UNITED THERAPEUTICS Corp

United Therapeutics operates in the biotechnology industry, focusing on the development and commercialization of therapies for rare diseases, specifically pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and high-risk neuroblastoma, as well as technologies to expand the availability of transplantable organs. The company is a public benefit corporation (PBC) with a public benefit purpose to provide a brighter future for patients through novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. The company markets and sells six commercial therapies in the United States to treat PAH: Tyvaso DPI, Nebulized Tyvaso, Remodulin, Orenitram, and Adcirca, and an oncology product, Unituxin, for high-risk neuroblastoma. Outside the United States, the company derives revenues from sales of Nebulized Tyvaso, Remodulin, and Unituxin. The company is also engaged in research and development for PAH, idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PPF), and other diseases, as well as organ manufacturing technologies including xenotransplantation, regenerative medicine, and ex vivo lung perfusion.

The company faces competition from many drug companies engaged in research, development, and commercialization of products to treat cardiopulmonary diseases, pulmonary diseases, and cancer. For PAH, competitors include large pharmaceutical companies such as Johnson & Johnson, Gilead Sciences, Bayer Schering Pharma AG, GSK plc, and Merck, as well as a variety of large generic drug manufacturers. Merck's Winrevair (sotatercept) was approved by the FDA in March 2024 to treat PAH. In May 2025, Liquidia received final FDA approval to market Yutrepia, a dry powder formulation of treprostinil, to treat PAH and PH-ILD, which competes directly with the company's treprostinil-based products. The company also faces competition from generic versions of its products, including generic treprostinil injection and generic tadalafil. The company believes its competitive advantages include the unique properties of its treprostinil-based products, such as Remodulin's stability at room temperature and the convenience of Tyvaso DPI's dry powder formulation, as well as its extensive patent portfolio and regulatory exclusivities.

The company generates revenue primarily through the sale of its commercial products: Tyvaso DPI, Nebulized Tyvaso, Remodulin, Orenitram, Unituxin, and Adcirca. Revenue is recognized when control of the product is transferred to distributors, which is generally when the product is shipped or delivered. The company's revenue is subject to various gross-to-net deductions, including rebates, chargebacks, prompt pay discounts, sales returns, and distributor fees. The company also derives revenues from the sale of commercial ex vivo lung perfusion services. The company's customer base is concentrated among a small number of principal customers, with two specialty pharmaceutical distributors, Accredo and CVS Specialty, distributing the majority of its treprostinil-based products in the United States.

The company's commercial product portfolio consists of six products. Tyvaso DPI is a dry powder inhaled formulation of treprostinil approved to improve exercise ability in patients with PAH and PH-ILD. Nebulized Tyvaso is a nebulized liquid inhaled formulation of treprostinil approved for PAH and PH-ILD. Remodulin is a continuously-infused formulation of treprostinil approved for subcutaneous and intravenous delivery for PAH. Orenitram is an oral extended-release tablet form of treprostinil approved to delay disease progression and improve exercise capacity in PAH patients. Unituxin is an infused monoclonal antibody approved for the treatment of high-risk neuroblastoma. Adcirca is an oral immediate-release tablet form of the PDE-5 inhibitor tadalafil approved to improve exercise ability in PAH patients. The company recognized $1,878.2 million ¹ in combined Tyvaso DPI and Nebulized Tyvaso net product sales, representing 59 percent ² of total revenues for the year ended December 31, 2025. Remodulin net product sales were $526.8 million ³, representing 17 percent ⁴ of total revenues. Orenitram net product sales were $496.9 million ⁵, representing 16 percent ⁶ of total revenues. Unituxin net product sales were $226.8 million ⁷, representing seven percent ⁸ of total revenues. Adcirca net product sales were $30.0 million ⁹, representing one percent ¹⁰ of total revenues.

The company's pipeline programs include Nebulized Tyvaso for IPF and PPF, ralinepag for PAH, and various organ manufacturing technologies. The TETON 2 phase 3 study of Nebulized Tyvaso in patients with IPF met its primary efficacy endpoint, demonstrating improvement in absolute forced vital capacity (FVC) relative to placebo by 95.6 mL ¹¹ (p <0.0001) from baseline to week 52. The TETON 1 study is ongoing, with data readout expected late in the first quarter, or early in the second quarter, of 2026. The ADVANCE OUTCOMES phase 3 study of ralinepag concluded enrollment in June 2025, with topline data expected late in the first quarter, or early in the second quarter, of 2026. The company's xenotransplantation program includes the UKidney, UHeart, and UThymoKidney products. In January 2025, the FDA cleared the IND for the EXPAND study of the UKidney product, which is expected to enroll an initial cohort of six end-stage renal disease patients, expanding to up to 50 participants. The first transplant in this study occurred in the fourth quarter of 2025. In August 2025, the FDA cleared the IND for the EXTEND clinical study of the UThymoKidney product. The company also has an ex vivo lung perfusion (EVLP) program using the XVIVO Perfusion System, and over 730 patients have received lung transplants following use of its centralized EVLP service.

In April 2025, the company entered into the 2025 Credit Agreement, which provides for an unsecured revolving credit facility of up to $2.5 billion ¹². The company borrowed $200.0 million ¹³ under the 2025 Credit Agreement and used the proceeds to repay all outstanding indebtedness under the 2022 Credit Agreement. During the second quarter of 2025, the company repaid the remaining $200.0 million ¹⁴ balance under the 2025 Credit Agreement, bringing the aggregate outstanding balance to zero as of June 30, 2025. In August 2025, the company entered into two accelerated share repurchase agreements (the 2025 ASR agreements), comprised of a $500.0 million ¹⁵ uncollared stock repurchase agreement and a $500.0 million ¹⁶ collared stock repurchase agreement, with Citibank, N.A. to repurchase $1.0 billion ¹⁷ of its common stock. In total, the company repurchased 2,642,498 ¹⁸ shares of its common stock under the 2025 ASR agreements. In July 2025, the company acquired approximately 60 acres of property containing five buildings located in Research Triangle Park, North Carolina for a total purchase price of $106.8 million ¹⁹. In September 2025, the company launched a new patient-filled version of the Remunity Pump, called RemunityPRO. In 2025, the company recorded a $21.7 million ²⁰ impairment charge to write down the carrying value of certain property, plant, and equipment.

Total revenues for the year ended December 31, 2025 were $3,182.7 million ²¹, compared to $2,877.4 million ²² for the year ended December 31, 2024, representing an increase of 11 percent ²³. Net income for the year ended December 31, 2025 was $1,334.7 million ²⁴, compared to $1,195.1 million ²⁵ for the year ended December 31, 2024. Diluted earnings per share for the year ended December 31, 2025 was $27.86 ²⁶, compared to $24.64 ²⁷ for the year ended December 31, 2024. Operating income for the year ended December 31, 2025 was $1,492.5 million ²⁸, compared to $1,377.0 million ²⁹ for the year ended December 31, 2024. Net cash provided by operating activities for the year ended December 31, 2025 was $1,561.2 million ³⁰, compared to $1,327.1 million ³¹ for the year ended December 31, 2024.

The company anticipates that revenue growth over the near-term will be driven primarily by continued growth in sales of Tyvaso DPI, continued growth in the number of PH-ILD patients prescribed Tyvaso DPI and Nebulized Tyvaso, continued growth in the number of patients prescribed Orenitram, and modest price increases for some of its products. The company believes that additional revenue growth in the medium- and longer-term will be driven by new products, new indications for existing products, and new devices to deliver its existing products. Key growth vectors include the TETON studies for Nebulized Tyvaso in IPF and PPF, the ADVANCE OUTCOMES study for ralinepag in PAH, and the development of organ manufacturing technologies including xenotransplantation, regenerative medicine, and ex vivo lung perfusion. The company is also developing a soft mist inhaler (SMI) version of inhaled treprostinil, targeting the same indications for which Nebulized Tyvaso is already approved, as well as IPF and PPF, and is planning a phase 2 study of treprostinil SMI to treat patients with PH-COPD.

The company is developing ralinepag, a next-generation, once-daily, oral, extended-release, titratable, selective, and potent prostacyclin receptor agonist for the treatment of PAH. The ADVANCE OUTCOMES study, a phase 3, event-driven clinical trial of an extended-release formulation of ralinepag, concluded enrollment in June 2025, and the company plans to release topline data from the study late in the first quarter, or early in the second quarter, of 2026. If approved and launched, the company expects ralinepag's once-daily dosing profile to position it favorably compared with Uptravi (selexipag), which is a twice-daily IP-receptor agonist marketed by Johnson & Johnson for the treatment of PAH. In 2025, Johnson & Johnson reported global sales of Uptravi of over $1.9 billion ³², including over $1.5 billion ³³ in U.S. sales, reflecting a growth rate of approximately 5 percent ³⁴ over 2024. Assuming the ADVANCE OUTCOMES study is successful, the company plans to develop an oral triple-combination therapy consisting of ralinepag, an endothelin receptor antagonist, and a PDE-5 inhibitor.

The company's cost of sales, excluding share-based compensation, increased for the year ended December 31, 2025, as compared to the same period in 2024, primarily due to increases in royalty expense resulting from a growth in revenues, inventory reserve expense, and the cost of products and services sold. Research and development expense increased for the year ended December 31, 2025, as compared to the same period in 2024, primarily due to increased expenditures related to manufactured organ and organ alternative projects and increased expenditures for drug delivery device and formulation technologies. Selling, general, and administrative expense increased for the year ended December 31, 2025, as compared to the same period in 2024, primarily due to increases in personnel expense due to growth in headcount and legal expenses related to litigation matters.

The company has budgeted approximately $400 million ³⁵ for capital expenditures during 2026 and through the end of 2028 to construct additional facilities to support the development and commercialization of its products and technologies. This amount is primarily dedicated to construction of a new manufacturing facility in RTP and construction of clinical-scale DPF facilities in Stewartville, Minnesota and Houston, Texas. The company plans to fund these capital expenditures using cash on hand. The company anticipates its existing DPF facility in Virginia and the two planned DPF facilities in Minnesota and Texas will provide an initial commercial supply of its xeno-organ products if and when they are approved by the FDA. The company is also constructing two additional DPF facilities in Minnesota and Texas.

Research and development spending for the year ended December 31, 2025 was $550.0 million ³⁶. Capital expenditures for the year ended December 31, 2025 were $520.5 million ³⁷. The company repurchased $1.0 billion ³⁸ of its common stock under the 2025 ASR agreements during the year ended December 31, 2025. The company has never paid and has no present intention to pay cash dividends on its common stock in the foreseeable future.

The company faces several headwinds and constraints. The availability of generic versions of its products has negatively impacted its revenues, and these and additional generic products launched in the future may continue to do so. The approval and launch of new therapies, such as Merck's Winrevair and Liquidia's Yutrepia, may materially negatively impact sales of its current and potential new products. The company also faces pricing pressure as a result of the Inflation Reduction Act (IRA) and other drug price reduction initiatives. The IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare, imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and redesigns the Medicare Part D benefit. The Trump administration is pursuing a two-fold strategy to reduce drug costs, including threatening to impose significant tariffs on pharmaceutical manufacturers and pursuing traditional regulatory pathways to impose drug pricing policies, such as the proposed GLOBE and GUARD regulations.

The company's manufacturing strategy exposes it to significant risks, including reliance on third-party manufacturers, the need to construct new facilities, and the complexity of manufacturing processes. The company relies entirely on MannKind to manufacture Tyvaso DPI finished drug product and inhalers, with no plans to develop an alternate or backup supply arrangement. The company also relies entirely on DEKA and its affiliates to manufacture the Remunity and RemunityPRO Pumps. The company's supply chain for raw materials and consumables extends worldwide and is complex, with suppliers based in China, India, and Taiwan playing a role in its supply chain. The company is also subject to extensive laws and regulations in the United States and other countries, and failure to obtain approvals on a timely basis or to comply with these requirements could delay, disrupt, or prevent commercialization of its products.

The company relies heavily on sales of its treprostinil-based therapies, which comprise the vast majority of its revenues, and substantially decreased sales of any of these products could have a material adverse impact on its operations. The company faces significant competition from established and newly developed drugs, including Merck's Winrevair, which was commercially launched in March 2024, and Liquidia's Yutrepia, which was launched in June 2025. The company's manufacturing strategy exposes it to significant risks, including reliance on third-party manufacturers such as MannKind for Tyvaso DPI and DEKA for the Remunity and RemunityPRO Pumps, with no plans to develop alternate supply arrangements for Tyvaso DPI. The company is subject to extensive government regulation, and the Inflation Reduction Act of 2022, which requires manufacturers of certain drugs to engage in price negotiations with Medicare and imposes rebates, is likely to have a significant impact on the company's revenues. The company's intellectual property rights may not effectively deter competitors, and it has entered into settlement agreements with generic companies permitting them to launch generic versions of Remodulin, Nebulized Tyvaso, and Orenitram, with a liability of $74.1 million ³⁹ accrued in connection with litigation with Sandoz.

Management's message emphasizes the company's mission to transform the treatment of rare diseases and expand the availability of transplantable organs through innovative organ manufacturing technologies. The company highlights its public benefit corporation status and its commitment to delivering meaningful impacts for patients, people, shareholders, and other stakeholders. Key strategic priorities include advancing the pipeline programs, particularly the TETON studies for Nebulized Tyvaso in IPF and PPF, the ADVANCE OUTCOMES study for ralinepag, and the xenotransplantation program. Management also focuses on driving revenue growth through continued expansion of Tyvaso DPI and Orenitram, and managing the impact of competition from generic products and new therapies such as Winrevair and Yutrepia. The company emphasizes its strong financial position, with total cash and cash equivalents and marketable investments of $4,697.0 million ⁴⁰ as of December 31, 2025, and its ability to fund capital expenditures and share repurchases.