UNITED THERAPEUTICS CORP

UNITED THERAPEUTICS CORP (UTHR) Q1 2026 Earnings Call Transcript

Bullish Other 22.44B USA
Next Earnings
2026-04-28

United Therapeutics Corporation, a biotechnology company, engages in the development and commercialization of products to address the unmet medical needs of patients with chronic and life-threatening diseases in the United States and internationally. The company offers Tyvaso DPI, an inhaled dry powder via pre-filled and single-use cartridges; Tyvaso, an inhaled solution via ultrasonic nebulizer; Remodulin (treprostinil) injection to treat patients with pulmonary arterial hypertension (PAH) to diminish symptoms associated with exercise; Orenitram, a tablet dosage form of treprostinil, to delay disease progression and improve exercise capacity in PAH patients; and Adcirca, an oral PDE-5 inhibitor to enhance the exercise ability in PAH patients. It also markets and sells Unituxin (dinutuximab) injection, a monoclonal antibody for treating high-risk neuroblastoma; and Remunity Pump, which contains a pump and separate controller for Remodulin. In addition, the company involved in developing RemoPro and Ralinepag for the treatment of PAH; Aurora-GT, a gene therapy product to rebuild the blood vessels in the lungs; and Nebulized Tyvaso, for the treatment of idiopathic pulmonary fibrosis, as well as xenografts, which are development-stage organ products. It has licensing and collaboration agreements with DEKA Research & Development Corp. to develop a semi-disposable system for the subcutaneous delivery of treprostinil; MannKind Corporation to develop and license treprostinil inhalation powder and the Dreamboat device; and Arena Pharmaceuticals, Inc. to develop Ralinepag. United Therapeutics Corporation was incorporated in 1996 and is headquartered in Silver Spring, Maryland.

United Therapeutics reports 2025 revenue growth and advances three transformative, upcoming launches including a once-daily super prostacyclin, a coughless Tresmi inhaler, and a superior IPF therapy, with strong Tyvaso DPI momentum and upcoming pivotal readouts.

Key Highlights

Three major product launches anticipated in 2027
UT expects a once-daily super prostacyclin for PAH, a coughless soft mist inhaler Tresmi for ILD, and a superior IPF treatment to launch commercially in 2027.
Record revenue achieved in 2025
Full-year 2025 revenue exceeded $3 billion with 11% growth vs 2024; Q4 revenue was $790 million, up 7% year over year.
Tyvaso DPI and portfolio growth
Tyvaso revenue was $464 million in Q4, up 12% YoY, with Tyvaso DPI delivering 24% YoY growth and new cartridge/dosing innovations expanding adoption.
Unblinding and data readthrough for late-stage programs
Unblinding of the TETON 2/IPF program next week with strong TETON-2 results; potential translation to TETON-1; Ralinepag data expectations discussed for improved outcomes.
AI-enabled translational platform and biotech partnerships
The AI-driven digital lung model is being used to pursue multiple BD discussions with three pharma partners, aiming to de-risk and accelerate clinical trials.

Positive Signals

  • 2025 total revenue of >$3 billion with 11% YoY growth reaffirming durable demand
  • Tyvaso revenue of $464 million in Q4 and Tyvaso DPI 24% YoY growth
  • Introduction of 80-microgram DPI cartridges and expanded dosing flexibility
  • Three major product launches expected by 2027 (once-daily super prostacyclin, Tresmi coughless inhaler, superior IPF therapy)
  • AI-enabled digital lung model powering potential partnerships and faster trial design

Negative Signals

  • Seasonal revenue patterns with Q1 and Q4 historically lighter, introducing near-term variability
  • Competitive dynamics with Liquidia and potential market pressures on DPI adoption
  • Reliance on timely regulatory approvals for Tresmi, TETON 1/2 results, and IPF program readouts
  • Operational execution risk around rapid multi-product launches and capacity planning
  • Need to demonstrate durable real-world uptake beyond early pipeline optimism

📊Financial Results

  • Full-year 2025 revenue: >$3.0 billion, up 11% year over year
  • Q4 2025 revenue: $790 million, up 7% year over year
  • Tyvaso: Q4 revenue $464 million, up 12% YoY; Tyvaso DPI up 24% YoY
  • Sequential revenue strength anticipated in Q2 as seasonal and weather-related factors ease
  • Divergence between current momentum and longer-term guidance will depend on new product launches and IPF/TETON trial readouts

🔮Future Guidance

  • Three disease-transformative launches expected by 2027: once-daily super prostacyclin for PAH, Tresmi coughless inhaler for ILD, and enhanced IPF therapy
  • Targeting $4 billion revenue run rate by end of 2027, with the trajectory bending upwards in the back half of the year
  • Tresmi filing this year with commercial launch planned for next year
  • TETON 2 unblinding next week with optimistic expectations; potential translation to TETON 1 results
  • Ongoing expansion of Tyvaso DPI and continued double-digit growth across Tyvaso, Orenitram, and Remodulin

💡Interesting Insights

  • The company positions Tresmi as a category-killer that directly targets the two main tolerability barriers (cough and frequency) for treprostinil therapies, and is publicly framing the product as a stealth-to-launch deep innovation with controlled disclosures until regulatory approval

Detailed Analysis

AI-generated summary of UNITED THERAPEUTICS CORP earnings call transcript.

United Therapeutics delivered 2025 with record revenue above $3 billion and double-digit growth driven by Tyvaso and Orenitram, while outlining a pipeline of three category-shifting launches for 2027: a once-daily super prostacyclin for PAH, a coughless Tresmi inhaler for ILD, and a best-in-class IPF treatment. Tyvaso DPI's momentum continued with 24% YoY growth and new cartridge options, reinforcing its lead in inhaled prostacyclin therapy. The company highlighted an early stage unblinding for a pivotal IPF study (TETON 2) with strong expectations to translate to TETON 1, and signaled continued market leadership against competitors like Liquidia. In addition, UT emphasized its AI-enabled digital lung model to accelerate trials and potential partnerships with three pharma companies, and management projected a $4 billion annual revenue run rate by late 2027, underscoring a sharpened growth trajectory driven by both existing franchises and new product launches.

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