Theravance Biopharma(US:TBPH)2024-11-14 11:06Financial Performance - YUPELRI net sales reached $62.2 million in Q3 2024, a 7% increase year-over-year, driven by a 14% rise in customer demand and market share growth to 19% in hospitals and 32% in community settings [95]. - TRELEGY global net sales for Q3 2024 were $789 million, representing a 17% year-over-year growth, and total sales for the nine months ended September 30, 2024, were $2.60 billion, reflecting a 30% increase [106]. - The company recognized $16.9 million in revenue from the Viatris collaboration agreement for Q3 2024, an 8% increase year-over-year, and $45.6 million for the nine months ended September 30, 2024, a 15% increase [121]. - As of September 30, 2024, YUPELRI's implied 35% share of net sales was $21.8 million for Q3 and $60.2 million for the nine months ended [95]. - The provision for income tax expense increased by 94% to $(2.6) million for the three months ended September 30, 2024, compared to $(1.4) million in the prior year [134]. - As of September 30, 2024, the company had approximately $91.4 million in cash, cash equivalents, and investments in marketable securities, with no long-term debt [135]. - Net cash used in operating activities was $10.6 million for the nine months ended September 30, 2024, an improvement from $26.1 million in the prior year [139]. - Net cash used in financing activities decreased significantly to $2.1 million for the nine months ended September 30, 2024, compared to $168.3 million in the prior year [144]. Research and Development - Ampreloxetine is in Phase 3 development for treating symptomatic neurogenic orthostatic hypotension in MSA patients, with the first pivotal study not meeting its primary endpoint [97][98]. - The company initiated a Phase 3 clinical study (CYPRESS) for ampreloxetine in MSA patients with symptomatic nOH in Q1 2023, with top-line data expected in mid-2025 [102]. - R&D expenses for Q3 2024 totaled $9.27 million, a 12% increase compared to the prior year, driven by external-related costs associated with the ampreloxetine Phase 3 study [124]. - R&D expenses decreased by $4.1 million for the nine months ended September 30, 2024, compared to the prior year period, primarily due to the discontinuation of investment in research activities [125]. - The company is focused on executing the ampreloxetine registration Phase 3 study and preparing for the NDA filing process [112]. Strategic Initiatives - The company has formed a Strategic Review Committee to explore strategic alternatives aimed at unlocking shareholder value [83]. - The roles of Chair of the Board and CEO have been separated to enhance corporate governance and operational focus [84]. - The company completed the sale of its 85% economic interest in TRELEGY for approximately $1.11 billion, retaining rights to future milestone payments and royalties [104]. - As of September 30, 2024, there are $200 million in potential milestone payments available, with thresholds for the next payments based on TRELEGY global net sales of $2.86 billion and $3.21 billion, representing increases of approximately 4% and 17% compared to 2023 [105]. Product Development and Market Position - The FDA approved YUPELRI in November 2018 for the maintenance treatment of COPD, with ongoing market research indicating a stable demand for nebulized delivery among COPD patients [85]. - The Phase 4 study comparing YUPELRI to Spiriva did not meet its primary endpoint, but YUPELRI maintained an efficacy and safety profile consistent with previous studies [94]. - The company retains worldwide rights to revefenacin in other dosage forms, while Viatris leads commercialization efforts in the US [88]. - In the China Region, the company could receive tiered royalties on net sales of nebulized revefenacin, ranging from 14% to 20% based on annual sales thresholds [93]. - Royalty Pharma invested up to $40 million in ampreloxetine, including a $25 million upfront payment and a $15 million payment upon regulatory approval, with future royalties of 2.5% on sales up to $500 million and 4.5% on sales over that threshold [103]. - The company anticipates TRELEGY to generate global peak sales of $4 billion in 2026 according to Bloomberg consensus estimates [106]. Expenses and Financial Management - Total SG&A expenses were $16.9 million for the three months ended September 30, 2024, representing a 5% increase from $16.1 million in the prior year period [126]. - Excluding share-based compensation, total SG&A expenses for the nine months ended September 30, 2024, were $38.8 million, down from $41.7 million in the prior year, reflecting a 7% reduction [127]. - Non-cash impairment charges of $1.6 million and $4.5 million were recognized for the three and nine months ended September 30, 2024, respectively, related to vacant laboratory space [130]. - Interest expense was $0.6 million and $1.9 million for the three and nine months ended September 30, 2024, respectively, primarily due to non-cash interest associated with $25.0 million received from Royalty Pharma [132]. - Interest and other income decreased by $0.4 million and $3.3 million for the three and nine months ended September 30, 2024, respectively, due to reduced interest income from cash and marketable securities [133]. Upcoming Events - The company will hold its 2025 Annual General Meeting of Shareholders on May 19, 2025, in Dublin, Ireland [113].