Could you elaborate on the human-based studies for the soft mist inhaler and its optimizing features? How do you expect physicians to react to its availability?

Physicians are expected to be very happy due to patient preference for soft mist over dry powder, leading to better tolerability. The product is expected to be equivalently effective. Details on competitive advantages will remain undisclosed until FDA approval, but the company is filing this year for a launch next year. “I think physicians will be super happy about it. It is -- as it says right in the name, it's soft mist versus dry powder. So I think physicians will be happy about it because patients will be happy about it.”

Can you confirm the $4 billion revenue run rate by the end of 2027? And how much will the three new product launches contribute to long-term growth, including that run rate?

Management confirmed the commitment to hit a $4 billion revenue run rate by the back half of 2026, not 2027, driven by existing products. The three new product launches are expected to significantly accelerate revenue growth beyond this $4 billion baseline, as they are considered 'category crusher' products. “So first of all, we can clearly double down on our commitment to hit that $4 billion revenue run rate next year. So it will be in the back half of the year. But if you just take our double-digit revenue growth and you roll it forward from the levels that we are at right now, you'll see that we would be hitting that $1 billion a quarter by the tail end of next year.”

Given the excitement for ralinepag, what are the most important outcomes to look for in the data (PVR, 6-minute walk, time to worsening)? What will resonate most with physicians?

The drug's potency, tight receptor binding, and long half-life are key, translating to once-a-day dosing and potential tolerability benefits. Physicians will appreciate statistically significant and clinically meaningful benefits in clinical worsening versus placebo, including reductions in hospitalizations and mortality. “But also, we're looking to -- I mean, we're looking to see the statistically significant and clinical meaningful benefit on top of that in clinical worsening versus placebo. And as you all know from our other studies as well as this one, clinical worsening is defined with specific parameters and seeing a benefit in the number of hospitalizations as well as mortality would be a super effect to see in this product.”

UTHR

United Therapeutics (UTHR) Q4 FY25 earnings call: guidance and Q&A

Earnings call· Dec 2025 (Q4 FY25)· Health Care· Feb 25, 2026

Source: earnings call transcript

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

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

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

Category	Target	Timeline	Confidence
Tresmi regulatory filing	File for approval high materiality	FY26	High
Tresmi commercial launch	Commercial launch high materiality	FY27	High
Tyvaso for IPF commercial launch	Commercial launch not later than June high materiality	June 2027 · FY27	High
Total revenue growth	Double-digit growth high materiality	FY26	High
Total revenue run rate	$4 billion high materiality	End of 2026 · FY26	High
Xenotransplantation trial enrollment	Fully enroll full 6-patient cohort medium materiality	Summer 2026 · FY26	High
Xenotransplantation trial registration enrollment	Enroll full balance of trial needed for registration medium materiality	FY27	High
Xenotransplantation commercial product launch	Commercial product on the market high materiality	2030 · FY30	High
Miromatrix FDA guidance	Expect FDA guidance medium materiality	FY26	High
Sequential revenue growth	Return to sequential revenue growth medium materiality	Q2 · FY26	Medium

Segment performance

Segment	Revenue	YoY	QoQ	Margin
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.	$3B	11%	—	—
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.	$464M	12%	—	—
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%	—	—

Product announcements

Product	Type	Timeline
Tresmi (treprostinil soft mist inhaler)	launch	Filing this year (2026), commercial launch next year (2027)
Once-daily super prostacyclin	launch	Unblinding outcome study next week (early March 2026)
Tyvaso for IPF	launch	Unblinding second pivotal trial next month (March 2026), commercial launch not later than June 2027
Tyvaso DPI 80-microgram cartridges	update	Recently introduced
Tyvaso DPI 96 and 112-microgram combination kits	update	Recently introduced

Deals & partnerships

Three pharmaceutical companies Discussions 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

Seasonal revenue trends Ongoing

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 lags Q4 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 issues During 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

Super prostacyclin outcome study unblinding

Next week (early March 2026)

Current Unblinding next week

Target Positive 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.

Find out whether UTHR delivers this. Inve re-checks your case every morning.

Q&A highlights

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 read 5 chapters

Detailed narrative

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.

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.

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.

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.

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.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.