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What changed in UNITED THERAPEUTICS Corp's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of UNITED THERAPEUTICS Corp's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+529 added−613 removedSource: 10-K (2026-02-25) vs 10-K (2025-02-26)

Top changes in UNITED THERAPEUTICS Corp's 2025 10-K

529 paragraphs added · 613 removed · 418 edited across 9 sections

Item 1. Business

Business — how the company describes what it does

233 edited+52 added−133 removed218 unchanged
Biggest changeSales and Marketing Our marketing strategy for our commercial PAH and PH-ILD products is to use our sales and marketing teams to reach out to the prescriber community to: (1) increase PAH and PH-ILD awareness; (2) increase understanding of the progressive nature of PAH and the importance of early treatment; (3) communicate the increased risks when ILD patients develop PH-ILD; and (4) increase awareness of our commercial products and how they fit into the various stages of disease progression and treatment.
Biggest changeSales and Marketing Our marketing strategy for our commercial PAH and PH-ILD products is to use our sales and marketing teams to reach out to the prescriber community to: (1) increase PAH and PH-ILD awareness; (2) increase understanding of the progressive nature of PAH and the importance of early treatment; (3) communicate the increased risks when ILD patients develop PH-ILD; and (4) increase awareness of our commercial products and how they fit into the various stages of disease progression and treatment. 12 United Therapeutics, a public benefit corporation Distribution of Commercial Products United States Distribution of Tyvaso DPI, Nebulized Tyvaso, Remodulin, Remunity and RemunityPRO Pumps, Orenitram, and Unituxin We distribute Tyvaso DPI, Nebulized Tyvaso, Remodulin, the Remunity and RemunityPRO Pumps, and Orenitram in the United States through two contracted specialty pharmaceutical distributors: Accredo Health Group, Inc. and its affiliates ( Accredo ) and Caremark, L.L.C.
( Merck ) obtained FDA approval for the first activin signaling inhibitor, known as Winrevair™ (sotatercept), to treat PAH, and launched sales of the product shortly thereafter. Because any or all of the these pathways may be therapeutic targets in a patient, these classes of drugs are used alone or in combination to treat patients with PAH.
( Merck ) obtained FDA approval for the first activin signaling inhibitor, known as Winrevair® (sotatercept), to treat PAH, and launched sales of the product shortly thereafter. Because any or all of these pathways may be therapeutic targets in a patient, these classes of drugs are used alone or in combination to treat patients with PAH.
T hese distributors are required to maintain certain minimum inventory levels to facilitate an uninterrupted supply to patients who are prescribed our therapies. We compensate Accredo and CVS Specialty on a fee-for-service basis for certain ancillary services in connection with the distribution of these products.
( CVS Specialty ). T hese distributors are required to maintain certain minimum inventory levels to facilitate an uninterrupted supply to patients who are prescribed our therapies. We compensate Accredo and CVS Specialty on a fee-for-service basis for certain ancillary services in connection with the distribution of these products.
Our orphan drug exclusivity in the United States for Unituxin expired in March 2022. Under a non-exclusive license agreement with The Scripps Research Institute, we pay a royalty of one percent of Unituxin net product sales. We have no patents covering Unituxin.
Our orphan drug exclusivity in the United States for Unituxin expired in March 2022. Under a non-exclusive license agreement with The Scripps Research Institute, we pay a royalty of one percent of Unituxin net product sales. We have no patents covering the Unituxin drug product.
All devices, unless exempt by FDA regulation, must adhere to a set of general controls, including compliance with the applicable portions of the FDA’s Quality System Regulation ( QSR ), which sets forth good manufacturing practice requirements; facility registration and product listing; reporting of adverse medical events; truthful and non-misleading labeling; and promotion of the device consistent with its cleared or approved intended uses.
All devices, unless exempt by FDA regulation, must adhere to a set of general controls, including compliance with the applicable portions of the FDA’s Quality System Regulation ( QSR ), which sets forth good manufacturing practice requirements; facility registration and product listing; reporting adverse medical events; truthful and non-misleading labeling; and promotion of the device consistent with its cleared or approved intended uses.
Each combination product is assigned a lead FDA Center, which has jurisdiction for the premarket review and regulation, based on which constituent part of the combination product provides the primary mode of action, i.e., the mode of action expected to make the greatest contribution to the overall intended therapeutic effect of the product.
Each combination product is assigned a lead FDA center, which has jurisdiction for the premarket review and regulation of the product, based on which constituent part of the combination product provides the primary mode of action, i.e., the mode of action expected to make the greatest contribution to the overall intended therapeutic effect of the product.
Depending on the type of combination product, the FDA may require a single application for approval, clearance, or licensure of the combination product, or separate applications for the constituent parts. During the review of marketing applications, the lead Center may consult or collaborate with other FDA Centers.
Depending on the type of combination product, the FDA may require a single application for approval, clearance, or licensure of the combination product, or separate applications for the constituent parts. During the review of marketing applications, the lead FDA center may consult or collaborate with other FDA centers.
We also plan to seek NADA approval for the pig lineage containing ten genetic modifications that we are using to generate our development-stage UKidney and UHeart products. In addition, production of xenografts intended for xenotransplantation must take place in DPF facilities that meet both cGMP requirements and unique requirements designed to ensure that our pigs are free of pathogens.
We also plan to seek NADA approval for the pig lineage containing ten genetic modifications that we are using to generate our development-stage UKidney and UHeart products. In addition, production of xenografts intended for xenotransplantation must take place in DPF facilities that meet both cGMP requirements and unique requirements designed to ensure that our pigs are free of designated pathogens.
A change in supplier or manufacturer could cause a delay in the manufacturing, distribution, and research efforts associated with our respective products or result in increased costs. See also Item 1A—Risk Factors included in this Report. Competition Many drug companies engage in research, development, and commercialization of products to treat cardiopulmonary diseases and cancer.
A change in supplier or manufacturer could cause a delay in the manufacturing, distribution, and research efforts associated with our respective products or result in increased costs. See also Item 1A—Risk Factors included in this Report. Competition Many drug companies engage in research, development, and commercialization of products to treat cardiopulmonary diseases, pulmonary diseases, and cancer.
In April 2024, surgeons at NYU Langone Health successfully transplanted a UThymoKidney into a living patient under an FDA authorization for compassionate use. The patient was suffering from heart and kidney failure, and received a left ventricular assist device to stabilize heart function prior to the UThymoKidney transplant.
In April 2024, surgeons at NYU Langone Health transplanted a UThymoKidney into a living patient under an FDA authorization for compassionate use. The patient was suffering from heart and kidney failure, and received a left ventricular assist device to stabilize heart function prior to the UThymoKidney transplant.
Under this program, we are obligated to make our products available for procurement under an FSS contract under which we must comply with standard government terms and conditions and charge a price to certain federal agencies that is no higher than the statutory federal ceiling price ( FCP ).
Under this program, we are obligated to make our products available for procurement under an FSS contract under which we must comply with standard government terms and conditions and charge a price to certain federal agencies that is no higher than the statutory federal ceiling price.
In November 2019, we entered into a supply agreement with an affiliate of DEKA to manufacture and supply the Remunity Pump, and later amended it to provide for manufacture and supply of the RemunityPRO Pump. Under this supply agreement, we are responsible for all costs associated with manufacturing the Remunity Pump and the RemunityPRO Pump.
In November 2019, we entered into a supply agreement with an affiliate of DEKA to manufacture and supply the Remunity Pump, and later amended it to provide for manufacture and supply of the RemunityPRO Pump. Under this supply agreement, we are responsible for all costs associated with manufacturing the Remunity and RemunityPRO Pumps.
In October 2024, we entered into a collaboration agreement with Robinson Helicopter Company to support our efforts to develop and certify zero-emission, hydrogen-powered helicopters based on Robinson’s R44 and R66 helicopter models.
In October 2024, we entered into a collaboration agreement with Robinson Helicopter Company to support our efforts to develop and certify zero-emission, hydrogen-electric powered helicopters based on Robinson’s R44 and R66 helicopter models.
EVLP technology increases the number of transplantable lungs by giving surgeons the ability to assess the function of lungs to determine if the lungs are suitable for transplantation. This allows for the transplantation of lungs that would have otherwise not been transplanted.
EVLP technology increases the number of transplantable lungs by giving surgeons the ability to assess the function of donor lungs to determine if the lungs are suitable for transplantation. This allows for the transplantation of lungs that would have otherwise not been transplanted.
Manufacturing and Supply We synthesize treprostinil, the active ingredient in Tyvaso DPI, nebulized Tyvaso, and Remodulin, and treprostinil diolamine, the active ingredient in Orenitram, at our facilities in Silver Spring, Maryland. We produce dinutuximab, the active ingredient in Unituxin, at our Silver Spring facility. We manufacture drug product for nebulized Tyvaso, Remodulin, and Unituxin at our Silver Spring facility.
Manufacturing and Supply 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. We produce dinutuximab, the active ingredient in Unituxin, at our Silver Spring facility. We manufacture drug product for Nebulized Tyvaso, Remodulin, and Unituxin at our Silver Spring facility.
The Biologics Price Competition and Innovation Act of 2009 ( BPCI Act ) created an abbreviated approval pathway for biological products shown to be “biosimilar” to an FDA-licensed reference biological product to minimize duplicative testing.
The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway for biological products shown to be “biosimilar” to an FDA-licensed reference biological product to minimize duplicative testing.
Remunity and RemunityPRO are covered by issued patents and pending patent applications both in the U.S. and other countries. The expiration dates of currently issued U.S. patents range from 2027 through 2033.
The Remunity and RemunityPRO Pumps are covered by issued patents and pending patent applications both in the U.S. and other countries. The expiration dates of currently issued U.S. patents range from 2027 through 2033.
Clinical trials in support of an NDA typically are conducted in sequential phases, but the phases may overlap. • Phase 1 involves the initial introduction of the drug into healthy human subjects or patients to assess metabolism, pharmacokinetics, pharmacological actions, side effects associated with increasing doses, and, if possible, early evidence on effectiveness. • Phase 2 usually involves studies in a limited patient population to assess the efficacy of the drug in specific, targeted indications, explore tolerance and optimal dosage, and identify possible adverse effects and safety risks. • Phase 3 trials, also called pivotal studies, major studies or advanced clinical trials, demonstrate clinical efficacy and safety in a larger number of patients, typically at geographically diverse clinical study sites, and permit the FDA to evaluate the overall benefit-risk relationship of the drug and provide adequate information for drug labeling. • Phase 4 studies are often conducted following marketing approval, in order to meet regulatory requirements or to provide additional data related to drug use.
Clinical trials in support of an NDA typically are conducted in sequential phases, but the phases may overlap. • Phase 1 involves the initial introduction of the drug into healthy human subjects or patients to assess metabolism, pharmacokinetics, pharmacological actions, side effects associated with increasing doses, and, if possible, early evidence on effectiveness. • Phase 2 usually involves studies in a limited patient population to assess the efficacy of the drug in specific, targeted indications, explore tolerance and optimal dosage, and identify possible adverse effects and safety risks. 2025 Annual Report 21 • Phase 3 trials, also called pivotal studies, major studies or advanced clinical trials, demonstrate clinical efficacy and safety in a larger number of patients, typically at geographically diverse clinical study sites, and permit the FDA to evaluate the overall benefit-risk relationship of the drug and provide adequate information for drug labeling. • Phase 4 studies are often conducted following marketing approval, in order to meet regulatory requirements or to provide additional data related to drug use.
Mahon, J.D. 61 Executive Vice President, General Counsel, and Corporate Secretary Martine Rothblatt, Ph.D., J.D., M.B.A . , founded United Therapeutics in 1996 and has served as Chairperson and Chief Executive Officer since its inception. Previously, she created the satellite radio company SiriusXM. She is an inventor or co‑inventor on ten U.S. patents, with additional patents pending.
Mahon, J.D. 62 Executive Vice President, General Counsel, and Corporate Secretary Martine Rothblatt, Ph.D., J.D., M.B.A ., founded United Therapeutics in 1996 and has served as Chairperson and Chief Executive Officer since its inception. Previously, she created the satellite radio company SiriusXM. She is an inventor or co‑inventor on ten U.S. patents, with additional patents pending.
We entered into exclusive agreements with Ferrer to distribute Orenitram and nebulized Tyvaso throughout the territories where it also has distribution rights for Remodulin. Feedback from the EMA indicated that approval of either Orenitram or nebulized Tyvaso would require another large c linical trial of the applicable product. As a result, we have terminated our contract with Ferrer concerning Orenitram.
We entered into exclusive agreements with Ferrer to distribute Orenitram and Nebulized Tyvaso in the territories where it also has distribution rights for Remodulin. Feedback from the EMA indicated that approval of either Orenitram or Nebulized Tyvaso would require another large c linical trial of the applicable product. As a result, we have terminated our contract with Ferrer concerning Orenitram.
After 47 days, surgeons electively removed the thymokidney and returned the patient to dialysis. According to NYU Langone Health, the thymokidney had sustained significant injury from episodes of insufficient blood flow due to reduced blood pressure generated by the heart pump and, on balance, was no longer contributing enough to justify continuing the patient’s immunosuppression regimen.
After 47 days, surgeons electively removed the UThymoKidney and returned the patient to dialysis. According to NYU Langone Health, the UThymoKidney had sustained significant injury from episodes of insufficient blood flow due to reduced blood pressure generated by the heart pump and, on balance, was no longer contributing enough to justify continuing the patient’s immunosuppression regimen.
We have a policy that prohibits all forms of unlawful harassment and retaliation and provide training to all Unitherians on their responsibilities and protections under this policy. PBC Conversion. In 2021, we converted United Therapeutics into a public benefit corporation, becoming the first company in our industry to do so.
We have a policy that prohibits all forms of unlawful harassment and retaliation, and we provide training to all Unitherians on their responsibilities and protections under this policy. PBC Conversion. In 2021, we converted United Therapeutics into a public benefit corporation, becoming the first publicly traded company in our industry to do so.
Meat from GalSafe pigs is currently being produced for individuals with alpha-gal syndrome, an allergy to meat caused by a bite from the lone star tick. This approval marked only the second FDA approval of a gene-edited animal as a source of food, and the first such approval for a mammal.
Meat from GalSafe pigs is currently being provided to individuals with alpha-gal syndrome, an allergy to meat caused by a bite from the lone star tick. This approval marked only the second FDA approval of a gene-edited animal as a source of food, and the first such approval for a mammal.
We offer market-leading benefit programs, including a 401(k) savings plan with a company match, as well as health and welfare benefits such as flexible spending accounts, generous paid time off, parental bonding leave, employee assistance programs, flexible work arrangements, tuition assistance, and more.
We offer market-leading benefit programs, including a 401(k) savings plan with a company match, as well as health and welfare benefits such as flexible spending accounts, generous paid time off, parental bonding leave, adoption and surrogacy assistance, employee assistance programs, flexible work arrangements, tuition assistance, and more.
In addition, before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP and the facility or the facilities at which the drug is manufactured to ensure they are in compliance with the FDA’s current Good Manufacturing Practices ( cGMP ).
In addition, before approving an NDA, the FDA will typically inspect one or more clinical sites to assess compliance with GCP and the facility or the facilities at which the drug is manufactured to ensure they are in compliance with the FDA’s current Good Manufacturing Practices ( cGMP ).
The Miromatrix external liver assist product, called miroliver ELAP ®, uses a decellularized porcine liver matrix that has been seeded with human-derived cells and an extracorporeal blood circuit to maintain liver support in patients experiencing acute liver failure.
The development-stage Miromatrix external liver assist product, called miroliver ELAP ®, uses a decellularized porcine liver matrix that has been seeded with human-derived cells and an extracorporeal blood circuit to maintain liver support in patients experiencing acute liver failure.
We have also entered into similar settlement agreements with other generic companies, some of which have also launched sales of generic versions of Remodulin. Through December 31, 2024, we have seen limited erosion of Remodulin sales as a result of generic treprostinil competition in the United States.
We have also entered into similar settlement agreements with other generic companies, some of which have also launched sales of generic versions of Remodulin. Through December 31, 2025, we have seen limited erosion of Remodulin sales as a result of generic treprostinil competition in the United States.
Our people mission focuses on five key commitments, providing Unitherians with: • Challenging, innovative work • Opportunities for career advancement • Autonomy to do their best work • Inspiring work environment allowing for work/life integration • Competitive pay and benefits In 2024, we achieved approximately $2.2 million in revenue per employee, which ranks near the top of our industry peer group.
Our people mission focuses on five key commitments, providing Unitherians with: • Challenging, innovative work • Opportunities for career advancement • Autonomy to do their best work • Inspiring work environment allowing for work/life integration • Competitive pay and benefits In 2025, we achieved approximately $2.25 million in revenue per employee, which ranks near the top of our industry peer group.
The “Unitherian” Culture. We are intentional in our effort to maintain our entrepreneurial culture. We believe this instills a greater sense of ownership, meaning, and commitment in Unitherians, motivating them to go above and beyond to achieve our ambitious goals.
We are intentional in our effort to maintain our entrepreneurial culture. We believe this instills a greater sense of ownership, meaning, and commitment in Unitherians, motivating them to go above and beyond to achieve our ambitious goals.
In the U.S., these competitive therapies include oral ERAs (Letairis ® (ambrisentan), Opsumit ® (macitentan), Tracleer ® (bosentan), generic bosentan, and generic ambrisentan); prostacyclin-class therapies (Flolan (intravenous epoprostenol), Uptravi ® (oral selexipag), Veletri ® (intravenous epoprostenol), Ventavis ® (inhaled iloprost), generic epoprostenol, and generic treprostinil injection); PDE-5 inhibitors (Revatio ® (sildenafil), generic sildenafil, and generic tadalafil); an SGC stimulator Adempas ® (riociguat); an activin pathway inhibitor Winrevair (sotatercept-csrk) delivered via subcutaneous injection; and an oral combination product known as Opsynvi®, comprised of tadalafil and macitentan.
In the U.S., these competitive therapies include oral ERAs (Letairis ® (ambrisentan), Opsumit ® (macitentan), Tracleer ® (bosentan), generic bosentan, and generic ambrisentan); prostacyclin-class therapies Uptravi ® (oral selexipag), Veletri ® (intravenous epoprostenol), Ventavis ® (inhaled iloprost), Yutrepia® (treprostinil inhalation powder), generic intravenous epoprostenol, and generic treprostinil injection; PDE-5 inhibitors (Revatio ® (sildenafil), generic sildenafil, and generic tadalafil); an SGC stimulator Adempas ® (riociguat); an activin pathway inhibitor Winrevair (sotatercept-csrk) delivered via subcutaneous injection; and an oral combination product known as Opsynvi®, comprised of tadalafil and macitentan.
The FCA prohibits any person from, among other things, presenting, or causing to be presented, a false or fraudulent claim for payment of government funds, or making, or causing to be made, a false statement material to a false or fraudulent claim.
The False Claims Act ( FCA ) prohibits any person from, among other things, presenting, or causing to be presented, a false or fraudulent claim for payment of government funds, or making, or causing to be made, a false statement material to a false or fraudulent claim.
We pay product fees and a single-digit royalty to DEKA based on commercial sales of the Remunity Pump and the RemunityPRO Pump, and the Remodulin drug product sold for use with the system.
We pay product fees and a single-digit royalty to DEKA based on commercial sales of the Remunity and RemunityPRO Pumps, and the Remodulin drug product sold for use with the system.
The effectiveness of these efforts is reflected in a recent external engagement survey conducted by Great Place to Work, where 91 percent of respondents indicated that they consider United Therapeutics “a great place to work.” We have consistently maintained this high level of engagement, with 90 percent or more of respondents from 2018 to 2024 affirming their positive experience with our organization.
The effectiveness of these efforts is reflected in a recent external engagement survey conducted by Great Place to Work, where 94 percent of respondents indicated that they consider United Therapeutics “a great place to work.” We have consistently maintained this high level of engagement, with 90 percent or more of respondents from 2018 to 2025 affirming their positive experience with our organization.
NYU Langone Health noted that a biopsy of the thymokidney did not show signs of rejection. • Second Successful Transplantation of a Porcine Kidney. In November 2024, surgeons at NYU Langone Health successfully transplanted a UKidney into a living patient under an FDA authorization for compassionate use.
NYU Langone Health noted that a biopsy of the UThymoKidney did not show signs of rejection. • Second Successful Transplantation of a Porcine Kidney. In November 2024, surgeons at NYU Langone Health transplanted a UKidney into a living patient under an FDA authorization for compassionate use.
Remunity Pump In February 2021, we launched limited commercial sales of the Remunity Pump, which is a semi-disposable system for subcutaneous delivery of treprostinil that we developed in collaboration with DEKA Research & Development Corp. ( DEKA ) under an exclusive development and license agreement.
Remunity and RemunityPRO Pumps In February 2021, we launched commercial sales of the Remunity Pump, which is a semi-disposable system for subcutaneous delivery of treprostinil that we developed in collaboration with DEKA Research & Development Corp. ( DEKA ) under an exclusive development and license agreement.
Under the terms of the agreement, we funded the development costs related to the Remunity Pump and the RemunityPRO Pump and will continue to fund any further development costs associated with new versions of the pump.
Under the terms of the agreement, we funded the development costs related to the Remunity and RemunityPRO Pumps and will continue to fund any further development costs associated with new versions.
A phase 2 study of an immediate-release formulation of ralinepag in 61 PAH patients (40 patients on 8 United Therapeutics, a public benefit corporation active ralinepag, 21 on placebo) met its primary endpoint, showing a 29.8 percent reduction (p=0.03) in median pulmonary vascular resistance ( PVR , the force or resistance that blood encounters as it flows through the blood vessels in the lungs) after 22 weeks of treatment with ralinepag compared with placebo.
A phase 2 study of an immediate-release formulation of ralinepag in 61 PAH patients (40 patients on active ralinepag, 21 on placebo) met its primary endpoint, showing a 29.8 percent reduction (p=0.03) in median pulmonary vascular resistance ( PVR , the force or resistance that blood encounters as it flows through the blood vessels in the lungs) after 22 weeks of treatment with ralinepag compared with placebo.
Section 505(b)(2) permits the filing of an NDA in which the applicant relies, at least in part, on information from studies made to show whether a drug is safe or effective that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use.
Section 505(b)(2) permits the filing of an NDA in which the applicant relies, at least in part, on information from studies made to show whether a drug is safe or effective that were not conducted by or for the applicant and for which the applicant has not 2025 Annual Report 23 obtained a right of reference or use.
This patent is also listed in the Orange Book. Additionally, we have been granted a patent directed to a method of improving exercise capacity in PH-ILD patients, which expires in 2042. 2024 Annual Report 13 • Remodulin . We have been granted three U.S. patents covering an improved diluent for Remodulin, which expire in 2028 and 2029.
This patent is also listed in the Orange Book. Additionally, we have been granted a patent directed to a method of improving exercise capacity in PH-ILD patients, which expires in 2042. • Remodulin . We have been granted three U.S. patents covering an improved diluent for Remodulin, which expire in 2028 and 2029.
Any failure to comply with applicable regulatory requirements could result in enforcement action by the FDA, which may include any of the following sanctions: • adverse publicity, warning letters, untitled letters, it has come to our attention letters, fines, injunctions, consent decrees, and civil penalties; • repair, replacement, refunds, recall, or seizure of products; • operating restrictions, partial suspension, or total shutdown of production; • denial of requests for regulatory clearance or PMA approval of new products or services, new intended uses, or modifications to existing products or services; • withdrawal of regulatory clearance or PMA approvals that have already been granted; or • criminal prosecution.
Any failure to comply with applicable regulatory requirements could result in enforcement action by the FDA, which may include sanctions such as: • adverse publicity, warning letters, untitled letters, it has come to our attention letters, fines, injunctions, consent decrees, and civil penalties; • repair, replacement, refunds, recall, or seizure of products; 2025 Annual Report 25 • operating restrictions, partial suspension, or total shutdown of production; • denial of requests for regulatory clearance or PMA approval of new products or services, new intended uses, or modifications to existing products or services; • withdrawal of regulatory clearance or PMA approvals that have already been granted; or • criminal prosecution.
Clinical trials involving significant risk devices (e.g., devices that present a potential for serious risk to the health, safety, or 2024 Annual Report 25 welfare of human subjects) are required to obtain both FDA approval of an investigational device exemption ( IDE ) application and IRB approval before study initiation.
Clinical trials involving significant risk devices (e.g., devices that present a potential for serious risk to the health, safety, or welfare of human subjects) are required to obtain both FDA approval of an investigational device exemption ( IDE ) application and IRB approval before study initiation.
The availability of adequate government reimbursement for our products is subject to regulatory changes and controls affecting these programs. Medicaid is a joint federal and state program that benefits low‑income and disabled individuals. It is administered by the states and the U.S. Centers for Medicare & Medicaid Services ( CMS ), the federal agency that also administers the Medicare program.
The availability of adequate government reimbursement for our products is subject to regulatory changes and controls affecting these programs. Medicaid is a joint federal and state program that benefits low‑income and disabled individuals. It is administered by the states and CMS, the federal agency that also administers the Medicare program.
We participate in the Medicaid Drug Rebate program, pursuant to which, as a condition of having federal funds 2024 Annual Report 27 made available for our drugs under Medicaid and Medicare Part B, we are required to pay a rebate to each state Medicaid program for each unit of our covered outpatient drugs dispensed to Medicaid beneficiaries and reimbursed by a state Medicaid program.
We participate in the Medicaid Drug Rebate Program, pursuant to which, as a condition of having federal funds made available for our drugs under Medicaid and Medicare Part B, we are required to pay a rebate to each state Medicaid program for each unit of our covered outpatient drugs dispensed to Medicaid beneficiaries and reimbursed by a state Medicaid program.
In addition to the treprostinil patents noted above, we have other patents specific to our individual treprostinil-based products, including the following: • Tyvaso DPI . We have three Orange Book-listed U.S. patents that we license from MannKind directed to the composition of Tyvaso DPI drug product, which expire in 2025, 2030, and 2035, respectively.
In addition to the treprostinil patents noted above, we have other patents specific to our individual treprostinil-based products, including the following: • Tyvaso DPI . We have two Orange Book-listed U.S. patents that we license from MannKind directed to the composition of Tyvaso DPI drug product, which expire in 2030 and 2035.
Key accomplishments in our xenotransplantation program include the following: • First Successful Xenotransplants of Porcine Hearts. University of Maryland School of Medicine ( UMSOM ) surgeons have successfully transplanted UHearts into two living human patients.
Additional key accomplishments in our xenotransplantation program include the following: • First Successful Xenotransplants of Porcine Hearts. University of Maryland School of Medicine ( UMSOM ) surgeons transplanted UHearts into two living human patients.
Our agreement with DEKA expires on the last to occur of 25 years from the first product launch under the agreement, or upon the expiration of the last valid claim of a patent licensed from DEKA under the agreement that covers the Remunity Pump.
Our agreement with DEKA expires on the last to occur of 25 years from the first product launch under the agreement, or upon the expiration of the last valid claim of a patent licensed from DEKA under the agreement that covers the pumps.
We are also conducting a phase 3 study of nebulized Tyvaso called TETON PPF for the treatment of progressive pulmonary fibrosis ( PPF ); we enrolled the first patient in TETON PPF in October 2023. The primary endpoint of each TETON study is the change in absolute forced vital capacity ( FVC ) from baseline to week 52.
We are also conducting a phase 3 study of Nebulized Tyvaso called TETON PPF for the treatment of progressive pulmonary fibrosis ( PPF ); we enrolled the first patient in TETON PPF in October 2023. The primary endpoint of the TETON PPF study is the change in absolute FVC from baseline to week 52.
In October 2021, we successfully completed the first-ever drone delivery of a human lung for transplant at Toronto General 2024 Annual Report 11 Hospital, demonstrati ng the feasibility of our goal of delivering our manufactured organs and organ alternatives with zero carbon footprint aircraft.
In October 2021, we successfully completed the first-ever drone delivery of a human lung for transplant at Toronto General Hospital, demonstrati ng the feasibility of our goal of delivering our manufactured organs and organ alternatives with zero carbon footprint aircraft.
We will also pay Arena: (1) a one-time payment of $250.0 million for the first, if any, marketing approval we receive in the United States for an inhaled version of ralinepag to treat PAH; (2) a one-time payment of $150.0 million for the first, if any, marketing approval we receive in any of Japan, France, Italy, the United Kingdom, Spain, or Germany for an oral version of ralinepag to treat any indication; and (3) low double-digit, tiered royalties on net sales of any pharmaceutical product containing ralinepag as an active ingredient, subject to certain adjustments for third-party license payments.
Under our license agreement, we are obligated to pay Arena: (1) a one-time payment of $250.0 million for the first, if any, marketing approval we receive in the United States for an inhaled version of ralinepag to treat PAH; (2) a one-time payment of $150.0 million for the first, if any, marketing approval we receive in any of Japan, France, Italy, the United Kingdom, Spain, or Germany for an oral version of ralinepag to treat any indication; and (3) low double-digit, tiered royalties on net sales of any pharmaceutical product containing ralinepag as an active ingredient, subject to certain adjustments for third-party license payments.
Health and Safety. We are committed to providing and maintaining a safe, healthy, and secure workplace for all Unitherians. We have an environmental health and safety program. We routinely provide training on workplace safety and security to all Unitherians. A Holistic Approach to Total Rewards and Employee Wellness. We require an exceptionally talented workforce.
Health and Safety. We are committed to providing and maintaining a safe, healthy, and secure workplace for all Unitherians. We have an environmental health and safety program. We routinely provide training on workplace safety and security to all Unitherians. A Holistic Approach to Total Rewards and Employee Wellness. Our success depends on an exceptionally talented workforce.
For additional discussion, see the risk factor entitled, Our intellectual property rights may not effectively deter competitors from developing competing products that, if successful, could have a material adverse effect on our revenues and profit s, contained in Part I , Item 1A—Risk Factors included in this Report. 2024 Annual Report 15 Adcirca License Agreement In 2008, Lilly granted us an exclusive license to develop, market, promote, and commercialize Adcirca for the treatment of pulmonary hypertension in the United States.
For additional discussion, see the risk factor entitled, Our intellectual property rights may not effectively deter competitors from developing competing products that, if successful, could have a material adverse effect on our revenues and profit s, contained in Part I , Item 1A—Risk Factors included in this Report. 16 United Therapeutics, a public benefit corporation Adcirca License Agreement In 2008, Lilly granted us an exclusive license to develop, market, promote, and commercialize Adcirca for the treatment of pulmonary hypertension in the United States.
We market and sell the following commercial therapies in the United States to treat PAH: Tyvaso DPI ® (treprostinil) Inhalation Powder ( Tyvaso DPI ); Tyvaso ® (treprostinil) Inhalation Solution ( nebulized Tyvaso ), which includes the Tyvaso Inhalation System; Remodulin ® (treprostinil) Injection ( Remodulin ); Orenitram ® (treprostinil) Extended-Release Tablets ( Orenitram ); and Adcirca ® (tadalafil) Tablets ( Adcirca ).
We market and sell the following commercial therapies in the United States to treat PAH: • Tyvaso DPI® (treprostinil) Inhalation Powder ( Tyvaso DPI ); • Tyvaso® (treprostinil) Inhalation Solution ( Nebulized Tyvaso ), which includes the Tyvaso Inhalation System; • Remodulin® (treprostinil) Injection ( Remodulin ); and the Remunity® and RemunityPRO™ Pumps for Remodulin ( Remunity ); • Orenitram® (treprostinil) Extended-Release Tablets ( Orenitram ); and • Adcirca® (tadalafil) Tablets ( Adcirca ).
Orenitram is currently only approved in the United States. Adcirca Adcirca is a PDE-5 inhibitor, the active pharmaceutical ingredient of which is tadalafil. Tadalafil is also the active pharmaceutical ingredient in Cialis®, which is marketed by Eli Lilly and Company ( Lilly ) for the treatment of erectile dysfunction.
Orenitram is currently only approved in the United States. 2025 Annual Report 7 Adcirca Adcirca is a PDE-5 inhibitor, the active pharmaceutical ingredient of which is tadalafil. Tadalafil is also the active pharmaceutical ingredient in Cialis®, which is marketed by Eli Lilly and Company ( Lilly ) for the treatment of erectile dysfunction.
( Smiths Medical , which was acquired by ICU Medical, Inc., or ICU Medical ) manufactured the pumps used by most patients in the United States to administer Remodulin, including the CADD-MS ® 3 ( MS-3 ) pump used to deliver subcutaneous Remodulin, 2024 Annual Report 5 and the CADD-Legacy ® pump to deliver intravenous Remodulin.
( Smiths Medical , which was acquired by ICU Medical, Inc., or ICU Medical ) manufactured the pumps used by most patients in the United States to administer Remodulin, including the CADD-MS ® 3 ( MS-3 ) pump used to deliver subcutaneous Remodulin, and the CADD-Legacy ® pump to deliver intravenous Remodulin.
Ralinepag Ralinepag is a next-generation, once-daily, oral, selective, and potent prostacyclin receptor agonist that we are developing for the treatment of PAH.
Ralinepag Ralinepag is a next-generation, once-daily, oral, extended-release, titratable, selective, and potent prostacyclin receptor agonist that we are developing for the treatment of PAH.
In May 2022, the FDA approved our dry powder formulation of inhaled 4 United Therapeutics, a public benefit corporation treprostinil called Tyvaso DPI, for the treatment of both PAH and PH-ILD. We developed this product under an in-license from MannKind Corporation ( MannKind ) and launched this product commercially in the United States in June 2022.
In May 2022, the FDA approved our dry powder formulation of inhaled treprostinil called Tyvaso DPI, for the treatment of both PAH and PH-ILD. We developed this product under an in-license from MannKind Corporation ( MannKind ) and launched this product commercially in the United States in June 2022.
Government Reimbursement of Pharmaceutical Products In the United States, many independent third-party health plans, and government health care programs, such as Medicaid and Medicare, pay for patient use of our commercial products. A material portion of our product sales are reimbursed under these government programs.
Government Reimbursement of Pharmaceutical Products In the United States, many independent third-party health plans, and government health care programs, such as Medicaid and Medicare, pay for patient use of our commercial products. A material portion of our product sales are reimbursed under 26 United Therapeutics, a public benefit corporation these government programs.
On October 2, 2024, Liquidia and Pharmosa announced that they amended the 18 United Therapeutics, a public benefit corporation licensing agreement to expand Liquidia’s licensed territory to include Europe, Japan, and elsewhere, and to include rights to Pharmosa’s nebulizers for use with L606. • Seralutinib (GB002) , a small molecule tyrosine kinase inhibitor being developed by Gossamer Bio, Inc.
On October 2, 2024, Liquidia and Pharmosa announced that they amended the licensing agreement to expand Liquidia’s licensed territory to include Europe, Japan, and elsewhere, and to include rights to Pharmosa’s nebulizers for use with L606. • Seralutinib (GB002) , a small molecule tyrosine kinase inhibitor being developed by Gossamer Bio, Inc.
While these projects will be capital-intensive, the timing and volume of these expenditures will be staggered and paced in a manner intended to balance our need to address market demand as soon as possible following FDA approval with the need to defer the most significant capital expenditures until we achieve certain clinical trial milestones.
While these projects will be capital-intensive, the timing and volume of these expenditures will be staggered and paced in a manner intended to balance our need to address market 10 United Therapeutics, a public benefit corporation demand as soon as possible following FDA approval with the need to defer the most significant capital expenditures until we achieve certain clinical trial milestones.
DEKA Agreements In December 2014, we entered into an exclusive agreement with DEKA to develop a semi-disposable system for subcutaneous delivery of Remodulin, which we refer to as the Remunity Pump.
DEKA Agreements In December 2014, we entered into an exclusive agreement with DEKA to develop a semi-disposable system for subcutaneous delivery of Remodulin, which we refer to as the Remunity and RemunityPRO Pumps.
Patients with PAH have also been shown to have reduced levels of the enzyme responsible for producing nitric oxide, a naturally occurring substance in the body that causes relaxation of the pulmonary blood vessels. Nitric oxide produces this effect by increasing intracellular levels of cyclic guanosine monophosphate GMP ( cyclic GMP ).
Patients with PAH have also been shown to have reduced levels of the enzyme responsible for producing nitric oxide, a naturally occurring 4 United Therapeutics, a public benefit corporation substance in the body that causes relaxation of the pulmonary blood vessels. Nitric oxide produces this effect by increasing intracellular levels of cyclic guanosine monophosphate GMP ( cyclic GMP ).
Based on the up-front purchase price alone, the implied net present value of future Tyvaso DPI net revenues at the time of the transaction was $15.0 billion. 16 United Therapeutics, a public benefit corporation Under our license agreement with MannKind, we have an exclusive license to a variety of granted and pending patents and patent applications related to treprostinil inhalation powder and the Dreamboat device, including multiple patent families covering the U.S. and other major market countries.
Based on the up-front purchase price alone, the implied net present value of future Tyvaso DPI net revenues at the time of the transaction was $15.0 billion. 2025 Annual Report 17 Under our license agreement with MannKind, we have an exclusive license to a variety of granted and pending patents and patent applications related to treprostinil inhalation powder and the Dreamboat device, including multiple patent families covering the U.S. and other major market countries.
We are enrolling ADVANCE OUTCOMES , which is a phase 3, event-driven study of an extended-release formulation of ralinepag in PAH patients with a primary endpoint of time to first clinical worsening event. ADVANCE OUTCOMES is a global, multi-center, placebo-controlled trial that includes patients on approved oral background PAH therapies.
In June 2025, we concluded enrollment of the ADVANCE OUTCOMES study, which is a phase 3, event-driven clinical trial of an extended-release formulation of ralinepag in PAH patients with a primary endpoint of time to first clinical worsening event. ADVANCE OUTCOMES is a global, multi-center, placebo-controlled trial that includes patients on approved oral background PAH therapies.
In January 2024, the FDA approved Florida’s drug importation plan. 2024 Annual Report 29 Anti-Kickback, False Claims Laws, and The Prescription Drug Marketing Act The federal Anti-Kickback Statute ( AKS ) prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving remuneration to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of, or referring an individual for the furnishing of, any healthcare item or service reimbursable under Medicare, Medicaid, or other federally financed healthcare programs.
Anti-Kickback, False Claims Laws, and The Prescription Drug Marketing Act The federal Anti-Kickback Statute ( AKS ) prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving remuneration to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of, or referring an individual for the furnishing of, any healthcare item or service reimbursable under Medicare, Medicaid, or other federally financed healthcare programs.
We are engaged in research and development of a variety of technologies designed to increase the supply of transplantable organs and tissues and to improve outcomes for transplant recipients through xenotransplantation, regenerative medicine, 3D bioprinting of organ alternatives, bio-artificial organ alternatives, and ex vivo lung perfusion.
We are engaged in research and development of a variety of technologies designed to increase the supply of transplantable organs and tissues and to improve outcomes for transplant recipients through xenotransplantation, regenerative medicine, and ex vivo lung perfusion.
We sell Tyvaso DPI and nebulized Tyvaso to specialty pharmaceutical distributors in the United States. We recognized $1,620.4 million, $1,233.7 million, and $873.0 million in combined Tyvaso DPI and nebulized Tyvaso net product sales, representing 56 percent, 53 percent, and 45 percent of our total revenues for the years ended December 31, 2024, 2023, and 2022, respectively.
We sell Tyvaso DPI and Nebulized Tyvaso to specialty pharmaceutical distributors in the United States. 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.
This study is expected to enroll an initial cohort of six end-stage renal disease ( ESRD ) patients, expanding to up to 50 participants, and we intend for this study to support a Biologics License Application ( BLA ) with the FDA.
This study is expected to enroll an initial cohort of six end-stage renal disease ( ESRD ) patients, expanding to up to 50 participants, and we intend to use the results of this study to support a BLA with the FDA.
An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing supplements as it does in reviewing NDAs.
An NDA supplement for a new indication typically requires clinical data similar to 22 United Therapeutics, a public benefit corporation that in the original application, and the FDA uses the same procedures and actions in reviewing supplements as it does in reviewing NDAs.
The GDPR imposes several requirements on companies that process personal data, strict rules on the transfer of personal data out of the EEA, including to the U.S., and fines and penalties for failure to comply with the requirements of the GDPR and the related national data protection laws of the EU member states.
The GDPR imposes several 28 United Therapeutics, a public benefit corporation requirements on companies that process personal data, strict rules on the transfer of personal data out of the EEA, including to the U.S., and fines and penalties for failure to comply with the requirements of the GDPR and the related national data protection laws of the EU member states.
We recognized $434.3 million, $359.4 million, and $325.1 million in Orenitram net product sales, representing 15 percent, 15 percent, and 17 percent of our total revenues for the years ended December 31, 2024, 2023, and 2022, respectively. In 2013, the FDA approved Orenitram for the treatment of PAH patients to improve exercise capacity.
We recognized $496.9 million, $434.3 million, and $359.4 million in Orenitram net product sales, representing 16 percent, 15 percent, and 15 percent of our total revenues for the years ended December 31, 2025, 2024, and 2023, respectively. In 2013, the FDA approved Orenitram for the treatment of PAH patients to improve exercise capacity.
In 2024, Lung Bioengineering completed a registrational study of another centralized EVLP technology called the Centralized Lung Evaluation System ( CLES ) and submitted a premarket approval application to the FDA in September 2024 for commercial approval of CLES, which has been accepted by the FDA. Over 500 patients have received lung transplants following use of our centralized EVLP service.
In 2024, Lung Bioengineering completed a registrational study of another centralized EVLP technology called the Centralized Lung Evaluation System ( CLES ) and submitted a premarket approval application to the FDA in September 2024 for commercial approval of CLES, which is under review by the FDA. Over 730 patients have received lung transplants following use of our centralized EVLP service.
Additionally, the FDA determined in August 2024 that we are entitled to a period of exclusivity for nebulized Tyvaso and Tyvaso DPI based on a clinical trial conducted to obtain approval for a PH-ILD indication, and that this exclusivity expires on May 23, 2025.
This exclusivity period covered both Nebulized Tyvaso and Tyvaso DPI for PH-ILD, and expired in March 2024 . Additionally, the FDA determined in August 2024 that we were entitled to a period of exclusivity for Nebulized Tyvaso and Tyvaso DPI based on a clinical trial conducted to obtain approval for a PH-ILD indication; this exclusivity expired on May 23, 2025.
Our xenotransplantation patent portfolio includes over 150 pending applications and issued patents, including nearly one hundred issued patents in the U.S. and abroad. Our regenerative medicine patent portfolio, including our newly-acquired Miromatrix and IVIVA programs, includes over 300 pending applications and issued patents.
Our xenotransplantation patent portfolio includes over 150 pending applications and issued patents, including nearly one hundred issued patents in the U.S. and abroad. Our regenerative medicine patent portfolio includes over 300 pending applications and issued patents.
As of December 31, 2024, we had approximately 1,305 employees working across our 14 locations worldwide. None of our employees are covered by a collective bargaining agreement and we believe our overall relations with our employees are good .
As of December 31, 2025, we had approximately 1,400 employees working across our 15 locations worldwide. None of our employees are covered by a collective bargaining agreement and we believe our overall relations with our employees are good .
In addition, we may rely on trade secret protection for certain aspects of our manufactured organ and organ alternative programs. 14 United Therapeutics, a public benefit corporation Generic Competition and Challenges to our Intellectual Property Rights Remodulin—Generic Competition We settled litigation with Sandoz, Inc.
In addition, we may rely on trade secret protection for certain aspects of our manufactured organ and organ alternative programs. Generic Competition and Challenges to our Intellectual Property Rights Remodulin—Generic Competition We settled litigation with Sandoz Inc.
A Paragraph IV certification asserts that the patent does not block approval of the ANDA, either because the patent is invalid or unenforceable or because the patent, even if valid, is not infringed by the new product.
A Paragraph III certification states that the ANDA applicant seeks approval after the patent expires. A Paragraph IV certification asserts that the patent does not block approval of the ANDA, either because the patent is invalid or unenforceable or because the patent, even if valid, is not infringed by the new product.
Name Age Position Martine Rothblatt, Ph.D., J.D., M.B.A. 70 Chairperson and Chief Executive Officer Michael Benkowitz 53 President and Chief Operating Officer James C. Edgemond 57 Chief Financial Officer and Treasurer Paul A.
Name Age Position Martine Rothblatt, Ph.D., J.D., M.B.A. 71 Chairperson and Chief Executive Officer Michael Benkowitz 54 President and Chief Operating Officer James C. Edgemond 58 Chief Financial Officer and Treasurer Paul A.
Secondary endpoint data, which are not included in the updated FDA-approved labeling, are summarized below: 6 United Therapeutics, a public benefit corporation • Change in 6MWD : The median 6MWD trended toward improvement at week 24 (Hodges-Lehmann treatment estimate: seven meters).
Secondary endpoint data, which are not included in the updated FDA-approved labeling, are summarized below: • Change in 6MWD : The median 6MWD trended toward improvement at week 24 (Hodges-Lehmann treatment estimate: seven meters).
In the event we enroll subjects in our ongoing or future clinical trials in the EU, we may be subject to additional privacy restrictions, including restrictions relating to the collection, use, storage, transfer, and other processing of personal data, including personal health data, regarding individuals in the European Economic Area ( EEA ) as governed by the GDPR.
Because we enroll EU subjects in certain of our clinical trials, we are subject to additional privacy restrictions, including restrictions relating to the collection, use, storage, transfer, and other processing of personal data, including personal health data, regarding individuals in the European Economic Area ( EEA ) as governed by the GDPR.
In March 2021, nebulized Tyvaso was approved to treat PH-ILD in addition to PAH. In May 2022, we also obtained FDA approval of Tyvaso DPI to treat both PAH and PH-ILD. We are engaged in further research and development of additional indications for nebulized Tyvaso to treat certain fibrotic lung conditions underlying PH-ILD.
In May 2022, we also obtained FDA approval of Tyvaso DPI to treat both PAH and PH-ILD. We are engaged in further research and development of additional indications for Nebulized Tyvaso to treat certain fibrotic lung conditions underlying PH-ILD. For further details, see Research and Development below.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIf our trade secrets were lawfully obtained or independently developed by a competitor, we would have no right to prevent such third party, or those to whom they communicate such technology or information, from using that technology or information to compete with us, and our business and competitive position could be harmed.
Biggest changeIf our trade secrets were lawfully obtained or independently developed by a competitor, we would have no right to prevent such third party, or those to whom they communicate such technology or information, from using that technology or information to compete with us, and our business and competitive position could be harmed. 42 United Therapeutics, a public benefit corporation Third parties have alleged, and may in the future allege, that our products or services infringe their patents and other intellectual property rights, which could result in the payment of royalties that negatively affect our profits, subject us to costly and time-consuming litigation, or cause us to lose the ability to sell the related products.
Actual or alleged cybersecurity incidents, including those caused by employee error, malfeasance, system failures, malware, ransomware, viruses, distributed denial of services attacks, credential harvesting, social engineering, and other forms of unauthorized access or disclosure to, or disrupting the operation of, our networks and systems or those of our customers, suppliers, vendors, and other service providers, can cause the loss, destruction, or unauthorized access or disclosure of data, including personal information of employees or confidential or proprietary information, disruption of our operations, and damage to our reputation and competitive position, any of which could be costly to address and remediate and adversely affect our business, financial condition, or results of operations.
Actual or alleged cybersecurity incidents, including those caused by employee error, malfeasance, system failures, malware, ransomware, viruses, distributed denial of services attacks, credential harvesting, social engineering, and other forms of unauthorized access or disclosure to, or disrupting the operation of, our networks and systems or those of our customers, suppliers, vendors, and other service providers, can cause the loss, destruction, or unauthorized access or disclosure of data, including personal information of employees or confidential or proprietary information, disruption of our manufacturing and other operations, and damage to our reputation and competitive position, any of which could be costly to address and remediate and adversely affect our business, financial condition, or results of operations.
Similarly, pricing and rebating strategies for new competitive therapies could put pressure on us to reduce the prices of our products and/ or offer increased rebates to third-party payers. If commercial or government payers do not cover our products or limit payment rates, patients and physicians could choose competing products or products with lower out-of-pocket costs.
Similarly, pricing and rebating strategies for competitive therapies could put pressure on us to reduce the prices of our products and/ or offer increased rebates to third-party payers. If commercial or government payers do not cover our products or limit payment rates, patients and physicians could choose competing products or products with lower out-of-pocket costs.
The approval and launch of new therapies may negatively impact sales of our current and potential new products. Sales may decrease if any third party that manufactures, markets, distributes, or sells our commercial products cannot do so satisfactorily, or we cannot manage our internal manufacturing processes.
The approval and launch of new therapies may materially negatively impact sales of our current and potential new products. Sales may decrease if any third party that manufactures, markets, distributes, or sells our commercial products cannot do so satisfactorily, or we cannot manage our internal manufacturing processes.
Should the prices of raw materials and consumables further increase significantly as a result of inflation or tariffs, we could see higher than average year-over-year increases in cost of goods sold.
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.
Our ability to exercise control over regulatory compliance by our third-party manufacturers is limited. • We believe we and our third-party manufacturers need to increase our respective manufacturing capacity by constructing new facilities, and/or expanding existing facilities, in order to continue meeting anticipated demand for our products. These efforts are often costly and time-consuming, and must meet rigorous regulatory requirements.
Our ability to exercise control over regulatory compliance by our third-party manufacturers is limited. • We and our third-party manufacturers may need to increase our respective manufacturing capacity by constructing new facilities, and/or expanding existing facilities, in order to continue meeting anticipated demand for our products. These efforts are often costly and time-consuming, and must meet rigorous regulatory requirements.
Similar political, economic, and regulatory developments are occurring in other countries and may affect our profitability. In addition to continuing pressure on prices and cost containment measures, legislative developments at the European Union ( EU ) or member state level may result in significant additional requirements or obstacles that may increase operating costs.
Similar political, economic, and regulatory developments are occurring in other countries and may affect our profitability. In addition to continuing pressure on prices and cost containment measures, legislative developments at the EU or member state level may result in significant additional requirements or obstacles that may increase operating costs.
Our bylaws provide that, to the fullest extent permitted by law, unless we agree in writing to an alternative forum, (1) the Delaware Court of Chancery (or, if such court does not have, or declines to accept, jurisdiction, another state court or a 2024 Annual Report 47 federal court located in Delaware) will be the exclusive forum for any complaint asserting any internal corporate claims, including claims in the right of the corporation based upon a violation of a duty by a current or former director, officer, employee, or shareholder in such capacity, or as to which the Delaware General Corporation Law confers jurisdiction upon the Court of Chancery, and (2) the federal district courts will be the exclusive forum for any complaint asserting a cause of action arising under the Securities Act of 1933, as amended.
Our bylaws provide that, to the fullest extent permitted by law, unless we agree in writing to an alternative forum, (1) the Delaware Court of Chancery (or, if such court does not have, or declines to accept, jurisdiction, another state court or a federal court located in Delaware) will be the exclusive forum for any complaint asserting any internal corporate claims, including claims in the right of the corporation based upon a violation of a duty by a current or former director, officer, employee, or shareholder in such capacity, or as to which the Delaware General Corporation Law confers jurisdiction upon the Court of Chancery; and (2) the federal district courts will be the exclusive forum for any complaint asserting a cause of action arising under the Securities Act of 1933, as amended.
The price of our common stock could decline sharply due to general market conditions as well as the following factors, among others: • quarterly and annual financial results and any failure to meet our expectations or those of securities analysts; • timing of enrollment and results of our clinical trials; 46 United Therapeutics, a public benefit corporation • announcements regarding generic or other challenges to the intellectual property related to our products, the launch of generic versions of our products or other competitive products, such as Yutrepia, and the impact of competition from generic and other products on our revenues; • announcements regarding litigation matters, including our ongoing litigation with Liquidia, among others; • announcements regarding our efforts to obtain regulatory approval of, and to launch commercial sales of, new products; • physician, patient, investor, or public concerns regarding the efficacy and/or safety of products marketed or being developed by us or by others; • changes in, or new laws and regulations affecting reimbursement of, our therapeutic products by government payers, changes in reimbursement policies of private insurance companies, including the implementation and impacts of the IRA, and negative publicity surrounding the cost of high-priced therapies; • announcements of technological innovations or new products or announcements regarding our existing products, including in particular the development of new, competing therapies; • substantial sales of our common stock by us or our existing shareholders, or concerns that such sales may occur; • future issuances of common stock by us or other activity which could be viewed as being dilutive to our shareholders; • rumors or incorrect statements by investors and/or analysts concerning our company, our products, or our operations; • failures or delays in our efforts to obtain or maintain domestic or international regulatory approvals; • discovery of previously unknown problems with our marketed products, or problems with our manufacturing, regulatory, compliance, promotional, marketing, or sales activities that result in regulatory penalties or restrictions on our products, up to the withdrawal of our products from the market; and • accumulation of significant short positions in our common stock by hedge funds or other investors or the significant accumulation of our common stock by hedge funds or other institutional investors with investment strategies that may lead to short-term holdings.
The price of our common stock could decline sharply due to general market conditions as well as the following factors, among others: • quarterly and annual financial results and any failure to meet our expectations or those of securities analysts; • timing of enrollment and results of our clinical trials; • announcements regarding generic or other challenges to the intellectual property related to our products, the launch and successful commercialization of generic versions of our products or other competitive products, and the impact of competition from generic and other products on our revenues; • announcements regarding litigation matters, including our ongoing litigation with Liquidia, among others; • announcements regarding our efforts to obtain regulatory approval of, and to launch commercial sales of, new products; • physician, patient, investor, or public concerns regarding the efficacy and/or safety of products marketed or being developed by us or by others; • changes in, or new laws and regulations affecting reimbursement of, our therapeutic products by government payers, changes in reimbursement policies of private insurance companies, including the implementation and impacts of the IRA and other governmental efforts to reduce drug prices, and negative publicity surrounding the cost of high-priced therapies; • announcements of technological innovations or new products or announcements regarding our existing products, including in particular the development of new, competing therapies; • substantial sales of our common stock by us or our existing shareholders, or concerns that such sales may occur; • future issuances of common stock by us or other activity which could be viewed as being dilutive to our shareholders; 44 United Therapeutics, a public benefit corporation • rumors or incorrect statements by investors and/or analysts concerning our company, our products, or our operations; • failures or delays in our efforts to obtain or maintain domestic or international regulatory approvals; • discovery of previously unknown problems with our marketed products, or problems with our manufacturing, regulatory, compliance, promotional, marketing, or sales activities that result in regulatory penalties or restrictions on our products, up to the withdrawal of our products from the market; and • accumulation of significant short positions in our common stock by hedge funds or other investors or the significant accumulation of our common stock by hedge funds or other institutional investors with investment strategies that may lead to short-term holdings.
These state legislative measures could limit the price or payment for certain drugs, and a number of states are authorized to impose civil monetary penalties or pursue other enforcement mechanisms against manufacturers who fail to comply with state law requirements, including the untimely, inaccurate, or incomplete reporting of drug pricing information under transparency obligations.
These state legislative measures could limit the price or payment for certain drugs or could complicate the distribution of drugs. A number of states are authorized to impose civil monetary penalties or pursue other enforcement mechanisms against manufacturers who fail to comply with state law requirements, including the untimely, inaccurate, or incomplete reporting of drug pricing information under transparency obligations.
A reduction in the availability or extent of reimbursement from domestic or foreign government health care programs could have a material adverse effect on our business and results of our operations. Government payers and third-party payers are increasingly attempting to limit the price of medicinal products and frequently challenge the pricing of new or expensive drugs.
A reduction in the availability or extent of reimbursement from domestic or foreign government health care programs could have a material adverse effect on our business and results of our operations. Government and commercial payers are increasingly attempting to limit the price of medicinal products and frequently challenge the pricing of new or expensive drugs.
The final rule allows certain prescription drugs to be imported from Canada, and the guidance 2024 Annual Report 41 describes procedures for drug manufacturers to facilitate the importation of FDA-approved drugs and biologics manufactured abroad and originally intended for sale in a foreign country into the United States. In January 2024, the FDA approved Florida’s drug importation plan.
The final rule allows certain prescription drugs to be imported from Canada, and the guidance describes procedures for drug manufacturers to facilitate the importation of FDA-approved drugs and biologics manufactured abroad and originally intended for sale in a foreign country into the United States. In January 2024, the FDA approved Florida’s drug importation plan.
Any of these factors could disrupt sales of our commercial products, delay clinical trials or commercialization of new products, result in product liability claims and product recalls, and entail higher costs.
Any of these factors could disrupt sales of our commercial products, delay clinical trials or commercialization of new products, result in product liability claims and product recalls, and entail higher costs or lost revenues.
To obtain approvals from the FDA and international regulatory agencies to sell new products, or to expand the product labeling for our existing products, we must conduct clinical trials demonstrating that our products are safe and effective. Regulators have substantial discretion over the approval process.
To obtain approvals from the FDA and international regulatory agencies to sell new products, to expand the product labeling for our existing products, or to launch new delivery devices for our existing products, we must conduct clinical trials demonstrating that our products are safe and effective. Regulators have substantial discretion over the approval process.
We have no issued patents or pending patent applications covering Unituxin. For further details, see Part I, Item 1—Business—Patents and Other Proprietary Rights, Strategic Licenses, and Market Exclusivity—Generic Competition and Challenges to our Intellectual Property Rights.
We have no issued patents or pending patent applications covering the Unituxin drug product. For further details, see Part I, Item 1—Business—Patents and Other Proprietary Rights, Strategic Licenses, and Market Exclusivity—Generic Competition and Challenges to our Intellectual Property Rights.
Failure to follow applicable rules and guidelines related to promotion and advertising can result in the adverse regulatory actions by the FDA and its international counterparts — such as warning letters, enforcement actions, civil lawsuits, or criminal prosecution. We must comply with various laws in jurisdictions around the world that restrict certain marketing practices.
Failure to follow applicable rules and guidelines related to promotion and advertising can result in the adverse regulatory actions by the FDA and its international counterparts — such as warning letters, enforcement actions, civil lawsuits, or criminal prosecution. 2025 Annual Report 37 We must comply with various laws in jurisdictions around the world that restrict certain marketing practices.
There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate comments about us on any social networking website. If any of these events occur or we otherwise 2024 Annual Report 43 fail to comply with applicable regulations, we could incur liability, face overly restrictive regulatory actions, or incur other harm to our business.
There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate comments about us on any social networking website. If any of these events occur or we otherwise fail to comply with applicable regulations, we could incur liability, face overly restrictive regulatory actions, or incur other harm to our business.
Our manufactured organ and organ alternative programs will involve exceptionally complicated manufacturing processes, many of which have never been attempted on a clinical or commercial scale. It will take substantial time and resources to develop and implement such manufacturing processes, and we may never be able to do so successfully.
Our manufactured organ and organ alternative programs will involve exceptionally complicated manufacturing processes, many of which have never been attempted on a clinical or commercial scale. It will take substantial time and resources to develop and implement such 2025 Annual Report 33 manufacturing processes, and we may never be able to do so successfully.
See, for example, the discussion of the IRA in the risk factor below entitled Government healthcare reform and other reforms could adversely affect our revenue, costs, and results of operations . Our prostacyclin analogue products (Tyvaso DPI, nebulized Tyvaso, Remodulin, and Orenitram) and our oncology product (Unituxin) are expensive therapies.
See, for example, the discussion of the IRA and the proposed GLOBE and GUARD regulations in the risk factor below entitled Government healthcare reform and other reforms could adversely affect our revenue, costs, and results of operations . Our prostacyclin analogue products (Tyvaso DPI, Nebulized Tyvaso, Remodulin, and Orenitram) and our oncology product (Unituxin) are expensive therapies.
Furthermore, Unituxin has a limited shelf life, which impacts our ability to stockpile inventory at comparable levels to our other commercial products. • Natural and man-made disasters (such as fires, contamination, power loss, hurricanes, earthquakes, flooding, terrorist attacks, and acts of war), disease outbreaks, and pandemics such as COVID-19 impacting our internal and third-party manufacturing sites could cause a supply disruption. • The sterility and quality of our products could be substandard and such products could not be sold or used or could be subject to recalls. • The FDA and its international counterparts would require new testing and compliance inspections of new manufacturers of our products, or new manufacturing facilities we operate. • If we produce products that do not meet FDA-approved specifications and we fail to detect these issues prior to distribution of these products, our products may be the subject of safety alerts, product recalls, or other corrective actions, and we may be charged in product liability claims and lawsuits which, regardless of their ultimate outcome, could have a material adverse effect on our business and reputation and on our ability to attract and retain customers. • Regulatory agencies may not be able to timely inspect our facilities, or those of our third-party manufacturers, which could result in delays in obtaining necessary regulatory approvals for our products. • We may be unable to contract with needed manufacturers on satisfactory terms or at all. • The supply of materials and components necessary to manufacture and package our products may become scarce or unavailable, which in the past has delayed, and in the future could delay, the manufacturing and subsequent sale of such products.
Furthermore, Unituxin has a limited shelf life, which impacts our ability to stockpile inventory at comparable levels to our other commercial products. • Natural and man-made disasters (such as fires, contamination, power loss, hurricanes and other forms of severe weather, earthquakes, flooding, terrorist attacks, and acts of war), some of which could be exacerbated by climate change, disease outbreaks, and pandemics such as COVID-19 impacting our internal and third-party manufacturing and warehousing sites could cause a supply disruption. • The chemical, microbiological, and physical quality attributes of our products could be substandard and such products could not be sold or used or could be subject to recalls. • The FDA and its international counterparts could require new testing and compliance inspections of new manufacturers of our products, or new manufacturing facilities we operate. • If we produce products that do not meet FDA-approved specifications and we fail to detect these issues prior to distribution of these products, our products may be the subject of safety alerts, product recalls, or other corrective actions, and we may be charged in product liability claims and lawsuits which, regardless of their ultimate outcome, could have a material adverse effect on our business and reputation and on our ability to attract and retain customers. • Regulatory agencies may not be able to timely inspect our facilities, or those of our third-party manufacturers, which could result in delays in obtaining necessary regulatory approvals for our products. • We may be unable to contract with needed manufacturers on satisfactory terms or at all. • The supply of materials and components necessary to manufacture and package our products may become scarce or unavailable, which in the past has delayed, and in the future could delay, the manufacturing and subsequent sale of such products.
Outside the United States, we rely substantially on our international distributors to obtain and maintain regulatory approvals for our products and to market and sell our products in compliance with applicable laws and regulations. In the United States, we derive substantially all our treprostinil-based revenues from sales to two distributors, Accredo and CVS Specialty.
Outside the United States, we rely substantially on our international distributors to obtain and maintain regulatory approvals for our products and to market and sell our products in 2025 Annual Report 35 compliance with applicable laws and regulations. In the United States, we derive substantially all our treprostinil-based revenues from sales to two distributors, Accredo and CVS Specialty.
We have been sued by Sandoz for violating our settlement agreement with them and we have accrued a liability of $71.1 million in connection with such suit, reflecting the final judgment and post-judgment interest accrued through the end of 2024, although our ultimate liability may be greater.
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.
Our shareholders will not be deemed, by operation of the choice of forum provision, to have waived our obligation to comply with all applicable federal securities laws and the rules and regulations thereunder. In 2021, we converted to a Delaware PBC.
Our shareholders will not be deemed, by operation of the choice of forum provision, to have waived our obligation to comply with all applicable federal securities laws and the rules and regulations thereunder. 2025 Annual Report 45 In 2021, we converted to a Delaware PBC.
Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare, with prices that can be negotiated subject to a cap (with resulting prices for the initial ten drugs first effective in 2026); imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); redesigns the Medicare Part D benefit (beginning in 2024); and replaces the Medicare Part D coverage gap discount program with a new manufacturer discounting program (beginning in 2025).
Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare, with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); redesigns the Medicare Part D benefit (beginning in 2024); and replaces the Medicare Part D coverage gap discount program with a new manufacturer discounting program (beginning in 2025).
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. Patient assistance programs for pharmaceutical products have come under increasing scrutiny by governments, legislative bodies, enforcement agencies, and other third parties.
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. 40 United Therapeutics, a public benefit corporation Patient assistance programs for pharmaceutical products have come under increasing scrutiny by governments, legislative bodies, enforcement agencies, and other third parties.
If we fail to attract and retain such employees, we may not be successful in developing and commercializing new therapies. 2024 Annual Report 39 Risks Related to Legal Compliance We must comply with extensive laws and regulations in the United States and other countries.
If we fail to attract and retain such employees, we may not be successful in developing and commercializing new therapies. Risks Related to Legal Compliance We must comply with extensive laws and regulations in the United States and other countries.
If any of these systems or equipment require long-term repair or replacement, the impacted facility may not be able to manufacture product for a substantial period of time. • We and our third-party manufacturers rely upon local municipalities to supply our facilities with clean water, which is processed into high purity water and used as a key ingredient for several of our commercial drug products.
If any of these systems or equipment require long-term repair or replacement, the impacted facility may not be able to manufacture product for a substantial period of time. 34 United Therapeutics, a public benefit corporation • We and our third-party manufacturers rely upon local municipalities to supply our facilities with clean water, which is subsequently processed into high purity water and used as a key ingredient for several of our commercial drug products.
Item 1A. Risk Factors Risks Related to Our Products and Our Operations We rely heavily on sales of our treprostinil-based therapies to generate revenues and support our operations. Sales of our treprostinil-based therapies — Tyvaso DPI, nebulized Tyvaso, Remodulin, and Orenitram — comprise the vast majority of our revenues.
Risks Related to Our Products and Our Operations We rely heavily on sales of our treprostinil-based therapies to generate revenues and support our operations. Sales of our treprostinil-based therapies — Tyvaso DPI, Nebulized Tyvaso, Remodulin, and Orenitram — comprise the vast majority of our revenues.
Certain programs, such as the 340B program, impose limits on the price we are permitted to charge certain entities for our products or for any future products for which we receive regulatory approval.
Certain programs, such as the 2025 Annual Report 39 340B program, impose limits on the price we are permitted to charge certain entities for our products or for any future products for which we receive regulatory approval.
The availability of generic treprostinil injection in the United States could materially impact our revenues, and generic competition materially impacted our Remodulin revenues outside the United States. Our competitors are also developing numerous new products that may compete with ours, including products intended to treat PAH and/or PH-ILD.
The availability of generic treprostinil injection in the United States could materially impact our revenues, and generic competition materially impacted our Remodulin revenues outside the United States. Our 32 United Therapeutics, a public benefit corporation competitors are also developing numerous new products that may compete with ours, including products intended to treat PAH and/or PH-ILD.
External factors, such as compliance with law, may also impact the successful integration of an acquired business. Acquisitions could involve dilutive issuances of equity securities, the incurrence of debt, one-time write-offs of goodwill (or IPR&D assets), and substantial amortization expenses of other intangible assets.
External factors, such as compliance with law, may also impact the successful integration of an acquired business. Acquisitions could involve dilutive issuances of equity securities, the incurrence of debt, one-time write-offs of goodwill (or in-process research and development assets), and substantial amortization expenses of other intangible assets.
Sanctions under these federal and state laws may include treble civil monetary penalties, payment of damages, fines, exclusion of our products from reimbursement under federal health care programs, imprisonment, and the curtailment or restructuring of our operations. 40 United Therapeutics, a public benefit corporation Government healthcare reform and other reforms could adversely affect our revenue, costs, and results of operations.
Sanctions under these federal and state laws may include treble civil monetary penalties, payment of damages, fines, exclusion of our products from reimbursement under federal health care programs, imprisonment, and the curtailment or restructuring of our operations. Government healthcare reform and other reforms could adversely affect our revenue, costs, and results of operations.
In September 2021, HRSA sent to us, along with the other manufacturers challenging HRSA’s 340B interpretation, letters stating that HRSA was referring this issue to the OIG for potential enforcement action. We have not had any communication from the OIG regarding our 340B 42 United Therapeutics, a public benefit corporation contract pharmacy policy.
In September 2021, HRSA sent to us, along with the other manufacturers challenging HRSA’s 340B interpretation, letters stating that HRSA was referring this issue to the OIG for potential enforcement action. We have not had any communication from the OIG regarding our 340B contract pharmacy policy.
Our clinical trials have been and in the future may be discontinued, delayed, canceled, or disqualified for various reasons, including: (1) pandemics such as the COVID-19 pandemic, which initially caused us to suspend enrollment of most of our clinical studies; (2) manufacturing and supply chain disruptions; (3) the drug is unsafe or ineffective, or physicians and/or patients believe that the drug is unsafe or ineffective, or that other therapies are safer, more effective, better tolerated, or more convenient; (4) patients do not enroll in or complete clinical trials at the rate we expect, due to the availability of alternative therapies, the enrollment of competing clinical trials, or other reasons; (5) we, or clinical trial sites or other third parties, do not adhere to trial protocols and required quality controls under good clinical practices ( GCP ) regulations and similar regulations outside the United States; (6) patients experience severe side effects during treatment or die during our trials because of adverse events; and (7) the results of clinical trials conducted in a particular country are not acceptable to regulators in other countries.
Our clinical trials have been and in the future may be discontinued, delayed, canceled, or disqualified for various reasons, including: (1) pandemics; (2) manufacturing and supply chain disruptions; (3) the drug is unsafe or ineffective, or physicians and/or patients believe that the drug is unsafe or ineffective, or that other therapies are safer, more effective, better tolerated, or more convenient; (4) patients do not enroll in or complete clinical trials at the rate we expect, due to the availability of alternative therapies, the enrollment of competing clinical trials, or other reasons; (5) we, or clinical trial sites or other third parties, do not adhere to trial protocols and required quality controls under GCP regulations; (6) patients experience severe side effects during treatment or die during our trials because of adverse events; and (7) the results of clinical trials conducted in a particular country are not acceptable to regulators in other countries.
Although we do not directly source any raw materials or consumables from Ukraine, Russia, Belarus, Gaza, Lebanon, or Israel, our European- and Middle East-based suppliers and service providers could be impacted by extended conflicts or an escalation of these conflicts into neighboring countries. • The cost of many key raw materials and consumables used in the manufacture of our products has increased due to significant inflationary pressure, and could increase further as a result of tariffs enacted by the Trump administration.
Although we do not directly source any raw materials or consumables from the directly impacted countries, our international suppliers and service providers in these regions could be impacted by extended conflicts or an escalation of these conflicts into neighboring countries. • The cost of many key raw materials and consumables used in the manufacture of our products has increased due to significant inflationary pressure, and could increase further as a result of tariffs enacted by the Trump administration.
We do not plan to engage a third party to manufacture Orenitram; however, we have initiated efforts to qualify a third party to manufacture the active ingredient in Unituxin, which will take multiple years and may not succeed.
We do not plan to engage a third party to manufacture Orenitram; however, we have initiated efforts to qualify a third party to manufacture Unituxin drug substance, which will take multiple years and may not succeed.
Among other things, there have been several U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things: bring more transparency to drug pricing; reduce the cost of prescription drugs under government payer programs; review the relationship between pricing and manufacturer patient programs; and reform government program reimbursement methodologies for drugs.
Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things: bring more transparency to drug pricing; reduce the cost of prescription drugs under government payer programs; review the relationship between pricing and manufacturer patient programs; and reform government program reimbursement methodologies for drugs. The IRA was enacted in 2022.
For example, Liquidia is challenging various patents related to nebulized Tyvaso and our other treprostinil-related products, and has successfully challenged some of them. Patent litigation can be time consuming, distracting, and costly, and the outcome may be difficult to predict and unfavorable to us.
For example, Liquidia is challenging various patents related to Nebulized Tyvaso and our other treprostinil-related products, and has successfully challenged some of them. Patent litigation can be time consuming, distracting, and costly, and the outcome may be difficult to predict and unfavorable to us. If we are unsuccessful in the defense of our patents, our business could be negatively impacted.
Tariffs could also cause a substantial increase in the material costs associated with our construction activities. 2024 Annual Report 37 • Any of our third-party manufacturers could undergo a change of control, causing a change in our business relationship with the relevant manufacturer.
Tariffs and other trade barriers could also cause a substantial increase in the material costs associated with our construction activities. • Any of our third-party manufacturers could undergo a change of control, causing a change in our business relationship with the relevant manufacturer.
We also have limited visibility into the supply chains on which our primary suppliers rely; as such, we rely on our primary suppliers to have robust risk mitigation strategies to detect issues and prevent supply disruption. • We are closely monitoring the military conflicts in Ukraine and Israel.
We also have limited visibility into the supply chains on which our primary suppliers rely; as such, we rely on our primary suppliers to have robust risk mitigation strategies to detect issues and prevent supply disruption.
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. 38 United Therapeutics, a public benefit corporation We rely on two contract manufacturers — Minnetronix Inc. and Phillips-Medisize Corp. — to manufacture the Tyvaso Inhalation System for nebulized Tyvaso.
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. We rely on two contract manufacturers — Forj Medical and Phillips-Medisize Corp. — to manufacture the Tyvaso Inhalation System for Nebulized Tyvaso.
The impact on Tyvaso DPI and Orenitram revenues could be offset because the IRA’s redesign of certain Part D components, some of which went into effect in 2024, resulted in an increase in the number of patients able to afford these therapies. The amount of the offset, if any, is inherently uncertain and difficult to predict.
The impact on 38 United Therapeutics, a public benefit corporation Tyvaso DPI and Orenitram revenues could be offset because the IRA’s Part D redesign, which went into effect in 2025 and resulted in an increase in the number of patients able to afford these therapies. The amount of the offset, if any, is inherently uncertain and difficult to predict.
Political unrest or trade disputes involving China, 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.
Suppliers based in China, India, and Taiwan play a role in our supply chain to support our second- and third-tier suppliers. 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.
In addition, our insurance coverage may not be adequate for all potential claims. If losses significantly exceed our liability insurance coverage, we may experience financial hardship or potentially be forced out of business.
We may not be able to maintain our current product liability insurance at an acceptable cost, if at all. In addition, our insurance coverage may not be adequate for all potential claims. If losses significantly exceed our liability insurance coverage, we may experience financial hardship or potentially be forced out of business.
As nebulized Tyvaso is a drug-device combination product, we cannot sell nebulized Tyvaso without the Tyvaso Inhalation System. We also rely on various third parties to supply the monthly disposable device accessories that are used with the Tyvaso Inhalation System. We currently rely entirely on MannKind to manufacture Tyvaso DPI finished drug product and inhalers for us.
As Nebulized Tyvaso is a drug-device combination product, we cannot sell Nebulized Tyvaso without the Tyvaso Inhalation System. We also rely on various third parties to supply the monthly disposable device accessories that are used with the Tyvaso Inhalation System.
Our Credit Agreement 2024 Annual Report 45 contains affirmative and negative covenants that, among other things, limit our ability to incur additional indebtedness.
Our credit agreement (the 2025 Credit Agreement ) contains affirmative and negative covenants that, among other things, limit our ability to incur additional indebtedness.
If we must restate or recalculate information provided under these programs, our costs of compliance could increase. We could be held liable for errors in our pricing data, including retroactive rebates and program refunds.
If we must restate or recalculate information provided under these programs, our costs of compliance could increase. We could be held liable for errors in the submissions we are required to make with regards to governmental drug pricing program, including retroactive rebates and program refunds.
Nonetheless, the HHS, in a non-binding (and now-retracted) Advisory Opinion, stated that manufacturers in the 340B program are obligated to sell their covered outpatient drugs at the 340B ceiling price to all contract pharmacies acting as agents of a covered entity.
Our contract pharmacy policy preserves patient access, while addressing compliance and integrity concerns resulting from the proliferation of contract pharmacies. Nonetheless, HHS, in a non-binding (and now-retracted) Advisory Opinion, stated that manufacturers in the 340B program are obligated to sell their covered outpatient drugs at the 340B ceiling price to all contract pharmacies acting as agents of a covered entity.
The Department of Justice ( DOJ ) has taken enforcement action against pharmaceutical companies alleging violations of the Federal False Claims Act and other laws in connection with patient assistance programs. In December 2017, we entered into a civil Settlement Agreement with the U.S.
The Department of Justice ( DOJ ) has taken enforcement action against pharmaceutical companies alleging violations of the Federal False Claims Act and other laws in connection with patient assistance programs.
Historically, these were the pumps primarily used to administer Remodulin to patients in the United States. 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. We rely entirely on DEKA and its affiliates to manufacture the Remunity and RemunityPRO Pumps.
In 2022, ICU Medical discontinued manufacturing and distribution of the CADD-Legacy system used to administer intravenous Remodulin. Historically, these were the pumps primarily used to administer Remodulin to patients in the United States. 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.
It is difficult to predict the impact, if any, that future legislation or executive actions might have on the use of and reimbursement for our products in the United States, including the potential for the importation of generic versions of our products.
It is difficult to predict the impact, if any, that future federal or state legislation, or executive actions, might have on the use of and reimbursement for our products in the United States, such as the potential for the importation of generic versions of our products, for price caps under state laws, or for increased difficulties and costs related to the distribution of our products.
If we are unable to obtain additional funding on commercially reasonable terms or at all, we may be compelled to delay clinical studies, curtail operations, or obtain funds through collaborative arrangements that may require us to relinquish rights to certain products or potential markets.
If we are unable to obtain additional funding on commercially reasonable terms or at all, we may be compelled to delay clinical studies, curtail operations, or obtain funds through collaborative arrangements that may require us to relinquish rights to certain products or potential markets. 2025 Annual Report 43 Our portfolio of investments is subject to market, interest, operational, and credit risk that may reduce its value.
Department of Agriculture, and their international counterparts, as applicable. The process of obtaining and maintaining regulatory approvals for new drugs, biologics, and medical devices is lengthy, expensive, and uncertain. The regulatory approval process is particularly uncertain for our transplantation programs, which include the development of xenotransplantation, regenerative medicine, 3D bioprinting of organ alternatives, and cell-based products.
Department of Agriculture, and their international counterparts, as applicable. The process of obtaining and maintaining regulatory approvals for new drugs, biologics, and medical devices is lengthy, expensive, and uncertain. The regulatory approval process is particularly uncertain for our organ manufacturing program.
Our portfolio of investments is subject to market, interest, operational, and credit risk that may reduce its value. We maintain a portfolio of investments that includes: (1) corporate debt securities; (2) strategic investments in publicly-traded equity securities; and (3) strategic equity investments in privately-held companies.
We maintain a portfolio of investments that includes: (1) corporate debt securities; (2) strategic investments in publicly-traded equity securities; and (3) strategic equity investments in privately-held companies.
This facility is a first of its kind, and unforeseen operational issues or disease outbreak amongst its herd could significantly impact the clinical development timelines for our xenotransplantation products. We have begun construction of a second clinical-scale DPF facility to mitigate operational risk and increase capacity, and are planning to construct a third clinical-scale DPF facility.
This facility houses gene-edited pigs in a highly controlled containment environment. This facility is a first of its kind, and unforeseen operational issues or disease outbreak amongst its herd could significantly impact the clinical development timelines for our xenotransplantation products. We are constructing two additional DPF facilities to mitigate operational risk and increase capacity.
If we are not able to successfully identify, finance, consummate, and/or integrate acquisitions, our business operations and financial position could be adversely affected. During the fourth quarter of 2023, we acquired IVIVA and Miromatrix. We may continue to seek to expand in part through acquisitions of complementary businesses, products, and technologies.
If we are not able to successfully identify, finance, consummate, and/or integrate acquisitions, our business operations and financial position could be adversely affected. We seek to expand our business in part through acquisitions of complementary businesses, products, and technologies. The success of this strategy will depend on our ability to identify, and the availability of, suitable acquisition candidates.
Smiths Medical (which has since been acquired by ICU Medical) discontinued manufacturing the MS-3 system used to administer subcutaneous Remodulin, and specialty pharmacy distributors informed us that supplies of MS-3 pumps are fully exhausted. In 2022, ICU Medical discontinued manufacturing and distribution of the CADD-Legacy system used to administer intravenous Remodulin.
Smiths Medical (which has since been acquired by ICU Medical) discontinued manufacturing the MS-3 system used to administer subcutaneous Remodulin, and specialty pharmacy distributors informed us that supplies of new MS-3 pumps are fully exhausted, although a limited number of refurbished pumps may be available for use with generic treprostinil.
Requirements of pharmaceutical manufacturers under such laws include advance notice of planned price increases; reporting price increase amounts and factors considered in taking such increases; wholesale acquisition cost information disclosure to prescribers, purchasers, and state agencies; and new product notice and reporting. Other legislation establishes so-called prescription drug affordability boards that could impose price caps on specific drugs.
A number of states have either implemented or are considering implementation of drug price transparency legislation. Requirements of pharmaceutical manufacturers under such laws include advance notice of planned price increases; reporting price increase amounts and factors considered in taking such increases; wholesale acquisition cost information disclosure to prescribers, purchasers, and state agencies; and new product notice and reporting.
The IRA and other healthcare reform measures that may be adopted in the future may result in additional downward pressure on the payment that we receive for any approved product, and may adversely impact our business. Any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in payment from commercial payers.
In November 2025, the FDA granted a six-month extension for Florida to begin implementing its plan. The IRA and other healthcare reform measures that may be adopted in the future may result in additional downward pressure on the payment that we receive for any approved product, and may adversely impact our business.
Risks Related to Our Intellectual Property and Data Privacy If any of the agreements under which we license or acquired intellectual property rights are breached or terminated, we could lose our rights to continue to develop, manufacture, and sell the products covered by such agreements.
Furthermore, use of artificial intelligence-based software may lead to the inadvertent release of confidential information which may impact our ability to realize the benefit of our intellectual property and expose us to liability and brand or reputational harm. 2025 Annual Report 41 Risks Related to Our Intellectual Property and Data Privacy If any of the agreements under which we license or acquired intellectual property rights are breached or terminated, we could lose our rights to continue to develop, manufacture, and sell the products covered by such agreements.
Our xenotransplantation and regenerative medicine programs rely heavily on the use of animals to manufacture and test our products. Certain special interest groups categorically object to the use of animals for research purposes. Any negative attention, threats, or acts of vandalism directed against our animal research or manufacturing activities could impede the operation of our business.
Our organ manufacturing programs rely heavily on the use of animals to manufacture and test our products. Certain special interest groups categorically object to the use of animals for research purposes.
If local municipalities are unable to supply water that meets relevant quality standards, we and our third-party manufacturers may be unable to manufacture these products until such a situation is remediated. • Our supply chain for raw materials and consumables extends worldwide and is complex. Suppliers based in China and Taiwan play a substantial role in our supply chain.
If local municipalities are unable to supply water that meets relevant quality standards, we and our third-party manufacturers may be unable to manufacture these products until such a situation is remediated. • We and our third-party manufacturers rely upon utility companies to supply our facilities with electrical power.
These efforts could be unsuccessful or take longer or cost more than we anticipate, due to a variety of factors including the lead time needed to procure, install, and qualify the highly specialized equipment necessary to manufacture the product.
These efforts could be unsuccessful or take longer or cost more than we anticipate, due to a variety of factors including the lead time needed to procure, install, and qualify the highly specialized equipment necessary to manufacture the product. • We may experience difficulty designing and implementing processes and procedures to comply with applicable regulations as we develop manufacturing operations for new products. • Our primary manufacturing facilities are located in rapidly growing biopharmaceutical manufacturing hubs.
The success of this strategy will depend on our ability to identify, and the availability of, suitable acquisition candidates. We may incur costs related to an acquisition but may be unable or unwilling to consummate the proposed transaction.
We may incur costs related to an acquisition but may be unable or unwilling to consummate the proposed transaction.
In addition, third parties may submit citizen petitions to the FDA seeking to delay approval of, or impose additional approval conditions for, our products. If successful, citizen petitions can significantly delay, or even prevent, the approval of our products.
In addition, third parties may submit citizen petitions to the FDA seeking to delay approval of, or impose additional approval conditions for, our products. Citizens petitions have in the past, and may in the future, significantly delay or prevent approval of our products. In April 2025, the Trump administration announced a reduction in force at the U.S.
If MannKind is unable to manufacture Tyvaso DPI in sufficient quantities for us for any reason, our commercial sales of Tyvaso DPI could be materially and adversely impacted. We also rely on various sole-source suppliers for manufacturing activities related to ralinepag.
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. If MannKind is unable to manufacture Tyvaso DPI in sufficient quantities for us for any reason, our commercial sales of Tyvaso DPI could be materially and adversely impacted.
We could also become subject to allegations under the False Claims Act and other laws and regulations. In addition, misreporting and failure to timely report data to CMS also can be grounds for CMS to terminate our Medicaid drug rebate agreement, pursuant to which we participate in the Medicaid Drug Rebate program.
In addition, misreporting and failure to timely report data to CMS also can be grounds for CMS to terminate our Medicaid drug rebate agreement, pursuant to which we participate in the Medicaid Drug Rebate program. If CMS terminates our rebate agreement, no federal payments would be available under Medicaid or Medicare Part B for our covered outpatient drugs.
Our confidentiality agreements with our employees and others to whom we disclose trade secrets and confidential information may not necessarily prevent our trade secrets from being used or disclosed without our authorization. These agreements may be difficult, time-consuming, and expensive to enforce or may not provide an adequate remedy in the event of unauthorized disclosure.
These agreements may be difficult, time-consuming, and expensive to enforce or may not provide an adequate remedy in the event of unauthorized disclosure.
We may incur significant civil monetary penalties if we are found to have knowingly provided false information to the government or to have charged 340B covered entities more than the statutorily mandated ceiling price. Certain failures to timely submit required data also could result in a civil monetary penalty for each day the information is late.
We may incur significant civil monetary penalties if we are found to have knowingly provided false information to the government or to have charged 340B covered entities more than the statutorily mandated ceiling price, and resolution of any claims that we violated these provisions could be costly.
We expect to begin construction of one or more commercial-scale DPF facilities well before our xenotransplantation products could potentially be approved, and if development of our xenotransplantation products fails or demand is significantly less than anticipated, we will not recoup our significant investment in these facilities.
We will need to construct additional DPF facilities at significant expense in order to support the development and commercialization of our xenotransplantation products. If development of our xenotransplantation products fails or demand is significantly less than anticipated, we will not recoup our significant investment in these unique facilities as they would be difficult to repurpose.
We rely heavily on third-party contract research organizations, contract laboratories, clinical investigative sites, and other third parties to conduct our clinical trials, preclinical studies, and other research and development activities. In addition, the success of certain products we are developing will depend on clinical trials sponsored by third parties.
For a further discussion of risks created by the use of third-party contract manufacturers, see the risk factor above entitled, Our manufacturing strategy exposes us to significant risks . We rely heavily on third-party contract research organizations, contract laboratories, clinical investigative sites, and other third parties to conduct our clinical trials, preclinical studies, and other research and development activities.
We may not maintain adequate insurance coverage to protect us against significant product liability claims. The testing, manufacturing, marketing, and sale of drugs and diagnostics involve product liability risks. We may not be able to maintain our current product liability insurance at an acceptable cost, if at all.
Any negative attention, threats, or acts of vandalism directed against our animal research or manufacturing activities could impede the operation of our business. 36 United Therapeutics, a public benefit corporation We may not maintain adequate insurance coverage to protect us against significant product liability claims. The testing, manufacturing, marketing, and sale of drugs and diagnostics involve product liability risks.
Finally, we rely entirely on Sanner GmbH (which recently acquired Gilero LLC) to manufacture cartridges that were cleared by the FDA for use with the MS-3 pump to administer Remodulin. For a further discussion of risks created by the use of third-party contract manufacturers, see the risk factor above entitled, Our manufacturing strategy exposes us to significant risks .
This effort could be unsuccessful or take longer or cost more than we anticipate, in which case we may be more reliant on our existing third-party contract manufacturers. 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.
Due to the nature of our products, alternative suppliers may not be readily available, causing us to rely solely on internal capabilities to meet future demand. • In 2024, we began operating a clinical-scale, designated pathogen-free facility ( DPF ) to produce our xenotransplantation products for human clinical studies. This facility houses gene-edited pigs in a highly controlled containment environment.
Such a change could impact our long-term supply outlook and cause us to seek alternatives that could require a lengthy regulatory approval process. Alternative suppliers may not be readily available, causing us to rely solely on internal capabilities to meet future demand. • In 2024 we completed a DPF to produce our xenotransplantation products for human clinical studies.
We are in the process of qualifying our Research Triangle Park facility to produce our primary commercial supply of ralinepag if and when it is approved by the FDA. This effort could be unsuccessful or take longer or cost more than we anticipate, in which case we may be more reliant on our existing third-party contract manufacturers.
We also rely on various sole-source suppliers for manufacturing activities related to ralinepag. We are in the process of qualifying our RTP facility to produce our primary commercial supply of ralinepag if and when it is approved by the FDA.
There are also two therapies approved for the treatment of IPF, and we are aware of a 2024 Annual Report 35 significant number of additional therapies being developed for the treatment of IPF, which would compete with Tyvaso DPI and nebulized Tyvaso if either of them is ultimately approved for that indication.
Existing and future approved IPF therapies would compete with Tyvaso DPI and Nebulized Tyvaso if either or both of them is ultimately approved for that indication. The introduction of lower-priced competing products may reduce both the price that we are able to charge for our products and the volume of products we sell.
Additional ancillary supplies are used with these pumps, and a limited number of manufacturers that supply them. In 2024, a manufacturer discontinued popular infusion tubing sets used with the Remunity Pumps (and expected to be used with RemunityPRO) and transferred this business to another manufacturer.
We rely entirely on DEKA and its affiliates to manufacture the Remunity and RemunityPRO Pumps. Additional ancillary supplies are used with these pumps, and a limited number of manufacturers that supply them. Lilly manufactures and supplies Adcirca for us. We use Lilly’s pharmaceutical wholesaler network to distribute Adcirca.
Removed
For example, Merck received approval for Winrevair (sotatercept-csrk) in March 2024, which competes with our treprostinil-based products.
Added
Item 1A. Risk Factors Investing in our securities involves uncertainty and risk due to a variety of factors. You should carefully consider each of the following risks and all of the other information contained in this Report and in other documents that we file with, or furnish to, the SEC before making any investment decision with respect to our securities.
Removed
In addition, Liquidia is developing Yutrepia, which could receive final approval from the FDA for both PAH and PH-ILD in May 2025 (or sooner depending on the pending outcome of Liquidia’s lawsuit against the FDA) and if successful would compete with our treprostinil-based products. Both products could potentially materially adversely affect our revenues.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeManagement At the management level, our Corporate Crisis Management Team ( CCMT ) is comprised of senior representatives from all key business functions, including finance, operations, and legal, and has broad oversight of our risk management processes, including management of cybersecurity risks.
Biggest changeOur board, through its interactions with our Audit Committee chair and our SRC Senior Director and Chief Information Officer receives periodic updates regarding cybersecurity risk matters and prompt and timely information regarding significant cybersecurity incidents and our response to such incidents. 46 United Therapeutics, a public benefit corporation Management At the management level, our Corporate Crisis Management Team ( CCMT ) is comprised of senior representatives from all key business functions, including finance, operations, and legal, and has broad oversight of our risk management processes, including management of cybersecurity risks.
These reports and presentations are provided by senior personnel with responsibility for IT security, including our Security, Risk and Compliance Director ( SRC Director ) and our Chief Information Officer.
These reports and presentations are provided by senior personnel with responsibility for IT security, including our Security, Risk and Compliance Senior Director ( SRC Senior Director ) and our Chief Information Officer.
Internal Cybersecurity Team Our Incident Management Team ( IMT ) is led by our SRC Director, who serves as the point of contact for all IT security related matters within our company, and also includes our Chief Information Officer. Our IMT is responsible for the implementation, monitoring, and maintenance of the cybersecurity and data protection practices across our company.
Internal Cybersecurity Team Our Incident Management Team ( IMT ) is led by our SRC Senior Director, who serves as the point of contact for all IT security related matters within our company, and also includes our Chief Information Officer. Our IMT is responsible for the implementation, monitoring, and maintenance of the cybersecurity and data protection practices across our company.
Our SRC Director has technical leadership experience and cybersecurity expertise gained from over 25 years of experience, including security leadership, program development, strategy formulation, data protection, and IT risk management within the health care, pharmaceutical, and biotechnology industries.
Our SRC Senior Director has technical leadership experience and cybersecurity expertise gained from over 25 years of experience, including security leadership, program development, strategy formulation, data protection, and IT risk management within the health care, pharmaceutical, and biotechnology industries.
In general, our incident response process involves five phases: • Identify — in which we gather an understanding of how to manage our cybersecurity risks to our systems, assets, data and capabilities, including through threat modeling, cybersecurity threat intelligence from industry-recognized forums and sources, internal audits, third-party reviews and assessments, vulnerability scans and penetration tests; • Protect — in which we implement controls and safeguards to protect or deter cybersecurity threats, including through firewalls, VPNs, identity and access management and intrusion prevention systems; • Detect— in which we engage in continuous monitoring to provide proactive and real-time alerts of cybersecurity-related events; • Respond — in which any threats are timely reported to responsible teams, and triaged for purposes of preliminary classification and escalation, and assessment for possible notification and disclosure requirements; and • Recover — in which business continuity plans are implemented, vulnerabilities are identified and mitigated, legal obligations and risks are identified, and our systems are returned to operational readiness.
In general, our incident response process involves five phases: • Identify — in which we gather an understanding of how to manage our cybersecurity risks to our systems, assets, data and capabilities, including through threat modeling, cybersecurity threat intelligence from industry-recognized forums and sources, internal audits, third-party reviews and assessments, vulnerability scans and penetration tests; • Protect — in which we implement controls and safeguards to protect or deter cybersecurity threats, including through firewalls, VPNs, identity and access management and intrusion prevention systems; • Detect— in which we engage in continuous monitoring to provide proactive and real-time alerts of cybersecurity-related events; 2025 Annual Report 47 • Respond — in which any threats are timely reported to responsible teams, and triaged for purposes of preliminary classification and escalation, and assessment for possible notification and disclosure requirements; and • Recover — in which business continuity plans are implemented, vulnerabilities are identified and mitigated, legal obligations and risks are identified, and our systems are returned to operational readiness.
Our SRC Director is responsible for ensuring the regular review and maintenance of the Computer Security Incident Response Plan ( CSIRP ) and the execution of all procedures within it.
Our SRC Senior Director is responsible for ensuring the regular review and maintenance of the Computer Security Incident Response Plan ( CSIRP ) and the execution of all procedures within it.
Our Chief Information Officer has nearly ten years of experience with our company, and an extensive background in security technology and operations, compliance, data privacy, business continuity, and disaster recovery. The security professionals in the IMT have cybersecurity backgrounds and expertise relevant to their roles, including, in certain circumstances, relevant industry certifications.
Our Chief Information Officer has over ten years of experience with our company, and an extensive background in security technology and operations, compliance, data privacy, business continuity, and disaster recovery. The security professionals in the IMT have cybersecurity backgrounds and expertise relevant to their roles, including, in certain circumstances, relevant industry certifications.
For the response phase of an incident, after the SRC Director or the designated alternate IRT leader receives notification of any potential or realized privacy or security incident, the SRC Director or the designated alternate IRT leader makes an initial severity classification and determines if it is appropriate to convene the IRT, the members of which will be based on the nature and severity of the incident.
For the response phase of an incident, after our SRC Senior Director or the designated alternate IRT leader receives notification of any potential or realized privacy or security incident, our SRC Senior Director or the designated alternate IRT leader makes an initial severity classification and determines if it is appropriate to convene the IRT, the members of which will be based on the nature and severity of the incident.
We have protocols by which the IMT escalates certain cybersecurity incidents within our company and, where appropriate, the IMT will notify appropriate stakeholders and our Audit Committee and provide updates on the status of the incident. Experienced employees responsible for various parts of our business and a team of trained cybersecurity professionals assist our SRC Director and the IMT.
We have protocols by which the IMT escalates certain cybersecurity incidents within our company and, where appropriate, the IMT will notify appropriate stakeholders and our Audit Committee and provide updates on the status of such incidents. Experienced employees responsible for various parts of our business and a team of trained cybersecurity professionals assist our SRC Senior Director and the IMT.
These plans outline a coordinated approach for protecting information security, managing vulnerabilities, and assessing, identifying, and managing risks from cybersecurity threats, including 2024 Annual Report 49 identifying and responding to cybersecurity incidents, and processes for categorizing incidents, reporting findings, and keeping senior management, our Audit Committee, and other key stakeholders informed and involved as appropriate.
These plans outline a coordinated approach for protecting information security, managing vulnerabilities, and assessing, identifying, and managing risks from cybersecurity threats, including identifying and responding to cybersecurity incidents, and processes for categorizing incidents, reporting findings, and keeping senior management, our Audit Committee, and other key stakeholders informed and involved as appropriate.
However, we do not have reason to believe that risks from cybersecurity threats, including as a result of any previous cybersecurity incidents, are reasonably likely to materially affect our business, reputation, operations, or revenue over the long term. 50 United Therapeutics, a public benefit corporation
Our business depends on the availability, reliability, and security of our information systems, networks, data, and intellectual property. However, we do not have reason to believe that risks from cybersecurity threats, including as a result of any previous cybersecurity incidents, are reasonably likely to materially affect our business, reputation, operations, or revenue over the long term.
Cybersecurity We have implemented a cybersecurity program consistent with industry practices to assess, identify, and manage risks from cybersecurity threats that may result in adverse effects on the confidentiality, integrity, and availability of our networks, systems, and data. 48 United Therapeutics, a public benefit corporation Governance Board of Directors Our board of directors exercises its oversight role through its Audit Committee, which has primary responsibility for overseeing risks related to cybersecurity matters.
Item 1C. Cybersecurity We have implemented a cybersecurity program consistent with industry practices to assess, identify, and manage risks from cybersecurity threats that may result in adverse effects on the confidentiality, integrity, and availability of our networks, systems, and data.
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Our board, through its interactions with our Audit Committee chair and our SRC Director and Chief Information Officer receives periodic updates regarding cybersecurity risk matters and prompt and timely information regarding significant cybersecurity incidents and our response to such incidents.
Added
Governance Board of Directors Our board of directors exercises its oversight role through its Audit Committee, which has primary responsibility for overseeing risks related to cybersecurity matters.
Removed
Our business depends on the availability, reliability, and security of our information systems, networks, data, and intellectual property.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeTexas—We have entered into an agreement to acquire 22 acres of land in Houston, Texas, where we intend to construct a clinical scale DPF facility intended to produce porcine hearts and kidneys for use in xenotransplantation clinical trials, and to support eventual commercial production of our xeno-organs following FDA approval.
Biggest changeNew Hampshire—We lease a 74,500 square foot office and laboratory facility in Manchester, New Hampshire, where we conduct our 3D organ alternative bioprinting research and development activities. 48 United Therapeutics, a public benefit corporation Texas—We are constructing a 65,000 square foot clinical scale DPF facility in Houston, Texas, where we intend to produce porcine hearts and kidneys for use in xenotransplantation clinical trials, and to support eventual commercial production of our xeno-organs following FDA approval.
We also plan to produce manufactured lung alternatives for clinical studies at our Silver Spring campus. Minnesota—Our Miromatrix subsidiary leases a 42,300 square foot office and laboratory facility in Eden Prairie, Minnesota, where it produces manufactured kidney and liver products for research and development purposes and clinical trials.
We plan to produce manufactured lung alternatives for clinical studies at our Silver Spring campus. Minnesota—Our Miromatrix subsidiary leases a 42,300 square foot office and laboratory facility in Eden Prairie, Minnesota, where it produces manufactured kidney and liver products for research and development purposes and clinical trials.
Maryland—We own a 415,000 square foot combination laboratory and office building campus in Silver Spring, Maryland that serves as our co-headquarters, is used to manufacture our products, and houses one of our ex vivo lung perfusion centers.
Maryland—We own a 415,000 square foot combination laboratory and office building campus in Silver Spring, Maryland that serves as our co-headquarters, is used to manufacture certain of our products, and houses one of our ex vivo lung perfusion centers.
Virginia—We own and operate a 65,000 square foot clinical-scale DPF facility in Christiansburg, Virginia intended to produce porcine hearts and kidneys for use in xenotransplantation clinical trials, and to support eventual commercial production of our xeno-organs following FDA approval. We also lease a laboratory and farm in Blacksburg, Virginia that support our xenotransplantation research and development efforts.
Virginia—We own and operate a 65,000 square foot clinical-scale DPF facility in Christiansburg, Virginia where we produce porcine hearts and kidneys for use in xenotransplantation clinical trials, and where we intend to support eventual commercial production of our xeno-organs following FDA approval. We also lease a laboratory and farm in Blacksburg, Virginia that support our xenotransplantation research and development efforts.
These manufacturing activities include the synthesis of treprostinil, the active ingredient in Tyvaso DPI, nebulized Tyvaso, and Remodulin, and treprostinil diolamine, the active ingredient in Orenitram, as well as dinutuximab, the active ingredient in Unituxin. We also manufacture nebulized Tyvaso drug product, Remodulin drug product, and Unituxin drug product in our Silver Spring campus.
Manufacturing activities at this campus include the synthesis of treprostinil, the active ingredient in Tyvaso DPI, Nebulized Tyvaso, and Remodulin, and treprostinil diolamine, the active ingredient in Orenitram, as well as dinutuximab, the active ingredient in Unituxin. We also manufacture Nebulized Tyvaso drug product, Remodulin drug product, and Unituxin drug product at our Silver Spring campus.
We recently commenced construction of a 55,000 square foot clinical-scale designated pathogen-free ( DPF ) facility in Stewartville, Minnesota intended to produce porcine hearts and kidneys for use in xenotransplantation clinical trials, and to support eventual commercial production of our xeno-organs following FDA approval.
We are constructing a 65,000 square foot clinical-scale DPF facility in Stewartville, Minnesota where we intend to produce porcine hearts and kidneys for use in xenotransplantation clinical trials and to support eventual commercial production of our xeno-organs following FDA approval.
Quebec—We own a 23,000 square foot facility in Bromont, Quebec, Canada, which is dedicated to the development of sustainable aircraft for the delivery of manufactured organs and organ alternatives. We believe that these facilities, along with various other owned and leased facilities, are adequate for our current operations and that additional land and facilities for future expansion are reasonably available.
In 2025, we purchased a 50,000 square foot facility in Lexington, Massachusetts, which is intended to serve as a cGMP site for clinical production of manufactured organs. We believe that these facilities, along with various other owned and leased facilities, are adequate for our current operations and that additional land and facilities for future expansion are reasonably available.
We lease approximately 21,000 square feet of office space in Morrisville, North Carolina to house representatives from our United Therapeutics Cares patient support program. In 2023, we demolished a 47,000 square foot administrative building near the RTP facility and have commenced construction of a new Tyvaso DPI manufacturing facility on this site.
Additionally, we lease approximately 21,000 square feet of office space in Morrisville, North Carolina to house our United Therapeutics Cares patient support program.
We manufacture Orenitram drug product and we package, warehouse, and distribute nebulized Tyvaso, Tyvaso DPI, Remodulin, Orenitram, and Unituxin at this location.
We manufacture Orenitram drug product and we package, warehouse, and distribute Nebulized Tyvaso, Tyvaso DPI, Remodulin, Orenitram, and Unituxin at this location. If the FDA approves ralinepag, we plan to transfer manufacturing of this product to our RTP campus following commercial launch. We also have an additional capacity for future growth and expansion at this campus.
Item 2. Properties North Carolina—We own a 380,000 square foot combination manufacturing facility and office building in Research Triangle Park, North Carolina ( RTP ), which serves as our co-headquarters and is occupied by our clinical research and development, commercialization, and logistics and manufacturing personnel.
Item 2. Properties North Carolina—We own a total of 279 acres and have active operations in approximately 630,000 square feet at our co-headquarters campus in RTP. Our clinical research and development, commercialization, manufacturing, warehousing and logistics hub, and our ULobe research and development laboratory, all operate within this campus.
Removed
We also own a 170-acre site containing approximately 225,000 square feet of building space in RTP, which we use for our research, development, warehousing and logistics hub and manufacturing facilities related to our lung regeneration program, office space, and for future expansion.
Added
Quebec—We own a 23,000 square foot facility in Bromont, Quebec, Canada, which is dedicated to the development of sustainable aircraft for the delivery of manufactured organs and organ alternatives. Massachusetts—Our IVIVA subsidiary leases a 23,500 square foot office and laboratory facility in Medford, Massachusetts, where it produces manufactured kidney alternative products for research and development purposes and clinical trials.
Removed
Additionally, in 2023, we completed construction of a new warehouse and logistics hub near our RTP facility to serve as the storage and distribution facility for Tyvaso DPI.
Removed
New Hampshire—We lease a 74,500 square foot office and laboratory facility in Manchester, New Hampshire, where we conduct our 3D organ alternative bioprinting research and development activities.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeSee Note 14— Litigation , to our consolidated financial statements, which is incorporated herein by reference. Item 4. Mine Safety Disclosures Not applicable. 2024 Annual Report 51 PART II
Biggest changeSee Note 14— Litigation , to our consolidated financial statements, which is incorporated herein by reference. Item 4. Mine Safety Disclosures Not applicable. PART II

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeItem 4. Mine Safety Disclosures 51 PART II 52 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 52 Item 6. [Reserved] 53 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 54 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 65 Item 8.
Biggest changeItem 4. Mine Safety Disclosures 49 PART II 49 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 49 Item 6. [Reserved] 51 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 52 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 63 Item 8.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeIssuer Purchases of Equity Securities We did not repurchase any of our outstanding equity securities during the three months ended December 31, 2024, as our most recent share repurchase program was completed in September 2024. 52 United Therapeutics, a public benefit corporation Comparison of Five-Year Total Cumulative Shareholder Return The following chart shows the performance from December 31, 2019 through December 31, 2024 of our common stock, compared with an investment in the stocks represented in each of the Nasdaq U.S.
Biggest changeIn total, we repurchased 2,642,498 shares of our common stock under the 2025 ASR agreements that we currently hold as treasury stock in our consolidated balance sheets. 50 United Therapeutics, a public benefit corporation Comparison of Five-Year Total Cumulative Shareholder Return The following chart shows the performance from December 31, 2020 through December 31, 2025 of our common stock, compared with an investment in the stocks represented in each of the Nasdaq U.S.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock trades on the Nasdaq Global Select Market under the symbol “UTHR”. Number of Holders As of February 19, 2025, there were 26 holders of record of our common stock.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock trades on the Nasdaq Global Select Market under the symbol “UTHR”. Number of Holders As of February 18, 2026, there were approximately 24 holders of record of our common stock.
Dividend Policy We have never paid and have no present intention to pay cash dividends on our common stock in the foreseeable future. We intend to retain any earnings for use in our business operations.
Dividend Policy We have never paid and have no present intention to pay cash dividends on our common stock in the foreseeable future.
Added
We intend to retain any earnings for use in our business operations. 2025 Annual Report 49 Issuer Purchases of Equity Securities Period Total Number of Shares (or Units) Purchased Average Price Paid Per Share (or Unit) Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs Approximate Dollar Value of Shares That May Yet Be Purchased Under the Plans or Programs October 1, 2025 - October 31, 2025 — $ — — $ — November 1, 2025 - November 30, 2025 (1) 3,882 391.18 3,882 — December 1, 2025 - December 31, 2025 — — — — Total 3,882 $ 391.18 3,882 $ — (1) As announced on July 30, 2025, our Board of Directors approved a share repurchase program authorizing up to $1.0 billion (plus the amount of any customary contingent settlement obligations that may arise upon the expiration or early termination of an accelerated share repurchase contract) in aggregate repurchases of our common stock, which program expires on March 31, 2026.
Added
Pursuant to this authorization, we entered into two accelerated share repurchase agreements (the 2025 ASR agreements ), comprised of a $500.0 million uncollared stock repurchase agreement (the Uncollared ASR ) and a $500.0 million collared stock repurchase agreement (the Collared ASR ), with Citibank, N.A. ( Citi ) on August 1, 2025 to repurchase $1.0 billion of our common stock.
Added
We made an aggregate upfront payment of $1.0 billion to Citi and received initial deliveries of 1,274,296 and 849,531 shares of our common stock on August 4, 2025, representing approximately 75 percent and 50 percent of the total shares that would be repurchased under the Uncollared ASR and Collared ASR, respectively, measured based on the closing price of our common stock on August 1, 2025.
Added
Upon completion of an agreed-upon hedging period and the subsequent determination of the minimum and maximum share amounts to be repurchased under the Collared ASR, we received an additional 514,789 shares of our common stock on August 25, 2025.
Added
The final settlement of the Uncollared ASR occurred in November 2025, and we received an additional 3,882 shares of our common stock upon settlement. The average price paid per share was based on the daily volume-weighted average price per share of our common stock during the repurchase period under the Uncollared ASR, less a discount.
Added
The final settlement of the Collared ASR occurred in January 2026, and we received no additional shares of our common stock upon settlement as a result of a collar provision that established the minimum and maximum number of shares to be repurchased, as well as other adjustments.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeShare-Based Compensation The table below summarizes share-based compensation expense by major category (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2024 2023 2022 2024 v. 2023 2023 v. 2022 2024 v. 2023 2023 v. 2022 Category: Stock options $ 29.8 $ 15.4 $ 22.6 $ 14.4 $ (7.2) 94 % (32) % Restricted stock units 79.7 52.4 35.7 27.3 16.7 52 % 47 % STAP awards 32.3 (30.7) 46.7 63.0 (77.4) 205 % (166) % Employee stock purchase plan 2.2 2.0 1.8 0.2 0.2 10 % 11 % Total share-based compensation expense $ 144.0 $ 39.1 $ 106.8 $ 104.9 $ (67.7) 268 % (63) % 2024 Annual Report 61 The table below summarizes share-based compensation expense by line item in our consolidated statements of operations (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2024 2023 2022 2024 v. 2023 2023 v. 2022 2024 v. 2023 2023 v. 2022 Cost of sales $ 5.4 $ 2.4 $ 4.9 $ 3.0 $ (2.5) 125 % (51) % Research and development 29.1 15.6 23.8 13.5 (8.2) 87 % (34) % Selling, general, and administrative 109.5 21.1 78.1 88.4 (57.0) 419 % (73) % Total share-based compensation expense $ 144.0 $ 39.1 $ 106.8 $ 104.9 $ (67.7) 268 % (63) % The increase in share-based compensation expense for the year ended December 31, 2024, as compared to the same period in 2023, was primarily due to: (1) an increase in STAP expense driven by a 60 percent increase in our stock price during 2024, as compared to a 21 percent decrease in our stock price during 2023; (2) an increase in restricted stock unit expense due to a greater number of awards granted and remaining outstanding in 2024, as compared to the same period in 2023; and (3) an increase in stock option expense due to a greater number of awards granted in 2024, as compared to the same period in 2023.
Biggest changeShare-Based Compensation The table below summarizes share-based compensation expense by major category (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2025 2024 2023 2025 v. 2024 2024 v. 2023 2025 v. 2024 2024 v. 2023 Category: Stock options $ 42.3 $ 29.8 $ 15.4 $ 12.5 $ 14.4 42 % 94 % Restricted stock units 103.1 79.7 52.4 23.4 27.3 29 % 52 % STAP awards (0.8) 32.3 (30.7) (33.1) 63.0 (102) % 205 % Employee stock purchase plan 3.1 2.2 2.0 0.9 0.2 41 % 10 % Total share-based compensation expense $ 147.7 $ 144.0 $ 39.1 $ 3.7 $ 104.9 3 % 268 % 58 United Therapeutics, a public benefit corporation The table below summarizes share-based compensation expense by line item in our consolidated statements of operations (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2025 2024 2023 2025 v. 2024 2024 v. 2023 2025 v. 2024 2024 v. 2023 Cost of sales $ 3.9 $ 5.4 $ 2.4 $ (1.5) $ 3.0 (28) % 125 % Research and development 32.3 29.1 15.6 3.2 13.5 11 % 87 % Selling, general, and administrative 111.5 109.5 21.1 2.0 88.4 2 % 419 % Total share-based compensation expense $ 147.7 $ 144.0 $ 39.1 $ 3.7 $ 104.9 3 % 268 % The increase in share-based compensation expense for the year ended December 31, 2025, as compared to the same period in 2024, was primarily due to: (1) an increase in restricted stock unit expense due to a greater number of outstanding performance-based restricted stock units during the year ended December 31, 2025, as compared to the same period in 2024; and (2) an increase in stock option expense due to a greater number of unvested and outstanding performance-based stock options during the year ended December 31, 2025, as compared to the same period in 2024, partially offset by a decrease in STAP expense, as all remaining STAP awards were exercised during the first quarter of 2025.
Under the ASR agreement, we made an aggregate upfront payment of $1.0 billion to Citi and received an aggregate initial delivery of 3,275,199 shares of our common stock on March 27, 2024, which represented approximately 80 percent of the total shares that would be repurchased under the ASR agreement, measured based on the closing price of our common stock on March 25, 2024.
Under the 2024 ASR agreement, we made an aggregate upfront payment of $1.0 billion to Citi and received an aggregate initial delivery of 3,275,199 shares of our common stock on March 27, 2024, which represented approximately 80 percent of the total shares that would be repurchased under the 2024 ASR agreement, measured based on the closing price of our common stock on March 25, 2024.
The share repurchase under the ASR agreement was divided into two tranches, resulting in upfront payments of $300 million and $700 million, respectively. The final settlement of the $300 million tranche occurred in June 2024, and we received an additional 181,772 shares of our common stock upon settlement.
The share repurchase under the 2024 ASR agreement was divided into two tranches, resulting in upfront payments of $300 million and $700 million, respectively. The final settlement of the $300 million tranche occurred in June 2024, and we received an additional 181,772 shares of our common stock upon settlement.
Obligations Under License Agreements and Acquisition Agreements We pay a ten percent royalty on our net sales of Tyvaso DPI under our license agreement with MannKind. Under our agreement with Arena, we will owe a low double-digit, tiered royalty on net product sales of ralinepag (for any route of administration), plus certain milestone payments upon defined regulatory events.
Obligations Under License Agreements and Acquisition Agreements We pay a ten percent royalty on our net sales of Tyvaso DPI under our license agreement with MannKind. Under our agreement with Arena Pharmaceuticals, Inc., we will owe a low double-digit, tiered royalty on net product sales of ralinepag (for any route of administration), plus certain milestone payments upon defined regulatory events.
Provisions attributed to sales in prior periods have been less than one percent of our total revenues for each of the years ended December 31, 2024, 2023, and 2022. For a roll-forward of the liability accounts associated with our gross-to-net deductions, see the section above entitled Results of Operations—Gross-to-Net Deductions .
Provisions attributed to sales in prior periods have been less than one percent of our total revenues for each of the years ended December 31, 2025, 2024, and 2023. For a roll-forward of the liability accounts associated with our gross-to-net deductions, see the section above entitled Results of Operations—Gross-to-Net Deductions .
The timing and amount of our obligations may differ based on certain future events. (5) In addition to amounts in the table above, we are contractually obligated to make payments upon the achievement of various development, regulatory, and commercial milestones for agreements we have entered into with third parties.
The timing and amount of our obligations may differ based on certain future events. (4) In addition to amounts in the table above, we are contractually obligated to make payments upon the achievement of various development, regulatory, and commercial milestones for agreements we have entered into with third parties.
(4) Purchase obligations primarily include: commitments related to research and development (including clinical trials) for new and existing products; open purchase orders for capital expenditures primarily related to our continued investment in construction of additional facilities to support the development and commercialization of our products and technologies; and open purchase orders for the acquisition of goods and services in the ordinary course of business.
(3) Purchase obligations primarily include: commitments related to research and development (including clinical trials) for new and existing products; open purchase orders for capital expenditures primarily related to our continued investment in construction of additional facilities to support the development and commercialization of our products and technologies; and open purchase orders for the acquisition of goods and services in the ordinary course of business.
See Note 8 —Share-Based Compensation , to our consolidated financial statements for more information. Other Income (Expense), Net The change in other income (expense), net for the year ended December 31, 2024, as compared to the same period in 2023, was primarily due to net unrealized gains on equity securities.
See Note 8 —Share-Based Compensation , to our consolidated financial statements for more information. Other Income (Expense), Net The change in other income (expense), net for the year ended December 31, 2025, as compared to the same period in 2024, was primarily due to net unrealized gains on equity securities.
(2) Internal research and development primarily includes salary-related expenses for research and development functions, internal costs to manufacture product candidates before FDA approval, and internal facilities-related expenses, including depreciation, related to research and development activities. (3) See Share-Based Compensation section below for discussion.
(2) Internal research and development primarily includes salary-related expenses for research and development functions, internal costs to manufacture product candidates before regulatory approval, and internal facilities-related expenses, including depreciation, related to research and development activities. (3) See Share-Based Compensation section below for discussion.
The information we have about patient demand, the number of patients using our products, and inventory held by our distributors, is based upon our review of patient utilization and inventory data provided to us by our specialty pharmaceutical distributors. 2024 Annual Report 55 Operating Expenses We devote substantial resources to our various clinical trials and other research and development efforts, which are conducted both internally and through third parties.
The information we have about patient demand, the number of patients using our products, and inventory held by our distributors, is based upon our review of patient utilization and inventory data provided to us by our specialty pharmaceutical distributors. 2025 Annual Report 53 Operating Expenses We devote substantial resources to our various clinical trials and other research and development efforts, which are conducted both internally and through third parties.
We caution you that these statements are not guarantees of future performance and are subject to numerous evolving risks and uncertainties that we may not be able to accurately predict or assess, and that may cause our actual results to differ materially from anticipated results, including the risks and uncertainties we describe in Part I, Item 1A—Risk Factors of this Report and risks and uncertainties described in other cautionary statements, cautionary language, and risk factors set forth in our other filings with the SEC. 54 United Therapeutics, a public benefit corporation Overview of Marketed Products We market and sell the following commercial products: • Tyvaso DPI , a dry powder inhaled formulation of the prostacyclin analogue treprostinil, approved by the FDA in May 2022 to improve exercise ability in patients with pulmonary arterial hypertension ( PAH ) and PH-ILD.
We caution you that these statements are not guarantees of future performance and are subject to numerous evolving risks and uncertainties that we may not be able to accurately predict or assess, and that may cause our actual results to differ materially from anticipated results, including the risks and uncertainties we describe in Part I, Item 1A—Risk Factors of this Report and risks and uncertainties described in other cautionary statements, cautionary language, and risk factors set forth in our other filings with the SEC. 52 United Therapeutics, a public benefit corporation Overview of Marketed Products We market and sell the following commercial products: • Tyvaso DPI , a dry powder inhaled formulation of the prostacyclin analogue treprostinil, approved by the FDA in May 2022 to improve exercise ability in patients with PAH and PH-ILD. • Nebulized Tyvaso, a nebulized liquid inhaled formulation of treprostinil, approved by the FDA to improve exercise ability in patients with PAH.
Because of the time lag for Medicaid and other rebates, in any particular quarter, our adjustments may incorporate revisions of accruals for prior quarters. Historically, adjustments to our estimates to reflect actual results or updated expectations have not been material to our overall financial results.
Because of the time lag in any particular quarter, adjustments to our rebates and chargebacks may incorporate revisions of accruals for prior quarters. Historically, adjustments to our estimates to reflect actual results or updated expectations have not been material to our overall financial results.
Discussions of year-to-year comparisons between 2023 and 2022 that are not included in this Report can be found in Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of Operations of our Form 10-K filed on February 21, 2024 (our 2023 Annual Report ).
Discussions of year-to-year comparisons between 2024 and 2023 that are not included in this Report can be found in Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of Operations of our Form 10-K filed on February 26, 2025 (our 2024 Annual Report ).
The increase of $349.1 million in net cash provided by operating activities for the year ended December 31, 2024, as compared to the same period in 2023, was primarily due to an increase in net cash received due to the growth in sales of our commercial products.
The increase of $234.1 million in net cash provided by operating activities for the year ended December 31, 2025, as compared to the same period in 2024, was primarily due to an increase in net cash received due to the growth in sales of our commercial products.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations The following discussion should be read in conjunction with our consolidated financial statements and related notes to our consolidated financial statements. All statements in this filing are made as of the date this Report is filed with the U.S. Securities and Exchange Commission ( SEC ).
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations The following discussion should be read in conjunction with our consolidated financial statements and related notes to our consolidated financial statements. All statements in this filing are made as of the date this Report is filed with the SEC.
The increase in sales and marketing expense for the year ended December 31, 2024, as compared to the same period in 2023, was primarily due to increases in: (1) personnel expense due to growth in headcount; (2) marketing expenses; and (3) consulting expenses.
The increase in sales and marketing expense for the year ended December 31, 2025, as compared to the same period in 2024, was primarily due to increases in: (1) personnel expense due to growth in headcount; and (2) marketing expenses.
Operating Activities Our operating assets and liabilities consist primarily of accounts receivable, inventories, accounts payable, accrued expenses, liabilities for our STAP awards, and tax-related payables and receivables.
Operating Activities Our operating assets and liabilities consist primarily of accounts receivable, inventories, accounts payable, accrued expenses, and tax-related receivables and payables.
See Note 4 —Investments and Note 5— Fair Value Measurements, to our consolidated financial statements for more information. Income Tax Expense Income tax expense was $343.9 million for the year ended December 31, 2024, compared to $289.5 million for the same period in 2023.
See Note 4 —Investments and Note 5— Fair Value Measurements, to our consolidated financial statements for more information. Income Tax Expense Income tax expense was $379.2 million for the year ended December 31, 2025, as compared to $343.9 million for the same period in 2024.
See Note 12— Commitments and Contingencies to our consolidated financial statements for further details. (6) As of December 31, 2024, our other non-current liabilities in our consolidated balance sheets includes a liability of $20.0 million for unrecognized tax benefits, including related interest and penalties.
See Note 12— Commitments and Contingencies to our consolidated financial statements for further details. (5) As of December 31, 2025, our other non-current liabilities in our consolidated balance sheets includes a liability of $28.2 million for unrecognized tax benefits, including related interest and penalties.
These statements, which are based on our beliefs and expectations about future outcomes and on information available to us through the date this Report on Form 10-K is filed with the SEC, include, among others, statements related to the following: • Expectations of revenues, expenses, profitability, cash flows, and growth in the number of patients being treated with our products, including continued growth in sales of our newest product, Tyvaso DPI, and anticipated growth in the number of patients with pulmonary hypertension associated with interstitial lung disease ( PH-ILD ) being treated with our Tyvaso products; • The sufficiency of our cash on hand to support operations; • Our ability to obtain and maintain domestic and international regulatory approvals; • Our ability to maintain attractive pricing and reimbursement levels for our products, in light of increasing competition, including from generic products, and pressure from government and other payers to decrease the costs associated with healthcare, including the potential impact of the Inflation Reduction Act of 2022 ( IRA ) on our business; • The anticipated impact our rebate agreements with pharmacy benefit managers will have on our net revenues; • The expected volume and timing of sales of our commercial products, as well as potential future commercial products, including the anticipated effect of various research and development efforts on sales of these products; • The timing and outcome of clinical studies, other research and development efforts, and related regulatory filings and approval s; • The outcome of pending and potential future legal and regulatory actions by the U.S.
These statements, which are based on our beliefs and expectations about future outcomes and on information available to us through the date this Report on Form 10-K is filed with the SEC, include, among others, statements related to the following: • Expectations of revenues, expenses, profitability, cash flows, and growth in the number of patients being treated with our products, including continued growth in sales of Tyvaso DPI, and anticipated growth in the number of patients with PH-ILD being treated with our Tyvaso products; • The sufficiency of our cash on hand to support operations; • Our ability to obtain and maintain domestic and international regulatory approvals; • Our ability to maintain attractive pricing and reimbursement levels for our products, in light of increasing competition, including from generic products, and pressure from government and other payers to decrease the costs associated with healthcare, including the potential impact of the IRA on our business and the Trump administration’s most favored nation pricing initiatives; • The expected volume and timing of sales of our commercial products, as well as potential future commercial products, including the anticipated effect of various research and development efforts on sales of these products; • The timing and outcome of clinical studies, other research and development efforts, and related regulatory filings and approval s; • The outcome of pending and potential future legal and regulatory actions by the U.S.
During the year ended December 31, 2023, we recorded $46.0 million in IPR&D expense in connection with the acquisition of IVIVA Medical, Inc. ( IVIVA ). (5) Calculation is not meaningful. Research and development, excluding share-based compensation.
During the year ended December 31, 2023, we recorded $46.0 million in IPR&D expense in connection with the acquisition of IVIVA. Research and development, excluding share-based compensation.
See Litigation accrual section below. (2) See Share-Based Compensation section below for discussion. (3) Calculation is not meaningful. General and administrative, excluding litigation accrual and share-based compensation .
See Impairment of PP&E and Litigation accrual sections below. (2) See Share-Based Compensation section below for discussion. (3) Calculation is not meaningful. General and administrative, excluding impairment of PP&E, litigation accrual, and share-based compensation .
The increase in general and administrative expense for the year ended December 31, 2024, as compared to the same period in 2023, was primarily due to increases in: (1) personnel expense due to growth in headcount; (2) legal expenses related to litigation matters; and (3) consulting expenses. Litigation accrual.
The increase in general and administrative expense for the year ended December 31, 2025, as compared to the same period in 2024, was primarily due to increases in: (1) personnel expense due to growth in headcount; and (2) legal expenses related to litigation matters. Impairment of PP&E.
Currently, we grant stock options and restricted stock units under the United Therapeutics Corporation Amended and Restated 2015 Stock Incentive Plan (as amended to date, the 2015 Plan ), which provides for the issuance of up to 13,820,000 shares of our common stock, including the 1,320,000 shares added pursuant to an amendment and restatement of the 2015 Plan approved by our shareholders in June 2024.
Share-Based Compensation Currently, we grant stock options and restricted stock units under the United Therapeutics Corporation Amended and Restated 2015 Stock Incentive Plan (as amended to date, the 2015 Plan ), which provides for the issuance of up to 14,770,000 shares of our common stock, including the 950,000 shares added pursuant to an amendment and restatement of the 2015 Plan approved by our shareholders in June 2025.
( Liquidia ) related to its new drug application ( NDA ) for Yutrepia; Liquidia’s lawsuit against the FDA related to the FDA’s decision to grant us a period of exclusivity and our cross-claims against the FDA related to Liquidia’s efforts to add an indication for PH-ILD to the NDA for Yutrepia; and our litigation with Humana Inc., United Healthcare Services, Inc., MSP Recovery Claims, Series LLC, and related entities; • The impact of competing therapies on sales of our commercial products, including the impact of generic versions of Remodulin; established therapies such as Uptravi; and therapies such as Merck’s recently-approved Winrevair and Liquidia’s Yutrepia, if it is approved by the FDA; • The expectation that we will be able to manufacture sufficient quantities and maintain adequate inventories of our commercial products, through both our in-house manufacturing capabilities and third-party manufacturing sites (including our plans to expand manufacturing capacity for Tyvaso DPI); • Expectations regarding the amount and timing of capital expenditures to construct new facilities to support our product development and commercialization efforts; • Expectations regarding the timing and impact of our business development efforts; • The adequacy of our intellectual property protection and the validity and expiration dates of the patents we own or license, as well as the regulatory exclusivity periods for our products; • Any statements that include the words “believe,” “seek,” “expect,” “anticipate,” “forecast,” “project,” “intend,” “estimate,” “should,” “could,” “may,” “will,” “plan,” or similar expressions; and • Other statements contained or incorporated by reference in this Report that are not historical facts.
Food and Drug Administration ( FDA ) and other regulatory and government enforcement agencies related to our products and potential competitive products; • The timing and outcome of ongoing litigation, including the lawsuit filed against us by Sandoz and Liquidia PAH, LLC (formerly known as RareGen); our patent and trade secret litigation with Liquidia related to Yutrepia; Liquidia’s patent lawsuit against us related to Tyvaso DPI; and our litigation with Humana Inc., United Healthcare Services, Inc., MSP Recovery Claims, Series LLC, and related entities; • The impact of competing therapies on sales of our commercial products, including the impact of generic versions of Remodulin; established therapies such as Uptravi®; and newer therapies such as Merck’s Winrevair and Liquidia’s Yutrepia; • The expectation that we will be able to manufacture sufficient quantities and maintain adequate inventories of our commercial products, through both our in-house manufacturing capabilities and third-party manufacturing sites (including our plans to expand manufacturing capacity for Tyvaso DPI); • Expectations regarding the amount and timing of capital expenditures to construct new facilities to support our product development and commercialization efforts, including our xenotransplantation-related facilities; • Expectations regarding the timing and impact of our business development efforts; • The adequacy of our intellectual property protection and the validity and expiration dates of the patents we own or license, as well as the regulatory exclusivity periods for our products; • Any statements that include the words “believe,” “seek,” “expect,” “anticipate,” “forecast,” “project,” “intend,” “estimate,” “should,” “could,” “may,” “will,” “plan,” or similar expressions; and • Other statements contained or incorporated by reference in this Report that are not historical facts.
Research and Development The table below summarizes the nature of research and development expense by major expense category (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2024 2023 2022 2024 v. 2023 2023 v. 2022 2024 v. 2023 2023 v. 2022 Category: External research and development (1) $ 217.5 $ 192.0 $ 168.8 $ 25.5 $ 23.2 13 % 14 % Internal research and development (2) 183.6 146.6 131.4 37.0 15.2 25 % 12 % Share-based compensation expense (3) 29.1 15.6 23.8 13.5 (8.2) 87 % (34) % Other (4) 50.8 53.8 (1.1) (3.0) 54.9 (6) % NM (5) Total research and development expense $ 481.0 $ 408.0 $ 322.9 $ 73.0 $ 85.1 18 % 26 % (1) External research and development primarily includes fees paid to third parties (such as clinical trial sites, contract research organizations, and contract laboratories) for preclinical and clinical studies and payments to third-party contract manufacturers before FDA approval of the relevant product.
Research and Development The table below summarizes the nature of research and development expense by major expense category (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2025 2024 2023 2025 v. 2024 2024 v. 2023 2025 v. 2024 2024 v. 2023 Category: External research and development (1) $ 245.8 $ 217.5 $ 192.0 $ 28.3 $ 25.5 13 % 13 % Internal research and development (2) 212.3 183.6 146.6 28.7 37.0 16 % 25 % Share-based compensation expense (3) 32.3 29.1 15.6 3.2 13.5 11 % 87 % Other (4) 59.6 50.8 53.8 8.8 (3.0) 17 % (6) % Total research and development expense $ 550.0 $ 481.0 $ 408.0 $ 69.0 $ 73.0 14 % 18 % (1) External research and development primarily includes fees paid to third parties (such as clinical trial sites, contract research organizations, and contract laboratories) for preclinical and clinical studies and payments to third-party contract manufacturers before regulatory approval of the relevant product.
Our ability to achieve our objectives, grow our business, and maintain profitability will depend on many factors, including among others: (1) the timing and outcome of preclinical research, clinical trials, and regulatory approval applications for products we develop; (2) the timing and degree of our success in commercially launching new products; (3) the demand for our products; (4) the net price of our products and the reimbursement of our products by public and private health insurance organizations, including the impact on such net prices and reimbursement amounts as a result of the IRA, and as a result of additional payer rebates; (5) the competition we face within our industry, including competition from generic companies and the anticipated launch of new PAH and PH-ILD therapies; (6) our ability to effectively manage our business in an increasingly complex legal and regulatory environment; (7) our ability to defend against challenges to our patents; and (8) the risks identified in Part I, Item 1A—Risk Factors , included in this Report.
We believe 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 our existing products, as described above under Part I, Item 1—Business—Research and Development. 54 United Therapeutics, a public benefit corporation Our ability to achieve our objectives, grow our business, and maintain profitability will depend on many factors, including among others: (1) the timing and outcome of preclinical research, clinical trials, and regulatory approval applications for products we develop; (2) the timing and degree of our success in commercially launching new products; (3) the demand for our products; (4) the net price of our products and the reimbursement of our products by public and private health insurance organizations, including the impact on such net prices and reimbursement amounts as a result of the IRA and other government initiatives focused on drug pricing, and as a result of additional payer rebates; (5) the competition we face within our industry, including competition from generic companies, the recent launch of Yutrepia, and the potential launch of new therapies for PAH, PH-ILD, IPF, and/or PPF; (6) our ability to effectively manage our business in an increasingly complex legal and regulatory environment; (7) our ability to defend against challenges to our patents; and (8) the risks identified in Part I, Item 1A—Risk Factors , included in this Report.
The tables below present a reconciliation of the liability accounts associated with these deductions (in millions): Year Ended December 31, 2024 Rebates & Chargebacks Prompt Pay Discounts Allowance for Sales Returns Distributor Fees Total Balance, January 1, 2024 $ 108.4 $ 5.3 $ 1.9 $ 10.4 $ 126.0 Provisions attributed to sales in: Current period 356.0 64.4 1.9 41.8 464.1 Prior periods (10.6) — (1.0) (0.9) (12.5) Payments or credits attributed to sales in: Current period (215.8) (59.3) — (30.4) (305.5) Prior periods (97.2) (5.3) (0.6) (9.3) (112.4) Balance, December 31, 2024 $ 140.8 $ 5.1 $ 2.2 $ 11.6 $ 159.7 Year Ended December 31, 2023 Rebates & Chargebacks Prompt Pay Discounts Allowance for Sales Returns Distributor Fees Total Balance, January 1, 2023 $ 81.3 $ 4.4 $ 3.3 $ 10.9 $ 99.9 Provisions attributed to sales in: Current period 278.0 52.5 1.3 40.7 372.5 Prior periods (2.5) (0.1) (1.9) (0.9) (5.4) Payments or credits attributed to sales in: Current period (169.8) (47.3) — (30.3) (247.4) Prior periods (78.6) (4.2) (0.8) (10.0) (93.6) Balance, December 31, 2023 $ 108.4 $ 5.3 $ 1.9 $ 10.4 $ 126.0 2024 Annual Report 59 Year Ended December 31, 2022 Rebates & Chargebacks Prompt Pay Discounts Allowance for Sales Returns Distributor Fees Total Balance, January 1, 2022 $ 67.8 $ 3.8 $ 6.3 $ 7.9 $ 85.8 Provisions attributed to sales in: Current period 202.8 43.2 2.3 34.5 282.8 Prior periods (4.3) (0.5) (3.1) 0.5 (7.4) Payments or credits attributed to sales in: Current period (121.1) (38.9) (0.7) (23.6) (184.3) Prior periods (63.9) (3.2) (1.5) (8.4) (77.0) Balance, December 31, 2022 $ 81.3 $ 4.4 $ 3.3 $ 10.9 $ 99.9 Cost of Sales The table below summarizes cost of sales by major category (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2024 2023 2022 2024 v. 2023 2023 v. 2022 2024 v. 2023 2023 v. 2022 Category: Cost of sales $ 304.3 $ 255.1 $ 146.7 $ 49.2 $ 108.4 19 % 74 % Share-based compensation expense (1) 5.4 2.4 4.9 3.0 (2.5) 125 % (51) % Total cost of sales $ 309.7 $ 257.5 $ 151.6 $ 52.2 $ 105.9 20 % 70 % (1) See Share-Based Compensation section below for discussion.
The tables below present a reconciliation of the liability accounts associated with these deductions (in millions): Year Ended December 31, 2025 Rebates & Chargebacks Prompt Pay Discounts Allowance for Sales Returns Distributor Fees Total Balance, January 1, 2025 $ 140.8 $ 5.1 $ 2.2 $ 11.6 $ 159.7 Provisions attributed to sales in: Current period 521.6 74.0 0.9 41.7 638.2 Prior periods 0.7 0.1 — (0.5) 0.3 Payments or credits attributed to sales in: Current period (296.6) (67.7) — (30.1) (394.4) Prior periods (127.6) (5.2) (1.7) (11.0) (145.5) Balance, December 31, 2025 $ 238.9 $ 6.3 $ 1.4 $ 11.7 $ 258.3 Year Ended December 31, 2024 Rebates & Chargebacks Prompt Pay Discounts Allowance for Sales Returns Distributor Fees Total Balance, January 1, 2024 $ 108.4 $ 5.3 $ 1.9 $ 10.4 $ 126.0 Provisions attributed to sales in: Current period 356.0 64.4 1.9 41.8 464.1 Prior periods (10.6) — (1.0) (0.9) (12.5) Payments or credits attributed to sales in: Current period (215.8) (59.3) — (30.4) (305.5) Prior periods (97.2) (5.3) (0.6) (9.3) (112.4) Balance, December 31, 2024 $ 140.8 $ 5.1 $ 2.2 $ 11.6 $ 159.7 56 United Therapeutics, a public benefit corporation Year Ended December 31, 2023 Rebates & Chargebacks Prompt Pay Discounts Allowance for Sales Returns Distributor Fees Total Balance, January 1, 2023 $ 81.3 $ 4.4 $ 3.3 $ 10.9 $ 99.9 Provisions attributed to sales in: Current period 278.0 52.5 1.3 40.7 372.5 Prior periods (2.5) (0.1) (1.9) (0.9) (5.4) Payments or credits attributed to sales in: Current period (169.8) (47.3) — (30.3) (247.4) Prior periods (78.6) (4.2) (0.8) (10.0) (93.6) Balance, December 31, 2023 $ 108.4 $ 5.3 $ 1.9 $ 10.4 $ 126.0 Cost of Sales The table below summarizes cost of sales by major category (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2025 2024 2023 2025 v. 2024 2024 v. 2023 2025 v. 2024 2024 v. 2023 Category: Cost of sales $ 380.5 $ 304.3 $ 255.1 $ 76.2 $ 49.2 25 % 19 % Share-based compensation expense (1) 3.9 5.4 2.4 (1.5) 3.0 (28) % 125 % Total cost of sales $ 384.4 $ 309.7 $ 257.5 $ 74.7 $ 52.2 24 % 20 % (1) See Share-Based Compensation section below for discussion.
Recently Issued Accounting Standards See Note 3— Recently Issued Accounting Standards , to our consolidated financial statements for information on our adoption and anticipated adoption of recently issued accounting standards.
Recently Issued Accounting Standards See Note 3— Recently Issued Accounting Standards , to our consolidated financial statements for information on our adoption and anticipated adoption of recently issued accounting standards. 62 United Therapeutics, a public benefit corporation
(2) Net product sales include sales of infusion devices, including the Remunity Pump. Gross-to-Net Deductions We recognize revenues net of: (1) rebates and chargebacks; (2) prompt pay discounts; (3) allowance for sales returns; and (4) distributor fees. These are referred to as gross-to-net deductions and are primarily based on estimates reflecting historical experiences as well as contractual and statutory requirements.
Gross-to-Net Deductions We recognize revenues net of: (1) rebates and chargebacks; (2) prompt pay discounts; (3) allowance for sales returns; and (4) distributor fees. These are referred to as gross-to-net deductions and are primarily based on estimates reflecting historical experiences as well as contractual and statutory requirements. We currently estimate our allowance for sales returns using reports from our distributors.
We operate in a highly competitive market in which several large pharmaceutical companies control many of the available PAH therapies. These pharmaceutical companies are well established in the market and possess greater financial, technical, and marketing resources than we do.
We operate in a highly competitive market in which several large pharmaceutical companies control many of the available PAH therapies, including Merck, which received FDA approval for Winrevair (sotatercept-csrk) to treat PAH in March 2024. These pharmaceutical companies are well established in the market and possess greater financial, technical, and marketing resources than we do.
Our commercial-scale DPF facilities will be very capital-intensive, but they will be executed in stages with the ability to adjust the schedule (and anticipated cost) depending on the progress of our clinical and regulatory activities.
Additional DPF facilities will be very capital-intensive, but we expect they will be executed in stages, which will enable us to adjust the schedule (and anticipated cost) of construction depending on the progress of our clinical and regulatory activities.
Selling, General, and Administrative The table below summarizes selling, general, and administrative expense by major category (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2024 2023 2022 2024 v. 2023 2023 v. 2022 2024 v. 2023 2023 v. 2022 Category: General and administrative (1) $ 432.8 $ 374.2 $ 333.2 $ 58.6 $ 41.0 16 % 12 % Litigation accrual 71.1 — — 71.1 — NM (3) — % Sales and marketing 96.3 81.8 70.8 14.5 11.0 18 % 16 % Share-based compensation expense (2) 109.5 21.1 78.1 88.4 (57.0) 419 % (73) % Total selling, general, and administrative expense $ 709.7 $ 477.1 $ 482.1 $ 232.6 $ (5.0) 49 % (1) % (1) Excluding litigation accrual.
Selling, General, and Administrative The table below summarizes selling, general, and administrative expense by major category (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2025 2024 2023 2025 v. 2024 2024 v. 2023 2025 v. 2024 2024 v. 2023 Category: General and administrative (1) $ 501.0 $ 432.8 $ 374.2 $ 68.2 $ 58.6 16 % 16 % Impairment of property, plant, and equipment ( PP&E ) 21.7 — — 21.7 — NM (3) NM (3) Litigation accrual 3.0 71.1 — (68.1) 71.1 (96) % NM (3) Sales and marketing 118.6 96.3 81.8 22.3 14.5 23 % 18 % Share-based compensation expense (2) 111.5 109.5 21.1 2.0 88.4 2 % 419 % Total selling, general, and administrative expense $ 755.8 $ 709.7 $ 477.1 $ 46.1 $ 232.6 6 % 49 % (1) Excluding impairment of PP&E and litigation accrual.
For additional detail regarding our commercial products, see Part I, Item 1—Business—Our Commercial Products. Research and Development We are engaged in research and development of new indications and delivery devices for our existing product s.
We sell Adcirca under an in-license from Lilly that expires December 31, 2026. For additional detail regarding our commercial products, see Part I, Item 1—Business—Our Commercial Products. Research and Development We are engaged in research and development of new indications and delivery devices for our existing product s.
These costs also include share-based compensation and salary-related expenses for direct manufacturing and indirect support personnel, quality review and release for commercial distribution, direct materials and supplies, depreciation, facilities-related expenses, and other overhead costs. Research and Development Our research and development expenses primarily include costs associated with the research and development of products and post-marketing research commitments.
These costs also include share-based compensation and salary-related expenses for direct manufacturing and indirect support personnel, quality review and release for commercial distribution, direct materials and supplies, depreciation, facilities-related expenses, and other overhead costs.
Nebulized Tyvaso was also approved by the FDA in March 2021 and by regulators in Israel and Japan in December 2022 and September 2024, respectively, to improve exercise ability in patients with PH-ILD.
Nebulized Tyvaso was also approved by the FDA in March 2021 to improve exercise ability in patients with PH-ILD.
Revenues The table below presents the components of total revenues (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2024 2023 2022 2024 v. 2023 2023 v. 2022 2024 v. 2023 2023 v. 2022 Net product sales: Tyvaso DPI (1) $ 1,033.6 $ 731.1 $ 158.3 $ 302.5 $ 572.8 41 % 362 % Nebulized Tyvaso (1) 586.8 502.6 714.7 84.2 (212.1) 17 % (30) % Total Tyvaso 1,620.4 1,233.7 873.0 386.7 360.7 31 % 41 % Remodulin (2) 538.1 494.8 500.2 43.3 (5.4) 9 % (1) % Orenitram 434.3 359.4 325.1 74.9 34.3 21 % 11 % Unituxin 238.7 198.9 182.9 39.8 16.0 20 % 9 % Adcirca 23.8 28.9 41.3 (5.1) (12.4) (18) % (30) % Other 22.1 11.8 13.8 10.3 (2.0) 87 % (14) % Total revenues $ 2,877.4 $ 2,327.5 $ 1,936.3 $ 549.9 $ 391.2 24 % 20 % (1) Net product sales include both the drug product and the respective inhalation device.
Revenues The table below presents the components of total revenues (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2025 2024 2023 2025 v. 2024 2024 v. 2023 2025 v. 2024 2024 v. 2023 Net product sales: Tyvaso DPI $ 1,292.5 $ 1,033.6 $ 731.1 $ 258.9 $ 302.5 25 % 41 % Nebulized Tyvaso 585.7 586.8 502.6 (1.1) 84.2 — % 17 % Total Tyvaso 1,878.2 1,620.4 1,233.7 257.8 386.7 16 % 31 % Remodulin (1) 526.8 538.1 494.8 (11.3) 43.3 (2) % 9 % Orenitram 496.9 434.3 359.4 62.6 74.9 14 % 21 % Unituxin 226.8 238.7 198.9 (11.9) 39.8 (5) % 20 % Adcirca 30.0 23.8 28.9 6.2 (5.1) 26 % (18) % Other 24.0 22.1 11.8 1.9 10.3 9 % 87 % Total revenues $ 3,182.7 $ 2,877.4 $ 2,327.5 $ 305.3 $ 549.9 11 % 24 % (1) Net product sales include sales of infusion devices, including the Remunity and RemunityPRO Pumps.
In February 2021, we launched U.S. sales of the Remunity Pump, a next-generation subcutaneous infusion system for Remodulin. • Orenitram , an oral extended-release tablet form of treprostinil, approved by the FDA to delay disease progression and improve exercise capacity in PAH patients. • Unituxin , an infused monoclonal antibody approved in the United States and Canada for the treatment of high-risk neuroblastoma and approved in Japan for the treatment of neuroblastoma after high-dose chemotherapy. • Adcirca , an oral immediate-release tablet form of the PDE-5 inhibitor tadalafil, approved by the FDA to improve exercise ability in PAH patients.
In September 2025, we launched a new patient-filled version of the Remunity Pump, called RemunityPRO, which is intended to improve the patient experience by making the pump easier to use. • Orenitram , an oral extended-release tablet form of treprostinil, approved by the FDA to delay disease progression and improve exercise capacity in PAH patients. • Unituxin , an infused monoclonal antibody approved in the United States and Canada for the treatment of high-risk neuroblastoma and approved in Japan for the treatment of neuroblastoma after high-dose chemotherapy. • Adcirca , an oral immediate-release tablet form of the PDE-5 inhibitor tadalafil, approved by the FDA to improve exercise ability in PAH patients.
(2) Estimated based on the intrinsic value of exercisable outstanding STAP awards as of December 31, 2024. See Note 8 —Share-Based Compensation—STAP Awards to our consolidated financial statements for further details. (3) Consists of actuarially derived, undiscounted, estimated future payouts of benefits. See Note 11— Employee Benefit Plans—Supplemental Executive Retirement Plan to our consolidated financial statements for further details.
As of December 31, 2025, our outstanding balance on the 2025 Credit Agreement was zero. (2) Consists of actuarially derived, undiscounted, estimated future payouts of benefits. See Note 11— Employee Benefit Plans—Supplemental Executive Retirement Plan to our consolidated financial statements for further details.
See Note 12— Commitments and Contingencies to our consolidated financial statements for further details. In addition, we may owe additional earn-out consideration to the former securityholders of IVIVA and Miromatrix, as described in Note 15 — Acquisitions to our consolidated financial statements. Off-Balance Sheet Arrangements We hold an interest in an unconsolidated variable interest entity ( VIE ).
In addition, we may owe additional earn-out consideration to the former securityholders of IVIVA, as described in Note 15— Acquisitions — Asset Acquisition to our consolidated financial statements. Off-Balance Sheet Arrangements We hold an interest in an unconsolidated variable interest entity ( VIE ). We determined that we are not the primary beneficiary of this entity.
In addition, we are developing a new product to treat PAH, ralinepag. We are also heavily engaged in research and development of organ transplantation-related technologies including xenotransplantation, regenerative medicine, bio-artificial organ alternatives, 3D organ alternative bioprinting, and ex vivo lung perfusion.
We are studying Nebulized Tyvaso in patients with IPF and PPF (the TETON studies). In addition, we are developing a new product to treat PAH, ralinepag. We are also heavily engaged in research and development of organ transplantation-related technologies including xenotransplantation, regenerative medicine, and ex vivo lung perfusion.
To the extent we have increased the price of any of these products, increases have typically been in the single-digit percentages per year, except for Adcirca, the price of which is set solely by Lilly.
W e also sell Nebulized Tyvaso, Remodulin, and Unituxin to distributors internationally. We sell Adcirca through Lilly’s pharmaceutical wholesale network. To the extent we have increased the price of any of these products, increases have typically been in the single-digit percentages per year, except for Adcirca, the price of which is set solely by Lilly.
In addition, marketing authorization applications for nebulized Tyvaso to treat PAH and/or PH-ILD have also been approved, and others are pending, in various other countries in Latin America, Asia, and the Middle East. • Remodulin , a continuously-infused formulation of treprostinil, approved by the FDA for subcutaneous and intravenous delivery to diminish symptoms associated with exercise in patients with PAH.
Nebulized Tyvaso has also been approved with respect to PAH and/or PH-ILD in various countries outside of the United States. • Remodulin , a continuously-infused formulation of treprostinil, approved by the FDA for subcutaneous and intravenous delivery to diminish symptoms associated with exercise in patients with PAH. Remodulin has also been approved in various countries outside of the United States.
The grant date fair values of stock options and restricted stock units are recognized as share-based compensation expense ratably over their vesting periods. The fair value of STAP awards and stock options is measured using inputs and assumptions under the Black-Scholes-Merton model. The fair value of restricted stock units is measured using our stock price on the date of grant.
The fair value of stock options is measured using inputs and assumptions under the Black-Scholes-Merton model. The fair value of restricted stock units is measured using our stock price on the date of grant.
ROW Total Net product sales: Tyvaso DPI (1) $ 1,033.2 $ 0.4 $ 1,033.6 $ 731.1 $ — $ 731.1 $ 158.3 $ — $ 158.3 Nebulized Tyvaso (1) 545.5 41.3 586.8 477.1 25.5 502.6 708.6 6.1 714.7 Total Tyvaso 1,578.7 41.7 1,620.4 1,208.2 25.5 1,233.7 866.9 6.1 873.0 Remodulin (2) 464.2 73.9 538.1 414.6 80.2 494.8 407.5 92.7 500.2 Orenitram 434.3 — 434.3 359.4 — 359.4 325.1 — 325.1 Unituxin 219.6 19.1 238.7 181.3 17.6 198.9 170.5 12.4 182.9 Adcirca 23.8 — 23.8 28.9 — 28.9 41.3 — 41.3 Other 19.1 3.0 22.1 9.8 2.0 11.8 2.8 11.0 13.8 Total revenues $ 2,739.7 $ 137.7 $ 2,877.4 $ 2,202.2 $ 125.3 $ 2,327.5 $ 1,814.1 $ 122.2 $ 1,936.3 (1) Net product sales include both the drug product and the respective inhalation device.
ROW Total Net product sales: Tyvaso DPI $ 1,291.8 $ 0.7 $ 1,292.5 $ 1,033.2 $ 0.4 $ 1,033.6 $ 731.1 $ — $ 731.1 Nebulized Tyvaso 531.9 53.8 585.7 545.5 41.3 586.8 477.1 25.5 502.6 Total Tyvaso 1,823.7 54.5 1,878.2 1,578.7 41.7 1,620.4 1,208.2 25.5 1,233.7 Remodulin (1) 448.9 77.9 526.8 464.2 73.9 538.1 414.6 80.2 494.8 Orenitram 496.9 — 496.9 434.3 — 434.3 359.4 — 359.4 Unituxin 214.7 12.1 226.8 219.6 19.1 238.7 181.3 17.6 198.9 Adcirca 30.0 — 30.0 23.8 — 23.8 28.9 — 28.9 Other 22.8 1.2 24.0 19.1 3.0 22.1 9.8 2.0 11.8 Total revenues $ 3,037.0 $ 145.7 $ 3,182.7 $ 2,739.7 $ 137.7 $ 2,877.4 $ 2,202.2 $ 125.3 $ 2,327.5 (1) Net product sales include sales of infusion devices, including the Remunity and RemunityPRO Pumps.
The final settlement of the $700 million tranche occurred in September 2024, and we received an additional 90,403 shares of our common stock upon settlement. In total, we repurchased 3,547,374 shares of our common stock under the ASR agreement that we currently hold as treasury stock in our consolidated balance sheets.
The final settlement of the $700 million tranche occurred in September 2024, and we received an additional 90,403 shares of our common stock upon settlement.
The increase in research and development expense for the year ended December 31, 2024, as compared to the same period in 2023, was due to: (1) increased expenditures related to manufactured organ and organ alternative projects; (2) non-refundable licensing payments for drug delivery device technologies and ex vivo lung perfusion technology; and (3) increased expenditures related to the TETON studies of nebulized Tyvaso in patients with IPF and PPF.
The increase in research and development expense for the year ended December 31, 2025, as compared to the same period in 2024, was primarily due to: (1) increased expenditures related to manufactured organ and organ alternative projects; and (2) increased expenditures for drug delivery device and formulation technologies.
During the year ended December 31, 2024, we recorded $40.2 million and $8.0 million in expense related to upfront non-refundable licensing payments for drug delivery device technologies and ex vivo lung 60 United Therapeutics, a public benefit corporation perfusion technology, respectively.
During the year ended December 31, 2025, we recorded (a) $42.2 million in expense related to milestone payments for drug delivery device and formulation technologies; and (b) $10.8 million in expense related to adjustments to the fair value of contingent consideration obligations for manufactured organ and organ alternative projects. 2025 Annual Report 57 During the year ended December 31, 2024, we recorded $40.2 million and $8.0 million in expense related to upfront non-refundable licensing payments for drug delivery device technologies and ex vivo lung perfusion technology, respectively.
Cost of sales, excluding share-based compensation. The increase in cost of sales for the year ended December 31, 2024, as compared to the same period in 2023, was primarily due to an increase in Tyvaso DPI royalty expense and product costs driven by growth in Tyvaso DPI revenues.
Cost of sales, excluding share-based compensation. The increase in cost of sales for the year ended December 31, 2025, as compared to the same period in 2024, was primarily due to increases in: (1) royalty expense resulting from a growth in revenues; (2) inventory reserve expense; and (3) the cost of products and services sold.
Investing Activities The increase of $1,136.8 million in net cash provided by investing activities for the year ended December 31, 2024, as compared to the same period in 2023, was primarily due to: (1) a $1,099.7 million decrease in cash used for total purchases, sales, and maturities of marketable investments; and (2) an $89.2 million decrease in net cash paid related to the acquisitions of IVIVA and Miromatrix in 2023; partially offset by: (1) a $30.5 million increase in cash paid to purchase investments in privately-held companies; (2) a $16.1 million increase in cash paid to purchase property, plant, and equipment; and (3) a $5.5 million increase in deposits.
Investing Activities The increase of $968.5 million in net cash used in investing activities for the year ended December 31, 2025, as compared to the same period in 2024, was primarily due to: (1) a $682.6 million increase in cash used for total purchases, sales, and maturities of marketable investments; and (2) a $274.0 million increase in cash paid to purchase property, plant, and equipment.
( CVS Specialty ) to distribute Tyvaso DPI, nebulized Tyvaso, Remodulin, the Remunity Pump, and Orenitram in the United States, and we have entered into an exclusive distribution agreement with ASD Specialty Healthcare, Inc., an affiliate of Cencora, Inc. (formerly known as AmerisourceBergen Corporation), to distribute Unituxin in the United States.
We have entered into separate, non-exclusive distribution agreements with Accredo and CVS Specialty to distribute Tyvaso DPI, Nebulized Tyvaso, Remodulin, the Remunity and RemunityPRO Pumps, and Orenitram in the United States, and we have entered into an exclusive distribution agreement with Cencora Global Procurement Ltd. to distribute Unituxin in the United States.
We anticipate our first commercial-scale DPF facility will provide an initial commercial supply of our xeno-organ products if and when they are approved by the FDA.
We plan to fund these capital expenditures using cash on hand. We anticipate our existing DPF facility in Virginia and the two planned DPF facilities in Minnesota and Texas will provide an initial commercial supply of our xeno-organ products if and when they are approved by the FDA.
For a description of our related accounting policies, see Note 2 —Summary of Significant Accounting Policies—Revenue Recognition to our consolidated financial statements. The following category of gross-to-net deductions involves the use of significant estimates and judgments and information obtained from external sources.
The following category of gross-to-net deductions involves the use of significant estimates and judgments and information obtained from external sources.
General and administrative expenses include the core corporate support functions such as human resources, finance, and legal, and associated external costs to support those functions. Share-Based Compensation Historically, we granted stock options under our Amended and Restated Equity Incentive Plan and awards under our Share Tracking Awards Plan (the STAP ).
General and administrative expenses include the core corporate support functions such as human resources, finance, and legal, and associated external costs to support those functions.
For information regarding the fluctuation explanations between 2023 and 2022 , see our 2023 Annual Report. 62 United Therapeutics, a public benefit corporation Cash and Cash Equivalents and Marketable Investments Cash and cash equivalents and marketable investments comprise the following (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2024 2023 2024 v. 2023 2024 v. 2023 Cash and cash equivalents $ 1,697.2 $ 1,207.7 $ 489.5 41 % Marketable investments—current 1,569.8 1,786.4 (216.6) (12) % Marketable investments—non-current 1,475.3 1,909.8 (434.5) (23) % Total cash and cash equivalents and marketable investments $ 4,742.3 $ 4,903.9 $ (161.6) (3) % Cash Flows Cash flows comprise the following (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2024 2023 2022 2024 v. 2023 2023 v. 2022 2024 v. 2023 2023 v. 2022 Net cash provided by operating activities $ 1,327.1 $ 978.0 $ 802.5 $ 349.1 $ 175.5 36 % 22 % Net cash provided by (used in) investing activities $ 417.2 $ (719.6) $ (811.5) $ 1,136.8 $ 91.9 158 % 11 % Net cash (used in) provided by financing activities $ (1,254.8) $ (11.9) $ 75.4 $ (1,242.9) $ (87.3) NM (1) (116) % (1) Calculation is not meaningful.
Cash and Cash Equivalents and Marketable Investments Cash and cash equivalents and marketable investments comprise the following (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2025 2024 2025 v. 2024 2025 v. 2024 Cash and cash equivalents $ 1,557.1 $ 1,697.2 $ (140.1) (8) % Marketable investments—current 1,363.2 1,569.8 (206.6) (13) % Marketable investments—non-current 1,776.7 1,475.3 301.4 20 % Total cash and cash equivalents and marketable investments $ 4,697.0 $ 4,742.3 $ (45.3) (1) % Cash Flows Cash flows comprise the following (dollars in millions): Year Ended December 31, Dollar Change Percentage Change 2025 2024 2023 2025 v. 2024 2024 v. 2023 2025 v. 2024 2024 v. 2023 Net cash provided by operating activities $ 1,561.2 $ 1,327.1 $ 978.0 $ 234.1 $ 349.1 18 % 36 % Net cash (used in) provided by investing activities $ (551.3) $ 417.2 $ (719.6) $ (968.5) $ 1,136.8 (232) % 158 % Net cash used in financing activities $ (1,150.0) $ (1,254.8) $ (11.9) $ 104.8 $ (1,242.9) 8 % NM (1) (1) Calculation is not meaningful.
Financial Condition, Liquidity, and Capital Resources We have funded our operations principally through sales of our commercial products and, from time-to-time, third-party financing arrangements. We believe that our current sources of liquidity are sufficient to fund ongoing operations and future business plans as we expect aggregate growth in revenues from our commercial products.
We believe that our current sources of liquidity are sufficient to fund ongoing operations and future business plans as we expect aggregate growth in revenues from our commercial products. Furthermore, our customer base remains stable, and we believe that it presents minimal credit risk.
GAAP requires that we make estimates and assumptions that affect the amounts and timing reported in our consolidated financial statements. As we become aware of updated information or new developments, these estimates and assumptions may change and materially impact reported amounts.
As we become aware of updated information or new developments, these estimates and assumptions may change and materially impact reported amounts. We consider the following accounting policies to be critical to our consolidated financial statements because they require the use of our judgment and estimates (including those that are forward-looking) in their application.
Rebates and Chargebacks Our most significant rebates relate to our participation in state Medicaid programs, contractual rebates to certain of our domestic distributors, and contractual rebates offered to managed care organizations covering Medicare Part D and commercial plans. Chargebacks relate to our participation in programs with the U.S. Department of Veterans Affairs and 340B covered entities.
Rebates and Chargebacks The most significant rebates we pay include rebates that relate to our participation in various government healthcare programs (including Medicare Part D inflationary rebates required under the IRA), contractual rebates to certain of our domestic distributors, and contractual rebates we pay to managed care organizations covering Medicare Part D and commercial plans.
The increase in Tyvaso DPI quantities sold was primarily due to continued growth in the number of patients following the product’s launch (including by PH-ILD patients) and, to a lesser extent, increased commercial utilization following implementation of the Part D redesign under the Inflation Reduction Act.
The increase in quantities sold was primarily due to continued growth in the number of patients following the product’s launch and, to a lesser extent, increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the IRA. 2025 Annual Report 55 Orenitram net product sales increased in 2025, as compared to 2024, primarily due to an increase in quantities sold of $46.0 million.
The following factors, among others, impact the amount of share-based compensation expense (benefit) recognized in connection with STAP awards from period to period: (1) volatility in the price of our common stock (specifically, increases in the price of our common stock will generally result in an increase in our liability and related compensation expense, while decreases in our stock price will generally result in a reduction in our liability and related compensation expense); and (2) decreases in the number of outstanding awards. 56 United Therapeutics, a public benefit corporation Future Prospects We anticipate that revenue growth over the near-term will be driven primarily by: (1) continued growth in sales of Tyvaso DPI; (2) continued growth in the number of PH-ILD patients prescribed Tyvaso DPI and nebulized Tyvaso; (3) continued growth in the number of patients prescribed Orenitram; and (4) modest price increases for some of our products.
Future Prospects We anticipate that revenue growth over the near-term will be driven primarily by: (1) continued growth in sales of Tyvaso DPI; (2) continued growth in the number of PH-ILD patients prescribed Tyvaso DPI and Nebulized Tyvaso; (3) continued growth in the number of patients prescribed Orenitram; and (4) modest price increases for some of our products.
We also pay The Scripps Research Institute a one percent royalty on sales of Unituxin. We have entered into other license agreements under which we are required to make milestone payments upon the achievement of certain developmental and commercialization objectives and royalty payments upon the commercialization of products covered by the license agreements.
We have entered into other license agreements under which we are required to make milestone payments upon the achievement of certain developmental and commercialization objectives and royalty payments upon the commercialization of products covered by the license agreements. See Note 12— Commitments and Contingencies to our consolidated financial statements for further 2025 Annual Report 61 details.
We have budgeted approximately $750 million for capital expenditures during 2025 through the end of 2027 to construct additional facilities to support the development and commercialization of our products and technologies.
We have budgeted approximately $400 million for capital expenditures during 2026 and through the end of 2028 to construct additional facilities to support the development and commercialization of our 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.
For additional details, see Note 10— Income Taxes to our consolidated financial statements. Share Repurchase In March 2024, we entered into an accelerated share repurchase agreement (the ASR agreement ) with Citibank, N.A. ( Citi ).
Our effective income tax rate was approximately 22 percent for the years ended December 31, 2025 and 2024. For additional details, see Note 10— Income Taxes to our consolidated financial statements. 2025 Share Repurchase In August 2025, we entered into the 2025 ASR agreements with Citi, comprised of a $500 million Uncollared ASR and a $500 million Collared ASR.
Unsecured Revolving Credit Facilities In March 2022, we entered into the 2022 Credit Agreement, which provides for unsecured revolving credit facilities of up to $2.0 billion in the aggregate. On March 31, 2022, we borrowed $800.0 million under the facilities and used the funds to repay outstanding indebtedness under our then-existing credit agreement.
On April 25, 2025, we terminated the 2022 Credit Agreement and entered into the 2025 Credit Agreement, which provides for an unsecured revolving credit facility of up to $2.5 billion in the aggregate.
Unituxin net product sales increased in 2024, as compared to 2023, primarily due to a price increase and an increase in quantities sold. 58 United Therapeutics, a public benefit corporation The table below presents the breakdown of total revenues between the United States and rest-of-world ( ROW ) (in millions): Year Ended December 31, 2024 2023 2022 U.S.
The increase in quantities sold was driven, at least in part, by increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the IRA. The table below presents the breakdown of total revenues between the United States and rest-of-world ( ROW ) (in millions): Year Ended December 31, 2025 2024 2023 U.S. ROW Total U.S.
We determined that we are not the primary beneficiary of this entity. As a result, we do not consolidate this VIE. See Note 4— Investments—Variable Interest Entities .
As a result, we do not consolidate this VIE. See Note 4— Investments—Variable Interest Entities . We do not have any other off-balance sheet arrangements within the meaning of Item 303(a)(4) of Regulation S-K.
Revenue is recognized when we transfer control of our products to our distributors, as our contracts have a single performance obligation (delivery of our product). These revenues are subject to various product sales allowances, referred to as gross-to-net deductions, which are deducted from revenues to determine net product sales.
Revenue Recognition We generate revenues from the sale of our commercial products: Tyvaso DPI, Nebulized Tyvaso, Remodulin, Orenitram, Unituxin, and Adcirca. Revenue is recognized when we transfer control of our products to our distributors, as our contracts have a single performance obligation (delivery of our product).
Estimates associated with our participation in state Medicaid programs are particularly susceptible to adjustment given the extensive time lag that may occur between our recording of an accrual and its ultimate invoicing by individual state Medicaid programs, which can occur up to several years after the sale of our product.
As of December 31, 2025 and 2024, we had a liability of $238.9 million and $140.8 million, respectively, related to rebates and chargebacks. Estimates associated with our participation in government healthcare programs are particularly susceptible to adjustment given the time lag that may occur between our recording of an accrual and its ultimate invoicing.
We paid down $400.0 million of our balance under the 2022 Credit Agreement during the year ended December 31, 2024. The aggregate balance of $300.0 million under our 2022 Credit Agreement remained outstanding as of both December 31, 2024 and February 26, 2025.
During the second quarter of 2025, we repaid the remaining $200.0 million balance under the 2025 Credit Agreement, which brought our aggregate outstanding balance to zero as of June 30, 2025. Our aggregate outstanding debt balance remained zero as of December 31, 2025 and February 25, 2026.
See Note 7— Debt, to our consolidated financial statements. 2024 Annual Report 63 Contractual Obligations As of December 31, 2024, we had the following contractual obligations (in millions): Payments Due by Period Total Less than 1 year 2-3 Years 4-5 Years More than 5 Years Operating lease obligations $ 38.6 $ 6.1 $ 12.1 $ 10.8 $ 9.6 Long-term debt obligations (1) 341.3 314.6 16.4 10.3 — Obligations under the STAP (2) 10.5 10.5 — — — Obligations under the SERP (3) 63.2 30.8 — 12.2 20.2 Purchase obligations (4) 1,139.4 829.1 277.0 28.3 5.0 Total (5) (6) $ 1,593.0 $ 1,191.1 $ 305.5 $ 61.6 $ 34.8 (1) Long-term debt obligations include future principal and interest payments on our adjusted variable rate obligations under the 2022 Credit Agreement.
Contractual Obligations As of December 31, 2025, we had the following contractual obligations (in millions): Payments Due by Period Total Less than 1 year 2-3 Years 4-5 Years More than 5 Years Operating lease obligations $ 37.6 $ 7.3 $ 14.1 $ 10.7 $ 5.5 Long-term debt obligations (1) 32.4 7.5 15.0 9.9 — Obligations under the SERP (2) 63.4 26.0 13.0 — 24.4 Purchase obligations (3) 1,022.8 869.5 136.9 14.7 1.7 Total (4) (5) $ 1,156.2 $ 910.3 $ 179.0 $ 35.3 $ 31.6 (1) We have contractual obligations to pay unused commitment fees under the 2025 Credit Agreement.
We do not have any other off-balance sheet arrangements within the meaning of Item 303(a)(4) of Regulation S-K. 64 United Therapeutics, a public benefit corporation Summary of Critical Accounting Policies and Estimates We prepare our consolidated financial statements in conformity with generally accepted accounting principles in the United States ( GAAP ).
Summary of Critical Accounting Policies and Estimates We prepare our consolidated financial statements in conformity with generally accepted accounting principles in the United States ( GAAP ). GAAP requires that we make estimates and assumptions that affect the amounts and timing reported in our consolidated financial statements.
For example, Yutrepia has been tentatively approved by the FDA for the treatment of PAH and PH-ILD, with final approval potentially occurring after expiration of an exclusivity period ending in May 2025.
In addition, Yutrepia was approved by the FDA in May 2025 for treatment of PAH and PH-ILD, and the product was launched commercially in June 2025.
Tyvaso DPI net product sales increased in 2024, as compared to 2023, due to an increase in quantities sold of $269.2 million and, to a lesser extent, price increases, partially offset by higher gross-to-net revenue deductions.
Total Tyvaso net product sales grew 16 percent to $1,878.2 million in 2025, compared to $1,620.4 million in 2024, driven by growth in Tyvaso DPI net product sales. Tyvaso DPI net product sales increased in 2025, as compared to 2024, primarily due to an increase in quantities sold of $268.5 million.
Furthermore, our customer base remains stable, and we believe that it presents minimal credit risk. However, any projections of future cash flows are inherently subject to uncertainty and we may seek other forms of financing.
However, any projections of future cash flows are inherently subject to uncertainty, and we may seek other forms of financing. In April 2025, we entered into the 2025 Credit Agreement, which provides for an unsecured revolving credit facility of up to $2.5 billion.
In March 2022, we entered into a credit agreement (the 2022 Credit Agreement ), which provides for unsecured revolving credit facilities of up to $2.0 billion in the aggregate. Our aggregate outstanding balance under the 2022 Credit Agreement was $300.0 million and $700.0 million as of December 31, 2024 and 2023, respectively .
Our outstanding balance under the 2025 Credit Agreement, which matures in 2030, was zero as of December 31, 2025. See Unsecured Revolving Credit Facilities below for further details. For information regarding the fluctuation explanations between 2024 and 2023 , see our 2024 Annual Report.
Financing Activities The increase of $1,242.9 million in net cash used in financing activities for the year ended December 31, 2024, as compared to the same period in 2023, was primarily due to: (1) a $1.0 billion payment in 2024 to repurchase shares of our common stock; and (2) a $300.0 million increase in cash paid for repayments on our line of credit; partially offset by a $54.5 million increase in proceeds from the exercise of stock options.
Financing Activities The decrease of $104.8 million in net cash used in financing activities for the year ended December 31, 2025, as compared to the same period in 2024, was primarily due to a $100.0 million decrease in net repayments on our line of credit. 60 United Therapeutics, a public benefit corporation Unsecured Revolving Credit Facilities In March 2022, we entered into a credit agreement (the 2022 Credit Agreement ) with Wells Fargo, as administrative agent and a swingline lender, and various other lender parties, which provided for: (1) an unsecured revolving credit facility of up to $1.2 billion; and (2) a second unsecured revolving credit facility of up to $800.0 million.
Removed
Food and Drug Administration ( FDA ) and other regulatory and government enforcement agencies related to our products and potential competitive products; • The timing and outcome of ongoing litigation, including the lawsuit filed against us by Sandoz, Inc.
Added
In February 2021, we launched U.S. sales of the Remunity Pump, a next-generation subcutaneous infusion system for Remodulin developed under an exclusive development and license agreement with DEKA.
Removed
( Sandoz ) and Liquidia PAH, LLC (formerly known as RareGen, LLC) ( RareGen ); our patent and trade secret litigation with Liquidia Technologies, Inc.
Added
Research and Development Our research and development expenses primarily include costs associated with the research and development of new products, new indications for existing products, and various post-marketing research activities.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeMany of our investments may be called by their respective issuers prior to maturity. 2024 Annual Report 65 The following table summarizes the expected maturities and weighted average interest rates as of December 31, 2024 (dollars in millions): Expected Maturity 2025 2026 2027 Available-for-sale investments $ 1,567.4 $ 1,071.7 $ 403.6 Weighted average interest rate 3.3 % 4.1 % 4.1 % During sustained periods of instability and uncertainty in the financial markets, we may be subjected to additional investment-related risks that could materially affect the value and liquidity of our investments.
Biggest changeThe following table summarizes the expected maturities and weighted average interest rates as of December 31, 2025 (dollars in millions): Expected Maturity 2026 2027 2028 Available-for-sale investments $ 1,273.3 $ 1,101.7 $ 675.0 Weighted average interest rate 3.9 % 4.0 % 4.0 % During sustained periods of instability and uncertainty in the financial markets, we may be subjected to additional investment-related risks that could materially affect the value and liquidity of our investments.
In general, as interest rates increase, the market value of a debt investment would be expected to decrease. Conversely, as interest rates decrease, the market value of a debt investment would be expected to increase. During the year ended December 31, 2024, we did not experience significant volatility in the value of these investments.
In general, as interest rates increase, the market value of a debt investment would be expected to decrease. Conversely, as interest rates decrease, the market value of a debt investment would be expected to increase. During the year ended December 31, 2025, we did not experience significant volatility in the value of these investments.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk Investment Risk As of December 31, 2024, we have invested $3.0 billion in corporate debt securities and U.S. government and agency securities. The market value of these investments varies inversely with changes in prevailing market interest rates.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk Investment Risk As of December 31, 2025, we have invested $3.1 billion in corporate debt securities and U.S. government and agency securities. The market value of these investments varies inversely with changes in prevailing market interest rates.
While we believe that we take prudent measures to mitigate investment related risks, such risks cannot be fully eliminated, as circumstances can occur that are beyond our control.
While we believe that we take prudent measures to mitigate investment related risks, such risks cannot be fully eliminated, as circumstances can occur that are beyond our control. 2025 Annual Report 63
To address market risk, we invest in debt securities with terms no longer than three years and typically hold these investments to maturity so that they can be redeemed at their stated or face value.
To address market risk, we invest in debt securities with terms no longer than three years and typically hold these investments to maturity so that they can be redeemed at their stated or face value. Many of our investments may be called by their respective issuers prior to maturity.
Removed
Interest Rate Risk As of December 31, 2024 and 2023, we had $300.0 million and $700.0 million aggregate principal amounts, respectively, outstanding under our 2022 Credit Agreement which bears interest at a variable rate. As a result, we are subject to interest rate risk with respect to such floating-rate debt.
Removed
A 100-basis point increase in the variable interest rate component of our borrowings would increase our annual interest expense by approximately $1.3 million or three percent, and $7.0 million or 12 percent, for the years ended December 31, 2024 and 2023, respectively. See Note 7— Debt, to our consolidated financial statements. 66 United Therapeutics, a public benefit corporation

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