LNTH · 10-K filed 26 Feb 2026 · year to 31 Dec 2025

Lantheus Holdings

35 named things its latest annual report says its results depend on, each in the company's own words. 15 of them are also named by other companies we've read.

Read the filing on SEC.gov ↗

Suppliers

Institute for Radioelements (IRE)

depends on · approximately 6.3% of our total purchases

For the year ended December 31, 2025, our largest suppliers of raw materials and supplies were Institute for Radioelements ("IRE"), the Australian Nuclear Science and Technology Organisation ("ANSTO"), and NTP RadioisotopesBusiness (Item 1)

PET manufacturing facilities (PMFs)

depends onnamed as a risk

We depend on some of our PMF partners to generate sales, accept, produce and deliver orders, collect payments and report related information for PYLARIFY.Risk factors (Item 1A)

Jubilant HollisterStier

depends onnamed as a risk

We rely on Jubilant HollisterStier as a substantial supplier of DEFINITY.Risk factors (Item 1A)

Partners and platforms

GE HealthCare

earns from · up to $60.0 million in regulatory and sales milestone paymentsnamed as a risk

Under the agreement, we received an upfront cash payment of $5.0 million and are eligible to receive up to $60.0 million in regulatory and sales milestone payments, tiered double-digit royalties on U.S. sales, and mid-single digit royalties on sales outside of the United States.Business (Item 1)

Also named by PROF

Curium Pharma

earns from · double-digit royaltiesnamed as a risk

Under the terms of the collaboration with Curium, we are entitled to double-digit royalties on net sales of piflufolastat F-18, which is commercialized in Europe under the name PYLCLARI.Risk factors (Item 1A)

Also named by BWXT

Bausch Health Companies, Inc.

earns from · $5.0 million in 2025

We received an initial payment in 2023 of approximately $98.0 million in connection with the sale and earned additional consideration of $5.0 million in 2025 as a result of the achievement of a sales-based milestone.Business (Item 1)

POINT Biopharma Global Inc.

depends onnamed as a risk

We are also dependent on POINT to develop commercial product capacity and manufacture for both PNT2003 and PNT2002.Risk factors (Item 1A)

Other companies

SHINE Technologies, LLC

up to $155.0 millionnamed as a risk

On January 1, 2026, we completed the sale of our single-photon emission computerized tomography ("SPECT") business to SHINE Technologies, LLC ("SHINE"), a wholly-owned subsidiary of Illuminated Holdings, Inc., for total consideration of up to $155.0 million, consisting of cash, a convertible installment note, a term note and contingent earnout payments.Business (Item 1)

Life Molecular Imaging Limited

$352.9 millionnamed as a risk

As consideration for the LMI Acquisition, we remitted a total upfront payment of $352.9 million in cash, after working capital-related settlements, and could be required to pay up to an additional $400.0 million in potential earn-out and milestone payments.Business (Item 1)

Evergreen Theragnostics, Inc.

$276.4 millionnamed as a risk

As consideration for the Evergreen Merger, we made an upfront payment of $276.4 million in cash.Business (Item 1)

Competitors

GE HealthCare

competes withnamed as a risk

DEFINITY currently competes with ultrasound enhancing agents produced by GE HealthCare Limited ("GE Healthcare") and Bracco Diagnostics Inc. ("Bracco"), as well as echocardiography without ultrasound enhancing agents and other non-echocardiography agents, and there is the potential for future competition from generic manufacturers who may submit regulatory applications using DEFINITY as the reference listed drug (RLD).Risk factors (Item 1A)

Also named by PROF

Telix Pharmaceuticals Limited

competes withnamed as a risk

PYLARIFY currently competes with three commercially available Gallium-68-based PSMA PET imaging agents, two from Telix Pharmaceuticals Limited and one from Novartis AG and an F-18 PSMA PET imaging agent from Blue Earth Diagnostics Ltd. ("Blue Earth"), as well as other non-PSMA PET imaging agents.Risk factors (Item 1A)

Novartis AG

competes withnamed as a risk

For example, 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 for PNT2003 and Paragraph IV certification, consistent with the process established by the Hatch-Waxman Act.Risk factors (Item 1A)

Blue Earth Diagnostics Ltd.

competes withnamed as a risk

For PYLARIFY, our competitors currently include approved imaging agents from Telix Pharmaceuticals Limited, Blue Earth, a subsidiary of Bracco, and Novartis AG, as well as other non-PSMA PET imaging agents, and there is the potential for future competition from others who may submit regulatory applications in anticipation of PYLARIFY's NCE exclusivity expiry in May 2026.Risk factors (Item 1A)

Bracco Diagnostics Inc.

competes withnamed as a risk

For DEFINITY, our competitors currently include GE Healthcare and Bracco, as well as echocardiography without ultrasound enhancing agents and other non-echocardiography agents, and there is the potential for future competition from generic manufacturers who may submit regulatory applications using DEFINITY as the reference listed drug (RLD).Risk factors (Item 1A)

Eli Lilly and Co

competes withnamed as a risk

When used for traditional Medicare patients in the hospital outpatient setting, Neuraceq is paid based on its MUC; however, Neuraceq currently competes with two commercially available F-18 beta-amyloid-targeting PET imaging agents from Eli Lilly and Co ("Lilly") and GE Healthcare, and those other competitive imaging agents are currently being paid based on a higher MUC rate.Risk factors (Item 1A)

Places

Outside the United States

operates in · approximately 5.4% of our revenues and sourced approximately 12.0% of our costs of goods soldnamed as a risk

For the year ended December 31, 2025, we derived approximately 5.4% of our revenues and sourced approximately 12.0% of our costs of goods sold outside of the United States.Risk factors (Item 1A)

Also named by APD, ARW, BALL, CCK, COO, GGG, GIS, HPE and 10 more

Iran

named as a risk

Changes in trade policies, regulatory requirements and other barriers, including, for example, U.S. trade sanctions against Iran and those countries and entities doing business with Iran, which could adversely impact international isotope production and, indirectly, our global supply chain;Risk factors (Item 1A)

Also named by DKS, EME

Evergreen CDMO facility

concentrated innamed as a risk

These services are conducted out of a single location.Risk factors (Item 1A)

North Billerica, Massachusetts

operates in

We have a specialized in-house FDA-approved manufacturing facility at our North Billerica campus for purposes of producing DEFINITY.Business (Item 1)

Commodities and inputs

Fluorine-18 (F-18)

depends on · 110-minute half-lifenamed as a risk

For example, the radioisotope used in PYLARIFY and Neuraceq is F-18, which has a 110-minute half-life, requiring that this product be manufactured and distributed within the same day to end-users.Risk factors (Item 1A)

Perflutren gas and lipid blend

depends onnamed as a risk

In addition, for reasons of quality assurance or cost-effectiveness, we purchase certain components and raw materials from sole suppliers (including, for example, the specially designed chemistry synthesis boxes and consumables used in the manufacturing of each of PYLARIFY and Neuraceq and the lipid blend material and perflutren gas used in the manufacturing of DEFINITY).Risk factors (Item 1A)

Euro

exposed to its price

The Euro and Canadian dollar present the primary currency risk on our earnings.Market risk (Item 7A)

Also named by ABBV, ABNB, ABT, ADBE, ADI, AME, AMG, AMGN and 186 more

Canadian dollar

exposed to its price

The Euro and Canadian dollar present the primary currency risk on our earnings.Market risk (Item 7A)

Also named by ABBV, ADBE, AMG, AYI, BBY, BWXT, CBRE, CDRE and 67 more

Regulators

Commonwealth of Massachusetts

subject to · approximately $20.4 million

In particular, we must maintain a nuclear byproducts materials license issued by the Commonwealth of Massachusetts.Business (Item 1)

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk

If FDA approval of manufacturing sites is delayed or withdrawn, if FDA requirements relating to site approval change, or our PMF sites experience manufacturing issues, our business, results of operations, financial condition and cash flows could be adversely affected.Risk factors (Item 1A)

Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more

Centers for Medicare & Medicaid Services (CMS)

subject tonamed as a risk

As a result, as of January 1, 2025, the payment rate for PYLARIFY is based on MUC and is less than the Average Sales Price ("ASP")-based amount that was paid during TPT Status.Risk factors (Item 1A)

Also named by A, ABT, AMGN, AXGN, BAX, BWIN, CNC, COO and 23 more

U.S. Nuclear Regulatory Commission (NRC)

subject to

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.Business (Item 1)

Also named by AEE, AEP, BRK/B, BWXT, CAH, CDRE, CEG, CW and 20 more

Laws and programs

One Big Beautiful Bill Act (OBBBA)

subject to · $490 billion in Medicare cuts from 2027 to 2034named as a risk

The Congressional Budget Office estimates that, absent future action, the OBBBA will lead to $490 billion in Medicare cuts from 2027 to 2034.Risk factors (Item 1A)

Also named by AA, ABR, ADI, ADM, ALB, AMAT, AMGN, AMKR and 121 more

Medicare Hospital Outpatient Prospective Payment System (OPPS)

subject to · per day costs greater than $655named as a risk

In November 2025, CMS released the final rule for its calendar year 2026 Medicare Hospital Outpatient Prospective Payment System, which continues to provide for separate payment for diagnostic radiopharmaceuticals with per day costs greater than $655 based on their MUC.Risk factors (Item 1A)

Medicare

earns fromnamed as a risk

A significant portion of our patient volume is derived from U.S. government healthcare programs, principally Medicare, which are highly regulated and subject to frequent and substantial changes.Risk factors (Item 1A)

Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more

Inflation Reduction Act of 2022

subject tonamed as a risk

Although the IRA provides for a limited number of categorical exclusions from Medicare negotiation, radiopharmaceuticals are not among those categorical exclusions.Business (Item 1)

Also named by ABBV, APD, ARE, BKH, DD, DHR, ELV, ENPH and 30 more

340B drug pricing program

subject tonamed as a risk

To the extent we reduce our best price, the 340B drug price will also be reduced.Risk factors (Item 1A)

Also named by ABBV, BAX, BIIB, BMY, CAH, COR, CVS, EXEL and 13 more

Hatch-Waxman Act

subject tonamed as a risk

Potential generic competitors may seek to enter the market as a result of regulatory exclusivity expiration, including the expiry of NCE regulatory exclusivity for PYLARIFY in May 2026.Risk factors (Item 1A)

Also named by ABBV, INCY, LLY, VTRS

CREATES Act

subject tonamed as a risk

We recently received a request for samples of DEFINITY pursuant to the Creating and Restoring Equal Access to Equivalent Samples ("CREATES") Act of 2019, a U.S. federal law designed to facilitate generic and biosimilar drug development.Risk factors (Item 1A)