidiaries, enter into transactions with third parties that are denominated in currencies other than our, or that subsidiary’s, functional currency.
Interest Rate Risk We are subject to interest rate risk in connection with our 2022 Revolving Facility, which is variable rate indebtedness. Interest rate changes could increase the amount of our interest payments and thus negatively impact our future earnings and cash flows.
Interest Rate Risk We are subject to interest rate risk in connection with our five-year revolving credit facility, which was amended in December 2024 (as amended, the “2022 Revolving Facility”), which is variable rate indebtedness. Interest rate changes could increase the amount of our interest payments and thus negatively impact our future earnings and cash flows.
At December 31, 2024, a hypothetical 10% change in value of the U.S. dollar relative to the Canadian dollar would not have materially affected our financial instruments. 76 Table of Contents
The Euro and Canadian dollar present the primary currency risk on our earnings. At December 31, 2025, a hypothetical 10% change in value of the U.S. dollar relative to the Euro and Canadian dollar would not have materially affected our financial instruments. 80 Table of Contents
We may enter into additional foreign currency forward contracts when deemed appropriate. We do not enter into foreign currency forward contracts for speculative or trading purposes. The Canadian dollar presents the primary currency risk on our earnings.
From time to time, we enter into foreign currency forward contracts primarily to reduce the effects of fluctuating foreign currency exchange rates. We may enter into additional foreign currency forward contracts when deemed appropriate. We do not enter into foreign currency forward contracts for speculative or trading purposes.

Other LNTH 10-K year-over-year comparisons