United Therapeutics Corporation (UTHR) is a biotechnology company dedicated to developing and commercializing innovative products for chronic and life-threatening conditions. The company focuses on addressing unmet medical needs through pharmaceutical therapies and technologies, particularly in the areas of pulmonary arterial hypertension (PAH) and oncology. UTHR also explores organ manufacturing technologies to expand the availability of transplantable organs.
- Tyvaso DPI - Provides inhalation powder therapy for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease .
- Nebulized Tyvaso - Offers inhalation solution for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease .
- Remodulin - Delivers treprostinil injection for pulmonary arterial hypertension management .
- Orenitram - Supplies extended-release tablets for pulmonary arterial hypertension treatment .
- Unituxin - Provides dinutuximab injection for high-risk neuroblastoma in pediatric patients .
- Adcirca - Offers tadalafil tablets for pulmonary arterial hypertension .
- Other - Includes various other products contributing to the company's therapeutic offerings .
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| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Martine Rothblatt ExecutiveBoard | Chairperson and CEO | Principal Researcher and AI Visionary at Google LLC | Founder of UTHR (1996), inventor/co-inventor on nine U.S. patents, and author of Your Life or Mine. Leads UTHR's strategic vision and innovation. | View Report → |
James C. Edgemond Executive | CFO and Treasurer | None | Joined UTHR in 2013, promoted to CFO and Treasurer in 2015. Oversees financial planning, treasury, and compliance. | |
Michael Benkowitz Executive | President and COO | None | Joined UTHR in 2011, promoted to President and COO in 2016. Oversees commercial, medical affairs, compliance, HR, IT, and business development. | |
Paul A. Mahon Executive | EVP, General Counsel, and Corporate Secretary | None | Joined UTHR in 2001, promoted to EVP in 2003. Guides legal and corporate governance strategies. | |
Christopher Causey Board | Director | Board of Trustees at The College of Wooster | Director since 2003. Nearly 30 years of experience in healthcare strategy and marketing. Meets Nasdaq financial sophistication requirements. | |
Christopher Patusky Board | Director | Founding Principal of Patusky Associates, LLC; Executive Manager of Slater Run Vineyards, LLC | Director since 2002. Legal, regulatory, and financial expert. Operates personal investment vehicle and family vineyard. | |
Judy D. Olian Board | Director | President of Quinnipiac University; Board Member at Ares Management, L.P., and Mattel, Inc. | Director since 2015. Former Dean of UCLA Anderson School of Management. Expertise in organizational strategy and human resource systems. | |
Linda Maxwell Board | Director | Operating Partner at DCVC; Board Member at ImmunityBio, Inc. | Director since 2020. Physician-surgeon, educator, and health tech entrepreneur. Founding Executive Director of the Biomedical Zone. | |
Louis Sullivan Board | Director | Board Member at Emergent BioSolutions, Inc.; Co-Chair of Henry Schein Cares Foundation | Director since 2002. Former U.S. Secretary of Health and Human Services and President of Morehouse School of Medicine. | |
Nilda Mesa Board | Director | Adjunct Professor at Columbia University | Director since 2018. Expert in sustainability and climate resilience. Former Director of NYC Mayor’s Office of Sustainability. | |
Raymond Dwek Board | Director | Emeritus Director at Glycobiology Institute, University of Oxford | Director since 2002. Renowned scientist and Fellow of the Royal Society. Founder of glycobiology. | |
Richard Giltner Board | Director | None | Director since 2009. Extensive experience in financial markets, derivatives, and asset management. Meets Nasdaq financial sophistication requirements. | |
Tommy Thompson Board | Director | Director at Healthpeak Properties, Inc.; Non-Executive Chair at TherapeuticsMD, Inc. | Director since 2010. Former U.S. Secretary of Health and Human Services and Governor of Wisconsin. Extensive healthcare and governance expertise. |
- Given the critical importance of the TETON trials for Tyvaso in pulmonary fibrosis, can you explain whether both ongoing studies need to succeed for FDA approval, or if one positive study could be sufficient?
- With the entrance of competitors like Merck into the PAH market, have you observed any changes in patient referrals or market dynamics that might affect your growth projections?
- Regarding capital allocation, how do you assess the potential for additional share buybacks or accelerated share repurchases in light of your investments in the xenotransplantation program?
- Can you elaborate on the drivers behind Tyvaso DPI's performance compared to Nebulized Tyvaso this quarter, and what factors are influencing patient and physician preference?
- While you've expressed confidence in the sustainability of your foundational products like Remodulin, Tyvaso, and Orenitram, what potential risks do you see that could impact their vitality, and how are you addressing them?
Research analysts who have asked questions during UNITED THERAPEUTICS earnings calls.
Andreas Argyrides
Oppenheimer & Co. Inc.
4 questions for UTHR
Ashwani Verma
UBS Group AG
4 questions for UTHR
Jessica Fye
JPMorgan Chase & Co.
4 questions for UTHR
Joseph Thome
TD Cowen
4 questions for UTHR
Jiale Song
Jefferies Financial Group Inc.
3 questions for UTHR
Roanna Clarissa Ruiz
Leerink Partners
3 questions for UTHR
Jason Gerberry
Bank of America Merrill Lynch
1 question for UTHR
Olivia Brayer
Cantor
1 question for UTHR
Roger Song
Jefferies
1 question for UTHR
Terence Flynn
Morgan Stanley
1 question for UTHR
| Customer | Relationship | Segment | Details |
|---|---|---|---|
Accredo Health Group, Inc. (Distributor 1) | Non-exclusive distribution for Tyvaso DPI, nebulized Tyvaso, Remodulin, Remunity Pump, and Orenitram in the U.S. | All | 51% of total revenues in 2024, 2023, and 2022 |
CVS Specialty (Distributor 2) | Non-exclusive distribution for Tyvaso DPI, nebulized Tyvaso, Remodulin, Remunity Pump, and Orenitram in the U.S. | All | 35% of total revenues in 2024, 34% in 2023, and 32% in 2022 |
Notable M&A activity and strategic investments in the past 3 years.
| Company | Year | Details |
|---|---|---|
Miromatrix Medical Inc. | 2023 | United Therapeutics acquired Miromatrix Medical Inc. in a deal announced on October 30, 2023 and completed on December 13, 2023, paying $3.25 per share in cash at closing with an additional contingent $1.75 per share upon a clinical milestone, bringing the total to $5.00 per share and a transaction value of approximately $91 million. The acquisition, which brought Miromatrix’s bioengineered organ technology (including products like mirokidney and miroliver) under United Therapeutics, strategically enhances its organ manufacturing and regenerative medicine capabilities. |
IVIVA Medical, Inc. | 2023 | United Therapeutics acquired IVIVA Medical, Inc. in October 2023 with an upfront cash payment of approximately $50.0 million and potential earn-out payments via a 2% royalty on net sales of its manufactured kidney products. The acquisition, treated as an asset acquisition with a major allocation to research and development, aligns with United Therapeutics’ strategy to expand its engineered kidney implant technologies and overall product portfolio. |
Recent press releases and 8-K filings for UTHR.
- United Therapeutics reported strong results from the Teton 2 study for Tyvaso in pulmonary fibrosis (PF), showing a nearly 100 milliliter increase in oxygen compared to placebo, with regulatory filing expected by mid-next year and approval by June 2027. The company anticipates 7 years of orphan drug exclusivity in the US and 10 years in Europe and Japan for this indication.
- The company's once-daily pill for pulmonary hypertension (PH), Ralinepag, is expected to have its Phase 3 trial read out in Q1 next year, with potential FDA approval in mid-2027, and is projected to capture 80% of the PH market.
- United Therapeutics is advancing its xenotransplantation program, with FDA authorization for two xenokidney clinical trials and the first transplant anticipated next month. The trials are expected to complete by end of 2028, leading to commercialization in 2030, supported by a production capacity of approximately 1,000 xenografts per year by 2026.
- The company has achieved double-digit growth in revenues and profits for about 12 consecutive quarters and is currently executing a $1 billion accelerated share repurchase program.
- United Therapeutics has achieved 12 consecutive quarters of record growth in both profits and revenues and is currently implementing a $1 billion accelerated share repurchase program.
- The company reported positive Phase 3 results for its pulmonary fibrosis (IPF) medicine, showing a nearly 100 milliliter increase in oxygen compared to placebo, with an anticipated filing for approval by mid-next year and potential FDA approval by June 2027.
- A Phase 3 trial for Ralinepag, a once-daily pill for pulmonary hypertension (PAH), is expected to read out in Q1 next year, with potential FDA approval by mid-2027.
- The xenotransplantation program has received FDA authorization for two xenokidney clinical trials, with the first transplant expected next month and commercialization anticipated by 2030.
- United Therapeutics announced that its Phase III TETON-two study for Tyvaso in pulmonary fibrosis (IPF) showed a nearly 100 milliliter increase in oxygen compared to placebo, with TETON-one results expected early next year. The company plans to file for FDA approval by mid-next year and expects approval by June 2027, benefiting from 7 years of orphan drug exclusivity in the US and 10 years in Europe and Japan.
- The Phase III trial for Ralinepag, a once-daily pill for pulmonary hypertension, is expected to read out in Q1 next year, with FDA approval anticipated in 2027. This drug is projected to become the dominant treatment for pulmonary hypertension.
- The company's xenotransplantation program has FDA authorization for two Xeno kidney clinical trials, with the first transplant expected next month, aiming for commercialization by 2030. Production capacity is planned for 600 Xeno kidneys and 300 Xeno hearts per year across three facilities.
- United Therapeutics continues its capital allocation strategy focusing on internal R&D, business development, and returning capital to shareholders, currently executing a $1 billion accelerated share repurchase program.
- United Therapeutics has achieved double-digit growth in both revenues and profits for 12 consecutive quarters.
- The company's Phase 3 trial for a new pulmonary fibrosis medicine (Teton 2) demonstrated a "nearly 100 milliliter increase in oxygen compared to placebo" , with regulatory filing expected not later than mid-next year and approval by June 2027. A Phase 3 trial for Ralinepag, a once-daily pill for pulmonary hypertension, is anticipated to read out in Q1 next year, with expected FDA approval in mid-2027.
- The FDA has authorized two clinical trials for xenokidneys, with the first transplant expected next month. Commercialization of xenokidneys is projected for 2030, supported by a production capacity of approximately 600 xenokidneys and 300 xenohearts per year.
- The company is currently executing a $1 billion accelerated share repurchase program that began on August 1, as part of its capital allocation strategy which prioritizes internal R&D and corporate development.
- United Therapeutics Corporation announced on September 2, 2025, that its TETON-2 study evaluating nebulized Tyvaso (treprostinil) Inhalation Solution for idiopathic pulmonary fibrosis (IPF) met its primary efficacy endpoint.
- The study demonstrated Tyvaso's superiority over placebo for the change in absolute forced vital capacity (FVC) by 95.6 mL from baseline to week 52 in IPF patients (Hodges-Lehmann estimate, p <0.0001).
- Statistically significant improvements relative to placebo were also observed in most secondary endpoints, including time to first clinical worsening event, changes in percent predicted FVC, King’s Brief Interstitial Lung Disease quality of life questionnaire (K-BILD), and diffusion capacity of lungs for carbon monoxide (DLCO).
- The company intends to use these results, along with data from the ongoing TETON-1 study, to support a supplemental New Drug Application (sNDA) to the FDA to add IPF to Tyvaso's labeled indications.
- United Therapeutics plans to meet with the FDA before the end of the year to discuss potentially expediting the regulatory review process once TETON-1 results are available, which are expected in the first half of 2026.
- United Therapeutics Corporation (UTHR) has exercised its option to develop a second dry powder inhalation therapy with MannKind Corporation (MNKD).
- This expanded agreement builds on their 2018 collaboration, which previously led to the U.S. FDA approval of Tyvaso DPI in May 2022.
- Under the terms, MannKind will formulate the new investigational molecule using its Technosphere® platform, while United Therapeutics will conduct preclinical and clinical development.
- MannKind will receive an upfront payment of $5 million, is eligible for up to $35 million in development milestones, and will receive 10% royalties on net sales of any resulting product.
- Palvella Therapeutics reported cash and cash equivalents of $70.4 million as of June 30, 2025, which are expected to fund operations into the second half of 2027.
- The company reported a net loss of $9.5 million for the three months ended June 30, 2025.
- Top-line results for the Phase 3 SELVA trial are on track for the first quarter of 2026, and for the Phase 2 TOIVA trial, results are expected in the fourth quarter of 2025.
- Palvella plans to announce a third clinical indication for QTORIN™ rapamycin and a second QTORIN™ platform candidate before year-end 2025.
- Liquidia Corporation reported total revenue of $8.8 million for the second quarter ended June 30, 2025, which included $6.5 million in product sales from the newly launched YUTREPIA™. The company's net loss for the quarter was $41.6 million, or $0.49 per basic and diluted share.
- Following its FDA approval on May 23, 2025, YUTREPIA™ was commercially launched in early June 2025, achieving over 900 unique patient prescriptions and more than 550 patient starts within 11 weeks of approval.
- As of June 30, 2025, Liquidia's cash and cash equivalents totaled $173.4 million.
- United Therapeutics Corporation (UTHR) announced on August 1, 2025, that it entered into two Accelerated Share Repurchase (ASR) agreements with Citibank, N.A. to repurchase an aggregate of $1 billion of its common stock.
- The company will make an aggregate upfront payment of $1 billion to Citi on August 4, 2025.
- Under the agreements, United Therapeutics will receive an initial delivery of approximately 1,274,296 shares for the uncollared ASR and approximately 849,531 shares for the collared ASR on August 4, 2025.
- Final settlement for the uncollared ASR is expected in the fourth quarter of 2025, and for the collared ASR, it is expected in the first quarter of 2026.
- The share repurchase program reflects management's confidence in the company's balance sheet strength, near-term prospects, intrinsic stock value, and ability to generate sustained revenue and cash flow growth.
- Q1 2025 achieved record product revenues of $794M (up 17%) and net income of $322.2M, driven by strong sales of treprostinil products including Tyvaso DPI, nebulized Tyvaso, and Orenitram .
- Robust liquidity with $1.4B TTM Operating Cash Flow and $5.0B in cash and investments .
- Accelerated pipeline progress with 5 registration studies, advancements in xenotransplantation and innovative device developments , plus full enrollment in TETON 1 and TETON 2 studies for idiopathic pulmonary fibrosis with data expected in 2H 2025 and 1H 2026 .
- Consistent record revenue performance over 9 of the past 12 quarters and sustained double-digit growth in key products .
- Significant capital allocation including investment in R&D, manufacturing expansion, and a $1 billion share repurchase, underscoring strong financial discipline .
- Effective expense management delivered solid operating income despite increased cost components .