United Therapeutics(US:UTHR)2020-10-28 19:36Financial Data and Key Metrics Changes - The company reported strong double-digit year-over-year growth in revenues for Orenitram, Tyvaso, and Unituxin, with adjusted US Remodulin revenues growing year-over-year and 5% sequentially [19][20] - Tyvaso and Orenitram revenues grew by approximately 30% each year-over-year [20] Business Line Data and Key Metrics Changes - The highest number of patients on treprostinil medicines was recorded, with double-digit growth in patients on Orenitram and Tyvaso year-over-year and quarter-to-quarter [9][10] - Solid performance of Remodulin is expected to be enhanced by two planned launches in 2021 [10] Market Data and Key Metrics Changes - Total treprostinil starts returned to pre-pandemic levels during the quarter, indicating recovery from COVID-related softness [21] - The number of patients utilizing treprostinil products reached an all-time high, marking the fourth consecutive quarter of record active patient census [21] Company Strategy and Development Direction - The company is expanding its focus from solely pulmonary hypertension to include pulmonary fibrosis and other forms of interstitial lung disease [76][78] - Upcoming product launches include the Remunity pump and the ISR for Remodulin, with expectations for significant market penetration [24][25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming FDA approval for Tyvaso in treating pulmonary hypertension associated with interstitial lung disease, highlighting the unmet medical need for over 30,000 patients [35][36] - The company is preparing for the launch of Tyvaso and is actively engaging with physicians to educate them about the new treatment options [23][68] Other Important Information - The company plans to file an IND for the xenokidney project in 2021, aiming to address the significant unmet medical need for kidney transplants [18][56] - A risk management group has been established to monitor the impacts of COVID-19 on various aspects of the business [72][74] Q&A Session Summary Question: Tyvaso's growth trend and physician overlap - Management noted that while there is enthusiasm for Tyvaso, it is difficult to determine the exact patient demographics being treated due to lack of specific prescription data [32][34] Question: Regulatory filing for Tyvaso ex-US and TreT study - The company is currently focused on gaining FDA approval before considering European filing schedules, and plans to conduct a BREEZE 2 study for the ILD population [40][42] Question: TreT study data and supply expectations - Preliminary data from the TreT study shows comparable PK to Tyvaso, and the company is confident in meeting supply demands for the TreT launch [51][52] Question: Market opportunity for xenokidney transplants - Management highlighted the significant unmet need for kidney transplants, with over 300,000 people in need, and plans to build a commercial scale DPF facility following successful clinical results [55][58] Question: Impact of COVID-19 on clinical trials and commercialization - The company has implemented a coordinated risk management approach to address COVID-19 impacts and remains hopeful for improvements in the near term [72][74]