• Total Revenue: $434 million for the third quarter, a 33% increase over the previous year.
• Revenue Growth: 23% growth from the third quarter of 2023, achieving a $3 billion revenue run rate.
• Orenitram Revenue: $113 million for the third quarter, a 23% growth from the same period last year.
• Remodulin Revenue: $128 million worldwide, with U.S. revenue growing by 3% year over year.
• Unituxin Revenue: $61 million for the third quarter, a 19% increase from the prior year quarter.
• Accelerated Share Repurchase Program: $1 billion repurchase, approximately 3.5 million shares at an average price of $282.
• Litigation Accrual: $65.1 million recorded under selling, general, and administrative expenses.

• Warning! GuruFocus has detected 4 Warning Sign with UTHR.

Release Date: October 30, 2024

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

Positive Points

• United Therapeutics Corp (NASDAQ:UTHR) reported record-breaking revenue of $749 million for the quarter, marking a 23% growth from the previous year.
• The company achieved a $3 billion revenue run rate just eight quarters after surpassing the $2 billion mark, demonstrating significant growth momentum.
• United Therapeutics Corp (NASDAQ:UTHR) has a strong pipeline with several important data reads and potential regulatory decisions expected over the next 36 months.
• The company successfully completed a $1 billion accelerated share repurchase program, reducing outstanding shares by approximately 7%.
• United Therapeutics Corp (NASDAQ:UTHR) is making progress in revolutionary organ alternative technology, with ongoing clinical studies and regulatory feedback from the FDA.

Negative Points

• The company recorded a litigation accrual of $65.1 million in connection with a potential judgment in the Sandoz case, which could impact future financials.
• Despite strong U.S. revenue growth, worldwide revenue for Remodulin saw a slight decline of 2% due to international order timing.
• There is uncertainty regarding the widespread adoption of transitioning patients from Remodulin to Orenitram, as it is not yet a widely used practice.
• The company faces competition in the market, which may impact future revenue growth and market share.
• United Therapeutics Corp (NASDAQ:UTHR) has entered into payer contracts that may result in higher gross-to-net adjustments, potentially affecting profitability.

Q & A Highlights

Q: Are patients transitioning from Remodulin to Orenitram, and how does this impact revenue? A: Michael Benkowitz, President and COO, explained that while some patients are transitioning from Remodulin to Orenitram, it is not yet a widespread trend. The expedite protocol allows for higher doses of Orenitram, which could increase revenue as patients transition more quickly to therapeutic doses.

Q: What are the drivers behind the growth of nebulized Tyvaso and DPI? A: Michael Benkowitz noted that the growth is partly due to destocking from the previous year. The mix between DPI and nebulizer is stable, with DPI favored two-thirds to one-third. Transitions between the two are marginal, and the portfolio allows doctors to switch based on patient needs.

Q: How does United Therapeutics plan to support manufacturing capacity for IPF, and what are the plans for share repurchase programs? A: James Edgemond, CFO, stated that the North Carolina facility is well-positioned to support IPF approval without shortages. Regarding share repurchases, the company completed a $1 billion ASR and will continue to evaluate capital allocation priorities, including potential future ASRs.

Q: How does Remodulin perform against generic competition, and what is its future outlook? A: Michael Benkowitz expressed confidence in Remodulin's durability despite generic competition. It remains a key treatment for pulmonary hypertension, and the company expects it to continue performing well, with potential variability as patients toggle between Remodulin and Orenitram.

Q: Can you elaborate on the FDA feedback for the 10G xeno kidney IND? A: Leigh Peterson, Product Development and Xenotransplantation, mentioned that they received positive feedback from the FDA and are working to submit the IND shortly. Details of the clinical study design will be shared once the IND is cleared.

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