Theravance Biopharma(US:TBPH)2024-08-08 20:57Company Overview - Theravance Biopharma is focused on developing and commercializing medicines, with YUPELRI® (revefenacin) approved for COPD maintenance treatment in the US[67]. Sales Performance - YUPELRI net sales for the three months ended June 30, 2024, were $54.5 million, a 1% decrease from $55.0 million in the same period last year, while six-month net sales increased by 8% to $109.8 million[75]. - Theravance Biopharma's COPD market share grew, with hospitals surpassing 18% and community settings reaching 32% market share in the second quarter of 2024[75]. - TRELEGY global net sales for the six months ended June 30, 2024 were $1.81 billion, representing a 37% year-over-year growth, with total 2023 sales at $2.74 billion, a 28% increase[84]. Financial Milestones and Royalties - The company is eligible for up to $205 million in global development, regulatory, and sales milestone payments from Viatris, with $160 million related to YUPELRI monotherapy[71]. - In the China Region, Theravance Biopharma could receive tiered royalties on net sales of nebulized revefenacin, ranging from 14% to 20% based on annual sales thresholds[73]. - Royalty Pharma invested up to $40.0 million in ampreloxetine, with a $25.0 million upfront payment and a $15.0 million payment upon regulatory approval, receiving royalties of 2.5% on sales up to $500.0 million and 4.5% on sales over that amount[81]. - As of June 30, 2024, $200.0 million in potential milestone payments remain available, with eligibility for $25.0 million if TRELEGY global net sales reach approximately $2.86 billion in 2024[83]. - The royalty rates for TRELEGY are tiered from 6.5% to 10% based on annual global net sales, with specific thresholds outlined[87]. Research and Development - Ampreloxetine, an investigational drug for symptomatic neurogenic orthostatic hypotension in MSA patients, is advancing to a Phase 3 study following positive results from earlier trials[76][80]. - The REDWOOD Phase 3 study for ampreloxetine did not meet its primary endpoint, but subgroup analysis indicated benefits for MSA patients[79]. - The company anticipates the final patient enrollment for the additional Phase 3 study of ampreloxetine in mid-2025, with top-line data expected approximately six months later[80]. - R&D expenses increased by $0.5 million for the three months ended June 30, 2024, primarily due to increased employee-related and external costs related to the ampreloxetine Phase 3 study[95]. Operating Expenses - SG&A expenses for the three months ended June 30, 2024 were $9.95 million, a 6% increase compared to the prior year[98]. - Employee-related costs in SG&A increased by 16% for the three months ended June 30, 2024, while share-based compensation decreased by 38%[98]. - Total SG&A expenses for the three months ended June 30, 2024, were $17.1 million, a decrease of 12% compared to $19.3 million in the prior year[100]. - Excluding share-based compensation, total SG&A expenses for the six months ended June 30, 2024, were $25.8 million, down 13% from $29.8 million in the prior year[101]. Financial Position - As of June 30, 2024, the company had approximately $96.1 million in cash, cash equivalents, and investments in marketable securities, with no long-term debt[110]. - Net cash used in operating activities for the six months ended June 30, 2024, was $5.4 million, a decrease of 77% from $23.7 million in the prior year[112]. - Net cash provided by investing activities was $14.0 million for the six months ended June 30, 2024, compared to a net cash outflow of $32.0 million in the prior year[113]. - Net cash used in financing activities was $1.8 million for the six months ended June 30, 2024, a significant decrease from $136.9 million in the prior year[116]. Tax and Interest - The provision for income tax expense for the six months ended June 30, 2024, was $2.6 million, a significant increase of 142% from $1.1 million in the prior year[109]. - Interest expense for the three months ended June 30, 2024, was $0.6 million, representing a 13% increase compared to $0.5 million in the prior year[106]. - Interest income and other income (expense), net, decreased by 55% to $1.1 million for the three months ended June 30, 2024, compared to $2.5 million in the prior year[107].