10-Q: United Therapeutics Q3 2025: Strong Tyvaso DPI Growth, Organ Programs Advance

United Therapeutics reports robust Q3 2025 revenue growth driven by Tyvaso DPI sales and significant progress in its organ manufacturing and xenotransplantation programs.

Summary

• Total revenues for the three months ended September 30, 2025, increased by 7% to $799.5 million, compared to $748.9 million for the same period in 2024.
• Total revenues for the nine months ended September 30, 2025, increased by 12% to $2,392.5 million, compared to $2,141.5 million for the same period in 2024.
• Net income for the three months ended September 30, 2025, was $338.7 million, up from $309.1 million in Q3 2024.
• Net income for the nine months ended September 30, 2025, was $970.4 million, up from $893.8 million in the same period in 2024.
• Tyvaso DPI net product sales grew by 22% to $336.2 million in Q3 2025 and 25% to $953.9 million for the nine months ended September 30, 2025, driven by increased quantities sold and a price increase.
• Nebulized Tyvaso net product sales decreased by 11% to $141.8 million in Q3 2025, primarily due to higher gross-to-net revenue deductions and a decrease in quantities sold.
• Orenitram net product sales increased by 16% to $131.1 million in Q3 2025 and 15% to $375.7 million for the nine months ended September 30, 2025.
• The TETON 2 Phase 3 study of Nebulized Tyvaso in patients with idiopathic pulmonary fibrosis (IPF) met its primary efficacy endpoint, demonstrating a 95.6 mL improvement in absolute forced vital capacity (FVC) relative to placebo.
• The FDA cleared Investigational New Drug (IND) applications for the UKidney (EXPAND study) in January 2025 and UThymoKidney (EXTEND study) in August 2025, enabling the commencement of clinical trials for these xenotransplantation products.
• The company entered into two accelerated share repurchase agreements in August 2025 to repurchase approximately $1.0 billion of common stock.
• An additional $2.2 million was accrued for the Sandoz litigation, bringing the total liability to $73.3 million as of September 30, 2025.

Sentiment

Score: 8

Explanation: The company demonstrates strong financial health with consistent revenue and net income growth, primarily driven by its flagship product, Tyvaso DPI. Crucially, its pioneering and capital-intensive organ manufacturing and xenotransplantation programs are advancing rapidly with FDA IND clearances and positive clinical study results (TETON 2). While some products show declines and litigation accruals exist, the overall strategic direction and pipeline progress are highly positive, indicating strong future growth potential.

Positives

• Total revenues increased by 7% in Q3 2025 and 12% for the nine months ended September 30, 2025, compared to the same periods in 2024.
• Net income increased by 9.6% in Q3 2025 and 8.6% for the nine months ended September 30, 2025, compared to the same periods in 2024.
• Tyvaso DPI sales showed strong growth of 22% in Q3 2025 and 25% for the nine months ended September 30, 2025, driven by increased patient numbers and Medicare Part D benefit redesign.
• The TETON 2 Phase 3 study for Nebulized Tyvaso in IPF met its primary efficacy endpoint, demonstrating a statistically significant improvement in absolute FVC by 95.6 mL.
• FDA clearance for UKidney (EXPAND study) and UThymoKidney (EXTEND study) INDs marks significant progress in the xenotransplantation program, enabling human clinical trials.
• Enrollment for the Ralinepag ADVANCE OUTCOMES study (Phase 3 for PAH) was concluded in June 2025.
• Launched RemunityPRO Pump in September 2025, a new patient-filled version of the Remunity Pump, aimed at improving patient experience.
• Acquired approximately 60 acres of property in Research Triangle Park in July 2025 for future growth.
• Completed the world's first successful test flight of a piloted hydrogen-powered helicopter in March 2025, supporting sustainable organ delivery efforts.
• Operating income increased by 13.2% in Q3 2025 to $388.5 million and by 11.4% YTD 2025 to $1,135.8 million.

Negatives

• Nebulized Tyvaso net product sales decreased by 11% in Q3 2025, primarily due to higher gross-to-net revenue deductions and a decrease in quantities sold.
• Unituxin net product sales decreased by 22% in Q3 2025 and 4% for the nine months ended September 30, 2025, primarily due to a decrease in quantities sold.
• Remodulin net product sales decreased by 2% in Q3 2025 and 1% for the nine months ended September 30, 2025.
• Increased gross-to-net revenue deductions, partly due to Medicare Part D benefit redesign and new pharmacy benefit manager contracts, impacted net revenues.
• Accrued an additional $2.2 million for the Sandoz litigation, bringing the total liability to $73.3 million as of September 30, 2025.
• Recorded a $21.7 million impairment charge for property, plant, and equipment during the second quarter of 2025.
• Cash and cash equivalents decreased by $357.1 million (21%) from December 31, 2024, to September 30, 2025.
• Net cash used in investing activities increased significantly by $864.1 million (160%) for the nine months ended September 30, 2025, compared to the same period in 2024.
• Net cash used in financing activities increased by $68.3 million (6%) for the nine months ended September 30, 2025, compared to the same period in 2024.

Risks

• Heavy reliance on sales of treprostinil-based therapies (Tyvaso DPI, Nebulized Tyvaso, Remodulin, Orenitram) means decreased sales of any could materially impact operations.
• Failure in clinical trials could prevent the sale of new products or new indications for existing products.
• Competition from established or newly developed drugs, such as Merck's Winrevair and Liquidia's Yutrepia, could negatively impact operating results and market share.
• Pharmaceutical pricing and reimbursement pressures from government and private payers, including the Inflation Reduction Act (IRA), may negatively impact product sales and profitability.
• The manufacturing strategy exposes the company to significant risks, including capacity limitations, regulatory compliance, supply chain disruptions, and the complexity of manufactured organ processes.
• Reliance on third parties for critical business activities (manufacturing, clinical trials, distribution) poses risks if these parties fail to perform satisfactorily.
• Reports of actual or perceived side effects and other adverse effects associated with products could cause sales to decrease or regulatory approvals to be revoked.
• Negative attention from special interest groups, particularly concerning animal research in organ manufacturing programs, may impair business operations.
• Inadequate insurance coverage may not protect against significant product liability claims, especially for new products or indications.
• Failure to attract and retain key management and qualified scientific and technical personnel could impede business objectives.
• Non-compliance with extensive laws and regulations in the United States and other countries could delay, disrupt, or prevent commercialization of products.
• Cybersecurity incidents and other disruptions impacting networks, systems, or data may have a material adverse effect on the business.
• Inability to obtain additional financing on commercially reasonable terms could limit product development and sales efforts.
• The portfolio of investments is subject to market, interest, operational, and credit risk that may reduce its value.
• Inability to successfully identify, finance, consummate, and/or integrate acquisitions could adversely affect business operations and financial position.
• The price of common stock can be highly volatile and may decline due to various market and company-specific factors.
• Provisions of Delaware law, the company's charter, bylaws, and employment/license agreements could prevent or delay a change of control or change in management.
• Shareholders must rely on stock appreciation for any return on investment as the company does not intend to pay cash dividends.
• The exclusive forum bylaw may limit shareholders' ability to bring claims in a forum they find favorable.
• Conversion to a Delaware Public Benefit Corporation (PBC) may not result in anticipated benefits, requires directors to balance interests, and may subject the company to increased litigation risk.
• Potential enforcement action or penalties in connection with the contract pharmacy policy implemented pursuant to the 340B program.
• Patient assistance programs are under increasing scrutiny, potentially leading to actions that reduce prices or demand for products.
• Improper handling of hazardous materials used in activities could expose the company to significant remediation liabilities.
• The increasing use of social media platforms and artificial intelligence-based software presents new risks and challenges, including flawed algorithms, data quality issues, and inadvertent information release.
• Intellectual property rights may not effectively deter competitors from developing competing products, and patents could be invalidated or found unenforceable.
• Third parties have alleged, and may in the future allege, that products or services infringe their patents and other intellectual property rights, leading to costly litigation or loss of sales ability.

Future Outlook

The company anticipates near-term revenue growth primarily from continued sales growth of Tyvaso DPI, an increasing number of PH-ILD patients being treated with Tyvaso products, continued growth in Orenitram prescriptions, and modest price increases for some products. Mediumand longer-term revenue growth is expected to be driven by new products, new indications for existing products, and new delivery devices, including advancements in manufactured organs and organ alternatives. The company has budgeted approximately $520 million for capital expenditures through the end of 2027 to construct additional facilities, including a new Tyvaso DPI manufacturing facility and designated pathogen-free (DPF) facilities for xenotransplantation products. The first transplant in the UKidney EXPAND study is expected shortly, and IND submissions for UHeart clinical studies are planned for the near term. Data readout from the TETON 1 study is expected in the first half of 2026, and topline data from the Ralinepag ADVANCE OUTCOMES study is also expected in the first half of 2026.

Management Comments

• We believe there are approximately 100,000 IPF patients in the United States.
• We believe there are at least 60,000 PPF patients in the United States, but the number could be significantly greater as some estimates indicate the U.S. patient population could exceed 180,000.
• The first transplant in the EXPAND study is expected to occur shortly.
• We are also preparing to submit one or more INDs for two clinical studies of UHeart products in the near term.
• We anticipate our existing DPF facility in Virginia and the two planned DPF facilities in Minnesota and Texas will provide an initial commercial supply of our xeno-organ products if and when they are approved by the FDA.

Industry Context

The company operates in a highly competitive pharmaceutical market, particularly for pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD) therapies, facing competition from over fifteen branded and generic drugs. New entrants like Merck's Winrevair (approved March 2024) and Liquidia's Yutrepia (launched June 2025) are intensifying competition. The idiopathic pulmonary fibrosis (IPF) market also has existing approved therapies and a pipeline of new treatments. United Therapeutics is a pioneer in the emerging and capital-intensive field of organ manufacturing and xenotransplantation, aiming to address the critical shortage of transplantable organs. Its efforts in developing DPF facilities and advanced EVLP technology position it at the forefront of this innovative sector, which complements its existing pharmaceutical business.

Comparison to Industry Standards

• Ralinepag, a next-generation, once-daily oral prostacyclin receptor agonist, is being developed to compete with Johnson & Johnson's twice-daily Uptravi (selexipag), which reported global sales of over $1.8 billion in 2024, including over $1.5 billion in U.S. sales.
• The TETON 2 Phase 3 study for Nebulized Tyvaso in IPF demonstrated a 95.6 mL improvement in absolute FVC, suggesting a potentially significant treatment option compared to existing IPF therapies like Boehringer Ingelheim's Jascayd (nerandomilast), approved in October 2025.
• The company's xenotransplantation program, including the first successful xenotransplants of porcine hearts and thymokidneys into living human patients, represents pioneering advancements in the field, collaborating with institutions like Johns Hopkins, NYU, UAB, and UMB.
• The development of designated pathogen-free (DPF) facilities for xenografts and the use of FDA-approved ex vivo lung perfusion (EVLP) technology for centralized services demonstrate advanced capabilities in organ manufacturing and utilization, aiming to increase the supply of transplantable organs beyond traditional methods.

Management Changes

Corporate Governance

Legal Proceedings

• **Sandoz Litigation**: A final judgment was entered on November 1, 2024, ordering the company to pay Sandoz approximately $61.6 million in damages and $9.0 million in prejudgment interest. An additional $2.2 million has been accrued through Q3 2025, bringing the total liability to $73.3 million. All parties have appealed the final judgment, with oral argument scheduled for November 12, 2025.
• **Liquidia Technologies, Inc. Litigation**: An ongoing patent infringement lawsuit against Liquidia, filed in September 2023 and amended in November 2023, alleges infringement of U.S. Patent No. 11,826,327 (expires Feb 3, 2042) related to Tyvaso for PH-ILD. Trial took place in June 2025, and the parties are awaiting the court's decision. The company also has trade secret misappropriation claims against Liquidia and a former executive in North Carolina state court, where summary judgment motions were denied. A new breach of contract case was filed on May 29, 2024, with Liquidia's appeal of a motion to dismiss pending. Liquidia filed a lawsuit on April 21, 2025, alleging Tyvaso DPI infringes U.S. Patent No. 10,898,494 (expires May 5, 2037), to which the company filed a motion to dismiss or stay. The company filed a lawsuit on May 9, 2025, alleging Yutrepia infringes U.S. Patent No. 11,357,782 (expires May 14, 2027), but a motion for preliminary injunction was denied.
• **MSP Recovery Litigation**: A class action complaint filed in July 2020 alleges violations of the federal RICO Act and various state laws related to donations to a PAH fund. In March 2024, the magistrate judge recommended dismissal of the plaintiffs' complaint against all defendants in its entirety with prejudice. The plaintiffs filed an objection, and the defendants responded.
• **Humana and United Healthcare Litigation**: Separate lawsuits filed in December 2022 and November 2022, respectively, alleged RICO and state law violations concerning charitable contributions. The district court dismissed both complaints in their entirety on March 25, 2024. Humana and United subsequently filed new lawsuits in Maryland state court on April 24, 2024, which were dismissed with prejudice on September 23, 2025. Humana and United appealed this decision on October 20, 2025.

Stakeholder Impact

• **Shareholders**: Positive financial results and a $1.0 billion share repurchase program aim to enhance shareholder value. However, ongoing litigation and the unique balancing act required by the Public Benefit Corporation (PBC) status introduce potential risks and may influence long-term value creation.
• **Patients**: The company's focus on developing novel therapies for chronic and life-threatening conditions, including successful clinical trials for Nebulized Tyvaso in IPF and advancements in xenotransplantation, directly benefits patients by expanding treatment options and addressing organ shortages. The launch of RemunityPRO Pump aims to improve patient experience.
• **Employees**: Share-based compensation plans are in place, and growth in headcount is noted. However, the intense competition for qualified scientific and technical personnel in the biopharmaceutical manufacturing hubs could pose staffing challenges.
• **Customers/Distributors**: Continued reliance on key specialty pharmaceutical distributors (Accredo and CVS Specialty) for treprostinil-based therapies. Increased gross-to-net deductions due to new PBM contracts and Medicare Part D benefit redesign impact net revenues for these partners.
• **Creditors**: The company maintains a strong cash position and has access to a $2.5 billion unsecured revolving credit facility. However, significant capital expenditures for new facilities and share repurchases represent substantial uses of capital.

Next Steps

• The first transplant in the EXPAND study (UKidney) is expected to occur shortly.
• The company is preparing to submit one or more INDs for two UHeart clinical studies in the near term.
• A meeting with the FDA is planned before the end of 2025 to discuss ways to potentially expedite the regulatory review process for the IPF indication for Nebulized Tyvaso.
• Data readout from the TETON 1 study is expected in the first half of 2026.
• Topline data from the Ralinepag ADVANCE OUTCOMES study is expected in the first half of 2026.
• The final settlement under the Uncollared ASR is expected to occur in the fourth quarter of 2025.
• The final settlement under the Collared ASR is expected to occur in the first quarter of 2026.
• Approximately $520 million is budgeted for capital expenditures during Q4 2025 through the end of 2027 to construct additional facilities, including a new Tyvaso DPI manufacturing facility and DPF facilities.
• If xeno-organ products are approved by the FDA, the company likely will need to continue building additional DPF facilities to satisfy demand.
• If the ADVANCE OUTCOMES study is successful, the company plans to develop an oral triple-combination therapy consisting of ralinepag, an endothelin receptor antagonist, and a PDE-5 inhibitor.
• The company plans 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.
• The company and its distributors will consider seeking amendments to marketing authorizations for Nebulized Tyvaso in other countries where it is approved, to include IPF and/or PPF indications, and will also consider seeking approval for these indications in countries where it is not yet approved.
• The company intends to continue to vigorously defend itself against claims made in the Sandoz, Liquidia, Humana, and United lawsuits.
• Oral argument for the Sandoz litigation appeal is scheduled for November 12, 2025.
• The company filed a motion to dismiss Liquidia's interlocutory notice of appeal on October 3, 2025, which is pending.

Key Dates

Recommendation

United Therapeutics demonstrates strong financial health with consistent revenue and net income growth, primarily driven by its flagship product, Tyvaso DPI. Crucially, its pioneering and capital-intensive organ manufacturing and xenotransplantation programs are advancing rapidly with FDA IND clearances and positive clinical study results (TETON 2). While the company faces competitive pressures and ongoing litigation, its strategic investments in R&D, particularly in organ manufacturing, position it as an innovator with substantial long-term upside. The share repurchase program also signals management's confidence and commitment to shareholder value. The combination of strong current performance and a promising, albeit high-risk, pipeline warrants a 'buy' recommendation for investors with a long-term horizon.

Keywords

Biotechnology, Pharmaceuticals, Pulmonary Hypertension, PAH, PH-ILD, IPF, Treprostinil, Tyvaso DPI, Nebulized Tyvaso, Remodulin, Orenitram, Unituxin, Adcirca, Xenotransplantation, Organ Manufacturing, Regenerative Medicine, 3D Bioprinting, Ralinepag, SEC Filing, 10-Q, Financial Results, Clinical Trials, FDA Approval, Share Repurchase