What changed in this filing

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Item 1A. Risk Factors

2024-11-06 compared with 2024-07-31 · 35 added, 25 removed, 130 unchanged (32% of the section changed)

There have been no material changes to the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2023, except as set forth below:

There have been no material changes to the risk factors set forth in our Form 10-K for the year ended December 31, 2023, except as set forth below:

Risks Related to Our Portfolio of Commercial Products

10 unchanged sentences

Other competitive PSMA PET imaging agents will continue to have TPT after December 31, 2024 which could result in PYLARIFY customers choosing to prescribe and use a competitor’s PSMA PET imaging agent instead of PYLARIFY.

In July 2024, CMS released the CY 2025 Proposed Hospital Outpatient Prospective Payment System, or OPPS, rule which recognizes the value and need for broad access to diagnostic radiopharmaceuticals by proposing separate payment for diagnostic radiopharmaceuticals with per day costs greater than $630.

If implemented in the final rule in November, the CMS rule would maintain separate payment for PYLARIFY after the expiration of TPT status for the approximately 20% of patients with traditional Medicare fee-for-service insurance coverage who are treated in the hospital outpatient setting.

However, we can give no assurance that CMS will adopt separate payment for diagnostic radiopharmaceuticals in its final CY 2025 OPPS rule, that it will follow the methodology set out in the Proposed OPPS rule for calculating such separate payment, that any CMS reimbursement in the hospital outpatient setting that follows the expiration of TPT Status (even if reimbursed as a separate payment) will be adequate to cover the cost of a PYLARIFY PET/CT imaging procedure, that any such rule will remain in effect if adopted or that legislative changes removing such a separate payment for diagnostic radiopharmaceuticals would not be adopted.

In November 2024, CMS released the final rule for its calendar year 2025 Medicare Hospital Outpatient Prospective Payment System (“OPPS”), which recognizes the value and need for broad access to diagnostic radiopharmaceuticals.

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

When implemented on January 1, 2025, CMS will maintain separate payment for PYLARIFY after the expiration of transitional pass-through for the approximately 20% of patients with traditional Medicare fee-for-service 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 and is equal to the current PYLARIFY payment rate.

In addition, if other government payors or private payors do not provide adequate reimbursement for the use of PYLARIFY, our business, results of operations, financial condition and cash flows could be adversely affected.

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 and we are also supporting trade associations in their efforts to lobby Congress to pass legislation that 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, however, we can give no assurances that we will be successful in those efforts or that the availability of TPT Status for other diagnostic radiopharmaceuticals will not impact clinical decision making regarding which product to use, which could have an adverse effect on our business, results of operations, financial condition and cash flows.

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

CMS has finalized its proposal for separate payment for diagnostic radiopharmaceuticals over a certain per day cost threshold based on mean unit costs, which would allow continued separate payment for PYLARIFY.

We will continue to work with coalition partners to support using average selling price to calculate payment for diagnostic radiopharmaceuticals in future years similar to the way Medicare OPPS currently pays for other drugs, biologics, and therapeutic radiopharmaceuticals.

However, we can give no assurances that we will be successful in those efforts or that the availability of TPT Status for other diagnostic radiopharmaceuticals will not impact clinical decision making regarding which product to use, which could have an adverse effect on our business, results of operations, financial condition and cash flows.

The successful growth of PYLARIFY is also dependent on our ability to promote PYLARIFY to customers, 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 environment in which other PSMA PET imaging agents have been approved, for which discounts related to those other agents may be offered to customers and for which TPT Status will extend beyond December 31, 2024.

PYLARIFY currently competes with two commercially available Ga-68-based PSMA PET imaging agents from Telix

Pharmaceuticals Limited and Novartis AG and an F 18 PSMA PET imaging agent from Blue Earth, as well as other non-PSMA PET imaging agents.

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.

PYLARIFY currently competes with two commercially available Ga-68-based PSMA PET imaging agents from Telix Pharmaceuticals Limited and Novartis AG and an F 18 PSMA PET imaging agent from Blue Earth, as well as other non-PSMA PET imaging agents.

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.

To the extent we are not successful in these efforts and we lose market share to existing or future competitors (including during any period of time in which our TPT Status has expired but TPT Status for a later-approved competitive products still exists), such loss of market share could have an adverse impact on our business, results of operations, financial condition and cash flows.

3 unchanged sentences

While we note that FDA-approved labels for F 18-based and PSMA-11 based PSMA PET imaging agents have generally been treated as a class of drugs, including by the National Comprehensive Cancer Center in its guidelines and the Society for Nuclear Medicine and Molecular Imaging in its appropriate use criteria, we can give no assurances that PLUVICTO prescribing information will be expanded to incorporate F 18-based PSMA PET imaging agents like PYLARIFY, or how current clinical practice may evolve.

In addition, we recently enrolled the first patient in a clinical trial to determine whether PYLARIFY can detect the presence or absence of additional prostate cancer lesions in patients with favorable intermediate-risk prostate cancer, as well as how it may change the patient’s intended management, but cannot predict whether the outcome of this clinical trial will support such a use for PYLARIFY.

In addition, we are conducting a clinical trial to determine whether PYLARIFY can detect the presence or absence of additional prostate cancer lesions in patients with favorable intermediate-risk prostate cancer, as well as how it may change the patient’s intended management, but cannot predict whether the outcome of this clinical trial will support such a use for PYLARIFY.

To the extent we are unsuccessful in establishing the use of PYLARIFY for approved or new indications or in new patient populations, such lack of success could have an adverse impact on our business, results of operations, financial condition and cash flows.

20 unchanged sentences

ITM Radiopharma;

Curium and RayzeBio (acquired by Bristol Myers Squibb), each of which has commercialized products or product candidates in advanced clinical stage of development.

Curium and RayzeBio (acquired by Bristol Myers Squibb), each of which has commercialized products or product candidates pending FDA approval or in advanced clinical stage of development.

• For MK-6240 and NAV-4694, our principal competitors may include Eli Lilly and Company, GE Healthcare, Life Molecular Imaging and Aprinoia Therapeutics, each of which has commercialized products or product candidates in advanced clinical stage of development and other companies that may have product candidates in development.

25 unchanged sentences

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

After TPT Status expires, under current Medicare rules, PYLARIFY would not be separately reimbursed in the hospital outpatient setting but rather would be bundled into the facility payment a hospital receives for a PET/CT imaging procedure, and the facility payment may not always cover the total cost of the procedure.

After TPT Status expires, under current Medicare rules, PYLARIFY would not be separately reimbursed in the hospital outpatient setting but rather would be bundled into the facility

payment a hospital receives for a PET/CT imaging procedure, and the facility payment may not always cover the total cost of the procedure.

Certain competitor PSMA PET products will continue to have TPT Status after PYLARIFY’s TPT Status expires and this could impact our customer’s prescribing habits.

In July 2024, CMS released the CY 2025 Proposed OPPS rule which recognizes the value and need for broad access to diagnostic radiopharmaceuticals by proposing separate payment for diagnostic radiopharmaceuticals with per day costs greater than $630.

If implemented in the final rule in November, CMS would maintain separate payment for PYLARIFY after the expiration of TPT Status for the approximately 20% of patients with traditional Medicare fee-for-service insurance coverage who are treated in the hospital outpatient setting.

We can give no assurance that CMS will adopt separate payment for diagnostic radiopharmaceuticals in its final CY 2025 OPPS rule, that it will follow the methodology set out in the Proposed OPPS rule for calculating such separate payment, that any CMS reimbursement in the hospital outpatient setting that follows the expiration of TPT Status (even if reimbursed as a separate payment) will be adequate to cover a PYLARIFY PET/CT imaging procedure, that any such rule will remain in effect if adopted or that legislative changes removing such a separate payment for diagnostic radiopharmaceuticals would not be adopted or that the availability of TPT Status for other diagnostic radiopharmaceuticals will not impact clinical decision making regarding which product to use, which could have an adverse effect on our business, results of operations, financial condition and cash flows.

In November 2024, CMS released the final rule for its calendar year 2025 Medicare Hospital OPPS, which recognizes the value and need for broad access to diagnostic radiopharmaceuticals.

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

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

However, we can give no assurance that such rule will remain in effect, that such payment will remain the same or that legislative changes removing such a separate payment for diagnostic radiopharmaceuticals would not be adopted, which could have an adverse effect on our business, results of operations, financial condition and cash flows.

Over the past several years, Medicare has implemented numerous changes to payment policies for imaging procedures in both the hospital setting and non-hospital settings (which include physician offices and freestanding imaging facilities).

24 unchanged sentences

In the CY 2024 Physician Fee Schedule Final Rule, CMS determined that it was not feasible to fully operationalize the AUC program consistent with the statute within the required time frame.

Accordingly, the agency finalized an indefinite pause to the AUC program and the recission of the regulations promulgated thus far to implement the AUC program.

Accordingly, the agency finalized an indefinite pause to the AUC program and the rescission of the regulations promulgated thus far to implement the AUC program.

While it is unclear when CMS will resume implementation of the AUC program, to the extent that these types of changes have the effect of reducing the aggregate number of diagnostic medical imaging procedures performed in the U.S., our business, results of operations, financial condition and cash flows could be adversely affected.

16 unchanged sentences

For example, we are aware of other groups investigating PSMA or related compounds and monoclonal antibodies directed at PSMA, and PSMA-targeted imaging agents and therapeutics, and of patents held, and patent applications filed, by these groups in those areas.

While the validity of these issued patents, the patentability of pending patent applications and the applicability of any of them to our products and programs are uncertain, if

asserted against us or our partners, any related patent or other intellectual property rights could adversely affect our ability to commercialize our products.

While the validity of these issued patents, the patentability of pending patent applications and the applicability of any of them to our products and programs are uncertain, if asserted against us or our partners, any related patent or other intellectual property rights could adversely affect our ability to commercialize our products.

We may be subject to litigation over infringement claims regarding the products we manufacture or distribute or intend to manufacture or distribute.

1 unchanged sentence

and Advanced Accelerator Applications SA, each a Novartis entity, for patent infringement in response to the filing of our ANDA for PNT2003 and Paragraph IV certification, consistent with the process established by the Hatch-Waxman Act.

This type of litigation can be costly and time consuming and could divert management’s attention and resources, generate significant expenses, damage payments (potentially including treble damages) or restrictions or prohibitions on our use of our technology, which could adversely affect our business, results of operations, financial condition and cash flows.

This type of litigation can be costly and time consuming and could divert management’s

attention and resources, generate significant expenses, damage payments (potentially including treble damages) or restrictions or prohibitions on our use of our technology, which could adversely affect our business, results of operations, financial condition and cash flows.

In addition, if we are found to be infringing on proprietary rights of others, we may be required to develop non-infringing technology, obtain a license (which may not be available on reasonable terms, or at all), make substantial one-time or ongoing royalty payments, or cease making, using and/or selling the infringing products, any of which could have a material adverse effect on our business, results of operations, financial condition and cash flows.

2 unchanged sentences

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

On July 15, 2024, we announced that we acquired Meilleur Technologies, Inc, which holds the rights under a license agreement to develop and commercialize NAV-4694, an investigational next-generation 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 investigational therapeutic trials.

On July 15, 2024, we announced that we acquired Meilleur, which holds the rights under a license agreement to develop and commercialize NAV-4694, an investigational next-generation 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 studies.

Previously, we acquired MK-6240, which is an investigational next-generation F 18-labeled PET imaging agent that targets Tau tangles.

Recently, we held a pre-NDA meeting with the FDA and we expect to submit an NDA for MK-6240 in 2025, but we can provide no assurance that we will meet that expected timeline, that our NDA will be accepted by the FDA, that MK-6240 will be approved by the FDA based on the data submitted or that we will be successful in commercializing MK-6240.

Recently, we held a pre-NDA meeting with the FDA and we expect to submit an NDA for MK-6240 in 2025, but we can provide no assurance that we will meet that expected timeline, that our NDA will be accepted by the FDA, that MK-6240 will be approved by the FDA based on the data submitted or, if approved, that we will be successful in commercializing MK-6240.

While we believe that both MK-6240, as a Tau imaging agent, and NAV-4694, as a Beta Amyloid imaging agent, have the potential to play an important role in diagnosing, staging and monitoring Alzheimer’s disease, we can give no assurance that we will be successful with continued development, regulatory approval and commercialization of these product candidates or that disagreements with the counterparties to our license agreements for MK-6240 and NAV-4694 or the former stockholders of the companies we acquired who could receive future milestone and royalty-based payments will not arise over proprietary rights, contract interpretation or the preferred course of product research, development or marketing that might cause delays or termination of the license agreements, or might result in litigation or arbitration, which could be time-consuming and expensive.

2 unchanged sentences

On December 8, 2022, we issued $575.0 million in aggregate principal amount of 2.625% Convertible Senior Notes due 2027 (the “Notes”), which included $75.0 million in aggregate principal amount of Notes sold pursuant to the full exercise of the initial purchasers’ option to purchase additional Notes.

The Notes were issued under an indenture, dated as of December 8, 2022 (the “Indenture”), among Holdings, LMI, and U.S.

The Notes were issued under an indenture, dated as of December 8, 2022 (the “Indenture”), among Lantheus Holdings, LMI, and U.S.

Bank Trust Company, National Association (“U.S.

2 unchanged sentences

For example, holders could elect to convert their Notes during a calendar quarter if the trading price of our common stock was greater than or equal to 130% of the conversion price of the Notes (initially $79.81 per share) for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter.

be required to settle any converted principal amount of such Notes through the payment of cash and by paying or delivering, at our election, cash, shares of our common stock, or a combination of cash and shares, with respect to the remainder of our conversion obligation in excess of the aggregate principal amount of the Notes being converted, which could adversely affect our liquidity.

Even if holders do not elect to convert their Notes, we could be required under applicable accounting rules to reclassify all or a portion of the outstanding principal of the Notes as a current rather than long-term liability, which would result in a material reduction of our net working capital, would require us to maintain total liquidity in excess of the principal balance of the Notes and any contingent liabilities due within twelve months and could require us to seek to increase the amount of our 2022 Revolving Credit Facility or seek alternative financing arrangements.

During the third quarter of 2024, the closing price of the Company’s common stock exceeded 130% of the conversion price of the Notes for more than 20 trading days of the last 30 consecutive trading days of the quarter.

As a result, the Notes are convertible at the option of the holders of the Notes during the fourth quarter of 2024, the quarter immediately following the quarter when the conditions are met, as stated in the terms of the Notes.

If one or more holders elect to convert their Notes, unless we elect to satisfy our conversion obligation by arranging for one or more financial institutions to take the Notes from converting holders and pay such holders in accordance with the Indenture, we would be required to settle any converted principal amount of such Notes through the payment of cash and by paying or delivering, at our election, cash, shares of our common stock, or a combination of cash and shares, with respect to the remainder of our conversion obligation in excess of the aggregate principal amount of the Notes being converted, which could adversely affect our liquidity.

Even if holders do not elect to convert their Notes, we reclassified the carrying value of the Notes as a current rather than long-term liability in accordance with accounting guidance.

This has resulted in a material reduction of our net working capital and requires us to maintain total liquidity in excess of the principal balance of the Notes and any contingent liabilities due within twelve months and could require us to seek to increase the amount of our 2022 Revolving Credit Facility or seek alternative financing arrangements.

In addition, our issuance of additional shares of common stock, if we elect to settle our conversion obligation in excess of the aggregate principal amount of the Notes being converted in shares of common stock (whether in whole or in part), will dilute the ownership interests of our existing common stockholders, including any holders of the Notes who have previously received shares of our common stock upon conversion of their Notes.

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-Q

Item 1A. Risk Factors