UTHR · 10-K filed 25 Feb 2026 · year to 31 Dec 2025

United Therapeutics

40 named things its latest annual report says its results depend on, each in the company's own words. 14 of them are also named by other companies we've read.

Read the filing on SEC.gov ↗

Customers

Accredo Health Group, Inc.

earns from · substantially all our treprostinil-based revenuesnamed as a risk

In the United States, we derive substantially all our treprostinil-based revenues from sales to two distributors, Accredo and CVS Specialty.Risk factors (Item 1A)

CVS Specialty (Caremark, L.L.C.)

earns from · substantially all our treprostinil-based revenuesnamed as a risk

In the United States, we derive substantially all our treprostinil-based revenues from sales to two distributors, Accredo and CVS Specialty.Risk factors (Item 1A)

Cencora Global Procurement Ltd

earns from

We distribute Unituxin in the United States through an exclusive distribution agreement with Cencora Global Procurement Ltd (Cencora).Business (Item 1)

Grupo Ferrer Internacional, S.A.

earns from

Our primary distributor outside the United States is Grupo Ferrer Internacional, S.A. (Ferrer), which holds Remodulin marketing authorization rights in many of these territories.Business (Item 1)

Mochida Pharmaceutical Co., Ltd.

earns from

We also sell Nebulized Tyvaso exclusively through Mochida Pharmaceutical Co., Ltd. (Mochida), in Japan, where the product was approved to treat PAH in late 2022, and to treat PH-ILD in 2024.Business (Item 1)

Suppliers

Eli Lilly and Company

depends on · royalty equal to ten percent of our net product salesnamed as a risk

If Lilly is unable to manufacture or supply Adcirca or its distribution network is disrupted, it could delay, disrupt, or prevent us from selling Adcirca.Risk factors (Item 1A)

Also named by BIIB, INCY, VKTX

MannKind Corporation

depends on · ten percent royaltynamed as a risk

We rely entirely on MannKind to manufacture Tyvaso DPI finished drug product and inhalers for us, with no plans to develop an alternate or backup supply arrangement.Risk factors (Item 1A)

DEKA Research & Development Corp.

depends onnamed as a risk

We rely entirely on DEKA and its affiliates to manufacture the Remunity and RemunityPRO Pumps.Risk factors (Item 1A)

Forj Medical

depends onnamed as a risk

We rely on two contract manufacturers — Forj Medical and Phillips-Medisize Corp. — to manufacture the Tyvaso Inhalation System for Nebulized Tyvaso.Risk factors (Item 1A)

Phillips-Medisize Corp.

depends onnamed as a risk

We rely on two contract manufacturers — Forj Medical and Phillips-Medisize Corp. — to manufacture the Tyvaso Inhalation System for Nebulized Tyvaso.Risk factors (Item 1A)

Sanner GmbH

depends onnamed as a risk

Finally, we rely entirely on Sanner GmbH to manufacture cartridges that were cleared by the FDA for use with the MS-3 pump to administer Remodulin.Risk factors (Item 1A)

ICU Medical, Inc.

depends onnamed as a risk

In 2021, we launched the Remunity Pump to administer subcutaneous Remodulin, and in 2022 ICU Medical made an alternative pump, the CADD-Solis, available for intravenous Remodulin.Risk factors (Item 1A)

Simtra BioPharma Solutions

depends on

For example, Simtra BioPharma Solutions (formerly known as Baxter Pharmaceutical Solutions, LLC) is approved by the FDA, the EMA, and various other international regulatory agencies to manufacture Remodulin for us.Business (Item 1)

Woodstock Sterile Solutions

depends on

We rely on Woodstock Sterile Solutions to serve as an additional manufacturer of Nebulized Tyvaso drug product.Business (Item 1)

Partners and platforms

Supernus Pharmaceuticals Inc.

depends on · single-digit percentage royalty

In 2006, we entered into an exclusive license agreement with Supernus to use certain of its technologies in manufacturing Orenitram.Business (Item 1)

Arena Pharmaceuticals (Pfizer Inc.)

depends on · $250.0 million

On November 15, 2018, we entered into an exclusive license agreement with Arena Pharmaceuticals, Inc. (Arena) related to ralinepag.Business (Item 1)

Other companies

Tyvaso DPI and Nebulized Tyvaso

concentrated in · 59 percentnamed as a risk

We recognized $1,878.2 million, $1,620.4 million, and $1,233.7 million in combined Tyvaso DPI and Nebulized Tyvaso net product sales, representing 59 percent, 56 percent, and 53 percent of our total revenues for the years ended December 31, 2025, 2024, and 2023, respectively.Business (Item 1)

Corporate debt securities and U.S. government securities

exposed to its price · $3.1 billionnamed as a risk

As of December 31, 2025, we have invested $3.1 billion in corporate debt securities and U.S. government and agency securities.Market risk (Item 7A)

Humana Inc. and United Healthcare Services, Inc. litigation

named as a risk

As discussed in Note 14—Litigation, to our consolidated financial statements, we have been sued by Humana Inc., United Healthcare Services, Inc., and various parties in the MSP Recovery litigation for allegedly violating RICO and various state laws in connection with our donations to a charity.Risk factors (Item 1A)

Competitors

Sandoz Inc.

competes with · $74.1 millionnamed as a risk

We have been sued by Sandoz for violating our settlement agreement with them and we have accrued a liability of $74.1 million in connection with such suit, reflecting the final judgment and post-judgment interest accrued through the end of 2025, although our ultimate liability may be greater.Risk factors (Item 1A)

Merck & Co., Inc. (Winrevair)

competes withnamed as a risk

However, some physicians may choose to prescribe Winrevair prior to initiating prostacyclin therapy, which could negatively impact our revenues, and Merck has completed clinical studies that could result in an earlier use of Winrevair for treating PAH.Business (Item 1)

Also named by GILD, REGN

Johnson & Johnson (Uptravi)

competes withnamed as a risk

Orenitram faces direct competition from Uptravi, which is indicated to delay disease progression and reduce the risk of hospitalization for PAH, and will compete with a generic version of Uptravi which is expected to launch in 2026.Business (Item 1)

Also named by ISRG, KVUE

Liquidia Corporation (Yutrepia)

competes withnamed as a risk

Yutrepia competes directly with Tyvaso DPI, Nebulized Tyvaso, and our other treprostinil-based products.Business (Item 1)

Watson Laboratories, Inc.

competes withnamed as a risk

Under the settlement, Watson was permitted to market its generic version of Nebulized Tyvaso in the United States as early as January 2026, although, to date, they have not received FDA approval to do so.Business (Item 1)

Actavis Laboratories FL, Inc. and ANI Pharmaceuticals, Inc.

competes withnamed as a risk

Under the settlement agreements, Actavis and ANI can market their generic versions of Orenitram in the United States beginning in June 2027 and December 2027, respectively, although either or both of them may be permitted to enter the market earlier under certain circumstances.Business (Item 1)

Places

Japan

earns fromnamed as a risk

During 2025 we encountered limitations on our ability to supply Unituxin to our distributor in Japan, which caused our distributor to delay starting new patients on this therapy in Japan.Risk factors (Item 1A)

Also named by A, AAPL, AFL, AMKR, ANET, BMY, BSX, CAT and 25 more

Silver Spring, Maryland

operates innamed as a risk

We synthesize treprostinil, the active ingredient in Tyvaso DPI, Nebulized Tyvaso, and Remodulin, and treprostinil diolamine, the active ingredient in Orenitram, at our facility in Silver Spring, Maryland.Business (Item 1)

China, India and Taiwan suppliers

depends onnamed as a risk

Political unrest or trade disputes involving China, India, Taiwan, or other countries in our supply chain could impact our ability and the ability of our third-party manufacturers to source raw materials and consumables.Risk factors (Item 1A)

Research Triangle Park, North Carolina

operates in

We manufacture Orenitram drug product, and we package, warehouse, and distribute Tyvaso DPI, Nebulized Tyvaso, Remodulin, Orenitram, and Unituxin, at our facilities in RTP.Business (Item 1)

Also named by BIIB, MTSI

Regulators

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk

If response and review delays persist and/or worsen, they could potentially impact our ability to timely progress our pipeline efforts or obtain regulatory approval for new products and new indications for existing products.Risk factors (Item 1A)

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

Health Resources and Services Administration (HRSA)

subject tonamed as a risk

If HRSA develops a new theory of liability, we may face enforcement action or penalties as well as adverse publicity.Risk factors (Item 1A)

Also named by EXEL, LLY

Laws and programs

Medicare Part D

subject to · 10 and 20 percent discountsnamed as a risk

Orenitram and Tyvaso DPI are both reimbursed under Medicare Part D, and the reimbursement amount will be impacted by the 10 and 20 percent discounts under the new manufacturer discounting program.Risk factors (Item 1A)

Also named by ABBV, AMGN, BMY, CI, CNC, CVS, ELV, INCY and 5 more

U.S. tariffs (Trump administration)

exposed to its pricenamed as a risk

Should the prices of raw materials and consumables further increase as a result of inflation or tariffs, we could see higher than average year-over-year increases in cost of goods sold.Risk factors (Item 1A)

Also named by A, AAPL, ACHR, ADI, AEHR, AEP, AIOT, AKAM and 170 more

Medicaid

earns fromnamed as a risk

Such reductions are expected to decrease the number of persons enrolled in Medicaid and reduce the services covered by Medicaid, which could adversely affect our sales of our commercial products.Risk factors (Item 1A)

Also named by ABBV, ABT, ARE, ARWR, BAX, BMY, BSX, CHE and 39 more

Inflation Reduction Act

subject tonamed as a risk

These increased discounts will impact Tyvaso DPI and Orenitram revenues, while also having an industry-wide impact on the cost of Part D drugs.Risk factors (Item 1A)

Also named by AEE, AMGN, ARWR, BIIB, BKNG, BMY, CAH, CI and 26 more

340B Drug Pricing Program

subject tonamed as a risk

If we are unable to curb the proliferation of abuses caused by 340B contract pharmacies, we could see increased sales at 340B ceiling prices, which could have a material adverse impact on our revenues.Risk factors (Item 1A)

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

Medicare Part B

earns fromnamed as a risk

Remodulin and Nebulized Tyvaso are reimbursable under Medicare Part B.Business (Item 1)

Also named by ABBV, COR, HROW, REGN

GLOBE and GUARD proposed regulations

subject tonamed as a risk

If finalized and adopted, these regulations would implement mandatory payment models under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of the units of their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation pricing.Risk factors (Item 1A)

Florida drug importation plan

subject tonamed as a risk

In January 2024, the FDA approved Florida’s drug importation plan.Risk factors (Item 1A)

Orphan Drug Act

subject to

This exclusivity expires in October 2026.Business (Item 1)

Also named by ARWR, IONS, KRYS, NBIX, PVLA, VKTX