UNITED THERAPEUTICS Corp Q4 FY2024 earnings call

• Record revenue in 2024, marking the third consecutive year of record-setting revenue. - Began a three-year cascade of clinical and regulatory events, including the recent IND clearance for the uKidney clinical trial. - Inhaled treprostinil Teton 1 study in idiopathic pulmonary fibrosis completed enrollment; Teton 2 study expected top-line data in the second half of 2024, and Teton 1 top-line data in the first half of 2026. - Ralinepag expected to conclude enrollment in the advanced outcome study later in 2024, with top-line data in 2026. - Capital allocation: Invested in capex for the Tyvaso DPI manufacturing facility, acquired companies (IVVA and MirrorMatrix), licensed new technologies, and returned $1 billion to shareholders via an accelerated share repurchase program. - Commercial performance: Double-digit revenue growth for major contributors (Tyvaso, U.S. Remodulin, Orenitram, Unituxan); details on Tyvaso's contracting efforts, Orenitram's strong patient shipments and Remodulin transitions, RemUnity Pro pump launch expected later in 2025, and Unituxan's record revenue driven by price and volume increases.

Tyvaso: Fourth-quarter revenue was $4 million, a 19% increase over the previous year. Orenitram: Fourth-quarter revenue was $108 million, a 28% growth. Remodulin: Fourth-quarter worldwide revenue was $135 million, up 17% from the prior year period; US revenue grew 11%. Unituxan: Fourth-quarter revenue was $68 million, up 25% from the prior year quarter. Revenue contribution details were not explicitly provided for each segment in terms of percentage, but major contributors showed strong growth.

• Expect to continue double-digit revenue growth in the foundational business in 2025 and beyond. - RemUnity Pro pump, the next generation in subcutaneous pump technology for PAH patients, expected to launch later in 2025. - For the uKidney trial, a formal review of data at 12 weeks to determine the risk-benefit ratio for proceeding with more patients, and consideration of additional DPF facilities as the trial progresses is premature but will be evaluated.

• Risks associated with forward-looking statements, where actual results may differ materially from expectations. - Uncertainties related to clinical trial outcomes, including those for uKidney, inhaled treprostinil, and Ralinepag. - Competitive dynamics in the pharmaceutical market, particularly related to contracting efforts and potential new entrants. - Regulatory uncertainties that could impact the approval and commercialization of products.

Q: Roger Song asks about the 2025 growth trajectory for the business and pipeline.

A: Michael Benkowitz states they expect to continue double-digit revenue growth in the foundational business, with the impact of contracting efforts having largely pulled through, creating a new base for growth.

Q: Jessica Fye inquires about what to look for to support proceeding to the next transplant in the uKidney trial and proof points for larger scale investment in additional DPF facilities.

A: Leigh Peterson explains the uKidney trial has a twelve-week review period involving the DSMB and steering committee to review safety and patient/graft survival data, looking at six-month graft survival, patient survival, kidney function, and safety parameters; she also notes it's premature to speculate on additional DPF facilities spending.

Q: Ash Verma asks about the Hyperion study and if Tyvaso can still grow on the PAH side.

A: Michael Benkowitz says Wind River doesn't replace prostacyclin, and the impact on Tyvaso growth is immaterial as PAH is a progressive disease.

Q: Joseph Thome asks about the baseline disease severity of the first uKidney trial patient and study follow-up.

A: Leigh Peterson clarifies clinical study patients will have patient privacy maintained, unlike public cases, and details the eligibility populations for the uKidney trial.

Q: Andreas Argyrides asks about Tyvaso's intellectual property moat and contracting dynamics.

A: Michael Benkowitz discusses the payer strategy of using rebates to stay at parity with competitors, aiming to keep Tyvaso competitive in the market.