Theravance Biopharma(US:TBPH)2025-11-12 21:16Sales Performance - YUPELRI (revefenacin) inhalation solution generated US net sales of $71.4 million in Q3 2025, a 15% increase from $62.2 million in Q3 2024[100]. - YUPELRI net sales for the three months ended September 30, 2025, were $71.4 million, a 15% increase year-over-year, and for the nine months, net sales were $196.0 million, also a 14% increase[122]. - Total revenues for the nine months ended September 30, 2025, were $61.6 million, a 35% increase compared to the prior year, driven by higher net sales of YUPELRI[125]. - TRELEGY global net sales for 2024 reached $3.46 billion, representing a 26% increase compared to 2023, and are expected to peak at approximately $4.0 billion in 2026[113]. - For the three months ended September 30, 2025, TRELEGY global net sales were $979 million, reflecting a 24% year-over-year growth, while for the nine months, sales were $2.92 billion, showing a 13% increase[113]. Milestone Payments and Royalties - The company is eligible to receive up to $205 million in potential global sales and regulatory milestone payments from Viatris, with $160 million associated with YUPELRI monotherapy[96]. - To achieve a $25 million sales milestone for YUPELRI in 2025, approximately $54 million in US net sales is required in Q4 2025[97]. - Viatris' Phase 3 study of YUPELRI in China yielded positive results, leading to regulatory approval and a $7.5 million milestone payment to the company[98]. - As of September 30, 2025, YUPELRI's cumulative net sales in the China Region could trigger additional sales milestones of up to $37.5 million[99]. - As of September 30, 2025, a total of $150.0 million in potential Milestone Payments remain available, with eligibility for $25.0 million or $50.0 million based on TRELEGY global net sales thresholds of approximately $3.06 billion and $3.41 billion, respectively[111]. - The company received a maximum $50 million milestone payment from Royalty Pharma in February 2025, based on achieving a minimum royalty amount from TRELEGY's global net sales of $3.46 billion in 2024[110]. - The company is eligible for tiered royalties on net sales of nebulized revefenacin in the China Region, with rates ranging from 14% to 20% based on sales thresholds[100]. Research and Development - Ampreloxetine is in a Phase 3 clinical study, with top-line data expected in Q1 2026, following positive results from earlier studies[106]. - Royalty Pharma invested $40 million in ampreloxetine, including a $25 million upfront payment and a $15 million payment upon the first regulatory approval[107]. Expenses and Financial Management - R&D expenses for the three months ended September 30, 2025, decreased by 12% to $8.1 million, primarily due to a reduction in external-related expenses[127]. - SG&A expenses for the three months ended September 30, 2025, were $18.3 million, a 9% increase compared to the prior year, with total SG&A expenses for the nine months at $55.1 million[131]. - Year-to-date G&A expenses (excluding SBC) increased by $2.7 million, primarily due to one-time legal costs; excluding these costs, G&A expenses were 3% lower compared to the prior year[134]. - Total SBC related to SG&A expenses was $3.5 million and $10.9 million for the three and nine months ended September 30, 2025, respectively, compared to $3.9 million and $11.8 million for the same periods in 2024[135]. - No impairment charges for long-lived assets were recognized for the three and nine months ended September 30, 2025, compared to non-cash impairment charges of $1.6 million and $4.5 million in the prior year[137]. Income and Cash Flow - A net gain of $75.1 million on realized contingent milestone and royalty assets was recognized for the nine months ended September 30, 2025, resulting from the sale of TRELEGY royalties to GSK[138]. - Interest expense for the three and nine months ended September 30, 2025, was $0.6 million and $1.9 million, respectively, representing non-cash interest expense associated with a $25.0 million funding received in July 2022[140]. - Interest and other income, net, increased by $2.7 million and $2.6 million for the three and nine months ended September 30, 2025, respectively, primarily due to increased interest income from cash and marketable securities[141]. - The provision for income tax expense for the nine months ended September 30, 2025, was $11.3 million, primarily due to the net gain on realized contingent milestone and royalty assets[144]. - As of September 30, 2025, the company had approximately $332.7 million in cash, cash equivalents, and investments in marketable securities, with no long-term debt[145]. - Net cash provided by operating activities was $244.6 million for the nine months ended September 30, 2025, driven by a net income of $44.9 million and significant cash inflows from milestone payments[149]. - Net cash used in investing activities was $105.9 million for the nine months ended September 30, 2025, primarily from the purchase and maturities of marketable securities[151]. Strategic Focus - The company remains focused on disciplined capital allocation and evaluating strategic alternatives to enhance shareholder value, as initiated by the Strategic Review Committee[115].