• Record Revenue Year: 2024 marked the third consecutive year of record-setting revenue for United Therapeutics.
• Overall Revenue Growth: Achieved almost 24% growth over the full year 2023.
• Fourth Quarter Revenue Growth: 20% increase from the fourth quarter of 2023.
• Tyvaso Revenue: $416 million for the fourth quarter, a 19% increase over the previous year.
• Orenitram Revenue: 28% growth in the fourth quarter of 2024 to $108 million.
• Remodulin Revenue: Fourth quarter worldwide revenue of $135 million, up 17% from the prior year period.
• Unituxin Revenue: Record revenue of $68 million for the fourth quarter, up 25% from the prior year quarter.
• Shareholder Returns: $1 billion returned through an accelerated share repurchase program.

• Warning! GuruFocus has detected 2 Warning Sign with UTHR.

Release Date: February 26, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• United Therapeutics Corp (NASDAQ:UTHR) achieved a record revenue year in 2024, marking the third consecutive year of record-setting revenue.
• The company has initiated a groundbreaking kidney clinical trial, which could potentially eliminate the need for dialysis for patients with end-stage renal disease.
• Enrollment for the inhaled Treprostinil TETON 1 study in idiopathic pulmonary fibrosis has been completed, with promising top-line data expected in the coming years.
• The development of ralinepag as a once-daily oral prostacyclin antagonist for pulmonary arterial hypertension could significantly alter treatment paradigms and represents a multibillion-dollar opportunity.
• United Therapeutics Corp (NASDAQ:UTHR) returned $1 billion to shareholders through an accelerated share repurchase program, demonstrating strong capital allocation and shareholder value focus.

Negative Points

• The company's fourth-quarter net revenue saw a slight sequential decline, attributed to recent contracting efforts for Tyvaso.
• There is uncertainty regarding the impact of potential competitors on Tyvaso's market position, despite efforts to secure payer contracts.
• The company does not provide specific sales guidance for 2025, leaving some uncertainty about future growth trajectories.
• The success of the kidney clinical trial and subsequent investments in additional facilities remain speculative and dependent on trial outcomes.
• The impact of new treatments like Windover on the PAH market could potentially affect the growth of Tyvaso, although the company remains optimistic about its positioning.

Q & A Highlights

Q: Can you provide insights into the growth trajectory for United Therapeutics' commercial franchise in 2025, given the absence of sales guidance? A: Michael Benkowitz, President and COO, stated that the company expects to continue double-digit growth into the mid-decade, driven by their foundational business. The anticipated approvals for ralinepag and Tyvaso in IPF are expected to significantly enhance growth.

Q: What are the criteria for proceeding to the next transplant in the UKidney clinical trial, and what would justify larger investments in additional DPF facilities? A: Dr. Leigh Peterson, EVP of Product Development & Xenotransplantation, explained that after the first cohort of six participants, there will be a 12-week review period to assess safety and patient survival data. The decision to invest in additional DPF facilities will depend on the trial's progress.

Q: How does the Hyperion study impact United Therapeutics' PAH business, and can Tyvaso still grow in this area? A: Michael Benkowitz noted that while the Hyperion study may influence treatment strategies, prostacyclins remain essential in PAH treatment. The company expects continued double-digit growth, as prostacyclins are used in combination with other treatments.

Q: Can you discuss the baseline disease severity of patients in the Xeno transplant trial and how their progress will be communicated? A: Dr. Leigh Peterson clarified that the trial includes patients not eligible for traditional transplants due to medical reasons or low likelihood of receiving a transplant. Unlike previous cases, patient data will be kept private, similar to traditional clinical studies.

Q: Could the growth in Tyvaso prescribing for PH-ILD and increased commercial volumes offset seasonal trends? A: Michael Benkowitz highlighted that the expansion of the sales force has successfully driven growth in PH-ILD prescribing. The company expects continued growth in both PH-ILD and PAH indications, with minimal impact from Part D redesign.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.