UNITED THERAPEUTICS (UTHR) Company Report

United Therapeutics reported significant growth in total Tyvaso and Tyvaso DPI in its Q3 report, identifying them as key future growth drivers, particularly in PH-ILD.
The company projects achieving a quarterly revenue run rate of $1 billion by the end of 2027, primarily driven by the expansion and growth of its current commercial products.
Following positive TETON 2 clinical study results for idiopathic pulmonary fibrosis (IPF), which showed a 96 ml benefit (placebo-adjusted difference on FVC), the company sees a multi-billion dollar opportunity and plans to meet with the FDA by the end of 2025 to discuss regulatory strategy.
The Advanced Outcomes trial for Ralinepag, a once-a-day oral prostacyclin, is expected to read out in the first half of 2026, with the potential for higher potency and efficacy than existing treatments.
United Therapeutics has initiated its xenotransplantation program, successfully completing a first transplant of a kidney into a human in the EXPAND clinical trial, with plans to expand to lung and heart transplants.

Nov 18, 2025, 12:00 PM

Transcript

United Therapeutics Outlines Growth Trajectory and Pipeline Progress at Jefferies Conference

UTHR

Guidance Update

New Projects/Investments

Legal Proceedings

United Therapeutics projects a quarterly revenue run rate of $1 billion by the end of 2027, primarily driven by the growth of its existing commercial business, including Tyvaso and Tyvaso DPI.
The Teton 2 clinical study for Idiopathic Pulmonary Fibrosis (IPF) showed a 96 milliliter benefit on FVC, with Teton 1 expected to unblind in H1 2026; both trials are required for FDA approval, targeting a multi-billion dollar market opportunity.
The company is confident in the continued growth of its Tyvaso DPI product, which achieved 22%-23% growth in Q3, despite ongoing litigation and competition from Utrepia.
United Therapeutics is advancing its pipeline with Rilendipag, a once-daily oral prostacyclin, with clinical trial results expected in H1 2026, and has initiated xenotransplantation with the first kidney transplant in the EXPAND clinical trial.

Nov 18, 2025, 12:00 PM

Transcript

United Therapeutics Provides Business Update and Future Outlook at Jefferies Conference

UTHR

Guidance Update

Product Launch

New Projects/Investments

United Therapeutics anticipates achieving a $1 billion quarterly revenue run rate by the end of 2027, predominantly from its current commercial products.
Tyvaso DPI demonstrated 22%-23% growth in Q3, and the company maintains confidence in its continued growth despite market competition and ongoing litigation.
The Teton 2 study for Idiopathic Pulmonary Fibrosis (IPF) showed a 96 milliliter benefit on FVC, with Teton 1 data expected in H1 2026 for this multi-billion dollar market.
The company expects Rilendipag (oral once-daily prostacyclin) clinical trial results in H1 2026, aiming for superior potency and efficacy.
The first kidney transplant in the xenotransplantation EXPAND clinical trial has been completed, with plans to expand to lung and heart transplants.

Nov 18, 2025, 12:00 PM

Transcript

United Therapeutics Discusses Q3 Growth, $4 Billion Revenue Target, and Pipeline Milestones at UBS Conference

UTHR

Guidance Update

Product Launch

New Projects/Investments

United Therapeutics reported double-digit year-over-year growth in its Tyvaso franchise for Q3 2025 and announced the first transplant of its U-Kidney under a clinical trial.
The company expressed confidence in reaching a $4 billion revenue run rate by the end of 2027, supported by the positive TETON-2 clinical trial data for IPF, which was described as the "best IPF study ever conducted".
Key upcoming data readouts include the TETON-1 trial for IPF and the ralinepag outcomes study, both anticipated in the first half of 2026.
United Therapeutics plans to introduce higher-dose Tyvaso cartridges (80, 96, and 112 micrograms) in the coming months, and noted that competitor Yutrepia's launch is expanding the overall PAH and PH-ILD markets rather than materially impacting Tyvaso's growth.

Nov 10, 2025, 2:30 PM

Transcript

United Therapeutics Discusses Q3 Performance, Pipeline Progress, and 2027 Revenue Target

UTHR

Guidance Update

New Projects/Investments

Revenue Acceleration/Inflection

United Therapeutics reported double-digit year-over-year growth in its Tyvaso franchise for the third quarter.
The company announced positive results from its TETON-2 clinical trial for IPF, described as the "best IPF study ever conducted," and anticipates TETON-1 results in the first half of 2026.
United Therapeutics is confident in achieving a $4 billion run rate by the end of 2027, partly driven by the clarity gained from the TETON-2 IPF trial.
Key pipeline updates include the recent first U-Kidney transplant under its clinical trial (the first clinical IND for a xeno organ) and expected outcomes study results for ralinepag in the first half of 2026.

Nov 10, 2025, 2:30 PM

Transcript

UTHR Highlights Q3 Growth, Key Clinical Milestones, and 2027 Revenue Target

UTHR

Guidance Update

New Projects/Investments

United Therapeutics reported double-digit year-over-year growth in its Tyvaso franchise for the third quarter.
The company announced positive results from the TETON-2 clinical trial for IPF in September, describing it as the "best IPF study ever conducted".
United Therapeutics expects to achieve a $4 billion revenue run rate by the end of 2027, driven by the clarity gained from the TETON-2 trial in IPF.
The first transplant of its U-Kidney under a clinical trial was announced last week, marking the first clinical IND for a xeno organ. The study will involve a first cohort of six patients, followed by a second cohort of 44 or more patients.
Upcoming pipeline milestones include results from the ralinepag outcomes study and the TETON-1 trial for IPF, both anticipated in the first half of 2026.

Nov 10, 2025, 2:30 PM

Transcript

Zetagen Therapeutics to Present Positive Phase 2a Clinical Trial Results for ZetaMet™

UTHR

New Projects/Investments

Zetagen Therapeutics will present preliminary Phase 2a clinical trial results for ZetaMet™ (Zeta-BC-003) at the San Antonio Breast Cancer Symposium (SABCS) 2025 on December 10, 2025.
The study investigated ZetaMet™ for safety and efficacy in treating lytic bone lesions in patients with metastatic breast cancer (MBC).
Patients who completed the study achieved complete remission in all treated lesions, with no active tumor detected by MRI, and demonstrated complete bone regeneration.
Treated lesions showed an 87.9% reduction in average lesion defect volume by day 180, and therapeutic effects extended to adjacent untreated lesions.
ZetaMet™ is a first-of-its-kind intratumorally administered small-molecule drug that has received multiple Breakthrough Designations from the FDA.

Nov 5, 2025, 6:31 PM

Press Release

Zetagen Therapeutics to Present Phase 2 Clinical Trial Results for ZetaMet™

UTHR

New Projects/Investments

Zetagen Therapeutics will present preliminary results from its Phase 2a clinical trial (NCT05280067) for ZetaMet™ (Zeta-BC-003) at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Wednesday, December 10, 2025.
The trial evaluated ZetaMet™ for safety and efficacy in treating metastatic breast cancer (MBC) lytic bone lesions in Stage 4 breast cancer patients.
Key findings include complete response (CR) in all treated lesions, with no active tumor detected on MRI and full bone regeneration, showing a mean lesion defect volume decrease of 87.9% at day 180.
The therapeutic effect of ZetaMet™ also extended to nearby non-treated lesions within the same vertebral body, achieving complete response.
No serious adverse events (SAEs), adverse events (AEs), or skeletal-related events (SREs) were observed in patients who received a single intratumoral injection.

Nov 4, 2025, 3:04 PM

Press Release

United Therapeutics Announces First Transplant in UKidney EXPAND Clinical Trial

UTHR

New Projects/Investments

United Therapeutics Corporation announced the first clinical xenotransplantation in its EXPAND study of the UKidney in patients with end-stage renal disease (ESRD).
The UKidney is an investigational xenokidney from a pig, engineered with 10 gene edits to facilitate immunological acceptance and reduce rejection.
The EXPAND study is designed as a combination phase 1/2/3 trial to evaluate safety and efficacy, with the goal of supporting a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA).
The first cohort of the study will consist of six transplants at two centers, with a 12-week waiting period between the first and second transplants.

Nov 3, 2025, 12:00 PM

Press Release

Liquidia Corporation Reports Third Quarter 2025 Financial Results

UTHR

Earnings

Product Launch

Revenue Acceleration/Inflection

Liquidia Corporation reported net product sales of $51.7 million for YUTREPIA in the third quarter ended September 30, 2025, marking its first full quarter of sales for the product.
The company achieved profitability in Q3 2025, reporting an operating income of $1.7 million and positive non-GAAP adjusted EBITDA of $10.1 million.
The net loss for the third quarter of 2025 was $3.5 million, a substantial improvement from a net loss of $31.0 million in the same period last year.
YUTREPIA's launch continues to show momentum with over 2,000 unique patient prescriptions and 1,500 patient starts as of October 30, 2025.

Nov 3, 2025, 11:30 AM

Press Release

Earnings Transcripts

Quarterly earnings call transcripts for UNITED THERAPEUTICS.

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