United Therapeutics Corporation (UTHR)

United Therapeutics Corporation Announces TETON-1 Study of Tyvaso Published in The New England Journal of Medicine and Presented at ATS 2026May 18, 2026 4:15 PM
Business Wire The pivotal TETON-1 phase 3 study of nebulized Tyvaso® (treprostinil) Inhalation Solution in idiopathic pulmonary fibrosis (IPF) preserved lung function as measured by absolute forced vital capacity (FVC) and demonstrated reduced risk of a clinical worsening event, meeting both its primary endpoint and a key secondary endpoint with statistical significance, respectively In combined analyses of TETON-1 and TETON-2 — also included in the NEJM publication and presented at ATS — nebulized Tyvaso achieved statistically significant treatment effects across the primary and most secondary efficacy endpoints Nebulized Tyvaso combines direct lung delivery with multi-modal activity across fibrotic, vascular, and inflammatory pathways that are not currently addressed by existing IPF therapies United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the New England Journal of Medicine has published the full results of its TETON-1 study, as well as combined analyses of its TETON-1 and TETON-2 studies, evaluating the use of nebulized Tyvaso for the treatment of IPF. The publication is available here. A summary of the publication was also presented today during a symposium at the annual meeting of the American Thoracic Society (ATS) International Conference in Orlando. The use of nebulized Tyvaso for IPF has not been approved by the U.S. Food and Drug Administration (FDA) and remains investigational for IPF. The results of TETON-1 were also presented at ATS during the Breaking News: 2026 Clinical Trial Results in Pulmonary Medicine session on Sunday, May 17. Combined results from TETON-1 and TETON-2 were presented today during an oral session at ATS. TETON-1 met its primary efficacy endpoint, with nebulized Tyvaso demonstrating statistically significant improvement in absolute FVC relative to placebo from baseline to week 52 in an IPF population broadly treated with background therapy. The median change in FVC at week 52 was -43.3 mL (95% confidence interval [CI], -92.1 to -9.1) in the nebulized Tyvaso group and -196.2 mL (95% CI, -227.1 to -155.6) in the placebo group; between-group difference was 130.1 mL (95% CI, 82.2 to 178.1; P

United Therapeutics Corporation Announces ADVANCE OUTCOMES Study of Ralinepag Presented at ATS 2026May 17, 2026 2:15 PM
Business Wire The long-term, pivotal, phase 3 ADVANCE OUTCOMES study met its primary endpoint, with ralinepag achieving a statistically significant 55% reduction in risk of clinical worsening in predominantly pre-treated patients with pulmonary arterial hypertension (PAH) Ralinepag achieved statistical significance for important secondary endpoints, reducing levels of N-terminal pro-B-type natriuretic peptide, a critical biomarker for heart failure, and improving exercise capacity Investigational ralinepag combines potent receptor binding affinity with continuous exposure to deliver long-term, durable efficacy, and disease-mitigating outcomes, and is expected to become the first and only once-daily oral prostacyclin receptor agonist upon FDA approval United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that full results of its ADVANCE OUTCOMES study are being presented today during the Breaking News: 2026 Clinical Trial Results in Pulmonary Medicine session at the annual meeting of the American Thoracic Society (ATS) International Conference in Orlando. Ralinepag has not been approved for use in any indication by the U.S. Food and Drug Administration (FDA) and remains investigational for PAH. Ralinepag reduced the risk of a clinical worsening event by 55% compared with placebo in patients with PAH (hazard ratio 0.45, 95% CI [0.33-0.62]; p

United Therapeutics Corporation Announces FDA Clearance to Proceed with UHeart Xenotransplantation Clinical TrialMay 15, 2026 6:00 PM
Business Wire First-ever human clinical trial of a xenoheart intended to support potential registration through the submission of a Biologics License Application to the U.S. FDA United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance under the company’s Investigational New Drug application to proceed with a clinical study of its investigational UHeart™ derived from a pig with 10 gene edits. The study, known as EXPRESS, will enroll an initial cohort of up to two participants. United Therapeutics will provide the FDA with safety and efficacy data from the first UHeart xenotransplant recipient in the study before enrolling a second participant. Following FDA review of available safety and efficacy data from the initial two transplants, the study may then be further expanded, with the intent to support a Biologics License Application (BLA) with the FDA. “Moving a porcine-derived heart into human clinical trials represents another defining advancement for the field of xenotransplantation,” said Kristina DeSmet, Ph.D., DABT, Senior Director, Product Development at United Therapeutics. “The heart is one of the most complex solid organs to transplant, and proceeding into the clinic reflects years of coordinated scientific progress. For United Therapeutics, this milestone represents our third clinical trial in xenotransplantation and underscores the breadth of our platform, spanning end-stage renal disease and now life-threatening heart disease. Together, these programs reinforce our commitment to expanding transplant options for patients who currently have no other alternatives.” Noah Byrd, Ph.D., RAC, Vice President, Global Regulatory Affairs at United Therapeutics, added: “Patients with end stage heart disease continue to face profound limitations in available treatment options. This FDA clearance to proceed with our EXPRESS clinical trial will allow us to begin evaluating an innovative therapeutic option designed to address this unmet need.” About EXPRESS Study Design The study will start at a single center enrolling up to two participants. If safety and efficacy data from these initial participants are supportive, United Therapeutics intends to expand the study to enroll participants at additional centers to support submission of a BLA. The study is designed as a phase 1/2/3 trial (sometimes referred to as a “phaseless” study) to evaluate safety and efficacy of the UHeart seamlessly without moving through separate phase 1, phase 2, and phase 3 studies that are typically associated with conventional drug approvals. Participants will receive a UHeart transplant followed by a 24-week post-transplant follow-up period, including the evaluation of all study endpoints and safety assessments. After the 24-week post-transplant follow-up period, participants who received a UHeart will continue to be followed for the rest of their lives, including for survival, UHeart survival, and screening for zoonotic infections. Safety and efficacy data will be reviewed frequently by an independent Data Monitoring Committee. After at least 12 weeks post-transplant of the first participant, United Therapeutics will provide data to FDA prior to initiating a second transplant. If safety and efficacy results from the first 2 participants are supportive, the study sample size will be increased to enable the study to support registration. Efficacy Endpoints Efficacy endpoints include participant survival rate, UHeart survival rate, UHeart function1, change in quality of life in participants2 at 24 weeks post-transplant, and participant exercise capacity3. Overall survival time of participants receiving a UHeart and overall survival time of the UHearts themselves are also efficacy endpoints. Safety Endpoints Safety endpoints include the incidence of adverse events and serious adverse events, all-cause mortality, and the incidence of arrythmias, thromboembolic and ischemic strokes, zoonotic infections, and opportunistic infections. Key Participation Criteria Key participation criteria include those ≥50 years of age, diagnosed with end-stage or advanced heart failure (HF) classified as American College of Cardiology/American Heart Association stage D and New York Heart Association Class IV, and no remaining therapeutic options. Participants will be screened using a crossmatch assay to assess expected immunological compatibility with the UHeart. Participants must not need multiple organ transplants; must not have had a prior solid organ transplant; must not have support with venoarterial ECMO; must not have severe medical co-morbidities, including but not limited to chronic liver disease, severe central vascular disease, severe neurologic diseases, and uncontrolled diabetes; and must not have a history of medical noncompliance that may preclude adherence to the demands and requirements of xenotransplantation. Full inclusion and exclusion criteria for this study will be provided in a future listing on the clinicaltrials.gov website. About Advanced Heart Failure According to the Journal of Cardiac Failure, in the United States nearly 6.7 million adults 20 years of age or older have HF, and in 2023, HF was responsible for 14.6% of all causes of death according to a CDC report4. In 2023, only a fraction of Americans with HF were considered candidates and waitlisted for a human heart transplant (0.12% or 8,000 Americans), and only approximately 4,000 heart transplants were performed5. About UHeart United Therapeutics’ xenoheart, known by the proposed trade name UHeart, is an investigational xenoheart from a pig with 10 gene edits. Six human genes are added to the pig genome to facilitate immunological acceptance and compatibility of the organ in the human recipient. Four porcine genes are inactivated or “knocked out” to reduce the risk of organ rejection and to moderate growth. About United Therapeutics Founded by CEO Martine Rothblatt to discover a cure for her daughter's life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build. Visit us at www.unither.com and follow us on LinkedIn, Facebook, and Instagram. Forward-Looking Statements Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others: our plans with respect to the conduct of the EXPRESS study of our UHeart product, including the potential to expand the study following review of data from the first two participants; our plan to submit a BLA seeking FDA approval of the UHeart; our commitment to expanding transplant options for patients through our xenotransplant programs; our belief that presentations of data from our clinical studies will provide important clinical insights that can meaningfully reshape how diseases are managed and improve outcomes; and our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language, and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of May 15, 2026, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason. UHEART is a trademark of United Therapeutics Corporation. ____________________ 1 UHeart function defined as left ventricular ejection fraction, global longitudinal strain, and right ventricular free-wall strain. 2 Quality of life will be measured using the following three surveys: the EuroQol 5-Dimension 5-Level, the Kansas City Cardiomyopathy Questionnaire-23, and the Patient Global Impression of Change. 3 Exercise capacity will be measured by change in 6-minute walk distance from baseline to 24 weeks post transplant. 4 About Heart Failure, Centers for Disease Control, https://www.cdc.gov/heart-disease/about/heart-failure.html. 5 Organ Procurement and Transplantation Network/Scientific Registry of Transplant Recipients 2025.   View source version on businesswire.com: https://www.businesswire.com/news/home/20260515765117/en/ For Further Information Contact:
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communications@unither.com Original: United Therapeutics Corporation Announces FDA Clearance to Proceed with UHeart Xenotransplantation Clinical Trial

United Therapeutics Corporation Presents New Data from TETON-1, ADVANCE OUTCOMES, and Additional Research in Pulmonary Hypertension and Pulmonary Fibrosis at ATS 2026May 11, 2026 6:30 AM
Business Wire Presentations of results from the positive TETON phase 3 pivotal studies of inhaled treprostinil in idiopathic pulmonary fibrosis (IPF) include efficacy and safety results from TETON-1 and integrated results from TETON-1 and TETON-2 Results from the successful ADVANCE OUTCOMES study of ralinepag in pulmonary arterial hypertension (PAH) will be presented Additional presentations include an interim analysis from the TETON-PPF study of inhaled treprostinil in progressive pulmonary fibrosis (PPF), preliminary results from the PHINDER study of patients with interstitial lung disease (ILD) with and without pulmonary hypertension (PH), and interim results from the ARTISAN study of parenteral treprostinil in PAH United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that 12 new data presentations across its commercial and development portfolio will be presented at the American Thoracic Society (ATS) International Conference, May 15-20, in Orlando. “We are thrilled to share additional positive data from the TETON-1 study in IPF and the ADVANCE OUTCOMES study in PAH, our pivotal studies that achieved unprecedented results in these two life-threatening diseases that have significant unmet needs. The data we are sharing from our research programs in pulmonary hypertension and ILD, including PHINDER, ARTISAN, and TETON-PPF, will also provide important clinical insights that may meaningfully impact how these devastating diseases are managed and help improve outcomes for the people living with them,” said Andrew Nelsen, PharmD, Vice President, Global Medical Affairs at United Therapeutics. Poster Presentations Include: ARTISAN Interim Analysis: Early Treatment with High-Dose Treprostinil Reduces Mean Pulmonary Artery Pressure and Improves Risk Status in Pulmonary Arterial Hypertension, Oral Session AQ19, Sunday, May 17, 9:27 - 9:39 am Patient Insights into Subcutaneous Pump Therapy in Pulmonary Arterial Hypertension, Poster Session A65, Sunday, May 17, 11:30 am - 1:15 pm Accuracy of Clinician Suspicion for Pulmonary Hypertension in Interstitial Lung Disease by Care Setting: Interim Comparison from the PHINDER Study, Poster Session B41, Monday, May 18, 11:30 am - 1:15 pm Real-world Dosing of Parenteral Treprostinil Post-Sotatercept Launch, Poster Session B67, Monday, May 18, 11:30 am - 1:15 pm Real-World Persistence to Oral Treprostinil in Patients with Pulmonary Arterial Hypertension: A Decade in Review, Poster Session B106, Monday, May 18, 2:15 pm - 4:15 pm TETON Phase 3 Clinical Trials of Inhaled Treprostinil for the Treatment of Idiopathic Pulmonary Fibrosis: Integrated Efficacy and Safety Results for TETON-1 and TETON-2, Mini-Symposium B95, Monday, May 18, 3:51 pm - 4:03 pm Clinical Outcomes with Parenteral Induction Therapy in Patients with Methamphetamine-Associated PAH: A Subgroup Analysis of the EXPEDITE Study, Poster Session C65, Tuesday, May 19, 11:30 am - 1:15 pm Patient Reported Outcomes in Interstitial Lung Disease with and without Pulmonary Hypertension: Interim Results from the PHINDER Study, Poster Session C104, Tuesday, May 19, 2:15 pm - 4:15 pm TETON-1 Phase 3 Clinical Trial of Inhaled Treprostinil for the Treatment of Idiopathic Pulmonary Fibrosis, Poster Session C103, Tuesday, May 19, 2:15 pm - 4:15 pm TETON-PPF Clinical Trial of Inhaled Treprostinil for the Treatment of Progressive Pulmonary Fibrosis, Poster Session C103, Tuesday, May 19, 2:15 pm - 4:15 pm ADVANCE OUTCOMES: A Phase 3, Double-Blind, Placebo-Controlled Clinical Trial of Ralinepag for the Treatment of Pulmonary Arterial Hypertension, Poster Session D28, Wednesday, May 20, 8:15 am - 10:15 am Real-World Comparison of Antifibrotic-Treated and Untreated Patients with Idiopathic Pulmonary Fibrosis in a Commercial and Medicare Advantage Population, Poster Session D22, Wednesday, May 20, 8:15 am - 10:15 am Sponsored events include: Patients and Experts Forum, Saturday, May 16, 10:00 AM - 2:00 PM, Hyatt Regency Orlando ATS Research Program Benefit, Saturday, May 16, 6:00 pm - 7:30 pm, Hyatt Regency Orlando Sponsored Symposium: Unmet Needs in IPF – Understanding Disease Burden and Current Approaches, Monday, May 18, 1:15 pm - 2:00 pm, Innovation Theater 5 Sponsored Symposium: Treating PAH – Are We Ready to Aim Higher? Tuesday, May 19, 12:00 pm - 12:30 pm, Innovation Theater 8 About United Therapeutics Founded by CEO Martine Rothblatt to discover a cure for her daughter's life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build. Visit us at www.unither.com and follow us on LinkedIn, Facebook, and Instagram. Forward-Looking Statements Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others: our belief that presentations of data from our clinical studies will provide important clinical insights that can meaningfully reshape how diseases are managed and improve outcomes; and our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language, and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of May 11, 2026, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason. View source version on businesswire.com: https://www.businesswire.com/news/home/20260511030304/en/ For Further Information Contact:
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communications@unither.com Original: United Therapeutics Corporation Presents New Data from TETON-1, ADVANCE OUTCOMES, and Additional Research in Pulmonary Hypertension and Pulmonary Fibrosis at ATS 2026

United Therapeutics Corporation Reports First Quarter 2026 Financial ResultsMay 6, 2026 6:30 AM
Business Wire United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the quarter ended March 31, 2026. Total revenues in the first quarter of 2026 decreased by two percent year-over-year to $781.5 million, compared to $794.4 million in the first quarter of 2025. “In the first quarter of 2026, we extended our run of clinical success, with positive results from both our ADVANCE OUTCOMES and TETON-1 studies,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “These readouts have the potential to meaningfully expand the breadth of our future growth and support further revenue diversification while reinforcing our long-term commitment to advancing therapies for patients with serious cardiopulmonary and respiratory disease. Moreover, given these successes, we’re excited to announce our development plans in pulmonary hypertension and fibrosis for ralinepag DPI, which we believe has the potential to achieve once-daily dosing and help broaden our therapeutic reach greater than ever before.” Michael Benkowitz, President and Chief Operating Officer of United Therapeutics, added, “While the competitive landscape for inhaled prostacyclins remains dynamic, our continued growth for Tyvaso DPI reflects the resilience of our commercial strategy. Going forward, we are committed to further sharpening our execution with relentless drive and unwavering discipline to return to sequential quarterly revenue growth across our commercial portfolio in the near term.” First Quarter 2026 Financial Results Key financial highlights include (dollars in millions, except per share data):   Three Months Ended
March 31,   Dollar
Change   Percentage
Change   2026   2025                     Total revenues $ 781.5   $ 794.4   $ (12.9 )   (2 )% Net income $ 274.9   $ 322.2   $ (47.3 )   (15 )% Net income, per basic share $ 6.32   $ 7.18   $ (0.86 )   (12 )% Net income, per diluted share $ 5.82   $ 6.63   $ (0.81 )   (12 )% Revenues The table below presents the components of total revenues (dollars in millions):   Three Months Ended
March 31,   Dollar
Change   Percentage
Change   2026   2025     Net product sales:               Tyvaso DPI® $ 330.3   $ 302.5   $ 27.8     9 % Nebulized Tyvaso®   127.2     163.8     (36.6 )   (22 )% Total Tyvaso   457.5     466.3     (8.8 )   (2 )% Remodulin®(1)   126.6     138.2     (11.6 )   (8 )% Orenitram®   135.6     120.7     14.9     12 % Unituxin®   53.6     58.2     (4.6 )   (8 )% Adcirca®   2.9     6.0     (3.1 )   (52 )% Other   5.3     5.0     0.3     6 % Total revenues $ 781.5   $ 794.4   $ (12.9 )   (2 )%   (1) Net product sales include sales of infusion devices, including the Remunity® and RemunityPRO® Pumps. Total Tyvaso revenues decreased by two percent to $457.5 million in the first quarter of 2026, compared to $466.3 million in the first quarter of 2025, driven by a decrease in Nebulized Tyvaso revenues, partially offset by growth in Tyvaso DPI revenues. The growth in Tyvaso DPI revenues resulted primarily from an increase in quantities sold of $16.0 million and, to a lesser extent, a price increase. The decrease in Nebulized Tyvaso revenues resulted primarily from a decrease in U.S. quantities sold of $33.3 million and, to a lesser extent, a decrease in international revenues, partially offset by a price increase. The decrease in Remodulin revenues resulted primarily from a decrease in quantities sold of $11.1 million. The growth in Orenitram revenues resulted primarily from an increase in quantities sold of $10.2 million. The table below presents the breakdown of total revenues between the United States and rest-of-world (ROW) (in millions):   Three Months Ended March 31,   2026   2025   U.S. ROW Total   U.S. ROW Total Net product sales:               Tyvaso DPI $ 330.3 $ — $ 330.3   $ 302.5 $ — $ 302.5 Nebulized Tyvaso   112.6   14.6   127.2     138.6   25.2   163.8 Total Tyvaso   442.9   14.6   457.5     441.1   25.2   466.3 Remodulin(1)   108.8   17.8   126.6     120.2   18.0   138.2 Orenitram   135.6   —   135.6     120.7   —   120.7 Unituxin   49.0   4.6   53.6     56.9   1.3   58.2 Adcirca   2.9   —   2.9     6.0   —   6.0 Other   5.0   0.3   5.3     4.7   0.3   5.0 Total revenues $ 744.2 $ 37.3 $ 781.5   $ 749.6 $ 44.8 $ 794.4   (1)   Net product sales include sales of infusion devices, including the Remunity and RemunityPRO Pumps. Expenses Cost of sales. The table below summarizes cost of sales by major category (dollars in millions):     Three Months Ended
March 31,   Dollar
Change   Percentage
Change     2026   2025     Category:                 Cost of sales   $ 132.4   $ 91.6   $ 40.8   45 % Share-based compensation expense(1)     1.0     0.9     0.1   11 % Total cost of sales   $ 133.4   $ 92.5   $ 40.9   44 %   (1)   See Share-based compensation expense below for discussion. Cost of sales, excluding share-based compensation. The increase in cost of sales for the three months ended March 31, 2026, compared to the same period in 2025, was mainly due to an increase in inventory reserve expense. Of this increase amount, $26.8 million relates to an estimated loss from a commercial supply agreement that we maintain to provide sufficient Tyvaso DPI inventory to meet the needs of our patients. Research and development expense. The table below summarizes the nature of research and development expense by major expense category (dollars in millions):     Three Months Ended
March 31,   Dollar
Change   Percentage
Change     2026   2025     Category:                 External research and development(1)   $ 57.8   $ 57.2   $ 0.6     1 % Internal research and development(2)     58.3     48.3     10.0     21 % Share-based compensation expense(3)     5.4     6.9     (1.5 )   (22 )% Other(4)     16.7     36.6     (19.9 )   (54 )% Total research and development expense   $ 138.2   $ 149.0   $ (10.8 )   (7 )%   (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. (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 expense below for discussion. (4)   Other primarily includes upfront fees and milestone payments to third parties under license agreements related to development-stage products and adjustments to the fair value of our contingent consideration obligations. Research and development, excluding share-based compensation. The decrease in research and development expense for the three months ended March 31, 2026, as compared to the same period in 2025, was primarily due to a decrease in milestone payments for drug delivery device technologies, partially offset by an increase in personnel expenses. Selling, general, and administrative expense. The table below summarizes selling, general, and administrative expense by major category (dollars in millions):     Three Months Ended
March 31,   Dollar
Change   Percentage
Change     2026   2025     Category:                 General and administrative   $ 127.9   $ 119.5   $ 8.4   7 % Sales and marketing     28.7     26.6     2.1   8 % Share-based compensation expense(1)     27.5     24.0     3.5   15 % Total selling, general, and administrative expense   $ 184.1   $ 170.1   $ 14.0   8 %   (1)   See Share-based compensation expense below for discussion. Share-based compensation expense. The table below summarizes share-based compensation expense by major category (dollars in millions):     Three Months Ended
March 31,   Dollar
Change   Percentage
Change     2026   2025     Category:                 Stock options   $ 11.5   $ 8.5     $ 3.0     35 % Restricted stock units     21.5     23.4       (1.9 )   (8 )% Share tracking awards plan     —     (0.8 )     0.8     100 % Employee stock purchase plan     0.9     0.7       0.2     29 % Total share-based compensation expense   $ 33.9   $ 31.8     $ 2.1     7 %   The increase in share-based compensation expense for the three months ended March 31, 2026, as compared to the same period in 2025, was primarily due to an increase in the number of unvested and outstanding performance-based stock options during the three months ended March 31, 2026, as compared to the same period in 2025. Other expense, net. The change in other expense, net for the three months ended March 31, 2026, as compared to the same period in 2025, was primarily due to net unrealized losses on equity securities. Income tax expense. Income tax expense for the three months ended March 31, 2026 and 2025 was $43.4 million and $101.3 million, respectively. Our effective income tax rate (ETR) for the three months ended March 31, 2026 and 2025 was 14 percent and 24 percent, respectively. Our ETR for the three months ended March 31, 2026 decreased compared to our ETR for the three months ended March 31, 2025, primarily due to increased excess tax benefits from share-based compensation. Share repurchase. In March 2026, our Board of Directors approved a share repurchase program authorizing up to $2.0 billion in aggregate repurchases of our common stock, which program expires on March 9, 2027. In March 2026, we also entered into accelerated share repurchase agreements (the 2026 ASR agreements) with Citibank, N.A. to repurchase approximately $1.5 billion of our common stock. During the three months ended March 31, 2026, we received 2,164,459 shares of our common stock under the 2026 ASR agreements. As of March 31, 2026, $500 million remained available under our Board's share repurchase authorization through March 9, 2027. Webcast We will host a webcast to discuss our first quarter 2026 financial results on Wednesday, May 6, 2026, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at https://ir.unither.com/events-and-presentations. An investor presentation is available now, and after the webcast a replay of the webcast will also be available, at the same location on our website. About United Therapeutics Founded by CEO Martine Rothblatt to discover a cure for her daughter's life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build. Forward-Looking Statements Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements related to the potential for the results of our ADVANCE OUTCOMES and TETON-1 clinical studies to meaningfully expand the breadth of our future growth and support further revenue diversification while reinforcing our long-term commitment to advancing therapies for patients with serious cardiopulmonary and respiratory disease; our development plans for ralinepag DPI; the potential for ralinepag DPI to achieve once-daily dosing and help broaden our therapeutic reach; our efforts to return to sequential quarterly revenue growth across our commercial portfolio; the potential that we may utilize the remaining $500 million under our $2.0 billion share repurchase authorization; and our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of May 6, 2026, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason. ORENITRAM, REMODULIN, REMUNITY, TYVASO, TYVASO DPI, and UNITUXIN are registered trademarks of United Therapeutics Corporation. REMUNITYPRO is a trademark of United Therapeutics Corporation. ADCIRCA is a registered trademark of Eli Lilly and Company. UNITED THERAPEUTICS CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (In millions, except per share data)       Three Months Ended
March 31,     2026   2025     (Unaudited) Total revenues   $ 781.5     $ 794.4   Operating expenses:         Cost of sales     133.4       92.5   Research and development     138.2       149.0   Selling, general, and administrative     184.1       170.1   Total operating expenses     455.7       411.6   Operating income     325.8       382.8   Interest income     41.8       51.1   Interest expense     (3.0 )     (6.1 ) Other expense, net     (46.3 )     (4.3 ) Total other (expense) income, net     (7.5 )     40.7   Income before income taxes     318.3       423.5   Income tax expense     (43.4 )     (101.3 ) Net income   $ 274.9     $ 322.2   Net income per common share:         Basic   $ 6.32     $ 7.18   Diluted   $ 5.82     $ 6.63   Weighted average number of common shares outstanding:         Basic     43.5       44.9   Diluted     47.2       48.6     SELECTED CONSOLIDATED BALANCE SHEET DATA (Unaudited, in millions)       March 31,
2026 Cash, cash equivalents, and marketable investments   $ 3,471.1 Total assets     6,714.2 Total liabilities     813.1 Total stockholders’ equity     5,901.1 Category: Earnings View source version on businesswire.com: https://www.businesswire.com/news/home/20260506844951/en/ For Further Information Contact: Investor Inquiries
https://ir.unither.com/contact-ir Media Inquiries
communications@unither.com Original: United Therapeutics Corporation Reports First Quarter 2026 Financial Results

United Therapeutics Corporation Presents New Data Spanning Pulmonary Hypertension Treatment, Lung Donor Expansion, and Xenotransplantation at ISHLT 2026April 20, 2026 6:30 AM
Business Wire
An interim analysis of the PHINDER study identifies non-invasive measures that may facilitate earlier detection and management of pulmonary hypertension (PH) in patients with interstitial lung disease (ILD)


An interim analysis from the ARTISAN study indicates that early, high-dose treatment with treprostinil reduced afterload, improved right ventricular function, and reversed cardiac remodeling in pulmonary arterial hypertension (PAH)


Additional presentations include comparing real-world outcomes for patients with ILD with and without PH after lung transplantation and data from United Therapeutics’ ex vivo lung perfusion (EVLP) and xenotransplantation programs


United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that 11 new data presentations across its commercial and development portfolio will be presented at the International Society for Heart and Lung Transplantation (ISHLT) 46th Annual Meeting and Scientific Sessions taking place April 22-25, 2026, in Toronto, Canada.


"The data from ARTISAN and PHINDER suggest that earlier detection and intervention are key to improving outcomes for patients with PH. Whether it is identifying PH sooner in patients with ILD or indicating that aggressive, early treatment with treprostinil can meaningfully reverse right heart remodeling in PAH, we believe these findings have the potential to reshape how these devastating diseases are managed,” said Andrew Nelsen, PharmD, Vice President, Global Medical Affairs at United Therapeutics. “Importantly, presentations highlighting innovations from our EVLP and xenotransplantation programs reflect the breadth of our scientific portfolio and our determination to address the shortage of transplantable organs.”


Posters and presentations include:


Machine-Learning–Based Prediction of Donor Lung Acceptance based on Ex-vivo Lung Perfusion (EVLP) Deflation Videos, Oral Session 9, Artificial Intelligence for Advancing Lung Transplantation, Wednesday, April 22, 5:07-5:15 pm


ARTISAN Interim Analysis: Early and High-Dose Treprostinil Reduces mPAP and Improves Right Heart Function in PAH, Poster Session 1-P, Pulmonary Vascular Disease, Wednesday, April 22, 6:00-7:00 pm


From Decline to Donor: Lungs Transplanted After List Exhaustion, Poster Session 2-I, CT Surgery, Thursday, April 23, 4:30-5:30 pm


Machine Learning Leads to Earlier, Real-Time Predictions of Lung Transplant Acceptance During rc-EVLP, Poster Session 2-E, CT Surgery, Thursday, April 23, 4:30-5:30 pm


Transesophageal Echocardiographic Sizing of Genetically Modified Porcine Hearts for Xenotransplantation, Poster Session 2-A, Cardiology, Thursday, April 23, 4:30-5:30 pm


Lung Allograft Recovery – A Complex Story: Perspective from Remote, Centralized Ex Vivo Lung Perfusion, Mini Oral Session 6, Temperature and Perfusion: The Tip of the Iceberg in Lung Preservation, Thursday, April 23, 4:54-4:58 pm


Use of Novel Serum Based Assays to Improve Complement Monitoring in Porcine to Human Cardiac Xenotransplantation, Oral Session 30, Innovations in Xenotransplantation and Cardiogenetics, Friday, April 24, 4:01-4:09 pm


Interstitial Lung Disease with and without Mean Pulmonary Artery Pressure >20 mmHg: Interim Results from the PHINDER Study, Poster Session 3-M, Pulmonology, Friday, April 24, 4:30-5:30 pm


Lung Transplantation in Patients with ILD with or without PH: Clinical Characteristics and Outcomes Pre- and Post-Transplant Using Linked Data, Poster Session 3-M Pulmonology, Friday, April 24, 4:30-5:30 pm


Comparison of Static Cold Storage and Controlled Hypothermic Storage in Ex Vivo Lung Perfusion Outcomes, Poster Session 3-L, Pulmonology, Friday, April 24, 4:30-5:30 pm


Prolonged Pig-to-baboon Lung Xenograft Survival with 11GE Pigs with HLA-E Expression and Macrophage Depletion, Oral Session 43, Surgical Management of Lung Transplantation, Saturday, April 25, 12:46-12:54 pm


Sponsored events include:



Reception honoring US and Canada-based investigators who are recipients of the United Therapeutics’ 2026 Jenesis Innovative Research Awards™ and Jenesis Trailblazer Awards™ for their innovative research and scientific contributions in PH, IPF, and lung transplantation. Wednesday, April 22, 7:00-9:00 pm. Registration details are available here.



Lung Bioengineering Through The Eras – From Innovation to Standardization: What 1000 Ex Vivo Lung Perfusions Have Taught Us. Industry Sponsored Symposium. Thursday, April 23, 11:45 AM. Room 718B.



About United Therapeutics


Founded by CEO Martine Rothblatt to discover a cure for her daughter's life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build. Visit us at www.unither.com and follow us on LinkedIn, Facebook, and Instagram.


Forward-Looking Statements


Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others: our expectation that an interim analysis of the PHINDER study identifies non-invasive measures that may facilitate earlier detection and management of PH in patients with ILD; the potential that earlier detection and intervention will improve outcomes for patients with PH; our belief that early treatment with treprostinil can meaningfully reverse right heart remodeling in PAH; our expectation that findings from the ARTISAN and PHINDER studies have the potential to reshape how PAH and PH-ILD are managed; and our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language, and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of April 20, 2026, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260420097319/en/
For Further Information Contact:

Investor Inquiries

https://ir.unither.com/contact-ir

Media Inquiries

communications@unither.com


Original: United Therapeutics Corporation Presents New Data Spanning Pulmonary Hypertension Treatment, Lung Donor Expansion, and Xenotransplantation at ISHLT 2026

United Therapeutics shares jump after positive results from Tyvaso trialMarch 30, 2026 8:37 AM
IH Market News
Shares of United Therapeutics Corporation (NASDAQ:UTHR) climbed about 12% on Monday after the company reported that its pivotal TETON-1 study of Tyvaso successfully achieved its primary endpoint in patients with idiopathic pulmonary fibrosis (IPF).The inhaled therapy demonstrated clear superiority over placebo in improving absolute forced vital capacity, showing a treatment difference of 130.1 mL. The drug also reduced the risk of clinical worsening in patients with IPF, with results surpassing those observed in the earlier TETON-2 trial.Tyvaso also reached statistical significance in lowering the likelihood of clinical deterioration and delivered numerical improvements across several secondary measures compared with placebo. These included time to first acute IPF exacerbation, percent predicted FVC, K-BILD quality-of-life scores, and DLCO measurements.Combined analysis of data from both the TETON-1 and TETON-2 trials showed a statistically significant benefit versus placebo for the primary endpoint, with an improvement of 111.8 mL in absolute FVC from baseline to week 52. Positive effects were observed across all patient subgroups, including individuals receiving background therapies such as nintedanib or pirfenidone.The nebulized formulation of Tyvaso was generally well tolerated, and its safety profile aligned with previous studies of the drug. Researchers reported no new safety concerns.United Therapeutics said it intends to request priority review from the U.S. Food and Drug Administration for a supplemental New Drug Application expected to be submitted by the end of the summer, seeking approval to include IPF among the labeled indications for nebulized Tyvaso. Both the FDA and the European Medicines Agency have already granted orphan drug designation to treprostinil for the treatment of IPF.Further findings from the TETON-1 study, along with results from the combined analysis of both trials, are scheduled to be presented at the American Thoracic Society Annual Meeting in Orlando in May 2026.United Therapeutics Corporation stock price

Original: United Therapeutics shares jump after positive results from Tyvaso trial

United Therapeutics Corporation Announces Full Results of TETON-2 Phase 3 Clinical Trial Published in The New England Journal of MedicineMarch 11, 2026 6:14 PM
Business Wire
The pivotal study of Tyvaso® (treprostinil) Inhalation Solution demonstrated a statistically significant preservation of lung function across all subgroups, as measured by absolute forced vital capacity (FVC), and fewer clinical worsening events, compared with placebo over 52 weeks in patients with idiopathic pulmonary fibrosis (IPF)


Study authors noted TETON-2 is the first study to show that an inhaled therapy slowed progression of fibrosis as assessed by FVC change in patients with IPF


The trial population reflected the characteristics of a general population of IPF patients, with 75% on background antifibrotic therapy, demonstrating nebulized Tyvaso’s differentiated anti-fibrotic properties


If approved, nebulized Tyvaso will be the first and only inhaled anti-fibrotic treatment for IPF


United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the New England Journal of Medicine has published full results of its phase 3 TETON-2 study evaluating the use of nebulized Tyvaso for the treatment of IPF. The publication is available online at NEJM.org.


The study met its primary efficacy endpoint, with nebulized Tyvaso demonstrating statistically significant improvement in absolute FVC relative to placebo from baseline to week 52 in an IPF population broadly treated with background therapy. The median change in FVC at week 52 was -49.9 mL (95% confidence interval [CI], -79.2 to -19.5) in the nebulized Tyvaso group and -136.4 mL (95% CI, -172.5 to -104.0) in the placebo group, and the between group difference was 95.6 mL (95% CI, 52.2 to 139.0; P

United Therapeutics Corporation Announces Ralinepag Achieved 55% Reduction in Risk of Clinical Worsening in Pivotal Pulmonary Arterial Hypertension Study, Delivering Exceptional, Highly Statistically Significant EfficacyMarch 2, 2026 6:30 AM
Business Wire
The phase 3 ADVANCE OUTCOMES study of ralinepag met its primary endpoint and several important secondary endpoints, including increasing odds of clinical improvement by 47%, in predominantly pre-treated patients with pulmonary arterial hypertension (PAH)


Ralinepag has the potential to redefine the PAH treatment landscape as the first and only once-daily oral prostacyclin, combining potent receptor affinity with continuous exposure to deliver long-term, durable efficacy and disease-mitigating outcomes


United Therapeutics intends to submit a New Drug Application (NDA) for ralinepag to the U.S. Food and Drug Administration (FDA) by the second half of 2026


United Therapeutics will host a webcast at 8:30 a.m. Eastern Time today to further discuss the study results


United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that its long-term pivotal phase 3 ADVANCE OUTCOMES study met its primary endpoint, with ralinepag reducing the risk of a clinical worsening event by 55% compared with placebo in patients with PAH (hazard ratio 0.45, 95% CI [0.33-0.62]; p

United Therapeutics shares drop nearly 5% after revenue miss despite earnings beatFebruary 25, 2026 8:44 AM
IH Market News
United Therapeutics Corporation (NASDAQ:UTHR) reported fourth-quarter results on Wednesday that exceeded profit expectations but fell short on revenue, sending shares down 4.88% in premarket trading.The biotechnology company posted adjusted earnings per share of $7.70 for the quarter, beating the analyst consensus estimate of $7.10 by $0.60.Revenue totaled $790.2 million, below expectations of $815.24 million, although it represented a 7% increase from $735.9 million recorded in the same quarter a year earlier. For full-year 2025, revenue reached a record $3.18 billion, marking an 11% increase compared with 2024.Total Tyvaso revenue rose 12% year on year to $464.3 million in the fourth quarter, supported by strong performance from Tyvaso DPI, which grew 24% to $338.6 million.The increase was primarily driven by higher volumes as patient adoption continued to expand following the product’s launch, along with greater commercial usage linked to Medicare Part D benefit redesign under the Inflation Reduction Act. Revenue from Orenitram increased 12% to $121.2 million.“As we close out another remarkable year with record total revenue for the fourth year in a row, I extend my thanks to our Unitherians whose unwavering commitment to innovation and excellence fuels our mission,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer.Net income for the quarter reached $364.3 million, or $7.70 per diluted share, compared with $301.3 million, or $6.19 per diluted share, in the fourth quarter of 2024. For the full year, net income totaled $1.33 billion, up from $1.20 billion in 2024.Management added that the company’s ADVANCE OUTCOMES and TETON-1 clinical programmes are expected to deliver pivotal data that could open new treatment pathways for patients.United Therapeutics Corporation stock price

Original: United Therapeutics shares drop nearly 5% after revenue miss despite earnings beat

United Therapeutics Corporation Reports Fourth Quarter and Full Year 2025 Financial ResultsFebruary 25, 2026 6:30 AM
Business Wire
United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the quarter and year ended December 31, 2025. Full year 2025 revenues rose to a record $3.18 billion, reflecting 11% growth over 2024.


“As we close out another remarkable year with record total revenue for the fourth year in a row, I extend my thanks to our Unitherians whose unwavering commitment to innovation and excellence fuels our mission,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “Looking ahead, our ADVANCE OUTCOMES and TETON-1 clinical programs are on the cusp of unveiling pivotal data that could unlock significant new treatment options for patients, launching a period of transformational growth for UT.”


Michael Benkowitz, President and Chief Operating Officer of United Therapeutics, added, “This was an exceptional year for our commercial organization, highlighted by strong double-digit revenue growth and disciplined execution by our teams. Tyvaso continued its impressive trajectory in a growing market where we are steadily increasing our share of voice. Looking ahead, we believe our commercial strength, differentiated therapies, and expanding market opportunities position us well to continue delivering durable double-digit revenue growth.”


Fourth Quarter and Full Year 2025 Financial Results


Key financial highlights include (in millions, except per share data):




 






Three Months Ended

December 31,






 






Year Ended

December 31,








 






 






2025






 






 






2024






 






 






2025






 






 






2024








 






 






 






 






 






 






 






 








Total revenues






$






790.2






 






$






735.9






 






$






3,182.7






 






$






2,877.4








Net income






$






364.3






 






$






301.3






 






$






1,334.7






 






$






1,195.1








Net income, per basic share






$






8.41






 






$






6.74






 






$






30.13






 






$






26.44








Net income, per diluted share






$






7.70






 






$






6.19






 






$






27.86






 






$






24.64







Revenues


The table below presents the components of total revenues (dollars in millions):




 






Three Months Ended

December 31,






 






Dollar

Change






 






Percentage

Change






 






Year Ended

December 31,






 






Dollar

Change






 






Percentage

Change








 






2025






 






2024






 






 






 






2025






 






2024






 






 








Net product sales:






 






 






 






 






 






 






 






 






 






 






 






 






 






 






 








Tyvaso DPI®






$






338.6






 






$






273.2






 






$






65.4






 






 






24






%






 






$






1,292.5






 






$






1,033.6






 






$






258.9






 






 






25






%








Nebulized Tyvaso®






 






125.7






 






 






142.7






 






 






(17.0






)






 






(12






)%






 






 






585.7






 






 






586.8






 






 






(1.1






)






 






—






%








Total Tyvaso






 






464.3






 






 






415.9






 






 






48.4






 






 






12






%






 






 






1,878.2






 






 






1,620.4






 






 






257.8






 






 






16






%








Remodulin®(1)






 






128.0






 






 






134.5






 






 






(6.5






)






 






(5






)%






 






 






526.8






 






 






538.1






 






 






(11.3






)






 






(2






)%








Orenitram®






 






121.2






 






 






107.8






 






 






13.4






 






 






12






%






 






 






496.9






 






 






434.3






 






 






62.6






 






 






14






%








Unituxin®






 






62.3






 






 






67.5






 






 






(5.2






)






 






(8






)%






 






 






226.8






 






 






238.7






 






 






(11.9






)






 






(5






)%








Adcirca®






 






7.8






 






 






4.7






 






 






3.1






 






 






66






%






 






 






30.0






 






 






23.8






 






 






6.2






 






 






26






%








Other






 






6.6






 






 






5.5






 






 






1.1






 






 






20






%






 






 






24.0






 






 






22.1






 






 






1.9






 






 






9






%








Total revenues






$






790.2






 






$






735.9






 






$






54.3






 






 






7






%






 






$






3,182.7






 






$






2,877.4






 






$






305.3






 






 






11






%
































 




(1)






Net product sales include sales of infusion devices, including the Remunity® and RemunityPRO™ Pumps.







Fourth Quarter 2025 Compared to Fourth Quarter 2024. Total Tyvaso revenues grew by 12 percent to $464.3 million in the fourth quarter of 2025, compared to $415.9 million in the fourth quarter of 2024. The growth in Tyvaso DPI revenues resulted primarily from an increase in quantities sold of $63.5 million, primarily due to continued growth in the number of patients following the product’s launch and, to a lesser extent, increased commercial utilization following implementation of the Medicare Part D benefit redesign under the Inflation Reduction Act (IRA). The decrease in Nebulized Tyvaso revenues resulted primarily from a decrease in quantities sold. The growth in Orenitram revenues resulted primarily from an increase in quantities sold of $10.3 million, driven, at least in part, by increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the IRA.


Full Year 2025 Compared to Full Year 2024. Total Tyvaso revenues grew by 16 percent to $1,878.2 million in 2025, compared to $1,620.4 million in 2024, driven by growth in Tyvaso DPI revenues. The growth in Tyvaso DPI revenues resulted from an increase in quantities sold of $268.5 million, primarily due to continued growth in the number of patients following the product’s launch and, to a lesser extent, increased commercial utilization following implementation of the Medicare Part D benefit redesign under the IRA. The growth in Orenitram revenues resulted primarily from an increase in quantities sold of $46.0 million, 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):




 






Three Months Ended December 31,






 






Year Ended December 31,








 






2025






 






2024






 






2025






 






2024








 






U.S.





 

ROW





 

Total






 






U.S.





 

ROW





 

Total






 






U.S.





 

ROW





 

Total






 






U.S.





 

ROW





 

Total








Net product sales:






 





 

 





 

 






 






 





 

 





 

 






 






 





 

 





 

 






 






 





 

 





 

 








Tyvaso DPI






$






338.3





 

$






0.3





 

$






338.6






 






$






272.8





 

$






0.4





 

$






273.2






 






$






1,291.8





 

$






0.7





 

$






1,292.5






 






$






1,033.2





 

$






0.4





 

$






1,033.6








Nebulized Tyvaso






 






118.9





 

 






6.8





 

 






125.7






 






 






136.4





 

 






6.3





 

 






142.7






 






 






531.9





 

 






53.8





 

 






585.7






 






 






545.5





 

 






41.3





 

 






586.8








Total Tyvaso






 






457.2





 

 






7.1





 

 






464.3






 






 






409.2





 

 






6.7





 

 






415.9






 






 






1,823.7





 

 






54.5





 

 






1,878.2






 






 






1,578.7





 

 






41.7





 

 






1,620.4








Remodulin(1)






 






104.3





 

 






23.7





 

 






128.0






 






 






118.0





 

 






16.5





 

 






134.5






 






 






448.9





 

 






77.9





 

 






526.8






 






 






464.2





 

 






73.9





 

 






538.1








Orenitram






 






121.2





 

 






—





 

 






121.2






 






 






107.8





 

 






—





 

 






107.8






 






 






496.9





 

 






—





 

 






496.9






 






 






434.3





 

 






—





 

 






434.3








Unituxin






 






55.9





 

 






6.4





 

 






62.3






 






 






61.8





 

 






5.7





 

 






67.5






 






 






214.7





 

 






12.1





 

 






226.8






 






 






219.6





 

 






19.1





 

 






238.7








Adcirca






 






7.8





 

 






—





 

 






7.8






 






 






4.7





 

 






—





 

 






4.7






 






 






30.0





 

 






—





 

 






30.0






 






 






23.8





 

 






—





 

 






23.8








Other






 






6.4





 

 






0.2





 

 






6.6






 






 






4.2





 

 






1.3





 

 






5.5






 






 






22.8





 

 






1.2





 

 






24.0






 






 






19.1





 

 






3.0





 

 






22.1








Total revenues






$






752.8





 

$






37.4





 

$






790.2






 






$






705.7





 

$






30.2





 

$






735.9






 






$






3,037.0





 

$






145.7





 

$






3,182.7






 






$






2,739.7





 

$






137.7





 

$






2,877.4










 


 





 


 





 


 





 


 

 




(1)






Net product sales include sales of infusion devices, including the Remunity and RemunityPRO Pumps.







Expenses


Cost of sales. The table below summarizes cost of sales by major category (dollars in millions):




 






Three Months Ended

December 31,






 






Dollar

Change






 






Percentage

Change






 






Year Ended

December 31,






 






Dollar

Change






 






Percentage

Change








 






 






2025






 






 






2024






 






 






 






 






2025






 






 






2024






 






 








Category:






 






 






 






 






 






 






 






 






 






 






 






 






 






 






 








Cost of sales






$






102.3






 






$






74.8






 






$






27.5






 






37






%






 






$






380.5






 






$






304.3






 






$






76.2






 






 






25






%








Share-based compensation expense(1)






 






1.1






 






 






1.1






 






 






—






 






—






%






 






 






3.9






 






 






5.4






 






 






(1.5






)






 






(28






)%








Total cost of sales






$






103.4






 






$






75.9






 






$






27.5






 






36






%






 






$






384.4






 






$






309.7






 






$






74.7






 






 






24






%































 




(1)






See Share-based compensation section below for discussion.







Cost of sales, excluding share-based compensation. The increase in cost of sales for the quarter and year ended December 31, 2025, as compared to the same periods 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.


Research and development expense. The table below summarizes the nature of research and development expense by major expense category (dollars in millions):




 






Three Months Ended

December 31,






 






Dollar Change






 






Percentage Change






 






Year Ended

December 31,






 






Dollar Change






 






Percentage Change








 






 






2025






 






 






2024






 






 






 






 






2025






 






 






2024






 






 








Category:






 






 






 






 






 






 






 






 






 






 






 






 






 






 






 








External research and development(1)






$






62.7






 






$






63.7






 






$






(1.0






)






 






(2






)%






 






$






245.8






 






$






217.5






 






$






28.3






 






13






%








Internal research and development(2)






 






57.3






 






 






50.3






 






 






7.0






 






 






14






%






 






 






212.3






 






 






183.6






 






 






28.7






 






16






%








Share-based compensation expense(3)






 






8.9






 






 






6.7






 






 






2.2






 






 






33






%






 






 






32.3






 






 






29.1






 






 






3.2






 






11






%








Other(4)






 






10.6






 






 






13.1






 






 






(2.5






)






 






(19






)%






 






 






59.6






 






 






50.8






 






 






8.8






 






17






%








Total research and development expense






$






139.5






 






$






133.8






 






$






5.7






 






 






4






%






 






$






550.0






 






$






481.0






 






$






69.0






 






14






%































 




(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.








(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.








(4)






Other primarily includes upfront fees and milestone payments to third parties under license agreements related to development-stage products, adjustments to the fair value of our contingent consideration obligations, and costs to acquire certain in-process research and development assets. 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. 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.







Research and development, excluding share-based compensation. 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.


Selling, general, and administrative expense. The table below summarizes selling, general, and administrative expense by major category (dollars in millions):




 






Three Months Ended

December 31,






 






Dollar

Change






 






Percentage

Change






 






Year Ended

December 31,






 






Dollar

Change






 






Percentage

Change








 






 






2025






 






 






2024






 






 






 






 






2025






 






 






2024






 






 








Category:






 






 






 






 






 






 






 






 






 






 






 






 






 






 






 








General and administrative(1)






$






128.1






 






$






116.3






 






$






11.8






 






 






10






%






 






$






501.0






 






$






432.8






 






$






68.2






 






 






16






%








Impairment of property, plant, and equipment (PP&E)






 






—






 






 






—






 






 






—






 






 






—






%






 






 






21.7






 






 






—






 






 






21.7






 






 






NM(3)








Litigation accrual






 






0.8






 






 






6.0






 






 






(5.2






)






 






(87






)%






 






 






3.0






 






 






71.1






 






 






(68.1






)






 






(96






)%








Sales and marketing






 






32.7






 






 






27.0






 






 






5.7






 






 






21






%






 






 






118.6






 






 






96.3






 






 






22.3






 






 






23






%








Share-based compensation expense(2)






 






29.0






 






 






19.2






 






 






9.8






 






 






51






%






 






 






111.5






 






 






109.5






 






 






2.0






 






 






2






%








Total selling, general, and administrative expense






$






190.6






 






$






168.5






 






$






22.1






 






 






13






%






 






$






755.8






 






$






709.7






 






$






46.1






 






 






6






%
































 




(1)






Excluding impairment of PP&E and litigation accrual. 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 quarter 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) consulting expenses. 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. During the second quarter of 2025, we recorded a $21.7 million impairment charge to write down the carrying value of certain PP&E.


Litigation accrual. During the years ended December 31, 2025 and 2024, we recorded accruals of $3.0 million and $71.1 million, respectively, related to ongoing litigation with Sandoz Inc. We currently do not expect that the amount of any loss in excess of this accrual would be material to our financial results; however, the amount ultimately payable, if any, could be higher or lower than this amount depending on the amount of post judgment interest and the outcome of appeals, as discussed in Note 14—Litigation, to our consolidated financial statements included within our Annual Report on Form 10-K for the year ended December 31, 2025. The litigation accrual is included within selling, general, and administrative in our consolidated statements of operations.


Sales and marketing, excluding share-based compensation. 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.


Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions):




 






Three Months Ended

December 31,






 






Dollar

Change






 






Percentage

Change






 






Year Ended

December 31,






 






Dollar

Change






 






Percentage

Change








 






 






2025






 






 






2024






 






 






 






 






2025






 






 






 






2024






 






 








Category:






 






 






 






 






 






 






 






 






 






 






 






 






 






 






 








Stock options






$






11.4






 






 






8.0






 






$






3.4






 






 






43






%






 






$






42.3






 






 






$






29.8






 






$






12.5






 






 






42






%








Restricted stock units






 






26.6






 






 






17.8






 






 






8.8






 






 






49






%






 






 






103.1






 






 






 






79.7






 






 






23.4






 






 






29






%








Share tracking awards plan (STAP)






 






—






 






 






0.6






 






 






(0.6






)






 






(100






)%






 






 






(0.8






)






 






 






32.3






 






 






(33.1






)






 






(102






)%








Employee stock purchase plan






 






1.0






 






 






0.6






 






 






0.4






 






 






67






%






 






 






3.1






 






 






 






2.2






 






 






0.9






 






 






41






%








Total share-based

compensation

expense






$






39.0






 






$






27.0






 






$






12.0






 






 






44






%






 






$






147.7






 






 






$






144.0






 






$






3.7






 






 






3






%

































 


The increase in share-based compensation expense for the quarter and year ended December 31, 2025, as compared to the same periods 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 quarter and year ended December 31, 2025, as compared to the same periods 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 quarter and year ended December 31, 2025, as compared to the same periods in 2024, partially offset by a decrease in STAP expense, as all remaining STAP awards were exercised during the first quarter of 2025.


Other income (expense), net. The changes in other income (expense), net for the quarter and year ended December 31, 2025, as compared to the same periods in 2024, were primarily due to net unrealized gains on equity securities.


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. Our effective income tax rate was approximately 22 percent for the years ended December 31, 2025 and 2024.


Share repurchases. We entered into accelerated share repurchase agreements (ASR agreements) with Citibank, N.A. to repurchase approximately $1.0 billion of our common stock in each August 2025 and March 2024 ($2.0 billion in the aggregate). During the quarter and year ended December 31, 2025, we received 3,882 shares and 2,642,498 shares of our common stock, respectively, under these ASR agreements. During the quarter and year ended December 31, 2024, we received zero and 3,547,374 shares of our common stock, respectively, under these ASR agreements.


Webcast


We will host a webcast to discuss our fourth quarter and full year 2025 financial results on Wednesday, February 25, 2026, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at https://ir.unither.com/events-and-presentations. A replay of the webcast will also be available at the same location on our website.


About United Therapeutics


Founded by CEO Martine Rothblatt to discover a cure for her daughter's life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build.


Forward-Looking Statements


Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements related to our anticipated readouts of our ADVANCE OUTCOMES and TETON-1 clinical trials and their impacts, including the possibility that they may result in significant new treatment options for patients or a period of transformational growth for our company; our expectation that we will continue delivering double-digit revenue growth; and our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of February 25, 2026, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason.


ORENITRAM, REMODULIN, REMUNITY, TYVASO, TYVASO DPI, and UNITUXIN are registered trademarks of United Therapeutics Corporation and/or its subsidiaries.


REMUNITYPRO is a trademark of United Therapeutics Corporation and/or its subsidiaries.


ADCIRCA is a registered trademark of Eli Lilly and Company.




UNITED THERAPEUTICS CORPORATION




CONSOLIDATED STATEMENTS OF OPERATIONS




(In millions, except per share data)










 



 






Three Months Ended

December 31,






 






Year Ended

December 31,








 






 






2025






 






 






 






2024






 






 






 






2025






 






 






 






2024






 








 






(Unaudited)






 






 






 






 








Total revenues






$






790.2






 






 






$






735.9






 






 






$






3,182.7






 






 






$






2,877.4






 








Operating expenses:






 






 






 






 






 






 






 








Cost of sales






 






103.4






 






 






 






75.9






 






 






 






384.4






 






 






 






309.7






 








Research and development






 






139.5






 






 






 






133.8






 






 






 






550.0






 






 






 






481.0






 








Selling, general, and administrative






 






190.6






 






 






 






168.5






 






 






 






755.8






 






 






 






709.7






 








Total operating expenses






 






433.5






 






 






 






378.2






 






 






 






1,690.2






 






 






 






1,500.4






 








Operating income






 






356.7






 






 






 






357.7






 






 






 






1,492.5






 






 






 






1,377.0






 








Interest income






 






43.2






 






 






 






49.3






 






 






 






192.0






 






 






 






199.1






 








Interest expense






 






(3.1






)






 






 






(7.9






)






 






 






(19.5






)






 






 






(42.9






)








Other income (expense), net






 






47.2






 






 






 






(2.6






)






 






 






48.9






 






 






 






5.8






 








Total other income, net






 






87.3






 






 






 






38.8






 






 






 






221.4






 






 






 






162.0






 








Income before income taxes






 






444.0






 






 






 






396.5






 






 






 






1,713.9






 






 






 






1,539.0






 








Income tax expense






 






(79.7






)






 






 






(95.2






)






 






 






(379.2






)






 






 






(343.9






)








Net income






$






364.3






 






 






$






301.3






 






 






$






1,334.7






 






 






$






1,195.1






 








Net income per common share:






 






 






 






 






 






 






 








Basic






$






8.41






 






 






$






6.74






 






 






$






30.13






 






 






$






26.44






 








Diluted






$






7.70






 






 






$






6.19






 






 






$






27.86






 






 






$






24.64






 








Weighted average number of common shares outstanding:






 






 






 






 






 






 






 








Basic






 






43.3






 






 






 






44.7






 






 






 






44.3






 






 






 






45.2






 








Diluted






 






47.3






 






 






 






48.7






 






 






 






47.9






 






 






 






48.5






 






















 




SELECTED CONSOLIDATED BALANCE SHEET DATA




(In millions)








 






December 31,








 






 






2025






 






 






2024








Cash, cash equivalents, and marketable investments






$






4,697.0






 






$






4,742.3








Total assets






 






7,880.0






 






 






7,364.0








Total liabilities






 






783.8






 






 






920.0








Total stockholders' equity






 






7,096.2






 






 






6,444.0







Category: Earnings

View source version on businesswire.com: https://www.businesswire.com/news/home/20260225523041/en/
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Original: United Therapeutics Corporation Reports Fourth Quarter and Full Year 2025 Financial Results