Theravance Biopharma(US:TBPH)2023-11-08 04:23Financial Data and Key Metrics Changes - The company reported quarterly net sales of $675 million and year-to-date net sales of $2 billion, representing a 22% and 25% increase year-on-year respectively [1] - A non-GAAP loss of approximately $700,000 was reported for the quarter, nearing the objective of achieving non-GAAP profitability [16] - The company ended the period with $134 million in cash and equivalents, having bought back approximately $31 million worth of shares [59] Business Line Data and Key Metrics Changes - YUPELRI achieved total third-quarter net sales of $58.3 million, reflecting a 9% year-on-year growth and the highest quarterly net sales since launch [14] - The hospital-based commercial organization contributed significantly to YUPELRI's performance, with a market share improvement to 16.1% in the hospital-based long-acting NEB market [30] - The retail channel also showed solid performance, with a 9% quarter-on-quarter growth in prescriptions filled [82] Market Data and Key Metrics Changes - The company anticipates continued strong results in the fourth quarter based on recent commercial initiatives and internal performance indicators [32] - The market share for YUPELRI in the community setting reached an all-time high of 30.2%, improving over a percentage point sequentially [55] Company Strategy and Development Direction - The company is focused on maximizing the value of YUPELRI and progressing ampreloxetine towards significant value inflection points [85] - The strategic initiatives include educating on concomitant use of YUPELRI with LAMA therapy and enhancing transition of care coordination [29] - The company plans to file for approval in China in mid-2024, with potential milestone payments and royalties from YUPELRI sales [53] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future success of Theravance Biopharma, highlighting the importance of the PIFR-2 study results expected in January [27] - The company remains committed to maintaining a disciplined approach to expense management while focusing on growth opportunities [34] - Management noted that the current operating environment remains challenging, but the company is well-positioned to achieve milestone payments in 2024 and beyond [61] Other Important Information - The company is currently debt-free and has no need to access capital markets to realize the full potential of its assets [17] - The transition in R&D leadership was announced, with Rick Graham leaving the company and Ãine Miller taking over as head of development [43] Q&A Session Summary Question: Could you provide details on the ampreloxetine CYPRESS study process and expected results? - The study design includes a randomized withdrawal phase after an eight-week open-label period, with top-line results expected after data cleaning [65] Question: Can you discuss YUPELRI's hospital market share and sales dynamics? - The hospital market share increased to 16.1%, but overall sales in terms of doses were relatively flat compared to the first quarter due to seasonal factors [70][111] Question: What are the growth trends in the DME segment versus retail for YUPELRI? - The company continues to focus on ensuring that patients receive the best possible support in both DME and retail channels, although DME fulfillment trends lag due to the Medicare adjudication process [82][106]