Financial Data and Key Metrics Changes - In Q4 2024, YUPELRI net sales increased by 10% year-over-year, reaching 239 million, with an 8% increase in net sales for 2024 and an 11% growth in demand [11][14] - Collaboration revenue grew by 8% to approximately 22 million due to commercial and medical affairs spending [32] Business Line Data and Key Metrics Changes - YUPELRI's hospital performance saw doses increase by 49% year-over-year, with 285,000 redoses pulled through to hospital customers [12][13] - The hospital business accounts for roughly 10% of total YUPELRI volume, with the remaining 90% coming from community settings [77] - Ampreloxetine is on track for expedited NDA filing, with solid enrollment in the CYPRESS study and positive FDA interactions [5][23] Market Data and Key Metrics Changes - GSK reported full year TRELEGY sales of 50 million milestone payment to Theravance [15] - The company expects to receive several hundred million in cumulative royalties starting in 2029 based on projected sales [17] Company Strategy and Development Direction - The company aims to grow YUPELRI revenue while increasing brand profitability, with potential near-term milestones in the U.S. and royalties from China [7][14] - There is a focus on completing enrollment in the CYPRESS study and preparing for an expedited NDA filing for ampreloxetine [8][23] - The company is committed to maximizing the value of TRELEGY and returning excess capital to shareholders [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong financial position entering 2025, with $88 million in cash and no debt [39] - The company is focused on driving YUPELRI growth through strong demand generation and a patient-centered strategy [40] - Management highlighted the potential impact of ampreloxetine on patients with MSA suffering from nOH symptoms [41] Other Important Information - The company plans to request priority review for ampreloxetine at the time of NDA filing [23] - The accounting treatment for TRELEGY milestones has been updated, affecting the recognition of other income [37] Q&A Session Summary Question: What drove the success on the hospital channel this quarter? - Management attributed the success to effective execution of strategy and wins in larger systems, leading to increased volume through therapeutic interchange [45][46] Question: What is the trajectory of the hospital performance into 2025? - Management noted that Q1 is typically softer but indicated that the need for YUPELRI is strong due to high hospital census [59][60] Question: What percentage of YUPELRI sales are non-hospital sales dollars? - Management clarified that the hospital business accounts for roughly 10% of total YUPELRI volume, with 90% from community settings [77] Question: What is the bar for success for the CYPRESS readout? - A one-point change in the OHSA composite score is considered clinically meaningful for success [88] Question: Will there be an increase in the commercial organization ahead of the data? - Management stated that no incremental FTEs are planned until after the CYPRESS data readout [93]
Theravance Biopharma(TBPH) - 2024 Q4 - Earnings Call Transcript