Associated Pulmonary Arterial Hypertension

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--( BUSINESS WIRE )--United Therapeutics Corporation (Nasdaq: UTHR ), a public benefit corporation, today announced that five presentations and one poster across its commercial and development portfolio will be presented at the CHEST 2024 Annual Meeting hosted by the American College of Chest Physicians taking place October 6-9, 2024, in Boston. United Therapeutics will sponsor the Tyvaso DPI®: Clinical Pearls and Drug-Device Characteristics Symposium . In addition, United Therapeutics is proud to sponsor the Women in Chest Medicine Annual Luncheon and the Advanced Practice Providers ( APPs ) in Chest Medicine Forum. “The CHEST Annual Meeting remains an important event for United Therapeutics and the pulmonary hypertension community, and this year we are excited to share additional analyses, particularly from the BREEZE open-label extension study, that continue to expand on these important learnings,” said Andrew Nelsen, PharmD , Vice President, Global Medical Affairs at United Therapeutics. “Equally, we are proud to sponsor a symposium entitled Tyvaso DPI®: Clinical Pearls and Drug-Device Characteristics , as well as a series of rapid-fire presentations showing interesting findings in health care resource utilization, patient reported outcomes, and health-related qualify of life.” Oral Presentations include: Rapid fire original investigation presentation , Tuesday, October 8, 10:20 a.m. to 10:24 a.m. ET: Rapid Area 4B/4071 – Patient-Reported Symptom Burden and Health-Related Quality of Life in Pulmonary Arterial Hypertension: Results from a Patient’s Perspective on Palliative Care Online Survey . Presented by Denise Sese, M.D., Medical University of South Carolina. Rapid fire original investigation presentation , Tuesday, October 8, 10:32 a.m. to 10:36 a.m. ET: Rapid Area 4B/4071 – Initial Validation of the Pulmonary Hypertension Functional Classification Self-Report (PH-FC-SR): A Patient Focused Measure for Use in Research and in the Clinic . Presented by Kristin Highland, M.D., FCCP, Cleveland Clinic. Rapid fire original investigation presentation , Tuesday, October 8, 1:45 p.m. to 1:49 p.m. ET: Rapid Area 4A/4072 – Real-World Hospitalization Differences in Patients with Pulmonary Hypertension due to Interstitial Lung Disease: Initiating Inhaled Treprostinil vs. Those Who Remain Untreated . Presented by Steven Cassady, M.D., University of Maryland Medical Center. Rapid fire original investigation presentation , Tuesday, October 8, 2:03 p.m. to 2:07 p.m. ET: Rapid Area 4A/4072 – Long-Term Outcomes and Dosing in the BREEZE Study Optional Extension Phase . Presented by Abubakr Bajwa, MBBS, FCCP, Mayo Clinic. Rapid fire original investigation presentation , Tuesday, October 8, 2:21 p.m. to 2:25 p.m. ET: Rapid Area 4A/4072 – Inhaled Treprostinil for the Treatment of Connective Tissue-Associated Pulmonary Arterial Hypertension . Presented by Kristin Highland, M.D., FCCP, Cleveland Clinic. Posters include: Poster discussion session , Wednesday, October 9, 10:20 a.m. to 11:05 a.m. ET: 4529/4430 – Real-World Oral Treprostinil Initiations: Insights from Specialty Pharmacy Data . Presented by Daniel Lachant, D.O., University of Rochester Medical Center. Sponsored events include: The APPs in Chest Medicine Forum , Sunday, October 6, 12:00 to 1:30 p.m. ET. The event will include a brief presentation on navigating opportunities and challenges APPs face in clinical practice, led by Danielle McCamey, DNP, CRNP, ACNP-BC, FCCP; and Corinne Young, MSN, FNP-C, FCCP. Presenters will give practical tips for making the most of the CHEST 2024 experience. The forum will be held in the Contemporary Ballroom at the Omni Hotel. The Women in Chest Medicine Annual Luncheon , Monday, October 7, 12:00 to 1:30 p.m. ET. National negotiation expert and best-selling author, Sara Laschever, will facilitate an interactive conversation about cultivating effective negotiation skills and how to be your best self-advocate. In addition, the 2024 recipient of the CHEST Women’s Lung Health grant will be honored at the luncheon. The luncheon will be held in room 156A at the Boston Convention and Exhibition Center. Tyvaso DPI® (Treprostinil Inhalation Powder): Clinical Pearls and Drug-Device Characteristics , Monday, October 7, 6:00 to 9:00 p.m. ET, featuring Anthony Hickey, Ph.D., Sc.D., University of North Carolina at Chapel Hill; Jennifer H Keeley, DNP, Allegheny General Hospital; and Sandeep Sahay, M.D., FCCP, Houston Methodist Hospital. The symposium will be held at the Omni Boston Hotel at the Seaport, Momentum ABC Ballroom, Level 5. About Tyvaso® Inhalation Solution and Tyvaso DPI® Inhalation Powder INDICATION TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prostacyclin mimetics indicated for the treatment of: Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with TYVASO establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities. While there are long-term data on use of treprostinil by other routes of administration, nearly all clinical experience with inhaled treprostinil has been on a background of an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor. The controlled clinical experience with TYVASO was limited to 12 weeks in duration. Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study with TYVASO establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS TYVASO and TYVASO DPI are pulmonary and systemic vasodilators. In patients with low systemic arterial pressure, either product may produce symptomatic hypotension. Both products inhibit platelet aggregation and increase the risk of bleeding. Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both C max and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness. Like other inhaled prostaglandins, TYVASO and TYVASO DPI may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment with TYVASO and TYVASO DPI. DRUG INTERACTIONS/SPECIFIC POPULATIONS The concomitant use of either product with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension. Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both C max and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8. Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production. Safety and effectiveness in pediatric patients have not been established. Across clinical studies used to establish the effectiveness of TYVASO in patients with PAH and PH‑ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy. ADVERSE REACTIONS Pulmonary Arterial Hypertension (WHO Group 1) In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%). In addition, adverse reactions occurring in ≥4% of patients were dizziness and diarrhea. In a 3-week, open-label, single-sequence, safety and tolerability study (BREEZE) conducted in 51 patients on stable doses of TYVASO who switched to a corresponding dose of TYVASO DPI, the most commonly reported adverse events seen with TYVASO DPI in ≥4% of PAH patients during the 3-week treatment phase included cough (35.3%), headache (15.7%), dyspnea (7.8%), and nausea (5.9%). Pulmonary Hypertension Associated with ILD (WHO Group 3) In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (WHO Group 3), adverse reactions with TYVASO were similar to the experience in studies of PAH. Please see Full Prescribing Information for TYVASO or TYVASO DPI , Instructions for Use manuals for TD-100 and TD-300 TYVASO ® Inhalation System and TYVASO DPI ™ Inhalation Powder , and additional information at www.TYVASOHCP.com or call 1‑877‑UNITHER (1-877-864-8437). TYVISIhcpMAY2022revised United Therapeutics: Enabling Inspiration At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation ( PBC ). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. You can learn more about what it means to be a PBC here: unither.com/pbc . Forward-Looking Statements Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders, furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of September 24, 2024, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason. TYVASO and TYVASO DPI are registered trademarks of United Therapeutics Corporation.

Dr. Gladwin to Present This Week at Symposium in Brazil, One of 22 Clinical Trial Locations RIO DE JANEIRO, Dec. 1, 2023 /PRNewswire/ -- University of Maryland School of Medicine Dean Mark T. Gladwin, MD will join prominent scientists and government health officials this week at a Symposium in Rio De Janeiro, Brazil, to discuss new treatments for sickle cell disease (SCD). The disease, which afflicts 20 million people around the world, notably affects the Black community, reducing their average lifespan by 22 years. Dr. Gladwin is currently heading a randomized multicenter clinical trial funded by the National Institutes of Health, that is being conducted across 22 sites in Brazil, France and the U.S. It is the largest clinical trial of its kind to test the effectiveness of a technique called red cell exchange transfusion in prolonging life and slowing or reversing end organ damage. At the Symposium, taking place at HEMORIO, a hematology research and transfusion center in Rio De Janeiro, Dr. Gladwin will provide a medical overview of pulmonary hypertension in SCD and an update on enrollment in the clinical trial, called Sickle Cell Disease and CardiovAscular Risk - Red Cell Exchange Trial (SCD-CARRE), to date. Dr. Gladwin will be joined by Dr. Claudia Mello, the Rio De Janeiro State Secretary of Health, along with Joice Aragão, the National Coordinator of the Brazilian Blood Program. Other presenters will include Luiz Amorim, General Director at HEMORIO; Clarisse Lobo, PhD, Clinical Research Specialist at HEMORIO; and Darrell Triulzi, MD, and Jude Jonassaint, RN from the University of Pittsburgh. In the SCD-CARRE trial, 150 patients at high risk of dying from their sickle cell disease will be randomly assigned to receive either the standard of care alone or in combination with monthly red blood cell exchange treatments for one year. While blood transfusions are commonly used to treat acute complications in sickle cell disease, they can cause iron toxicity due to the presence of excessive red blood cells. In red cell exchange transfusion, the sickled red blood cells are removed and replaced with normal red blood cells, but the process is longer, more expensive, and requires more donor blood. "Approximately 30 percent of patients with sickle cell disease develop serious organ damage, such as cardiopulmonary complications, and kidney or liver failure, with the risks steadily increasing with age," Dr. Gladwin said. "The goal of the study is to determine whether red cell exchange can lower deaths, reduce hospitalizations, and slow down or reverse the development of major end-stage organ damage." Overall, Dr. Gladwin's scientific work is focused on translational biochemistry and vascular biology, with a particular emphasis on nitrite and nitric oxide-hemoglobin interactions. With an active federally-funded research laboratory, Dr. Gladwin is engaged in studies and clinical trials centered around nitric oxide, nitrite, and vascular biology. Dr. Gladwin has extensively studied a novel disease mechanism known as hemolysis-associated endothelial dysfunction. This groundbreaking research has identified a state of nitric oxide resistance in patients with conditions such as sickle cell disease, malaria, transfusion of aged blood, and other hemolytic disorders. This resistance is caused by the scavenging of nitric oxide by hemoglobin released into the plasma during hemolysis. Dr. Gladwin's studies have translated into clinical and epidemiological insights, leading to the recognition of a human disease syndrome called hemolysis-associated pulmonary hypertension, which is highly prevalent in individuals with sickle cell anemia. Dr. Gladwin's contributions in the fields of vascular biology, nitric oxide, and nitrite research have had a profound impact on the medical community. His work has not only advanced our understanding of the intricate mechanisms underlying blood flow regulation and the role of reactive nitrogen molecules but has also translated into tangible therapeutic advancements. The development of intravenous, oral, and inhaled nitrite as potential therapies represents a significant milestone in the treatment of various conditions, including those related to hypoxia and hemolysis. These innovative therapeutic approaches offer promising avenues for improving patient outcomes and enhancing quality of life. Media Contacts: Office of Public Affairs 655 West Baltimore Street Bressler Research Building 14-002 Baltimore, Maryland 21201-1559 This news release was issued on behalf of Newswise(TM). For more information, visit . SOURCE University of Maryland School of Medicine

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the quarter ended June 30, 2022. Total revenues in the second quarter of 2022 grew 5% year-over-year to $466.9 million, compared to $446.5 million in the second quarter of 2021. “I’m extraordinarily pleased with our business performance this past quarter,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “The FDA’s approval of our Tyvaso DPI medicine and recent major medical journal publications demonstrate our continuing product development success. I’m especially excited about our ongoing registration trials, such as PERFECT for assessing Tyvaso’s usefulness in COPD-associated pulmonary hypertension, ADVANCE OUTCOMES for studying whether once-daily ralinepag can reduce morbidity and mortality in pulmonary arterial hypertension, and TETON which is intended to demonstrate the disease-modifying potential of Tyvaso in idiopathic pulmonary fibrosis. Also very significant is our ARTISAN study, which will confirm whether Remodulin can be a short-term bridge to Orenitram when dosed rapidly to reduce right heart afterload and improve right ventricular structure and function.” “We ended the second quarter with a record number of patients on our treprostinil therapies, including the addition of approximately 500 Tyvaso patients this quarter,” said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. “The recent approval and launch of Tyvaso DPI, coupled with the Medicare coverage decision for Tyvaso in PH-ILD, will provide additional momentum toward reaching our goal of 6,000 patients on Tyvaso by the end of the year.” SECOND QUARTER 2022 FINANCIAL RESULTS Key financial highlights include (dollars in millions, except per share data): Three Months Ended June 30, Dollar Change Percentage Change 2022 2021 Revenues $ 466.9 $ 446.5 $ 20.4 5 % Net income $ 116.0 $ 172.6 $ (56.6 ) (33 )% Net income, per basic share $ 2.56 $ 3.85 $ (1.29 ) (34 )% Net income, per diluted share $ 2.41 $ 3.65 $ (1.24 ) (34 )% Revenues The table below summarizes the components of total revenues (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2022 2021 Net product sales: Tyvaso®(1) $ 201.0 $ 153.8 $ 47.2 31 % Remodulin®(2) 132.0 139.8 (7.8 ) (6 )% Orenitram® 79.0 76.2 2.8 4 % Unituxin® 44.5 53.1 (8.6 ) (16 )% Adcirca® 10.4 23.6 (13.2 ) (56 )% Total revenues $ 466.9 $ 446.5 $ 20.4 5 % (1) Net product sales include both the drug product and the respective inhalation devices for both Tyvaso and Tyvaso DPI™. (2) Net product sales include sales of infusion devices, such as the Remunity® Pump. Net product sales from our treprostinil-based products (Tyvaso, Remodulin, and Orenitram) grew by $42.2 million for the second quarter of 2022, as compared to the same period in 2021. The growth in Tyvaso revenues resulted primarily from an increase in quantities sold, reflecting an increased number of patients following the label expansion to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). The decrease in Unituxin revenues resulted primarily from a decrease in quantities sold, partially offset by a price increase. The decrease in quantities sold was primarily due to the timing of orders by our distributors and does not precisely reflect trends in underlying patient demand. The decrease in Adcirca revenues resulted primarily from higher gross-to-net deductions and, to a lesser extent, a decline in bottles sold as a result of generic competition for Adcirca. Expenses Cost of product sales. The table below summarizes cost of product sales by major category (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2022 2021 Category: Cost of product sales $ 27.1 $ 35.8 $ (8.7 ) (24 )% Share-based compensation expense(1) 2.6 1.4 1.2 86 % Total cost of product sales $ 29.7 $ 37.2 $ (7.5 ) (20 )% (1) Refer to Share-based compensation below. Cost of product sales, excluding share-based compensation. Cost of product sales for the three months ended June 30, 2022 decreased as compared to the same period in 2021, primarily due to a decrease in royalty expense for Adcirca resulting from a decrease in Adcirca net product sales. Research and development expense. The table below summarizes research and development expense by major category (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2022 2021 Category: Research and development projects $ 79.5 $ 69.5 $ 10.0 14 % Share-based compensation expense(1) 14.4 4.8 9.6 200 % Total research and development expense $ 93.9 $ 74.3 $ 19.6 26 % (1) Refer to Share-based compensation below. Research and development expense, excluding share-based compensation. Research and development expense for the three months ended June 30, 2022 increased as compared to the same period in 2021, primarily due to increased spending on preclinical work on technologies designed to increase the supply of transplantable organs. Selling, general, and administrative expense. The table below summarizes selling, general, and administrative expense by major category (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2022 2021 Category: General and administrative $ 76.9 $ 72.8 $ 4.1 6 % Sales and marketing 16.1 17.1 (1.0 ) (6 )% Share-based compensation expense(1) 48.5 22.9 25.6 112 % Total selling, general, and administrative expense $ 141.5 $ 112.8 $ 28.7 25 % (1) Refer to Share-based compensation below. Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2022 2021 Category: Stock options $ 5.6 $ 5.7 $ (0.1 ) (2 )% Restricted stock units 7.4 6.5 0.9 14 % Share tracking awards plan (STAP) 52.1 16.4 35.7 218 % Employee stock purchase plan 0.4 0.5 (0.1 ) (20 )% Total share-based compensation expense $ 65.5 $ 29.1 $ 36.4 125 % The increase in share-based compensation expense for the three months ended June 30, 2022, as compared to the same period in 2021, was primarily due to an increase in STAP expense driven by a 31 percent increase in our stock price for the three months ended June 30, 2022, as compared to a seven percent increase in our stock price for the same period in 2021. Other expense, net. The change in other expense, net for the three months ended June 30, 2022, as compared to the same period in 2021, was primarily due to unrealized losses on equity securities. Income tax expense. Income tax expense for the three months ended June 30, 2022 and 2021 was $34.6 million and $43.9 million, respectively. The effective income tax rate (ETR) for the three months ended June 30, 2022 and 2021 was 23% percent and 20% percent, respectively. The ETR for the three months ended June 30, 2022 increased compared to the ETR for the three months ended June 30, 2021 primarily due to an increase in the valuation allowance in the current period compared to a decrease in the prior period. PRODUCT COMMERCIALIZATION UPDATE Tyvaso DPI. The FDA approved Tyvaso DPI in May 2022 for pulmonary arterial hypertension (PAH) and PH-ILD, and we launched commercial efforts shortly thereafter. Our first commercial shipments to specialty pharmacies occurred in June 2022 and the first patients started Tyvaso DPI therapy shortly thereafter. Tyvaso Inhalation Solution in PH-ILD. The FDA approved Tyvaso for the PH-ILD indication on March 31, 2021, and we launched commercial efforts for the new indication shortly thereafter. In April 2022, the Centers for Medicare and Medicaid Services updated its Local Coverage Determination (LCD) for Tyvaso to include an indication for PH-ILD. This LCD became effective on June 5, 2022. RESEARCH AND DEVELOPMENT UPDATE Updates on select later-stage programs are below. Tyvaso in IPF — TETON 1 and TETON 2. We are enrolling a phase 3 study called TETON 1, which is a U.S. study of Tyvaso for the treatment of idiopathic pulmonary fibrosis (IPF). The primary endpoint of this study is the change in absolute forced vital capacity (FVC) from baseline to week 52. We are in the process of commencing an additional phase 3 study of Tyvaso in IPF patients that will be similar to TETON 1, called TETON 2, but will be conducted outside of the United States. The TETON program was prompted by data from the INCREASE study which demonstrated improvements in certain key parameters of lung function in pulmonary hypertension patients with fibrotic lung disease. Specifically, in the INCREASE study, treatment with Tyvaso resulted in significant improvements in percent predicted FVC at weeks 8 and 16, with subjects having underlying etiologies of idiopathic interstitial pneumonias showing greater improvement. Consistent positive effects were also observed in patients with chronic hypersensitivity pneumonitis and environmental/occupational lung disease. These data points, combined with substantial preclinical evidence of antifibrotic activity of treprostinil, suggest that Tyvaso may offer a treatment option for patients with fibrotic lung disease. Tyvaso in PH-COPD — PERFECT. Enrollment is ongoing for the phase 3 PERFECT study evaluating Tyvaso for the treatment of WHO Group 3 pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). Recently, we decided to trigger a pre-specified transition and convert the PERFECT study from a crossover study into a single treatment period of 12 weeks. While this increased the size of the study from 136 patients to 314 patients, we believe this decision may increase site and subject participation with a simpler, shorter, and more traditional study design. Ralinepag phase 3 studies — ADVANCE CAPACITY and ADVANCE OUTCOMES. We are enrolling two phase 3 studies to support the potential approval of oral ralinepag for PAH. WEBCAST We will host a webcast to discuss our second quarter 2022 financial results on Wednesday, August 3, 2022, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at . A replay of the webcast will also be available at the same location on our website. UNITED THERAPEUTICS: ENABLING INSPIRATION At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization. You can learn more about what it means to be a PBC here: unither.com/PBC. FORWARD-LOOKING STATEMENTS Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements related to: our revenue growth prospects, our clinical trials and other research and development plans, including the PERFECT and TETON studies of Tyvaso, the ADVANCE studies of ralinepag, the ARTISAN study of Remodulin and Orenitram, our goal of 6,000 patients being treated with Tyvaso by the end of 2022, and our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders, furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs, providing superior financial performance for shareholders, and providing our communities with earth-sensitive energy utilization. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of August 3, 2022, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason. ORENITRAM, REMODULIN, REMUNITY, TYVASO, and UNITUXIN are registered trademarks of United Therapeutics Corporation and/or its subsidiaries. TYVASO DPI is a trademark of United Therapeutics Corporation. ADCIRCA is a registered trademark of Eli Lilly and Company. UNITED THERAPEUTICS CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (In millions, except per share data) Three Months Ended June 30, 2022 2021 (Unaudited) Revenues: Net product sales $ 466.9 $ 446.5 Total revenues 466.9 446.5 Operating expenses: Cost of product sales 29.7 37.2 Research and development 93.9 74.3 Selling, general, and administrative 141.5 112.8 Total operating expenses 265.1 224.3 Operating income 201.8 222.2 Interest income 6.8 4.0 Interest expense (6.2 ) (4.7 ) Other expense, net (51.8 ) (2.7 ) Impairments of investments in privately-held companies — (2.3 ) Total other expense, net (51.2 ) (5.7 ) Income before income taxes 150.6 216.5 Income tax expense (34.6 ) (43.9 ) Net income $ 116.0 $ 172.6 Net income per common share: Basic $ 2.56 $ 3.85 Diluted $ 2.41 $ 3.65 Weighted average number of common shares outstanding: Basic 45.4 44.8 Diluted 48.1 47.3 SELECTED CONSOLIDATED BALANCE SHEET DATA (Unaudited, in millions) June 30, 2022 Cash, cash equivalents, and marketable investments $ 3,897.1 Total assets 5,543.3 Total liabilities 1,224.9 Total stockholders’ equity 4,318.4 Category: Earnings View source version on businesswire.com: Contacts Dewey Steadman Phone: (202) 919-4097 Email: ir@unither.com Source: United Therapeutics Corporation View this news release online at: