• Revenue: $715 million, 20% growth from Q2 2023.
• Tyvaso Revenue: $398 million, up 25% over last year.
• Orenitram Revenue: $107 million, 13% growth from Q2 2023.
• Remodulin Revenue: $147 million, up 16% from last year.
• Unituxin Revenue: $52 million, up 17% from the prior year quarter.

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

Release Date: July 31, 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 revenue of $715 million for the second quarter of 2024, marking a 20% growth from the same period in 2023.
• The company experienced meaningful worldwide revenue growth across all key products, including Tyvaso, Orenitram, Remodulin, and Unituxin.
• Tyvaso revenue increased by 25% year-over-year, driven by continued uptake of Tyvaso DPI, price increases, and increased commercial utilization.
• Orenitram achieved record revenue of $107 million, representing a 13% growth from the previous year, supported by increased commercial utilization and pricing.
• The company has a strategic focus on three waves of success: current market-leading products, next-generation products, and an organ manufacturing business with transformative potential.

Negative Points

• The company faces uncertainty in its second wave of success, particularly with Tyvaso for pulmonary fibrosis and Ralinepag for PAH, due to the unpredictability of clinical trial outcomes.
• There is a modest decline in patient access program utilization for Tyvaso DPI and Orenitram, which could impact future growth.
• The company is not immune to potential future impacts from the Inflation Reduction Act, although current products are not on the list for price negotiation.
• The organ manufacturing business, while promising, still requires significant work to achieve FDA approval and quantity production.
• The success of the TETON trial for pulmonary fibrosis is critical, with high stakes as it could more than double the current $3 billion revenue run rate.

Q & A Highlights

Q: Could you elaborate on the different drivers for Tyvaso DPI versus Nebulized Tyvaso this quarter? Were there any changes or reasons for greater confidence, such as increased referrals or ramping the new field force? A: The underlying demand metrics for Tyvaso continue to be strong, with growth in referrals and starts from both Group 1 PAH and Group III PH-ILD. The impact of the sales force expansion, fully deployed by January 1, is starting to show, particularly with an increase in ILD prescribers writing Tyvaso. This growth is crucial for realizing the full opportunity in PH-ILD due to the large patient base and limited bandwidth of PAH clinics.

Q: What are you seeing in the PAH marketplace regarding the initial WINREVAIR launch? Do your observations align with Merck's commentary, and have there been any changes in referrals or starts in PAH? A: The PAH market remains strong with solid referral and start growth, reflected in our financial results. Most patients in Merck's clinical trial used sotatercept in combination with prostacyclins, which aligns with our observations.

Q: Given the favorable stock reaction to the ASR, what is your appetite for another significant share buyback or ASR? A: Our current ASR is still in process, and we are focused on executing it. We remain committed to wise capital allocation, prioritizing R&D initiatives, corporate development, and our current share repurchase program. Future opportunities will be evaluated based on this capital allocation strategy.

Q: Regarding the filing strategy for IPF, do both ongoing IPF studies need to be successful for a filing, or could one study suffice? Any feedback from the FDA on this? A: Typically, the FDA requires two positive studies for registration. However, if TETON 2 results are highly positive, we will discuss with the FDA the possibility of filing based on one study. We are committed to ensuring the credibility and approvability of our IPF trials.

Q: What kind of bridging study might the FDA require to approve Tyvaso DPI in addition to the nebulized version if TETON is successful? Is there a chance for an interim readout? A: We will not conduct an interim analysis. For bridging to DPI, we will discuss requirements with the FDA, as it involves a different division. A small sub-study in our TETON OLE program might be needed, but it should not delay the approval process.

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