United Therapeutics Corporation Q4 FY2025 earnings call

• Revenue growth is a religious focus, with teams committed to durable double-digit growth. - Development pipeline includes transformative products like Tresmi, a soft mist inhaler for PAH and ILD, expected to be filed for approval this year and launched next year. Also, unblinding of an outcome study next week for once-a-day treatments for pulmonary hypertension. - Product development team led by Dr. Leigh Peterson is working on key trials like TETON 1 and TETON 2 for IPF. - Business development involves fruitful discussions with three pharmaceutical companies driven by the AI-enabled digital lung model. - Transplantation efforts are firing on all thrusters, with Xeno having two patients transplanted and on track to enroll the full 6-patient cohort by summer, and Miromatrix having fully enrolled and completed the first manufactured liver clinical trial. - Strategic clinical development group is innovating with products like Tresmi and other stealth mode products for PAH and IPF.

2025 marked another year of record-breaking revenue, with total revenue surpassing $3 billion for the first time. For the fourth quarter, total revenue was $790 million, representing 7% growth from the fourth quarter of 2024. Tyvaso contributed $464 million in total revenue for the fourth quarter, a 12% increase over the previous year, underpinned by robust 24% year-over-year growth in Tyvaso DPI. Orenitram and Remodulin remain backbones to treprostinil-based therapy in treating pulmonary hypertension and are strong foundational pieces to the commercial business, with data from the ongoing ARTISAN study reinforcing their benefits.

• Expect three disease transformative commercial launches in 2027: a once-daily super prostacyclin for PAH, a coughless inhaler for ILD, and a better than everything new treatment for IPF. - Expect durable double-digit growth and ongoing success over the long term. - Committed to hitting a $4 billion revenue run rate by the end of 2027, with the three new product launches expected to bend the revenue curve upwards beyond that.

Remarks involve forward-looking statements representing expectations or beliefs regarding future events, which involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Forms 10-K and 10-Q, contain additional information on these risks and uncertainties.

Q: So just on TETON 1 data coming up, I wanted to understand your level of confidence here in a positive study for IPF. I know you're very confident ahead of the TETON 2 study, but just in terms of how you're thinking about for this second study, I would love to get your thoughts. And then secondly, it seems like this question keeps coming up, just the impact from Yutrepia. I know previously, you talked about that this is -- there was a give it a try dynamic. But just what are you seeing latest in terms of the patient adds for DPI or nebulizer and if there is any impact from the competitor?

A: Leigh Peterson said they are extremely encouraged by the TETON 2 results and are optimistic to show a treatment effect in TETON 1 as the study populations are relatively similar. Michael Benkowitz said Tyvaso remains the well-entrenched market leader, referrals have been at pre-Liquidia launch levels in 3 of the last 4 months, patient starts lagged due to seasonality and weather but trends suggest return to sequential revenue growth no later than Q2; Q: So I thought it was a really interesting update on the soft mist inhaler product. And I was curious if you could talk a bit more about the human-based studies you've done so far and what additional features you've been optimizing for this product? And how you think physicians will react in terms of prescribing it if it's fully available and commercialized?

A: Martine Rothblatt said physicians will be super happy as it's soft mist vs dry powder, equivalently effective, and product was just brought out of stealth mode, details not fully shared but to be filed this year and launched next year; Q: Maybe the team, so I think you confirmed the double-digit growth this year. I think, Martine, you mentioned the $4 billion run rate by 2027 -- the end of 2027. Can you also comment on that kind of soft guidance? And also given those three new product launches next year, so how much contribution from those launches will contribute to the long-term growth, including the $4 billion run rate?

A: Martine Rothblatt said committed to hitting $4 billion revenue run rate by end of 2027, double-digit growth from current products is base, and three new product launches are category crusher products that will bend the revenue curve upwards beyond $4 billion; Q: Congrats on the progress. Maybe given your excitement for ralinepag, what are the most important outcomes that we should be looking at when we see those data? Is it on PVR, 6-minute walk, time to worsening event? Kind of what do you think will resonate most with physicians in addition to the dosing benefit to drive adoption there?

A: Leigh Peterson said the drug is a very potent one with tight IP receptor binding and long half-life translating to once-a-day dosing and potentially more tolerability, and looking to see statistically significant and clinical meaningful benefit on top of that in clinical worsening versus placebo, including benefit in hospitalizations and mortality