UNITED THERAPEUTICS Corp

Previous wording

•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;

Current wording

•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; our litigation with Humana Inc., United Healthcare Services, Inc., MSP Recovery Claims, Series LLC, and related entities; and the lawsuit filed against us by Boehringer Ingelheim Pharmaceuticals, Inc.;

Previous wording

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.

Current wording

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 June 30, 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 supporting efforts to develop a new subcutaneous infusion system for its generic treprostinil product. See Note 12—Litigation, to our consolidated financial statements included in this Report.

Previous wording

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.

Current wording

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 using a specified dosage regimen. This patent expires in May 2027.

Previous wording

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.

Current wording

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 have in the past been, and could in the future be, invalidated, found unenforceable, or found not to cover one or more generic forms of our products. If another 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 further adverse impact on our treprostinil-based product revenues, our profits, and our stock price. These potential effects are inherently difficult to predict, and could be significant. For additional discussion, see the risk factor entitled, Limitations on our intellectual property rights may limit our ability to prevent third parties from competing with our products, and we may not prevail in litigation to enforce or defend those rights, contained in Part II, Item 1A—Risk Factors included in this Report.

Previous wording

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.

Current wording

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, and adjustments to the fair value of our contingent consideration obligations. We do not track fully burdened research and development expenses by individual product candidate.

Previous wording

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.

Current wording

Currently, we grant stock options and restricted stock units under the United Therapeutics Corporation 2026 Stock Incentive Plan (the 2026 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 United Therapeutics Corporation Amended and Restated 2015 Stock Incentive Plan (the Prior Plan), including during the six months ended June 30, 2026, and our Share Tracking Awards Plan (the STAP). The 2026 Plan replaced the Prior Plan and no further awards may be granted under the Prior Plan, although awards previously granted under the Prior Plan remain outstanding in accordance with their terms. Issuance of awards under the STAP was discontinued in 2015 and all remaining outstanding STAP awards were exercised during the first quarter of 2025.

Previous wording

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.

Current wording

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. Data from the TETON-1 study, and combined analyses of data from the TETON-1 and TETON-2 studies, were published in The New England Journal of Medicine in May 2026.

Previous wording

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.

Current wording

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. In June 2026, we submitted a supplemental NDA (sNDA) to the FDA to add IPF to the labeled indications for Nebulized Tyvaso. We believe there are approximately 100,000 IPF patients in the United States.

Previous wording

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-PPFstudy. While estimates vary, we believe the size of the U.S. PPF population is approximately 200,000 patients.

Current wording

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

Previous wording

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.

Current wording

In June 2026, we submitted an NDA to the FDA seeking approval to market ralinepag extended-release tablets for PAH. 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.

Previous wording

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

Current wording

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 our proposed clinical development strategy. 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.

Previous wording

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.

Current wording

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 conducting IND-enabling non-clinical studies. In parallel, we are planning a 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 us to file separate INDs, and conduct 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.

Previous wording

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.

Current wording

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

Previous wording

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

Current wording

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 scope to the EXPAND study described above. In May 2026, the FDA granted clearance under our IND to proceed with a clinical study of our UHeart product. The study, which is known as the EXPRESS study, is expected to enroll an initial cohort of up to two adult patients with advanced heart failure. Following FDA review of available safety and efficacy data from the initial two transplants, the study may then be further expanded, with the intent to support a BLA with the FDA.

Previous wording

•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 miroliver ELAP®, uses a decellularized porcine liver matrix that has been seeded with human-derived cells and an extracorporeal blood circuit to maintain liver support in patients experiencing acute liver failure. 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 miroliver ELAP 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 miroliver ELAP 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.

Current wording

•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 kidney and liver alternatives composed of human primary cells. The development-stage Miromatrix external liver assist product, called miroliver ELAP®, uses a decellularized porcine liver matrix that has been seeded with human-derived cells and an extracorporeal blood circuit to maintain liver support in patients experiencing acute liver failure. 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 miroliver ELAP 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 miroliver ELAP 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.

Previous wording

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.

Current wording

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 June 2026, Lung Bioengineering obtained FDA approval of a premarket approval application (PMA) for another centralized EVLP technology known as the LungFX™ system (formerly referred to as the Centralized Lung Evaluation System, or CLES). LungFX is the first device approved for centralized EVLP for donor organs not otherwise used for transplant. Lung Bioengineering expects to add LungFX to its commercially available services in 2027.

Previous wording

Over 750 patients have received lung transplants following use of our centralized EVLP service.

Current wording

Over 800 patients have received lung transplants following use of our centralized EVLP services.

Previous wording

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.

Current wording

We anticipate that revenue growth over the near-term will be driven primarily by: (1) continued growth in sales of Tyvaso DPI; (2)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.

Previous wording

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.

Current wording

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

Previous wording

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.

Current wording

We have budgeted approximately $180 million for capital expenditures for the period July 1, 2026 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.

Previous wording

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.

Current wording

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. Competition from these products has adversely affected our treprostinil-based product sales, and competition from these and any future approved products could materially adversely affect our revenues. Despite this increase in competition, we believe revenues from our existing product portfolio will 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.

Previous wording

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.

Current wording

Total Tyvaso net product sales decreased four percent to $452.6 million for the three months ended June 30, 2026, and three percent to $910.1 million for the six months ended June 30, 2026, as compared to $469.6 million and $935.9 million for the same periods in 2025, respectively, driven by a decrease in Nebulized Tyvaso net product sales, partially offset by growth in Tyvaso DPI net product sales.

Previous wording

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.

Current wording

Nebulized Tyvaso net product sales decreased for the three and six months ended June 30, 2026, as compared to the same periods in 2025, primarily due to a decrease in U.S. quantities sold of $37.6 million and $70.9 million, respectively, partially offset by a price increase.

Previous wording

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.

Current wording

Orenitram net product sales increased for the six months ended June 30, 2026, as compared to the same period in 2025, primarily due to an increase in quantities sold of $12.2 million.

Previous wording

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):

Current wording

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 gross-to-net deductions (in millions):

Previous wording

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.

Current wording

Cost of sales, excluding share-based compensation. The increase in cost of sales for the three and six months ended June 30, 2026, as compared to the same periods in 2025, was primarily due to an increase in inventory reserve expense. Of these increased amounts for the three- and six-month periods, $7.5 million and $34.3 million, respectively, related to estimated losses under a commercial supply agreement intended to provide sufficient Tyvaso DPI inventory to meet the needs of our patients.

Previous wording

(3)See Share-Based Compensation section below for discussion.

Current wording

(3)See Share-Based Compensation below for discussion.

Previous wording

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.

Current wording

The increase in research and development expense for the six months ended June 30, 2026, as compared to the same period in 2025, was primarily due to: (1) an increase in expenditures related to cardiopulmonary treatment projects; and (2) an increase in personnel expense due to growth in headcount, partially offset by a decrease in milestone payments for drug delivery device technologies.

Previous wording

The change inother 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—Investmentsand Note 4—Fair Value Measurements to our consolidated financial statements.

Current wording

Other income (expense), net for the three months ended June 30, 2026 and 2025 was $13.3 million in income and $0.1 million in expense, respectively. Other income (expense), net for the six months ended June 30, 2026 and 2025 was $33.0 million and $4.4 million in expense, respectively. The changes in both periods were primarily due to net unrealized gains and losses on equity securities. See Note 3—Investmentsand Note 4—Fair Value Measurements to our consolidated financial statements.

Previous wording

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.

Current wording

Income tax expense for the six months ended June 30, 2026 and 2025 was $83.1 million and $200.2 million, respectively. Our effective income tax rate (ETR) for the six months ended June 30, 2026 and 2025 was 12 percent and 24 percent, respectively. Our ETR for the six months ended June 30, 2026 decreased compared to our ETR for the six months ended June 30, 2025, primarily due to increased excess tax benefits from share-based compensation.

Previous wording

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.

Current wording

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 the 2026 ASR agreements with Citibank, N.A. (Citi) which were comprised of 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 on March 11, 2026, and we received initial deliveries of 992,120 and 708,657 shares of our common stock, 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 settlement of the 2026 Uncollared ASR occurred in June 2026, and we received an additional 378,936 shares of our common stock upon settlement. The final settlement of the 2026 Collared ASR occurred in August 2026, and we received 215,948 shares of our common stock upon settlement. In total, we repurchased 2,759,343 shares of our common stock under the 2026 ASR agreements, of which 2,543,395 were held as treasury stock in our consolidated balance sheets as of June 30, 2026.

Previous wording

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.

Current wording

The final number of shares that we ultimately repurchased pursuant to the 2026 Uncollared ASR was 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 Uncollared ASR.

Previous wording

As of March 31, 2026, $500 million remained available under our Board’s share repurchase authorization through March 9, 2027.

Current wording

As of June 30, 2026, $500 million remained available under the share repurchase program authorized by our Board for purchases through March 9, 2027.

Previous wording

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

Current wording

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 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.

Previous wording

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.

Current wording

The increase of $1,295.8 million in net cash provided by investing activities for the six months ended June 30, 2026, as compared to the same period in 2025, was primarily due to a $1,389.1 million increase in cash provided by sales and maturities of marketable investments, net of purchases, partially offset by: (1) a $71.7 million increase in cash paid to purchase

Previous wording

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.

Current wording

The increase of $1,069.6 million in net cash used in financing activities for the six months ended June 30, 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 net $300.0 million decrease in cash used for our line of credit; and (2) a $159.9 million increase in proceeds from the exercise of stock options.