United Therapeutics Corporation
05/06/2026 | Press release | Distributed by Public on 05/06/2026 04:31
Quarterly Report for Quarter Ending March 31, 2026 (Form 10-Q)
Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2025 (the 2025 Annual Report), and our consolidated financial statements and accompanying notes included in Part I, Item 1 of this Quarterly Report on Form 10-Q (this Report). All statements in this filing are made as of the date this Quarterly Report on Form 10-Q is filed with the U.S. Securities and Exchange Commission (SEC). We undertake no obligation to publicly update or revise these statements, whether as a result of new information, future events, or otherwise.
The following Management's Discussion and Analysis of Financial Condition and Results of Operations and other sections of this report contain forward-looking statements made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934 (the Exchange Act) and the Private Securities Litigation Reform Act of 1995. These statements, which are based on our beliefs and expectations about future outcomes and on information available to us through the date this Report 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 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 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 and the Trump administration's most favored nation (MFN) pricing initiatives, as well as the timing and outcome of our efforts to secure Medicare coverage for Nebulized Tyvaso to treat idiopathic pulmonary fibrosis (IPF), following the anticipated approval by the U.S. Food and Drug Administration (FDA);
•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 approvals, including our efforts to obtain FDA approval for Nebulized Tyvaso to treat IPF and ralinepag extended-release tablets to treat PAH;
•The outcome of pending and potential future legal and regulatory actions by the 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. (Sandoz) and Liquidia PAH, LLC (formerly known as RareGen, LLC) (RareGen); our patent and trade secret litigation with Liquidia Technologies, Inc. (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;
•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.
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 II, 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.
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Part I. Financial Information
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.
•Nebulized Tyvaso, a nebulized liquid inhaled formulation of treprostinil, approved by the FDA to improve exercise ability in patients with PAH. Nebulized Tyvaso was also approved by the FDA in March 2021 to improve exercise ability in patients with PH-ILD. 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. In February 2021, we launched U.S. sales of the Remunity Pump, a next-generation subcutaneous infusion system for Remodulin. In September 2025, we launched a new 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. We sell Adcirca under an in-license from Eli Lilly and Company (Lilly) that expires December 31, 2026.
Revenues
Our total revenues consist primarily of sales of the commercial products noted above, including the delivery devices (in the case of Tyvaso DPI, Nebulized Tyvaso, and Remodulin). We have entered into separate, non-exclusive distribution agreements with Accredo Health Group, Inc. and its affiliates (Accredo) and Caremark, L.L.C. (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 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. We also derive revenues from the sale of commercial ex vivo lung perfusion services, which are presented under Other within Note 11-Segment Information to our consolidated financial statements included in this Report.
We require our specialty pharmaceutical distributors to maintain reasonable levels of inventory reserves for our treprostinil-based therapies because the interruption of these therapies can be life threatening. Our specialty pharmaceutical distributors typically place monthly or semi-monthly orders based on current utilization trends and contractual minimum and maximum inventory requirements. As a result, sales of our treprostinil-based therapies can vary depending on the timing and magnitude of these orders and do not precisely reflect changes in patient demand. 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.
Generic Competition and Challenges to our Intellectual Property Rights
Remodulin-Generic Competition
We settled litigation with Sandoz related to its abbreviated new drug application (ANDA) seeking FDA approval to market a generic version of Remodulin and in March 2019, Sandoz announced the availability of its generic product 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 March 31, 2026, we have seen limited erosion of Remodulin sales as a result of generic treprostinil competition in the United States. We are currently engaged in litigation with Sandoz and its marketing partner, RareGen (now a subsidiary of Liquidia Corporation, the parent company of Liquidia), related to the infusion devices used to administer Remodulin subcutaneously. We understand that generic treprostinil was initially launched by Sandoz/RareGen for use only by intravenous infusion. In May 2021, Sandoz/Liquidia Corporation announced that Sandoz's generic treprostinil was made available for subcutaneous use, following FDA clearance of a cartridge that can administer the product via the Smiths Medical CADD MS-3 pump. In addition, Liquidia has announced it is developing a new subcutaneous infusion system for its generic treprostinil product. See Note 12-Litigation, to our consolidated financial statements included in this Report.
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Part I. Financial Information
Regulatory authorities in various European countries began approving generic versions of Remodulin in 2018, followed by pricing approvals and commercial launches in most of these countries in 2019 and 2020. As a result, our international Remodulin revenues have decreased compared to the period prior to generic launch, due to increased competition and a reduction in our contractual transfer price for Remodulin sold by certain international distributors for sales in countries in which the pricing of Remodulin is impacted by the generic competition.
Nebulized Tyvaso and Orenitram-Potential Future Generic Competition
We settled litigation with Watson Laboratories, Inc. (Watson) related to its ANDA seeking FDA approval to market a generic version of Nebulized Tyvaso before the expiration of certain of our U.S. patents. Under the settlement, Watson was permitted to market its generic version of Nebulized Tyvaso in the United States as early as January 2026, although, to date, it has not received FDA approval to do so.
We also settled litigation with Actavis Laboratories FL, Inc. (Actavis) and ANI Pharmaceuticals, Inc. (ANI) related to their ANDAs seeking FDA approval to market generic versions of Orenitram before the expiration of certain of our U.S. patents. Under the settlement agreements, Actavis and ANI can market their generic versions of Orenitram in the United States beginning in June 2027 and December 2027, respectively, although either or both of them may be permitted to enter the market earlier under certain circumstances. Competition from these generic companies could reduce our net product sales and profits.
Liquidia-Yutrepia
In May 2025, Liquidia obtained final FDA approval to market Yutrepia, a dry powder formulation of treprostinil for inhalation, to treat PAH and PH-ILD. Liquidia announced that it launched sales of Yutrepia in June 2025. The Yutrepia new drug application (NDA) was submitted under the 505(b)(2) regulatory pathway with Nebulized Tyvaso as the reference listed drug. Yutrepia competes directly with Tyvaso DPI, Nebulized Tyvaso, and our other treprostinil-based products.
We are engaged in patent litigation with Liquidia concerning Yutrepia. Specifically, we allege that Yutrepia infringes a patent we own covering the treatment of PH-ILD to improve exercise capacity in patients suffering from PH-ILD by inhaling treprostinil at specific dosages. If we are successful in this litigation, we believe Liquidia will be required to remove PH-ILD as a labeled indication for Yutrepia until the expiration of our patent in February 2042. We are also engaged in litigation with Liquidia alleging trade secret misappropriation. In this case, we allege that a former executive of ours misappropriated trade secrets related to Tyvaso when he utilized them as an executive of Liquidia to aid in the development of Yutrepia. Finally, we are engaged in separate litigation against Liquidia alleging that Yutrepia infringes a patent that claims a method of treating pulmonary hypertension using inhaled treprostinil delivered in a specified dosage using a specified dosage regimen. This patent expires in May 2027.
Liquidia has also sued us, alleging infringement of a patent with claims directed to the treatment of pulmonary hypertension by administering specified amounts of treprostinil via a dry powder inhaler in a specified number of breaths. That case is currently stayed pending developments in the trade secret misappropriation litigation described above.
For further details regarding these and other litigation matters involving Liquidia and Yutrepia, please see Note 12-Litigation, to our consolidated financial statements included in this Report.
General
We intend to vigorously enforce our intellectual property rights related to our products. However, we may not prevail in defending our patent rights, and additional challenges from other ANDA filers or other challengers may surface with respect to our products. Our patents could be invalidated, found unenforceable, or found not to cover one or more generic forms of our products. If any ANDA filer or filer of a 505(b)(2) NDA for a branded treprostinil product were to receive approval to sell its treprostinil product and/or prevail in any patent litigation, our affected product(s) would become subject to increased competition. Patent expiration, patent litigation, and competition from generic or other branded treprostinil manufacturers could have a significant, adverse impact on our treprostinil-based product revenues, our profits, and our stock price. These potential effects are inherently difficult to predict. 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 profits, contained in Part II, Item 1A-Risk Factors included in this Report.
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. From time to time, we also license or acquire additional technologies and compounds to be incorporated into our development pipeline. Our operating expenses include the costs described below.
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Part I. Financial Information
Cost of Sales
Our cost of sales primarily includes costs to manufacture our products, royalty and sales-based milestone payments under license agreements granting us rights to sell related products, direct and indirect distribution costs incurred in the sale of our products, and the costs of inventory reserves for current and projected obsolescence. 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 new products, new indications for existing products, and various post-marketing research activities. These costs also include share-based compensation and salary-related expenses for research and development functions, professional fees for preclinical and clinical studies, costs associated with clinical manufacturing, facilities-related expenses, regulatory costs, and costs associated with payments to third-party contract manufacturers before FDA approval of the relevant product. Expenses also include costs for third-party arrangements, including upfront fees and milestone payments required under license arrangements for therapies under development. We do not track fully burdened research and development expenses by individual product candidate.
Selling, General, and Administrative
Our selling, general, and administrative expenses primarily include costs associated with the commercialization of approved products and general and administrative costs to support our operations, including share-based compensation and salary-related expenses. Selling expenses include product marketing and sales operations costs, as well as other costs incurred to support our sales efforts. 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
Currently, we grant stock options and restricted stock units under the United Therapeutics Corporation Amended and Restated 2015 Stock Incentive Plan (the 2015 Plan), and we may grant restricted stock units to newly hired employees under our 2019 Inducement Stock Incentive Plan (the 2019 Inducement Plan). 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 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. Historically, we granted awards under our Share Tracking Awards Plan (the STAP). Issuance of awards under this plan was discontinued in 2015 and all remaining outstanding STAP awards were exercised during the first quarter of 2025.
Research and Development
We focus our research and development efforts on the following pipeline programs. We also engage in a variety of additional research and development efforts, including efforts to develop new and improved devices to deliver our current commercial products and other small molecule therapies, some of which are intended for once-daily or as-needed administration, for a variety of pulmonary indications. In addition, we are developing technologies designed to increase the supply of transplantable organs and organ alternatives and improve outcomes for transplant recipients through xenotransplantation, regenerative medicine, and ex vivo lung perfusion.
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Part I. Financial Information
Select Pipeline Programs
| Product | Mode of Administration | Indication |
Current Status
STUDY NAME
|
Our Territory | ||||||||||
|
Nebulized Tyvaso (treprostinil) |
Inhaled | IPF |
Phase 3 TETON-1 and TETON-2 studies successful; preparing sNDA
|
Worldwide | ||||||||||
|
Nebulized Tyvaso (treprostinil) |
Inhaled | PPF |
Phase 3 TETON-PPF study
|
Worldwide | ||||||||||
|
Ralinepag Tablets
(IP receptor agonist)
|
Oral | PAH |
Phase 3 ADVANCE OUTCOMES study successful; preparing NDA
|
Worldwide | ||||||||||
|
Ralinepag DPI
|
Inhaled
|
PAH, PH-ILD, IPF, PPF
|
Pre-IND non-clinical testing
|
Worldwide
|
||||||||||
|
Treprostinil SMI
|
Inhaled
|
PAH, PH-ILD, IPF, PPF
|
Pivotal pharmacokinetic studies for PAH and PH-ILD ongoing
|
Worldwide
|
||||||||||
|
Treprostinil SMI
|
Inhaled
|
PH-COPD
|
Preparing IND for phase 2 study
|
Worldwide
|
||||||||||
|
Treprostinil-Iloprost SMI
|
Inhaled PRN
|
PAH
|
Preparing IND for phase 1 study
|
Worldwide
|
||||||||||
|
Triple Combination Therapy
|
Oral
|
PAH
|
Formulation development and dosage design complete; planning pre-IND engagement with the FDA
|
Worldwide
|
||||||||||
Nebulized Tyvaso - TETON Studies
In September 2025, we announced that the TETON-2 phase 3 study of Nebulized Tyvaso in patients with IPF met its primary efficacy endpoint of demonstrating improvement in absolute forced vital capacity (FVC) relative to placebo. Nebulized Tyvaso demonstrated superiority over placebo for the change in absolute FVC by 95.6 mL (Hodges-Lehmann [H-L] estimate, p <0.0001) from baseline to week 52 in patients with IPF.
Statistically significant improvements relative to placebo were also observed in most secondary endpoints, including time to first clinical worsening event, as well as changes from baseline to week 52 in percent predicted FVC, King's Brief Interstitial Lung Disease quality of life questionnaire (K-BILD) score, and diffusion capacity of lungs for carbon monoxide (DLCO). While not statistically significant, both time to first acute exacerbation of IPF and overall survival at week 52 trended in favor of Nebulized Tyvaso. Data from the TETON-2 study were published in The New England Journal of Medicine in March 2026.
In March 2026, we announced that the TETON-1 study also met its primary endpoint, with an even stronger treatment effect than the TETON-2 study. Specifically, the study demonstrated superiority of Nebulized Tyvaso over placebo for the change in absolute FVC by 130.1 mL (H-L estimate, p <0.0001) from baseline to week 52. Nebulized Tyvaso achieved statistical significance for reducing the risk of clinical worsening and showed numerical improvement in other important secondary endpoints relative to placebo, including time to first acute exacerbation of IPF and changes in percent predicted FVC, K-BILD score, and DLCO.
Integrated analyses of TETON-1 and TETON-2 showed statistically significant treatment effects compared to placebo from baseline to week 52 for the primary endpoint of change in absolute FVC by 111.8 mL (H-L estimate, p <0.0001) and most secondary endpoints, including time to first clinical worsening and first acute exacerbation of IPF and changes in percent predicted FVC, K-BILD score, and DLCO. Overall survival at week 52 trended in favor of Nebulized Tyvaso but did not meet statistical significance.
The TETON-2 study enrolled 597 patients and was conducted outside the United States and Canada. TETON-1 enrolled 598 patients in the United States and Canada. Treatment with Nebulized Tyvaso in these studies was well-tolerated, and the safety profile was consistent with previous Tyvaso studies and known prostacyclin-related adverse events. No new safety signal was seen in either study. Benefits of Nebulized Tyvaso were observed across all subgroups, such as use of background therapy (nintedanib, pirfenidone, or no background therapy), smoking status, and supplemental oxygen use. We intend to use the data from both the TETON-2 and TETON-1 studies to support a supplemental NDA (sNDA) to the FDA to add IPF to the labeled indications for Nebulized Tyvaso, which we plan to submit by the end of summer 2026. We believe there are approximately 100,000 IPF patients in the United States.
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. The TETON-PPF study was also prompted by a post-hoc analysis of data from the INCREASE study. PPF is a group of ILD conditions that exhibit progressive, self-sustaining fibrosis, and a similar disease course to IPF. PPF includes idiopathic interstitial pneumonias, autoimmune ILDs, chronic fibrosing hypersensitivity pneumonitis, and fibrotic ILDs related to environmental/occupational exposure. We are targeting enrollment of 698 patients in the TETON-PPF study. While estimates vary, we believe the size of the U.S. PPF population is approximately 200,000 patients.
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Part I. Financial Information
We and our distributors will also consider seeking amendments to the marketing authorizations for Nebulized Tyvaso in other countries where it is approved, to include IPF and/or PPF indications, and we will also consider seeking approval of Nebulized Tyvaso for these indications in countries where it is not yet approved. We also plan to seek FDA approval to expand the Tyvaso DPI label to include IPF and/or PPF, as applicable, following completion of any FDA-required bridging studies. Based on preliminary feedback from the FDA, these bridging studies may include pivotal clinical trials to establish safety and efficacy of Tyvaso DPI for treating patients with IPF and PPF. Both the FDA and the European Medicines Agency have granted orphan designation for treprostinil to treat IPF.
Treprostinil SMI
We are developing a version of inhaled treprostinil that will be a drug-device combination consisting of treprostinil solution and a device known as a soft mist inhaler (SMI). SMI devices are propellant-free, hand-held mechanical devices that deliver an aerosol cloud of medication via a single breath. SMI devices would be more convenient for our patients than the current Tyvaso nebulizer, which requires several breaths using a much larger device that needs electricity. SMI devices are pocket-sized and disposable, and would be delivered with a pre-filled, multi-dose cartridge of drug product that is stored at room temperature and easily inserted into the device to begin use. Due to the multi-dose cartridge, which is intended to provide sufficient doses for up to 14 days of use, there is no need to fill the SMI device every day like a nebulizer. SMI devices may also provide a favorable adverse event profile compared to dry powder inhalers. We are targeting the same indications for which Nebulized Tyvaso is already approved (PAH and PH-ILD), as well as those for which we plan to seek FDA approval in the future (IPF and PPF), following completion of any FDA-required bridging studies. We are currently conducting pivotal pharmacokinetic studies to establish comparability between treprostinil SMI and Nebulized Tyvaso, to support a 505(b)(1) NDA for PAH and PH-ILD. Additionally, we are preparing an IND to enable us to conduct a phase 2 study of treprostinil SMI to treat patients with pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD).
Treprostinil-Iloprost SMI
We are developing a fixed-dose, drug-device combination product consisting of treprostinil and iloprost solution and an SMI. We are targeting this product for pro re nata (PRN), or "as-needed", use for PAH patients whose primary therapy is either an oral or inhaled prostacyclin-class therapy who may from time to time need a bridge between doses due to exercise activity. Iloprost is a prostacyclin-class therapy that is approved by the FDA to treat PAH via nebulized inhalation solution. Based on a preclinical research study, we believe there may be beneficial synergies when treprostinil and iloprost are dosed together on a PRN basis. We have completed pre-IND engagement with the FDA and are in the process of preparing an IND. Once the IND is cleared, we plan to proceed to a phase 1 pharmacokinetics and safety study in healthy volunteers, and eventually, a pivotal efficacy study in PAH patients.
Ralinepag Extended-Release Tablets
Ralinepag is a next-generation, once-daily, oral, extended-release, titratable, selective, and potent prostacyclin (IP) receptor agonist that we are developing for the treatment of PAH. In March 2026, we announced the successful results of our pivotal ADVANCE OUTCOMES study, which was a phase 3, event-driven clinical trial of an extended-release formulation of ralinepag tablets in PAH patients with a primary endpoint of time to first clinical worsening event. The study met its primary endpoint, with ralinepag reducing the risk of a clinical worsening event by 55 percent compared with placebo in patients with PAH (hazard ratio 0.45, p<0.0001).
Ralinepag demonstrated durable efficacy in delaying disease progression during the study, in which 80 percent of patients were on dual background therapy and 70 percent of patients were considered World Health Organization (WHO)/New York Heart Association (NYHA) Functional Class (FC) II at baseline. Statistically significant improvements relative to placebo were also observed in important secondary endpoints, including six-minute walk distance (6MWD) and change in N-terminal pro-B-type natriuretic peptide (NT-proBNP), with ralinepag increasing the odds of achieving clinical improvement by 47 percent from baseline to week 28 (p=0.015).
Benefits were consistent across all patient subgroups, including time since diagnosis, disease etiology, baseline 6MWD, and use of background therapies, reinforcing the robustness of the treatment effect and the potential broad therapeutic relevance of ralinepag. Treatment with ralinepag was well-tolerated and the safety profile was consistent with known prostacyclin-related adverse events. No new safety signals were observed.
We plan to submit an NDA for ralinepag extended-release tablets to the FDA by the end of summer 2026. If approved and launched, we expect ralinepag's once-daily dosing profile to position it favorably compared with Uptravi (selexipag), which is a twice-daily IP-receptor agonist marketed by Johnson & Johnson for the treatment of PAH. In 2025, Johnson & Johnson reported global sales of Uptravi of over $1.9 billion, including over $1.5 billion in U.S. sales, reflecting a growth rate of approximately 5 percent over 2024.
Triple Combination Therapy
We are developing an oral triple combination therapy consisting of ralinepag, an endothelin receptor antagonist (ERA), and a PDE-5 inhibitor. We have completed formulation development and dosage design work and plan to engage with the FDA on
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Part I. Financial Information
our proposed clinical development strategy following submission of our NDA for ralinepag extended-release tablets. Our triple combination therapy is intended to provide a convenient means of dosing patients with existing first-line oral therapies for PAH (an ERA and a PDE-5 inhibitor), along with once-daily ralinepag.
Ralinepag DPI
We are developing a dry powder inhalation (DPI) version of ralinepag. In August 2025, we exercised the option under our license and collaboration agreement with MannKind Corp. to develop ralinepag DPI utilizing the dry powder formulation technology used to manufacture Tyvaso DPI. We believe the half-life of ralinepag may support once-daily dosing of ralinepag DPI. We are currently in the process of formulating ralinepag DPI for non-clinical studies and a subsequent phase 1 study in healthy volunteers to assess dosing and pharmacokinetic comparability with ralinepag extended-release tablets, which will inform a pivotal study in PAH patients to further assess safety and pharmacokinetic comparability. We initially intend to seek FDA approval of ralinepag DPI for PAH. We also plan to seek approval for PH-ILD, IPF, and PPF, which will require additional clinical studies assessing safety and efficacy in patients with these conditions. Under the terms of our expanded agreement with MannKind, we will pay MannKind up to $35 million in development milestones and a 10 percent royalty on net sales of ralinepag DPI. Under our license agreement with Arena Pharmaceuticals Inc. (now owned by Pfizer Inc.), we will be obligated to pay a $250.0 million milestone payment upon FDA approval of ralinepag DPI, and a low double-digit, tiered royalty on net sales. We are constructing a manufacturing facility in Research Triangle Park, North Carolina, which we plan to use to manufacture ralinepag DPI.
Manufactured Organs and Organ Alternatives
Each year, end-stage organ failure kills millions of people. A significant number of these patients could have benefited from an organ transplant. Unfortunately, the number of usable, donated organs available for transplantation has not grown significantly over the past half century, while the need has soared. Our long-term goals are aimed at addressing this shortage. With advances in technology, we believe that creating an unlimited supply of tolerable manufactured organs and organ alternatives is now principally an engineering challenge, and we are dedicated to finding engineering solutions. 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.
While we continue to develop and commercialize therapies for rare and life-threatening conditions, we view manufactured organs and organ alternatives as complementary solutions for a broad array of diseases, many of which (such as PAH and PH-ILD) have proven incurable to date despite the availability of pharmaceutical and biologic therapies. For this reason, we included the development of "technologies that expand the availability of transplantable organs" as part of our express public benefit purpose when we converted United Therapeutics to a public benefit corporation (PBC) in 2021.
Xenotransplantation
Our xenotransplantation program includes three development-stage organ products known as "xenografts", which are intended to be transplanted from gene-edited pigs into humans.
The UKidney™ is an investigational-stage kidney from a pig with ten gene edits to support organ functioning in the human body. Six human genes were added to the pig genome to facilitate immune acceptance of the organ, while four genes were inactivated: three that contribute to porcine organ rejection in humans and one that can cause organ growth beyond what is normal for humans. The UHeart™ is a heart from the same pig with ten gene edits.
The UThymoKidney™ is an investigational-stage kidney from a pig with a single gene edit, together with tissue from the pig's thymus. The pig's thymus tissue is intended to condition the recipient's immune system to recognize the UThymoKidney as "self" and reduce the likelihood of rejection. The single gene that is disrupted in the pig is responsible for the synthesis of alpha-gal, a sugar on the surface of cells that can cause immediate rejection of a porcine organ when transplanted into the human body. Because tissues from pigs containing this gene edit do not contain detectable levels of the alpha-gal sugar, we refer to materials derived from this pig as GalSafe®. In December 2020, the GalSafe pig was approved by the FDA for use as human food and as a potential source for biomedical purposes. 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.
In January 2025, the FDA cleared our Investigational New Drug application (IND) related to the EXPAND study of our UKidney product. 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 Biologics License Application (BLA) with the FDA. This study is designed as a combination phase 1/2/3 trial (sometimes referred to as a "phaseless" study) to evaluate safety and efficacy seamlessly without moving through separate phase 1, phase 2, and phase 3 studies that are typically associated with conventional drug approvals. The first transplant in this study occurred in the fourth quarter of 2025, and the study is ongoing.
In July 2025, we submitted an IND to the FDA related to our anticipated EXTEND clinical study of our UThymoKidney product. In August 2025, the FDA cleared this IND, enabling us to commence this study, which we expect will be similar in size and
| United Therapeutics, a public benefit corporation | |||||
Part I. Financial Information
scope to the EXPAND study described above. We are engaging with the FDA on a potential IND for a study of our UHeart product.
In February 2024, we completed a designated pathogen-free (DPF) facility in Virginia. We expect this DPF facility to supply xenografts compliant with FDA current Good Manufacturing Practices (cGMP) for human clinical trials, with a target capacity of up to 125 organs per year. We are constructing two additional DPF facilities in Minnesota and Texas. While we believe these DPF facilities will be capable of producing organs for commercial use, we are also planning to build additional and potentially larger cGMP DPF facilities for commercial use. 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.
Regenerative Medicine
•Miromatrix. In December 2023, we acquired Miromatrix Medical Inc. (Miromatrix), a company based in Minnesota focused on the development of new technologies for generating manufactured kidneys and liver alternatives composed of human primary cells. The development-stage Miromatrix external liver assist product, called miroliverELAP®, 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. Miromatrix first used its decellularization technology to successfully develop two acellular products, MiroMesh® and MiroDerm®, which received FDA 510(k) clearance for hernia repair and wound care applications, respectively, and which were later spun off by Miromatrix. In January 2026, we announced that Miromatrix completed a phase 1 study of miroliverELAP in patients with acute liver failure. This study, which was the first human clinical trial of a manufactured organ alternative, met its primary endpoint. Miromatrix is planning to commence a phase 2 study, and the FDA has granted miroliverELAP Regenerative Medicine Advanced Therapy designation. Miromatrix is also developing miroliver®, a fully implantable manufactured liver alternative product, and mirokidney®, a fully implantable manufactured kidney alternative product, both of which are based on decellularized porcine organ scaffolds that have been reseeded with human-derived cells. Initially the Miromatrix products are intended to be made with cells from a human donor other than the recipient (also called "allogeneic" cells), requiring the use of standard immunosuppression protocols. Future versions may be based on the patient's own cells (known as "autologous" cells), reducing or eliminating the need for immunosuppression drugs.
•ULobe™. The ULobe is a development-stage engineered lung lobe alternative made using a porcine lung scaffold that is decellularized and then re-cellularized with allogeneic human cells. In 2025, our Regenerative Medicine Laboratory in Research Triangle Park, North Carolina (RTP) produced 830 decellularized lung scaffolds, 345 recellularized lungs, and 1.65 trillion human cells for use in recellularization.
•ULung™. The ULung is a development-stage engineered lung alternative composed of a 3D printed lung scaffold cellularized with human lung cells, with the goal of using autologous cells and reducing or eliminating the need for immunosuppression. The lung scaffold used in the ULung is printed using 3D printers being developed in collaboration with 3D Systems, Inc. Our Organ Manufacturing Group, located in Manchester, New Hampshire, has achieved recognition for developing the world's most complex 3D printed object. Its lung scaffold designs consist of a record 44 trillion voxels that lay out 4,000 kilometers of pulmonary capillaries and 200 million alveoli, which demonstrate gas exchange in preclinical models. Under our agreement with 3D Systems, we also have the exclusive right to develop additional human solid organ alternatives using 3D Systems' printing technology.
•IVIVA. In October 2023, we completed the acquisition of IVIVA Medical, Inc. (IVIVA), a preclinical stage company based in Massachusetts, focused on bio-artificial manufactured kidney alternative products. IVIVA's preclinical implantable kidney alternative product uses autologous cells to mimic important physiological functions of native kidneys in recipients to support their native kidney function without the need for immunosuppression. The product is designed to replace the need for external kidney dialysis.
Ex Vivo Lung Perfusion
Our ex vivo lung perfusion (EVLP) program uses the first FDA-approved acellular EVLP technology on the market, the XVIVO Perfusion System (XPS™) with Steen Solution™ Perfusate, to offer the only commercially available centralized EVLP service in the United States. 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. Centralized EVLP services make EVLP available to small and large transplant centers and remove barriers to the transplantation process to optimize organ utilization and increase the supply of transplantable lungs.
Our wholly owned subsidiary, Lung Bioengineering Inc., provides commercial EVLP services on a fee-for-service basis to transplant centers through dedicated facilities located in Silver Spring, Maryland and Jacksonville, Florida, using the XPS System. 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 for commercial approval of CLES, which is under review by the FDA.
Over 750 patients have received lung transplants following use of our centralized EVLP service.
| Quarterly Report | |||||
Part I. Financial Information
Sustainable Delivery of Organs and Organ Alternatives
Together with our work on therapeutic interventions, we are working with third parties to develop scalable technologies to efficiently deliver an unlimited supply of manufactured organs and organ alternatives to transplant centers and waiting patients, while minimizing environmental impact. Our organ delivery research efforts are focused on the development of piloted and autonomous electric vertical take-off and landing aircraft systems to quickly, reliably, and sustainably deliver organs and organ alternatives from manufacturing facilities to transplant centers.
Beginning in 2017, we entered into a series of agreements with BETA Technologies, Inc. to support the development of all-electric aircraft to help us meet our future distribution requirements for manufactured organs and organ alternatives. In October 2021, we successfully completed the first-ever drone delivery of a human lung for transplant at Toronto General Hospital, demonstrating the feasibility of our goal of delivering our manufactured organs and organ alternatives with zero carbon footprint aircraft. 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. In March 2025, we completed what we believe was the world's first successful test flight of a piloted hydrogen-electric powered helicopter at our test and development facility located in Quebec.
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) the launch of ralinepag extended-release tablets for PAH, following FDA approval; (4) the launch of Nebulized Tyvaso for IPF, following FDA approval; (5) FDA approval and launch of treprostinil SMI; (6) continued growth in the number of patients prescribed Orenitram; and (7) modest price increases for some of our products. We believe that additional revenue growth in the medium- and longer-term will be driven by the additional products and indications described above under Research and Development.
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 new products and new indications for existing products; (2) the timing and degree of our success in commercially launching new products and new indications for existing 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, MFN, and other government initiatives focused on drug pricing, and as a result of additional payer rebates, and the timing and degree of success in obtaining reimbursement for new products and new indications for existing products; (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 II, Item 1A-Risk Factors, included in this Report.
We have budgeted approximately $290 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 (a) construction of a new manufacturing facility in RTP that we intend to use to manufacture ralinepag DPI; and (b) construction of clinical-scale DPF facilities in Stewartville, Minnesota and Houston, Texas. We plan to fund these capital expenditures using cash on hand.
We anticipate that 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 these products are approved by the FDA. However, if our xeno-organ products are approved by the FDA, we likely will need to continue building additional DPF facilities to address anticipated demand for these products. 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, regulatory, and commercial activities.
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. 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. Despite this increase in competition, we believe revenues from our existing product portfolio will continue to grow, particularly given the addressable U.S. market opportunity for Tyvaso DPI and Nebulized Tyvaso in patients with PH-ILD. In addition, with the successful results of our ADVANCE OUTCOMES, TETON-1, and TETON-2 studies, we anticipate FDA approval of ralinepag extended-release tablets for PAH and Nebulized Tyvaso for IPF in the near-term, providing the opportunity for significant revenue through the end of the decade and beyond.
| United Therapeutics, a public benefit corporation | |||||
Part I. Financial Information
Results of Operations
Three Months Ended March 31, 2026 and March 31, 2025
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 net product sales decreased two percent to $457.5 million for the three months ended March 31, 2026, as compared to $466.3 million for the same period in 2025, driven by a decrease in Nebulized Tyvaso net product sales, partially offset by growth in Tyvaso DPI net product sales. Tyvaso DPI net product sales increased for the three months ended March 31, 2026, as compared to the same period in 2025, primarily due to an increase in quantities sold of $16.0 million and, to a lesser extent, a price increase. Nebulized Tyvaso net product sales decreased for the three months ended March 31, 2026, as compared to the same period in 2025, primarily due to a decrease in U.S. quantities sold of $33.3 million and, to a lesser extent, a decrease in international net product sales, partially offset by a price increase.
Remodulin net product sales decreased for the three months ended March 31, 2026, as compared to the same period in 2025, primarily due to a decrease in quantities sold of $11.1 million.
Orenitram net product sales increased for the three months ended March 31, 2026, as compared to the same period in 2025, primarily due to 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.
| Quarterly Report | |||||
Part I. Financial Information
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. The tables below present a reconciliation of the accounts associated with these deductions (in millions):
| Three Months Ended March 31, 2026 | |||||||||||||||||||||||||||||
| Rebates and Chargebacks |
Prompt Pay Discounts
|
Allowance for Sales Returns
|
Distributor Fees
|
Total | |||||||||||||||||||||||||
| Balance, January 1, 2026 | $ | 238.9 | $ | 6.3 | $ | 1.4 | $ | 11.7 | $ | 258.3 | |||||||||||||||||||
| Provisions attributed to sales in: | |||||||||||||||||||||||||||||
| Current period | 143.3 | 18.3 | 0.1 | 9.8 | 171.5 | ||||||||||||||||||||||||
| Prior periods | (6.4) | (0.2) | 1.2 | (0.5) | (5.9) | ||||||||||||||||||||||||
| Payments or credits attributed to sales in: | |||||||||||||||||||||||||||||
| Current period | (23.7) | (12.6) | - | (1.8) | (38.1) | ||||||||||||||||||||||||
| Prior periods | (122.7) | (6.1) | (1.4) | (7.7) | (137.9) | ||||||||||||||||||||||||
| Balance, March 31, 2026 | $ | 229.4 | $ | 5.7 | $ | 1.3 | $ | 11.5 | $ | 247.9 | |||||||||||||||||||
| Three Months Ended March 31, 2025 | |||||||||||||||||||||||||||||
| Rebates and 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 | 124.8 | 18.4 | 0.2 | 10.5 | 153.9 | ||||||||||||||||||||||||
| Prior periods | 8.4 | 0.1 | (0.1) | (0.3) | 8.1 | ||||||||||||||||||||||||
| Payments or credits attributed to sales in: | |||||||||||||||||||||||||||||
| Current period | (22.1) | (12.1) | - | (2.0) | (36.2) | ||||||||||||||||||||||||
| Prior periods | (93.1) | (5.2) | (1.0) | (8.4) | (107.7) | ||||||||||||||||||||||||
| Balance, March 31, 2025 | $ | 158.8 | $ | 6.3 | $ | 1.3 | $ | 11.4 | $ | 177.8 | |||||||||||||||||||
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 section 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.
| United Therapeutics, a public benefit corporation | |||||
Part I. Financial Information
Research and Development
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 section 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
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 below for discussion.
Share-Based Compensation
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) | % | ||||||||||||||||||
| STAP awards | - | (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 table below summarizes share-based compensation expense by line item in our consolidated statements of operations (dollars in millions):
| Quarterly Report | |||||
Part I. Financial Information
|
Three Months Ended March 31, |
Dollar Change |
Percentage Change |
|||||||||||||||||||||
| 2026 | 2025 | ||||||||||||||||||||||
| Cost of sales | $ | 1.0 | $ | 0.9 | $ | 0.1 | 11 | % | |||||||||||||||
| Research and development | 5.4 | 6.9 | (1.5) | (22) | % | ||||||||||||||||||
| Selling, general, and administrative | 27.5 | 24.0 | 3.5 | 15 | % | ||||||||||||||||||
|
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. For more information, see Note 8-Share-Based Compensation to our consolidated financial statements.
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. See Note 3-Investments and Note 4-Fair Value Measurements to our consolidated financial statements.
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.
2026 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 (plus the amount of any customary contingent settlement obligations that may arise upon the expiration or early termination of an accelerated share repurchase contract), which program expires on March 9, 2027. In connection with the repurchase program, in March 2026, we entered into two accelerated share repurchase agreements (the 2026 ASR agreements) with Citibank, N.A. (Citi) which comprise a $750 million uncollared share repurchase agreement (the 2026 Uncollared ASR) and a $750 million collared share repurchase agreement (the 2026 Collared ASR). Under the 2026 ASR agreements, we made an aggregate upfront payment of $1.5 billion to Citi and received initial deliveries of 992,120 and 708,657 shares of our common stock on March 11, 2026, representing approximately 70 percent and 50 percent of the total shares that would be repurchased under the 2026 Uncollared ASR and 2026 Collared ASR, respectively, measured based on the closing price of our common stock on March 9, 2026. Upon completion of an agreed-upon hedging period and the subsequent determination of the minimum and maximum share amounts to be repurchased under the 2026 Collared ASR, we received an additional 463,682 shares of our common stock on March 30, 2026.
The final number of shares that we will ultimately repurchase pursuant to the 2026 ASR agreements will be determined based on the average of the daily volume-weighted average price per share of our common stock during the repurchase period, less a discount and subject to adjustments pursuant to the terms and conditions of the 2026 ASR agreements. As discussed above, under the 2026 Collared ASR, the final number of shares we will ultimately repurchase will also be subject to a collar provision establishing the minimum and maximum numbers of shares to be repurchased, as well as other adjustments. At the final settlement of the 2026 ASR agreements, we may be entitled to receive additional shares of our common stock, or, under certain limited circumstances, be required to make an additional cash payment to Citi or, if we so elect, deliver shares of our common stock to Citi. The scheduled termination date of the 2026 Uncollared ASR is in the second quarter of 2026. The scheduled termination date of the 2026 Collared ASR is in the third quarter of 2026.
As of March 31, 2026, $500 million remained available under our Board's share repurchase authorization through March 9, 2027.
2025 Share Repurchase
In August 2025, we entered into two accelerated share repurchase agreements (the 2025 ASR agreements) with Citi, comprised of a $500 million uncollared share repurchase agreement (the 2025 Uncollared ASR) and a $500 million collared share repurchase agreement (the 2025 Collared ASR). Under the 2025 ASR agreements, 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 2025 Uncollared ASR and 2025 Collared ASR, respectively, measured based on the closing price of our common stock on August 1, 2025. Upon completion of an agreed-upon hedging period and the subsequent determination of the minimum and maximum share amounts to be repurchased under the 2025 Collared ASR, we received an additional 514,789 shares of our common stock on August 25, 2025. The final settlement of the 2025 Uncollared ASR occurred in November 2025, and we received an additional 3,882 shares of our common stock upon settlement. The final settlement of the 2025 Collared ASR occurred in January 2026, and we received no additional shares of our common stock upon settlement as a result of a collar
| United Therapeutics, a public benefit corporation | |||||
Part I. Financial Information
provision that established the minimum and maximum number of shares to be repurchased, as well as other adjustments. In 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.
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. 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. In April 2025, we entered into a credit agreement (the 2025 Credit Agreement), which provides for an unsecured revolving credit facility of up to $2.5 billion. Our outstanding balance under the 2025 Credit Agreement, which matures in 2031, was zero as of March 31, 2026. See Unsecured Revolving Credit Facilities below for further details.
Cash and Cash Equivalents and Marketable Investments
Cash and cash equivalents and marketable investments comprise the following (dollars in millions):
| March 31, 2026 | December 31, 2025 | Dollar Change | Percentage Change | |||||||||||||||||||||||
| Cash and cash equivalents | $ | 1,279.7 | $ | 1,557.1 | $ | (277.4) | (18) | % | ||||||||||||||||||
| Marketable investments-current | 874.0 | 1,363.2 | (489.2) | (36) | % | |||||||||||||||||||||
| Marketable investments-non-current | 1,317.4 | 1,776.7 | (459.3) | (26) | % | |||||||||||||||||||||
| Total cash and cash equivalents and marketable investments | $ | 3,471.1 | $ | 4,697.0 | $ | (1,225.9) | (26) | % | ||||||||||||||||||
Cash Flows
Cash flows comprise the following (dollars in millions):
| Three Months Ended March 31, | Dollar Change | Percentage Change | |||||||||||||||||||||
| 2026 | 2025 | ||||||||||||||||||||||
| Net cash provided by operating activities | $ | 463.3 | $ | 461.2 | $ | 2.1 | - | % | |||||||||||||||
|
Net cash provided by (used in) investing activities
|
$ | 743.7 | $ | (164.7) | $ | 908.4 | 552 | % | |||||||||||||||
|
Net cash used in financing activities
|
$ | (1,484.4) | $ | (93.8) | $ | (1,390.6) |
NM(1)
|
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(1)Calculation is not meaningful.
Operating Activities
Our operating assets and liabilities consist primarily of accounts receivable, inventories, accounts payable, accrued expenses, and tax-related payables and receivables.
Investing Activities
The increase of $908.4 million in net cash provided by investing activities for the three months ended March 31, 2026, as compared to the same period in 2025, was primarily due to a $955.8 million increase in net proceeds from marketable investments; partially offset by: (1) a $25.9 million increase in cash paid to purchase property, plant, and equipment and (2) a $25.0 million increase in cash paid to purchase an investment in a privately held company.
Financing Activities
The increase of $1,390.6 million in net cash used in financing activities for the three months ended March 31, 2026, as compared to the same period in 2025, was primarily due to a $1.5 billion payment to repurchase our common stock; partially offset by: (1) a $100.0 million decrease in cash used for a repayment on our line of credit and (2) a $51.7 million increase in proceeds from the exercise of stock options.
| Quarterly Report | |||||
Part I. Financial Information
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.
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. On April 25, 2025, we borrowed $200.0 million under the 2025 Credit Agreement and used the proceeds to repay all outstanding indebtedness under the 2022 Credit Agreement in connection with its termination. 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 March 31, 2026. Refer to Note 7-Debt-2025 Credit Agreement to our consolidated financial statements.
Summary of Critical Accounting Policies and Estimates
The preparation of our consolidated financial statements in conformity with U.S. generally accepted accounting principles requires our management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. We continually evaluate our estimates and judgments to determine whether they are reasonable, relevant, and appropriate. These assumptions are frequently developed from historical data or experience, currently available information, and anticipated developments. By their nature, our estimates are subject to an inherent degree of uncertainty; consequently, actual results may differ. We discuss critical accounting policies and estimates that involve a higher degree of judgment and complexity in Part II, Item 7-Management's Discussion and Analysis of Financial Condition and Results of Operations in our 2025 Annual Report. There have been no material changes to our critical accounting policies and estimates as disclosed in our 2025 Annual Report.
Recently Issued Accounting Standards
See Note 2-Basis of Presentation, to our consolidated financial statements for information on our anticipated adoption of recently issued accounting standards.
United Therapeutics Corporation published this content on May 06, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on May 06, 2026 at 10:37 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]