UNITED THERAPEUTICS Corp

Previous wording

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations and other sections of this report contain forward-looking statements made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934 (the Exchange Act) and the Private Securities Litigation Reform Act of 1995. These statements, which are based on our beliefs and expectations about future outcomes and on information available to us through the date this Report is filed with the SEC, include, among others, statements related to the following:

Current wording

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, as amended (the Exchange Act) and the Private Securities Litigation Reform Act of 1995. These statements, which are based on our beliefs and expectations about future outcomes and on information available to us through the date this Report is filed with the SEC, include, among others, statements related to the following:

Previous wording

•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;

Current wording

•The expected volume and timing of sales of our commercial products, as well as potential future commercial products, including the anticipated effect of various sales, marketing, research and development efforts on sales of these products;

Previous wording

•The timing and outcome of clinical studies, other research and development efforts, and related regulatory filings and approvals, including our efforts to obtain FDA approval for Nebulized Tyvaso to treat IPF and ralinepag extended-release tablets to treat PAH;

Current wording

•The timing and outcome of clinical studies, other research and development efforts, and related regulatory filings and approvals, including our efforts to obtain FDA approval for Nebulized Tyvaso to treat IPF and ralinepag extended-release tablets to treat PAH and the potential impact of quality issues affecting our suppliers on such efforts;

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; 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.;

Current wording

•The timing and outcome of ongoing litigation, including 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

•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.

Current wording

•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. We have no plans to enter into an amendment to extend the term of the license, and our rights to commercialize Adcirca will terminate upon its expiration.

Previous wording

Our total revenues consist primarily of sales of the commercial products noted above, including the delivery devices (in the case of Tyvaso DPI, Nebulized Tyvaso, and Remodulin). We have entered into separate, non-exclusive distribution agreements with Accredo Health Group, Inc. and its affiliates (Accredo) and Caremark, L.L.C. (CVS Specialty) to distribute Tyvaso DPI, Nebulized Tyvaso, Remodulin, the Remunity and RemunityPRO Pumps, and Orenitram in the United States, and we have entered into an exclusive distribution agreement with Cencora Global Procurement Ltd. to distribute Unituxin in the United States. We also sell Nebulized Tyvaso, Remodulin, and Unituxin to distributors internationally. We sell Adcirca through Lilly’s pharmaceutical wholesale network. To the extent we have increased the price of any of these products, increases have typically been in the single-digit percentages per year, except for Adcirca, the price of which is set solely by Lilly. We also derive revenues from the sale of commercialex vivo lung perfusion services, which are presented under Other within Note 11—Segment Information to our consolidated financial statements included in this Report.

Current wording

Our total revenues consist primarily of sales of the commercial products noted above, including the delivery devices (in the case of Tyvaso DPI, Nebulized Tyvaso, and Remodulin). We have entered into separate, non-exclusive distribution agreements with Accredo Health Group, Inc. and its affiliates (Accredo) and Caremark, L.L.C. (CVS Specialty) to distribute Tyvaso DPI, Nebulized Tyvaso, Remodulin, the Remunity and RemunityPRO Pumps, and Orenitram in the United States, and we have entered into an exclusive distribution agreement with Cencora Global Procurement Ltd. to distribute Unituxin in the United States. We also sell Nebulized Tyvaso, Remodulin, and Unituxin to distributors internationally. We currently sell Adcirca through Lilly’s pharmaceutical wholesale network. To the extent we have increased the price of any of our 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 commercialex vivo lung perfusion services, which are presented under Other within Note 11—Segment Information to our consolidated financial statements included in this Report.

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 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.

Current wording

We settled litigation with Sandoz Inc. (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, 2026, we have seen limited erosion of Remodulin sales as a result of generic treprostinil competition in the United States. We recently entered into an agreement with Liquidia to settle the litigation brought against us by Sandoz and its former marketing partner, RareGen, LLC (now known as Liquidia PAH, LLC, a subsidiary of Liquidia Corporation, the parent company of Liquidia) (RareGen), related to the infusion devices used to administer Remodulin subcutaneously, and the case was dismissed by the District Court on October 28, 2026. 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

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, 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.

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 to acquire certain in-process research and development (IPR&D) assets, costs for third-party arrangements, including upfront fees and milestone payments required under license arrangements for therapies under development (including the $525.0 million payment we made to Arena Pharmaceuticals, Inc., a subsidiary of Pfizer Inc. (Arena) on November 3, 2026 in connection with an amendment to our licensing agreement with Arena (the Arena Amendment), discussed below, which we expect to record during the fourth quarter of 2026), 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 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.

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 first and second quarters of 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

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.

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. 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. In September 2026, we were notified that the FDA had accepted our sNDA with a user fee goal date of April 26, 2027. 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

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 completed enrollment of the study in

Previous wording

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

Current wording

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

Previous wording

We and our distributors will also consider seeking amendments to the marketing authorizations for Nebulized Tyvaso in other countries where it is approved, to include IPF and/or PPF indications, and we will also consider seeking approval of Nebulized Tyvaso for these indications in countries where it is not yet approved. We also plan to seek FDA approval to expand the Tyvaso DPI label to include IPF and/or PPF, as applicable, following completion of any FDA-required bridging studies. Based on preliminary feedback from the FDA, these bridging studies may include pivotal clinical trials to establish safety and efficacy of Tyvaso DPI for treating patients with IPF and PPF. Both the FDA and the European Medicines Agency have granted orphan designation for treprostinil to treat IPF.

Current wording

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. Based on FDA pre-IND feedback, we are preparing an Investigational New Drug application (IND) to enable us to conduct a pivotal clinical trial of Tyvaso DPI to treat patients with IPF. We intend to conduct a similar study to treat patients with PPF pending the outcome of TETON-PPF. Both the FDA and the European Medicines Agency (EMA) have granted orphan designation for treprostinil to treat IPF. In October 2026, our distributor Grupo Ferrer announced that the EMA accepted for review its marketing authorization application for Nebulized Tyvaso to treat IPF.

Previous wording

We are developing a version of inhaled treprostinil that will be a drug-device combination consisting of treprostinil solution and a device known as a soft mist inhaler (SMI). SMI devices are propellant-free, hand-held mechanical devices that deliver an aerosol cloud of medication via a single breath. SMI devices would be more convenient for our patients than the current Tyvaso nebulizer, which requires several breaths using a much larger device that needs electricity. SMI devices are pocket-sized and disposable, and would be delivered with a pre-filled, multi-dose cartridge of drug product that is stored at room temperature and easily inserted into the device to begin use. Due to the multi-dose cartridge, which is intended to provide sufficient doses for up to 14 days of use, there is no need to fill the SMI device every day like a nebulizer. SMI devices may also provide a favorable adverse event profile compared to dry powder inhalers. We are targeting the same indications for which Nebulized Tyvaso is already approved (PAH and PH-ILD), as well as those for which we plan to seek FDA approval in the future (IPF and PPF), following completion of any FDA-required bridging studies. We are currently conducting pivotal pharmacokinetic studies to establish comparability between treprostinil SMI and Nebulized Tyvaso, to support a 505(b)(1) NDA for PAH and PH-ILD. Additionally, we are preparing an IND to enable us to conduct a phase 2 study of treprostinil SMI to treat patients with pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD).

Current wording

We are developing a version of inhaled treprostinil that will be a drug-device combination consisting of treprostinil solution and a device known as a soft mist inhaler (SMI). SMI devices are propellant-free, hand-held mechanical devices with no compressor, tubing, or power source, which deliver an aerosol cloud of medication via a single breath. SMI devices would be more convenient for our patients than the current Tyvaso nebulizer, which requires several breaths using a much larger, electrically powered device. SMI devices are pocket-sized and disposable, require low upkeep, and include a pre-filled, multi-dose cartridge of drug product that is stored at room temperature and easily inserted into the device to begin use. Due to the multi-dose cartridge, which is intended to provide sufficient doses for up to 14 days of use, there is no need to fill the SMI device every day like a nebulizer. SMI devices may offer a more favorable tolerability profile than dry powder inhalers in patients prone to cough. We are targeting the same indications for which Nebulized Tyvaso is already approved (PAH and PH-ILD), as well as those for which we plan to seek FDA approval in the future (IPF and PPF), following completion of pivotal safety and efficacy trials. We are currently conducting pivotal pharmacokinetic studies to establish comparability between treprostinil SMI and Nebulized Tyvaso, to support a 505(b)(1) NDA for PAH and PH-ILD. In September 2026, we submitted an IND to the FDA to enable us to conduct a phase 2 study (known as SUMMIT) of treprostinil SMI to treat patients with pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). In October 2026, this IND cleared, and we are preparing to commence the SUMMIT study.

Previous wording

We are developing a fixed-dose, drug-device combination product consisting of treprostinil and iloprost solution and an SMI. We are targeting this product forpro re nata (PRN), or “as-needed,” use for PAH patients whose primary therapy is either an oral or inhaled prostacyclin-class therapy who may from time to time need a bridge between doses due to exercise activity. Iloprost is a prostacyclin-class therapy that is approved by the FDA to treat PAH via nebulized inhalation solution. Based on a preclinical research study, we believe there may be beneficial synergies when treprostinil and iloprost are dosed together on a PRN basis. We have completed pre-IND engagement with the FDA and are in the process of preparing an IND. Once the IND is cleared, we plan to proceed to a phase 1 pharmacokinetics and safety study in healthy volunteers, and eventually, a pivotal efficacy study in PAH patients.

Current wording

We are developing a fixed-dose, drug-device combination product consisting of treprostinil and iloprost solution and an SMI. We are targeting this product forpro re nata (PRN), or “as-needed,” use for PAH patients whose primary therapy is either an oral or inhaled prostacyclin-class therapy who may from time to time need a bridge between doses to provide episodic PAH symptom relief. Iloprost is a prostacyclin-class therapy that is approved by the FDA to treat PAH via nebulized inhalation solution. Based on a preclinical research study, we believe there may be beneficial synergies when treprostinil and iloprost are dosed together on a PRN basis. In October 2026, our IND with the FDA was cleared, enabling us to commence a phase 1 pharmacokinetics and safety study in healthy volunteers, and eventually, a pivotal efficacy study in PAH patients.

Previous wording

Benefits were consistent across all patient subgroups, including time since diagnosis, disease etiology, baseline 6MWD, and use of background therapies, reinforcing the robustness of the treatment effect and the potential broad therapeutic relevance of ralinepag. Treatment with ralinepag was well-tolerated and the safety profile was consistent with known prostacyclin-related adverse events. No new safety signals were observed.

Current wording

Benefits were consistent across all patient subgroups, including time since diagnosis, disease etiology, baseline 6MWD, and use of background therapies, reinforcing the robustness of the treatment effect and the potential broad therapeutic relevance of ralinepag. Treatment with ralinepag was well-tolerated and the safety profile was consistent with known prostacyclin-related adverse events.

Previous 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.

Current wording

If and when 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 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.

Current wording

We are developing an oral triple combination therapy consisting of multiple strengths of ralinepag, an endothelin receptor antagonist (ERA), and a PDE-5 inhibitor intended to provide 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. We have completed formulation development and dosage design work and proposed to the FDA that we would conduct an initial study in healthy volunteers to demonstrate bioequivalence between the triple combo product and the three individual drugs. In October 2026, we received feedback from the FDA indicating that this study would not be sufficient to support approval, and that a full factorial pivotal clinical study would be needed to assess the safety and efficacy of the individual components of the product, which would include arms that would limit patients’ available therapeutic options for the duration of the study. Due to the challenges in executing such a study, this program is paused while we consider alternative development pathways.

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 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.

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 characterize the pharmacokinetic profile of ralinepag inhalation powder, and evaluate systemic exposure relative to oral ralinepag extended-release tablets. This study will inform our subsequent clinical development plans. We initially intend to seek FDA approval of ralinepag DPI for PH-ILD. We also plan to seek approval for the treatment of IPF and PPF, which will require us to 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. In October 2026, we completed construction of 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

Current wording

In January 2025, the FDA cleared our 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 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 and biologic approvals. The first transplant in this study occurred in the fourth quarter of 2025, and the study is ongoing.

Previous wording

In February 2024, we completed a designated pathogen-free (DPF) facility in Virginia. We expect this DPF facility to supply xenografts compliant with FDA current Good Manufacturing Practices (cGMP) for human clinical trials, with a target capacity of up to 125 organs per year. We are constructing two additional DPF facilities in Minnesota and Texas. While we believe these DPF facilities will be capable of producing organs for commercial use, we are also planning to build additional and potentially larger cGMP DPF facilities for commercial use. While these projects will be capital-intensive, the timing and volume of these expenditures will be staggered and paced in a manner intended to balance our need to address market demand as soon as possible following FDA approval with the need to defer the most significant capital expenditures until we achieve certain clinical trial milestones.

Current wording

In February 2024, we completed a designated pathogen-free (DPF) facility in Virginia. We expect this DPF facility to supply xenografts compliant with FDA cGMP for human clinical trials, with a target capacity of up to 125 organs per year. In August and October 2026, we completed construction of two additional DPF facilities of similar size and capacity to the Virginia facility in Minnesota and Texas, respectively. While we believe these DPF facilities will be capable of producing organs for commercial use, we are also planning to build additional and potentially larger cGMP DPF facilities for commercial use. While these projects will be capital-intensive, the timing and volume of these expenditures will be staggered and paced in a manner intended to balance our need to address market demand as soon as possible following FDA approval with the need to defer the most significant capital expenditures until we achieve certain clinical trial milestones.

Previous wording

Beginning in 2017, we entered into a series of agreements with BETA Technologies, Inc. to support the development of all-electric aircraft to help us meet our future distribution requirements for manufactured organs and organ alternatives. In October 2021, we successfully completed the first-ever drone delivery of a human lung for transplant at Toronto General Hospital, demonstrating the feasibility of our goal of delivering our manufactured organs and organ alternatives with zero carbon footprint aircraft. In October 2024, we entered into a collaboration agreement with Robinson Helicopter Company to support our efforts to develop and certify zero-emission, hydrogen-electric powered helicopters based on Robinson’s R44 and R66 helicopter models. In March 2025, wecompleted what we believe was the world’s first successful test flight of a piloted hydrogen-electric powered helicopter at our test and development facility located in Quebec.

Current wording

Hospital, demonstrating the feasibility of our goal of delivering our manufactured organs and organ alternatives with zero carbon footprint aircraft. In October 2024, we entered into a collaboration agreement with Robinson Helicopter Company to support our efforts to develop and certify zero-emission, hydrogen-electric powered helicopters based on Robinson’s R44 and R66 helicopter models. In March 2025, wecompleted what we believe was the world’s first successful test flight of a piloted hydrogen-electric powered helicopter at our test and development facility located in Quebec.

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)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, including as a result of the expected removal of PH-ILD from the Yutrepia label; (2) growth in the number of PH-ILD patients prescribed Tyvaso DPI and Nebulized Tyvaso, which we believe will accelerate as a result of the anticipated removal of PH-ILD from the Yutrepia label; (3) the launch of ralinepag extended-release tablets for PAH, following FDA approval; (4) the launch of Nebulized Tyvaso for the treatment of 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

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 and the effects of our patient access programs on the timing and amount of revenues; (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) competition within our industry, including competition from generic companies, competition from Winrevair and Yutrepia, which launched in the United States in 2024 and 2025, respectively, competition from Boehringer’s Jascayd, which was approved for IPF and PPF in the fourth quarter of 2025; and the potential launch of new branded and generic therapies for PAH, PH-ILD, IPF, and/or PPF, such as Insmed Incorporated’s treprostinil palmitil inhalation powder (TPIP) and Liquidia’s L606; (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.

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. 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.

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. In October 2026, we entered into the Settlement Agreement with Liquidia which requires Liquidia to, among other actions, file with the FDA an amendment to its NDA for Yutrepia to remove the PH-ILD indication and references to PH-ILD from the product’s labeling. 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. We believe revenues from our existing product portfolio will grow, particularly given the

Previous 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.

Current wording

Total Tyvaso net product sales increased five percent to $503.8 million for the three months ended September 30, 2026, as compared to $478.0 million for the same period in 2025, driven by an increase in Tyvaso DPI net product sales, partially offset by a decrease in Nebulized Tyvaso net product sales. For the nine months ended September 30, 2026, total Tyvaso net product sales were unchanged as compared to the same period in 2025, as an increase in Tyvaso DPI net product sales was offset by a decrease in Nebulized Tyvaso net product sales.

Previous wording

Tyvaso DPI net product sales increased for the three and six months ended June 30, 2026, as compared to the same periods in 2025, primarily due to an increase in quantities sold of $6.9 million and $22.9 million, respectively, and a price increase of $9.4 million and $20.9 million, respectively, partially offset by higher gross-to-net deductions.

Current wording

Tyvaso DPI net product sales increased for the three and nine months ended September 30, 2026, as compared to the same periods in 2025, primarily due to an increase in quantities sold of $43.9 million and $66.8 million, respectively, and a price increase, partially offset by an increase in gross-to-net deductions.

Previous 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.

Current wording

Nebulized Tyvaso net product sales decreased for the three and nine months ended September 30, 2026, as compared to the same periods in 2025, primarily due to a decrease in U.S. quantities sold of $20.0 million and $90.9 million, respectively, partially offset by a price increase.

Previous wording

Remodulin 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 $12.3 million and $23.4 million, respectively, partially offset by an increase in international Remodulin net product sales.

Current wording

Remodulin net product sales decreased for the nine months ended September 30, 2026, as compared to the same period in 2025, primarily due to a decrease in U.S. quantities sold of $25.2 million, partially offset by an increase in international Remodulin net product sales.

Previous wording

We believe the availability of competitive therapies negatively impacted sales of Nebulized Tyvaso, Tyvaso DPI, and Remodulin for the three and six months ended June 30, 2026.

Current wording

We believe the availability of competitive therapies negatively impacted sales of Nebulized Tyvaso, Tyvaso DPI, and Remodulin for the three and nine months ended September 30, 2026.

Previous 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.

Current wording

Orenitram net product sales increased for the three and nine months ended September 30, 2026, as compared to the same periods in 2025, primarily due to an increase in quantities sold of $14.9 million and $27.1 million, respectively, and a price increase, partially offset by an increase in gross-to-net deductions.

Previous wording

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

Current wording

(1)See Share-Based Compensation below.

Previous 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.

Current wording

Cost of sales, excluding share-based compensation. The increase in cost of sales for the nine months ended September 30, 2026, as compared to the same period in 2025, was primarily due to an increase in inventory reserve expense. Of this increased amount for the nine-month period, $34.4 million 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 below for discussion.

Current wording

(3)See Share-Based Compensation below.

Previous wording

(4)Other primarily includes upfront fees and milestone payments to third parties under license agreements related to development-stage products and adjustments to the fair value of our contingent consideration obligations.

Current wording

(4)Other primarily includes costs to acquire certain IPR&D assets, 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.

Previous wording

Research and development, excluding share-based compensation. The increase in research and development expense for the three 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 the fair value of our contingent consideration obligations for manufactured organ and organ alternative projects obtained through acquisition.

Current wording

Research and development, excluding share-based compensation. The increase in research and development expense for the three months ended September 30, 2026, as compared to the same period in 2025, was primarily due to: (1) an increase in IPR&D expense in connection with the acquisition of Thymmune, which we accounted for as an asset acquisition; (2) an increase in expenditures related to manufactured organ and organ alternative projects; and (3) an increase in expenditures related to cardiopulmonary treatment projects.

Previous 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.

Current wording

The increase in research and development expense for the nine months ended September 30, 2026, as compared to the same period in 2025, was primarily due to: (1) an increase in IPR&D expense in connection with the asset acquisition of Thymmune; (2) an increase in expenditures related to cardiopulmonary treatment projects; and (3) an increase in expenditures related to manufactured organ and organ alternative projects, partially offset by a decrease in milestone payments for drug delivery device technologies.

Previous wording

(1)Excluding impairment of PP&E. See Impairment of PP&Esection below.

Current wording

(1)Excluding impairment of PP&E and litigation accrual. See Impairment of PP&Eand litigation accrual sections below.

Previous wording

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

Current wording

(2)See Share-Based Compensation below.

Previous wording

General and administrative, excluding impairment of PP&E and share-based compensation. The increase in general and administrative expense for the three and six months ended June 30, 2026, as compared to the same periods in 2025, was primarily due to: (1) an increase in personnel expense due to growth in headcount; and (2) an increase in consulting expenses, partially offset by a decrease in legal expenses related to litigation matters.

Current wording

General and administrative, excluding impairment of PP&E, litigation accrual, and share-based compensation. The increase in general and administrative expense for the three months ended September 30, 2026, as compared to the same period in 2025, was primarily due to: (1) an increase in personnel expense due to growth in headcount; (2) an increase in legal expenses related to litigation matters; and (3) an increase in consulting expenses.