United Therapeutics Corporation
10/29/2025 | Press release | Distributed by Public on 10/29/2025 04:33
Quarterly Report for Quarter Ending September 30, 2025 (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, 2024 (the 2024 Annual Report), and our consolidated financial statements and accompanying notes included inPart I, Item 1 of this Quarterly Report on Form 10-Q. 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 Quarterly Report on Form 10-Q 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 attractive pricing and reimbursement levels for our products, in light of increasing competition, including from generic products, and pressure from government and other payers to decrease the costs associated with healthcare, including the potential impact of the Inflation Reduction Act of 2022 (IRA) on our business and President Trump's most favored nation pricing initiative;
•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;
•The outcome of pending and potential future legal and regulatory actions by the U.S. Food and Drug Administration (FDA) and other regulatory and government enforcement agencies related to our products and potential competitive products;
•The timing and outcome of ongoing litigation, including the lawsuit filed against us by Sandoz Inc. (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 (including our plans to expand manufacturing capacity for Tyvaso DPI);
•Expectations regarding the amount and timing of capital expenditures to construct new facilities to support our product development and commercialization efforts, including our xenotransplantation-related facilities;
•Expectations regarding the timing and impact of our business development efforts;
•The adequacy of our intellectual property protection and the validity and expiration dates of the patents we own or license, as well as the regulatory exclusivity periods for our products;
•Any statements that include the words "believe," "seek," "expect," "anticipate," "forecast," "project," "intend," "estimate," "should," "could," "may," "will," "plan," or similar expressions; and
•Other statements contained or incorporated by reference in this report that are not historical facts.
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 Factorsof this Quarterly Report on Form 10-Q 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 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 developed under an exclusive development and license agreement with DEKA Research & Development Corp. (DEKA). In September 2025, we launched a new patient-filled version of the Remunity Pump, called RemunityPRO, which is intended to improve the patient experience by making the pump easier to use.
•Orenitram, an oral extended-release tablet form of treprostinil, approved by the FDA to delay disease progression and improve exercise capacity in PAH patients.
•Unituxin, an infused monoclonal antibody approved in the United States and Canada for the treatment of high-risk neuroblastoma and approved in Japan for the treatment of neuroblastoma after high-dose chemotherapy.
•Adcirca, an oral immediate-release tablet form of the PDE-5 inhibitor tadalafil, approved by the FDA to improve exercise ability in PAH patients. 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 Pump, the RemunityPRO Pump, 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 vivolung perfusion services, which are presented under Otherwithin Note 11-Segment Informationto our consolidated financial statements included in this Quarterly Report on Form 10-Q.
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 September 30, 2025, 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
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Part I. Financial Information
infusion system for its generic treprostinil product. See Note 12-Litigation, to our consolidated financial statements included in this Quarterly Report on Form 10-Q.
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) and Actavis Laboratories FL, Inc. (Actavis) related to their ANDAs seeking FDA approval to market generic versions of Nebulized Tyvaso and Orenitram, respectively, before the expiration of certain of our U.S. patents. Under the settlement agreements, Watson and Actavis can market their generic versions of Nebulized Tyvaso and Orenitram, respectively, in the United States beginning in January 2026 and June 2027, respectively, although either or both of them may be permitted to enter the market earlier under certain circumstances. In May 2022, we settled litigation with ANI Pharmaceuticals, Inc. (ANI) regarding its ANDA seeking FDA approval to market a generic version of Orenitram. Under the settlement agreement, ANI can market its generic version of Orenitram in the United States beginning in December 2027, although it 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 tradesecret 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. We filed a motion to dismiss or, alternatively, a motion to stay, the case based on the argument that we co-own the asserted patent based on the alleged trade secret misappropriation discussed 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 Quarterly Report on Form 10-Q.
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 Quarterly Report on Form 10-Q.
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
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. 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 restricted stock units 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.
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, bio-artificial organ alternatives, three-dimensional (3D) bioprinting of organ alternatives, and ex vivolung perfusion.
Select Pipeline Programs
| Product | Mode of Administration | Indication |
Current Status
STUDY NAME
|
Our Territory | ||||||||||
|
Nebulized Tyvaso (treprostinil) |
Inhaled | IPF |
Phase 3 TETON 1andTETON 2 studies
|
Worldwide | ||||||||||
|
Nebulized Tyvaso (treprostinil) |
Inhaled | PPF |
Phase 3 TETON PPF study
|
Worldwide | ||||||||||
|
Ralinepag (IP receptor agonist) |
Oral | PAH |
Phase 3 ADVANCE OUTCOMESstudy
|
Worldwide | ||||||||||
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Part I. Financial Information
Nebulized Tyvaso - TETON studies
On September 2, 2025, we announced that the TETON 2phase 3 study of Nebulized Tyvaso in patients with idiopathic pulmonary fibrosis (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 estimate, p <0.0001) from baseline to week 52 in patients with IPF. 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.
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, and diffusion capacity of lungs for carbon monoxide. While not statistically significant, both time to first acute exacerbation of IPF and overall survival at week 52 trended in favor of Nebulized Tyvaso. Treatment with Nebulized Tyvaso was well-tolerated, and the safety profile was consistent with previous Nebulized Tyvaso studies and known prostacyclin-related adverse events. No new safety signal was seen.
TheTETON 2study enrolled 597 patients and was conducted outside the United States and Canada. A second phase 3 study of Nebulized Tyvaso in IPF patients, called TETON 1, is being conducted in the United States and Canada. We intend to use the data from both theTETON 2study and the ongoing TETON 1study to support a supplemental NDA to the FDA to add IPF to the labeled indications for Nebulized Tyvaso. We plan to meet with the FDA before the end of 2025 to discuss ways to potentially expedite the regulatory review process when TETON 1results are available. Data readout from TETON 1is expected in the first half of 2026.
The TETON 1and TETON 2studies were prompted by data from theINCREASEstudy of Nebulized Tyvaso for the treatment of PH-ILD, which demonstrated in a post-hoc analysis that treatment with Nebulized Tyvaso resulted in significant improvements in percent predicted FVC at weeks 8 and 16, with subjects having an underlying etiology of IPF showing the greatest improvement (week 8: 2.5 percent; p=0.038 and week 16: 3.5 percent; p=0.015). Further, open-label extension (OLE) data published in 2023 showed that these improvements in FVC were sustained for at least 64 weeks. For those patients who received placebo during the INCREASEstudy, marked improvements in FVC were observed following transition to Nebulized Tyvaso during the OLE study. These data points, combined with substantial preclinical evidence of antifibrotic activity of treprostinil and the results of the TETON 2study, suggest that Nebulized Tyvaso may offer a treatment option for patients with IPF. We believe there are approximately 100,000 IPF patients in the United States.
We are also conducting a phase 3 study of Nebulized Tyvaso calledTETON PPFfor the treatment of progressive pulmonary fibrosis (PPF); we enrolled the first patient in TETON PPFin October 2023. The primary endpoint of the TETON PPFstudy is the change in absolute FVC from baseline to week 52.
The TETON PPFstudy was also prompted by a post-hoc analysis of data from the INCREASEstudy. 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. Due to the similarities in the mechanism of fibrosis between IPF and PPF, we anticipate that anti-fibrotic therapies will impact disease progression similarly in patients with these conditions. Therefore, based on the FVC improvements in subjects with IPF observed in the INCREASEstudy, we are conducting the TETON PPF study to evaluate the safety and efficacy of Nebulized Tyvaso for the treatment of PPF. We are targeting enrollment of 698 patients in this study. We believe there are at least 60,000 PPF patients in the United States, but the number could be significantly greater as some estimates indicate the U.S. patient population could exceed 180,000.
If the TETON studies result in FDA approval to add IPF and/or PPF to the Nebulized Tyvaso label, 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. 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. Both the FDA and the European Medicines Agency have granted orphan designation for treprostinil to treat IPF, but not for PPF.
Ralinepag
Ralinepag is a next-generation, once-daily, oral, extended-release, selective, and potent prostacyclin receptor agonist that we are developing for the treatment of PAH. A phase 2 study of an immediate-release formulation of ralinepag in 61 PAH patients (40 patients on active ralinepag, 21 on placebo) met its primary endpoint, showing a 29.8 percent reduction (p=0.03) in median pulmonary vascular resistance (PVR, the force or resistance that blood encounters as it flows through the blood vessels in the lungs) after 22 weeks of treatment with ralinepag compared with placebo. After participation in the phase 2 study, 45 patients entered into an OLE study to further determine if ralinepag may be safe and effective for long-term use to treat patients with PAH. The study found that ralinepag had a manageable side effect profile, with a decrease in side effects for patients who continued taking ralinepag over time. Moreover, two years after entering the OLE study, the study showed that ralinepag improved the ability to exercise as the 6MWD significantly increased by a mean of 36.3 meters (p=0.004), and over 85 percent of patients remained stable in their functional class. Additionally, hemodynamic measures (metrics to
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Part I. Financial Information
measure how well the heart is working) taken either one or two years after entering the OLE study demonstrated significant improvements (p=0.05) in both median PVR and mean pulmonary arterial pressure (the pressure in the blood vessels connecting the heart).
In June 2025, we concluded enrollment of the ADVANCE OUTCOMES study, which is a phase 3, event-driven clinical trial of an extended-release formulation of ralinepag in PAH patients with a primary endpoint of time to first clinical worsening event. ADVANCE OUTCOMESis a global, multi-center, placebo-controlled trial that includes patients on approved oral background PAH therapies. We expect to continue accruing clinical worsening events in this study through the end of 2025, and release topline data from the study in the first half of 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 2024, Johnson & Johnson reported global sales of Uptravi of over $1.8 billion, including over $1.5 billion in U.S. sales, reflecting a growth rate of approximately 14 percent over 2023.
Assuming the ADVANCE OUTCOMES study is successful, we plan to develop an oral triple-combination therapy consisting of ralinepag,an endothelin receptor antagonist, and a PDE-5 inhibitor.
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, 3D bioprinting of organ alternatives, bio-artificial organ alternatives, and ex vivolung 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 a development-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 a development-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.
Johns Hopkins University (JHU), New York University (NYU), the University of Alabama at Birmingham (UAB), and the University of Maryland, Baltimore (UMB) have performed preclinical testing of our porcine xenografts in animal models. In addition, we have worked with NYU and UAB to employ innovative preclinical human models to obtain insights into how xenografts function inside the human body.
In December 2024, we submitted an Investigational New Drug application (IND) to the FDA related to our UKidney product. In January 2025, the FDA cleared this IND, which enables us to commence a clinical trial. This study, which we refer to as the EXPAND 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 study has been initiated, and we expect the first transplant to occur shortly.
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Part I. Financial Information
In July 2025, we submitted an IND to the FDA related to our anticipated EXTENDclinical 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 scope to the EXPANDstudy described above.
We are also preparing to submit one or more INDs for two clinical studies of UHeart products in the near term. One study is expected to relate to full UHeart transplants into adult patients. A second is expected to relate to partial UHeart transplants into pediatric patients.
In February 2024, we inaugurated a designated pathogen-free (DPF) facility in Virginia and began populating the facility with animals during the first quarter of 2024. 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. In 2024, we acquired land in Minnesota where we are constructing a second DPF facility for redundancy, and to support breeding of animals for future commercial use. In March 2025, we purchased land in Houston, Texas, where we are constructing a third DPF facility. While we believe these DPF facilities will be capable of producing organs for commercial use, we are 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.
Additional key accomplishments in our xenotransplantation program include the following:
•First Successful Xenotransplants of Porcine Hearts.University of Maryland School of Medicine (UMSOM) surgeons successfully transplanted UHearts into two living human patients. Each of these procedures were authorized by the FDA on a single-patient, expanded access (also called "compassionate use") basis, and marked the first known examples of transplanting whole organs from gene-edited pigs to humans. The FDA's compassionate use regulations allow a physician to apply to use an unapproved product outside of a clinical trial to treat an individual patient with a serious or immediately life-threatening disease or condition when no satisfactory alternative therapy is available. The first patient, who received a xenotransplant in January 2022, survived for approximately two months with the UHeart. In June 2022, data from this procedure were published in the New England Journal of Medicine. The second patient, who received a xenotransplant in September 2023, survived for approximately six weeks with the UHeart. We and our collaborators continue to evaluate data from these human transplants.
•First Successful Transplantation of Porcine Thymokidney.In April 2024, surgeons at NYU Langone Health successfully transplanted a UThymoKidney into a living patient under an FDA authorization for compassionate use. The patient was suffering from heart and kidney failure, and received a left ventricular assist device to stabilize heart function prior to the UThymoKidney transplant. The procedure marked the first known transplantation of a thymokidney into a human, the first known transplantation of a gene-edited porcine kidney into a human using only FDA-cleared immunosuppression drugs, and the first known procedure combining the use of a heart pump with a transplanted porcine xenokidney. After 47 days, surgeons electively removed the UThymoKidney and returned the patient to dialysis. According to NYU Langone Health, the UThymoKidney had sustained significant injury from episodes of insufficient blood flow due to reduced blood pressure generated by the heart pump and, on balance, was no longer contributing enough to justify continuing the patient's immunosuppression regimen. NYU Langone Health noted that a biopsy of the UThymoKidney did not show signs of rejection.
•Second Successful Transplantation of a Porcine Kidney.In November 2024, surgeons at NYU Langone Health successfully transplanted a UKidney into a living patient under an FDA authorization for compassionate use. In March 2025, the patient developed an infection unrelated to the transplant that led to the reduction of immunosuppression drugs and the rejection of the organ. As a result, the UKidney was removed and the patient returned to dialysis. The UKidney performed well for over four months.
•Successful UKidney and UHeart Tests in Preclinical Human Models.In 2021, surgeons at NYU and UAB tested UThymoKidneys and UKidneys from our gene-edited pigs in brain-dead organ donors maintained on artificial support, providing preclinical evidence that gene-edited pig organs could transcend the most proximate immunological barriers to xenotransplantation. These studies using a preclinical human decedent model were conducted in brain-dead organ donors whose organs were determined to be ineligible for donation, with the consent of each donor's family. Results of the UAB experiments were published in the American Journal of Transplantationin January 2022 and the Journal of Clinical Investigationin January 2024, and results of the NYU experiments were published in the New England Journal of Medicinein May 2022.
In June and July 2022, NYU surgeons tested two UHearts from our gene-edited pigs in brain-dead organ donors maintained on artificial support. In each case, normal function was observed for our UHearts over a three-day study period, without signs of early rejection. The results were published in Nature Medicinein July 2023.
In September 2023, NYU surgeons completed a 61-day study of a UThymoKidney in a brain-dead organ donor maintained on artificial support. At the time, this experiment marked the longest documented case of a xenotransplanted organ functioning in a human body.
| Quarterly Report | |||||
Part I. Financial Information
Regenerative Medicine, Bio-Artificial Organ Alternatives, and 3D Bioprinting of Organ Alternatives
•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 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 October 2024, Miromatrix initiated screening of patients for a phase 1 study of miroliverELAPin patients with acute liver failure, which is the first human clinical trial of a manufactured organ alternative. In June 2025, Miromatrix enrolled the first patient in this study. 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 2023, our Regenerative Medicine Laboratory in Research Triangle Park, North Carolina (RTP) produced 518 decellularized lung scaffolds, 240 recellularized lungs, and 1 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 either allogeneic or autologous human lung cells, with the goal of 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 VivoLung Perfusion
Our ex vivolung 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 in September 2024 for commercial approval of CLES, which has been accepted by the FDA and is under active review by the agency.
Over 670 patients have received lung transplants following use of our centralized EVLP service.
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
| United Therapeutics, a public benefit corporation | |||||
Part I. Financial Information
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 completedwhat we believe was the world's first successful test flight of a piloted hydrogen-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) continued growth in the number of patients prescribed Orenitram; and (4) modest price increases for some of our products. We believe that additional revenue growth in the medium- and longer-term will be driven by new products, new indications for existing products, and new devices to deliver our existing products, as described above under 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 products we develop; (2) the timing and degree of our success in commercially launching new products; (3) the demand for our products; (4) the net price of our products and the reimbursement of our products by public and private health insurance organizations, including the impact on such net prices and reimbursement amounts as a result of the IRA and other government initiatives focused on drug pricing, and as a result of additional payer rebates; (5) the competition we face within our industry, including competition from generic companies, the recent launch of Yutrepia, and the potential launch of new therapies for PAH, PH-ILD, IPF, and/or PPF; (6) our ability to effectively manage our business in an increasingly complex legal and regulatory environment; (7) our ability to defend against challenges to our patents; and (8) the risks identified in Part II, Item 1A-Risk Factors, included in this Quarterly Report on Form 10-Q.
We have budgeted approximately $520 million for capital expenditures during the fourth quarter of 2025 through the end of 2027 to construct additional facilities to support the development and commercialization of our products and technologies. This amount is primarily dedicated to construction of a new Tyvaso DPI manufacturing facility in RTP; and construction of DPF facilities in Stewartville, Minnesota and Houston, Texas. We plan to fund these capital expenditures using cash on hand.
We anticipate our existing DPF facility in Virginia and the two planned DPF facilities in Minnesota and Texas will provide an initial commercial supply of our xeno-organ products if and when they are approved by the FDA. However, if our xeno-organ products are approved by the FDA, we likely will need to continue building additional DPF facilities to satisfy 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 and regulatory 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. While we have not seen a material impact on our net revenues as a result of Winrevair or Yutrepia's launch to date, our net revenues could be materially impacted if either or both of these products gain significant market share or cause material price erosion for our existing products.
| Quarterly Report | |||||
Part I. Financial Information
Results of Operations
Three and Nine Months Ended September 30, 2025 and September 30, 2024
Revenues
The table below presents the components of total revenues (dollars in millions):
|
Three Months Ended September 30, |
Dollar Change |
Percentage Change |
Nine Months Ended September 30, |
Dollar Change |
Percentage Change |
||||||||||||||||||||||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||||||||||||||||||||||||||
| Net product sales: | |||||||||||||||||||||||||||||||||||||||||||||||
|
Tyvaso DPI(1)
|
$ | 336.2 | $ | 274.6 | $ | 61.6 | 22 | % | $ | 953.9 | $ | 760.4 | $ | 193.5 | 25 | % | |||||||||||||||||||||||||||||||
|
Nebulized Tyvaso(1)
|
141.8 | 159.2 | (17.4) | (11) | % | 460.0 | 444.1 | 15.9 | 4 | % | |||||||||||||||||||||||||||||||||||||
| Total Tyvaso | 478.0 | 433.8 | 44.2 | 10 | % | 1,413.9 | 1,204.5 | 209.4 | 17 | % | |||||||||||||||||||||||||||||||||||||
|
Remodulin(2)
|
125.9 | 128.3 | (2.4) | (2) | % | 398.8 | 403.6 | (4.8) | (1) | % | |||||||||||||||||||||||||||||||||||||
| Orenitram | 131.1 | 113.2 | 17.9 | 16 | % | 375.7 | 326.5 | 49.2 | 15 | % | |||||||||||||||||||||||||||||||||||||
| Unituxin | 47.9 | 61.1 | (13.2) | (22) | % | 164.5 | 171.2 | (6.7) | (4) | % | |||||||||||||||||||||||||||||||||||||
| Adcirca | 9.7 | 7.0 | 2.7 | 39 | % | 22.2 | 19.1 | 3.1 | 16 | % | |||||||||||||||||||||||||||||||||||||
| Other | 6.9 | 5.5 | 1.4 | 25 | % | 17.4 | 16.6 | 0.8 | 5 | % | |||||||||||||||||||||||||||||||||||||
| Total revenues | $ | 799.5 | $ | 748.9 | $ | 50.6 | 7 | % | $ | 2,392.5 | $ | 2,141.5 | $ | 251.0 | 12 | % | |||||||||||||||||||||||||||||||
(1)Net product sales include both the drug product and the respective inhalation device.
(2)Net product sales include sales of infusion devices, including the Remunity Pump and the RemunityPRO Pump.
Total Tyvaso net product sales grew 10% to $478.0 million for the three months ended September 30, 2025, and 17% to $1,413.9 million for the nine months ended September 30, 2025, as compared to $433.8 million and $1,204.5 million for the same periods in 2024, respectively. Tyvaso DPI net product sales increased for the three and nine months ended September 30, 2025, as compared to the same periods in 2024, due to an increase in quantities sold of $58.1 million and $204.6 million, respectively, and, to a lesser extent, a price increase, partially offset by higher gross-to-net revenue deductions. The increase in Tyvaso DPI quantities sold was primarily due to continued growth in the number of patients following the product's launch and, to a lesser extent, increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the Inflation Reduction Act. Nebulized Tyvaso net product sales decreased for the three months ended September 30, 2025, as compared to the same period in 2024, primarily due to higher gross-to-net revenue deductions and a decrease in quantities sold. Nebulized Tyvaso net product sales increased for the nine months ended September 30, 2025, as compared to the same period in 2024, primarily due to a price increase and, to a lesser extent, an increase in international Nebulized Tyvaso net product sales, partially offset by higher gross-to-net revenue deductions.
Orenitram net product sales increased for the three and nine months ended September 30, 2025, as compared to the same periods in 2024, due to an increase in quantities sold of $11.7 million and $35.7 million, respectively and, to a lesser extent, a price increase. The increase in quantities sold was driven, at least in part, by increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the Inflation Reduction Act.
Unituxin net product sales decreased for the three and nine months ended September 30, 2025, as compared to the same periods in 2024, primarily due to a decrease in quantities sold, partially offset by a price increase.
We have entered into contracts with all of the major pharmacy benefit managers for Medicare Part D and commercial insurance plans, which provide rebates on utilization of Tyvaso DPI and, in some cases, Orenitram and Nebulized Tyvaso. Many of these rebates went into effect beginning in the second half of 2024 and have impacted our net revenues since such time by increasing gross-to-net deductions for the relevant products.
| United Therapeutics, a public benefit corporation | |||||
Part I. Financial Information
The table below presents the breakdown of total revenues between the United States and rest-of-world (ROW) (in millions):
|
Three Months Ended September 30,
|
|||||||||||||||||||||||
| 2025 | 2024 | ||||||||||||||||||||||
| U.S. | ROW | Total | U.S. | ROW | Total | ||||||||||||||||||
| Net product sales: | |||||||||||||||||||||||
|
Tyvaso DPI(1)
|
$ | 336.2 | $ | - | $ | 336.2 | $ | 274.6 | $ | - | $ | 274.6 | |||||||||||
|
Nebulized Tyvaso(1)
|
133.9 | 7.9 | 141.8 | 145.2 | 14.0 | 159.2 | |||||||||||||||||
|
Total Tyvaso
|
470.1 | 7.9 | 478.0 | 419.8 | 14.0 | 433.8 | |||||||||||||||||
|
Remodulin(2)
|
110.7 | 15.2 | 125.9 | 115.4 | 12.9 | 128.3 | |||||||||||||||||
|
Orenitram
|
131.1 | - | 131.1 | 113.2 | - | 113.2 | |||||||||||||||||
|
Unituxin
|
46.5 | 1.4 | 47.9 | 57.6 | 3.5 | 61.1 | |||||||||||||||||
|
Adcirca
|
9.7 | - | 9.7 | 7.0 | - | 7.0 | |||||||||||||||||
| Other | 6.7 | 0.2 | 6.9 | 4.3 | 1.2 | 5.5 | |||||||||||||||||
|
Total revenues
|
$ | 774.8 | $ | 24.7 | $ | 799.5 | $ | 717.3 | $ | 31.6 | $ | 748.9 | |||||||||||
|
Nine Months Ended September 30,
|
|||||||||||||||||||||||
| 2025 | 2024 | ||||||||||||||||||||||
| U.S. | ROW | Total | U.S. | ROW | Total | ||||||||||||||||||
| Net product sales: | |||||||||||||||||||||||
|
Tyvaso DPI(1)
|
$ | 953.5 | $ | 0.4 | $ | 953.9 | $ | 760.4 | $ | - | $ | 760.4 | |||||||||||
|
Nebulized Tyvaso(1)
|
413.0 | 47.0 | 460.0 | 409.1 | 35.0 | 444.1 | |||||||||||||||||
|
Total Tyvaso
|
1,366.5 | 47.4 | 1,413.9 | 1,169.5 | 35.0 | 1,204.5 | |||||||||||||||||
|
Remodulin(2)
|
344.6 | 54.2 | 398.8 | 346.2 | 57.4 | 403.6 | |||||||||||||||||
|
Orenitram
|
375.7 | - | 375.7 | 326.5 | - | 326.5 | |||||||||||||||||
|
Unituxin
|
158.8 | 5.7 | 164.5 | 157.8 | 13.4 | 171.2 | |||||||||||||||||
|
Adcirca
|
22.2 | - | 22.2 | 19.1 | - | 19.1 | |||||||||||||||||
| Other | 16.4 | 1.0 | 17.4 | 14.9 | 1.7 | 16.6 | |||||||||||||||||
|
Total revenues
|
$ | 2,284.2 | $ | 108.3 | $ | 2,392.5 | $ | 2,034.0 | $ | 107.5 | $ | 2,141.5 | |||||||||||
(1) Net product sales include both the drug product and the respective inhalation device.
(2) Net product sales include sales of infusion devices, including the Remunity Pump and the RemunityPRO Pump.
Gross-to-Net Deductions
We recognize revenues net of: (1) rebates and chargebacks; (2) prompt pay discounts; (3) allowance for sales returns; and (4) distributor fees. These are referred to as gross-to-net deductions and are primarily based on estimates reflecting historical experiences as well as contractual and statutory requirements. 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):
| Quarterly Report | |||||
Part I. Financial Information
| Three Months Ended September 30, 2025 | |||||||||||||||||||||||||||||
| Rebates and Chargebacks |
Prompt Pay Discounts
|
Allowance for Sales Returns
|
Distributor Fees
|
Total | |||||||||||||||||||||||||
| Balance, July 1, 2025 | $ | 173.8 | $ | 7.3 | $ | 1.6 | $ | 11.9 | $ | 194.6 | |||||||||||||||||||
| Provisions attributed to sales in: | |||||||||||||||||||||||||||||
| Current period | 126.4 | 18.6 | 0.3 | 10.2 | 155.5 | ||||||||||||||||||||||||
| Prior periods | (6.2) | - | (0.2) | (0.4) | (6.8) | ||||||||||||||||||||||||
| Payments or credits attributed to sales in: | |||||||||||||||||||||||||||||
| Current period | (18.2) | (13.0) | - | (1.6) | (32.8) | ||||||||||||||||||||||||
| Prior periods | (88.3) | (7.3) | (0.4) | (8.4) | (104.4) | ||||||||||||||||||||||||
| Balance, September 30, 2025 | $ | 187.5 | $ | 5.6 | $ | 1.3 | $ | 11.7 | $ | 206.1 | |||||||||||||||||||
| Three Months Ended September 30, 2024 | |||||||||||||||||||||||||||||
| Rebates and Chargebacks |
Prompt Pay Discounts
|
Allowance for Sales Returns
|
Distributor Fees
|
Total | |||||||||||||||||||||||||
| Balance, July 1, 2024 | $ | 115.8 | $ | 5.6 | $ | 1.9 | $ | 9.4 | $ | 132.7 | |||||||||||||||||||
| Provisions attributed to sales in: | |||||||||||||||||||||||||||||
| Current period | 90.7 | 16.4 | 0.3 | 10.7 | 118.1 | ||||||||||||||||||||||||
| Prior periods | (9.0) | - | 0.3 | 0.2 | (8.5) | ||||||||||||||||||||||||
| Payments or credits attributed to sales in: | |||||||||||||||||||||||||||||
| Current period | (15.8) | (10.2) | - | (2.1) | (28.1) | ||||||||||||||||||||||||
| Prior periods | (64.9) | (5.5) | (0.1) | (6.4) | (76.9) | ||||||||||||||||||||||||
| Balance, September 30, 2024 | $ | 116.8 | $ | 6.3 | $ | 2.4 | $ | 11.8 | $ | 137.3 | |||||||||||||||||||
| Nine Months Ended September 30, 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 | 375.1 | 55.5 | 0.7 | 31.2 | 462.5 | ||||||||||||||||||||||||
| Prior periods | 2.6 | 0.1 | - | (0.5) | 2.2 | ||||||||||||||||||||||||
| Payments or credits attributed to sales in: | |||||||||||||||||||||||||||||
| Current period | (202.3) | (49.9) | - | (19.6) | (271.8) | ||||||||||||||||||||||||
| Prior periods | (128.7) | (5.2) | (1.6) | (11.0) | (146.5) | ||||||||||||||||||||||||
| Balance, September 30, 2025 | $ | 187.5 | $ | 5.6 | $ | 1.3 | $ | 11.7 | $ | 206.1 | |||||||||||||||||||
| Nine Months Ended September 30, 2024 | |||||||||||||||||||||||||||||
| Rebates and Chargebacks | Prompt Pay Discounts | Allowance for Sales Returns | Distributor Fees | Total | |||||||||||||||||||||||||
| Balance, January 1, 2024 | $ | 108.4 | $ | 5.3 | $ | 1.9 | $ | 10.4 | $ | 126.0 | |||||||||||||||||||
| Provisions attributed to sales in: | |||||||||||||||||||||||||||||
| Current period | 252.5 | 47.5 | 1.5 | 31.0 | 332.5 | ||||||||||||||||||||||||
| Prior periods | (10.7) | - | (0.5) | (0.9) | (12.1) | ||||||||||||||||||||||||
| Payments or credits attributed to sales in: | |||||||||||||||||||||||||||||
| Current period | (137.9) | (41.2) | - | (19.4) | (198.5) | ||||||||||||||||||||||||
| Prior periods | (95.5) | (5.3) | (0.5) | (9.3) | (110.6) | ||||||||||||||||||||||||
| Balance, September 30, 2024 | $ | 116.8 | $ | 6.3 | $ | 2.4 | $ | 11.8 | $ | 137.3 | |||||||||||||||||||
| United Therapeutics, a public benefit corporation | |||||
Part I. Financial Information
Cost of Sales
The table below summarizes cost of sales by major category (dollars in millions):
|
Three Months Ended September 30, |
Dollar Change | Percentage Change |
Nine Months Ended September 30, |
Dollar Change |
Percentage Change |
||||||||||||||||||||||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||||||||||||||||||||||||||
| Category: | |||||||||||||||||||||||||||||||||||||||||||||||
| Cost of sales | $ | 100.0 | $ | 81.8 | $ | 18.2 | 22 | % | $ | 278.2 | $ | 229.5 | $ | 48.7 | 21 | % | |||||||||||||||||||||||||||||||
|
Share-based compensation expense(1)
|
0.9 | 1.3 | (0.4) | (31) | % | 2.8 | 4.3 | (1.5) | (35) | % | |||||||||||||||||||||||||||||||||||||
| Total cost of sales | $ | 100.9 | $ | 83.1 | $ | 17.8 | 21 | % | $ | 281.0 | $ | 233.8 | $ | 47.2 | 20 | % | |||||||||||||||||||||||||||||||
(1)See Share-Based Compensationsection below for discussion.
Cost of sales, excluding share-based compensation. Cost of sales for the three and nine months ended September 30, 2025 increased as compared to the same periods in 2024, primarily due to increases in: (1) royalty expense resulting from a growth in revenues; and (2) inventory reserve expense.
Research and Development
The table below summarizes the nature of research and development expense by major expense category (dollars in millions):
|
Three Months Ended September 30, |
Dollar Change | Percentage Change |
Nine Months Ended September 30, |
Dollar Change |
Percentage Change |
||||||||||||||||||||||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||||||||||||||||||||||||||
| Category: | |||||||||||||||||||||||||||||||||||||||||||||||
|
External research and development(1)
|
$ | 63.5 | $ | 51.7 | $ | 11.8 | 23 | % | $ | 183.1 | $ | 153.8 | $ | 29.3 | 19 | % | |||||||||||||||||||||||||||||||
|
Internal research and development(2)
|
50.8 | 43.9 | 6.9 | 16 | % | 155.0 | 133.3 | 21.7 | 16 | % | |||||||||||||||||||||||||||||||||||||
|
Share-based compensation expense(3)
|
8.4 | 7.4 | 1.0 | 14 | % | 23.4 | 22.4 | 1.0 | 4 | % | |||||||||||||||||||||||||||||||||||||
|
Other(4)
|
4.8 | 0.5 | 4.3 | 860 | % | 49.0 | 37.7 | 11.3 | 30 | % | |||||||||||||||||||||||||||||||||||||
| Total research and development expense | $ | 127.5 | $ | 103.5 | $ | 24.0 | 23 | % | $ | 410.5 | $ | 347.2 | $ | 63.3 | 18 | % | |||||||||||||||||||||||||||||||
(1)External research and developmentprimarily 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 developmentprimarily 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 Compensationsection below for discussion.
(4)Otherprimarily 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.Research and development expense for the three months ended September 30, 2025 increased as compared to the same period in 2024, primarily due to: (1) increased expenditures related to manufactured organ and organ alternative projects; and (2) a $5.0 million milestone payment for drug delivery technologies.
Research and development expense for the nine months ended September 30, 2025 increased as compared to the same period in 2024, primarily due to: (1) an increase of $40.0 million related to milestone payments for drug delivery technologies; (2) increased expenditures related to manufactured organ and organ alternative projects; and (3) $6.9 million related to adjustments to the fair value of contingent consideration obligations for manufactured organ and organ alternative projects, partially offset by (4) $36.0 million in upfront non-refundable license payments for drug delivery technologies in 2024.
| Quarterly Report | |||||
Part I. Financial Information
Selling, General, and Administrative
The table below summarizes selling, general, and administrative expense by major category (dollars in millions):
|
Three Months Ended September 30, |
Dollar Change | Percentage Change |
Nine Months Ended September 30, |
Dollar Change |
Percentage Change |
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| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||||||||||||||||||||||||||
| Category: | |||||||||||||||||||||||||||||||||||||||||||||||
|
General and administrative(1)
|
$ | 123.7 | $ | 100.4 | $ | 23.3 | 23 | % | $ | 372.9 | $ | 316.5 | $ | 56.4 | 18 | % | |||||||||||||||||||||||||||||||
|
Impairment of property, plant, and equipment (PP&E)
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- | - | - | - | % | 21.7 | - | 21.7 |
NM(2)
|
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Litigation accrual
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0.8 | 65.1 | (64.3) | (99) | % | 2.2 | 65.1 | (62.9) | (97) | % | |||||||||||||||||||||||||||||||||||||
| Sales and marketing | 28.3 | 20.7 | 7.6 | 37 | % | 85.9 | 69.3 | 16.6 | 24 | % | |||||||||||||||||||||||||||||||||||||
|
Share-based compensation expense(3)
|
29.8 | 33.0 | (3.2) | (10) | % | 82.5 | 90.3 | (7.8) | (9) | % | |||||||||||||||||||||||||||||||||||||
| Total selling, general, and administrative expense | $ | 182.6 | $ | 219.2 | $ | (36.6) | (17) | % | $ | 565.2 | $ | 541.2 | $ | 24.0 | 4 | % | |||||||||||||||||||||||||||||||
(1)Excluding impairment of PP&E and litigation accrual. See Impairment of PP&E and Litigation accrual sections below.
(2)Calculation is not meaningful.
(3)See Share-Based Compensationbelow for discussion.
General and administrative, excluding impairment of PP&E, litigation accrual, and share-based compensation. General and administrative expense for the three and nine months ended September 30, 2025 increased as compared to the same periods in 2024, primarily due to increases in: (1) personnel expense due to growth in headcount; (2) legal expenses related to litigation matters; and (3) branded prescription drug fee expense associated with sales of Tyvaso DPI.
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. In the third quarter of 2024, we accrued a liability of $65.1 million related to ongoing litigation with Sandoz. This liability was $73.3 million as of September 30, 2025. 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. The litigation accrual is included within selling, general, and administrativein our consolidated statements of operations.
Sales and marketing, excluding share-based compensation. Sales and marketing expense for the three and nine months ended September 30, 2025 increased as compared to the same periods in 2024, primarily due to increases in: (1) marketing expense; (2) personnel expense due to growth in headcount; and (3) sales commissions.
Share-Based Compensation
The table below summarizes share-based compensation expense by major category (dollars in millions):
|
Three Months Ended September 30, |
Dollar Change | Percentage Change |
Nine Months Ended September 30, |
Dollar Change |
Percentage Change |
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| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||||||||||||||||||||||||||
| Category: | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock options | $ | 11.3 | $ | 8.0 | $ | 3.3 | 41 | % | $ | 30.9 | $ | 21.8 | $ | 9.1 | 42 | % | |||||||||||||||||||||||||||||||
| Restricted stock units | 27.1 | 27.2 | (0.1) | - | % | 76.5 | 61.9 | 14.6 | 24 | % | |||||||||||||||||||||||||||||||||||||
| STAP awards | - | 5.9 | (5.9) | (100) | % | (0.8) | 31.7 | (32.5) | (103) | % | |||||||||||||||||||||||||||||||||||||
| Employee stock purchase plan | 0.7 | 0.6 | 0.1 | 17 | % | 2.1 | 1.6 | 0.5 | 31 | % | |||||||||||||||||||||||||||||||||||||
|
Total share-based compensation expense
|
$ | 39.1 | $ | 41.7 | $ | (2.6) | (6) | % | $ | 108.7 | $ | 117.0 | $ | (8.3) | (7) | % | |||||||||||||||||||||||||||||||
The table below summarizes share-based compensation expense by line item in our consolidated statements of operations (dollars in millions):
| United Therapeutics, a public benefit corporation | |||||
Part I. Financial Information
|
Three Months Ended September 30, |
Dollar Change | Percentage Change |
Nine Months Ended September 30, |
Dollar Change |
Percentage Change |
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| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||||||||||||||||||||||||||
| Cost of sales | $ | 0.9 | $ | 1.3 | $ | (0.4) | (31) | % | $ | 2.8 | $ | 4.3 | $ | (1.5) | (35) | % | |||||||||||||||||||||||||||||||
| Research and development | 8.4 | 7.4 | 1.0 | 14 | % | 23.4 | 22.4 | 1.0 | 4 | % | |||||||||||||||||||||||||||||||||||||
| Selling, general, and administrative | 29.8 | 33.0 | (3.2) | (10) | % | 82.5 | 90.3 | (7.8) | (9) | % | |||||||||||||||||||||||||||||||||||||
|
Total share-based compensation expense
|
$ | 39.1 | $ | 41.7 | $ | (2.6) | (6) | % | $ | 108.7 | $ | 117.0 | $ | (8.3) | (7) | % | |||||||||||||||||||||||||||||||
The decrease in share-based compensation expense for the nine months ended September 30, 2025, as compared to the same period in 2024, was primarily due to a decrease in STAP expense, as all remaining STAP awards were exercised during the first quarter of 2025, partially offset by: (1) an increase in restricted stock unit expense due to a greater number of performance-based restricted stock units outstanding during the nine months ended September 30, 2025, as compared to the same period in 2024; and (2) an increase in stock option expense due to a greater number of performance-based stock options unvested and outstanding during the nine months ended September 30, 2025, as compared to the same period in 2024. For more information, see Note 8-Share-Based Compensation to our consolidated financial statements.
Income Tax Expense
Income tax expense for the nine months ended September 30, 2025 and 2024 was $299.5 million and $248.7 million, respectively. Our effective income tax rate (ETR) for the nine months ended September 30, 2025 and 2024 was 24 percent and 22 percent, respectively. Our ETR for the nine months ended September 30, 2025 increased compared to our ETR for the nine months ended September 30, 2024, primarily due to year-over-year changes in actual and forecasted annual pre-tax earnings and a decrease in excess tax benefits from share-based compensation.
2025 Share Repurchase
In August 2025, we entered into two accelerated share repurchase agreements (the 2025 ASR agreements) with Citibank, N.A. (Citi) which comprise a $500 million uncollared stock repurchase agreement (the Uncollared ASR) and a $500 million collared stock repurchase agreement (the 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 Uncollared ASR and 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 Collared ASR, we received an additional 514,789 shares of our common stock on August 25, 2025.
The final number of shares that we will ultimately repurchase pursuant to the 2025 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 2025 ASR agreements. As discussed above, under the 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 2025 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 final settlement under the Uncollared ASR and Collared ASR is expected to occur in the fourth quarter of 2025 and the first quarter of 2026, respectively.
2024 Share Repurchase
In March 2024, we entered into an accelerated share repurchase agreement (the 2024 ASR agreement) with Citi. Under the 2024 ASR agreement, we made an aggregate upfront payment of $1.0 billion to Citi and received an aggregate initial delivery of 3,275,199 shares of our common stock on March 27, 2024, which represented approximately 80 percent of the total shares that would be repurchased under the 2024 ASR agreement, measured based on the closing price of our common stock on March 25, 2024.
The share repurchase under the 2024 ASR agreement was divided into two tranches, resulting in upfront payments of $300 million and $700 million, respectively. The final settlement of the $300 million tranche occurred in June 2024, and we received an additional 181,772 shares of our common stock upon settlement. The final settlement of the $700 million tranche occurred in September 2024, and we received an additional 90,403 shares of our common stock upon settlement. In total, we repurchased 3,547,374 shares of our common stock under the 2024 ASR agreement that we currently hold as treasury stock in our consolidated balance sheets.
| Quarterly Report | |||||
Part I. Financial Information
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 2030, was zero as of September 30, 2025. See Unsecured Revolving Credit Facilitiesbelow for further details.
Cash and Cash Equivalents and Marketable Investments
Cash and cash equivalents and marketable investments comprise the following (dollars in millions):
| September 30, 2025 | December 31, 2024 | Dollar Change | Percentage Change | |||||||||||||||||||||||
| Cash and cash equivalents | $ | 1,340.1 | $ | 1,697.2 | $ | (357.1) | (21) | % | ||||||||||||||||||
| Marketable investments-current | 1,427.5 | 1,569.8 | (142.3) | (9) | % | |||||||||||||||||||||
| Marketable investments-non-current | 1,567.3 | 1,475.3 | 92.0 | 6 | % | |||||||||||||||||||||
| Total cash and cash equivalents and marketable investments | $ | 4,334.9 | $ | 4,742.3 | $ | (407.4) | (9) | % | ||||||||||||||||||
Cash Flows
Cash flows comprise the following (dollars in millions):
| Nine Months Ended September 30, | Dollar Change | Percentage Change | |||||||||||||||||||||
| 2025 | 2024 | ||||||||||||||||||||||
| Net cash provided by operating activities | $ | 1,215.0 | $ | 985.9 | $ | 229.1 | 23 | % | |||||||||||||||
|
Net cash (used in) provided by investing activities
|
$ | (323.7) | $ | 540.4 | $ | (864.1) | (160) | % | |||||||||||||||
|
Net cash used in financing activities
|
$ | (1,248.4) | $ | (1,180.1) | $ | (68.3) | (6) | % | |||||||||||||||
Operating Activities
Our operating assets and liabilities consist primarily of accounts receivable, inventories, accounts payable, accrued expenses, and tax-related payables and receivables.
The increase of $229.1 million in net cash provided by operating activities for the nine months ended September 30, 2025, as compared to the same period in 2024, was primarily due to an increase in net cash received due to growth in sales of our commercial products.
Investing Activities
The increase of $864.1 million in net cash used in investing activities for the nine months ended September 30, 2025, as compared to the same period in 2024, was primarily due to: (1) a $648.3 million increase in cash used for total purchases, sales, and maturities of marketable investments; (2) a $187.8 million increase in cash paid to purchase property, plant, and equipment; and (3) a $29.5 million increase in cash paid to purchase an investment in a privately-held company.
Financing Activities
The increase of $68.3 million in net cash used in financing activities for the nine months ended September 30, 2025, as compared to the same period in 2024, was primarily due to a $51.9 million decrease in proceeds from the exercise of stock options.
| United Therapeutics, a public benefit corporation | |||||
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, providing 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 funds to repay all outstanding indebtedness under the 2022 Credit Agreement in connection with its termination. During the second quarter of 2025, we paid down 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 September 30, 2025. Refer to Note 7-Debt-2025 Credit Agreementto 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 Operationsin our 2024 Annual Report. There have been no material changes to our critical accounting policies and estimates as disclosed in our 2024 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 October 29, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on October 29, 2025 at 10:33 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]