UNITED THERAPEUTICS Corp Q1 FY2025 earnings call

• United Therapeutics has had record revenue for 9 out of the past 12 quarters, with double-digit revenue growth for 11 consecutive quarters.
• Innovation and revolution waves: 5 registration phase studies underway, a pending marketing application at the FDA, and new preclinical candidates including 3 xeno organs.
• Planning for the first transplant in the UKidney clinical study (EXPAND) mid-year, with INDs for EXTEND and EXPRESS studies expected within a year. Positive FDA feedback on the UTHYMOKIDNEY program.
• Capital allocation: Invested in CapEx for manufacturing facilities, corporate development (acquired IVIVA and Miromatrix), and returned $1 billion to shareholders via share repurchase.
• Commercial business is strong, with Tyvaso DPI positioned for sustained growth due to device convenience, unlimited dosing potential, and large prescriber/patient base.

United Therapeutics reported a record revenue quarter with $794 million in Q1 2025, representing 17% growth from Q1 2024. This was driven by robust results for treprostinil products including Tyvaso, Orenitram, Remodulin, and Unituxin. The revenue contribution from these products reflects consistent patient demand, growth in prescribers, and depth of prescribing within practices.

• Expect momentum to continue led by Tyvaso and Tyvaso DPI.
• Confident in sustained double-digit revenue growth with existing portfolio.
• Potential TETON data in idiopathic pulmonary fibrosis could shift Tyvaso use into a larger market with orphan drug exclusivity.
• Ralinepag expected for commercialization, aiming to expand prostacyclin utilization in pulmonary arterial hypertension (PAH).

• Risks associated with forward-looking statements in SEC filings.
• Unrelated infections impacting xenotransplantation trials and the need to manage immunosuppression.
• Competitive landscape in PAH and pulmonary hypertension-related interstitial lung disease (PH-ILD).

Q: On the UTHYMOKIDNEY program enrollment and learnings from Ms. Looney's experience A: Dr. Leigh Peterson stated enrollment will be similar to the 10-gene kidney study, and they learned about tweaking immunosuppression despite an unrelated infection causing rejection Q: Magnitude of year-over-year contribution to sales from Part D redesign for Tyvaso A: Michael Benkowitz said there is a modest benefit, but Part D redesign obligations somewhat offset it Q: Split of prescriber and patient demand driving Tyvaso DPI growth and price increase impact A: Michael Benkowitz said new patient starts are split ~2/3 DPI and 1/3 nebulizer, price increase in January, with gross to net impact mostly realized in Q4 Q: Capital allocation, acquisitions, share repurchase A: James Edgemond discussed prioritizing internal R&D and manufacturing, with external corporate development for acquisitions, and continued focus on returning cash to shareholders via repurchases Q: Patient adds for Tyvaso and competitive position vs Insmed's TPIP A: Michael Benkowitz mentioned patient add metrics not disclosed, and views on TPIP data and Tyvaso's competitiveness in PH-ILD and PAH