What changed in this filing

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Item 1. Business

2025-02-26 compared with 2024-02-22 · 395 added, 385 removed, 475 unchanged (62% of the section changed)

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Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue.

Our Radiopharmaceutical Oncology diagnostics and therapeutic candidates help healthcare professionals (“HCPs”) Find, Fight and Follow cancer, with a focus in prostate cancer.

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.

Our Strategic Partnerships focus on enabling precision medicine through the use of biomarkers, digital solutions and pharma solutions platforms.

Our Strategic Partnerships include 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 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.

We believe that our diagnostic products provide improved diagnostic 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 throughout the healthcare system.

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 the “U.S.”), selling primarily to hospitals, independent diagnostic testing facilities, and radiopharmacies.

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Our executive offices are located in Bedford, Massachusetts, with additional offices in North Billerica, Massachusetts;

Somerset, New Jersey (subject to the satisfaction of closing conditions for the sale of the Somerset facility and related assets to Perspective anticipated in the first half of 2024);

Montreal, Canada and Lund, Sweden.

CEO Succession Plan

On January 23, 2024, we announced that, effective March 1, 2024, Brian Markison, our current Chair of the Board of Directors (“Board”), will become our Chief Executive Officer, and Mary Anne Heino, our current Chief Executive Officer, will retire and become the Chair of the Board.

Chief Executive Officer Transition

On March 1, 2024, Brian Markison, became our Chief Executive Officer (“CEO”), and Mary Anne Heino retired as our CEO and became the Chair of our Board of Directors (“Board”).

As part of this leadership transition, Mr.

Markison assumed the role of Executive Chair of the Board as of January 23, 2024 until the effectiveness of his Chief Executive Officer appointment in March, and Board Member Julie McHugh became Lead Independent Director.

Strategic Agreements with Perspective Therapeutics

On January 9, 2024, we announced that we entered into multiple strategic agreements with Perspective, a radiopharmaceutical company that is pursuing advanced treatment applications for cancers throughout the body.

Markison assumed the role of Executive Chair of the Board as of January 23, 2024 until the effectiveness of his CEO appointment in March 2024, and Board Member Julie McHugh became Lead Independent Director.

Evolution into Fully-Integrated, Radiopharmaceutical Company

During 2024, we executed on our strategy to evolve into a fully integrated radiopharmaceutical company, supported by our increasingly diversified portfolio and our targeted initiatives to expand our pipeline, commercial, development and manufacturing capabilities.

Over the course of the year and into 2025, we announced multiple strategic transactions, which further our goals to focus on new high growth markets and expand and diversify our capabilities and development pipeline with complementary assets.

A brief description of these transactions is summarized below.

Pending Acquisition of Life Molecular Imaging

On January 13, 2025, we announced that we entered into a definitive agreement to acquire Life Molecular.

Life Molecular is based in Berlin, Germany and is dedicated to advancing novel PET radiopharmaceutical diagnostics.

The definitive agreement provides for an upfront payment of $350.0 million and up to an additional $400.0 million in potential earn-out and milestone payments.

The transaction is expected to close in the second half of 2025, subject to the satisfaction of customary regulatory and closing conditions.

This acquisition would enable us to establish a commercial franchise in Alzheimer’s disease, expand our growth profile with Neuraceq, an approved Alzheimer’s disease radiodiagnostic, enhance our research and development and clinical development capabilities, and strengthen our innovative radiodiagnostic pipeline.

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”).

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.

We expect LNTH-2401 could be used as a companion diagnostic, and that together, LNTH-2401 and LNTH-2402 could potentially allow us to enter into new disease areas.

For more information on the acquisition of the global rights to RM2, 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.

Pending Acquisition of Evergreen Theragnostics

On January 27, 2025, we announced that we entered into an Agreement and Plan of Merger (the “Evergreen Merger Agreement”) with Evergreen and Shareholder Representative Services LLC, pursuant to which we will acquire Evergreen by means of a statutory merger of our subsidiary with and into Evergreen, with Evergreen surviving as our wholly-owned subsidiary (the “Evergreen Merger”).

Evergreen is a clinical-stage radiopharmaceutical company engaged in contract development and manufacturing services, as well as drug discovery and commercialization of proprietary products.

Our acquisition of Evergreen would enhance our capabilities across the radiopharmaceutical value chain, specifically strengthening our clinical and commercial manufacturing capabilities in therapeutic oncology;

expand our late-stage pipeline with a registrational-stage PET diagnostic agent that could complement PNT2003;

and grow our early-stage pipeline with multiple clinical and pre-clinical theranostic pairs.

Acquisition of NAV-4694

On June 18, 2024, we acquired Meilleur Technologies, Inc.

(“Meilleur”), including its asset NAV-4694, an investigational F-18-PET imaging agent that targets beta amyloids in Alzheimer’s disease.

Under the terms of the agreement, we paid the stockholders of Meilleur (“Meilleur Stockholders”) an upfront payment of $32.9 million and an additional $10.0 million payment in August 2024 after the successful completion of a technology transfer.

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.

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.

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”).

We acquired global, exclusive rights to both a monoclonal antibody that targets LRRC15, a preclinical therapeutic candidate targeting osteosarcoma, and a Trophoblast cell surface antigen 2 (“TROP2”)-targeted nanobody, a preclinical stage therapy.

In connection with this acquisition, we are assuming the underlying license agreements related to the two preclinical assets, together with their respective milestone and royalty payment obligations.

Strategic Agreements with Perspective Therapeutics, Inc.

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.

Under the agreements, we obtained an option to exclusively license Perspective’s Pb212-VMT- ⍺-NET, a clinical stage alpha therapy in development for the treatment of neuroendocrine tumors, and an option to co-develop certain early-stage therapeutic candidates targeting prostate cancer using Perspective’s innovative platform technology for an aggregate upfront payment of $28.0 million in cash.

We also agreed to purchase up to 19.9% of Perspective’s outstanding shares of common stock for up to approximately $33 million, subject to Perspective’s completion of a qualified third-party financing transaction and certain other closing conditions.

In addition, Perspective agreed to acquire the assets and associated lease of our radiopharmaceutical manufacturing facility in Somerset, New Jersey.

Following satisfaction of the closing conditions, on January 22, 2024, our subsidiary, Lantheus Alpha purchased 56,342,355 shares of Perspective’s common stock at a purchase price of $0.37 per share in a private placement transaction.

The total consideration for the purchase was approximately $20.8 million in cash, which resulted in Lantheus Alpha holding approximately 10.74% of Perspective’s common stock as of the purchase date and retaining the right to purchase additional shares to bring its ownership up to an aggregate of 19.9%.

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.

During 2024, we also purchased an aggregate of 11,677,339 shares of Perspective’s common stock (the “Perspective Shares”), after giving effect to a 1-for-10 reverse stock split, resulting in the Company holding approximately 19.9% of Perspective’s outstanding common stock (or 17.35% on a fully diluted basis) as of March 6, 2024.

Other Notable Transactions

Prior to 2024, we executed on some additional transactions that are notable to our business, including the following:

Exclusive License for PNT2002 & PNT 2003

On December 20, 2022, we announced the closing of a set of strategic collaborations with 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.

On December 20, 2022, we announced the closing of a set of strategic collaborations with POINT Biopharma Global Inc.

(“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

PNT2002 is a PSMA-targeted radiopharmaceutical therapy in development for the treatment of metastatic castration-resistant prostate cancer (“mCRPC”).

PNT2003 is a somatostatin receptor (“SSTR”) therapy with non-carrier added lutetium-177, which is in registration to treat patients with SSTR-positive neuroendocrine tumors.

On December 27, 2023, Eli Lilly and Company announced the completion of its acquisition of POINT.

The acquisition is not expected to impact the status of the license agreements related to these product candidates or the work being performed in connection with those license agreements and our collaboration with POINT.

With respect to PNT2002, POINT is generally responsible for funding and development activities required for FDA approval, including generating all clinical and nonclinical data, analysis and other information, and we are responsible for preparing for and seeking regulatory approval, as well as performing and funding all future development and commercialization following such approval.

POINT will be responsible for all manufacturing of PNT2002, subject to certain exceptions described in the license and collaboration agreement between Lantheus Two and POINT, dated November 11, 2022 (the “PNT2002 License Agreement”).

In April 2023, we announced with POINT that the FDA had granted Fast Track designation for PNT2002.

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address unmet needs.

On December 18, 2023, we announced positive topline results from SPLASH.

SPLASH is designed to evaluate the efficacy and safety of PNT2002 in patients with mCRPC who have progressed following treatment with an androgen receptor pathway inhibitor (“ARPI”).

The SPLASH trial met its primary endpoint, demonstrating a median radiographic progression-free survival (rPFS) per blinded independent central review of 9.5 months for patients treated with PNT2002, compared to 6.0 months for patients treated with ARPI in the control arm, a statistically significant 29% reduction in the risk of radiographic progression or death (hazard ratio (“HR”) 0.71;

At the time of the analysis, interim overall survival (“OS”) results were immature (46% of protocol-specified target OS events reached), and the HR was 1.11.

We expect more mature overall survival data in 2024 prior to the potential submission of a New Drug Application (“NDA”).

PNT2002 demonstrated a favorable safety profile with grade ≥3 treatment-emergent adverse events (“TEAEs”) per Common Terminology Criteria for Adverse Events, serious TEAEs, and TEAEs leading to discontinuation occurring at lower rates in the PNT2002 arm than in the ARPI arm (30.1%, 17.1%, and 1.9% versus 36.9%, 23.1%, and 6.2%, respectively).

On December 27, 2023, Lilly announced the completion of its acquisition of POINT.

The acquisition has not impacted the status of the license agreements related to these product candidates or the work being performed in connection with those license agreements and our collaboration with POINT.

POINT is generally responsible for funding and development activities required for FDA approval of PNT2002, including generating all clinical and nonclinical data, analysis and other information, and we are responsible for preparing for and seeking regulatory approval, as well as performing and funding all future development and commercialization following such approval.

POINT will be responsible for all manufacturing of PNT2002, subject to certain exceptions described in the license and collaboration agreement between the Company and POINT, dated November 11, 2022 (the “PNT2002 License Agreement”).

The Phase 3 registrational clinical trial for PNT2002 (“SPLASH”) was designed to evaluate the efficacy and safety of PNT2002 in patients with mCRPC who have progressed following treatment with an androgen receptor pathway inhibitor (“ARPI”).

On December 18, 2023, we announced that the SPLASH trial met its primary endpoint, demonstrating a median radiographic progression-free survival (“rPFS”) per blinded independent central review of 9.5 months for patients treated with PNT2002, compared to 6 months for patients treated with ARPI in the control arm, a statistically significant 29% reduction in the risk of radiographic progression or death (hazard ratio (“HR”) 0.71;

At the time of the analysis, interim overall survival (“OS”) results were immature (46% of protocol pre-specified target OS events reached), and the HR was 1.11.

On September 15, 2024, we presented additional clinical data from initial topline results of SPLASH during the European Society of Medical Oncology Congress 2024.

On November 6, 2024, we announced that the second interim analysis performed at 75% of protocol pre-specified overall survival events demonstrated results for both rPFS and OS that did not materially change from the interim analysis that was performed at 46% of pre-specified events.

The OS results and HR in the intent-to-treat population remain confounded by the overwhelming number of patients who crossed over to receive PNT2002.

Crossover adjusted analyses were post-hoc, and we are continuing to review the data and perform additional subset analyses in collaboration with our partner in preparation for further interactions on our path forward.

PNT2002 demonstrated a favorable safety profile compared to patients treated with ARPI in the control arm.

Only 3.0% of patients treated with PNT2002 halted or reduced therapy as a result of treatment-emergent adverse events (“TEAEs”), compared to 11.5% of patients treated with ARPI, and 17.1% of PNT2002 patients experienced serious TEAEs compared to 23.1% of ARPI patients.

The open-label study randomized 412 patients with PSMA-expressing mCRPC who had progressed on ARPI therapy and either refused or were not eligible for chemotherapy, in a 2:1 randomization ratio.

At the time of the analysis, 84.6% of patients who experienced progressive disease in the control arm subsequently crossed over to receive PNT2002.

At the time of the first interim analysis, 84.6% of patients who experienced progressive disease in the control arm subsequently crossed over to receive PNT2002.

SPLASH was conducted across the United States, Canada, Europe, and the United Kingdom.

Eighty percent of SPLASH patients resided in North America and approximately ten percent of all participants were Black or African American.

During 2023, we worked on establishing an Expanded Access Program, (“EAP”), for PNT2002.

EAPs, which are also referred to as compassionate use programs, provide a potential pathway for patients with serious or life-threatening conditions to gain access to an investigational drug for treatment outside of a clinical trial.

We expect to enroll the first patient in the EAP for PNT2002 during the first quarter of 2024.

With respect to 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.

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 of PNT2003 following such approval.

POINT will be responsible for all manufacturing of PNT2003, subject to certain exceptions described in the license and collaboration agreement between Lantheus Three and POINT, dated November 11, 2022 (the “PNT2003 License Agreement”).

On January 11, 2024, we announced that our ANDA for Lutetium Lu 177 Dotatate (177Lu-PNT2003) had been accepted for filing by the FDA.

In June 2024, Endocyte, Novartis and Purdue Research Foundation sued POINT and Lilly alleging that POINT’s manufacturing and sale of PNT2002 infringes an Endocyte patent.

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 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.

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 the Company’s ANDA filing.

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.

Under the terms of the Hatch-Waxman Act, full FDA approval of our ANDA filing could be subject to a stay of up to 30 months.

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.

Based on the most recent update to the FDA’s online Paragraph IV database listings, we believe we are the first applicant to have filed a substantially complete ANDA for lutetium Lu 177 dotatate containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act.

As the first applicant, we believe we will be eligible for 180 days of generic marketing exclusivity in the U.S.

Under the Hatch-Waxman Act, any company submitting an ANDA must make certain certifications with respect to the patent status of the drug for which it is seeking approval.

In the event that such applicant plans to challenge the validity or enforceability of an existing listed patent or asserts that the proposed product does not infringe an existing listed patent, it files a “Paragraph IV” certification.

We filed a Paragraph IV certification in connection with PNT2003.

In the case of ANDAs, the Hatch-Waxman Act provides for a potential 180-day period of generic exclusivity for the first company to submit an ANDA with a Paragraph IV certification.

This filing triggers a regulatory process in which the FDA is required to delay the final approval of subsequently filed ANDAs containing Paragraph IV certifications until 180 days after the first commercial marketing.

When litigation is brought by the

patent holder in response to a Paragraph IV certification (like the Novartis entities did for our ANDA for PNT2003), the FDA generally may not approve the ANDA until the earlier of 30 months or a court decision finding the patent invalid, not infringed or unenforceable.

The submission of our ANDA for PNT2003 could result in protracted and expensive patent litigation and the outcome of such litigation is uncertain.

Acquisition of Cerveau

On February 6, 2023, we announced that we acquired Cerveau.

Cerveau holds the rights under a license agreement to develop and commercialize MK-6240, an investigational second-generation F 18-labeled PET imaging agent that targets Tau tangles in Alzheimer’s disease.

Under the terms of our purchase agreement, we paid the stockholders of Cerveau (the “Selling Stockholders”) an upfront payment of $35.0 million in February 2023 and an additional $10.0 million in May 2023 upon the successful completion of a technology transfer.

The Selling Stockholders are also eligible to receive additional development and commercial milestone payments.

Additionally, we will pay double-digit royalty payments for research revenue and commercial sales.

Research revenue is derived from existing partnerships with pharmaceutical companies that use MK-6240 in clinical trials and includes milestone and dose-related payments.

Pursuant to the terms of the stock purchase agreement for Cerveau, certain members of the Selling Stockholders will also provide transition and clinical development services for a prescribed time following the closing of the transaction.

Our Portfolio of Commercial Products

As the first applicant, if our ANDA is approved, we

believe we will be eligible for 180 days of generic marketing exclusivity in the U.S.

Upon approval, we believe PNT2003 will be the first radioequivalent to lutetium Lu 177 dotatate, which is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (“GEP-NETs”), including foregut, midgut, and hindgut neuroendocrine tumors.

We define radioequivalent as a radiopharmaceutical whose mechanism of action is determined to be equivalent to that of the reference product by the FDA, or a similar regulator outside the United States.

Our Portfolio of Commercial Products and Other Sources of Revenue

Radiopharmaceutical Oncology

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• DEFINITY is an injectable ultrasound enhancing agent with perflutren-containing lipid microspheres, or microbubbles, that is used in echocardiography exams.

We offer two formulations of DEFINITY, one of which requires refrigerated storage (branded DEFINITY) and one which allows both storage and shipment at room temperature and provides clinicians an additional choice for greater utility of this formulation in broader clinical settings (branded DEFINITY RT).

The indication for both formulations in the U.S.

is for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

We believe we are currently the leading worldwide provider of ultrasound enhancing agents for use in echocardiography.

The indication for DEFINITY in the U.S.

is 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.

We believe we are currently the most utilized worldwide provider of ultrasound enhancing agents for use in echocardiography.

DEFINITY is approved under the name LUMINITY in Europe and sold through third-party distribution relationships.

• TechneLite is a Technetium (“Tc-99m”) generator that provides the essential nuclear material used by radiopharmacies to radiolabel NEUROLITE, CARDIOLITE and other Tc-99m-based radiopharmaceuticals used in nuclear medicine procedures.

TechneLite uses Mo-99 as its active ingredient.

TechneLite uses Molybdenum-99 (“Mo-99”) as its active ingredient.

• NEUROLITE is an injectable, Tc-99m-labeled imaging agent used with single-photon emission computed tomography (“SPECT”) technology to identify the area within the brain where blood flow has been blocked or reduced due to stroke.

• Xenon-133 (“Xenon”) is a radiopharmaceutical gas that is inhaled and used to assess pulmonary function and also to image cerebral blood flow.

Our Xenon is manufactured by a third party as a bi-product of Mo-99 production and is processed and finished by us.

Xenon is manufactured by a third party as a bi-product of Mo-99 production and is processed and finished by us.

• CARDIOLITE, also known by its generic name sestamibi, is an injectable, Tc-99m-labeled imaging agent used in myocardial perfusion imaging (“MPI”) procedures to assess blood flow to the muscle of the heart using SPECT.

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Our commercial products in our Strategic Partnerships and Other Revenue product category include the following:

• RELISTOR (methylnaltrexone bromide) is a treatment for opioid-induced constipation (“OIC”) that decreases the constipating side effects induced by opioid pain medications such as morphine and codeine without diminishing their ability to relieve pain.

• 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.

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.

For example, flurpiridaz is an F-18-based PET MPI agent that we previously licensed to GE Healthcare Limited (“GE Healthcare”).

Flurpiridaz was approved by the FDA in 2024 under the name Flyrcado for PET MPI under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (“CAD”) to evaluate for myocardial ischemia and infarction.

Similarly, RELISTOR (methylnaltrexone bromide) is a treatment for opioid-induced constipation that decreases the constipating side effects induced by opioid pain medications such as morphine and codeine without diminishing their ability to relieve pain.

RELISTOR is approved in two forms:

a subcutaneous injection and an oral tablet.

In 2011 Progenics licensed methylnaltrexone (MNTX) along with products containing MNTX, including both approved forms of RELISTOR, to Salix Pharmaceuticals, Inc., a Bausch Health company (“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.

aBSI is FDA cleared and CE marked.

The software is currently used as one of the correlative objectives of the DORA trial, an open-labeled, randomized, Phase 3 study of docetaxel versus docetaxel in combination with radium-223 (Ra-223) in subjects with mCRPC.

aBSI is also approved in Japan and part of the JSMO guidelines (Japanese Society of Medical Oncology) in support of clinicians with patient treatment selection.

The Japanese non-exclusive rights to aBSI have been transferred and sold to FUJIFILM Toyama Chemical Co.

(“FUJIFILM”) under the name BONENAVI®.

• aPROMISE, which is currently commercialized as PYLARIFY AI in the U.S., 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.

In 2011 Progenics licensed

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.

Additional Information about our Product Categories

Radiopharmaceutical Oncology

Continued Growth of PYLARIFY

PYLARIFY is the leading radiopharmaceutical diagnostic agent indicated for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and in men with suspected recurrence based on elevated PSA levels.

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.

PYLARIFY works by binding to PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells.

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Based on estimates from third-party sources regarding the incidence of prostate cancer in men in the U.S., we believe the current market potential for PSMA PET imaging agents in the U.S.

for 2024 could be about 445,000 scans, and the total addressable market by 2029 could be over 700,000 annual scans.

for 2025 could be about 525,000 scans, and the total addressable market by 2030 could be approximately 750,000 annual scans.

PYLARIFY is manufactured on a diverse, F-18 distributor supply network of PMFs, ensuring convenient and reliable supply.

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Because each PMF manufacturing PYLARIFY is deemed by the FDA to be a separate manufacturing site, each is separately approved by the FDA.

As of December 31, 2023, we had activated 54 PMF manufacturing sites in our PMF network, up from 37 activated sites as of December 31, 2022.

These additional sites provide geographic breadth, out-the-door time flexibility and added optionality within our existing PMF network.

As of December 31, 2024, we had activated a total of 62 PMF manufacturing sites in our PMF network, up from 54 activated sites as of December 31, 2023.

These additional sites provide geographic breadth, out-the-door time flexibility and added optionality.

Overall, we have achieved broad national distribution of PYLARIFY with customers in 48 of 50 states, the District of Columbia and Puerto Rico.

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PYLARIFY can then be used by the academic medical center itself, and in some cases distributed to other customers under separate purchase agreements.

Our Healthcare Procedure Coding System (“HCPCS”) code, which enables streamlined billing, went into effect as of January 1, 2022.

In addition, effective January 1, 2022, the Centers for Medicare and Medicaid Services (“CMS”) granted TPT Status in the hospital outpatient setting for PYLARIFY, enabling traditional Medicare to provide an incremental payment for PET/CT scans performed with PYLARIFY in that setting.

TPT Status for PYLARIFY is expected to expire on December 31, 2024.

In July 2023, CMS proposed possible changes to its regulations covering payment for diagnostic radiopharmaceuticals.

This included, for the first time since 2008, options for separate payment for diagnostics instead of the current packaged payment following expiration of TPT Status.

We, along with numerous industry organizations, submitted comments to CMS.

In completing its 2023 rulemaking for the 2024 payment calendar year, CMS recognized the challenges of patient access to diagnostic radiopharmaceuticals and requested feedback on various payment alternatives that could provide separate reimbursement for these items, but the agency did not adopt any of these proposals in the final rule, while stating that it would continue to evaluate this issue in subsequent rulemaking.

We plan to submit additional comments to CMS in connection with its 2024 rulemaking for the 2025 payment calendar year.

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 leading PSMA PET imaging agent in a competitive marketplace.

PYLARIFY’s current competition is primarily two Gallium-68 (“Ga-68”)-based PSMA imaging agents, a fluorine-18-based PSMA

imaging agent, and other non-PSMA-based imaging agents commonly referred to as conventional imaging.

Continued growth and revenue contribution from PYLARIFY will also depend on our ability to differentiate PYLARIFY in light of the potential loss of TPT Status, including through flexible and dependable access to PYLARIFY nationally, a best in class customer experience and through long-term strategic contracts.

Our Healthcare Procedure Coding System code, which enables streamlined billing, went into effect as of January 1, 2022.

In addition, effective January 1, 2022, the Centers for Medicare and Medicaid Services (“CMS”) granted transitional pass-through payment status (“TPT Status”) in the hospital outpatient setting for PYLARIFY, enabling traditional Medicare fee-for-service (“FFS”) to provide separate payment for PYLARIFY in addition to the payment for the PET/CT procedure in that setting.

TPT Status for PYLARIFY expired on December 31, 2024.

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 in diagnostic radiopharmaceuticals.

The rule provides separate payment for those diagnostic radiopharmaceuticals with per day costs greater than $630.

Effective January 1, 2025, CMS is maintaining separate payment for PYLARIFY after the expiration of TPT Status for the approximately 20% of patients with traditional Medicare FFS insurance coverage who are treated in the hospital outpatient setting.

The calendar year 2025 payment rate for PYLARIFY is listed in Addendum B of the final rule.

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”).

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.

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.

The potential for future generic entrants to the market as a result of the expiry of PYLARIFY’s five-year new chemical entity (“NCE”) exclusivity period in 2026, on the fifth anniversary of the FDA’s approval, could generate increased competition for PYLARIFY.

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.

We actively pursue patents in connection with PYLARIFY, both in the U.S.

and internationally.

for PYLARIFY, we have five Orange Book-listed patents, including composition of matter patents, the last of which expires in 2037.

Outside of the U.S., we have, and are currently pursuing, additional PYLARIFY patents to obtain similar patent protection as 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.

Outside of the U.S., we have, and are currently pursuing, additional patents related to piflufolastat F-18 to obtain similar patent protection as in the U.S.

See Part I, Item 1A.

“Risk Factors” for information regarding certain risks associated with PYLARIFY and Part II, Item 7.

“Management’s Discussion and Analysis of Financial Condition and Results of Operations - Comparison of the Periods Ended December 31, 2023 and 2022 - Revenues” 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, 2024 and 2023 - Revenues” of this Form 10-K for further information on total revenue contributed by PYLARIFY since its approval.

Precision Diagnostics

Continued Growth of DEFINITY

DEFINITY is the leading ultrasound enhancing agent in the U.S.

and is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

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.

Numerous patient conditions can decrease the quality of images of the left ventricle, the primary pumping chamber of the heart.

The term DEFINITY includes its activated and non-activated forms and the two formulations it is commercially available in;

one that requires refrigerated storage and one that we have branded as DEFINITY RT that may be stored at room temperature.

The term DEFINITY refers to both its activated and non-activated forms.

DEFINITY is a clear, colorless, sterile liquid that, upon activation in a VIALMIX or VIALMIX RFID, medical devices specifically designed for DEFINITY, becomes a homogenous, opaque, milky white injectable suspension of perflutren-containing lipid microspheres.

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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 25 million studies throughout the world.

Since its launch in 2001, DEFINITY has been used in imaging procedures in more than 28 million echocardiograms throughout the world.

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.

We estimate that, as of December 31, 2024, DEFINITY had over 80% share of the U.S.

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See Part I, Item 1A.

“Risk Factors-Ultrasound enhancing agents may cause side effects which could limit our ability to sell DEFINITY.”

We continue to actively pursue additional patents in connection with DEFINITY and DEFINITY RT, both in the U.S.

“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.

for DEFINITY, we have six Orange Book-listed method-of-use patents, one of which expires in 2035 and five of which expire in 2037, as well as additional manufacturing patents that are not Orange Book-listed expiring in 2037.

for DEFINITY RT, we have eight Orange Book-listed patents, including two composition of matter patents which expire in 2035.

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.

The Orange Book-listed patents include a patent on the use of VIALMIX RFID (see below), which expires in 2037;

we have submitted additional VIALMIX RFID patent applications in major markets throughout the world.

Even though our longest duration Orange Book-listed DEFINITY patent extends until March 2037, because our Orange Book-listed composition of matter patent expired in June 2019, we may face generic DEFINITY challenges in the near to intermediate term.

See “Intellectual Property – Patents” below.

As noted above, DEFINITY is activated through the use of medical devices branded as VIALMIX and VIALMIX RFID.

DEFINITY is activated through the use of medical devices branded as VIALMIX and VIALMIX RFID.

The activation rate and time are controlled by VIALMIX RFID through the use of radio-frequency identification technology (“RFID”) to ensure reproducible activation of DEFINITY.

The RFID tag, which is affixed to the vial label, enables the DEFINITY vial to be appropriately activated with the VIALMIX RFID activation device.

To manufacture DEFINITY that requires refrigeration, historically, we have relied on Jubilant HollisterStier (“JHS”) as a significant supplier.

We constructed a specialized in-house manufacturing facility at our North Billerica campus for purposes of

producing this formulation of DEFINITY and, potentially, other sterile vial products.

On February 22, 2022, we received FDA approval of our supplemental new drug application (“sNDA”), authorizing commercial manufacturing of this formulation of DEFINITY at our new facility.

We believe this investment provides supply chain redundancy, improved flexibility and reduced costs in a potentially more price competitive environment.

We rely on Jubilant HollisterStier (“JHS”) as a significant supplier of DEFINITY.

We also produce DEFINITY in our in-house manufacturing facility at our North Billerica campus.

See Part I, Item 1A.

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Tc-99m results from the radioactive decay of Mo-99, itself a radioisotope with a 66-hour half-life sourced in our supply chain in nuclear research reactors located in Belgium, South Africa and Australia from enriched uranium.

The TechneLite generator is a self-contained system that houses a vertical glass column at its core that contains Mo-99, which degrades to Tc-99m.

The TechneLite generator houses a vertical glass column at its core that contains Mo-99, which degrades to Tc-99m.

During our manufacturing process, Mo-99 is added to the column within the generator where it is adsorbed onto alumina powder.

The column is sterilized, enclosed in a lead shield and further sealed in a cylindrical plastic container, which is then immediately shipped to our radiopharmacy customers.

Because of the short half-lives of Mo-99 and Tc-99m, radiopharmacies typically purchase TechneLite generators on a weekly basis pursuant to standing orders.

The Tc-99m produced by our TechneLite generator is the medical radioisotope that can be attached to a number of imaging agents, including our own NEUROLITE and CARDIOLITE products, during the radiolabeling process.

To radiolabel a Tc-99m-based radiopharmaceutical, a vial of sterile saline and a vacuum vial are each affixed to the top of a TechneLite generator.

The sterile saline is pulled through the generator where it attracts Tc-99m resulting from the radioactive decay of Mo-99 within the generator column.

The Tc-99m-containing radioactive saline is then pulled into a vacuum vial and subsequently combined by a radiopharmacist with the applicable imaging agent, which allows the preparation of individual patient-specific radiolabeled imaging agent doses.

When administered, the imaging agent binds to specific tissues or organs for a period of time, enabling the Tc-99m to illuminate the functional health of the imaged tissues or organs in a diagnostic image.

Because of the half-lives of Mo-99 and Tc-99m, radiopharmacies typically purchase TechneLite generators on a weekly basis pursuant to standing orders.

Our ability to produce and market TechneLite is highly dependent on our supply of Mo-99.

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TechneLite is currently marketed primarily in the U.S., Canada, Central America and South America, largely to radiopharmacies that prepare unit doses of radiopharmaceutical imaging agents and ship these preparations directly to hospitals for administration to patients.

In the U.S., we have supply contracts with large radiopharmacy groups, including PharmaLogic Holdings Corp (“PharmaLogic”), Cardinal Health (“Cardinal”), RLS (USA) Inc.

(previously GE Healthcare) (“RLS”) and United Pharmacy Partners (“UPPI”).

We also supply generators on a purchase order basis to other customers.

We estimate that TechneLite had approximately one third of the U.S.

generator market as of December 31, 2023, competing primarily with Tc-99m-based generators produced by Curium.

We believe that our substantial capital investments in our TechneLite production line and our extensive experience in complying with the stringent regulatory requirements for the handling of nuclear materials, create significant and sustainable competitive advantages for us in generator manufacturing and distribution.

Given our significant know-how and trade secrets associated with the methods of manufacturing and assembling the TechneLite generator, we believe we have a substantial amount of valuable and defensible proprietary intellectual property associated with the product.

In addition, TechneLite has patent protection in the U.S.

and various foreign countries on certain component technology currently until 2029, and we are pursuing additional patent protection in the U.S.

and world-wide on other component technology that, if granted, would expire in 2040.

See Part II, Item 7.

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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.

In particular, we are focused on radiopharmaceutical therapeutic and diagnostic product opportunities in oncology and other strategic areas that complement our existing portfolio.

Our Pharma Solutions business focuses on advancing innovative imaging biomarker solutions, such as MK-6240, through collaborations with pharmaceutical companies and academic centers.

We continue to seek ways to further increase the overall value of our products and product candidates.

In addition to our recently announced plans to acquire Life Molecular and Evergreen, 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.

In particular, we are focused on radiopharmaceutical diagnostic and therapeutic product opportunities in oncology, neurology and other strategic areas that complement our existing portfolio.

Our Biomarker Solutions business focuses on advancing innovative imaging biomarker solutions, such as our investigational late-stage Alzheimer’s disease radiodiagnostic candidates, MK-6240 and NAV-4694, through collaborations with pharmaceutical companies and academic centers.

Our Biomarker Solutions business also includes our Microbubble Platform, in which we generally enter into collaborations with partners seeking to include our microbubble as part of a kit used with our partner’s medical device for therapeutic applications.

In these collaborations, our microbubble is generally intended to be used as a vehicle to deliver a therapeutic drug.

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.

As we continue to pursue expanding strategic partnerships, our Pharma Solutions activities in oncology include:

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.

▪ In July 2023, Curium (our licensee that is developing and commercializing piflufolastat F 18 in Europe) announced that it received marketing authorization for piflufolastat F 18, under the name PYLCLARI, from the European Commission.

▪ Curium (our licensee for piflufolastat F-18 in Europe) is commercializing piflufolastat F-18 under the name PYLCLARI in Europe.

In addition, we previously entered into an agreement with Curium to add PYLARIFY to its U.S.

ECLIPSE trial, a multi-center, open-label, randomized Phase 3 trial comparing the safety and efficacy of Curium’s PSMA-targeted therapeutic versus hormone therapy in patients mCRPC.

PYLARIFY will be used to determine PSMA-avidity as part of patient selection.

• We have also entered into several other separate agreements, including with RefleXion Medical, Inc., POINT and Regeneron Pharmaceuticals, Inc., under which we supply PYLARIFY in connection with their clinical trials and with the Prostate Cancer Clinical Trial Consortium (“PCCTC”), a premier multicenter clinical research organization that specializes in prostate cancer research.

The intent of the strategic collaboration with PCCTC is to integrate our artificial intelligence (“AI”) platform into PCCTC studies to advance the development and validation of novel AI-enabled biomarkers.

◦ Immuno-Oncology - We entered into a strategic collaboration and license agreement with NanoMab Technology Limited (“NanoMab”), a privately-held biopharmaceutical company focused on the development of next generation radiopharmaceuticals for cancer precision medicine, to develop NM-01, a novel technetium-99m SPECT imaging agent under development to assess PD-L1 expression in cancer cells.

In connection with the collaboration, NanoMab recently completed a Phase 2 clinical trial at King’s College London.

The Phase 2 clinical trial was an open-label, single-arm trial in non-small cell lung cancer patients.

The primary endpoint was the assessment of PD-L1 expression in primary tumor and metastatic lesions by NM-01 compared to immunohistochemistry.

Other objectives were aimed at quantifying intra- and inter-tumoral heterogeneity of PD-L1 expression by NM-01, as well as establishing correlations with other diagnostic procedures.

We expect results from the clinical trial to be presented at an upcoming medical congress.

◦ Pan-Oncology - In collaboration with Ratio Therapeutics LLC (“Ratio”) (previously Noria Therapeutics, Inc.), we are developing LNTH-1363S, a novel copper-64 labeled PET imaging agent, targeting fibroblast activation protein alpha.

We believe this diagnostic agent candidate could have broad potential applicability and use in oncology and also in inflammatory diseases.

Recently, in collaboration with Ratio, we completed a Phase 1 study for LNTH-1363S to evaluate the pharmacokinetics, biodistribution and radiation dosimetry in adult healthy volunteers.

We plan to initiate a Phase 1/2a study in patients in 2024.

Microbubble Franchise

In addition, we continue to seek to optimize our microbubble platform through new collaborations.

Some of our microbubble collaborations are with the following parties:

(i) Cerevast Medical, Inc.

(“Cerevast”), in which our microbubbles will be used in connection with Cerevast’s ocular ultrasound device to improve blood flow in occluded retinal veins in the eye;

(ii) CarThera SAS (“CarThera”), for the use of our microbubbles in combination with SonoCloud, a proprietary implantable device in development for the treatment of recurrent glioblastoma;

(iii) Insightec Ltd.

(“Insightec”), which will use our microbubbles in connection with the development of Insightec’s transcranial guided focused ultrasound device for the treatment of glioblastoma as well as other neurodegenerative conditions;

(iv) Allegheny Health Network (“AHN”) which will use our microbubbles in combination with AHN’s ultrasound-assisted non-viral gene transfer technology for the development of a proposed treatment of xerostomia;

and (v) SonoThera, Inc.

(“SonoThera”), who will use our microbubbles in combination with their ultrasound-guided, non-viral, gene therapy platform and treatments.

In March 2012, we entered into a development and distribution arrangement with China Resources Double-Crane (“Double-Crane”) for DEFINITY in China, Hong Kong and Macau.

Double-Crane has conducted on our behalf three confirmatory clinical trials in pursuit of cardiac, liver and kidney imaging indications, as well as one small pharmacokinetic study.

In November 2022, we announced the approval of our Import Drug License application with the National Medical Products Administration (“NMPA”) for the use of DEFINITY in patients with suboptimal conventional echocardiography and to better identify the left ventricular endocardial border.

Double-Crane is responsible for obtaining adequate coding, coverage and payment and commercializing DEFINITY in China under a local brand name.

Double-Crane is also in the process of analyzing the clinical results relating to liver and kidney indications and will also work with us to prepare an Import Drug License application for those indications, as appropriate.

MK-6240 is an investigational clinical stage F 18-labeled PET imaging development candidate designed to detect Tau protein in the form of neurofibrillary tangles in the brains of patients with known or suspected Alzheimer’s disease.

MK-6240 is being used as a

biomarker in more than 90 active clinical trials for Alzheimer’s disease therapeutic candidates.

Research revenue related to MK-6240 is derived from the use of MK-6240 in those clinical trials and includes milestone and dose-related payments.

• On August 2, 2023, we sold our right to our RELISTOR net sales royalties under our license agreement with Bausch;

PYLARIFY is being used to determine PSMA-avidity as part of patient selection.

• We have also entered into several other separate agreements, including with POINT and Regeneron Pharmaceuticals, Inc., under which we supply PYLARIFY in connection with their clinical trials.

Under a strategic collaboration with the Prostate Cancer Clinical Trial Consortium (“PCCTC”), a premier multicenter clinical research organization that specializes in prostate cancer research, our artificial intelligence (“AI”) platform is being integrated into PCCTC studies to advance the development and validation of novel AI-enabled biomarkers.

◦ Pan-Oncology - In collaboration with Ratio Therapeutics LLC (previously Noria Therapeutics, Inc.), we are developing LNTH-1363S, a novel copper-64 labeled PET imaging agent, targeting fibroblast activation protein alpha.

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.

Microbubble Platform

We previously entered into microbubble collaborations with strategic partners that are using our microbubbles in connection with the development of their medical devices.

For example, CarThera SAS is developing SonoCloud, a proprietary implantable device in development for the treatment of recurrent glioblastoma that will be used in combination with our microbubbles.

Similarly, Insightec Ltd.

is developing a transcranial guided focused ultrasound device for the treatment of glioblastoma, as well as other neurodegenerative conditions, and such device will also be used in combination with our microbubbles.

MK-6240 is an investigational late-stage F-18-labeled PET imaging agent designed to detect tau protein in the form of neurofibrillary tangles in the brains of patients with known or suspected Alzheimer’s disease.

MK-6240 is currently in Phase 3 development and is also being used as a biomarker in more than 100 ongoing academic and industry sponsored clinical trials, many for late-stage therapeutic candidates.

Research revenue is derived from the use of MK-6240 in those clinical trials and includes milestone and dose-related payments.

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.

Research revenue is derived from the use of NAV-4694 in those clinical trials and includes milestone and dose-related payments.

On August 2, 2023, we sold our right to our RELISTOR net sales royalty asset under our license agreement with Bausch;

we retained the rights to future sales-based milestone payments.

We received an initial payment of approximately $98.0 million in connection with the sale.

Pursuant to our license agreement with Bausch, we are eligible to receive one-time sales milestone payments upon achievement of specified U.S.

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Net Sales Levels in any Single Calendar Year

(In thousands)

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

Each sales milestone payment is payable one time only, regardless of the number of times the condition is satisfied, and all five remaining payments could be made within the same calendar year.

During the fourth quarter of 2023, the Company earned the $15.0 million sales-based milestone payment listed above.

$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.

Each sales milestone payment is payable one time only, regardless of the number of times the condition is satisfied.

The remaining milestone payments could be made within the same calendar year if the highest sales levels were reached in any single calendar year.

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.

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on August 5, 2019.

In February 2020, Progenics received European Conformity Marking (“CE marking”) for the standalone workstation model of aBSI, meeting the quality standards set by the European Economic Area.

In February 2020, Progenics received a CE mark for the standalone workstation model of aBSI, meeting the quality standards set by the European Economic Area.

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.

• PYLARIFY AI is artificial intelligence medical device software that is designed to allow healthcare professionals and researchers to perform standardized quantitative assessment of PSMA PET/CT images in prostate cancer, including those images obtained by using PYLARIFY.

PYLARIFY AI has demonstrated improved consistency, accuracy and efficiency in quantitative assessment of PSMA PET/CT.

The technology analyzes the PET/CT image to segment anatomical regions, including 51 bones and 12 soft tissue organs.

This image segmentation enables automated localization, detection and quantification of potential PSMA-avid lesions in the PET/CT image, which is incorporated into a standardized report for physicians.

PYLARIFY AI can be deployed either as a secure web cloud application or within the secure firewall of the institution on a local server.

Once deployed, the adaptive application can be integrated into an institution’s existing clinical workflow, delivering a unique combination of clinical utility and technical flexibility.

PYLARIFY AI is an FDA-cleared AI medical device software that is designed to allow healthcare professionals and researchers to perform standardized quantitative assessment of PSMA PET/CT images in prostate cancer, including those images obtained by using PYLARIFY.

Our subsidiary, EXINI, was granted 510(k) clearance by the FDA in the U.S.

and received a CE marking in Europe for aPROMISE.

and received a CE mark in Europe for aPROMISE.

We commercially launched aPROMISE under the name PYLARIFY AI in the U.S.

in November 2021 and the FDA granted us an additional 510(k) clearance during the second quarter of 2022.

[ 18 F] flurpiridaz

• GE Healthcare Agreement – In 2017, we entered into a definitive, exclusive Collaboration and License Agreement with GE Healthcare for the continued Phase 3 development and worldwide commercialization of flurpiridaz, a fluorine 18-based PET MPI agent designed to assess blood flow to the heart in patients suspected of coronary artery disease (“CAD”).

Under our agreement, GE Healthcare will complete the development of flurpiridaz, pursue worldwide regulatory approvals, and, if successful, lead a worldwide launch and commercialization of the agent, with us collaborating on both development and commercialization through a joint steering committee.

We also have retained the right to co-promote the agent in the U.S.

GE Healthcare’s development plan initially focuses on obtaining regulatory approval in the U.S., Japan, Europe and Canada.

In 2017, we entered into a definitive, exclusive global Collaboration and License Agreement with GE Healthcare for development and worldwide commercialization of flurpiridaz, an F-18-based PET MPI agent designed to assess blood flow to the heart in patients suspected of CAD.

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 U.S.

In September 2022, we announced with GE Healthcare that the second Phase 3 clinical trial had met its co-primary endpoints of exceeding a 60% threshold for both sensitivity and specificity for detecting CAD.

The findings,

shared at an American Society of Nuclear Cardiology conference, also indicated that cardiac PET imaging with flurpiridaz demonstrated higher diagnostic efficacy and image quality in patients with suspected CAD, compared with SPECT MPI, the predominant procedure currently used in nuclear cardiology.

GE Healthcare recently announced that it had filed an NDA with the FDA for flurpiridaz.

Assuming regulatory approval, we anticipate commercialization by GE Healthcare beginning in the second half of 2024.

sales, and mid-single digit

royalties on sales outside of the U.S.

In September 2024, GE Healthcare announced that it had received FDA approval of flurpiridaz under the name Flyrcado for coronary artery disease diagnosis and anticipated commercialization to begin in the first half of 2025.

See Part I, Item 1A.

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Our Clinical Development Candidates

In addition to our commercial products and strategic partnerships with third parties, we also have ongoing clinical development programs, including, among others, the following:

In addition to our commercial products and strategic partnerships with third parties, we also have ongoing clinical development programs, including the following:

• MK-6240 is an investigational late-stage F-18-labeled PET imaging agent that targets tau tangles in Alzheimer’s disease.

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.

On December 18, 2023, we announced positive topline results from SPLASH, the Phase 3 registrational trial for PNT2002 designed to evaluate superiority to the standard of care in mCRPC pre-chemotherapy patients who have failed one androgen receptor pathway inhibitor.

At the time of the analysis, interim OS results were immature (46% of protocol pre-specified target OS events reached), and the HR was 1.11.

On September 15, 2024, we presented additional clinical data from initial topline results of SPLASH during the European Society of Medical Oncology Congress 2024.

On November 6, 2024, we announced that the second interim analysis performed at 75% of protocol pre-specified OS demonstrated results for both rPFS and OS that did not materially change from the interim analysis that was performed at 46% of pre-specified OS events.

Crossover adjusted analyses were post hoc, and we are continuing to review the data and perform additional subset analyses in collaboration with our partner in preparation for further interactions on our path forward.

• PNT2003 is an investigational SSTR therapy with non-carrier added lutetium-177, which is in registration to treat patients with SSTR-positive neuroendocrine tumors.

On January 11, 2024, we announced that our ANDA for PNT2003 was accepted for filing by the FDA.

On January 26, 2024, we were sued in the United States 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 the filing of our ANDA and Paragraph IV certification, consistent with the process established by the Hatch-Waxman Act.

• MK-6240 is an investigational second-generation F 18-labeled PET imaging agent that targets Tau tangles in Alzheimer’s disease.

MK-6240 is currently being used in more than 90 active clinical trials for several Alzheimer’s disease therapeutic candidates being developed.

On January 11, 2024, we announced that our ANDA for PNT2003, which included Paragraph IV certification, was accepted for filing by the FDA.

Pursuant to the procedure set forth in the Hatch Waxman Act, we were sued for patent infringement by Advanced Accelerator Applications USA, Inc.

and Advanced Accelerator Applications SA, each a Novartis entity.

See Part I, Item 1.

“Business - Other Notable Transactions - Exclusive License for PNT2002 & PNT2003 - PNT2003,” for more information on the litigation.

• LNTH-1363S is an investigational fibroblast activation protein, alpha targeted, copper-64 labeled PET imaging agent candidate that we believe could have broad potential imaging applicability and use in oncology.

Recently, we completed a Phase 1 study for LNTH-1363S to evaluate the pharmacokinetics, biodistribution and radiation dosimetry in adult healthy volunteers.

• 1095 (also known as 131 I-MIP-1095) is an investigational PSMA-targeted iodine-131-labeled small molecule that is designed to deliver a dose of beta radiation directly to prostate cancer cells with minimal impact on the surrounding healthy tissues.

We enrolled the last patient in our ARROW Phase 2 study during the second quarter of 2022.

Patients in this study will be followed for one year after their first treatment for all efficacy endpoints and survival and safety data will be collected for an additional year.

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.

• LNTH-2401 , also known as 68Ga-DOTA-RM2, is a novel radiodiagnostic targeting the gastrin-releasing peptide receptor.

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 intend to begin a Phase 1/2a study with LNTH-2402 in prostate cancer patients in 2025.

• LNTH-2403 , also known as LRRC15, is a leucine-Rich Repeat-Containing Protein 15 targeted radiotherapeutic.

It received Orphan Drug and Rare Pediatric Disease designation from the FDA for the treatment of osteosarcoma.

• LNTH-2404 is a Trophoblast cell surface antigen-2 targeted radiotherapeutic designed to target TROP2, an intracellular calcium signal transducer that is overexpressed in various types of adenocarcinomas with minimal expression in normal tissues and is associated with tumor aggressiveness, poor prognosis and drug resistance.

For the years ended December 31, 2024, 2023 and 2022, we invested $168.1 million, $77.7 million and $311.7 million in research and development (“R&D”), respectively, primarily related to our clinical development candidates.

In addition to our clinical development group, our R&D team also includes our Medical Affairs and Medical Information functions, which educate physicians on the scientific aspects of our commercial products and the approved indications.

In addition to our clinical development group, our R&D team also includes our Medical Affairs, Regulatory, Clinical Operations, Research and Pharmaceutical Development, and Isotope Strategy functions.

See Part I, Item 1A.

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DEFINITY (or LUMINITY) Australia, Canada, China, European Union, European Economic Area, Israel, New Zealand, United Kingdom, United States

DEFINITY RT United States

TechneLite Australia, Canada, Colombia, Costa Rica, South Korea, Taiwan, United States

NEUROLITE Australia, Belgium, Canada, Costa Rica, Denmark, France, Hong Kong, Italy, Japan, Luxembourg, South Korea, Spain, Taiwan, United States

TechneLite Australia, Canada, Colombia, South Korea, Taiwan, United States

NEUROLITE Australia, Austria, Belgium, Canada, Costa Rica, Denmark, France, Germany, Hong Kong, Italy, Japan, Luxembourg, South Korea, Spain, Taiwan, United States

Xenon United States

CARDIOLITE Australia, Canada, Israel, Japan, New Zealand, South Korea, Taiwan, United States

Strategic Partnerships and Other Revenue

RELISTOR (Solution for Injection 12 mg/0.6 mL vial) Austria, Belgium, Bulgaria, Canada, Switzerland, Cypress, Czechia, Germany, Denmark, Estonia, Greece, Spain, Finland, France, Croatia, Hungary, Ireland, Iceland, Italy, Liechtenstein, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, United Kingdom, United States

RELISTOR (Solution for Injection in pre-filled syringe 8mg and pre-filled syringe 12 mg) Austria, Belgium, Bulgaria, Canada, Cypress, Czechia, Germany, Denmark, Estonia, Greece, Spain, Finland, France, Croatia, Hungary, Ireland, Iceland, Italy, Liechtenstein, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, United Kingdom, United States

RELISTOR (methylnaltrexone bromide) Oral Tablet 140 mg United States

*Approved under the name PYLCLARI and licensed to Curium.

With respect to our medical devices:

• Progenics received CE marking for the standalone workstation model of aBSI, meeting the quality standards set by the European Economic Area.

• Progenics received a CE mark for the standalone workstation model of aBSI, meeting the quality standards set by the European Economic Area.

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 CE marking in Europe for aPROMISE.

and received a CE mark in Europe for aPROMISE.

We launched aPROMISE under the name PYLARIFY AI in the U.S.

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through an internal DEFINITY sales team.

While a small portion of our nuclear imaging product sales in the U.S.

are generated through our internal sales force to hospitals and clinics that maintain their own in-house radiopharmaceutical preparation capabilities, we primarily sell our nuclear imaging products, including TechneLite, NEUROLITE, Xenon, and CARDIOLITE, to large radiopharmacy chains.

While a small portion of our SPECT product sales in the U.S.

are generated through our internal sales force to hospitals and clinics that maintain their own in-house radiopharmaceutical preparation capabilities, we primarily sell our SPECT products, including TechneLite, NEUROLITE, Xenon, and CARDIOLITE, to large radiopharmacy chains.

We have licensed RELISTOR to Bausch, and while we have sold the right to our RELISTOR net sales royalties under our license agreement, we have retained the rights to future sales-based milestone payments generated by Bausch.

Flurpiridaz F-18 is licensed to GE Healthcare, which is commercializing it as Flyrcado in the United States.

We are entitled to milestone and royalty-based payments for Flyrcado.

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.

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Orders included in backlog may be canceled or rescheduled by customers at any time with the exception of TechneLite orders.

For TechneLite, customers must provide us with four weeks advanced notice to cancel an order.

TechneLite customers must provide us with four weeks advanced notice to cancel an order.

We do not believe that our backlog at any particular time is meaningful because it has historically been immaterial relative to our consolidated revenues and is not necessarily indicative of future revenues for any given period.

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Our 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 Diagonstics Ltd.

(“Blue Earth”), a subsidiary of Bracco Diagnostics Inc.

• For PYLARIFY, our principal competitors are currently Telix Pharmaceuticals Limited, Novartis AG, and Blue Earth Diagnostics Ltd., a subsidiary of Bracco Diagnostics Inc.

and there is the potential for future competition from others who may submit regulatory applications in anticipation of PYLARIFY’s NCE exclusivity expiry in 2026.

• For DEFINITY, our competitors currently include GE Healthcare and Bracco.

• For a number of our SPECT radiopharmaceutical commercial products, our competitors currently include Curium, GE Healthcare, Bracco and Jubilant Life Sciences, an affiliate of JHS and Jubilant Radiopharma, and potentially BWXT Medical.

The markets into which any of our product candidates would be launched, if approved, are also highly competitive and continually evolving.

• For PNT2002 and 1095, our principal competitors may include Novartis AG;

Telix Pharmaceuticals Limited;

and Curium, each of which has commercialized products or product candidates in advanced clinical stage of development.

• For PNT2003, our principal competitor may include Novartis AG;

• For a number of our SPECT products, our competitors currently include Curium, GE Healthcare, Bracco, and Jubilant Life Sciences, an affiliate of JHS and Jubilant Radiopharma, and potentially BWXT Medical.

Any product candidates that we successfully develop and commercialize will compete with existing products and new products that may become available in the future.

For example, for PNT2003, our principal competitors may include Novartis AG;

ITM Radiopharma;

and RayzeBio (under agreement to be acquired by Bristoll Meyers Squibb), each of which has commercialized products or product candidates in advanced clinical stage development.

• For MK-6240, our principal competitors may include Eli Lilly and Company and Life Molecular Imaging, each of which has commercialized products or product candidates in advanced clinical stage of development.

• For LNTH-1363S, our principal competitors may include Sofie Bioscience;

GE Healthcare;

and Novartis AG, each of which has product candidates in clinical stage of development.

We cannot anticipate the actions of our current or future competitors in the same or competing therapeutic and diagnostic modalities, such as significant price reductions on products that are comparable to our own, development of new products or other technologies that are more cost-effective or have superior performance than our current products or the introduction of generic versions after our proprietary products lose their patent protection.

In addition, distributors of our products could attempt to shift end-users to competing modalities and products, or bundle the sale of a portfolio of products, to the detriment of our specific products.

Curium, and RayzeBio (acquired by Bristol Myers Squibb).

For MK-6240 and NAV-4694, our principal competitors may include Lilly and GE Healthcare.

We cannot anticipate the actions of our current or future competitors in the same or competing modalities, such as significant price reductions on competitive products, development of new products that are more cost-effective or have superior performance than our current or future products, or the introduction of generic versions after our proprietary products lose their patent or regulatory exclusivity protection.

In addition, distributors of our products could attempt to shift end-users to competing modalities and products, or bundle the sale of a portfolio of products, in either case to the detriment of our specific products.

Our current or future products could be rendered obsolete or uneconomical as a result of these activities.

Further, the radiopharmaceutical and biopharmaceutical industry continues to evolve strategically, with several market participants recently sold.

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.

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), government reimbursement policies, such as TPT Status, and group purchasing arrangements.

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Due to the specialized nature of our products and the limited, and sometimes intermittent, supply of raw materials available in the market, we have established relationships with several key suppliers.

For the year ended December 31, 2023, our largest suppliers of raw materials and supplies were Institute for Radioelements (“IRE”), the Australian Nuclear Science and Technology Organisation (“ANSTO”) and NTP Radioisotopes (“NTP”), which, in the aggregate, accounted for approximately 9.3% of our total purchases.

For the year ended December 31, 2024, our largest suppliers of raw materials and supplies were Institute for Radioelements (“IRE”), the Australian Nuclear Science and Technology Organisation (“ANSTO”), and NTP Radioisotopes (“NTP”), which, in the aggregate, accounted for approximately 7.8% of our total purchases and relate specifically to TechneLite.

Molybdenum-99

Our TechneLite, CARDIOLITE and NEUROLITE products all rely on Mo-99, the radioisotope which is produced by bombarding uranium with neutrons in research reactors.

With a 66-hour half-life, Mo-99 decays into, among other things, Tc-99m, another radioisotope with a half-life of six hours.

Tc-99m is the isotope that is attached to radiopharmaceuticals, including our own NEUROLITE and CARDIOLITE, during the labeling process and is the most common radioisotope used for medical diagnostic imaging purposes.

With a 66-hour half-life, Mo-99 decays into, among other things, Tc-99m, a radioisotope with a half-life of six hours.

Tc-99m is an isotope that is attached to radiopharmaceuticals, including our own NEUROLITE and CARDIOLITE, during the labeling process and is the most common radioisotope used for medical diagnostic imaging purposes.

We currently purchase finished Mo-99 from three of the four main processing sites in the world, namely IRE in Belgium, NTP in South Africa and ANSTO in Australia.

These processing sites provide us Mo-99 from five of the six main Mo-99-producing reactors in the world, namely BR2 in Belgium, LVR-15 in the Czech Republic, HFR in The Netherlands, SAFARI in South Africa and OPAL in Australia.

Our agreement with IRE (the “IRE Agreement”) contains minimum percentage volume requirements and unit pricing.

The IRE Agreement also requires IRE to provide certain favorable allocations of Mo-99 during periods of supply shortage or failure.

The IRE Agreement allows for termination upon the occurrence of certain events, including failure by IRE to provide our required amount of Mo-99, material breach of any provision by either party, bankruptcy by either party or force majeure events.

The IRE Agreement expires on December 31, 2024, and automatically renews on an annual basis thereafter, subject to prior notice of non-renewal by either party.

Our agreement with NTP (the “NTP Agreement”), with NTP acting for itself and on behalf of its subcontractor ANSTO, specifies our percentage purchase requirements and unit pricing, and provides for the supply of Mo-99.

The NTP Agreement allows for termination upon the occurrence of certain events, including failure by NTP to provide our required amount of Mo-99, material breach of any provision by either party, bankruptcy by either party or force majeure events.

The NTP Agreement expires on December 31, 2024.

Although we have a globally diverse Mo-99 supply with IRE in Belgium, NTP in South Africa, and ANSTO in Australia, we still face supplier and logistical challenges in our Mo-99 supply chain.

When one supplier experiences outages, we generally rely on Mo-99 supply from the other suppliers to limit the impact of the outages.

Although we believe we have the most globally diverse Mo-99 supply, we still face supplier and logistical challenges in our Mo-99 supply chain.

When one supplier experiences outages, we generally rely on other suppliers to limit the impact of the outages.

We believe we effectively manage these various supply chain challenges, but depending on reactor and processor schedules and operations, at times we have not been able to fill some or all of the demand for our TechneLite generators on certain manufacturing days.

A prolonged disruption of service from one of our three Mo-99 processing sites or one of their main Mo-99-producing reactors could have a substantial negative effect on our business, results of operations, financial condition and cash flows.

A prolonged disruption of service from one of our three Mo-99 processing sites or one of their main Mo-99-producing reactors could have a negative effect on our business, results of operations, financial condition and cash flows.

Xenon is a by-product of the Mo-99 production process.

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Other Materials

We have additional supply arrangements for active pharmaceutical ingredients, excipients, packaging materials and other materials and components, none of which are exclusive, but a number of which are sole source, and all of which we currently believe are either in good standing or replaceable without any material disruption to our business.

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.

“Risk Factors” for information regarding certain risks associated with our raw materials and supply arrangements.

“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 required us to create a field-based network of specialized PMFs with radioisotope-producing cyclotrons.

The commercial manufacture of PYLARIFY requires us to create a field-based network of specialized PMFs with radioisotope-producing cyclotrons.

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 then combined with certain chemical ingredients in specially designed chemistry synthesis boxes to manufacture PYLARIFY.

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 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.

We have a specialized in-house manufacturing facility at our North Billerica campus for purposes of producing the formulation of DEFINITY that requires refrigerated storage and, potentially, other sterile vial products.

On February 22, 2022, we received FDA

approval of our sNDA, authorizing commercial manufacturing of DEFINITY at our new facility.

We have a specialized in-house FDA-approved manufacturing facility at our North Billerica campus for purposes of producing DEFINITY.

On February 22, 2022, we received FDA approval of our sNDA, authorizing commercial manufacturing of DEFINITY at our new facility.

DEFINITY manufactured at this facility became commercially available on February 23, 2022.

We believe this investment provides supply chain redundancy, improved flexibility and reduced costs in a potentially more price competitive environment.

We also manufacture TechneLite on an automated production line and we process and finish Xenon on a hot cell line at our North Billerica, Massachusetts facility.

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 either ground or air custom logistics.

We believe that our substantial capital investments in our automated generator production line and our other manufacturing assets, which we have made over the years, and our extensive experience in complying with the stringent regulatory requirements for the handling of nuclear materials and operations in a highly regulated environment, create significant and sustainable competitive advantages for us.

We manufacture TechneLite on an automated production line and we process and finish Xenon on a hot cell line at our North Billerica, Massachusetts facility.

In addition to our in-house manufacturing capabilities, a substantial portion of our products are manufactured by third party contract manufacturing organizations, and in certain instances, we rely on them for sole source manufacturing.

To ensure the quality of the products that are manufactured by third parties, the key raw materials used in those products are first sent to our North Billerica, Massachusetts facility, where we test them prior to the third party manufacturing of the final product.

To ensure the quality of the products that are manufactured by third parties, certain of the key raw materials used in those products are first sent to our North Billerica, Massachusetts facility, where we test them prior to the third party manufacturing of the final product.

For many of our products, after the final products are manufactured, they are sent back to us for final quality control testing, and then we ship them to our customers.

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• PYLARIFY —We have entered into commercial supply agreements with different PMF networks.

Our agreements with our PMF networks allow for the termination upon the occurrence of specified events, including material breach or bankruptcy by either party, and have various termination dates generally terminating between 2025 and 2030 and are subject to renewal provisions.

Our agreements with our PMF networks allow for termination upon the occurrence of specified events, including material breach or bankruptcy by either party, and have various termination dates generally terminating between 2027 and 2030 and subject to renewal provisions.

• DEFINITY, CARDIOLITE and NEUROLITE —In February 2022, we entered into a Manufacturing and Supply Agreement with JHS, for the manufacture of DEFINITY, CARDIOLITE, NEUROLITE and evacuation vials, the latter being an ancillary component for our TechneLite generators.

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The agreement allows for termination upon the occurrence of certain events such as a material breach or default by either party, or bankruptcy by either party.

The agreement also requires us to order from JHS a specified minimum percentage of our requirements for DEFINITY and fixed quantities of CARDIOLITE and NEUROLITE each year during the contract term.

The agreement also requires us to order from JHS a specified minimum percentage of our total requirements for DEFINITY, as well as specified quantities of CARDIOLITE, NEUROLITE and evacuation vial products, each year during the contract term.

See Part I, Item 1A.

“Risk Factors” for information regarding certain risks associated with our manufacturing and supply relationships.

Intellectual Property

“Risk Factors” of this Form 10-K for information regarding certain risks associated with our manufacturing and supply relationships.

Intellectual Property Matters

Patents, trademarks and other intellectual property rights, both in the U.S.

and foreign countries, are very important to our business.

We also rely on trade secrets, manufacturing know-how, technological innovations, licensing agreements and confidentiality agreements to maintain and improve our competitive position.

We also rely on trade secrets, manufacturing know-how, technological innovations, licensing agreements and confidentiality agreements and regulatory exclusivities to maintain and improve our competitive position.

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.

Our ability to enforce, defend and protect our intellectual property rights may be limited in certain countries outside the U.S., which could make it easier for competitors to capture market position in those countries by utilizing technologies that are similar to those developed or licensed by us.

Competitors also may harm our sales by designing products that mirror the capabilities of our products or technology without infringing our intellectual property rights.

If we do not obtain sufficient protection for our intellectual property, or if we are unable to effectively enforce or defend our intellectual property rights or our freedom to operate, our competitiveness could be impaired, which would limit our growth and future revenue.

If we elect to enforce our intellectual property rights, or are required to defend our rights, we could incur significant litigation expense.

Description of Patent Rights

Patents grant the legal right to exclude others from practicing an invention.

In the United States, patent rights prohibit (subject to certain exceptions) others from making, using, selling, offering for sale, or importing the claimed invention without the permission of the patentee.

Patent rights are territorial and must be obtained in every jurisdiction in which protection is desired.

The legal requirements for obtaining a patent vary by jurisdiction and can include the requirement that the claimed subject matter is new (novel) and nonobvious (or inventive).

Other requirements, depending on jurisdiction, can include that the invention be adequately described so as to enable others to make and use it, and that the inventors be properly identified.

Patent rights are defined by the claims set forth in the granted patent, which define the scope of the right to exclude others from practicing the patented invention.

Patent infringement arises when a third party practices without authorization, each element of the claims set forth in the granted patent.

It is also possible to indirectly infringe a patent, such as by inducing a third party to directly infringe the patent, or by contributorily infringing by making a material component of the invention that is not subject to any substantial non-infringing use.

Duration of Patent Rights

Patents are granted for limited periods of time.

In the United States, the standard patent term is 20 years from the earliest nonprovisional filing to which the patent claims priority.

The patent term can be extended as a result of delays in the patent office, resulting in patent term adjustment.

In addition, patent term extension can compensate for time lost during product development and the regulatory review process by returning up to five years of patent life for a patent that covers a new product or its use.

Patent Litigation

Patent rights are not self-executing and may need to be asserted, such as through litigation.

Litigation typically starts when a patentee sues a defendant alleging infringement of one or more patents.

It can also occur when the target of a perceived patent assertion preemptively files a lawsuit, a so-called declaratory judgment action, seeking a declaration by a court that it does not infringe a patent or that the patent is invalid.

In the United States, patent litigation is conducted in federal district court with a right of appeal to the United States Court of Appeals for the Federal Circuit, and discretionary review by petition to the Supreme Court of the United States.

In the United States, patent cases are generally tried to a jury, with the exception of Hatch-Waxman cases, discussed below, which are tried to a judge.

The judge determines the meaning of disputed claim terms during a process called claim construction.

Patent litigation can be expensive and burdensome, both in terms of time, money, and company resources.

The outcome of patent litigation is always uncertain to varying degrees.

The subject matter is often highly technical and difficult for lay juries, and judges, to understand.

Context is provided by dueling experts about whom the fact-finder must make credibility determinations.

The issue of infringement frequently turns on the construction (interpretation) of particular claim language during a process culminating in a so-called “ Markman Order.”

During patent litigation, the validity of the patents is almost always challenged, because invalidity is a defense to infringement.

Although a patent is presumed valid, this presumption can be overcome by clear and convincing evidence.

In the United States, typical grounds for challenge include lack of novelty or obviousness by introducing evidence of relevant “prior art,” referring to activity that pre-dated the relevant priority dates of the challenged patents.

During litigation, patent challengers often devote significant resources to identifying prior art from repositories around the world, often far exceeding the search capacities and budgets of the patent offices that conducted screening searches before issuing the patents in the first instance.

Other grounds of challenge in the United States include lack of written description and enablement, generally alleging that the full scope of the claimed invention was either not in the possession of the inventor of the time of filing or that one of skill in the art would not have been able to practice the full scope of the invention without undue experimentation.

Both of these inquiries are highly fact-specific.

Improper inventorship can be the basis for an invalidity challenge, as can an allegation that the patent is not the subject of statutory subject matter, which is known as a so-called “Section 101” challenge.

Although patent infringement actions are tried in district courts, patent validity can also be challenged in special proceedings before the U.S.

Patent and Trademark Office (“USPTO”), such as Inter Partes Reviews and Post-Grant Reviews.

Patent-related Aspects of Regulatory Matters

The FDA approval process for drugs is described below, including new drug applications (“NDAs”) for innovator drugs, ANDAs for generics, and 505(b)(2) applications for modifications to formulations or uses of products previously approved by the FDA.

See “ Regulatory Matters” below for more information.

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.

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.

An FDA approved drug relied upon for comparison is referred to as a “reference listed drug” (“RLD”) and may be cited by potential competitors in support of approval of an ANDA or 505(b)(2) application.

See “Regulatory Matters – Hatch-Waxman Act” below for more information.

With respect to any RLD patents listed in the Orange Book, the applicant must certify to one of the following four items:

(i) the required patent information has not been filed;

(ii) the listed patent has expired;

(iii) the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration;

or (iv) the listed patent is invalid or will not be infringed by the new drug.

A certification to the fourth item (a so-called a Paragraph IV certification) constitutes a technical act of patent infringement under the U.S.

Patent Laws, which can give rise to litigation to determine whether or not the product, if approved and launched, would infringe the listed patents, and whether those patents are invalid.

The applicant may also elect to submit a "section viii" statement certifying that its proposed label does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent.

The first company or companies to submit an application that (1) is determined by the FDA to be “substantially complete” upon submission and (2) contains a paragraph IV certification to at least one of the patents listed in the Orange Book is generally eligible for the exclusive right to market the generic drug for 180 days.

After filing a Paragraph IV certification, the applicant has 45 days from filing to submit a “Notice Letter” to the Orange Book patent holder.

The patent holder can then sue for infringement.

The resulting litigation is known as Hatch-Waxman litigation.

If the patent holder sues for infringement within 45 days of receiving this Notice Letter, the FDA cannot approve the application for 30 months (the so-called “30 month stay”), unless the patents expire in the interim, the lawsuit is settled, or there is decision on the merits favorable to applicant.

Independent of the 30-month stay, the FDA also will not approve a 505(b)(2) NDA or an ANDA application that references an RLD until any applicable non-patent exclusivity listed in the Orange Book for the respective RLD has expired.

See “Regulatory Matters – Hatch-Waxman Act” below for more information.

Trademarks, Service Marks and Trade Names

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and/or numerous foreign jurisdictions.

We actively seek to protect the proprietary technology that we consider important to our business, including chemical species, compositions and formulations, their methods of use and processes for their manufacture, as new intellectual property is developed.

In addition to seeking patent protection in the U.S., we file patent applications in numerous foreign countries in order to further protect the inventions that we consider important to the development of our international business.

We also rely upon trade secrets and contracts to protect our proprietary information.

We have patent protection on certain of our commercial products and clinical development candidates.

Trade Secrets

We possess considerable know-how, including trade secrets from which we derive commercial value.

In addition to patents, we rely, where necessary, upon unpatented trade secrets and know-how, proprietary information and continuing technological innovation to develop and maintain our competitive position.

We seek to protect our proprietary information, in part, using confidentiality agreements with our collaborators, employees, consultants and other third parties and invention assignment agreements with our employees.

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.

All patent terms described below are presented without giving effect to any applicable patent term adjustments or regulatory extensions.

PYLARIFY - We actively pursue patents in connection with PYLARIFY, both in the U.S.

and internationally.

for PYLARIFY, we have five Orange Book-listed patents, including composition of matter patents, the last of which expire in 2037.

Outside of the U.S., we have, and are currently pursuing, additional PYLARIFY patents to obtain similar patent protection as in the U.S.

DEFINITY - We continue to actively pursue additional patents in connection with DEFINITY and DEFINITY RT, both in the U.S.

In addition, a list of Orange Book-listed patents, together with expiration dates, and applicable regulatory exclusivity can be obtained from the FDA through its website.

Further comments on selected IP assets are below:

PYLARIFY — A portfolio of patents protects PYLARIFY, both in the U.S.

and internationally, and we continue to pursue additional patent protection.

Currently, there are six Orange Book-listed patents for PYLARIFY.

Our longest duration Orange Book-listed PYLARIFY patent extends until June 2037.

The NCE-1 date for PYLARIFY is May 26, 2025.

As described below, this is the date after which the FDA is allowed to accept an ANDA or 505(b)(2) applications from generic challengers.

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.

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.

for DEFINITY RT, we have eight Orange Book-listed patents, including two composition of matter patents which expire in 2035.

Outside of the U.S., we are currently pursuing additional DEFINITY and DEFINITY RT patents to obtain similar patent protection as in the U.S.

The Orange Book-listed patents include a patent on the use of VIALMIX RFID which expires in 2037;

additional VIALMIX RFID patent applications have been submitted in major markets throughout the world.

Under the Hatch-Waxman Act, the FDA can approve ANDAs for generic versions of drugs if the ANDA applicant demonstrates, among other things, that (i) its generic candidate is the same as the innovator product by establishing bioequivalence and providing relevant chemistry, manufacturing and product data, and (ii) either the marketing of that generic candidate does not infringe the Orange Book-listed patent(s) or the Orange Book-listed patent(s) is invalid.

Similarly, the FDA can approve a Section 505(b)(2) NDA from an applicant that relies on some of the information required for marketing approval to come from studies which the applicant does not own or have a legal right of reference.

With respect to the Orange Book-listed patent(s) covering an innovator product, the ANDA applicant or the Section 505(b)(2) applicant (if relying on studies related to the innovator product) (together, the “Applicant”) must give a notice (a “Notice”) to the innovator of its certification that its generic candidate will not infringe the innovator’s Orange Book-listed patent(s) or that the Orange Book-listed patent(s) is invalid.

The innovator can then file suit against the Applicant within 45 days of receiving the Notice, and FDA approval to commercialize the generic candidate will be stayed (that is, delayed) for up to 30 months (measured from the date on which a Notice is received) while the patent dispute between the innovator and the Applicant is resolved in court.

The 30-month stay could potentially expire sooner if the courts determine that no infringement had occurred or that the challenged Orange Book-listed patent is invalid or if the parties otherwise settle their dispute.

Submission of an ANDA with a Paragraph IV certification can result in protracted and expensive patent litigation.

As of the date of filing of this Annual Report on Form 10-K, we have not received any Notice from an Applicant.

If we were to (i) receive any such Notice in the future, (ii) bring a patent infringement suit against the Applicant within 45 days of receiving that Notice, and (iii) successfully obtain the full 30-month stay, then the Applicant would be precluded from commercializing a generic version of DEFINITY prior to the expiration of that 30-month stay period and, potentially, thereafter, depending on how the patent dispute is resolved.

Solely by way of example and not based on any knowledge we currently have, if we received a Notice from an Applicant in March 2024 and the full 30-month stay were obtained, then the Applicant would be precluded from commercialization until at least September 2026.

If we received a Notice some number of months in the future and the full 30-month stay were obtained, the commercialization date would roll forward in the future by the same number of months.

In the event a 505(b)(2) applicant does not rely on studies related to the innovator product, the 30-month stay would not apply, but additional clinical trials may be required.

Currently, there are nine Orange Book-listed patents for DEFINITY.

Our longest duration Orange Book-listed DEFINITY patent extends until May 2037.

TechneLite — We currently own patents in the U.S.

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In addition, given the significant know-how and trade secrets associated with the methods of manufacturing and assembling the TechneLite generator, we believe we have a substantial amount of valuable and defensible proprietary intellectual property associated with the product.

PYLARIFY AI - U.S.

Patents and pending patent applications worldwide relating to automated medical image analysis, have expiration ranging from 2037 to 2041.

Other Nuclear Products - Neither CARDIOLITE nor NEUROLITE is covered any longer by patent protection in either the U.S.

or the rest of the world.

We have patent protection in the U.S.

that expires in October 2035 for an improved container for Xenon, and are pursuing similar patent protection outside the U.S.

aPROMISE — U.S.

Patents and pending patent applications worldwide relating to automated medical image analysis, have expiration dates ranging from 2037 to 2041.

Other Nuclear Products — Neither CARDIOLITE nor NEUROLITE is covered any longer by patent protection.

We have patent protection for an improved container for Xenon in the U.S., Canada and Australia that expires in October 2035.

aBSI — We own patents relating to automated detection of bone cancer metastases.

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and worldwide relating to aBSI improvements, which have expiration ranging from 2040 to 2041.

flurpiridaz - We own patents and patent applications in numerous jurisdictions covering composition, use, formulation and manufacturing, including in the U.S.

flurpiridaz (Flyrcado) — We own patents and patent applications in numerous jurisdictions covering composition, use, formulation, and manufacturing, including in the U.S.

a composition of matter patent expiring in 2026, a formulation patent expiring in 2032, a method-of-use patent expiring in 2028, and manufacturing-related patents expiring in 2031 and 2033, and various patent applications, some of which, if granted, will expire in 2033.

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MK-6240 — We exclusively license patents directed to composition of matter and methods of use of MK-6240 which expire in 2035.

1095 - We own patents relating to 1095, with the composition of matter patent as well as radiolabeled forms patent in the U.S.

and Europe expiring in 2027.

Additional U.S.

patents that we own for stable compositions and radiolabeling processes expire, respectively, in 2030 and 2031.

NAV-4694 — We exclusively license patents directed to composition of matter and methods of use of NAV-4694 which expire in 2029.

LNTH-1363S — We exclusively license patent applications directed to compositions of matter and methods of use of LNTH-1363S.

If granted, the last patent will expire in 2043.

NM-01 - We exclusively license in the field of imaging, patents and applications directed to compositions of matter of NM-01.

The granted U.S.

patents expire in 2037.

1404 - We own patents relating to composition of matter, as well as technetium-99 labeled forms of 1404 expiring in the U.S.

from 2029 to 2030, and expiring worldwide in 2029.

In addition, we license third-party technologies and other intellectual property rights that are incorporated into some elements of our drug discovery and development efforts.

Some of these licenses are material to our business – for example, the licenses on the PYLARIFY patent family from Johns Hopkins University (“JHU”).

See Part I, Item 1A.

“Risk Factors” for information regarding certain risks associated with our intellectual property.

“Risk Factors” of this Form 10-K for information regarding certain risks associated with our intellectual property.

Regulatory Matters

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Nuclear Regulatory Commission (“NRC”), the U.S.

Department of Health and Human Services (“HHS”), Health Canada, the European Medicines Agency (“EMA”), the U.K.

Medicines and Healthcare Products Regulatory Agency (“MHRA”), the NMPA and various state and provincial boards of pharmacy, state and provincial controlled substance agencies, state and provincial health departments and/or comparable state and provincial agencies, as well as foreign agencies, and certain accrediting bodies depending upon the type of operations and location of product distribution, manufacturing and sale.

Department of Health and Human Services, Health Canada, the European Medicines Agency, the U.K.

Medicines and Healthcare Products Regulatory Agency, the NMPA and various state and provincial boards of pharmacy, state and provincial controlled substance agencies, state and provincial health departments and/or comparable state and provincial agencies, as well as foreign agencies, and certain accrediting bodies depending upon the type of operations and location of product distribution, manufacturing and sale.

The FDA and various state regulatory authorities regulate the research, testing, manufacture, safety, labeling, storage, recordkeeping, premarket approval, marketing, advertising and promotion, import and export, and sales and distribution of pharmaceutical products in the U.S.

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• 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;

• 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;

• FDA review and approval of the NDA.

• FDA review and approval of the NDA or ANDA.

The testing and approval process requires substantial time, effort, and financial resources, and we cannot be certain that any approvals for our products in development will be granted on a timely basis, if at all.

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Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.

The FDA or the clinical trial sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being

exposed to an unacceptable health risk.

The FDA or the clinical trial sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.

Similarly, any IRB serving any of the institutions participating in the clinical trial can suspend or terminate approval of a clinical trial at an institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product has been associated with unexpected serious harm to patients.

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In the United States, Orphan Drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers.

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 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.

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.

Any drug products for which we receive FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, complying with certain electronic records and signature requirements, and complying with FDA promotion and advertising requirements.

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The FDA may withdraw marketing authorization for a product if compliance with regulatory standards is not maintained or if problems occur after the product reaches the market.

The exercise of broad regulatory powers by the FDA continues to result in increases in the amount of testing and documentation required for approval or clearance of new drugs and devices, all of which add to the expense of product introduction and the cost of continuing to make an approved drug or device available.

Later discovery of previously-unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.

Further, the failure to maintain compliance with regulatory requirements may result in administrative or judicial actions, such as fines, civil monetary penalties, warning letters, holds on clinical trials, product recalls or seizures, product detention or refusal to permit the import or export of products, refusal to approve pending applications or supplements, restrictions on marketing or manufacturing, injunctions, or civil or criminal penalties.

Regulations are subject to change as a result of legislative, administrative or judicial action, which may also increase our costs or reduce sales or otherwise adversely impact our products.

For example, on April 16, 2021 in the case Genus Medical Technologies LLC v.

Food and Drug Administration, the U.S.

Court of Appeals for the D.C.

Circuit held that a product (other than a combination product) that meets the definitions of both “drug” and “device” under the FDCA must be regulated as a device.

On August 9, 2021, the FDA announced that, as part of its implementation of this court decision, the FDA intended to regulate products that meet both the device and drug definition as devices, except where Congress intended a different classification.

The FDA further indicated that it intended to bring previously classified products into line with the court decision and would reexamine whether individual imaging agents meet the device definition, which raised uncertainty as to how our some of our products would be regulated.

Congress subsequently resolved this issue when it passed the Consolidated Appropriations Act of 2023, which amended the FDCA by adding a provision that deemed any contrast agent or radioactive drug to be a drug.

In addition, regulations are subject to change as a result of legislative, administrative or judicial action, which may also increase our costs or reduce sales or otherwise adversely impact our products.

Because our operations include the manufacture and distribution of medical radioisotopes and other medical products, we are subject to regulation by the NRC and the departments of health of each state in which we operate and the applicable state boards of pharmacy.

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Pharmacopeia requirements for PET drug compounding.

Drug laws also are in effect in many of the non-U.S.

Drug laws also are in effect in the non-U.S.

markets in which we or our partners conduct business.

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In addition, inspection of and controls over manufacturing, as well as monitoring of adverse events, are components of most of these regulatory systems.

Most of our business is subject to varying degrees of governmental regulation in the countries in which we or our partners operate, and the general trend is toward increasingly stringent regulation.

Similar trends also are evident in major non-U.S.

markets, including Canada, the European Union, Australia and Japan.

Our business is subject to varying degrees of governmental regulation in the countries in which we or our partners operate, and the general trend is toward increasingly stringent regulation.

To assess and facilitate compliance with applicable FDA, NRC and other state, federal and foreign regulatory requirements, we regularly review our quality systems to assess their effectiveness and identify areas for improvement.

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First, the Hatch-Waxman Act permits the FDA to approve ANDAs for generic versions of drugs if the ANDA applicant demonstrates, among other things, that its product is bioequivalent to the innovator product and provides relevant chemistry, manufacturing and product data.

Business - Patents.” Second, the Hatch-Waxman Act created what is known as a Section 505(b)(2) NDA, which requires the same information as a full NDA (known as a Section 505(b)(1) NDA), including full reports of clinical and preclinical studies but allows some of the information from the reports required for marketing approval to come from studies which the applicant does not own or have a legal right of reference.

A Section 505(b)(2) NDA permits a manufacturer to obtain marketing approval for a drug without needing to conduct or obtain a right of reference for all of the required studies.

See “Intellectual Property Matters,” above for more information.

Second, the Hatch-Waxman Act created what is known as a Section 505(b)(2) NDA, which requires the same information as a full NDA (known as a Section 505(b)(1) NDA), including full reports of clinical and preclinical studies but allows some of the information from the reports required for marketing approval to come from studies which the applicant does not own or have a legal right of reference.

A Section 505(b)(2) NDA permits a manufacturer to obtain marketing approval for a drug without needing to conduct or obtain a right of reference for all of the studies that would be required for a Section 505(b)(1) NDA submission.

Under the Hatch-Waxman Act, the FDA can approve ANDAs for generic versions of drugs before the expiration of an Orange Book-listed patent covering the innovator product if the ANDA applicant demonstrates, among other things, that (i) its generic candidate is the same as the innovator product by establishing bioequivalence and providing relevant chemistry, manufacturing and product data, and (ii) either the marketing of that generic candidate does not infringe the Orange Book-listed patent(s) or the Orange Book-listed patent(s) is invalid.

An applicant submitting an application relying on either the ANDA or this Section 505(b)(2) approval pathway must also give Notice to the innovator, which would then enable the innovator to file suit against the applicant within 45 days of receiving the Notice.

If the innovator challenges the applicant in court in a timely manner, then FDA approval to commercialize the generic candidate will be stayed (that is, delayed) for up to 30 months while the dispute is resolved in court.

The 30-month stay can be shortened if the patent infringement suit is resolved in the applicant’s favor before the 30-month stay expires, and this may involve a successful challenge of the patent’s validity in USPTO proceedings and appeals process.

In the event a 505(b)(2) applicant does not rely on studies related to the innovator product, the 30-month stay would not apply, but additional clinical trials may be required by the FDA for approval.

We can give no assurance that we would have grounds to file a patent infringement suit, that we would obtain the full 30-month stay, that we would be successful on the merits asserting that an Applicant infringes our Orange Book-listed patent, or that we would be successful defending the validity of our Orange Book-listed patent in court or in a USPTO adversarial proceeding if a third party were to submit an ANDA or Section 505(b)(2) NDA application to the FDA in connection with one of our commercial products.

The Hatch-Waxman Act also provides for:

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Patent term extensions, however, are subject to a maximum extension of five years, and the patent term extension cannot extend the remaining term of a patent beyond a total of 14 years.

The application for patent term extension is subject to approval by the U.S.

Patent and Trademark Office in conjunction with the FDA.

The application for patent term extension is subject to approval by the USPTO in conjunction with the FDA.

The Hatch-Waxman Act also provides for a period of statutory protection for new drugs that receive NDA approval from the FDA.

If the FDA approves a Section 505(b)(1) NDA for a new drug that is a new chemical entity, meaning that the FDA has not previously approved any other new drug containing the same active moiety, then the Hatch-Waxman Act prohibits the submission or approval of an ANDA or a Section 505(b)(2) NDA for a period of five years from the date of approval of the NDA, except that the FDA may accept an application for review after four years under certain circumstances, specifically a patent challenge for one or more patents listed by the NDA holder in FDA’s publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”), submitted in a “Paragraph IV” Certification.

If the FDA approves a Section 505(b)(1) NDA for a new drug that is an NCE, meaning that the FDA has not previously approved any other new drug containing the same active moiety, then the Hatch-Waxman Act prohibits the submission or approval of an ANDA or a Section 505(b)(2) NDA for a period of five years from the date of approval of the NDA, except that the FDA may accept an application for review after four years under certain circumstances, specifically a patent challenge for one or more patents listed by the NDA holder in the Orange Book, submitted in a “Paragraph IV” Certification.

Because this four-year date occurs one year before the end of the five-year NCE exclusivity, it is commonly referred to as the “NCE-1” date.

The Hatch-Waxman Act will not prevent the filing or approval of a full NDA, as opposed to an ANDA or Section 505(b)(2) NDA, for any drug, but the competitor would be required to conduct its own clinical trials, and any use of the drug for which marketing approval is sought could not violate another NDA holder’s patent claims.

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Exclusion from or restriction in coverage can reduce product use.

For government payors, we participate, as required, in the Medicaid drug rebate program, the Federal Supply Schedule (FSS) and the Public Health Service Act 340B program, which each require discounts for participation and may be subject to change.

For Medicare, reimbursement to customers for our products is generally established through the rulemaking process or in discussion with Medicare Administrative Contractors (MACs).

For government payors, we participate, as required, in the Medicaid drug rebate program, the Federal Supply Schedule and the Public Health Service Act 340B program, which each require discounts for participation and may be subject to change.

For Medicare, reimbursement to customers for our products is generally established through the rulemaking process or in discussion with Medicare Administrative Contractors.

We have ongoing conversations with third-party payors to advocate for appropriate coding, coverage and payment for our portfolio of products.

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Part B of the Medicare program generally reimburses medical services and supplies, including drugs, provided to beneficiaries by physicians and other qualified healthcare professionals.

Generally, drugs furnished “incident to” a physician’s service in the hospital outpatient setting of care are reimbursed at Average Sales Price (“ASP”) plus a certain additional percent, unless the product is treated as a “supply” in the performance of the procedure and “packaged” and paid as part of bundled payment for the procedure.

Novel 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.

PYLARIFY has received TPT Status effective January 1, 2022 through December 31, 2024, thereby providing separate reimbursement to customers using PYLARIFY in the hospital outpatient setting during this specified period.

The reimbursement rate for PYLARIFY was initially based on the wholesale acquisition cost (WAC) plus three percent until ASP could be established.

Generally, drugs furnished “incident to” a physician’s service in the hospital outpatient setting of care are reimbursed at ASP plus a certain additional percent, unless the product is treated as a “supply” in the performance of the procedure and “packaged” and paid as part of bundled payment for the procedure.

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.

Since 2008, under the hospital outpatient program, diagnostic radiopharmaceuticals have been considered supplies and their payment bundled into the payment for the procedure after expiration of TPT Status.

In November 2024, CMS released the CMS 2025 OPPS Rule to pay separately for diagnostic radiopharmaceuticals, such as PYLARIFY, with a per day cost greater than $630, based on their MUC.

MUC differs from ASP as it is an indirect measure of a product’s cost based on hospital-reported claims data.

We believe MUC is a less accurate reflection of actual purchasing costs of the hospital.

PYLARIFY’s TPT Status was effective from January 1, 2022 through December 31, 2024, providing separate payment to customers using PYLARIFY in the hospital outpatient setting during that period.

Effective January 1, 2025, under the CMS 2025 OPPS Rule, CMS is maintaining separate payment for PYLARIFY for the approximately 20% of patients with traditional Medicare FFS insurance coverage who are treated in the hospital outpatient setting.

The reimbursement rate for PYLARIFY was initially based on the wholesale acquisition cost plus three percent until ASP could be established.

In 2023, CMS established an ASP for PYLARIFY and reimbursed at a rate equal to ASP plus an add-on percentage that varied throughout the year.

PYLARIFY has been assigned Healthcare Common Procedure Coding System code A9595 (piflufolastat F 18, diagnostic, 1 millicurie) for identification in claims and can be used by both public and private payors.

Under existing Medicare policy for the hospital outpatient setting of care, non-pass-through diagnostic radiopharmaceuticals are not separately paid and are instead packaged into payment for the underlying procedure.

Therapeutic radiopharmaceuticals are paid separately by Medicare OPPS regardless of TPT Status.

We plan to continue our advocacy efforts with CMS and private insurers so that PYLARIFY customers will have appropriate and adequate reimbursement following the expiration of TPT Status.

We are also supporting trade associations in their efforts to have Congress pass the Facilitating Innovative Nuclear Diagnostics (FIND) Act, which would allow for separate payment for certain diagnostic radiopharmaceuticals, including PYLARIFY, similar to the way Medicare OPPS currently pays for other drugs, biologics, and therapeutic radiopharmaceuticals instead of under the current TPT structure of a separate payment that is limited to three years.

The calendar year 2025 payment rate for PYLARIFY is based on MUC, which will lead to a decrease in payment in 2025 relative to previous ASP-based payment methodologies.

PYLARIFY’s MUC payment rate is based on charges reported by hospitals in claims data that CMS uses to set payment rates.

Hospitals report their charges related to the goods and services provided and CMS applies a specific cost-to-charge ratio to estimate the true costs.

Issues arise because hospitals do not apply uniform mark-ups to all items, and higher cost items and services, such as PYLARIFY, tend to have smaller mark-ups, which often leads to an underestimation of a product’s true cost.

Additionally, product billing errors may lead to an underestimation of total cost.

We believe these factors cause a misalignment between ASP and MUC, and therefore, a decrease in payment.

In rulemaking, CMS has indicated a willingness to move to ASP-based payment for diagnostic radiopharmaceuticals in future years, and we plan to continue to work with CMS on the potential adoption of payment based on ASP in the future.

Healthcare Reform and Other Laws Affecting Payment

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and state governments continue to propose and pass legislation that may affect the availability and cost of healthcare.

For example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “Healthcare Reform Act”), substantially changes the way in which healthcare is financed by both governmental and private insurers and has a significant impact on the pharmaceutical industry.

For example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “Healthcare Reform Act”), substantially changed the way in which healthcare is financed by both governmental and private insurers and has a significant impact on the pharmaceutical industry.

The Healthcare Reform Act contains a number of provisions that affect coverage, reimbursement and/or delivery of drug products and the medical imaging procedures in which our drug products are used.

Key provisions that currently affect our business include the following:

• increasing the presumed utilization rate for imaging equipment costing $1.0 million or more in the physician office and free-standing imaging facility setting which reduces the Medicare per procedure medical imaging reimbursement;

which rate was further increased by subsequent legislation effective January 1, 2014;

• increasing drug rebates paid to state Medicaid programs under the Medicaid Drug Rebate Program for brand name prescription drugs and extending those rebates to Medicaid managed care organizations;

• expanding access to the 340B program by allowing additional covered entities to participate in the program;

• imposing a non-deductible annual fee on pharmaceutical manufacturers or importers who sell brand name prescription drugs to specified federal government programs.

The Healthcare Reform Act also amended the federal self-referral laws, requiring referring physicians to inform patients under certain circumstances that the patients may obtain services, including PET, CT, MRI and certain other diagnostic imaging services, from a provider other than that physician, another physician in his or her group practice, or another individual under direct supervision of the physician or another physician in the group practice.

The referring physician must provide each patient with a written list of other suppliers who furnish those services in the area in which the patient resides.

These requirements could have the effect of shifting where certain diagnostic medical imaging procedures are performed.

The Healthcare Reform Act has been subject to political and judicial challenges, but it has generally withstood such challenges, and the main provisions of the Healthcare Reform Act remain in effect.

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Although the IRA provides for a limited number of categorical exclusions from Medicare negotiation, radiopharmaceuticals are not among those categorical exclusions.

CMS plans to begin implementing the first year of Medicare negotiation, which will be restricted to Part D drugs, starting in calendar years 2026 and 2027.

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.

We are currently focused on drugs that are covered under Part B, therefore we do not expect the Part D benefit redesign to have an impact on our portfolio.

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The IRA also introduces rebate obligations for manufacturers of Part B and D drugs that take price increases which exceed the rate of inflation, similar to the longstanding Medicaid inflation rebates.

Under these new Medicare inflation rebates, each Part B and D

single-source drug/biological and biosimilar will have an “inflation adjusted” payment amount calculated by CMS.

Under these new Medicare inflation rebates, each Part B and D single-source drug/biological and biosimilar will have an “inflation adjusted” payment amount calculated by CMS.

If the manufacturer’s price increases for the relevant product exceeds the inflation adjusted payment amount, as trended forward by the rate of inflation, the manufacturer will be required to reimburse Medicare the difference between what Medicare paid for the product and what it would have paid based on the inflation adjusted payment amount.

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Some of those efforts have been subject to legal challenge.

General legislative cost control measures may also affect reimbursement for our products or services provided with our products.

General legislative cost control measures may also affect reimbursement for our products (or services provided by healthcare providers using our products).

The Budget Control Act, as amended by the Bipartisan Budget Act of 2019, resulted in the imposition of 2% reductions in Medicare (but not Medicaid) payments to providers beginning in 2013 and will remain in effect through fiscal year 2030 unless additional Congressional action is taken.

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The Healthcare Reform Act clarifies the intent requirements of the federal Anti-Kickback Statute, providing that a person or entity does not need to have actual knowledge of the statute or a specific intent to violate the statute.

Violations of the federal Anti-Kickback Statute can result in exclusion from Medicare, Medicaid or other governmental programs as well as civil and criminal fines and penalties of up to $104,330 per violation and three times the amount of the unlawful remuneration.

Violations of the federal Anti-Kickback Statute can result in exclusion from Medicare, Medicaid or other governmental programs, as well as civil and criminal fines and penalties for each violation and three times the amount of the unlawful remuneration.

In addition, the Healthcare Reform Act revised the FCA to provide that a claim arising from a violation of the Federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA.

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As discussed, a claim arising from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA.

False or fraudulent claims for purposes of the FCA carry fines and civil penalties for violations ranging from $11,665 to $23,331 for each false claim, plus up to three times the amount of damages sustained by the federal government and, most critically, may provide the basis for exclusion from federally funded healthcare programs.

False or fraudulent claims for purposes of the FCA carry fines and civil penalties for violations for each false claim, plus up to three times the amount of damages sustained by the federal government and, most critically, may provide the basis for exclusion from federally funded healthcare programs.

There is also a criminal FCA statute by which individuals or entities that submit false claims can face criminal penalties.

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The laws and regulations include requirements that can be unclear in their scope, nature, and required implementation by regulated entities.

If we fail to comply with such laws and regulations, we could be subject to penalties and administrative actions under such laws and regulations.

If we fail to comply with such laws and regulations, in the U.S.

or in countries outside the U.S., we could be subject to penalties and administrative actions under such laws and regulations.

Data Privacy, Security and Breach Notification

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The legislative and regulatory landscape for data protection continues to evolve, and in recent years there has been an increasing focus on data protection and other data privacy and security issues.

Data protection laws and regulations can be complex and are becoming more stringent over time.

In the United States, numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws and federal and state consumer protection laws govern the collection, use, disclosure and protection of health-related and other personal information.

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For example, the processing of personal data in the European Union is governed by the provisions of the General Data Protection Regulation, or GDPR, which came into effect on May 25, 2018.

The GDPR applies to an entity established in the 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.

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.

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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.

In the United States, several state legislatures are considering enacting new data privacy legislation.

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.

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Penalties under the Bribery Act include potentially unlimited fines for companies and criminal sanctions for corporate officers under certain circumstances.

Our policies mandate compliance with these anti-bribery laws.

Our policies mandate compliance with all anti-bribery laws.

Our operations reach 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.

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See Part I, Item 1A.

“Risk Factors” for information regarding certain risks related to reimbursement and regulation.

“Risk Factors” of this Form 10-K for information regarding certain risks related to reimbursement and regulation.

Environmental Matters

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and in other jurisdictions in which we operate.

Our operations, like those of other medical product companies, involve the transport, use, handling, storage, exposure to and disposal of materials and wastes regulated under environmental laws, including hazardous and radioactive materials and wastes.

Our operations, like those of other radiopharmaceutical companies, involve the transport, use, handling, storage, exposure to and disposal of materials and wastes regulated under environmental laws, including hazardous and radioactive materials and wastes.

If we violate these laws and regulations, we could be fined, criminally charged or otherwise sanctioned by regulators.

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We currently are not party to any claims or any obligations to investigate or remediate any material contamination at any of our facilities, however, if we were found to be liable under one or more of these laws or regulations, it could create a substantial liability.

We are required to maintain a number of environmental permits and nuclear licenses for our North Billerica, Massachusetts campus, which includes our primary manufacturing, packaging and distribution facility.

We are required to maintain a number of environmental permits and nuclear licenses for our North Billerica campus, which includes our primary manufacturing, packaging and distribution facility.

In particular, we must maintain a nuclear byproducts materials license issued by the Commonwealth of Massachusetts.

This license requires that we provide financial assurance demonstrating our ability to cover the cost of decommissioning and decontaminating (“D&D”) the Billerica site at the end of its use as a nuclear facility.

In addition, we have a radioactive production facility in Somerset, NJ where we must also maintain a number of environmental permits and nuclear licenses.

This license requires that we provide financial assurance demonstrating our ability to cover the cost of decommissioning and decontaminating (“D&D”) the North Billerica site at the end of its use as a nuclear facility.

We store low level radioactive waste at our facilities until the materials are below regulatory limits, as allowed by our licenses and permits.

As of December 31, 2023, we currently estimate the D&D cost of all of our manufacturing sites to be approximately $25.1 million.

As of December 31, 2024, we estimate the D&D cost of all of our manufacturing sites to be approximately $25.1 million.

As of December 31, 2024 and 2023, we have a liability of approximately $23.3 million and $22.9 million, respectively associated with our asset retirement obligations.

We currently provide this financial assurance in the form of surety bonds.

We currently provide this financial assurance in the form of a surety bond.

We also actively monitor and seek to reduce our solid waste, energy and water usage, waste water discharge and greenhouse gas emissions.

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and (iv) using salt brine as a pretreatment for winter storms to reduce the amount of salt use and run off.

With respect to sustainability, we track and monitor our energy use, water use, a limited scope of greenhouse gas emissions, and waste generation.

We use an Energy Star Portfolio Manager to track energy and water use and have calculated scope 1 and 2 greenhouse gas emissions for our North Billerica Campus, with plans to expand these activities to other Lantheus properties.

We will continue to compare our usage data against annual baselines, national medians, and similar buildings.

With respect to sustainability, we track and monitor our energy use, water generation and a limited scope of greenhouse gas emissions.

Since 2022, we have powered our North Billerica campus with renewable wind energy through a contract with National Grid.

We use a third-party environmental software to track available environmental data fields and in 2024 expanded our scope to include data for all of our locations.

The implementation of this software rapidly improved our efficiency in data collection and reporting.

To drive continuous improvement, we compare our usage data against prior annual baselines, national medians, and similar businesses.

Environmental laws and regulations are complex, change frequently and have become more stringent over time.

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See Part I, Item 1A.

“Risk Factors” for information regarding certain risks associated with environmental matters.

“Risk Factors” of this Form 10-K for information regarding certain risks associated with environmental matters.

Human Capital Management

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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.

We have a female Chief Executive Officer who, effective March 1, 2024, will transition to Chair of the Board, over half of our Vice Presidents and above (including our senior management team, which we refer to as our “Expanded Executive Team”) are women, and approximately 50% of our employees are women.

We continue to strive to improve our diversity and inclusion with a strategic emphasis beyond gender, and we require recruiters working with us to present diverse candidates.

We also sponsor three Employee Resource Groups (“ERGs”), the Lantheus Diversity Connection ERG, the Women Leaders of Lantheus ERG, and the Professional Networking at Lantheus ERG.

Five of eleven of the directors on our Board, including our Chairperson, are women, and over half of our senior management team, which we refer to as our “Expanded Executive Team,” as well as employees holding the position of Vice President or above are women.

Approximately 49% of our employees are women.

We continue to strive to improve our diversity and inclusion compliantly with a strategic emphasis beyond gender, and we require recruiters working with us to present a diverse candidate slate for posted positions as we believe that we benefit from having a skilled team with a diversity of viewpoints, backgrounds and experiences.

We also sponsor Employee Resource Groups (“ERGs”) that are open to all of our employees, including the Lantheus Diversity Connection ERG, the Women Leaders of Lantheus ERG and the Lantheus Veterans, Employees and Reservists Inspired to Act and Serve ERG.

We are committed to promoting a culture of ethics and compliance.

Our Code of Conduct and Ethics reflects our commitment to corporate integrity and the underlying business practices and principles of behavior that support this commitment.

Each year our employees complete mandatory training that includes anti-bribery/anti-corruption rules, insider trading prohibitions, confidentiality obligations, as well as specialized training in healthcare industry marketing practices.

We have a formal Ethics and Compliance Committee that develops, implements and oversees our ethics and compliance programs.

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.

Compensation and Benefits

We seek to provide pay, benefits, and services that are competitive to market and create incentives to attract and retain employees.

Our compensation package includes, among other things, market-competitive pay, cash bonuses, healthcare and defined contribution plan benefits, paid time off and family leave, and restricted stock and other equity grants to certain levels of employees.

Our compensation package includes, among other things, market-competitive pay, cash bonuses, healthcare and defined contribution plan benefits, paid time off and family leave, and, to certain levels of employees, restricted stock and other equity grants.

We are focused on pay equity and regularly assess pay among similar roles and responsibilities throughout our organization and in comparison to our peer group.

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(i) quarterly town hall meetings for our entire company;

(ii) regular ongoing update communications, including through monthly newsletters and our recently launched intranet site;

(ii) regular ongoing update communications, including through monthly newsletters and our intranet site;

and (iii) an externally administered whistleblower hotline and website that is prominently advertised to our employees, and a whistleblower’s anonymity is protected, if so requested.

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On June 30, 2015, we completed an initial public offering of our common stock.

We completed our acquisition of Progenics on June 19, 2020 (the “Progenics Acquisition”).

We completed our acquisition of Cerveau Technologies, Inc.

on February 6, 2023 (the “Cerveau Acquisition”).

Our common stock is traded on the NASDAQ Global Market under the symbol “LNTH”.

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Our global Internet site is www.lantheus.com.

We routinely make available important information, including copies of our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after those reports are electronically filed with, or furnished to, the SEC, free of charge on our website at investor.lantheus.com.

We routinely make available important information, including copies of our Form 10-K, Quarterly Reports on Form 10-Q (“Form 10-Q”), Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after those reports are electronically filed with, or furnished to, the Securities and Exchange Commission (“SEC”), free of charge on our website at investor.lantheus.com.

We recognize our website as a key channel of distribution to reach public investors and as a means of disclosing material non-public information to comply with our disclosure obligations under SEC Regulation FD.

Information contained on our website shall not be deemed incorporated into, or to be part of this Annual Report on Form 10-K, and any website references are not intended to be made through active hyperlinks.

Our reports filed with, or furnished to, the SEC are also available on the SEC’s website at www.sec.gov, and for Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, in an Inline Extensible Business Reporting Language (“iXBRL”) format.

Information contained on our website shall not be deemed incorporated into, or to be part of this Form 10-K, and any website references are not intended to be made through active hyperlinks.

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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business