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    UTHR
    Earnings call· Dec 2025(Q4 FY25)

    UNITED THERAPEUTICS Q4 FY25 earnings call UTHR

    Feb 25, 2026 Source

    Executive summary

    United Therapeutics Q4 FY25 — Transformative Product Launches and Strong Revenue Growth

    United Therapeutics delivered strong Q4 FY25 results, driven by double-digit growth in key products like Tyvaso. The company is poised for a transformative period with three major product launches expected by 2027: Tresmi (a coughless soft mist inhaler), a once-daily super prostacyclin, and an improved IPF treatment. Management reaffirmed its commitment to double-digit revenue growth and a $4 billion run rate by late 2026, independent of these new launches, while also advancing its xenotransplantation and AI-enabled drug discovery programs.

    Highlights

    5

    • Total revenue surpassed $3 billion for the first time in FY25, growing 11% over FY24.

    • Q4 FY25 total revenue was $790 million, representing 7% growth year-over-year.

    • Tyvaso total revenue for Q4 was $464 million, a 12% increase over the previous year.

    • Tyvaso DPI showed robust 24% year-over-year growth.

    • Referrals for total Tyvaso reached their highest level in two years, with 3 of the last 4 months at or above pre-competitive launch levels.

    Concerns

    3

    • Q4 FY25 and Q1 FY26 are typically lighter ordering quarters due to seasonal revenue trends.

    • Patient starts lagged in Q4 FY25 and January due to typical seasonality and severe cross-country weather.

    • Initial curiosity for a new market entrant (Yutrepia) created some competitive dynamics.

    Guidance & targets

    10
    CategoryTargetConfidence
    Tresmi regulatory filing
    File for approval
    high materiality
    High
    Tresmi commercial launch
    Commercial launch
    high materiality
    High
    Tyvaso for IPF commercial launch
    Commercial launch not later than June
    high materiality
    High
    Total revenue growth
    Double-digit growth
    high materiality
    High
    Total revenue run rate
    $4 billion
    high materiality
    High
    Xenotransplantation trial enrollment
    Fully enroll full 6-patient cohort
    medium materiality
    High
    Xenotransplantation trial registration enrollment
    Enroll full balance of trial needed for registration
    medium materiality
    High
    Xenotransplantation commercial product launch
    Commercial product on the market
    high materiality
    High
    Miromatrix FDA guidance
    Expect FDA guidance
    medium materiality
    High
    Sequential revenue growth
    Return to sequential revenue growth
    medium materiality
    Medium

    Segment performance

    3
    SegmentRevenueYoYQoQMargin
    Total Company
    Record-breaking revenue for full year 2025, driven by double-digit growth from Tyvaso and Orenitram. Q4 FY25 total revenue was $790 million, representing 7% growth from Q4 2024. Orenitram and Remodulin remain backbones to treprostinil-based therapy and strong foundational pieces to the commercial business.
    		$3B11%——
    Tyvaso
    Total revenue for the fourth quarter, underpinned by robust growth in Tyvaso DPI. Reflects strategic positioning in a large and growing addressable market in PAH and PH-ILD.
    		$464M12%——
    Tyvaso DPI
    Impressive trajectory reflecting strategic positioning and expected to continue delivering double-digit growth. Recently introduced 80-microgram cartridges and 96/112-microgram combination kits to enhance the platform.
    		—24%——

    Operational metrics

    7
    Total revenue growth
    11%over FY24
    FY25

    First time surpassing $3 billion in total revenue.

    Total revenue growth
    7%YoY
    Q4 FY25

    Q4 FY25 total revenue was $790 million.

    Tyvaso referral rate
    highest levelin two years
    Mid-February

    The referral rate in 3 of the last 4 months was at or above where it was heading into a competitive launch early summer of last year.

    Tyvaso DPI cartridge introduction
    —
    Recent

    Enables delivery of equivalent of 15 nebulized treprostinil breaths in a single DPI breath, improving convenience and expanding dosing flexibility.

    Xenotransplantation patients transplanted
    2
    Current

    Patients are doing well in the FDA-approved phase-less clinical trial.

    Manufactured liver clinical trial
    —
    Current

    First manufactured liver clinical trial ever fully enrolled and successfully completed.

    Patient starts
    lagged
    Q4 FY25 and January

    Primarily due to typical Q4 seasonality and cross-country severe weather. Log jam seems to have broken in February.

    Industry KPIs

    6
    MetricValueDetails
    Pipeline read out calendarUnblinding next week (super prostacyclin) and next month (Tyvaso for IPF)
    Product franchise net sales$464MUSD
    Regulatory approvals filingsFiling this year (2026)
    Peak long term sales guidance$4BUSD
    Prescription volume new startsHighest level in two years
    Clinical trial efficacy safety data95.6 millilitersmL

    Product announcements

    5
    ProductTypeDetails
    Tresmi (treprostinil soft mist inhaler)launch
    Once-daily super prostacyclinlaunch
    Tyvaso for IPFlaunch
    Tyvaso DPI 80-microgram cartridgesupdate
    Tyvaso DPI 96 and 112-microgram combination kitsupdate

    Deals & partnerships

    1
    Three pharmaceutical companiesDiscussions driven by interest in UT's AI-enabled digital lung model

    These companies are interested in the proven predictive power of UT's AI-enabled digital lung model, which can run hundreds of accurate in silico Phase III trials.

    Risks & headwinds

    4
    Seasonal revenue trendsOngoing

    Q1 and Q4 tend to be lighter ordering quarters

    Mitigation: Management reminds investors of historical seasonal patterns; focus on underlying patient demand.

    Competitive market entry (Yutrepia)Past year

    Initial curiosity to evaluate a new market entrant

    Mitigation: Reinforcing Tyvaso DPI's differentiation (consistent delivery, low inspiratory flow); market research indicates belief in competitor's unsubstantiated claims is weighing.

    Patient start lagsQ4 FY25 and January

    Patient starts have lagged trends

    Mitigation: Attributed to typical Q4 seasonality and severe cross-country weather; observed a 'log jam' breaking in February with improving trends.

    Conference call technical issuesDuring Q4 FY25 earnings call

    Martine and Michael were dropped from the call

    Mitigation: Rejoined the call and continued remarks; acknowledged the interruption.

    What to watch in Q1 FY26

    5

    Super prostacyclin outcome study unblinding

    Next week (early March 2026)
    CurrentUnblinding next week
    TargetPositive outcome data

    Why it matters

    This could usher in a new era of once-a-day treatments for PAH, significantly impacting the company's future growth algorithm.

    Also transformative for our markets will be the unblinding of our outcome study next week. We are optimistic that this unblinding will usher in a new era of once-a-day treatments for pulmonary hypertension.

    Q&A highlights

    4

    What is the confidence level for TETON 1 data for IPF, especially given TETON 2 results? And what is the latest impact from Yutrepia on patient adds for DPI or nebulizer?

    Management is highly optimistic for TETON 1, expecting similar robust results to TETON 2 due to similar patient populations. Regarding Yutrepia, Tyvaso remains the market leader; while there was initial curiosity, doctors recognize Tyvaso DPI's advantages. Referral rates are back to pre-Liquidia launch levels, but patient starts lagged in Q4/January due to seasonality and weather, though February showed a strong rebound.

    “So just to reiterate, we're extremely enthusiastic about the TETON 2 results. And we have great confidence that these results are going to be translated to a second successful study, in particular, TETON 1.”

    asked by Ashwani Verma · answered by Leigh Peterson

    2 min read5 chapters

    Detailed Narrative

    01

    Transformative Product Pipeline

    United Therapeutics is preparing for a period of significant product innovation, highlighted by three anticipated commercial launches by 2027. These include Tresmi, a novel soft mist inhaler for PAH and ILD designed to reduce cough by up to 90%; a once-daily super prostacyclin for PAH, offering extended efficacy; and a new treatment for IPF, which demonstrated superior efficacy in its first pivotal trial (TETON 2) and is expected to be confirmed by TETON 1 results. The company plans to file for Tresmi approval this year for a 2027 launch, and for the IPF treatment after TETON 1 unblinding next month, targeting a June 2027 launch.

    02

    Strong Revenue Performance and Market Leadership

    The company achieved record-breaking revenue in FY25, surpassing $3 billion for the first time, an 11% increase over FY24. Q4 FY25 revenue reached $790 million, up 7% year-over-year. This growth was primarily driven by Tyvaso, which saw a 12% increase in total revenue to $464 million in Q4, with Tyvaso DPI growing 24% year-over-year. Despite seasonal ordering patterns and competitive dynamics, Tyvaso maintains its market leadership, with referral rates at two-year highs and prescriber breadth and patient retention at or above pre-competitive launch levels.

    03

    Advancements in Xenotransplantation and Organ Manufacturing

    United Therapeutics is making significant strides in its transplantation programs. The xenotransplantation program has successfully transplanted two patients in its FDA-approved phase-less clinical trial and aims to fully enroll the 6-patient cohort by summer 2026, with a commercial product targeted for 2030. Additionally, its Miromatrix subsidiary completed the first manufactured liver clinical trial and expects FDA guidance this year for both the liver recovery product and the mirokidney implanted product, showcasing broad efforts in creating transplantable organs.

    04

    AI-Enabled Drug Discovery and 'Skunkworks' Innovation

    The company is leveraging its AI-enabled digital lung model, which can simulate hundreds of Phase III trials in silico, significantly accelerating drug development and reducing costs. This technology has attracted interest from three pharmaceutical companies for potential collaborations. The 'Skunkworks' division, responsible for Tresmi, continues to develop innovative products, including once-daily and PRN inhalers, improved oral therapies, and additional PAH/IPF treatments, all with long intellectual property protection.

    05

    Competitive Landscape and Q1 Outlook

    While Tyvaso remains the market leader, the company acknowledged initial curiosity around a new market entrant (Yutrepia). However, internal data suggests that the advantages of Tyvaso DPI (consistent delivery, low inspiratory flow) are being recognized by healthcare providers. Patient starts experienced a lag in Q4 and January due to seasonality and severe weather but showed a strong rebound in February. Management anticipates a return to sequential revenue growth no later than Q2 FY26 if these positive trends continue.

    AI-generated summary of the company’s earnings call. Not investment advice.